PROPOSED MERGER

YOUR VOTE IS VERY IMPORTANT

To the Stockholders of Passage Bio, Inc.,

Passage Bio, Inc., a Delaware corporation (“Passage Bio”), and Remix Therapeutics, Inc., a Delaware corporation (“Remix”) have entered into an Amended and Restated Agreement and Plan of Merger, dated September 2, 2026, (the “Merger Agreement” or the “Amended and Restated Merger Agreement”), pursuant to which, among other matters, Peregrine Merger Sub, Inc., a Delaware corporation and wholly owned subsidiary of Passage Bio (“Merger Sub”), will merge with and into Remix, with Remix surviving as a wholly owned subsidiary of Passage Bio (the “First Merger”), and immediately following thereof, Remix will merge with and into Peregrine Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of Passage Bio (“Merger Sub II”), with Merger Sub II surviving as a wholly owned subsidiary of Passage Bio ( the “Second Merger” and, together with the First Merger, the “Mergers”). In connection with the Mergers, Passage Bio will change its name to Remix Therapeutics, Inc. (together with its subsidiaries following the Mergers, the “combined company”). The Amended and Restated Merger Agreement amended and restated the Agreement and Plan of Merger entered into by Passage Bio, Merger Sub and Remix on June 24, 2026 (the “Original Merger Agreement”).

At the effective time of the First Merger (the “Initial Effective Time”), (a) each outstanding share of Remix common stock, par value $0.0001 per share (“Remix Common Stock”), and each share of Remix preferred stock, par value $0.0001 per share (“Remix Preferred Stock” and, together with the Remix Common Stock, “Remix Capital Stock”) (excluding shares held by Remix stockholders who have exercised and perfected appraisal rights, shares of Remix Capital Stock held as treasury stock by Remix or held or owned by Passage Bio, Merger Sub, Merger Sub II or any subsidiary of Passage Bio or Remix, and any shares described in the following clause (b)) will be converted into the right to receive approximately     shares of common stock of Passage Bio, par value $0.0001 per share (“Passage Bio Common Stock”), based on an assumed exchange ratio of 0.1728 (the “Merger Exchange Ratio”), assuming a reverse stock split of Passage Bio Common Stock at a ratio of   -for-   to be implemented prior to the closing of the Mergers (the “Closing”) as may be adjusted and as discussed in the accompanying proxy statement/prospectus, and which is further subject to certain adjustments as described below, and (b) each share of Remix Common Stock issued in the Concurrent Financing (as defined and described in more detail below) will be converted into the right to receive a number of shares of Passage Bio Common Stock calculated in accordance with the exchange ratio formula set forth in the Merger Agreement (the “Concurrent Financing Exchange Ratio”), which is assumed to be     and is subject to the same assumptions as the Merger Exchange Ratio described above and below. Passage Bio will assume outstanding and unexercised options to purchase shares of Remix Common Stock, and in connection with the First Merger such options will be converted into options to purchase shares of Passage Bio Common Stock based on the Merger Exchange Ratio.

At the effective time of the Second Merger (the “Effective Time”), each share of common stock of Remix, as the surviving corporation of the First Merger, will automatically be cancelled and extinguished without any conversion thereof consideration paid therefor.

Each share of Passage Bio Common Stock issued and outstanding at the time of the First Merger will remain issued and outstanding, and, subject to the proposed reverse stock split, will be unaffected by the Mergers. In addition, on September 2, 2026, Remix entered into an amended and restated subscription agreement with certain investors (the “Subscription Agreement”), pursuant to which Remix has agreed to sell, and such investors have agreed to purchase, shares of Remix Common Stock and Remix pre-funded warrants for an aggregate purchase price of approximately $70.0 million, immediately prior to the Effective Time of the First Merger. The Subscription Agreement amended and restated the original subscription agreement entered into by Remix and certain investors on June 24, 2026 (the “Original Subscription Agreement”), pursuant to which Remix had agreed to sell, and such investors had agreed to purchase, Remix Common Stock for an aggregate purchase price of approximately $70 million.

The transactions contemplated by the Subscription Agreement, together with the issuance by Remix of approximately $30.0 million of convertible promissory notes pursuant to a convertible promissory note purchase agreement (the “Remix Note Purchase Agreement (2026)”), comprises the concurrent financing (such transactions, collectively, the “Concurrent Financing”), which is expected to result in aggregate gross proceeds of approximately $100.0 million. The closing of the portion of the Concurrent Financing contemplated by the Subscription Agreement is conditioned upon the satisfaction or waiver of each of the conditions to the Closing as well as certain other conditions. The Concurrent Financing is more fully described in the section titled “Questions and Answers—What is the Concurrent Financing?” and “Agreements Related to the Mergers—Subscription Agreement and Registration Rights Agreement.”

Under the Merger Exchange Ratio and Concurrent Financing Exchange Ratio formulas in the Merger Agreement, immediately after the Closing, on a pro forma basis and based upon the number of shares of Passage Bio Common Stock expected to be issued in connection with the First Merger, pre-closing equityholders of Remix (other than investors in the Concurrent Financing) are expected to own approximately 65% of the combined company, pre-closing equityholders of Passage Bio are expected to own approximately 6% of the combined company and the investors in the Concurrent Financing are expected to own approximately 29% of the combined company (assuming proceeds from the Concurrent Financing of approximately $100.0 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 Passage Bio of approximately $20.0 million (assuming Passage Bio has net cash (“Passage Bio Net Cash”) of $5.0 million as of the Closing), (ii) an equity value for Remix of $226.0 million, and (iii) the relative capitalization of Passage Bio and Remix. The percentage of the combined company that each party’s equityholders will own following the Closing is subject to certain adjustments (as described in more detail in the section titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio”), including the amount of the final Passage Bio Net Cash at the Closing. As of the date of this prospectus, we currently anticipate the Passage Bio Net Cash at the Closing to be approximately $10.9 million.

Shares of Passage Bio Common Stock are currently listed on The Nasdaq Capital Market (“Nasdaq”) under the symbol “PASG.” Remix will file an initial listing application for the combined company with Nasdaq. After completion of the Mergers, Passage Bio will be renamed “Remix Therapeutics, Inc.”, and it is expected that the common stock of the combined company will trade on Nasdaq under the symbol “RMTX.” On September 1, 2026, the last trading day before the date of the accompanying proxy statement/prospectus, the closing sale price of Passage Bio Common Stock was $4.44 per share.

Passage Bio stockholders are cordially invited to attend a special meeting of Passage Bio stockholders (the “Passage Bio special meeting”). The Passage Bio special meeting is being held on    , 2026 unless postponed or adjourned to a later date, in order to obtain the stockholder approvals necessary to complete the Mergers and related matters. The Passage Bio special meeting will be held entirely online. Passage Bio stockholders will be able to attend and participate in the Passage Bio special meeting by registering at     where they will be able to listen to the meeting live, submit questions and vote.

After careful consideration, each of Passage Bio’s board of directors (the “Passage Bio Board”) and Remix’s board of directors (the “Remix Board”) have approved the Merger Agreement and the Contemplated Transactions (as defined below) and have determined that it is advisable to consummate the Mergers. The Passage Bio Board has approved the proposals described in the accompanying proxy statement/prospectus and unanimously recommends that its stockholders vote “FOR” the proposals described in the accompanying proxy statement/prospectus.

At the Passage Bio special meeting, Passage Bio will ask its stockholders to:

As described in the accompanying proxy statement/prospectus, certain Passage Bio stockholders who in the aggregate beneficially owned approximately 1% of the outstanding shares of Passage Bio Common Stock as of June 24, 2026, and certain Remix stockholders who in the aggregate beneficially owned approximately 60% of the outstanding shares of Remix Capital Stock as of September 2, 2026 (immediately following the consummation of the Exchange Agreement (as defined below) transactions), are parties to support agreements with Passage Bio and Remix, respectively, whereby such stockholders have agreed to vote (i) in the case of Passage Bio stockholders, in favor of the Mergers and the other transactions and actions contemplated by the Merger Agreement (collectively, the “Contemplated Transactions”), including (a) the Nasdaq Stock Issuance Proposal, (b) the Reverse Stock Split Proposal, (c) the Charter Proposal, and (d) the other transactions and actions contemplated by the Merger Agreement, including the Concurrent Financing (as defined in the Merger Agreement), and (ii) in the case of Remix stockholders, in favor of adopting the Merger Agreement and approving the Mergers and the other Contemplated Transactions, in each case, subject to the terms of the support agreements. Following the effectiveness of the registration statement on Form S-4 of which the accompanying proxy statement/prospectus is a part, and pursuant to the Merger Agreement, Remix shall seek to obtain approval for the Merger Agreement and the Contemplated Transactions from stockholders holding a sufficient number of shares of Remix Capital Stock to adopt and approve such matters.

More information about Passage Bio, Remix, the Merger Agreement and Contemplated Transactions, and the foregoing proposals is contained in the accompanying proxy statement/prospectus. Passage Bio urges you to read the accompanying proxy statement/prospectus carefully and in its entirety. IN PARTICULAR, YOU SHOULD CAREFULLY CONSIDER THE MATTERS DISCUSSED UNDER “RISK FACTORS” BEGINNING ON PAGE 23 OF THE ACCOMPANYING PROXY STATEMENT/ PROSPECTUS.

Passage Bio is excited about the opportunities the Mergers bring to Passage Bio’s stockholders and thanks you for your consideration and continued support.

William Chou, M.D.

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

The accompanying proxy statement/prospectus is dated    , 2026, and is first being mailed to Passage Bio’s stockholders on or about    , 2026.

On behalf of the Passage Bio Board, we are pleased to deliver this proxy statement/prospectus for the proposed Mergers between Passage Bio and Remix pursuant to which, among other matters, Merger Sub will merge with and into Remix, with Remix surviving as a wholly owned subsidiary of Passage Bio, and immediately following thereof, Remix will merge with and into Merger Sub II, with Merger Sub II surviving as a wholly owned subsidiary of Passage Bio.

The Passage Bio special meeting will be held on    , 2026 unless postponed or adjourned to a later date. The Passage Bio special meeting will be held entirely online. You will be able to attend and participate in the Passage Bio special meeting by registering at    . Upon entry of your control number and other required information, you will receive further instructions via email that provide you access to the Passage Bio special meeting and to vote and submit questions during the Passage Bio special meeting. The Passage Bio special meeting will be held for the following purposes, which are collectively referred to as the “Proposals”:

The Passage Bio Board has fixed    , 2026 as the record date for the determination of stockholders entitled to notice of, and to vote at, the Passage Bio special meeting and any adjournment or postponement thereof. Only holders of record of shares of Passage Bio Common Stock at the close of business on the record date are entitled to notice of, and to vote at, the Passage Bio special meeting. At the close of business on the record date, Passage Bio had     shares of Passage Bio Common Stock outstanding and entitled to vote.

Your vote is important. The affirmative vote of the holders of a majority of the voting power of all outstanding shares of Passage Bio Common Stock entitled to vote thereon is required for the approval of Proposal Nos. 2 and 3. The affirmative approval of a majority of the votes cast on the proposal by the holders of Passage Bio Common

Stock entitled to vote at the Passage Bio special meeting, assuming a quorum is present, is required for the approval of Proposal Nos. 1, 4, 5, 6, 7 and 8. Each of Proposal Nos. 1, 2 and 3 is a condition to completion of the Mergers. The closing of the Concurrent Financing is conditioned upon the satisfaction or waiver of each of the conditions to the Closing as well as certain other conditions. Therefore, the Mergers and the Concurrent Financing cannot be consummated without the approval of Proposal Nos. 1, 2 and 3. The issuance of Passage Bio Common Stock in connection with the First Merger and the change of control of Passage Bio resulting from the First Merger will not take place unless Proposal Nos. 1, 2 and 3 are approved by Passage Bio stockholders and the reverse stock split is effected, Passage Bio’s name is changed to “Remix Therapeutics, Inc.” and the First Merger is consummated. The approval of Proposal Nos. 4, 5, 6, 7 and 8 is not a condition to the completion of the Mergers.

Even if you plan to virtually attend the Passage Bio special meeting, Passage Bio requests that you sign and return the enclosed proxy or vote by mail, by phone or online to ensure that your shares will be represented at the Passage Bio special meeting if you are unable to virtually attend. You may change or revoke your proxy at any time before it is voted at the Passage Bio special meeting.

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

William Chou, M.D.

   , 2026

The issuances of (i) all shares of Passage Bio Common Stock and all pre-funded warrants to purchase shares of Passage Bio Common Stock in exchange for shares of Remix Common Stock and pre-funded warrants to purchase shares of Remix Common Stock, respectively, including the shares of Remix Common Stock and the Remix pre-funded warrants to be issued in the Subscription Financing immediately prior to the Initial Effective Time, after giving effect to (A) the conversion of all outstanding shares of Remix preferred stock into shares of Remix Common Stock, (B) the conversion of the 2025 Convertible Notes and the associated warrants into shares of Remix Common Stock, and (C) the conversion of the 2026 Convertible Notes into shares of Remix Common Stock, (ii) shares of Passage Bio Common Stock issuable upon exercise of warrants issued in exchange for Remix warrants, and (iii) shares of Passage Bio Common Stock issuable upon exercise of options to purchase shares of Passage Bio Common Stock in exchange for options to purchase shares of Remix Common Stock outstanding under the Remix 2019 Plan, are intended to be covered by this registration statement on Form S-4 of which this proxy statement/prospectus is a part.

There is no difference between (i) the shares of Passage Bio Common Stock that will be issued in exchange for each share of Remix Common Stock, (ii) the shares of Passage Bio Common Stock that will be issuable upon the exercise of Passage Bio Warrants issued in exchange for Remix Warrants, (iii) the shares of Passage Bio Common Stock that will be issuable upon the exercise of options to purchase shares of Passage Bio Common Stock issued in exchange for Remix Options.

Except where specifically noted, the following information and all other information contained in this proxy statement/prospectus does not give effect to the proposed reverse stock split described in Proposal No. 2 of this proxy statement/prospectus.

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.

On September 2, 2026, Remix entered into the Subscription Agreement with certain accredited investors (the “Investors”), pursuant to which Remix agreed to sell, and the Investors agreed to purchase, immediately prior to the Initial Effective Time, shares of Remix Common Stock and Remix pre-funded warrants for an aggregate purchase price of approximately $70.0 million. On June 29, 2026, Remix issued approximately $30 million of convertible promissory notes pursuant to the Remix Note Purchase Agreement (2026).

Shares of Remix Common Stock and Remix pre-funded warrants issued pursuant to the Concurrent Financing will be or will have the right to be, respectively, converted into shares of Passage Bio Common Stock in accordance with the Concurrent Financing Exchange Ratio in the Merger Agreement. Remix and Passage Bio have also agreed to enter into a registration rights agreement (the “Registration Rights Agreement”) with the Investors at the closing of the Concurrent Financing.

Immediately after the Closing, under the Merger Exchange Ratio and Concurrent Financing Exchange Ratio formulas in the Merger Agreement, on a pro forma basis and based upon the number of shares of Passage Bio Common Stock expected to be issued in connection with the First Merger, the Investors are expected to own approximately 29% of the combined company, calculated on a fully diluted basis, using the treasury stock method and subject to certain assumptions (as described in more detail in the section titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio”).

Each party’s obligation to effect the Merger and otherwise consummate the Contemplated Transactions is subject to the satisfaction or the written waiver by each of the parties, at or prior to the Closing, of Remix having received, or receiving substantially simultaneously with the Closing, cash proceeds of not less than the Concurrent Investment Amount of $99,929,000 in connection with the Concurrent Financing (as described in more detail in the section titled “The Merger Agreement—Conditions to the Completion of the Merger”).

The approval of each of Proposal Nos. 1, 2 and 3 by Passage Bio's stockholders is a condition to the completion of the Merger.

The approval of Proposal Nos. 4, 5, 6, 7 and 8 is not a condition to the Mergers.

As of the date of this proxy statement/prospectus, the Passage Bio Board does not know of any business to be presented at the Passage Bio special meeting other than as set forth in the notice accompanying this proxy statement/prospectus. If any other matters should properly come before the Passage Bio special meeting, it is intended that the shares represented by proxies will be voted with respect to such matters in accordance with the judgment of the persons voting the proxies.

The affirmative vote of the holders of a majority of the voting power of all outstanding shares of Passage Bio Common Stock entitled to vote thereon is required for the approval of Proposal Nos. 2 and 3. The affirmative approval of a majority of the votes cast on the proposal by the holders of Passage Bio Common Stock entitled to vote at the Passage Bio special meeting, assuming a quorum is present, is required for the approval of Proposal Nos. 1, 4, 5, 6, 7 and 8. Each of Proposal Nos. 1, 2 and 3 is a condition to completion of the Mergers.

Abstentions and broker non-votes will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Passage Bio special meeting. With respect to Proposal Nos. 1, 4, 5, 6, 7 and 8, abstentions and broker non-votes will not be counted as votes cast and will have no effect on the outcome of the vote. With respect to Proposal Nos. 2 and 3, which require the affirmative vote of a majority of all outstanding shares of Passage Bio Common Stock thereon, abstentions and broker non-votes will count as votes against such proposals.

As of    , 2026, the directors and executive officers of Passage Bio owned or controlled     outstanding shares of Passage Bio Common Stock entitled to vote at the Passage Bio special meeting. As of June 24, 2026, the Passage Bio stockholders that are party to a support agreement, including the directors and executive officers of Passage Bio, owned an aggregate number of shares of Passage Bio Common Stock representing approximately 1% of the outstanding shares of Passage Bio Common Stock. Each stockholder that entered into a Passage Bio support agreement has agreed to vote all shares of Passage Bio Common Stock owned by him, her or it as of the Record Date (i) in favor of approving the Mergers and the other transactions and actions contemplated by the Merger Agreement, including the Nasdaq Stock Issuance Proposal, Reverse Stock Split Proposal, Charter Proposal, and the Concurrent Financing (collectively, the “Contemplated Transactions”), (ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Mergers and (iii) against any acquisition proposal involving a third party.

Further, holders of Passage Bio Common Stock of record as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one Passage Bio CVR for each outstanding share of Passage Bio Common Stock held by such stockholder on such date, as described in more detail in the section titled “Agreements Related to the Mergers—Passage Bio Contingent Value Rights Agreement.”

The Merger Agreement provides that, prior to the Closing, Passage Bio will take all actions necessary to provide that (i) all Passage Bio Options will be fully vested and exercisable as of immediately prior to the Effective Time and will continue on the same terms and conditions in effect as of immediately prior to the Effective Time, and (ii) all Passage Bio Restricted Stock Unit Awards will be fully vested and settled in shares of Passage Bio Common Stock no later than the day immediately prior to the record date for the Pre-Closing Distribution (which is the distribution of the contingent value rights to Passage Bio stockholders).

For a more complete description of the treatment of Passage Bio securities in the Mergers, please see the sections titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio” and “Market Price and Dividend Information” of this proxy statement/prospectus.

Each Passage Bio CVR will represent the contractual right to receive payments from Passage Bio upon the actual receipt by Passage Bio or its subsidiaries of certain contingent proceeds derived from Passage Bio’s existing license arrangements with Gemma Biotherapeutics, Inc. relating to its GM1 and MLD programs, net of certain tax, transaction costs and certain other expenses. The Passage Bio CVR Agreement will terminate automatically upon the earlier of the payment of the contingent payments thereunder (if any) and (i) December 31, 2027 for the contingent payment in respect of the MLD program and (ii) July 31, 2028 for the contingent payment in respect of the GM1 program. During the applicable CVR Period, Passage Bio will, and will cause its subsidiaries to, use commercially reasonable efforts to collect the Legacy Asset Payments, to the

extent payable to Passage Bio. The contingent payments under the Passage Bio CVR Agreement, if they become payable, will become payable to the rights agent for subsequent distribution to the holders of the Passage Bio CVRs. There can be no assurance that any holders of Passage Bio CVRs will receive payments with respect thereto. For more detail, see the section titled “Agreements Related to the Mergers—Passage Bio Contingent Value Rights Agreement.”

Under the Merger Exchange Ratio and Concurrent Financing Exchange Ratio formulas in the Merger Agreement, immediately after the Closing, on a pro forma basis and based upon the number of shares of Passage Bio Common Stock expected to be issued in connection with the First Merger and the Concurrent Financing, pre-Merger equityholders of Remix (other than investors in the Concurrent Financing) are expected to own approximately 65% of the combined company, pre-Mergers equityholders of Passage Bio are expected to own approximately 6% of the combined company and the investors in the Concurrent Financing are expected to own approximately 29% of the combined company (assuming proceeds from the Concurrent Financing of approximately $100.0 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 Passage Bio of approximately $20.0 million (assuming Passage Bio Net Cash of $5.0 million as of the Closing), (ii) an equity value for Remix of $226.0 million, and (iii) the relative capitalization of Passage Bio and Remix. The percentage of the combined company that each party’s equityholders will own following the Closing is subject to certain adjustments (as described in more detail in the section titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio”), including the amount of the final Passage Bio Net Cash at the Closing. As of the date of this prospectus, we currently anticipate the Passage Bio Net Cash at closing to be approximately $10.9 million.

For a more complete description of the treatment of Remix Common Stock and Remix Options in the First Merger, please see the sections titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio” of this proxy statement/prospectus. For a description of the effect of the Concurrent Financing on Remix’s current securityholders, please see the sections titled “Agreements Related to the Mergers—Subscription Agreement” and “Agreements Related to the Mergers—Registration Rights Agreement” of this proxy statement/prospectus.

If you are a Passage Bio stockholder of record, as of the record date, you may provide your proxy instructions in one of four different ways:

We provide internet proxy voting to allow you to vote your shares online, with procedures designed to ensure the authenticity and correctness of your proxy vote instructions. However, please be aware that you must bear any costs associated with your internet access, such as usage charges from internet access providers and telephone companies.

If you hold your shares in “street name” (as described below), you may provide your proxy instructions by following the instructions on your vote instruction form provided by your broker, bank or other agent. 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 Passage Bio special meeting.

If you are a beneficial owner of shares registered in the name of your broker, bank or other agent, you should have received a voting instruction card and voting instructions with these proxy materials from that organization rather than from Passage Bio. Simply complete and mail the voting instruction card to ensure that your vote is counted. To vote at the Passage Bio special meeting, you may visit    , press the “Attend Meeting” button and follow the instructions. You may be instructed to obtain a legal proxy from your broker, bank, or other nominee and submit a copy in advance of the meeting. Further instructions will be provided to you via email.

Whether or not you plan to attend the Passage Bio special meeting, Passage Bio encourages you to vote by proxy to ensure your vote is counted. Even if you have submitted a proxy before the Passage Bio special meeting, you may still attend the Passage Bio special meeting and vote. In such case, your previously submitted proxy will be disregarded.

Proposal, “FOR” the Reverse Stock Split Proposal, “FOR” the Charter Proposal, “FOR” the Governance Proposals, “FOR” the 2026 Plan Proposal, “FOR” the 2026 ESPP Proposal, “FOR” the Merger Compensation Proposal, and “FOR” the Adjournment Proposal, in accordance with the recommendations of the Passage Bio Board. If any other matter is properly presented at the Passage Bio special meeting, your proxy holder (one of the individuals named on your proxy card) will vote your shares using his or her best judgment. If you are a beneficial owner of shares held in “street name” and do not provide your broker, bank or other agent with voting instructions, please see the question “If my shares of Passage Bio Common Stock are held in “street name” by my broker, will my broker vote my shares for me?” below.

Passage Bio expects that Proposal Nos. 1, 2, 3, 4, 5, 6, 7 and 8 will be considered to be “non-routine” matters, and thus a Passage Bio stockholder’s broker, bank or other agent may not vote shares on those Proposals in the absence of such holders’ voting instructions. To make sure that your vote is counted, you should instruct your broker or other agent to vote your shares, following the procedures provided by your broker.

It is anticipated that all of the proposals currently scheduled for consideration at the Passage Bio special meeting will be considered “non-routine” matters, and a broker will lack the authority to vote shares at its discretion on such proposals. Consequently, Passage Bio expects that there will not be any broker non-votes at the Passage Bio special meeting.

Broker non-votes, if any, will be treated as shares present for the purpose of determining the presence of a quorum for the transaction of business at the Passage Bio special meeting. With respect to Proposal Nos. 1, 4, 5, 6, 7 and 8, broker non-votes will not be counted as votes cast and will have no effect on the outcome of the vote. With respect to Proposal Nos. 2 and 3, which require the affirmative vote of a majority of all outstanding shares of Passage Bio Common Stock entitled to vote thereon, broker non-votes will count as votes against such proposals.

