As filed with the Securities and Exchange Commission on October 16, 2026

Registration No. 333-298868

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

AMENDMENT NO. 1

TO

FORM S-4

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

 

 

SONIC HOLDCO, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware		2834		42-4820410
(State or other jurisdiction of incorporation or organization)		(Primary Standard Industrial Classification Code Number)		(I.R.S. Employer Identification Number)

Sonic Holdco, Inc.

PO Box 30

Winchester, MA 01890

(617) 659-2802

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

 

 

Mary Beth Dooley

President and Treasurer

Sonic Holdco, Inc.

PO Box 30

Winchester, MA 01890

(617) 659-2802

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

 

 

With copies to:

 

Mary Beth Dooley Principal Executive Officer and Principal Financial Officer Synlogic, Inc. PO Box 30 Winchester, MA 01890 (617) 659-2802		Daniel A. Bagliebter, Esq. Nishant Dharia, Esq. Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. 919 Third Avenue New York, New York 10022 (212) 935-3000		Praveen Tipirneni, MD, MBA Caldera Therapeutics, Inc. 300 Technology Square, 8th Floor Cambridge, MA 02139 (781) 254-6624		Effie Toshav, Esq. David Michaels, Esq. Amanda L. Rose, Esq. Ryan Mitteness, Esq. Fenwick & West LLP One Front Street, 33rd Floor San Francisco, California 94111 (415) 875-2300

 

 

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effectiveness of this registration statement and the completion of the transactions 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 an 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.

 

Large accelerated filer		☐		Accelerated filer		☐
Non-accelerated filer		☒		Smaller reporting company		☒
				Emerging Growth Company		☒

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 or until the registration statement shall become effective on such date as the United States Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

assumed and converted into an option to purchase Parent Common Stock, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable to such Synlogic Option immediately prior to the Synlogic Effective Time, subject to adjustment as set forth in the Merger Agreement.

Each then-outstanding option to purchase Caldera Common Stock (a “Caldera Option”) will be immediately prior to the Caldera Effective Time, assumed and converted into an option to purchase Parent Common Stock, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable to such Caldera Option immediately prior to the Caldera Effective Time, subject to adjustment as set forth in the Merger Agreement.

Prior to the closing of the Mergers and after the effectiveness of the registration statement of which the accompanying proxy statement/prospectus forms a part, Synlogic will effect an amendment to its Amended and Restated Certificate of Incorporation, as amended (the “Synlogic Charter”), to authorize a reverse stock split of Synlogic Common Stock with a ratio to be determined by the Synlogic Board (as defined below) within a range of not less than 1: and not more than 1: (the “Synlogic Reverse Stock Split”), subject to stockholder approval as contemplated herein.

Immediately following the closing of the Mergers and the Concurrent Financing, on a pro forma basis and based upon the number of shares of Parent Common Stock expected to be issued in connection with the Mergers and the Concurrent Financing, pre-merger equityholders of Caldera (other than the Investors in the Concurrent Financing) are expected to own approximately 62.8% of Parent, pre-merger equityholders of Synlogic are expected to own approximately 2.3% of Parent and the Investors in the Concurrent Financing are expected to own approximately 34.9% (assuming proceeds from the Concurrent Financing of $278.0 million), in each case, calculated on a fully diluted basis, using the treasury stock method, and subject to certain assumptions, including (i) a valuation for Synlogic of $18.0 million, assuming Synlogic has net cash of $6.0 million as of the closing of the Mergers, (ii) a valuation for Caldera of $500.0 million, and (iii) the relative capitalization of Synlogic and Caldera. The percentage of Parent that each party’s equity holders will own following the Closing is subject to certain adjustments as described in the Merger Agreement, including the amount of the Final Synlogic Net Cash (as defined in the Merger Agreement) at Closing.

The percentage of Parent that pre-closing Synlogic securityholders will own as of the closing of the Mergers is subject to adjustment based on the valuation of Synlogic immediately prior to the closing (as described in more detail in the section entitled “The Merger Agreement — Merger Consideration” beginning on page 167 of the accompanying proxy statement/prospectus). The valuation of Synlogic is subject to a dollar-for-dollar adjustment if Final Synlogic Net Cash (as defined in the Merger Agreement) is above or below the Synlogic target net cash amount of $6.0 million. For every $    decrease in the Final Synlogic Net Cash below $6.0 million, pre-closing Synlogic securityholders would own approximately   basis points (or     of a percentage point) less, and the pre-closing Caldera securityholders and the Investors in the Concurrent Financing, collectively, would own approximately   basis points (or     of a percentage point) more, of the outstanding shares of Parent Common Stock at closing. Final Synlogic Net Cash can be a negative number, provided, however, the amount of the adjustment described above is capped such that the valuation of Synlogic is no lower than $8.0 million. As an illustration, if the Final Synlogic Net Cash is $   million, the valuation of Synlogic would be $   million, the pre-closing Synlogic securityholders would own approximately   % of Parent, and the pre-closing Caldera securityholders (other than those Investors in the Concurrent Financing) would own approximately   % of Parent, and Investors in the Concurrent Financing would own approximately   % of Parent in each case on a fully diluted basis, using the treasury stock method.

As of      , 2026, the exchange ratio of shares of Synlogic Common Stock for Parent Common Stock (the “Synlogic Exchange Ratio”) is estimated to be approximately    (after giving effect to the Synlogic Reverse Stock Split and assuming a Synlogic Reverse Stock Split ratio of 1: ). This estimate is subject to adjustment prior to closing for the number of outstanding shares of Parent Common Stock and Synlogic Common Stock, in each case as of immediately prior to the Synlogic Effective Time, and the Final Synlogic Net Cash (and as a result, Synlogic stockholders could own more or less of Parent than may be implied by the

assumed Synlogic Exchange Ratio). The assumed Synlogic Exchange Ratio is based on (a) a valuation of Synlogic at $18.0 million, subject to adjustment if the Final Synlogic Net Cash exceeds or falls below $6.0 million (with any such difference resulting in a dollar-for-dollar adjustment to Synlogic’s valuation, subject to the cap described above), and (b) the assumed Synlogic Reverse Stock Split ratio noted above, although Synlogic’s board of directors (the “Synlogic Board”) may instead effect the Synlogic Reverse Stock Split at another ratio within the approved range of 1: to 1: , which would result in a corresponding adjustment to the Synlogic Exchange Ratio.

As of     , 2026, the exchange ratio of shares of Caldera Common Stock for Parent Common Stock, including shares of Caldera Common Stock issued in the Concurrent Financing (the “Caldera Exchange Ratio”) is estimated to be approximately    (after giving effect to the Synlogic Reverse Stock Split and assuming a Synlogic Reverse Stock Split ratio of 1: ). This estimate is subject to adjustment prior to closing for the number of outstanding shares of Synlogic Common Stock and Caldera Common Stock, in each case as of immediately prior to the Caldera Effective Time. The assumed Caldera Exchange Ratio is based on a valuation of Caldera at $500.0 million.

The estimated aggregate number of shares of Parent Common Stock that Parent expects to issue to Synlogic’s securityholders at the closing of the Synlogic Merger is      shares, reflecting an expected per share value of $  , assuming the Synlogic Merger occurred as of     , 2026 (after giving effect to the assumed Synlogic Reverse Stock Split ratio). The estimated aggregate number of shares of Parent Common Stock that Parent expects to issue to Caldera’s securityholders at the closing of the Caldera Merger is      shares, which amount includes      shares of Parent Common Stock that Parent expects to issue to Investors in the Concurrent Financing, reflecting an expected per share value of $  , assuming the Caldera Merger occurred as of     , 2026, the assumed Synlogic Reverse Stock Split ratio and the assumed Caldera Exchange Ratio.

This registration statement covers      shares of Parent Common Stock, which is the estimated maximum number of shares expected to be issued to Caldera’s stockholders at the closing of the Caldera Merger (including      shares expected to be issued to certain investors in the Concurrent Financing and excluding      shares expected to be issued to certain Investors in the Concurrent Financing) and to Synlogic’s stockholders at the closing of the Synlogic Merger, in each case subject to the adjustments described in the accompanying proxy statement/prospectus. This maximum number of shares includes up to      additional shares of Parent Common Stock reserved for issuance pursuant to outstanding Synlogic and Caldera equity awards.

Synlogic stockholders are cordially invited to attend a special meeting (the “Special Meeting”) of the stockholders of Synlogic relating to the Mergers. Synlogic is holding the Special Meeting in order to obtain the stockholder approvals necessary to complete the Mergers and related matters, as well as the election of directors. The Special Meeting, which will be held at    :  A.M., Eastern time, on      , 2026, unless postponed or adjourned to a later date. The Special Meeting will be held in a virtual meeting format only. You can attend the Special Meeting online, vote your shares electronically, and submit your questions during the Special Meeting by visiting      and entering your 16-digit control number found on the Notice of Internet Availability or the proxy card that you receive. For further information about the Special Meeting, please see the section entitled “The Special Meeting of Synlogic Stockholders” beginning on page 126. You will not be able to attend the Special Meeting in person.

At the Special Meeting, Synlogic will ask its stockholders:

 

1.

To approve the Merger Agreement by and among Synlogic, Parent, Caldera Merger Sub, Synlogic Merger Sub and Caldera, and the transactions contemplated thereby, including issuance of Parent Common Stock in the Mergers pursuant to the Merger Agreement;

 

2.

To approve a proposed amendment to the Synlogic Charter to effect a reverse stock split at a ratio to be determined by the Synlogic Board within a range of not less than 1: and not more than 1: , with the exact ratio to be set within that range at the discretion of the Synlogic Board without further approval

or authorization of our stockholders and with the Synlogic Board able to elect to abandon such proposed amendment and not effect the reverse stock split authorized by stockholders, in its sole discretion;

 

3.

To approve the amended and restated certificate of incorporation of Parent to be in effect following the Closing (the “Parent Charter”);

 

4.

To approve, on a non-binding advisory basis, certain material differences between the Synlogic Charter and the Parent Charter, presented as separate subproposals;

 

5.

To approve the Parent 2026 Equity Incentive Plan;

 

6.

To approve the Parent 2026 Employee Stock Purchase Plan;

 

7.

To elect one director of Synlogic to serve a three-year term expiring in 2029 (provided, however, that, if the Mergers are completed, the board of directors of Parent will be reconstituted as provided in the Merger Agreement);

 

8.

To ratify the appointment of KPMG LLP as Synlogic’s independent registered public accounting firm for the fiscal year ending December 31, 2026;

 

9.

To approve by an advisory vote the compensation of Synlogic’s named executive officer, as disclosed in this proxy statement;

 

10.

To approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to Synlogic’s named executive officer as a result of the Mergers; and

 

11.

To consider and vote upon an adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of one or more proposals presented to the stockholders.

As described in the accompanying proxy statement/prospectus, certain of Caldera’s stockholders who in the aggregate own approximately 72.6% of the outstanding Caldera capital stock are parties to support agreements whereby such stockholders have agreed, among other things, to vote in favor of the adoption of the Merger Agreement and the approval of the transactions contemplated therein, including the Mergers, subject to the terms of the support agreements. In addition, certain Synlogic stockholders who in the aggregate own approximately 50.9% of the outstanding shares of Synlogic Common Stock are parties to support agreements with Caldera whereby such stockholders have agreed, among other things, to vote any Synlogic securities held by them as of the record date for the Special Meeting in favor of the adoption of the Merger Agreement and the approval of the transactions contemplated therein, including the Mergers and the issuance of Parent Common Stock in the Mergers pursuant to the Merger Agreement, subject to the terms of the support agreements. In addition, following the registration statement on Form S-4, of which the accompanying proxy statement/prospectus is a part, being declared effective by the U.S. Securities and Exchange Commission and pursuant to the conditions of the Merger Agreement, Caldera’s stockholders who are party to the support agreements will each execute an action by written consent of Caldera’s stockholders, adopting the Merger Agreement, thereby approving the Mergers and related transactions. Therefore, no meeting of Caldera’s stockholders is required to adopt the Merger Agreement and approve the Mergers and related transactions and no meeting of Caldera’s stockholders will be held.

After careful consideration, the Synlogic Board has (i) determined that the transactions contemplated by the Merger Agreement are fair to, advisable and in the best interests of Synlogic and its stockholders, (ii) approved and declared advisable the Merger Agreement and the transactions contemplated thereby and (iii) determined to recommend, upon the terms and subject to the conditions set forth in the Merger Agreement, that its stockholders vote to adopt or approve, as applicable, the Merger Agreement and, therefore, approve the transactions contemplated therein. The Synlogic Board recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.

Completion of the Mergers is subject to, among other conditions, the Parent Common Stock being approved for listing on the New York Stock Exchange American (“NYSE American”) or another national securities exchange, subject to official notice of issuance. Although it is expected that Parent Common Stock will be traded on the NYSE American following the completion of the Mergers under the ticker symbol “CALD,” it currently does not trade on any exchange and there has never been a public market for Parent Common Stock. There can be no assurance such listing condition will be met or that Parent will obtain such approval from NYSE American. If such listing condition is not met or if such approval is not obtained, the Mergers will not be consummated unless the condition is waived in writing by each of the parties at or prior to closing. The terms of the Merger

Agreement permit that this condition may be waived by agreement among the parties without re-circulation or re-solicitation of this proxy statement/prospectus. As a result of the Mergers, Synlogic Common Stock will no longer be quoted on the OTC Markets Group, Inc. quotation system.

Upon closing of the Mergers, Parent will be renamed “Caldera Therapeutics, Inc.”

More information about Parent, Synlogic, Caldera, the Mergers, the Concurrent Financing, the transaction documents and other related matters is contained in the accompanying proxy statement/prospectus. Synlogic and Caldera urge you to read the accompanying proxy statement/prospectus carefully and in its entirety, including all its annexes, and the documents incorporated by reference therein. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER THE SECTION ENTITLED “RISK FACTORS” BEGINNING ON PAGE 27 OF THE ACCOMPANYING PROXY STATEMENT/PROSPECTUS. You also can obtain information about the proposed Mergers and the Concurrent Financing, and Synlogic, from documents that Synlogic has filed with the U.S. Securities and Exchange Commission.

Synlogic and Caldera are excited about the opportunities the Mergers bring to both Synlogic’s and Caldera’s respective equity holders, and thank you for your consideration and continued support.

Sincerely,

 

Peter Barrett, Ph.D. Chairman of the Board Synlogic, Inc.		Praveen Tipirneni, M.D., M.B.A. Director and Chief Executive Officer Caldera Therapeutics, Inc.

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

This proxy statement/prospectus is dated      , 2026, and is first being mailed to Synlogic’s stockholders on or about     , 2026.

 

 

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

TO BE HELD ON      , 2026

Dear Stockholders of Synlogic:

On behalf of the board of directors (the “Synlogic Board”) of Synlogic, Inc., a Delaware corporation (“Synlogic”), we are pleased to deliver this proxy statement/prospectus for the proposed mergers of Synlogic and Caldera Therapeutics, Inc., a Delaware corporation (“Caldera”), pursuant to which (1) Yellowstone Merger Sub, Inc. (“Caldera Merger Sub”), a Delaware corporation and a wholly owned subsidiary of Sonic Holdco, Inc. (“Parent”), a Delaware corporation formed for the purposes of effecting transactions contemplated by the Merger Agreement (as defined herein), merges with and into Caldera, with Caldera surviving as a wholly owned subsidiary of Parent (the “Caldera Merger”) and (2) Sonic Merger Sub, Inc. (“Synlogic Merger Sub”), a Delaware corporation and a wholly owned subsidiary of Parent, merges with and into Synlogic, with Synlogic surviving as a wholly owned subsidiary of Parent (the “Synlogic Merger” and together with the Caldera Merger, the “Mergers”).

The special meeting of stockholders of Synlogic (the “Special Meeting”) will be held on      , 2026, at    :  A.M., Eastern time, unless postponed or adjourned to a later date. The Special Meeting will be held in a virtual meeting format only. You can attend the Special Meeting online, vote your shares electronically, and submit your questions during the Special Meeting by visiting     and entering your 16-digit control number found on the Notice of Internet Availability or the proxy card that you receive. You will not be able to attend the Special Meeting in person.

The Special Meeting is being held for the following purposes:

 

1.

To approve the Agreement and Plan of Merger, dated as of July 28, 2026, by and among Synlogic, Parent, Caldera Merger Sub, Synlogic Merger Sub and Caldera, as amended by the Amendment to Agreement and Plan of Merger, dated as of September 10, 2026, a copy of which is attached as Annex A to this proxy statement/prospectus (the “Merger Agreement”), and the transactions contemplated thereby, including issuance of Parent Common Stock in the Mergers pursuant to the Merger Agreement;

 

2.

To approve a proposed amendment to the Synlogic Charter, a copy of which is attached as Annex B to this proxy statement/prospectus, to effect a reverse stock split at a ratio to be determined by the Synlogic Board within a range of not less than 1: and not more than 1: , with the exact ratio to be set within that range at the discretion of the Synlogic Board without further approval or authorization of our stockholders and with the Synlogic Board able to elect to abandon such proposed amendment and not effect the reverse stock split authorized by stockholders, in its sole discretion (the “Synlogic Reverse Stock Split”);

 

3.

To approve the amended and restated certificate of incorporation of Parent to be in effect following the Closing (the “Parent Charter”), a form of which is attached as Annex C to this proxy statement/prospectus (the “Charter Proposal”);

 

4.

To approve, on a non-binding advisory basis, certain material differences between the Synlogic Charter and the Parent Charter, presented as separate subproposals (the “Governance Proposals”);

 

5.

To approve the Parent 2026 Equity Incentive Plan, in the form attached as Annex D to this proxy statement/prospectus (the “Parent 2026 Plan”);

 

6.

To approve the Parent 2026 Employee Stock Purchase Plan, in the form attached as Annex E to this proxy statement/prospectus (the “Parent 2026 ESPP”);

 

7.

To elect one director of Synlogic to serve a three-year term expiring in 2029 (provided, however, that, if the Mergers are completed, the board of directors of Parent (the “Parent Board”) will be reconstituted as provided in the Merger Agreement);

8.

To ratify the appointment of KPMG LLP as Synlogic’s independent registered public accounting firm for the fiscal year ending December 31, 2026;

 

9.

To approve by an advisory vote the compensation of Synlogic’s named executive officer, as disclosed in this proxy statement;

 

10.

To approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to Synlogic’s named executive officer as a result of the Mergers; and

 

11.

To consider and vote upon an adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of one or more proposals presented to the stockholders.

The Synlogic Board has fixed      , 2026, as the record date (the “Record Date”) for the determination of stockholders entitled to notice of, and to vote at, the Special Meeting and any adjournment or postponement thereof. Only holders of record of shares of common stock of Synlogic, $0.001 par value per share (the “Synlogic Common Stock”) at the close of business on the Record Date are entitled to notice of, and to vote at, the Special Meeting. At the close of business on the Record Date, there were     shares of Synlogic Common Stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of the holders of a majority of the shares of Synlogic Common Stock having voting power outstanding on the Record Date, voting as a single class, is required for approval of Proposal Nos. 1, 2 and 3. The affirmative vote of the holders of a majority of the voting power of the votes cast at the Special Meeting and voting affirmatively or negatively on the matter is required for approval of Proposal Nos. 4, 5, 6, 8, 9, 10 and 11. With respect to Proposal No. 7, directors are elected by a plurality of the affirmative votes cast at the meeting or by proxy at the Synlogic Special Meeting, and the nominee for director receiving the highest number of affirmative votes will be elected. Approval of Proposal No. 1 is a condition to the completion of the Mergers. Therefore, the Mergers cannot be consummated without the approval of Proposal No. 1. Proposal Nos. 3, 4, 5, and 6 are conditioned upon the consummation of the Mergers. If the Mergers are not completed, Proposal Nos. 5 and 6 will not be implemented, and the Parent 2026 Plan and the Parent 2026 ESPP will not become effective. Synlogic requests that you sign and return the enclosed proxy to ensure that your shares will be represented at the Special Meeting if you are unable to attend.

If you have any questions concerning the Special Meeting, the Mergers, or the accompanying proxy statement/prospectus, or need help voting your shares of Synlogic Common Stock, please contact Alliance Advisors, LLC, the proxy solicitor for Synlogic. You may also request additional copies from Synlogic’s proxy solicitor using the following contact information:

ALLIANCE ADVISORS, LLC

Stockholders call toll-free: 1-866-206-8304

Email: SYBX@allianceadvisors.com

By Order of the Synlogic Board,

Peter Barrett, Ph.D.

Synlogic, Inc.

Winchester, Massachusetts

    , 2026

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

REFERENCES TO ADDITIONAL INFORMATION

This proxy statement/prospectus incorporates important business and financial information about Synlogic that is not included in or delivered with this document. You may obtain this information, as well as the documents incorporated by reference herein, without charge through the U.S. Securities and Exchange Commission (“SEC”) website (www.sec.gov) or upon your written or oral request by contacting Synlogic’s Investor Relations department at Synlogic, Inc., PO Box 30, Winchester, Massachusetts 01890, or by calling (617) 659-2802.

To ensure timely delivery of these documents, any request should be made no later than     , 2026 to receive them before the special meeting of Synlogic stockholders.

For additional details about where you can find information about Synlogic, please see the section entitled “Where You Can Find More Information” in this proxy statement/prospectus.

TABLE OF CONTENTS

 

QUESTIONS AND ANSWERS ABOUT THE MERGERS			1
PROSPECTUS SUMMARY			10
The Companies			10
The Mergers and the Merger Agreement (see pages 131 and 167)			12
Effect of the Mergers			12
Exchange Ratios in the Mergers			13
Reasons for the Mergers			15
Opinion of the Synlogic Financial Advisor (see page 147)			16
Conditions of the Mergers (see pages 175)			17
No Solicitation of Acquisition Proposals (see page 173)			18
Termination of the Merger Agreement (see page 177)			19
Support Agreements (see page 180)			20
Lock-Up Agreements (see page 182)			20
Concurrent Financing Agreements (see page 184)			21
Synlogic Reverse Stock Split (see page 194)			21
Parent Board Following the Mergers (see page 316)			21
Interests of Directors, Officers and Affiliates of Synlogic and Caldera (see pages 158 and 161)			21
Material U.S. Federal Income Tax Consequences of the Mergers (see page 186)			22
Risk Factors (see page 27)			22
NYSE American Listing (see page 356)			25
Anticipated Accounting Treatment (see page 165)			25
Appraisal Rights and Dissenters’ Rights (see page 165)			25
Comparison of Stockholders’ Rights (see page 357)			25
Emerging Growth Company			25
RISK FACTORS			27
Risks Related to the Mergers			27
Risks Related to the Proposed Synlogic Reverse Stock Split			39
Risks Related to Synlogic			39
Risks Related to Caldera			55
Risks Related to Parent Following the Mergers			114
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS			125
THE SPECIAL MEETING OF SYNLOGIC STOCKHOLDERS			126
Date, Time and Place			126
Purposes of the Special Meeting			126
Recommendation of the Synlogic Board			126
Record Date and Voting Power			127
Voting and Revocation of Proxies			128
Required Vote			129
Solicitation of Proxies			129
Assistance			130
Adjournments			130
Postponements			130
Stockholder List			130
Other Matters			130
THE MERGERS			131
Background of the Mergers			131
Synlogic Reasons for the Mergers			142
Caldera Reasons for the Mergers			144
Opinion of the Synlogic Financial Advisor			147

 

i

Interests of the Synlogic Directors and Executive Officers in the Mergers			158
Interests of the Caldera Directors and Executive Officers in the Mergers			161
Form of the Mergers			163
Procedures for Exchanging Caldera Stock Certificates			163
Exchange of Shares for Merger Consideration			163
Deposit with Exchange Agent			163
Mailing of Transmittal Material			164
Issued Shares			164
Exchange Agent Deliveries			164
Unclaimed Merger Consideration			164
No Fractional Shares			165
Regulatory Approvals Required for the Mergers			165
Anticipated Accounting Treatment			165
Withholding Rights.			165
Appraisal Rights and Dissenters’ Rights			165
Resales of Parent Common Stock			166
THE MERGER AGREEMENT			167
Structure			167
Merger Consideration			167
Pre-Merger Conversions			168
Treatment of Stock Options and Warrants			168
Fractional Shares			169
Dissenting Shares / Appraisal Rights			169
Procedures for Exchanging Shares; Exchange Agent			169
Directors and Executive Officers of Parent Following the Mergers			170
Representations and Warranties			170
Covenants; Conduct of Business Pending the Mergers			172
No Solicitation			173
Board Recommendation; Adverse Recommendation Change			174
Indemnification of Directors and Officers; D&O Insurance			175
Conditions to Completion of the Mergers			175
Termination of the Merger Agreement			177
Termination Fees			178
Exclusive Remedy; Liquidated Damages			178
Fees and Expenses			179
Governing Law; Specific Performance			179
Amendment			179
AGREEMENTS RELATED TO THE MERGER			180
Support Agreements			180
Lock-Up Agreements			182
Concurrent Financing Agreements			184
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES			185
Material U.S. Federal Income Tax Consequences of the Mergers			186
Material U.S. Federal Income Tax Consequences of Owning and Disposing of Parent Common Stock to Both U.S. Holders and Non-U.S. Holders			188
Material U.S. Federal Income Tax Consequences of the Synlogic Reverse Stock Split			191
Additional Withholding and Reporting Requirements			191
Information Reporting and Backup Withholding			192
MATTERS BEING SUBMITTED TO A VOTE OF SYNLOGIC STOCKHOLDERS			193

 

ii

PROPOSAL NO. 1: APPROVAL OF THE MERGER AGREEMENT AND TRANSACTIONS CONTEMPLATED THEREUNDER, INCLUDING ISSUANCE OF PARENT CAPITAL STOCK IN THE MERGERS PURSUANT TO THE MERGER AGREEMENT			193
Required Vote			193
Recommendation of the Synlogic Board			193
PROPOSAL NO. 2: APPROVAL OF THE SYNLOGIC REVERSE STOCK SPLIT			194
Criteria to be Used for Decision to Apply the Synlogic Reverse Stock Split			195
Reasons for the Synlogic Reverse Stock Split			195
Effect of the Synlogic Reverse Stock Split			196
Procedure for Effecting a Synlogic Reverse Stock Split and Exchange of Stock Certificates			196
Fractional Shares			197
No Appraisal Rights			197
Accounting Matters			198
Reservation of Right to Abandon the Amendment to our Restated Certificate of Incorporation, As Amended			198
Required Vote			198
Recommendation of the Synlogic Board			198
PROPOSAL NO. 3: APPROVAL OF THE CHARTER PROPOSAL			199
General			199
Required Vote			200
Recommendation of the Synlogic Board			200
PROPOSAL NO. 4: APPROVAL OF THE GOVERNANCE PROPOSALS			201
Other Changes			202
Reasons for the Proposals			202
Required Vote			204
Recommendation of the Synlogic Board			204
PROPOSAL NO. 5: APPROVAL OF THE PARENT 2026 EQUITY INCENTIVE PLAN			205
Overview			205
Reasons for the Proposal			205
Treatment of Existing Equity Plans			205
Summary of the Parent 2026 Plan			205
Material U.S. Federal Income Tax Consequences			209
New Plan Benefits			211
Registration with the SEC			211
Required Vote			211
Recommendation of the Synlogic Board			211
PROPOSAL NO. 6: APPROVAL OF THE PARENT 2026 EMPLOYEE STOCK PURCHASE PLAN			212
Overview			212
2026 Employee Stock Purchase Plan			212
Material U.S. Federal Income Tax Consequences			214
New Plan Benefits			215
Registration with the SEC			215
Required Vote			215
Recommendation of the Synlogic Board			215
PROPOSAL NO. 7: ELECTION OF DIRECTOR			216
Required Vote			216
Recommendation of the Synlogic Board			216
PROPOSAL NO. 8: RATIFICATION OF APPOINTMENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM			217
Policy on Audit Committee Pre-Approval of Audit and Permissible Non-audit Services of Independent Public Accountant			217
Required Vote			218
Recommendation of the Synlogic Board			218

 

iii

PROPOSAL NO. 9: ADVISORY VOTE ON APPROVAL OF EXECUTIVE COMPENSATION AS DISCLOSED IN THIS PROXY STATEMENT/PROSPECTUS			219
Required Vote			219
Recommendation of the Synlogic Board			219
PROPOSAL NO. 10: ADVISORY VOTE ON APPROVAL OF GOLDEN PARACHUTE COMPENSATION			220
Required Vote			220
Recommendation of the Synlogic Board			220
PROPOSAL NO. 11: APPROVAL OF POSSIBLE ADJOURNMENT OF THE SPECIAL MEETING			221
Required Vote			221
Recommendation of the Synlogic Board			221
SYNLOGIC BUSINESS			222
Overview			222
Corporate Information and History			222
Nasdaq Delisting			223
Intellectual Property and Technology Licenses			223
Human Capital			226
SYNLOGIC’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			227
Overview			227
Nasdaq Delisting			227
Effects of Inflation			228
Financial Overview			228
Critical Accounting Policies and Estimates			228
Results of Operations			229
Liquidity and Capital Resources			232
Contractual Commitments and Obligations			234
Off-Balance Sheet Arrangements			235
Related Party Transactions			235
Recently Issued Accounting Pronouncements			235
SYNLOGIC DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE			236
The Board of Directors			236
Committees of the Board of Directors and Meetings			237
Board Leadership Structure and Role in Risk Oversight			240
Corporate Responsibility			240
Insider Trading Policy and Prohibition on Hedging			241
SYNLOGIC EXECUTIVE OFFICER COMPENSATION			243
Summary Compensation Table			243
Outstanding Equity Awards at Fiscal Year End			244
Other Benefits			246
401(k) Retirement Plan			246
SYNLOGIC DIRECTOR COMPENSATION			247
SYNLOGIC EQUITY COMPENSATION PLAN INFORMATION			248
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS OF SYNLOGIC			249
CALDERA BUSINESS			252
Overview			252
Our Strategy			254
Our Team			254
Our Strengths			255
Our Focus: Inflammatory Bowel Disease			256
Current Treatment Landscape			257
Market Opportunity			257
Unmet Needs Remain Despite Available Treatment Options			258

 

iv

Simultaneously Targeting Two Disease Pathways May Potentially Transform the IBD Treatment Paradigm			259
Our Approach: Bispecific Antibodies for Dual-Target Inhibition			259
Our Solution: CLD-423			261
License Agreement			273
Manufacturing and Supply			274
Competition			275
Intellectual Property			275
Government Regulation			276
Employees and Human Capital Resources			289
Facilities			289
Legal Proceedings			290
CALDERA’S MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS			291
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS OF CALDERA			306
EXECUTIVE COMPENSATION OF CALDERA			309
DIRECTOR COMPENSATION OF CALDERA			315
INFORMATION REGARDING PARENT			316
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS OF PARENT			325
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS			329
Synlogic Transactions			329
Caldera Transactions			330
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS			337
DESCRIPTION OF PARENT CAPITAL STOCK			350
NYSE American Listing			356
Transfer Agent and Registrar			356
COMPARISON OF STOCKHOLDERS’ RIGHTS			357
Current Synlogic Rights and Caldera Rights Versus Parent Rights Post-Mergers			357
LEGAL MATTERS			372
EXPERTS			372
WHERE YOU CAN FIND MORE INFORMATION			373
OTHER MATTERS			374
Stockholder Communications with the Synlogic Board			374
Householding of Proxy Materials			374
INDEX TO FINANCIAL STATEMENTS			F-1
PART II — INFORMATION NOT REQUIRED IN PROSPECTUS			II-1
Item 20. Indemnification of Directors and Officers.			II-1
Item 21. Exhibits and Financial Statement Schedules.			II-2
Item 22. Undertakings.			II-2
ANNEX A — AGREEMENT AND PLAN OF MERGER (AS AMENDED)			A-1
ANNEX B — FORM OF AMENDMENT TO SYNLOGIC CHARTER			B-1
ANNEX C — FORM OF AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF PARENT			C-1
ANNEX D — FORM OF PARENT 2026 EQUITY INCENTIVE PLAN			D-1
ANNEX E — FORM OF PARENT 2026 EMPLOYEE STOCK PURCHASE PLAN			E-1
ANNEX F — OPINION OF LUCID CAPITAL MARKETS, LLC			F-1
ANNEX G — FORM OF SYNLOGIC STOCKHOLDER SUPPORT AGREEMENT			G-1
ANNEX H — FORM OF CALDERA STOCKHOLDER SUPPORT AGREEMENT			H-1
ANNEX I — FORM OF CALDERA LOCK-UP AGREEMENT			I-1
ANNEX J — FORM OF SECURITIES PURCHASE AGREEMENT			J-1
ANNEX K — FORM OF REGISTRATION RIGHTS AGREEMENT			K-1
ANNEX L — FORM OF SYNLOGIC PROXY CARD			L-1

 

v

QUESTIONS AND ANSWERS ABOUT THE MERGERS

The following section provides answers to frequently asked questions about the Mergers. 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 are the Mergers?

 

A:

On July 28, 2026, Synlogic, Inc., Parent, Caldera Merger Sub, Synlogic Merger Sub, and Caldera entered into the Merger Agreement providing for (1) the Caldera Merger, pursuant to which Caldera Merger Sub will merge with and into Caldera, with Caldera surviving as a wholly owned subsidiary of Parent, and (2) the Synlogic Merger, pursuant to which Synlogic Merger Sub will merge with and into Synlogic, with Synlogic surviving as a wholly owned subsidiary of Parent.

Subject to the terms and conditions of the Merger Agreement, (1) at the effective time of the Caldera Merger (the “Caldera Effective Time”) and following the conversion into shares of common stock of Caldera, $0.00001 par value per share, (“Caldera Common Stock”) of Caldera’s (a) Series A Preferred Stock, $0.00001 par value per share, and (b) Series A-1 Preferred Stock, $0.00001 par value per share (collectively, the “Caldera Preferred Stock”), each then-outstanding share of Caldera Common Stock, including shares of Caldera Common Stock issued in connection with the Concurrent Financing (excluding any shares of Caldera Common Stock held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of common stock of Parent, $0.001 par value per share (“Parent Common Stock”), calculated in accordance with the applicable exchange ratio as set forth in the Merger Agreement, and (2) immediately following the Caldera Effective Time, at the effective time of the Synlogic Merger (the “Synlogic Effective Time”), each then-outstanding share of common stock of Synlogic, $0.001 par value per share (the “Synlogic Common Stock”) (excluding any shares of Synlogic Common Stock held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Parent Common Stock, calculated in accordance with the applicable exchange ratio as set forth in the Merger Agreement.

At the Synlogic Effective Time, each then-outstanding option to purchase shares of Synlogic Common Stock (a “Synlogic Option”) with an exercise price per share less than the closing trading price of a share of Synlogic Common Stock, on the last full trading day on which the Synlogic Common Stock is traded prior to the date on which the Synlogic Effective Time occurs (the “Specified Trading Price”), will become fully vested and converted into net-exercised shares of Parent Common Stock, subject to adjustment as set forth in the Merger Agreement. At the Synlogic Effective Time, each then-outstanding option to purchase Synlogic Common Stock with an exercise price per share greater than the Specified Trading Price, will be immediately prior to the Synlogic Effective Time, assumed and converted into an option to purchase Parent Common Stock, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable to such Synlogic Option immediately prior to the Synlogic Effective Time, subject to adjustment as set forth in the Merger Agreement.

Each then-outstanding option to purchase Caldera Common Stock (a “Caldera Option”) will be immediately prior to the Caldera Effective Time, assumed and converted into an option to purchase Parent Common Stock, on the same terms and conditions (including the same vesting and exercisability terms and conditions) as were applicable to such Caldera Option immediately prior to the Caldera Effective Time, subject to adjustment as set forth in the Merger Agreement.

Immediately following the closing of the Mergers and the Concurrent Financing (the “Closing”), on a pro forma basis and based upon the number of shares of Parent Common Stock expected to be issued in connection with the Mergers and the Concurrent Financing, pre-merger equityholders of Caldera (other than the Investors in the Concurrent Financing) are expected to own approximately 62.8% of Parent, pre-merger equityholders of Synlogic are expected to own approximately 2.3% of Parent and the Investors in the Concurrent Financing are expected to own approximately 34.9% (assuming proceeds from the Concurrent Financing of $278.0 million), in each case,

 

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calculated on a fully diluted basis, using the treasury stock method, and subject to certain assumptions, including (i) a valuation for Synlogic of $18.0 million, assuming Synlogic has net cash of $6.0 million as of the Closing of the Mergers, (ii) a valuation for Caldera of $500.0 million, and (iii) the relative capitalization of Synlogic and Caldera. The percentage of Parent that each party’s equity holders will own following the Closing is subject to certain adjustments as described in the Merger Agreement, including the amount of the Final Synlogic Net Cash (as defined in the Merger Agreement) at Closing.

