Rallybio (NASDAQ: RLYB) to merge into Avenzo Therapeutics with $215M private financing and CVRs
Rhea-AI Filing Summary
Rallybio Corporation announced a definitive agreement to acquire Avenzo Therapeutics in an all‑stock reverse‑triangular merger combined with a $215.0 million concurrent private financing. Avenzo will become a wholly owned Rallybio subsidiary, and the combined company is expected to be renamed Avenzo Therapeutics and trade on Nasdaq as “AVZO.”
Based on an implied valuation of $15.0 million for Rallybio and $300.0 million for Avenzo and assuming Rallybio distributes substantially all pre‑closing net cash, pre‑transaction Rallybio equityholders are expected to own about 2.8% of the combined company and pre‑transaction Avenzo equityholders, including financing investors, about 97.2%, on a fully diluted treasury‑stock basis.
Rallybio stockholders will also receive contingent value rights tied to potential future proceeds from legacy asset dispositions. The combined company expects its cash at closing, including the $215.0 million financing, to fund operations into late 2028 and advance four clinical‑stage oncology programs through multiple Phase 1 updates and the start of several Phase 2 studies.
Positive
- The concurrent oversubscribed private placement is expected to provide $215.0 million of gross proceeds, giving the combined company projected cash runway into late 2028 to fund four clinical-stage oncology programs through multiple Phase 1 updates and several Phase 2 trial initiations.
- The transaction installs an experienced oncology leadership team from Avenzo, with its Chair, President and CEO and other senior executives assuming the key management roles of the combined company, aligning governance with the clinical-stage oncology strategy.
Negative
- Pre-transaction Rallybio equityholders are expected to own only about 2.8% of the combined company on a fully diluted basis (assuming Rallybio has no net cash at closing), with Avenzo equityholders, including financing investors, holding approximately 97.2% economic ownership.
- The Merger Agreement includes significant break fees, including up to $20.0 million payable by Avenzo and $600,000 payable by Rallybio in certain termination scenarios, which could deter competing strategic alternatives once the transaction is announced.
Insights
Rallybio is effectively becoming a cash-and-CVR shell for Avenzo’s oncology platform, backed by a $215M private round.
The deal combines Rallybio with clinical‑stage oncology company Avenzo via an all‑stock merger alongside a $215.0 million oversubscribed private placement. Pro forma ownership is heavily tilted toward Avenzo and new investors, reflecting implied valuations of $15.0 million for Rallybio and $300.0 million for Avenzo.
Pre‑transaction Rallybio holders are slated to receive substantial pre‑closing cash distributions plus contingent value rights over future proceeds from legacy assets, while retaining about 2.8% of the combined company. Avenzo and financing investors are expected to own about 97.2%, aligning control and economics with the oncology platform being funded.
The $215.0 million raise is expected to fund the combined company into late 2028, covering multiple Phase 1 readouts and several Phase 2 trial initiations across four programs. Closing is targeted for Q4 2026, subject to shareholder approvals, an effective Form S‑4, Nasdaq listing conditions and completion of the financing, with termination fees up to $20.0 million on Avenzo and $600,000 on Rallybio in specified break scenarios.
8-K Event Classification
Key Figures
Key Terms
reverse-triangular merger financial
Contingent Value Rights Agreement financial
Form S-4 regulatory
Support Agreements financial
Lock-Up Agreements financial
registration rights agreement financial
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
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| Item 1.01. | Entry into a Material Definitive Agreement. |
Merger Agreement
On May 31, 2026, Rallybio Corporation, a Delaware corporation (“Rallybio”), entered into an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”) with Avenzo Therapeutics, Inc., a Delaware corporation (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, and Farmington Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Rallybio (“Merger Sub”). Upon the terms and subject to the satisfaction of the conditions described in the Merger Agreement, Merger Sub will be merged with and into Avenzo, with Avenzo surviving as a wholly owned subsidiary of Rallybio (the “Merger” and, together with all of the other transactions contemplated by the Merger Agreement, the “Contemplated Transactions”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the “Effective Time”), (a) each then-outstanding share of common stock or preferred stock of Avenzo (each such share, an “Avenzo Share”) (excluding any share described in clauses (b) or (c) below and Avenzo Shares held by stockholders who have exercised and perfected appraisal rights for such shares) will be converted into the right to receive a number of shares of Rallybio Common Stock, par value $0.0001 per share (“Rallybio Common Stock”), calculated in accordance with the Exchange Ratio as set forth in the Merger Agreement (the “Exchange Ratio”), (b) each Avenzo Share issued in the Concurrent Financing (as defined below) will be converted into the right to receive a number of shares of Rallybio Common Stock calculated in accordance with the Merger Agreement, (c) any Avenzo Shares held as treasury shares or held or owned by Rallybio, Merger Sub or any subsidiary of Rallybio or Avenzo immediately prior to the Effective Time will be canceled and shall cease to exist, and no consideration shall be delivered in exchange therefor. Each then-outstanding option to purchase Avenzo Shares will be converted into an option to purchase Rallybio Common Stock, subject to adjustment as set forth in the Merger Agreement.