All properly executed proxies that are not revoked will be voted at the Passage Bio special meeting and at any adjournments or postponements of the Passage Bio special meeting in accordance with the instructions contained in the proxy. If a holder of Passage Bio Common Stock executes and returns a proxy and does not specify otherwise, the shares represented by that proxy will be voted “FOR” all of the Proposals in accordance with the recommendations of the Passage Bio Board.

If a Passage Bio stockholder who owns shares of Passage Bio Common Stock in “street name” has instructed a broker to vote its shares of Passage Bio Common Stock, the stockholder must follow directions received from its broker to change those instructions.

The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained or incorporated by reference in this proxy statement/prospectus, you should carefully consider the material risks described below before deciding how to vote your shares of Passage Bio Common Stock. You should also read and consider the other information in this proxy statement/prospectus. Please see the section titled “Where You Can Find More Information” beginning on page 333 of this proxy statement/prospectus for further information.

The Merger Exchange Ratio will not change based on changes in the trading price of Passage Bio Common Stock. Therefore, if before the completion of the Mergers, the market price of Passage Bio Common Stock increases from the market price on the date of the Merger Agreement, Remix stockholders could then receive merger consideration with substantially higher value for their shares of Remix common stock than the parties had negotiated when they established the Merger Exchange Ratio. The Merger Agreement does not include a price-based termination right. Under the Merger Exchange Ratio and Concurrent Financing Exchange Ratio formulas in the Merger Agreement, immediately after the Closing, on a pro forma basis and based upon the number of shares of Passage Bio Common Stock expected to be issued in connection with the Mergers, pre-Mergers equityholders of Remix (other than investors in the Concurrent Financing) are expected to own approximately 65% of the combined company, pre-Mergers equityholders of Passage Bio are expected to own approximately 6% of the combined company and the investors in the Concurrent Financing are expected to own approximately 29% of the combined company (assuming proceeds from the Concurrent Financing of $100.0 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 Passage Bio of approximately $20.0 million (assuming Passage Bio Net Cash of $5.0 million as of the Closing), (ii) a fixed valuation for Remix of $226.0 million, and (iii) the relative capitalization of Passage Bio and Remix. The percentage of the combined company that each party’s equityholders will own following the Closing is subject to certain adjustments (as described in more detail in the section titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio”), including the amount of the final Passage Bio Net Cash at the Closing.

Even if Proposal Nos. 1, 2 and 3 are approved by the stockholders of Passage Bio, specified conditions must be satisfied or, to the extent permitted by applicable law, waived to complete the Mergers. These conditions are set forth in the Merger Agreement and each material condition to the completion of the Mergers is described in the section titled “The Merger Agreement—Conditions to the Completion of the Mergers” of this proxy statement/prospectus. Passage Bio and Remix cannot assure you that all of the conditions will be satisfied or waived. If the conditions are not satisfied or waived, the Mergers may not occur or will be delayed, and Passage Bio and Remix each may lose some or all of the intended benefits of the Mergers.

In general, either Passage Bio or Remix can refuse to complete the Mergers if there is a Passage Bio Material Adverse Effect (as defined in the Merger Agreement) or a Remix Material Adverse Effect (as defined in the Merger Agreement), as applicable, between June 24, 2026, the date of the Merger Agreement, and the Closing. However, certain types of changes do not permit either party to refuse to complete the Mergers, even if such change could be said to have a material adverse effect on Passage Bio or Remix, including:

If a material adverse change occurs with respect to either party or both parties and Passage Bio and Remix still complete the Mergers, the stock price of the combined company following the Closing may suffer and may reduce the value of the Mergers to the stockholders of Passage Bio, Remix or both.

Some executive officers and directors of Passage Bio have interests in the Mergers that are different from those of the stockholders of Passage Bio and that may influence them to support or approve the Mergers without regard to the interests of Passage Bio stockholders.

Certain executive officers and directors of Passage Bio are parties to arrangements that provide them with interests in the Mergers that are different from, or in addition to, the interests of Passage Bio stockholders generally. With respect to Passage Bio’s directors and executive officers, these interests may include severance or other separation payments and benefits, the acceleration of their outstanding Passage Bio equity awards, the extension of the post-termination exercise period of certain Passage Bio Options held by executive officers, and rights to continued indemnification, expense advancement and directors’ and officers’ liability insurance coverage. With respect to Remix’s directors and executive officers, these interests may include the conversion of their Remix Options into options to purchase shares of combined company common stock, the expected continuation of certain Remix executive officers and directors with the combined company following the Effective Time, and rights to indemnification and liability insurance coverage under the Merger Agreement.

The Passage Bio Board was aware of and considered these interests, among other matters, in reaching its determination (i) that the terms of the Merger Agreement and the Mergers and the other Contemplated Transactions are fair to, advisable and in the best interest of Passage Bio and its stockholders, (ii) to approve and declare advisable the Merger Agreement and the Contemplated Transactions, including the Mergers and the issuance of shares of Passage Bio Common Stock to the stockholders of Remix pursuant to the Merger Agreement and (iii) to recommend, upon the terms and subject to the terms and conditions set forth in the Merger Agreement, that the stockholders of Passage Bio vote to approve Proposal Nos. 1, 2 and 3. These interests, among other factors, may have influenced the directors and executive officers of Passage Bio to support or approve the Mergers.

For more information regarding the interests of Passage Bio’s and Remix’s executive officers and directors in the Mergers, see the sections titled “The Mergers—Interests of Passage Bio’s Directors and Executive Officers in the Mergers” and “The Mergers—Interests of Remix’s Directors and Executive Officers in the Mergers.”

If the combined company is unable to realize the full strategic and financial benefits currently anticipated from the Mergers, Passage Bio 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 the combined company is able to realize only part of the strategic and financial benefits currently anticipated from the Mergers.

The market price of Passage Bio Common Stock is subject to significant fluctuations. During the 12-month period ended June 24, 2026, the closing per share sales price of Passage Bio Common Stock on Nasdaq ranged from a high of $19.85 on January 9, 2026 to a low of $4.08 on May 7, 2026. Market prices for securities of pharmaceutical, biotechnology and other life science companies have historically been particularly volatile. In addition, the market price of Passage Bio Common Stock will likely be volatile based on whether stockholders and other investors believe that Passage Bio can complete the Mergers or otherwise raise additional capital to support Passage Bio’s operations if the Mergers are not consummated and another strategic transaction cannot be identified, negotiated and consummated in a timely manner, if at all.

Additional factors that may cause the market price of Passage Bio Common Stock to fluctuate include:

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of Passage Bio Common Stock. In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against such companies.

After the completion of the Mergers, the current stockholders of Passage Bio and Remix will own a smaller percentage of the combined company than their ownership of their respective companies prior to the Mergers. For the expected pro forma ownership percentages of the combined company and the assumptions on which they are based, see the risk factor above titled “—The Merger Exchange Ratio will not be adjusted based on the market price of Passage Bio Common Stock, so the consideration at the Closing may have a greater or lesser value than at the time the Merger Agreement was signed” and the section titled “The Merger Agreement—Merger Consideration and Merger Exchange Ratio.”

The consummation of the Mergers is subject to numerous conditions, including (1) the effectiveness of the registration statement of which this proxy statement/prospectus forms a part, (2) the approval by Passage Bio’s stockholders of the Passage Bio Stockholder Matters, (3) the approval by Remix’s stockholders of the Remix Stockholder Matters, and (4) other customary closing conditions and there can be no assurance that the Mergers will be consummated. See the section titled “The Merger Agreement—Conditions to the Completion of the Mergers.”

If the Mergers are not completed for any reason, the price of Passage Bio Common Stock may decline to the extent that the market price of Passage Bio Common Stock reflects or previously reflected positive market assumptions that the Mergers would be completed and the related benefits would be realized. In addition, Passage Bio and Remix have expended and will continue to expend significant management time and resources and have incurred and will continue to incur significant expenses due to legal, advisory, printing and financial services fees related to the Mergers. These expenses must be paid regardless of whether the Mergers are consummated.

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

Covenants in the Merger Agreement impede the ability of Passage Bio and Remix to make acquisitions, subject to specified exceptions relating to fiduciary duties, or complete other mergers, sales of assets or other business combinations pending completion of the Mergers. As a result, if the Mergers are not completed, the parties may be at a disadvantage to their competitors during that period. In addition, while the Merger Agreement is in effect, each party is generally prohibited from soliciting, initiating, knowingly encouraging or entering into specified extraordinary transactions, such as a merger, sale of assets or other business combination, with any third party, subject to specified exceptions, even if any such transaction could be favorable to such party’s stockholders, as applicable. For a more complete description of the restrictions on pursuing alternative transactions please see the section titled “The Merger Agreement.”

The terms of the Merger Agreement prohibit each of Passage Bio and Remix from soliciting competing proposals or cooperating with persons making unsolicited takeover proposals, except in certain limited circumstances. With respect to Passage Bio, the Passage Bio Board may respond to an unsolicited competing proposal if it determines in good faith, after consultation with its outside financial advisor and outside legal counsel, that the unsolicited competing proposal constitutes, or is reasonably likely to result in, a superior competing proposal and, after consultation with its outside legal counsel, that failure to take such action would be inconsistent with the fiduciary duties of the Passage Bio Board. With respect to Remix, following receipt of a bona fide acquisition proposal by any person that the Remix Board has determined constitutes, or is reasonably likely to result in, a superior offer, Remix may solicit acquisition proposals and furnish information to, and enter into discussions with, any person (including persons not making such proposal) if the Remix Board concludes in good faith, after consultation with its outside legal counsel and financial advisor, that failure to take such action would be inconsistent with the fiduciary duties of the Remix Board.

In certain circumstances, and subject to compliance with the Merger Agreement, the Passage Bio Board or the Remix Board may change its recommendation to its respective stockholders if it determines such recommendation change is required to avoid a breach of its fiduciary duties. Additionally, subject to compliance with the procedures set forth in the Merger Agreement, including paying the applicable termination fee, Remix may terminate the Merger Agreement in order to enter into an agreement with respect to a Superior Offer.

Upon termination of the Merger Agreement in certain circumstances, Remix may be required to pay to Passage Bio a termination fee of (x) $17.5 million, including (i) where the Remix Board changes or withdraws its recommendation in favor of the Merger or recommends to enter into an alternative transaction, (ii) in certain circumstances where Remix enters into a Permitted Alternative Agreement (as defined in the Merger Agreement); or (iii) if (a) the Merger Agreement is terminated because Remix (1) fails to obtain the requisite stockholder approval of the Merger Agreement and the transactions contemplated thereby or (2) breaches the Merger Agreement, (b) an alternative acquisition proposal was announced or disclosed prior to obtaining Remix’s stockholder approval, and (c) within 12 months of the termination of the Merger Agreement, Remix enters into a definitive agreement with respect to an alternative transaction; or (iv) if (a) the Merger Agreement is terminated because the Mergers have not been consummated by the Outside Date, (b) an alternative acquisition proposal was announced or disclosed prior to obtaining the Required Remix Stockholder Vote, and (c) within 12 months of such termination, Remix enters into a definitive agreement with respect to an alternative transaction (for which the applicable termination fee is also $17.5 million).

Upon termination of the Merger Agreement in certain circumstances, a termination fee of $1.5 million may be payable by Passage Bio to Remix if (i)(a) the Merger Agreement is terminated because the Mergers have not been consummated by the Outside Date (as defined in the Merger Agreement) or Passage Bio (1) fails to obtain the requisite stockholder approval of the Passage Bio Stockholder Matters or (2) breaches the Merger Agreement, (b) an alternative acquisition proposal was announced or disclosed prior to such termination, and (c) within 12 months of the termination of the Merger Agreement, Passage Bio enters into a definitive agreement with respect to an alternative transaction, (ii) Passage Bio fails to include its board recommendation in this proxy statement/prospectus, or (iii) the Passage Bio Board of directors changes or withdraws its recommendation in favor of the Mergers or approves an alternative transaction, or willfully and intentionally breaches its non-solicitation or certain other obligations under the Merger Agreement.

These termination fees may discourage third parties from submitting competing proposals to Passage Bio or Remix or their respective stockholders and may cause the Passage Bio Board or the Remix Board, as the case may be, to be less inclined to recommend a competing proposal. For more information regarding the potential termination fees, see the section titled “The Merger Agreement—Termination and Termination Fees.”

The outstanding shares of Remix Capital Stock are privately held and are not traded in any public market. The lack of a public market makes it extremely difficult to determine the fair market value of the shares of Remix Capital Stock. Because the percentage of Passage Bio equity to be issued to Remix stockholders was determined based on negotiations between the parties, it is possible that the value of the Passage Bio Common Stock to be received by Remix stockholders will be less than the fair market value of the shares of Remix Capital Stock, or Passage Bio may pay more than the aggregate fair market value for the shares of Remix Capital Stock.

The Passage Bio Board has not obtained an updated opinion either as of the date of this proxy statement/prospectus or as of any other date subsequent to the date of the opinion of Redwood, Passage Bio’s financial advisor. Changes in circumstances, including without limitation the operations and prospects of Passage Bio or Remix, stock prices, general market and economic conditions and other factors, some or all of which may be beyond the control of Passage Bio and Remix, are not reflected in the opinion of Redwood. The opinion of Redwood does not speak as of any date other than the date thereof.

Conditions to Passage Bio’s or Remix’s obligations to complete the Mergers may be waived, in whole or in part, to the extent permitted by law, in certain circumstances unilaterally or by agreement of Passage Bio and Remix. In the event of a waiver of a condition, the Passage Bio 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. If Passage Bio were to waive the requirement (either in whole or in part) that Remix receive the Concurrent Investment Amount, the combined company may have less cash than currently expected as of closing of this transaction to conduct its operations.

In the event that the Passage Bio Board, in its own reasonable discretion, determines any such waiver is not significant enough to require recirculation of this proxy statement/prospectus and re-solicitation of its stockholders, it will have the discretion to complete the Mergers without seeking further stockholder approval, which decision may have a material adverse effect on Passage Bio stockholders. For example, if Passage Bio and Remix agree to waive the requirement that the shares of Passage Bio Common Stock to be issued in the Mergers have been approved for listing (subject to official notice of issuance) on Nasdaq as of the Closing, and their respective boards of directors elect to proceed with the Closing, Nasdaq may notify the combined company of its determination to delist the combined company’s securities based upon the failure to satisfy the initial inclusion criteria in the Nasdaq application. The combined company may appeal the determination to a hearings panel but such appeal will not stay the suspension and delisting action and Nasdaq may notify the combined company that its common stock will be immediately suspended from trading and delisted.

In addition, in order to meet the initial listing requirements of Nasdaq or as otherwise determined in the discretion of the combined company board pursuant to the terms of the Lock-Up Agreements, the Passage Bio Board or combined company board may release stockholders from their Lock-Up Agreements and waive the requirement that such Lock-Up Agreements be in full force and effect immediately following the Effective Time. Such release would increase the number of shares that may be sold in the public market immediately after the Mergers and any such sales could cause the combined company’s stock price to decline.

A significant portion of the combined company’s securities will be restricted from immediate resale. Holders should be aware that transfers of Passage Bio’s securities pursuant to Rule 144 may be limited as Rule 144 is not available, subject to certain exceptions, for the resale of securities initially issued by shell companies (other than business combination related shell companies) or issuers that have previously been a shell company. Passage Bio’s wind-down of its general and administrative operations that will not be needed after Closing and the proposed Mergers (including the issuance of the Passage Bio CVRs in connection therewith) will make Passage Bio subject to the SEC requirements applicable to reporting shell company business combinations. Passage Bio anticipates that following the consummation of the Mergers, the combined company will no longer be a shell company. As a result, Passage Bio anticipates that holders of restricted securities of the combined company, including affiliates of the combined company, will not be able to sell such securities pursuant to Rule 144 without registration until one year after the combined company files Form 10 information with the SEC. For more information, see the section titled “Securities Act Restrictions on Resale of Combined Company Common Stock.”

According to SEC guidance, the requirements applicable to reporting shell company business combinations apply to any company that sells or otherwise disposes of its historical assets or operations in connection with or as part of a plan to combine with a non-shell private company in order to convert the private company into a public one. Passage Bio has taken steps to wind-down its general and administrative operations that will not be needed after Closing and expects to issue the Passage Bio CVRs in connection with the Closing and, as such, Passage Bio’s plan to merge with Remix, resulting in the conversion of Remix into a public company, will be subject to the SEC requirements applicable to reporting shell company business combinations, which are as follows:

The foregoing SEC requirements will increase the combined company’s time and cost of raising capital, offering stock under equity plans, and complying with securities laws. Furthermore, such requirements will add burdensome restrictions on the resale of the combined company common stock by affiliates of Remix and any holders of “restricted” or “control” securities of the combined company.

For more information about the conditions to the completion of the Mergers, see the section titled “The Merger Agreement—Conditions to the Completion of the Mergers.”

The right of Passage Bio stockholders to receive any payment in respect of, or to derive any value from, the Passage Bio CVRs is contingent on Passage Bio or the combined company actually receiving the Legacy Asset Payments — the GM1 Payments and the MLD Payments payable by Gemma Biotherapeutics, Inc. (“Gemma”) under Passage Bio’s sublicense arrangements with Gemma relating to its GM1 and MLD programs (the “Gemma Sublicenses”) — during the applicable CVR Period, and on the amount of any such payments remaining after the permitted deductions specified in the Passage Bio CVR Agreement. The GM1 Payments may give rise to a Passage Bio CVR Payment only if received during the GM1 CVR Period, which ends on July 31, 2028, and the MLD Payments only if received during the MLD CVR Period, which ends on December 31, 2027; any amounts received after the applicable CVR Period will not give rise to any Passage Bio CVR Payment. In addition, the GM1 Payments depend on the continued effectiveness of Passage Bio’s underlying license, which requires Passage Bio to make the GM1 2027 License Payment (as defined in the Passage Bio CVR Agreement) to The Trustees of the University of Pennsylvania to extend that license; if that payment is not made, the GM1 Payments may not be realized. If the applicable payments are not made, are not received during the applicable CVR Period, or are not sufficient to result in any Passage Bio CVR Payment after giving effect to the permitted deductions, no payments will be made in respect of the Passage Bio CVRs, and the Passage Bio CVRs will expire valueless.

Following the effective time, the combined company will have sole authority over whether and how to monetize the Legacy Assets (if at all), and the combined company’s only obligations will be to carry out the obligations set forth in the Passage Bio CVR Agreement.

Furthermore, the Passage Bio CVRs will be unsecured contractual obligations of the combined company. The Passage Bio CVRs will not be transferable except in the limited circumstances specified in the Passage Bio CVR Agreement, will not be evidenced by any certificate or other instrument, will not be registered with the SEC and will not be listed on any exchange. The Passage Bio CVRs will not have any voting or dividend rights, will not represent any equity or ownership interest in the combined company, and will not accrue interest. As a result, there will be no public market for the Passage Bio CVRs, and holders may not be able to realize any value from the Passage Bio CVRs other than through the payments, if any, made under the Passage Bio CVR Agreement.

Passage Bio intends to treat a holder’s receipt of the Passage Bio CVRs as not constituting a current distribution of property with respect to the holder’s existing shares of Passage Bio Common Stock for U.S. federal income tax purposes, and future cash payments (if any) on the CVRs being reported as dividends to the extent of the combined company’s current and accumulated earning and profits in the year(s) in which such payments are made. However, the U.S. federal income tax treatment of the Passage Bio CVRs is uncertain. There is no legal authority directly addressing the U.S. federal income tax treatment of the receipt of, and payments under, the Passage Bio CVRs, and there can be no assurance that the Internal Revenue Service (“IRS”) would not assert, or that a court would not sustain, a position that could result in adverse U.S. federal income tax consequences to holders of the Passage Bio CVRs. For more information regarding the U.S. federal income tax consequences of the CVRs, see the section titled “Agreements Related to the Mergers—Passage Bio Contingent Value Rights Agreement.”

The principal purposes of the reverse stock split are to increase the per share market price of Passage Bio Common Stock so that the combined company is able to satisfy the minimum bid price requirement and the other initial listing standards of Nasdaq in connection with the Mergers, and to increase the number of authorized but unissued shares of

common stock available for future issuance. The combined company cannot assure you, however, that the reverse stock split will accomplish any sustained increase in the per share market price of its 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 the combined company’s common stock, the combined company cannot assure you that the reverse stock split will increase the market price of its common stock by a multiple of the reverse stock split ratio, or result in any permanent or sustained increase in the market price, which depends on many factors, including the combined company’s business and financial performance, general market conditions and prospects for future success. Accordingly, even if the market price of the combined company’s common stock satisfies the applicable Nasdaq listing requirements initially following the reverse stock split, the combined company cannot assure you that it will continue to do so.

Although the Passage Bio Board believes that the anticipated increase in the market price of the combined company’s common stock resulting from the reverse stock split could encourage interest in the common stock and possibly promote greater liquidity for the combined company’s stockholders, that liquidity could also be adversely affected by the reduced number of shares of common stock that would be outstanding after the reverse stock split, particularly if the per share market price does not increase as a result of the reverse stock split. The reduction in the number of outstanding shares may lead to reduced trading and a smaller number of market makers for the combined company’s common stock, and may make it more difficult to effect transactions in the common stock.

Should the market price of the combined company’s common stock decline after the reverse stock split, the percentage decline, as an absolute number and as a percentage of the combined company’s overall market capitalization, may be greater than would occur in the absence of the reverse stock split. A reverse stock split is sometimes viewed negatively by the market and, consequently, can lead to a decrease in the combined company’s overall market capitalization. If the per share market price of the combined company’s common stock does not increase in proportion to the reverse stock split ratio, or declines to its pre-split level, the combined company’s overall market capitalization will be reduced. In some cases, the per share stock price of companies that have effected reverse stock splits has subsequently declined back to or below pre-split levels, and there can be no assurance that the total market value of the combined company’s common stock will not decline as a result of the reverse stock split.

Unless otherwise indicated or the context otherwise requires, references in this section to “Passage Bio,” the “Company,” “we,” “us,” “our” and other similar terms refer to Passage Bio and its subsidiaries.

Passage Bio has wound down its development programs and has limited remaining operations. Biotechnology product development is a highly speculative undertaking and involves a substantial degree of risk. Its operations to date have been limited primarily to staffing its company, business planning, raising capital, entering into collaboration and vendor agreements for conducting preclinical research and clinical development activities for its product candidates, and performing clinical development activities and manufacturing clinical supply. Passage Bio has outlicensed or discontinued its product candidates and is no longer advancing a development pipeline. Passage Bio has no products approved for commercial sale and has not generated any revenue from commercial product sales, and it expects to incur costs associated with the proposed Mergers. It has generally funded its operations to date through proceeds from sales of convertible preferred stock and public offerings, and does not expect to receive revenue from commercial product sales, for many years, if ever.

Passage Bio has incurred net losses since its inception in 2017. Passage Bio incurred net losses of $45.5 million and $64.8 million for the years ended December 31, 2025 and 2024, respectively and incurred net losses of $15.4 million

and $24.8 million for the six months ended June 30, 2026 and 2025, respectively. As of December 31, 2025 and June 30, 2026, Passage Bio had an accumulated deficit of $704.8 million and $720.1 million, respectively. Substantially all of its operating losses have resulted from expenses incurred in connection with its research and development programs, acquiring the rights to its product candidates, and from general and administrative expenses associated with its operations. Passage Bio expects to continue to incur significant expenses and operating losses over the next several years and for the foreseeable future in connection with the wind-down of its operations and the proposed Mergers, which expenses, together with anticipated general and administrative expenses, will likely result in it incurring significant losses for the foreseeable future. Its prior losses, combined with expected future losses, have had and will continue to have an adverse effect on its stockholders’ equity and working capital.

There can be no assurance that the Mergers will be completed. Passage Bio has wound down its historical development operations, and it has outlicensed or discontinued its product programs and has not and will continue to not generate revenue from operations. If the Mergers are not completed and it is unable to identify and complete an alternative strategic transaction, Passage Bio’s board of directors may decide to pursue a dissolution and liquidation. In that event, the amount of cash available for distribution to its stockholders will depend heavily on the timing of, and costs related to, such dissolution and liquidation, as well as the amount of cash required to settle its remaining obligations and to establish reserves for contingent liabilities. Passage Bio may also become subject to litigation or other claims in connection with a dissolution and liquidation. As a result of these and other factors, its stockholders could lose all or a significant portion of their investment in the event of a dissolution and liquidation.