The percentage of Parent that pre-Closing Synlogic securityholders will own as of the Closing of the Mergers is subject to adjustment based on the valuation of Synlogic immediately prior to the Closing (as described in more detail in the section entitled “The Merger Agreement — Merger Consideration” beginning on page 167 of the accompanying proxy statement/prospectus). The valuation of Synlogic is subject to a dollar-for-dollar adjustment if Final Synlogic Net Cash (as defined in the Merger Agreement) is above or below the Synlogic target net cash amount of $6.0 million. For every $   decrease in the Final Synlogic Net Cash below $6.0 million, pre-Closing Synlogic securityholders would own approximately    basis points (or      of a percentage point) less, and the pre-Closing Caldera securityholders and the Investors in the Concurrent Financing (each as defined below), collectively, would own approximately    basis points (or      of a percentage point) more, of the outstanding shares of Parent Common Stock at Closing. Final Synlogic Net Cash can be a negative number, provided, however, the amount of the adjustment described above is capped such that the valuation of Synlogic is no lower than $8.0 million. As an illustration, if the Final Synlogic Net Cash is $6.0 million, the valuation of Synlogic would be $18.0 million, the pre-Closing Synlogic securityholders would own approximately 2.3% of Parent, and the pre-Closing Caldera securityholders (other than those Investors in the Concurrent Financing) would own approximately 62.8% of Parent, and Investors in the Concurrent Financing would own approximately 34.9% of Parent in each case on a fully diluted basis, using the treasury stock method.

 

Q:	What will happen to Synlogic if, for any reason, the Mergers do not close?

 

A:

If the Mergers are not completed, holders of Caldera Common Stock and Synlogic Common Stock will not receive any merger consideration for their shares in connection with the Caldera Merger or the Synlogic Merger. Instead, each of Caldera and Synlogic will remain an independent company. In addition, in certain circumstances, a termination fee may be required to be paid. The Caldera Termination Fee is $5.0 million (payable by Caldera to Synlogic in specified circumstances) and the Synlogic Termination Fee is $1.0 million (payable by Synlogic to Caldera in specified circumstances). See the section entitled “The Merger Agreement — Termination Fees” for a discussion of the circumstances under which a termination fee will be required to be paid.

If, for any reason, the Mergers do not close, the Synlogic Board may elect to, among other things, attempt to complete another strategic transaction like the Mergers, attempt to sell or otherwise dispose of the various assets of Synlogic or continue to operate the business of Synlogic.

 

Q:	Why are Synlogic and Caldera proposing the Mergers?

 

A:

Caldera’s board of directors (the “Caldera Board”) and the Synlogic Board believe that the Mergers will benefit Caldera stockholders and Synlogic stockholders, respectively, by creating a combined company with a promising development candidate, CLD-423, a bispecific antibody targeting Tumor Necrosis Factor (“TNF”)-like ligand 1A (“TL1A”) and IL-23p19 for inflammatory bowel disease (“IBD”) and other immune-mediated diseases, that will be able to leverage Parent’s business model and growth potential as a publicly listed company and its cash resources. For more details on the reasons for the Mergers, see the sections entitled “The Mergers — Caldera’s Reasons for the Mergers” and “The Mergers — Synlogic’s Reasons for the Mergers.”

 

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Q:	What is the Concurrent Financing?

 

A:

Concurrently with the execution of the Merger Agreement, Caldera entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain qualified institutional buyers and/or accredited investors (the “Investors”), pursuant to which Caldera has agreed to sell, and such Investors have agreed to purchase, shares of Caldera Common Stock for an aggregate purchase price of approximately $278.0 million, prior to the Closing of the Mergers (such transaction, the “Concurrent Financing”). The price per share is equal to the Caldera Equity Value (as defined in the Merger Agreement) divided by the number of shares of Caldera Common Stock outstanding as of immediately prior to the Closing. As of September 30, 2026, the estimated price per share is approximately $3.45. The aggregate amount of financing that is anticipated to be provided by Caldera’s existing investors or affiliates of such investors in the Concurrent Financing is approximately $96.0 million. For more information on the commitment amounts of such investors, see the section entitled “Certain Relationships and Related Party Transactions — Caldera Transactions — Agreements Related to the Mergers — Concurrent Financing.”

The Closing of the Concurrent Financing is conditioned upon the satisfaction or waiver of each of the conditions to the Closing of the Mergers (other than those conditions which, by their nature, are to be satisfied at the Closing of the transactions contemplated by the Merger Agreement), as well as certain other conditions, including, without limitation, Caldera’s receipt at the Closing of aggregate proceeds from the purchase of shares under the Securities Purchase Agreement of not less than $200.0 million. Investors in the Concurrent Financing are expected to hold approximately 34.9% of the outstanding shares of Parent, subject to certain assumptions. As such, at the time that Synlogic stockholders are expected to vote at the Special Meeting, whether the Concurrent Financing will close in a timely manner or at all will not be known. The Closing of the Mergers is separately conditioned upon the receipt by Caldera of cash proceeds of not less than $278.0 million in connection with the consummation of the Concurrent Financing. While, as of the date of this proxy statement/prospectus, Synlogic and Caldera do not intend to waive this condition, there can be no assurance that Synlogic and Caldera will ultimately determine, in their sole discretion, not to waive this or any other condition to the Mergers. In the event the Mergers close without receipt of the $278.0 million from the Concurrent Financing, Parent would not have the same liquidity at Closing as it would have had if the condition was satisfied. If Parent does not receive any portion of the $278.0 million proceeds from the Concurrent Financing, Parent would have to raise significant additional capital by issuing equity securities or through additional debt or licensing arrangements, which may cause significant dilution to Parent’s stockholders or restrict Parent’s operations. The Concurrent Financing is more fully described in the section entitled “Agreements Related to the Mergers — Concurrent Financing” beginning on page 184 of the accompanying proxy statement/prospectus.

 

Q:	Why am I receiving this proxy statement/prospectus?

 

A:	You are receiving this proxy statement/prospectus because you have been identified as a Synlogic stockholder as of the applicable Record Date. Synlogic stockholders are entitled to vote on the proposals being presented at the Special Meeting. This document serves as:

 

•

a proxy statement of Synlogic used to solicit proxies for the Special Meeting; and

 

•

a prospectus of Parent used to offer shares of Parent Common Stock in exchange for Caldera Common Stock in the Caldera Merger, which amount includes shares of Parent Common Stock that Parent expects to issue to certain Investors in the Concurrent Financing, and Synlogic Common Stock in the Synlogic Merger.

 

Q:	What proposals will be voted on at the special meeting in connection with the Mergers?

 

A:	Pursuant to the terms of the Merger Agreement, Synlogic stockholders must approve Proposal No. 1 to consummate the Mergers. The adoption of the Merger Agreement and approval of the transactions

 

3

contemplated thereby, including the Mergers, requires the affirmative vote of the holders of a majority of the shares of Synlogic Common Stock having voting power outstanding on     , 2026 (the “Record Date”). Approval of Proposal No. 1 is a condition to the completion of the Mergers. Therefore, the Mergers cannot be consummated without the approval of Proposal No. 1.

The adoption of the Merger Agreement and the approval of the Mergers and related transactions by the Caldera stockholders requires the written consent of the holders of a majority of the outstanding Caldera Common Stock and a majority of the outstanding Caldera Preferred Stock, voting together as a single class on an as-converted basis.

Certain of Caldera’s stockholders who in the aggregate own approximately 72.6% of the outstanding Caldera capital stock are parties to support agreements in favor of Synlogic whereby such stockholders have agreed to vote in favor of the adoption of the Merger Agreement and the approval of the transactions contemplated therein, including the Mergers, subject to the terms of the support agreements. In addition, certain of Synlogic’s stockholders who in the aggregate own approximately 50.9% of the outstanding shares of Synlogic Common Stock are parties to support agreements in favor of Caldera, whereby such equity holders have agreed to vote the Synlogic shares held by them as of the Record Date in favor of the adoption or approval of the Merger Agreement, as applicable, and the approval of the transactions contemplated therein, including the Mergers and the issuance of Parent Common Stock in the Mergers pursuant to the Merger Agreement, respectively, subject to the terms of such support agreements. In addition, following the registration statement on Form S-4, of which this proxy statement/prospectus is a part, being declared effective by the SEC and pursuant to the conditions of the Merger Agreement, Caldera’s stockholders who are party to the support agreements will each execute an action by written consent of Caldera’s stockholders, adopting the Merger Agreement, thereby approving the Mergers and related transactions. Therefore, holders of a sufficient number of shares of Caldera capital stock required to adopt the Merger Agreement will adopt the Merger Agreement, and no meeting of Caldera’s stockholders is required to adopt the Merger Agreement and approve the Mergers and related transactions and no meeting of Caldera’s stockholders will be held.

In addition to the requirement of obtaining such stockholder approvals and appropriate regulatory approvals, each of the other closing conditions set forth in the Merger Agreement must be satisfied or waived. In the event of a waiver of a condition, the Synlogic Board will evaluate the materiality of any such waiver to determine whether amendment of this proxy statement/prospectus and re-solicitation of stockholder approval is necessary. For more information, refer to the section titled “Risk Factors Related to the Merger — Synlogic or Caldera may waive one or more of the conditions to the Mergers and may do so without amending this proxy statement/prospectus or re-soliciting stockholder approval.” beginning on page 35 of this proxy statement/prospectus.

For a more complete description of the closing conditions under the Merger Agreement, Synlogic urges you to read the section titled “The Merger Agreement — Conditions to Completion of the Mergers” in this proxy statement/prospectus.

 

Q:	What proposals are to be voted on at the special meeting, other than Proposal No. 1?

 

A:	At the special meeting, the Synlogic stockholders will also be asked to consider the following proposals:

 

•

Proposal No. 2 — to approve a proposed amendment to the Synlogic Charter to effect a reverse stock split at a ratio to be determined by the Synlogic Board within a range of not less than 1: and not more than 1: , with the exact ratio to be set within that range at the discretion of the Synlogic Board without further approval or authorization of our stockholders and with the Synlogic Board able to elect to abandon such proposed amendment and not effect the reverse stock split authorized by stockholders, in its sole discretion;

 

•

Proposal No. 3 — to approve the Parent Charter (the “Charter Proposal”);

 

4

•

Proposal No. 4 — to approve, on a non-binding advisory basis, certain material differences between the Synlogic Charter and the Parent Charter, presented as separate subproposals (the “Governance Proposals”);

 

•

Proposal No. 5 — to approve the Parent 2026 Plan;

 

•

Proposal No. 6 — to approve the Parent 2026 ESPP;

 

•

Proposal No. 7 — to elect one director of Synlogic to serve a three-year term expiring in 2029 (provided, however, that, if the Mergers are completed, the Parent Board will be reconstituted as provided in the Merger Agreement);

 

•

Proposal No. 8 — to ratify the appointment of KPMG LLP as Synlogic’s independent registered public accounting firm for the fiscal year ending December 31, 2026;

 

•

Proposal No. 9 — to approve by an advisory vote the compensation of Synlogic’s named executive officer, as disclosed in this proxy statement;

 

•

Proposal No. 10 — to approve, on an advisory basis, the golden parachute compensation that may be paid or become payable to Synlogic’s named executive officer as a result of the Mergers; and

 

•

Proposal No. 11 — to consider and vote upon an adjournment of the Special Meeting, if necessary, to solicit additional proxies if there are not sufficient votes in favor of one or more proposals presented to the stockholders.

The approval of Proposal Nos. 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 are not a condition to the Mergers. Synlogic does not expect that any matter other than the proposals above will be brought before the Special Meeting.

 

Q:	What stockholder votes are required to approve the proposals at the Special Meeting?

 

A:

The approval of Proposal Nos. 1, 2 and 3 require the affirmative vote of the holders of a majority of the shares of Synlogic Common Stock having voting power outstanding as of the Record Date, voting as a single class. The approval of Proposal Nos. 4, 5, 6, 8, 9, 10 and 11 require the affirmative vote of a majority of the shares cast affirmatively or negatively for each respective proposal. Votes will be counted by the inspector of election appointed for the Special Meeting, who will separately count “FOR” and “AGAINST” votes, abstentions and broker non-votes. Abstentions and broker non-votes will not be considered votes cast by the holders of all the shares of Synlogic Common Stock present at the meeting or by proxy at the Special Meeting and voting affirmatively or negatively, and will therefore not have any effect with respect to Proposal Nos. 4, 5, 6, 8, 9, 10 and 11. Abstentions and broker non-votes will have the same effect as a vote “AGAINST” Proposal Nos. 1, 2 and 3. The nominee for director who receives the most votes (also known as a “plurality” of the votes cast) will be elected under Proposal No. 7. You may vote either FOR the nominee or “WITHHOLD” your vote from the nominee. Votes that are withheld will not be included in the vote tally for the election of the director. Broker non-votes will have no effect with respect to Proposal No. 7. Brokerage firms have authority to vote customers’ unvoted shares held by the firms in street name on Proposal No. 8.

 

Q:	What is the quorum requirement?

 

A:

A quorum of stockholders is necessary to hold a valid meeting. A quorum will be present if stockholders holding at least a majority in voting power of the shares of Synlogic Common Stock issued and outstanding and entitled to vote at the Special Meeting, present at the meeting or represented by proxy, are present at the Special Meeting. On     , 2026, the Record Date, there were    shares of Synlogic Common Stock outstanding and entitled to vote. Accordingly, Synlogic expects that the holders of at least     shares of Synlogic Common Stock must be present at the Special Meeting for a quorum to exist. Your shares of Synlogic Common Stock will be counted toward the quorum at the Special Meeting only if you attend the Special Meeting or are represented at the Special Meeting by proxy.

 

5

Abstentions and broker non-votes (as described below) will be counted towards the quorum requirement. If there is no quorum, the holders of a majority of shares present and entitled to vote at the meeting or represented by proxy may adjourn the Special Meeting to another date.

 

Q:	What are “broker non-votes”?

 

A:

If you hold shares beneficially in street name and do not provide your broker or other agent with voting instructions, your shares may constitute “broker non-votes.” Broker non-votes occur on a matter when banks, brokers and other nominees are not permitted to vote on certain non-discretionary matters without instructions from the beneficial owner and instructions are not given. These matters are referred to as “non-routine” matters. All of the proposals to be acted on at the Special Meeting, except Proposal No. 8, are anticipated to be non-routine matters. Broker non-votes will be counted toward the vote total for Proposal Nos. 1, 2 and 3 and will have the same effect as a vote “AGAINST” such proposals. Broker non-votes will not, however, be considered votes cast by the holders of all of the shares of Synlogic Common Stock present in person or by proxy at the Special Meeting and voting affirmatively or negatively, and will therefore not have any effect with respect to Proposal Nos. 4, 5, 6, 8, 9, 10 and 11. Abstentions and broker non-votes will have the same effect as a vote “AGAINST” Proposal Nos. 1, 2 and 3. Broker non-votes will have no effect with respect to Proposal No. 7. Brokerage firms have authority to vote customers’ unvoted shares held by the firms in street name on Proposal No. 8.

 

Q:	As a Synlogic stockholder, how does the Synlogic Board recommend that I vote?

 

A:	After careful consideration, the Synlogic Board recommends that Synlogic stockholders vote “FOR” all of the proposals.

 

Q:	If the mergers are completed, will the Parent common stock be listed for trading?

 

A:	Yes. The shares of Parent Common Stock you will receive in the Mergers are expected to be listed on NYSE American following the completion of the Mergers. Until the Mergers are consummated, the Parent Common Stock will not be listed on any securities exchange.

Completion of the Mergers is subject to, among other conditions, the Parent Common Stock being approved for listing on NYSE American or another national securities exchange, subject to official notice of issuance. There can be no assurance such listing condition will be met or that Parent will obtain such approval from NYSE American. If such listing condition is not met or if such approval is not obtained, the Mergers will not be consummated unless the condition is waived. The terms of the Merger Agreement permit that this condition may be waived by agreement among the parties without re-circulation or re-solicitation of this proxy statement/prospectus. The NYSE American condition set forth in the Merger Agreement is not expected to be waived by the applicable parties.

Shares of Parent Common Stock received in the Mergers are expected to be freely transferable under applicable securities laws, except for any shares of Parent Common Stock subject to the lock-up agreements entered into by certain executive officers, directors and stockholders of Caldera.

 

Q:	Who will be the directors of Parent following the Mergers?

 

A:

Immediately following the consummation of the Mergers, the Parent Board is expected to be composed of five members selected by the Caldera Board, subject to compliance with applicable NYSE American listing rules. Caldera’s initial appointees to the Parent Board are expected to be Praveen Tipirneni, Michael Gladstone, Aaron Royston, Michelle Doig and John Crowley. The current members of the Synlogic Board, Peter Barrett, James Flynn, Edward Mathers and Richard P. Shea, are expected to resign from the Synlogic Board effective as of the Synlogic Effective Time. For additional information, please see the section titled “Information Regarding Parent — Governance Overview” beginning on page 316 of this proxy statement/prospectus.

 

6

Q:	Who will be the executive officers of Parent immediately following the Mergers?

 

A:

Immediately following the consummation of the Mergers, the executive management team of Parent is expected to be composed of the current members of Caldera’s executive management team, who will be appointed to equivalent positions as officers of Parent. The executive officers of Parent are expected to be as follows: Praveen Tipirneni, M.D., M.B.A., President and Chief Executive Officer; Liangsu Wang, Ph.D., Chief Scientific Officer; Zhong Liu, Ph.D., Chief Technology Officer; and Aaron Pelta, M.B.A., Chief Business Officer. Mary Beth Dooley, the current Principal Executive Officer and Principal Financial Officer of Synlogic, is expected to resign concurrently with the completion of the Mergers. For additional information, please see the section titled “Information Regarding Parent — Governance Overview” beginning on page 316 of this proxy statement/prospectus.

 

Q:	What are the material U.S. federal income tax consequences of the Mergers?

 

A:

Parent, Synlogic and Caldera each intend that, subject to the limitations and qualifications described in “Material U.S. Federal Income Tax Consequences — Material U.S. Federal Income Tax Consequences of the Mergers,” (i) the Caldera Merger will qualify as a transaction described in Section 368(a) of the Internal Revenue Code of 1986, as amended (the “Code”) and (ii) the Mergers, taken together, will qualify as a transaction described in Section 351(a) of the Code. If such treatment applies, U.S. holders (as such term is defined in the section titled “Material U.S. Federal Income Tax Consequences — Material U.S. Federal Income Tax Consequences of the Mergers”) of Synlogic Common Stock and Caldera Common Stock generally will not recognize gain or loss upon the exchange of their Synlogic Common Stock or Caldera Common Stock for Parent Common Stock in the Mergers. For a more detailed summary of the material U.S. federal income tax consequences of the Mergers, see “Material U.S. Federal Income Tax Consequences — Material U.S. Federal Income Tax Consequences of the Mergers” beginning on page 186 of this proxy statement/prospectus. For a more detailed summary of the risks related to the U.S. federal income tax treatment, see the risk factors under “Material U.S. Federal Income Tax Consequences — Material U.S. Federal Income Tax Consequences of the Ownership and Disposition of Parent Common Stock to Both U.S. Holders and Non-U.S. Holders” beginning on page 188 of this proxy statement/prospectus.

 

Q:	What risks should I consider in deciding whether to vote in favor of the Mergers or to execute and return the written consent, as applicable?

 

A:

You should carefully review the section of this proxy statement/prospectus titled “Risk Factors,” which sets forth certain risks and uncertainties related to the Mergers, risks and uncertainties to which Parent’s business will be subject, and risks and uncertainties to which Caldera, as an independent company, is subject.

 

Q:	Do Synlogic stockholders have appraisal or dissenters’ rights?

 

A:

Yes. Under Section 262 of the General Corporation Law of the State of Delaware (the “DGCL”), Synlogic stockholders who do not vote in favor of the Synlogic Merger at the Special Meeting have the right to dissent from the Synlogic Merger and, by complying with the applicable statutory procedures, to receive payment in cash of the “fair value” of their shares of Synlogic Common Stock as determined by the Delaware Court of Chancery. Perfection of appraisal rights is complex and requires strict compliance with the procedures set forth in Section 262 of the DGCL. The procedures for exercising appraisal rights are described in the section entitled “Appraisal Rights.” Additionally, the full text of Section 262 of the DGCL may be accessed without subscription or cost at the following publicly available website: https://delcode.delaware.gov/title8/c001/sc09/#262 and is expressly incorporated herein by reference.

 

Q:	Who can vote at the Special Meeting?

 

A:	Only Synlogic stockholders of record at the close of business on the Record Date will be entitled to vote at the Special Meeting. As of     , 2026, there were     shares of Synlogic Common Stock outstanding and entitled to vote.

 

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Stockholder of Record: Shares Registered in Your Name. If, at the close of business on the Record Date, your shares of Synlogic Common Stock were registered directly in your name with Synlogic’s transfer agent, Equiniti Trust Company, LLC, then you are a Synlogic stockholder of record. As a Synlogic stockholder of record, you may vote at the Special Meeting or vote by proxy. Whether or not you plan to attend the Special Meeting, please vote as soon as possible by completing and returning the enclosed proxy card or vote by proxy over the telephone or on the internet as instructed below to ensure your vote is counted.

Beneficial Owner: Shares Registered in the Name of a Broker or Bank. If, at the close of business on the Record Date, your shares of Synlogic Common Stock were not held in your name, but rather in an account at a brokerage firm, bank, dealer or other similar organization, then you are the beneficial owner of shares held in “street name” and these proxy materials are being forwarded to you by that organization. The organization holding your account is considered to be the stockholder of record for purposes of voting at the Special Meeting. As a beneficial owner, you have the right to direct your broker or other agent how to vote the shares in your account. You are also invited to attend the Special Meeting. However, because you are not the stockholder of record, you may not vote your shares at the Special Meeting unless you request and obtain a valid legal proxy from your broker or other agent, giving you the right to vote the shares at the meeting.

 

Q:	How many votes do I have?

 

A:	On each matter to be voted upon, you have one vote for each share of Synlogic Common Stock you own as of the Record Date.

 

Q:	When do you expect the Mergers to be consummated?

 

A:	Synlogic and Caldera anticipate that the Mergers will close in early 2027, but the companies cannot predict the exact timing. For more information, please see the section titled “The Merger Agreement — Conditions to Completion of the Mergers” in this proxy statement/prospectus.

 

Q:	What do I need to do now?

 

A:	Synlogic urges you to read this proxy statement/prospectus carefully, including its annexes, and to consider how the Mergers affect you.

If you are a Synlogic stockholder of record, you may provide your proxy instructions in one of two different ways. First, you can mail your signed proxy card in the enclosed return envelope. You may also provide your proxy instructions via telephone or via the Internet by following the instructions on your proxy card or voting instruction form. Please provide your proxy instructions only once, unless you are revoking a previously delivered proxy instruction, and as soon as possible so that your shares can be voted at the Special Meeting.

 

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

 

A:

If you are a Synlogic stockholder, and if your shares are registered in your name or if you have stock certificates, they will not be counted if you do not vote as described above under “What do I need to do now?” If your shares are held in street name and you do not provide voting instructions to the bank, broker or other nominee that holds your shares as described above, the bank, broker or other nominee that holds your shares has the authority to vote your unvoted shares only on the ratification of the appointment of our independent registered public accounting firm (Proposal No. 8 of this proxy statement) without receiving instructions from you. Therefore, we encourage you to provide voting instructions to your bank, broker or other nominee. This ensures your shares will be voted at the special meeting and in the manner you desire. The failure to return your proxy card or otherwise provide proxy instructions will reduce the aggregate number of votes required to approve Proposal Nos. 4, 5, 6, 7, 8, 9, 10 and 11 and will have the same effect as a vote “AGAINST” Proposal Nos. 1, 2 and 3.

 

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Q:	What happens if there are technical difficulties during the Special Meeting?

 

A:

We will have technicians ready to assist you with any technical difficulties you may have accessing the virtual Special Meeting, voting at the Special Meeting or submitting questions at the Special Meeting. If you encounter any difficulties accessing the virtual meeting during the check-in or meeting time, please call the technical support number that will be posted on the Virtual Shareholder Meeting login page.

 

Q:	When and where is the Special Meeting of Synlogic stockholders?

 

A:	The Special Meeting will be held virtually via live internet webcast at   a.m., Eastern time, on     , 2026. All Synlogic stockholders as of the Record Date, or their duly appointed proxies, may attend the Special Meeting.

 

Q:	May I change my vote after I have submitted a proxy or provided proxy instructions?

 

A:

Synlogic stockholders of record, other than those Synlogic stockholders who are parties to Synlogic Support Agreements (as defined below), may change their vote at any time before their proxy is voted at the Special Meeting in one of three ways. First, a Synlogic stockholder of record can send a written notice to the Secretary of Synlogic stating that it would like to revoke its proxy. Second, a Synlogic stockholder of record can submit new proxy instructions either on a new proxy card via telephone or the Internet. Third, a Synlogic stockholder of record can attend the Special Meeting virtually and vote at the Special Meeting. Attendance alone will not revoke a proxy. If a Synlogic stockholder who owns shares of Synlogic Common Stock in “street name” has instructed a broker to vote its shares of Synlogic Common Stock, the stockholder must follow directions received from its broker to change those instructions.

 

Q:	Who is paying for this proxy solicitation?

 

A:

Synlogic and Caldera will share equally the cost of printing and filing this proxy statement/prospectus and the proxy card. Arrangements will also be made with brokerage firms and other custodians, nominees and fiduciaries who are record holders of Synlogic Common Stock for the forwarding of solicitation materials to the beneficial owners of Synlogic Common Stock. Synlogic will reimburse these brokers, custodians, nominees and fiduciaries for the reasonable out-of-pocket expenses they incur in connection with the forwarding of solicitation materials. Synlogic has retained Alliance Advisors, LLC (the “proxy solicitor”), to assist it in soliciting proxies using the means referred to above. Synlogic will pay the fees of the proxy solicitor, which Synlogic expects to be up to $15,000, plus reimbursement of out-of-pocket expenses.

 

Q:	Who can help answer my questions?

 

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

ALLIANCE ADVISORS, LLC

Stockholders call toll-free: 1-866-206-8304

Email: SYBX@allianceadvisors.com

If you are a Caldera securityholder and would like additional copies, without charge, of this proxy statement/prospectus or if you have questions about the Mergers, you should contact:

Caldera Therapeutics, Inc.

300 Technology Square, 8th Floor, Cambridge, MA 02139

Telephone: (781) 254-6624

Attention: Corporate Secretary

 

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RISK FACTORS

Investing in Parent Common Stock involves risks some of which are related to the Mergers. In addition to the other information contained or incorporated by reference in this proxy statement/prospectus or incorporated by reference herein, you should carefully consider the material risks described below and those described in the section of this proxy statement/prospectus entitled “Forward-Looking Statements” before deciding how to vote your shares of stock. You should also read and consider the other information in this proxy statement/prospectus and the other documents incorporated by reference into this proxy statement/prospectus. Please see the section entitled “Where You Can Find More Information” in this proxy statement/prospectus. References to “Parent” in this section refer to Sonic Holdco, Inc. These risk factors are not exhaustive, and investors are encouraged to perform their own investigation with respect to each of the businesses of Caldera and Synlogic because these risks will relate to the combined business of Caldera and Synlogic following the consummation of the Mergers. The occurrence of one or more of the events or circumstances described in these risk factors, alone or in combination with other events or circumstances, may adversely affect the ability to complete or realize the anticipated benefits of the Mergers, and may have a material adverse effect on Parent, as well as the respective businesses of Caldera and Synlogic, as well as their respective financial condition or results of operations. The risks discussed below may not prove to be exhaustive and are based on certain assumptions made by Caldera and Synlogic which later may prove to be incorrect or incomplete. Caldera, Synlogic and Parent may face additional risks and uncertainties that are not presently known to Caldera or Synlogic, or that are currently deemed immaterial, which may also impair their business or financial condition.

Risks Related to the Mergers

Caldera and Synlogic may not be successful in consummating the Mergers.

There can be no assurance that the Mergers will be successfully consummated or lead to increased stockholder value. The completion of the Mergers is dependent on a number of factors that may be beyond the control of Caldera and Synlogic, including, among other things, market conditions, regulatory approval and stockholder approval. Any failure to consummate the Mergers would have a material adverse effect on Caldera’s and Synlogic’s businesses and could significantly impair Caldera’s and Synlogic’s ability to enter into alternative strategic transactions.

The process of completing the Mergers is costly, time-consuming and complex. Caldera and Synlogic have incurred, and may in the future incur, significant costs related to the Mergers, including legal and accounting fees and expenses and other related charges, which have been and will be incurred regardless of whether the Mergers are completed. Caldera and Synlogic may also incur additional unanticipated expenses in connection with the Mergers. These expenses will decrease the remaining cash available for use in Caldera’s and Synlogic’s businesses. Also, the Mergers could have a variety of negative consequences, or yield unexpected results, that adversely affect Caldera’s and Synlogic’s businesses and decrease the remaining cash available for use in Parent’s future business.

If the Mergers are not completed in a timely fashion, Caldera and Synlogic may experience reputational harm and the value of the Caldera Common Stock and the Synlogic Common Stock may be adversely impacted. In addition, speculation regarding the completion of the Mergers and perceived uncertainties related to the future of Caldera could cause Caldera’s stock price to fluctuate significantly. Also, if the Merger Agreement is terminated and the Caldera Board determines to seek another business combination, there can be no assurance that Caldera will be able to find another third party to transact a business combination with, yielding comparable or greater benefits.

 

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The Synlogic Exchange Ratio, which determines the number of shares to be issued to the Synlogic stockholders, will vary based on the extent to which Final Synlogic Net Cash at Closing is more or less than $6.0 million.

The value of the Merger consideration will also be impacted by the amount of Final Synlogic Net Cash (as defined in the Merger Agreement) that Synlogic has at Closing. The Synlogic Exchange Ratio, which determines the number of shares of Parent Common Stock to be issued to former Synlogic stockholders, will vary in part based on the amount of Final Synlogic Net Cash that Synlogic has at Closing. To the extent that Final Synlogic Net Cash is more than $6.0 million, the Synlogic Exchange Ratio will be higher and Synlogic stockholders will receive more shares of Parent Common Stock, resulting in incremental dilution to the Caldera stockholders; to the extent that Final Synlogic Net Cash is less than $6.0 million, the Synlogic Exchange Ratio will be lower and Synlogic stockholders will receive fewer shares of Parent Common Stock. The term “Final Synlogic Net Cash” (as defined in the Merger Agreement), is subject to a floor such that the Synlogic valuation will not be less than $8.0 million.

The Caldera Exchange Ratio and the Synlogic Exchange Ratio will not be adjusted based on the market price of Synlogic Common Stock, so the merger consideration received by stockholders at Closing may have a greater or lesser value than at the time the Merger Agreement was signed.

At the Caldera Effective Time, each share of Caldera Common Stock outstanding immediately prior to the Caldera Effective Time (including shares issued in the Concurrent Financing and shares resulting from the conversion of the Caldera Preferred Stock) will be converted into the right to receive a number of shares of Parent Common Stock equal to the Caldera Exchange Ratio. The Caldera Exchange Ratio is based on a fixed Caldera valuation of $500.0 million. At the Synlogic Effective Time, each share of Synlogic Common Stock outstanding immediately prior to the Synlogic Effective Time will be converted into the right to receive a number of shares of Parent Common Stock equal to the Synlogic Exchange Ratio. The Synlogic Exchange Ratio is based on a Synlogic valuation of $18.0 million, subject to dollar-for-dollar adjustment if the Final Synlogic Net Cash is above or below the Synlogic target net cash amount of $6.0 million (provided that the Synlogic valuation will not be less than $8.0 million). Neither exchange ratio will be adjusted to reflect changes in the market price of Synlogic Common Stock. The final exchange ratios will not be determined until the Closing of the Mergers.

The post-Closing ownership percentages of Caldera stockholders, Synlogic stockholders and the Investors in Parent will be determined by each group’s respective allocation percentage, which is calculated by dividing each group’s valuation (or, in the case of the Investors, the proceeds of the Concurrent Financing) by the aggregate valuation of Synlogic, Caldera and the Concurrent Financing proceeds. Any decrease in the amount of Final Synlogic Net Cash at Closing below the $6.0 million target will decrease the Synlogic valuation (subject to the $8.0 million floor) and correspondingly decrease the number of shares of Parent Common Stock that Synlogic stockholders will be entitled to receive pursuant to the Merger Agreement (and their corresponding post-Closing ownership percentage).

Any changes in the market price of Synlogic Common Stock before the completion of the Mergers will not affect the number of shares of Parent Common Stock that stockholders of either company will be entitled to receive pursuant to the Merger Agreement. Therefore, if before the completion of the Mergers the market price of Synlogic Common Stock increases from the market price on the date of the Merger Agreement, Synlogic stockholders could receive merger consideration with substantially less value relative to the then-current market price of Synlogic Common Stock than the parties had negotiated when they established the Synlogic Exchange Ratio. Similarly, if before the completion of the Mergers the market price of Synlogic Common Stock declines, Synlogic stockholders could receive merger consideration with substantially more value relative to the then-current market price of Synlogic Common Stock. The Merger Agreement does not include a price-based termination right.

For further information regarding the Caldera Exchange Ratio and the Synlogic Exchange Ratio, see the section entitled “The Merger Agreement — Merger Consideration” in this proxy statement/prospectus.

 

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Failure to complete the Mergers may result in Caldera or Synlogic paying a termination fee to the other party, which could harm the future business and operations of the applicable party.

If the Mergers are not completed, each of Caldera and Synlogic is subject to the following risks:

 

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if the Merger Agreement is terminated by Synlogic due to a Caldera Triggering Event (including a Caldera Board Adverse Recommendation Change) or by Caldera upon Caldera’s entry into a Permitted Alternative Agreement for a Superior Offer, Caldera may be required to pay the Caldera Termination Fee of $5.0 million;

 

•

if the Merger Agreement is terminated by Caldera due to a Synlogic Triggering Event or by Synlogic upon Synlogic’s entry into a Permitted Alternative Agreement for a Superior Offer, Synlogic may be required to pay the Synlogic Termination Fee of $1.0 million;

 

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the price of Synlogic Common Stock may decline and could fluctuate significantly; and

 

•

costs related to the Mergers, such as financial advisor, legal and accounting fees, must be paid by the applicable party even if the Mergers are not completed.

In addition, under the Merger Agreement, if following certain terminations a party enters into or consummates a Subsequent Transaction (as defined in the Merger Agreement) within 12 months after a publicly announced Acquisition Proposal, the applicable termination fee (Caldera Termination Fee or Synlogic Termination Fee) becomes payable as a tail termination fee.

The parties to the Merger Agreement have acknowledged that each termination fee represents a good faith, fair estimate of the damages that the receiving party and its affiliates would suffer upon termination of the Merger Agreement, and that any amount payable pursuant to the termination fee provisions is not a penalty, but rather liquidated damages. The parties have further agreed that the payment of the applicable termination fee shall be the sole and exclusive remedy of a party following a termination of the Merger Agreement by the other party (subject to certain exceptions for fraud or willful material breach).

If the Merger Agreement is terminated and the Caldera Board or the Synlogic Board, as applicable, determines to seek another business combination, there can be no assurance that such party will be able to find a partner with whom a business combination would yield greater benefits than the benefits to be provided under the Merger Agreement.

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

Even if the Required Caldera Stockholder Approval and the Required Synlogic Stockholder Approval are obtained, specified conditions must be satisfied or waived to complete the Mergers. These conditions include, among others: (i) the absence of any law or order prohibiting the consummation of the Mergers; (ii) the effectiveness of the registration statement of which this registration statement/prospectus forms a part; (iii) the approval for listing of the shares of Parent Common Stock to be issued in connection with the Mergers on NYSE American; (iv) the securities purchase agreement for the Concurrent Financing being in full force and effect with all funding conditions satisfied or waived and minimum proceeds received; (v) the accuracy of the representations and warranties of each party, subject to specified materiality or de minimis standards; (vi) the performance in all material respects by each party of its obligations under the Merger Agreement; and (vii) the absence of a material adverse effect with respect to each of Caldera and Synlogic. These conditions are described in more detail in the section entitled “The Merger Agreement — Conditions to Closing” in this proxy statement/prospectus.

It is a condition of the consummation of the Mergers that the shares of Parent Common Stock to be issued in connection with the Mergers are approved for listing on NYSE American or another national securities exchange. If NYSE American determines not to approve the listing application, the Mergers may not be consummated. Accordingly, there can be no assurance such listing condition will be met.

 

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If Parent’s Common Stock is not listed on NYSE American, there may be no established public trading market for such common stock, which would likely result in limited liquidity and increased volatility, and would adversely affect Parent’s ability to raise additional capital or to enter into strategic transactions. In addition, the absence of a NYSE American listing would make it more difficult for stockholders to sell Parent’s Common Stock in the public market.

Neither Caldera nor Synlogic can assure you that all of the conditions to the consummation of the Mergers will be satisfied or waived. If the conditions are not satisfied or waived, the Mergers may not occur or the Closing may be delayed, and each of Caldera and Synlogic may lose some or all of the intended benefits of the Mergers.

The Concurrent Financing may not be completed on the terms or timing contemplated, which could jeopardize the Closing of the Mergers.

