As filed with the Securities and Exchange Commission on May 12, 2025

No. 333-285035​

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

AMENDMENT NO. 3
to

FORM S-4

REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

GLYCOMIMETICS, INC.​

(Exact name of registrant as specified in its charter)​

P.O. Box 65
Monrovia, Maryland 21770
(240) 243-1201

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)​

Brian Hahn
Principal Executive and Financial Officer
GlycoMimetics, Inc.
P.O. Box 65
Monrovia, Maryland 21770
(240) 243-1201

(Name, address, including zip code, and telephone number, including area code, of agent for service)​

Copies of all communications, including communications sent to agent for service, should be sent to:

Approximate date of commencement of proposed sale of the securities to the public: As soon as practicable after the effective date of this registration statement and the satisfaction or waiver of all other conditions under the Merger Agreement described herein.

If the securities being registered on this Form are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box  ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

GlycoMimetics, Inc.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act.  ☐

If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:

Exchange Act Rule 13e-4(i) (Cross-Border Issuer Tender Offer)  ☐

Exchange Act Rule 14d-1(d) (Cross-Border Third-Party Tender Offer)  ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary proxy statement/prospectus is not complete and may be changed. GlycoMimetics, Inc. may not sell the securities described in this preliminary proxy statement/prospectus until the registration statement filed with the Securities and Exchange Commission is effective. This preliminary proxy statement/prospectus is not an offer to sell and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARY PROXY STATEMENT/PROSPECTUS
SUBJECT TO COMPLETION, DATED MAY 12, 2025

PROPOSED MERGER
YOUR VOTE IS VERY IMPORTANT

To the Stockholders of GlycoMimetics, Inc. and Crescent Biopharma, Inc.,

GlycoMimetics, Inc., a Delaware corporation (“GlycoMimetics”), and Crescent Biopharma, Inc., a Delaware corporation (“Crescent”), entered into an Agreement and Plan of Merger and Reorganization on October 28, 2024, which agreement was subsequently amended on February 14, 2025 and April 28, 2025 (as amended, the “Merger Agreement”), pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, Gemini Merger Sub Corp., a Delaware corporation (“First Merger Sub”), will merge with and into Crescent, with Crescent continuing as a wholly owned subsidiary of GlycoMimetics and the surviving corporation of the merger (the “First Merger”), and Crescent will merge with and into Gemini Merger Sub II, LLC, a Delaware limited liability company (“Second Merger Sub” and together with First Merger Sub, “Merger Subs”), with Second Merger Sub being the surviving entity of the merger (the “Second Merger” and, together with the First Merger, the “Merger”). After the completion of the Merger, Second Merger Sub will change its corporate name to “Crescent Biopharma Operating Company, LLC” and GlycoMimetics will change its name to “Crescent Biopharma, Inc.” The term “Combined Company” when used in the accompanying proxy statement/​prospectus refers to the post-Merger corporate structure including Crescent Biopharma, Inc. (f/k/a GlycoMimetics, Inc.) as the parent entity and Crescent Biopharma Operating Company, LLC as its wholly-owned subsidiary.

At the closing of the First Merger (the “First Effective Time”), upon the terms and subject to the conditions set forth in the Merger Agreement: (i) each then-outstanding share of Crescent common stock (including shares of Crescent common stock issued in the Crescent Pre-Closing Financing (as defined below) and excluding shares to be canceled pursuant to the Merger Agreement and excluding dissenting shares) will be automatically converted solely into the right to receive a number of shares of GlycoMimetics common stock equal to the Exchange Ratio as described in more detail in the section titled “The Merger Agreement —​Exchange Ratio” beginning on page 158 of the accompanying proxy statement/prospectus (the “Exchange Ratio”); (ii) each then-outstanding share of Crescent preferred stock will be converted into the right to receive a number of shares of GlycoMimetics Series A non-voting convertible preferred stock, par value $0.001 per share (“GlycoMimetics Series A Preferred Stock”), equal to the Exchange Ratio divided by 1,000; (iii) each then-outstanding option to purchase Crescent common stock will be assumed by GlycoMimetics, subject to adjustment as set forth in the Merger Agreement and described in more detail in the section titled “The Merger Agreement — Crescent Options” beginning on page 161 of the accompanying proxy statement/​prospectus; (iv) each then-outstanding Crescent restricted stock unit will be assumed by GlycoMimetics, subject to adjustment as set forth in the Merger Agreement and described in more detail in the section titled “The Merger Agreement — Crescent Restricted Stock Units” beginning on page 162 of the accompanying proxy statement/prospectus; (v) each then-outstanding pre-funded warrant to purchase shares of Crescent common stock will be converted into a pre-funded warrant to purchase shares of GlycoMimetics common stock, subject to adjustment as set forth in the Merger Agreement and described in more detail in the section titled “The Merger Agreement — Crescent Warrants” beginning on page 162 of the accompanying proxy statement/prospectus; (vi) each in-the-money option to acquire shares of GlycoMimetics common stock (the “GlycoMimetics In the Money Option”) that is issued and outstanding (whether vested or unvested) will be cancelled and converted into the right to receive a number of shares of GlycoMimetics common stock equal to the number of shares underlying such option; (vii) each GlycoMimetics restricted stock unit will be cancelled and converted into the right to receive a number of shares of GlycoMimetics common stock equal to the number of unsettled shares of GlycoMimetics common stock underlying such GlycoMimetics

restricted stock unit; and (viii) each share of GlycoMimetics common stock that is issued and outstanding at the First Effective Time will remain issued and outstanding in accordance with its terms and such shares, subject to the proposed reverse stock split, and will be unaffected by the Merger.

Based on GlycoMimetics’ and Crescent’s capitalization as of May 3, 2025 and taking into account GlycoMimetics’ current cash position, each share of Crescent common stock is currently estimated to be entitled to receive approximately 15.4192 shares of GlycoMimetics common stock. Each share of Crescent preferred stock will be converted into the right to receive a number of shares of GlycoMimetics Series A Preferred Stock, equal to the Exchange Ratio divided by 1,000. This estimated Exchange Ratio does not give effect to the proposed GlycoMimetics reverse stock split and is subject to adjustment based on GlycoMimetics’ estimated net cash at the closing of the First Merger as described in more detail in the section titled “The Merger Agreement — Exchange Ratio” beginning on page 158 of the accompanying proxy statement/prospectus.

In connection with the Merger, on February 14, 2025, Crescent and GlycoMimetics entered into an amended and restated subscription agreement (the “Subscription Agreement”) with certain institutional and accredited investors for the purchase of shares of Crescent common stock and Crescent pre-funded warrants for an aggregate purchase price of approximately $200.0 million (which includes $37.5 million of proceeds previously received by Crescent from the issuance of its convertible notes in October 2024 (the “Convertible Notes”) and accrued interest on such note), immediately prior to the closing of the Merger (referred to herein as the “Crescent Pre-Closing Financing”). The shares of Crescent common stock and Crescent pre-funded warrants that are issued in the Crescent Pre-Closing Financing will be converted into the right to receive a number of shares of GlycoMimetics common stock and pre-funded warrants to purchase shares of GlycoMimetics common stock, respectively, equal to the Exchange Ratio described in more detail in the section titled “The Merger Agreement — Exchange Ratio” beginning on page 158 of the accompanying proxy statement/prospectus. Crescent and the investors participating in the Crescent Pre-Closing Financing have also agreed to enter into a registration rights agreement (the “Registration Rights Agreement”) at the closing of the Crescent Pre-Closing Financing, pursuant to which, among other things, the Combined Company will agree to provide for the registration and resale of certain shares of Crescent common stock that are held by the investors participating in the Crescent Pre-Closing Financing from time to time pursuant to Rule 415 under the Securities Act (“Rule 415”). The Crescent Pre-Closing Financing is more fully described in the sections titled “Agreements Related to the Merger — Subscription Agreement” and “Agreements Related to the Merger — Registration Rights Agreement” beginning on pages 176 and 178, respectively, of the accompanying proxy statement/prospectus.

In connection with the Merger (based on GlycoMimetics’ and Crescent’s capitalization as of May 3, 2025, the estimated Exchange Ratio as described in the accompanying proxy statement/prospectus, and without giving effect to the proposed GlycoMimetics reverse stock split or dilution from any equity issued by Crescent after the date of the Merger Agreement and before the closing), GlycoMimetics is expected to issue approximately 1,430,841,779 shares of GlycoMimetics common stock, pre-funded warrants to purchase 278,010,526 shares of GlycoMimetics common stock, and 308,384 shares of GlycoMimetics Series A Preferred Stock, options to purchase 359,204,314 shares of GlycoMimetics common stock, and 46,779,077 GlycoMimetics restricted stock units. This registration statement/proxy relates to the offering and registration of such securities, as well as 278,010,526 shares of GlycoMimetics common stock reserved for issuance upon exercise of such pre-funded warrants, 308,384,000 shares of GlycoMimetics common stock reserved for issuance upon conversion of such GlycoMimetics Series A Preferred Stock, 359,204,314 shares of GlycoMimetics common stock reserved for issuance upon conversion of such GlycoMimetics stock options, and 46,779,077 shares of GlycoMimetics common stock reserved for issuance upon settlement of such GlycoMimetics restricted stock units (in each case, in the amounts actually issued or reserved for issuance in connection with the Merger).

Immediately after the Merger, based on the estimated Exchange Ratio as described in the accompanying proxy statement/prospectus, GlycoMimetics securityholders as of immediately prior to the Merger are expected to own approximately 2.6% of the outstanding shares of capital stock of the Combined Company (on a fully-diluted basis, and subject to dilution from any equity issued by Crescent after May 3, 2025 and before the closing), and former holders of Crescent securities (including those issued in the Crescent Pre-Closing Financing) are expected to own approximately 97.4% of the outstanding shares of capital stock of the Combined Company (on a fully-diluted basis), subject to certain assumptions, including, but not limited to, GlycoMimetics’ net cash as of closing being equal to $1.8 million. Under certain circumstances described in more detail in the section titled “The Merger Agreement — Exchange Ratio” beginning on page 158 of the accompanying proxy statement/prospectus, the ownership percentages may be adjusted up or down

including, but not limited to, if GlycoMimetics’ net cash as of closing is less than $1.725 million or more than $1.875 million. GlycoMimetics currently estimates that its net cash as of closing will be approximately $1.8 million, and the currently estimated ownership percentages reflect this projection.

Shares of GlycoMimetics common stock are currently listed on Nasdaq under the symbol “GLYC.” GlycoMimetics is not currently in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market and has until June 16, 2025 to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). GlycoMimetics plans to file an initial listing application for the Combined Company with Nasdaq. After completion of the Merger, GlycoMimetics will be renamed “Crescent Biopharma, Inc.” and it is expected that the common stock of the Combined Company will trade on Nasdaq under the symbol “CBIO.” It is a condition to the consummation of the Merger that GlycoMimetics will receive confirmation from Nasdaq that the Combined Company has been approved for listing on Nasdaq, but there can be no assurance such listing condition will be met or that GlycoMimetics will obtain such confirmation from Nasdaq. If such listing condition is not met or if such confirmation is not obtained, the Merger will not be consummated unless the condition is waived. The Nasdaq condition set forth in the Merger Agreement is not expected to be waived by the applicable parties. However, in the event that the shares of GlycoMimetics common stock to be issued in the Merger are not approved for listing on Nasdaq, it is possible that GlycoMimetics and Crescent may mutually agree to waive the applicable condition and nonetheless proceed with completion of the Merger. If such condition is waived, GlycoMimetics will not recirculate an updated proxy statement/prospectus, nor will it solicit a new vote of stockholders prior to proceeding with the Merger. Accordingly, you are advised that GlycoMimetics stockholders will not have certainty regarding the listing of the Combined Company’s shares at the time you are asked to vote at the special meeting described below. On May 9, 2025, the last trading day before the date of the accompanying proxy statement/prospectus, the closing sale price of GlycoMimetics common stock was $0.2402 per share.

GlycoMimetics stockholders are cordially invited to attend the special meeting in lieu of the annual meeting of GlycoMimetics stockholders. GlycoMimetics is holding its special meeting in lieu of the annual meeting of stockholders (the “GlycoMimetics Special Meeting”) on June 5, 2025, at 9:00 a.m. Eastern Time, unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the Merger and related matters. At the GlycoMimetics Special Meeting, GlycoMimetics will ask its stockholders to:

1.

Approve (i) the issuance of shares of GlycoMimetics common stock (including the shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock), which will represent more than 20% of the shares of GlycoMimetics common stock outstanding immediately prior to the Merger, to stockholders of Crescent, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A, including the amendments thereto, to the accompanying proxy statement/prospectus, and (ii) the change of control of GlycoMimetics resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively (the “Nasdaq Stock Issuance Proposal” or “Proposal No. 1”);

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2.

Approve an amendment to the amended and restated certificate of incorporation of GlycoMimetics, as amended (the “GlycoMimetics Charter”), to increase the number of shares of GlycoMimetics common stock that GlycoMimetics is authorized to issue from 150,000,000 shares to 175,000,000, in the form attached as Annex G to the accompanying proxy statement/prospectus (the “Authorized Share Increase Proposal” or “Proposal No. 2”);

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3.

Approve an amendment to the GlycoMimetics Charter to effect a reverse stock split of GlycoMimetics’ issued and outstanding common stock at a ratio in the range between 70:1 to 110:1, inclusive, in the form attached as Annex H to the accompanying proxy statement/prospectus, with the final ratio and effectiveness of such amendment and the abandonment of such amendment to be mutually agreed by the GlycoMimetics board of directors (the “GlycoMimetics Board”) and the Crescent board of directors (the “Crescent Board”) prior to the First Effective Time or, if the Nasdaq Stock Issuance Proposal is not approved by GlycoMimetics stockholders, determined solely by the GlycoMimetics Board (the “Reverse Stock Split Proposal” or “Proposal No. 3”);

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4.

Approve (A) the redomestication of GlycoMimetics from the State of Delaware to the Cayman Islands by conversion (“Proposal No. 4A”) and (B)(i) the redomestication of GlycoMimetics from the State of Delaware to the Cayman Islands by way of continuation and (ii) the adoption of the memorandum and articles of association of the Combined Company (the “Cayman Articles”),

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substantially in the form attached as Annex J to this proxy statement/prospectus (“Proposal No. 4B” and together with Proposal No. 4A, the “Redomestication Proposal” or “Proposal No. 4”);

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5.

Elect Patricia Andrews to the GlycoMimetics Board and to hold office until GlycoMimetics’ annual meeting of stockholders in 2028, and until her successor has been duly elected and qualified, or until her earlier death, resignation or removal (the “Director Election Proposal” or “Proposal No. 5”), provided that if the Merger is consummated, the approval of Proposal No. 5 will only have an effect until the completion of the Merger because the composition of the GlycoMimetics Board will be reconstituted upon completion of the Merger, in accordance with the Merger Agreement;

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6.

Ratify the appointment of Ernst & Young LLP as GlycoMimetics’ independent registered public accounting firm for fiscal year ending December 31, 2025, provided that PricewaterhouseCoopers LLP is expected to be appointed for that fiscal year if the Merger is completed, as the Combined Company’s independent registered public accounting firm (the “Auditor Ratification Proposal” or “Proposal No. 6”);

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7.

Approve the Crescent Biopharma, Inc. 2025 Stock Incentive Plan (the “Stock Plan Proposal” or “Proposal No. 7”);

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8.

Approve the Crescent Biopharma, Inc. 2025 Employee Stock Purchase Plan (the “ESPP Proposal” or “Proposal No. 8”);

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9.

Approve, on an advisory basis, certain compensation arrangements for GlycoMimetics’ named executive officers that are based on or otherwise relate to the Merger (the “Merger Compensation Proposal” or “Proposal No. 9”);

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10.

Approve, on an advisory basis, the compensation of GlycoMimetics’ named executive officers (the “Say-on-Pay Proposal” or “Proposal No. 10”);

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11.

Approve an adjournment of the GlycoMimetics Special Meeting, if necessary, to solicit additional proxies if there is not a sufficient number of votes in favor of the Nasdaq Stock Issuance Proposal, the Authorized Share Increase Proposal and/or the Reverse Stock Split Proposal (the “Adjournment Proposal” or “Proposal No. 11”); and

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12.

Transact such other business as may properly come before the stockholders at the GlycoMimetics Special Meeting or any adjournment or postponement thereof.

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As described in the accompanying proxy statement/prospectus, current and certain former directors and officers of GlycoMimetics who in the aggregate owned approximately 1.7% of the outstanding shares of GlycoMimetics common stock as of May 3, 2025, and certain Crescent stockholders who in the aggregate owned approximately 98.4% of the outstanding shares of Crescent capital stock as of May 3, 2025, are parties to stockholder support agreements with GlycoMimetics and Crescent, respectively, whereby such stockholders have agreed to vote in favor of the adoption of the Merger Agreement and the approval of the Merger and related transactions contemplated by the Merger Agreement, subject to the terms of the support agreements. Following the effectiveness of the registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part and pursuant to the Merger Agreement, Crescent stockholders holding a sufficient number of shares of Crescent capital stock to adopt the Merger Agreement and approve the Merger and related transactions will be asked to execute written consents providing for such adoption and approval.

While the Combined Company will not be considered a “controlled company” under the relevant listing rules of Nasdaq, it is anticipated that the Combined Company executive officers, directors and principal stockholders will, in the aggregate, beneficially own approximately 40.8% of the Combined Company’s outstanding shares of common stock (on a fully-diluted basis). As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to the Combined Company stockholders for approval, as well as the Combined Company’s management and affairs, though they have no agreement to do so nor any expectation of entering into such an agreement.

After careful consideration, each of the GlycoMimetics and the Crescent boards of directors has approved the Merger Agreement and has determined that it is advisable to consummate the Merger. The GlycoMimetics Board has approved the proposals described in the accompanying proxy statement/prospectus and recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.

More information about GlycoMimetics, Crescent, the Merger Agreement and transactions contemplated thereby and the foregoing proposals is contained in the accompanying proxy statement/prospectus. GlycoMimetics urges you to read the accompanying proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 19 OF THE ACCOMPANYING PROXY STATEMENT/​PROSPECTUS.

GlycoMimetics and Crescent are excited about the opportunities the Merger brings to GlycoMimetics’ and Crescent’s stockholders and thank you for your consideration and continued support.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of the accompanying proxy statement/​prospectus. Any representation to the contrary is a criminal offense.

The accompanying proxy statement/prospectus is dated May 12, 2025, and is first being mailed to GlycoMimetics’ stockholders on or about May 14, 2025.

 

GLYCOMIMETICS, INC.
P.O. Box 65
Monrovia, MD 21770

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS IN LIEU OF ANNUAL MEETING OF STOCKHOLDERS

To the stockholders of GlycoMimetics, Inc.:

NOTICE IS HEREBY GIVEN that a virtual special meeting in lieu of annual meeting of stockholders (the “GlycoMimetics Special Meeting”) will be held on Thursday, June 5, 2025 at 9:00 a.m. Eastern Time, unless postponed or adjourned to a later date. The GlycoMimetics Special Meeting will be held exclusively online. You will be able to attend and participate in the GlycoMimetics Special Meeting online by visiting www.virtualshareholdermeeting.com/GLYC2025SM, where you will be able to listen to the meeting live, submit questions and vote.

The GlycoMimetics Special Meeting will be held for the following purposes:

1.

To approve (i) the issuance of shares of GlycoMimetics common stock (including the shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock), which will represent more than 20% of the shares of GlycoMimetics common stock outstanding immediately prior to the Merger, to stockholders of Crescent, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A, including the amendments thereto, to the accompanying proxy statement/prospectus, and (ii) the change of control of GlycoMimetics resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively;

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2.

To approve an amendment to the amended and restated certificate of incorporation of GlycoMimetics, as amended (the “GlycoMimetics Charter”), to increase the number of shares of GlycoMimetics common stock that GlycoMimetics is authorized from 150,000,000 to issue to 175,000,000, in the form attached as Annex G to the accompanying proxy statement/prospectus;

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3.

To approve an amendment to the GlycoMimetics Charter to effect a reverse stock split of GlycoMimetics’ issued and outstanding common stock at a ratio in the range between 70:1 to 110:1, inclusive, in the form attached as Annex H to the accompanying proxy statement/prospectus, with the final ratio and effectiveness of such amendment and the abandonment of such amendment to be mutually agreed by the GlycoMimetics Board and the Crescent Board prior to the First Effective Time or, if the Nasdaq Stock Issuance Proposal is not approved by GlycoMimetics stockholders, determined solely by the GlycoMimetics Board;

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4.

To approve (A) the redomestication of GlycoMimetics from the State of Delaware to the Cayman Islands by conversion and (B)(i) the redomestication of GlycoMimetics from the State of Delaware to the Cayman Islands by way of continuation and (ii) and, as a special resolution for the purposes of Cayman Islands law, the adoption of the memorandum and articles of association of the Combined Company (the “Cayman Articles”), substantially in the form attached as Annex J to this proxy statement/prospectus;

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5.

To elect Patricia Andrews to the GlycoMimetics Board and to hold office until GlycoMimetics’ annual meeting of stockholders in 2028, and until her successor has been duly elected and qualified, or until her earlier death, resignation or removal, provided that if the Merger is consummated, the approval of Proposal No. 5 will only have an effect until the completion of the Merger because the composition of the GlycoMimetics Board will be reconstituted upon completion of the Merger, in accordance with the Merger Agreement;

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6.

To ratify the appointment of Ernst & Young LLP as GlycoMimetics’ independent registered public accounting firm for fiscal year ending December 31, 2025, provided that PricewaterhouseCoopers LLP is expected to be appointed for that fiscal year if the Merger is completed as the Combined Company’s independent registered public accounting firm;

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7.

To approve the Crescent Biopharma, Inc. 2025 Stock Incentive Plan;

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8.

To approve the Crescent Biopharma, Inc. 2025 Employee Stock Purchase Plan;

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9.

To approve, on an advisory basis, certain compensation arrangements for GlycoMimetics’ named executive officers that are based on or otherwise relate to the Merger;

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10.

To approve, on an advisory basis, the compensation of GlycoMimetics’ named executive officers;

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11.

To approve an adjournment of the GlycoMimetics Special Meeting, if necessary, to solicit additional proxies if there is not a sufficient number of votes in favor of the Nasdaq Stock Issuance Proposal, the Authorized Share Increase Proposal and/or the Reverse Stock Split Proposal; and

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12.

To transact such other business as may properly come before the stockholders at the GlycoMimetics Special Meeting or any adjournment or postponement thereof.

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These proposals are collectively referred to as the “Proposals.”

The GlycoMimetics Board has fixed May 13, 2025 as the record date (the “Record Date”) for the determination of stockholders entitled to notice of, and to vote at, the GlycoMimetics Special Meeting and any adjournment or postponement thereof. Only holders of record of shares of GlycoMimetics common stock at the close of business on the Record Date are entitled to notice of, and to vote at, the GlycoMimetics Special Meeting. At the close of business on May 3, 2025, GlycoMimetics had 64,532,091 shares of common stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of a majority of the shares of GlycoMimetics common stock entitled to vote on the subject matter and present at the GlycoMimetics Special Meeting, assuming a quorum is present, is required for approval of Proposal No. 1, Proposal No. 6, Proposal No. 7, Proposal No. 8, Proposal No. 9, Proposal No. 10 and Proposal No. 11. The affirmative vote of a majority of the votes properly cast by the holders of GlycoMimetics common stock in person or represented by proxy at the GlycoMimetics Special Meeting, assuming a quorum is present, is required for approval of Proposal No. 2 and Proposal No. 3. The affirmative vote of a majority of the outstanding shares of GlycoMimetics common stock entitled to vote thereon is required for approval of Proposal No 4A. The affirmative vote of not less than two-thirds of the votes properly cast by the holders of GlycoMimetics common stock in person or represented by proxy at the GlycoMimetics Special Meeting, assuming a quorum is present, is required for approval of Proposal No. 4B. With respect to Proposal No. 5, the director is elected by a plurality of the votes properly cast at the GlycoMimetics Special Meeting, and the director nominee receiving the highest numbers of affirmative votes properly cast will be elected. Approval of each of Proposal No. 1, Proposal No. 2 and Proposal No. 3 is a condition to the completion of the Merger. Therefore, the Merger cannot be consummated without the approval of Proposal Nos. 1, 2 and 3.

All stockholders are cordially invited to attend the special meeting. Even if you plan to attend the GlycoMimetics Special Meeting, GlycoMimetics requests that you sign and return the enclosed proxy or vote by mail or online to ensure that your shares will be represented at the GlycoMimetics Special Meeting if you are unable to attend. You may change or revoke your proxy at any time before it is voted at the GlycoMimetics Special Meeting.

THE GLYCOMIMETICS BOARD HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS FAIR TO, IN THE BEST INTERESTS OF, AND ADVISABLE TO GLYCOMIMETICS AND ITS STOCKHOLDERS AND HAS APPROVED EACH SUCH PROPOSAL. THE GLYCOMIMETICS BOARD RECOMMENDS THAT GLYCOMIMETICS STOCKHOLDERS VOTE “FOR” EACH SUCH PROPOSAL.

Important Notice Regarding the Availability of Proxy Materials for the Stockholders’ Meeting to Be Held on June 5, 2025 at 9:00 a.m. Eastern Time.

The proxy statement/prospectus, which also serves as the annual report to stockholders in connection with the special meeting in lieu of annual meeting, is available at www.glycomimetics.com.

By Order of the GlycoMimetics Board of Directors,

Brian Hahn
Principal Executive and Financial Officer
May 12, 2025

 

 

EXPLANATORY NOTE

The issuances of (i) all shares of GlycoMimetics common stock in exchange for each share of Crescent common stock (including shares of Crescent common stock issued in the Crescent Pre-Closing Financing), (ii) all pre-funded warrants to purchase GlycoMimetics common stock in exchange for pre-funded warrants to purchase Crescent common stock (including pre-funded warrants issued in the Crescent Pre-Closing Financing), (iii) all shares of GlycoMimetics Series A Preferred Stock in exchange for shares of Crescent Series Seed Convertible Preferred Stock, par value $0.0001 per share (“Crescent Preferred Stock”), (iv) all options to purchase shares of GlycoMimetics common stock in exchange for options to purchase shares of Crescent common stock, (v) all GlycoMimetics restricted stock units in exchange for Crescent restricted stock units, (vi) all shares of GlycoMimetics common stock issuable upon exercise of pre-funded warrants to purchase shares of GlycoMimetics common stock issued in exchange for pre-funded warrants to purchase shares of Crescent common stock, (vii) all shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock issued in exchange for Crescent Preferred Stock, (viii) all shares of GlycoMimetics common stock issuable upon exercise of options to purchase shares of GlycoMimetics common stock issued in exchange for options to purchase shares of Crescent common stock, and (ix) all shares of GlycoMimetics common stock issuable upon settlement of GlycoMimetics restricted stock units issued in exchange for Crescent restricted stock units, are intended to be covered by this registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part. There is no difference between the shares of GlycoMimetics common stock that will be issued in exchange for each share of Crescent common stock issued in the Crescent Pre-Closing Financing, the shares of GlycoMimetics common stock that will be issued in exchange for each other share of Crescent common stock, the shares of GlycoMimetics common stock that will be issuable upon the exercise of GlycoMimetics pre-funded warrants issued in exchange for Crescent pre-funded warrants, the shares of GlycoMimetics common stock that will be issuable upon conversion of GlycoMimetics Series A Preferred Stock issued in exchange for each share of Crescent Preferred Stock, the shares of GlycoMimetics common stock that will be issuable upon the exercise of GlycoMimetics options issued in exchange for Crescent options, and the shares of GlycoMimetics common stock that will be issuable upon the settlement of restricted stock units that will be issued in exchange for Crescent restricted stock units.

 

 

REFERENCES TO ADDITIONAL INFORMATION

The accompanying proxy statement/prospectus incorporates important business and financial information about GlycoMimetics, Inc. that is not included in or delivered with this document. You may obtain this information without charge through the Securities and Exchange Commission (“SEC”) website (www.sec.gov) or upon your written or oral request by contacting P.O. Box 65, Monrovia, MD 21770, Attention: Principal Executive and Financial Officer, or by calling (240) 243-1201. GlycoMimetics also maintains a website at www.glycomimetics.com, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. However, the information contained in or accessible through GlycoMimetics’ website is not part of the accompanying proxy statement/prospectus or the registration statement of which the accompanying proxy statement/​prospectus forms a part.

To ensure timely delivery of these documents, any request should be made no later than May 22, 2025 to receive them before the GlycoMimetics Special Meeting.

For additional details about where you can find information about GlycoMimetics, please see the section titled “Where You Can Find More Information” beginning on page 401 of the accompanying proxy statement/prospectus.

 

 

TABLE OF CONTENTS

 

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QUESTIONS AND ANSWERS ABOUT THE MERGER

Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus does not give effect to the proposed reverse stock split described in Proposal No. 3 of this proxy statement/prospectus.

All references to Crescent’s “product candidates,” “programs,” “portfolio” and “pipeline” in this proxy statement/prospectus refer to the research programs with respect to which Crescent has the option to acquire intellectual property license rights pursuant to each of that certain (i) Antibody Discovery and Option Agreement, dated September 19, 2024 (the “Antibody Paragon Option Agreement”), and (ii) Amended and Restated ADC Discovery and Option Agreement, dated April 28, 2025 (the “ADC Paragon Option Agreement,” and together with the Antibody Paragon Option Agreement, the “Paragon Option Agreements”), each by and among Crescent, Paragon Therapeutics, Inc. (“Paragon”) and Parascent Holding LLC (“Parascent”). As of the date of this proxy statement/ prospectus, Crescent has exercised the option and entered into a license agreement for CR-001, but it has not exercised the option or entered into a license agreement for CR-002 or CR-003, nor does it expect to do so prior to the time that this registration statement on Form S-4 is declared effective by the SEC.

The following section provides answers to frequently asked questions about the Merger. This section, however, provides only summary information. For a more complete response to these questions and for additional information, please refer to the cross-referenced sections.

Q:

What is the Merger?

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A:

On October 28, 2024, GlycoMimetics, Crescent, First Merger Sub and Second Merger Sub entered into the Merger Agreement, which agreement was subsequently amended on February 14, 2025 and April 28, 2025. A copy of the Merger Agreement is attached as Annex A, including the amendments thereto. The Merger Agreement contains the terms and conditions of the proposed Merger. Pursuant to the Merger Agreement, First Merger Sub will merge with and into Crescent, with Crescent continuing as a wholly owned subsidiary of GlycoMimetics and the surviving corporation of the First Merger. Crescent will then merge with and into Second Merger Sub, with Second Merger Sub being the surviving entity of the Second Merger. This entire transaction is referred to in this proxy statement/prospectus as the Merger. In connection with the Merger, GlycoMimetics will change its corporate name to “Crescent Biopharma, Inc.”

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At the First Effective Time, upon the terms and subject to the conditions set forth in the Merger Agreement, (i) each then-outstanding share of Crescent common stock (including shares of Crescent common stock issued in the Crescent Pre-Closing Financing) (excluding shares to be canceled pursuant to the Merger Agreement and excluding dissenting shares) will be automatically converted solely into the right to receive a number of shares of GlycoMimetics common stock equal to the Exchange Ratio (described in more detail in the section titled “The Merger Agreement — Exchange Ratio” beginning on page 158 of this proxy statement/prospectus), (ii) each then-outstanding share of Crescent preferred stock will be converted into the right to receive a number of shares of GlycoMimetics Series A Preferred Stock equal to the Exchange Ratio divided by 1,000, in accordance with the terms of the Merger Agreement, (iii) each then-outstanding option to purchase Crescent common stock will be assumed by GlycoMimetics, subject to adjustment as set forth in the Merger Agreement, (iv) each then-outstanding Crescent restricted stock unit will be assumed by GlycoMimetics, subject to adjustment as set forth in the Merger Agreement, (v) each then-outstanding pre-funded warrant to purchase shares of Crescent common stock will be converted into a pre-funded warrant to purchase shares of GlycoMimetics common stock, subject to adjustment as set forth in the Merger Agreement and the form of warrant, (vi) each in-the-money option to acquire shares of GlycoMimetics common stock that is issued and outstanding (whether vested or unvested) will be cancelled and converted into the right to receive immediately prior to the First Effective Time a number of shares of GlycoMimetics common stock equal to the number of shares underlying such option, and (vii) each GlycoMimetics restricted stock unit will be cancelled and converted into the right to receive a number of shares of GlycoMimetics common stock equal to the number of unsettled shares of GlycoMimetics common stock underlying such GlycoMimetics restricted stock unit. Each share of GlycoMimetics common stock that is issued

 

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and outstanding at the First Effective Time will remain issued and outstanding in accordance with its terms and such shares, subject to the proposed reverse stock split, will be unaffected by the Merger.

In connection with the Merger (based on GlycoMimetics’ and Crescent’s capitalization as of May 3, 2025, the estimated Exchange Ratio as described in the accompanying proxy statement/prospectus, and without giving effect to the proposed GlycoMimetics reverse stock split or dilution from any equity issued by Crescent after the date of the Merger Agreement and before the closing), GlycoMimetics is expected to issue approximately 1,430,841,779 shares of GlycoMimetics common stock, pre-funded warrants to purchase 278,010,526 shares of GlycoMimetics common stock, 308,384 shares of GlycoMimetics Series A Preferred Stock, options to purchase 359,204,314 shares of GlycoMimetics common stock, and 46,779,077 GlycoMimetics restricted stock units. Additionally, it is expected there will be 278,010,526 shares of GlycoMimetics common stock reserved for issuance upon exercise of such pre-funded warrants to purchase shares of GlycoMimetics common stock, and 308,384,000 shares of GlycoMimetics common stock reserved for issuance upon conversion of such GlycoMimetics Series A Preferred Stock, 359,204,314 shares of GlycoMimetics common stock reserved for issuance upon conversion of such GlycoMimetics stock options, and 46,779,077 shares of GlycoMimetics common stock reserved for issuance upon settlement of such GlycoMimetics restricted stock units (in each case, in the amounts actually issued or reserved for issuance in connection with the Merger).

Immediately after the Merger and prior to closing of the Crescent Pre-Closing Financing, based solely on the estimated Exchange Ratio as described in this proxy statement/prospectus, GlycoMimetics securityholders as of immediately prior to the Merger are expected to own approximately 2.6% of the outstanding shares of capital stock of the Combined Company (on a fully-diluted basis, and subject to dilution from any equity issued by Crescent after May 3, 2025 and before the closing), and former holders of Crescent securities (including those issued in the Crescent Pre-Closing Financing) are expected to own approximately 97.4% of the outstanding shares of capital stock of the Combined Company (on a fully-diluted basis), subject to certain assumptions, including, but not limited to, GlycoMimetics’ net cash as of closing being equal to $1.8 million. Under certain circumstances described in more detail in the section titled “The Merger Agreement — Exchange Ratio” beginning on page 158 of this proxy statement/prospectus, the ownership percentages may be adjusted up or down including, but not limited to, if GlycoMimetics’ net cash as of closing is less than $1.725 million or more than $1.875 million. GlycoMimetics currently estimates that its net cash as of closing will be approximately $1.8 million, and the currently estimated ownership percentages reflect this projection.

Q:

Why are the two companies proposing to merge?

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A:

GlycoMimetics and Crescent believe that combining the two companies will result in a company with a promising pipeline, a strong leadership team and substantial capital resources, focused on developing novel biologics designed to set a new standard for the treatment of solid tumors. For a more complete description of the reasons for the Merger, please see the sections titled “The Merger — GlycoMimetics’ Reasons for the Merger” and “The Merger — Crescent’s Reasons for the Merger” beginning on pages 126 and 130, respectively, of this proxy statement/prospectus.

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Q:

What will happen to GlycoMimetics if, for any reason, the Merger with Crescent does not close?

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A:

GlycoMimetics has invested significant time and incurred, and expects to continue to incur, significant expenses related to the proposed Merger with Crescent. In the event the Merger does not close, GlycoMimetics will have a limited ability to continue its current operations without obtaining additional financing. Although the GlycoMimetics Board may elect, among other things, to attempt to complete another strategic transaction if the Merger with Crescent does not close, the GlycoMimetics Board may instead divest all or a portion of GlycoMimetics’ business or take steps necessary to liquidate or dissolve GlycoMimetics’ business and assets if a viable alternative strategic transaction is not available. If GlycoMimetics decides to dissolve and liquidate its assets, GlycoMimetics would be required to pay all of its contractual obligations, and to set aside certain reserves for potential future claims, and there can be no assurance as to the amount of and the timing of such liquidation and distribution of available cash left to distribute to stockholders after paying the obligations of GlycoMimetics and setting aside funds for reserves.

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Q:

Why am I receiving this proxy statement/prospectus?

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A:

You are receiving this proxy statement/prospectus because you have been identified as a stockholder of GlycoMimetics as of the applicable Record Date, and you are entitled to vote to approve the matters set forth herein. This document serves as:

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a proxy statement of GlycoMimetics used to solicit proxies for the GlycoMimetics Special Meeting to vote on the matters set forth herein;

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a prospectus of GlycoMimetics used to offer (i) shares of GlycoMimetics common stock issued in exchange for shares of Crescent common stock (including shares of Crescent common stock issued in the Crescent Pre-Closing Financing), (ii) shares of GlycoMimetics common stock issuable upon exercise of pre-funded warrants issued in exchange for pre-funded warrants to purchase shares of Crescent common stock sold in the Crescent Pre-Closing Financing, and (iii) shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock issued in exchange for shares of Crescent preferred stock in the Merger; and

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the annual report of GlycoMimetics provided in connection with the special meeting in lieu of annual meeting.

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Q:

What is the Crescent Pre-Closing Financing?

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A:

In connection with the Merger, Crescent and GlycoMimetics entered into the Subscription Agreement with certain investors named therein, including, among others, Fairmount, Venrock Healthcare Capital Partners, BVF Partners, Paradigm BioCapital, RTW Investments, Blackstone Multi-Asset Investing, Frazier Life Sciences, Commodore Capital, Perceptive Advisers, Deep Track Capital, Boxer Capital Management, Soleus, Logos Capital, Driehaus Capital Management, Braidwell LP, and Wellington Management, pursuant to which such investors agreed to purchase shares of Crescent common stock and pre-funded warrants to purchase shares of Crescent common stock for an aggregate purchase price of approximately $200.0 million (which includes $37.5 million of proceeds previously received by Crescent from the issuance of its Convertible Notes and accrued interest on such note). Shares of Crescent common stock and pre-funded warrants issued pursuant to this financing transaction will be converted into shares of GlycoMimetics common stock and pre-funded warrants to acquire shares GlycoMimetics common stock, in accordance with the Exchange Ratio and the Merger Agreement.

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Immediately after the First Merger, the shares of Crescent common stock and Crescent pre-funded warrants issued in the Crescent Pre-Closing Financing are expected to represent approximately 65.3% of the outstanding shares of common stock of the Combined Company (on a fully-diluted basis, and subject to dilution from any equity issued by Crescent after May 3, 2025 and before the closing). GlycoMimetics, Crescent and the investors participating in the Crescent Pre-Closing Financing have also agreed to enter into a Registration Rights Agreement at the closing of the Crescent Pre-Closing Financing, pursuant to which, among other things, the Combined Company will agree to provide for the registration and resale of certain shares of GlycoMimetics common stock that are held by the investors participating in the Crescent Pre-Closing Financing from time to time pursuant to Rule 415. The closing of the Crescent Pre-Closing Financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the Merger as well as certain other conditions.