In connection with the wind-down of its development programs, Passage Bio reduced its workforce and ceased its laboratory operations, and its ability to consummate the Mergers or any alternative strategic transaction depends on its ability to retain its remaining employees. The uncertainty associated with the Merger, together with its cash-conservation efforts, may make it more difficult to retain these employees, and the loss of their services could adversely affect its ability to complete the Mergers. Passage Bio may not be able to retain its remaining employees on acceptable terms, or at all.

If Passage Bio breaches any of the agreements under which it licenses the use, development and commercialization rights to its product candidates or technology from third parties, it could lose license rights that are important to its business. Passage Bio has provided notice terminating the Penn License Agreement with respect to PBFT02, its former lead product candidate, while the Penn License Agreement otherwise remains in effect with respect to its other licensed products. Under the Penn License Agreement, Passage Bio is subject to various obligations, including payment obligations, diligence obligations such as development and commercialization obligations, as well as potential royalty payments and other obligations. If Passage Bio fails to comply with any of these obligations or otherwise breaches its license agreements, its licensors may have the right to terminate the applicable license in whole or in part. Generally, the loss of any one of its current licenses, or any other license it may acquire in the future, could harm its business, prospects, financial condition and results of operations.

Licensing of intellectual property is of critical importance to its business and involves complex legal, business and scientific issues. Disputes may arise between Passage Bio and its licensors regarding intellectual property subject to a license agreement, including:

If disputes over intellectual property that Passage Bio has licensed prevent or impair its ability to maintain its current licensing arrangements on acceptable terms or at all, it may be unable to realize the value of the affected license rights. In addition, if disputes arise as to ownership of licensed intellectual property, its ability to pursue or enforce the licensed patent rights may be jeopardized. If Passage Bio or its licensors fail to adequately protect this intellectual property, the value of its remaining license rights could suffer.

Passage Bio’s stock price has been and is likely to continue to be volatile. The stock market in general and the market for biotechnology companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. The market price for its common stock may be influenced by many factors, including:

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), Passage Bio is required to furnish a report by its management on its internal control over financial reporting within its Form 10-K. However, while Passage Bio remains a smaller reporting company, it will not be required to include an attestation report on internal control over financial reporting issued by its independent registered public accounting firm. Ensuring that Passage Bio has adequate internal financial and accounting controls and procedures in place so that it can produce accurate financial statements on a timely basis is a costly and time-consuming effort that will need to be frequently evaluated. Its failure to maintain the effectiveness of its internal controls in accordance with the requirements of the Sarbanes-Oxley Act could have a material adverse effect on its business. If Passage Bio identifies one or more material weaknesses, it could result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of its financial statements. In addition, if Passage Bio is not able to continue to meet these requirements, it may not be able to remain listed on Nasdaq.

Passage Bio may hire additional personnel and may utilize external temporary resources to implement, document and modify policies and procedures to maintain effective internal controls. However, it is possible that it may

identify deficiencies and weaknesses in its internal controls. If material weaknesses or deficiencies in its internal controls exist and go undetected or unremediated, its financial statements could contain material misstatements that, when discovered in the future, could cause it to fail to meet its future reporting obligations and cause the price of its common stock to decline.

As a public company Passage Bio will continue to incur significant legal, accounting and other expenses. In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and Nasdaq have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Its management and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase its legal and financial compliance costs and will make some activities more time-consuming and costly. Passage Bio is a “smaller reporting company,” and the reduced disclosure requirements applicable to smaller reporting companies may make its common stock less attractive to investors.

Passage Bio is a “smaller reporting company,” meaning that the market value of its stock held by non-affiliates is less than $700.0 million and its annual revenue is less than $100.0 million during the most recently completed fiscal year. Passage Bio will continue to be a smaller reporting company if either (i) the market value of its stock held by non-affiliates is less than $250.0 million or (ii) its annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of its stock held by non-affiliates is less than $700.0 million. Passage Bio may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company it may choose to present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K and have reduced disclosure obligations regarding executive compensation.

Passage Bio’s 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 its behalf; any action asserting a breach of fiduciary duty; any action asserting a claim against it arising pursuant to the Delaware General Corporation Law (the “DGCL”), its restated certificate of incorporation, or its restated bylaws; any action to interpret, apply, enforce, or determine the validity of its restated certificate of incorporation or its restated bylaws; or any action asserting a claim against it 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 rules and regulations thereunder. There is uncertainty as to whether a court would enforce such provision with respect to claims under the Securities Act, and its stockholders will not be deemed to have waived its compliance with the federal securities laws and the rules and regulations thereunder.

Passage Bio’s amended and restated bylaws also provide that the federal district courts of the United States of America will, to the fullest extent permitted by law, be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act, or a Federal Forum Provision. Its decision to adopt a Federal Forum Provision followed a decision by the Supreme Court of the State of Delaware holding that such provisions are facially valid under Delaware law. While there can be no assurance that federal or state courts will follow the holding of the Delaware Supreme Court or determine that the Federal Forum Provision should be enforced in a particular case, application of the Federal Forum Provision means that suits brought by its stockholders to enforce any duty or liability created by the Securities Act must be brought in federal court and cannot be brought in state court.

These choice of forum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with it or any of its 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 its restated certificate of incorporation or amended and restated bylaws to be inapplicable or unenforceable in an action, it may incur additional costs associated with resolving such action in other jurisdictions, which could harm its business, results of operations and financial condition.

In addition, Section 203 of the DGCL may discourage, delay or prevent a change in control of Passage Bio. Section 203 imposes certain restrictions on mergers, business combinations and other transactions between it and holders of 15% or more of its common stock.

Provisions in its restated certificate of incorporation and its restated bylaws may discourage, delay or prevent a merger, acquisition or other change in control of Passage Bio that stockholders may consider favorable, including transactions in which you might otherwise receive a premium for your shares. These provisions could also limit the price that investors might be willing to pay in the future for shares of its common stock, thereby depressing the market price of its common stock. In addition, because its board of directors is responsible for appointing the members of its management team, these provisions may frustrate or prevent any attempts by its stockholders to replace or remove its current management by making it more difficult for stockholders to replace members of its board of directors. Among other things, these provisions:

Moreover, Passage Bio is governed by the provisions of Section 203 of the DGCL, which prohibits a person who owns in excess of 15% of its outstanding voting stock from merging or combining with it for a period of three years after the date of the transaction in which the person acquired in excess of 15% of its outstanding voting stock, unless the merger or combination is approved in a prescribed manner.

Any of these provisions of its charter documents or Delaware law could, under certain circumstances, depress the market price of its common stock.

The market price of its common stock has been and may continue to be volatile. The stock market in general, and Nasdaq and biopharmaceutical companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. In the past,

companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. Passage Bio may be the target of this type of litigation in the future. Securities litigation against it could result in substantial costs and divert its management’s attention from other business concerns, which could seriously harm its business.

The trading market for its common stock relies in part on the research and reports that industry or financial analysts publish about it or its business. Passage Bio does not have any control over the analysts, or the content and opinions included in their reports. If one or more of the analysts covering its business downgrades their evaluations of its stock, the trading price of its stock would likely decrease. Even if Passage Bio does obtain analyst coverage, if one or more of the analysts covering its business downgrade their evaluations of its stock, the price of its stock could decline. If one or more of these analysts cease to cover its stock, it could lose visibility in the market for its stock, which in turn could cause its stock price to decline.

Passage Bio’s results of operations could be adversely affected by general conditions in the global economy and in the global financial markets. For example, the global financial crisis caused extreme volatility and disruptions in the capital and credit markets, and, in recent months, the global economy has been impacted by fluctuating interest rates, tariffs, and inflation. Likewise, the capital and credit markets may be adversely affected by ongoing military conflicts around the world, global sanctions imposed in response thereto, and potential recessions. Moreover, Passage Bio may also be impacted by turmoil in the global banking system. Passage Bio regularly maintains cash balances at third-party financial institutions in excess of the FDIC insurance limit and there is no guarantee that the federal government would guarantee all depositors if such financial institutions were to fail, in the event of bank closures and continued instability in the global banking system. A severe or prolonged economic downturn, such as the global financial crisis, could result in a variety of risks to its business, including its ability to raise additional capital when needed on acceptable terms, if at all. A weak or declining economy could also strain its suppliers, possibly resulting in operational disruption, or cause its sublicense partners to delay making payments for its services. Any of the foregoing could harm its business and Passage Bio cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact its business.

Remix is a clinical stage biopharmaceutical company with a limited operating history upon which investors can evaluate its business and prospects.

Remix commenced operations in July 2019, has no products approved for commercial sale and has never generated any revenue from sales. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. To date, Remix has devoted substantially all of its resources to developing REM-422, its research and development activities, business planning, establishing and maintaining its intellectual property portfolio, hiring personnel, raising capital, and providing general and administrative support for these operations.

Remix has not yet demonstrated its ability to complete pivotal clinical trials, obtain marketing 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 Remix’s likelihood of success and viability than it could be if Remix had a longer operating history.

In addition, Remix may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by biopharmaceutical companies in rapidly evolving fields. Remix also expects that, as it advances its product candidates, it will need to transition from a company with a research and development focus to a company capable of supporting commercial activities. Remix has not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If Remix does not adequately address these risks and difficulties or successfully make such a transition, its business will suffer.

Remix incurred significant net losses in each reporting period since its inception, has not generated any products revenue to date and has financed its operations principally through private placements of its preferred stock and convertible notes. Remix expects that it will be many years, if ever, before it has commercialized a product and can generate revenue from product sales. Even if Remix succeeds in receiving marketing approval for and commercializing one or more of its product candidates, it expects to continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.

Remix expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses Remix incurs may fluctuate significantly from quarter to quarter such that a period-to-period comparison of Remix’s results of operations may not be a good indication of its future performance. The size of Remix’s future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenue. Remix’s prior losses and expected future losses have had and will continue to have an adverse effect on its working capital, its ability to fund the development of its product candidates and its ability to achieve and maintain profitability and the performance of its stock. Remix’s future funding requirements will depend on many factors, including:

If Remix is unable to raise additional capital when needed, Remix may be required to delay, limit, reduce or terminate Remix’s product development or future commercialization efforts or grant rights to develop and market product candidates that Remix would otherwise prefer to develop and market itself, and Remix’s ability to grow and support its business and to respond to market challenges could be significantly limited, which could have a material adverse effect on Remix’s business, financial condition and results of operations.

In addition, Remix’s management has evaluated adverse conditions and events that raise substantial doubt about Remix’s ability to continue as a going concern, and its independent registered public accounting firm included an explanatory paragraph in its report on its financial statements as of and for the year ended December 31, 2025 included in this proxy statement/prospectus with respect to this uncertainty. This substantial doubt about Remix’s ability to continue as a going concern could materially limit its ability to raise additional funds through the issuance of new debt or equity securities or otherwise. Future reports on its financial statements may include an explanatory paragraph with respect to its ability to continue as a going concern. Even if the Mergers and Concurrent Financing are successfully completed, there is no assurance that adequate additional financing needed to allow Remix to continue as a going concern will be available to it on acceptable terms, or at all. The perception that Remix may not be able to continue as a going concern may cause others to choose not to do business with Remix due to concerns about its ability to meet its contractual obligations.

Remix has never generated any revenue from commercial product sales. To become and remain profitable, Remix must develop and eventually commercialize product candidates with significant market potential, which will require Remix to be successful in a range of challenging activities. These activities can include completing preclinical studies and clinical trials of Remix’s product candidates, obtaining regulatory approval for these product candidates, manufacturing, marketing and selling those products that are approved and satisfying any postmarketing requirements. Remix does not anticipate generating any revenue from product sales for many years, if ever. Remix’s ability to generate revenue and achieve profitability depends significantly on its ability to achieve several objectives, including:

Remix may never be successful in achieving its objectives and, even if it does, may never generate revenue that is significant or large enough to achieve profitability. Even if Remix successfully obtains regulatory approval to market a product candidate, its revenue will depend, in part, upon the size of the markets in the territories for which it receives regulatory approval and has commercial rights, the availability of competitive therapies and whether there are sufficient levels of reimbursement and adoption by physicians. If Remix does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. Remix’s failure to become and remain profitable would decrease the value of the company and could impair its ability to maintain or further its research and development efforts, raise additional necessary capital, grow its business and continue its operations.

Remix is substantially dependent on the success of its lead product candidate REM-422, which is in clinical development. Remix’s other programs are still in the preclinical or discovery stages. Remix will need to progress REM-422, through Remex’s ongoing and planned clinical trials and progress its other current and future development programs through preclinical studies and submit Investigational New Drug applications (INDs) to the FDA or comparable submissions to applicable foreign authorities prior to initiating their clinical development. Remix’s ability to generate product revenues, which it does not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of its product candidates. The success of Remix’s product candidates will depend on several factors, including the following:

Remix has not yet succeeded and may not succeed in demonstrating efficacy and safety for any product candidates in clinical trials or in obtaining regulatory approval thereafter. Given its stage of development, it will take several years before Remix can demonstrate the safety or efficacy of a product candidate sufficient to warrant approval for commercialization, if it can do so at all. If Remix is unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize its product candidates, Remix may not be able to generate sufficient revenue to continue its business.

Remix will be required to demonstrate with substantial evidence through well-controlled clinical trials that its product candidates are safe and effective for their intended uses before it can seek regulatory approvals for their commercial sale. Preclinical and clinical testing is expensive and can take many years to complete, and Remix’s outcome is inherently uncertain. Failure can occur at any time during the preclinical study and clinical trial processes, and, because Remix’s product candidates are in early stages of developments, there is a high risk of failure and it may never succeed in developing marketable products.

The results of preclinical studies may not be predictive of the results of clinical trials of Remix’s product candidates. Moreover, the results of early clinical trials may not be predictive of the results of later-stage clinical trials. Although product candidates may demonstrate promising results in preclinical studies and early clinical trials, they may not

prove to be safe or effective in subsequent clinical trials. Favorable results from certain animal studies may not accurately predict the results of other animal studies or of human trials, due to the inherent biologic differences in species, the differences between testing conditions in animal studies and human trials, and the particular goals, purposes, and designs of the relevant studies and trials.

There is typically an extremely high rate of attrition from the failure of product candidates proceeding through preclinical studies and clinical trials. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy profile despite having progressed through preclinical studies and initial clinical trials. Likewise, early, smaller-scale clinical trials may not be predictive of eventual safety or effectiveness in large-scale pivotal clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain regulatory approval of their drugs. A number of companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy, insufficient durability of efficacy or unacceptable safety issues, notwithstanding promising results in earlier trials. Most product candidates that commence preclinical studies and clinical trials are never approved as products. The development of Remix’s product candidates and its stock price may also be impacted by inferences, whether correct or not, that are drawn between the success or failure of preclinical studies or clinical trials of Remix’s competitors or other companies in the biopharmaceutical industry, in addition to its own preclinical studies and clinical trials.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dose and dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. This variability can increase the uncertainty of, and adversely impact, Remix’s clinical trial outcomes. As a result, Remix does not know whether any preclinical studies or clinical trials it may conduct will demonstrate consistent or adequate efficacy or safety sufficient to obtain approval to market any of its product candidates.

Remix is currently focusing its resources and efforts on REM-422 and advancing its other research programs. Because it has limited financial and managerial resources, Remix must focus on a limited number of research programs and product candidates and on specific indications. As a result, Remix may forgo or delay pursuit of opportunities for other target indications or with other product candidates that may have greater commercial potential. Remix’s resource allocation decisions may cause it to fail to capitalize on viable commercial products or profitable market opportunities. Its spending on current and future research and development activities for REM-422 and its other research programs may not yield any commercially viable products. If Remix does not accurately evaluate the commercial potential or target markets for REM-422 and its other research programs, or the product candidates it is currently developing in these programs, it may relinquish valuable rights to its product candidates or programs through collaboration, licensing or other strategic arrangements in cases in which it would have been more advantageous for Remix to retain sole development and commercialization rights to such product candidate or program.

Remix will need to successfully complete pivotal clinical trials in order to seek FDA or applicable foreign authority approval to market REM-422 and any future product candidates it may develop. Carrying out clinical trials and the preparation and submission of NDA and comparable marketing applications is complicated, and its experience is limited. Remix is concurrently conducting a Phase 1/2 clinical trial of REM-422 in ACC and a Phase 1 trial of REM-422 in AML. Remix has not yet completed any pivotal clinical trials, and has limited experience as a company in preparing, submitting and prosecuting regulatory applications and has not previously submitted an NDA or other applicable foreign regulatory submission for any product candidate. Remix also plans to conduct a number of clinical trials for in parallel over the next several years. This may be a difficult process to manage with its limited resources and may divert the attention of management. Consequently, it may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to regulatory submission and approval

of any of its product candidates. Remix may require more time and incur greater costs than its competitors and may not succeed in obtaining regulatory approvals of product candidates that it develops. Failure to commence or complete, or delays in, its planned clinical trials, could prevent Remix from or delay it in submitting marketing applications for and commercializing its product candidates.

Before obtaining approval from regulatory authorities for the commercialization of any of its product candidates, Remix must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidate in humans. Before it can initiate clinical trials for any product candidates, Remix must submit the results of preclinical studies to the FDA or comparable foreign regulatory authorities along with other information, including information about product candidate chemistry, manufacturing and controls and its proposed clinical trial protocol, as part of an IND or similar regulatory submission. The FDA or comparable foreign regulatory authorities may require Remix to conduct additional preclinical studies for any product candidate before it allows Remix to initiate clinical trials under any IND or similar regulatory submission, which may lead to delays and increase the costs of its preclinical development programs. Moreover, even if Remix commences clinical trials, issues may arise that could cause regulatory authorities to suspend or terminate such clinical trials. Any such delays in the commencement or completion of Remix’s ongoing and planned clinical trials for its product candidates could significantly affect its product development timelines and product development costs and harm its financial position.

Remix may experience delays in initiating or completing clinical trials or reporting data readouts for such trials, due to unforeseen events or otherwise, that could delay or prevent its ability to receive regulatory approval or commercialize its current and any future product candidates, including:

Clinical trials must be conducted in accordance with the FDA and other applicable regulatory authorities’ legal requirements, regulations and guidelines, and remain subject to oversight by these governmental agencies as well as ethics committees or IRBs responsible for overseeing the conduct of clinical trials and ensuring the welfare of the research participants. Remix could similarly encounter delays if a clinical trial is suspended or terminated by it, the IRBs of the institutions in which such trials are being conducted, the FDA or comparable foreign regulatory authorities or the Data Safety Monitoring Board 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 or its clinical trial protocols, adverse findings from inspection of the clinical trial operations or trial site by the FDA or comparable foreign regulatory authorities, unforeseen safety issues or adverse side effects, 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. In addition, changes in regulatory requirements and policies may occur, and Remix may need to amend clinical trial protocols to comply with these changes. Amendments may require Remix to resubmit its clinical trial protocols to regulators or to IRBs for reexamination, which may impact the costs, timing or successful completion of a clinical trial. Clinical trials may also be delayed or terminated as a result of ambiguous or negative interim results.

Further, conducting clinical trials in foreign countries, as Remix may do for its product candidates, presents additional risks that may delay completion of its clinical trials. These risks include the failure of enrolled subjects in foreign countries to adhere to clinical protocols as a result of differences in healthcare services or cultural customs, managing additional administrative burdens associated with foreign regulatory schemes, and political and economic risks, including war, relevant to such foreign countries.

Many of the factors that cause, or lead to, a delay in the commencement or completion of, or the termination or suspension of clinical trials may also ultimately lead to the denial of regulatory approval of Remix’s product candidates. Further, the FDA may disagree with its interpretation of data from clinical trials or may change the requirements for approval even after it has reviewed and commented on the design for its clinical trials.

Ultimately, Remix’s product development costs will increase if Remix experiences delays in clinical testing or in seeking regulatory approvals. Remix does not know whether any of its clinical trials will begin as planned, will need to be redesigned or will be completed on schedule, or at all. Significant clinical trial delays also could shorten any periods during which Remix may have the exclusive right to commercialize its product candidates and may allow its competitors to bring products to market before Remix does, potentially impairing its ability to successfully commercialize its product candidates, if approved. Any delays or increase in costs in Remix’s clinical development programs may harm its business, financial condition, results of operations and prospects.

Patient enrollment is a significant factor impacting the duration of Remix’s clinical trials, along with treatment duration and completion of required follow-up periods. Clinical trials may be prolonged, or Remix may not be able to initiate or continue clinical trials for its product candidates if it is unable to locate and enroll a sufficient number of eligible patients to participate as required by the FDA or applicable foreign authorities. Remix also may encounter difficulties in identifying and enrolling patients with a stage of disease appropriate for its planned clinical trials and monitoring such patients adequately during and after treatment. Additionally, other pharmaceutical companies targeting these same diseases are recruiting clinical trial patients from these patient populations, which may make it more difficult to fully enroll Remix’s clinical trials. In addition, the process of finding and diagnosing patients may prove costly.

The eligibility criteria of Remix’s clinical trials, once established, may further limit the pool of available trial participants. If the actual number of patients with these diseases is smaller than Remix anticipates, it may encounter difficulties in enrolling patients in its clinical trials, thereby delaying or preventing development and approval of its product candidates. Even once enrolled, Remix may be unable to retain a sufficient number of patients to complete any of its trials.

The timely completion of clinical trials in accordance with their protocols depends on, among other things, Remix’s ability to enroll a sufficient number of patients who remain in the study until its conclusion. Remix may experience difficulties in patient enrollment or retention in its clinical trials for a variety of reasons. Patient enrollment and retention in clinical trials depends on many factors, including:

Furthermore, Remix’s efforts to build relationships with patient communities may not succeed, which could result in delays in patient enrollment in its clinical trials. If Remix encounters any delays in enrolling such additional

participants, this may further delay its clinical trial. In addition, any negative results Remix may report in clinical trials of its product candidate may make it difficult or impossible to recruit and retain patients in other clinical trials of that same product candidate. Delays or failures in planned patient enrollment or retention may result in increased costs, program delays or both, which could have a harmful effect on Remix’s ability to develop its product candidates, or could render further development impossible. Further, if patients drop out of its clinical trials, miss scheduled doses or follow-up visits, or otherwise fail to follow clinical trial protocols, the integrity of data from its clinical trials may be compromised or not accepted by the FDA or applicable foreign authorities, which would represent a significant setback for the applicable program. In addition, Remix may rely on CROs and clinical trial sites to ensure proper and timely conduct of its future clinical trials and, while it has entered and intends to enter into agreements governing their services, it will be limited in its ability to compel their actual performance. Such delays or failures could adversely affect its business, operating results, financial condition and prospects.

As is the case with oncology drugs generally, it is likely that there may be side effects and adverse events associated with use of Remix’s product candidates. Results of Remix’s clinical trials could reveal a high and unacceptable severity and prevalence of expected or unexpected adverse events or unexpected characteristics. Undesirable effects caused by its product candidates when used alone or in combination with other therapies could cause Remix or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive label, or lead to the delay or denial of regulatory approval by the FDA or comparable foreign regulatory authorities. Any drug-related adverse events could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm Remix’s business, financial condition, results of operations, and prospects significantly.

It is possible that as Remix tests its product candidates in larger, longer, and more extensive clinical trials, including with different dosing regimens, or as the use of these product candidates becomes more widespread following any regulatory approval, more illnesses, injuries, discomforts, and other adverse events than were observed in earlier trials, as well as new conditions that did not occur or went undetected in previous trials, may be discovered. If such side effects become known later in development or upon approval, if any, such findings may harm its business, financial condition, and prospects significantly.

In addition, Remix may decide to study its product candidates in combination with other therapies, which may exacerbate adverse events associated with such product candidates. Patients treated with its product candidates may also be undergoing surgical, radiation, and/or chemotherapy treatments, which can cause side effects or adverse events that are unrelated to its product candidates but may still impact the success of its clinical trials. The inclusion of critically ill patients in its clinical trials may result in deaths or other adverse medical events due to other therapies or medications that such patients may be using or due to the gravity of such patients’ illnesses. For example, Remix expects that some of the patients enrolled in its clinical trials will die or experience major clinical events either during the course of its clinical trials or after participating in such trials.