The Closing of the Mergers is conditioned upon the Securities Purchase Agreement (Concurrent Financing) being in full force and effect, all funding conditions thereunder having been satisfied or waived, and the minimum Concurrent Financing Proceeds having been received. If the Investors participating in the Concurrent Financing fail to fund their commitments, if the conditions to their funding obligations are not satisfied, or if the Securities Purchase Agreement is terminated prior to Closing, the Mergers may not be consummated. Failure to complete the Concurrent Financing could result in the termination of the Merger Agreement if the parties are unable to find alternative sources of funding on acceptable terms prior to the Outside Date. In such event, the anticipated benefits of the Mergers would not be realized, and each of Caldera and Synlogic would be subject to the risks described above relating to a failure to complete the Mergers.

If Caldera and Synlogic complete the Mergers, Parent may need to raise additional capital by issuing equity securities or additional debt or through licensing arrangements, which may cause significant dilution to Parent’s stockholders or restrict Parent’s operations.

Additional financing may not be available to Parent when it is needed or may not be available on favorable terms. To the extent that Parent raises additional capital by issuing equity securities, such financing will cause additional dilution to all securityholders of Parent, including Caldera’s pre-merger stockholders, Synlogic’s pre-merger stockholders and Investors in the Concurrent Financing. It is also possible that the terms of any new equity securities may have preferences over the Parent Common Stock. Any debt financing Parent 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 Parent’s assets, as well as prohibitions on its ability to create liens, pay dividends, redeem its stock or make investments. In addition, if Parent raises additional funds through licensing arrangements, it may be necessary to grant licenses on terms that are not favorable to Parent.

Synlogic stockholders and Caldera stockholders may not realize a benefit from the Mergers commensurate with the ownership dilution they will experience in connection with the Mergers, including the issuance of Parent Common Stock in the Concurrent Financing.

If Parent is unable to realize the full strategic and financial benefits currently anticipated from the Mergers, Synlogic stockholders and Caldera stockholders will have experienced substantial dilution of their ownership interests without receiving any commensurate benefit, or only receiving part of the commensurate benefit to the extent Parent is able to realize only part of the strategic and financial benefits currently anticipated from the Mergers.

The consummation of the Mergers may not be completed by the Outside Date of January 28, 2027, which could result in termination of the Merger Agreement.

The Merger Agreement provides that either Caldera or Synlogic may terminate the Merger Agreement if the Mergers have not been consummated by the Outside Date of January 28, 2027. If the SEC has not declared the

 

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Form S-4 effective by the date that is 25 days prior to the Outside Date, the parties are required to engage in good-faith discussions regarding a potential extension of the Outside Date by up to 30 days (including a possible loan by Synlogic to Caldera for working capital purposes during the extension period). However, there can be no assurance that the parties will agree to any such extension or that the Mergers will be consummated by the Outside Date (or any extended date). If the Merger Agreement is terminated due to the failure to close by the Outside Date, neither party will be obligated to pay a termination fee (unless the termination arises from circumstances that independently give rise to a termination fee obligation), and the anticipated benefits of the Mergers would not be realized.

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

The terms of the Merger Agreement prohibit each of Caldera and Synlogic from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in limited circumstances where the applicable board determines in good faith, after consultation with outside legal counsel and financial advisors, that such action is required by its fiduciary duties. Even where the fiduciary-out exception applies, the board must comply with notice requirements (including a four-business day notice period and matching-rights negotiation) before changing its recommendation. In addition, if the Merger Agreement is terminated under specified circumstances, Caldera may be required to pay the Caldera Termination Fee of $5.0 million and Synlogic may be required to pay the Synlogic Termination Fee of $1.0 million. These termination fees may discourage third parties from submitting competing proposals to Caldera or Synlogic or their respective stockholders, and may cause the Caldera Board or the Synlogic Board to be less inclined to recommend a competing proposal.

The Required Caldera Stockholder Approval and Required Synlogic Stockholder Approval are conditions to Closing and may not be obtained.

The consummation of the Mergers is conditioned upon the receipt of both the Required Caldera Stockholder Approval (approval by holders of a majority of outstanding Caldera Common Stock and a majority of outstanding Caldera Preferred Stock, voting together as a single class on an as-converted basis, by written consent under DGCL Section 228) and the Required Synlogic Stockholder Approval (approval by holders of a majority of the outstanding shares of Synlogic Common Stock at the Special Meeting, to be held within 45 days after the Registration Statement becomes effective). There can be no assurance that either or both approvals will be obtained. If the Required Caldera Stockholder Approval is not obtained within 15 days of Registration Statement effectiveness, or if the Required Synlogic Stockholder Approval is not obtained at the Special Meeting, the Merger Agreement may be terminated by either party, and the Mergers will not be consummated.

Because the lack of a public market for Caldera Common Stock makes it difficult to evaluate the fair market value of Caldera’s capital stock, the value of the Parent Common Stock to be issued to Caldera stockholders may be more or less than the fair market value of Caldera Common Stock.

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

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

In general, neither Caldera nor Synlogic is obligated to complete the Mergers if there is a continuing material adverse effect affecting the other party between July 28, 2026, the date of the Merger Agreement, and the Closing. However, certain types of changes are excluded from the concept of a “material adverse effect.”

 

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Such exclusions include, but are not limited to, general economic, financial and capital markets, political conditions or conditions generally affecting the industry in which the applicable party operates; any natural disaster or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing) anywhere in the world or any governmental or other response or reaction to any of the foregoing; any change in law or GAAP; any change in the stock price or trading volume of Synlogic Common Stock; a failure to meet internal or analysts’ expectations or projections; and the execution or announcement of the Merger Agreement or the pendency of the Mergers.

Therefore, if any of these events were to occur, impacting Caldera or Synlogic, the other party would still be obliged to consummate the Closing. If any such adverse changes occur and Caldera and Synlogic consummate the Closing, the stock price of Parent may suffer. This in turn may reduce the value of the Mergers to the stockholders of Caldera, Synlogic or both. For a more complete discussion of what constitutes a material adverse effect on Caldera or Synlogic, see the section entitled “The Merger Agreement — Conditions to the Completion of the Mergers” beginning on page 175 of this proxy statement/prospectus.

The business of Parent following the Mergers will be different than the business of Synlogic prior to the Mergers.

Synlogic was focused on developing therapeutics using its proprietary synthetic biology platform. Following the Mergers, the business of Parent will consist of Caldera’s business. Caldera is a clinical-stage biopharmaceutical company developing immunology therapeutics. Caldera’s lead development candidate, CLD-423, is a bispecific antibody targeting TL1A x IL-23p19 for inflammatory bowel disease (IBD) and other immune-mediated diseases.

This change in the business of Synlogic from developing synthetic biology-based therapeutics to being a clinical-stage biopharmaceutical company focused on immunology could have a significant impact on the trading and market price of the common stock of Parent following the Mergers. The change in business may attract different investors and analysts and could result in Parent’s common stock being more volatile than it was prior to the Mergers. We cannot predict with certainty how the change in business will impact Parent’s common stock following the consummation of the Mergers. There can be no assurance that the change in business will not have a material adverse impact on the trading price and liquidity of Parent’s common stock.

Following the consummation of the Mergers, the composition of the board of directors and management of Parent will be different from the composition of the current board of directors and management of Synlogic.

Following the consummation of the Mergers, the Parent Board is expected to consist of five members selected by the Caldera Board, including Praveen Tipirneni, Michael Gladstone, Aaron Royston, Michelle Doig and John Crowley. In addition, the management team of Caldera will become the management team of Parent. In particular, Praveen Tipirneni, M.D., M.B.A., currently the President and Chief Executive Officer of Caldera, will serve as President and Chief Executive Officer of Parent, Liangsu Wang, Ph.D., currently the Chief Scientific Officer of Caldera, will serve as Chief Scientific Officer of Parent, Zhong Liu, Ph.D., currently the Chief Technology Officer of Caldera, will serve as Chief Technology Officer of Parent, and Aaron Pelta, M.B.A., currently the Chief Business Officer of Caldera, will serve as Chief Business Officer of Parent. For more information about the management and board of Parent, see “Information Regarding Parent” beginning on page 316 of this proxy statement/prospectus.

This change in board membership and management of Parent may affect Parent’s business strategy and operating decisions following the consummation of the Mergers, as compared to those of Synlogic prior to the Mergers. In addition, there can be no assurances that the Parent Board will function effectively as a team and that any differences or difficulties, should they arise, will not have an adverse effect on Parent’s business or results after the Closing Date.

 

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Following consummation of the Mergers, the former Synlogic stockholders will own less than a majority of the outstanding common stock of Parent and will therefore have less influence over Parent than they do now.

Immediately following completion of the Mergers and the issuance of the Parent Common Stock to the Caldera stockholders at the Caldera Effective Time and the Synlogic stockholders at the Synlogic Effective Time, Synlogic’s current stockholders in the aggregate will not have a majority ownership and voting interest in Parent, which will result in Synlogic stockholders having significantly less influence on Parent’s management and policies. Immediately following completion of the Mergers, and based on the assumptions set forth in this proxy statement/prospectus, Caldera stockholders (other than Investors in the Concurrent Financing) are expected to own approximately 62.8% of Parent, Synlogic stockholders are expected to own approximately 2.3% of Parent, and the Investors in the Concurrent Financing are expected to own approximately 34.9% of Parent, in each case, calculated on a fully diluted basis, using the treasury stock method. As a result, current Synlogic stockholders will have significantly less influence on Parent’s management and policies than they currently have.

Failure to consummate the Mergers could negatively impact future stock prices, operations and financial results of Synlogic.

If the Mergers are not consummated for any reason, Synlogic may be subject to a number of material risks, including the following:

 

•

a decline in the market price of Synlogic Common Stock to the extent that its current market price reflects a market assumption that the Mergers will be consummated and will be beneficial to the value of the common stock after the Closing Date;

 

•

having to pay certain costs related to the proposed Mergers, such as legal, accounting, financial advisory, printing and mailing fees, which must be paid regardless of whether the Mergers are consummated;

 

•

addressing the consequences of operational decisions made since the signing of the Merger Agreement, including decisions made as a result of restrictions on Synlogic’s operations imposed by the terms of the Merger Agreement and decisions to delay or defer capital expenditures;

 

•

returning the focus of management and personnel to operating Synlogic on a standalone basis, without any of the benefits expected to have been provided by the consummation of the Mergers; and

 

•

negative reactions from stockholders, customers, suppliers and employees.

In addition to the above risks, Synlogic may be required, under certain circumstances, to pay a termination fee of $1.0 million to Caldera, including if Caldera terminates the Merger Agreement due to a change in the Synlogic Board recommendation in favor of the transactions, which may adversely affect Synlogic’s financial condition.

The business of Synlogic may be adversely impacted by the failure to pursue other beneficial opportunities due to the focus of Synlogic management on the Mergers. A failure to consummate the Mergers may also result in negative publicity, reputational harm, potential litigation against Synlogic or its directors and officers, and a negative impression of the companies in the financial markets. If the Mergers are not consummated, we cannot assure the Synlogic stockholders that these risks will not materialize and will not materially adversely affect the business, financial results and stock price of Synlogic.

If the Mergers are not completed, and there is no superior alternative transaction available, the Synlogic Board may decide to pursue a dissolution and liquidation of the Synlogic business. In such an event, the amount of cash available for distribution to Synlogic’s 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.

If the Mergers are not completed, and there is no superior alternative transaction available, the Synlogic Board may decide to pursue a dissolution and liquidation of the Synlogic business if it concludes that such

 

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strategy is in the best interests of the Synlogic stockholders. In such an event, the amount of cash available for distribution to Synlogic’s stockholders will depend heavily on the timing of such decision and, with the passage of time, the amount of cash available for distribution will be reduced as Synlogic continues to fund its operations.

In addition, if the Synlogic Board were to approve and recommend, and Synlogic stockholders were to approve, a dissolution and liquidation, Synlogic would be required under Delaware corporate law to pay its outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to Synlogic’s stockholders. As a result of this requirement, a portion of Synlogic’s assets may need to be reserved pending the resolution of such obligations and the timing of any such resolution is uncertain. In addition, Synlogic may be subject to litigation or other claims related to a dissolution and liquidation.

If a dissolution and liquidation were pursued, the Synlogic Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Synlogic Common Stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up.

The opinion of Synlogic’s financial advisor does not reflect changes in circumstances that may have occurred or that may occur between the signing of the Merger Agreement and the consummation of the Mergers.

The opinion rendered to the Synlogic Board by Lucid was provided in connection with, and at the time of, the Synlogic Board’s evaluation of the Mergers. The opinion was based on the financial analyses performed, which considered market and other conditions then in effect, and financial forecasts and other information made available to Lucid, as of the date of the opinion, which may have changed, or may change, after the date of the opinion.

The Synlogic Board has not obtained an updated opinion from Lucid as of the date of this proxy statement/prospectus or as of any other date, nor does it expect to receive an updated, revised or reaffirmed opinion prior to the consummation of the Mergers. Changes in the operations and prospects of Caldera or Synlogic, general market and economic conditions and other factors that may be beyond the control of Caldera or Synlogic, and which changes were not taken into account by Lucid in rendering its opinion, may significantly alter the value of Caldera or Synlogic or the price of Synlogic Common Stock by the time the Mergers are consummated. The opinion does not speak as of the time the Mergers will be consummated or as of any date other than the date of such opinion.

Because there are no plans for Lucid to update its opinion, the opinion does not address the fairness of the Exchange Ratios or the merger consideration, as applicable, from a financial point of view, at any time other than the time such opinion was rendered, even though the Synlogic Board’s recommendation that Synlogic stockholders vote “FOR” the Synlogic Proposals is made as of the date of this proxy statement/prospectus. For a description of the opinion that the Synlogic Board received from Lucid, see “The Mergers — Opinion of the Synlogic Financial Advisor” beginning on page 147 of this proxy statement/prospectus.

The market price for Parent Common Stock following completion of the Mergers may fluctuate.

The market price of the Parent Common Stock could fall following the consummation of the Mergers. Caldera stockholders may decide not to hold the Parent Common Stock they receive in the Mergers. Other stockholders, such as funds with limitations on the amount of stock they are permitted to hold in individual issuers, may be required to sell Parent Common Stock that they receive in the Mergers. Such sales, or market perception of such sales, of Parent Common Stock could result in a higher-than-average trading volume following the Closing and may cause the market price for Parent Common Stock to decline.

 

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Synlogic or Caldera may waive one or more of the conditions to the Mergers and may do so without amending this proxy statement/prospectus or re-soliciting stockholder approval.

Synlogic or Caldera may agree to waive (to the extent permitted by applicable law), in whole or in part, some of the conditions to each party’s obligations to complete the Mergers, to the extent permitted by applicable law. For example, it is a condition to Synlogic’s and Caldera’s respective obligations to close the Mergers that certain of the representations and warranties of the other party are true and correct in all respects as of the Closing Date, except where the failure of such representations and warranties to be true and correct would not have a material adverse effect. However, if the board of directors of either party determines that it is in the best interests of the stockholders of that company to waive any breach of representation by the other party, then such board of directors may elect to waive that condition (to the extent permitted by applicable law).

In the event of a waiver of a condition (to the extent permitted by applicable law), the Synlogic Board will evaluate the materiality of any such waiver to determine whether amendment of this proxy statement/prospectus and re-solicitation of proxies is necessary. In the event that the Synlogic Board, in its own reasonable discretion, determines any such waiver is not significant enough to require re-solicitation of its stockholders, it will have the discretion to cause the Mergers to be completed without seeking further stockholder approval, which decision may have a material adverse effect on the stockholders of Parent following the Mergers. For example, the market could react negatively to such information, which may cause a substantial decline in the price of the common stock of Parent following the Mergers.

Notwithstanding the foregoing, certain closing conditions may not be waived due to applicable law or otherwise. The following closing conditions may not be waived: receipt of the requisite stockholder approvals; the effectiveness of the registration statement on Form S-4 of which this proxy statement/prospectus forms a part; and the absence of any order or injunction that has the effect of prohibiting the consummation of the Mergers. The foregoing closing conditions are the only closing conditions to the Mergers that may not be waived. All other closing conditions to the Mergers may be waived (to the extent permitted by applicable law) by Synlogic and/or Caldera, as applicable. See the section “The Merger Agreement — Conditions to the Completion of the Mergers” beginning on page 175 of this proxy statement/prospectus for further information.

Stockholders could file lawsuits relating to the Mergers.

As of the date of this registration statement/prospectus, there are no pending lawsuits challenging the Mergers. However, potential plaintiffs may file lawsuits challenging the Mergers. The outcome of any future litigation is uncertain. Such litigation, if not resolved, could prevent or delay consummation of the Mergers and result in substantial costs to Caldera, Synlogic, or Parent, including any costs associated with the indemnification of directors and officers. One of the closing conditions is the absence of any order or legal requirement that restrains, enjoins, or otherwise prevents the consummation of the Mergers. Therefore, if a plaintiff were successful in obtaining an injunction prohibiting the consummation of the Mergers on the agreed-upon terms, then such injunction may prevent the Mergers from being consummated, or from being consummated within the expected time frame.

The representations and warranties of the parties contained in the Merger Agreement will not survive the Closing, and Parent will have no post-closing indemnification rights for breaches thereof.

The Merger Agreement provides that all of the representations and warranties of the parties contained therein shall not survive the Closing. As a result, following the consummation of the Mergers, neither Parent nor any of its stockholders will have any remedy available under the Merger Agreement if it is later revealed that there was a breach of any of the representations or warranties made by Synlogic, Caldera, Synlogic Merger Sub or Caldera Merger Sub at or prior to the time of the Mergers. This means that Parent will bear the risk of any undisclosed or unknown liabilities of Synlogic, Caldera, Synlogic Merger Sub or Caldera Merger Sub that existed at or prior to the Closing, and Parent’s stockholders will have no contractual recourse against the former

 

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stockholders of Synlogic, Caldera, Synlogic Merger Sub or Caldera Merger Sub for any such liabilities. This is a material departure from the protections typically available in private company acquisition transactions, where the representations and warranties of the target company often survive the closing for a specified period and the acquiror has indemnification rights for breaches thereof. The absence of post-closing indemnification protections could have a material adverse effect on Parent’s financial condition and results of operations if undisclosed liabilities materialize after the Closing.

Parent is a newly formed holding company with no operating history, and the Mergers are structured as two interdependent mergers under a new holding company, which creates additional execution risk.

Parent was incorporated in Delaware on July 27, 2026 solely for the purpose of acting as the parent company for the combined businesses of Synlogic and Caldera. Parent has no operating history, no operations, no material assets and no employees, and there has never been a public market for Parent Common Stock. Because the transaction is structured as two separate mergers under a common newly formed parent, sometimes referred to as a “double dummy” or “top hat” structure, completion of the transaction requires the substantially simultaneous satisfaction of the conditions to both the Caldera Merger and the Synlogic Merger, the approval of the stockholders of each of Synlogic and Caldera, the effectiveness of the Registration Statement covering the Parent Common Stock, and the approval of the Parent Common Stock for listing on NYSE American. Neither Merger will be completed unless all conditions to the other Merger have been satisfied or waived, and the failure of any one element of the structure could prevent the entire transaction from being completed. In addition, because Parent has no operating or reporting history of its own, investors will not be able to evaluate Parent Common Stock on the basis of its own historical trading performance, and the historical financial statements and SEC reports of Synlogic will not be indicative of the business, financial condition or results of operations of Parent following the Closing.

Stockholders holding a substantial percentage of the outstanding capital stock of each of Synlogic and Caldera have agreed to support the Mergers, which makes approval of the Mergers substantially more likely and may deter competing proposals.

Concurrently with the execution of the Merger Agreement, stockholders holding approximately 50.9% of the outstanding Synlogic capital stock entered into Synlogic Stockholder Support Agreements in favor of Caldera, and stockholders holding approximately 72.6% of the outstanding Caldera capital stock entered into Caldera Stockholder Support Agreements, in each case agreeing to vote in favor of the Mergers and against any competing proposal. As a result, the approval of the proposals to be considered at the Special Meeting and the delivery of the Caldera stockholder written consent are substantially more likely than would otherwise be the case, and the outcome of the Synlogic stockholder vote may not reflect the views of Synlogic stockholders who are not party to a Support Agreement. The Support Agreements may also deter a third party from proposing an alternative transaction that could be more favorable to Synlogic or Caldera stockholders. In addition, because the Required Caldera Stockholder Approval will be obtained by written consent rather than at a meeting, Caldera stockholders will not have an opportunity to consider the Mergers at a stockholders meeting, and Caldera stockholders who do not execute the written consent may be entitled to seek appraisal of the fair value of their shares under Section 262 of the DGCL. Any exercise of appraisal rights could require Parent to make cash payments and would reduce the number of shares of Parent Common Stock issued in the Caldera Merger.

Synlogic and Caldera directors and executive officers have interests in the Mergers that may be different from, or in addition to, the interests of Synlogic and Caldera stockholders.

Certain of the directors and executive officers of Synlogic and Caldera have interests in the Mergers that may be different from, or in addition to, those of Synlogic and Caldera stockholders. These interests include, but are not limited to, the continued service of certain Caldera directors as directors, and of Caldera executive officers as executive officers, of Parent after the Closing Date, the assumption of Caldera Options by Parent in accordance with the Merger Agreement, the accelerated vesting of Synlogic equity awards held by Synlogic

 

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non-employee directors on the Closing Date, certain severance payments and benefits (including acceleration of equity awards) for Synlogic’s executive officer in the event of a qualifying termination in connection with the consummation of the transactions contemplated by the Merger Agreement, and provisions in the Merger Agreement regarding continued indemnification of, and advancement of expenses to, the directors and executive officers of Synlogic and Caldera.

The members of the Synlogic Board and the Caldera Board were aware of and considered these interests, among other matters, in evaluating the Merger Agreement and the Mergers and in recommending that Synlogic stockholders approve the proposals to be considered at the Special Meeting. Synlogic stockholders should be aware of these interests when they consider the recommendation of the Synlogic Board.

The pendency of the Mergers could materially adversely affect the business, financial condition, results of operations or cash flows of Synlogic or Caldera.

The pendency of the Mergers could disrupt Synlogic’s and Caldera’s businesses, in any of the following ways, among others:

 

•

Synlogic’s or Caldera’s employees may experience uncertainty about their future roles with Parent, which might adversely affect each company’s ability to retain and hire key managers and other employees;

 

•

the attention of Synlogic management or Caldera management may be directed toward completion of the Mergers and transaction-related considerations and may be diverted from each company’s day-to-day business operations and, following the completion of the Mergers, the attention of Parent’s management may also be diverted to such matters;

 

•

vendors, suppliers, business partners or others may seek to modify or terminate their business relationship with Synlogic, Caldera or Parent following completion of the Mergers;

 

•

Synlogic, Caldera or Parent, and their respective officers and directors, could become subject to lawsuits relating to the Mergers; and

 

•

Synlogic or Caldera may experience negative reactions from their stockholders, among others.

These disruptions could be exacerbated by a delay in the completion of the Mergers or termination of the Merger Agreement. Additionally, if the Mergers are not consummated, each company will have incurred significant costs and diverted the time and attention of management. A failure to consummate the Mergers may also result in negative publicity, reputational harm, litigation against Synlogic, Caldera and/or their respective directors and officers, and a negative impression of the companies in the financial markets. The occurrence of any of these events individually or in combination could have a material adverse effect on either or both companies’ financial performance and stock price.

The interim operating covenants contained in the Merger Agreement may prevent Synlogic or Caldera from pursuing opportunities that would be beneficial to stockholders of Parent.

The Merger Agreement restricts Synlogic and Caldera from taking certain actions until the Caldera Effective Time or the Synlogic Effective Time, as applicable, without the consent of the other party, including, among others: the payment of dividends; the issuance of equity (including certain equity incentive awards); certain increases to employee compensation and benefits; capital expenditures; the incurrence of indebtedness; acquisitions and divestitures; and the entry into or amendment of certain material contracts. Synlogic and Caldera are also required to conduct their business in the ordinary course of business in all material respects. These restrictive covenants, which are subject to various specific exceptions, may prevent Synlogic or Caldera from pursuing attractive business opportunities that may arise prior to the consummation of the Mergers. Although Synlogic and Caldera may be able to pursue such activities with the other company’s consent, the other company may not be willing to provide its consent.

 

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If the Mergers, taken together, do not qualify as a transaction described in Section 351(a) of the Code, Synlogic stockholders may recognize substantial taxable gain as a result of the Mergers, and may be required to pay substantial additional U.S. federal income taxes, in the taxable year in which the transactions occur.

The Mergers, taken together, are intended to qualify as a transaction described in Section 351(a) of the Code. The positions of Synlogic and Caldera are not binding on the IRS or the courts, and the parties do not intend to request a ruling from the IRS with respect to the transactions described in the Merger Agreement. Accordingly, there can be no assurance that the IRS will not challenge the qualification of the Mergers, taken together, as a transaction described in Section 351(a) of the Code or that a court will not sustain such a challenge. If the IRS were to be successful in any such contention, or if for any other reason the Mergers, taken together, were not treated as a transaction described in Section 351(a) of the Code, then the Synlogic stockholders would not be entitled to defer any portion of the gain realized as a result of receiving shares of Parent Common Stock in the transactions and may be required to pay substantial additional U.S. federal income taxes with respect to the taxable year in which such transactions occur.

If the Mergers, taken together, do not qualify as a transaction described in Section 351(a) of the Code (and, in the case of the Caldera stockholders, if the Caldera Merger, by itself, does not qualify as a reorganization within the meaning of Section 368(a) of the Code), Caldera stockholders may recognize substantial taxable gain as a result of the Mergers, and may be required to pay substantial additional U.S. federal income taxes, in the taxable year in which the transactions occur.

The Mergers, taken together, are intended to qualify as a transaction described in Section 351(a) of the Code. The Caldera Merger, by itself, is intended to qualify as a reorganization within the meaning of Section 368(a) of the Code. The positions of Synlogic and Caldera are not binding on the IRS or the courts, and the parties do not intend to request a ruling from the IRS with respect to the transactions described in the Merger Agreement. Accordingly, there can be no assurance that the IRS will not challenge the qualification of the Mergers, taken together, as a transaction described in Section 351(a) of the Code or that a court will not sustain such a challenge. If the IRS were to be successful in any such contention, or if for any other reason the Mergers, taken together, were not treated as a transaction described in Section 351(a) of the Code (and if the Caldera Merger did not qualify as a reorganization within the meaning of Section 368(a) of the Code), then the Caldera stockholders would not be entitled to defer any portion of the gain realized as a result of receiving shares of Parent Common Stock in the transactions and may be required to pay substantial additional U.S. federal income taxes with respect to the taxable year in which such transactions occur.

NYSE American may delist Parent’s securities from trading on its exchange, which could limit investors’ ability to make transactions in its securities and subject the Parent to additional trading restrictions.

In connection with the proposed Mergers, Parent will file an initial listing application with NYSE American. Parent will be required to meet the initial listing requirements for its securities to be listed on NYSE American.

We cannot assure you that Parent will be able to meet the NYSE American initial listing requirements. Even if Parent’s securities are so listed, Parent may be unable to maintain the listing of its securities in the future. In order to continue listing its securities on NYSE American following the proposed Mergers, Parent will be required to maintain certain financial, distribution and stock price levels. If NYSE American delists Parent’s securities from trading on its exchange after closing of the Mergers and Parent is not able to list its securities on another national securities exchange or regain compliance with NYSE American, Parent’s securities could be quoted on an over-the-counter market. If this were to occur, Parent could face significant material adverse consequences, including:

 

•

a limited availability of market quotations for its securities;

 

•

reduced liquidity for its securities;

 

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•

a determination that Parent’s common stock is a “penny stock” which will require brokers trading in Parent’s common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities;

 

•

a limited amount of news and analyst coverage; and

 

•

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

Risks Related to the Proposed Synlogic Reverse Stock Split

The Synlogic Reverse Stock Split may not increase Parent’s ability to satisfy the NYSE American listing requirements of the Parent Common Stock or increase Parent’s stock price over the short- or long-term, which may further impact Parent’s ability to maintain listing on NYSE American.

The principal purpose for effecting the Synlogic Reverse Stock Split is to increase the per-share trading price of Synlogic Common Stock to: (i) increase the minimum bid price of Synlogic Common Stock, thereby increasing Parent’s ability to satisfy the NYSE American listing requirements of the Parent Common Stock, (ii) generate investor interest in Synlogic and ultimately Parent and to help Parent attract and retain employees, and (iii) increase the trading volume in, and facility future financings by, Parent. It cannot be assured, however, that the Synlogic Reverse Stock Split will accomplish any increase in the per-share market price of Synlogic Common Stock for any meaningful period of time, thereby increasing Parent’s ability to satisfy the NYSE American listing requirements of the Parent Common Stock. While it is expected that the reduction in the number of outstanding shares of common stock will proportionally increase the market price of Synlogic Common Stock, it cannot be assured that the Synlogic Reverse Stock Split will increase the market price of Synlogic Common Stock by a multiple of the Synlogic Reverse Stock Split ratio approved by the Synlogic Board, thereby increasing Parent’s ability to satisfy the NYSE American listing requirements of the Parent Common Stock, and subsequently, sustain or increase the market price of the Parent Common Stock, which is dependent upon many factors, including Parent’s business and financial performance, general market conditions and prospects for future success. Even if the Synlogic Reverse Stock Split results in the Parent Common Stock meeting the initial listing requirements for NYSE American upon the consummation of the Mergers, it cannot be assured that the Parent Common Stock will continue to meet the listing requirements of NYSE American.

The Synlogic Reverse Stock Split may decrease the liquidity of the Parent Common Stock.

Although the Synlogic Board believes that the anticipated higher market price of the Parent Common Stock resulting from the proposed Synlogic Reverse Stock Split could encourage interest in the Parent Common Stock and possibly promote greater liquidity for Parent’s stockholders, such liquidity could also be adversely affected by the reduced number of shares of the Parent Common Stock issued outstanding as a result of the Synlogic Reverse Stock Split. In addition, the Synlogic Reverse Stock Split may not result in an increase in Synlogic’s stock price necessary to satisfy NYSE American’s initial listing requirements for the Parent Common Stock.

Risks Related to Synlogic

Throughout these “Risks Related to Synlogic,” unless otherwise noted, “our,” “we,” and “the Company” refers to Synlogic, Inc. and its subsidiaries.

Risks Related to Synlogic’s Securities

Our securities have been delisted from Nasdaq, which has limited and may continue to limit investors’ ability to make transactions in our securities.

The trading of our securities on Nasdaq was suspended at the open of trading on January 21, 2026. See “Item 1. Business — Nasdaq Delisting” of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 12, 2026 (the “Annual Report”). Nasdaq filed a Form 25 Notification of

 

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Delisting with the SEC on May 18, 2026. The delisting became effective on January 21, 2026. As of the date of this proxy statement/prospectus, the Synlogic Common Stock is traded on the OTCID Basic Market, under the symbol “SYBX.”

We face adverse consequences as a result of our securities not being listed on a national securities exchange, including (i) a limited availability of market quotations for our securities, (ii) reduced liquidity for our securities, (iii) a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for our securities, (iv) a limited amount of news and analyst coverage, if any, in the future; (v) a decreased ability to issue additional securities or otherwise obtain additional financing in the future; and (vi) a decreased ability of our securityholders to sell their securities in certain states.

We are a non-operating shell company.

We are a public shell company with no operations and we are seeking to effect the Mergers with Caldera by using a combination of capital stock, cash on hand, or other funding sources, if available. There can be no assurances that we will be successful in consummating the Mergers.

An active trading market for our securities may never develop and investors may find it difficult to buy and sell our shares, which would further adversely affect the liquidity and price of our securities.

Although the Synlogic Common Stock is quoted on the over-the-counter market, such market is an unorganized, interdealer market which provides significantly less liquidity than the Nasdaq or other national securities exchange. Securities traded on the over-the-counter market are usually thinly traded, highly volatile, have fewer market makers and are not followed by analysts. Any significant trading volume in our common stock may not be sustained. These factors may have an adverse impact on the trading and price of our common stock. See “— Our securities have been delisted from Nasdaq, which has limited and may continue to limit investors’ ability to make transactions in our securities” above for further discussion.

Our securityholders may face restrictions on the resale of our securities due to state “blue sky” laws.

Each state has its own securities laws, often called “blue sky” laws, which (i) limit sales of securities to a state’s residents unless the securities are registered in that state or qualify for an exemption from registration, and (ii) govern the reporting requirements for broker-dealers doing business directly or indirectly in the state. Before a security is sold in a state, there must be a registration or qualification in place to cover the transaction, or the transaction must be exempt from registration or qualification. The applicable broker must be registered in that state. There may be state blue sky law restrictions on the ability of investors to sell, and on purchasers to buy, our common stock. As a result of our delisting from Nasdaq, our securities currently do not qualify as “covered securities” under Section 18(b)(1) of the Securities Act and are therefore subject to regulation in each state in which we offer our securities and may not qualify for offering and sale in certain states. Our common stock is quoted and traded on the OTCID Basic Market, which is not recognized as a securities manual in a majority of states. The “manual exemption” permits a security to be distributed in a particular state without being registered if the company issuing the security has a listing for that security in a securities manual recognized by that state. We do not qualify for the “manual exemption” as our securities are not quoted and traded on a securities manual recognized in a majority of states.

As a result of our delisting from Nasdaq, we are more likely to require holders of our warrants who exercise their warrants to do so on a cashless basis and such holders may receive fewer shares of Synlogic Common Stock upon exercise than they would have received had they been able to pay the exercise price of their warrants in cash.

As a result of our delisting from Nasdaq, our securities currently do not qualify as “covered securities” under Section 18(b)(1) of the Securities Act and are therefore subject to regulation in each state in which we

 

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offer our securities and may not qualify for offering and sale in certain states. Consequently, unless an exemption from qualification of our shares of common stock is then available in any relevant state, we are more likely to require holders of warrants who exercise their warrants to do so on a cashless basis in accordance with Section 3(a)(9) of the Securities Act. The number of shares we issue in a cashless exercise may be lower than if the warrants were exercised on a cash basis, which could adversely affect the value of our common stock, and the holders of the warrants may experience a lower rate of return than they would have in a cash exercise if the trading price of our shares of common stock increases.

We may be further delisted from the OTC Markets and may face additional adverse consequences.

Failure to comply with the continuing listing standards of the OTC Markets could result in further delisting, which would significantly affect the ability of investors to trade our securities and could further reduce their value and liquidity. Additional negative consequences may include the loss of federal preemption of state securities laws, greater difficulty in raising capital, the potential loss of institutional investor interest, and fewer business development opportunities. These risks collectively may impair our ability to operate effectively and achieve our strategic objectives.

Risks Related to Synlogic’s Evaluation of Strategic Alternatives

Our business to date has been significantly dependent on the success of SYNB1934, and we have decided to discontinue further development of SYNB1934 and devote significant time and resources to identifying and evaluating strategic alternatives, including the Mergers, which may not be successful.

To date, we have invested significant efforts and financial resources in the research and development of SYNB1934, which was our lead product candidate in clinical trials. In February 2024, we voluntarily halted Synpheny-3 based on results of an internal review in advance of an upcoming independent Data Monitoring Committee (DMC) assessment, which indicated the trial was unlikely to meet its primary endpoint. The decision was not based on concerns regarding safety or tolerability. Beginning in February 2024, we started to reduce operating expenses while we evaluated our strategic alternatives with a goal to enhance stockholder value, including the Mergers. There can be no assurance that the Mergers will be approved or consummated. In addition, there can be no assurance that the Mergers, if consummated, would enhance shareholder value. There also can be no assurance that we will conduct further drug research or development activities in the future.

Pursuing the Mergers, or any other such strategic transaction, requires us to incur non-recurring or other charges, may increase our near-and long-term expenditures and may pose significant integration challenges or disrupt our management or business, which could adversely affect our operations and financial results.

If we do not successfully consummate the Mergers, our board of directors may decide to pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our 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.

There can be no assurance that we will consummate the Mergers. If the Mergers are not completed, our board of directors may decide to pursue a dissolution and liquidation of our company. In such an event, the amount of cash available for distribution to our 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 we fund our operations while we evaluate our strategic alternatives. In addition, if our board of directors were to approve and recommend, and our stockholders were to approve, a dissolution and liquidation of our company, we would be required under Delaware corporate law to pay our outstanding obligations, as well as to make reasonable provision for contingent and unknown obligations, prior to making any distributions in liquidation to our stockholders. Our commitments and contingent liabilities may include (i) obligations under our employment and related agreements with certain employees that provide for severance and other payments following a

 

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termination of employment occurring for various reasons, including a change in control of our company; and (ii) potential litigation against us, and other various claims and legal actions arising in the ordinary course of business. As a result of this requirement, a portion of our assets may need to be reserved pending the resolution of such obligations. In addition, we may be subject to litigation or other claims related to a dissolution and liquidation of our company. If a dissolution and liquidation were pursued, our board of directors, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of our common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of our company.

Risks Related to Synlogic’s Financial Condition, Capital Requirements and Operating Results

Our stock price is volatile, and our stockholders may not be able to resell shares of our common stock at or above the price they paid.

The trading price of our common stock is highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, such as reports by industry analysts, investor perceptions, general industry trends, macro-economic conditions, or negative announcements by other companies involving similar technologies or diseases. These factors also include those discussed in this “Risk Factors” section and others such as:

 

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announcements relating to the Mergers;

 

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announcements relating to our delisting or further delisting;

 

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prevailing economic conditions;

 

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future sales or issuances of equity or debt securities by us;

 

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lack of an active, liquid and orderly market in our common stock; and

 

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the issuance of new or changed securities analysts’ reports or recommendations regarding us.