Under the Exchange Ratio formula in the Merger Agreement, upon the Closing, on a pro forma basis and based upon the number of shares of Rallybio Common Stock expected to be issued in connection with the Merger and the Concurrent Financing, pre-Merger equityholders of Avenzo (other than Investors (as defined below) in the Concurrent Financing) are expected to own approximately 56.6% of the combined company, pre-Merger equityholders of Rallybio will own approximately 2.8% of the combined company and the Investors in the Concurrent Financing are expected to own approximately 40.6% (assuming gross proceeds from the Concurrent Financing of $215.0 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 Rallybio of $15.0 million (assuming Rallybio has no net cash as a result of its pre-closing distributions (“Rallybio Net Cash”) as of the closing of the Merger (the “Closing” and such date, the “Closing Date”), (ii) a valuation for Avenzo of $300.0 million, and (iii) the relative capitalization of Rallybio and Avenzo. The percentage of the combined company that each party’s equityholders will own following the Closing is subject to certain adjustments as described in the Merger Agreement, including the amount of the final Rallybio Net Cash at Closing. At any time prior to the Closing, Rallybio will declare distributions (each a “Rallybio Distribution”) of Rallybio Net Cash to holders of Rallybio Common Stock and, if applicable, securities convertible into or exchangeable or exercisable for shares of Rallybio Common Stock outstanding as of the applicable record date, subject to the terms of the Merger Agreement.
Following the Closing, it is expected that Athena Countouriotis, M.D., the Chair, President and Chief Executive Officer of Avenzo, will serve as the Chair, President and Chief Executive Officer of the combined company; Scott Lipman, M.B.A., the Chief Financial Officer and Chief Business Officer of Avenzo, will serve as the Chief Financial Officer and Chief Business Officer of the combined company; Mohammad Hirmand, M.D., the Chief Medical Officer of Avenzo, will serve as the Chief Medical Officer of the combined company; and Brian Sun, J.D., the Chief Legal Officer of Avenzo, will serve as the Chief Legal Officer of the combined company. Additionally, following the Closing, the board of directors of the combined company is expected to consist of seven directors, which members will initially be designated by the Company prior to the Closing. In connection with the Closing, each of the current Rallybio executive officers and directors are expected to tender their resignations.
The Merger Agreement contains representations and warranties of the parties regarding their respective businesses. The Merger Agreement also contains certain covenants made by each of Avenzo and Rallybio, including non-solicitation restrictions binding each party (and subject to certain exceptions as further described in the Merger Agreement) and its representatives and restrictions on the operation of each party’s business between the date of the Merger Agreement and the Closing.
In connection with the Merger, Rallybio will prepare and file a registration statement on Form S-4, which will contain a proxy statement and prospectus, to register the shares issued pursuant to the Merger Agreement (the “Form S-4”) and will seek the approval of Rallybio’s stockholders of, among other matters, (i) the issuance of the shares of Rallybio Common Stock and other securities of Rallybio pursuant to the Merger and the change of control of Rallybio resulting from the Merger, (ii) a reverse stock split of Rallybio Common Stock at a ratio to be mutually agreed upon by Rallybio and Avenzo, (iii) the change of the name of Rallybio to “Avenzo Therapeutics, Inc.” ((i) through (iii), the “Rallybio Stockholder Matters”), (iv) an increase in the number of authorized shares of Rallybio Common Stock to a number determined by Avenzo (the “Authorized Share Increase Proposal”), (v) the Avenzo 2026 Equity Incentive Plan, and (vi) the Avenzo 2026 Employee Stock Purchase Plan.