If Remix’s product candidates are associated with undesirable side effects in clinical trials or have characteristics that are unexpected, Remix may elect to halt or abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial value for the product candidate if approved. Many compounds that initially showed promise in early-stage testing have later been found to cause side effects that prevented further development of the compound. In addition, regulatory authorities may draw different conclusions or require additional testing to confirm these determinations.

In addition, if any of Remix’s product candidates receive regulatory approval, the FDA could require it to include a black box warning in the product label or adopt a Risk Evaluation and Mitigation Strategy (REMS), to ensure that the benefits of the product outweigh its risks, which may include a medication guide outlining the risks of the drug for distribution to patients and a communication plan to health care practitioners. For example, the FDA could require Remix to adopt a REMS to ensure that the benefits of treatment with such product candidates outweigh the risks for each potential patient, which may include, among other things, a communication plan to health care practitioners, patient education, extensive patient monitoring or distribution systems and processes that are highly

controlled, restrictive and more costly than what is typical for the industry. Furthermore, if Remix or others later identify undesirable side effects caused by its product candidates, several other potentially significant negative consequences could result, including:

Any of these events could prevent Remix from achieving or maintaining market acceptance of its product candidates and could significantly harm its business, prospects, financial condition and results of operations.

The clinical development, manufacturing, labeling, storage, recordkeeping, advertising, promotion, import, export, marketing and distribution of Remix’s product candidates are subject to extensive regulation by the FDA in the U.S. and by comparable foreign regulatory authorities in foreign markets. In the U.S., Remix is not permitted to market its product candidates in the U.S. until it receives regulatory approval of an NDA from the FDA. The process of obtaining such regulatory approval is expensive, often takes many years following the commencement of clinical trials and can vary substantially based upon the type, complexity and novelty of the product candidates involved, as well as the target indications and patient population. Approval policies or regulations may change, and the FDA and comparable regulatory have substantial discretion in the approval process, including the ability to delay, limit or deny approval of a product candidate for many reasons. Despite the time and expense invested in clinical development of product candidates, regulatory approval of a product candidate is never guaranteed. Of the large number of drugs in development, only a small percentage successfully complete the FDA or foreign regulatory approval processes and are commercialized.

Prior to obtaining approval to commercialize a product candidate in the U.S. or abroad, Remix must demonstrate with substantial evidence from adequate and well-controlled clinical trials, and to the satisfaction of the FDA or comparable foreign regulatory authorities, that such product candidates are safe and effective for their intended uses. Results from nonclinical studies and clinical trials can be interpreted in different ways. Even if Remix believes available nonclinical or clinical data support the safety and/or efficacy of its product candidates, such data may not be sufficient to obtain approval from the FDA and comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authorities, as the case may be, may also require Remix to conduct additional preclinical studies or clinical trials for its product candidates either prior to or post-approval, or may object to elements of its clinical development program.

The FDA or comparable foreign regulatory authorities can delay, limit or deny approval of a product candidate for many reasons, including:

With respect to foreign markets, approval procedures vary among countries and, in addition to the foregoing risks, may involve additional product testing, administrative review periods and agreements with pricing authorities. Even if Remix eventually completes clinical trials and receives approval of an NDA or comparable foreign marketing application for its product candidates, the FDA or comparable foreign regulatory authority may grant approval contingent on the performance of costly additional clinical trials and/or the implementation of a REMS, which may be required because the FDA believes it is necessary to ensure safe use of the product after approval. Any delay in obtaining, or inability to obtain, applicable regulatory approval would delay or prevent commercialization of that product candidate and would materially adversely impact Remix’s business and prospects.

In March 2026, the FDA granted Fast Track designation for REM-422 for the treatment of patients with recurrent, metastatic or unresectable ACC whose tumors express MYB transcripts containing a poison exon. Depending on the data from its preclinical and clinical studies, Remix may decide to seek such designation for some or all of its other product candidates. The Fast Track program is intended to expedite or facilitate the process for reviewing product candidates that meet certain criteria. Specifically, drugs and biologics are eligible for Fast Track designation if they are intended, alone or in combination with one or more drugs or biologics, to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition. Fast Track designation applies to the combination of the product candidate and the specific indication for which it is being studied. 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 an NDA is submitted, the application may be eligible for priority review. An NDA submitted for a Fast Track product candidate may also be eligible for rolling review, where the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

The FDA has broad discretion whether or not to grant this designation. Even if Remix believes a particular product candidate is eligible for this designation, there can be no assurance that the FDA would decide to grant it. Even if Remix does receive Fast Track Designation for any of its product candidates, such product candidates may not experience a faster development process, review or approval compared to conventional FDA procedures. The FDA may also withdraw Fast Track Designation if it believes that the designation is no longer supported by data from

Remix’s clinical development program. Furthermore, such a designation does not increase the likelihood that REM-422 or any other product candidate that may be granted Fast Track designation will receive regulatory approval in the U.S. Many product candidates that have received Fast Track Designation have ultimately failed to obtain approval.

Remix may in the future seek accelerated approval for one or more of its product candidates. Under the accelerated approval program, the FDA may grant accelerated approval to a product candidate designed to treat a serious or life-threatening condition that provides meaningful therapeutic benefit over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint that is reasonably likely to predict clinical benefit. The FDA considers a clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as irreversible morbidity or mortality. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinical endpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit.

The accelerated approval pathway may be used in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinically important improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’s agreement to conduct, in a diligent manner, additional confirmatory studies to verity and describe the drug’s predicted clinical benefit. If such post-approval studies fail to confirm the drug’s clinical benefit or are not completed in a timely manner, the FDA may withdraw its approval of the drug on an expedited basis. In addition, the Food and Drug Omnibus Reform Act of 2022, among other things, provided FDA additional statutory authority to mitigate potential risks to patients from continued marketing of ineffective drugs previously granted accelerated approval. Under these provisions, the FDA may require a sponsor of a product seeking accelerated approval to have a confirmatory trial underway prior to such approval being granted.

Prior to seeking accelerated approval for any of its product candidates, Remix intends to seek feedback from the FDA and will otherwise evaluate its ability to seek and receive accelerated approval. There can be no assurance that after its evaluation of the feedback and other factors Remix will decide to pursue or submit an NDA for accelerated approval or any other form of expedited development, review or approval. Furthermore, if Remix decides to submit an application for accelerated approval for its product candidates, there can be no assurance that such application will be accepted or that any expedited development, review or approval will be granted on a timely basis, or at all. The FDA could also require Remix to conduct further studies prior to considering its application or granting approval of any type. A failure to obtain accelerated approval or any other form of expedited development, review or approval for its product candidates would result in a longer time period to commercialization of such product candidate, if any, could increase the cost of development of such product candidate and could harm Remix’s competitive position in the marketplace.

According to FDA guidance, if the FDA determines that a companion diagnostic in vitro device is essential to the safe and effective use of a novel therapeutic product or indication, the FDA generally will not approve the therapeutic product or therapeutic product indication if the companion diagnostic is not also approved or cleared for that indication. Depending on the data from its clinical trials, Remix may decide to collaborate with diagnostic companies during its clinical trial enrollment process to help identify patients with characteristics that it believes will be most likely to respond to its product candidates. If a satisfactory companion diagnostic is not commercially

available in this situation, Remix may be required to develop or obtain such test, which would be subject to regulatory approval requirements. The process of obtaining or creating such diagnostic is time consuming and costly.

Companion diagnostics are developed in conjunction with clinical programs for the associated product and are subject to regulation as medical devices by the FDA and comparable foreign regulatory authorities, and the FDA has generally required premarket approval of companion diagnostics for cancer therapies. The approval or clearance of a companion diagnostic as part of the therapeutic product’s further labeling limits the use of the therapeutic product to only those patients who express the specific characteristic that the companion diagnostic was developed to detect.

Further, in December 2025, the FDA proposed reclassifying certain nucleic acid-based in vitro tests intended as companion diagnostics for oncology therapeutics from Class III into Class II. If such reclassification proposals become finalized, any companion diagnostics that are the subject of the down-classification may no longer require premarket approval, but rather may be marketed pursuant to the generally less burdensome 510(k) clearance process. However, there is no assurance that any companion diagnostic required for Remix’s pharmaceutical development programs will benefit from the reclassification, or that the reclassification, even if it does occur, will result in a shorter timeline to development or marketing of the companion diagnostic.

If the FDA or a comparable foreign regulatory authority requires approval or clearance of a companion diagnostic for any of Remix’s product candidates, whether before or after the product candidate obtains regulatory approval, Remix and/or third-party collaborators may encounter difficulties in developing and obtaining approval or clearance for these companion diagnostics. Any delay or failure by Remix or third-party collaborators to develop or obtain regulatory approval or clearance of a companion diagnostic could delay or prevent approval or continued marketing of the relevant product. Remix or its collaborators may also experience delays in developing a sustainable, reproducible and scalable manufacturing process for the companion diagnostic or in transferring that process to commercial partners or negotiating insurance reimbursement plans, all of which may prevent Remix from completing its clinical trials or commercializing its product candidates, if approved, on a timely or profitable basis, if at all.

From time to time, Remix may publicly disclose preliminary, interim, or topline data from its preclinical studies and clinical trials. These interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. For example, Remix may report responses in certain patients that are unconfirmed at the time and which do not ultimately result in confirmed responses to treatment after follow-up evaluations.

Remix also makes assumptions, estimations, calculations and conclusions as part of its analyses of data, and may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that Remix reports may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data it previously published. As a result, topline data should be viewed with caution until the final data are available.

In addition, Remix may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical trials that it may complete 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 interim data and final data could significantly harm its business and prospects. Further, additional disclosure of interim data by Remix or by its competitors in the future could result in volatility in the price of its common stock.

In addition, the information Remix chooses to publicly disclose regarding a particular study or trial is typically selected from a more extensive amount of available information. Investors may not agree with what Remix determines is the material or otherwise appropriate information to include in its disclosure, and any information it determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or its business. If the preliminary or topline data that

Remix reports differ from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, its ability to obtain approval for, and commercialize, any of its product candidates may be harmed, which could harm its business, financial condition, results of operations and prospects.

We incorporate AI solutions into our platform technologies. There are significant risks involved in utilizing AI, including that AI-generated content, analyses, or recommendations we utilize could be deficient, that our competitors may more quickly or effectively adopt AI capabilities, or that our use of AI or other emerging technologies increases regulatory, cybersecurity and other significant risks. If our AI systems fail to achieve their intended purposes, such as identifying viable therapeutic candidates or targets, predicting biological outcomes, producing reproducible results, and other similar or related purposes, our product development efforts may be delayed or unsuccessful. If we are unable to successfully integrate and manage AI within our business, or if AI fails to deliver the expected benefits, our ability to develop our product candidates could be materially adversely affected.

Issues relating to the use of new and evolving technologies such as AI may cause us to experience brand or reputational harm, competitive harm, legal liability and new or enhanced governmental or regulatory scrutiny, and we may incur additional costs to resolve such issues. Known risks of AI currently include inaccuracy, bias, toxicity, intellectual property infringement or misappropriation, data privacy and cybersecurity issues and data provenance disputes. Perceived or actual technical, legal, compliance, privacy, security, ethical or other issues relating to the use of AI may cause public confidence in AI to be undermined, which could slow market acceptance of products discovered and developed using AI. In addition, litigation or government regulation related to the use of AI may also adversely impact our and others’ abilities to discover and develop products using AI, as well as increase the cost and complexity of doing so. For example, regulators may limit our ability to develop or implement our proprietary AI algorithms and/or may eliminate or restrict the confidentiality of our proprietary technology, which could have an adverse effect on our business, results of operations and financial condition.

We also face increased competition from other companies that are using AI and related methods for drug discovery and development, some of which have more resources than we do and may have developed more effective methods than we and any third-party collaborators have, which may reduce our and any third-party collaborators’ effectiveness in identifying potential product candidates and attracting additional collaborators to work with us. If our competitors are able to utilize new technologies more effectively (including but not limited to those that may involve AI or be created using AI) to discover, develop and commercialize products that compete with any of our product candidates or potential commercial products, such technologies could adversely impact our ability to compete.

Further, AI presents additional risks and challenges, especially as the use of these technologies becomes more important to our operations over time. AI may have or produce errors or inadequacies that are not easily detectable. The quality of AI outputs depends heavily on the quality and quantity of input data. If the data used to train AI or the content, analyses or recommendations that AI applications assist in producing are or are alleged to be deficient, inaccurate, incomplete, overbroad or biased, our business, financial condition and results of operations may be adversely affected. Developing, testing and deploying AI systems may also increase the cost profile of our product offerings due to the nature of the computing costs involved in such systems, which could impact our project margin and adversely affect our business and operating results.

The legal landscape and subsequent legal protection for the use of AI remains uncertain, and the increasing use of AI in drug discovery and development introduces new and evolving risks related to ownership, inventorship and protection of intellectual property generated by or with the assistance of AI technologies. For example, generative AI may be used improperly or inappropriately, which could lead to the tainting of our proprietary information and render us unable to qualify for certain patent or trade secret protection. Its use by people, including our vendors, employees, suppliers and contractors, with access to our proprietary and confidential information, including know-how, may continue to increase and may lead to the release of such information, which may impact our ability to realize the benefit of our intellectual property. If we do not have sufficient rights to collect or use the data on which our AI relies or to the outputs produced by our platform, we may incur liability through the alleged violation of certain laws, third-party privacy rights, online terms of service or other contracts to which we or our data providers are a party. Regulatory and legal frameworks governing inventions created with or using AI are still developing and may create uncertainty regarding our ability to secure and enforce rights in such inventions.

Issues in the development and use of AI, combined with an uncertain regulatory environment, may result in reputational harm, liability or other adverse consequences to our business operations. As with many technological innovations, AI presents risks and challenges that could impact our business. In addition to our platform technologies, we have adopted and integrated, and in the future may adopt and integrate, generative AI tools into our systems for specific use cases reviewed by legal and information security. Our vendors may incorporate generative AI tools into their offerings without disclosing this use to us, and the providers of these generative AI tools may not meet existing or rapidly evolving regulatory or industry standards with respect to privacy and data protection and may inhibit our or our vendors’ ability to maintain an adequate level of service and experience. If we, our vendors or our third-party partners experience an actual or perceived breach or privacy or security incident because of the use of generative AI, we may lose valuable intellectual property and confidential information and our reputation and the public perception of the effectiveness of our security measures could be harmed. Further, bad actors around the world use increasingly sophisticated methods, including the use of AI, to engage in illegal activities involving the theft and misuse of personal information, confidential information and intellectual property. Any of these outcomes could damage our reputation, result in the loss of valuable property and information, and adversely impact our business.

Our use of AI may also lead to novel and urgent cybersecurity and privacy risks, which may adversely affect our operations and reputation, as well as the operations of any third-party collaborators. Emerging ethical issues surround the use of AI, and we may be subject to reputational and legal risk if our deployment or use of AI becomes controversial. Our use of AI may also, in the future, result in cybersecurity incidents that implicate the personal data of customers or patients. Any such cybersecurity incidents related to our use of AI could adversely affect our reputation and results of operations.

A growing number of legislators and regulators are adopting laws and regulations and have focused enforcement efforts on the adoption of AI, and use of such technologies in compliance with ethical standards and societal expectations. These developments may increase our compliance burden and costs in connection with use of AI and lead to legal liability if we fail to meet evolving legal standards or if use of such technologies results in harms or other causes of action we did not predict. For example, the EU’s Artificial Intelligence Act entered into force on August 1, 2024, with most provisions becoming effective on August 2, 2026. This legislation imposes significant obligations on providers and deployers of AI systems, and encourages providers and deployers of AI systems to account for EU ethical principles in their development and use of these systems. Likewise, in the U.S., several states, including Colorado and California, passed laws to regulate various AI uses, including AI used to make consequential decisions. In addition, various federal regulators have issued guidance and focused enforcement efforts on the use of AI in regulated sectors. The FDA, for example, issued draft guidance on the use of AI in regulatory decision-making for drug and biological products that centers on the context of use while establishing a credibility assessment framework for establishing and evaluating AI model outputs intended to support regulatory decision-making. If we develop or use AI systems governed by these laws or regulations, including as informed by regulatory guidance, we would need to meet higher standards of data quality, transparency, monitoring and human oversight, and we would need to adhere to specific and potentially burdensome and costly ethical, accountability and administrative requirements, with the potential for significant enforcement or litigation in the event of any perceived non-compliance. We expect other jurisdictions will adopt similar laws. Uncertainty in the legal regulatory regime may require significant resources to modify and maintain business practices to comply with U.S. and non-U.S. laws, the nature of which cannot be determined at this time. The scope of requirements depends on legal and risk determinations that rely on novel legal provisions that have not yet been interpreted by courts or regulators, and non-compliance can lead to significant fines.

We utilize software that is licensed from third parties under open source licenses, and we expect to continue to use such OSS in the future. We cannot ensure that we have effectively monitored our use of OSS, validated the quality or source of such software, or are in compliance with the terms of the applicable open source licenses or our policies and procedures. Use of OSS may entail greater risks than use of third-party commercial software because open source licensors generally do not provide support, updates or warranties or other contractual protections regarding infringement claims or the quality of the code. OSS may also be more susceptible to security vulnerabilities.

Third-party OSS providers could experience service outages, data loss, privacy breaches, cyber-attacks and other events relating to the applications and services they provide, which could diminish the utility of these services and harm our business. We also could be subject to lawsuits by third parties claiming that what we believe to be licensed OSS infringes such parties’ intellectual property rights, which could be costly for us to defend and require us to devote additional research and development resources to change our solutions. Some OSS licenses contain requirements that we make available source code for modifications or derivative works we create based upon the type of OSS we use. If we combine our proprietary software with OSS in a certain manner, we could, under certain of the OSS licenses, be required to release the source code of our proprietary software to the public. This could allow our competitors to create similar products with lower development effort and time, and ultimately could result in a loss of product sales for us. Although we monitor our use of OSS, the terms of many OSS licenses have not been interpreted by U.S. courts, and there is a risk that those licenses could be construed in a manner that could impose unanticipated conditions or restrictions on our ability to commercialize our product candidates. We could be required to seek licenses from third parties in order to continue using our software, to re-engineer our software or to discontinue use of our software in the event re-engineering cannot be accomplished on a timely basis, any of which could materially and adversely affect our business, financial condition, results of operations and prospects.

The pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. In particular, precision oncology is a very competitive space and Remix has chosen to prioritize addressing well-validated biological targets, and therefore expects to face competition from existing products and products in development for each of its product candidates. While Remix believes that its technology, the expertise of its team, and its development experience and scientific knowledge provide it with competitive advantages, it faces increasing competition from many different sources, including pharmaceutical and biotechnology companies, academic institutions, governmental agencies and public and private research institutions. Product candidates that Remix successfully develops and commercializes may compete with existing therapies and new therapies that may become available in the future.

Many of Remix’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, preclinical and clinical testing, obtaining regulatory approvals and reimbursement and marketing approved products than Remix does. These competitors also compete with Remix in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, its programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. Additional mergers and acquisitions may result in even more resources being concentrated in its competitors. As a result of all of these factors, Remix’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 its field before Remix does.

Remix’s commercial potential could be reduced or eliminated if its competitors develop and commercialize products that are safer or more effective, have fewer or less severe side effects, and are more convenient or less expensive than products that it may develop. Its competitors also may obtain FDA or other regulatory approval for their products more rapidly than Remix can, which could result in its competitors establishing a strong market position before Remix is able to enter the market or could otherwise make its development more complicated. Remix believes the key competitive factors affecting the success of all of its programs are likely to be efficacy, safety and patient convenience. Even if the product candidates it develops obtain regulatory approval, they may be priced at a significant premium over competitive products if any have been approved by then, resulting in reduced competitiveness.

There are no FDA-approved drugs for ACC. However, there are competitors developing therapies for ACC, including Emi-Le, which is in development by Les Laboratoires Servier SAS (“Servier”), and RGT-61159, which is in development by Rgenta Therapeutics, Inc. (“Rgenta”).

Finally, there are numerous other investigational therapies, spanning many modalities, that are being evaluated preclinically and in clinical trials for various subtypes of AML.

Technological advances or products developed by Remix’s competitors may render its technologies or product candidates obsolete, less competitive or not economical. If Remix is unable to compete effectively, its opportunity to generate revenue from the sale of its products it may develop, if approved, could be adversely affected.

As product candidates progress through preclinical and clinical trials to regulatory approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize yield and manufacturing batch size, minimize costs and achieve consistent quality and results. For example, Remix may introduce an alternative formulation of one or more of its product candidates during the course of its clinical trials. Such changes carry the risk that they will not achieve these intended objectives.

Any of these changes could cause Remix’s product candidates to perform differently and affect the results of clinical trials conducted with the altered materials, or adversely affect a product’s safety or profile that has been previously established. In particular, such changes could delay completion of clinical trials, require the conduct of bridging clinical trials or the repetition of one or more clinical trials, increase clinical trial costs, delay approval of Remix’s product candidates and jeopardize or impair its ability to commercialize its product candidates, if approved, and generate revenue.

Remix may develop or seek strategic collaborations to develop its current or future product candidates in combination with one or more currently approved cancer therapies or therapies in development. Even if any of its current or future product candidates were to receive regulatory approval or be commercialized for use in combination with other existing therapies, Remix would continue to be subject to the risks that the FDA or other comparable foreign regulatory authorities could revoke approval of the therapy used in combination with any of its product candidates, or safety, efficacy, manufacturing or supply issues could arise with these existing therapies. In addition, it is possible that existing therapies with which its product candidates are approved for use could themselves fall out of favor or be relegated to later lines of treatment. Such events could result in the need to identify other combination therapies for its product candidates or its own products being removed from the market or being less successful commercially. In addition, developing combination regimens may require that Remix adequately demonstrate the safety and efficacy of each therapy within the combination regimen, which may prove difficult, and otherwise require it to generate more data than it would in connection with a monotherapy program.

If the FDA, or other comparable foreign regulatory authorities do not approve or withdraw their approval of these other therapies, or if safety, efficacy, commercial adoption, manufacturing or supply issues arise with the therapies Remix chooses to evaluate in combination with any of its current or future product candidates, Remix may be unable to obtain approval of or successfully market any one or all of the current or future product candidates it develops. Additionally, if the third-party providers of therapies or therapies in development used in combination with its current or future product candidates are unable to produce sufficient quantities for clinical trials or for commercialization of its current or future product candidates, or if the cost of combination therapies are prohibitive, its development and commercialization efforts would be impaired, which would have an adverse effect on its business, financial condition, results of operations and growth prospects.

Remix has conducted or is conducting clinical trials for REM-422 in France, and will likely conduct additional clinical trials for REM-422 and its other product candidates at sites outside of the United States. The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA or applicable foreign authority 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, regardless of whether the trials were conducted pursuant to an IND, the FDA will generally not approve an NDA on the basis of foreign data alone 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 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, if the trial was not otherwise subject to an IND, the FDA will not accept the data as support for a submission unless the study was conducted in accordance with GCP requirements

and the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA or any applicable foreign authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA or applicable foreign authorities do not accept any such data, Remix would likely be required to conduct additional clinical trials, which would be costly and time consuming, and delay aspects of its development plan, which could harm its business.

Conducting clinical trials outside the United States exposes Remix to additional risks, including risks associated with:

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

If any of Remix’s product candidates are approved but do not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, Remix may not generate or derive sufficient revenue from that product candidate and its financial results could be negatively impacted.

When cancer is detected early (referred to as localized disease), conventional treatments which include chemotherapy, hormone therapy, surgery and radiation therapy and/or selected targeted therapies may be adequate to cure the patient in many cases. However, once cancer has spread to other areas (advanced or metastatic disease), cancer treatments may not be sufficient to provide a cure but often can significantly prolong life without curing the cancer. First-line (1L) therapies designate treatments that are initially administered to patients with advanced or metastatic disease, while second-line (2L) and third or later line (3L+) therapies are administered to patients when the prior therapies lose their effectiveness. The FDA and other comparable foreign regulatory bodies often approve cancer therapies for a particular line of treatment. Typically, drug approvals are initially granted for use in later lines of treatment, but with additional evidence of significant efficacy from clinical trials, biopharmaceutical companies can successfully seek and gain approval for use in earlier lines of treatment.