Our short operating history may make it difficult for stockholders to evaluate the success of our business to date and to assess our future viability.

We are a biopharmaceutical company with a limited operating history. We commenced active operations in 2014. Our operations to date have been limited to organizing and staffing our company, research and development activities, business planning and raising capital. In February 2024, we voluntarily halted Synpheny-3 based on results of an internal review in advance of an upcoming independent Data Monitoring Committee (DMC) assessment, which indicated the trial was unlikely to meet its primary endpoint. The decision was not based on concerns regarding safety or tolerability. We have not yet demonstrated our ability to successfully complete large-scale, pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product, or arrange for a third-party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. Typically, it takes many years to develop one new product candidate from the time it is discovered to the time that it becomes available for treating patients. We may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors that may hinder our success in commercializing one or more of our product candidates. Further, drug development is a capital-intensive and highly speculative undertaking that involves a substantial degree of risk. You should consider our prospects in light of the costs, uncertainties, delays and difficulties frequently encountered by companies in the early stages of development and clinical trials. Any forward-looking statements regarding our future prospects, plans or viability may not be as accurate as they may be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products.

 

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Our internal computer systems, or those of our collaborators or other contractors or consultants, may fail or suffer cybersecurity incidents, which could result in a material disruption of our product development programs.

Our internal information technology, or IT, systems and those of our current and any future collaborators and other contractors, consultants, or clinical trial sites are vulnerable to damage from cyberattacks, computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. Cyberattacks are increasing in their frequency, sophistication and intensity, and have become increasingly difficult to detect. Cyberattacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, unauthorized access to or deletion of files, social engineering, phishing and other means to affect service reliability and threaten the confidentiality, integrity and availability of information and IT systems. If any of the above events were to occur and cause interruptions in our operations, it could result in a material disruption of our development programs and our business operations, whether due to a loss of our trade secrets or other proprietary information or other similar disruptions. To the extent that any disruption or cybersecurity incident were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability, our competitive position could be harmed. The market perception of the effectiveness of our security measures could be harmed and our reputation and credibility could be damaged. Although we develop and maintain systems and controls designed to prevent these events from occurring, and we have processes to identify and mitigate threats, the development and maintenance of these systems, controls and processes is costly and requires ongoing monitoring and updating as technologies evolve and efforts to overcome security measures become increasingly sophisticated. Moreover, despite our efforts, the possibility of these events occurring cannot be eliminated entirely. In addition, there can be no assurance that we will promptly detect any such disruption or cybersecurity incident, if at all. As we outsource more of our information systems to vendors, engage in more electronic transactions with payors and patients, and rely more on cloud-based information systems, the related security risks will increase and we will need to expend additional resources to protect our technology and information systems. In addition, there can be no assurance that our internal IT systems or those of our third-party contractors, or our consultants’ efforts to implement adequate security and control measures, will be sufficient to protect us against breakdowns, service disruption, data deterioration or loss in the event of a system malfunction, or prevent data from being stolen or corrupted in the event of a cyberattack, cybersecurity incident, industrial espionage attacks or insider threat attacks which could result in financial, legal, business or reputational harm, as well as loss of competitive advantage or loss of consumer confidence.

Our ability to use our net operating losses to offset future taxable income is subject to certain limitations.

As of December 31, 2025, we had approximately $401.8 million of federal net operating losses (“NOLs”). Federal NOLs generated in taxable years ending after December 31, 2017, may be carried forward indefinitely, but the deductibility of such federal NOLs is limited to 80% of our taxable income for the particular taxable year. As of December 31, 2025, we had approximately $387.9 million of state NOLs. Of the state NOLs, some are of indefinite life, but most are of definite life with various expiration dates, beginning in 2029. As of December 31, 2025, we had approximately $7.5 million of federal research and development tax credit carryforwards. Federal tax credit carryforwards expire at various dates, beginning in 2034. As of December 31, 2025, we had approximately $4.4 million of state research and development tax credit carryforwards. The state tax credits, which have various carryforward rules, begin to expire in 2030. Our ability to utilize these NOLs and tax credits to offset future tax liabilities depends on the successful development of our product candidates and future financial performance.

Under Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by “5 percent shareholders” over a three-year period, the corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income or taxes may be limited. A corporation that experiences an ownership change will generally be subject to an annual limitation on

 

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the use of its pre-ownership change NOLs equal to the value of the corporation immediately before the ownership change, multiplied by the long-term tax-exempt rate (subject to certain adjustments). We may have experienced ownership changes in the past and may experience ownership changes as a result of the Mergers and/or subsequent shifts in our stock ownership (some of which are outside our control). There is also a risk that due to regulatory changes, such as suspensions on the use of NOLs by federal or state taxing authorities or other unforeseen reasons, our existing NOLs could expire or otherwise be unavailable to reduce future income tax liabilities. As a result, our ability to use our pre-change NOLs and tax credits to offset future taxable income, if any, could be subject to limitations. Similar provisions of state tax law may also apply. As a result, even if we attain profitability, we may be unable to use a material portion of our NOLs and tax credits.

Risks Related to Synlogic’s Intellectual Property

We may not be successful in obtaining or maintaining necessary rights to synthetic biotics, product candidates and processes for our development pipeline through acquisitions and in-licenses.

Presently, we have rights to certain intellectual property, through licenses from third parties and under patents and patent applications owned by us. The growth of our business will likely depend in part on our ability to obtain, maintain or enforce our and our licensors’ intellectual property rights and to acquire or in-license additional proprietary rights. For example, our programs may involve additional product candidates or delivery systems that may require the use of additional proprietary rights held by third parties.

We may be unable to develop, acquire or in-license compositions, methods of use, processes or other third-party intellectual property rights from third parties that we identify. The licensing and acquisition of third-party intellectual property rights is a competitive area, and a number of other companies may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These companies could have a competitive advantage over us due to their size, cash resources and greater clinical development and commercialization capabilities.

For example, we have previously collaborated with academic institutions to accelerate our preclinical research or development under written agreements with these institutions. Typically, these institutions provide an option to negotiate a license to any of the institution’s rights in technology resulting from the collaboration. Regardless of such right of first negotiation for intellectual property, we may be unable to negotiate a license within the specified time frame or under terms that are acceptable to it. If we are unable to do so, the institution may offer intellectual property rights to other parties, potentially blocking our ability to pursue our program.

In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. We also may be unable to license or acquire third-party intellectual property rights on terms that would allow us to make an appropriate return on our investment. If we are unable to successfully obtain rights to third-party intellectual property rights, our business, financial condition and prospects for growth could suffer.

We may not have sufficient patent term protections to effectively protect our business.

Patents have a limited term. In the United States, the statutory expiration of a patent is generally 20 years after it is filed. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our product candidates are obtained, once the patent life has expired for a product candidate, we may be open to competition. In addition, upon issuance in the United States any patent term can be adjusted based on specified delays caused by the applicant(s) or the USPTO Patent term extensions under the Hatch-Waxman Act in the United States and under supplementary protection certificates in Europe may be available to extend the patent or data exclusivity terms of our product candidates. We will likely seek patent term extensions, and we cannot provide any assurances that any such patent term extensions will be obtained and, if so, for how long. As a result, we may not be able to maintain exclusivity for our product candidates for an extended period after regulatory approval, if any, which would negatively impact our business, financial condition, results of operations and prospects. If we do not have sufficient patent terms or regulatory exclusivity to protect our product candidates, our business and results of operations will be adversely affected.

 

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Changes in U.S. and foreign patent law could diminish the value of patents in general, thereby impairing our ability to protect our products, and recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

As is the case with other biotechnology companies, our success is heavily dependent on patents. Obtaining and enforcing patents in the biotechnology industry involves both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition, the United States has recently enacted and is currently implementing wide-ranging patent reform legislation. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in specified circumstances and weakened the rights of patent owners in specified situations. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future.

European patent practice is expected to change now that the European Unitary Patent and Unified Patent Court (“UPC”) went into force on June 1, 2023. The new system will impact both pending European applications and granted European patents, and uncertainty remains about long-term implications of this change. The UPC may particularly present uncertainties for our ability to protect and enforce our patent rights against competitors in Europe. While the UPC is being implemented to provide more certainty and efficiency to patent enforcement throughout Europe, it will also provide our competitors with a new forum to use to centrally revoke our European patents. It will be several years before we will understand the scope of patent rights that will be recognized and the strength of patent remedies that will be provided by the UPC. We will have the right to opt our patents out of the UPC system over the first seven years, but doing so may preclude us from realizing the benefits of the new unified court.

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

Periodic maintenance fees on any issued patents are due to be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Although 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. Noncompliance events that could result in abandonment or lapse of a patent or patent application include failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. In any such event, our competitors might be able to enter the market, which would have a material adverse effect on our business.

If we are unable to maintain effective proprietary rights for our product candidates or any future product candidates, we may not be able to compete effectively in our proposed markets.

In addition to the protection afforded by patents, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent. We also utilize processes for which patents are difficult to enforce. In addition, other elements of our products, and many elements of our product candidate discovery and development processes involve proprietary know-how, information or technology that is not covered by patents. Trade secrets may be difficult to protect. We seek to protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, collaborators, advisors, independent contractors or other third parties. We also seek to

 

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preserve the integrity and confidentiality of our data and trade secrets, including by maintaining physical and electronic security of our premises and our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, competitors may otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Furthermore, the laws of some foreign countries do not protect proprietary rights to the same extent or in the same manner as the laws of the United States. As a result, we may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent unauthorized material disclosure of our intellectual property to third parties, or misappropriation of our intellectual property by third parties, we may not be able to establish or maintain a competitive advantage in our market, which could materially adversely affect our business, operating results, and financial condition.

Although we expect all of our employees and consultants to assign their inventions to us, and all of our employees, consultants, collaborators, advisors, independent contractors and any third parties who have access to our proprietary know-how, information, or technology to enter into confidentiality agreements, we cannot provide any assurances that all such agreements have been duly executed or that our trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. Misappropriation or unauthorized disclosure of our trade secrets could impair our competitive position and may have a material adverse effect on our business, financial condition or results of operations. Additionally, if the steps taken to maintain our trade secrets are deemed inadequate, we may have insufficient recourse against third parties for misappropriating the trade secret.

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

Our success depends in part on our ability to develop, manufacture, market and sell our product candidates and use our proprietary technology without infringing the patent rights of third parties. Numerous third-party U.S. and non-U.S. issued patents and pending applications exist in the area of synthetic biology. We may become aware of U.S. and foreign patents and pending patent applications owned by third parties that cover similar therapeutic uses as the product candidates we may develop and we may in the future pursue available proceedings in the U.S. and foreign patent offices to challenge the validity of such patents and patent applications. In addition, or alternatively, we may consider whether to seek to negotiate a license of rights to technology covered by one or more of such patents and patent applications. If any patents or patent applications cover our product candidates or technologies, we may not be free to manufacture or market our product candidates as planned, absent such a license, which may not be available to us on commercially reasonable terms, or at all.

It is possible that we have failed to identify relevant third-party patents or applications. For example, applications filed before November 29, 2000 and applications filed after that date that will not be filed outside the United States remain confidential until patents issue. Moreover, it is difficult for industry participants, including us, to identify all third-party patent rights that may be relevant to our product candidates and technologies because patent searching is imperfect due to differences in terminology among patents, incomplete databases and the difficulty in assessing the meaning of patent claims. We may fail to identify relevant patents or patent applications or may identify pending patent applications of potential interest but incorrectly predict the likelihood that such patents may issue with claims of relevance to our technology. In addition, we may be unaware of one or more issued patents that would be infringed by the manufacture, sale or use of a future product candidate, or we may incorrectly conclude that a third-party patent is invalid, unenforceable or not infringed by our activities. Additionally, pending patent applications that have been published can, subject to specified limitations, be later amended in a manner that could cover our technologies, our product candidates or the use of our product candidates.

 

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There have been many lawsuits and other proceedings filed by third parties involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions, and reexamination, post-grant review and equivalent proceedings before the USPTO and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

We depend, in part, on our licensors to file, prosecute, maintain, defend and enforce patents and patent applications that are material to our business.

While we normally seek and gain the right to fully prosecute the patent applications relating to our product candidates, there may be times when the patent applications enabling our product candidates are controlled by our licensors. If any of our future licensors fail to appropriately and broadly prosecute and maintain patent protection for patents covering any of our product candidates, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using, importing, and selling competing products. In addition, even where we may have the right to control patent prosecution of patents and patent applications we license from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensors in effect from actions prior to us assuming control over patent prosecution.

If we fail to comply with obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business.

We may enter into license agreements in the future. Our future license agreements may impose certain obligations, including the payment of milestones and royalties based on revenues from sales of our products utilizing the technologies licensed from our licensors, and such obligations could adversely affect the overall profitability for us of any products that we may seek to commercialize. In addition, we may need to outsource and rely on third parties for many aspects of the clinical development, sales and marketing of our product candidates covered under our license agreements. Delay or failure by these third parties could adversely affect the continuation of our license agreements with our third-party licensors. If we fail to comply with our obligations under these agreements, or we are subject to a bankruptcy, these agreements may be subject to termination by the licensor which could have a material adverse effect on our business.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming, and unsuccessful.

Competitors may infringe our patents or the patents of our licensors. To cease such infringement or unauthorized use, we or one of our licensing partners may be required to file patent infringement claims against a third-party to enforce one of our patents which can be expensive, time-consuming and unpredictable. In addition, in an infringement proceeding or a declaratory judgment action against us, a court may decide that one or more of our patents is not valid or is unenforceable or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result in any litigation

 

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or defense proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly and could put our patent applications at risk of not issuing. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.

If we or one of our licensing partners were to initiate legal proceedings against a third-party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third-party can assert invalidity or unenforceability of a patent. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, written description, clarity or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or other jurisdictions, even outside the context of litigation. Such mechanisms include re-examination, inter partes review, post-grant review and equivalent proceedings in foreign jurisdictions, such as opposition or derivation proceedings. Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover and protect our product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity of our patents, for example, we cannot be certain that there is no invalidating prior art of which we, our patent counsel, and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity, unpatentability and/or unenforceability, we may lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection could have a material adverse impact on our business.

Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions or correct inventorship with respect to our patents or patent applications or those of our licensors. An unfavorable outcome could result in a loss of our current patent rights and could require us to cease using the related technology or to attempt to license rights to us from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our defense of litigation, derivation or interference proceedings may result in a decision adverse to our interests and, even if successful, may result in substantial costs and distract our management and other employees. In addition, we may be unable to raise the funds necessary to conduct our clinical trials, continue our research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring our product candidates to market.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. Any disclosure of confidential information could adversely affect our business. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

We may be subject to claims challenging the inventorship of our patents and other intellectual property.

We may in the future be subject to claims that former employees, consultants, collaborators, advisors, independent contractors or other third parties have an interest in our patents or other intellectual property as an inventor or co-inventor or other claims challenging the inventorship of our patents or ownership of our intellectual property (including patents and intellectual property that we in-license). Therefore, our rights to these patents may not be exclusive and third parties, including competitors, may have access to intellectual property that is important to our business. In addition, co-owners from whom we do not yet have a license or assignment may raise claims surrounding inventorship or ownership of patents that ultimately issue from this patent family, potentially resulting in issued patents to which we would not have rights under our existing license agreements.

 

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Further, in jurisdictions outside the United States, a license may not be enforceable unless all the owners of the intellectual property agree or consent to the license. In addition, we may have inventorship disputes arising from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship of our patents. If we fail in defending any such claims, in addition to paying monetary damages, we 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 our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may be subject to claims that our employees, consultants, collaborators, advisors, independent contractors or other third parties have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

We have received confidential and proprietary information from third parties. In addition, we have in the past employed, and may in the future employ, individuals who were previously employed at universities, academic research institutions and at other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we expect to have written agreements with and make every effort to ensure that our employees, consultants, collaborators, advisors, independent contractors or other third parties do not use the proprietary information or intellectual property rights of others in their work for us, we may in the future be subject to claims that our employees, consultants, collaborators, advisors, independent contractors or other third parties have inadvertently or intentionally used or disclosed confidential information of these third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

We may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside the United States. Filing, prosecuting, and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and intellectual property rights in some countries outside the United States can have a different scope and strength and be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties (including competitors) from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but where enforcement rights are not as strong as those in the United States. These products may compete with our products and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of some countries, particularly some developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult in those jurisdictions for us to stop the infringement or misappropriation of our patents or other intellectual property rights, or the marketing of competing products in violation of our proprietary rights. Proceedings to enforce our patents and other intellectual property rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business. Furthermore, such proceedings could put our patents at risk of being invalidated, held unenforceable or interpreted narrowly and could put our patent applications at risk of not issuing and could provoke third parties to assert claims of infringement or misappropriation against us. We may not prevail in any lawsuits that we initiate, and the damages or other

 

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remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

Additionally, Europe’s Unified Patent Court (UPC) may present uncertainties for our ability to protect and enforce our patent rights against competitors in Europe. Although this new court has been implemented to provide more certainty and efficiency to patent enforcement throughout Europe, it will also provide our competitors with a new forum to use to centrally challenge our patents if opted into the UPC, rather than having to seek invalidity or non-infringement decisions on a country-by-country basis. It will be several years before the scope of patent rights that will be recognized and the strength of patent remedies that will be provided is known.

Some of our intellectual property may be subject to federal regulations such as “march-in” rights, certain reporting requirements and a preference for U.S.-based companies if it is determined that our intellectual property has been discovered through government-funded programs. Compliance with such regulations may limit our exclusive rights, and limit our ability to contract with non-U.S. manufacturers.

Some of the intellectual property rights we have acquired or licensed or may acquire or license in the future may have been generated through the use of U.S. government funding and may therefore be subject to certain federal regulations. These U.S. government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the U.S. government has the right, under certain limited circumstances, to require us to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (i) adequate steps have not been taken to commercialize the invention; (ii) government action is necessary to meet public health or safety needs; or (iii) government action is necessary to meet requirements for public use under federal regulations (also referred to as “march-in rights”). The U.S. government also has the right to take title to these inventions if the grant recipient fails to disclose the invention to the government or fails to file an application to register the intellectual property within specified time limits. Intellectual property generated under a government funded program is also subject to certain reporting requirements, compliance with which may require us to expend substantial resources. In addition, the U.S. government requires that any products embodying any of these inventions or produced through the use of any of these inventions be manufactured substantially in the United States. This preference for U.S. industry may be waived by the federal agency that provided the funding if the owner or assignee of the intellectual property can show that reasonable but unsuccessful efforts have been made to grant licenses on similar terms to potential licensees that would be likely to manufacture substantially in the United States or that under the circumstances domestic manufacture is not commercially feasible. This preference for U.S. industry may limit our ability to contract with non-U.S. product manufacturers for products relating to such intellectual property. To the extent any of our future intellectual property is also generated through the use of U.S. government funding, the provisions of the Bayh-Dole Act may similarly apply.

If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected.

We have filed for trademark registration of certain marks relating to our current branding. If our trademarks and trade names are not adequately protected, we may not be able to build name recognition in our markets of interest and our business may be adversely affected. Our unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of our unregistered trademarks or trade names. Over the long term, if we are unable to successfully register our trademarks and trade names and establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and

 

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our business may be adversely affected. Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations.

General Risk Factors

We have identified a material weakness in our internal control over financial reporting as of December 31, 2025, due to an ineffective internal information and communication process related to significant and non-routine transactions to ensure that relevant and reliable information was communicated on a timely basis across the organization, to enable financial personnel to effectively carry out their financial reporting and internal control roles and responsibilities. If we are not able to remediate this material weakness, or if we experience additional material weaknesses or other deficiencies in our internal control over financial reporting in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial results or prevent fraud, and we may conclude that our internal control over financial reporting is not effective, which may adversely affect our business.

Effective internal control over financial reporting is necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, is designed to prevent fraud. Any failure to maintain or implement required new or improved controls, or difficulties encountered in implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us, as and when required, conducted in connection with Section 404 or any testing by our independent registered public accounting firm may reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our consolidated financial statements or identify other areas for further attention or improvement.

As disclosed in our Annual Report, we identified a material weakness in our internal control over financial reporting as of December 31, 2025. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented or detected on a timely basis. Specifically, our management concluded that we did not have an effective internal information and communication process to ensure that relevant and reliable information was communicated on a timely basis across the organization, to enable financial personnel to effectively carry out their financial reporting and internal control roles and responsibilities. The failure, relating to significant and non-routine transactions, resulted in a misstatement of our warrant liabilities, transaction costs, change in fair value of warrant liabilities, additional paid-in-capital, accumulated deficit and certain related financial disclosures. This material weakness resulted in the correction of our consolidated financial statements as of and for the year ended December 31, 2023, and for the quarterly periods ended March 31, 2024 and June 30, 2024. For further discussion of the material weakness, see Part II, Item 9A, “Controls and Procedures” in our Annual Report.

We have taken and plan to continue to take actions to remediate this material weakness, including (i) strengthening our formal accounting policies, procedures and controls over accounting for significant and non-routine transactions with a focus on ensuring the analysis is complete and includes each of the material components of the transaction; (ii) specific oversight procedures, including the requirement of the finance staff and consultants, to attend any and all meetings regarding significant and non-routine transactions; and (iii) specific review procedures, requiring review of all documents pertaining to significant and non-routine transactions by both finance staff and consultants. However, we cannot provide assurance that we will be able to correct this material weakness in a timely manner or that our remediation efforts will be adequate to allow us to conclude that our internal control over financial reporting will be effective in the future. Even if this material weakness is remediated in the future, we could identify additional material weaknesses or deficiencies in our internal control over financial reporting that could require correction or remediation.

 

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In addition, our conclusion that we have a material weakness could give rise to increased scrutiny, review, audit and investigation over our accounting controls and procedures, which could then lead to additional areas of deficiency or errors in our financial statements.

We will need to continue to dedicate internal resources, engage outside consultants and maintain a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to remediate the material weakness relating to our internal information and communication process described above relating to significant and non-routine transactions, and any future control deficiencies or material weaknesses, and improve control processes as appropriate, validate through testing that controls are functioning as documented and maintain a continuous reporting and improvement process for internal control over financial reporting. If we are not able to correct material weaknesses or deficiencies in internal controls in a timely manner or otherwise comply with the requirements of Section 404 in a timely manner, our ability to record, process, summarize and report financial information accurately and within applicable time periods may be adversely affected, and we could be subject to sanctions or investigations by the SEC or other regulatory authorities as well as stockholder litigation which, even if resolved in our favor, would require additional financial and management resources and could adversely affect the market price of our common stock. Any failure to maintain or implement required effective internal control over financial reporting, or any difficulties we encounter in their implementation, could result in additional material weaknesses, cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements. Furthermore, if we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our common stock and could also affect our ability to raise capital to fund future business initiatives.

Our principal stockholders own a significant percentage of our stock and are able to exert significant control over matters subject to stockholder approval.

Our directors, together with holders of 5% or more of our common stock outstanding and their respective affiliates, beneficially own the majority of our common stock. As of August 15, 2026, affiliates of Cable Car Capital LLC (“Cable Car”) and New Enterprise Associates 14, L.P. (“NEA 14”) owned approximately 27% and 24% of our outstanding common stock, respectively. Although we are not a “controlled company” within the meaning of the corporate governance standards of the New York Stock Exchange, affiliates of Cable Car and NEA 14 are able to significantly influence our decisions, including the election of directors, consolidation or sale of all or substantially all of our assets or any other significant corporate transaction. The interests of these stockholders may not be the same as or may even conflict with your interests. For example, these stockholders could delay or prevent a change of control, even if such a change of control would benefit our other stockholders, which could deprive our stockholders of an opportunity to receive a premium for their common stock as part of a sale of the company or our assets and might affect the prevailing market price of our common stock. The significant concentration of stock ownership may adversely affect the trading price of our common stock due to investors’ perception that conflicts of interest may exist or arise.

Future sales of our common stock or securities convertible or exchangeable for our common stock may depress our stock price.

If our existing stockholders or holders of our options sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline. The perception in the market that these sales may occur could also cause the trading price of our common stock to decline. As of August 15, 2026, there were a total of 12,248,950 shares of our common stock outstanding. We have also registered and intend to continue to register all shares of common stock that we may issue under our equity compensation plans. Once we register these shares, they can be freely sold in the public market upon issuance, subject to volume limitations applicable to affiliates and vesting provisions, as applicable.

 

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Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.

We expect our operating results to be subject to quarterly fluctuations.

If our quarterly operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any quarterly fluctuations in our operating results may, in turn, cause the price of the company’s stock to fluctuate substantially. We believe that quarterly comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

Provisions of our charter documents or Delaware law could delay or prevent an acquisition of us, even if the acquisition would be beneficial to our stockholders and could make it more difficult for you to change management.

Provisions in our amended and restated certificate of incorporation and our amended and restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control that our stockholders may consider favorable, including transactions in which our stockholders might otherwise receive a premium for their shares. In addition, these provisions may frustrate or prevent any attempt by our stockholders to replace or remove our current management by making it more difficult to replace or remove our Board of Directors. These provisions include:

 

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a classified board of directors so that not all directors are elected at one time;

 

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a prohibition on stockholder action through written consent;

 

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no cumulative voting in the election of directors;

 

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the exclusive right of our Board of Directors to elect a director to fill a vacancy created by the expansion of our Board of Directors or the resignation, death or removal of a director;

 

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a requirement that special meetings of our Stockholders be called only by our Board of Directors, the chairman of our Board of Directors, the chief executive officer or, in the absence of a chief executive officer, the president;

 

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an advance notice requirement for stockholder proposals and nominations;

 

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the authority of our Board of Directors to issue preferred stock with such terms as our Board of Directors may determine; and

 

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a requirement of approval of not less than 66 2/3% of all outstanding shares of our capital stock entitled to vote to amend any bylaws by stockholder action, or to amend specific provisions of our certificate of incorporation.

In addition, Delaware law prohibits a publicly held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person who, together with its affiliates, owns or within the last three years has owned 15% or more of the company’s voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner. Accordingly, Delaware law may discourage, delay or prevent a change in control of the company.

In addition, our amended and restated certificate of incorporation, to the fullest extent permitted by law, provides that the Court of Chancery of the State of Delaware will be the exclusive forum for: any derivative action or proceeding brought on our behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against us arising pursuant to the Delaware General Corporation Law, or the DGCL, our amended and restated certificate of incorporation, or our amended and restated bylaws; or any action asserting a claim against

 

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us that is governed by the internal affairs doctrine. This exclusive forum provision does not apply to suits brought to enforce a duty or liability created by the Securities Exchange Act of 1934, as amended (the “Exchange Act”). It could apply, however, to a suit that falls within one or more of the categories enumerated in the exclusive forum provision and asserts claims under the Securities Act, inasmuch as Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rule and regulations thereunder. There is uncertainty as to whether a court would enforce such provision with respect to claims under the Securities Act, and our stockholders will not be deemed to have waived our compliance with the federal securities laws and the rules and regulations thereunder.

This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers, or other employees, which may discourage lawsuits with respect to such claims. Alternatively, if a court were to find the choice of forum provisions contained in our restated certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, results of operations and financial condition.

If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our common stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which might cause our stock price and trading volume to decline.

Changes in, or interpretations of, accounting rules and regulations could result in unfavorable accounting charges or require us to change our compensation policies.

Accounting methods and policies for biopharmaceutical companies, including policies governing revenue recognition, research and development and related expenses and accounting for stock-based compensation, are subject to further review, interpretation and guidance from relevant accounting authorities, including the SEC. Changes to, or interpretations of, accounting methods or policies may require us to reclassify, restate or otherwise change or revise our financial statements, including those contained in this proxy statement/prospectus.

We will continue to incur costs as a result of being a public company, and our management will continue to devote substantial time to compliance initiatives and corporate governance practices.

As a public company, we have incurred and will continue to incur significant legal, accounting and other expenses. The Sarbanes-Oxley Act of 2002, the Dodd-Frank Wall Street Reform and Consumer Protection Act, the listing requirements of any national securities exchange on which our securities are listed and other applicable securities rules and regulations impose various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel devote and will need to continue to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations have increased and will continue to increase our legal and financial compliance costs and make some activities more time-consuming and costly. For example, we expect that these rules and regulations will continue to make it more difficult and more expensive for us to maintain director and officer liability insurance, which in turn could make it more difficult for us to attract and retain qualified members of our board of directors.

These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by

 

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regulatory and governing bodies. This could result in future uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices.

Changes in tax law could adversely affect our business and 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 IRS and the U.S. Treasury Department. Changes to tax laws (which changes may have retroactive application), including with respect to NOLs and research and development tax credits, could adversely affect us or holders of our Common Stock. For example, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law on July 4, 2025 and made significant changes to U.S. federal tax law. Under Section 174 of the Code, in taxable years beginning after December 31, 2021, expenses that are incurred for research and development performed outside the U.S. will be capitalized and amortized, which may have an adverse effect on our cash flow. The OBBBA provides that for taxable years beginning after December 31, 2024, expenses that are incurred for research and development performed in the United States may, at the taxpayer’s election, be immediately deducted or capitalized and amortized. In addition, the OBBBA provides that for taxable years beginning after December 31, 2021 and before January 1, 2025, certain eligible taxpayers generally may elect to retroactively deduct expenses for research and development performed in the United States in such taxable years by filing amended tax returns for such taxable years, and all other taxpayers that are not eligible to make such an election and that amortized expenses for research and development performed in the United States in such taxable years generally may elect to accelerate and deduct the remaining unamortized amounts of such research and development expenses (i) in the first taxable year beginning after December 31, 2024, or (ii) ratably over the two-taxable year period beginning with the first taxable year beginning after December 31, 2024. In recent years, many changes to tax laws have been made and changes are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition, or results of operations. We urge investors to consult with their legal and tax advisors regarding the implications of potential changes in tax laws on an investment in our Common Stock.

Risks Related to Caldera

Risks Related to Caldera’s Financial Position, Limited Operating History and Need for Additional Capital

Caldera is an early clinical-stage biopharmaceutical company with a limited operating history, has not completed clinical development and has no products approved for commercial sale, which may make it difficult for investors to evaluate Caldera’s business, likelihood of success and viability.

Caldera is an early clinical-stage biopharmaceutical company with a limited operating history. Caldera was incorporated in Delaware in April 2025, has no products approved for commercial sale and has never generated any revenue. Caldera has a single clinical-stage product candidate, CLD-423, which it in-licensed from Qyuns Therapeutics Co., Ltd. (“Qyuns”) in April 2025 and which is currently being evaluated in Phase 1 healthy volunteer trials. Caldera has never conducted a clinical trial in patients with inflammatory bowel disease and has no clinical data in its target patient population. Drug development is a highly speculative undertaking and involves a substantial degree of risk. It entails substantial upfront capital expenditures and significant risk that any product candidate will fail to demonstrate adequate efficacy or an acceptable safety profile, gain regulatory approval or become commercially viable. To date, Caldera has devoted substantially all of its resources to acquiring, developing and advancing CLD-423, conducting nonclinical studies and its ongoing Phase 1 clinical trials, organizing and staffing its company, business planning, establishing and maintaining its intellectual property position, establishing arrangements with third parties for the manufacture of CLD-423, raising capital and providing general and administrative support for these operations.

To date, Caldera has funded its operations primarily with proceeds from sales of its convertible preferred stock and simple agreements for future equity (“SAFEs”). From inception through June 30, 2026, Caldera received an aggregate of approximately $112.5 million in gross proceeds from sales of its common stock, preferred stock, and SAFE instruments, and expects to require substantial additional funding, including the

 

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proceeds of the Concurrent Financing, to complete development of CLD-423. Caldera has incurred net losses in each period since inception and expects its losses to increase substantially as it advances CLD-423 into Phase 2 clinical development UC, CD, and potentially other indications.

Caldera has not yet demonstrated an ability to successfully complete any clinical trials, including for CLD-423, obtain regulatory approvals, manufacture a 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. As a result, it may be more difficult for investors to accurately predict its likelihood of success and viability than it could be if it had a longer operating history.

In addition, Caldera may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by clinical-stage biopharmaceutical companies. Caldera also may need to transition from a company with a research and development focus to a company capable of supporting commercial activities. Caldera has not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If Caldera does not adequately address these risks and difficulties or successfully make such a transition, its business will suffer.

Caldera has incurred significant net losses in each period since its inception and has not generated any product revenue. It expects to continue to incur significant net losses for the foreseeable future and may never achieve or maintain profitability.

Caldera has incurred significant operating losses since its inception, has not generated any product revenue to date and has financed its operations primarily through private placements of its convertible preferred stock and SAFE instruments. There is no assurance that Caldera will obtain financing from other sources, or that it will be able to obtain such financing on favorable terms, if at all. Substantially all of Caldera’s losses have resulted from expenses incurred in connection with operations identifying, acquiring and developing its product candidates and technologies, including CLD-423, and other potential or future product candidates, building its pipeline, conducting nonclinical studies and early-stage clinical trials, organizing and staffing its company, business planning, establishing and maintaining its intellectual property portfolio, establishing arrangements with third parties for the manufacture of its product candidates, raising capital and providing general and administrative support for these operations. Caldera expects to incur increasing levels of operating losses for the foreseeable future as it continues its research and development activities, continues its ongoing Phase 1 clinical trials, initiates additional clinical trials, seeks regulatory approval for CLD-423 if clinical development is successful, and invests in its organization, including the additional costs of operating as a public company following the Mergers. Caldera expects its research and development expenses in particular to increase significantly as it advances CLD-423 through Phase 2 clinical development. In addition, if Caldera obtains regulatory approval for CLD-423 or any other product candidate in the future, it will incur significant sales, marketing, manufacturing and distribution expenses in connection with the commercialization of CLD-423 or any other product candidates. Furthermore, upon the completion of the Mergers, Caldera expects to incur additional costs associated with operating as a public company that it did not incur as a private company. Caldera may never succeed in these activities and, even if it does, it may never generate any revenue or revenue that is significant enough to achieve profitability.

Because of the numerous risks and uncertainties associated with developing therapeutic products, Caldera is unable to predict the extent of any future losses or when it will become profitable, if at all. To become and remain profitable, Caldera must succeed in developing, obtaining regulatory approval for, and eventually commercializing products that generate significant revenue, and it is only in the preliminary stages of these activities.

Even if Caldera does become profitable, it may not be able to sustain or increase its profitability on a quarterly or annual basis. In addition, Caldera expects its financial condition and operating results to fluctuate significantly from quarter-to-quarter and year-to-year due to a variety of factors, many of which are beyond its

 

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control. Accordingly, you should not rely on the results of any quarterly or annual periods as indications of future operating performance. If Caldera fails to become and remain profitable, there may be an adverse effect on the value of Caldera which could impair its ability to raise capital, expand its business, maintain its research and development efforts, diversify its product candidate pipeline, achieve its strategic objectives or even continue its operations. A decline in the value of Caldera could also cause you to lose all or part of your investment.

Caldera will require additional capital to finance its operations. If Caldera is unable to raise such capital when needed, or on acceptable terms, Caldera may be forced to delay, reduce or eliminate one or more of its research and drug development programs, future commercialization efforts, product development or other operations.

Developing therapeutic product candidates, including conducting nonclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Caldera’s operations have consumed substantial amounts of cash since inception, and Caldera expects its expenses to increase substantially as it advances CLD-423 through later-stage clinical development and, if the candidate obtains regulatory approval, prepares for commercialization. Accordingly, Caldera will need to obtain substantial additional funding in connection with its continuing operations.

Based on Caldera’s current operating plan, it believes its existing cash and cash equivalents as of June 30, 2026, along with the net cash held by Synlogic upon consummation of the Mergers and the proceeds of the Concurrent Financing, will enable Caldera to fund Caldera’s operations into 2029. Caldera has based this estimate on assumptions that may prove to be wrong, and Caldera could use its capital resources sooner than it currently expects. Changes beyond Caldera’s control may occur that would cause it to use its available capital before that time, including changes in and progress of its drug development activities and changes in regulations. See “Caldera Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 291 of this proxy statement/prospectus. Caldera’s future capital requirements will be dependent on many factors, including:

 

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the progress, timing and results of nonclinical studies and clinical trials for CLD-423 or other potential or future product candidates;

 

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the extent to which Caldera develops, in-licenses, out-licenses or acquires any future product candidates or technologies;

 

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the number and development requirements of any future product candidates that Caldera may pursue, and other indications for Caldera’s current product candidate that it may pursue;

 

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the costs, timing and outcome of seeking regulatory approvals of Caldera’s current or future product candidates;

 

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the scope and costs of making arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of Caldera’s current or future product candidates;

 

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the costs involved in growing Caldera’s organization to the size needed to allow for the research, development and potential commercialization of its current or future product candidates;

 

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the costs associated with commercializing any approved product candidates, including establishing sales, marketing, market access and distribution capabilities;

 

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the costs associated with operating as a growing public company that it did not incur as a private company;

 

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to the extent Caldera pursues strategic collaborations, including collaborations to commercialize CLD-423 or any of its other potential or future product candidates, its ability to establish and maintain collaborations on favorable terms, if at all, as well as the timing and amount of any milestone or royalty payments it is required to make or are eligible to receive under such collaborations or its current licenses;

 

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the costs associated with completing any post-marketing studies or trials requested or required by the U.S. Food and Drug Administration (“FDA”), or other comparable foreign regulatory authorities;

 

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the revenue, if any, received from commercial sales of CLD-423 or any of Caldera’s other potential or future product candidates, if any are approved;

 

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the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing Caldera’s intellectual property rights and defending intellectual property-related claims that it may become subject to, including any litigation costs and the outcome of such litigation; and

 

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the costs associated with potential product liability claims, including the costs associated with obtaining insurance against such claims and with defending against such claims.