For a more complete description of the Crescent Pre-Closing Financing, please see the sections titled “Agreements Related to the Merger — Subscription Agreement” and “— Registration Rights Agreement” beginning on pages 176 and 178 of this proxy statement/prospectus, respectively.

Q:

What proposals will be voted on at the GlycoMimetics Special Meeting in connection with the Merger?

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A:

Pursuant to the terms of the Merger Agreement, the following proposals must be approved by the requisite stockholder vote at the GlycoMimetics Special Meeting in order for the Merger to close:

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Proposal No. 1 — The Nasdaq Stock Issuance Proposal to approve (i) the issuance of shares of GlycoMimetics common stock (including the shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock), which will represent more than 20% of the

 

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shares of GlycoMimetics common stock outstanding immediately prior to the Merger, to stockholders of Crescent, pursuant to the terms of the Merger Agreement, a copy of which is attached as Annex A, including the amendments thereto, to this proxy statement/prospectus, and (ii) the change of control of GlycoMimetics resulting from the Merger, pursuant to Nasdaq Listing Rules 5635(a) and 5635(b), respectively;

Proposal No. 2 — Authorized Share Increase Proposal to approve an amendment to the GlycoMimetics Charter to increase the number of shares of GlycoMimetics common stock that GlycoMimetics is authorized to issue from 150,000,000 to 175,000,000, in the form attached as Annex G to this proxy statement/prospectus;

If the GlycoMimetics Share Increase Amendment is approved by stockholders, upon its effectiveness, and without giving effect to the proposed reverse stock split described in Proposal No. 3 of this proxy statement/prospectus, GlycoMimetics will have a total of 175,000,000 authorized shares of GlycoMimetics common stock, with 64,532,091 shares of GlycoMimetics common stock issued and outstanding (as of May 3, 2025), and 20,811,991 shares reserved for issuance (as of May 3, 2025), leaving a balance of 89,655,918 shares of GlycoMimetics common stock authorized and unissued and not reserved for any specific purpose.

In connection with the Merger (based on the estimated Exchange Ratio as described in the accompanying proxy statement/prospectus, and without giving effect to the proposed GlycoMimetics reverse stock split), GlycoMimetics is expected to issue approximately 1,430,841,779 shares of GlycoMimetics common stock, and reserve (a) 278,010,526 shares of GlycoMimetics common stock for issuance upon exercise of pre-funded warrants to purchase shares of GlycoMimetics common stock, (b) 308,384,000 shares of GlycoMimetics common stock reserved for issuance upon conversion of GlycoMimetics Series A Preferred Stock, and (c) 405,983,391 shares of GlycoMimetics common stock in connection with the assumption of Crescent’s 2024 Equity Incentive Plan and outstanding options and restricted stock units. If the Authorized Share Increase Proposal is effected, the number of authorized shares of GlycoMimetics common stock available for issuance immediately following the Merger will be dependent upon the final reverse stock split ratio mutually agreed by the GlycoMimetics Board and the Crescent Board prior to the First Effective Time or, if the Nasdaq Stock Issuance Proposal is not approved by GlycoMimetics stockholders, determined solely by the GlycoMimetics Board. Assuming a reverse-stock split ratio of 90:1, the mid-point of the range for the reverse stock split ratio set forth in the Reverse Stock Split Proposal, as of immediately following the Merger, GlycoMimetics will have 16,615,265 shares of GlycoMimetics common stock issued and outstanding, and 11,257,665 shares of GlycoMimetics common stock reserved for issuance, leaving a balance of 147,127,070 shares of GlycoMimetics common stock authorized and unissued and not reserved for any specific purpose. The foregoing does not consider the effects of any reservations of GlycoMimetics common stock in connection with the Stock Plan Proposal or the ESPP Proposal, or the termination of the GlycoMimetics Amended and Restated 2013 Equity Incentive Plan and GlycoMimetics 2013 Employee Stock Purchase Plan in connection with such proposals; and

Proposal No. 3 — Reverse Stock Split Proposal to approve an amendment to the GlycoMimetics Charter to effect a reverse stock split of GlycoMimetics’ issued and outstanding common stock at a ratio in the range between 70:1 to 110:1, inclusive, with the final ratio and effectiveness of such amendment and the abandonment of such amendment to be mutually agreed by the GlycoMimetics Board and the Crescent Board prior to the First Effective Time or, if the Nasdaq Stock Issuance Proposal is not approved by GlycoMimetics stockholders, determined solely by the GlycoMimetics Board, the form attached as Annex H to this proxy statement/prospectus.

Each of Proposal Nos. 1, 2, and 3 is a condition to completion of the Merger. The issuance of GlycoMimetics common stock, including shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock, and GlycoMimetics Series A Preferred Stock in connection with the Merger and the change of control of GlycoMimetics resulting from the Merger will not take place unless Proposal Nos. 1, 2, and 3 are approved by GlycoMimetics stockholders and the Merger is consummated. Notwithstanding the approval of Proposal No. 2, if Proposal No. 1 is not approved or if the Merger is not consummated for any reason, the actions contemplated by Proposal No. 2 will not be effected. However, the GlycoMimetics Board may determine to effect the reverse stock

 

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split if approved by GlycoMimetics stockholders following the special meeting, even if Proposal No. 1 or Proposal No. 2 is not approved or the Merger is not otherwise completed.

In addition to the requirement of obtaining GlycoMimetics stockholder approval of Proposal No. 1 and Proposal No. 2, the closing of the Merger is subject to the satisfaction or waiver of each of the other closing conditions set forth in the Merger Agreement. For a more complete description of the closing conditions under the Merger Agreement, please see the section titled “The Merger Agreement — Conditions to the Completion of the Merger” beginning on page 171 of this proxy statement/prospectus.

The presence, by attending or being represented by proxy, at the GlycoMimetics Special Meeting of the holders of a majority of the shares of GlycoMimetics common stock outstanding and entitled to vote at the GlycoMimetics Special Meeting is necessary to constitute a quorum at the meeting for the Proposals.

Q:

What proposals are to be voted on at the GlycoMimetics Special Meeting, other than the Nasdaq Stock Issuance Proposal, the Reverse Stock Split Proposal and the Authorized Share Increase Proposal?

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A:

At the GlycoMimetics Special Meeting, the holders of GlycoMimetics common stock will also be asked to consider the following proposals:

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Proposal No. 4 — The Redomestication Proposal to approve (A) the redomestication of GlycoMimetics from the State of Delaware to the Cayman Islands by conversion and (B)(i) the redomestication of GlycoMimetics from the State of Delaware to the Cayman Islands by way of continuation and (ii) the adoption of the Cayman Articles;

Proposal No. 5 — The Director Election Proposal to elect one director nominee, Patricia Andrews, to serve until GlycoMimetics’ 2028 annual meeting of stockholders, or until her successor has been duly elected and qualified, or until her earlier death, resignation or removal;

Proposal No. 6 — The Auditor Ratification Proposal to ratify the selection of Ernst & Young LLP as GlycoMimetics’ independent registered public accounting firm for the fiscal year ending December 31, 2025;

Proposal No. 7 — The Stock Plan Proposal to approve the Crescent Biopharma, Inc. 2025 Stock Incentive Plan;

Proposal No. 8 — The ESPP Proposal to approve the Crescent Biopharma, Inc. 2025 Employee Stock Purchase Plan;

Proposal No. 9 — The Merger Compensation Proposal to approve, on an advisory basis, certain compensation arrangements for GlycoMimetics’ named executive officers that are based on or otherwise relate to the Merger;

Proposal No. 10 — The Say-on-Pay Proposal to approve, on an advisory basis, the compensation of GlycoMimetics’ named executive officers; and

Proposal No. 11 — The Adjournment Proposal to approve an adjournment of the GlycoMimetics Special Meeting, if necessary, to solicit additional proxies if there is not a sufficient number of votes in favor of the Nasdaq Stock Issuance Proposal, the Authorized Share Increase Proposal and/or the Reverse Stock Split Proposal.

The approval of Proposal Nos. 4, 5, 6, 7, 8, 9, 10 and 11 are not a condition to the Merger. GlycoMimetics does not expect that any matter other than the Proposals will be brought before the GlycoMimetics Special Meeting.

The presence, by attending or being represented by proxy, at the GlycoMimetics Special Meeting of the holders of a majority of the shares of GlycoMimetics common stock outstanding and entitled to vote at the GlycoMimetics Special Meeting is necessary to constitute a quorum at the meeting for the purpose of approving the Proposals.

 

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Q:

What stockholder votes are required to approve the Proposals at the GlycoMimetics Special Meeting?

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A:

The affirmative vote of a majority of the shares of GlycoMimetics common stock entitled to vote on the subject matter and present at the GlycoMimetics Special Meeting, assuming a quorum is present, is required for approval of Proposal Nos. 1, 6, 7, 8, 9, 10 and 11. The affirmative vote of a majority of the votes properly cast by the holders of GlycoMimetics common stock in person or represented by proxy at the GlycoMimetics Special Meeting, assuming a quorum is present, is required for approval of Proposal No. 2 and Proposal No. 3. The affirmative vote of a majority of the outstanding shares of GlycoMimetics common stock entitled to vote thereon is required for approval of Proposal No. 4A. The affirmative vote of not less than two-thirds of the votes properly cast by the holders of GlycoMimetics common stock in person or represented by proxy at the GlycoMimetics Special Meeting, assuming a quorum is present, is required for approval of Proposal No. 4B. With respect to Proposal No. 5, the director nominee is elected by a plurality of the votes properly cast at the GlycoMimetics Special Meeting, and the director nominee receiving the highest numbers of affirmative votes properly cast will be elected. Proposal No. 1 is conditioned on the approval of Proposal No. 2. Notwithstanding the approval of Proposal No. 1, if Proposal No. 2 is not approved, the actions contemplated by Proposal No. 1 will not be effected and the Merger will not be consummated.

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Q:

What will Crescent stockholders, participants in Crescent’s 2024 Equity Incentive Plan, option holders and warrant holders receive in the Merger?

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A:

Crescent stockholders will receive shares of GlycoMimetics common stock. GlycoMimetics will assume Crescent’s 2024 Equity Incentive Plan, as amended, along with issued and outstanding awards under such plan. Outstanding and unexercised options to purchase shares of Crescent common stock and outstanding Crescent restricted stock units immediately prior to the First Effective Time will be converted into options to purchase shares of GlycoMimetics common stock and GlycoMimetics restricted stock units, respectively, with necessary adjustments being made to the number of shares and exercise price underlying such options and restricted stock units in order to reflect the economic equivalent of the prior equity award in light of the Exchange Ratio. Crescent pre-funded warrant holders’ outstanding and unexercised pre-funded warrants to purchase shares of Crescent common stock immediately prior to the First Effective Time will be assumed by GlycoMimetics and each outstanding and unexercised pre-funded warrant will be converted into a pre-funded warrant to purchase shares of GlycoMimetics common stock, with necessary adjustments to the number of shares and exercise price to reflect the Exchange Ratio. Applying the Exchange Ratio, the former Crescent securityholders immediately before the Merger are expected to own approximately 97.4% of the aggregate number of shares of the Combined Company’s capital stock following the Merger (on a fully-diluted basis, and subject to dilution from any equity issued by Crescent after May 3, 2025 and before the closing), and GlycoMimetics securityholders immediately before the Merger are expected to own approximately 2.6% of the aggregate number of shares of the Combined Company capital stock following the Merger (on a fully-diluted basis), subject to certain assumptions, including, but not limited to, GlycoMimetics’ net cash as of closing being equal to $1.8 million. Under certain circumstances further described in the Merger Agreement, the ownership percentages may be adjusted up or down including, but not limited to, if GlycoMimetics’ net cash is less than $1.725 million or more than $1.875 million. GlycoMimetics’ management currently anticipates GlycoMimetics’ net cash as of closing will be approximately $1.8 million, and the currently estimated ownership percentages reflect this projection.

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For a more complete description of the treatment of Crescent common stock, Crescent’s 2024 Equity Incentive Plan, Crescent options, Crescent restricted stock units, and Crescent warrants in the Merger, please see the sections titled “The Merger Agreement — Merger Consideration” and “The Merger Agreement — Exchange Ratio” beginning on pages 157 and 158, respectively, of this proxy statement/​prospectus. For a description of the effect of the Crescent Pre-Closing Financing on GlycoMimetics’ and Crescent’s current securityholders, please see the section titled “Agreements Related to the Merger — Subscription Agreement” beginning on page 176 of this proxy statement/prospectus.

Q:

Will the common stock of the Combined Company trade on an exchange?

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A:

Shares of GlycoMimetics common stock are currently listed on Nasdaq under the symbol “GLYC.”

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GlycoMimetics is not currently in compliance with the minimum bid price requirement for continued listing on The Nasdaq Capital Market and has until June 16, 2025 to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). GlycoMimetics intends to file an initial listing application for the common stock of the Combined Company with Nasdaq. After completion of the Merger, GlycoMimetics will be renamed “Crescent Biopharma, Inc.” and it is expected that the common stock of the Combined Company will trade on Nasdaq under the symbol “CBIO.” It is a condition to the consummation of the Merger that GlycoMimetics will receive confirmation from Nasdaq that the Combined Company has been approved for listing on Nasdaq, but there can be no assurance such listing condition will be met or that GlycoMimetics will obtain such confirmation from Nasdaq. If such listing condition is not met or if such confirmation is not obtained, the Merger will not be consummated unless the condition is waived. The Nasdaq condition set forth in the Merger Agreement is not expected to be waived by the applicable parties; however, if such condition is waived, GlycoMimetics will not recirculate an updated proxy statement/prospectus, nor will it solicit a new vote of stockholders prior to proceeding with the Merger. Accordingly, you are advised that GlycoMimetics stockholders will not have certainty regarding the listing of the Combined Company’s shares at the time you are asked to vote at the GlycoMimetics Special Meeting. For more information, please see the section entitled “Risk Factors — Risks Related to the Merger — GlycoMimetics and Crescent may mutually agree to waive the condition to the Merger requiring approval for listing on Nasdaq, and if such condition is waived, the Combined Company’s stock may not be listed on Nasdaq following completion of the Merger.” on page 19 of this proxy statement/prospectus.

On May 9, 2025, the last trading day before the date of this proxy statement/prospectus, the closing sale price of GlycoMimetics common stock was $0.2402 per share.

Q:

Who will be the directors of the Combined Company immediately following the Merger?

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A:

Immediately following the Merger, the Combined Company’s board of directors will be composed of six members, all six of whom will have been designated by Crescent.

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Effective as of the First Effective Time, the GlycoMimetics Board will appoint the following Crescent designees: Alexandra Balcom, Joshua Brumm, Peter Harwin, David Lubner, Susan Moran and Jonathan Violin to the board of directors of the Combined Company, and concurrent therewith all of GlycoMimetics’ current directors will resign from their positions as directors of the GlycoMimetics Board effective as of the First Effective Time. Peter Harwin is expected to be appointed as Chair of the board of directors of the Combined Company.

The staggered structure of three classes of directors of the GlycoMimetics Board will remain in place for the Combined Company following the completion of the Merger. See the section titled “Management Following the Merger” for additional information.

Q:

Who will be the executive officers of the Combined Company immediately following the Merger?

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A:

Immediately following the Merger, the executive management team of the Combined Company is expected to consist of the following members of the Crescent executive management team:

​

 

ix

 

Q:

As a GlycoMimetics stockholder, how does the GlycoMimetics Board recommend that I vote?

​

A:

The GlycoMimetics Board, in consultation with financial and legal advisors and management, evaluated the terms of the Merger Agreement and the related transactions contemplated thereby and: (i) determined that the Merger and the related transactions contemplated by the Merger Agreement are fair to, advisable and in the best interests of GlycoMimetics and its stockholders; (ii) approved and declared advisable the Merger Agreement and the related transactions contemplated by the Merger Agreement and the Subscription Agreement, including the issuance of shares of GlycoMimetics common stock, including shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock, in connection with the Merger and the Crescent Pre-Closing Financing, respectively; and (iii) recommends that GlycoMimetics’ stockholders vote “FOR” each of the Proposals.

​

Q:

What risks should I consider in deciding whether to vote in favor of the Merger?

​

A:

You should carefully review the section titled “Risk Factors” beginning on page 19 of this proxy statement/​prospectus and the documents incorporated by reference herein, which set forth certain risks and uncertainties related to the Merger, risks and uncertainties to which the Combined Company’s business will be subject, and risks and uncertainties to which each of GlycoMimetics and Crescent, as independent companies, are subject.

​

Q:

When do you expect the Merger to be consummated?

​

A:

The Merger is anticipated to close in the late second quarter of 2025, but the exact timing cannot be predicted. For more information, please see the section titled “The Merger Agreement — Conditions to the Completion of the Merger” beginning on page 171 of this proxy statement/prospectus.

​

Q:

Why is GlycoMimetics seeking approval for the redomestication to the Cayman Islands (the “Cayman Redomestication”)?

​

A:

The GlycoMimetics and Crescent boards of directors believe that there are several reasons why the Cayman Redomestication is in the best interests of GlycoMimetics and GlycoMimetics’ stockholders. First, the Cayman Redomestication will eliminate the Combined Company’s obligation to pay the annual Delaware franchise tax, which GlycoMimetics and Crescent expect will result in substantial savings to the Combined Company over the long term. In addition, the Cayman Redomestication may help the Combined Company attract and retain qualified management by reducing the risk of lawsuits being filed against the Combined Company and its directors and officers. GlycoMimetics and Crescent believe that for the reasons described in this proxy statement/prospectus, in general, Cayman Islands law will provide greater protection to the Combined Company and its directors and officers than Delaware law. The GlycoMimetics Board believes that the Cayman Redomestication will give the Combined Company more flexibility and predictability in various corporation transactions. For more information, please see the section titled “Proposal No. 4 — The Redomestication Proposal” below.

​

Q:

How will the Cayman Redomestication affect the rights of the Combined Company’s stockholders?

​

A:

Your rights as a stockholder currently are governed by Delaware law and the provisions of the amended and restated certificate of incorporation of GlycoMimetics, and GlycoMimetics’ amended and restated bylaws. As a result of the Cayman Redomestication, you will become a shareholder of the Combined Company with rights governed by Cayman Islands law and the provisions of the memorandum and articles of association of the Combined Company, in the form attached as Annex J to this proxy statement/prospectus, which differ in certain respects from your current rights. These important differences are discussed and summarized in this proxy statement/prospectus under “Proposal No. 4 — The Redomestication — Effects of the Cayman Redomestication — Comparison of Rights of Holders of the Delaware Corporation Capital Stock and the Cayman Company Share Capital” beginning on page 213 of this proxy statement/prospectus.

​

 

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Q:

What are the U.S. federal income tax considerations of the Cayman Redomestication to the Combined Company’s stockholders?

​

​

A:

Subject to the limitations and qualifications described in the section titled “Proposal No. 4 — The Redomestication Proposal — U.S. Federal Income Tax Considerations of the Cayman Redomestication” beginning on page 234 of this proxy statement/prospectus, GlycoMimetics intends that the Cayman Redomestication qualify as a “reorganization” within the meaning of Section 368(a) of the Code. As a result, a U.S. Holder (as defined therein) of the Combined Company stock (as defined therein) will not recognize gain or loss upon the Cayman Redomestication. For a more detailed discussion of the U.S. federal income tax considerations of the Cayman Redomestication, see the section titled “Proposal No. 4 — The Redomestication Proposal — U.S. Federal Income Tax Considerations of the Cayman Redomestication” beginning on page 234 of this proxy statement/prospectus.

​

Q:

What do I need to do now?

​

A:

GlycoMimetics urges you to read this proxy statement/prospectus carefully, including the annexes and the documents incorporated by reference, and to consider how the Merger affects you.

​

Stockholder of Record: Shares Registered in Your Name

If you are a stockholder of record, you may vote at the GlycoMimetics Special Meeting, vote by proxy over the telephone, vote by proxy through the Internet or vote by proxy using a proxy card that you may request or that we may elect to deliver at a later time, the form of which is attached as Annex P. Whether or not you plan to attend the meeting, we urge you to vote by proxy to ensure your vote is counted. You may still attend the meeting and vote even if you have already voted by proxy.

​

•

To vote, attend the Special Meeting via the Internet and vote during the meeting.

​

•

To vote using the proxy card, simply complete, sign and date the proxy card that you may request or that we may elect to deliver at a later time and return it promptly in the envelope provided. If you return your signed proxy card to us before the special meeting, we will vote your shares as you direct.

​

​

•

To vote over the telephone, dial toll-free 1-800-690-6903 using a touch-tone phone and follow the recorded instructions. You will be asked to provide the company number and control number found on the Notice. Your vote must be received by June 4, 2025 at 11:59 p.m. Eastern Time to be counted.

​

​

•

To vote through the Internet, go to www.proxyvote.com to complete an electronic proxy card. You will be asked to provide the company number and control number from the Notice. Your vote must be received by June 4, 2025 at 11:59 p.m. Eastern Time to be counted.

​

Beneficial Owner: Shares Registered in the Name of Broker or Bank

If you are a beneficial owner of shares registered in the name of your broker, bank, or other agent, you should have received a Notice containing voting instructions from that organization rather than from GlycoMimetics. Simply follow the voting instructions in the Notice to ensure that your vote is counted. You may vote by telephone or over the Internet as instructed by your broker or bank. To vote at the GlycoMimetics Special Meeting, you must obtain a valid proxy from your broker, bank, or other agent. Follow the instructions from your broker or bank included with these proxy materials, or contact your broker or bank to request a proxy form.

Q:

What if I return a proxy card or otherwise vote but do not make specific choices?

​

A:

If you return a signed and dated proxy card or otherwise vote without marking voting selections, your shares will be voted, as applicable, “For” the Nasdaq Stock Issuance Proposal, “For” the Authorized Share Proposal, “For” the Reverse Stock Split Proposal, “For” the Redomestication Proposal, “For” the Director Election Proposal, “For” the Auditor Ratification Proposal, “For” the Stock Plan Proposal, “For” the ESPP Proposal, “For” the Merger Compensation Proposal, and “For” the Adjournment Proposal. If any other matter is properly presented at the meeting, your proxy holder (one of the individuals named on your proxy card) will vote your shares using his or her best judgment.

​

 

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Q:

What happens if I do not return a proxy card or otherwise vote or provide proxy instructions, as applicable?

​

A:

If you are a stockholder of record and fail to return your proxy card or otherwise vote, your shares will not be voted. If you are a beneficial owner of GlycoMimetics common stock and fail to provide proxy instructions, your shares will not be voted on non-routine matters.

​

Q:

If my GlycoMimetics shares are held in “street name” by my broker and I do not provide my broker or bank with voting instructions, what happens?

​

A:

If you are a beneficial owner of shares held in street name and you do not instruct your broker, bank or other agent how to vote your shares, your broker, bank or other agent will only be able to vote your shares with respect to proposals considered to be “routine.” Your broker, bank or other agent is not entitled to vote your shares with respect to “non-routine” proposals, which GlycoMimetics refers to as a “broker non-vote.” Whether a proposal is considered routine or non-routine is subject to stock exchange rules and final determination by the stock exchange. Even with respect to routine matters, some brokers are choosing not to exercise discretionary voting authority. As a result, GlycoMimetics urges you to direct your broker, bank or other agent how to vote your shares on all proposals to ensure that your vote is counted.

​

Q:

What are broker non-votes and do they count for determining a quorum?

​

A:

Generally, a “broker non-vote” occurs when shares held by a broker are not voted with respect to a particular proposal because the broker has not received voting instructions from its client(s) with respect to such shares on how to vote and does not have discretionary authority to vote on the matter.

​

Broker non-votes, if any, will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the GlycoMimetics Special Meeting. Broker non-votes, if any, will not be counted as “votes properly cast” or “shares entitled to vote” and will therefore have no effect on Proposal Nos. 1, 2, 3, 4B, 5, 6, 7, 8, 9, 10 and 11 and will have the effect of a vote “AGAINST” Proposal No. 4A.

Q:

May I revoke and/or change my vote after I have submitted a proxy or provided proxy instructions?

​

A:

GlycoMimetics stockholders of record, unless such stockholder’s vote is subject to a support agreement, may revoke and/or change their vote at any time before their proxy is voted at the GlycoMimetics Special Meeting in one of four ways:

​

•

You may submit another properly completed proxy with a later date by mail or via the internet.

​

•

You can provide your proxy instructions via telephone at a later date.

​

•

You may send a notice that you are revoking your proxy over the internet, following the instructions provided on your proxy card.

​

•

You may attend the GlycoMimetics Special Meeting and vote during the meeting. Simply attending the GlycoMimetics Special Meeting will not, by itself, revoke your proxy and/or change your vote.

​

Q:

What are the material U.S. federal income tax considerations of the Merger to a U.S. Holder of Crescent common stock and Crescent preferred stock?

​

A:

Subject to the limitations and qualifications described in the section titled “The Merger — U.S. Federal Income Tax Considerations of the Merger” beginning on page 151 of this proxy statement/prospectus, each of GlycoMimetics and Crescent intend that the Merger qualify as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”) for U.S. federal income tax purposes. Assuming the Merger so qualifies, a U.S. Holder of Crescent stock (as defined therein) will not recognize gain or loss upon the exchange of its Crescent stock for GlycoMimetics stock. For a more detailed discussion of the U.S. federal income tax considerations of the Merger, see the section titled “The Merger — U.S. Federal Income Tax Considerations of the Merger” beginning on page 151.

​

 

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Q:

What are the U.S. federal income tax considerations of the reverse stock split to a U.S. Holders of GlycoMimetics common stock?

​

A:

A U.S. Holder of GlycoMimetics common stock should not recognize gain or loss upon the reverse stock split, except to the extent such holder receives cash in lieu of a fractional share of GlycoMimetics common stock, and subject to the discussion in the section titled “Proposal No. 3 — The Reverse Stock Split Proposal — U.S. Federal Income Tax Considerations of the Reverse Stock Split” beginning on page 211 of this proxy statement/prospectus. Please review the information in the section titled “Proposal No. 3 — The Reverse Stock Split Proposal — U.S. Federal Income Tax Considerations of the Reverse Stock Split” beginning on page 211 of this proxy statement/prospectus for a more complete description of the U.S. federal income tax considerations of the reverse stock split to a U.S. Holder of GlycoMimetics common stock.

​

Q:

Who can help answer my questions?

​

A:

If you are a GlycoMimetics stockholder and would like additional copies of this proxy statement/​prospectus without charge or if you have questions about the Merger or related matters, including the procedures for voting your shares, you should contact:

​

Banks and Brokers Call: (877) 750-8310
Stockholders Call Toll Free: (212) 750-5833

 

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5

 

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6

 

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8

 

9

 

10

 

11

 

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Name	​	​	Age	​	​	Position	​
Executive Officers	​	​	​	​	​	​	​
Joshua Brumm	​	​	47	​	​	Chief Executive Officer and Director	​
Jonathan McNeill	​	​	40	​	​	Chief Operating Officer and President	​
Ellie Im	​	​	47	​	​	Chief Medical Officer	​
Richard Scalzo	​	​	39	​	​	Chief Financial Officer	​
Christopher Doughty	​	​	38	​	​	Chief Business Officer	​
Ryan Lynch	​	​	41	​	​	Treasurer, Senior Vice President of Finance and Chief Accounting Officer	​
Barbara Bispham	​	​	39	​	​	General Counsel and Corporate Secretary	​
Non-Employee Directors:	​	​	​	​	​	​	​
Alexandra Balcom	​	​	41	​	​	Director	​
Peter Harwin	​	​	39	​	​	Chair and Director	​
David Lubner	​	​	61	​	​	Director	​
Susan Moran	​	​	55	​	​	Director	​
Jonathan Violin	​	​	49	​	​	Director	​

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17

 

MARKET PRICE AND DIVIDEND INFORMATION

The GlycoMimetics common stock is currently listed on The Nasdaq Capital Market under the symbol “GLYC.”

The closing price of the GlycoMimetics common stock on October 25, 2024, the last day of trading prior to the announcement of the Merger, as reported on The Nasdaq Capital Market, was $0.17 per share. The closing price of the GlycoMimetics common stock on May 9, 2025, as reported on The Nasdaq Capital Market, was $0.2402 per share.

Because the market price of the GlycoMimetics common stock is subject to fluctuation, the market value of the shares of the GlycoMimetics common stock that the Crescent stockholders will be entitled to receive in the Merger may increase or decrease.

Crescent is a private company, and its shares of common stock and preferred stock are not publicly traded.

Assuming approval of Proposal Nos. 1 and 2 and successful application for initial listing with Nasdaq, following the consummation of the Merger, shares of GlycoMimetics common stock will trade on Nasdaq under GlycoMimetics’ new name, “Crescent Biopharma, Inc.,” and new trading symbol “CBIO.”

As of May 3, 2025, there were approximately 22 registered holders of record of the GlycoMimetics common stock. As of May 3, 2025, Crescent had seven holders of record of Crescent common stock and one holder of record of Crescent preferred stock. For detailed information regarding the beneficial ownership of certain GlycoMimetics and Crescent stockholders, see the sections of this proxy statement/prospectus titled “Principal Stockholders of GlycoMimetics,” “Principal Stockholders of Crescent” and “Principal Stockholders of the Combined Company.”

Dividends

GlycoMimetics has never declared or paid any cash dividends on the GlycoMimetics common stock and does not anticipate paying cash dividends on the GlycoMimetics common stock for the foreseeable future. Notwithstanding the foregoing, any determination to pay cash dividends subsequent to the Merger will be at the discretion of the combined organization’s then-current board of directors and will depend upon a number of factors, including the combined organization’s results of operations, financial condition, future prospects, contractual restrictions, restrictions imposed by applicable law and other factors the then-current board of directors deems relevant.

Crescent has never paid or declared any cash dividends on Crescent capital stock. If the Merger does not occur, Crescent does not anticipate paying any cash dividends on the Crescent capital stock in the foreseeable future, and Crescent intends to retain all available funds and any future earnings to fund the development and expansion of its business. Any future determination to pay dividends will be at the discretion of the Crescent Board and will depend upon a number of factors, including its results of operations, financial condition, future prospects, contractual restrictions, and restrictions imposed by applicable laws and other factors the Crescent Board deems relevant.

 

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RISK FACTORS

The Combined Company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained or incorporated by reference in this proxy statement/prospectus, you should carefully consider the material risks described below before deciding how to vote your shares of GlycoMimetics common stock. You should also read and consider the other information in this proxy statement/prospectus. Please see the section titled “Where You Can Find More Information” beginning on page 401 of this proxy statement/prospectus for further information. Moreover, some of the factors, events and contingencies discussed below may have occurred in the past, but the disclosures below are not representations as to whether or not the factors, events or contingencies have occurred in the past and instead reflect our beliefs and opinions as to the factors, events, or contingencies that could materially and adversely affect us in the future.

Risks Related to the Proposed Merger

Failure to complete, or delays in completing, the potential Merger with Crescent could materially and adversely affect GlycoMimetics’ results of operations, business, financial results and/or common stock price.

On October 28, 2024, GlycoMimetics entered into the Merger Agreement with Crescent, which agreement was subsequently amended on February 14, 2025 and April 28, 2025, pursuant to which, among other matters, and subject to the satisfaction or waiver of the conditions set forth in the Merger Agreement, First Merger Sub will merge with and into Crescent, with Crescent continuing as a wholly owned subsidiary of GlycoMimetics and the surviving corporation of the First Merger and, immediately following the First Merger and as part of the same overall transaction as the First Merger, Crescent will merge with and into Second Merger Sub as part of the Second Merger, with Second Merger Sub continuing as a wholly owned subsidiary of GlycoMimetics and the surviving entity of the Second Merger. Consummation of the Merger is subject to certain closing conditions, a number of which are not within GlycoMimetics’ control. Any failure to satisfy these required conditions to closing may prevent, delay or otherwise materially adversely affect the completion of the transaction. GlycoMimetics cannot predict with certainty whether or when any of the required closing conditions will be satisfied or if another uncertainty may arise and cannot assure you that it will be able to successfully consummate the Merger as currently contemplated under the Merger Agreement or at all.

GlycoMimetics’ efforts to complete the Merger could cause substantial disruptions in, and create uncertainty surrounding, its business, which may materially adversely affect its results of operation and its business. Uncertainty as to whether the Merger will be completed in a timely manner or at all may affect GlycoMimetics’ ability to retain and motivate existing employees. Uncertainty as to whether the Merger will be completed in a timely manner or at all could adversely affect GlycoMimetics’ business and its relationship with collaborators, suppliers, vendors, regulators and other business partners. The adverse effects of the pendency of the transaction could be exacerbated by any delays in completion of the transaction or termination of the Merger Agreement.

If the conditions to the Merger are not satisfied or waived, the Merger may not occur.

Even if the Merger is approved by the stockholders of Crescent and GlycoMimetics, specified conditions must be satisfied or, to the extent permitted by applicable law, waived to complete the Merger. These conditions are set forth in the Merger Agreement and described further in the section titled “The Merger Agreement” of this proxy statement/prospectus. GlycoMimetics cannot assure you that all of the conditions to the consummation of the Merger will be satisfied or waived. If the conditions are not satisfied or waived, the Merger may not occur or the closing may be delayed.

GlycoMimetics and Crescent may mutually agree to waive the condition to the Merger requiring approval for listing on Nasdaq, and if such condition is waived, the Combined Company’s stock may not be listed on Nasdaq following completion of the Merger.

Pursuant to the Merger Agreement, GlycoMimetics agreed, to the extent required by the rules and regulations of Nasdaq, to use its commercially reasonable efforts to cause the shares of GlycoMimetics common stock being issued in the Merger to be approved for listing on Nasdaq at or prior to the Effective

 

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Time. Additionally, under the Merger Agreement, each of GlycoMimetics’ and Crescent’s obligation to complete the Merger is subject to the satisfaction or waiver by each of the parties of various conditions, including that the shares of GlycoMimetics common stock to be issued in the Merger have been approved for listing (subject to official notice of issuance) on Nasdaq as of the closing of the Merger. In the event that the shares of GlycoMimetics common stock to be issued in the Merger are not approved for listing on Nasdaq, it is possible that GlycoMimetics and Crescent may mutually agree to waive the applicable condition and nonetheless proceed with completing the Merger. If such condition is waived, GlycoMimetics will not recirculate an updated proxy statement/prospectus, nor will it solicit a new vote of stockholders prior to proceeding with the Merger. If GlycoMimetics proceeds with the Merger in these circumstances, the Combined Company’s stock may not be listed on Nasdaq.

If the Combined Company’s stock is not listed on Nasdaq following completion of the Merger, trading of the shares could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it is likely that there would be significantly less liquidity in the trading of the common stock of the Combined Company; decreases in institutional and other investor demand for the shares, coverage by securities analysts, market making activity and information available concerning trading prices and volume; and fewer broker dealers willing to execute trades in the common stock of the Combined Company. Also, it may be difficult for the Combined Company to raise additional capital if the Combined Company’s common stock is not listed on a major exchange. The occurrence of any of these events could result in a further decline in the market price of the common stock of the Combined Company and could have a material adverse effect on the Combined Company.

The Exchange Ratio for the Merger will not change or otherwise be adjusted based on the market price of GlycoMimetics common stock.

Applying the Exchange Ratio, based on GlycoMimetics’ and Crescent’s capitalization as of May 3, 2025 and taking into account GlycoMimetics’ current cash position, each share of Crescent common stock is currently estimated to be entitled to receive approximately 15.4192 shares of GlycoMimetics common stock. Each share of Crescent preferred stock will be converted into the right to receive a number of shares of GlycoMimetics Series A Preferred Stock, equal to the Exchange Ratio divided by 1,000. Applying the Exchange Ratio, the former Crescent securityholders immediately before the Merger are expected to own approximately 97.4% of the aggregate number of shares of the Combined Company’s capital stock following the Merger (on a fully-diluted basis, and subject to dilution from any equity issued by Crescent after May 3, 2025 and before the closing), and GlycoMimetics securityholders immediately before the Merger are expected to own approximately 2.6% of the aggregate number of shares of the Combined Company capital stock following the Merger (on a fully-diluted basis), subject to certain assumptions, including, but not limited to, GlycoMimetics’ net cash as of closing being equal to $1.8 million. In the event GlycoMimetics’ net cash is below $1.725 million, the Exchange Ratio will be adjusted such that the number of shares issued to Crescent’s pre-closing securityholders will be increased, and GlycoMimetics stockholders will own a smaller percentage of the Combined Company following the consummation of the Merger.

Any changes in the market price of GlycoMimetics’ stock before the completion of the First Merger will not affect the number of shares Crescent stockholders will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the First Merger, the market price of GlycoMimetics common stock increases from the market price on the date of the Merger Agreement, then Crescent stockholders could receive merger consideration with substantially more value for their shares of Crescent capital stock than the parties had negotiated when they established the Exchange Ratio. Similarly, if before the completion of the First Merger, the market price of GlycoMimetics common stock declines from the market price on the date of the Merger Agreement, then Crescent stockholders could receive merger consideration with substantially lower value. The Merger Agreement does not include a price-based termination right.

 

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The issuance of GlycoMimetics common stock, including the shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock, to Crescent stockholders pursuant to the Merger Agreement and the resulting change in control from the First Merger must be approved by GlycoMimetics stockholders, and the Merger Agreement and transactions contemplated thereby must be approved by the Crescent stockholders. Failure to obtain these approvals would prevent the closing of the Merger.

Before the Merger can be completed, GlycoMimetics stockholders must approve, among other things, the issuance of GlycoMimetics common stock, including shares of GlycoMimetics common stock issuable upon conversion of GlycoMimetics Series A Preferred Stock, to Crescent stockholders pursuant to the Merger Agreement and the resulting change in control from the First Merger, and Crescent stockholders must adopt the Merger Agreement and approve the Merger and the related transactions. Failure to obtain the required stockholder approvals may result in a material delay in, or the abandonment of, the Merger. Any delay in completing the Merger may materially adversely affect the timing and benefits that are expected to be achieved from the Merger.

The Merger may be completed even though a material adverse effect may result from the announcement of the Merger, industry-wide changes or other causes.

In general, neither GlycoMimetics nor Crescent is obligated to complete the Merger if there is a material adverse effect affecting the other party between October 28, 2024, the date of the Merger Agreement, and the closing of the Merger. However, certain types of causes are excluded from the concept of a “material adverse effect.” Such exclusions include, but are not limited to, changes in general economic or political conditions, industry-wide changes, changes resulting from the announcement of the Merger, natural disasters, pandemics, other public health events or force majeure events and changes in U.S. generally accepted accounting principles. Therefore, if any of these events were to occur and adversely affect GlycoMimetics or Crescent, the other party would still be obliged to consummate the closing of the Merger notwithstanding such material adverse effect. If any such adverse effects occur and GlycoMimetics consummates the closing of the Merger, the stock price of the Combined Company may suffer. This in turn may reduce the value of the Merger to the stockholders of GlycoMimetics, Crescent or both.

If the Merger is not completed, GlycoMimetics’ stock price may decline significantly.

The market price of GlycoMimetics common stock is subject to significant fluctuations. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of GlycoMimetics common stock will likely be volatile based on whether stockholders and other investors believe that GlycoMimetics can complete the Merger or otherwise raise additional capital to support GlycoMimetics’ operations if the Merger is not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all. The volatility of the market price of GlycoMimetics common stock has been and may be exacerbated by low trading volume. Additional factors that may cause the market price of GlycoMimetics common stock to fluctuate include:

•

announcements of the results of its clinical trials, discussions with regulators, and regulatory approval decisions;

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•

the entry into, or termination of, key agreements, including commercial partner agreements;

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•

announcements by commercial partners or competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

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•

the loss of key employees;

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•

future sales of GlycoMimetics common stock;

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•

general and industry-specific economic conditions that may affect GlycoMimetics’ research and development expenditures; and

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period-to-period fluctuations in financial results.