In the event the Rallybio Board of Directors makes a Parent Board Adverse Recommendation Change (as defined in the Merger Agreement) as a result of a Superior Offer (as defined in the Merger Agreement), Rallybio will remain obligated to hold the stockholder meeting to vote on the Rallybio Stockholder Matters under the terms of the Merger Agreement and may not terminate the Merger Agreement in order to enter into an agreement with respect to such Superior Offer.
The Closing is subject to certain closing conditions, including: (i) the approval by the Rallybio stockholders of the Rallybio Stockholder Matters; (ii) approval by the requisite Avenzo stockholders of the adoption and approval of the Merger Agreement and the Contemplated Transactions; (iii) the existing shares of Rallybio Common Stock having been continually listed on the Nasdaq Stock Market (including the Nasdaq Capital Market) (“Nasdaq”) and Nasdaq’s approval of the shares of Rallybio Common Stock to be issued in the Merger; (iv) the Subscription Agreement (as defined below) being in full force and effect with cash gross proceeds of not less than $215.0 million having been received by Avenzo; (v) the effectiveness of the Form S-4; (vi) determination of Rallybio Net Cash; (vii) the amount of any Rallybio Distribution declared or intended to be declared by Rallybio having been either declared, distributed or deposited with Rallybio’s transfer agent, if applicable, for further distribution on such date as determined by Parent; (viii) termination by Avenzo of certain agreements with investors; (ix) Rallybio Net Cash being greater than an amount equal to $500,000 below $0 and (x) no legal restraint. The Closing is also subject to other specified customary closing conditions of each party, including the accuracy of each party’s representations and warranties, subject to applicable materiality qualifications, compliance by each party with its covenants under the Merger Agreement in all material respects, respectively, delivery of certain customary closing documents by each of Rallybio and Avenzo, and no Avenzo material adverse effect or Rallybio material adverse effect since the date of the Merger Agreement that is continuing, respectively.
The Merger Agreement contains certain termination rights of each of Avenzo and Rallybio. Upon termination of the Merger Agreement in certain circumstances, Avenzo may be required to pay to Rallybio a termination fee of (x) $20.0 million, including (i) where Avenzo’s board of directors changes or withdraws its recommendation in favor of the Merger or recommends to enter into an alternative transaction, (ii) in certain circumstances where Avenzo enters into a Permitted Alternative Agreement (as defined in the Merger Agreement); or (iii) if (a) the Merger Agreement is terminated because Avenzo (1) fails to obtain the requisite stockholder approval of the Merger Agreement and the Contemplated Transactions or (2) breaches the Merger Agreement, (b) an alternative acquisition proposal was announced or disclosed prior to obtaining Avenzo’s stockholder approval, and (c) within 12 months of the termination of the Merger Agreement, Avenzo enters into a definitive agreement with respect to an alternative transaction; or (y) $8 million, if (i) the Merger Agreement is terminated because the Merger has not been consummated by the End Date (as defined in the Merger Agreement), (ii) an alternative acquisition proposal was announced or disclosed prior to obtaining Avenzo’s stockholder approval, and (iii) within 12 months of the termination of the Merger Agreement, Avenzo enters into a definitive agreement with respect to an alternative transaction.
Upon termination of the Merger Agreement in certain circumstances, a termination fee of $600,000 may be payable by Rallybio to Avenzo if (i)(a) the Merger Agreement is terminated because the Merger has not been consummated by the End Date (as defined in the Merger Agreement) or Rallybio (1) fails to obtain the requisite stockholder approval of the Rallybio 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, Rallybio enters into a definitive agreement with respect to an alternative transaction, (ii) Rallybio fails to include its board recommendation in the Form S-4, or (iii) the Rallybio board of directors changes or withdraws its recommendation in favor of the Merger or approves an alternative transaction, or willfully and intentionally breaches its non-solicitation or certain other obligations under the Merger Agreement. Avenzo and Rallybio have also each agreed to reimburse the other party for up to $750,000 for third-party expenses, as applicable, if the Merger Agreement is terminated in certain circumstances.