Even if the Mergers are successful, Caldera will require additional capital to complete its planned nonclinical studies and clinical trials for its current and other potential or future product candidates to obtain regulatory approval, and Caldera anticipates needing to raise additional capital to complete the development of, and eventually commercialize, its product candidates, if approved. Adequate additional financing may not be available to Caldera on favorable terms, or at all. Caldera’s ability to raise additional funds will be dependent on financial, economic and market conditions, geopolitical issues and other factors, over which Caldera may have limited or no control. In addition, Caldera may seek additional capital due to favorable market conditions or strategic considerations even if it believes it has sufficient funds for its current or future operating plans. If adequate funds are not available on commercially acceptable terms when needed, Caldera may be forced to delay, reduce or terminate the development or commercialization, if approved, of all or part of its research programs or product candidates or it may be unable to take advantage of future business opportunities, including pursuing new in-licenses and acquisitions. Furthermore, any additional capital-raising efforts may divert Caldera’s management from their day-to-day activities, which may adversely affect Caldera’s ability to develop and commercialize its current and other product candidates, if approved. Changing circumstances, some of which may be beyond its control, could cause it to consume capital significantly faster than it currently anticipates, and it may need to seek additional funds sooner than planned.

Caldera’s failure to raise capital as and when needed or on acceptable terms could significantly harm its business, financial condition, results of operations and prospects, and Caldera may have to delay, reduce the scope of, suspend or eliminate one or more of its research or drug development programs, nonclinical studies, clinical trials or future commercialization efforts.

Risks Related to Caldera’s Product Development, Regulatory Approval, Commercialization and Manufacturing

Caldera is substantially dependent on the success of CLD-423, its only product candidate. If Caldera is unable to advance CLD-423 through development, obtain regulatory approval and ultimately commercialize it, or experiences significant delays in doing so, Caldera’s business will be materially harmed.

Caldera’s future success is highly dependent on Caldera’s ability to timely complete successful nonclinical studies and clinical trials, obtain regulatory approval for, and then successfully commercialize, its product candidates. Caldera’s only clinical-stage product candidate is CLD-423, which is being evaluated in a Phase 1 clinical trial in healthy adult volunteers in Australia, which commenced in January 2026 and has completed dosing, and in an ongoing Phase 1a healthy volunteer bridging trial in China that is currently dosing participants and being conducted by Qyuns on Caldera’s behalf. Caldera has not yet administered CLD-423 to any patient with inflammatory bowel disease, and has not yet submitted an investigational new drug application (“IND”) to the FDA for CLD-423, although it intends to submit an IND in the fourth quarter of 2026 in support of its planned Phase 2b clinical trial in ulcerative colitis. Caldera currently has no products that are approved for sale in any jurisdiction. Caldera has invested substantially all of its efforts and financial resources in CLD-423, and in conducting nonclinical studies and its ongoing Phase 1 clinical trials. Because CLD-423 is Caldera’s only product candidate, and because Caldera has no other program that could offset a failure of CLD-423, any failure

 

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of CLD-423 to advance through development, demonstrate adequate safety or efficacy, to obtain regulatory approval or to achieve commercial acceptance would have a disproportionate and material adverse effect on Caldera’s business, financial condition, results of operations and prospects. There can be no assurance that CLD-423 or any other product candidates Caldera develops will achieve success in their clinical trials or obtain regulatory approval. In the future, Caldera may also become dependent on other product candidates that it may develop or acquire; however, given Caldera’s early stage of development, it may be several years, if at all, before it has demonstrated the safety and efficacy of a treatment sufficient to warrant approval for commercialization.

Caldera’s ability to generate product revenue, which it does not expect will occur for many years, if ever, will be heavily dependent on the successful development and eventual commercialization of its current product candidate, and the development of potential or future product candidates. The success of CLD-423 and other potential or future product candidates will be dependent on several factors, including the following:

 

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timely completion of successful current and future nonclinical studies and clinical trials resulting in attractive, competitive target product profiles;

 

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clearance of INDs by the FDA or other similar clinical trial applications by comparable foreign regulatory authorities for Caldera’s future clinical trials for Caldera’s pipeline product candidates;

 

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timely and successful enrollment and completion of clinical trials with favorable results, including in compliance with good clinical practices (“GCPs”) and any additional regulatory requirements from the FDA or comparable foreign regulatory authorities;

 

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Caldera’s ability to enroll adequate subjects to allow the results to be generalizable to the U.S. population;

 

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the frequency and severity of adverse events in clinical trials;

 

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demonstration of safety, purity, and potency, and acceptable risk-benefit profiles of Caldera’s product candidates to the satisfaction of the FDA and comparable foreign regulatory authorities;

 

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approval of Biologics License Applications (“BLAs”) by the FDA or similar marketing applications by other comparable foreign regulatory authorities, including Caldera’s ability to complete any post-marketing commitments or requirements;

 

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raising additional funds necessary to complete clinical development of and commercialize Caldera’s current or future product candidates;

 

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obtaining, maintaining, expanding and protecting Caldera’s patent, trade secret and other intellectual property and regulatory exclusivity for Caldera’s current and future product candidates;

 

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making arrangements with third-party manufacturers, or establishing manufacturing capabilities, for both clinical and commercial supplies of Caldera’s current and future product candidates and ensuring a resilient, effective supply chain that produces supply that outpaces demand;

 

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developing and implementing marketing and reimbursement strategies, and creating adequate demand forecasts for supply and sales planning;

 

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establishing sales, marketing and distribution capabilities and launching commercial sales of Caldera’s products, if approved, whether alone or in collaboration with others;

 

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approval of therapeutic products with risk-benefit profiles attractive to physicians, patients, advocates, payors and caregivers;

 

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acceptance of Caldera’s products, if approved, by patients, the medical community and third-party payors underpinned by adequate health economic data and a meaningful value proposition;

 

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effectively competing with existing and future therapies, including timing of market entry and the authorized labeling of Caldera’s products, if approved, relative to competing products;

 

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•

obtaining and maintaining third-party payor coverage and adequate reimbursement in both public and private payor spaces;

 

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obtaining appropriate support from patient advocacy organizations;

 

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addressing any delays in Caldera’s clinical trials resulting from any major natural disasters, regional and global geopolitical conflicts, supply chain issues, health pandemics or significant political events; and

 

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maintaining a continued acceptable safety and efficacy profile of Caldera’s products following approval, if approved.

Many of these factors are beyond Caldera’s control, and it is possible that none of Caldera’s product candidates will ever obtain regulatory approval even if it expends substantial time and resources seeking such approval. If Caldera does not achieve one or more of these factors in a timely manner or at all, it could experience significant delays or an inability to successfully commercialize its product candidates, which would materially harm its business. For example, Caldera’s business could be harmed if results of its ongoing or planned clinical trials of CLD-423 show unexpected adverse events or a lack of efficacy in the indications Caldera intends to treat, do not meet the clinical endpoints or if Caldera experiences other regulatory or developmental issues.

Drug development is a lengthy and expensive process, the outcome of clinical testing is inherently uncertain, and results of earlier nonclinical studies and clinical trials may not be predictive of future clinical trial results.

CLD-423 is Caldera’s only clinical-stage product candidate and is in Phase 1 clinical development in healthy adult volunteers. The risk of failure is high for early clinical-stage product candidates, and is heightened where, as here, no clinical data are yet available in the patient populations that Caldera intends to treat. It is impossible to predict when or if Caldera’s current product candidate or any future product candidates will receive regulatory approval. To obtain the requisite regulatory approvals to commercialize any product candidate, Caldera must demonstrate through extensive nonclinical studies and lengthy, complex and expensive clinical trials that Caldera’s product candidates are safe, pure and potent, which includes clinical effectiveness. Clinical testing can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the nonclinical study and clinical trial processes. Safety, pharmacokinetic, pharmacodynamic and immunogenicity findings observed in healthy volunteers may differ materially from findings in patients with inflammatory bowel disease, whose disease characteristics and concomitant medications differ from those of healthy volunteers, and Caldera’s Phase 1 trials are not designed to provide any evidence of clinical efficacy. The results of nonclinical studies and early clinical trials of Caldera’s current product candidate or any future product candidates, or a competitor’s product candidate in the same class, may not be predictive of the results of later-stage clinical trials. Interim, topline or preliminary results of a clinical trial are not necessarily indicative of final results. Caldera may be unable to establish benefit on clinical endpoints that applicable regulatory authorities would consider clinically meaningful, and a clinical trial can fail at any stage of testing. Differences in trial design between early-stage clinical trials and later-stage clinical trials make it difficult to extrapolate the results of earlier clinical trials to later clinical trials. Moreover, clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain regulatory approval of their products. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the clinical trial protocols and the rate of dropout among clinical trial participants. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or to unfavorable safety profiles, notwithstanding promising results in earlier trials. Most product candidates that commence clinical trials are never approved as products and there can be no assurance that any of Caldera’s future clinical trials will ultimately be successful or support clinical development of Caldera’s current product candidate or any future product candidates.

 

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Additionally, Caldera’s ongoing Phase 1 clinical trials of CLD-423 are randomized, placebo-controlled, blinded trials in healthy adult volunteers, and certain cohorts remain blinded as of the date of this proxy statement/prospectus. Caldera’s planned Phase 2a trial of CLD-423 in Crohn’s disease is expected to use an open-label design, and future clinical trials may also utilize an open-label design. An open-label clinical trial is one where both the patient and investigator know whether the patient is receiving the investigational product candidate or either an existing approved drug or placebo. Most typically, open-label clinical trials test only the investigational product candidate and sometimes may do so at different dose levels. Open-label clinical trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open-label clinical trials are aware when they are receiving treatment. Open-label clinical trials may be subject to a patient bias where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. In addition, open-label clinical trials may be subject to an investigator bias where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The results from an open-label trial of Caldera’s product candidate may not be predictive of future clinical trial results when studied in a controlled environment with a placebo or active control.

Additionally, if the results of Caldera’s clinical trials are inconclusive or if there are safety concerns or serious adverse events (“SAEs”) associated with Caldera’s current or future product candidates, Caldera may:

 

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be delayed in obtaining regulatory approval, if at all;

 

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obtain approval for indications or patient populations that are not as broad as intended or desired or for a therapeutic product that may have restricted duration expectations or guidance;

 

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obtain approval with product labeling that includes significant use or distribution restrictions or safety warnings, such as a boxed warning or multiple contraindications;

 

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be required to perform additional clinical trials to support approval or be subject to one or more post-marketing testing requirements;

 

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have regulatory authorities withdraw or suspend their approval of the product or impose restrictions on its distribution in the form of a Risk Evaluation and Mitigation Strategy (“REMS”);

 

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be subject to lawsuits; or

 

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experience damage to Caldera’s reputation.

Caldera may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of CLD-423 and/or other potential or future product candidates for many reasons.

Caldera may experience delays in initiating or completing clinical trials. Caldera also may experience numerous unforeseen events during, or as a result of, any future clinical trials that could delay or prevent Caldera’s ability to receive regulatory approval or commercialize Caldera’s current product candidate or any future product candidates, including:

 

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reports from clinical testing of other therapies may raise safety or efficacy concerns about Caldera’s current or future product candidates;

 

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regulatory authorities, institutional review boards (“IRBs”) or ethics committees may not authorize Caldera or Caldera’s investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site, or may halt or suspend an ongoing clinical trial;

 

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Caldera may be unable to generate sufficient nonclinical, toxicology or other in vivo or in vitro data to support the initiation or continuation of clinical trials;

 

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Caldera 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 may deviate from the trial protocol or drop out of a trial;

 

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clinical trials of any of Caldera’s product candidates may fail to show adequate safety or efficacy or produce negative or inconclusive results and Caldera may decide, or regulatory authorities may require Caldera, to conduct additional nonclinical studies or clinical trials or Caldera 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 Caldera anticipates, enrollment in these clinical trials may be slower than Caldera anticipates or subjects may discontinue their participation in these clinical trials or fail to return for post-treatment follow-up at a higher rate than Caldera anticipates;

 

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Caldera’s third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to Caldera 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 Caldera add new clinical trial sites or investigators;

 

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

 

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the cost of clinical trials of Caldera’s current product candidate or any future product candidates may be greater than Caldera anticipates, and Caldera may not have sufficient funds to complete such trials;

 

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

 

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Caldera may be unable to manufacture sufficient quantities of Caldera’s current or future product candidates for use in nonclinical studies or clinical trials;

 

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Caldera may be unable to meet drug specifications suitable for use in clinical trials and commercial applications;

 

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Caldera may receive feedback from regulatory authorities that requires Caldera to modify the design of Caldera’s clinical trials;

 

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the FDA or other comparable foreign regulatory authorities may require Caldera to submit additional data such as long-term toxicology studies, conduct additional dose optimization or dose-ranging studies, evaluate multiple doses or dosing regimens, or satisfy other requirements before permitting Caldera to initiate a clinical trial, including a pivotal clinical trial; and

 

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global health crises or regional or global geopolitical conflicts may increase the likelihood that Caldera encounters such difficulties or delays in initiating, enrolling, conducting, or completing Caldera’s ongoing or planned clinical trials.

Caldera could also encounter delays if a clinical trial is suspended or terminated by Caldera, the IRBs overseeing the institutions in which such trials are being conducted, or the FDA or other comparable regulatory authorities, or if a clinical trial is recommended for suspension or termination by the Data Safety Monitoring Board (“DSMB”) for such trial. A suspension or termination may be imposed due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements, including the GCP regulations, or Caldera’s clinical protocols, inspection of the clinical trial operations or trial site by the FDA, comparable foreign regulatory authorities, or IRBs resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a product or treatment, failure to establish or achieve clinically meaningful trial endpoints, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Adverse safety findings involving similar

 

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product candidates or approved products to Caldera’s product candidates that are developed or commercialized by third parties could likewise result in clinical holds, delays or additional regulatory requirements for Caldera’s current or future product candidates, even where Caldera’s own trials have not raised the same or similar level of concerns. Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results. Many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of Caldera’s current product candidate or any future product candidates. Further, the FDA or other comparable foreign regulatory authorities may disagree with Caldera’s clinical trial design and Caldera’s interpretation of data from clinical trials, or may change the perceived requirements for approval even after they have reviewed and commented on the design for Caldera’s clinical trials.

Caldera cannot predict with any certainty the schedule for commencement and completion of future clinical trials. Further, conducting clinical trials in foreign countries, as Caldera is currently doing and may do in the future for Caldera’s current or future product candidates, presents additional risks that may delay completion of Caldera’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, managing additional administrative burdens associated with foreign regulatory schemes, as well as political and economic risks relevant to such foreign countries. If Caldera is required to conduct additional clinical trials or other testing of Caldera’s current or future product candidates beyond those that Caldera currently contemplates, if Caldera is unable to successfully complete clinical trials of Caldera’s current or future product candidates or other testing in a timely manner, if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, Caldera may incur unplanned costs, or be delayed in seeking and obtaining regulatory approval. Additionally, if Caldera receives no such approval at all, or receives more limited or restrictive regulatory approval than anticipated, becomes subject to additional post-marketing testing requirements, or has the product removed from the market after obtaining regulatory approval, Caldera could incur significant costs and limitations which may adversely affect Caldera’s financial condition and operating results.

Also, delays in obtaining regulatory approval may increase commercialization costs if the competitive environment becomes more intense prior to market entry. Caldera does not know whether any of Caldera’s future nonclinical studies or clinical trials will begin as planned, need to be restructured or be completed on schedule, if at all.

Moreover, principal investigators for Caldera’s clinical trials may serve as scientific advisors or consultants to Caldera from time to time and receive compensation in connection with such services. Under certain circumstances, Caldera may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between Caldera and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study results. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of Caldera’s marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of regulatory approval of one or more of Caldera’s product candidates.

Caldera may make manufacturing changes to Caldera’s product candidates, in which case Caldera may need to conduct additional nonclinical studies or clinical trials to bridge Caldera’s modified product candidates to earlier versions. If Caldera experiences delays in the commencement or completion of Caldera’s clinical trials, or if Caldera terminates a clinical trial prior to completion, the commercial prospects of Caldera’s current or any future product candidates could be negatively impacted, and Caldera’s ability to generate revenues from Caldera’s current or future product candidates may be delayed or eliminated entirely.

 

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CLD-423 is a bispecific antibody with a novel monovalent format that has limited clinical and regulatory precedent, and adverse developments affecting the anti-TL1A or anti-IL-23 antibody class, or bispecific antibodies generally, could delay, limit or prevent the development and approval of CLD-423.

CLD-423, Caldera’s lead and only clinical-stage product candidate, is a bispecific antibody targeting IL-23p19 and TL1A that is exclusively in-licensed on a worldwide basis from Qyuns. The anti-TL1A antibody class has experienced high immunogenicity rates in Phase 1 healthy volunteer studies, with published data from competing programs showing substantial rates of anti-drug antibody (“ADA”) positivity for bivalent TL1A-targeting antibodies. Although CLD-423’s design, including its monovalent engagement of TL1A and the optimization of its sequence and product quality attributes, is intended to reduce format- and target-based immunogenicity, and interim clinical data have shown a favorable ADA profile to date, there can be no assurance that immunogenicity will not emerge as a clinically meaningful issue with repeat dosing, in larger or longer-duration studies, or in patient populations with inflammatory bowel disease. Adverse immunogenicity findings in competing anti-TL1A programs could also increase regulatory scrutiny of the entire class, including CLD-423, and may result in additional testing requirements, more restrictive labeling, or delays in regulatory approval. In addition, several large pharmaceutical companies are developing or have advanced anti-TL1A antibodies and IL-23/TL1A-targeting agents into late-stage clinical trials for inflammatory bowel disease, and any adverse safety signal, clinical failure, or regulatory action affecting a competing program targeting TL1A or IL-23 could negatively affect the perception of CLD-423 among regulators, investigators, and patients, and could delay or limit Caldera’s clinical development or regulatory pathway.

While bispecific antibodies have been approved for certain indications, the specific monovalent format and targets used in CLD-423 have limited clinical and regulatory precedent, and the FDA and comparable foreign regulatory authorities have limited experience reviewing bispecific antibodies targeting this combination of targets for inflammatory bowel disease. As a result, the regulatory pathway for CLD-423 may be longer, more uncertain, more complex or more costly than for therapies based on more established formats or single-target approaches, and regulators may apply novel or evolving standards or require additional nonclinical or clinical data. CLD-423’s format may also present development and manufacturing challenges and may be associated with unexpected safety, efficacy, pharmacokinetic or immunogenicity findings that are not yet fully understood.

In addition, Caldera’s expectation that CLD-423 may be administered subcutaneously as infrequently as once every eight or twelve weeks in maintenance is based on pharmacokinetic data from non-human primates and from healthy adult volunteers in its ongoing Phase 1 trial in Australia. Pharmacokinetic parameters observed in healthy volunteers and in animals may not be reproduced in patients with inflammatory bowel disease, in whom drug clearance may differ. If the half-life, bioavailability or exposure of CLD-423 in the target patient population is materially less favorable than observed to date, Caldera may be required to administer CLD-423 more frequently or at higher doses than anticipated, which could increase manufacturing requirements and cost of goods, reduce any competitive advantage relative to existing and other investigational therapies, and adversely affect the commercial potential of CLD-423 if approved.

Caldera relies, and expects to continue to rely, on third parties to conduct its discovery, nonclinical studies, and clinical trials, and if these third parties do not satisfactorily carry out their contractual duties, fail to comply with applicable regulatory requirements or do not meet expected deadlines, Caldera’s development programs may be delayed or subject to increased costs or Caldera may be unable to obtain marketing authorization for its current or future product candidates, each of which may have an adverse effect on Caldera’s business, financial condition, results of operations and prospects.

Caldera does not independently conduct all aspects of its discovery, nonclinical studies, and clinical trials. It relies, and expects to continue to rely, on third parties such as CROs, consultants, clinical investigators, clinical trial sites, collaborators and other independent contractors to conduct, supervise or monitor its nonclinical studies and clinical trials. The timing of the initiation and completion of these activities will therefore be partially controlled by such third parties and may result in delays to Caldera’s development programs. Specifically,

 

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Caldera expects CROs, independent clinical investigators and consultants to play a significant role in the conduct of these studies and trials and the subsequent collection and analysis of data. However, these third parties are not Caldera’s employees, may have competing priorities and commitments to other entities, and may not devote sufficient time or resources to Caldera’s programs or meet expected deadlines. In addition, Caldera has less control over the timing, quality and other aspects of discovery, nonclinical studies, and clinical trials than it would if it were to conduct these activities on its own. Nevertheless, Caldera is responsible for ensuring that these third parties comply with GCP and Good Laboratory Practice (“GLP”) requirements and other applicable regulations, and if they fail to do so, or fail to conduct a study or trial in accordance with the applicable protocol, or fail to be diligent, careful or timely, the data generated may be deemed unreliable and Caldera may be required to repeat, extend or delay its studies or trials or conduct additional ones. Caldera cannot make any assurances that, upon inspection, the FDA will determine that its nonclinical studies comply with GLPs or its clinical trials comply with GCPs. Caldera’s failure or the failure of third parties on whom Caldera relies to comply with these regulations may require Caldera to repeat nonclinical studies or stop and/or repeat clinical trials, which would delay the marketing authorization process or prevent marketing authorization.

There is no guarantee that any such CROs, clinical trial investigators, clinical trial sites or other third parties on which Caldera relies will devote adequate time and resources to Caldera’s development activities or perform as contractually required. In addition, these third parties may be subject to macroeconomic conditions, such as staffing shortages and supply chain or inflationary pressures that limit their ability to achieve anticipated timelines or result in a greater cost to Caldera. Caldera has relied on non-human primate studies to characterize the pharmacokinetics of CLD-423 and to support extrapolation of dosing intervals to humans, and Caldera is aware of recurrent shortages in the supply of non-human primates available for nonclinical studies. If Caldera is required to conduct additional non-human primate toxicology or pharmacokinetic studies, whether to support later-stage development of CLD-423 or to advance new product development programs, it could experience longer development times, increased costs or difficulty completing necessary research.

Furthermore, these third parties may also have relationships with other entities, some of which may be Caldera’s competitors, for whom they may also be conducting clinical trials or other therapeutic candidate development activities that could harm Caldera’s competitive position.

If any of these third parties terminate their engagement with Caldera, perform inadequately, experience their own regulatory, financial or operational difficulties, or fail to meet applicable standards, Caldera’s business could be adversely affected, research and development programs may be delayed or impaired, its costs may increase, and its ability to obtain regulatory approval for and to commercialize its product candidates may be impaired.

From time to time, Caldera may support investigator-initiated or investigator-sponsored clinical trials of its product candidates that are conducted by third-party investigators or institutions over whose design, conduct, data collection and regulatory compliance Caldera has limited control. Adverse events, protocol deviations, non-compliance with applicable regulatory requirements or unfavorable or inconsistent results arising in any such trial could delay, limit or otherwise harm the clinical development or regulatory approval of Caldera’s current or future product candidates, even though Caldera would not control these trials. Caldera may also have obligations to collect, evaluate and report to the FDA or comparable foreign regulatory authorities safety information arising from any such third-party trials. Serious adverse events or other safety findings in any such trial could be attributed to Caldera’s product candidates, could result in a clinical hold or other regulatory action affecting Caldera’s own clinical trials, and could harm the reputation of, or market perception regarding, the affected product candidate.

If Caldera experiences delays or difficulties in the enrollment of patients in clinical trials, Caldera’s receipt of necessary regulatory approvals could be delayed or prevented.

Patient enrollment, a significant factor in the timing and completion of clinical trials, is affected by many factors including the size and nature of the patient population, the number and location of enrolling clinical sites

 

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engaged by Caldera, the proximity of patients to clinical sites, the eligibility and exclusion criteria for the trial, the design of the clinical trial, the inability to obtain and maintain patient consents, the risk that enrolled participants will drop out before completion, competing clinical trials, and clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new drugs or therapeutic biologics, including those being developed by Caldera’s competitors, that may be approved for the indications being investigated by Caldera, and patients’ inability to complete treatment due to illness or other events. Clinical trials in IBD are highly competitive, with numerous ongoing trials for anti-TL1A antibodies, anti-IL-23 antibodies, and other therapies. Clinical sites participating in Caldera-sponsored clinical trials will need to screen and identify patients meeting specific eligibility criteria, and it may be difficult to identify and enroll a sufficient number of eligible patients in a timely manner. In addition, some of Caldera’s competitors currently have ongoing clinical trials for product candidates that target the same patient populations as CLD-423, and patients who would otherwise be eligible for Caldera’s clinical trials may instead enroll in clinical trials of Caldera’s competitors’ product candidates.

Additionally, Caldera could encounter delays if treating physicians face unresolved ethical issues associated with enrolling patients in current or planned clinical trials of Caldera’s current or any future product candidates in lieu of prescribing existing treatments that have established safety and efficacy profiles.

Caldera may not be able to initiate or continue its ongoing or planned clinical trials for its current or future product candidates if it is unable to enroll a sufficient number of eligible patients to participate in these trials as required by the FDA or comparable foreign regulatory authorities. Caldera cannot be certain (i) how many patients will meet its criteria for inclusion in its clinical trials, (ii) that the number of patients enrolled in each program will suffice for marketing authorization or (iii) whether the indication targeted will be included in the approved product labeling. If Caldera’s strategies for patient identification and enrollment prove unsuccessful, it may have difficulty enrolling or maintaining patients appropriate for Caldera’s product candidates. Patient enrollment is also affected by other factors, including:

 

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severity of the disease under investigation;

 

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the incidence and prevalence of Caldera’s target indications;

 

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Caldera’s ability to recruit clinical trial investigators of appropriate competencies and experience;

 

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clinicians’ and patients’ awareness of, and perceptions as to, the potential advantages and risks of Caldera’s product candidates in relation to other available therapies, including any new products that may be approved for the indications it is investigating;

 

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the availability, expertise, dedication and selection of CROs to manage operations related to clinical trial enrollment;

 

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competing studies or trials with similar eligibility criteria;

 

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invasive procedures required to enroll patients and to obtain evidence of the product candidate’s performance during the clinical trial;

 

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availability, safety, and efficacy of approved medications for the disease under investigation;

 

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eligibility criteria defined in the protocol for the trial in question;

 

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the size and nature of the patient population required for analysis of the trial’s primary endpoints;

 

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efforts to facilitate timely enrollment in clinical trials;

 

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whether Caldera is subject to a partial or full clinical hold on any of its clinical trials;

 

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the willingness of physicians or patient advocacy organizations to encourage patient participation in clinical trials;

 

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the ability to monitor patients adequately during and after treatment;

 

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Caldera’s ability to obtain and maintain patient consents; and

 

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proximity and availability of clinical trial sites for prospective patients.

If Caldera is unable to enroll a sufficient number of patients for its clinical trials, it would result in significant delays or might require Caldera to abandon one or more clinical trials altogether. Even if Caldera is able to enroll a sufficient number of patients for its clinical trials, it may have difficulty retaining patients in its clinical trials. For example, if patients are receiving placebo in a clinical trial, those patients may perceive that they are not receiving the product candidate being tested, and they may decide to withdraw from that clinical trial to pursue alternative therapies rather than continue the trial. Enrollment delays in Caldera’s clinical trials may result in increased development costs for CLD-423, or other potential or future product candidates, slow down or halt Caldera’s product candidate development and approval process and jeopardize its ability to seek and obtain the regulatory approval required to commence product sales and to generate revenue, if needed.

Adverse side effects or other safety risks associated with CLD-423 or other potential or future product candidates Caldera may develop could delay or preclude approval, cause Caldera to suspend or discontinue clinical trials or abandon further development, limit the commercial profile of an approved product, or result in significant negative consequences following regulatory approval, if any.

There may be treatment-related SAEs or unexpected serious adverse reactions suspected to be associated with the use of CLD-423 or other potential or future product candidates. Caldera’s clinical trials may reveal significant adverse events not seen in its nonclinical studies or prior clinical trials and may result in a safety or tolerability profile that could delay or prevent regulatory approval or market acceptance of CLD-423 or other current or future product candidates. Undesirable or clinically unmanageable side effects observed in Caldera’s clinical trials for its product candidates or of a competitor developing similar product candidates could occur and cause it or regulatory authorities to interrupt, delay or halt Caldera’s clinical trials and could result in more restrictive labeling than anticipated or the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. If additional adverse events, SAEs or other side effects are observed in any of Caldera’s or its competitor’s clinical trials that are atypical of, or more severe than, the known side effects of the respective class of agents that each of Caldera’s product candidates is a part of, or other products in development for the same indications, or the current standard of care, Caldera may have difficulty recruiting participants to its clinical trials, participants may drop out of its trials, or Caldera may be required to abandon those trials or its development efforts of one or more product candidates altogether. Furthermore, clinical trials by their nature utilize a sample of the potential patient population. With a limited number of subjects and limited duration of exposure, rare and severe side effects of Caldera’s product candidates or those of its competitors may only be uncovered with a significantly larger number of patients exposed to the drug. Undesirable or clinically unmanageable side effects observed in Caldera’s clinical trials could also occur following discontinuation of CLD-423, or other product candidates with sufficient recovery periods, and Caldera will need to monitor the severity and duration of side effects in its clinical trials. If such effects are more severe, less reversible than Caldera expects or not reversible at all, it may decide or be required to perform additional studies or to halt or delay further clinical or nonclinical development of CLD-423, as applicable, or other product candidates, which could result in the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities. Adverse events and SAEs that emerge during clinical investigation of or treatment with CLD-423 or other product candidates may be deemed to be related to Caldera’s product candidates. Moreover, if Caldera’s product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, Caldera may elect to abandon or limit its 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, which may limit the commercial expectations for Caldera’s product candidates, if approved. This may require longer and more extensive clinical development, or regulatory authorities may increase the amount of data and information required to approve, market or maintain approval for CLD-423 or future product candidates and could result in warnings and precautions in Caldera’s product labeling or a restrictive REMS or other form of risk management program. This may also result in an inability to obtain

 

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approval of CLD-423 or future product candidates. Caldera, the FDA or other comparable foreign regulatory authorities or an IRB or ethics committee may suspend clinical trials of a product candidate at any time for various reasons, including a belief that participants in such trials are being exposed to unacceptable health risks or adverse side effects. Even if the side effects do not preclude a product candidate from obtaining or maintaining regulatory approval, undesirable side effects may inhibit market acceptance of such approved product due to its safety or tolerability versus other therapies. Further, it is possible that, as Caldera tests its product candidates in larger, longer and more extensive clinical trials, including with different dosing regimens, or as the use of its drug candidates becomes more widespread following any regulatory approval, illnesses, injuries, discomforts and other adverse events that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by patients. Any of these developments could materially harm Caldera’s business, financial condition, results of operations and prospects.

CLD-423 has been generally well tolerated in the single ascending dose cohorts of Caldera’s ongoing Phase 1 healthy volunteer trial in Australia for which unblinded data are available, with no dose-limiting toxicities, no SAEs, no deaths and no Grade 3 or higher treatment-emergent adverse events reported as of the May 2026 data cut-off for the interim analysis. However, Caldera’s safety database is small, exposure has been limited in duration, and certain cohorts remain blinded, so the safety and tolerability profile of CLD-423 observed to date may not be representative of the profile that emerges with repeat dosing, at higher doses, over longer durations, or in patients with inflammatory bowel disease who may be receiving concomitant immunosuppressive therapy. Additional or more severe adverse events may be observed as Caldera enrolls additional participants and advances into patient trials, and the complete data from Caldera’s Phase 1 clinical trials, when available, may be materially less favorable than the interim data described in this proxy statement/prospectus.

Preliminary, topline or interim data from Caldera’s clinical trials that it announces or publishes from time to time may change as more patient data become available and/or are subject to audit and verification procedures that could result in material changes in the final data.

From time to time, Caldera may publicly disclose preliminary, topline or interim data from its clinical trials, such as preliminary, topline or interim data analysis from its ongoing Phase 1 clinical trials for CLD-423. These data and related findings and conclusions may only reflect certain endpoints rather than all endpoints and are subject to change. Caldera also makes assumptions, estimations, calculations and conclusions as part of its analyses of data, and it may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the preliminary or topline results that Caldera 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.

Preliminary or topline data also remain subject to review and verification procedures that may result in the final data being materially different from the preliminary or topline data Caldera previously published. As a result, preliminary and topline data should be viewed with caution until the final data are available. In addition, Caldera may report preliminary data or interim analyses of the clinical trials it may conduct and complete, which 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. Adverse changes between preliminary or interim data and final data could significantly harm Caldera’s business and prospects.

Further, the information Caldera chooses to publicly disclose regarding a particular study or clinical trial is typically selected from a more extensive amount of available information. You or others may not agree with what Caldera determines is the material or otherwise appropriate information to include in its disclosure, and any information Caldera determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product, product candidate or its business. If the preliminary, topline or interim data that Caldera reports differ from later, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Caldera’s ability to obtain

 

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approval for, and commercialize, its product candidates may be harmed, which could harm its business, financial condition, results of operations and prospects.

Caldera has limited financial and managerial resources and may allocate those resources to product candidates or indications that prove less valuable than others it might have pursued, and it may be unable to in-license or acquire additional product candidates on acceptable terms.

Caldera may expend its limited resources to pursue a particular product candidate in specific indications and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success. Because Caldera has limited financial and managerial resources, it focuses its development efforts on certain selected product candidates in certain selected indications. As a result, Caldera may forgo or delay pursuit of opportunities with other potential or future product candidates, or other indications for its current or any future product candidates that later prove to have greater commercial potential. Caldera’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Caldera’s spending on current and future development programs and product candidates for specific indications may not yield any commercially viable product candidates. If Caldera does not accurately evaluate the commercial potential or target market for a particular product candidate, Caldera 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, Caldera intends to expand its pipeline principally by in-licensing or acquiring product candidates developed by third parties rather than through internal discovery, and it faces significant competition for those opportunities from companies with substantially greater financial resources. Caldera may be unable to identify or complete additional in-licensing or acquisition transactions on acceptable terms, or at all, and any product candidates it does acquire may not perform as expected.

Caldera is conducting, and may in the future conduct, clinical trials of CLD-423 outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. Conducting clinical trials in certain foreign jurisdictions also exposes Caldera to additional political, regulatory and geopolitical risks.

Caldera is conducting, and expects to continue to conduct, clinical trials of CLD-423 outside the United States, and the FDA and comparable foreign regulatory authorities may not accept data from such trials. Caldera’s ongoing Phase 1 healthy volunteer studies of CLD-423 are being conducted in Australia and China. Caldera’s ongoing Phase 1a healthy volunteer bridging study in China is currently dosing participants and is being conducted in cooperation with Qyuns, and Caldera’s planned Phase 2a Crohn’s disease trial is expected to be conducted in China. Caldera has not yet conducted any clinical trial in the United States. The acceptance of data from clinical trials conducted outside the United States by the FDA or other comparable foreign regulatory authorities may be subject to certain conditions or may not be accepted at all. In cases where data from foreign clinical trials are intended to serve as the sole basis for regulatory approval in the United States, the FDA will generally not approve the application unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, the FDA will not accept the data from a foreign clinical trial not conducted under an IND as support for an application for marketing approval unless the study is well-designed and well-conducted in accordance with GCPs and the FDA is able to validate the data from the study through an on-site inspection if deemed necessary. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials are subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. Conducting clinical trials outside the United States also exposes Caldera to additional risks, including risks associated with foreign exchange fluctuations, compliance with foreign

 

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manufacturing, customs, shipment and storage requirements, and cultural differences in medical practice and clinical research, and diminished protection of intellectual property in some countries.

There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. For example, for FDA acceptance, Caldera will have to demonstrate that the foreign data are applicable to the U.S. population and U.S. medical practice. The current Congress is also conducting certain investigations and is considering certain proposals that could limit the use of clinical trial sites in China or impact FDA’s ability to accept data originating in China in review of an IND or BLA, if enacted. If the FDA or other comparable foreign regulatory authorities do not accept such data, either now or in the future, it would result in the need for additional trials, which could be costly and time-consuming, and which may result in current or future product candidates that Caldera may develop being delayed or not receiving approval for commercialization in the applicable jurisdiction.