​

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also

 

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adversely affect the trading price of GlycoMimetics common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

If GlycoMimetics completes the Merger, the Combined Company will need to raise additional capital and satisfy certain contractual obligations by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to the Combined Company’s stockholders or restrict the Combined Company’s operations.

In connection with the Merger, Crescent and GlycoMimetics entered into the Subscription Agreement with certain investors, including existing investors of Crescent, pursuant to which the investors agreed to purchase, in the aggregate, $200.0 million (which includes $37.5 million of proceeds previously received by Crescent from the issuance of its Convertible Notes and accrued interest on such note) in shares of common stock and pre-funded warrants of Crescent in the Crescent Pre-Closing Financing immediately prior to the closing of the Merger. The closing of the Crescent Pre-Closing Financing is conditioned upon the satisfaction or waiver of the conditions to the closing of the Merger as well as certain other conditions. The shares of Crescent common stock and pre-funded warrants issued in the Crescent Pre-Closing Financing will result in dilution to all securityholders of the Combined Company (i.e., both GlycoMimetics’ pre-Merger securityholders and former Crescent securityholders).

Additional financing may not be available to the Combined Company when it is needed or may not be available on favorable terms. To the extent that the Combined Company raises additional capital by issuing equity securities, such financing will cause additional dilution to all securityholders of the Combined Company, including GlycoMimetics’ pre-Merger securityholders and Crescent’s former securityholders. It is also possible that the terms of any new equity securities may have preferences over the Combined Company’s common stock. Any debt financing the Combined Company enters into may involve covenants that restrict its operations. These restrictive covenants may include limitations on additional borrowing and specific restrictions on the use of the Combined Company’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if the Combined Company raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to the Combined Company.

In addition, as a result of GlycoMimetics’ assumption of the Paragon Option Agreements in connection with the Merger, the Combined Company will be subject to the obligation to grant to Parascent, on each of December 31, 2025 and December 31, 2026, warrants to purchase a number of shares equal to 1.00% of the outstanding shares of GlycoMimetics common stock as of the date of the grant on a fully-diluted basis, with an exercise price equal to the fair market value of the underlying shares on the grant date. Such warrants granted will result in further dilution to all securityholders of the Combined Company.

Transfers of the Combined Company’s securities utilizing Rule 144 of the Securities Act may be limited.

A significant portion of the Combined Company’s securities will be restricted from immediate resale. Holders should be aware that transfers of the Combined Company’s securities pursuant to Rule 144 may be limited as Rule 144 is not available, subject to certain exceptions, for the resale of securities initially issued by shell companies (other than business combination related shell companies) or issuers that have been at any time previously a shell company. GlycoMimetics’ expected disposal of GlycoMimetics’ historical assets and operations in connection with the Merger is expected to make GlycoMimetics a shell company. GlycoMimetics anticipates that following the consummation of the Merger, the Combined Company will no longer be a shell company. As a result, GlycoMimetics anticipates that holders will not be able to sell their restricted Combined Company securities pursuant to Rule 144 without registration until one year after GlycoMimetics files the Current Report on Form 8-K following the closing that includes the required Form 10 information that reflects that the Combined Company is no longer a shell company.

GlycoMimetics’ is expected to be deemed a shell company. As a result, if GlycoMimetics completes the Merger, the Combined Company will be subject to more stringent reporting requirements, offering limitations and resale restrictions.

GlycoMimetics’ or the Combined Company’s expected disposal of GlycoMimetics’ historical assets and operations prior to or following the Merger is expected to make GlycoMimetics a shell company. As

 

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such, the Combined Company would be subject to the requirements applicable to shell company business combinations. The requirements applicable to shell company business combinations are as follows:

•

the Combined Company will need to file a Form 8-K to report the Form 10 type information after closing with the SEC reflecting its status as an entity that is not a shell company;

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GlycoMimetics is not, and the Combined Company will not be, eligible to use a Form S-3 until 12 full calendar months after closing;

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the Combined Company will need to wait at least 60 calendar days after closing to file a Form S-8 for any equity plans or awards;

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•

the Combined Company will be an “ineligible issuer” for three years following the closing, which will prevent the Combined Company from (i) incorporating by reference in its Form S-1 filings, (ii) using a free writing prospectus, or (iii) taking advantage of well-known seasoned issuer status despite its public float;

​

•

investors who (i) are affiliates of Crescent at the time the Merger is submitted for the vote or consent of Crescent stockholders, (ii) receive securities of the Combined Company in the Merger (i.e., Rule 145(c) securities) and (iii) publicly offer or sell such securities, will be deemed to be engaged in a distribution of such securities, and therefore to be underwriters with respect to resales of those securities, and accordingly such securities may not be included in the Form S-1 resale registration statement anticipated to be filed after the closing of the Merger unless such securities are sold only in a fixed price offering in which such investors are named as underwriters in the prospectus; and

​

•

Rule 144(i)(2) will limit the ability to publicly resell Rule 145(c) securities per Rule 145(d), as well as any other “restricted” or “control” securities of the Combined Company per Rule 144 (i.e., holders of restricted securities and any affiliates of the public company are also affected) until one year after the Form 10 information is filed with the SEC.

​

The foregoing SEC requirements would increase the Combined Company’s time and cost of raising capital, offering stock under equity plans, and complying with securities laws. Further, such requirements will add burdensome restrictions on the resale of Combined Company shares by affiliates of Crescent and any holders of “restricted” or “control” securities.

Some of GlycoMimetics’ and Crescent’s directors and executive officers have interests in the Merger that are different from yours and that may influence them to support or approve the Merger without regard to your interests.

Directors and executive officers of GlycoMimetics and Crescent have interests in the Merger that are different from, or in addition to, the interests of other GlycoMimetics stockholders generally. These interests with respect to GlycoMimetics’ directors and executive officers may include, among others, retention bonus payments, extension of exercisability periods of previously issued stock option grants, severance payments if employment is terminated in a qualifying termination in connection with the Merger and rights to continued indemnification, expense advancement and insurance coverage.

Further, certain current members of the Crescent Board will continue as directors of the Combined Company after the effective time, and, following the closing of the Merger, will be eligible to be compensated as non-employee directors of the Combined Company pursuant to GlycoMimetics’ non-employee director compensation policy that is expected to remain in place following the effective time.

The GlycoMimetics Board was aware of and considered those interests, among other matters, in reaching their decisions to approve and adopt the Merger Agreement, approve the Merger, and recommend the approval of the Merger Agreement to GlycoMimetics and Crescent stockholders. These interests, among other factors, may have influenced the directors and executive officers of each company to support or approve the Merger.

GlycoMimetics stockholders and Crescent stockholders may not realize a benefit from the Merger commensurate with the ownership dilution they will experience in connection with the Merger, including the conversion of Crescent common stock issued in the Crescent Pre-Closing Financing.

If the Combined Company is unable to realize the full strategic and financial benefits currently anticipated from the Merger, GlycoMimetics stockholders and Crescent stockholders will have experienced

 

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substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent the Combined Company is able to realize only part of the strategic and financial benefits currently anticipated from the Merger.

GlycoMimetics securityholders will generally have a reduced ownership and voting interest in, and will exercise less influence over the management of, the Combined Company following the completion of the Merger as compared to their current ownership and voting interests in the respective companies.

After the completion of the Merger, GlycoMimetics’ current stockholders will generally own a smaller percentage of the Combined Company than their ownership of GlycoMimetics prior to the Merger. Immediately after the Merger, GlycoMimetics securityholders as of immediately prior to the Merger are expected to own approximately 2.6% of the outstanding shares of capital stock of the Combined Company (on a fully-diluted basis, and subject to dilution from any equity issued by Crescent after May 3, 2025 and before the closing), and former holders of Crescent securities are expected to own approximately 97.4% of the outstanding shares of capital stock of the Combined Company (on a fully-diluted basis), subject to certain assumptions, including, but not limited to, GlycoMimetics’ net cash as of closing being equal to $1.8 million. The Chief Executive Officer of Crescent will serve as the Chief Executive Officer of the Combined Company following the completion of the Merger.

Certain provisions of the Merger Agreement may discourage third parties from submitting competing proposals, including proposals that may be superior to the transactions contemplated by the Merger Agreement.

While the Merger Agreement is in effect, each party is generally prohibited from, among other things, soliciting, initiating or knowingly encouraging, inducing or facilitating the communication, making, submission or announcement of any acquisition proposal or acquisition inquiry. In addition, GlycoMimetics’ current directors and executive officers and certain significant stockholders have entered into support agreements pursuant to the terms of the Merger Agreement, and as an inducement to Crescent’s willingness to enter into the Merger Agreement, by which they have agreed to vote all of their shares of GlycoMimetics capital stock in favor of the Merger Agreement and the transactions contemplated thereby and against any competing proposals, subject to certain limited exceptions. These provisions could discourage a potential competing acquirer from considering or proposing an acquisition or merger, even if it were prepared to pay consideration with a higher value than that implied by the merger consideration in the combination.

Because the lack of a public market for Crescent common stock makes it difficult to evaluate the fair market value of its capital stock, the value of GlycoMimetics common stock to be issued to Crescent stockholders may be more or less than the fair market value of Crescent common stock.

The outstanding capital stock of Crescent is privately held and is not traded on any public market. The lack of a public market makes it difficult to determine the fair market value of Crescent capital stock. Because the percentage of GlycoMimetics’ equity to be issued to Crescent stockholders was determined based on negotiations between the parties, it is possible that the value of GlycoMimetics common stock and GlycoMimetics Series A Preferred Stock to be issued to Crescent stockholders will be more or less than the fair market value of Crescent capital stock.

Lawsuits may be filed against GlycoMimetics, Crescent, or any of the members of their respective boards of directors arising out of the Merger, which may delay or prevent the Merger.

Putative stockholder complaints, including stockholder class action complaints, and other complaints may be filed against GlycoMimetics, the GlycoMimetics Board, Crescent, the Crescent Board and others in connection with the transactions contemplated by the Merger Agreement. The outcome of litigation is uncertain, and GlycoMimetics or Crescent may not be successful in defending against any such future claims. Lawsuits that may be filed against GlycoMimetics, the GlycoMimetics Board, Crescent, or the Crescent Board could delay or prevent the Merger, divert the attention of GlycoMimetics’ and Crescent’s management and employees from their day-to-day business and otherwise adversely affect GlycoMimetics and Crescent financially.

 

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GlycoMimetics has never paid and, other than in connection with the Merger with Crescent, does not intend to pay any cash dividends in the foreseeable future.

GlycoMimetics has never paid cash dividends on any of its capital stock. GlycoMimetics does not currently anticipate declaring or paying cash dividends on its capital stock in the foreseeable future.

If GlycoMimetics does not successfully consummate the Merger or another strategic transaction, the GlycoMimetics Board may decide to pursue a dissolution and liquidation of GlycoMimetics. In such an event, the amount of cash available for distribution to GlycoMimetics stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that will need to be reserved for commitments and contingent liabilities, as to which GlycoMimetics can give you no assurance.

There can be no assurance that the Merger will be completed. If the Merger is not completed, the GlycoMimetics Board may decide to pursue a dissolution and liquidation of GlycoMimetics. In such an event, the amount of cash available for distribution to GlycoMimetics stockholders will depend heavily on the timing of such decision and, ultimately, such liquidation, since the amount of cash available for distribution continues to decrease as GlycoMimetics funds its operations while pursuing the Merger. In addition, if the GlycoMimetics Board were to approve and recommend, and GlycoMimetics stockholders were to approve, a dissolution and liquidation of GlycoMimetics, GlycoMimetics would be required under Delaware law to pay GlycoMimetics’ outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to stockholders. GlycoMimetics’ commitments and contingent liabilities may include obligations under GlycoMimetics’ employment and related agreements with certain employees that provide for severance and other payments following a termination of employment occurring for various reasons, including a change in control of GlycoMimetics, litigation against GlycoMimetics, and other various claims and legal actions arising in the ordinary course of business, and other unexpected and/or contingent liabilities. As a result of this requirement, a portion of GlycoMimetics’ assets would need to be reserved pending the resolution of such obligations.

In addition, GlycoMimetics may be subject to litigation or other claims related to a dissolution and liquidation of GlycoMimetics. If a dissolution and liquidation were to be pursued, the GlycoMimetics Board, in consultation with GlycoMimetics’ advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of GlycoMimetics common stock could lose all or a significant portion of their investment in the event of liquidation, dissolution or winding up of GlycoMimetics. A liquidation would be a lengthy and uncertain process with no assurance of any value ever being returned to GlycoMimetics stockholders.

GlycoMimetics and its stockholders will not have any right to make damage claims against Crescent for the breach of any representation, warranty or covenant made by Crescent in the Merger Agreement.

The Merger Agreement provides that all of the representations, warranties and covenants of the parties contained therein shall not survive the closing of the Merger, except for those covenants contained therein that by their terms apply or are to be performed in whole or in part after the Closing, and then only with respect to breaches occurring after the closing of the Merger. Accordingly, there are no remedies available to the parties with respect to any breach of the representations, warranties, covenants or agreements of the parties to the Merger Agreement after the Closing of the Merger, except for covenants to be performed in whole or in part after the Closing. As a result, GlycoMimetics and its stockholders will have no remedy available to it if the Merger is consummated and it is later revealed that there was a breach of any of the representations, warranties and covenants made by Crescent at the time of the Merger.

Additionally, GlycoMimetics cannot assure you that the due diligence conducted in relation to Crescent has identified all material issues or risks associated with Crescent, its business or the industry in which it competes. Furthermore, GlycoMimetics cannot assure you that factors outside of its or Crescent’s control will not later arise, or that any previously identified risks will not materialize in a manner inconsistent with the preliminary analysis. As a result of these factors, following the closing of the Merger, the Combined Company may be exposed to liabilities and incur additional costs and expenses and it may be forced to later write-down or write off assets, restructure its operations, or incur impairment or other charges. GlycoMimetics and its stockholders have no indemnification rights against Crescent or its stockholders under the Merger Agreement. Accordingly, any stockholders of GlycoMimetics that remain stockholders of the

 

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Combined Company following the Merger could suffer a reduction in the value of their securities. Such stockholders are unlikely to have a remedy for such reduction in value unless they are able to successfully claim that the reduction was due to the breach by GlycoMimetics’ directors or officers of a duty of care or other fiduciary duty owed to them, or if they are able to successfully bring a private claim under securities laws that the registration statement or proxy statement/prospectus relating to the Merger contained an actionable material misstatement or material omission.

Risks Related to the Proposed Reverse Stock Split

The reverse stock split could result in a significant devaluation of GlycoMimetics’ market capitalization and the trading price of GlycoMimetics common stock.

Although GlycoMimetics expects that the reverse stock split will result in an increase in the market price of GlycoMimetics common stock, GlycoMimetics cannot assure stockholders that the reverse stock split, if implemented, will increase the market price of GlycoMimetics common stock in proportion to the reduction in the number of shares of GlycoMimetics common stock outstanding or result in a permanent increase in the market price. Accordingly, the total market capitalization of GlycoMimetics common stock after the reverse stock split may be lower than the total market capitalization before such reverse stock split and, in the future, the market price of GlycoMimetics common stock following such reverse stock split may not exceed or remain higher than the market price prior to the corresponding reverse stock split.

The effect the reverse stock split may have upon the market price of GlycoMimetics common stock cannot be predicted with any certainty. The market price of GlycoMimetics common stock is dependent on many factors, including GlycoMimetics’ business and financial performance, general market conditions, prospects for future success and other factors detailed from time to time in the reports GlycoMimetics files with the SEC.

The reverse stock split may result in some stockholders owning “odd lots” that may be more difficult to sell or require greater transaction costs per share to sell.

The reverse stock split may result in some stockholders owning “odd lots” of less than 100 shares of GlycoMimetics common stock on a post-split basis. These odd lots may be more difficult to sell, or require greater transaction costs per share to sell, than shares in “round lots” of even multiples of 100 shares.

The reverse stock split may not generate additional investor interest.

While the GlycoMimetics Board believes that a higher stock price may help generate investor interest, there can be no assurance that the reverse stock split will result in a per share price that will attract institutional investors or investment funds or that such share price will satisfy the investing guidelines of institutional investors or investment funds. As a result, the trading liquidity of GlycoMimetics common stock may not necessarily improve.

The reverse stock split may not increase the Combined Company’s stock price over the long term.

The principal purposes of the reverse stock split are to (i) increase the per-share market price of GlycoMimetics common stock above the minimum bid price requirement under the Nasdaq rules so that the listing of GlycoMimetics and the shares of GlycoMimetics common stock being issued in the Merger on Nasdaq will be approved and (ii) increase the number of authorized and unissued shares available for future issuance in connection with the Merger, though such increase will not alone be sufficient to complete the Merger. It cannot be assured, however, that the reverse stock split will accomplish any increase in the per share market price of GlycoMimetics common stock for any meaningful period of time. While it is expected that the reduction in the number of outstanding shares of GlycoMimetics common stock will proportionally increase the market price of GlycoMimetics common stock, it cannot be assured that the reverse stock split will increase the market price of GlycoMimetics common stock by a multiple of the reverse stock split ratio mutually agreed by GlycoMimetics and Crescent, or result in any permanent or sustained increase in the market price of GlycoMimetics common stock, which is dependent upon many factors, including GlycoMimetics’ business and financial performance, general market conditions and

 

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prospects for future success. Thus, while the stock price of GlycoMimetics common stock might meet the listing requirements for Nasdaq initially after the reverse stock split, it cannot be assured that it will continue to do so.

The reverse stock split may decrease the liquidity of the Combined Company’s common stock.

Although the GlycoMimetics Board believes that the anticipated increase in the market price of the Combined Company’s common stock resulting from the proposed reverse stock split could encourage interest in its common stock and possibly promote greater liquidity for its stockholders, such liquidity could also be adversely affected by the reduced number of shares outstanding after the reverse stock split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for the Combined Company’s common stock. In addition, the reverse stock split may not result in an increase in the Combined Company’s stock price necessary to satisfy Nasdaq’s initial listing requirements for the Combined Company.

The reverse stock split may lead to a decrease in the Combined Company’s overall market capitalization.

Should the market price of the Combined Company’s common stock decline after the reverse stock split, the percentage decline will be greater, due to the smaller number of shares outstanding, than it would have been prior to the reverse stock split. A reverse stock split is often viewed negatively by the market and, consequently, can lead to a decrease in the Combined Company’s overall market capitalization. If the per share market price does not increase in proportion to the reverse stock split ratio, then the value of the Combined Company, as measured by its stock capitalization, will be reduced. In some cases, the per-share stock price of companies that have effected reverse stock splits subsequently declined back to pre-reverse split levels, and accordingly, it cannot be assured that the total market value of the Combined Company’s common stock will remain the same after the reverse stock split is effected, or that the reverse stock split will not have an adverse effect on the Combined Company’s stock price due to the reduced number of shares outstanding after the reverse stock split.

Risks Related to GlycoMimetics

Risks Related to GlycoMimetics’ Financial Position and Capital Needs

GlycoMimetics has incurred significant losses since its inception. GlycoMimetics expects to continue to incur losses and may never achieve or maintain profitability.

GlycoMimetics has incurred significant losses since its inception and, as of December 31, 2024, GlycoMimetics had an accumulated deficit of $494.4 million. In recent years, GlycoMimetics has financed its operations primarily with proceeds from public offerings of its common stock.

GlycoMimetics has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials. However, GlycoMimetics has not completed development of any drugs, and in July 2024, following the announcement of the data from its Phase 3 pivotal trial and its discussions with the FDA, GlycoMimetics announced that GlycoMimetics would initiate a review of strategic alternatives focused on maximizing stockholder value. GlycoMimetics also reduced its workforce by approximately 80% in order to conserve its cash resources as part of a streamlined operating plan while GlycoMimetics undertook its strategic review. Following the strategic review, GlycoMimetics entered into an acquisition agreement with Crescent to consummate the proposed Merger.

In connection with the termination of GlycoMimetics’ clinical programs, its research and development expenses have decreased. GlycoMimetics expects to continue to incur costs and expenditures in connection with the merger process. Based on its current operating plan, which includes the ceasing of its clinical development programs, GlycoMimetics expects that its current cash and cash equivalents will fund its operations until the closing of the Merger; however, GlycoMimetics has based this estimate on assumptions that may prove to be wrong, and GlycoMimetics could use its capital resources sooner than GlycoMimetics expects. There can be no assurance that the proposed Merger with Crescent, or any other course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated

 

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or lead to increased stockholder value. If GlycoMimetics is unable to close the Merger or raise additional capital, GlycoMimetics will need to eliminate some or all of its operations or liquidate.

GlycoMimetics expects to continue to incur significant expenses in connection with its ongoing activities, including continuing to operate as a public company. If GlycoMimetics were to resume clinical development activities in the future, GlycoMimetics would expect to incur significant additional expenses and operating losses.

To become and remain profitable, GlycoMimetics must succeed in developing and eventually commercializing drugs that generate significant revenue. This would require GlycoMimetics to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of its drug candidates, obtaining regulatory approval for these drug candidates and manufacturing and commercializing any drugs for which GlycoMimetics may obtain regulatory approval, as well as discovering additional drug candidates. If GlycoMimetics were to resume its development programs, GlycoMimetics may never succeed in these activities and, even if GlycoMimetics did, GlycoMimetics may never generate revenue that is significant enough to achieve profitability.

Even if GlycoMimetics achieves profitability, GlycoMimetics may not be able to sustain or increase profitability on a quarterly or annual basis. GlycoMimetics’ failure to become and remain profitable would depress the value of GlycoMimetics and could impair its ability to raise capital, expand its business, maintain its research and development efforts or even continue its operations. A decline in the value of GlycoMimetics could also result in significant harm to its financial position and adversely affect its stock price.

If GlycoMimetics decides to resume development of its drug candidates, GlycoMimetics would need substantial additional funding. If GlycoMimetics was unable to raise that capital when needed, GlycoMimetics may not be able to continue as a going concern and could be forced to delay, reduce or eliminate drug development programs or potential commercialization efforts.

If GlycoMimetics were to resume development of drug candidates, its capital requirements would depend on many factors, including:

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the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials;

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the number and development requirements of other drug candidates that GlycoMimetics may pursue;

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the costs, timing and outcome of regulatory review of its drug candidates;

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the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of its drug candidates for which GlycoMimetics receives marketing approval;

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the revenue, if any, received from commercial sales of its drug candidates for which GlycoMimetics receives marketing approval;

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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing its intellectual property rights and defending any intellectual property-related claims; and

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the extent to which GlycoMimetics acquires or in-licenses other drug candidates and technologies.

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Identifying potential drug candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and GlycoMimetics or any current or future collaborators may never generate the necessary data or results required to obtain regulatory approval and achieve product sales. In addition, drug candidates, if approved, may not achieve commercial success. Accordingly, if GlycoMimetics were to resume development activities, GlycoMimetics’ ability to fund its operations would be dependent upon management’s plans, which could include raising additional capital through a combination of equity and debt financings, collaborations and strategic alliances. However, there can be no assurances that new financings or other transactions will be available to GlycoMimetics on commercially acceptable terms, or at all. GlycoMimetics’ ability to raise additional capital could also be adversely impacted by global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide. If GlycoMimetics is unable to raise capital to fund its

 

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operations when needed or on attractive terms, GlycoMimetics could be forced to delay, reduce the scope of or eliminate its research and development programs or any future commercialization efforts.

Raising additional capital may cause dilution to GlycoMimetics’ stockholders, restrict its operations or require GlycoMimetics to relinquish rights to its drug candidates.

If GlycoMimetics were to resume its development activities, GlycoMimetics would expect to finance its cash needs through a combination of equity offerings, debt financings and license and development agreements until such time, if ever, as GlycoMimetics could generate substantial commercial revenues. To the extent that GlycoMimetics raises additional capital through the sale of equity or convertible debt securities, your ownership interest would be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

If GlycoMimetics were to raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, GlycoMimetics may be required to relinquish valuable rights to its research programs or drug candidates or grant licenses on terms that may not be favorable to GlycoMimetics or that may be at less than the full potential value of such rights. If GlycoMimetics is unable to raise additional funds through equity or debt financings or other arrangements with third parties when needed, GlycoMimetics may be required to delay, limit, reduce or terminate its drug development or future commercialization efforts or grant rights to third parties to develop and market drug candidates that GlycoMimetics would otherwise prefer to develop and market itself.

If GlycoMimetics fails to comply or regain compliance with Nasdaq’s continued listing standards, its common stock may be delisted and the price of its common stock, its ability to access the capital markets and its financial condition could be negatively impacted.

GlycoMimetics common stock was previously listed on The Nasdaq Global Market, and GlycoMimetics was required to meet certain listing requirements, including with respect to minimum closing bid prices, market value of publicly held shares, stockholders’ equity and market value of listed securities.

In June 2024, GlycoMimetics received notice from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, that GlycoMimetics was not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Market. Pursuant to Nasdaq listing rules, GlycoMimetics was provided an initial compliance period until December 18, 2024 to regain compliance. In order to qualify for additional time to regain compliance, GlycoMimetics transferred the listing of GlycoMimetics common stock from The Nasdaq Global Market to The Nasdaq Capital Market, which became effective as of December 20, 2024. In connection with that transfer, on December 19, 2024, GlycoMimetics received notice from Nasdaq that GlycoMimetics had been granted an additional 180 calendar days, or until June 16, 2025, to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

If necessary to regain compliance with Nasdaq listing standards, GlycoMimetics may, subject to approval of the GlycoMimetics Board and stockholders, implement a reverse stock split. However, there can be no assurance that a reverse stock split, or any other alternatives GlycoMimetics may consider to regain compliance with the minimum bid price requirement, would be approved or would result in a sustained higher stock price that would allow GlycoMimetics to meet the Nasdaq stock price listing requirements.

Separately, Nasdaq listing rules requires companies listed on the Nasdaq Capital Market to maintain a stockholders’ equity of at least $2.5 million. As of December 31, 2024, GlycoMimetics had stockholders’ equity of $5.3 million. As a result of GlycoMimetics’ expected decrease in stockholders’ equity prior to the Merger due to continued net losses, there can be no assurance that GlycoMimetics will be able to maintain the minimum required stockholders’ equity under the Nasdaq continued listing standards.

If GlycoMimetics is not able to maintain compliance within the compliance periods allotted by Nasdaq, its common stock could be delisted, which would have a further material adverse effect on the

 

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market price of its common stock and on stockholder liquidity. GlycoMimetics intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the listing requirement; however, there can be no assurance that GlycoMimetics will be able to regain compliance with the listing requirement or will otherwise be in compliance with the other Nasdaq listing criteria. If Nasdaq delists its common stock for failure to meet its listing standards, and its common stock is not eligible for quotation or listing on another market or exchange, GlycoMimetics and its stockholders could face significant negative consequences, including:

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trading of its common stock being conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities, such as the Pink Sheets or the OTC Bulletin Board, which could result in limited availability of market quotations for its common stock and increased difficulty of disposing of shares of common stock;

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a determination that the common stock is a “penny stock,” which would require brokers trading in the common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of its common stock;

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a limited amount of analyst coverage; and

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a decreased ability to issue additional securities or obtain additional financing in the future.

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Risks Related to the Discovery and Development of GlycoMimetics’ Drug Candidates

Should GlycoMimetics resume development of its drug candidates, its focus on discovering and developing novel glycomimetic drugs and its approach to discovering and developing drugs may never lead to marketable drugs.

A key element of GlycoMimetics’ prior development strategy was to use and expand its platform to build a pipeline of novel glycomimetic drug candidates and progress these drug candidates through clinical development for the treatment of a variety of diseases. The discovery of therapeutic drugs based on molecules that mimic the structure of carbohydrates is an emerging field, and the scientific discoveries that form the basis for GlycoMimetics’ past efforts to discover and develop drug candidates are relatively new. The scientific evidence to support the feasibility of developing drug candidates based on these discoveries is both preliminary and limited. Although its research and development efforts resulted in a pipeline of glycomimetic drug candidates, GlycoMimetics was unable to successfully progress those drug candidates through clinical trials. If GlycoMimetics were to resume its development activities, the drug candidates that GlycoMimetics identifies may not be suitable for clinical development, including as a result of being shown to have harmful side effects or other characteristics that indicate that they are unlikely to be drugs that will receive marketing approval and achieve market acceptance. If GlycoMimetics does not successfully develop and commercialize drug candidates based upon its glycomimetics platform, GlycoMimetics will not be able to obtain product revenue in future periods.

If GlycoMimetics were to resume development activities, GlycoMimetics would need to conduct additional clinical trials. All of its other drug candidates other than uproleselan were in earlier stages of clinical trials or in preclinical development.

Uproleselan is GlycoMimetics’ only drug candidate that was recently in a Phase 2 or Phase 3 clinical trial. In the second quarter of 2024, GlycoMimetics announced results of its pivotal Phase 3 clinical trial of uproleselan in R/R AML. The study of uproleselan combined with chemotherapy did not meet its primary endpoint of overall survival in the intent to treat population. Following the announcement of the data from the Phase 3 trial, GlycoMimetics requested and held a meeting with the FDA to discuss whether any of the results summarized above could serve as a basis for a submission for regulatory approval. Based on the feedback received, GlycoMimetics concluded that any potential regulatory path for uproleselan in this patient population would require an additional clinical trial, the conduct of which would require capital resources beyond those available to it.

GlycoMimetics’ other drug candidates were in earlier stages of clinical trials or in preclinical development. GlycoMimetics has not completed the development of any drug candidates, GlycoMimetics currently generates no revenue from the sale of any drugs, and even if GlycoMimetics were to resume its

 

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development activities, GlycoMimetics may never be able to develop a marketable drug. As a company, GlycoMimetics has no experience in submitting and obtaining FDA approval for an NDA. GlycoMimetics previously invested substantially all of its efforts and financial resources in the development of its glycomimetics platform, the identification of potential drug candidates using that platform and the development of its drug candidates. If GlycoMimetics were to resume development, its ability to generate revenue from its other drug candidates, would depend heavily on their successful development and eventual commercialization. The success of those drug candidates would depend on several factors, including:

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successful completion of preclinical studies and clinical trials;

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receipt of marketing approvals from applicable regulatory authorities;

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obtaining and maintaining patent and trade secret protection and regulatory exclusivity for its drug candidates;

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making arrangements with third-party manufacturers for, or establishing, commercial manufacturing capabilities;

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launching commercial sales of the drugs, if and when approved, whether alone or in collaboration with others;

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acceptance of the drugs, if and when approved, by patients, the medical community and third-party payors;

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effectively competing with other therapies;

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obtaining and maintaining healthcare coverage and adequate reimbursement;

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protecting its rights in its intellectual property portfolio; and

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maintaining a continued acceptable safety profile of the drugs following approval.

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Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. Should GlycoMimetics resume development of its drug candidates, GlycoMimetics may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of its drug candidates.

The risk of failure of GlycoMimetics’ drug candidates is high. It is impossible to predict when or if any of its drug candidates will prove safe or effective in humans or will receive regulatory approval. Before obtaining marketing approval from regulatory authorities for the sale of any drug candidate, GlycoMimetics or a collaborator must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of the drug candidate in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. For example, in May 2024, GlycoMimetics announced results of its pivotal Phase 3 clinical trial of uproleselan in R/R AML. Even though GlycoMimetics observed favorable results in earlier trials of uproleselan, uproleselan combined with chemotherapy did not meet the primary endpoint of overall survival in the intent to treat population in its Phase 3 trial. A failure of one or more clinical trials can occur at any stage of development. The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and interim results of a clinical trial do not necessarily predict final results. In addition, changes in patient treatment options over time may make the relevance of historical control data for a given indication less relevant to the drug candidate being studied, which could impact the success of the trial or, even if successful, the desirability of a successful drug candidate versus other available treatment options. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their drug candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.

If GlycoMimetics were to resume development activities, GlycoMimetics or its current or future collaborators may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent its or their ability to receive marketing approval or commercialize its drug candidates, including:

 

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regulators or institutional review boards may not authorize GlycoMimetics or its investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

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GlycoMimetics may experience delays in reaching, or fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

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clinical trials of its drug candidates may produce negative or inconclusive results, including failure to demonstrate statistical significance, and GlycoMimetics may decide, or regulators may require us, to conduct additional clinical trials or abandon drug development programs as GlycoMimetics has done with respect to uproleselan following the Phase 3 pivotal clinical trial;

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the number of patients required for clinical trials of its drug candidates may be larger than GlycoMimetics anticipates, enrollment in these clinical trials may be slower than GlycoMimetics anticipates or participants may drop out of these clinical trials at a higher rate than GlycoMimetics anticipates;

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its third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to GlycoMimetics in a timely manner, or at all;

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regulators or institutional review boards may require that GlycoMimetics or its investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

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the cost of clinical trials of its drug candidates may be greater than GlycoMimetics anticipates;

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the supply or quality of its drug candidates or other materials necessary to conduct clinical trials of its drug candidates may be insufficient or inadequate; and

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its drug candidates may have undesirable side effects or other unexpected characteristics, causing GlycoMimetics or its investigators, regulators or institutional review boards to suspend or terminate the trials.

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GlycoMimetics’ drug development costs would also increase if GlycoMimetics experiences delays in testing or marketing approvals. Preclinical studies or clinical trials may not begin as planned, could need to be restructured or may not be completed on schedule, or at all. Significant preclinical study or clinical trial delays also could shorten any periods during which GlycoMimetics may have the exclusive right to commercialize its drug candidates or allow its competitors to bring drugs to market before GlycoMimetics does, and thereby impair its ability to successfully commercialize its drug candidates.

Should GlycoMimetics resume development of its drug candidates, serious adverse or unacceptable side effects could be identified, in which case GlycoMimetics would need to abandon or limit their development.

If GlycoMimetics were to resume the development of its drug candidates and those candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, GlycoMimetics may need to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective. Many drug candidates that initially showed promise in early-stage testing have later been found to cause side effects that prevented their further development.

If GlycoMimetics were to resume development of its drug candidates, GlycoMimetics may expend its limited resources to pursue a particular drug candidate or indication and fail to capitalize on drug candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Even if GlycoMimetics resumes its drug development activities, GlycoMimetics would have limited financial and management resources and as a result would need to focus on a limited number of research programs and drug candidates. As a result, GlycoMimetics may forego or delay pursuit of opportunities with other drug candidates or for other indications that later prove to have greater commercial potential. GlycoMimetics’ resource allocation decisions could cause GlycoMimetics to fail to capitalize on viable commercial drugs or profitable market opportunities. GlycoMimetics’ spending on research and development programs and drug candidates for specific indications may not yield any commercially viable drugs. If GlycoMimetics does not accurately evaluate the commercial potential or target market for a particular drug

 

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candidate, GlycoMimetics may relinquish valuable rights to that drug candidate through collaboration, licensing or other arrangements in cases in which it would have been more advantageous for GlycoMimetics to retain sole development and commercialization rights.

Risks Related to GlycoMimetics’ Dependence on Third Parties

Should GlycoMimetics resume development activities, its success would depend in part on collaborations. If GlycoMimetics is unable to maintain any of these collaborations, or if these collaborations are not successful, its business could be adversely affected.

Even before its decision to cease development activities, GlycoMimetics had limited capabilities for drug development and do not have any capabilities for sales, marketing or distribution. If GlycoMimetics were to resume drug development, it expects that it would need to engage collaborators to support its operations. GlycoMimetics cannot assure you that collaborators will develop its drug candidates in a timely manner, or at all, or, if regulatory approval for a drug candidate is achieved, that such collaborator will successfully commercialize the candidate.

Any collaborations GlycoMimetics might enter into may pose a number of risks, including:

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collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;

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collaborators may not perform their obligations as expected;

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collaborators may not pursue the commercialization of any drug candidates that achieve regulatory approval or may elect not to pursue, continue or renew development or commercialization of drug candidates based on clinical trial results, changes in such collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;

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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a drug candidate, repeat or conduct new clinical trials or require a new formulation of a drug candidate for clinical testing;

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collaborators could experience delays in initiating or conducting clinical trials for any number of reasons;

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collaborators could independently develop, or develop with third parties, drugs that compete directly or indirectly with its drugs or drug candidates if such collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than GlycoMimetics’;

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drug candidates discovered in collaboration with GlycoMimetics may be viewed by its collaborators as competitive with their own drug candidates or drugs, which may cause such collaborators to cease to devote resources to the commercialization of its drug candidates;

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a collaborator with marketing and distribution rights to one or more of its drug candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such drug or drugs;

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disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of drug candidates, might lead to additional responsibilities for GlycoMimetics with respect to drug candidates or might result in litigation or arbitration, any of which would be time consuming and expensive;

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collaborators may not properly maintain or defend its or their intellectual property rights or may use its or their proprietary information in such a way as to invite litigation that could jeopardize or invalidate such intellectual property or proprietary information or expose GlycoMimetics to potential litigation;

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collaborators may infringe the intellectual property rights of third parties, which may expose GlycoMimetics to litigation and potential liability; and

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•

collaborations may be terminated for the convenience of the collaborator and, if terminated, GlycoMimetics could be required to raise additional capital to pursue further development or commercialization of the applicable drug candidates.

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If any collaborations GlycoMimetics might enter into do not result in the successful development and commercialization of drugs, or if one of its collaborators terminates its agreement with GlycoMimetics, GlycoMimetics may not receive any future research funding or milestone or royalty payments under the collaboration. For example, in 2020, GlycoMimetics’ former collaborator Pfizer terminated its license agreement with GlycoMimetics for the worldwide development and commercialization of its prior drug candidate rivipansel, thereby eliminating its right to receive any future development or commercialization milestones or royalty payments for sales of that drug candidate. In addition, even if GlycoMimetics is eligible to receive any such payments from a collaborator, they could be substantially delayed. If GlycoMimetics does not receive the funding it expects under these agreements, the development of its drug candidates could be delayed and GlycoMimetics may need additional resources to develop its drug candidates. All of the risks relating to drug development, regulatory approval and commercialization described in this report also apply to the activities of its collaborators.

If a current or future collaborator of ours is involved in a business combination, the collaborator might deemphasize or terminate development or commercialization of any drug candidate licensed to it by GlycoMimetics. If one of its collaborators terminates its agreement with GlycoMimetics, GlycoMimetics may find it more difficult to attract new collaborators and its reputation in the business and financial communities could be adversely affected. GlycoMimetics may in the future determine to collaborate with pharmaceutical and biotechnology companies for their development and potential commercialization of its drug candidates. GlycoMimetics faces significant competition in seeking appropriate collaborators. GlycoMimetics’ ability to reach a definitive agreement for a collaboration will depend, among other things, upon its assessment of a collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. If GlycoMimetics is unable to reach agreements with suitable collaborators on a timely basis, on acceptable terms, or at all, GlycoMimetics may have to curtail the development of a drug candidate, reduce or delay its development or one or more of its other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase its expenditures and undertake development or commercialization activities at its own expense. If GlycoMimetics elects to fund and undertake development or commercialization activities on its own, GlycoMimetics may need to obtain additional expertise and additional capital, which may not be available to GlycoMimetics on acceptable terms or at all. If GlycoMimetics fails to enter into collaborations and does not have sufficient funds or expertise to undertake the necessary development and commercialization activities, GlycoMimetics may not be able to further develop its drug candidates or bring them to market, which would impair its business prospects.