Remix plans to initially seek approval of its product candidates in most instances at least as a second- or third-line therapy, for use in patients with advanced or metastatic cancer where at least one prior therapy has limited clinical benefit or has lost its effectiveness. For those product candidates that prove to be sufficiently safe and effective, if any, Remix would expect to seek approval as a 2L therapy and potentially ultimately as a 1L therapy. There is no guarantee that its product candidates, even if approved as a second, third or subsequent line of therapy would be approved for an earlier line of therapy, and prior to any such approvals Remix may have to conduct additional clinical trials that may be costly, time-consuming and subject to risk.

Remix’s projections of both the number of people who have the cancers it is targeting, as well as the subset of people with these cancers in a position to receive a particular line of therapy and who have the potential to benefit from treatment with its product candidates, are based on its beliefs and estimates. These estimates have been derived from a variety of sources, including scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of the cancers that Remix is targeting. The potentially addressable patient population for Remix’s product candidates may be limited or may not be amenable to treatment with its product candidates. Consequently, even if Remix’s product candidates are approved, the number of patients that may be eligible for treatment with its product candidates may turn out to be much lower than expected. In addition, Remix has not yet conducted market research to determine how treating physicians would expect to prescribe a product that is approved for multiple tumor types if there are different lines of approved therapies for each such tumor type. Even if Remix obtains significant market share for its products, if approved, if the potential target populations are small, it may never achieve profitability without obtaining regulatory approval for additional indications.

The availability and extent of coverage and adequate reimbursement by third-party payors, including government health administration authorities, private health coverage insurers, managed care organizations and other third-party payors is essential for most patients to be able to afford expensive treatments. Sales of any of Remix’s product candidates that receive regulatory approval will depend substantially, both in the United States and internationally, on the extent to which the costs of such product candidates will be covered and reimbursed by third-party payors. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow Remix to establish or maintain pricing sufficient to realize an adequate return on its investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which Remix obtains regulatory approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, Remix may not successfully commercialize any product candidate for which it obtains regulatory approval.

There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, no uniform policy for coverage and reimbursement for products exists among third-party payors. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement rates, but also have their own methods and approval process apart from Medicare determinations. Therefore, coverage and reimbursement for products can differ significantly from payor to payor. One third-party payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. As a result, the coverage determination process is often time-consuming and costly. This process will require Remix to provide scientific and clinical support for the use of its products to each third-party payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

As federal and state governments implement additional health care cost containment measures, including measures to lower prescription drug pricing, Remix cannot be sure that its products, if approved, will be covered by private or public payors, and if covered, whether the reimbursement will be adequate or competitive with other marketed products. Any actions by federal and state governments and health plans aimed at putting additional downward pressure on pharmaceutical pricing and health care costs could negatively impact coverage and reimbursement for Remix’s product candidates if approved, its revenue, and its ability to compete with other marketed products and to recoup the costs of its research and development. For further discussion, see “— Remix may face difficulties from changes to current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on its business and results of operations.”

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 product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-party payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication. Remix may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost effectiveness of its products. Nonetheless, Remix’s product candidates may not be considered medically necessary or cost effective. Remix cannot be sure that coverage and reimbursement will be available for any product that it commercializes and, if reimbursement is available, what the level of reimbursement will be.

In addition, companion diagnostic tests require coverage and reimbursement separate and apart from the coverage and reimbursement for their companion pharmaceutical or biological products. Similar challenges to obtaining coverage and reimbursement, applicable to pharmaceutical or biological products, will apply to companion diagnostics. Additionally, if any companion diagnostic provider is unable to obtain reimbursement or is inadequately reimbursed, that may limit the availability of such companion diagnostic, which would negatively impact prescriptions for Remix’s product candidates, if approved.

Outside the United States, the commercialization of therapeutics is generally subject to extensive governmental price controls and other market regulations, and Remix believes the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics such as its product candidates. In many countries, particularly the countries of the European Union (EU), medical product prices are subject to varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives regulatory approval. To obtain reimbursement or pricing approval in some countries, Remix may be required to conduct a clinical trial that compares the cost-effectiveness of its product candidate to other available therapies. In general, product prices under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for products but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that Remix is able to charge for its product candidates. Accordingly, in markets outside the United States, the reimbursement for Remix products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

If Remix is unable to establish or sustain coverage and adequate reimbursement for any product candidates from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates, if approved. Coverage policies and third-party payor reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which Remix receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Remix’s business exposes Remix to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of Remix’s development programs. If Remix succeeds in marketing products, such claims could result in an FDA or other regulatory authority investigation of the safety and effectiveness of Remix’s products, Remix’s manufacturing processes and facilities or Remix’s marketing programs. FDA or other regulatory authority investigations could potentially lead to a recall of Remix’s products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or

eventual outcome, liability claims may also result in decreased demand for Remix’s products, injury to Remix’s reputation, costs to defend the related litigation, a diversion of management’s time and Remix’s resources and substantial monetary awards to trial participants or patients. Remix currently has product liability insurance that Remix believes is appropriate for Remix’s stage of development and may need to obtain higher levels prior to advancing Remix’s product candidates into clinical trials or marketing any of Remix’s product candidates, if approved. Any insurance Remix has or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, Remix may be unable to obtain sufficient insurance at a reasonable cost to protect Remix against losses caused by product liability claims that could have an adverse effect on Remix’s business and financial condition.

Remix has never commercialized a product candidate as a company. Remix may license certain rights with respect to Remix’s product candidates to collaborators, and, if so, Remix will rely on the assistance and guidance of those collaborators. For product candidates for which Remix retains commercialization rights and obtains regulatory approval, Remix will have to develop Remix’s own sales, marketing and supply organization or outsource these activities to a third party.

Factors that may affect Remix’s ability to commercialize its product candidates, if approved, on Remix’s own include recruiting and retaining adequate numbers of effective sales and marketing personnel, developing adequate educational and marketing programs to increase public acceptance of Remix’s approved product candidates, ensuring regulatory compliance of Remix’s company, employees and third parties under applicable healthcare laws, and other unforeseen costs associated with creating an independent sales and marketing organization. Developing a sales and marketing organization will be expensive and time consuming and could delay the launch of Remix’s product candidates upon approval. Remix may not be able to build an effective sales and marketing organization. If Remix is unable to build its own distribution and marketing capabilities or to find suitable partners for the commercialization of its product candidates, Remix may not generate revenues from them or be able to reach or sustain profitability.

Obtaining and maintaining regulatory approval of Remix’s product candidates in one jurisdiction does not guarantee that Remix 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 and reimbursement of the product candidate in those countries. 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 preclinical 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 Remix intends to charge for Remix’s products is also subject to approval.

Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for Remix and could delay or prevent the introduction of Remix’s products in certain countries. If Remix or any future collaborator fails to comply with the regulatory requirements in international markets or fails to receive applicable regulatory approvals, Remix’s target market will be reduced and Remix’s ability to realize the full market potential of Remix’s potential product candidates will be harmed.

For any regulatory approvals that Remix may receive for Remix’s product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for Remix’s product candidates will be subject to extensive and ongoing regulatory requirements. These

requirements include submissions of safety and other post-marketing information and reports, registration, as well as ongoing compliance with cGMPs and GCPs for any clinical trials. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMPs and other applicable regulations and standards. In addition, any regulatory approvals Remix may receive will require the submission of periodic reports to regulatory authorities and ongoing surveillance to monitor the safety and efficacy of the product. Such approvals may also contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a REMS as a condition of approval of Remix’s product candidates, which could limit their commercial potential.

If Remix or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or Remix, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. In addition, failure to comply with FDA and other comparable foreign regulatory requirements may subject Remix’s company to administrative or judicially imposed sanctions, including:

The occurrence of any event or penalty described above may inhibit Remix’s ability to commercialize its product candidates and generate revenue and could require Remix to expend significant time and resources in response and could generate negative publicity.

In addition, the FDA’s and other regulatory authorities’ policies may change and additional government regulations may be promulgated that could prevent, limit or delay marketing authorization of any product candidates Remix develops. Remix also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Remix is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if Remix is not able to maintain regulatory compliance, Remix may be subject to enforcement action and Remix may not achieve or sustain profitability.

The FDA strictly regulates marketing, labeling, advertising and promotion of prescription drugs. These regulations include standards and restrictions for direct-to-consumer advertising, industry-sponsored scientific and educational activities, promotional activities involving the internet and off-label promotion. Any regulatory approval that the FDA grants is limited to those specific diseases and indications for which a product is deemed to be safe and effective by FDA. While physicians in the United States may choose, and are generally permitted, to prescribe drugs for uses that are not described in the product’s labeling and for uses that differ from those tested in clinical trials and approved by the regulatory authorities, Remix’s ability to promote any products will be narrowly limited to those indications that are specifically approved by the FDA.

If any of Remix’s product candidates are approved and it is found to have improperly promoted off-label uses of those products, Remix may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription products, such as Remix’s product candidates, if approved. If Remix is found to have promoted such off-label uses, it may become subject to significant liability. The United States federal government has levied large civil and criminal fines against companies for alleged

improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The government has also required companies to enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If Remix cannot successfully manage the promotion of its product candidates, if approved, it could become subject to significant liability, which would materially adversely affect its business and financial condition.

Regulatory authorities in some jurisdictions, including the U.S., may designate drugs designed to address relatively small patient populations as “orphan drugs.” Under the Orphan Drug Act, the FDA may grant orphan drug designation to a drug intended to treat a rare disease or condition, which is defined as one occurring in a patient population of fewer than 200,000 in the United States, or a patient population greater than 200,000 in the United States, where there is no reasonable expectation that the cost of developing the drug will be recovered from sales in the United States. In the U.S., orphan designation entitles a party to financial incentives such as opportunities for grant funding for clinical trial costs, tax advantages and user-fee waivers. In addition, if a product candidate that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications, including an NDA, to market the same drug for the same approved use or indication within such rare disease or condition for seven years, except in limited circumstances.

Remix has received the FDA Orphan Drug Designations for REM-422 for the treatment of ACC and for the treatment of acute AML. Remix may seek Orphan Drug Designations for REM-422 in other diseases or conditions or for its other product candidates. There can be no assurances that Remix will be able to obtain such designations. Even if Remix, or any future collaborators, obtain orphan drug designation for a product candidate, Remix, or they, may not be able to obtain or maintain orphan drug exclusivity for that product candidate. Further, even if Remix, or any future collaborators, obtain orphan drug exclusivity for a product, that exclusivity may not effectively protect the product from competition because different drugs with different active ingredients may be approved for the same uses or indications. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same use or indication within the same rare disease or condition if the FDA concludes that the later drug is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care with respect to the exclusivity-protected use or indication, or if the manufacturer of the product with orphan exclusivity is unable to maintain sufficient product quantity to meet the needs relating to the relevant indication or use. Orphan drug designation neither shortens the development or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of Remix’s product candidates. Remix cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If Remix is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if it is not able to maintain regulatory compliance, Remix may lose any regulatory approval that it may have obtained, and it may not achieve or sustain profitability.

For example, in March 2010, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the ACA), was passed, which substantially changed the way healthcare is financed by both the government and private insurers, and continues to significantly impact the United States pharmaceutical industry. The ACA, which, among other things, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual fees and taxes for certain branded prescription drugs; and provided incentives to programs that increase the federal government’s comparative effectiveness research. Since its enactment, there have been executive, judicial and Congressional challenges to certain aspects of the ACA. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the ACA have been signed into law. For example, on August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed

into law, which among other things, extended enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025. The IRA also eliminated the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. For example, the Budget Control Act of 2011 was signed into law, which, among other things, resulted in aggregate reductions to Medicare payments to providers, effective April 1, 2013, which, due to subsequent legislative amendments, will stay in effect through 2032. In addition, the American Rescue Plan Act of 2021, effective January 1, 2024, was signed into law, which eliminated the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs. The cap was previously capped at 100% of the Average Manufacturer Price (AMP) for a covered outpatient drug.

In July 2025, the One Big Beautiful Bill Act, or OBBBA, was signed into law, which is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. OBBBA also narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits, which expired at the end of 2025. The OBBBA is anticipated to reduce the number of Americans with health insurance. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

Moreover, there has been heightened governmental scrutiny recently over the manner in which drug manufacturers set prices for their marketed products, which has resulted in several Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products. The IRA included prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single-source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Further, under the IRA, orphan drugs are exempted from the Medicare drug price negotiation program, but only if they have one or more orphan designations and for which the only approved indication or indications are for rare diseases or conditions. Since the IRA’s passage, the government selected and negotiated two rounds of drugs and has announced a third round of drugs that have been selected for negotiation, which is currently the subject to several constitutional challenges. The outcome of these challenges on the IRA, and the effect of IRA on Remix’s business and the healthcare industry in general are not yet known.

On May 12, 2025, President Trump signed an executive order directing the Secretary of HHS to set and communicate most-favored-nation, or MFN, price targets to manufacturers and propose a rulemaking plan to impose MFN pricing if “significant progress” is not made, and also directing the federal government to support regulatory paths to allow direct-to-patient sales for companies that meet these targets. The executive order further states that the Administration will take additional action (for example, examining whether marketing approvals should be modified or rescinded or considering individual drug importation waiver authorities) should manufacturers fail to offer American consumers the MFN lowest price. In July 2025, President Trump sent letters to certain pharmaceutical companies demanding that these companies extend MFN pricing to Medicaid and newly launched drugs as well as move to direct-to-consumer models priced at MFN pricing, and soliciting binding commitments by September 29, 2025. Since this time, multiple drug manufacturers have announced plans to, for certain of their drugs, lower prices to reflect similar pricing around the world, and to sell these reduced-price drugs on a direct-to-consumer purchasing platform developed by the federal government; however, it is not known what results will occur to the extent the recipients of these letters do not reduce their U.S. prices. In April 2026, the Trump administration issued a proclamation imposing tariffs under Section 232 of the Trade Expansion Act on imports of brand pharmaceuticals, biologics and associated pharmaceutical ingredients, beginning July 31, 2026. Exempted from these tariffs, among others, are companies that have executed or are negotiating agreements with the federal government regarding most favored nation pricing and onshoring of production and research and development.

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, or 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, or 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, if finalized, 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, or 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.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. In 2021, many states have passed or are considering state drug price transparency and reporting laws that substantially increase the compliance burdens on pharmaceutical manufacturers. The impact of these legislative, executive, and administrative actions and any future healthcare measures and agency rules implemented by the Trump administration on Remix and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent Remix from being able to generate revenue, attain profitability, or commercialize its product candidates if approved. Complying with any new legislation and regulatory changes could be time-intensive and expensive, resulting in a material adverse effect on its business, and expose it to greater liability.

Remix is unable to predict the future course of federal or state healthcare legislation in the United States directed at broadening the availability of healthcare and containing or lowering the cost of healthcare, particularly as a result of the recent presidential election. These and any further changes in the law or regulatory framework that reduce Remix’s revenue or increase its costs could also have a material and adverse effect on its business, financial condition and results of operations. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect:

Remix expects that other healthcare reform measures that may be adopted in the future may result in more rigorous coverage criteria and in additional downward pressure on the price that it receives for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent Remix from being able to generate revenue, attain profitability or commercialize its product candidates.

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

The ability of the FDA or comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which Remix’s operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable. Disruptions at the FDA and other agencies may also slow the time necessary for new drugs or modifications to approved drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect Remix’s business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities. In addition, the current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA, which have led to substantial personnel changes, and it remains unclear the degree to which these efforts or the resulting changes in FDA personnel may limit or otherwise adversely affect the FDA’s ability to conduct routine activities.

If a prolonged government shutdown occurs, or if funding shortages, staffing limitations or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process Remix’s regulatory submissions, which could have a material adverse effect on its business.

Remix is exposed to the risk that its employees, independent contractors, consultants, commercial collaborators, healthcare professionals, clinical investigators, CROs, suppliers, vendors and third-party payors may engage in misconduct or other improper activities. Healthcare providers and third-party payors play a primary role in the recommendation and prescription of any product candidates for which Remix obtains regulatory approval. Remix’s current and future arrangements with healthcare professionals, clinical investigators, CROs, third-party payors and customers may expose it to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which Remix researches, as well as markets, sells and distributes its product candidates for which it obtains regulatory approval.

The laws that may affect Remix’s ability to operate include, but are not limited to:

Remix may also be subject to federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers.

Efforts to ensure that Remix’s current and future business arrangements with third parties will comply with applicable healthcare regulatory laws and regulations will involve ongoing substantial costs. Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that governmental authorities will conclude that Remix’s business practices, including certain advisory and consulting agreements it has entered into with physicians who are paid, in part, in the form of stock or stock options, 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 Remix’s operations are found to be in violation of any of the federal and state healthcare laws described above or any other governmental regulations that apply to Remix, it may be subject to significant penalties, including without limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, exclusion, debarment or refusal to allow Remix to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, additional reporting requirements and/or oversight if Remix becomes subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of Remix’s operations, any of which could adversely affect its ability to operate its business and its results of operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if Remix is successful in defending against any such actions that may be brought against it, its business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom Remix expects to do business is found to be not in compliance with applicable laws, they may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

The global data protection landscape is rapidly evolving, and Remix is or may become subject to numerous state, federal and foreign laws, requirements and regulations governing the collection, use, disclosure, retention, and security of personal information, such as information that Remix may collect in connection with clinical trials in the U.S. and abroad. Implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and Remix cannot yet determine the impact future laws, regulations, standards, or perception of their requirements may have on its business. This evolution may create uncertainty in its business, affect its ability to operate in certain jurisdictions or to collect, store, transfer use and share personal information, necessitate the acceptance of more onerous obligations in Remix’s contracts, result in liability or impose additional costs on it. The cost of compliance with these laws, regulations and standards is high and is likely to increase in the future. Any failure or perceived failure by Remix to comply with federal, state or foreign laws or regulations, its internal policies and procedures or its contracts governing its processing of personal information could result in negative publicity, government investigations and enforcement actions, claims by third parties and damage to Remix’s reputation, any of which could have a material adverse effect on Remix’s business, results of operation, and financial condition.

As Remix’s operations and business grow, it may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the U.S., HIPAA imposes, among other things, certain standards relating to the privacy, security, transmission and breach reporting of individually identifiable health information. Remix may obtain health information from third parties, such as research institutions with which it collaborates, that are subject to privacy and security requirements under HIPAA. Although Remix does not believe that it is directly subject to HIPAA, other than potentially with respect to providing certain employee benefits, Remix could be subject to criminal penalties if it knowingly obtains or discloses individually identifiable health information maintained by a HIPAA covered entity in a manner that is not authorized or permitted by HIPAA. Certain states have also adopted comparable privacy and security laws and regulations, which govern the privacy, processing and protection of health-related and other personal information. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for Remix and its future customers and strategic partners. For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act (collectively, the CCPA) requires covered businesses that process the personal information of California residents to, among other things: (i) provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; (ii) receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt out of certain disclosures of their personal information; and (iii) enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. Additional compliance investment and potential business process changes may also be required. Similar laws have been passed in other states, and are continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation in the United States. For example,

Washington State enacted the Washington My Health My Data Act, which broadly defines consumer health data, creates a private right of action to allow individuals to sue for violations of the law, imposes stringent consent requirements, and grants consumers certain rights with respect to their health data, including to request deletion of their information. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. In the event that Remix is subject to or affected by HIPAA, the CCPA, or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect its financial condition.

Remix’s operations abroad may also be subject to increased scrutiny or attention from data protection authorities. For example, in Europe, the European Union General Data Protection Regulation (the EU GDPR) and in the United Kingdom, the United Kingdom General Data Protection Regulation and Data Protection Act 2018 (the UK GDPR and together with the EU GDPR, referred to as the GDPR) impose strict requirements for processing the personal data of individuals within the European Economic Area (EEA) and the United Kingdom (UK). Companies that must comply with the GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance under both the EU GDPR and UK GDPR of up to €20 million/ GBP 17.5 million or 4% of the annual global revenues of the noncompliant company, whichever is greater. In addition to fines, a breach of the GDPR may result in regulatory investigations, reputational damage, orders to cease/ change Remix’s data processing activities, enforcement notices, assessment notices (for a compulsory audit) and/ or civil claims (including class actions). Among other requirements, the GDPR regulates transfers of personal data subject to the GDPR to third countries that have not been found to provide adequate protection to such personal data, including the United States, and the efficacy and longevity of current transfer mechanisms between the EEA, and the United States remains uncertain. Case law from the Court of Justice of the European Union (CJEU) states that reliance on the standard contractual clauses a standard form of contract approved by the European Commission as an adequate personal data transfer mechanism alone may not necessarily be sufficient in all circumstances and that transfers must be assessed on a case-by-case basis. On July 10, 2023, the European Commission adopted its Adequacy Decision in relation to the new EU-US Data Privacy Framework (DPF), rendering the DPF effective as a GDPR transfer mechanism to U.S. entities self-certified under the DPF.

In relation to such cross border transfers of personal data, Remix expects the existing legal complexity and uncertainty regarding international personal data transfers to continue, and international transfers to the United States, China, and to other jurisdictions more generally to continue to be subject to enhanced scrutiny by regulators. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, Remix could suffer additional costs, complaints and/or regulatory investigations or fines; Remix may have to stop using certain tools and vendors and make other operational changes; Remix may have to implement alternative data transfer mechanisms under the GDPR and/or take additional compliance and operational measures; and/or it could otherwise affect the manner in which Remix operates its business, and could adversely affect its business, operations and financial condition. As Remix continues to expand into other foreign countries and jurisdictions, it may be subject to additional laws and regulations that may affect how it conducts business.

Even though Remix believes it and its vendors are generally in compliance with applicable laws, rules and regulations relating to privacy and data security, these laws are in some cases relatively new and the interpretation and application of these laws are uncertain. Any failure or perceived failure by Remix to comply with data privacy laws, rules, regulations, industry standards and other requirements could result in proceedings or actions against it by individuals, government agencies, or others. It could incur significant costs in investigating and defending such claims and, if found liable, pay significant damages or fines or be required to make changes to its business. Further, these proceedings and any subsequent adverse outcomes may subject it to significant negative publicity and an erosion of trust. If any of these events were to occur, its business, results of operations, and financial condition could be materially adversely affected.

Remix is subject to the FCPA, the U.S. domestic public corruption and commercial bribery statutes contained in 18 U.S.C. § 201, the U.S. Travel Act and possibly other anti-bribery and anti-corruption laws and anti-money laundering laws in countries outside of the United States in which where Remix conducts its activities.

Anti-corruption and anti-bribery laws have been enforced aggressively in recent years and are interpreted broadly to generally prohibit companies, their employees, agents, representatives, business partners, and third-party intermediaries from authorizing, offering, or providing, directly or indirectly, improper payments or benefits to recipients in the public or private sector.

Remix may leverage third parties to sell its products and conduct its business abroad. Remix and its employees, agents, representatives, business partners and third-party intermediaries may have direct or indirect interactions with officials and employees of government agencies or state-owned or affiliated entities and may be held liable for the corrupt or other illegal activities of these employees, agents, representatives, business partners or third-party intermediaries even if Remix does not explicitly authorize such activities. Remix’s business activities may be subject to the FCPA and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which Remix operates. The FCPA generally prohibits companies and their employees and third-party intermediaries from offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Remix’s business is heavily regulated and therefore may involve significant interaction with public officials, including officials of non-U.S. governments. Additionally, in many other countries, hospitals are owned and operated by the government, and doctors and other hospital employees would be considered foreign officials under the FCPA. Recently, the SEC and DOJ have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies. There can be no assurance that all of Remix’s employees, agents, representatives, business partners or third-party intermediaries will not take actions in violation of applicable law for which Remix may be ultimately held responsible. As Remix commercializes its product candidates and increases its international sales and business, its risks under these laws may increase. There is no certainty that all of Remix’s employees, agents or contractors, or those of its affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against Remix, its officers or its employees, disgorgement, and other sanctions and remedial measures, and prohibitions on the conduct of its business. Any such violations could include prohibitions on Remix’s ability to offer its products in one or more countries and could materially damage its reputation, its brand, its international activities, its ability to attract and retain employees and its business, prospects, operating results and financial condition.

These laws also require that Remix keep accurate books and records and maintain internal controls and compliance procedures designed to prevent any such actions. While Remix has policies and procedures to address compliance with such laws, there can be no assurance that none of its employees, agents, representatives, business partners or third-party intermediaries will take actions in violation of its policies and applicable law, for which Remix may be ultimately held responsible.