Caldera’s clinical development activities are also concentrated in a small number of foreign jurisdictions, which exposes Caldera to jurisdiction-specific risks. Caldera’s ongoing Phase 1a healthy volunteer bridging trial is currently dosing participants, and its planned Phase 2a Crohn’s disease trial is expected to be conducted, in China by Qyuns, Caldera’s licensor, and Caldera’s current Phase 1 and planned Phase 2 drug substance and drug product are manufactured in China. Changes in U.S. or Chinese law or policy, including export controls, sanctions, tariffs, restrictions on the transfer of clinical or genetic data outside of China, restrictions on U.S. companies’ use of China-based biotechnology service providers, or a deterioration in relations between the United States and China, could delay or prevent the conduct of those trials, restrict Caldera’s access to the resulting data, increase costs or require Caldera to identify alternative sites, investigators or manufacturers. In addition, if Caldera or its clinical research organizations select clinical trial sites in regions affected by armed conflict, political instability, public health emergencies or economic disruption, Caldera could experience delays in site activation and patient enrollment, interruptions in drug supply, loss of or inability to monitor trial data, questions regarding data integrity or compliance with good clinical practices, and exposure to sanctions and export control requirements, any of which could delay or compromise the trial and require Caldera to repeat or supplement the affected work.

If, in the future, Caldera is unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any product it may develop, Caldera may not be successful in commercializing those products if they are approved.

Caldera does not have a sales or marketing infrastructure and has no experience in the sales, marketing or distribution of any therapeutic products. To achieve commercial success for any approved product, Caldera must either develop a sales and marketing organization or outsource these functions to third parties. In the future and if any of Caldera’s product candidates are approved, it may choose to build a focused sales, marketing and commercial support infrastructure to sell, or participate in sales activities with collaborators for some of Caldera’s current or future product candidates.

There are risks involved with both establishing Caldera’s own commercial capabilities and entering into arrangements with third parties to perform these services. For example, factors that may inhibit Caldera’s efforts to commercialize any approved product candidates include:

 

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the inability to recruit and retain adequate numbers of effective sales, marketing, coverage or reimbursement, customer service, medical affairs and other support personnel;

 

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the inability of sales personnel to obtain access to or persuade adequate numbers of decision makers of the utility of future approved product candidates;

 

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the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement and other acceptance by payors;

 

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the inability to price any of Caldera’s current or future product candidates at a sufficient price point to ensure an adequate and attractive level of profitability;

 

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restricted or closed distribution channels that make it difficult to distribute Caldera’s current or future product candidates, if approved, to segments of the patient population;

 

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the lack of complementary products to be offered by sales personnel, which may put Caldera at a competitive disadvantage relative to companies with more extensive product lines; and

 

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unforeseen costs and expenses associated with creating an independent commercialization organization.

If the commercial launch of a product candidate, if approved, for which Caldera recruits a sales force and establishes marketing and other commercialization capabilities is delayed or does not occur for any reason, Caldera would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and Caldera’s investment would be lost if Caldera cannot retain or reposition its commercialization personnel.

If Caldera were to enter into arrangements with third parties to perform sales, marketing, commercial support and distribution services, Caldera’s sales revenue or the profitability of sales revenue may be lower than if Caldera were to do so itself. In addition, Caldera may not be successful in entering into arrangements with third parties to commercialize its product candidates or may be unable to do so on terms that are favorable to it. Caldera may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market Caldera’s product candidates effectively. If Caldera does not establish commercialization capabilities successfully, either on its own or in collaboration with third parties, it will not be successful in commercializing its product candidates, if approved.

Caldera’s current or future product candidates, if approved, may not achieve adequate market acceptance among physicians, patients or their families, healthcare payors and others in the medical community necessary for commercial success.

Even if Caldera’s current or future product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients or their families, third-party payors and others in the medical community. The degree of market acceptance of any of Caldera’s approved product candidates will be dependent on a number of factors, including:

 

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the efficacy, durability and safety profile as demonstrated in clinical trials compared to alternative treatments;

 

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the timing of market introduction of the approved product as well as competitive products;

 

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the clinical indications for which a product candidate is approved;

 

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restrictions on the use of products in the labeling approved by regulatory authorities, such as boxed warnings or contraindications in labeling, or a REMS, if any, which may not be required of alternative treatments and competitor products;

 

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the terms of any approvals and the countries in which approvals are obtained;

 

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the potential and perceived advantages of Caldera’s future approved products over alternative treatments;

 

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the cost of treatment in relation to alternative treatments and the cost/benefit ratios of each;

 

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the availability of coverage and adequate reimbursement by third-party payors, including government authorities, and timing of relevant formulary decision-making resulting in this coverage and reimbursement;

 

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relative convenience and ease of administration in relation to competition;

 

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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 effectiveness of sales, marketing efforts and market access;

 

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publicity relating to Caldera’s future products or those of Caldera’s competitors;

 

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potential product liability claims; and

 

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the approval of new therapies for the same indications.

If any of Caldera’s current or future product candidates are approved but do not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, it may not generate or derive sufficient revenue from that product candidate and its financial results could be negatively impacted. Caldera’s efforts to educate the medical community and third-party payors regarding the benefits of its products may require significant resources and may never be successful.

If Caldera’s product candidates do not achieve projected development milestones or commercialization in the announced or expected timeframes, the further development or commercialization of such product candidates may be delayed, and Caldera’s business will be harmed.

Caldera has estimated, and may in the future estimate, the timing of the accomplishment of various scientific, clinical, manufacturing, regulatory and other product development objectives. These milestones have and may include Caldera’s expectations regarding the commencement or completion of nonclinical studies and clinical trials, data readouts, the submission of regulatory filings, the receipt of marketing approval or the realization of other commercialization objectives. The achievement of many of these milestones may be outside of Caldera’s control. All of these milestones are based on a variety of assumptions, including assumptions regarding capital resources, constraints and priorities, progress of and results from development activities and the receipt of key regulatory approvals or actions, any of which may cause the timing of achievement of the milestones to vary considerably from Caldera’s estimates. If Caldera or its collaborators fail to achieve announced milestones in the expected timeframes, the commercialization of the product candidates may be delayed, its credibility may be undermined and its business and results of operations may be harmed.

Even if Caldera completes the necessary nonclinical studies and clinical trials, Caldera cannot predict when, or if, Caldera will obtain regulatory approval to commercialize a product candidate and the approval may be for a narrower indication than Caldera seeks.

Prior to commercialization, Caldera’s product candidates must be approved by the FDA pursuant to a BLA in the United States and pursuant to similar marketing applications by comparable foreign regulatory authorities. The process of obtaining marketing approvals, both in the United States and abroad, is expensive and takes many years, 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. Failure to obtain marketing approval for a product candidate will prevent Caldera from commercializing the product candidate. Caldera has not received approval to market Caldera’s current product candidate from regulatory authorities in any jurisdiction. Caldera has no experience in submitting and supporting the applications necessary to gain marketing approvals, and, in the event regulatory authorities indicate that Caldera may submit such applications, Caldera may be unable to do so as quickly and efficiently as desired. Securing marketing approval requires the submission of extensive nonclinical and clinical data and supporting information to regulatory authorities for each therapeutic indication to establish the product 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, the regulatory authorities. Caldera’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 in the target patient population that may preclude Caldera’s obtaining marketing approval or prevent or limit commercial use. Regulatory authorities have substantial discretion in the approval process and may refuse to accept or file any application or may decide that Caldera’s data are insufficient for approval and require additional nonclinical clinical or other studies. In addition, varying interpretations of the data obtained from nonclinical and clinical testing could delay, limit or prevent marketing approval of a product candidate.

 

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Approval of Caldera’s current or future product candidates may be delayed or refused for many reasons, including:

 

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the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of Caldera’s clinical trials;

 

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Caldera may be unable to demonstrate, to the satisfaction of the FDA or comparable foreign regulatory authorities, that Caldera’s product candidates are safe and effective for any of their proposed indications;

 

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the populations studied in clinical trials may not be sufficiently broad or representative to assure efficacy and safety in the populations for which Caldera seeks approval;

 

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the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

 

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Caldera may be unable to demonstrate that Caldera’s product candidates’ benefits outweigh their safety risks; or

 

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the data collected from clinical trials of Caldera’s product candidates may not be sufficient to support the submission of a BLA or other comparable submission in foreign jurisdictions or to obtain regulatory approval in the United States or elsewhere.

Even if Caldera’s product candidates meet their pre-specified safety and efficacy endpoints in clinical trials, the regulatory authorities may not complete their review processes in a timely manner and may not consider such clinical trial results sufficient to grant, or Caldera may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, Caldera may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical trials and the review process.

Regulatory authorities also may approve a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings, contraindications or a REMS or other form of risk management program. These regulatory authorities may also grant approval subject to the performance of costly post-marketing clinical trials. In addition, regulatory authorities may not approve the labeling claims that are necessary or desirable for the successful commercialization of Caldera’s product candidates. Any of the foregoing scenarios could materially harm the commercial prospects for Caldera’s current or future product candidates and adversely affect Caldera’s business, financial condition, results of operations and prospects.

Adverse events in the therapeutic fields being pursued by Caldera, including immunology and gastroenterology, or in the biopharmaceutical and biotechnology industries, could damage public perception of Caldera’s current or future product candidates and negatively affect Caldera’s business.

Adverse events in clinical trials of CLD-423, or in post-marketing activities, or in clinical trials of others developing similar products or approved therapies with similar targets or formats to CLD-423, and the resulting publicity, as well as any other adverse events that may occur in the future in the immunology and inflammation field, could result in a decrease in demand for any product that Caldera may develop and receive regulatory approval to market. If public perception is influenced by claims that the use of therapies targeting TL1A or IL-23, or other targets of Caldera’s future product candidates, or biologics generally, is unsafe, whether related to Caldera’s therapy or those of its competitors, CLD-423 or Caldera’s future product candidates, if approved, may not be accepted by the general public or the medical community.

Future adverse events in any of the therapeutic fields or modalities being pursued by Caldera or the biopharmaceutical and biotechnology industries could also result in greater government regulation, stricter labeling requirements and potential regulatory delays in the testing or approvals of Caldera’s products. Any

 

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increased scrutiny could delay or increase the costs of obtaining marketing approval for Caldera’s current or future product candidates.

Moreover, because CLD-423 represents a novel dual-targeting approach that departs from currently approved single-target therapies for inflammatory bowel disease, potential patients and their physicians may be inclined to use established approved therapies, including anti-TNF agents, anti-integrins, JAK inhibitors, S1P receptor modulators, and single-target anti-IL-23 antibodies, rather than participate in clinical trials for CLD-423 or adopt CLD-423 as a treatment option, if approved. Any reluctance by physicians or patients to adopt CLD-423, even if approved, could limit Caldera’s ability to generate revenue and achieve profitability.

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

Caldera’s future growth may be dependent, in part, on its ability to develop and commercialize CLD-423, if approved, and other potential or future product candidates in foreign markets for which it may rely on collaboration with third parties. Caldera is not permitted to market or promote CLD-423 or other product candidates before it receives regulatory approval from the applicable regulatory authority in that foreign market and may never receive such regulatory approval for CLD-423 or other product candidates. To obtain separate regulatory approval in many other countries, Caldera must comply with numerous and varying regulatory requirements of such countries regarding safety and efficacy and governing, among other things, manufacturing, clinical trials and commercial sales, pricing and distribution of CLD-423 or other product candidates, and it cannot predict success in these jurisdictions. If Caldera fails to comply with the regulatory requirements in international markets and receive applicable regulatory approvals, its target market will be reduced and its ability to realize the full market potential of CLD-423 or other product candidates will be harmed and its business will be adversely affected. Caldera may not obtain foreign regulatory approvals on a timely basis, if at all. Its failure to obtain approval of any of CLD-423 or other product candidates by regulatory authorities in another country may significantly diminish the commercial prospects of that product candidate and its business, financial condition, results of operations and prospects could be materially and adversely affected. Moreover, even if Caldera obtains approval of CLD-423 or other product candidates and ultimately commercializes CLD-423 or other product candidates in foreign markets, it 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.

The manufacture of biological drugs is complex, and Caldera’s third-party manufacturers may encounter difficulties in production. If any of Caldera’s third-party manufacturers encounter such difficulties, Caldera’s ability to provide supply of Caldera’s current or future product candidates for clinical trials, Caldera’s ability to obtain marketing approval, or Caldera’s ability to provide supply of Caldera’s product candidates for patients, if approved, could be delayed or stopped.

Caldera does not own or operate facilities for the manufacture of its product candidates and instead relies, and expects to continue to rely, on third-party manufacturers and supply partners to manufacture its current and future product candidates and the components thereof. The timing of the initiation and completion of these activities will therefore be partially controlled by such third parties and may result in delays to Caldera’s development programs. However, these third parties are not Caldera’s employees, may have competing priorities and commitments to other entities, and may not devote sufficient time or resources to Caldera’s programs or meet expected deadlines. Caldera has less control over the timing, quality and other aspects of manufacturing than it would if it were to conduct these activities on its own. Caldera intends to establish manufacturing relationships with a limited number of suppliers to manufacture raw materials, the drug substance and finished product of any product candidate for which Caldera is responsible for nonclinical or clinical development. As part of any marketing approval, the FDA (or comparable regulatory authorities outside of the United States) must approve the manufacturing processes identified in the application and determine that the manufacturer has an acceptable compliance status. If supply from a vendor identified in the approved application is interrupted, there

 

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could be a significant disruption in commercial supply. An alternative vendor would need to be qualified through appropriate regulatory filings which could result in further delay. The FDA or other regulatory agencies outside of the United States may also require additional studies if a new supplier is relied upon for commercial production. Switching vendors may involve substantial costs and is likely to result in a delay in Caldera’s desired clinical and commercial timelines.

The process of manufacturing biological drugs is complex, highly regulated and subject to multiple risks. Manufacturing drugs is highly susceptible to product loss due to contamination, equipment failure, improper installation or operation of equipment, vendor or operator error, inconsistency in yields, variability in product characteristics and difficulties in scaling the production process. Even minor deviations from normal manufacturing processes could result in reduced production yields, product defects and other supply disruptions. If microbial, viral or other contaminations are discovered at the facilities of Caldera’s manufacturers, such facilities may need to be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials and adversely harm Caldera’s business. Moreover, if the FDA determines that Caldera’s contract development and manufacturing organizations (“CDMOs”) are not in compliance with applicable laws and FDA regulations, including those governing current Good Manufacturing Practice requirements (“cGMPs”), the FDA may deny BLA approval until the deficiencies are corrected or Caldera replaces the manufacturer in Caldera’s BLA with a manufacturer that is in compliance. In addition, approved products and the facilities at which they are manufactured are required to maintain ongoing compliance with extensive FDA requirements and the requirements of other similar agencies, including ensuring that quality control and manufacturing procedures conform to cGMP requirements. As such, Caldera’s CDMOs are subject to continual review and periodic inspections to assess compliance with cGMPs. Furthermore, although Caldera does not have day-to-day control over the operations of its CDMOs, it is responsible for ensuring compliance with applicable laws and regulations, including cGMPs, with respect to its drug products.

In addition, Caldera currently relies on third parties located in China for its contract manufacturing, and has historically used China-based third-party manufacturers and service providers for development and manufacturing services. Caldera intends to move its supply chain outside of China for Phase 2 supply chain redundancy, Phase 3 clinical development, and commercialization, but that transfer has not been completed. For any activities conducted in China, Caldera is exposed to the possibility of product supply disruption and increased costs in the event of changes in the policies of the United States or Chinese governments, political unrest or unstable economic conditions in China. In addition, certain Chinese biotechnology companies may become subject to trade restrictions, sanctions, other regulatory requirements, or legislation enacted or proposed by the U.S. government, which could restrict or even prohibit Caldera’s ability to work with such entities, thereby potentially disrupting the supply of material to Caldera. For example, the BIOSECURE Act, which was signed into law in December 2025 as part of the National Defense Authorization Act for Fiscal Year 2026, prohibits U.S. federal agencies from entering into or renewing any contract, loan, or grant with any entity that uses biotechnology equipment or services produced or provided by a “biotechnology company of concern” to perform that contract. The BIOSECURE Act also prohibits U.S. government loan and grant recipients from using federal loan or grant money to enter into contracts with entities that use equipment from “biotechnology companies of concern” in the performance of any federal prime contract or subcontract. The Office of Management and Budget (“OMB”) of the U.S. Government will issue a list of “biotechnology companies of concern,” which will include certain companies that are identified on the U.S. Department of Defense’s annual List of Chinese Military Companies, also known as the 1260H List, other entities which the U.S. Government has deemed as such pursuant to a separate designation process, and certain subsidiary, parent, and successor entities of the foregoing. If Qyuns, Jiangsu Cellularforce Biopharma Co. Ltd. (“Jiangsu Cellularforce”), or any other China-based counterparty of Caldera were designated as a “biotechnology company of concern,” or if the scope of these restrictions were expanded, Caldera may be restricted in its ability to continue working with such companies to the extent Caldera would contract with, or otherwise receive funding from, the U.S. government, and Caldera could be required to accelerate its planned technology transfer or to qualify alternative suppliers. While Caldera believes it will be able to identify and contract with alternative CDMOs, Caldera cannot guarantee that alternative CDMOs with the necessary capabilities and capacity would be available on a timeline that would

 

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not materially delay the development of CLD-423, and cannot predict the terms of any such alternative arrangement nor what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by China or the other countries in retaliation. Actions taken by Chinese authorities affecting the transfer of intellectual property, biological materials, clinical data or personal information out of China could have similar effects. In addition, any unfavorable government policies on international trade, such as export controls, capital controls or tariffs, new legislation or regulations, renegotiation of existing trade agreements, or any retaliatory trade actions due to recent or future trade tension, may impede, delay, limit, or increase the cost of manufacturing CLD-423. Such events could result in Caldera’s clinical or commercial supply of drug, packaging and other services being interrupted or limited, which would have an adverse effect on Caldera’s business, financial condition, results of operations and prospects.

In addition, there are risks associated with large scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility or validation, stability issues, compliance with cGMPs, product quality, product comparability, mitigating potential sources of contamination, lot consistency and timely availability of raw materials. Even if Caldera obtains regulatory approval for any of Caldera’s product candidates, there is no assurance that manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential launch of the product or to meet potential future demand. If Caldera’s manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, commercialization efforts would be impaired, which would have an adverse effect on Caldera’s business, financial condition, results of operations and prospects.

Caldera relies on a limited number of manufacturers for CLD-423 and has identified single-source suppliers for various steps of manufacture. In particular, Caldera currently obtains its Phase 1 and planned Phase 2 drug substance and drug product from a CDMO located in China that is a wholly owned subsidiary of Qyuns, Caldera’s licensor, and Caldera also engages other China-based service providers for development and analytical work. Caldera intends to complete a technology transfer to a contract development and manufacturing organization located outside of China for Phase 3 clinical development and commercial supply, but that transfer has not been completed and may be delayed, may require additional comparability or bridging studies, and may result in supply interruptions, increased costs, or product quality or specification differences. This reliance on a limited number of manufacturers, the concentration of manufacturing in a single jurisdiction, the affiliation between Caldera’s sole current manufacturer and Caldera’s licensor, the complexity of biologics manufacturing and the difficulty of scaling up a manufacturing process could cause the delay of clinical trials, regulatory submissions, required approvals or commercialization of CLD-423, cause Caldera to incur higher costs and prevent Caldera from commercializing CLD-423 successfully. Furthermore, if Caldera’s suppliers fail to deliver the required clinical or commercial quantities of materials on a timely basis and at commercially reasonable prices, and Caldera is unable to secure one or more replacement suppliers capable of production in a timely manner at a substantially equivalent cost, Caldera’s clinical trials may be delayed or Caldera could lose potential revenue.

Caldera may also be unable to transfer its manufacturing processes to additional third-party manufacturers successfully, or to scale those processes for later-stage clinical or commercial production. Technology transfer is complex and may require significant process development, equipment qualification, analytical method transfer, process validation and regulatory activities. Differences among manufacturing facilities, equipment, raw materials, personnel or processes could result in manufacturing failures, delays, product quality or specification issues, or an inability to demonstrate comparability between product manufactured at different facilities. Because Caldera’s current drug substance and drug product are manufactured by a single contract development and manufacturing organization affiliated with its licensor, a transfer to an unaffiliated manufacturer outside of China may present heightened execution risk. If Caldera or its third-party manufacturers are unable to complete technology transfer successfully or on Caldera’s anticipated timelines, Caldera could experience delays in its clinical trials, regulatory approval or commercialization, interruptions in product supply, increased costs, or the need to repeat manufacturing, validation, comparability or other studies.

 

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Caldera may not be successful in finding strategic collaborators for development of existing or future product candidates or successfully commercializing or competing in the market for certain indications.

In the future, Caldera may decide to collaborate with other pharmaceutical and biotechnology companies for the development and potential commercialization of existing and future product candidates. It faces significant competition in seeking appropriate collaborators. Whether Caldera reaches a definitive agreement for a collaboration will depend, among other things, upon 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. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to its ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that may result in a reduced number of potential future collaborators.

Caldera may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If Caldera is unable to do so, it may have to curtail the development of the product candidate for which it is seeking to collaborate, reduce or delay its development program 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 Caldera elects to increase its expenditures to fund development or commercialization activities on its own, it may need to obtain additional capital, which may not be available to Caldera on acceptable terms or at all. If it does not have sufficient funds, it may not be able to further develop its product candidates or bring them to market and generate product revenue.

The success of any potential collaboration arrangements will depend heavily on the efforts and activities of its collaborators. Collaborators generally have significant discretion in determining the efforts and resources that they will apply to these collaborations. Disagreements between parties to a collaboration arrangement regarding clinical development and commercialization matters can lead to delays in the development process or commercializing the applicable product candidate and, in some cases, termination of such collaboration arrangements. These disagreements can be difficult to resolve if neither of the parties has final decision-making authority. Collaborations with pharmaceutical or biotechnology companies and other third parties often are terminated or allowed to expire by the other party. Any such termination or expiration would adversely affect Caldera financially and could harm its business reputation.

Risks Related to Government Regulation

The regulatory approval process is highly uncertain, and Caldera may be unable to obtain, or may be delayed in obtaining, U.S. or foreign regulatory approval and, as a result, unable to commercialize Caldera’s current product candidates and any future product candidates. Even if Caldera believes its current, or planned, clinical trials are successful, regulatory authorities may not agree that they provide adequate data on safety or efficacy.

Caldera’s current and any future product candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, post-approval monitoring, marketing and distribution of products. Rigorous nonclinical testing and clinical trials and an extensive regulatory approval process are required to be completed successfully in the United States and in many foreign jurisdictions before a new biopharmaceutical product can be marketed. Satisfaction of these and other regulatory requirements is costly, time-consuming, uncertain and subject to unanticipated delays. It is possible that none of the product candidates Caldera may develop will obtain the regulatory approvals necessary for it to begin marketing and selling them.

 

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While Caldera has Phase 1 clinical trials currently ongoing, it has limited experience as a company in conducting and managing clinical trials and has no experience completing the later-stage clinical trials necessary to obtain regulatory approvals, including approval by the FDA, or obtaining marketing approval for any product candidate. The time required to obtain FDA and other approvals is unpredictable but typically takes many years following the commencement of clinical trials, depending on the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when regulating Caldera require judgment and can change, which makes it difficult to predict with certainty their application. Any analysis Caldera performs of data from nonclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. Caldera may also encounter unexpected delays or increased costs due to new government regulations, for example, from future legislation or administrative action, or from changes in FDA policy during the period of product development, clinical trials and FDA regulatory review. It is not possible to predict whether additional legislative changes will be enacted, or whether FDA or foreign regulations, guidance or interpretations will be changed, or the impact of such changes, if any. Any elongation or de-prioritization of nonclinical studies or clinical trials or delay in regulatory review resulting from such disruptions could adversely affect the development and study of Caldera’s current or other future product candidates.

Further, the FDA and other comparable foreign regulatory authorities may respond to any IND or BLA (and their foreign equivalents) that Caldera may submit by defining requirements that Caldera does not anticipate. Such responses could delay clinical development of Caldera’s current or any future product candidates.

In addition, the approval policies or regulations of the FDA and other comparable regulatory authorities in other jurisdictions may change in a manner rendering Caldera’s clinical, nonclinical, or manufacturing data insufficient for approval. Any delay or failure in obtaining required approvals could have a material and adverse effect on Caldera’s ability to generate revenues from the particular product candidate for which it is seeking approval. Furthermore, any regulatory approval to market a product may be subject to limitations on the approved uses for which Caldera may market the product or on the labeling or other restrictions.

Caldera is also subject to or may in the future become subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process varies among countries and may include all of the risks associated with the FDA approval process described above, as well as risks attributable to the satisfaction of local regulations in foreign jurisdictions. Moreover, the time required to obtain foreign approval may differ from that required to obtain FDA approval. FDA approval does not ensure approval by regulatory authorities outside the United States and vice versa. Any delay or failure to obtain United States or foreign regulatory approval for a product candidate could have a material and adverse effect on Caldera’s business, financial condition, results of operations and prospects.

From time to time during the development and regulatory approval process for Caldera’s product candidates, Caldera engages in discussions with the FDA and other regulatory authorities regarding its development programs, including discussions about the regulatory requirements for approval. Sometimes different regulatory authorities provide different or conflicting advice. While Caldera will attempt to harmonize the advice it receives from multiple regulatory authorities, it is not always practical to do so. Also, Caldera may choose not to harmonize conflicting advice when harmonization would significantly delay clinical trial data or when it believes it is otherwise inappropriate. In addition, regulatory authorities may change their views on aspects of the clinical programs, including study designs, or the ability of the studies as designed to support approval of a product. If Caldera is unable to effectively and efficiently resolve and comply with the inquiries and requests of the FDA and other regulatory authorities, the approval of its product candidates may be delayed or denied, and their value may be reduced.

 

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The designation of any of Caldera’s product candidates for an expedited program by the FDA or any comparable foreign regulatory authority, even if granted, may not lead to a faster development or regulatory review or approval process, and does not increase the likelihood that Caldera’s product candidates will receive regulatory approval.

Where an expedited program is available in a particular country, Caldera may seek to utilize such program for some or all of Caldera’s product candidates. For example, various regulatory programs in the United States, such as Breakthrough Therapy Designation, Fast Track Designation or Priority Review Designation, are designed to expedite the development and review of therapies to treat certain diseases. Caldera may seek such designations, and comparable designations by foreign regulatory authorities, for one or more of its product candidates for the treatment of certain indications, as applicable. However, regulatory authorities have broad discretion as to whether or not to grant such designations.

A Breakthrough Therapy is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug, or biologic in our case, may demonstrate substantial improvement over existing therapies with respect to one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For product candidates that have been designated as Breakthrough Therapies, interaction and communication between the FDA and the sponsor can help to identify the most efficient path for development.

If a biologic is intended for the treatment of a serious or life-threatening condition and the biologic demonstrates the potential to address unmet medical needs for this condition, the biologic sponsor may apply for Fast Track Designation. The sponsor of a Fast Track product candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA is submitted, the application may be eligible for priority review. With regard to a Fast Track product candidate, the FDA may consider for review sections of the BLA on a rolling basis before the complete application is submitted if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a Fast Track product may be effective.

A BLA is eligible for Priority Review if the product candidate is designed to treat a serious condition, and if approved, would provide a significant improvement in safety or efficacy compared to available therapies. The FDA will attempt to direct additional resources to the evaluation of a BLA designated for Priority Review in an effort to facilitate the review. The FDA endeavors to review applications with Priority Review designations within six months of the filing date as compared to ten months for review of original BLAs under its current Prescription Drug User Fee Act (“PDUFA”) review goals.

Even if Caldera receives such a designation for any product candidates in the future, Caldera may not experience a faster development process, review or approval compared to drugs considered for approval under conventional regulatory procedures and such a designation does not assure ultimate approval by the applicable regulatory authority. Even if one or more of Caldera’s product candidates qualify for such a designation, the applicable regulatory authority may later decide that such product candidates no longer meet the conditions for qualification.

We may seek Orphan Drug Designation for one or more of our product candidates, as applicable. We may not be able to obtain orphan drug designation or orphan drug exclusivity for our product candidates and, even if we do, that exclusivity may not prevent the FDA or other comparable foreign regulatory authorities from approving other competing products.

Regulatory authorities in some jurisdictions, including the FDA, may designate drugs for relatively small patient populations as orphan drugs. In the United States, Orphan Drug Designation entitles a party to financial incentives such as tax advantages and user fee waivers or exemptions. In addition, if a product receives the first

 

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FDA approval of a drug for the condition for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug for the same condition for a period of seven years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or where the manufacturer is unable to assure sufficient product quantity. In the case of a biological product, sameness is based on the principal molecular features of the product. In the European Union, Orphan Drug Designation entitles a party to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity for the orphan indication following drug or biological product approval, provided that the criteria for orphan designation are still applicable at the time of the granting of the marketing authorization. The respective Orphan Drug Designation and exclusivity frameworks in the United States and in the European Union are subject to change, and any such changes may affect our ability to obtain, or the impact of obtaining, European Union or U.S. orphan designations in the future.

We may pursue Orphan Drug Designation for one or more of our product candidates, as applicable. However, obtaining an Orphan Drug Designation can be difficult, and we may not be successful in doing so. Even if we obtain Orphan Drug Designation, we may not be able to maintain such designation. Orphan Drug Designation neither shortens the development time or regulatory review time of a therapeutic candidate nor gives the therapeutic candidate any advantage in the regulatory review or approval process. Even if we obtain Orphan Drug Designation for our product candidates in specific conditions, we may not be the first to obtain regulatory approval of these drugs for the orphan-designated condition and therefore we may not be eligible for orphan drug exclusivity in the United States. In addition, exclusive marketing rights in the United States may not be awarded if we seek approval for an indication broader than the orphan-designated condition or, if awarded, may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Our inability to obtain Orphan Drug Designation for any product candidates and our inability to maintain that designation for the duration of the applicable exclusivity period, could reduce our ability to make sufficient sales of the applicable product candidate to balance our expenses incurred to develop it.

We may decide to pursue accelerated approval for any of our product candidates. A decision to pursue accelerated approval may not lead to a faster regulatory review or approval process and does not increase the likelihood that our product candidates will receive marketing approval.

As part of our business strategy, we may pursue accelerated approval for one or more of our product candidates. Under the FDA’s accelerated approval program, the FDA may approve a drug for a serious or life-threatening illness that addresses an unmet medical need based upon a surrogate endpoint that is considered by the FDA to be reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality that is considered by the FDA to be reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments. We may seek accelerated approval for one or more of our product candidates on the basis of a surrogate endpoint that we believe is reasonably likely to predict clinical benefit.

If any of our product candidates receive accelerated approval from the FDA, we will be required to undergo one or more confirmatory clinical trials. If such a therapeutic candidate fails to meet its safety and efficacy endpoints in such confirmatory clinical trials, the FDA may withdraw the accelerated approval. The FDA has put increased focus on ensuring that confirmatory studies are conducted with diligence and, ultimately, that such studies confirm clinical benefit. In addition, the FDA is authorized to require a post-approval study to be underway prior to approval or within a specified time period following approval. The FDA must also specify conditions of any required post-approval study, and sponsors must submit progress reports for required post-approval studies, including progress toward enrollment targets, milestones, and other conditions required by the FDA. The FDA can also initiate enforcement action for the failure to conduct with due diligence a required post-approval study, including a failure to meet any required conditions specified by the FDA or to submit timely reports.

 

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There is no assurance that any product candidate will successfully advance through its confirmatory clinical trial(s). Therefore, even if a product candidate receives accelerated approval from the FDA, such approval may be withdrawn at a later date.

Obtaining and maintaining regulatory approval of Caldera’s product candidates in one jurisdiction does not mean that Caldera will be successful in obtaining regulatory approval of Caldera’s product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of Caldera’s product candidates in one jurisdiction does not guarantee that Caldera will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, even if the FDA grants regulatory approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion of the product candidate in those countries. Moreover, the receipt of regulatory approval in another jurisdiction does not expedite or result in approval in the United States or other jurisdictions. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional nonclinical studies or clinical trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Caldera intends to charge for its products is also subject to approval. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Caldera and could delay or prevent the introduction of Caldera’s products in certain countries. If Caldera or any partner Caldera works with fails to comply with the regulatory requirements in international markets or fails to receive applicable regulatory approvals, Caldera’s target market will be reduced and Caldera’s ability to realize the full market potential of its product candidates will be harmed.

Even if Caldera receives regulatory approval for Caldera’s current product candidate and any future product candidates, Caldera will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense. Additionally, Caldera’s current product candidate and any future product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal. Caldera may also be subject to penalties if Caldera fails to comply with regulatory requirements or experiences unanticipated problems with Caldera’s products.

Any regulatory approvals that Caldera obtains for Caldera’s current or any future product candidates may also be subject to limitations on the approved indicated uses for which a product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing and surveillance to monitor the safety and efficacy of the product candidate. In addition, if the FDA or other comparable foreign regulatory authorities approve any of Caldera’s product candidates, the manufacturing processes, labeling, packaging, distribution, post-approval monitoring and adverse event reporting, storage, import, export, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. The FDA has significant post-market authority, including the authority to require labeling changes based on new safety information and to require post-market studies or clinical trials to evaluate safety risks related to the use of a product or to require withdrawal of the product from the market. The FDA also has the authority to require a REMS after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug. The manufacturing facilities Caldera uses to make future approved products, if any, will also be subject to periodic review and inspection by the FDA or other comparable foreign regulatory authorities, including for continued compliance with cGMP requirements. The discovery of any new or previously unknown problems with Caldera’s CDMOs, manufacturing processes or facilities may result in restrictions on the product, manufacturer or facility, including withdrawal of the product from the market. If Caldera relies on CDMOs, Caldera will not have control over compliance with applicable rules and regulations by such manufacturers.

 

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Moreover, any product promotion and advertising will also be subject to regulatory requirements and continuing regulatory review. The FDA imposes stringent restrictions on manufacturers’ communications regarding use of their products. If Caldera promotes Caldera’s future approved products, if any, in a manner inconsistent with FDA-approved labeling or otherwise not in compliance with FDA regulations, Caldera may be subject to enforcement action. Moreover, if Caldera believes that Caldera’s current product candidate or any future product candidates may provide better safety or effectiveness as compared to approved products, if Caldera does not study Caldera’s current product candidates or any future product candidates in head-to-head trials with those products, Caldera will not be able to make comparative claims for Caldera’s products, if approved.

If Caldera or Caldera’s CDMOs or other service providers fail to comply with applicable continuing regulatory requirements in the United States or foreign jurisdictions in which Caldera seeks to market Caldera’s future approved products, Caldera or they may be subject to, among other things:

 

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restrictions on the manufacturing of the product, product recalls or withdrawal of the product from the market;

 

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inspectional observations (e.g., Form 483), warning letters or untitled letters;

 

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partial or full holds on clinical trials;

 

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refusal of the FDA or comparable foreign regulatory authorities to accept new marketing applications or approve pending applications or supplements to approved applications, or suspension or revocation of product approvals;

 

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product seizure or detention, or refusal to permit the import or export of products;

 

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consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;

 

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mandated modification of promotional materials and labeling and the issuance of corrective information;

 

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a requirement to implement a REMS or comparable foreign risk management program, which may result in additional requirements or restrictions on the distribution or use of a product;

 

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the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or other safety information about the product; and/or

 

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injunctions or the imposition of fines or civil or criminal penalties.

Any government investigation of alleged violations of law could require Caldera to expend significant time and resources in response and could generate adverse publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect Caldera’s ability to commercialize and generate revenue from Caldera’s products, if approved. If regulatory sanctions are applied or if regulatory approval is withdrawn, the value of Caldera and Caldera’s operating results will be adversely affected.

Subsequent discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with Caldera’s CDMOs or manufacturing processes, or failure to comply with regulatory requirements, may result in these same consequences.

Caldera’s product candidates for which it intends to seek approval as biologic products may face competition sooner than anticipated.

With the enactment of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), an abbreviated pathway for the licensure of highly similar and interchangeable biosimilar products was created in the United States. The abbreviated regulatory pathway establishes legal authority for the FDA to review and

 

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approve a biosimilar biologic, including the possible designation of a biosimilar as interchangeable, based on its similarity to an existing reference product. The BPCIA provides a period of reference product exclusivity for biological products during which an application for a biosimilar product referencing such products cannot be licensed by the FDA until 12 years after the first licensure date of the reference product. Additionally, a biosimilar application referencing such exclusivity-protected biological products may not be submitted for four years after the first licensure date of the reference product. The date of first licensure does not include the date of licensure of (and a new period of exclusivity is not available for) a biological product if the licensure is for a supplement for the biological product or for a subsequent application by the same sponsor or manufacturer of the biological product (or licensor, predecessor in interest, or other related entity) for a change (not including a modification to the structure of the biological product) that results in a new indication, route of administration, dosing schedule, dosage form, delivery system, delivery device or strength, or for a modification to the structure of the biological product that does not result in a change in safety, purity or potency.

During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA licenses a full BLA for the competing product containing the other company’s own nonclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when and how such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have an adverse effect on the future commercial prospects for Caldera’s product candidates.

We believe that the first BLA licensure for any of our biological products should qualify for the 12-year period of exclusivity. However, there is a risk that any product candidates Caldera may develop that are licensed as a biological product under a BLA would not qualify for the 12-year period of exclusivity or that this exclusivity could be shortened due to congressional action or otherwise, potentially creating the opportunity for biosimilar competition sooner than anticipated.