Should GlycoMimetics resume development of its drug candidates, GlycoMimetics would expect to rely on third parties to conduct additional clinical trials for its drug candidates, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials.

GlycoMimetics previously engaged a third-party contract research organization, or CRO, to conduct its clinical trials for uproleselan. If GlycoMimetics were to resume clinical development, GlycoMimetics would expect to engage CROs with respect to any further clinical trials of uproleselan or any of its other drug candidates that may progress to clinical development. GlycoMimetics would also expect to rely on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct those clinical trials. Agreements with such third parties might terminate for a variety of reasons, including a failure to perform by the third parties. If GlycoMimetics needs to enter into alternative arrangements, that would delay its drug development activities.

GlycoMimetics’ reliance on these third parties for research and development activities would reduce its control over these activities, but would not relieve GlycoMimetics of its responsibilities. For example, GlycoMimetics would remain responsible for ensuring that each of its clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires GlycoMimetics to comply with standards, commonly referred to as good clinical practices, or GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and

 

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accurate and that the rights, integrity and confidentiality of trial participants are protected. GlycoMimetics also is required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within specified timeframes. Failure to do so can result in fines, adverse publicity and significant civil and criminal sanctions.

Furthermore, these third parties may also have relationships with other entities, some of which may be GlycoMimetics’ competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct GlycoMimetics’ clinical trials in accordance with regulatory requirements or its stated protocols, GlycoMimetics will not be able to obtain, or may be delayed in obtaining, marketing approvals for its drug candidates and will not be able to, or may be delayed in its efforts to, successfully commercialize its drug candidates.

GlycoMimetics also expects to rely on other third parties to store and distribute drug supplies for any further clinical trials that GlycoMimetics were to conduct. Any performance failure on the part of its distributors could delay clinical development or marketing approval of its drug candidates or commercialization of GlycoMimetics’drugs, producing additional losses and depriving GlycoMimetics of potential revenue.

GlycoMimetics previously contracted with third parties for the manufacturing of its drug candidates for preclinical and clinical testing, and if GlycoMimetics were to resume development activities and pursue commercialization, GlycoMimetics would expect to continue to do so. This reliance on third parties increases the risk that GlycoMimetics would not have sufficient quantities of its drug candidates or drugs, or such quantities at an acceptable cost, which could delay, prevent or impair its potential development or commercialization efforts.

GlycoMimetics does not have any manufacturing facilities or personnel. GlycoMimetics has in the past relied on third parties for the manufacturing of its drug candidates for preclinical and clinical testing, as well as for potential commercial manufacture. If GlycoMimetics were to resume its drug development activities, GlycoMimetics would need to re-engage those third parties. Its reliance on third parties would increase the risk that GlycoMimetics will not have sufficient quantities of its drug candidates or drugs, or such quantities at an acceptable cost or quality, which could delay, prevent or impair its ability to timely conduct clinical trials or its other potential development or commercialization efforts.

GlycoMimetics would also expect to rely on third-party manufacturers or third-party collaborators for the manufacturing of commercial supply of any other drug candidates for which GlycoMimetics or its collaborators obtain marketing approval. For example, in January 2024 GlycoMimetics entered into an agreement with Patheon Manufacturing Services LLC, or Patheon, for manufacture and supply of uproleselan for commercial sale. Pursuant to the agreement, Patheon was to manufacture commercial quantities of injectable uproleselan from active pharmaceutical ingredient GlycoMimetics was to supply.

If GlycoMimetics were to resume its development activities, GlycoMimetics may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms. Even if GlycoMimetics is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

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reliance on the third party for regulatory compliance and quality assurance;

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the possible breach of the manufacturing agreement by the third party;

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the possible misappropriation of GlycoMimetics’ proprietary information, including its trade secrets and know-how; and

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the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for GlycoMimetics.

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Third-party manufacturers may not be able to comply with current good manufacturing practices, or cGMP, regulations or similar regulatory requirements outside the United States. GlycoMimetics’ failure, or the failure of its third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on GlycoMimetics, including clinical holds, fines, injunctions, civil penalties, delays, suspension

 

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or withdrawal of approvals, license revocation, seizures or recalls of drug candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of its drugs.

In addition, in the event that any of its third-party manufacturers fails to comply with such requirements or to perform its obligations to GlycoMimetics in relation to quality, timing or otherwise, or if its supply of components or other materials becomes limited or interrupted for other reasons, GlycoMimetics may be forced to manufacture the materials itself, for which GlycoMimetics currently does not have the capabilities or resources, or enter into an agreement with another third party, which GlycoMimetics may not be able to do on commercially reasonable terms, if at all. If its contract manufacturers cannot perform as agreed, GlycoMimetics may be required to replace such manufacturers and GlycoMimetics may incur added costs and delays in identifying and qualifying any such replacement. Any replacement of GlycoMimetics’ manufacturers could require significant effort and expertise because there may be a limited number of qualified replacements. If GlycoMimetics is required to change manufacturers for any reason, GlycoMimetics will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer could negatively affect GlycoMimetics’ ability to develop its drug candidates in a timely manner or within budget.

GlycoMimetics’ dependence upon others for the manufacturing of its drug candidates or drugs may adversely affect its ability to commercialize any drugs that receive marketing approval on a timely and competitive basis.

Risks Related to the Potential Commercialization of GlycoMimetics’ Drug Candidates

Should GlycoMimetics resume development of drug candidates, if any of those drug candidates were to receive marketing approval, it may still fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.

GlycoMimetics does not intend to continue development of uproleselan or any of its other product candidates. However, should GlycoMimetics decide to resume development activities and any of its drug candidates receives marketing approval, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. If its drug candidates do not achieve an adequate level of acceptance, GlycoMimetics may not generate significant revenue from drug sales and it may not become profitable. The degree of market acceptance of GlycoMimetics’ drug candidates, even if approved for commercial sale, would depend on a number of factors, including:

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the efficacy and potential advantages compared to alternative treatments;

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GlycoMimetics’ ability to offer its drugs for sale at competitive prices;

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the convenience and ease of administration compared to alternative treatments;

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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

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the strength of marketing and distribution support;

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the availability of third-party coverage and adequate reimbursement;

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the prevalence and severity of any side effects; and

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any restrictions on the use of GlycoMimetics’ drugs together with other medications.

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Should GlycoMimetics resume development of its drug candidates, GlycoMimetics would need to establish sales, marketing and distribution capabilities for its drug candidates and may not be successful in commercializing those drug candidates if approved.

Even prior to its decision to cease drug development and commercialization activities, GlycoMimetics did not have a sales or marketing infrastructure and had no experience in the sale, marketing or distribution of pharmaceutical drugs. If GlycoMimetics were to resume development, GlycoMimetics would need to

 

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establish a sales and marketing organization to market or co-promote any drugs that achieve marketing approval. There are risks involved with establishing sales, marketing and distribution capabilities. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a drug candidate for which GlycoMimetics recruits a sales force and establish marketing capabilities is delayed or does not occur for any reason, GlycoMimetics would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and its investment would be lost if GlycoMimetics cannot retain or reposition its sales and marketing personnel.

Other factors that could inhibit GlycoMimetics’ efforts to commercialize drugs on its own include:

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its inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;

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the inability of sales personnel to obtain access to physicians or its failure to educate adequate numbers of physicians on the benefits of any future drugs;

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the lack of complementary drugs to be offered by sales personnel, which could put GlycoMimetics at a competitive disadvantage relative to companies with more products; and

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unforeseen costs and expenses associated with creating an independent sales and marketing organization.

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If GlycoMimetics is unable to establish its own sales, marketing and distribution capabilities and therefore enter into arrangements with third parties to perform these services, its revenue and its profitability, if any, would likely be lower than if GlycoMimetics were to sell, market and distribute any drugs that GlycoMimetics develops itself. In addition, GlycoMimetics may not be successful in entering into arrangements with third parties to sell, market and distribute its drug candidates or may be unable to do so on terms that are favorable to GlycoMimetics. GlycoMimetics likely would have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market its drugs effectively. Even if GlycoMimetics were to resume drug development, in the event that GlycoMimetics does not establish sales, marketing and distribution capabilities successfully, either on its own or in collaboration with third parties, GlycoMimetics would not be successful in commercializing its drug candidates.

Should GlycoMimetics resume drug development, GlycoMimetics would face substantial competition, which may result in others discovering, developing or commercializing drugs before or more successfully than GlycoMimetics does.

The development and commercialization of new drugs is highly competitive. GlycoMimetics has faced competition with respect to its drug candidates, and should GlycoMimetics resume drug development GlycoMimetics would face competition with respect to any drug candidates that GlycoMimetics may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies, biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Should any competitors’ drug candidates receive regulatory or marketing approval prior to GlycoMimetics’, they may establish a strong market position and diminish the need for GlycoMimetics’ drug candidates.

The key competitive factors affecting the success of all of GlycoMimetics’ drug candidates, if approved, are likely to be their safety, efficacy, convenience, price, the level of generic competition and the availability of coverage and reimbursement from government and other third-party payors. To the extent that competitive drugs or drug candidates developed by others are successful in treating GlycoMimetics’ target indications, it would reduce the market opportunity for its drug candidates.

Many of the companies against which GlycoMimetics may compete in the future, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved drugs than GlycoMimetics does. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of GlycoMimetics’ competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with GlycoMimetics

 

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in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, its programs.

GlycoMimetics’ commercial opportunity could be reduced or eliminated if its competitors develop and commercialize drugs that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any drugs that GlycoMimetics may develop. GlycoMimetics’ competitors also may obtain FDA or other regulatory approval for their drugs more rapidly than GlycoMimetics may obtain approval for its, which could result in its competitors establishing a strong market position before GlycoMimetics is able to enter the market.

In addition, because GlycoMimetics has no patents with respect to its glycomimetics platform, its competitors may use its methods, or acquire similar expertise, in order to develop glycomimetic drug candidates and progress these drug candidates through clinical development and commercialization, which could impair its ability to successfully commercialize its drug candidates or otherwise limit its commercial opportunities.

Even if GlycoMimetics or its collaborators are able to commercialize any of its drug candidates, the drugs may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies.

GlycoMimetics’ and its collaborators’ ability to commercialize any of its drug candidates successfully would depend, in part, on the extent to which coverage and adequate reimbursement for these drugs and related treatments will be available from government payor programs at the federal and state levels authorities, including Medicare and Medicaid, private health insurers, managed care plans and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for drugs. Coverage and reimbursement may not be available for any drug that GlycoMimetics or its collaborators commercialize and, even if these are available, the level of reimbursement may not be satisfactory. Inadequate reimbursement levels may adversely affect the demand for, or the price of, any drug candidate for which GlycoMimetics or its collaborators obtain marketing approval. Obtaining and maintaining adequate reimbursement for its drugs may be difficult. GlycoMimetics may be required to conduct expensive pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement relative to other therapies. If coverage and adequate reimbursement are not available or reimbursement is available only to limited levels, GlycoMimetics or its collaborators may not be able to successfully commercialize any drug candidates for which marketing approval is obtained.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the indications for which the drug is approved by the FDA or similar regulatory authorities outside the United States. Moreover, eligibility for coverage and reimbursement does not imply that a drug will be paid for in all cases or at a rate that covers GlycoMimetics’ costs, including research, development, manufacture, sale and distribution expenses. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover GlycoMimetics’ costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. However, one payor’s determination to provide coverage for a drug does not assure that other payors will also provide coverage for the drug. GlycoMimetics’ or its collaborators’ inability to promptly obtain coverage and adequate reimbursement rates from both government-funded and private payors for any approved drugs that GlycoMimetics develops could adversely affect its operating results, its ability to raise capital needed to commercialize drugs and its overall financial condition.

 

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The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, GlycoMimetics or its collaborators might obtain marketing approval for a drug in a particular country, but then be subject to price regulations that delay commercial launch of the drug, possibly for lengthy time periods, and negatively impact its ability to generate revenue from the sale of the drug in that country. Adverse pricing limitations may hinder GlycoMimetics’ ability to recoup its investment in one or more drug candidates, even if its drug candidates obtain marketing approval.

There can be no assurance that GlycoMimetics’ drug candidates, if they are approved for sale in the United States or in other countries, will be considered medically reasonable and necessary for a specific indication, that they will be considered cost-effective by third-party payors, that coverage or an adequate level of reimbursement will be available or that third-party payors’ reimbursement policies will not adversely affect its ability to sell its drug candidates profitably if they are approved for sale.

Product liability lawsuits against GlycoMimetics could cause GlycoMimetics to incur substantial liabilities and to limit commercialization of any drugs that GlycoMimetics may develop.

GlycoMimetics faces an inherent risk of product liability exposure related to the testing of its drug candidates in human clinical trials, and will face an even greater risk if GlycoMimetics commercially sells any drugs that GlycoMimetics may develop. If GlycoMimetics cannot successfully defend itself against claims that its drug candidates or drugs caused injuries, GlycoMimetics will incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

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decreased demand for any drug candidates or drugs that GlycoMimetics may develop;

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injury to its reputation and significant negative media attention;

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withdrawal of clinical trial participants;

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significant costs to defend the related litigation;

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substantial monetary awards paid to trial participants or patients;

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loss of revenue;

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reduced resources of its management to pursue its business strategy; and

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the inability to commercialize any drugs that GlycoMimetics may develop.

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GlycoMimetics has carried clinical trial insurance coverage in an amount that GlycoMimetics believes was sufficient in relation to its clinical trials that were conducted in the United States and in foreign countries where GlycoMimetics had sites. The use of its drug candidates in clinical trials may result in liability claims for which its insurance would not be adequate to cover all liabilities that GlycoMimetics may incur. In addition, if GlycoMimetics were to resume drug development activities, GlycoMimetics may need to increase its insurance coverage as GlycoMimetics expands its clinical trials or if GlycoMimetics commences commercialization of its drug candidates. Insurance coverage is increasingly expensive. GlycoMimetics may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Risks Related to GlycoMimetics’ Intellectual Property

Should GlycoMimetics resume drug development activities but are unable to obtain and maintain patent protection for its drug candidates, or if the scope of the patent protection obtained is not sufficiently broad, its competitors could develop and commercialize drug candidates similar or identical to ours, and its ability to successfully commercialize its drug candidates may be impaired.

If GlycoMimetics elects to resume its drug development activities, its success would depend in large part on its ability to obtain and maintain patent protection in the United States and other countries with

 

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respect to its drug candidates. GlycoMimetics has in the past sought to protect its proprietary position by filing patent applications in the United States and abroad related to its drug candidates and would need to maintain its intellectual property rights should GlycoMimetics decide to further pursue the development of any of those drug candidates.

The patent prosecution process is expensive and time consuming, and GlycoMimetics may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that GlycoMimetics will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. GlycoMimetics may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed to third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of GlycoMimetics’ business.

The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years been the subject of much litigation. In addition, the laws of foreign countries may not protect GlycoMimetics’ rights to the same extent as the laws of the United States, or vice versa. For example, European patent law restricts the patentability of methods of treatment of the human body more than U.S. law does. Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, GlycoMimetics cannot know with certainty whether GlycoMimetics was the first to make the inventions claimed in its patents or pending patent applications, or that GlycoMimetics was the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of its patent rights are highly uncertain. GlycoMimetics’ pending and future patent applications may not result in patents being issued that protect its drug candidates, in whole or in part, or which effectively prevent others from commercializing competitive drug candidates. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of GlycoMimetics’ patents or narrow the scope of its patent protection.

Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of GlycoMimetics’ patent applications and the enforcement or defense of its issued patents. On September 16, 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted and may also affect patent litigation. The USPTO recently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first to file provisions, became effective on March 16, 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of GlycoMimetics’ business if GlycoMimetics were to continue the development of its drug candidates. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of GlycoMimetics’ patent applications and the enforcement or defense of GlycoMimetics’ issued patents, all of which could have a material adverse effect on GlycoMimetics’ business and financial condition.

Moreover, GlycoMimetics may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging its patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, GlycoMimetics’ patent rights, allow third parties to commercialize its drug candidates and compete directly with GlycoMimetics, without payment to GlycoMimetics, or result in its inability to manufacture or commercialize drugs without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by its patents and patent applications is threatened, it could dissuade companies from collaborating with GlycoMimetics to license, develop or commercialize current or future drug candidates.

Even if GlycoMimetics’ patent applications issue as patents, they may not issue in a form that will provide GlycoMimetics with any meaningful protection, prevent competitors from competing with

 

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GlycoMimetics or otherwise provide GlycoMimetics with any competitive advantage. GlycoMimetics’ competitors may be able to circumvent its patents by developing similar or alternative drug candidates in a non-infringing manner.

In addition, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and GlycoMimetics’ patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit GlycoMimetics’ ability to stop others from using or commercializing similar or identical drug candidates, or limit the duration of the patent protection of GlycoMimetics’ drug candidates. Given the amount of time required for the development, testing and regulatory review of new drug candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, GlycoMimetics’ patent portfolio may not provide it with sufficient rights to exclude others from commercializing drugs similar or identical to its drugs.

GlycoMimetics may become involved in lawsuits to protect or enforce its patents or other intellectual property, which could be expensive, time consuming and unsuccessful.

Competitors may infringe GlycoMimetics’ issued patents or other intellectual property. To counter infringement or unauthorized use, GlycoMimetics may be required to file infringement claims, which can be expensive and time consuming. Any claims GlycoMimetics asserts against perceived infringers could provoke these parties to assert counterclaims against GlycoMimetics alleging that GlycoMimetics infringes their patents. In addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that GlycoMimetics’ patents do not cover the technology. An adverse result in any litigation proceeding could put one or more of GlycoMimetics’ patents at risk of being invalidated or interpreted narrowly.

GlycoMimetics may need to license intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms.

A third party may hold intellectual property, including patent, rights that are important or necessary to the development of GlycoMimetics’ drug candidates should GlycoMimetics elect to resume such activities. It may be necessary for GlycoMimetics to use patented or proprietary technology of third parties to commercialize its drug candidates, in which case GlycoMimetics would be required to obtain a license from these third parties on commercially reasonable terms, or GlycoMimetics’ business could be harmed, possibly materially.

Third parties may initiate legal proceedings alleging that GlycoMimetics is infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of its business.

If GlycoMimetics were to resume drug development, its commercial success would depend upon its ability, and the ability of its collaborators, to develop, manufacture, market and sell its drug candidates without infringing the proprietary rights of third parties. There is considerable intellectual property litigation in the biotechnology and pharmaceutical industries. GlycoMimetics may become party to, or threatened with, future adversarial proceedings or litigation regarding intellectual property rights with respect to its drug candidates, including interference or derivation proceedings before the USPTO. Third parties may assert infringement claims against GlycoMimetics based on existing patents or patents that may be granted in the future.

If GlycoMimetics is found to infringe a third party’s intellectual property rights, GlycoMimetics could be required to obtain a license from such third party to continue developing and marketing its drug candidates. However, GlycoMimetics may not be able to obtain any required license on commercially reasonable terms or at all. Even if GlycoMimetics was able to obtain a license, it could be non-exclusive, thereby giving its competitors access to the same technologies licensed to GlycoMimetics. GlycoMimetics could be forced, including by court order, to cease commercializing the infringing drug. In addition, GlycoMimetics could be found liable for monetary damages, including treble damages and attorneys’ fees if

 

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GlycoMimetics is found to have willfully infringed a patent. A finding of infringement could prevent GlycoMimetics from commercializing its drug candidates or force GlycoMimetics to cease some of its business operations. Claims that GlycoMimetics has misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on its business.

GlycoMimetics may be subject to claims by third parties asserting that GlycoMimetics or its employees have misappropriated their intellectual property, or claiming ownership of what GlycoMimetics regards as its own intellectual property.

Many of GlycoMimetics’ current and former employees were previously employed at universities or other biotechnology or pharmaceutical companies. Although GlycoMimetics has tried to ensure that its employees do not use the proprietary information or know-how of others in their work for it, GlycoMimetics may be subject to claims that these employees or GlycoMimetics has used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Litigation may be necessary to defend against these claims.

In addition, while it is GlycoMimetics’ policy to require its employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to GlycoMimetics, GlycoMimetics may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that GlycoMimetics regards as its own. GlycoMimetics’ assignment agreements may not be self-executing or may be breached, and GlycoMimetics may be forced to bring claims against third parties, or defend claims they may bring against GlycoMimetics, to determine the ownership of what GlycoMimetics regards as its intellectual property.

If GlycoMimetics fails in prosecuting or defending any such claims, in addition to paying monetary damages, GlycoMimetics may lose valuable intellectual property rights or personnel. Even if GlycoMimetics is successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to management.

Intellectual property litigation could cause GlycoMimetics to spend substantial resources and distract its personnel from their normal responsibilities.

Even if resolved in its favor, litigation or other legal proceedings relating to intellectual property claims may cause GlycoMimetics to incur significant expenses and could distract its technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments, and if securities analysts or investors perceive these results to be negative it could have a substantial adverse effect on the price of GlycoMimetics common stock. Such litigation or proceedings could substantially increase GlycoMimetics’ operating losses and reduce the resources available for potential development activities or any future sales, marketing or distribution activities. GlycoMimetics may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of its competitors may be able to sustain the costs of such litigation or proceedings more effectively than GlycoMimetics can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise its ability to compete in the marketplace.

If GlycoMimetics is unable to protect the confidentiality of its trade secrets, its business and competitive position would be harmed.

In addition to seeking patents for its drug candidates, GlycoMimetics has also relied on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain its historical competitive position. For example, its platform was based on trade secrets that consist largely of expertise in carbohydrate chemistry and knowledge of carbohydrate biology. GlycoMimetics does not believe that GlycoMimetics can obtain patent protection for its platform. Thus, GlycoMimetics’ competitors may use its methods, or acquire similar expertise, in order to develop glycomimetic drug candidates and progress these drug candidates through clinical development and commercialization, which could impair its ability to successfully commercialize its drug candidates.

 

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GlycoMimetics has sought to protect its trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as its employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. GlycoMimetics has also entered into confidentiality and invention or patent assignment agreements with its current and former employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose GlycoMimetics’ proprietary information, including its trade secrets, and GlycoMimetics may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of its trade secrets were to be lawfully obtained or independently developed by a competitor, GlycoMimetics would have no right to prevent them, or those to whom they communicate it, from using that technology or information to compete with GlycoMimetics. If any of GlycoMimetics’ trade secrets were to be disclosed to or independently developed by a competitor, its competitive position would be harmed.

Risks Related to Regulatory Approval of GlycoMimetics’ Drug Candidates and Other Legal Compliance Matters

Should GlycoMimetics resume development of its drug candidates but GlycoMimetics or its collaborators are not able to obtain, or if there are delays in obtaining, required regulatory approvals, GlycoMimetics or they would not be able to commercialize its drug candidates and its ability to generate revenue would be materially impaired.

In the event that GlycoMimetics resumes development of its drug candidates, the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale and distribution, would be subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by the EMA and similar regulatory authorities outside the United States. Failure to obtain marketing approval for a drug candidate would prevent GlycoMimetics or its collaborators from commercializing the drug candidate. GlycoMimetics has not received approval to market any of its drug candidates from regulatory authorities in any jurisdiction. GlycoMimetics has only limited experience in filing and supporting the applications necessary to gain marketing approvals and would expect to rely on third-party CROs to assist GlycoMimetics in this process. Securing marketing approval requires the submission of extensive preclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the drug candidate’s safety and efficacy. Securing marketing approval also requires the submission of information about the product manufacturing process to, and inspection of manufacturing facilities by, applicable regulatory authorities. GlycoMimetics’ drug candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude its ability to obtain marketing approval or prevent or limit commercial use. If any of GlycoMimetics’ drug candidates receives marketing approval, the accompanying label may limit the approved use of its drug, which could limit sales of the drug.

The process of obtaining marketing approvals, both in the United States and abroad, is expensive and may take many years if additional clinical trials are required, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the drug candidates involved. Changes in marketing approval policies during the development period, changes in or the enactment of additional statutes or regulations or changes in regulatory review for each submitted drug application may cause delays in the approval or rejection of an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application, or may decide that GlycoMimetics’ data are insufficient for approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit or prevent marketing approval of a drug candidate. Any marketing approval GlycoMimetics ultimately obtains may be limited or subject to restrictions or post-approval commitments that render the approved drug not commercially viable.

If GlycoMimetics resumes development activities but experiences delays in obtaining approval or if GlycoMimetics fails to obtain approval of its drug candidates, the commercial prospects for its drug candidates may be harmed and its ability to generate revenue will be materially impaired.

 

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Even though GlycoMimetics previously obtained Orphan Drug designation for several of its drug candidates, GlycoMimetics may not be able to obtain orphan drug marketing exclusivity for these or any of its other drug candidates should GlycoMimetics resume their development.

Regulatory authorities in some jurisdictions, including the United States and the European Union, or EU, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. GlycoMimetics previously obtained Orphan Drug designation from the FDA for some of its drug candidates. However, in order to obtain marketing exclusivity in a particular jurisdiction, GlycoMimetics must receive the first marketing approval of the drug for its intended indication. In addition, the orphan designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.

Generally, if a drug with an orphan designation subsequently receives the first marketing approval for the indication for which it has such designation, the drug is entitled to a period of marketing exclusivity, which precludes the FDA or the EMA from approving another marketing application for the same drug for the same indication for that time period. The applicable period is seven years in the United States and 10 years in the EU. The EU exclusivity period can be reduced to six years if a drug no longer meets the criteria for orphan designation or if the drug is sufficiently profitable so that market exclusivity is no longer justified. Orphan drug exclusivity may be lost if the FDA or the EMA determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantity of the drug to meet the needs of patients with the rare disease or condition.

Even though GlycoMimetics has obtained orphan drug exclusivity for a drug candidate, that exclusivity may not effectively protect the candidate from competition because different drugs can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve another drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care.

Even if GlycoMimetics were to resume the development of uproleselan, the FDA fast track designation and additional breakthrough therapy designation for uproleselan may not actually lead to a faster development or regulatory review or approval process.

If a drug is intended for the treatment of a serious or life-threatening disease or condition and the drug demonstrates the potential to address unmet medical needs for this disease or condition, the drug sponsor may apply for the FDA fast track designation. If fast track designation is obtained, the FDA may initiate review of sections of a NDA before the application is complete. This “rolling review” is available if the applicant provides, and the FDA approves, a schedule for submission of the individual sections of the application.

Although GlycoMimetics previously obtained a fast track designation from the FDA for uproleselan to treat AML and breakthrough therapy designation for uproleselan to treat AML, even if GlycoMimetics were to continue to advance uproleselan toward potential regulatory approval, GlycoMimetics may not experience a faster development process, review or approval compared to conventional FDA procedures. Its fast track designation may be withdrawn by the FDA if it believes that the designation is no longer supported by data from its clinical development programs. Its fast track designation does not guarantee that GlycoMimetics will qualify for or be able to take advantage of the expedited review procedures or obtain regulatory approval.

Failure to obtain marketing approval in international jurisdictions would prevent GlycoMimetics drug candidates from being marketed abroad.

In order to market and sell its drugs in the EU and any other jurisdictions, GlycoMimetics or its collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with

 

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obtaining FDA approval. In addition, in many countries outside the United States, it is required that the drug be approved for reimbursement before it can be approved for sale in that country. If GlycoMimetics resumes development activities, GlycoMimetics or its collaborators may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. However, failure to obtain approval in one jurisdiction may impact GlycoMimetics’ ability to obtain approval elsewhere. GlycoMimetics or its collaborators may not be able to file for marketing approvals and may not receive necessary approvals to commercialize its drugs in any market.

Should GlycoMimetics resume drug development activities, a variety of risks associated with developing and marketing its drug candidates internationally could hurt its business.

If GlycoMimetics were to continue the development of its drug candidates, GlycoMimetics or its collaborators may seek regulatory approval for its drug candidates outside of the United States and, accordingly, GlycoMimetics expects that GlycoMimetics will be subject to additional risks related to operating in foreign countries if GlycoMimetics obtains the necessary approvals, including:

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differing regulatory requirements in foreign countries;

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the potential for so-called parallel importing, which is what happens when a local seller, faced with high or higher local prices, opts to import goods from a foreign market with low or lower prices rather than buying them locally;

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unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

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economic weakness, including inflation or political instability in particular foreign economies and markets;

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compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;

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foreign taxes, including withholding of payroll taxes;

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foreign currency fluctuations, which could result in increased operating expenses and reduced revenues, and other obligations related to doing business in another country;

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difficulties staffing and managing foreign operations;

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workforce uncertainty in countries where labor unrest is more common than in the United States;

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potential liability under the Foreign Corrupt Practices Act or comparable foreign regulations;

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challenges enforcing its contractual and intellectual property rights, especially in foreign countries that do not respect and protect intellectual property rights to the same extent as the United States;

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production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and

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business interruptions resulting from pandemic, epidemic or disease outbreaks or geo-political actions, including war and terrorism.

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Any drug candidate for which GlycoMimetics obtains marketing approval could be subject to post-marketing restrictions or recall or withdrawal from the market, and GlycoMimetics may therefore be subject to penalties if GlycoMimetics fails to comply with regulatory requirements or if GlycoMimetics experiences unanticipated problems with its drug candidates, when and if any of them are approved.

Any drug candidate for which GlycoMimetics obtains marketing approval, along with manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such drug candidate, will be subject to continual requirements of and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports,

 

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registration and listing requirements, cGMP requirements relating to manufacturing, quality control, quality assurance and corresponding maintenance of records and documents, requirements regarding the distribution of samples to physicians and recordkeeping. Even if marketing approval of a drug candidate is granted, the approval may be subject to limitations on the indicated uses for which the drug may be marketed or to the conditions of approval, including the requirement to implement a risk evaluation and mitigation strategy. If any of GlycoMimetics’ drug candidates receives marketing approval, the accompanying label may limit the approved use of GlycoMimetics’ drug, which could limit its sales.

The FDA may also impose requirements for costly post-marketing studies or clinical trials and surveillance to monitor the safety or efficacy of the drug. The FDA closely regulates the post-approval marketing and promotion of drugs to ensure drugs are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use, and if GlycoMimetics does not market its drugs for their approved indications, GlycoMimetics may be subject to enforcement action for off-label marketing. Violations of the Federal Food, Drug, and Cosmetic Act relating to the promotion of prescription drugs may lead to investigations alleging violations of federal and state healthcare fraud and abuse laws, as well as state consumer protection laws.

In addition, later discovery of previously unknown adverse events or other problems with GlycoMimetics’ drugs, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may have negative consequences, including:

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restrictions on such drugs, manufacturers or manufacturing processes;

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restrictions on the labeling or marketing of a drug;

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restrictions on product distribution or use;

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requirements to conduct post-marketing studies or clinical trials;

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warning letters;

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recall or withdrawal of the drugs from the market;

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refusal to approve pending applications or supplements to approved applications that GlycoMimetics submits;

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clinical holds;

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fines, restitution or disgorgement of revenue or profit;

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suspension or withdrawal of marketing approvals;

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refusal to permit the import or export of GlycoMimetics’ drugs;

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product seizure; or

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injunctions or the imposition of civil or criminal penalties.

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Non-compliance with the EU requirements regarding safety monitoring or pharmacovigilance, and with requirements related to the development of drugs for the pediatric population, can also result in significant financial penalties. Similarly, failure to comply with the EU’s requirements regarding the protection of personal information can also lead to significant penalties and sanctions.

GlycoMimetics’ business and relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose GlycoMimetics to significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Healthcare providers and third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of any drug candidates for which GlycoMimetics obtains marketing approval. Any arrangements with third-party payors and customers may expose GlycoMimetics to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal

 

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Anti-Kickback Statute and the federal False Claims Act, which may constrain the business or financial arrangements and relationships through which GlycoMimetics conducts clinical research, sell, market and distribute any drugs for which GlycoMimetics obtains marketing approval. In addition, GlycoMimetics may be subject to transparency laws and patient data privacy and security regulation by the U.S. federal and state governments and by governments in foreign jurisdictions in which GlycoMimetics conducts its business. The applicable federal, state and foreign healthcare laws and regulations that may affect its ability to operate include:

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the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs, such as Medicare and Medicaid;

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federal civil and criminal false claims laws, including the federal False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, and civil monetary penalty laws that prohibit individuals or entities for knowingly presenting, or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

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the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business associates and covered subcontractors that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

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the federal Open Payments program, pursuant to the Physician Payments Sunshine Act, which requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists, optometrists, podiatrists and chiropractors, other healthcare professionals (such as physician assistants and nurse practitioners) and teaching hospitals, and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members, with disclosure of such information to be made by CMS on a publicly available website; and

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; state and foreign laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers; state and foreign laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; state and local laws requiring the registration of pharmaceutical sales representatives; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

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Efforts to ensure that GlycoMimetics’ business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial costs. It is possible that governmental authorities will conclude that GlycoMimetics’ business practices may not comply with current or future

 

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statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If GlycoMimetics’ operations are found to be in violation of any of these laws or any other governmental regulations that may apply to GlycoMimetics, it may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, fines, individual imprisonment, additional reporting requirements and oversight if GlycoMimetics becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, contractual damages, reputational harm, diminished profits and future earnings, disgorgement, exclusion from participation in government healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of GlycoMimetics’ operations, which could have a material adverse effect on GlycoMimetics’ business. If any of the physicians or other healthcare providers or entities with whom GlycoMimetics expects to do business, including its collaborators, is found not to be in compliance with applicable laws, it may be subject to criminal, civil or administrative sanctions, including exclusions from participation in government healthcare programs, which could also materially affect its business.

Even if GlycoMimetics were to resume drug development activities, recently enacted and future legislation may increase the difficulty and cost for GlycoMimetics to obtain marketing approval of and commercialize its drug candidates and affect the prices GlycoMimetics may obtain.

In the United States and some foreign jurisdictions, there have been a number of enacted and proposed legislative and regulatory changes regarding the healthcare system that could prevent or delay marketing approval of GlycoMimetics’ drug candidates, restrict or regulate post-approval activities and affect its ability to profitably sell any drug candidates for which GlycoMimetics obtains marketing approval.

Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts, which include major legislative initiatives to reduce the cost of care through changes in the healthcare system, including limits on the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded health care programs, and increased governmental control of drug. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “PRACA”), is a sweeping law intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, improve quality of care, enhance remedies against fraud and abuse, add new transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. The PPACA, among other things, increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs; required collection of rebates for drugs paid by Medicaid managed care organizations; required manufacturers to participate in a coverage gap discount program, under which they must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D; imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs, implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected; expanded the types of entities eligible for the 340B drug discount program; expanded eligibility criteria for Medicaid programs; created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research; and established a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

There have been amendments and judicial and Congressional challenges to certain aspects of PPACA. For example, in 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in PPACA marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program. It is possible that the PPACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and additional reform measures

 

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of the second Trump administration will impact the PPACA. Additional legislative proposals to reform healthcare and government insurance programs, along with the trend toward managed healthcare in the United States, could influence the purchase of medicines and reduce reimbursement and/or coverage of GlycoMimetics’ product candidates, if approved. Current and future healthcare reform measures may result in more rigorous coverage criteria and in additional downward pressure on the price that GlycoMimetics receives for any approved drug. Any reduction in reimbursement from Medicare or other government-funded programs may result in a similar reduction in payments from private payors.

In addition, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. For example, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs that have been on the market for at least seven years and covered under Medicare, known as the Medicare Drug Price Negotiation Program, and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions began to take effect progressively in fiscal year 2023. In August 2024, HHS announced the agreed-upon prices of the first 10 drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges. On January 17, 2025, HHS selected fifteen additional drugs covered under Part D for price negotiation in 2025. Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.

Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act was announced. On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights. While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing. The implementation of cost containment measures or other healthcare reforms may prevent GlycoMimetics from being able to generate revenue, attain profitability or commercialize its drugs.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for drugs. GlycoMimetics cannot be sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of its drug candidates, if any, may be. In addition, increased scrutiny by the U.S. Congress of the FDA’s approval process may significantly delay or prevent marketing approval, as well as subject GlycoMimetics to more stringent product labeling and post-marketing testing and other requirements.

Governments outside the United States tend to impose strict price controls, which may adversely affect GlycoMimetics’ revenue, if any, from the potential commercialization of drug candidates.

In some countries, particularly in the EU, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a drug. To obtain coverage and reimbursement or pricing approval in some countries, GlycoMimetics may be required to conduct a clinical trial that compares the cost-effectiveness of its drug candidate to other available therapies. If reimbursement of GlycoMimetics’ drugs is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, its business could be harmed, possibly materially, to the extent that GlycoMimetics seeks to commercialize drugs.

If GlycoMimetics fails to comply with environmental, health and safety laws and regulations, GlycoMimetics could become subject to fines or penalties or incur costs that could harm its business.

GlycoMimetics is subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous

 

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materials and wastes. GlycoMimetics’ prior operations involved the use of hazardous and flammable materials, including chemicals and biological materials. GlycoMimetics’ prior operations also produced hazardous waste products. GlycoMimetics has generally contracted with third parties for the disposal of these materials and wastes. GlycoMimetics cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from its use of hazardous materials, GlycoMimetics could be held liable for any resulting damages, and any liability could exceed its resources. GlycoMimetics also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations.

Although GlycoMimetics has historically maintained workers’ compensation insurance to cover GlycoMimetics for costs and expenses GlycoMimetics may incur due to injuries to its employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. GlycoMimetics does not maintain insurance for environmental liability or toxic tort claims that may be asserted against GlycoMimetics in connection with its storage or disposal of biological, hazardous or radioactive materials.

In addition, to the extent GlycoMimetics resumes significant drug development activities, GlycoMimetics may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair its research, development or production efforts. GlycoMimetics’ failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Risks Related to GlycoMimetics’ Operations

GlycoMimetics’ employees and employees of its collaborators may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.

GlycoMimetics and its collaborators are exposed to the risk of employee fraud or other misconduct. Misconduct by employees could include intentional failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with manufacturing standards GlycoMimetics has established, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data accurately or to disclose unauthorized activities to GlycoMimetics. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Employee misconduct could also involve the improper use of individually identifiable information, including, without limitation, information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to GlycoMimetics’ reputation. GlycoMimetics has adopted a code of business conduct and ethics, but it is not always possible to identify and deter employee misconduct, and the precautions GlycoMimetics takes to detect and prevent improper activities may not be effective in controlling unknown or unmanaged risks or losses or in protecting GlycoMimetics from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations. If any such actions are instituted against GlycoMimetics, and GlycoMimetics is not successful in defending itself or asserting its rights, or any such actions are instituted against any of its collaborators, those actions could have a significant impact on its business, including the imposition of significant fines or other sanctions.

If GlycoMimetics’ information technology systems or data, or those of third parties upon which GlycoMimetics relies, are or were compromised, GlycoMimetics could experience adverse consequences resulting from such compromise, including, but not limited to, regulatory investigations or actions; litigation; fines and penalties; a disruption of its business operations, including its clinical trials; reputational harm; loss of revenue and profits; and other adverse consequences.

In the ordinary course of its business, GlycoMimetics and the third parties upon which GlycoMimetics has relied collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets. GlycoMimetics has

 

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also relied upon third parties, such as service providers, for its data processing-related activities and has shared or received sensitive data with or from third parties. To the extent GlycoMimetics resumes its drug development activities, GlycoMimetics will be increasingly dependent on information technology systems and infrastructure, including mobile technologies, to operate its business. Cyberattacks, malicious internet-based activity, and online and offline fraud are prevalent and continue to increase. These threats are becoming increasingly difficult to detect. These threats come from a variety of sources, including traditional computer “hackers,” threat actors, personnel (such as through theft or misuse), sophisticated nation states, and nation-state-supported actors. Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities.