Any allegations or violation of the FCPA or other applicable anti-bribery and anti-corruption laws and anti-money laundering laws could result in whistleblower complaints, sanctions, settlements, prosecution, enforcement actions, fines, damages, adverse media coverage, investigations, loss of export privileges, severe criminal or civil sanctions, or suspension or debarment from government contracts, all of which may have an adverse effect on Remix’s reputation, business, results of operations, and prospects. Responding to any investigation or action will likely result in a materially significant diversion of management’s attention and resources and significant defense costs and other professional fees.

In addition, Remix’s products may be subject to U.S. and foreign export controls, trade sanctions and import laws and regulations. Governmental regulation of the import or export of Remix’s products, or its failure to obtain any required import or export authorization for its products, when applicable, could harm Remix’s international or domestic sales and adversely affect its revenue. Compliance with applicable regulatory requirements regarding the export of Remix’s products may create delays in the introduction of its products in international markets or, in some cases, prevent the export of its products to some countries altogether. Furthermore, United States export control laws and economic sanctions prohibit the shipment of certain products and services to countries, governments, and persons targeted by United States sanctions. If Remix fails to comply with export and import regulations and such economic sanctions, penalties could be imposed, including fines and/or denial of certain export privileges. Moreover, any new export or import restrictions, new legislation or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or products targeted by such regulations, could result in

decreased use of Remix’s products by, or in its decreased ability to export its products to, existing or potential customers with international operations. Any decreased use of Remix’s products or limitation on its ability to export or sell its products would likely adversely affect its business.

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

Remix’s operations involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. Remix’s operations also produce hazardous waste products. Remix generally contracts with third parties for the disposal of these materials and wastes. Remix cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from its use of hazardous materials, Remix could be held liable for any resulting damages, and any liability could exceed its resources. Remix also could incur significant costs associated with civil or criminal fines and penalties.

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

Remix may in the future become subject to legal proceedings and claims that arise in the ordinary course of business, including intellectual property, product liability, employment, class action, whistleblower and other litigation claims, and governmental and other regulatory investigations and proceedings. Such matters can be time-consuming, divert management’s attention and resources, cause Remix to incur significant expenses or liability, or require it to change its business practices. In addition, the expense of litigation and the timing of this expense from period to period are difficult to estimate, subject to change, and could adversely affect Remix’s financial condition and results of operations. Because of the potential risks, expenses, and uncertainties of litigation, Remix may, from time to time, settle disputes, even where it has meritorious claims or defenses, by agreeing to settlement agreements. Any of the foregoing could adversely affect its business, financial condition, and results of operations.

Remix currently has a small team focused on research and development of small oncology therapies. Remix’s ability to discover and develop any product candidates is dependent on its chemists. To succeed, Remix must recruit, hire, retain, manage and motivate qualified clinical, scientific, technical and management personnel, and Remix faces significant competition for experienced personnel. Remix is highly dependent on the principal members of its management and scientific and medical staff, particularly Peter Smith, its President, Chief Executive Officer and director and Dominic Reynolds, its Chief Scientific Officer. Charles Michaud, our Vice President of Finance, will serve as the interim Chief Financial Officer of the combined company while a search for a permanent Chief Financial Officer continues. If Remix does not succeed in attracting and retaining qualified personnel, particularly a Chief Financial Officer and other management level positions, it could adversely affect Remix’s ability to execute its business plan and harm its operating results. In particular, the loss of one or more of its executive officers could be detrimental to Remix if it cannot recruit suitable replacements in a timely manner. Remix does not maintain “Key Person” insurance for any of its executives or other employees. Remix could in the future have difficulty attracting and retaining experienced personnel and may be required to expend significant financial resources in its employee recruitment and retention efforts.

Many of the other biotechnology companies that Remix competes against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry than Remix does. They also may provide higher compensation, more diverse opportunities and better prospects for career advancement. Some of

these characteristics may be more appealing to high-quality candidates than what Remix has to offer. If Remix is unable to continue to attract and retain high-quality personnel, the rate and success at which it can discover, develop and commercialize its product candidates will be limited and the potential for successfully growing Remix’s business will be harmed.

Remix’s scientific and clinical advisors and consultants typically will not enter into non-compete agreements with us. If a conflict of interest arises between their work for Remix and their work for another entity, Remix may lose their services. Furthermore, Remix’s advisors may have arrangements with other companies to assist those companies in developing products or technologies that may compete with Remix. In particular, if Remix is unable to maintain consulting or employment relationships with its scientific founders and other scientific and clinical advisors and consultants, or if they provide services to Remix’s competitors, Remix’s development and commercialization efforts will be impaired and its business will be significantly harmed.

As of June 23, 2026, Remix had 37 full-time employees. Of these employees, 29 were engaged in research or product development and clinical activities. The small size of Remix’s centralized team may limit its ability to devote adequate personnel, time, and resources to support its operations or research and development activities, and the management of financial, accounting, and reporting matters. If Remix’s team fails to provide adequate administrative, research and development, or other services across Remix’s organization, its business, financial condition, and results of operations could be harmed.

In order to successfully implement Remix’s development and commercialization plans and strategies, it expects to need significant additional managerial, operational, sales, marketing, financial and other personnel. Future growth will impose significant added responsibilities on members of management, including:

Remix’s future financial performance and its ability to successfully develop and, if approved, commercialize REM-422 and other research programs will depend, in part, on its ability to effectively manage any future growth, and its management may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amount of time to managing these growth activities.

Remix currently relies, and for the foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants to provide certain services, including key aspects of research, clinical development and manufacturing. There can be no assurance that the services of independent organizations, advisors and consultants will continue to be available to Remix on a timely basis when needed, or that it can find qualified replacements. In addition, if Remix is unable to effectively manage its outsourced activities or if the quality or accuracy of the services provided by third-party service providers is compromised for any reason, its preclinical studies and clinical trials may be extended, delayed or terminated, and Remix may not be able to obtain regulatory approval for any of its product candidates or otherwise advance its business. There can be no assurance that Remix will be able to manage its existing third-party service providers or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If Remix is not able to effectively expand its organization by hiring new employees and/or engaging additional third-party service providers, Remix may not be able to successfully implement the tasks necessary to further develop and commercialize REM-422 and any other product candidates and, accordingly, may not achieve its research, development and commercialization goals.

Remix collects and maintains information in digital form that is necessary to conduct its business, and Remix is increasingly dependent on information technology systems and infrastructure to operate its business. In the ordinary course of its business, Remix collects, stores and transmits confidential information, including intellectual property, proprietary business information, preclinical and clinical trial data, and personal information (collectively, Confidential Information). It is critical that Remix does so in a secure manner to maintain the confidentiality and integrity of such Confidential Information.

Remix’s information technology systems and those of Remix’s third-party service providers, strategic partners and other contractors or consultants are vulnerable to attack, damage and interruption from computer viruses and malware (e.g., ransomware), misconfigurations, “bugs” or other vulnerabilities, malicious code, natural disasters, terrorism, war, telecommunication and electrical failures, hacking, cyberattacks, phishing attacks and other social engineering schemes, employee theft or misuse, human error, fraud, denial or degradation of service attacks and sophisticated nation-state and nation-state-supported actors. Remix has also outsourced elements of its information technology infrastructure, and as a result a number of third-party vendors may or could have access to Remix’s confidential information.

The risk of a security breach or disruption, particularly through cyberattacks or cyber intrusion, including by computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks and intrusions from around the world have increased and evolved. If Remix or Remix’s third-party vendors were to experience a significant cybersecurity breach of Remix’s or their information systems or data, the costs associated with the investigation, remediation and potential notification of the breach to counterparties and data subjects could be material. In addition, Remix’s remediation efforts may not be successful. If Remix does not allocate and effectively manage the resources necessary to build and sustain the proper technology and cybersecurity infrastructure, Remix could suffer significant business disruption, including data loss or the loss of or damage to intellectual property or other proprietary information. There can also be no assurance that Remix’s and Remix’s third-party service providers’, strategic partners’, contractors’, consultants’, CROs’ and collaborators’ cybersecurity risk management program and processes, including policies, controls or procedures, will be fully implemented, complied with or effective in protecting Remix’s systems, networks and Confidential Information.

Remix and certain of its service providers are from time to time subject to cyberattacks and security incidents. While Remix does not believe that it has experienced any significant system failure, accident or security breach to date, if such an event were to occur and cause interruptions in its operations, it could result in a material disruption of Remix’s development programs and its business operations, whether due to a loss, corruption or unauthorized disclosure of its trade secrets, personal information or other proprietary or sensitive information or other similar disruptions. For example, the loss of clinical trial data from completed or ongoing clinical trials for any of Remix’s therapeutic candidates could result in delays in its development and regulatory approval efforts and significantly increase its costs to recover or reproduce the data.

If a security breach or other incident were to result in the unauthorized access to or unauthorized use, disclosure, release or other processing of personal information, it may be necessary to notify individuals, governmental authorities, supervisory bodies, and other parties pursuant to privacy and security laws. Any security compromise affecting us, Remix’s service providers, strategic partners, other contractors, consultants, or Remix’s industry, whether real or perceived, could harm Remix’s reputation, erode confidence in the effectiveness of its security measures and lead to regulatory scrutiny. To the extent that any disruption or security breach were to result in a loss of, or damage to, Remix’s data or systems, or inappropriate disclosure of confidential or proprietary or personal information, Remix could incur liability, including litigation exposure, penalties and fines, Remix could become the subject of regulatory action or investigation, its competitive position could be harmed and the further development and commercialization of its products and services could be delayed. If such an event were to occur and cause interruptions in Remix’s operations, it could result in a material disruption of Remix’s business. Furthermore, federal, state and international laws and regulations can expose Remix to enforcement actions and investigations by regulatory authorities, and potentially result in regulatory penalties, fines and significant legal liability, if its information technology security efforts fail. Any adverse impact to the availability, integrity or confidentiality of Remix’s or third-party systems or Confidential Information can result in legal claims or proceedings (such as class actions), regulatory investigations and enforcement actions, fines and penalties, negative reputational impacts that

cause Remix to lose existing or future customers, and/or significant incident response, system restoration or remediation and future compliance costs. Remix may also be exposed to a risk of loss or litigation and potential liability, which could materially and adversely affect its business, results of operations or financial condition.

Attacks upon information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives and expertise. Furthermore, because the techniques used to obtain unauthorized access to, or to sabotage, systems change frequently and often are not recognized until launched against a target, Remix may be unable to anticipate these techniques or implement adequate preventative measures. Remix may also experience security breaches that may remain undetected for an extended period. Even if identified, Remix may be unable to adequately investigate or remediate incidents or breaches due to attackers increasingly using tools and techniques — including artificial intelligence — that are designed to circumvent controls, to avoid detection, and to remove or obfuscate forensic evidence.

Remix’s existing general liability and cyber liability insurance policies may not cover, or may cover only a portion of, any potential claims related to security breaches to which it is exposed or may not be adequate to indemnify it for all or any portion of liabilities that may be imposed. Remix also cannot be certain that its existing insurance coverage will continue to be available on acceptable terms or in amounts sufficient to cover the potentially significant losses that may result from a security incident or breach or that the insurer will not deny coverage of any future claim. Accordingly, if Remix’s cybersecurity measures, and those of its service providers, fail to protect against unauthorized access, attacks (which may include sophisticated cyberattacks) and the mishandling of data by Remix’s employees and third-party service providers, then its reputation, results of operations and financial condition could be adversely affected.

Remix currently does not have and has never had a marketing or sales team. In order to commercialize any product candidates, if approved, Remix must build marketing, sales, distribution, managerial and other non-technical capabilities or make arrangements with third parties to perform these services for each of the territories in which Remix may have approval to sell or market its product candidates. Remix may not be successful in accomplishing these required tasks.

Establishing an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize Remix’s product candidates will be expensive and time-consuming and will require significant attention of its executive officers to manage. Any failure or delay in the development of Remix’s internal sales, marketing and distribution capabilities could adversely impact the commercialization of any of its product candidates that Remix obtains approval to market if Remix does not have arrangements in place with third parties to provide such services on its behalf. Alternatively, if Remix chooses to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales forces and established distribution systems, either to augment its own sales force and distribution systems or in lieu of its own sales force and distribution systems, Remix will be required to negotiate and enter into arrangements with such third parties relating to the proposed collaboration and such arrangements may prove to be less profitable than commercializing the product on its own. If Remix is unable to enter into such arrangements when needed, on acceptable terms or at all, Remix may not be able to successfully commercialize any of its product candidates that receive regulatory approval, or any such commercialization may experience delays or limitations. If Remix is unable to successfully commercialize its approved product candidates, either on its own or through collaborations with one or more third parties, Remix’s future product revenue will suffer, and it may incur significant additional losses.

Remix may seek regulatory approval of its product candidates outside of the United States and, accordingly, Remix expects that it will be subject to additional risks related to operating in foreign countries if it obtains the necessary approvals, including:

These and other risks associated with international operations may materially adversely affect Remix’s ability to attain or maintain profitable operations.

Remix relies, and may in the future rely, upon a combination of patent, trade secret and trademark protection for its product candidates and proprietary technologies to prevent third parties from exploiting its achievements, thus

eroding its competitive position in its market. These legal measures afford only limited protection, and competitors or others may gain access to or use Remix’s intellectual property and proprietary information. Remix’s success depends in large part on its ability to obtain, maintain, expand, enforce, and defend the scope, ownership or control, validity and enforceability of its intellectual property protection in the United States and other countries with respect to its product candidates and other proprietary technologies it may develop. Remix generally seeks, and may in the future seek, to protect its proprietary position, in part, by filing patent applications in the United States and abroad relating to its product candidates and technology, manufacturing processes and methods of use. Remix may also seek to protect its proprietary position by acquiring or in-licensing relevant issued patents or pending patent applications from third parties. If Remix is unable to obtain, maintain, expand, enforce and defend the scope, ownership or control, validity and enforceability of its intellectual property protection, its business, financial condition, results of operations and prospects could be materially harmed.

Changes in either the patent laws or their interpretation in the United States and other jurisdictions may diminish Remix’s ability to protect its intellectual property, obtain, maintain, expand, enforce and defend its intellectual property rights and, more generally, could affect the value of its intellectual property or narrow the scope of its protection. Remix cannot predict whether the patent applications it currently or may in the future pursue or may in-license will issue as patents in any particular jurisdiction, whether the claims of any issued patents will provide sufficient protection against competitors or other third parties, or if these patents are challenged by its competitors, whether the patents will be found to be invalid, unenforceable, or not infringed or not owned or controlled by Remix. The patent prosecution process is expensive, time-consuming, and complex, and Remix may not be able to file, prosecute, maintain, enforce, defend or license all necessary or desirable patent applications or patents at a reasonable cost or in a timely manner or in all jurisdictions. It is also possible that Remix will fail to identify patentable aspects of its research and development output in time to obtain patent protection. Although Remix enters into non-disclosure and confidentiality agreements with parties who have access to confidential or patentable aspects of its research and development output, such as its employees, licensees, third-party collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing Remix’s ability to seek patent protection. Consequently, Remix may not be able to prevent any third party from using any of its technology that is in the public domain to compete with its product candidates or technologies. In addition, Remix’s ability to obtain and maintain valid and enforceable patents depends on whether the differences between its inventions and the prior art allow its inventions to be patentable in light of the prior art. Furthermore, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, Remix cannot be certain that it or its licensors were the first to invent the inventions claimed in any of its licensed patents or pending patent applications, or that Remix was the first to make the inventions claimed in those owned or licensed patents or pending patent applications, or that Remix or its licensors were the first to file for patent protection of such other inventions. If a third party can establish that Remix was not the first to make or the first to file for patent protection of such other inventions, its owned and licensed patents and patent applications may not issue as patents and even if issued, may be challenged and invalidated or rendered unenforceable.

The patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability, and commercial value of Remix’s patent rights are highly uncertain. Its current and future patent applications may not result in patents being issued.

Any issued patents may not afford sufficient protection of Remix’s product candidates or their intended uses against competitors, nor can there be any assurance that the issued patents will not be infringed, designed around, invalidated by third parties, or effectively prevent others from commercializing competitive technologies, products or product candidates. Further, even if these patents are granted, they may be difficult to enforce. Obtaining and maintaining Remix’s patent protection depends on compliance with various procedural, document submission, information disclosure, fee payment and other requirements imposed by governmental patent agencies, and its patent protection could be reduced or eliminated if Remix fails to comply with these requirements. In the event Remix experiences noncompliance events that cannot be corrected and it loses its patent rights, competitors could enter the market, which would have a material adverse effect on its business. Further, any issued patents that Remix owns or may license in the future covering its product candidates could be narrowed or found invalid or unenforceable if challenged in court or before administrative bodies in the United States or other countries, including the U.S. Patent and Trademark Office (USPTO). Grounds for a validity challenge could be an alleged failure to meet any of several

statutory requirements, including lack of novelty, obviousness, written description or non-enablement. In addition, patent validity challenges may, under certain circumstances, be based upon non-statutory obviousness-type double patenting, which, if successful, could result in a finding that the claims are invalid for obviousness-type double patenting or the loss of patent term, including a patent term adjustment granted by the USPTO. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld information material to patentability from the USPTO, or made a misleading statement, during prosecution. Also, patent terms, including any extensions or adjustments that may or may not be available to Remix, may be inadequate to protect its competitive position on its product candidates for an adequate amount of time, and Remix may be subject to claims challenging the inventorship, ownership, validity, enforceability of its patents and/or other intellectual property. Changes in U.S. patent law, or laws in other countries, could diminish the value of patents in general, thereby impairing Remix’s ability to protect its product candidates. Further, if Remix encounters delays in its development and testing of its product candidates, clinical trials or regulatory review and approval of its product candidates, the period of time during which it could market its product candidates under patent protection may be reduced, since any patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. Thus, Remix’s patents may not provide it with sufficient rights to exclude others from commercializing products similar or identical to its own or afford it any meaningful competitive advantage.

Moreover, the claim coverage in a patent application can be significantly reduced before the corresponding patent is granted. Even if Remix’s owned or in-licensed patent applications issue as patents, they may not issue in a form that will provide it with any meaningful protection, prevent competitors or other third parties from competing with it or otherwise provide it with any competitive advantage. Any patents issuing from Remix’s owned or in-licensed patent applications may be challenged, narrowed, circumvented or invalidated by third parties. Consequently, Remix does not know whether its product candidates and other proprietary technology will be protectable or remain protected by valid and enforceable patents. Even if a patent is granted, Remix’s competitors or other third parties may be able to circumvent the patent by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect its business, financial condition, results of operations and prospects. Furthermore, Remix’s competitors or other third parties may avail themselves of safe harbors under the Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Amendments) to conduct research and clinical trials.

The issuance of a patent is not conclusive as to its inventorship, ownership, scope, validity, or enforceability and Remix’s owned or in-licensed patent rights may be challenged in the courts or patent offices in the United States and abroad. Remix may be subject to a post-grant proceeding at the USPTO challenging the validity of one or more claims of its patents or patents it may license in the future. Third-party submissions may also be made prior to a patent’s issuance, precluding the granting of a patent based on Remix’s pending patent application or patent application it may license in the future. A third party may also claim that Remix’s patent rights are invalid or unenforceable in a litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. In addition, Remix may become involved in opposition, derivation, revocation, reexamination, reissue, interference proceedings or other similar proceedings in the United States and/or foreign jurisdictions challenging its patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, Remix’s patent rights, and may allow third parties, including generic drug companies, to commercialize its product candidates and other proprietary technologies it may develop and compete directly with Remix.

It is also possible that defects of form in the preparation or filing of Remix’s patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If there are material defects in the form, preparation, prosecution, or enforcement of Remix’s patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair Remix’s ability to prevent competition from third parties, which may have an adverse impact on its business.

Moreover, in the future, some of Remix’s patent rights may be co-owned with third parties. In the United States, each co-owner has the freedom to license and exploit the technology. If Remix is unable to obtain an exclusive license to any such third-party co-owners’ interest in such patent rights, such co-owners may be able to license their rights to other third parties, including Remix’s competitors, and its competitors could market competing products

and technology. In addition, Remix may need the cooperation of any such co-owners of such patent rights in order to enforce such patent rights against third parties, and such cooperation may not be provided to it. Any of the foregoing could have a material adverse effect on Remix’s competitive position, business, financial condition, results of operations and prospects.

Remix’s commercial success depends in part on its ability to avoid infringing, misappropriating and otherwise violating the patents and other intellectual property rights of third parties. There is a substantial amount of complex litigation involving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challenging patents, including interference, derivation and reexamination proceedings before the USPTO or oppositions and other comparable proceedings in foreign jurisdictions.

Numerous U.S. and foreign-issued patents and pending patent applications owned by third parties exist in the fields in which Remix plans to commercialize its programs and in which it is developing other proprietary technologies. As the biotechnology and pharmaceutical industries expand and more patents are issued, and as Remix gains greater visibility and market exposure as a public company, the risk increases that its therapeutic programs and commercializing activities may give rise to claims of infringement of the patent rights of others. Remix cannot guarantee that its therapeutic programs and other proprietary technologies it develops will not infringe existing or future patents owned by third parties. Remix may not be aware of patents that have already been issued for which a third party, such as a competitor in the fields in which it is developing its therapeutic programs, might assert as infringed by Remix. It is also possible that patents owned by third parties of which Remix is aware, but which it does not believe it infringes or that it believes it has valid defenses to any claims of patent infringement, could be found to be infringed by Remix. It is not unusual that corresponding patents issued in different countries have different scopes of coverage, such that in one country a third-party patent does not pose a material risk, but in another country, the corresponding third-party patent may pose a material risk to Remix’s products or product candidates. In addition, because patent applications can take many years to issue, there may be currently pending patent applications that may later result in issued patents that Remix may infringe. For example, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover Remix’s product candidates or the use any such product candidates.

In the event that any third-party claims that Remix infringes their patents or that Remix is otherwise employing their proprietary technology without authorization and initiates litigation against it, even if Remix believes such claims are without merit, a court could hold that such patents are valid, enforceable and infringed by Remix. Defense of infringement claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and other employee resources from Remix’s business, and may impact its reputation. In the event of a successful claim of infringement against Remix, it may be enjoined from further developing or commercializing the infringing products or technologies. In addition, Remix may be required to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties and/or redesign its infringing products or technologies, which may be impossible or require substantial time and monetary expenditure. Such licenses may not be available on commercially reasonable terms or at all. Even if Remix is able to obtain a license, the license would likely obligate it to pay license fees or royalties or both, and the rights granted to it might be nonexclusive, which could result in its competitors gaining access to the same intellectual property. If Remix is unable to obtain a necessary license to a third-party patent on commercially reasonable terms or at all, it may be unable to commercialize the infringing products or technologies or such commercialization efforts may be significantly delayed, which could in turn significantly harm its business. In addition, Remix may in the future pursue patent challenges with respect to third-party patents, including as a defense against the foregoing infringement claims. The outcome of such challenges is unpredictable.

Even if resolved in Remix’s favor, the foregoing proceedings could be very expensive, particularly for a company of Remix’s size, and time-consuming. Such proceedings could substantially increase its operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. Remix may not have sufficient financial or other resources to conduct such proceedings adequately. Some of its competitors may be able to sustain the costs of litigation or administrative proceedings more effectively than Remix can because of greater financial resources. Such proceedings may also absorb significant time of Remix’s technical and

management personnel and distract them from their normal responsibilities. Uncertainties resulting from such proceedings could impair Remix’s ability to compete in the marketplace. 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 Remix’s common stock. The occurrence of any of the foregoing could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects.

Remix may in the future pursue invalidity proceedings with respect to third-party patents. The outcome following legal assertions of invalidity is unpredictable. Even if resolved in Remix’s favor, these legal proceedings may cause it to incur significant expenses, and could distract its technical and management personnel from their normal responsibilities. In addition, there could be public announcements of the results of hearings, motions or other interim proceedings or developments and if securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of Remix’s common stock. Such proceedings could substantially increase its operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. Remix may not have sufficient financial or other resources to conduct such proceedings adequately. Some of these third parties may be able to sustain the costs of such proceedings more effectively than Remix can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent proceedings could compromise Remix’s ability to compete in the marketplace. If Remix does not prevail in the patent proceedings the third parties may assert a claim of patent infringement directed at its product candidates.

Remix’s patent rights may be subject to priority, validity, inventorship, ownership and enforceability disputes. Legal proceedings relating to intellectual property claims, with or without merit, are unpredictable and generally expensive and time-consuming and likely to divert significant resources from Remix’s core business, including distracting its management and scientific personnel from their normal responsibilities and generally harm its business. If Remix or its licensors are unsuccessful in any of these proceedings, such patents and patent applications may be narrowed, invalidated or held unenforceable. Any of the foregoing could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects.