Support Agreements and Lock-Up Agreements
Support Agreements
Concurrently with the execution of the Merger Agreement, the executive officers and directors and certain other stockholders of Rallybio holding approximately 24.3% of the outstanding Rallybio capital stock entered into support agreements (the “Rallybio Support Agreements”) in favor of Avenzo, providing among other things, that such officers, directors and stockholders (x) will vote all of their shares of Rallybio capital stock, among other things: (i) in favor of approving the Contemplated Transactions, including the Rallybio Stockholder Matters, the Authorized Share Increase Proposal and the other actions contemplated by the Merger Agreement, (ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party and (y) will not solicit or negotiate alternative acquisition proposal or inquiries in their capacities as stockholders of Rallybio.
Concurrently with the execution of the Merger Agreement, certain officers, directors and stockholders of Avenzo holding approximately 78% of the outstanding Avenzo capital stock entered into support agreements (the “Avenzo Support Agreements” and, together with Rallybio Support Agreements, the “Support Agreements”) in favor of Rallybio, providing among other things, that such executive officers, directors and stockholders (x) will vote all of their shares of Avenzo capital stock, among other things: (i) in favor of adopting the Merger Agreement and approving the Merger, the other Contemplated Transactions, the Company Stockholder Matters (as defined in the Merger Agreement) and the other actions contemplated by the Merger Agreement, (ii) against any proposal made in opposition to, or in competition with, the Merger Agreement or the Merger and (iii) against any acquisition proposal involving a third party and (y) will not solicit or negotiate alternative acquisition proposal or inquiries in their capacities as stockholders of Avenzo.
Lock-Up Agreements
Concurrently with the execution of the Merger Agreement, certain executive officers, directors and stockholders of Avenzo entered into lock-up agreements (the “Lock-Up Agreements”), pursuant to which, subject to specified exceptions, such persons accepted certain restrictions on transfers of the shares of Rallybio Common Stock beneficially held by such persons or such persons’ family members (other than shares received as a result of the conversion of shares received in the Concurrent Financing) for the 180-day period following the Effective Time.
The foregoing descriptions of the Merger Agreement, the form of Rallybio Support Agreement, form of the Avenzo Support Agreement and the form of Lock-Up Agreement (collectively, the “Agreements”), are not complete and are qualified in their entirety by reference to those Agreements, which are filed as Exhibits 2.1, 10.1, 10.2 and 10.3, respectively, to this Current Report on Form 8-K and incorporated herein by reference. In particular, the assertions embodied in the representations and warranties contained in the Merger Agreement are qualified by information in confidential disclosure schedules provided by each of Rallybio and Avenzo in connection with the signing of the Merger Agreement. These confidential disclosure schedules contain information that modifies, qualifies and creates exceptions to the representations and warranties and certain covenants set forth in the Merger Agreement. Moreover, certain representations and warranties in the Agreements were used for the purpose of allocating risk between the parties thereto rather than establishing matters as facts. Accordingly, the representations and warranties may not describe the actual state of affairs at the date they were made or at any other time, and investors should not rely on them as statements of fact.
Rallybio Contingent Value Rights Agreement
Immediately prior to the Effective Time, Rallybio and a rights agent (the “Rights Agent”) are expected to enter into a Contingent Value Rights Agreement (the “CVR Agreement”), pursuant to which holders of record of certain Rallybio securities 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 Rallybio Common Stock, pre-funded warrant, Rallybio restricted stock unit or In the Money Parent Option (as defined in the Merger Agreement) held as of such date.
Pursuant to the CVR Agreement, each CVR holder will be entitled to receive their pro rata share of all of the net proceeds (including cash or the value of stock to the extent listed on a national exchange, at the time of disposition), if any, received by Rallybio as a result of payments (“CVR Payments”) made to Rallybio of (i) any upfront, milestone, royalty and other payments received under any disposition agreement related to Rallybio’s pre-Merger assets (the “Legacy Assets”), and (ii) all of the cash proceeds, if any, received from Recursion Pharmaceuticals, Inc. under the Membership Interest Purchase Agreement, dated July 8, 2025, by and among Recursion Pharmaceuticals, Inc., Exscientia Ventures I, Inc., Rallybio Corporation and Rallybio IPB, LLC. For a period of four months after the Closing Date, Rallybio will use commercially reasonable efforts to effect the disposition of the Legacy Assets with respect to a third party that Rallybio had been in discussions with regarding a disposition prior to the Closing Date, subject to certain limitations. Such net proceeds will be subject to certain permitted deductions, including for applicable tax payments, certain expenses incurred or other liabilities borne by Rallybio or its affiliates in respect of the Legacy Assets, and losses incurred by Rallybio or its affiliates due to a third-party proceeding in connection with such disposition.