During times of war and other major conflicts, GlycoMimetics and the third parties upon which GlycoMimetics may rely could be vulnerable to a heightened risk of these attacks, including cyber-attacks that could materially disrupt its systems and operations, supply chain, and ability to operate clinical trials and develop its drug candidates. GlycoMimetics and the third parties upon which GlycoMimetics may rely could also be subject to a variety of evolving threats, including but not limited to social-engineering attacks (including through deep fakes, which may be increasingly more difficult to identify as fake, and phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing), personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, attacks enhanced or facilitated by artificial intelligence (AI), telecommunications failures, earthquakes, fires, floods, and other similar threats. Ransomware attacks, including those perpetrated by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe and can lead to significant interruptions in GlycoMimetics’ operations, loss of data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but GlycoMimetics may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

If GlycoMimetics resumes its drug development activities, GlycoMimetics expects that GlycoMimetics would need to rely on third parties and technologies to operate critical business systems to process sensitive information in a variety of contexts, including, without limitation, cloud-based infrastructure, data center facilities, encryption and authentication technology, employee email, content delivery to customers, and other functions. GlycoMimetics would also rely on CROs and CMOs. GlycoMimetics’ ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If the third parties GlycoMimetics may rely upon experience a security incident or other interruption, GlycoMimetics could experience adverse consequences. While GlycoMimetics may be entitled to damages if the third parties it relies upon fail to satisfy their privacy or security-related obligations to GlycoMimetics, any award may be insufficient to cover its damages, or GlycoMimetics may be unable to recover such award. Similarly, supply-chain attacks have increased in frequency and severity, and GlycoMimetics cannot guarantee that third parties and infrastructure in its potential supply chain or its third-party partners’ supply chains have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to its information technology systems or the third-party information technology systems that would support GlycoMimetics and its services.

Remote work has also increased risks to GlycoMimetics’ information technology systems and data, as its current and former employees have utilized network connections, computers and devices outside its premises or network, including working at home, while in transit and in public locations. Future or past business transactions could expose GlycoMimetics to additional cybersecurity risks and vulnerabilities, as its systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, GlycoMimetics may discover security issues that were not found during due diligence of such acquired or integrated entities, and it may be difficult to integrate companies into its information technology environment and security program.

While GlycoMimetics previously implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. GlycoMimetics has taken steps

 

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designed to detect, mitigate, and remediate vulnerabilities in its information systems (such as its hardware and/or software, including that of third parties upon which GlycoMimetics has relied). GlycoMimetics may not, however, have detected and remediated all such vulnerabilities on a timely basis. GlycoMimetics may experience further delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident.

Any of the previously identified or similar threats could cause a security incident. A security incident could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to data. A security incident could disrupt its ability (and that of third parties upon whom GlycoMimetics relies) to conduct its business. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in its regulatory approval efforts and significantly increase its costs to recover or reproduce the data. GlycoMimetics may expend significant resources or modify its business activities (including its clinical trial activities) in an effort to protect against security incidents. Certain data privacy and security obligations may require GlycoMimetics to implement and maintain specific security measures, industry-standard or reasonable security measures to protect its information technology systems and data. Applicable data privacy and security obligations may require GlycoMimetics to notify relevant stakeholders of security incidents, including affected individuals, customers, regulators, and investors. Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences. If GlycoMimetics (or a third party upon whom GlycoMimetics relies) experiences a security incident or are perceived to have experienced a security incident, GlycoMimetics may experience adverse consequences. These consequences may include government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); interruptions in GlycoMimetics’ operations, including disruption of GlycoMimetics’ development programs, if any; additional reporting requirements and/or oversight; interruptions or restrictions on processing sensitive data (which could result in delays in obtaining, or GlycoMimetics’ inability to obtain, regulatory approvals and significantly increase GlycoMimetics’ costs to recover or reproduce the data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversion of management attention; interruptions in GlycoMimetics’ operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant consequences may negatively impact GlycoMimetics’ ability to grow and operate GlycoMimetics’ business.

GlycoMimetics’ contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in its contracts are sufficient to protect GlycoMimetics from liabilities, damages, or claims related to its data privacy and security obligations. Additionally, GlycoMimetics cannot be sure that its insurance coverage will be adequate or sufficient to protect GlycoMimetics from or to mitigate liabilities arising out of its privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about GlycoMimetics from public sources, data brokers, or other means that reveals competitively sensitive details about GlycoMimetics’ organization and could be used to undermine GlycoMimetics’ competitive advantage or market position. Additionally, sensitive information of GlycoMimetics could be leaked, disclosed, or revealed as a result of or in connection with use of generative AI technologies by GlycoMimetics’ employees, personnel or vendors.

GlycoMimetics and the third parties with whom GlycoMimetics has worked are subject to stringent and changing U.S. and foreign laws, regulations, rules, contractual obligations, industry standards, policies and other obligations related to data privacy and security. GlycoMimetics’ actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class claims) and mass arbitration; fines and penalties; disruptions of GlycoMimetics’ business operations; reputational harm; loss of revenue and profits; and other adverse business impacts.

In the ordinary course of its business, GlycoMimetics has processed personal data and other sensitive data, including proprietary and confidential business data, trade secrets, intellectual property, clinical trial participant data, and other sensitive third-party data. The data processing activities related to its work subject GlycoMimetics and the third parties with whom GlycoMimetics has worked to numerous data privacy and security obligations, such as federal, state, local and foreign laws, regulations, guidance, industry standards,

 

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external and internal privacy and security policies, contracts, and other obligations governing the processing and security of personal data. These obligations may change, are subject to differing interpretations and may be inconsistent among jurisdictions or conflict. The global data protection landscape is rapidly evolving, and implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future. This evolution may create uncertainty in GlycoMimetics’ business; affect GlycoMimetics’ (or the third parties upon which GlycoMimetics relies) ability to operate in certain jurisdictions or to collect, store, transfer, use and share personal data; necessitate the acceptance of more onerous obligations in GlycoMimetics’ contracts; result in liability; or impose additional costs on GlycoMimetics. These obligations may necessitate changes to GlycoMimetics’ information technologies, systems, and practices and to those of any third parties that process personal data on GlycoMimetics’ behalf.

Outside the U.S., an increasing number of laws, regulations, and industry standards apply to data privacy and security. For example, the European Union’s General Data Protection Regulation (GDPR) (EU) 2016/679, or the EU GDPR and the United Kingdom’s GDPR (the “UK GDPR”), or collectively GDPR, impose strict requirements on the processing of personal data. Under the GDPR, government regulators may impose temporary or definitive bans on data processing, as well as fines in the event of violations. Under the GDPR, companies may face temporary or definitive bans on data processing and other corrective actions; fines of up to 20 million Euros under the EU GDPR, 17.5 million pounds sterling under the UK GDPR or, in each case, 4% of annual global revenue, whichever is greater; or private litigation related to processing of personal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.

GlycoMimetics may transfer personal data from Europe and other jurisdictions to the United States or other countries. Europe and other jurisdictions have enacted laws requiring data to be localized or limiting the transfer of personal data to other countries. In particular, the European Economic Area (the “EEA”) and the UK have significantly restricted the transfer of personal data to the United States and other countries whose privacy laws it generally believes are inadequate. Other jurisdictions have adopted or may adopt similarly stringent data localization and cross-border data transfer laws. Although there are currently various mechanisms that may be used to transfer personal data from the EEA and UK to the U.S. in compliance with law, such as the EEA standard contractual clauses, the UK’s International Data Transfer Agreement / Addendum, and the EU-U.S. Data Privacy Framework and the UK extension thereto (which allows for transfers to relevant U.S.-based organizations who self-certify compliance and participate in the Framework), these mechanisms are subject to legal challenges, and there is no assurance that GlycoMimetics can satisfy or rely on these measures to lawfully transfer personal data to the U.S. If there is no lawful manner for GlycoMimetics to transfer personal data from the EEA, the UK, or other jurisdictions to the U.S., or if the requirements for a legally-compliant transfer are too onerous, GlycoMimetics could face significant adverse consequences, including the interruption or degradation of its operations, the need to relocate part of or all of its business or data processing activities to other jurisdictions (such as Europe) at significant expense, increased exposure to regulatory actions, substantial fines and penalties, the inability to transfer data and work with partners, vendors and other third parties, and injunctions against its processing or transferring of personal data necessary to operate its business. Some EEA regulators have prevented companies from transferring personal data out of the EEA for allegedly violating the GDPR’s cross-border data transfer limitations.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), and other similar laws (e.g., wiretapping laws). For example, HIPAA, as amended by HITECH, imposes specific requirements relating to the privacy, security, and transmission of individually identifiable health data. See the risk factor captioned “GlycoMimetics’ business and relationships with customers and third-party payors in the United States and elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, transparency, health information privacy and security and other healthcare laws and regulations, which could expose GlycoMimetics to significant penalties, including criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.”

Numerous U.S. states have also enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with

 

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certain rights concerning their personal data. As applicable, such rights may include the right to access, correct, or delete certain personal data, and to opt-out of certain data processing activities, such as targeted advertising, profiling, and automated decision-making. The exercise of these rights may impact GlycoMimetics’ business and ability to provide its products and services. Certain states also impose stricter requirements for processing certain personal data, including sensitive information, such as conducting data privacy impact assessments. These state laws allow for statutory fines for noncompliance. For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act of 2020, or CPRA, collectively CCPA, applies to personal data of consumers, business representatives, and employees who are California residents. These obligations include, but are not limited to, providing specific disclosures in privacy notices and honoring requests of such individuals certain rights related to their personal data. The CCPA provide for fines of up to $7,500 per intentional violation and allows private litigants affected by certain data breaches to recover significant statutory damages. While the CCPA and other comprehensive state privacy laws contain limited exceptions for clinical trial data, these developments may further complicate compliance efforts, and increase legal risk and compliance costs for GlycoMimetics and the third parties upon whom GlycoMimetics relies. Similar laws are being considered in several other states, as well as at the federal and local levels, and GlycoMimetics expects more states to pass similar laws in the future.

In addition to data privacy and security laws, GlycoMimetics may be contractually subject to industry standards adopted by industry groups and may become subject to such obligations in the future. GlycoMimetics is also bound by other contractual obligations related to data privacy and security, and its efforts to comply with such obligations may not be successful. For example, clinical trial participants or research subjects about whom GlycoMimetics or its vendors obtain information, as well as the providers who share this information with GlycoMimetics, may contractually limit its ability to use and disclose the information. GlycoMimetics has published privacy policies, marketing materials, and other statements, such as compliance with certain certifications or self-regulatory principles, regarding data privacy and security. If these policies, materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentative of its practices, GlycoMimetics may be subject to investigation, enforcement actions by regulators, or other adverse consequences.

Obligations related to data privacy and security (and consumers’ data privacy expectations) are quickly changing, becoming increasingly stringent, and creating uncertainty. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions. Preparing for and complying with these obligations requires GlycoMimetics to devote significant resources, which may necessitate changes to its services, information technologies, systems, and practices and to those of any third parties that process personal data on its behalf.

It is possible that, in the future, GlycoMimetics may fail or be perceived to have failed to comply with applicable data privacy and security obligations. Moreover, despite GlycoMimetics’ best compliance efforts, its personnel or third parties whom it relies on could fail to comply with such obligations, which could negatively impact its business operations and compliance posture. If GlycoMimetics or the third parties on which it relies fail, or are perceived to have failed, to address or comply with data privacy and security obligations, GlycoMimetics could face significant consequences. These consequences may include, but are not limited to, government enforcement actions; litigation (including class claims) and mass arbitration demands; additional reporting requirements and/or oversight; bans on processing personal data; orders to destroy or not use personal data; and imprisonment of company officials. In particular, plaintiffs have become increasingly more active in bringing privacy-related claims against companies, including class claims and mass arbitration demands. Some of these claims allow for the recovery of statutory damages on a per violation basis, and, if viable, carry the potential for monumental statutory damages, depending on the volume of data and the number of violations. Any of these events could have a material adverse effect on GlycoMimetics’ reputation, business, or financial condition, including but not limited to: interruptions or stoppages in GlycoMimetics’ business operations including, as relevant, clinical trials; inability to process personal data or to operate in certain jurisdictions; limited ability to develop or commercialize uproleselan; expenditure of time and resources to defend any claim or inquiry; adverse publicity; or revision or restructuring of GlycoMimetics’ operations.

 

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General Risk Factors

GlycoMimetics may become involved in litigation, including securities class action litigation, that could divert management’s attention and harm its business, and insurance coverage may not be sufficient to cover all costs and damages.

In the past, litigation, including securities class action litigation, has often followed certain significant business transactions, such as the sale of a company or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials. These events may also result in investigations by the SEC. GlycoMimetics may be exposed to such litigation, even if no wrongdoing occurred. Litigation is usually expensive, uncertain, and diverts management’s attention and resources, which could adversely affect GlycoMimetics’ business and cash resources and its ability to consummate the Merger with Crescent.

Unfavorable global economic conditions could adversely affect GlycoMimetics’ business, financial condition or results of operations.

GlycoMimetics’ results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. A severe or prolonged economic downturn, or additional global financial crises, including related to health epidemics or armed conflicts and geopolitical tensions around the world, could result in a variety of risks to GlycoMimetics’ business, including weakened demand for its product candidates, if approved, or its ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain GlycoMimetics’ suppliers, possibly resulting in supply disruption. Any of the foregoing could harm GlycoMimetics’ business and GlycoMimetics cannot anticipate all of the ways in which the economic climate and financial market conditions could adversely impact its business.

In addition, GlycoMimetics’ available cash and cash equivalents are held in accounts managed by third-party financial institutions and consist of cash in its operating accounts and cash invested in U.S. Government money market funds. At any point in time, the funds in GlycoMimetics’ operating accounts may exceed the Federal Deposit Insurance Corporation insurance limits. While GlycoMimetics monitors the cash balances in its operating accounts and adjusts the cash balances as appropriate, these cash balances could be impacted if the underlying financial institutions fail. GlycoMimetics can provide no assurances that access to its operating cash or invested cash and cash equivalents will not be impacted by adverse conditions in the financial markets.

If GlycoMimetics fails to comply or regain compliance with Nasdaq’s continued listing standards prior to the consummation of the Merger, GlycoMimetics common stock may be delisted and the price of its common stock, its ability to access the capital markets and its financial condition could be negatively impacted.

GlycoMimetics common stock was previously listed on the Nasdaq Global Market, and it was required to meet certain listing requirements, including with respect to minimum closing bid prices, market value of publicly held shares, stockholders’ equity and market value of listed securities.

In June 2024, GlycoMimetics received notice from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) that it was not in compliance with the minimum bid price requirement for continued listing on the Nasdaq Global Market. Pursuant to Nasdaq listing rules, GlycoMimetics was provided an initial compliance period until December 18, 2024 to regain compliance. In order to qualify for additional time to regain compliance, GlycoMimetics transferred the listing of its common stock from the Nasdaq Global Market to the Nasdaq Capital Market, which became effective as of December 20, 2024. In connection with that transfer, on December 19, 2024, GlycoMimetics received notice from Nasdaq that it had been granted an additional 180 calendar days, or until June 16, 2025, to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2).

If necessary to regain compliance with Nasdaq listing standards, GlycoMimetics may, subject to approval of the GlycoMimetics Board and stockholders, implement a reverse stock split. However, there can be no assurance that a reverse stock split, or any other alternatives GlycoMimetics may consider to regain

 

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compliance with the minimum bid price requirement, would be approved or would result in a sustained higher stock price that would allow GlycoMimetics to meet the Nasdaq stock price listing requirements.

Separately, Nasdaq listing rules requires companies listed on the Nasdaq Capital Market to maintain a stockholders’ equity of at least $2.5 million. As of December 31, 2024, GlycoMimetics had stockholders’ equity of $5.3 million. As a result of GlycoMimetics’ expected decrease in stockholders’ equity prior to the Merger due to continued net losses, there can be no assurance that GlycoMimetics will be able to maintain the minimum required stockholders’ equity under the Nasdaq continued listing standards.

If GlycoMimetics is not able to maintain compliance within the compliance periods allotted by Nasdaq, its common stock could be delisted, which would have a further material adverse effect on the market price of its common stock and on stockholder liquidity. GlycoMimetics intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the listing requirement; however, there can be no assurance that GlycoMimetics will be able to regain compliance with the listing requirement or will otherwise be in compliance with the other Nasdaq listing criteria. If Nasdaq delists GlycoMimetics common stock for failure to meet its listing standards, and GlycoMimetics common stock is not eligible for quotation or listing on another market or exchange, GlycoMimetics and GlycoMimetics stockholders could face significant negative consequences, including:

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trading of GlycoMimetics common stock being conducted only in the over-the-counter market or on an electronic bulletin board established for unlisted securities, such as the Pink Sheets or the OTC Bulletin Board, which could result in limited availability of market quotations for GlycoMimetics common stock and increased difficulty of disposing of shares of common stock;

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a determination that the common stock is a “penny stock,” which would require brokers trading in GlycoMimetics common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of GlycoMimetics common stock;

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a limited amount of analyst coverage; and

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a decreased ability to issue additional securities or obtain financing in the future.

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An active trading market for GlycoMimetics common stock may not be sustained.

Although GlycoMimetics common stock is listed on The Nasdaq Capital Market, GlycoMimetics cannot assure you that an active trading market for GlycoMimetics’ shares will be sustained. If an active market for GlycoMimetics common stock is not sustained, it may be difficult for investors in GlycoMimetics common stock to sell shares without depressing the market price for the shares or to sell the shares at all.

The trading price of GlycoMimetics common stock has been and is likely to continue to be volatile.

GlycoMimetics’ stock price from time to time has been volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. The market price for GlycoMimetics common stock may be influenced by many factors, including:

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expectations regarding the consummation of the Merger with Crescent;

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announcements relating to development, regulatory approvals or commercialization of GlycoMimetics’ drug candidates;

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actual or anticipated variations in GlycoMimetics’ operating results;

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changes in financial estimates by GlycoMimetics or by any securities analysts who might cover GlycoMimetics’ stock;

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conditions or trends in GlycoMimetics’ industry;

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changes in laws or other regulatory actions affecting GlycoMimetics or its industry, such as drug pricing and reimbursement;

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•

stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

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announcements by GlycoMimetics or its competitors of significant acquisitions, strategic partnerships or divestitures;

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announcements of investigations or regulatory scrutiny of GlycoMimetics’ operations or lawsuits filed against GlycoMimetics;

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•

capital commitments;

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investors’ general perception of GlycoMimetics and its business;

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•

disputes concerning GlycoMimetics’ intellectual property or other proprietary rights;

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recruitment or departure of key personnel; and

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sales of GlycoMimetics common stock, including sales by its directors and officers or specific stockholders.

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In addition, the stock markets have experienced extreme price and volume fluctuations that have affected and continue to affect the market prices of equity securities of many companies, which has resulted in volatile stock prices for many companies notwithstanding the lack of a fundamental change in their underlying business models or prospects. These fluctuations have often been unrelated or disproportionate to the operating performance of those companies. Broad market and industry factors, including worsening economic conditions and other adverse effects or developments relating to political, regulatory and other market conditions, may negatively affect the market price of shares of GlycoMimetics common stock, regardless of GlycoMimetics’ actual operating performance.

In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ stock. Such litigation, if instituted against GlycoMimetics, could cause GlycoMimetics to incur substantial costs and divert management’s attention and resources from its business.

If equity research analysts do not publish research or reports, or publish unfavorable research or reports, about GlycoMimetics, its business or its market, its stock price and trading volume could decline.

The trading market for GlycoMimetics common stock is influenced by the research and reports that equity research analysts publish about GlycoMimetics and its business. GlycoMimetics has only limited research coverage by equity research analysts. Equity research analysts may elect not to initiate or continue to provide research coverage of GlycoMimetics common stock, and such lack of research coverage may adversely affect the market price of GlycoMimetics common stock. Even if GlycoMimetics has equity research analyst coverage, GlycoMimetics will not have any control over the analysts or the content and opinions included in their reports. The price of GlycoMimetics common stock could decline if one or more equity research analysts downgrade GlycoMimetics common stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of GlycoMimetics or fails to publish reports on GlycoMimetics regularly, demand for its stock could decrease, which in turn could cause GlycoMimetics common stock price or trading volume to decline.

The issuance of additional stock in connection with financings, acquisitions, investments, GlycoMimetics’ stock incentive plan, GlycoMimetics’ employee stock purchase plan or otherwise will dilute all other stockholders.

GlycoMimetics’ certificate of incorporation authorizes GlycoMimetics to issue up to 150,000,000 shares of common stock and up to 5,000,000 shares of preferred stock with such rights and preferences as may be determined by the GlycoMimetics Board. Subject to compliance with applicable rules and regulations, GlycoMimetics may issue its shares of common stock or securities convertible into its common stock from time to time in connection with a financing, acquisition, investment, its stock incentive plan, its employee stock purchase plan or otherwise. Any such issuance could result in substantial dilution to GlycoMimetics’ existing stockholders and cause the trading price of GlycoMimetics common stock to decline.

 

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If a substantial number of GlycoMimetics’ total outstanding shares are sold into the market, or if the market perceives that such sales may occur, it could cause the market price of GlycoMimetics common stock to drop significantly.

Sales of a substantial number of shares of GlycoMimetics common stock in the public market could occur at any time. If GlycoMimetics’ stockholders sell, or if the market perceives that GlycoMimetics’ stockholders intend to sell, substantial amounts of GlycoMimetics common stock in the public market, the market price of GlycoMimetics common stock could decline significantly. All of GlycoMimetics’ outstanding shares of common stock are available for sale in the public market, subject only to the restrictions of Rule 144 under the Securities Act in the case of GlycoMimetics’ affiliates.

In addition, GlycoMimetics has filed registration statements on Form S-8 registering the issuance of shares of common stock subject to options or other equity awards issued or reserved for future issuance under its equity incentive plans. Shares registered under these registration statements are available for sale in the public market subject to vesting arrangements and exercise of options, as well as Rule 144 in the case of GlycoMimetics’ affiliates. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of GlycoMimetics common stock could decline.

Provisions in GlycoMimetics’ corporate charter documents and under Delaware law may prevent or frustrate attempts by GlycoMimetics’ stockholders to change its management and hinder efforts to acquire a controlling interest in it, and the market price of its common stock may be lower as a result.

Provisions in GlycoMimetics’ certificate of incorporation and bylaws that could make it difficult for a third party to acquire, or attempt to acquire, control of GlycoMimetics, even if a change in control was considered favorable by some or all of its stockholders. For example, the GlycoMimetics Board has the authority to issue up to 5,000,000 shares of preferred stock. The GlycoMimetics Board can fix the price, rights, preferences, privileges and restrictions of the preferred stock without any further vote or action by GlycoMimetics’ stockholders. The issuance of shares of preferred stock may delay or prevent a change in control transaction. As a result, the market price of GlycoMimetics common stock and the voting and other rights of GlycoMimetics’ stockholders may be adversely affected. An issuance of shares of preferred stock may result in the loss of voting control to other stockholders.

GlycoMimetics’ charter documents also contain other provisions that could have an anti-takeover effect, including:

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only one of GlycoMimetics’ three classes of directors is elected each year;

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stockholders are not entitled to remove directors other than by a 662∕3% vote and only for cause;

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stockholders are not permitted to take actions by written consent;

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stockholders cannot call a special meeting of stockholders; and

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•

stockholders must give advance notice to nominate directors or submit proposals for consideration at stockholder meetings.

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In addition, GlycoMimetics is subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law, which regulates corporate acquisitions by prohibiting Delaware corporations from engaging in specified business combinations with particular stockholders of those companies. These provisions could discourage potential acquisition proposals and could delay or prevent a change in control transaction. They could also have the effect of discouraging others from making tender offers for GlycoMimetics common stock, including transactions that may be in your best interests. These provisions may also prevent changes in GlycoMimetics’ management or limit the price that investors are willing to pay for GlycoMimetics’ stock.

GlycoMimetics’ certificate of incorporation also provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between GlycoMimetics and its stockholders.

If GlycoMimetics fails to maintain proper and effective internal controls, its ability to produce accurate financial statements on a timely basis could be impaired.

GlycoMimetics is subject to the reporting requirements of the Securities Exchange Act of 1934, the Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010

 

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and the rules and regulations of The Nasdaq Capital Market. The Sarbanes-Oxley Act requires, among other things, that GlycoMimetics maintains effective disclosure controls and procedures and internal control over financial reporting and perform system and process evaluation and testing of its internal control over financial reporting to allow management to report on the effectiveness of its internal control over financial reporting. This requires that GlycoMimetics incur substantial additional professional fees and internal costs to expand its accounting and finance functions and that GlycoMimetics expends significant management efforts.

GlycoMimetics may discover areas of its internal financial and accounting controls and procedures that need improvement. GlycoMimetics’ internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If GlycoMimetics is unable to maintain proper and effective internal controls in the future, GlycoMimetics may not be able to produce timely and accurate financial statements, and GlycoMimetics may conclude that its internal controls over financial reporting are not effective. If that were to happen, the market price of its stock could decline and GlycoMimetics could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.

GlycoMimetics does not anticipate paying any cash dividends on its common stock, and its stock may not appreciate in value.

GlycoMimetics has never declared or paid cash dividends on its common stock. GlycoMimetics intends to retain all available funds to continue its operations through the Merger and do not anticipate declaring or paying any cash dividends on its common stock. Any return to stockholders will therefore be limited to the appreciation of their stock, if any. There is no guarantee that shares of GlycoMimetics common stock will appreciate in value or that the price at which GlycoMimetics’ stockholders have purchased their shares will be able to be maintained.

GlycoMimetics’ ability to use net operating loss carryforwards may be subject to limitations.

As of December 31, 2024, GlycoMimetics had federal and state net operating loss carryforwards of $351.8 million, research and development tax credit carryforwards of $10.9 million and $44.1 million of orphan drug tax credit carryforwards. The federal and state net operating loss carryforwards will begin to expire, if not utilized, beginning in 2025, the research and development tax credits in 2025 and the orphan drug tax credit in 2033. These net operating loss and tax credit carryforwards could expire unused and be unavailable to offset future income tax liabilities.

Under federal income tax laws, federal net operating losses incurred in 2018 and in future years may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited. In addition, under Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50% change, by value, in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income or taxes may be limited. The Merger with Crescent, if consummated, could result in an ownership change that would limit the ability of the Combined Company to use GlycoMimetics’ net operating loss carryforwards.

Risks Related to Crescent

All references to Crescent’s “product candidates,” “programs,” “portfolio” and “pipeline” in this proxy statement/prospectus refer to the research programs with respect to which Crescent has the option to acquire intellectual property license rights pursuant to the Paragon Option Agreements. As of the date of this proxy statement/prospectus, Crescent has exercised the option and entered into a license agreement for CR-001, but it has not exercised the option or entered into a license agreement for CR-002 or CR-003, nor does it expect to do so prior to the time that this registration statement on Form S-4 is declared effective by the SEC.

 

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Risks Related to Crescent’s Financial Condition and Capital Requirements

Crescent has concluded there is substantial doubt about its ability to continue as a going concern for at least twelve months from the date its financial statements as of December 31, 2024 are available to be issued. Even if the Merger and Crescent Pre-Closing Financing are successful, Crescent will need to raise additional capital, and if it is unable to do so when needed, that will raise substantial doubt about Crescent’s ability to continue as a going concern.

As of December 31, 2024, Crescent had $34.8 million of cash. Should this Merger and Crescent Pre-Closing Financing be successful, Crescent will need to raise additional capital to continue to fund its operations and service its debt obligations in the future. If Crescent is unable to raise additional capital when needed, that will raise substantial doubt about Crescent’s ability to continue as a going concern. As a result, Crescent has concluded there is substantial doubt about its ability to continue as a going concern for at least twelve months from the date its financial statements as of December 31, 2024 are available to be issued. In light of these concerns, Crescent’s independent registered public accounting firm included in its opinion on the financial statements an explanatory paragraph expressing substantial doubt about Crescent’s ability to continue as a going concern beyond twelve months from the date Crescent’s financial statements are available to be issued.

Developing Crescent’s product candidates requires a substantial amount of capital. Following the Merger and Crescent Pre-Closing Financing, the Combined Company will also incur additional costs associated with operating as a public company. Crescent expects its research and development expenses to increase in connection with its ongoing activities, particularly as it advances its product candidates through preclinical studies and clinical trials. Crescent will need to raise additional capital to fund its operations, and such funding may not be available to Crescent on acceptable terms, or at all, and such funding may become even more difficult to obtain due to rising interest rates and the current downturn in the U.S. capital markets and the biotechnology sector in general. Competition for additional capital among biotechnology companies may be particularly intense during economic downturns. Crescent may be unable to raise capital through public offerings of its common stock and may need to turn to alternative financing arrangements. Such arrangements, if Crescent pursues them, could involve the issuance of one or more types of securities, including common stock, preferred stock, convertible debt, warrants to acquire common stock or other securities. These securities could be issued at or below the then prevailing market price for Crescent common stock. In addition, if Crescent issues debt securities, the holders of the debt would have a claim to Crescent’s assets that would be superior to the rights of stockholders until the principal, accrued and unpaid interest and any premium or make-whole has been paid. Interest on any newly-issued debt securities and/or newly-incurred borrowings would increase Crescent’s operating costs and reduce its net income (or increase its net loss), and these impacts may be material. If the issuance of new securities results in diminished rights to holders of Crescent common stock, the market price of Crescent common stock could be materially and adversely affected.

Crescent does not currently have any products approved for sale and does not generate any revenue from product sales. Accordingly, Crescent expects to rely primarily on equity and/or debt financings to fund its continued operations. Crescent’s ability to raise additional funds will depend, in part, on the success of its preclinical studies and clinical trials and other product development activities, regulatory events, its ability to identify and enter into licensing or other strategic arrangements, and other events or conditions that may affect its value or prospects, as well as factors related to financial, economic and market conditions, many of which are beyond Crescent’s control. There can be no assurances that sufficient funds will be available to Crescent when required or on acceptable terms, if at all.

If Crescent is unable to raise additional capital when required or on acceptable terms, it may be required to:

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significantly delay, scale back, or discontinue the development or commercialization of its product candidates;

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seek strategic partnerships, or amend existing partnerships, for research and development programs at an earlier stage than otherwise would be desirable or that Crescent otherwise would have sought to develop independently, or on terms that are less favorable than might otherwise be available in the future;

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•

dispose of technology assets, or relinquish or license on unfavorable terms, Crescent’s rights to technologies or any of its product candidates that it otherwise would seek to develop or commercialize itself;

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pursue the sale of the company to a third party at a price that may result in a loss on investment for Crescent’s stockholders; or

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file for bankruptcy or cease operations altogether (and face any related legal proceedings).

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Any of these events could have a material adverse effect on Crescent’s business, operating results, and prospects.

Even if successful in raising new capital, Crescent could be limited in the amount of capital it raises due to investor demand restrictions placed on the amount of capital it raises or other reasons.

Additionally, any capital raising efforts are subject to significant risks and contingencies, as described in more detail under the risk factor titled “Raising additional capital may cause dilution to Crescent’s stockholders, restrict its operations, or require it to relinquish rights.”

Crescent has never generated any revenue from product sales and may never be profitable.

Crescent has no products approved for commercialization and has never generated any revenue from product sales. Crescent’s ability to generate revenue and achieve profitability depends on its ability, alone or with strategic collaborators, to successfully complete the development of, and obtain the regulatory and marketing approvals necessary to commercialize, one or more of its product candidates. Crescent does not anticipate generating revenue from product sales for the foreseeable future. Crescent’s ability to generate future revenue from product sales depends heavily on its success in many areas, including but not limited to:

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completing research and development of its product candidates;

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obtaining regulatory and marketing approvals for its product candidates for which it completes clinical trials;

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manufacturing product candidates and establishing and maintaining supply and manufacturing relationships with third parties that are commercially feasible, meet regulatory requirements and Crescent’s supply needs in sufficient quantities to meet market demand for its product candidates, if approved;

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qualifying for adequate coverage and reimbursement by government and third-party payors for any product candidates for which Crescent obtains regulatory and marketing approval;

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marketing, launching, and commercializing product candidates for which Crescent obtains regulatory and marketing approval, either directly or with a collaborator or distributor;

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gaining market acceptance of Crescent’s product candidates as treatment options;

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addressing any competing products and technological and market developments;

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implementing internal systems and infrastructure, as needed;

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protecting and enforcing Crescent’s intellectual property rights, including patents, trade secrets, and know-how;

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negotiating favorable terms in any collaboration, licensing, or other arrangements into which Crescent may enter;

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obtaining coverage and adequate reimbursement from third-party payors and maintaining pricing for Crescent’s product candidates that supports profitability; and

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attracting, hiring, and retaining qualified personnel.

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Even if one or more of the product candidates that Crescent develops is approved for commercial sale, Crescent anticipates incurring significant costs associated with commercializing any approved product

 

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candidate. Crescent’s expenses could increase beyond expectations if it is required by regulatory authorities to perform clinical and other studies in addition to those that Crescent anticipates. Even if Crescent is able to generate revenues from the sale of any approved products, it may not become profitable and may need to obtain additional funding to continue operations. Crescent will also have to develop or acquire manufacturing capabilities or continue to contract with contract manufacturers in order to continue development and potential commercialization of its product candidates. For instance, if the costs of manufacturing Crescent’s drug product are not commercially feasible, Crescent will need to develop or procure its drug product in a commercially feasible manner in order to successfully commercialize a future approved product, if any. Additionally, if Crescent is not able to generate revenue from the sale of any approved products, it may never become profitable.

Crescent is a preclinical-stage biotechnology company with a limited operating history on which to assess its business; it has not initiated, conducted or completed any clinical trials, has no products approved for commercial sale, has historically incurred losses, and anticipates that it will continue to incur significant losses for the foreseeable future.

Crescent is a preclinical-stage biotechnology company with a limited operating history. Since September 19, 2024 (inception), Crescent has incurred significant operating losses. For the period between September 19, 2024 (inception) to December 31, 2024, Crescent reported a net loss of $17.9 million and had an accumulated deficit of $17.9 million. Crescent will need to raise substantial additional capital to continue to fund its operations in the future. Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on Crescent’s financial condition and its ability to develop its product candidates. Changing circumstances may cause Crescent to consume capital significantly faster or slower than it currently anticipates. If Crescent is unable to acquire additional capital or resources, it will be required to modify its operational plans to complete future milestones and it may be required to delay, limit, reduce or eliminate development or future commercialization efforts of product candidates and/or programs. Crescent has based these estimates on assumptions that may prove to be wrong, and it could exhaust its available financial resources sooner than it currently anticipates. Crescent may be forced to reduce its operating expenses and raise additional funds to meet its working capital needs, principally through the additional sales of its securities or debt financings or entering into strategic collaborations.

Crescent has devoted substantially all of its financial resources to identify, acquire, and develop its product candidates, organizing and staffing its company, and providing general and administrative support for its operations. To date, Crescent has funded its operations primarily from the sale and issuance of convertible preferred and common equity securities and unsecured convertible notes. The amount of Crescent’s future net losses will depend, in part, on the rate of its future expenditures and its ability to obtain funding through equity or debt financings, strategic collaborations, or grants.

Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. Crescent expects its losses to increase as its product candidates enter more advanced clinical trials. It may be several years, if ever, before Crescent completes pivotal clinical trials and/or has a product candidate approved for commercialization. Crescent expects to invest significant funds into the research and development of its current programs to determine the potential to advance product candidates to regulatory approval. If Crescent obtains regulatory approval to market a product candidate, its future revenue will depend upon the size of any markets in which its product candidates may receive approval, and its ability to achieve sufficient market acceptance, pricing, coverage and adequate reimbursement from third-party payors, and adequate market share for its product candidates in those markets. Even if Crescent obtains adequate market share for its product candidates, because the potential markets in which its product candidates may ultimately receive regulatory approval could be very small, Crescent may never become profitable despite obtaining such market share and acceptance of its products.

Crescent expects to continue to incur significant expenses and increasing operating losses for the foreseeable future and its expenses will increase substantially if and as it:

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continues the preclinical development and initiates the clinical development of its product candidates;

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continues efforts to discover and develop new product candidates;

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continues the manufacturing of its product candidates or increases volumes manufactured by third parties;

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advances its product candidates into larger, more expensive clinical trials;

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initiates additional preclinical studies or clinical trials for its product candidates;

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seeks regulatory and marketing approvals and reimbursement for its product candidates;

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establishes a sales, marketing, and distribution infrastructure to commercialize any products for which it may obtain regulatory and marketing approval and market for itself;

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seeks to identify, assess, acquire, and/or develop other product candidates;

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makes milestone, royalty, or other payments under third-party license agreements;

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seeks to maintain, protect, and expand its intellectual property portfolio;

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is required to pay penalties under its Registration Rights Agreement for failing to timely register the applicable securities;

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seeks to attract and retain skilled personnel;

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experiences any delays or encounters issues with the development and potential regulatory approval of its clinical and product candidates such as safety issues, manufacturing delays, clinical trial accrual delays, longer follow-up for planned studies or trials, additional major studies or trials, or supportive trials necessary to support regulatory and marketing approval; and

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and incurs additional costs associated with operating as a public company.

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Crescent has no significant experience as a company in initiating, conducting or completing clinical trials. In part because of this lack of experience, Crescent cannot be certain that its planned clinical trials will begin or be completed on time, if at all. In addition, Crescent has not yet demonstrated an ability to obtain regulatory and marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on its behalf, or conduct sales, marketing and distribution activities necessary for successful product commercialization. Consequently, any predictions you make about Crescent’s future success or viability may not be as accurate as they could be if Crescent had a longer operating history. Further, the net losses Crescent incurs may fluctuate significantly from quarter to quarter and year to year, such that a period-to-period comparison of its results of operations may not be a good indication of its future performance.

Raising additional capital may cause dilution to Crescent’s stockholders, restrict its operations, or require it to relinquish rights.

Until such time, if ever, as Crescent can generate substantial revenue from the sale of its product candidates, Crescent expects to finance its cash needs through a combination of equity offerings, debt financings and license and development agreements. To the extent that Crescent raises additional capital through the sale of equity securities or convertible debt securities, the ownership interest of its stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of Crescent common stock. Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting Crescent’s ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.

If Crescent raises additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, it may be required to relinquish valuable rights to its research programs or product candidates or grant licenses on terms that may not be favorable to it. If Crescent is unable to raise additional funds through equity or debt financings or other arrangements with third parties when needed, it may be required to delay, limit, reduce or terminate its product development or future commercialization efforts or grant rights to third parties to develop and market product candidates that Crescent would otherwise prefer to develop and market itself.

To the extent that Crescent raises additional capital through the sale of equity, including pursuant to any sales under convertible debt or other securities convertible into equity, the ownership interest of its

 

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stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of its stockholders. For instance, at its inception in September 2024, Crescent sold an aggregate of 20,000,000 shares of Series Seed Preferred Stock, and in October 2024, it sold the Convertible Notes for gross proceeds of $37.5 million.