If Remix initiates legal proceedings against a third party to enforce a patent covering its product candidates, the defendant could counterclaim that such 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 include an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement, lack of sufficient written description, failure to claim patent-eligible subject matter or obviousness-type double patenting. 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 or inconsistent statement, during prosecution. Third parties may raise claims challenging the validity or enforceability of a patent before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post-grant review, inter partes review, interference proceedings, derivation proceedings, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in the revocation of, cancellation of, shortening the term of or amendment to Remix’s owned or in-licensed patent rights or any patent rights it may obtain or license in the future in such a way that they no longer cover its product candidates or prevent third parties from competing with its product candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, Remix cannot be certain that there is no invalidating prior art, of which it or its licensing partners and the patent examiner were unaware during prosecution. If a third party were to prevail on a legal assertion of invalidity or unenforceability, Remix would lose at least part, and perhaps all, of the patent protection for its product candidates. Such a loss of patent protection would have a material adverse impact on Remix’s business, financial condition, results of operations and prospects.

In addition, if the breadth or strength of protection provided by Remix’s patents and patent applications or the patents and patent applications of its future licensors is threatened, it could dissuade companies from collaborating with Remix to license, develop or commercialize current or future product candidates.

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

Finally, the issuance of a patent does not give Remix the right to practice the patented invention. Third parties may have blocking patents that could prevent Remix from marketing its own patented product and practicing its own patented technology.

During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings or developments in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of Remix’s existing product candidates, approved products, programs or intellectual property could be diminished. Accordingly, the market price of shares of Remix’s common stock may decline. Such announcements could also harm Remix’s reputation or the market for its future products, which could have a material adverse effect on its business.

Remix cannot guarantee that any of its or its licensors’ patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are or will be complete or thorough, nor can Remix be certain that it or its licensors have identified or will identify each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of its current and future products and product candidates in any jurisdiction. Patent applications in the United States and elsewhere are not published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering Remix’s product candidates could have been filed by others without its knowledge. The scope of a patent claim is determined by the interpretation of the law, the words of a patent claim, the written disclosure in a patent and the patent’s prosecution history. Remix’s interpretation of the relevance or the scope of a patent or a pending patent application may be incorrect, which may negatively impact its ability to market its products. Remix may incorrectly determine that its products or product candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending patent application will issue with claims of relevant scope. Alternatively, Remix may incorrectly determine that the Hatch-Waxman Amendments are a defense for a safe harbor to infringement of a patent it considers relevant to the research or clinical development of its product candidates. Remix’s determination of the expiration date of any patent in the United States or abroad that it considers relevant may be incorrect, and Remix may incorrectly conclude that a third-party patent is invalid and unenforceable or not infringed. Remix’s failure to identify and correctly interpret relevant patents may negatively impact its ability to develop and market its products and product candidates. If Remix fails to identify and correctly interpret relevant patents, it may be subject to infringement claims. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that Remix infringes. As the number of competitors in the market grows and the number of patents issued in this area increases, the possibility of patent infringement claims escalates. Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, Remix may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that its products and business operations infringe or violate the intellectual property rights of others. Remix cannot guarantee that it will be able to successfully settle or otherwise resolve such infringement claims. If Remix fails in any such dispute, in addition to being forced to pay damages, it may be temporarily or permanently prohibited from commercializing any of its product candidates that are held to be infringing. Remix might, if possible, also be forced to redesign product candidates or services so that it no longer infringes the third-party intellectual property rights. Any of these events, even if Remix were ultimately to prevail, could require it to divert substantial financial and management resources that it would otherwise be able to devote to its business.

As is the case with other pharmaceutical companies, Remix’s success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involve a high degree of technological and legal complexity. Therefore, obtaining and enforcing pharmaceutical patents is costly, time consuming and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of Remix’s intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Remix cannot predict the breadth of claims that may be allowed or enforced in its patents or in third-party patents. In addition, Congress or other foreign legislative bodies may pass patent reform legislation that is unfavorable to Remix.

Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to the patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy-Smith America Invents Act (the America Invents Act) enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before Remix or its licensors could therefore be awarded a patent covering an invention of Remix or its licensors even if Remix or its licensors had made the invention before it was made by such third party. This requires Remix to be cognizant of the time from invention to filing of a patent application. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, Remix cannot be certain that it or its licensors are the first to either (i) file any patent application related to its product candidates and other proprietary technologies it may develop or (ii) invent any of the inventions claimed in its patents or patent applications.

The America Invents Act also included a number of significant changes that affect the way patent applications filed after March 2013 are prosecuted and also affect patent litigation. These include allowing third party protests and submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes review and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate Remix’s owned or in-licensed patent claims or any patent claims it may license in the future that would not have been invalidated if first challenged by the third party as a defendant in a district court action.

In addition, the patent positions of companies in the development and commercialization of pharmaceuticals are particularly uncertain. Recent United States Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. For example, the U.S. Supreme Court held in Amgen v. Sanofi (2023) that a functionally claimed genus was invalid for failing to comply with the enablement requirement of the Patent Act. As such, Remix’s patent rights with functional claims may be vulnerable to third party challenges seeking to invalidate these claims for lacking enablement or adequate support in the specification. In addition to increasing uncertainty with regard to Remix’s 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 United States Congress, the United States federal courts, the USPTO, or similar authorities in foreign jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken Remix’s ability to obtain new patents or to enforce its existing patent and the patents it might obtain or license in the future. 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 Remix’s ability to obtain new patents or to enforce patents that it has or may obtain or license in the future.

For example, on June 1, 2023, the European Union Patent Package (EU Patent Package) regulations were implemented with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (UPC) for litigation involving European patents. As a result, all European patents, including those issued prior

to ratification of the EU Patent Package, now by default automatically fall under the jurisdiction of the UPC, unless otherwise opted out. It is uncertain how the UPC will impact granted European patents in the biotechnology and pharmaceutical industries. Remix’s European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC’s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. Remix may decide to opt out its future European patents from the UPC, but doing so may preclude it from realizing the benefits of the UPC. Moreover, if Remix does not meet all of the formalities and requirements for opt-out under the UPC, its future European patents could remain under the jurisdiction of the UPC. The UPC will provide Remix’s competitors with a new forum to centrally revoke its European patents, and allow for the possibility of a competitor to obtain pan-European injunction. Such a loss of patent protection could have a material adverse impact on Remix’s business and its ability to commercialize its technology and its product candidates due to increased competition and, resultantly, on its business, financial condition, results of operations and prospects. The UPC and Unitary Patent are significant changes in European patent practice. As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty of any litigation in the UPC.

Remix may also be subject to claims that former employees or other third parties have an ownership interest in its patents or other intellectual property. Remix may be subject to ownership disputes in the future arising, for example, from conflicting obligations of consultants or others who are involved in developing its product candidates. Although it is Remix’s policy to require its employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to Remix, Remix may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that Remix regards as its own, and Remix cannot be certain that its agreements with such parties will be upheld in the face of a potential challenge, or that they will not be breached, for which Remix may not have an adequate remedy. The assignment of intellectual property rights may not be self-executing or the assignment agreements may be breached, and litigation may be necessary to defend against these and other claims challenging inventorship or ownership. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If Remix fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights. Such an outcome could have a material adverse effect on its business. Even if Remix is successful in defending against such claims, litigation could result in substantial costs and distraction to management and other employees. Any of the foregoing could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects.

The USPTO has taken the position that inventors and joint inventors named on U.S. patents and patent applications must be natural persons, and that, for AI-assisted inventions, patent protection may be available only where one or more natural persons made a legally sufficient contribution to the claimed invention. The USPTO’s guidance requires the inventorship analysis to focus on human contributions to the conception of the claimed invention, and not merely on the use, operation or ownership of an AI system. As a result, if an AI system materially contributes to the conception of an invention and no natural person can be shown to have made the required contribution to one or more claims, we may be unable to obtain patent protection for those claims, or any patents that issue could be challenged as invalid or unenforceable.

Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest United States non-provisional filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering Remix’s product candidates are obtained, once the patent life has expired, Remix may be open to competition from competitive products. 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, Remix’s patent portfolio may not provide it with sufficient rights to exclude others from commercializing products similar or identical to its own. If Remix does not have sufficient patent life to protect its products, its business, financial condition, results of operations and prospects will be adversely affected.

Depending upon the timing, duration and specifics of FDA marketing approval of Remix’s product candidates, one or more of its United States patents or those of its future licensors may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act). The Hatch-Waxman Act permits a patent restoration term of up to five years as compensation for patent term lost during product development and the FDA regulatory review process. A maximum of one patent may be extended per FDA approved product as compensation for the 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 and only those claims covering such approved drug product, a method for using it or a method for manufacturing it may be extended. Patent term extension may also be available in certain foreign countries upon regulatory approval of Remix’s product candidates. However, Remix may not be granted an extension because of, for example, 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 Remix requests. If Remix is unable to obtain patent term extension or restoration or the term of any such extension is less than it requests, its competitors may obtain approval of competing products following its patent expiration, and its revenue could be reduced, possibly materially. Further, if this occurs, Remix’s competitors may take advantage of its investment in development and trials by referencing its clinical and preclinical data and launch their product earlier than might otherwise be the case.

Although Remix has pending patent applications in the United States and will have pending patent applications in other countries in the future, filing, prosecuting and defending patents in all countries throughout the world would be prohibitively expensive, and its 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. For example, other countries may impose substantial restrictions on the scope of claims, including limiting patent protection to specifically disclosed embodiments. Consequently, Remix may not be able to prevent third parties from practicing its inventions in all countries outside the United States, or from selling or importing products made using its intellectual property in and into the United States or other jurisdictions. Consequently, Remix may not be able to prevent third parties from practicing its inventions in all countries outside the United States or from selling or importing products made using its inventions in and into the United States or other jurisdictions. Competitors may use Remix’s technologies in jurisdictions where it has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where Remix has patent protection, but enforcement is not as strong as that in the United States. These products may compete with Remix’s product candidates, and its current patents, the patents of its future 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 Remix to stop the infringement of its patents or its future licensors’ patents or marketing of competing products in violation of its proprietary rights generally. In addition, some jurisdictions, such as Europe, Japan and China, may have a heightened standard for patentability than in the United States, including, for example, the requirement of claims having literal support in the original patent filing and the limitation on using supporting data that is not in the original patent filing. Under those heightened patentability requirements, Remix may not be able to obtain sufficient patent protection in certain jurisdictions even though the same or similar patent protection can be secured in the United States and other jurisdictions.

Proceedings to enforce Remix’s patent rights in foreign jurisdictions could result in substantial costs and divert its efforts and attention from other aspects of its business, could put its patents or the patents of its future licensors at risk of being invalidated or interpreted narrowly and its patent applications or the patent applications of its future licensors at risk of not issuing and could provoke third parties to assert claims against Remix. Remix may not prevail in any lawsuits that it initiates, and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, Remix’s efforts to enforce its intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that it 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 Remix is forced to grant a license to third parties with respect to any patents relevant to its business, its competitive position may be impaired, and its business, financial condition, results of operations and prospects may be adversely affected. 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 Remix’s patent applications or those of any future licensors and the maintenance, enforcement or defense of its issued patents which could impair its competitive intellectual property position. For example, the United States and foreign government actions related to Russia’s conflict in Ukraine may limit or prevent filing, prosecution, and maintenance of patent applications in Russia. In addition, a decree was adopted by the Russian government in March 2022, allowing Russian companies and individuals to exploit inventions owned by patentees from the United States without consent or compensation. Consequently, Remix would not be able to prevent third parties from practicing its inventions in Russia or from selling or importing products made using its inventions in and into Russia.

The USPTO and various non-U.S. government agencies require compliance with several procedural, documentary, fee payment and other similar provisions during the patent application process. In some circumstances, Remix is dependent on its licensors to take the necessary action to comply with these requirements with respect to its licensed intellectual property. For example, periodic maintenance fees, renewal fees, annuity fees, and various other government fees on patents and applications will be due to be paid to the USPTO and various government patent agencies outside of the United States over the lifetime of Remix’s owned or licensed patents and applications. In certain circumstances, Remix may rely on its licensing partners to pay these fees due to the U.S. and non-U.S. patent agencies. In some cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in a partial or complete loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the market with similar or identical products or technology, which could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects.

The USPTO and various non-U.S. government agencies require compliance with certain foreign filing requirements during the patent application process. For example, in some countries, including the United States, China, India and some European countries, a foreign filing license is required before certain patent applications are filed. The foreign filing license requirements vary by country and depend on various factors, including where the inventive activity occurred, citizenship status of the inventors, the residency of the inventors and the invention owner, the place of business for the invention owner and the nature of the subject matter to be disclosed (e.g., items related to national security or national defense). In some, but not all cases, for example in China and India, a foreign filing license cannot be obtained retroactively in accordance with the applicable rules. There are situations, however, in which non-compliance can result in abandonment of a pending patent application or can be grounds for revoking or invalidating an issued patent, resulting in the loss of patent rights in the relevant jurisdiction. In such an event, potential competitors might be able to enter the relevant markets with similar or identical products or technology, which could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects. Remix may also be dependent on its licensors to take the necessary actions to comply with these requirements with respect to its licensed intellectual property.

Public health pandemics (such as the COVID-19 pandemic), geopolitical instability (war and terrorism), natural disasters, or similar events may impair Remix’s and its licensors’ ability to comply with these procedural, document submission, fee payment, and other requirements imposed by government patent agencies, which may materially and adversely affect Remix’s ability to obtain or maintain patent protection for its product candidates.

Remix intends to use trademarks or trade names to brand its products. Its trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. Remix may not be able to protect its rights to these trademarks and trade names, which it needs to build name recognition among

potential partners or customers in its markets of interest. During trademark registration proceedings, Remix may receive rejections of its applications by the USPTO or in other foreign jurisdictions. Although Remix is given an opportunity to respond to such rejections, it may be unable to overcome them. In the event that Remix’s trademarks are successfully challenged or determined to be infringing, misappropriating or violating other marks, it could be forced to rebrand its products, which could result in loss of brand recognition, and could require it to devote resources to advertising and marketing new brands. 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 Remix’s trademarks, which may not survive such proceedings. Moreover, any name Remix may propose to use with its product candidates in the United States must be approved by the FDA, regardless of whether it has registered it, or applied to register it, as a trademark. Similar requirements exist in Europe. 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 Remix’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, misappropriate or otherwise violate 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.

Remix may not be able to obtain, protect or enforce its rights to these trademarks and trade names, which it needs to build name recognition among potential partners or customers in its markets of interest. At times, competitors or other third parties may adopt trade names or trademarks similar to Remix’s, thereby impeding its ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement, misappropriation, dilution or other claims brought by owners of other registered trademarks or trademarks that incorporate variations of Remix’s registered or unregistered trademarks or trade names. Over the long term, if Remix is unable to establish name recognition based on its trademarks and trade names, then it may not be able to compete effectively and its business may be adversely affected. Remix’s efforts to obtain, enforce or protect its proprietary rights related to trademarks, trade names, domain name, or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect its business, financial condition, results of operations and prospects.

In addition to seeking patent protection for its product candidates and proprietary technologies, Remix may rely on trade secret protection and confidentiality agreements to protect its unpatented know-how, technology, and other proprietary information and to maintain its competitive position. Remix seeks to protect these trade secrets and other proprietary technology, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as its employees, licensees, third-party collaborators, CROs, contract manufacturers, consultants, advisors and other third parties. Remix also enters into confidentiality and invention or patent assignment agreements with its employees and consultants. Trade secrets and know-how can be difficult to protect. Remix cannot guarantee that it has entered into applicable agreements with each party that may have or have had access to its trade secrets or proprietary technology and processes. Despite these efforts, any of these parties may breach the agreements and disclose Remix’s proprietary information, including its trade secrets, and Remix may not be able to obtain adequate remedies for such breaches. Monitoring unauthorized uses and disclosures is difficult, and Remix does not know whether the steps it has taken to protect its proprietary technologies will be effective. Remix cannot guarantee that any potential trade secrets and other proprietary and confidential information will not be disclosed or that competitors will not otherwise gain access to trade secrets. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of Remix’s trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, Remix would have no right to prevent them from using that technology or information to compete with it. Furthermore, others may independently discover similar trade secrets and proprietary information. Remix may also need to share its trade secrets and proprietary know-how with current or future partners, collaborators, contractors and others located in countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or foreign actors, and those affiliated with or controlled by state actors. As a result, Remix may encounter significant problems in protecting and defending its intellectual property

both in the United States and abroad. If any of Remix’s trade secrets were to be disclosed or misappropriated or if any such information were to be independently developed by a competitor or other third party, its competitive position would be materially and adversely harmed.

Remix may be subject to claims that third parties have an ownership interest in its trade secrets. For example, Remix may have disputes arise from conflicting obligations of its employees, consultants or others who are involved in developing its product candidates. Litigation may be necessary to defend against these and other claims challenging ownership of Remix’s trade secrets. If Remix fails in defending any such claims, in addition to paying monetary damages, it may lose valuable trade secret rights, such as exclusive ownership of, or right to use, trade secrets that are important to its product candidates and other proprietary technologies it may develop. Such an outcome could have a material adverse effect on Remix’s business. Even if Remix is successful in defending against such claims, litigation could result in substantial costs and be a distraction to its management and other employees. Any of the foregoing could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects.

Some of Remix’s employees, consultants and advisors are currently or were previously employed at universities or other biotechnology or pharmaceutical companies, including its competitors or potential competitors. Although Remix tries to ensure that its employees, consultants and advisors do not use the proprietary information or know-how of others in their work for Remix, Remix may be subject to claims that it or these individuals have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such individual’s current or former employer. Litigation may be necessary to defend against these claims. If Remix fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights or personnel. Even if Remix is successful in defending against such claims, litigation could result in substantial costs and be a distraction to its management.

In addition, while it is Remix’s policy to require its employees and contractors who may be involved in the conception or development of intellectual property to execute agreements assigning such intellectual property to Remix, Remix may be unsuccessful in executing such an agreement with each party who, in fact, conceives or develops intellectual property that Remix regards as its own. The assignment of intellectual property rights may not be self-executing, or the assignment agreements may be breached, and Remix may be forced to bring claims against third parties, or defend claims that they may bring against Remix, to determine the ownership of what Remix regards as its intellectual property. Such claims could have a material adverse effect on Remix’s business, financial condition, results of operations and prospects.

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

Remix may enter into license agreements in the future with others to advance its existing or future research or allow commercialization of its existing or future product candidates. These licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which Remix may wish to develop or commercialize its technology and products in the future.

In addition, subject to the terms of any such license agreements, Remix may not have the right to control the preparation, filing, prosecution, maintenance, enforcement, and defense of patents and patent applications covering the technology that it licenses from third parties. In such an event, Remix cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests of its business. If Remix’s future licensors fail to prosecute, maintain, enforce, and defend such patents or patent applications, or lose rights to those patents or patent applications, the rights Remix has licensed may be reduced or eliminated, and its right to develop and commercialize any of its future product candidates that are subject of such licensed rights could be adversely affected.

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

It is possible that Remix may be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all. Even if Remix is able to obtain a license, it may be non-exclusive, thereby giving its competitors access to the same technologies licensed to Remix. In that event, Remix may be required to expend significant time and resources to redesign its technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If Remix is unable to do so, it may be unable to develop or commercialize the affected product candidates, which could harm its business, financial condition, results of operations, and prospects significantly. Remix cannot provide any assurances that third-party patents do not exist which might be enforced against its current technology, manufacturing methods, product candidates, or future methods or products resulting in either an injunction prohibiting its manufacture or future sales, or, with respect to its future sales, an obligation on its part to pay royalties and/or other forms of compensation to third parties, which could be significant.

Disputes may arise between Remix and its future licensors regarding intellectual property subject to a license agreement, including:

In addition, the agreements under which Remix licenses intellectual property or technology from third parties are complex, and certain provisions in such agreements may be susceptible to multiple interpretations. The resolution of

any contract interpretation disagreement that may arise could narrow what Remix believes to be the scope of its rights to the relevant intellectual property or technology, or increase what Remix believes to be its financial or other obligations under the relevant agreement, either of which could have a material adverse effect on its business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property that Remix licenses in the future prevent or impair its ability to maintain its licensing arrangements on commercially acceptable terms, it may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on its business, financial conditions, results of operations, and prospects.

Despite Remix’s best efforts, its future licensors might conclude that Remix materially breached its license agreements and might therefore terminate the license agreements, thereby removing its ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products identical to Remix’s. This could have a material adverse effect on Remix’s competitive position, business, financial conditions, results of operations, and prospects.

While Remix normally seeks to obtain the right to control prosecution, maintenance and enforcement of the patents relating to its product candidates, there may be times when the filing and prosecution activities for patents and patent applications relating to its product candidates are controlled by its future licensors or collaboration partners. If any of Remix’s future licensors or collaboration partners fail to prosecute, maintain and enforce such patents and patent applications in a manner consistent with the best interests of its business, including by payment of all applicable fees for patents covering its product candidates, Remix could lose its rights to the intellectual property or its exclusivity with respect to those rights, its ability to develop and commercialize those product candidates may be adversely affected and Remix may not be able to prevent competitors from making, using and selling competing products. In addition, even where Remix has the right to control patent prosecution of patents and patent applications it has licensed to and from third parties, Remix may still be adversely affected or prejudiced by actions or inactions of its licensees, its future licensors and their counsel that took place prior to the date upon which Remix assumed control over patent prosecution.

Although Remix does not currently own issued patents or pending patent applications that have been generated through the use of United States government funding, it may acquire or license in the future intellectual property rights that have been generated through the use of United States government funding or grants. Pursuant to the Bayh-Dole Act of 1980, the United States government has certain rights in inventions developed with government funding. These United States government rights include a non-exclusive, non-transferable, irrevocable worldwide license to use inventions for any governmental purpose. In addition, the United States government has the right, under certain limited circumstances, to require Remix to grant exclusive, partially exclusive, or non-exclusive licenses to any of these inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize the invention; (2) government action is necessary to meet public health or safety needs; or (3) government action is necessary to meet requirements for public use under federal regulations, also referred to as march-in rights. If the United States government exercised its march-in rights in Remix’s future intellectual property rights that are generated through the use of United States government funding or grants, Remix could be forced to license or sublicense intellectual property developed by it or that it licenses on terms unfavorable to it, and there can be no assurance that Remix would receive compensation from the United States government for the exercise of such rights. The United States 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 Remix to expend substantial resources. In addition, the United States 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 United States 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 United States industry may limit Remix’s ability to contract with non-United States product manufacturers for products covered by such intellectual property.

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

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

Remix is dependent on third parties to conduct its clinical trials and preclinical studies. Specifically, Remix relies on, and will continue to rely on, medical institutions, clinical investigators, CROs and consultants to conduct preclinical studies and clinical trials, in each case in accordance with trial protocols and regulatory requirements. These CROs, investigators and other third parties play a significant role in the conduct and timing of these trials and subsequent collection and analysis of data. Though Remix expects to carefully manage its relationships with such CROs, investigators and other third parties, there can be no assurance that Remix will not encounter challenges or

delays in the future, or that these delays or challenges will not have a material adverse impact on its business, financial condition and prospects. Further, while Remix has and will have agreements governing the activities of its third-party contractors, Remix has limited influence over their actual performance. Nevertheless, Remix is responsible for ensuring that each of its clinical trials is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards and requirements, and Remix’s reliance on its CROs and other third parties does not relieve it of its regulatory responsibilities.

In addition, Remix and its CROs are required to comply with Good Laboratory Practice (“GLP”) and GCP requirements, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities, for Remix’s product candidates in clinical development. Regulatory authorities enforce GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If Remix or any of its CROs or trial sites fail to comply with applicable GLP, GCP or other requirements, the data generated in its clinical trials may be deemed unreliable, and the FDA or comparable foreign regulatory authorities may require Remix to perform additional clinical trials before approving its marketing applications, if ever. Furthermore, Remix’s clinical trials must be conducted with materials manufactured in accordance with cGMP regulations. Failure to comply with these regulations may require Remix to repeat clinical trials, which would delay the regulatory approval process.