Most states have enacted substitution laws that permit substitution of interchangeable biosimilars. The extent to which a biosimilar, once licensed, will be substituted for any one of Caldera’s reference products that may be approved is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

The policies of the FDA or other regulatory authorities may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of any of Caldera’s product candidates or Caldera’s future product candidates.

If Caldera is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Caldera is not able to maintain regulatory compliance, Caldera may lose any regulatory approval that Caldera may have obtained and Caldera may not achieve or sustain profitability, which would adversely affect Caldera’s business. Caldera also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad.

In addition, three decisions from the U.S. Supreme Court in July 2024 may lead to an increase in litigation against regulatory agencies that could create uncertainty and thus negatively impact Caldera’s business. The first decision overturned established precedent that required courts to defer to regulatory agencies’ interpretations of ambiguous statutory language. The second decision overturned regulatory agencies’ ability to impose civil penalties in administrative proceedings. The third decision extended the statute of limitations within which entities may challenge agency actions. These cases may result in increased litigation by industry against regulatory agencies and impact how such agencies choose to pursue enforcement and compliance actions. However, the specific, lasting effects of these decisions, which may vary within different judicial districts and circuits, are unknown. Caldera also cannot predict the extent to which regulations, policies, and decisions of the FDA or other regulatory authorities, such as the SEC, may become subject to increasing legal challenges, delays, and changes.

 

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Disruptions at the FDA and other government agencies caused by, among other factors, funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, slow the time necessary for new products to be reviewed and/or approved, or otherwise prevent those agencies from performing normal business functions on which the operation of Caldera’s business may rely, which would adversely affect Caldera’s business. In addition, there is substantial uncertainty regarding new initiatives and how these might impact the FDA and other government agencies, which could prevent, limit or delay development and regulatory approval of Caldera’s product candidates and adversely affect Caldera’s business.

The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, government shutdowns, statutory, regulatory, and policy changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise affect the FDA’s ability to perform routine functions. In addition, government funding of other government agencies on which Caldera’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 government agencies or comparable foreign regulatory authorities may also slow the time necessary for the review and/or approval of clinical trial or marketing applications, which would adversely affect Caldera’s business. For example, the U.S. government has reduced the number of federal employees, including at FDA, by establishing voluntary termination programs, by position eliminations or by involuntary terminations, and the FDA has experienced turnover at senior levels. Changes in FDA staffing could result in delays in the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance, or implement or enforce regulatory requirements in a timely fashion or at all.

Similar consequences would also result in the event of a significant shutdown of the federal government. For example, over the last several years, and most recently in late 2025, the U.S. government has shut down several times, and certain regulatory agencies, such as the FDA, had to furlough critical employees and stop critical activities. If a prolonged government shutdown occurs, or if geopolitical or global health concerns prevent the FDA from conducting their regular inspections, reviews, or other regulatory activities, or if the volume of applications to the FDA for new product candidates increases materially, it could significantly impact the ability of the FDA to timely review and process Caldera’s regulatory submissions, which could have a material adverse effect on Caldera’s business. Further, future government shutdowns or delays could impact Caldera’s ability to access the public markets and obtain necessary capital in order to properly capitalize and continue Caldera’s operations. If any legislation, executive orders, or lapses in agency funding impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, Caldera’s business may be negatively impacted.

FDA-regulated industries, such as Caldera’s, face uncertainty with regard to the regulatory environment Caldera will face as Caldera proceeds with research and development, and possibly in the future, commercialization. Some of these efforts have manifested to date in the form of personnel measures that could impact the FDA’s ability to hire and retain key personnel, which could result in delays or limitations on Caldera’s ability to obtain guidance from the FDA on Caldera’s product candidates in development and obtain the requisite regulatory approvals in the future. Moreover, the U.S. government paused payments by, reduced the budget of, and terminated grants provided by the National Institutes of Health (“NIH”) related to its funding for medical research, which has decreased, and may continue to decrease, the ability of facilities that rely on NIH funding to enroll and conduct clinical trials or increase the costs to Caldera of conducting clinical trials. Some of these actions have been challenged in court and there remains general uncertainty regarding future activities. New executive orders, regulations, policies or guidance could be issued or promulgated that adversely affect Caldera or create a more challenging or costly environment to pursue the development of new therapeutic products. Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to Caldera’s operations. If Caldera becomes negatively impacted by future governmental orders, regulations, policies or guidance, there could be a material adverse effect on Caldera and Caldera’s business.

 

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Caldera’s operations and relationships with healthcare providers, healthcare organizations, customers and third-party payors will be subject to applicable anti-bribery, anti-kickback, fraud and abuse, transparency and other healthcare laws and regulations, which could expose Caldera to, among other things, enforcement actions, criminal sanctions, civil penalties, contractual damages, reputational harm, administrative burdens and diminished profits and future earnings.

Caldera’s current and future arrangements with healthcare providers, healthcare organizations, third-party payors and customers expose Caldera to broadly applicable anti-bribery, fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which Caldera researches, markets, sells and distributes any of Caldera’s product candidates, if approved. Restrictions under applicable federal and state anti-bribery and healthcare laws and regulations, include the following:

 

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the federal Anti-Kickback Statute, which prohibits, among other things, individuals and entities from knowingly and willfully soliciting, receiving, offering, 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, or the purchase, order or recommendation of, any good or service for which payment may be made under a federal and state healthcare program such as Medicare and Medicaid. The term remuneration has been broadly interpreted to include anything of value. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

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the federal criminal and civil false claims and civil monetary penalties laws, including the federal False Claims Act, which can be enforced through civil whistleblower or qui tam actions against individuals or entities, and the Federal Civil Monetary Penalties Law, which prohibit, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent, knowingly making, using or causing to be made or used, a false record or statement material to a false or fraudulent claim, or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, certain marketing practices, including off-label promotion, may also violate false claims laws. Moreover, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act;

 

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the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and its implementing regulations, which imposes criminal and civil liability, prohibits, among other things, knowingly and willfully executing, or attempting to execute a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective implementing regulations, which impose obligations on certain healthcare providers, health plans, and healthcare clearinghouses, known as covered entities, as well as their business associates and covered subcontractors that perform certain services involving the storage, use or disclosure of individually identifiable health information for or on behalf of a covered entity and their business associates, including mandatory contractual terms, with respect to safeguarding the privacy, security, and transmission of individually identifiable health information, and require notification to affected individuals and regulatory authorities of certain breaches of security of individually identifiable health information;

 

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the federal Physician Payments Sunshine Act, which requires certain manufacturers of covered drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program, with certain exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors),

 

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certain other health care professionals (such as physician assistants and certain advanced practice nurses), and teaching hospitals, as well as ownership and investment interests held by the physicians described above and their immediate family members, with the information made publicly available on a searchable website;

 

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the Foreign Corrupt Practices Act (“FCPA”), which prohibits U.S. businesses and their representatives from directly or indirectly offering to pay, paying, promising to pay or authorizing the payment of money or anything of value to a foreign official in order to influence any act or decision of the foreign official in his or her official capacity or to secure any other improper advantage in order to obtain or retain business;

 

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analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

 

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certain state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to payments to physicians and other healthcare providers or marketing expenditures and drug pricing information, and state and local laws that require the registration of biopharmaceutical sales representatives; and

 

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state and non-U.S. laws governing the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Efforts to ensure that Caldera’s current and future business arrangements with third parties comply with applicable healthcare laws and regulations could involve substantial costs. It is possible that governmental authorities will conclude that Caldera’s business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations. If Caldera’s operations are found to be in violation of any such requirements, Caldera may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, the curtailment or restructuring of Caldera’s operations, loss of eligibility to obtain approvals from the FDA, exclusion from participation in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid, integrity oversight and reporting obligations, or reputational harm, any of which could adversely affect Caldera’s financial results. These risks cannot be entirely eliminated. Any action against Caldera for an alleged or suspected violation could cause Caldera to incur significant legal expenses and could divert Caldera’s management’s attention from the operation of Caldera’s business, even if Caldera’s defense is successful. In addition, achieving and sustaining compliance with applicable laws and regulations may be costly to Caldera in terms of money, time and resources.

Caldera may face difficulties from healthcare legislative and regulatory reform measures.

In the United States and some foreign jurisdictions, there have been, and Caldera expects there will continue to be, a number of legislative and regulatory changes to the healthcare system, including cost containment measures that may reduce or limit coverage and reimbursement for newly approved drugs and affect Caldera’s ability to profitably sell any product candidates for which Caldera obtains marketing approval. In particular, there have been and continue to be a number of initiatives at the U.S. federal and state levels that seek to reduce healthcare costs and improve the quality of care.

For example, the Patient Protection and Affordable Care Act, as amended (the “ACA”), made significant changes to the healthcare system, including an increase to manufacturers’ rebate liability under the Medicaid Drug Rebate Program, the imposition of a significant annual fee on companies that manufacture or import branded prescription drug products, and other health policy reforms that substantially changed the way healthcare

 

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is financed by both governmental and private insurers. In addition, legislative changes adopted since the ACA include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and, as a result of subsequent legislation, will remain in effect through 2032 unless additional Congressional action is taken.

Since that time, there has continued to be heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products, which has resulted in several presidential executive orders, Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, reduce the costs of drugs under Medicare, and reform government program reimbursement methodologies for drug products. Several of these initiatives culminated in the enactment of the Inflation Reduction Act (“IRA”) in August 2022, which, among other things, requires the U.S. Department of Health and Human Services (“HHS”) to directly negotiate the selling price of a statutorily specified number of drugs and biologics each year that CMS reimburses under Medicare Part B and Part D. The negotiated price may not exceed a statutory ceiling price. Only high-expenditure single-source biologics that have been approved for at least 11 years (7 years for single-source drugs) are eligible to be selected by CMS for negotiation, with the negotiated price taking effect two years after the selection year. For 2026, the first year in which negotiated prices become effective, CMS selected 10 high-cost Medicare Part D products in 2023, negotiations began in 2024, and the negotiated maximum fair price for each product has been announced and become effective. In addition, CMS selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs, which will become effective in 2027. For 2028, CMS has selected an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B. For 2029 and subsequent years, 20 Part B or Part D drugs will be selected. Currently, a drug or biological product that has an orphan drug designation for only one rare disease or condition is excluded from the IRA’s price negotiation requirements, as long as the drug or biological product is approved only for an indication within that disease or condition. However, as a result of a statutory amendment enacted in July 2025, beginning with the 2028 negotiated price applicability year, a drug or biological product may be designated for more than one rare disease or condition and still be excluded from the IRA’s price negotiation requirements, but will lose that exclusion if it is approved for an indication that is not one of the designated rare diseases or conditions, unless such disqualifying approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation. The law also imposes rebates on Medicare Part B and Part D drugs whose prices have increased at a rate greater than the rate of inflation, and in November 2024, CMS finalized regulations for these inflation rebates. In addition, the law eliminated the “donut hole” under Medicare Part D beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and requiring manufacturers to subsidize, through a newly established manufacturer discount program, 10% of Part D enrollees’ prescription costs for brand drugs below the out-of-pocket limit, and 20% once the out-of-pocket limit has been reached. The IRA permits the Secretary of HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years. Manufacturers that fail to comply with the IRA may be subject to various penalties, including civil monetary penalties. The provisions related to the negotiation of selling prices of high-expenditure single-source drugs and biologics have been challenged in numerous lawsuits, but to date those challenges have been unsuccessful, and in May 2026 the U.S. Supreme Court declined to review the first wave of manufacturer challenges, leaving in place lower court decisions that upheld the program. Additional challenges to later negotiation cycles remain pending and further challenges may be brought, but CMS is continuing to implement the program, which is expected to have a significant impact on the biopharmaceutical industry.

Further, in July 2025, the OBBBA was enacted, which, among other things, narrowed access to ACA marketplace enrollment, and is anticipated to reduce Medicaid spending and enrollment through measures such as work requirements and other eligibility conditions for certain beneficiaries, caps on state-directed payments in Medicaid managed care, and limits on states’ ability to use provider taxes to finance their Medicaid programs. The current federal administration is pursuing policies to reduce regulations and expenditures across government including at HHS, which include the FDA and CMS, and related agencies. These actions included, for example, directives to reduce agency workforce, rescind a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending, and

 

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promote most-favored-nation (“MFN”) drug pricing, among other directives. For example, on May 12, 2025, President Trump issued an Executive Order that, among other things, required HHS, within 30 days, to establish and communicate to drug manufacturers MFN price targets designed to bring drug prices for American patients in line with those in comparably developed nations. If significant progress towards MFN pricing is not achieved, the Executive Order requires HHS to propose a rulemaking to implement MFN pricing. On December 19, 2025, CMS released two proposed rules that would incorporate MFN pricing principles into federal reimbursement for prescription drugs. The first proposal, the Global Benchmark for Efficient Drug Pricing Model (“GLOBE”) for Medicare Part B, would require manufacturers of specified single source drugs and sole source biologics to pay incremental rebates based on international benchmark prices, with participation triggered for products meeting CMS’s spending and eligibility criteria. The second proposal, the Guarding U.S. Medicare Against Rising Drug Costs (“GUARD”) model for Medicare Part D, would similarly mandate manufacturer rebates for qualifying sole source drugs where the Medicare net price exceeds an MFN benchmark derived from international reference pricing methodologies. As proposed, GLOBE would begin a five-year performance period on October 1, 2026 and GUARD would begin its performance period in 2027. These proposals will likely be subject to legal challenges that could delay their implementation or modify their impact on manufacturer pricing and revenue. Additionally, in November 2025, CMS introduced the GENErating cost Reductions for U.S. Medicaid (“GENEROUS”) Model, a voluntary MFN framework for manufacturers participating in the Medicaid Drug Rebate Program. Although it is voluntary, the GENEROUS model could also impact the drug pricing landscape for manufacturers.

If the proposed GLOBE and GUARD model rules or other MFN pricing rules are finalized, they are likely to mandate reduced prices of at least some drugs in the United States, if they are also sold in comparator countries. Even if Caldera does not market drugs in such countries, Caldera will be indirectly affected if Caldera’s drugs compete with drugs that were reduced by MFN pricing. Further, as part of the Make America Healthy Again Commission’s recent Strategy Report, the administration is working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising. These actions and policies may significantly reduce U.S. drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, restrictions or prohibitions on certain marketing practices, reporting of specified categories of remuneration provided to health care practitioners, marketing cost disclosure and transparency measures, including reporting and justification of launch prices or price increases above specified thresholds, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing.

Caldera expects that additional state and federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that federal and state governments will pay for pharmaceuticals and other healthcare products and services, lead to more rigorous coverage criteria, or result in reduced demand for Caldera’s product candidates or any future product candidates or additional pricing pressures. The implementation of cost containment measures or other healthcare reforms may prevent Caldera from being able to generate revenue, attain profitability, or commercialize Caldera’s products, if approved.

Even if Caldera is able to commercialize Caldera’s current product candidates and any future product candidates, if approved, such product candidate may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which would harm Caldera’s business.

The availability of coverage and the adequacy of reimbursement by governmental healthcare programs, such as Medicare and Medicaid, private health insurers and other third-party payors are essential for most patients to be able to afford prescription medications such as Caldera’s product candidates, if approved. Sales of any of Caldera’s product candidates that receive regulatory approval will be dependent substantially, both in the

 

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United States and internationally, on the extent to which the costs of Caldera’s product candidates will be paid by health maintenance, managed care, pharmacy benefit, and similar healthcare management organizations or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. If reimbursement is not available, or is available only to limited levels, Caldera may not be able to successfully commercialize Caldera’s product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow Caldera to establish or maintain pricing sufficient to realize an adequate return on Caldera’s investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which Caldera obtains regulatory approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, Caldera may not successfully commercialize any product candidate for which Caldera obtains regulatory approval.

There is significant uncertainty related to insurance coverage and reimbursement of newly approved products. In the United States, principal decisions about reimbursement for new products are typically made by CMS. CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. As a result, the coverage determination process is often time-consuming and costly. This process will require Caldera to provide scientific and clinical support for the use of Caldera’s products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. Increasingly, third-party payors are requiring that drug companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical products. Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical products. There may be especially significant delays in obtaining coverage and reimbursement for newly approved products. Third-party payors may limit coverage to specific products on an approved list, known as a formulary, which might not include all FDA-approved products for a particular indication. Caldera may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost effectiveness of Caldera’s products. Nonetheless, Caldera’s product candidates may not be considered medically necessary or cost effective. Caldera cannot be sure that coverage and reimbursement will be available for any product that Caldera commercializes and, if reimbursement is available, what the level of reimbursement will be.

Moreover, increasing efforts by governmental and third-party payors in the United States and abroad to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for newly approved products and, as a result, they may not cover or provide adequate payment for Caldera’s product candidates, if approved. Caldera expects to experience pricing pressures in connection with the sale of Caldera’s product candidates due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

Caldera is subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws and anti-money laundering laws and regulations. Compliance with these legal standards could impair Caldera’s ability to compete in domestic and international markets. Caldera can face criminal liability and other serious consequences for violations, which can harm Caldera’s business.

U.S. and foreign anti-corruption, anti-money laundering, export control, sanctions and other trade laws and regulations prohibit, among other things, companies and their employees, agents, CROs, CDMOs, legal counsel, accountants, consultants, contractors and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of these laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm and other consequences. Caldera has direct or indirect interactions with officials and

 

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employees of government agencies or government-affiliated hospitals, universities and other organizations. Caldera also expects Caldera’s non-U.S. activities to increase over time. Caldera expects to rely on third parties for research, nonclinical studies and clinical trials and/or to obtain necessary permits, licenses, patent registrations and other regulatory approvals. Caldera can be held liable for the corrupt or other illegal activities of Caldera’s personnel, agents, or partners, even if Caldera does not explicitly authorize or have prior knowledge of such activities.

Caldera is also subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations and various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control. Compliance with applicable regulatory requirements regarding the export of Caldera’s products may create delays in the introduction of Caldera’s products in international markets or, in some cases, prevent the export of Caldera’s products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the provision of certain products and services to countries, governments and persons targeted by U.S. sanctions.

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 Caldera’s revenue, if any.

In some countries, particularly member states of the EU, the pricing of therapeutic products is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after receipt of regulatory approval for a product. 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 member states, can further reduce prices. Reduced prices in EU member states could also result in reduced prices in the U.S. if the U.S. finalizes the proposed GLOBE or GUARD models or other MFN pricing rules (see “Risks Related to Government Regulation — Caldera may face difficulties from healthcare legislative and regulatory reform measures.”). In addition, to obtain coverage and reimbursement or pricing approvals in some countries, Caldera may be required to conduct a clinical trial or other studies that compare the cost-effectiveness of Caldera’s current or any future 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, Caldera’s business, financial condition, results of operations or prospects could be materially and adversely affected.

Risks Related to Caldera’s Intellectual Property

If Caldera is unable to obtain and maintain patent protection or other necessary rights for any of Caldera’s current or future product candidates and technology, or if the scope of the patent protection obtained is not sufficiently broad or Caldera’s rights under Caldera’s patents are not sufficiently broad, Caldera’s competitors could develop and commercialize products and technology similar or identical to Caldera’s, and Caldera’s ability to successfully commercialize Caldera’s products and technology may be adversely affected.

Caldera’s success is dependent in part on Caldera’s ability to obtain and maintain proprietary or intellectual property protection in the United States and other countries for Caldera’s current product candidates or any future product candidates, as well as Caldera’s core technologies, including Caldera’s manufacturing know-how.

 

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Caldera strives to protect and enhance the proprietary technology, inventions and improvements that are commercially important to the development of Caldera’s business by seeking, maintaining and defending Caldera’s intellectual property, whether developed internally or licensed from third parties. Caldera also relies on trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop, strengthen and maintain Caldera’s proprietary position in the therapeutic fields being pursued by Caldera.

The patent position of biotechnology and biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has in recent years been the subject of much litigation. The degree of patent protection Caldera requires to successfully compete in the marketplace may be unavailable or severely limited in some cases and may not adequately protect Caldera’s rights or permit Caldera to gain or keep any competitive advantage. Caldera cannot provide any assurances that any of Caldera’s owned or licensed patent applications will mature into issued patents, and cannot provide any assurances that any such patents, if issued, will include claims with a scope sufficient to protect Caldera’s current and future product candidates or otherwise provide any competitive advantage. Additionally, patents can be enforced only in those jurisdictions in which the patent has issued. Furthermore, patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first nonprovisional U.S. filing. The natural expiration of a patent outside of the United States varies in accordance with provisions of applicable local law, but is generally 20 years from the earliest local filing date. Various extensions may be available; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.

Caldera’s patent position with respect to CLD-423 depends entirely on rights licensed from Qyuns. As of the date of this proxy statement/prospectus, Caldera does not own any issued patents or pending patent applications relating to CLD-423, its components or their uses, and its patent rights consist solely of an exclusive license under four patent families licensed from Qyuns under the license agreement, dated as of April 23, 2025, between Caldera and Qyuns, as amended by Amendment #1 thereto, dated November 21, 2025 (as amended, the “Qyuns License Agreement”). Two of those four families, relating to the anti-TL1A binder composition and to the CLD-423 bispecific composition and their methods of use, currently consist only of pending patent applications, and no patents have issued in those families in any jurisdiction. Any patents issuing from the anti-TL1A binder and bispecific composition families are expected to expire in 2046, and the issued patents and pending applications relating to the anti-IL-23p19 binder composition, its formulations and methods of manufacture are expected to expire in 2040, in each case assuming payment of all applicable maintenance fees and without giving effect to any patent term adjustment, patent term extension or supplementary protection certificate. If the pending applications in the anti-TL1A binder and bispecific composition families do not issue, or issue with claims that are narrower than sought, Caldera may be unable to prevent competitors from developing bispecific antibodies with a similar format or target combination. Because Caldera owns no patents or patent applications of its own, Caldera does not control the prosecution, maintenance, enforcement or defense of the patent rights on which CLD-423 depends and must rely on Qyuns to take those actions.

Caldera’s licensed patent portfolio may not provide Caldera with adequate and continuing patent protection sufficient to exclude others from commercializing products similar to Caldera’s product candidates, including biosimilar and interchangeable versions of such products. In addition, the patent portfolio licensed to Caldera is, or may be, licensed to third parties outside Caldera’s licensed field, and such third parties may have certain enforcement rights. Thus, patents licensed to Caldera could be put at risk of being invalidated or interpreted narrowly in litigation filed by or against another licensee or in administrative proceedings brought by or against another licensee in response to such litigation or for other reasons.

Other parties have developed technologies that may be related or competitive to Caldera’s own and such parties may have filed or may file patent applications, or may have received or may receive patents, claiming inventions that may overlap or conflict with those claimed in Caldera’s own patent applications or issued patents. Publication of discoveries in the scientific literature lags behind the actual discoveries, and patent applications in

 

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the United States and in other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, Caldera cannot know with certainty whether the inventors of Caldera’s patents and applications were the first to make the inventions claimed in those patents or pending patent applications, or that they were the first to file for patent protection of such inventions. Further, Caldera cannot assure that all of the potentially relevant prior art relating to Caldera’s patents and patent applications has been found. If such prior art exists, it can invalidate a patent or prevent a patent from issuing from a pending patent application. As a result, the issuance, scope, validity and commercial value of Caldera’s patent rights cannot be predicted with any certainty. Further, if the breadth or strength of protection provided by Caldera’s patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with Caldera to license, develop or commercialize current or future product candidates.

In addition, the patent prosecution process is expensive and time-consuming, and Caldera or Caldera’s licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. In addition, the scope of the claims initially submitted for examination may be significantly narrowed by the time they issue, if at all. It is also possible that Caldera or Caldera’s licensors will fail to identify patentable aspects of Caldera’s research and development output before it is too late to obtain patent protection. Caldera cannot provide any assurances that Caldera will be able to pursue or obtain additional patent protection based on Caldera’s research and development efforts, or that any such patents or other intellectual property Caldera generates will provide any competitive advantage. Moreover, Caldera may not have the right to control the preparation, filing and prosecution of patent applications, or to control the maintenance of the patents, covering technology that Caldera licenses from third parties. Therefore, these patents and applications may not be filed, prosecuted or maintained in a manner consistent with the best interests of Caldera’s business.

Even if Caldera acquires patent protection that Caldera expects should enable Caldera to maintain competitive advantage, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability. Third parties, including former employees, consultants, collaborators and competitors, may challenge the inventorship, scope, validity, or enforceability thereof, which may result in such patents being narrowed, invalidated or held unenforceable. If issued, Caldera’s patents may be challenged in patent offices in the United States and abroad, or in court. For example, Caldera may be subject to Post Grant Review or Inter Partes Review proceedings to the U.S. Patent Trial and Appeal Board challenging the validity of one or more claims of Caldera’s patents, once issued. Such submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on one of Caldera’s patent applications. Caldera may become involved in opposition, reexamination, inter partes review, post-grant review, derivation, or similar proceedings in the United States or abroad challenging the claims of Caldera’s patents, once issued. Furthermore, patents may be challenged in court, once issued. Competitors may have filed patent applications before the inventors of Caldera’s patents did. A competitor may also claim that Caldera is infringing its patents and that Caldera therefore cannot practice Caldera’s technology as claimed under Caldera’s patent applications and patents, if issued. As a result, one or more claims of Caldera’s patents may be narrowed or invalidated. In litigation, a competitor could claim that Caldera’s patents, if issued, are not valid for a number of reasons. If a court agrees, Caldera would lose Caldera’s rights to those challenged patents.

Even if they are unchallenged, Caldera’s patents and pending patent applications, if issued, may not provide Caldera with any meaningful protection or prevent competitors from designing around Caldera’s patent claims to circumvent Caldera’s patents by developing similar or alternative technologies or therapeutics in a non-infringing manner. For example, even if Caldera has a valid and enforceable patent, Caldera may not be able to exclude others from practicing Caldera’s invention if the other party can show that they used the invention in commerce before Caldera’s filing date or the other party benefits from an ex-U.S. compulsory license. If the patent protection provided by the patents and patent applications Caldera holds or pursues with respect to Caldera’s product candidates is not sufficiently broad to impede such competition, Caldera’s ability to successfully commercialize Caldera’s product candidates could be negatively affected, which would harm Caldera’s business.

 

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Certain regulatory exclusivities may be available. However, the scope of such regulatory exclusivities is subject to change, and may not provide Caldera with adequate and continuing protection sufficient to exclude others from commercializing products similar to Caldera’s product candidates.

If Caldera is unable to protect the confidentiality of Caldera’s trade secrets, Caldera’s business and competitive position could be harmed.

In addition to patent protection, Caldera relies on the protection of Caldera’s trade secrets, unpatented know-how, technology and other proprietary information to maintain Caldera’s competitive position. Although Caldera has taken steps to protect Caldera’s trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions agreements with employees, consultants and advisors, Caldera cannot provide any assurances that any party thereto will not breach the agreement and disclose Caldera’s proprietary information, including Caldera’s trade secrets, and Caldera 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.

Moreover, third parties may still obtain this information or may come upon this or similar information independently, and Caldera would have no right to prevent them from using that technology or information to compete with Caldera. If any of these events occurs or if Caldera otherwise loses protection for Caldera’s trade secrets, the value of this information may be greatly reduced, and Caldera’s competitive position could be harmed. If Caldera does not apply for patent protection prior to such publication or if Caldera cannot otherwise maintain the confidentiality of Caldera’s proprietary technology and other confidential information, then Caldera’s ability to obtain patent protection or to protect Caldera’s trade secret information may be jeopardized.

If Caldera breaches its license agreement with Qyuns Therapeutics Co., Ltd., or any other agreements with third parties, or if there are disputes over the intellectual property that Caldera licenses, it could have a material adverse effect on Caldera’s commercialization efforts for CLD-423 or its current or future product candidates.

Caldera is party to the Qyuns License Agreement that enables Caldera to utilize third-party intellectual property, including certain know-how and four patent families covering the anti-IL-23p19 binder composition and its methods of use, formulations of and methods of manufacturing the anti-IL-23p19 binder composition, the anti-TL1A binder composition and its methods of use, and the CLD-423 bispecific composition and its methods of use, for the development and commercialization of CLD-423, and Caldera may in the future enter into additional license agreements with third parties under which Caldera licenses the use, development and commercialization rights to current or future product candidates or technology from third parties. Because Caldera does not own any patents or patent applications covering CLD-423, the loss or termination of the Qyuns License Agreement, in whole or in part, would deprive Caldera of the patent rights on which CLD-423 depends and would be expected to prevent Caldera from continuing to develop or commercialize CLD-423.

These intellectual property license agreements may require Caldera to comply with various obligations, including diligence obligations such as development and commercialization obligations, as well as potential royalty and milestone payments and other obligations. If Caldera fails to comply with its obligations under any of these license agreements, uses the licensed intellectual property in an unauthorized manner, becomes subject to bankruptcy-related proceedings or otherwise materially breaches any of these license agreements, the terms of the license granted may be materially modified, such as by rendering currently exclusive licenses non-exclusive, or it may give Caldera’s licensors the right to terminate the applicable license agreement, in whole or in part. Generally, the loss of or termination of Caldera’s rights under the license agreement, or any other licenses Caldera may acquire in the future, could harm Caldera’s business, financial condition, results of operations and prospects.

 

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Caldera may also, in the future, enter into license agreements with third parties under which Caldera is a sublicensee. If Caldera’s sublicensor fails to comply with its obligations under its upstream license agreement with its licensor, the licensor may have the right to terminate the upstream license, which may result in termination of Caldera’s sublicense. If this were to occur, Caldera would no longer have rights to the applicable intellectual property unless Caldera is able to secure Caldera’s own direct license with the owner of the relevant rights, which Caldera may not be able to do on reasonable terms, or at all, which may impact Caldera’s ability to continue to develop and commercialize product candidates incorporating the relevant intellectual property.

Licensing of intellectual property is important to Caldera’s business and involves complex legal, business and scientific issues. Disputes may arise between Caldera and Caldera’s licensors regarding intellectual property subject to a license agreement, including:

 

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the scope of rights granted under the license agreement and other interpretation-related issues;

 

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whether and the extent to which Caldera’s technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

 

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Caldera’s right to sublicense patent and other intellectual property rights to third parties under collaborative development relationships;

 

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Caldera’s diligence obligations with respect to the use of the licensed technology in relation to Caldera’s development and commercialization product candidates, and what activities satisfy those diligence obligations;

 

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Caldera’s right to transfer or assign the license;

 

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the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by Caldera’s licensors and Caldera and Caldera’s partners; and

 

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whether and the extent to which inventors are able to contest the assignment of their rights to Caldera’s licensors.

If disputes over intellectual property that Caldera has licensed or licenses in the future prevent or impair Caldera’s ability to maintain Caldera’s current licensing arrangements on acceptable terms or at all, Caldera may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on Caldera’s business. In addition, if disputes arise as to ownership of licensed intellectual property, Caldera’s ability to pursue or enforce the licensed patent rights may be jeopardized. If Caldera or Caldera’s licensors fail to adequately protect this intellectual property, Caldera’s ability to commercialize Caldera’s products could suffer. Further, certain of Caldera’s future license agreements with third parties may limit or delay Caldera’s ability to consummate certain transactions, may impact the value of those transactions or may limit Caldera’s ability to pursue certain activities (e.g., Caldera may in the future enter into license agreements that are not assignable or transferable, or that require the licensor’s express consent in order for an assignment or transfer to take place).

Caldera may not be able to protect Caldera’s intellectual property rights throughout the world.

Caldera’s patent applications are being processed by national patent offices around the world. There is uncertainty about which patents will issue and, if they do, as to when, to whom, and with what scope of claims. In addition, third parties may attempt to invalidate Caldera’s intellectual property rights. Even if Caldera’s rights are not directly challenged, disputes could lead to the weakening of Caldera’s intellectual property rights. Caldera’s defense against any attempt by third parties to circumvent or invalidate Caldera’s intellectual property rights could be costly to Caldera, could require significant time and attention of Caldera’s management and could have a material and adverse effect on Caldera’s business, financial condition, results of operations and prospects or Caldera’s ability to successfully compete. If Caldera is found to infringe a third-party’s intellectual property

 

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rights, Caldera could be forced, including by court order, to cease developing, manufacturing or commercializing the infringing product candidate or product.

Although the patent portfolio licensed to Caldera includes pending patent applications in the United States and other countries, filing, prosecuting, maintaining, enforcing and defending patents in all countries throughout the world would be prohibitively expensive, and Caldera’s intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, Caldera may not be able to prevent third parties from practicing the inventions claimed in its licensed patents in all countries outside the United States or from selling or importing products made using those inventions in and into the United States or other jurisdictions.

Competitors may use Caldera’s technologies in jurisdictions where Caldera has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where Caldera has patent protection, but enforcement is not as strong as that in the United States. These products may compete with Caldera’s product candidates, and Caldera’s patents, the patents of Caldera’s licensors, or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of many foreign countries do not favor the enforcement of patents and other intellectual property protection, which could make it difficult for Caldera to stop the infringement of Caldera’s patents or Caldera’s licensors’ patents or marketing of competing products in violation of Caldera’s proprietary rights. Proceedings to enforce Caldera’s patent rights in foreign jurisdictions could result in substantial costs and divert Caldera’s efforts and attention from other aspects of Caldera’s business, could put Caldera’s patents or the patents of Caldera’s licensors at risk of being invalidated or interpreted narrowly and Caldera’s patent applications or the patent applications of Caldera’s licensors at risk of not issuing and could provoke third parties to assert claims against Caldera. Caldera may not prevail in any lawsuits that Caldera initiates, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Caldera’s efforts to enforce Caldera’s intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that Caldera develops or licenses.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If Caldera is forced to grant a license to third parties with respect to any patents relevant to Caldera’s business, Caldera’s competitive position may be impaired, and Caldera’s business, financial condition, results of operations and prospects may be adversely affected.

Caldera, Caldera’s licensors, or any future collaborators and strategic partners may need to resort to litigation to protect or enforce Caldera’s patents, if and when granted, or other proprietary rights, all of which could be costly, time consuming, delay or prevent the development and commercialization of product candidates and any future product candidates, or put Caldera’s patents, if and when granted, and other proprietary rights at risk.

Competitors may infringe Caldera’s patents, if and when granted, or other intellectual property. If Caldera were to initiate legal proceedings against a third party to enforce a patent covering one of Caldera’s products or Caldera’s technology, the defendant could counterclaim that Caldera’s patent is invalid or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, for example, lack of utility, lack of novelty, lack of adequate written description, obviousness, including obviousness-type double patenting, or non-enablement. Grounds for an unenforceability assertion could be an allegation that an individual connected with prosecution of the patent withheld relevant information

 

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from the United States Patent and Trademark Office (“USPTO”), or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity or unenforceability during patent litigation is unpredictable. With respect to the validity question, for example, Caldera cannot be certain that there is no invalidating prior art, of which Caldera and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, Caldera would lose at least part, and perhaps all, of the patent protection on one or more of Caldera’s products or certain aspects of Caldera’s technology. Such a loss of patent protection could have a material and adverse effect on Caldera’s business, financial condition, results of operations and prospects. Derivation proceedings provoked by third parties or brought by Caldera may be necessary to determine the inventorship of inventions with respect to Caldera’s patents or patent applications. An unfavorable outcome could require Caldera to cease using the related technology or to attempt to license rights to it from the prevailing party. Caldera’s business could be harmed if the prevailing party does not offer Caldera a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and Caldera’s competitors gain access to the same technology. In addition, the uncertainties associated with litigation could have a material adverse effect on Caldera’s ability to raise the funds necessary to continue Caldera’s clinical trials, continue Caldera’s research programs, license necessary technology from third parties, or enter into development partnerships that would help Caldera bring Caldera’s product candidates or any future product candidates to market. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Caldera’s confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of Caldera’s common stock. Patents and other intellectual property rights will not protect Caldera’s technology if competitors design around Caldera’s protected technology without legally infringing Caldera’s patents or other intellectual property rights.

Intellectual property rights of third parties could adversely affect Caldera’s ability to commercialize Caldera’s product candidates and any future product candidates, and Caldera, Caldera’s licensors or collaborators, or any future strategic partners may become subject to third-party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate patents or other proprietary rights. Caldera might be required to litigate or obtain licenses from third parties in order to develop or market Caldera’s product candidates and any future product candidates. Such litigation or licenses could be costly or not available on commercially reasonable terms.