Debt financing, if available, would likely involve agreements that include covenants limiting or restricting Crescent’s ability to take specific actions, such as incurring additional debt, making capital expenditures, making additional product acquisitions, or declaring dividends. If Crescent raises additional funds through strategic collaborations or licensing arrangements with third parties, Crescent may have to relinquish valuable rights to its product candidates or future revenue streams or grant licenses on terms that are not favorable to Crescent. Crescent cannot assure that it will be able to obtain additional funding if and when necessary to fund its entire portfolio of product candidates to meet its projected plans. If Crescent is unable to obtain funding on a timely basis, it may be required to delay or discontinue one or more of its development programs or the commercialization of any product candidates or be unable to expand its operations or otherwise capitalize on potential business opportunities, which could materially harm Crescent’s business, financial condition, and results of operations.

Risks Related to Discovery, Development and Commercialization

Crescent faces competition from entities that have developed or may develop programs for the diseases addressed by product candidates developed by Crescent.

The development and commercialization of drugs is highly competitive. Product candidates developed by Crescent, if approved, will face significant competition and Crescent’s failure to effectively compete may prevent it from achieving significant market penetration. Crescent competes with a variety of multinational biopharmaceutical companies, specialized biotechnology companies and emerging biotechnology companies, including Merck, Bristol Myers Squibb, Genetech, AstraZeneca, Summit Therapeutics Inc., BioNTech SE, LaNova Medicines Ltd., and Compass Therapeutics, Inc., as well as academic institutions, governmental agencies, and public and private research institutions, among others. Many of the companies with which Crescent is currently competing or will compete against in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing regulatory approved products than Crescent does, and are further along in the clinical development and/or commercialization process than Crescent is. Mergers and acquisitions in the pharmaceutical and biotechnology industry may result in even more resources being concentrated among a smaller number of Crescent’s competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with Crescent in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites, raising capital, registering patients for clinical trials, establishing and defending rights to intellectual property, as well as in acquiring technologies complementary to, or necessary for, Crescent’s product candidates.

Crescent’s competitors have developed, are developing or may in the future develop programs and processes competitive with Crescent’s programs and processes. Competitive therapeutic treatments include those that have already been approved and accepted by the medical community and any potential new treatments, including those currently under clinical development. Crescent’s success will depend partially on its ability to develop and commercialize products that have a competitive safety, efficacy, dosing and/or presentation profile. Crescent’s commercial opportunity and success will be reduced or eliminated if competing products are safer, more effective, have a more attractive dosing profile or presentation or are less expensive than the products Crescent develops, or if Crescent’s competitors develop competing products or if biosimilars enter the market more quickly than Crescent does and are able to gain market acceptance. Conversely, the lack of commercial success of other competing programs may raise concerns about the financial viability of Crescent’s programs. Please see the section titled “Crescent’s Business — Competition” beginning on page 296 of this proxy statement/prospectus for a more detailed description of Crescent’s competitors.

 

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Crescent’s programs are in preclinical stages of development and may fail in development or suffer delays that materially and adversely affect their commercial viability. If Crescent or its current or future collaborators are unable to complete development of or commercialize Crescent’s product candidates, or experience significant delays in doing so, Crescent’s business will be materially harmed.

Crescent has no products on the market, and all of its programs are in preclinical stages of development and have not been tested in humans. As a result, Crescent expects it will be many years before it commercializes any product candidate, if ever. Crescent’s ability to achieve and sustain profitability depends on obtaining regulatory approvals for, and successfully commercializing, its product candidates, either alone or with third parties, and Crescent cannot guarantee you that it will ever obtain regulatory approval for any of its product candidates. Crescent has not yet demonstrated its ability to initiate or complete any clinical trials, obtain regulatory approvals, manufacture a clinical or commercial scale product or arrange for a third party to do so on its behalf, or conduct sales and marketing activities necessary for successful product commercialization. Before obtaining regulatory approval for the commercial distribution of Crescent’s product candidates, Crescent or an existing or future collaborator must conduct extensive preclinical tests and clinical trials to demonstrate the safety and efficacy in humans of Crescent’s programs and product candidates.

Crescent or its collaborators may experience delays in initiating or completing clinical trials. Crescent or its collaborators also may experience numerous unforeseen events during, or as a result of, any clinical trials that they could conduct that could delay or prevent Crescent’s ability to receive regulatory and marketing approval or commercialize its product candidates, including:

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regulators or institutional review boards (“IRBs”), the FDA or ethics committees may not authorize Crescent or its investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

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Crescent may experience delays in reaching, or fail to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations (“CROs”), the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;

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•

clinical trial sites deviating from trial protocol or dropping out of a trial;

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clinical trials of any product candidates may fail to show safety or efficacy, produce negative or inconclusive results, and Crescent may decide, or regulators may require it, to conduct additional preclinical studies or clinical trials or Crescent may decide to abandon product development programs;

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the number of subjects required for clinical trials of any product candidates may be larger than Crescent anticipates, especially if regulatory bodies require completion of non-inferiority or superiority trials, enrollment in these clinical trials may be slower than Crescent anticipates or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than Crescent anticipates;

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Crescent’s third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to Crescent in a timely manner, or at all, or may deviate from the clinical trial protocol or drop out of the trial, which may require that Crescent add new clinical trial sites or investigators;

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Crescent may elect to, or regulators, IRBs or ethics committees may require that Crescent or its investigators, suspend or terminate clinical research or trials for various reasons, including noncompliance with regulatory requirements or a finding that the patients in Crescent’s trials are being exposed to unacceptable health risks;

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the cost of clinical trials of any of Crescent’s programs may be greater than Crescent anticipates;

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the quality of Crescent’s product candidates or other materials necessary to conduct clinical trials of Crescent’s product candidates may be inadequate to initiate or complete a given clinical trial;

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Crescent’s inability to manufacture sufficient quantities of its product candidates for use in clinical trials;

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reports from clinical testing of other therapies may raise safety or efficacy concerns about Crescent’s programs;

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Crescent’s failure to establish an appropriate safety profile for a product candidate based on clinical or preclinical data for such product candidates as well as data emerging from other therapies in the same class as Crescent’s product candidates; and

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the FDA or other regulatory authorities may require Crescent to submit additional data such as long-term toxicology studies, or impose other requirements before permitting Crescent to initiate a clinical trial.

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Commencing clinical trials in the United States is subject to acceptance by the FDA of an IND application, biologics license application (“BLA”) or similar application and finalizing the trial design based on discussions with the FDA and other regulatory authorities. In the event that the FDA requires Crescent to complete additional preclinical studies or it is required to satisfy other FDA or foreign regulatory authority requests, respectively, prior to commencing clinical trials, the start of Crescent’s first clinical trials may be delayed. Even after Crescent receives and incorporates guidance from these regulatory authorities, the FDA or other regulatory authorities could disagree that Crescent has satisfied their requirements to commence any clinical trial or change their position on the acceptability of Crescent’s trial design or the clinical endpoints selected, which may require Crescent to complete additional preclinical studies or clinical trials, delay the enrollment of Crescent’s clinical trials or impose stricter approval conditions than Crescent currently expects. There are equivalent processes and risks applicable to clinical trial applications in other countries, including countries in the European Union (“EU”).

Crescent may not have the financial resources to continue development of, or to modify existing or enter into new collaborations for, a product candidate if it experiences any issues that delay or prevent regulatory approval of, or its ability to commercialize, its product candidates. Crescent or its current or future collaborators’ inability to complete development of, or commercialize Crescent’s product candidates, or significant delays in doing so, could have a material and adverse effect on Crescent’s business, financial condition, results of operations and prospects.

Crescent is substantially dependent on the success of its lead program, CR-001, and its anticipated clinical trials of such program may not be successful.

Crescent’s future success is substantially dependent on its ability to timely obtain regulatory and marketing approval for, and then successfully commercialize, its lead program, CR-001. Crescent also intends to advance its CR-002 and CR-003 programs. Crescent is investing a majority of its efforts and financial resources into the research and development of these programs. Crescent anticipates that the IND for CR-001 will be submitted by the fourth quarter of 2025 followed by a Phase 1 clinical trial with results expected in the second half of 2026 in patients with solid tumors. Crescent anticipates that the IND for CR-002 will be submitted by mid-2026. The success of Crescent’s CR-001 is dependent on observing in CR-001 the targeting, binding, cooperativity and pharmacokinetics of ivonescimab, an anti-PD-1/anti-VEGF bispecific antibody that demonstrated significantly improved progression-free survival (“PFS”) to market-leading pembrolizumab in a large Phase 3 clinical trial, while avoiding the mechanistic risks that could perturb the balance of efficacy and safety that define this new class of immunotherapy, assuming Crescent successfully completes clinical development and obtains regulatory and marketing approval for CR-001. To the extent Crescent does not observe this recapitulation of ivonescimab in CR-001, it would significantly and adversely affect the clinical and commercial potential of CR-001.

Crescent’s programs will require additional clinical development, evaluation of clinical, preclinical and manufacturing activities, product development, regulatory and marketing approval in multiple jurisdictions, substantial investment and significant marketing efforts before Crescent generates any revenues from product sales. Crescent is not permitted to market or promote these programs, or any other programs, before it receives regulatory and marketing approval from the FDA and comparable foreign regulatory authorities, and Crescent may never receive such regulatory or marketing approvals.

The success of Crescent’s product candidates will depend on a variety of factors. Crescent does not have complete control over many of these factors, including certain aspects of clinical development and the

 

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regulatory submission process, potential threats to Crescent’s intellectual property rights and the manufacturing, marketing, distribution and sales efforts of any current or future collaborator. Accordingly, Crescent cannot assure you that it will ever be able to generate revenue through the sale of these product candidates, even if approved. If Crescent is not successful in obtaining regulatory approval and commercializing its CR-001, CR-002 or CR-003 programs, or is significantly delayed in doing so, Crescent’s business will be materially harmed.

If Crescent does not achieve its projected development goals in the time frames it announces and expects, the commercialization of Crescent’s product candidates may be delayed and its expenses may increase and, as a result, its stock price may decline.

From time to time, Crescent estimates the timing of the anticipated accomplishment of various scientific, clinical, regulatory and other product development goals, which it sometimes refers to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials, such as the expected timing for the anticipated commencement of Crescent’s Phase 1 studies, and clinical trials in solid tumor and other target indications, as well as the receipt of clinical data, and submission of regulatory filings. From time to time, Crescent may publicly announce the expected timing of some of these milestones. All of these milestones are and will be based on numerous assumptions. The actual timing of these milestones can vary dramatically compared to Crescent’s estimates, in some cases for reasons beyond Crescent’s control. If Crescent does not meet these milestones as publicly announced, or at all, the commercialization of its product candidates may be delayed or never achieved and, as a result, its stock price may decline. Additionally, delays relative to Crescent’s projected timelines are likely to cause overall expenses to increase, which may require Crescent to raise additional capital sooner than expected and prior to achieving targeted development milestones.

Any drug delivery device that Crescent potentially uses to deliver its product candidates may have its own regulatory, development, supply and other risks.

Crescent expects to deliver its product candidates via a drug delivery device, such as an injector or other delivery system. There may be unforeseen technical complications related to the development activities required to bring such a product to market, including primary container compatibility and/or dose volume requirements. Crescent’s product candidates may not be approved or may be substantially delayed in receiving approval if the devices that Crescent chooses to develop do not gain and/or maintain their own regulatory approvals or clearances. Where approval of the drug product and device is sought under a single application, the increased complexity of the review process may delay approval. In addition, some drug delivery devices are provided by single-source unaffiliated third-party companies. Crescent may be dependent on the sustained cooperation and effort of those third-party companies both to supply the devices and, in some cases, to conduct the studies required for approval or other regulatory clearance of the devices. Even if approval is obtained, Crescent may also be dependent on those third-party companies continuing to maintain such approvals or clearances once they have been received. Failure of third-party companies to supply the devices, to successfully complete studies on the devices in a timely manner, or to obtain or maintain required approvals or clearances of the devices could result in increased development costs, delays in or failure to obtain regulatory approval and delays in product candidates reaching the market or in gaining approval or clearance for expanded labels for new indications.

Crescent’s approach to the discovery and development of its programs is unproven, and Crescent may not be successful in its efforts to build a pipeline of programs with commercial value.

Crescent’s approach to the discovery and development of its programs, particularly CR-001, leverages clinically validated mechanisms of action and incorporates the targeting, binding, cooperativity and pharmacokinetics of ivonescimab, an anti-PD-1/anti-VEGF bispecific antibody that demonstrated significantly improved PFS to market-leading pembrolizumab in HARMONi-2, a large Phase 3 clinical trial for the treatment of naïve, or not previously treated, advanced and metastatic NSCLC. Crescent’s programs are purposefully designed to avoid mechanistic risks that could perturb the balance of efficacy and safety that defines this new class of immunotherapy. However, the scientific research that forms the basis of Crescent’s efforts to develop programs using ivonescimab-like technologies is ongoing and may not result in viable programs. There is limited clinical data available on product candidates utilizing the same mechanism of

 

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action as ivonescimab, especially in solid tumor indications, demonstrating whether they are safe or effective for long-term treatment in humans. The long-term safety and efficacy of these technologies and exposure profile of Crescent’s programs compared to currently approved products is unknown. Additionally, there can be no assurance that Crescent’s clinical trials, which are expected to cover a broader set of indications than in HARMONi-2, will demonstrate similar or comparable safety and efficacy results to HARMONi-2. Crescent may ultimately discover that reproducing ivonescimab’s established pharmacology for its specific targets and indications and any programs resulting therefrom does not possess certain properties required for therapeutic effectiveness. Crescent currently has only preclinical data regarding the ivonescimab-like properties of its programs and the same results may not be seen in humans. In addition, programs using ivonescimab-like technologies may demonstrate different chemical and pharmacological properties in patients than they do in laboratory studies. This technology and any programs resulting therefrom may not demonstrate the same chemical and pharmacological properties in humans and may interact with human biological systems in unforeseen, ineffective or harmful ways. Many product candidates that appeared highly promising in preclinical studies or in early-stage clinical trials have failed when advanced into, or further in, clinical development. In addition, the failure of companies that are developing products similar to Crescent or targeting the same indications as Crescent to demonstrate safety and efficacy of their product candidates may be harmful to Crescent’s business, financial condition, results of operations and prospects.

In addition, Crescent may in the future seek to discover and develop programs that are based on novel targets and technologies that are unproven. If Crescent’s discovery or business development activities fail to identify novel targets or technologies for drug development, or such targets prove to be unsuitable for treating human disease, Crescent may not be able to develop viable additional programs. Crescent and its existing or future collaborators may never receive approval to market and commercialize any product candidate. Even if Crescent or an existing or future collaborator obtains regulatory approval, the approval may be for targets, disease indications or patient populations that are not as broad as Crescent intended or desired or may require labeling that includes significant use or distribution restrictions or safety warnings. If the products resulting from Crescent’s programs prove to be ineffective, unsafe or commercially unviable, such programs would have little, if any, value, which would have a material and adverse effect on Crescent’s business, financial condition, results of operations and prospects.

Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results. If Crescent’s preclinical studies and clinical trials are not sufficient to support regulatory approval of any of its product candidates, Crescent may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development of such product candidate.

Before obtaining regulatory and marketing approval from regulatory authorities for the sale of any product candidate, Crescent must complete preclinical studies and then conduct extensive clinical trials to demonstrate the safety and efficacy of such product candidate in humans. Crescent’s clinical trials may not be conducted as planned or completed on schedule, if at all, and failure can occur at any time during the preclinical study or clinical trial process. For example, Crescent depends on the availability of non-human primates (“NHPs”) to conduct certain preclinical studies that it is required to complete prior to submitting an IND and initiating clinical development. There is currently a global shortage of NHPs available for drug development. This could cause the cost of obtaining NHPs for Crescent’s future preclinical studies to increase significantly and, if the shortage continues, could also result in delays to Crescent’s development timelines.

Furthermore, a failure of one or more clinical trials can occur at any stage of testing. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory and marketing approval of their product candidates. In addition, Crescent expects to rely on patients to provide feedback on measures such as measures of quality of life, which are subjective and inherently difficult to evaluate. These measures can be influenced by factors outside of Crescent’s control, and can vary widely from day-to-day for a particular patient, and from patient to patient and from site to site within a clinical trial.

 

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Crescent cannot be sure that the FDA or comparable foreign regulatory authorities will agree with its clinical development plan. Crescent plans to design a Phase 1 clinical trial for CR-001 based on the clinical profile of ivonescimab. If the FDA or comparable foreign regulatory authorities require Crescent to conduct additional trials or enroll additional patients, Crescent’s development timelines may be delayed. Crescent cannot be sure that submission of an IND, BLA or similar application will result in the FDA or comparable foreign regulatory authorities, as applicable, allowing clinical trials to begin in a timely manner, if at all. Moreover, even if these trials begin, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Events that may prevent successful or timely initiation or completion of clinical trials include: inability to generate sufficient preclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials; delays in reaching a consensus with regulatory authorities on study design or implementation of the clinical trials; delays or failure in obtaining regulatory authorization to commence a trial; delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; delays in identifying, recruiting and training suitable clinical investigators; delays in obtaining required IRB approval or positive ethics committee opinions at each clinical trial site; delays in manufacturing, testing, releasing, validating or importing/exporting sufficient stable quantities of Crescent’s product candidates for use in clinical trials or the inability to do any of the foregoing; failure by Crescent’s CROs, other third parties or Crescent to adhere to clinical trial protocols; failure to perform in accordance with the FDA’s or any other regulatory authority’s current Good Clinical Practice requirements (“GCPs”) or applicable regulatory guidelines in other countries; changes to the clinical trial protocols; clinical sites deviating from trial protocol or dropping out of a trial; changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; selection of clinical endpoints that require prolonged periods of observation or analyses of resulting data; transfer of manufacturing processes to facilities operated by a contract manufacturing organization (“CMO”) and delays or failure by Crescent’s CMOs or Crescent to make any necessary changes to such manufacturing process; and third parties being unwilling or unable to satisfy their contractual obligations to Crescent.

Crescent could also encounter delays if a clinical trial is suspended or terminated by it, by the IRBs or ethics committees of the institutions in which such clinical trials are being conducted, by the Data Safety Monitoring Board, if any, for such clinical trial or by the FDA or comparable foreign regulatory authorities. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or Crescent’s clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from the programs, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. If Crescent is required to conduct additional clinical trials or other testing of its product candidates beyond those that Crescent currently contemplates, if Crescent is unable to successfully complete clinical trials of its product candidates, if the results of these trials are not positive or are only moderately positive or if there are safety concerns, Crescent’s business and results of operations may be adversely affected and it may incur significant additional costs.

If Crescent encounters difficulties enrolling patients in its future clinical trials, its clinical development activities could be delayed or otherwise adversely affected.

Crescent may experience difficulties in patient enrollment in its future clinical trials for a variety of reasons, including the competitive landscape for solid tumor indications and competition for establishing trial sites and clinical trial enrollment. The timely completion of clinical trials in accordance with their protocols depends, among other things, on Crescent’s ability to enroll a sufficient number of patients who remain in the trial until its conclusion. The enrollment of patients in future trials for any of Crescent’s programs will depend on many factors, including if patients choose to enroll in clinical trials, rather than using approved products, or if Crescent’s competitors have ongoing clinical trials for programs that are under development for the same indications as its programs, and patients instead enroll in such clinical trials. Additionally, the number of patients required for clinical trials of Crescent’s programs may be larger than Crescent anticipates, especially if regulatory bodies require the completion of non-inferiority or superiority trials. Even if Crescent is able to enroll a sufficient number of patients for its future clinical trials, it may have difficulty maintaining patients in its clinical trials. Crescent’s inability to enroll or maintain a sufficient

 

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number of patients would result in significant delays in completing clinical trials or receipt of regulatory and marketing approvals and increased development costs or may require Crescent to abandon one or more clinical trials altogether.

Preliminary, “topline” or interim data from Crescent’s clinical trials that it announces or publishes from time to time may change as more patient data become available and are subject to audit and verification procedures.

From time to time, Crescent may publicly disclose preliminary or topline data from its preclinical studies and clinical trials, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data. Crescent also makes assumptions, estimations, calculations and conclusions as part of its analyses of these data without the opportunity to fully and carefully evaluate complete data. As a result, the preliminary or topline results that Crescent reports may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated or subsequently made subject to audit and verification procedures.

Any preliminary or topline data should be viewed with caution until the final data are available. From time to time, Crescent may also disclose interim data from its preclinical studies and clinical trials. Interim data are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available or as patients from Crescent’s clinical trials continue other treatments. Further, others, including regulatory agencies, may not accept or agree with Crescent’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular product candidate, the approvability or commercialization of the particular product candidate and Crescent in general. In addition, the information Crescent chooses to publicly disclose regarding a particular preclinical study or clinical trial is based on what is typically extensive information, and you or others may not agree with what Crescent determines is material or otherwise appropriate information to include in its disclosure. As a result, you or others may have reached different conclusions based on such extensive information in comparison to Crescent’s publicly disclosed conclusion regarding a particular preclinical study or clinical trial. If the preliminary, topline or interim data that Crescent reports differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Crescent’s ability to obtain approval for, and commercialize, its product candidates may be harmed, which could harm its business, operating results, prospects or financial condition.

Crescent’s future clinical trials or those of its future collaborators may reveal significant adverse events or undesirable side effects not seen in Crescent’s preclinical studies and may result in a safety profile that could halt clinical development, inhibit regulatory approval or limit commercial potential or market acceptance of any of Crescent’s product candidates.

Results of Crescent’s clinical trials could reveal a high and unacceptable severity and prevalence of side effects, adverse events or unexpected characteristics. While preclinical studies conducted with respect to Crescent’s programs have not shown any such characteristics to date, Crescent has not yet initiated any clinical trials in humans. If significant adverse events or other side effects are observed in any of Crescent’s future clinical trials, Crescent may have difficulty recruiting patients to such trials, patients may drop out of the trials, or Crescent may be required to abandon the trials or its development efforts of one or more programs altogether. For example, clinical experience in NSCLC with anti-VEGF inhibitors, such as bevacizumab, identified serious adverse events, including fatal pulmonary hemorrhage, that have limited the number of patients eligible for treatment. Other adverse events associated with bevacizumab include proteinuria and hypertension. Crescent, the FDA or other applicable regulatory authorities, or an IRB, may suspend any clinical trials of any program at any time for various reasons, including a belief that subjects or patients in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential products developed in the biotechnology industry that initially showed therapeutic promise in early-stage studies and trials have later been found to cause side effects that prevented their further development. Other potential products have shown side effects in preclinical studies, which side effects do not present themselves in clinical trials in humans. Even if the side effects do not preclude the product candidate from obtaining or maintaining regulatory and marketing approval, undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Treatment-emergent adverse events could

 

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also affect patient recruitment or the ability of enrolled subjects to complete Crescent’s clinical trials or could result in potential product liability claims. Potential side effects associated with Crescent’s product candidates may not be appropriately recognized or managed by the treating medical staff, as toxicities resulting from Crescent’s product candidates may not be normally encountered in the general patient population and by medical personnel. Any of these occurrences could harm Crescent’s business, financial condition, results of operations and prospects significantly.

In addition, even if Crescent successfully advances its product candidates or any future product candidates through clinical trials, such trials will only include a limited number of patients and limited duration of exposure to Crescent’s product candidates. As a result, Crescent cannot be assured that adverse effects of its product candidates will not be uncovered when a significantly larger number of patients are exposed to the product candidate after approval. Further, any clinical trials may not be sufficient to determine the effect and safety consequences of using Crescent’s product candidates over a multi-year period.

If any of the foregoing events occur or if one or more of Crescent’s programs proves to be unsafe, Crescent’s entire pipeline could be affected, which would have a material adverse effect on its business, financial condition, results of operations and prospects.

Crescent may expend its limited resources to pursue a particular program and fail to capitalize on programs that may be more profitable or for which there is a greater likelihood of success.

Because Crescent has limited financial and managerial resources, it focuses its research and development efforts on certain selected programs and utilizes Paragon to conduct certain research activities (primarily preclinical studies) pursuant to the Paragon Option Agreements. For example, Crescent is initially focused on its lead program, CR-001, and other expected programs, CR-002 and CR-003, for which Crescent has or expects to develop a research plan with Paragon and has or expects to obtain a license from Paragon pursuant to a Paragon Option Agreement. As a result, Crescent may forgo or delay pursuit of opportunities with other programs that later prove to have greater commercial potential. Crescent’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Crescent’s spending on current and future research and development programs for specific indications may not yield any commercially viable product candidates. If Crescent does not accurately evaluate the commercial potential or target market for a particular product candidate, it may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for it to retain sole development and commercialization rights to such product candidate. In addition, Crescent selects product candidates amongst a variety of potential product candidates from Paragon, and the product candidates it selects may fail to be viable commercial products or the product candidates it does not select may have a greater likelihood of success.

Any approved products resulting from Crescent’s current programs or any future program may not achieve adequate market acceptance among clinicians, patients, healthcare third-party payors and others in the medical community necessary for commercial success and Crescent may not generate any future revenue from the sale or licensing of such products.

Even if regulatory approval is obtained for a product candidate resulting from one of Crescent’s current or future programs, they may not gain market acceptance among physicians, healthcare professionals, patients, healthcare payors or the medical community. Crescent may not generate or sustain revenue from sales of the product due to factors such as whether the product can be sold at a competitive cost and whether it will otherwise be accepted in the market. There are several approved products and product candidates in later stages of development for the treatment of solid tumors, including pembrolizumab. In addition, Opdivo, a PD-1 inhibitor, and Yervoy®, a CTLA-4 inhibitor, in combination are approved by the FDA for treating various cancers, including metastatic melanoma, advanced renal cell carcinoma, and certain types of colorectal cancer. Crescent’s CR-001 utilizes a proprietary anti-PD-1/anti-VEGF bispecific antibody for its method of action, and is designed to recapitulate the targeting, binding, cooperativity and pharmacokinetics of ivonescimab, an anti-PD-1/anti-VEGF bispecific antibody that demonstrated significantly improved PFS to market-leading pembrolizumab in a large Phase 3 clinical trial. Although checkpoint inhibitors are highly effective in some patients, most patients with solid tumors fail to respond to these therapies. Furthermore, patients who do respond do not always achieve durable responses. Market participants with significant

 

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influence over acceptance of new treatments, such as clinicians and third-party payors, may not adopt a biologic that uses cooperative binding qualities for Crescent’s targeted indications, and Crescent may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any programs developed by it or its existing or future collaborators. Serious adverse events, including fatal pulmonary hemorrhage, observed in anti-VEGF inhibitors, such as bevacizumab, may adversely affect Crescent’s ability to gain market acceptance. Market acceptance of Crescent’s product candidates may be negatively impacted by potential poor performance of its competitors, including the occurrence of serious adverse events in such competitors’ clinical trials or failure by such competitors to obtain and maintain regulatory approval for their product candidates.

Sales of medical products also depend on the willingness of clinicians to prescribe the treatment. Crescent cannot predict whether clinicians, clinicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that its product is safe, therapeutically effective, cost effective or less burdensome as compared with competing treatments. If any of Crescent’s product candidates is approved but does not achieve an adequate level of acceptance by such parties, Crescent may not generate or derive sufficient revenue from that product candidate and may not become or remain profitable. Market acceptance of Crescent’s product candidates will depend on many factors, including factors that are not within its control.

Certain of Crescent’s programs may compete with its other programs, which could negatively impact Crescent’s business and reduce its future revenue.

Crescent is developing product candidates for the same indication, solid tumors, and may in the future develop its programs for other oncology indications. Each such program targets a different mechanism of action. However, developing multiple programs for a single indication may negatively impact Crescent’s business if the programs compete with each other. For example, if multiple programs are conducting clinical trials at the same time, they could compete for the enrollment of patients. In addition, if multiple product candidates are approved for the same indication, they may compete for market share, which could limit Crescent’s future revenue.

Crescent may conduct clinical trials for programs at sites outside the United States, and the FDA may not accept data from trials conducted in such locations.

Crescent may choose to conduct one or more of its future clinical trials outside the United States. Although the FDA may accept data from clinical trials conducted outside the United States, acceptance of this data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population must also adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In addition, while these clinical trials are subject to the applicable local laws, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that Crescent conducts outside the United States, it would likely result in the need for additional trials, which would be costly and time-consuming and would delay or permanently halt Crescent’s development of the applicable product candidates. Even if the FDA accepted such data, it could require Crescent to modify its planned clinical trials to receive clearance to initiate such trials in the United States or to continue such trials once initiated.

Further, conducting international clinical trials presents additional risks that may delay completion of Crescent’s clinical trials. These risks include the failure of enrolled patients in foreign countries to adhere to clinical protocol as a result of differences in healthcare services or cultural customs that could restrict or limit Crescent’s ability to conduct its clinical trials, the administrative burdens of conducting clinical trials under multiple sets of foreign regulations, foreign exchange fluctuations, diminished protection of intellectual property in some countries, as well as political and economic risks relevant to foreign countries.

 

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Risks Related to Government Regulation

The regulatory approval processes of the FDA and other comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If Crescent is not able to obtain, or if there are delays in obtaining, required regulatory approvals for its product candidates, Crescent will not be able to commercialize, or will be delayed in commercializing, its product candidates, and its ability to generate revenue will be materially impaired.

The process of obtaining regulatory approvals, both in the United States and abroad, is unpredictable, expensive and typically takes many years following commencement of clinical trials, if approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the product candidates involved. Crescent cannot commercialize product candidates in the United States without first obtaining regulatory approval from the FDA. Similarly, Crescent cannot commercialize product candidates outside of the United States without obtaining regulatory approval from comparable foreign regulatory authorities. Before obtaining regulatory approvals for the commercial sale of Crescent’s product candidates, including its lead program, CR-001, and other expected programs, CR-002 and CR-003, Crescent must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that its product candidates are both safe and effective for each targeted indication. Securing regulatory approval also requires the submission of information about the drug manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Further, Crescent’s product candidates may not be effective, may be only moderately effective or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude Crescent’s obtaining regulatory and marketing approval. The FDA and comparable foreign regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that Crescent’s data are insufficient for approval and require additional preclinical, clinical or other data. Crescent’s product candidates could be delayed in receiving, or fail to receive, regulatory approval for many reasons, including: the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Crescent’s clinical trials; Crescent may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication; the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval; serious and unexpected drug-related side effects may be experienced by patients in Crescent’s clinical trials or by individuals using drugs similar to Crescent’s product candidates; Crescent may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks; the FDA or comparable foreign regulatory authorities may disagree with Crescent’s interpretation of data from preclinical studies or clinical trials; the data collected from clinical trials of Crescent’s product candidates may not be acceptable or sufficient to support the submission of a BLA or other submission or to obtain regulatory approval in the United States or elsewhere, and Crescent may be required to conduct additional clinical trials; the FDA or the applicable foreign regulatory authority may disagree regarding the formulation, labeling and/or the specifications of Crescent’s product candidates; the FDA or comparable foreign regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which Crescent contracts for clinical and commercial supplies; and the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering Crescent’s clinical data insufficient for approval. In addition, the FDA and comparable foreign regulatory authorities may undergo leadership changes, change their policies, issue additional regulations or revise existing regulations, or take other actions, such as those implemented by the recently established Department of Government Efficiency, which may impact Crescent’s clinical development plans or prevent or delay approval of its programs under development on a timely basis. Such policy or regulatory changes could impose additional requirements upon Crescent that could delay its ability to obtain approvals and increase the costs of compliance.

Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized. The lengthy approval process as well as the unpredictability of future clinical trial results may result in Crescent’s failing to obtain regulatory approval to market its product candidates, which would significantly harm Crescent’s business, results of operations and prospects.

 

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If Crescent were to obtain approval, regulatory authorities may approve any of Crescent’s product candidates for fewer or more limited indications than Crescent requests, including failing to approve the most commercially promising indications, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. If Crescent is not able to obtain, or if there are delays in obtaining, required regulatory approvals for its product candidates, Crescent will not be able to commercialize, or will be delayed in commercializing, its product candidates and its ability to generate revenue will be materially impaired.

Disruptions at the FDA and other government agencies could negatively affect the review of Crescent’s regulatory submissions, which could negatively impact its business.

The ability of the FDA to review and approve regulatory submissions can be affected by a variety of factors, including statutory, regulatory and policy changes, inadequate government budget funding levels or a reduction in the FDA’s workforce and its ability to hire and retain key personnel, disruptions caused by government shutdowns and public health crises. There have been mass layoffs of federal employees since the start of the current presidential administration in January 2025, the full impact of which is unclear at this time. Such disruptions could significantly impact the ability of the FDA or other regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on Crescent’s business. In addition, the presidential administration has made and is expected to continue to make changes in the leadership of various U.S. federal regulatory agencies and changes to U.S. federal government policy that have led to, in some cases, legal challenges and uncertainty around the funding, functioning and policy priorities of the U.S. federal regulatory agencies, including the FDA.

Crescent is unable to predict the extent to which the presidential administration may impose or seek to impose leadership or policy changes at the FDA or changes to rules and policies impacting Crescent’s business and operations. It is unclear how these executive actions or other potential actions by the federal government will impact the FDA or other regulatory authorities that oversee Crescent’s business. Government proposals to reduce or eliminate budgetary deficits may include reduced allocations to the FDA and other related government agencies. These budgetary pressures may reduce the FDA’s ability to perform its responsibilities, which could result in delays in Crescent’s clinical trial timelines. If a significant reduction in the FDA’s workforce occurs, the FDA’s budget is significantly reduced or a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process Crescent’s regulatory submissions or take other actions critical to the development or manufacturing of its programs, which could have a material adverse effect on Crescent’s business.

Crescent may not be able to meet requirements for the chemistry, manufacturing and control of its programs.

In order to receive approval of its products by the FDA and comparable foreign regulatory authorities, Crescent must show that it and its contract manufacturing partners are able to characterize, control and manufacture its drug products safely and in accordance with regulatory requirements. This includes manufacturing the active ingredient, developing an acceptable formulation, manufacturing the drug product, performing tests to adequately characterize the formulated product, documenting a repeatable manufacturing process, and demonstrating that Crescent’s drug products meet stability requirements. Meeting these chemistry, manufacturing and control requirements is a complex task that requires specialized expertise. If Crescent is not able to meet the chemistry, manufacturing and control requirements, it may not be successful in getting its products approved.

Crescent’s product candidates for which it intends to seek approval as biologics may face competition sooner than anticipated.

The Patient Protection and Affordable Act, as amended by the Healthcare and Education Reconciliation Act (the “ACA”), includes a subtitle called the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a highly similar or “biosimilar” product may not be submitted to the FDA until four years following the date that the reference product was first approved by the FDA. In addition, the approval of a biosimilar

 

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product may not be made effective by the FDA until 12 years from the date on which the reference product was first approved. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

Crescent believes that any of its product candidates approved as biologics under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider Crescent’s product candidates to be reference products for competing products, potentially creating the opportunity for competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. Moreover, the extent to which a biosimilar, once approved, will be substituted for any reference products in a way that is similar to traditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

Even if Crescent receives regulatory approval of its product candidates, Crescent will be subject to extensive ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and Crescent may be subject to penalties if it fails to comply with regulatory requirements or experiences unanticipated problems with its product candidates.

Any regulatory approvals that Crescent may receive for its product candidates will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a risk evaluation and mitigation strategy (“REMS”) in order to approve Crescent’s product candidates, which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or comparable foreign regulatory authorities approve Crescent’s product candidates, its product candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export will be subject to comprehensive regulation by the FDA and other regulatory agencies in the United States and by comparable foreign regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with current cGMPs and GCPs for any clinical trials that Crescent conducts following approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMPs.

If Crescent or a regulatory authority discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory authority may impose restrictions on that product, the manufacturing facility or Crescent, including requiring recall or withdrawal of the product from the market or suspension of manufacturing, restrictions on Crescent’s ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials, restrictions on the manufacturing process, warning or untitled letters, civil and criminal penalties, injunctions, product seizures, detentions or import bans, voluntary or mandatory publicity requirements and imposition of restrictions on operations, including costly new manufacturing requirements. The occurrence of any event or penalty described above may inhibit Crescent’s ability to commercialize its product candidates and generate revenue and could require Crescent to expend significant time and resources in response and could generate negative publicity.

Crescent may face difficulties from healthcare legislative reform measures.

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Crescent’s product candidates. Crescent cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or

 

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administrative action, either in the United States or abroad. For example, the Trump Administration has discussed several changes to the reach and oversight of the FDA, which could affect its relationship with the pharmaceutical industry, transparency in decision-making and ultimately the cost and availability of prescription drugs. If Crescent is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if it is not able to maintain regulatory compliance, Crescent may lose any regulatory and marketing approval that it may have obtained and it may not achieve or sustain profitability. See the section titled “Crescent’s Business — Government Regulation — Healthcare Reform” for a more detailed description of healthcare reform measures that may prevent or limit Crescent’s ability to generate revenue, attain profitability, or commercialize its product candidates.

Crescent’s business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers will be subject to applicable healthcare regulatory laws, which could expose Crescent to penalties.

Crescent’s business operations and current and future arrangements with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers may expose Crescent to broadly applicable fraud and abuse and other healthcare laws and regulations. These laws may constrain the business or financial arrangements and relationships through which Crescent conducts its operations, including how Crescent researches, markets, sells and distributes its product candidates, if approved. See the section titled “Crescent’s Business — Government Regulation — Other Healthcare Laws and Compliance Requirements” for a more detailed description of the laws that may affect Crescent’s ability to operate.

Ensuring that Crescent’s internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. If Crescent’s operations are found to be in violation of any of these laws or any other governmental laws and regulations that may apply to it, Crescent may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from government-funded healthcare programs, integrity oversight and reporting obligations to resolve allegations of non-compliance, disgorgement, individual imprisonment, contractual damages, reputational harm, diminished profits and the curtailment or restructuring of Crescent’s operations. Further, defending against any such actions can be costly and time-consuming and may require significant personnel resources. Therefore, even if Crescent is successful in defending against any such actions that may be brought against it, its business may be impaired.

Even if Crescent is able to commercialize any product candidates, due to unfavorable pricing regulations and/or third-party coverage and reimbursement policies, it may not be able to offer such product candidates at competitive prices which would seriously harm its business.

Crescent intends to seek approval to market its product candidates in both the United States and in selected foreign jurisdictions. If Crescent obtains approval in one or more foreign jurisdictions for its product candidates, Crescent will be subject to rules and regulations in those jurisdictions. Crescent’s ability to successfully commercialize any product candidates that it may develop will depend in part on the extent to which reimbursement for these product candidates and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and other third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. These entities may create preferential access policies for a competitor’s product, including a branded or generic/biosimilar product, over Crescent’s products in an attempt to reduce their costs, which may reduce Crescent’s commercial opportunity. Additionally, if any of Crescent’s product candidates are approved and Crescent is found to have improperly promoted off-label uses of those product candidates, Crescent may become subject to significant liability, which would materially adversely affect its business and financial condition. See the sections titled “Crescent’s Business — Government Regulation — Coverage and Reimbursement” and “Crescent’s Business — Other Government Regulation Outside of the United States — Regulation in the European Union” for a more detailed description of the government regulations and third-party payor practices that may affect Crescent’s ability to commercialize its product candidates.

 

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Crescent is subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Crescent can face criminal liability and other serious consequences for violations, which can harm its business.

Crescent is subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which Crescent conducts activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to or from recipients in the public or private sector. Crescent may engage third parties to sell its products outside the United States, to conduct clinical trials, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory approvals. Crescent has direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. Crescent can be held liable for the corrupt or other illegal activities of its employees, agents, contractors, and other collaborators, even if Crescent does not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

Governments outside the United States tend to impose strict price controls, which may adversely affect Crescent’s revenue, if any.