There is no guarantee that any of Remix’s CROs, investigators or other third parties will devote adequate time and resources to such trials or studies or perform as contractually required. If any of these third parties fails to meet expected deadlines, adhere to Remix’s clinical protocols or meet regulatory requirements, or otherwise perform in a substandard manner, Remix’s clinical trials may be extended, delayed or terminated. In addition, many of the third parties with whom Remix contracts may also have relationships with other commercial entities, including its competitors, for whom they may also be conducting clinical trials or other activities that could harm Remix’s competitive position.

In addition, principal investigators for Remix’s clinical trials may be asked to serve as scientific advisors or consultants to Remix from time to time and may receive cash or equity compensation in connection with such services. If these relationships and any related compensation result in perceived or actual conflicts of interest, or the FDA concludes that the financial relationship may have affected the interpretation of the study, the integrity of the data generated at the applicable clinical trial site may be questioned and the utility of the clinical trial itself may be jeopardized, which could result in the delay or rejection by the FDA of any NDA Remix submits. Any such delay or rejection could prevent Remix from commercializing its product candidates.

In addition, Remix’s CROs have the right to terminate their agreements with Remix in the event of an uncured material breach and under other specified circumstances. If any of Remix’s relationships with these third parties terminate, it may not be able to enter into arrangements with alternative third parties on commercially reasonable terms or at all. Switching or adding additional CROs, investigators and other third parties involves additional cost and requires Remix’s management’s time and focus. In addition, there is a natural transition period when a new CRO commences work. As a result, delays occur, which can materially impact Remix’s ability to meet its desired clinical development timelines. Though Remix works to carefully manage its relationships with its CROs, investigators and other third parties, there can be no assurance that it will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on its business, financial condition and prospects.

Remix does not currently have the infrastructure or internal capability to manufacture supplies of its product candidates for use in development and commercialization. Remix relies, and expects to continue to rely, on third-party manufacturers for the production of its product candidates for preclinical studies and clinical trials under the guidance of members of its organization. Any supply interruption in limited or sole sourced materials could materially harm Remix’s ability to manufacture its product candidates until a new source of supply, if any, could be identified and qualified. Remix may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms. To date, Remix has obtained active pharmaceutical ingredients (API) and drug product for its product candidates from certain single-source contract manufacturing organizations (CMOs). Any performance failures by such CMOs could materially harm Remix’s business. Remix does not have long-term supply agreements, and it purchases its required drug product on a purchase order basis, which means that aside

from any binding purchase orders it has from time to time, its supplier could cease supplying to Remix or change the terms on which it is willing to continue supplying to Remix at any time. If Remix were to experience an unexpected loss of supply of any of its product candidates for any reason, whether as a result of manufacturing, supply or storage issues or otherwise, it could experience delays, disruptions, suspensions or terminations of, or be required to restart or repeat, any pending or ongoing preclinical studies or clinical trials.

Remix expects to continue to rely on third-party manufacturers for the commercial supply of any of its product candidates for which it obtains regulatory approval. Remix may be unable to maintain or establish required agreements with third-party manufacturers or to do so on acceptable terms. Even if Remix is able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

Remix does not have complete control over all aspects of the manufacturing process of its contract manufacturing partners and is dependent on these contract manufacturing partners for compliance with cGMP regulations for manufacturing both APIs and finished drug products. To date, Remix has obtained API and drug product for its product candidates from single-source third party CMOs. Remix is in the process of developing its supply chain for each of its product candidates and intends to put in place framework agreements under which third-party CMOs will generally provide Remix with necessary quantities of API and drug product on a project-by-project basis based on its development needs. As Remix advances its product candidates through development, it will consider its lack of redundant supply for the API and drug product for each of its product candidates to protect against any potential supply disruptions. However, Remix may be unsuccessful in putting in place such framework agreements or protecting against potential supply disruptions.

Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside of the United States. If Remix’s CMOs cannot successfully manufacture material that conforms to its specifications and the strict regulatory requirements of the FDA or comparable regulatory authorities, they will not be able to secure and/or maintain approval for use of their manufacturing facilities in connection with Remix’s product candidates. In addition, Remix does not have control over the ability of its CMOs to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority does not approve these facilities for the manufacture of Remix’s product candidates or if it withdraws any such approval in the future, Remix will need to find alternative manufacturing facilities, and those new facilities would need to be inspected and approved by FDA or comparable regulatory authority prior to commencing manufacturing, which would significantly impact Remix’s ability to develop, obtain regulatory approval for or market its product candidates, if approved. Remix’s failure, or the failure of its third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on Remix, including fines, injunctions, civil penalties, delays,

suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or drugs, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of Remix’s product candidates or drugs and harm its business and results of operations.

In addition, certain CMOs and CROs outside of the U.S. could become subject to U.S. legislation, sanctions, trade restrictions and other foreign regulatory requirements which could increase the cost or reduce the supply of material available to us, delay the procurement or supply of such material or have an adverse effect on our ability to secure significant commitments from governments to purchase our potential therapies. For example, the U.S. BIOSECURE Act, which was enacted in December 2025, prohibits federal agencies from procuring or using any biotechnology equipment or services from “biotechnology companies of concern”, or entering into, extending, or renewing any contracts with entities that use such biotechnology equipment or services from “biotechnology companies of concern”. Congress has interpreted a “biotechnology company of concern” as an entity that is under the control of a foreign adversary and that poses a risk to national security based on its research or multiomic data collection (e.g., collection of genomic information). While the U.S. BIOSECURE Act has a grandfathering period of five years for existing contracts, and has carveouts for manufacture of drugs for supply under Medicaid and Medicare Part B, subject to the Secretary of Veteran Affairs’ discretion, the impact of the U.S. BIOSECURE Act on the biotechnology industry is uncertain. If the foreign CROs and CMOs we rely on in the future become subject to trade restrictions, sanctions, increased tariffs or other regulatory requirements by the U.S. government (including designation as a “biotechnology company of concern” under the U.S. BIOSECURE Act), or if the U.S. or other foreign governments take retaliatory actions due to recent or increased tensions between the U.S. and other countries, it may have the potential to severely restrict the ability of U.S. biopharmaceutical companies like us to purchase services or products from, or otherwise collaborate with, certain “biotechnology companies of concern” without losing the ability to contract with, or otherwise receive funding from, the U.S. government.

Remix’s current and anticipated future dependence upon others for the manufacture of its product candidates may adversely affect its future profit margins and its ability to commercialize any product candidates that receive regulatory approval on a timely and competitive basis.

Remix’s research and development activities involve the controlled use of potentially hazardous substances, including chemical materials, by its third-party manufacturers. Remix’s manufacturers are subject to federal, state and local laws and regulations in the United States governing the use, manufacture, storage, handling and disposal of medical and hazardous materials. Although Remix believes that its manufacturers’ procedures for using, handling, storing and disposing of these materials comply with legally prescribed standards, it cannot completely eliminate the risk of contamination or injury resulting from medical or hazardous materials. As a result of any such contamination or injury, Remix may incur liability or local, city, state or federal authorities may curtail the use of these materials and interrupt its business operations. In the event of an accident, Remix could be held liable for damages or penalized with fines, and the liability could exceed its resources. Remix does not have any insurance for liabilities arising from medical or hazardous materials. Compliance with applicable environmental laws and regulations is expensive, and current or future environmental regulations may impair Remix’s research, development and production efforts, which could harm its business, prospects, financial condition or results of operations.

From time to time, Remix evaluates various acquisition opportunities and strategic partnerships, including licensing or acquiring complementary products, product candidates, intellectual property rights, technologies or businesses. Any potential acquisition or strategic partnership may entail numerous risks, including:

In addition, if Remix undertakes acquisitions or pursues partnerships in the future, it may issue dilutive securities, assume or incur debt obligations, incur large onetime expenses and acquire intangible assets that could result in significant future amortization expense.

Remix’s drug development programs, and the potential commercialization of its product candidates will require substantial additional cash to fund expenses. Remix may seek to selectively form additional collaborations to expand its capabilities, potentially accelerate research and development activities and provide for commercialization activities by third parties. Remix may also seek strategic collaborations to develop combination therapy strategies for its portfolio products, and/or maximize portfolio value globally through selective co-development and/or commercialization collaborations. Any of these relationships may require Remix to incur non-recurring and other charges, increase its near-and long-term expenditures, issue securities that dilute its existing stockholders, or disrupt its management and business.

Remix faces significant competition in seeking appropriate collaborators and the negotiation process is time-consuming and complex. Whether Remix reaches a definitive agreement for a collaboration depends, 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 preclinical studies or 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 Remix’s ownership of intellectual property and industry and market conditions generally. The potential collaborator may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such collaboration could be more attractive than the one with Remix for its product candidate. Further, Remix may not be successful in its efforts to establish a collaboration or other alternative arrangements for product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.

In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Even if Remix is successful in entering into a collaboration, the terms and conditions of that collaboration may restrict it from entering into future agreements on certain terms with potential collaborators.

If and when Remix seeks to enter into collaborations, it may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If Remix is unable to do so, it may have to curtail the development of a product candidate, reduce or delay its development program or one or more of its other research 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 Remix 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 Remix on acceptable terms or at all. If Remix 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.

Remix has entered into a collaboration with Roche and may enter into additional collaborations and licenses with other third parties in the future. For some programs, Remix also depends on, or may in the future depend on, third party collaborators to design and conduct its research development program. Remix will likely have limited control over the amount and timing of resources that its collaborators dedicate to the development or commercialization of its product candidates. Remix’s ability to generate revenue from these arrangements will depend on its collaborators’ abilities and efforts to successfully perform the functions assigned to them in these arrangements. Collaborations involving Remix’s product candidates would pose numerous risks to Remix, including the following:

Remix’s quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult for Remix to predict its future operating results. From time to time, Remix may enter into license or collaboration agreements or strategic partnerships with other companies that include development funding and significant upfront and milestone payments and/or royalties, which may become an important source of Remix’s revenue. These upfront and milestone payments may vary significantly from period to period and any such variance could cause a significant fluctuation in Remix’s operating results from one period to the next.

In addition, Remix measures compensation cost for stock-based awards made to employees at the grant date of the award, based on the fair value of the award as determined by its board of directors, and recognizes the cost as an expense over the employee’s requisite service period. As the variables that Remix uses as a basis for valuing these awards change over time, the magnitude of the expense that it must recognize may vary significantly.

Furthermore, Remix’s operating results may fluctuate due to a variety of other factors, many of which are outside of its control and may be difficult to predict, including the following:

The cumulative effect of these factors could result in large fluctuations and unpredictability in Remix’s quarterly and annual operating results. As a result, comparing Remix’s operating results on a period-to-period basis may not be meaningful. Investors should not rely on Remix’s past results as an indication of its future performance. This

variability and unpredictability could also result in Remix’s failing to meet the expectations of industry or financial analysts or investors for any period. If Remix’s revenue or operating results fall below the expectations of analysts or investors or below any forecasts it may provide to the market, or if the forecasts Remix provides to the market are below the expectations of analysts or investors, the price of Remix’s common stock could decline substantially. Such a stock price decline could occur even when Remix has met any previously publicly stated guidance it may provide.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is expensive. Remix has not generated any revenues from the commercial sale of products and will not be able to generate any product revenues until, and only if, Remix receives approval to sell its product candidates from the FDA or other regulatory authorities. Remix expects its current cash, together with the net proceeds from the Transaction and related financing, to fund operations into early 2028. However, as Remix has not generated any revenue from commercial sales to date and does not expect to generate any revenue for several years, if ever, Remix will need to raise substantial additional capital in order to fund its general corporate activities and to fund Remix’s research and development, including its currently planned clinical trials and plans for new clinical trials and product development.

Remix may seek to raise additional funds through various potential sources, such as equity and debt financings, or through strategic collaborations and license agreements. Remix can give no assurances that it will be able to secure such additional sources of funds to support its operations or, if such funds are available, that such additional financing will be sufficient to meet its needs. Moreover, to the extent that Remix raises additional funds by issuing equity securities, Remix’s stockholders may experience additional significant dilution and new investors could gain rights, preferences and privileges senior to the holders of common stock. Debt financing, if available, may involve restrictive covenants. To the extent that it raises additional funds through collaboration and licensing arrangements, Remix may be necessary to relinquish some rights to its technologies or product candidates, or grant licenses on terms that may not be favorable.

Given Remix’s capital constraints, Remix will need to prioritize spending on its clinical and preclinical programs. If Remix is unable to raise sufficient funds to support its current and planned operations, Remix may elect to discontinue certain of its ongoing activities or programs. Remix’s inability to raise additional funds could also prevent it from taking advantage of opportunities to pursue promising new or existing programs in the future.

Remix’s forecasts regarding its beliefs in the sufficiency of Remix’s financial resources to support its current and planned operations are forward-looking statements and involve significant risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. These estimates are based on assumptions that may prove to be wrong, and Remix could utilize its available capital resources sooner than currently expected.

Remix will incur significant legal, accounting and other expenses as a public company that it did not incur as a private company, including costs associated with public company reporting obligations under the Exchange Act. Some of Remix’s management team have not previously managed and operated a public company. These executive officers and other personnel will need to devote substantial time to gaining expertise related to public company reporting requirements and compliance with applicable laws and regulations to ensure that it complies with all of these requirements. Any changes Remix makes to comply with these obligations may not be sufficient to allow it to satisfy its obligations as a public company on a timely basis, or at all. These reporting requirements, rules and regulations, coupled with the increase in potential litigation exposure associated with being a public company, could also make it more difficult for Remix to attract and retain qualified persons to serve on the board of directors or on--board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms.

Remix is subject to the reporting requirements of the Exchange Act, which requires, among other things, that Remix file with the SEC, annual, quarterly and current reports with respect to Remix’s business and financial condition as well as other disclosure and corporate governance requirements. However, as a smaller reporting company, Remix may take advantage of exemptions from various requirements such as an exemption from the requirement to have Remix’s independent auditors attest to its internal control over financial reporting under Section 404 of the Sarbanes Oxley Act as well as an exemption from the “say on pay” voting requirements pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act of 2010. Once Remix is no longer a smaller reporting company or otherwise qualifies for these exemptions, it will be required to comply with these additional legal and regulatory requirements applicable to public companies and will incur significant legal, accounting and other expenses to do so. If Remix is not able to comply with the requirements in a timely manner or at all, Remix’s financial condition or the market price of its common stock may be harmed. For example, if Remix or Remix’s independent auditor identifies deficiencies in its internal control over financial reporting that are deemed to be material weaknesses Remix could face additional costs to remedy those deficiencies, the market price of Remix’s stock could decline or Remix could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

The current expectation is that Remix will retain its future earnings, if any, to fund the growth of its business as opposed to paying dividends. As a result, capital appreciation, if any, of the common stock of Remix will be investors’ sole source of gain, if any, for the foreseeable future.

An active trading market for Remix’s shares of common stock may not be sustained. If an active market for Remix’s common stock is not sustained, it may be difficult for Remix’s stockholders to sell their shares at an attractive price or at all.

Remix’s executive officers, directors and principal stockholders, in the aggregate, beneficially own approximately 93.3% of Remix’s outstanding shares of common stock. As a result, if these stockholders were to choose to act together, they would be able to control or significantly influence all matters submitted to Remix’s stockholders for approval, as well as Remix’s management and affairs. For example, these persons, if they choose to act together, would control or significantly influence the election of directors and approval of any merger, consolidation or sale of all or substantially all of Remix’s assets. This concentration of voting power could delay or prevent an acquisition of Remix on terms that other stockholders may desire.

Remix may be exposed to increased litigation from stockholders, suppliers and other third parties due to the combination of Remix’s business. Such litigation may have an adverse impact on Remix’s business and results of operations or may cause disruptions to its operations. In addition, in the past, stockholders have initiated class action lawsuits against biotechnology companies following periods of volatility in the market prices of these companies’ stock. Such litigation, if instituted against Remix, could cause Remix to incur substantial costs and divert management’s attention and resources, which could have a material adverse effect on its business, financial condition and results of operations.

The trading market for Remix’s common stock will be influenced by the research and reports that equity research analysts publish about Remix and Remix’s business. Equity research analysts may elect not to provide research coverage of Remix’s common stock, and such lack of research coverage may adversely affect the market price of

Remix’s common stock. In the event Remix does have equity research analyst coverage, Remix will not have any control over the analysts or the content and opinions included in their reports. The price of Remix’s common stock could decline if one or more equity research analysts downgrade Remix’s stock or issue other unfavorable commentary or research. If one or more equity research analysts ceases coverage of Remix or fails to publish reports on Remix regularly, demand for Remix’s common stock could decrease, which in turn could cause Remix’s stock price or trading volume to decline.

Pursuant to Section 404 of Sarbanes-Oxley, Remix’s management will be required to report upon the effectiveness of Remix’s internal control over financial reporting. When Remix no longer qualifies as a “smaller reporting company”, Remix’s independent registered public accounting firm will be required to attest to the effectiveness of Remix’s internal control over financial reporting. The rules governing the standards that must be met for Remix’s management to assess Remix’s internal control over financial reporting are complex and require significant documentation, testing and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, Remix may need to upgrade its information technology systems; implement additional financial and management controls, reporting systems and procedures; and hire additional accounting and finance staff. If Remix or, if required, Remix’s auditors are unable to conclude that Remix’s internal control over financial reporting is effective, investors may lose confidence in Remix’s financial reporting and the trading price of Remix’s common stock may decline.

There can be no assurance that there will not be material weaknesses or significant deficiencies in Remix’s internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit Remix’s ability to accurately report its financial condition, results of operations or cash flows. If Remix is unable to conclude that its internal control over financial reporting is effective, or if its independent registered public accounting firm determines Remix has a material weakness or significant deficiency in its internal control over financial reporting once that firm begins its Section 404 reviews, investors may lose confidence in the accuracy and completeness of Remix’s financial reports, the market price of its common stock could decline, and Remix could be subject to sanctions or investigations by Nasdaq, the SEC, or other regulatory authorities. Failure to remedy any material weakness in its internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict its future access to the capital markets.

Remix’s office facilities are located in Massachusetts. Remix has not undertaken a systematic analysis of the potential consequences to its business and financial results from a major blizzard, flood, fire, earthquake, power loss, telecommunications failure, terrorist activity, pandemics or other disasters and do not have a recovery plan for such disasters. In addition, Remix does not carry sufficient insurance to compensate Remix for actual losses from interruption of its business that may occur, and any losses or damages incurred by Remix could harm its business. The occurrence of any of these business disruptions could seriously harm Remix’s operations and financial condition and increase its costs and expenses.

In determining whether you should approve the proposals contained in this proxy statement/prospectus, you should carefully read the following risk factors in addition to the risks described above.

Following completion of the Mergers, the combined company will be susceptible to many of the risks described in the sections titled “Risk Factors—Risks Related to Passage Bio” and “Risk Factors—Risks Related to Remix ” in this proxy statement/prospectus. To the extent any of the events in the risks described in those sections occur, the potential benefits of the Mergers may not be realized and the results of operations and financial condition of the combined company could be adversely affected in a material way. This could cause the market price of the combined company’s common stock to decline.

The Mergers involve the combination of two companies which currently operate as independent companies. Following the Mergers, the combined company will be required to devote significant management attention and resources to integrating its business practices and operations. The combined company may fail to realize some or all of the anticipated benefits of the Mergers if the integration process takes longer than expected or is more costly than expected. Potential difficulties the combined company may encounter in the integration process include the following:

In addition, Passage Bio and Remix have operated and, until the completion of the Mergers, will continue to operate, independently. It is possible that the integration process also could result in the diversion of each company’s management’s attention, the disruption or interruption of, or the loss of momentum in, each company’s ongoing businesses or inconsistencies in standards, controls, procedures and policies, any of which could adversely affect the combined company’s ability to maintain its business relationships or the ability to achieve the anticipated benefits of the merger, or could otherwise adversely affect the business and financial results of the combined company.

The market price of the combined company’s common stock following the Mergers could be subject to significant fluctuations. Market prices for securities of early-stage pharmaceutical, biotechnology and other life sciences companies have historically been particularly volatile. Some of the factors that may cause the market price of the combined company’s common stock to fluctuate include:

Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of the combined company’s common stock.

In the past, following periods of volatility in the market price of a company’s securities, stockholders have often instituted class action securities litigation against those companies. Such litigation, if instituted, could result in substantial costs and diversion of management attention and resources, which could significantly harm the combined company’s profitability and reputation.

Additionally, a decrease in the stock price of the combined company may cause the combined company’s common stock to no longer satisfy the continued listing standards of Nasdaq. If the combined company is not able to maintain the requirements for listing on Nasdaq, it could be delisted, which could have a materially adverse effect on its ability to raise additional funds as well as the price and liquidity of its common stock.

The combined company will incur significant legal, accounting and other expenses that Remix did not incur as a private company, including costs associated with public company reporting requirements.

The combined company will also incur costs associated with corporate governance requirements, including requirements under the laws, rules and regulations of the SEC as well as the Nasdaq rules. These laws, rules and

regulations are expected to increase the combined company’s legal and financial compliance costs and to make some activities more time consuming and costly. These laws, rules and regulations also may make it difficult and expensive for the combined company to obtain directors’ and officers’ liability insurance. As a result, it may be more difficult for the combined company to attract and retain qualified individuals to serve on the combined company board of directors or as executive officers of the combined company, which may adversely affect investor confidence in the combined company and could cause the combined company’s business or stock price to suffer.

At the Effective Time, Passage Bio and a third party rights agent, will enter into the CVR Agreement, pursuant to which Passage Bio’s common stockholders of record as of the close of business on the last business day prior to the day on which the Effective Time occurs will receive one contingent value right (each, a “CVR”) for each outstanding share of Passage Bio Common Stock held by such stockholder on such date. Each CVR will represent the contractual right to receive payments from Passage Bio upon the actual receipt by Passage Bio or its subsidiaries of certain contingent proceeds derived from certain existing license agreements of Passage Bio, net of certain tax, transaction costs and certain other expenses. For additional information, please see the section titled “Agreements Related to the Mergers—Passage Bio Contingent Value Rights Agreement.”

If Passage Bio does not receive such proceeds prior to the Closing, the combined company may need to allocate time and resources to recover such proceeds. As a result, the combined company’s stockholders may receive no or limited benefits from any time or resources allocated to recovering such proceeds and such activities may be a distraction to the combined company’s management and employees. As a result, the combined company’s operations and financial condition may be adversely affected.

Currently, Passage Bio’s common stock is publicly traded on Nasdaq. In connection with the proposed Mergers, Remix will file an initial listing application with Nasdaq pursuant to Nasdaq’s “reverse merger” rules. The combined company will be required to meet the initial listing requirements for its securities to be listed on Nasdaq.

If the combined company fails to meet the Nasdaq listing requirements and their respective boards choose to close the Mergers without Nasdaq’s approval, then Nasdaq may notify the combined company of its determination to delist the company’s securities based upon the failure to satisfy the criteria in the Nasdaq application. For more information, refer to the section titled “Risk Factors—Risks Related to the Mergers—Passage Bio or Remix may waive one or more of the conditions to the Mergers without recirculation of this proxy statement/prospectus or resoliciting stockholder approval”.

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

The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts states from regulating the sale of certain securities, which are referred to as “covered securities.” Since the Passage Bio

Common Stock is listed on Nasdaq, they are covered securities. Although states are preempted from regulating the sale of covered securities, the federal statute does allow states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then states can regulate or bar the sale of covered securities in a particular case. If Passage Bio was no longer listed on Nasdaq, its securities would not be covered securities and it would be subject to regulation in each state in which it offers its securities, including in connection with the Mergers.

The amended and restated certificate of incorporation and amended and restated bylaws of the combined company will be the amended and restated certificate of incorporation and amended and restated bylaws of Passage Bio, which, along with Delaware law will contain provisions that may have the effect of discouraging, delaying or preventing a change in control of the combined company or changes in the combined company’s management that stockholders may consider favorable, including transactions in which the combined company’s stockholders might otherwise receive a premium for their shares. The combined company’s amended and restated certificate of incorporation and bylaws will include provisions that:

These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in the combined company’s management. These provisions could also limit the price that investors might be willing to pay in the future for shares of the combined company’s common stock, thereby depressing the market price of the combined company’s common stock.

In addition, because the combined company will be incorporated in the State of Delaware, the combined company will be governed by the provisions of Section 203 of the DGCL which will prohibit a person who owns in excess of 15% of the combined company’s outstanding voting stock from merging or combining with the combined company for a period of three years after the date of the transaction in which the person acquired in excess of 15% of the combined company’s outstanding voting stock, unless the merger or combination is approved in a prescribed manner.