Caldera, Caldera’s licensors or collaborators, or any future strategic partners, may be subject to third-party claims for infringement or misappropriation of patent or other proprietary rights. There are a substantial number of forums available for challenging intellectual property rights, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and biopharmaceutical industries, including patent infringement lawsuits, interferences, derivations, post-grant reviews, oppositions and inter partes review proceedings before the USPTO, and corresponding foreign patent offices. There may be issued patents and pending patent applications that claim aspects of Caldera’s targets or Caldera’s product candidates or any future product candidates and modifications that Caldera may need to apply to Caldera’s product candidates or any future product candidates. There may be issued patents that claim methods which may be relevant to the products Caldera wishes to develop. Thus, it is possible that one or more entities will hold patent rights to which Caldera will need a license. If those entities refuse to grant Caldera a license to such patent rights on reasonable terms, Caldera may not be able to market products or perform research and development or other activities covered by these patents, which could have a material and adverse effect on Caldera’s business, financial condition, results of operations and prospects. If Caldera, Caldera’s licensors or collaborators, or any future strategic partners are found to infringe a third-party patent or other intellectual property rights, Caldera could be required to pay damages, potentially including treble damages and attorneys’ fees if Caldera or they are found to have infringed willfully. In addition, Caldera, Caldera’s licensors or collaborators, or any future strategic partners may choose to seek, or be required to seek, a license from a third party, which may not be available on acceptable terms, if at all. Even if a license can be obtained on acceptable terms, the rights may be non-exclusive, which could give Caldera’s competitors access to the same technology or intellectual property rights licensed to

 

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Caldera. If Caldera fails to obtain a required license, Caldera or Caldera’s existing or future collaborators, or any future strategic partners, may be unable to effectively market product candidates based on Caldera’s technology, which could limit Caldera’s ability to generate revenue or achieve profitability and possibly prevent Caldera from generating revenue sufficient to sustain Caldera’s operations. In addition, Caldera may find it necessary to pursue claims or initiate lawsuits to protect or enforce Caldera’s patent or other intellectual property rights. The cost to Caldera in defending or initiating any litigation or other proceeding relating to patent or other proprietary rights, even if resolved in Caldera’s favor, could be substantial, and litigation could divert Caldera’s management’s attention. Some of Caldera’s competitors may be able to sustain the costs of complex patent litigation more effectively than Caldera can because they have substantially greater resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could delay Caldera’s research and development efforts and limit Caldera’s ability to continue Caldera’s operations.

Caldera’s competitive position may suffer if patents issued to third parties or other third-party intellectual property rights cover Caldera’s products or product candidates or elements thereof, or Caldera’s manufacture or uses relevant to Caldera’s development plans. In such cases, Caldera may not be in a position to develop or commercialize products or product candidates until such patents expire or unless Caldera successfully pursues litigation to nullify or invalidate the third-party intellectual property right concerned, or enters into a license agreement with the intellectual property right holder, if available on commercially reasonable terms. There may be pending patent applications or issued patents held by third parties of which Caldera is aware but does not believe are valid or enforceable or does not believe Caldera infringes, or of which Caldera is not aware, which applications or patents, if found to be valid and enforceable, could be alleged to be infringed by Caldera’s product candidates or any future product candidates. If such an infringement claim should be brought and be successful, Caldera may be required to pay substantial damages, including potentially treble damages and attorneys’ fees for willful infringement, and Caldera may be forced to abandon Caldera’s product candidates or any future product candidates or seek a license from any patent holders. No assurances can be given that a license will be available on commercially reasonable terms, if at all.

The bispecific antibody field is subject to a particularly complex and evolving patent landscape, with multiple companies holding patents covering various aspects of bispecific antibody design, engineering, and manufacturing. Companies developing bispecific antibodies have been, and may in the future be, subject to patent infringement claims from holders of patents covering bispecific antibody technologies, including claims relating to specific antibody formats, Fc engineering, and methods of producing bispecific molecules. For example, patent disputes involving bispecific antibody technologies have recently been litigated in the biopharmaceutical industry, and similar claims could be asserted against Caldera or its licensors. Because CLD-423 utilizes a novel monovalent 1+1 bispecific antibody format, the risk that third parties may assert patent claims covering aspects of this format or related bispecific technologies is particularly relevant. Any such claims, regardless of merit, could be costly and time-consuming to defend and could delay or prevent the development and commercialization of CLD-423.

It is also possible that Caldera has failed to identify relevant third-party patents or applications. Patent applications covering Caldera’s products could have been filed by others without Caldera’s knowledge. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover Caldera’s products or the use of Caldera’s products. Third-party intellectual property right holders may also actively bring infringement claims against Caldera. Caldera cannot guarantee that Caldera will be able to successfully settle or otherwise resolve such infringement claims. If Caldera is unable to successfully settle future claims on terms acceptable to Caldera, Caldera may be required to engage in or continue costly, unpredictable and time-consuming litigation and may be prevented from or experience substantial delays in marketing Caldera’s products. Parties making claims against Caldera may be able to sustain the costs of complex patent litigation more effectively than Caldera can because they have substantially greater resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of Caldera’s confidential information could be compromised by disclosure. In addition, any uncertainties resulting

 

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from the initiation and continuation of any litigation could have material adverse effect on Caldera’s ability to raise additional funds or otherwise have a material adverse effect on Caldera’s business, financial condition, results of operations and prospects. If Caldera fails in any such dispute, in addition to being forced to pay damages, Caldera may be temporarily or permanently prohibited from commercializing any of Caldera’s product candidates or any future product candidates that are held to be infringing. Caldera might, if possible, also be forced to redesign product candidates so that Caldera no longer infringes the third-party intellectual property rights. Any of these events, even if Caldera were ultimately to prevail, could require Caldera to divert substantial financial and management resources that Caldera would otherwise be able to devote to Caldera’s business and could have a material and adverse effect on Caldera’s business, financial condition, results of operations and prospects.

Intellectual property litigation could cause Caldera to spend substantial resources and distract Caldera’s personnel from their normal responsibilities.

Litigation and other legal proceedings relating to intellectual property claims, with or without merit, are unpredictable and generally expensive and time consuming and are likely to divert significant resources from Caldera’s core business, including distracting Caldera’s technical and management personnel from their normal responsibilities. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of Caldera’s confidential information could be compromised by disclosure during this type of litigation. 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 Caldera’s Common Stock. Moreover, such litigation or proceedings could substantially increase Caldera’s operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities.

Caldera may not have sufficient financial or other resources to adequately conduct such litigation or proceedings. Some of Caldera’s competitors may be able to sustain the costs of such litigation or proceedings more effectively than Caldera can because of their greater financial resources and more mature and developed intellectual property portfolios. Accordingly, despite Caldera’s efforts, Caldera may not be able to prevent third parties from infringing upon or misappropriating or from successfully challenging Caldera’s intellectual property rights. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on Caldera’s ability to compete in the marketplace.

Caldera may be subject to claims that Caldera or Caldera’s employees or consultants have wrongfully used or disclosed alleged intellectual property of Caldera’s employees’ or consultants’ former employers or their clients. These claims may be costly to defend and if Caldera does not successfully do so, Caldera may be required to pay monetary damages and may lose valuable intellectual property rights or personnel.

Many of Caldera’s employees, including Caldera’s management, were previously employed at biotechnology or biopharmaceutical companies, including Caldera’s competitors or potential competitors. Some of these employees executed proprietary rights, non-disclosure and non-competition agreements in connection with such previous employment. From time to time, Caldera may be subject to claims that these employees or Caldera has inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information of their former employers. Litigation may be necessary to defend against these claims. If Caldera fails in defending such claims, in addition to paying monetary damages, Caldera may lose valuable intellectual property rights or personnel. A loss of key research personnel or their work product could hamper Caldera’s ability to develop and ultimately commercialize, or prevent Caldera from developing and commercializing, Caldera’s product candidates or any future product candidates, which could severely harm Caldera’s business, financial condition, results of operations and prospects. Even if Caldera is successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.

 

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Patent terms may be insufficient to protect Caldera’s competitive position on Caldera’s product candidates and any future 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 U.S. non-provisional filing date. Various patent term adjustments or extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering Caldera’s product candidates or any future product candidates are obtained, once the patent life has expired, Caldera may be open to competition from competitive products, including biosimilars or interchangeables. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, Caldera’s owned and licensed patent portfolio may not provide Caldera with sufficient rights to exclude others from commercializing products similar or identical to Caldera’s.

If Caldera does not obtain patent term extension for any product candidates Caldera may develop, Caldera’s business may be harmed.

Depending upon the timing, duration and specifics of any FDA regulatory approval of any product candidates Caldera may develop and Caldera’s technology, Caldera’s U.S. patent or one or more U.S. patents that may issue in the future based on a patent application that Caldera licenses or owns may be eligible for limited patent term extension under the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval, only one patent may be extended and only those claims covering the approved product, a method for using it or a method for manufacturing it may be extended. The application for the extension must be submitted prior to the expiration of the patent for which extension is sought and within 60 days of FDA approval. A patent that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. However, Caldera may not be granted an extension because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or the scope of patent protection afforded could be less than Caldera requests. In addition, to the extent Caldera wishes to pursue patent term extension based on a patent that Caldera in-licenses from a third party, Caldera would need the cooperation of that third party. If Caldera is unable to obtain patent term extension or the term of any such extension is less than Caldera requests, Caldera’s competitors may obtain approval of competing products following Caldera’s patent expiration, and Caldera’s revenue could be reduced. Any of the foregoing could have a material adverse effect on Caldera’s business, financial condition, results of operations and prospects.

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

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. Caldera has systems in place to remind Caldera to pay these fees, and Caldera employs an outside firm and/or relies on Caldera’s outside counsel to pay these fees due to the USPTO and non-U.S. governmental patent agencies. The USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. Caldera employs reputable law firms and other professionals to help Caldera comply, and in many cases an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance 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. In such an event, Caldera’s competitors might be able to enter the market and this circumstance would have a material adverse effect on Caldera’s business.

 

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Changes in U.S. patent and ex-U.S. patent laws could diminish the value of patents in general, thereby impairing Caldera’s ability to protect Caldera’s current or future product candidates.

Changes in either the patent laws or interpretation of the patent laws in the United States or in other jurisdictions could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. In the United States, numerous recent changes to the patent laws and proposed changes to the rules of the USPTO may have a significant impact on Caldera’s ability to protect Caldera’s technology and enforce Caldera’s intellectual property rights.

In addition, the patent positions of companies in the development and commercialization of pharmaceuticals and biologics are particularly uncertain. U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. 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 Caldera’s patent rights and Caldera’s ability to protect, defend and enforce Caldera’s patent rights in the future. For example, in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023), the Supreme Court held that claims with functional language may face high hurdles in fulfilling the enablement requirement. Recent Federal Circuit decisions raise questions regarding the award of patent term adjustment (“PTA”) for patents where related patents have been issued without a PTA. Thus, it cannot be said with certainty how PTA will or will not be viewed in the future and whether patent expiration dates may be impacted. Caldera cannot predict how this and future decisions by the courts, the U.S. Congress or the USPTO may impact the value of Caldera’s patents.

Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken Caldera’s ability to obtain new patents or to enforce patents that Caldera has licensed or that Caldera may obtain in the future. For example, the complexity and uncertainty of European patent laws have also increased in recent years. In certain member states of the European Union, a new unitary patent system took effect June 1, 2023, which will significantly impact European patents, including those granted before the introduction of such a system. Under the unitary patent system, European applications have the option, upon grant of a patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court (“UPC”). As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation. Patents granted before the implementation of the UPC will have the option of opting out of the jurisdiction of the UPC and remaining as national patents in the UPC countries. Patents that remain under the jurisdiction of the UPC will be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could invalidate the patent in all countries who are signatories to the UPC. Caldera cannot predict with certainty the long-term effects of any potential changes.

If Caldera’s trademarks and trade names are not adequately protected, then Caldera may not be able to build name recognition in Caldera’s markets of interest and Caldera’s business may be adversely affected.

Caldera’s current or future trademarks or trade names may be challenged, infringed, circumvented or declared generic or descriptive or determined to be infringing on other marks. Caldera may not be able to protect Caldera’s rights to these trademarks and trade names or may be forced to stop using these names, which Caldera needs for name recognition by potential partners or customers in Caldera’s markets of interest.

During trademark registration proceedings, Caldera may receive rejections of Caldera’s applications by the USPTO or by the comparable agencies in other foreign jurisdictions. Although Caldera would be given an opportunity to respond to those rejections, Caldera may be unable to overcome such rejections. In addition, in the USPTO and in comparable agencies in many foreign jurisdictions, third parties are given an opportunity to oppose pending trademark applications and to seek to cancel registered trademarks. Opposition or cancellation proceedings may be filed against Caldera’s trademarks, and Caldera’s trademarks may not survive such

 

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proceedings. If Caldera is unable to establish name recognition based on Caldera’s trademarks and trade names, Caldera may not be able to compete effectively and Caldera’s business may be adversely affected. Caldera may license Caldera’s trademarks and trade names to third parties, such as distributors. Although these license agreements may provide guidelines for how Caldera’s trademarks and trade names may be used, a breach of these agreements or misuse of Caldera’s trademarks and trade names by Caldera’s licensees may jeopardize Caldera’s rights in or diminish the goodwill associated with Caldera’s trademarks and trade names. Moreover, any name Caldera has proposed to use with Caldera’s therapeutic candidate in the United States must be approved by the FDA, regardless of whether Caldera has registered it, or applied to register it, as a trademark. Similar requirements exist in the European Union and in other countries. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion with other product names. If the FDA (or an equivalent administrative body in a foreign jurisdiction) objects to any of Caldera’s proposed proprietary product names, it may be required to expend significant additional resources in an effort to identify a suitable substitute name that would qualify under applicable trademark laws, not infringe the existing rights of third parties and be acceptable to the FDA. Furthermore, in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement claim asserted by the owner of a senior trademark. At times, competitors or other third parties may adopt trade names or trademarks similar to Caldera’s, thereby impeding Caldera’s ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations of Caldera’s registered or unregistered trademarks or trade names. If Caldera asserts trademark infringement claims, a court may determine that the marks Caldera has asserted are invalid or unenforceable, or that the party against whom Caldera has asserted trademark infringement has superior rights to the marks in question. In this case, Caldera could ultimately be forced to cease use of such trademarks. In addition, geo-political actions in the United States and in foreign countries could increase the uncertainties and costs surrounding the prosecution or maintenance of Caldera’s patent applications or those of any current or future licensors and the maintenance, enforcement or defense of Caldera’s issued patents or those of any current or future licensors.

Intellectual property rights do not necessarily address all potential threats to Caldera’s business.

The degree of future protection afforded by Caldera’s intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect Caldera’s business or permit Caldera to maintain Caldera’s competitive advantage. For example:

 

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others may be able to develop products that are similar to Caldera’s product candidates but that are not covered by the claims of the patents that Caldera owns or licenses;

 

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Caldera or Caldera’s licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that Caldera owns or licenses;

 

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Caldera or Caldera’s licensors or collaborators might not have been the first to file patent applications covering certain of Caldera’s inventions;

 

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others may independently develop similar or alternative technologies or duplicate any of Caldera’s technologies without infringing Caldera’s intellectual property rights;

 

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it is possible that the pending patent applications Caldera owns or licenses will not lead to issued patents;

 

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issued patents that Caldera owns or licenses may be held invalid or unenforceable, as a result of legal challenges by Caldera’s competitors;

 

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Caldera’s competitors might conduct research and development activities in countries where Caldera does not have patent rights and then use the information learned from such activities to develop competitive products for sale in Caldera’s major commercial markets;

 

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Caldera may not develop additional proprietary technologies that are patentable;

 

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the patents of others may have an adverse effect on Caldera’s business;

 

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Caldera may fail to adequately protect and police Caldera’s trademarks and trade secrets; and

 

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Caldera may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.

Should any of these events occur, it could significantly harm Caldera’s business, financial condition, results of operations and prospects.

Caldera’s use of artificial intelligence tools in its research, development and business processes could expose Caldera to legal, regulatory, intellectual property and reputational risks.

Caldera uses, and expects to increase its use of, artificial intelligence (“AI”) tools, including generative AI tools, in support of its research and development, clinical development, regulatory, business development and corporate functions. AI tools may produce outputs that are inaccurate, incomplete, biased or not reproducible, and those deficiencies may not be readily detectable. If Caldera or the third parties on which it relies make development, regulatory or business decisions based on deficient AI outputs, Caldera’s development programs could be delayed, its analyses could prove unreliable, and its business, financial condition, results of operations and prospects could be adversely affected. Because Caldera operates with a small internal organization and relies extensively on third-party service providers, it has limited ability to verify whether, or how, those providers use AI tools in performing services for Caldera.

The use of AI tools also presents risks to Caldera’s confidential information and intellectual property. Inputting Caldera’s proprietary or confidential information, including unpublished clinical data, trade secrets or know-how licensed from Qyuns, into third-party AI tools could result in the loss of confidentiality or trade secret protection, could breach Caldera’s contractual confidentiality obligations, and could compromise Caldera’s ability to obtain or enforce patent protection. The legal frameworks governing inventorship and ownership of inventions and other works created with the assistance of AI remain unsettled, and Caldera may be unable to obtain or enforce intellectual property rights in AI-assisted outputs. AI tools may also generate outputs that infringe or misappropriate the intellectual property rights of third parties, exposing Caldera to claims.

In addition, the legal and regulatory landscape governing AI is evolving rapidly and is uncertain. The European Union’s Artificial Intelligence Act entered into force on August 1, 2024, with most of its provisions becoming applicable on August 2, 2026, and imposes obligations on providers and deployers of AI systems. Several U.S. states, including Colorado and California, have enacted laws regulating certain uses of AI, and U.S. federal agencies have issued guidance addressing AI. Compliance with these and future requirements could require Caldera to modify its practices, implement additional governance, monitoring and human oversight measures, and incur additional costs, and any actual or perceived non-compliance, or any controversy regarding Caldera’s use of AI, could result in enforcement action, litigation, reputational harm or other adverse consequences.

Risks Related to Caldera’s Business and Operations

Caldera’s future performance is dependent on its ability to retain key employees and to attract, retain and motivate qualified personnel and manage its human capital.

Caldera’s ability to compete in the highly competitive biopharmaceutical industry is largely dependent on its ability to attract, motivate and retain highly qualified clinical, quality control, scientific, medical and managerial personnel. Caldera is highly dependent on the development and management expertise of its executive officer team, including Praveen Tipirneni, M.D., its Chief Executive Officer and co-founder, Liangsu Wang, Ph.D., its Chief Scientific Officer and co-founder, Zhong Liu, Ph.D., its Chief Technology Officer, and Aaron Pelta, its Chief Business Officer. Caldera currently does not maintain “key person” life insurance on these individuals or

 

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any of its employees. This lack of insurance means that Caldera may not have adequate compensation for the loss of the services of these individuals. The loss of one or more members of Caldera’s management team or other key employees or advisors could delay its research and development programs and have a material and adverse effect on its business, financial condition, results of operations and prospects. Caldera is dependent on the continued service of its technical personnel, because of the highly technical nature of Caldera’s product candidates, and the specialized nature of the regulatory approval process. Because Caldera’s management team and key employees are not obligated to provide it with continued service, they could terminate their employment with Caldera at any time without penalty. Caldera’s dependence on a small executive team is heightened by the fact that Caldera had only 14 full-time employees as of June 30, 2026.

Caldera operates with a distributed workforce, with employees located throughout the United States and United Kingdom. Caldera is currently a remote-based company, and substantially all of its employees work remotely. Competition for skilled personnel in Caldera’s market, and nationally, is intense and may limit Caldera’s ability to hire and retain highly qualified personnel on acceptable terms or at all. Caldera also faces competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations. Because Caldera recruits nationally rather than in a single regional market, it competes for personnel with a broader set of employers, including larger companies able to offer greater compensation and resources. Caldera’s future performance will be dependent in large part on its continued ability to attract and retain highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing, manufacturing, governmental regulation and commercialization. Managing and retaining a distributed workforce also presents additional challenges relating to supervision, collaboration and company culture. If Caldera is unable to continue to attract and retain high-quality personnel, the rate and success at which it can discover and develop product candidates will be limited, which could have a material and adverse effect on its business, financial condition, results of operations and prospects.

Caldera expects to expand its development and regulatory capabilities, and as a result, Caldera may encounter difficulties in managing its growth, which could disrupt Caldera’s operations.

As of June 30, 2026, Caldera had 14 full-time employees. Caldera expects to increase the number of its employees and the scope of its operations, particularly in the areas of clinical development, clinical operations, manufacturing, late-stage regulatory affairs, finance, accounting, management information systems, business operations, public company compliance, communications and other corporate development functions, and, if CLD-423 or any of its other potential or future product candidates receive regulatory approval, sales, marketing and distribution capabilities. If Caldera acquires additional product candidates or enters into future collaborations, it may have to further expand its employee base beyond its current projections, which may include further nonclinical research and development or later-stage regulatory operations. To manage Caldera’s anticipated future growth and operations as a public company, it must continue to implement and improve its managerial, operational and financial systems, expand its facilities and continue to recruit and train additional qualified personnel. Due to Caldera’s limited financial resources and the limited experience of its management team in managing a company with such anticipated growth and with developing sales, marketing and distribution infrastructure, it may not be able to effectively manage the expansion of its operations or recruit and train additional qualified personnel. As Caldera’s operations expand, it also expects that it will need to manage additional relationships with various strategic partners, suppliers and other third parties. The expansion of Caldera’s operations may lead to significant costs and may divert its management and business development resources.

If Caldera is not able to effectively manage growth and expand its operations, it may not be able to successfully implement the tasks necessary to further develop and commercialize, if approved, CLD-423 or other potential or future product candidates and, accordingly, it may not achieve its research, development and commercialization goals.

 

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Caldera faces substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than Caldera does.

The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary and novel products and product candidates. Caldera’s competitors have developed, are developing or may develop products, product candidates and processes competitive with Caldera’s product candidates. Any product candidates that Caldera successfully develops and commercializes will compete with existing therapies and new therapies that may become available in the future. Caldera believes that a significant number of product candidates are currently under development, and may become commercially available in the future, for the treatment of conditions for which Caldera is currently attempting and may in the future attempt to develop product candidates. In addition, Caldera’s product candidates may need to compete with drugs physicians use off-label to treat the indications for which Caldera seeks approval. This may make it difficult for Caldera to replace existing therapies with Caldera’s product candidates.

In particular, there is intense competition in the pharmaceutical and biotechnology industries. Caldera has competitors both in the U.S. and internationally, including major multinational pharmaceutical companies, established biotechnology companies, specialty pharmaceutical companies, emerging and start-up companies, universities and other research institutions. Caldera also competes with these organizations to recruit and retain qualified scientific and management personnel, which could negatively affect Caldera’s level of expertise and Caldera’s ability to execute its business plan. Caldera will also face competition in establishing clinical trial sites and patient enrollment in clinical trials, as well as in acquiring technologies complementary to, or necessary for, Caldera’s programs.

Many of Caldera’s competitors, either alone or with their collaborators, have significantly greater financial resources, established presence in the market, and expertise in research and development, manufacturing, nonclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than Caldera. Large pharmaceutical and biotechnology companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients and manufacturing biotechnology product candidates. These companies also have significantly greater research and marketing capabilities than Caldera and may also have product candidates that have been approved or are in late stages of development, and collaborative arrangements in Caldera’s target markets with leading companies and research institutions. Established pharmaceutical and biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that Caldera develops obsolete. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies, as well as in acquiring technologies complementary to, or necessary for, Caldera’s programs. As a result of all of these factors, Caldera’s competitors may succeed in obtaining approval from the FDA or other comparable foreign regulatory authorities or in discovering, developing and commercializing product candidates in Caldera’s field before Caldera does.

In particular, if approved for the treatment of patients with IBD, CLD-423 would compete with numerous approved therapies, including TNF inhibitors such as Humira (adalimumab, AbbVie), Remicade (infliximab, Johnson & Johnson) and Simponi (golimumab, Johnson & Johnson); IL-12/23 and IL-23 inhibitors such as Stelara (ustekinumab, Johnson & Johnson), Skyrizi (risankizumab, AbbVie), Omvoh (mirikizumab, Eli Lilly) and Tremfya (guselkumab, Johnson & Johnson); the α4ß7 integrin inhibitor Entyvio (vedolizumab, Takeda); JAK inhibitors such as Xeljanz (tofacitinib, Pfizer) and Rinvoq (upadacitinib, AbbVie); and S1P receptor modulators such as Zeposia (ozanimod, Bristol Myers Squibb) and Velsipity (etrasimod, Pfizer). CLD-423 would also compete with biosimilars and generic products that are currently marketed or in development for many of these therapies.

CLD-423 would also compete with investigational anti-TL1A monoclonal antibodies in clinical development, including tulisokibart (Merck), afimkibart (Roche) and duvakitug (Sanofi and Teva). In addition,

 

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CLD-423 would compete with investigational dual-antibody combination therapies in clinical development, including anti-TL1A plus anti-IL-23 combination therapies such as SPY-230 (Spyre) and ABBV-7066 (AbbVie), as well as combination therapies targeting other inflammatory pathways being developed by Spyre, AbbVie, and Johnson & Johnson. CLD-423 would also compete with investigational bispecific antibodies targeting TL1A and IL-23, including RG6730 (Roche), SIM0709 (Boehringer Ingelheim), XmAb412 (Xencor) and other investigational bispecific antibody programs.

Several of these investigational therapies are significantly further advanced in clinical development than CLD-423 and are being developed by companies with substantially greater financial, technical, clinical, manufacturing and commercial resources than Caldera. As a result, these competitors may be better positioned to enroll patients in clinical trials, recruit experienced clinical investigators, obtain regulatory approvals, manufacture products at commercial scale, and achieve market acceptance for their products. Consequently, these factors may make it more difficult for Caldera to successfully develop, obtain regulatory approval for and commercialize CLD-423, if approved.

Caldera’s potential commercial opportunity could be reduced or eliminated if competitors develop and commercialize products that are safer, more effective, have fewer or less severe adverse events, are more convenient, have a broader label, are marketed more effectively, are more widely reimbursed or are less expensive than any products that Caldera may develop. Physicians may be more willing to prescribe competitors’ products for various reasons, and may rely on guidelines related to treatment of patients issued by medical societies, industry groups or other organizations, which may not include, and may never include, Caldera’s products. Caldera’s competitors also may obtain marketing approval from the FDA or other comparable foreign regulatory authorities for their products more rapidly than Caldera may obtain approval for its product candidates, which could result in competitors establishing a strong market position before Caldera is able to enter the market, or make Caldera’s development and marketing more complicated. Even if the product candidates Caldera develops achieve marketing approval, they may be priced at a significant premium over competitive products if any have been approved by then, resulting in reduced competitiveness. Technological advances or products developed by Caldera’s competitors may render Caldera’s technologies or product candidates obsolete, less competitive or not economical. If Caldera is unable to compete effectively, Caldera’s opportunity to generate revenue from the sale of products Caldera may develop, if approved, could be adversely affected.

Caldera depends on its information technology systems and data, and those of the third parties with whom it works, and any disruption to, or security incident affecting, those systems or data could result in material adverse consequences to Caldera’s business.

Caldera is increasingly dependent on information technology systems, infrastructure and data to operate Caldera’s business. In the ordinary course of business, Caldera, and the third parties with whom Caldera works, collect, process, store, generate, transfer, and transmit (collectively, process) a significant amount of personal information and other sensitive information, including Caldera’s proprietary and confidential business data, trade secrets, employee data, intellectual property, data Caldera collects about trial participants in connection with clinical trials, and other sensitive third-party data (collectively, sensitive data). It is important that Caldera does so in a manner designed to maintain the availability, confidentiality, and integrity of such data.

Caldera and the third parties with whom Caldera works may experience security incidents caused by Caldera’s personnel, vendors, or other external actors, including cyber-attacks, malicious internet-based activity, online and offline fraud, and other activities that could threaten the confidentiality, integrity, and availability of Caldera’s sensitive data and information technology systems and those of the third parties with whom Caldera works. Such threats are prevalent, continue to rise, are increasingly difficult to detect, and come from a variety of sources, including criminals, “hacktivists,” insiders, and sophisticated nation state or state-supported actors. Caldera and the third parties with whom Caldera works are subject to evolving threats such as social engineering attacks (including deep fakes and phishing), malicious code (such as viruses and worms), malware (including advanced persistent threat intrusions), denial-of-service attacks, credential stuffing, credential harvesting,

 

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personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data, adware, telecommunications failures, earthquakes, fires, floods, attacks enhanced or facilitated by artificial intelligence, and other similar threats.

It may be difficult or costly to detect, investigate, mitigate, contain, and remediate a security incident. Caldera’s efforts to do so may not be successful. Actions taken by Caldera or the third parties with whom Caldera works to detect, investigate, mitigate, contain, and remediate a security incident could result in outages, data losses, and disruptions of Caldera’s business. Threat actors may also gain access to the same or other networks and systems after a compromise of Caldera’s networks and systems or those of the third parties with whom Caldera works.

Remote work has increased risks to Caldera’s information technology systems and data, as Caldera’s employees utilize network connections, computers and devices outside Caldera’s premises or network, including working at home, while in transit and in public locations.

Future business transactions (such as acquisitions) could expose Caldera to additional cybersecurity risks and vulnerabilities as Caldera’s systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Furthermore, Caldera may discover security issues not found during due diligence of such acquired or integrated entities or it may be difficult to integrate companies into Caldera’s information technology environment and security program. In particular, in connection with the Mergers, Caldera (and, following the Closing, Parent) expects to integrate, continue to operate, or wind down certain information technology systems and data of Synlogic and any undetected vulnerabilities or prior security incidents in those systems could expose Parent to additional cybersecurity risks.

Caldera also outsources certain elements of Caldera’s information technology systems and operations to various third parties. Caldera’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 despite any applicable contractual representations and warranties to do so. If the third parties with whom Caldera works experience a security incident or other interruption, Caldera could experience adverse consequences. While Caldera may be entitled to damages if such third parties fail to satisfy their privacy or security related obligations to Caldera, any award may be insufficient to cover Caldera’s damages, or Caldera may be unable to recover any such award. In addition, supply chain attacks have increased in frequency and severity, and Caldera cannot guarantee that third parties’ infrastructure in Caldera’s supply chain or that of the third parties with whom Caldera works have not been or will not be compromised.

Caldera, and the third parties with whom Caldera works, take steps designed to detect, mitigate, and remediate vulnerabilities in Caldera’s information systems; however, Caldera may not detect and remediate all such vulnerabilities on a timely basis. Further, Caldera may experience delays in developing and deploying remedial measures and patches designed to address identified vulnerabilities. Vulnerabilities could be exploited and result in a security incident.

Despite the implementation of these security measures, any of the previously identified or similar threats could cause a security incident or other interruption that could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to Caldera’s sensitive data, or Caldera’s information technology systems, or those of the third parties with whom Caldera works. A security incident or other interruption could disrupt the ability of Caldera, or the third parties with whom Caldera works, to provide Caldera’s services.

To try to protect Caldera’s information technology systems and sensitive data, Caldera has expended and may expend significant resources to implement and maintain specific security measures, industry standards, and reasonable security measures. Applicable data privacy and security obligations may require Caldera, or Caldera may voluntarily choose, to notify relevant stakeholders, including affected individuals, customers, regulatory

 

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authorities, and investors, of security incidents, or to take other actions, such as providing credit monitoring and identity theft protection services. Such disclosures and related actions can be costly, and the disclosure or the failure to comply with such applicable requirements could lead to adverse consequences.

The risk of a security incident or other disruption has generally increased as the number, intensity, and the sophistication of attempted and successful attacks and intrusions from around the world have increased. Caldera may not be able to anticipate all types of security threats, nor implement effective preventive measures against all such security threats. If Caldera (or a third party with whom Caldera works) experiences or is perceived to have experienced a security incident involving sensitive data or information technology systems, Caldera may experience material adverse consequences, such as government enforcement actions (for example, investigations, fines, penalties, audits, or inspections); additional reporting requirements or oversight; restrictions on processing sensitive data; litigation (including possible class action claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; diversion of management attention; interruptions in Caldera’s operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant material consequences may cause existing customers to stop enrolling patients in Caldera’s sponsored clinical trials or prescribing Caldera’s products, deter new customers from doing so, and negatively impact Caldera’s ability to grow and operate Caldera’s business. Furthermore, if the information technology systems of a third party with whom Caldera works become subject to a security incident or other disruption, Caldera may have insufficient recourse against such third parties and Caldera may have to expend significant resources to mitigate the impact of such an event, and to develop and implement protections to prevent future events of this nature from occurring.

Significant disruptions of Caldera’s information technology systems or those of the third parties with whom Caldera works, or security breaches could result in the loss, misappropriation or unauthorized access, use, or disclosure of, or the prevention of access to, confidential information (including trade secrets or other intellectual property or proprietary business information) and claims by Caldera’s counterparties that Caldera has failed to comply with legal or contractual obligations, which could result in financial, legal, business, and reputational harm to Caldera.

There can be no assurance that the limitations of liability in Caldera’s contracts would be enforceable or adequate to protect Caldera from liabilities and damage, and Caldera may not have adequate insurance coverage to cover all types of costs, expenses and losses Caldera could incur with respect to security breaches or disruptions. The successful assertion of one or more large claims against Caldera that exceed any available insurance coverage, or results in changes to Caldera’s insurance policies (including premium increases or the imposition of large deductible or co-insurance requirements), could have an adverse effect on Caldera’s business. In addition, Caldera cannot be sure that Caldera’s existing insurance coverage will continue to be available on acceptable terms or that Caldera’s insurers will not deny coverage as to any future claim.

Caldera and the third parties with whom it works are, or may in the future become, subject to stringent and changing obligations related to data privacy and security. Caldera’s (or their) actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation (including class action claims) or mass arbitration demands; fines or penalties; disruptions to Caldera’s business operations; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse business consequences.

The global data protection landscape is rapidly evolving and Caldera’s data processing activities subject Caldera to numerous data privacy and security obligations, such as various state, federal and foreign laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements and other obligations that govern the processing of sensitive data by Caldera and on Caldera’s behalf, and Caldera may be subject to new or additional obligations related to data privacy and security and face increased scrutiny from regulatory authorities as Caldera’s business grows. The legislative and regulatory landscape for data privacy and security continues to evolve worldwide, and there has been an increasing focus on

 

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these issues with the potential to adversely affect Caldera’s business. Various global legislative and regulatory bodies, or self-regulatory organizations, may expand current laws, rules or regulations, enact new ones or issue guidance regarding data privacy and security that could impact Caldera’s business. As implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, Caldera cannot yet determine the impact that future privacy and security obligations may have on Caldera’s business. This evolution creates uncertainty in Caldera’s business and may affect Caldera’s ability to operate in certain jurisdictions or to process sensitive data, necessitate the acceptance of more onerous obligations in Caldera’s contracts, result in liability, or impose additional costs on Caldera. The cost of compliance with these obligations is high and is likely to increase in the future. Any failure or perceived failure by Caldera to comply with federal, state or foreign laws or regulations, Caldera’s internal policies and procedures or Caldera’s contracts governing Caldera’s processing of sensitive data could result in negative publicity, government investigations or actions, claims by third parties or damage to Caldera’s reputation, any of which could have a material adverse effect on Caldera’s business, financial condition, results of operations and prospects.

In the United States, federal, state, and local governments have enacted numerous data privacy and security laws, including consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), comprehensive consumer privacy laws, sector-specific privacy laws, data breach notification laws, laws regarding marketing, and other similar laws governing the processing of sensitive data that Caldera is or may in the future be required to comply with. In addition, Caldera obtains health information from third parties (including research institutions from which Caldera obtains clinical trial data) that is subject to privacy and security requirements under HIPAA, which imposes among other things, certain requirements relating to the privacy, security, transmission, and breach of individually identifiable health information. If Caldera violates HIPAA, depending on the specific facts and circumstances, Caldera could be subject to significant fines, penalties or regulatory inquiries or actions.

Over a third of U.S. states have enacted comprehensive consumer privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal information. Similar laws are being considered in several other states, as well as at the federal and local levels, and Caldera expects more states to pass similar laws in the future. While these states exempt some data processed in the context of clinical trials, these developments may further complicate compliance efforts and increase legal risk and compliance costs for Caldera and the third parties with whom Caldera works. Certain states have also adopted specific privacy and security laws and regulations which govern the privacy, processing and protection of health-related personal information. Such laws and regulations will likely be subject to interpretation by various courts and other governmental authorities, creating potentially complex compliance issues for Caldera and Caldera’s future customers and strategic partners. In addition to government activity, privacy advocacy groups and technology and other industries continue to consider new or revised self-regulatory standards related to privacy and security that may place additional burdens on Caldera.

Outside the United States, an increasing number of laws, regulations, and industry standards govern data privacy and security. For example, in Canada, the Personal Information Protection and Electronic Documents Act and various related provincial laws apply to Caldera’s operations. In the European Union, the General Data Protection Regulation (the “GDPR”) imposes stringent requirements on the processing of personal data, including health data collected in connection with clinical trials, and restricts transfers of personal data outside the European Economic Area; non-compliance can result in fines of up to the greater of €20 million or 4% of total worldwide annual turnover. In the United Kingdom, the UK GDPR and the Data Protection Act 2018 impose comparable obligations and potential penalties. In Australia, the Privacy Act 1988 (Cth) and the Australian Privacy Principles govern the handling of personal information, and in Singapore, the Personal Data Protection Act 2012 imposes obligations relating to the collection, use, and disclosure of personal data, in each case including in connection with the clinical trials Caldera conducts in those jurisdictions. These and other non-U.S. data protection regimes may impose obligations that differ from, or are more onerous than, those applicable in the United States, and may increase Caldera’s compliance costs and legal risk.

 

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