In some countries, particularly member states of the EU (“EU Member States”), the pricing of prescription drugs is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of regulatory and marketing approval for a therapeutic. In addition, there can be considerable pressure by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU Member States and parallel distribution, or arbitrage between low-priced and high-priced EU Member States, can further reduce prices. To obtain coverage and reimbursement or pricing approvals in some countries, Crescent or current or future collaborators may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of Crescent’s product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval. Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries. If reimbursement of any product candidate approved for marketing is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, Crescent’s business, financial condition, results of operations or prospects could be materially and adversely affected. Brexit could lead to legal uncertainty and potentially divergent national laws and regulations, including those related to the pricing of prescription pharmaceuticals, as the United Kingdom (“UK”) determines which EU laws to replicate or replace. If the UK were to significantly alter its regulations affecting the pricing of prescription pharmaceuticals, Crescent could face significant new costs.

Crescent may attempt to obtain accelerated approval of its product candidates. If Crescent is unable to obtain accelerated approval, Crescent may be required to conduct clinical trials beyond those that it contemplates, or the size and duration of Crescent’s pivotal clinical trials could be greater than currently planned, which could increase the expense of obtaining, reduce the likelihood of obtaining, and/or delay the timing of obtaining necessary regulatory approvals. Even if Crescent receives accelerated approval from the FDA or comparable foreign regulatory authorities, the FDA or comparable foreign regulatory authorities may require that Crescent conducts confirmatory trials to verify clinical benefit. If Crescent’s confirmatory trials do not verify clinical benefit, or if Crescent does not comply with rigorous post-approval requirements, the FDA may seek to withdraw accelerated approval.

Crescent may seek accelerated approval for Crescent’s product candidates. The FDA may grant accelerated approval to a product designed to treat a serious or life-threatening condition that provides

 

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meaningful therapeutic advantage over available therapies and demonstrates an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease. If granted, accelerated approval may be contingent on the sponsor’s agreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verify and describe the drug’s predicted effect on irreversible morbidity or mortality or other clinical benefit. Under the Food and Drug Omnibus Reform Act of 2022, the FDA may require, as appropriate, that such studies be underway prior to approval or within a specific time period after the date of approval for a product granted accelerated approval. The FDA may require that any such confirmatory study be initiated or substantially underway prior to the submission of an application for accelerated approval. If such post-approval studies fail to confirm the drug’s clinical benefits relative to its risks, the FDA may withdraw its approval of the drug. If Crescent chooses to pursue accelerated approval, there can be no assurance that the FDA will agree that Crescent’s proposed primary endpoint is an appropriate surrogate endpoint. Similarly, there can be no assurance that after subsequent FDA feedback that Crescent will continue to pursue accelerated approval or any other form of expedited development, review, or approval, even if Crescent initially decides to do so. Furthermore, if Crescent submits an application for accelerated approval, there can be no assurance that such application will be accepted or that approval will be granted on a timely basis, or at all. The FDA also could require Crescent to conduct further studies or trials prior to considering Crescent’s application or granting approval of any type. Crescent might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays, or approval might not be granted because Crescent’s submission is deemed incomplete by the FDA. Comparable considerations apply outside of the United States.

Even if Crescent receives accelerated approval from the FDA, Crescent will be subject to rigorous post-approval requirements, including submission to the FDA of all promotional materials prior to their dissemination. The FDA will require Crescent to conduct a confirmatory study to verify the predicted clinical benefit. The FDA could withdraw accelerated approval for multiple reasons, including Crescent’s failure to conduct any required post-approval study with due diligence, or the inability of such study to confirm the predicted clinical benefit. A failure to obtain accelerated approval or any other form of expedited review or approval for a product candidate could result in a longer time period prior to commercializing such product candidate, increase the cost of development of such product candidate, and harm Crescent’s competitive position in the marketplace.

A breakthrough therapy, fast track, or other expedited designation for Crescent’s product candidates may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that those product candidates will receive regulatory and marketing approval.

Crescent may seek a breakthrough therapy, fast track, or other designation for appropriate product candidates. Designations such as these are within the discretion of the FDA, or other comparable regulatory authorities. The receipt of a designation for a product candidate may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of Crescent’s product candidates qualifies under one of FDA’s designation programs, the FDA may later decide that the products no longer meet the conditions for qualification or decide that the time period for FDA review or approval will not be shortened. See the section titled “Crescent’s Business — Government Regulation —  Expedited Development and Review Programs” for a more detailed description of the process for seeking expedited designations such as fast track or breakthrough therapy designations.

Disruptions at the FDA, the SEC and other government agencies and regulatory authorities caused by funding shortages, changes or reductions in agency personnel, or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of Crescent’s business may rely, which could negatively impact Crescent’s business.

The ability of the FDA to review regulatory filings and Crescent’s ability to commence human clinical trials can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government

 

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funding of the SEC, and other government agencies on which Crescent’s operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies or comparable foreign regulatory authorities may also slow the time necessary for the review and approval of applications for clinical trial or marketing authorization, which would adversely affect Crescent’s business. For example, in previous years, including in 2018 and 2019, the U.S. government shut down several times and certain regulatory agencies, such as the FDA and the SEC, had to furlough critical employees and stop critical activities. Additionally, action by the new Trump Administration to limit federal agency budgets or personnel may result in reductions to the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting our ability to progress development of Crescent’s product candidates or obtain regulatory approval for Crescent’s product candidates. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process Crescent’s regulatory submissions, which could have a material adverse effect on Crescent’s business. Further, future government shutdowns or changes or reductions in agency personnel could impact Crescent’s ability to access the public markets and obtain necessary capital in order to properly capitalize and continue Crescent’s operations.

If a prolonged government shutdown occurs, if there is a significant change or reduction in agency personnel, or if global health concerns prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA or other regulatory authorities to timely review and process Crescent’s regulatory submissions, which could have a material adverse effect on its business.

Risks Related to Crescent’s Intellectual Property

Crescent does not currently own any issued patents or pending patent applications. Therefore, Crescent’s ability to obtain and protect its patent rights, and protect other proprietary rights, is uncertain, exposing Crescent to the possible loss of competitive advantage.

Crescent’s success depends in large part on its ability to obtain and maintain patent protection for its platform technologies, programs and their uses, as well as its ability to operate without infringing on or violating the proprietary rights of others. Crescent’s ability to protect its technologies from unauthorized making, using, selling, offering to sell or importing by third parties is dependent on the extent to which Crescent has rights under valid and enforceable patents that cover these activities. Crescent relies upon a combination of future patents, trademarks, trade secret protection, confidentiality agreements and the Paragon Option Agreements to protect the intellectual property related to its programs and technologies. Crescent does not currently own any patents, but it expects to license certain patent rights from Paragon and, in the future, prosecute underlying intellectual property for some or all of the in-licensed or owned product candidates that it develops. Paragon has filed provisional patent applications and intends to file one or more additional provisional patent applications directed to antibodies that target PD-1 and VEGF, including applications covering composition of matter, pharmaceutical formulations, and methods of using such antibodies, including CR-001. In addition, Paragon intends to file one or more additional provisional patent applications directed to ADCs, including applications covering composition of matter, pharmaceutical formulations, and methods of using such antibodies, including CR-002 and CR-003. However, Crescent may not be able to protect its intellectual property rights throughout the world and the legal systems in certain countries may not favor enforcement or protection of patents, trade secrets, and other intellectual property. Filing, prosecuting and defending patents on programs worldwide would be expensive and Crescent’s intellectual property rights in some foreign jurisdictions can be less extensive than those in the United States; the reverse may also occur. As such, Crescent may not have patents in all countries or all major markets and may not be able to obtain patents in all jurisdictions even if it applies for them. Crescent’s competitors may operate in countries where Crescent does not have patent protection and can freely use Crescent’s technologies and discoveries in such countries to the extent such technologies and discoveries are publicly known or disclosed in countries where Crescent does have patent protection or pending patent applications.

Crescent’s intellectual property portfolio is at an early stage. Crescent does not currently own any issued patents or pending patent applications. Crescent’s future optioned in-licensed or owned patent

 

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applications may not result in patents being issued. Any issued patents may not afford sufficient protection of Crescent’s programs or their intended uses against competitors, nor can there be any assurance that the patents issued will not be infringed, designed around, invalidated by third parties, or effectively prevent others from commercializing competitive technologies, products or programs. Even if these patents are granted, they may be difficult to enforce. If Crescent does not obtain patent coverage for the work it is conducting, or if Crescent obtains such rights but they are invalidated or rendered unenforceable, it may be unable to exclude competitors from pursuing and marketing the same or similar product candidates. Other risks Crescent faces if it is not able to obtain and maintain patent coverage for its product candidates are the reduction in valuation of Crescent’s product candidates, and ultimately of Crescent as a company, by potential investors, and Crescent’s inability to assert claims for infringement against third parties or counterclaim against such third parties or negotiate more advantageous settlement parameters Further, any issued patents that Crescent may license or own covering Crescent’s programs could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad, including the United States Patent and Trademark Office (“USPTO”). Further, if Crescent encounters delays in its clinical trials or delays in obtaining regulatory approval, the period of time during which Crescent could market its product candidates under patent protection would be reduced. Thus, the patents that Crescent may own and license may not afford Crescent any meaningful competitive advantage.

In addition to seeking patents for some of its technology and programs, Crescent may also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain its competitive position. Any disclosure, either intentional or unintentional, by Crescent’s employees, the employees of third parties with whom Crescent shares its facilities or third-party consultants and vendors that Crescent engages to perform research, clinical trials or manufacturing activities, or misappropriation by third parties (such as through a cybersecurity breach) of Crescent’s trade secrets or proprietary information could enable competitors to duplicate or surpass Crescent’s technological achievements, thus eroding Crescent’s competitive position in its market. In order to protect Crescent’s proprietary technology and processes, it relies in part on confidentiality agreements and, if applicable, material transfer agreements, consulting agreements, or other similar agreements prior to beginning research or disclosing proprietary information with parties, such as collaborators, employees, consultants, outside scientific collaborators and sponsored researchers and other advisors. Crescent also enters into confidentiality and invention or patent assignment agreements with its employees and consultants under which they are obligated to maintain confidentiality and to assign their inventions to Crescent. These agreements typically limit the rights of the third parties to use or disclose Crescent’s confidential information, including Crescent’s trade secrets. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. Crescent may need to share its proprietary information, including trade secrets, with future business partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or state actors and those affiliated with or controlled by state actors. In addition, while Crescent undertakes efforts to protect its trade secrets and other confidential information from disclosure, others may independently discover trade secrets and proprietary information, and in such cases, Crescent may not be able to assert any trade secret rights against such party. Enforcing a claim that a party disclosed or misappropriated Crescent’s trade secrets, or securing title to an employee- or consultant-developed invention if a dispute arises, is challenging and the outcome is unpredictable. In addition, courts outside of the United States may be less willing to protect trade secrets. Costly and time-consuming litigation could be necessary to enforce and determine the scope of Crescent’s proprietary rights and failure to obtain or maintain trade secret protection could adversely affect Crescent’s competitive business position.

The enforceability of confidentiality agreements may vary from jurisdiction to jurisdiction. In addition, these agreements typically restrict the ability of Crescent’s advisors, employees, third-party contractors and consultants to publish data potentially relating to Crescent’s trade secrets, although Crescent’s agreements may contain certain limited publication rights. Despite Crescent’s efforts to protect its trade secrets, competitors may discover Crescent’s trade secrets, either through breach of its agreements with third parties, independent development or publication of information by any of its third-party collaborators. A competitor’s discovery of Crescent’s trade secrets would impair its competitive position and have an adverse impact on its business.

 

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Lastly, if Crescent’s trademarks and trade names are not registered or adequately protected, then Crescent may not be able to build name recognition in its markets of interest and its business may be adversely affected.

If Crescent is unable to obtain or maintain necessary rights to its programs through acquisitions and in-licenses, its business may be materially harmed.

Because Crescent’s development programs currently do and may in the future require the use of proprietary rights held by third parties, the growth of Crescent’s business may depend in part on its ability to acquire, in-license, or use these third-party proprietary rights. Crescent may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights from third parties that it identifies as necessary for its programs. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of more established companies may pursue strategies to license or acquire third-party intellectual property rights that Crescent may consider attractive or necessary. These established companies may have a competitive advantage over Crescent due to their size, capital resources and greater clinical development and commercialization capabilities. In addition, companies that perceive Crescent to be a competitor may be unwilling to assign or license rights to Crescent. Crescent also may be unable to license or acquire third-party intellectual property rights on commercially reasonable terms or at all. If Crescent is unable to successfully obtain rights to required third-party intellectual property rights or maintain the existing intellectual property rights it does obtain, Crescent’s ability to commercialize any of its targeted therapeutics, if approved, would likely be delayed, or Crescent may have to abandon development of the relevant program, which could have a material adverse effect on its business, financial condition, results of operations, and prospects.

While Crescent plans to obtain the right to control prosecution, defense, maintenance and enforcement of the patents relating to its programs, there may be times when the filing and prosecution activities for patents and patent applications relating to Crescent’s programs are controlled by future licensors or collaboration partners. For example, Paragon currently has the right to file patent applications and control prosecution with respect to any inventions that may fall within the ADC Paragon Option Agreement for CR-002 and CR-003. If Crescent, Paragon or any of Crescent’s future licensors or collaboration partners fail to prosecute, maintain and enforce such patents and patent applications in a manner consistent with the best interests of Crescent’s business, including by payment of all applicable fees for patents covering its product candidates, Crescent could lose its rights to the intellectual property or its exclusivity with respect to those rights, its ability to develop and commercialize those product candidates may be adversely affected and it may not be able to prevent competitors from making, using and selling competing products. In addition, even where Crescent is granted the right to control patent prosecution of patents and patent applications it has licensed to and from third parties, Crescent may still be adversely affected or prejudiced by actions or inactions of its licensees, its future licensors and their counsel that took place prior to the date upon which Crescent assumed control over patent prosecution. For example, because Crescent has not yet entered into a license agreement for CR-002 or CR-003, Paragon is currently responsible for the prosecution, defense, maintenance and enforcement of patents related to such programs. Subsequent to entering into a license agreement with Paragon for each such program, Crescent expects to control patent prosecution over such program following the trigger for transfer of prosecution control to Crescent.

Crescent’s future licensors may rely on third-party consultants or collaborators or on funds from third parties such that Crescent’s future licensors are not the sole and exclusive owners of the patents Crescent in-licenses. If other third parties have ownership rights to Crescent’s future in-licensed patents, they may be able to license such patents to Crescent’s competitors, and Crescent’s competitors could market competing products and technology. This could have a material adverse effect on Crescent’s competitive position, business, financial conditions, results of operations, and prospects.

It is possible that Crescent may be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all. Even if Crescent is able to obtain a license, it may be non-exclusive, including with respect to the use, field or territory of the licensed intellectual property, thereby giving Crescent’s competitors access to the same technologies licensed to Crescent. In that event, Crescent may be required to expend significant time and resources to redesign its technology, programs, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial

 

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basis. If Crescent is unable to do so, it may be unable to develop or commercialize the affected product candidates, which could harm its business, financial condition, results of operations, and prospects significantly. Crescent cannot provide any assurances that third-party patents do not exist which might be enforced against Crescent’s current technology, manufacturing methods, programs, or future methods or products resulting in either an injunction prohibiting Crescent’s manufacture or future sales, or, with respect to its future sales, an obligation on Crescent’s part to pay royalties and/or other forms of compensation to third parties, which could be significant.

Disputes may arise between Crescent and its future licensors regarding intellectual property subject to a license agreement, including: the scope of rights granted under the license agreement and other interpretation-related issues; whether and the extent to which Crescent’s technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; Crescent’s right to sublicense patents and other rights to third parties; Crescent’s right to transfer or assign the license; the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Crescent’s future licensors and it and its partners; and the priority of invention of patented technology. If Crescent or its future licensors breach the terms of its license agreements, such breach may have a material adverse effect on Crescent’s business and the commercialization efforts for Crescent’s programs.

Crescent may be subject to patent infringement claims or may need to file claims to protect its intellectual property, which could result in substantial costs and liability and prevent Crescent from commercializing its potential products.

Because the intellectual property landscape in the biotechnology industry is rapidly evolving and interdisciplinary, it is difficult to conclusively assess Crescent’s freedom to operate and guarantee that Crescent can operate without infringing on or violating third-party rights. If certain of Crescent’s product candidates are ultimately granted regulatory approval, patent rights held by third parties, if found to be valid and enforceable, could be alleged to render one or more of Crescent’s product candidates infringing. If a third party successfully brings a claim against Crescent, Crescent may be required to pay substantial damages, be forced to abandon any affected product candidate and/or seek a license from the patent holder. In addition, any intellectual property claims (e.g., patent infringement or trade secret misappropriation) brought against Crescent, whether or not successful, may cause Crescent to incur significant legal expenses and divert the attention of its management and key personnel from other business concerns. Crescent cannot be certain that future patents, if filed and issued, owned or licensed by it will not be challenged by others, whether in the course of litigation or in agencies like the USPTO. Some of Crescent’s competitors may be able to sustain the costs of complex intellectual property litigation more effectively than Crescent can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have a material adverse effect on Crescent’s ability to raise funds.

Competitors may infringe or otherwise violate Crescent’s future patents, trademarks, copyrights or other intellectual property. To counter infringement or other violations, Crescent may be required to file claims, which can be expensive and time-consuming. Any such claims could provoke these parties to assert counterclaims against Crescent, including claims alleging that Crescent infringes their patents or other intellectual property rights and/or that Crescent’s patents are invalid and/or unenforceable. In addition, in a patent infringement proceeding, a court or administrative body may decide that one or more of the patents Crescent asserts is invalid or unenforceable, in whole or in part, construe the patent’s claims narrowly or refuse to prevent the other party from using the technology at issue on the grounds that Crescent’s patents do not cover the technology. Similarly, if Crescent asserts trademark infringement claims, a court or administrative body may determine that the marks Crescent has asserted are invalid or unenforceable or that the party against whom Crescent has asserted trademark infringement has superior rights to the marks in question. In such a case, Crescent could ultimately be forced to cease use of such marks. In any intellectual property litigation, even if Crescent is successful, any award of monetary damages or other remedy Crescent receives may not be commercially valuable.

Further, Crescent may be required to protect its future patents, if filed and issued, through procedures created to challenge the validity of a patent before administrative bodies in the United States such as the USPTO or abroad. Such mechanisms include re-examination, post grant review and equivalent proceedings in foreign jurisdictions, e.g., opposition proceedings. An adverse determination in any such submission or

 

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proceeding could reduce the scope or enforceability of, or invalidate, Crescent’s patent rights, which could adversely affect Crescent’s competitive position. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action.

In addition, if Crescent’s programs are found to infringe the intellectual property rights of third parties, these third parties may assert infringement claims against Crescent’s future licensees and other parties with whom Crescent has business relationships and Crescent may be required to indemnify those parties for any damages they suffer as a result of these claims, which may require Crescent to initiate or defend protracted and costly litigation on behalf of licensees and other parties regardless of the merits of such claims. If any of these claims succeed, Crescent may be forced to pay damages on behalf of those parties or may be required to obtain licenses for the products they use.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to Crescent’s intellectual property rights, there is a risk that some of Crescent’s confidential information could be compromised by disclosure during this type of litigation or other proceedings.

Crescent may be subject to claims that it has wrongfully hired an employee from a competitor or that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.

As is common in the biotechnology industry, in addition to Crescent’s employees, Crescent engages the services of consultants to assist it in the development of its programs. Many of these consultants, and many of Crescent’s employees, were previously employed at, or may have previously provided or may be currently providing consulting services to, other biotechnology or pharmaceutical companies including Crescent’s competitors or potential competitors. Crescent could in the future be subject to claims that it or its employees have inadvertently or otherwise used or disclosed alleged trade secrets or other confidential information of former employers or competitors. Although Crescent tries to ensure that its employees and consultants do not use the intellectual property, proprietary information, know-how or trade secrets of others in their work for Crescent, Crescent may become subject to claims that it caused an employee to breach the terms of his or her non-competition or non-solicitation agreement, or that Crescent or these individuals have, inadvertently or otherwise, used or disclosed the alleged trade secrets or other proprietary information of a former employer or competitor.

While Crescent may litigate to defend itself against these claims, even if it is successful, litigation could result in substantial costs and could be a distraction to management. If Crescent’s defenses to these claims fail, in addition to requiring it to pay monetary damages, a court could prohibit Crescent from using technologies or features that are essential to its programs, if such technologies or features are found to incorporate or be derived from the trade secrets or other proprietary information of the former employers. Moreover, any such litigation or the threat thereof may adversely affect Crescent’s reputation, its ability to form strategic alliances or sublicense its rights to collaborators, engage with scientific advisors or hire employees or consultants, each of which would have an adverse effect on Crescent’s business, results of operations and financial condition. Even if Crescent is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

Changes to patent laws in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing Crescent’s ability to protect its products.

Although Crescent does not currently own or in-license any patents or applications, if it obtains such patents and applications in the future, changes in either the patent laws or interpretation of patent laws in the United States, including patent reform legislation such as the Leahy-Smith Act could increase the uncertainties and costs surrounding the prosecution of Crescent’s owned and in-licensed patent applications, if any, and the maintenance, enforcement or defense of its owned and in-licensed issued patents, if any. The Leahy-Smith Act includes a number of significant changes to United States patent law. These changes include provisions that affect the way patent applications are prosecuted, redefine prior art, provide more

 

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efficient and cost-effective avenues for competitors to challenge the validity of patents, and enable third-party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent at USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith Act, the United States transitioned to a first-to-file system in which, assuming that the other statutory requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. As such, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of Crescent’s patent applications, if any, and the enforcement or defense of its issued patents, if any, all of which could have a material adverse effect on Crescent’s business, financial condition, results of operations and prospects. Additionally, the USPTO and patent offices in other jurisdictions have often required that patent applications directed to pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive challenges. Accordingly, even if Crescent or its licensors are able to obtain patents, the patents might be substantially narrower than anticipated. Thus, there is no assurance as to the degree and range of protections any of Crescent’s patents, if issued, may afford Crescent or whether patents will be issued.

In addition, the patent positions of companies in the development and commercialization of biologics and pharmaceuticals are particularly uncertain. U.S. Supreme Court and U.S. Court of Appeals for the Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations, including in the antibody arts. For example, the United States Supreme Court in Amgen, Inc. v. Sanofi (Amgen) recently held that Amgen’s patent claims to a class of antibodies functionally defined by their ability to bind a particular antigen were invalid for lack of enablement where the patent specification provided twenty-six exemplary antibodies, but the claimed class of antibodies covered a “vast number” of additional antibodies not disclosed in the specification. The Court stated that if patent claims are directed to an entire class of compositions of matter, then the patent specification must enable a person skilled in the art to make and use the entire class of compositions. This decision makes it unlikely that Crescent will be granted U.S. patents with composition of matter claims directed to antibodies functionally defined by their ability to bind a particular antigen. Even if Crescent is granted claims directed to functionally defined antibodies, it is possible that a third party may challenge Crescent’s patents, when issued, relying on the reasoning in Amgen or other recent precedential court decisions. Additionally, there have been proposals for additional changes to the patent laws of the United States and other countries that, if adopted, could impact Crescent’s ability to enforce its proprietary technology. This combination of events has created uncertainty with respect to the validity and enforceability of patents once obtained. Depending on future actions by the U.S. Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on Crescent’s patent rights and its ability to protect, defend and enforce its patent rights in the future.

Geopolitical instability in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of patent applications and the maintenance, enforcement or defense of issued patents. For example, the United States and foreign government actions related to Russia’s invasion of Ukraine may limit or prevent filing, prosecution and maintenance of patent applications in Russia. Government actions may also prevent maintenance of issued patents in Russia. These actions could result in abandonment or lapse of patents or patent applications, resulting in partial or complete loss of patent rights in Russia. If such an event were to occur, it could have a material adverse effect on Crescent’s business. In addition, a decree was adopted by the Russian government in March 2022 allowing Russian companies and individuals to exploit inventions owned by patentees that have citizenship or nationality in, are registered in, or have predominately primary place of business or profit-making activities in the United States and other countries that Russia has deemed unfriendly without consent or compensation. Consequently, Crescent would not be able to prevent third parties from practicing its inventions in Russia or from selling or importing products made using its inventions in and into Russia. Accordingly, Crescent’s competitive position may be impaired, and its business, financial condition, results of operations and prospects may be adversely affected.

 

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In addition, a European Unified Patent Court (“UPC”) entered into force on June 1, 2023. The UPC is a common patent court that hears patent infringement and revocation proceedings effective for EU Member States. The broad geographic reach of the UPC could enable third parties to seek revocation of any of Crescent’s future European patents in a single proceeding at the UPC rather than through multiple proceedings in each of the individual European Union member states in which the European patent is validated. Under the UPC, a successful revocation proceeding for a European Patent under the UPC would result in loss of patent protection in those European Union countries. Accordingly, a single proceeding under the UPC could result in the partial or complete loss of patent protection in numerous European Union countries. Such a loss of patent protection could have a material adverse impact on Crescent’s business and its ability to commercialize its technology and product candidates and, resultantly, on its business, financial condition, prospects and results of operations. Moreover, the controlling laws and regulations of the UPC will develop over time and Crescent cannot predict what the outcomes of cases tried before the UPC will be. The case law of the UPC may adversely affect Crescent’s ability to enforce or defend the validity of its European patents. Patent owners have the option to opt-out their European patents from the jurisdiction of the UPC, defaulting to pre-UPC enforcement mechanisms.

Although Crescent does not currently own any European patents or applications, if it obtains such patents and applications in the future, any such revocation and loss of patent protection could have a material adverse impact on Crescent’s business and its ability to commercialize or license its technology and products. Moreover, the controlling laws and regulations of the UPC will develop over time, and may adversely affect Crescent’s ability to enforce or defend the validity of any European patents it may obtain. Crescent may decide to opt out from the UPC any future European patent applications that it may file and any patents it may obtain. If certain formalities and requirements are not met, however, such European patents and patent applications could be challenged for non-compliance and brought under the jurisdiction of the UPC. Crescent cannot be certain that future European patents and patent applications will avoid falling under the jurisdiction of the UPC, if Crescent decides to opt out of the UPC.

Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and Crescent’s patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuities fees and various other governmental fees on patents and/or patent applications are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent and/or patent application. The USPTO and various foreign governmental patent agencies also require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time limits, non-payment of fees and failure to properly legalize and submit formal documents. If Crescent fails to maintain any future patents and patent applications, if filed and issued, covering its programs, Crescent’s competitive position would be adversely affected.

Crescent may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect Crescent’s ability to develop and market its products.

Crescent cannot guarantee that any of its patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can Crescent be certain that it has identified each and every third-party patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of its product candidates in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent, the patent’s prosecution history and in some cases certain extrinsic evidence of the meaning of terms in a claim. Crescent’s interpretation of the relevance or the scope of a patent or a pending application may be incorrect. For example, Crescent may incorrectly determine that its products are

 

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not covered by a third-party patent or may incorrectly predict whether a third-party’s pending application will issue with claims of relevant scope. Crescent’s determination of the expiration date of any patent in the United States or abroad that it considers relevant may be incorrect. Crescent’s failure to identify and correctly interpret relevant patents may negatively impact its ability to develop and market its products.

In addition, because some patent applications in the United States may be maintained in secrecy until the patents are issued, patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing, and publications in the scientific literature often lag behind actual discoveries, Crescent cannot be certain that others have not filed patent applications for technology covered by Crescent’s future issued patents or its pending applications, if filed, or that Crescent was the first to invent the technology. Crescent’s competitors may have filed, and may in the future file, patent applications covering products or technology similar to Crescent’s. Any such patent application may have priority over Crescent’s future patent applications or patents, if filed and issued, which could require Crescent to obtain rights to issued patents covering such technologies.

Crescent may become subject to claims challenging the inventorship or ownership of its patents and other intellectual property.

Crescent may be subject to claims that former employees, collaborators or other third parties have an interest in Crescent’s future patents, if filed and issued, or other intellectual property as an inventor or co-inventor. The failure to name the proper inventors on a patent application can result in the patents issuing thereon being invalid or unenforceable. Inventorship disputes may arise from conflicting views regarding the contributions of different individuals named as inventors, the effects of foreign laws where foreign nationals are involved in the development of the subject matter of the patent, conflicting obligations of third parties involved in developing Crescent’s programs or as a result of questions regarding co-ownership of potential joint inventions. Litigation may be necessary to resolve these and other claims challenging inventorship and/or ownership. While Crescent typically requires employees, consultants and contractors who may develop intellectual property on its behalf to execute agreements assigning such intellectual property to Crescent, Crescent may be unsuccessful in obtaining execution of assignment agreements with each party who in fact develops intellectual property that Crescent regards as its own. Moreover, even when Crescent obtains agreements assigning intellectual property to it, the assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached. In either case, Crescent may be forced to bring claims against third parties, or defend claims that they may bring against Crescent, to determine the ownership of what Crescent regards as its intellectual property. If Crescent fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on Crescent’s business. Even if Crescent is successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Patent terms may be inadequate to protect the competitive position of Crescent’s product candidates for an adequate amount of time.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date or international Patent Cooperation Treaty Filing. The patent term of a U.S. patent may be lengthened by patent term adjustment, which compensates a patentee for administrative delays by the USPTO in granting a patent, or may be shortened if a patent is terminally disclaimed over an earlier-filed patent.

Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering Crescent’s product candidates are obtained, once the patent life has expired, Crescent may be open to competition from competitive products, including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. As a result, Crescent’s owned and licensed patent portfolio may not provide it with sufficient rights to exclude others from commercializing products similar or identical to Crescent’s.

In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a Patent Term Extension (“PTE”) of up to five years beyond the normal expiration of the patent to compensate

 

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patent owners for loss of an enforceable patent term due to the lengthy regulatory approval process. A PTE grant cannot extend the remaining term of a patent beyond a total of 14 years from the date of the product approval. Further, PTE may only be applied once per product, and only with respect to an approved indication — in other words, only one patent (for example, covering the product itself, an approved use of said product, or a method of manufacturing said product) can be extended by PTE. Crescent anticipates applying for PTE in the United States. Similar extensions may be available in other countries where anticipates is prosecuting patents, and Crescent likewise anticipates applying for such extensions.

The granting of a PTE is not guaranteed and is subject to numerous requirements. Crescent might not be granted an extension because of, for example, failure to apply within applicable periods, failure to apply prior to the expiration of relevant patents or otherwise failure to satisfy any of the numerous applicable requirements. In addition, to the extent Crescent wishes to pursue a PTE based on a patent that it in-licenses from a third party, Crescent would need the cooperation of that third party. Moreover, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with Crescent’s assessment of whether such extensions are available, and may refuse to grant extensions to Crescent’s patents, or may grant more limited extensions than Crescent requests. If this occurs, Crescent’s competitors may be able to obtain approval of competing products following its patent expiration by referencing Crescent’s clinical and preclinical data and launch their product earlier than might otherwise be the case. If this were to occur, it could have a material adverse effect on Crescent’s ability to generate revenue.

Crescent’s technology licensed from various third parties in the future, including Paragon, may be subject to retained rights.

Crescent’s future licensors may retain certain rights under the relevant agreements with Crescent, including the right to use or license the licensed technology outside of the scope of Crescent’s license, use the underlying technology for noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether Crescent’s licensors limit their use of the technology to these uses, and Crescent could incur substantial expenses to enforce its rights to its licensed technology in the event of misuse. In addition, while there are certain restrictions on Paragon’s ability to develop products that could be competitive with Crescent’s, these restrictions may not prevent the possible future license or development by Paragon of certain technology that could lead to product candidates competitive with Crescent’s. This could have a material adverse effect on Crescent’s competitive position, business, financial condition, results of operations, and prospects.

Risks Related to Crescent’s Reliance on Third Parties

Crescent expects to rely on licensing arrangements with Paragon through the Paragon Option Agreements. If Crescent is unable to maintain collaborations or licensing arrangements, or if its collaborations or licensing arrangements are not successful, Crescent’s business could be negatively impacted.

Crescent expects to rely on its current and future licensing arrangements with Paragon, including through the Paragon Option Agreements, for a substantial portion of its discovery capabilities, including for CR-001, CR-002 and CR-003, and in-licenses.

Collaborations or licensing arrangements that Crescent enters into may not be successful, including in connection with the Paragon Option Agreements, and any success will depend heavily on the efforts and activities of such collaborators or licensors. If any of Crescent’s current or future collaborators or licensors experiences delays in performance of, or fails to perform its obligations under their agreement with Crescent, disagrees with Crescent’s interpretation of the terms of such agreement or terminates their agreement with Crescent, Crescent’s programs could be adversely affected. If Crescent fails to comply with any of the obligations under its collaborations or license agreements, including payment terms and diligence terms, Crescent’s collaborators or licensors may have the right to terminate such agreements, in which event Crescent may lose intellectual property rights and may not be able to develop, manufacture, market or sell the products covered by its agreements or may face other penalties under its agreements. Crescent’s collaborators and licensors may also fail to properly maintain or defend the intellectual property Crescent

 

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has licensed from them, if required by Crescent’s agreement with them, or even infringe upon, Crescent’s intellectual property rights, leading to the potential invalidation of Crescent’s intellectual property or subjecting it to litigation or arbitration, any of which would be time-consuming and expensive and could harm Crescent’s ability to commercialize its product candidates. In addition, collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with Crescent’s programs and products if the collaborators believe that the competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than Crescent’s.

As part of Crescent’s strategy, Crescent plans to evaluate additional opportunities to enhance its capabilities and expand its development pipeline or provide development or commercialization capabilities that complement Crescent’s. Crescent may not realize the benefits of such collaborations, alliances or licensing arrangements. Any of these relationships may require Crescent to incur non-recurring and other charges, increase its near and long-term expenditures, issue securities that dilute its existing stockholders or disrupt its management and business.

Crescent may face significant competition in attracting appropriate collaborators, and more established companies may also be pursuing strategies to license or acquire third-party intellectual property rights that Crescent considers attractive. These companies may have a competitive advantage over Crescent due to their size, financial resources and greater clinical development and commercialization capabilities. In addition, companies that perceive Crescent to be a competitor may be unwilling to assign or license rights to Crescent. Whether Crescent reaches a definitive agreement for a collaboration will depend upon, among other things, its assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Collaborations are complex and time-consuming to negotiate, document and execute. In addition, consolidation among large pharmaceutical and biotechnology companies has reduced the number of potential future collaborators. Crescent may not be able to negotiate additional collaborations on a timely basis, on acceptable terms or at all. If Crescent fails to enter into collaborations and does not have sufficient funds or expertise to undertake the necessary development and commercialization activities, it may not be able to further develop its product candidates or bring them to market.

Crescent currently relies, and plans to rely in the future, on third parties to conduct and support its preclinical studies and clinical trials. If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, Crescent may not be able to obtain regulatory approval of or commercialize its product candidates.

Crescent has utilized and plans to continue to utilize and depend upon independent investigators and collaborators, such as medical institutions, CROs, contract testing labs and strategic partners, to conduct and support its preclinical studies and clinical trials under agreements with Crescent. Crescent will rely heavily on these third parties over the course of its preclinical studies and clinical trials, and Crescent controls only certain aspects of their activities. As a result, Crescent will have less direct control over the conduct, timing and completion of these preclinical studies and clinical trials and the management of data developed through preclinical studies and clinical trials than would be the case if it were relying entirely upon its own staff. Nevertheless, Crescent is responsible for ensuring that each of its studies and trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards, and its reliance on these third parties does not relieve Crescent of its regulatory responsibilities. Crescent and its third-party contractors and CROs are required to comply with GCP regulations, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for all of Crescent’s programs in clinical development. If Crescent or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in Crescent’s clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require Crescent to perform additional clinical trials before approving Crescent’s marketing applications. Crescent cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of Crescent’s clinical trials comply with GCP regulations. In addition, Crescent’s clinical trials must be conducted with products produced under cGMP regulations. Crescent’s failure to comply with these regulations may require it to repeat clinical trials, which would delay the regulatory approval process. Moreover, Crescent’s business may be implicated if any

 

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of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting Crescent’s clinical trials will not be Crescent’s employees and, except for remedies available to Crescent under its agreements with such third parties, Crescent cannot control whether they devote sufficient time and resources to Crescent’s programs. These third parties may be involved in mergers, acquisitions or similar transactions and may have relationships with other commercial entities, including Crescent’s competitors, for whom they may also be conducting clinical trials or other product development activities, which could negatively affect their performance on Crescent’s behalf and the timing thereof and could lead to products that compete directly or indirectly with Crescent’s product candidates. If these third parties do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to Crescent’s clinical protocols or regulatory requirements or for other reasons, Crescent’s clinical trials may be extended, delayed or terminated and Crescent may not be able to complete development of, obtain regulatory approval of or successfully commercialize its product candidates.

In addition, Crescent currently relies on foreign CROs and CMOs, including WuXi Biologics (Hong Kong) Limited (“WuXi”) for formulation and manufacturing of Crescent’s stage 1 clinical trial materials, and will likely continue to rely on foreign CROs and CMOs in the future. WuXi is a subsidiary or affiliate of WuXi Biologics, which is identified in the proposed U.S. legislation known as the BIOSECURE Act as a biotechnology “company of concern.” The BIOSECURE Act, if passed, would prohibit federal agencies from entering into procurement contracts with an entity that uses biotechnology equipment or services from a biotechnology company of concern. Foreign CMOs may be subject to U.S. legislation, including the proposed BIOSECURE Act, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to Crescent, delay the procurement or supply of such material or have an adverse effect on Crescent’s ability to secure significant commitments from governments to purchase its potential therapies. For example, in April 2025, the United States government imposed significant tariffs on imports from China and other countries and may impose more restrictions on goods, including biologically derived substances, manufactured in or imported from China or impose other restrictions on companies’ ability to work with Chinese biotech companies. To the extent these or future tariffs are applicable to the material we import from China and other countries, our financial condition could be adversely affected.

Further, the biopharmaceutical industry in China is strictly regulated by the Chinese government. Changes to Chinese regulations or government policies affecting biopharmaceutical companies are unpredictable and may have a material adverse effect on Crescent’s collaborators in China which could have an adverse effect on Crescent’s business, financial condition, results of operations and prospects. In addition, the United States government has imposed a 10% additional tariff on imports from China and may impose more restrictions on goods, including biologically derived substances, manufactured in or imported from China or impose other restrictions on companies’ ability to work with Chinese biotech companies. Evolving changes in China’s public health, economic, political, and social conditions and the uncertainty around China’s relationship with other governments, such as the United States and the UK, could also negatively impact Crescent’s ability to manufacture its product candidates for its planned clinical trials or have an adverse effect on its ability to secure government funding, which could adversely affect Crescent’s financial condition and cause it to delay its clinical development programs. Furthermore, if the BIOSECURE Act is passed and one or more of Crescent’s collaborators or vendors in China, including WuXi, is deemed to be a biotechnology company of concern, Crescent’s operations and financial condition may be negatively impacted as a result of any delays or increased costs arising from the trade restrictions and other foreign regulatory requirements affecting such collaborators. In addition, while Crescent has established relationships with CROs and CMOs outside of China, moving to those suppliers in the event of a geopolitical instability affecting Crescent’s collaborators in China could introduce delays into the development program.

Crescent currently relies and expects to rely in the future on the use of manufacturing suites in third-party facilities or on third parties to manufacture its product candidates, and Crescent may rely on third parties to produce and process its products, if approved. Crescent’s business could be adversely affected if it is unable to use third-party manufacturing suites or if the third-party manufacturers encounter difficulties in production.

Crescent does not currently own any facility that may be used as its clinical or commercial manufacturing and processing facility and must currently rely on CMOs to manufacture its product candidates. Crescent

 

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has not yet caused any product candidates to be manufactured on a commercial scale and may not be able to do so for any of its product candidates, if approved. Crescent currently has a sole source relationship for its supply of the CR-001, CR-002 programs and expects to have a sole source relationship for the supply of the CR-003 program]. If there should be any disruption in such supply arrangement, including any adverse events affecting Crescent’s sole supplier, it could have a negative effect on the clinical development of Crescent’s programs and other operations while Crescent works to identify and qualify an alternate supply source. Crescent may not control the manufacturing process of, and may be completely dependent on, its contract manufacturing partners for compliance with cGMP requirements and any other regulatory requirements of the FDA or comparable foreign regulatory authorities for the manufacture of its product candidates. Beyond periodic audits, Crescent has limited control over the ability of its CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of Crescent’s product candidates or if it withdraws any approval in the future, Crescent may need to find alternative manufacturing facilities, which would require the incurrence of significant additional costs, delays, and materially adversely affect Crescent’s ability to develop, obtain regulatory approval for or market its product candidates, if approved. Similarly, Crescent’s failure, or the failure of its CMOs, to comply with applicable regulations could result in sanctions being imposed on Crescent, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of Crescent’s product candidates or drugs and harm Crescent’s business and results of operations.

Moreover, Crescent’s CMOs may experience manufacturing difficulties due to resource constraints, supply chain issues, or as a result of labor disputes or unstable political environments. If any CMOs on which Crescent will rely fail to manufacture quantities of Crescent’s product candidates at quality levels necessary to meet regulatory requirements and at a scale sufficient to meet anticipated demand at a cost that allows Crescent to achieve profitability, Crescent’s business, financial condition and prospects could be materially and adversely affected. In addition, Crescent’s CMOs are responsible for transporting temperature-controlled materials that can be inadvertently degraded during transport due to several factors, rendering certain batches unsuitable for trial use for failure to meet, among others, Crescent’s integrity and purity specifications. Crescent and any of its CMOs may also face product seizure or detention or refusal to permit the import or export of products. Crescent’s business could be materially adversely affected by business disruptions to its third-party providers that could materially adversely affect its anticipated timelines, potential future revenue and financial condition and increase its costs and expenses. Each of these risks could delay or prevent the completion of Crescent’s preclinical studies and clinical trials or the approval of any of its product candidates by the FDA, result in higher costs or adversely impact commercialization of its product candidates. See the section titled “Crescent’s Business — Manufacturing” for a more detailed description of Crescent’s manufacturing plans and assumptions and the factors that may affect the success of Crescent’s programs.

Risks Related to Employee Matters, Managing Growth and Other Risks Related to Crescent’s Business

In order to successfully implement Crescent’s plans and strategies, Crescent will need to grow the size of its organization and it may experience difficulties in managing this growth.

Crescent expects to experience significant growth in the number of its employees and the scope of its operations, particularly in the areas of preclinical and clinical drug development, technical operations, clinical operations, regulatory affairs and, potentially, sales and marketing. To manage Crescent’s anticipated future growth, Crescent must continue to implement and improve its managerial, operational and financial personnel and systems, expand its facilities and continue to recruit and train additional qualified personnel. Due to Crescent’s limited financial resources and the limited experience of its management team working together in managing a company with such anticipated growth, Crescent may not be able to effectively manage the expansion of its operations or recruit and train additional qualified personnel.

Crescent is highly dependent on its key personnel and anticipates hiring new key personnel. If Crescent is not successful in attracting and retaining highly qualified personnel, it may not be able to successfully implement its business strategy.

Crescent is a preclinical stage biotechnology company with a limited operating history, and, as of May 3, 2025, it had 22 full-time employees. Crescent has been and will continue to be highly dependent on

 

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the research and development, clinical and business development expertise of its executive officers, as well as the other principal members of its management, scientific and clinical team. Any of Crescent’s management team members may terminate their employment with Crescent at any time. Crescent does not maintain “key person” insurance for any of its executives or other employees.

Attracting and retaining qualified personnel will also be critical to Crescent’s success, including with respect to any strategic transaction that it may pursue. The loss of the services of Crescent’s executive officers or other key employees could impede the achievement of its research, development and commercialization objectives and seriously harm its ability to successfully implement its business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in Crescent’s industry with the breadth of skills and experience required to successfully develop, facilitate regulatory approval of and commercialize product candidates. Competition to hire from this limited pool is intense, and Crescent may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. Crescent also experiences competition for the hiring of scientific and clinical personnel from universities and research institutions.

In addition, Crescent relies on consultants and advisors, including scientific and clinical advisors, to assist it in formulating its discovery and nonclinical and clinical development and commercialization strategy. Crescent’s consultants and advisors may be employed by employers other than Crescent and may have commitments under consulting or advisory contracts with other entities that may limit their availability to Crescent. If Crescent is unable to continue to attract and retain high quality personnel, its ability to pursue its growth strategy will be limited.

Crescent’s future growth may depend, in part, on its ability to operate in foreign markets, where it would be subject to additional regulatory burdens and other risks and uncertainties.

Crescent’s future growth may depend, in part, on its ability to develop and commercialize its product candidates in foreign markets for which it may rely on collaboration with third parties. Crescent is not permitted to market or promote any of its product candidates before it receives regulatory approval from the applicable foreign regulatory authority, and may never receive such regulatory approval for any of its product candidates. To obtain separate regulatory approval in many other countries, Crescent must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, clinical trials and commercial sales, pricing and distribution of its product candidates, and Crescent cannot predict success in these jurisdictions. If Crescent fails to comply with the regulatory requirements in international markets and receive applicable regulatory and marketing approvals, its target market will be reduced and its ability to realize the full market potential of its product candidates will be harmed and its business will be adversely affected. Moreover, even if Crescent obtains approval of its product candidates and ultimately commercializes its product candidates in foreign markets, Crescent would be subject to the risks and uncertainties, including the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements and reduced protection of intellectual property rights in some foreign countries.

Crescent’s estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which Crescent competes achieve the forecasted growth, its business may not grow at similar rates, or at all.

Crescent’s market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates which may not prove to be accurate. Crescent’s estimates and forecasts relating to size and expected growth of its target market may prove to be inaccurate. Even if the markets in which Crescent competes meet Crescent’s size estimates and growth forecasts, Crescent’s business may not grow at similar rates, or at all. Crescent’s growth is subject to many factors, including its success in implementing its business strategy, which is subject to many risks and uncertainties.

Crescent’s revenue will be dependent, in part, upon the size of the markets in the territories for which it gains regulatory approval, the accepted price for the product, the ability to obtain coverage and reimbursement and whether Crescent owns the commercial rights for that territory. If the number of Crescent’s addressable patients is not as significant as it estimates, the indication approved by regulatory authorities is narrower

 

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than it expects or the treatment population is narrowed by competition, physician choice or treatment guidelines, Crescent may not generate significant revenue from sales of such products, even if approved.

Crescent’s employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Crescent is exposed to the risk that its employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, CMOs, suppliers and vendors acting for or on its behalf may engage in misconduct or other improper activities. Crescent will adopt a code of conduct, which will become effective as of the Closing, but it is not always possible to identify and deter misconduct by these parties and the precautions Crescent takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting Crescent from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations.

Crescent’s internal information technology systems, or those of any of its CROs, manufacturers, other contractors or consultants, third-party service providers, or potential future collaborators, may fail or suffer security or data privacy breaches or other unauthorized or improper access to, use of, or destruction of Crescent’s proprietary or confidential data, employee data or personal data, which could result in additional costs, loss of revenue, significant liabilities, harm to Crescent’s brand and material disruption of its operations.

In the ordinary course of its business, Crescent and the third parties upon which it relies collect, receive, store, process, generate, use, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share (collectively, process) proprietary, confidential, and sensitive data, including personal data, intellectual property, trade secrets, and other sensitive data (collectively, sensitive information).

Despite the implementation of security measures in an effort to protect systems that store Crescent’s information, given their size and complexity and the increasing amounts of information maintained on Crescent’s internal information technology systems and those of its third-party CROs, other contractors (including sites performing Crescent’s clinical trials), third-party service providers and supply chain companies, and consultants, these systems are potentially vulnerable to breakdown or other damage or interruption from service interruptions, system malfunction, natural disasters, terrorism, war and telecommunication and electrical failures, as well as security breaches from inadvertent or intentional actions by Crescent’s employees, contractors, consultants, business partners and/or other third parties, or from cyber-attacks by malicious third parties, which may compromise Crescent’s system infrastructure or lead to the loss, destruction, alteration or dissemination of, or damage to, Crescent’s data.

Some actors now engage and are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction with military conflicts and defense activities. During times of war and other major conflicts, Crescent, and the third parties upon which it relies, may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt Crescent’s systems and operations, supply chain, and ability to produce, sell and distribute its goods and services. In particular, severe ransomware attacks are becoming increasingly prevalent and can lead to significant interruptions in Crescent’s operations, ability to provide its products or services, loss of sensitive data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but Crescent may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.

To the extent that any disruption or security breach were to result in loss, destruction, unavailability, alteration or dissemination of, or damage to, Crescent’s data or applications, or for it to be believed or reported that any of these occurred, Crescent could incur liability and reputational damage and the development and commercialization of its product candidates could be delayed. Further, Crescent’s insurance policies may not be adequate to compensate it for the potential losses arising from any such disruption in, or failure or security breach of, its systems or third-party systems where information important to Crescent’s business operations or commercial development is stored.

Crescent’s fully-remote workforce may create additional risks for its information technology systems and data because its employees work remotely and utilize network connections, computers, and devices

 

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working at home, while in transit and in public locations. Additionally, business transactions (such as acquisitions or integrations) could expose Crescent to additional cybersecurity risks and vulnerabilities, as its systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.

While Crescent has implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. Crescent may be unable in the future to detect vulnerabilities in its information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. Further, Crescent may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities. Applicable data privacy and security obligations may require Crescent to notify relevant stakeholders of security incidents. Such disclosures are costly, and the disclosure or the failure to comply with such requirements could lead to adverse consequences.

Crescent relies on third-party service providers and technologies to operate critical business systems to process sensitive information in a variety of contexts. Crescent’s ability to monitor these third parties’ information security practices is limited, and these third parties may not have adequate information security measures in place. If Crescent’s third-party service providers experience a security incident or other interruption, Crescent could experience adverse consequences. While Crescent may be entitled to damages if its third-party service providers fail to satisfy their privacy or security-related obligations to it, any award may be insufficient to cover Crescent’s damages, or Crescent may be unable to recover such award. In addition, supply-chain attacks have increased in frequency and severity, and Crescent cannot guarantee that third parties’ infrastructure in its supply chain or its third-party partners’ supply chains have not been compromised.

If Crescent (or a third party upon whom it relies) experiences a security incident or are perceived to have experienced a security incident, Crescent may experience adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptions in Crescent’s operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant consequences may cause stakeholders (including investors and potential customers) to stop supporting Crescent’s platform, deter new customers from products, and negatively impact Crescent’s ability to grow and operate its business.

Crescent’s contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in Crescent’s contracts are sufficient to protect Crescent from liabilities, damages, or claims related to its data privacy and security obligations. Crescent cannot be sure that its insurance coverage will be adequate or sufficient to protect it from or to mitigate liabilities arising out of its privacy and security practices, that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay future claims.

Crescent is subject to stringent and changing laws, regulations and standards, and contractual obligations relating to privacy, data protection, and data security. The actual or perceived failure to comply with such obligations could lead to government enforcement actions (which could include civil or criminal penalties), fines and sanctions, private litigation and/or adverse publicity and could negatively affect Crescent’s operating results and business.

Crescent and third parties who it works with are or may become subject to numerous domestic and foreign laws, regulations, and standards relating to privacy, data protection, and data security, the scope of which is changing, subject to differing applications and interpretations, and may be inconsistent among countries, or conflict with other rules. Crescent is or may become subject to the terms of contractual obligations related to privacy, data protection and data security. Crescent’s obligations may also change or expand as its business grows. The actual or perceived failure by Crescent or third parties related to Crescent to comply with such laws, regulations and obligations could increase Crescent’s compliance and operational costs, expose it to regulatory scrutiny, actions, fines and penalties, result in reputational harm, lead to a loss of customers, result in litigation and liability, and otherwise cause a material adverse effect on its business,

 

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financial condition, and results of operations. See the section titled “Crescent’s Business — Government Regulation — Data Privacy and Security” for a more detailed description of the laws that may affect Crescent’s ability to operate.

If Crescent fails to comply with environmental, health and safety laws and regulations, it could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of its business.

Crescent is subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Crescent’s operations may involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. In addition, Crescent may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair Crescent’s research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Crescent may be subject to adverse legislative or regulatory tax changes that could negatively impact its financial condition.

The rules dealing with U.S. federal, state and local income taxation are constantly under review by persons involved in the legislative process and by the Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws (which may have retroactive application) could adversely affect Crescent’s stockholders or Crescent. Crescent assesses the impact of various tax reform proposals and modifications to existing tax treaties in all jurisdictions where it has operations to determine the potential effect on its business and any assumptions it has made about its future taxable income. Crescent cannot predict whether any specific proposals will be enacted, the terms of any such proposals or what effect, if any, such proposals would have on its business if they were to be enacted. For example, the United States enacted the Inflation Reduction Act of 2022 (“IRA”), which implements, among other changes, a 1% excise tax on certain stock buybacks. In addition, beginning in 2022, the Tax Cuts and Jobs Act eliminated the previously available option to deduct research and development expenditures and requires taxpayers to amortize them generally over five years for research activities conducted in the United States and over 15 years for research activities conducted outside the United States. The U.S. Congress is considering legislation that would restore the current deductibility of research and development expenditures; however, Crescent has no assurance that the provision will be repealed or otherwise modified. Such changes, among others, may adversely affect Crescent’s effective tax rate, results of operation and general business condition.

Crescent may acquire businesses or products, or form strategic alliances, in the future, and may not realize the benefits of such acquisitions.

Crescent may acquire additional businesses or products, form strategic alliances, or create joint ventures with third parties that it believes will complement or augment its existing business. If Crescent acquires businesses with promising markets or technologies, it may not be able to realize the benefit of acquiring such businesses if it is unable to successfully integrate them with its existing operations and company culture. Crescent may encounter numerous difficulties in developing, manufacturing and marketing any new product candidates or products resulting from a strategic alliance or acquisition that delay or prevent it from realizing their expected benefits or enhancing Crescent’s business. There is no assurance that, following any such acquisition, Crescent will achieve the synergies expected in order to justify the transaction, which could result in a material adverse effect on Crescent’s business and prospects.

Crescent maintains its cash at financial institutions, often in balances that exceed federally-insured limits. The failure of financial institutions could adversely affect Crescent’s ability to pay its operational expenses or make other payments.

Crescent’s cash held in non-interest-bearing and interest-bearing accounts exceeds the Federal Deposit Insurance Corporation (“FDIC”) insurance limits. If such banking institutions were to fail, Crescent could lose all or a portion of those amounts held in excess of such insurance limitations. For example, the FDIC took control of Silicon Valley Bank on March 10, 2023. The Federal Reserve subsequently announced

 

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that account holders would be made whole. However, the FDIC may not make all account holders whole in the event of future bank failures. In addition, even if account holders are ultimately made whole with respect to a future bank failure, account holders’ access to their accounts and assets held in their accounts may be substantially delayed. Any material loss that Crescent may experience in the future or inability for a material time period to access its cash and cash equivalents could have an adverse effect on its ability to pay its operational expenses or make other payments, which could adversely affect its business.

General Risk Factors

Crescent’s estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the markets in which Crescent competes achieve the forecasted growth, its business may not grow at similar rates, or at all.

Crescent’s market opportunity estimates and growth forecasts are subject to significant uncertainty and are based on assumptions and estimates which may not prove to be accurate. Crescent’s estimates and forecasts relating to size and expected growth of its target market may prove to be inaccurate. Even if the markets in which Crescent competes meet its size estimates and growth forecasts, Crescent’s business may not grow at similar rates, or at all. Crescent’s growth is subject to many factors, including its success in implementing its business strategy, which is subject to many risks and uncertainties.

Crescent’s revenue will be dependent, in part, upon the size of the markets in the territories for which Crescent gains regulatory approval, the accepted price for the product, the ability to obtain coverage and reimbursement and whether Crescent owns the commercial rights for that territory. If the number of its addressable patients is not as significant as Crescent estimates, the indication approved by regulatory authorities is narrower than Crescent expects or the treatment population is narrowed by competition, physician choice or treatment guidelines, Crescent may not generate significant revenue from sales of such products, even if approved.

Crescent may become exposed to costly and damaging liability claims, either when testing a product candidate in the clinical or at the commercial stage, and its product liability insurance may not cover all damages from such claims.

Crescent is exposed to potential product liability and professional indemnity risks that are inherent in the research, development, manufacturing, marketing, and use of pharmaceutical products. While Crescent currently has no products that have been approved for commercial sale, the future use of a product candidate in clinical trials, and the sale of any approved products in the future, may expose Crescent to liability claims. These claims may be made by patients that use the product, healthcare providers, pharmaceutical companies, or others selling such product. Any claims against Crescent, regardless of their merit, could be difficult and costly to defend and could materially and adversely affect the market for Crescent’s products or any prospects for commercialization of its products. Although Crescent intends to obtain product liability insurance for its future clinical trials, it is possible that any liabilities could exceed Crescent’s insurance coverage or that in the future Crescent may not be able to maintain insurance coverage at a reasonable cost or obtain insurance coverage that will be adequate to satisfy any liability that may arise. If a successful product liability claim or series of claims is brought against Crescent for uninsured liabilities or in excess of insured liabilities, Crescent’s assets may not be sufficient to cover such claims and its business operations could be impaired.

Litigation costs and the outcome of litigation could have a material adverse effect on Crescent’s business.

From time to time Crescent may be subject to litigation claims through the ordinary course of its business operations regarding, but not limited to, employment matters, security of patient and employee personal information, contractual relations with collaborators and intellectual property rights. Litigation to defend itself against claims by third parties, or to enforce any rights that Crescent may have against third parties, may continue to be necessary, which could result in substantial costs and diversion of its resources, causing a material adverse effect on its business, financial condition, results of operations or cash flows.

 

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Crescent’s business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, political crises, geopolitical events, or other macroeconomic conditions, which could have a material and adverse effect on its results of operations and financial condition.

The global economy, including credit and financial markets, has experienced extreme volatility and disruptions, including, among other things, diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, supply chain shortages, increases in inflation rates, higher interest rates, and uncertainty about economic stability. Adverse macroeconomic conditions, including inflation, slower growth or recession, new or increased tariffs and other barriers to trade, especially in light of recent comments and executive orders made by the Trump Administration, changes to fiscal and monetary policy or government budget dynamics (particularly in the pharmaceutical and biotech areas), tighter credit, fluctuating interest rates, volatility in financial markets, high unemployment, labor availability constraints, currency fluctuations and other challenges in the global economy have in the past adversely affected, and may in the future adversely affect, Crescent and Crescent’s business partners and suppliers. In addition, on February 1, 2025, the United States imposed a 25% tariff on imports from Canada and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China. On April 2, 2025, the United States announced a baseline 10% tariff on all foreign goods, with goods imported from specified nations, including China and those in the European Union, taxed at higher rates. On April 9, 2025, the United States suspended certain of these tariffs, while increasing the tariff on imports from China to 145%. Historically, tariffs have led to increased trade and political tensions. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods. Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange and other economic activities between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global financial markets. There is substantial uncertainty about the duration of existing tariffs and whether additional tariffs may be imposed, modified or suspended. The Federal Reserve has raised interest rates multiple times in response to concerns about inflation and it may raise them again. Higher interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending. Similarly, the ongoing military conflict between Russia and Ukraine and in the Middle East and rising tensions with China have created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of the global supply chain. For example, trade policies and geopolitical disputes (including as a result of China-Taiwan relations) and other international conflicts can result in tariffs, sanctions and other measures that restrict international trade, and can materially adversely affect Crescent’s business, particularly if these measures occur in regions where Crescent sources its components or raw materials. In addition, tensions between the United States and China have led to a series of tariffs being imposed by the United States on imports from China mainland, as well as other business restrictions. Tariffs increase the costs of the components and raw materials Crescent sources. Countries may also adopt other measures, such as controls on imports or exports of goods, technology or data, that could adversely impact Crescent’s operations and supply chain. Any such volatility and disruptions may adversely affect Crescent’s business or the third parties on whom Crescent relies. If the equity and credit markets deteriorate, including as a result of political unrest or war, it may make any necessary debt or equity financing more costly, more dilutive, or more difficult to obtain in a timely manner or on favorable terms, if at all. Increased inflation rates can adversely affect Crescent by increasing its costs, including labor and employee benefit costs.

Crescent may in the future experience disruptions as a result of such macroeconomic conditions, including delays or difficulties in initiating or expanding clinical trials and manufacturing sufficient quantities of materials. Any one or a combination of these events could have a material and adverse effect on Crescent’s results of operations and financial condition.

Risks Related to the Cayman Redomestication

Currently, GlycoMimetics is governed by Delaware law, GlycoMimetics Charter and GlycoMimetics Bylaws, but upon effectiveness of the Cayman Redomestication the Combined Company will be governed by Cayman Islands law and the Cayman Articles, provisions of which have anti-takeover implications.

Upon effectiveness of the Cayman Redomestication, the Combined Company’s organizational documents will change and the Combined Company and its organizational documents will be governed by

 

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Cayman Islands law rather than Delaware law. Provisions that will be included in the Cayman Articles may discourage, delay or prevent a merger, acquisition or other change in control of the Combined Company that shareholders may consider favorable, including transactions in which its ordinary shareholders might otherwise receive a premium price for their ordinary shares. These provisions could also limit the price that investors might be willing to pay in the future for the Combined Company’s ordinary shares, thereby depressing the market price of its ordinary shares. In addition, because the Combined Company board of directors will be responsible for appointing the members of the Combined Company management team, these provisions may frustrate or prevent any attempts by the Combined Company shareholders to replace or remove its current management by making it more difficult for shareholders to replace members of the Combined Company board of directors. Among other things, these provisions will:

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continue the use of a classified board of directors such that not all members of the Combined Company board of directors are elected at one time;

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allow the authorized number of the Combined Company directors to be changed only by resolution of its board of directors, subject to the terms of the Cayman Certificate of Designation;

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limit the manner in which shareholders can remove directors from the Combined Company’s board of directors;

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provide for advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on at shareholder meetings;

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limit who may call a general meeting of shareholders;

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authorize the Combined Company board of directors to issue preferred shares without shareholder approval, which could be used to institute a “poison pill” that would work to dilute the share ownership of a potential hostile acquirer, effectively preventing acquisitions that have not been approved by the Combined Company board of directors; and

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require a special resolution passed by the affirmative vote of not less than two-thirds of the votes cast at a general meeting of the Combined Company will be required to amend provisions of the Cayman Articles.

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In addition, upon effectiveness of the Cayman Redomestication, the Cayman Certificate of Designation (as defined below) relating to the Cayman Series A Preferred Shares (as defined below) may delay or prevent a change in control of the Combined Company. At any time while at least 30% of the originally issued Cayman Series A Preferred Shares remain issued and outstanding, we may not consummate a Fundamental Transaction (as defined in the Cayman Certificate of Designation) or any merger or consolidation of the Combined Company with or into another entity or any share sale to, or other business combination in which the Combined Company’s shareholders immediately before such transaction do not hold at least a majority of the Combined Company’s share capital immediately after such transaction, without the affirmative vote of the Cayman Preferred Directors (as defined below), acting together, or a simple majority of the then issued and outstanding Cayman Series A Preferred Shares. This provision of the Cayman Certificate of Designation may make it more difficult for the Combined Company to enter into any of the aforementioned transactions, even potential change of control transactions that could offer a premium over the market value of the Combined Company to the ordinary shareholders, as it would require the separate consent of the Cayman Preferred Directors, acting together, or a simple majority of the issued and outstanding Cayman Series A Preferred Shares.

Because the Cayman Articles designate the courts of the Cayman Islands as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our shareholders, this could limit your ability to obtain a favorable judicial forum for disputes with our company or our company’s directors, officers or other employees.

The Cayman Articles will provide that unless the Combined Company consents in writing to the selection of an alternative forum, the courts of the Cayman Islands shall have exclusive jurisdiction over any claim or dispute arising out of or in connection with the Cayman Articles or otherwise related in any way to each shareholder’s shareholding in the Combined Company, including but not limited to (i) any derivative action or proceeding brought on behalf of the Combined Company, (ii) any action asserting a claim of

 

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breach of any fiduciary or other duty owed by any of the Combined Company’s current or former director, officer or other employee to the Combined Company or its shareholders, (iii) any action asserting a claim arising pursuant to any provision of the Companies Act or the Cayman Articles, or (iv) any action asserting a claim against the Combined Company governed by the internal affairs doctrine (as such concept is recognized under the laws of the United States of America) and that each shareholder irrevocably submits to the exclusive jurisdiction of the courts of the Cayman Islands over all such claims or disputes. The forum selection provision in Cayman Articles will not apply to actions or suits brought to enforce any liability or duty created by the Securities Act, Exchange Act or any claim for which the federal district courts of the United States of America are, as a matter of the laws of the United States of America, the sole and exclusive forum for determination of such a claim.

The Cayman Articles will also provide that, without prejudice to any other rights or remedies that we may have, each of the Combined Company’s shareholders acknowledges that damages alone would not be an adequate remedy for any breach of the selection of the courts of the Cayman Islands as exclusive forum and that accordingly the Combined Company shall be entitled, without proof of special damages, to the remedies of injunction, specific performance or other equitable relief for any threatened or actual breach of the selection of the courts of the Cayman Islands as exclusive forum.

This choice of forum provision may increase a shareholder’s cost and limit the shareholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage lawsuits against the Combined Company and its directors, officers and other employees. Any person or entity purchasing or otherwise acquiring any of the Combined Company’s shares or other securities, whether by transfer, sale, operation of law or otherwise, shall be deemed to have notice of and have irrevocably agreed and consented to these provisions. There is uncertainty as to whether a court would enforce such provisions, and the enforceability of similar choice of forum provisions in other companies’ memorandum and articles of association or other charter documents has been challenged in legal proceedings. It is possible that a court could find this type of provisions to be inapplicable or unenforceable, and if a court were to find this provision in the Cayman Articles to be inapplicable or unenforceable in an action, the Combined Company may incur additional costs associated with resolving the dispute in other jurisdictions, which could have adverse effect on the Combined Company’s business and financial performance.

Risks Related to the Combined Company

If any of the events described in “Risks Related to GlycoMimetics” or “Risks Related to Crescent” occur, those events could cause potential benefits of the Merger not to be realized.

Following completion of the Merger, the Combined Company will be susceptible to many of the risks described in the sections herein entitled “Risks Related to GlycoMimetics” and “Risks Related to Crescent.” To the extent any of the events in the risks described in those sections occur, the potential benefits of the Merger may not be realized and the results of operations and financial condition of the Combined Company could be adversely affected in a material way. This could cause the market price of the Combined Company common stock to decline.

The market price of the Combined Company common stock is expected to be volatile, and the market price of the common stock may drop following the Merger.

The market price of the Combined Company common stock following the Merger could be subject to significant fluctuations. Some of the factors that may cause the market price of the Combined Company common stock to fluctuate include:

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results of clinical trials and preclinical studies of the Combined Company’s product candidates, or those of the Combined Company’s competitors or the Combined Company’s existing or future collaborators;

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failure to meet or exceed financial and development projections the Combined Company may provide to the public;

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failure to meet or exceed the financial and development projections of the investment community;

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if the Combined Company does not achieve the perceived benefits of the Merger as rapidly or to the extent anticipated by financial or industry analysts;

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announcements of significant acquisitions, strategic collaborations, joint ventures or capital commitments by the Combined Company or its competitors;

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actions taken by regulatory agencies with respect to the Combined Company’s product candidates, clinical studies, manufacturing process or sales and marketing terms;

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disputes or other developments relating to proprietary rights, including patents, litigation matters, and the Combined Company’s ability to obtain patent protection for its technologies;

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additions or departures of key personnel;

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significant lawsuits, including patent or stockholder litigation;

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if securities or industry analysts do not publish research or reports about the Combined Company’s business, or if they issue adverse or misleading opinions regarding its business and stock;

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changes in the market valuations of similar companies;

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general market or macroeconomic conditions or market conditions in the pharmaceutical and biotechnology sectors;

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sales of securities by the Combined Company or its securityholders in the future;

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if the Combined Company fails to raise an adequate amount of capital to fund its operations or continued development of its product candidates;

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trading volume of the Combined Company common stock;

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announcements by competitors of new commercial products, clinical progress or lack thereof, significant contracts, commercial relationships or capital commitments;

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adverse publicity relating to precision medicine product candidates, including with respect to other products in such markets;

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the introduction of technological innovations or new therapies that compete with the products and services of the Combined Company; and

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period-to-period fluctuations in the Combined Company’s financial results.

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Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the Combined Company common stock. In addition, a recession, depression or other sustained adverse market event could materially and adversely affect the Combined Company’s business and the value of its common stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies. Furthermore, market volatility may lead to increased shareholder activism if the Combined Company experiences a market valuation that activists believe is not reflective of its intrinsic value. Activist campaigns that contest or conflict with the Combined Company’s strategic direction or seek changes in the composition of its board of directors could have an adverse effect on its operating results, financial condition and cash flows.

The Combined Company may incur losses for the foreseeable future and may never achieve profitability.

The Combined Company may never become profitable, even if it is able to complete clinical development for one or more product candidates and eventually commercialize such product candidates. The Combined Company will need to successfully complete significant research, development, testing and regulatory compliance activities that, together with projected general and administrative expenses, is expected to result in substantial increased operating losses for at least the next several years. Even if the Combined Company does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis.

 

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If the Combined Company fails to attract and retain management and other key personnel, it may be unable to continue to successfully develop or commercialize its product candidates or otherwise implement its business plan.

The Combined Company’s ability to compete in the highly competitive pharmaceuticals industry depends on its ability to attract and retain highly qualified managerial, scientific, medical, legal, sales and marketing and other personnel. The Combined Company will be highly dependent on its management and scientific personnel. The loss of the services of any of these individuals could impede, delay, or prevent the successful development of the Combined Company’s product pipeline, completion of its planned clinical trials, commercialization of its product candidates or in-licensing or acquisition of new assets and could impact negatively its ability to implement successfully its business plan. If the Combined Company loses the services of any of these individuals, it might not be able to find suitable replacements on a timely basis or at all, and its business could be harmed as a result. The Combined Company might not be able to attract or retain qualified management and other key personnel in the future due to the intense competition for qualified personnel among biotechnology, pharmaceutical and other businesses.

The Combined Company will need to raise additional financing in the future to fund its operations, which may not be available to it on favorable terms or at all.

The Combined Company will require substantial additional funds to conduct the costly and time-consuming clinical efficacy trials necessary to pursue regulatory approval of each potential product candidate and to continue the development of CR-001, CR-002, CR-003 and Crescent’s future programs and future product candidates. The Combined Company’s future capital requirements will depend upon a number of factors, including: the number and timing of future product candidates in the pipeline; progress with and results from preclinical testing and clinical trials; the ability to manufacture sufficient drug supplies to complete preclinical and clinical trials; the costs involved in preparing, filing, acquiring, prosecuting, maintaining and enforcing patent and other intellectual property claims; and the time and costs involved in obtaining regulatory approvals and favorable reimbursement or formulary acceptance. Raising additional capital may be costly or difficult to obtain and could, for example, through the sale of common stock or securities convertible or exchangeable into common stock, significantly dilute the Combined Company stockholders’ ownership interests or inhibit the Combined Company’s ability to achieve its business objectives. If the Combined Company raises additional funds through public or private equity offerings, the terms of these securities may include liquidation or other preferences that adversely the rights of its common stockholders. In addition, any debt financing may subject the Combined Company to fixed payment obligations and covenants limiting or restricting its ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If the Combined Company raises additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, the Combined Company may have to relinquish certain valuable intellectual property or other rights to its product candidates, technologies, future revenue streams or research programs or grant licenses on terms that may not be favorable to it. Even if the Combined Company were to obtain sufficient funding, there can be no assurance that it will be available on terms acceptable to the Combined Company or its stockholders.

The Combined Company will incur additional costs and increased demands upon management as a result of complying with the laws and regulations affecting public companies.

The Combined Company will incur significant legal, accounting and other expenses as a public company that Crescent did not incur as a private company, including costs associated with public company reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The Combined Company’s management team will consist of the executive officers of Crescent prior to the Merger. These executive officers and other personnel will need to devote substantial time to gaining expertise related to public company reporting requirements and compliance with applicable laws and regulations to ensure that the Combined Company complies with all of these requirements. Any changes the Combined Company makes to comply with these obligations may not be sufficient to allow it to satisfy its obligations as a public company on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for the Combined Company to attract and retain qualified persons to serve on the board of

 

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directors or on board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

Upon completion of the Merger, failure by the Combined Company to comply with the initial listing standards of Nasdaq will prevent its stock from being listed on Nasdaq.

Upon completion of the Merger, GlycoMimetics, under the new name “Crescent Biopharma, Inc.,” will be required to meet the initial listing requirements to maintain the listing and continued trading of its shares on Nasdaq. These initial listing requirements are more difficult to achieve than the continued listing requirements. Pursuant to the Merger Agreement, GlycoMimetics agreed to use its commercially reasonable efforts to cause the shares of GlycoMimetics common stock being issued in the Merger (including any common stock issuable upon conversion of the GlycoMimetics Series A Preferred Stock) to be approved for listing on Nasdaq at or prior to the effective time of the Merger. Based on information currently available to GlycoMimetics, GlycoMimetics anticipates that its stock will be unable to meet the $4.00 minimum bid price initial listing requirement at the closing of the Merger unless it effects a reverse stock split. The GlycoMimetics Board intends to effect a reverse stock split of the shares of GlycoMimetics common stock at a ratio of between 70:1 to 110:1. In addition, often times a reverse stock split will not result in a trading price for the affected common stock that is proportional to the ratio of the split. Following the Merger, if the Combined Company is unable to satisfy Nasdaq listing requirements, Nasdaq may notify the Combined Company that its shares of common stock will not be listed on Nasdaq.

Upon a potential delisting from Nasdaq, if the Combined Company common stock is not then eligible for quotation on another market or exchange, trading of the shares could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it is likely that there would be significantly less liquidity in the trading of the Combined Company common stock; decreases in institutional and other investor demand for the shares, coverage by securities analysts, market making activity and information available concerning trading prices and volume; and fewer broker dealers willing to execute trades in the Combined Company common stock. Also, it may be difficult for the Combined Company to raise additional capital if the Combined Company common stock is not listed on a major exchange. The occurrence of any of these events could result in a further decline in the market price of the Combined Company common stock and could have a material adverse effect on the Combined Company.

Once the Combined Company is no longer a smaller reporting company or otherwise no longer qualifies for applicable exemptions, the Combined Company will be subject to additional laws and regulations affecting public companies that will increase the Combined Company’s costs and the demands on management and could harm the Combined Company’s operating results and cash flows.

The Combined Company will be subject to the reporting requirements of the Exchange Act, which requires, among other things, that the Combined Company file with the SEC, annual, quarterly and current reports with respect to the Combined Company’s business and financial condition as well as other disclosure and corporate governance requirements. However, as a “smaller reporting company,” as such term is defined in Rule 12b-2 under the Exchange Act, in at least the near term, the Combined Company may take advantage of exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in this proxy statement/prospectus and in the Combined Company’s periodic reports and proxy statements. Once the Combined Company is no longer a smaller reporting company or otherwise no longer qualifies for these exemptions, the Combined Company will be required to comply with these additional legal and regulatory requirements applicable to public companies and will incur significant legal, accounting and other expenses to do so. If the Combined Company is not able to comply with the requirements in a timely manner or at all, the Combined Company’s financial condition or the market price of the Combined Company common stock may be harmed. For example, if the Combined Company or its independent auditor identifies deficiencies in the Combined Company’s internal control over financial reporting that are deemed to be material weaknesses the Combined Company could face additional costs to remedy those deficiencies, the market price of the Combined Company stock could decline or the Combined Company could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

 

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If the Combined Company fails to maintain proper and effective internal controls, its ability to produce accurate financial statements on a timely basis could be impaired.

Provided the Combined Company continues to be listed on Nasdaq, the Combined Company will be subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act and the rules and regulations of Nasdaq. The Sarbanes-Oxley Act requires, among other things, that the Combined Company maintain effective disclosure controls and procedures and internal control over financial reporting. The Combined Company must perform system and process evaluation and testing of its internal control over financial reporting to allow management to report on the effectiveness of its internal controls over financial reporting in its Annual Report on Form 10-K filing for that year, as required by Section 404 of the Sarbanes-Oxley Act. As a private company, Crescent has not been required to document and test its internal controls over financial reporting nor has its management been required to certify the effectiveness of its internal controls and its auditors have not been required to opine on the effectiveness of its internal control over financial reporting. Following the Merger, the Combined Company will be required to incur substantial professional fees and internal costs to expand its accounting and finance functions and expend significant management efforts. The Combined Company may experience difficulty in meeting these reporting requirements in a timely manner.

The Combined Company may discover weaknesses in its system of internal control over financial reporting that could result in a material misstatement of its financial statements. The Combined Company’s internal control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to error or fraud will not occur or that all control issues and instances of fraud will be detected.

If the Combined Company is not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if it is unable to maintain proper and effective internal controls, the Combined Company may not be able to produce timely and accurate financial statements. If that were to happen, the market price of its common stock could decline and it could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities.

The unaudited pro forma condensed combined financial information for GlycoMimetics and Crescent included in this proxy statement/prospectus are preliminary, and the Combined Company’s actual financial position and operations after the Merger may differ materially from the unaudited pro forma financial information included in this proxy statement/prospectus.

The unaudited pro forma financial information for GlycoMimetics and Crescent included in this proxy statement/prospectus are presented for illustrative purposes only and is not necessarily indicative of the Combined Company’s actual financial condition or results of operations of future periods, or the financial condition or results of operations that would have been realized had the entities been combined during the period presented. The Combined Company’s actual results and financial position after the Merger may differ materially and adversely from the unaudited pro forma financial information included in this proxy statement/prospectus. The Exchange Ratio reflected in this proxy statement/prospectus is preliminary. The final Exchange Ratio could differ materially from the preliminary Exchange Ratio used to prepare the pro forma adjustments. For more information see the section titled “Unaudited Pro Forma Condensed Combined Financial Information” beginning on page 364.

Provisions that will be in the Combined Company’s certificate of incorporation and bylaws and provisions under Delaware law could make an acquisition of the Combined Company more difficult and may prevent attempts by its stockholders to replace or remove its management.

Provisions that will be included in the Combined Company’s certificate of incorporation and bylaws may discourage, delay or prevent a merger, acquisition or other change in control of the Combined Company that stockholders may consider favorable, including transactions in which its common stockholders might otherwise receive a premium price for their shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of the Combined Company common stock, thereby depressing the market price of its common stock. In addition, because the Combined Company board of directors

 

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