The CVR Payments, if any, will become payable to the Rights Agent for subsequent distribution to the CVR holders. In the event that no such proceeds are received during the CVR Term (as defined in the CVR Agreement), holders of the CVRs will not receive any payment pursuant to the CVR Agreement. There can be no assurance that any CVR holders will receive any CVR Payments.
The right to the contingent payments contemplated by the CVR Agreement is a contractual right only and is not transferable, except in the limited circumstances specified in the CVR Agreement. The CVRs will not be evidenced by a certificate or any other instrument and will not be registered with the Securities and Exchange Commission (“SEC”). The CVRs will not have any voting or dividend rights and will not represent any equity or ownership interest in Rallybio or any of its respective affiliates. No interest will accrue on any amounts payable in respect of the CVRs.
The foregoing summary of the CVR Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the form of CVR Agreement, which is filed herewith as Exhibit 10.4 and is incorporated by reference herein.
Concurrent Financing
Concurrently with entering into the Merger Agreement, Avenzo entered into a subscription agreement (the “Subscription Agreement”) with certain accredited investors (the “Investors”).
Pursuant to the Subscription Agreement, and subject to the terms and conditions therein, Avenzo agreed to sell, and the Investors agreed to purchase, immediately prior to the Effective Time, shares of Avenzo Class A common stock for an aggregate purchase price of $215.0 million (the “Concurrent Financing”). Shares of Avenzo Class A common stock issued pursuant to the Concurrent Financing will be converted into shares of Rallybio Common Stock in accordance with the Exchange Ratio and the Merger Agreement. The closing of the Concurrent Financing is anticipated to occur on or about the Closing Date, subject to the satisfaction of customary closing conditions.
Avenzo and Rallybio have also agreed to enter into a registration rights agreement (the “Registration Rights Agreement”) with the Investors at the closing of the Concurrent Financing. Pursuant to the Registration Rights Agreement, the combined company will prepare and file a resale registration statement with the SEC within 30 calendar days following the closing of the Concurrent Financing. The combined company will use its reasonable best efforts to cause such registration statement to become effective as promptly as practicable.
The combined company will also agree to, among other things, indemnify the Investors, their members, shareholders, directors, officers, partners, employees, members, managers, agents, representatives and advisors under the registration statement from certain liabilities and pay all fees and expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the combined company’s obligations under the Registration Rights Agreement.
The foregoing descriptions of the Subscription Agreement and Registration Rights Agreement do not purport to be complete and are qualified in their entirety by reference to the Subscription Agreement, and the Registration Rights Agreement the forms of which are filed as Exhibits 10.5 and 10.6, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
| Item 3.02. | Unregistered Sales of Equity Securities. |
To the extent required by this Item, the information included in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
The shares of Avenzo Class A common stock to be issued in the Concurrent Financing will be issued in private placements exempt from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder, because the offer and sale of such securities does not involve a “public offering” as defined in Section 4(a)(2) of the Securities Act, and other applicable requirements were met. Neither this Current Report on Form 8-K nor any of the exhibits attached hereto is an offer to sell or the solicitation of an offer to buy the shares of Avenzo Class A common stock or any other securities of Avenzo or Rallybio.
| Item 5.01. | Changes in Control of Registrant. |
To the extent required by this Item, the information included in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
| Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
To the extent required by this Item, the information included in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
Amendments to Employment Agreements
Each of Stephen Uden and Jonathan Lieber has entered into a previously disclosed employment agreement with Rallybio, pursuant to which they may become eligible for certain payment and benefits in connection with a change of control of Rallybio, and have each subsequently entered into an amendment to such employment agreement (each, an “Employment Agreement Amendment”). In addition, Steven Ryder entered into a previously disclosed separation agreement with Rallybio that provided for certain treatment of Dr. Ryder’s equity awards in connection with a change of control of Rallybio and has entered into an amendment to such agreement (the “Separation Agreement Amendment”). Pursuant to the Employment Agreement Amendments and the Separation Agreement Amendment, the Merger will constitute a change in control.
The foregoing description of the Employment Agreement Amendments and the Separation Agreement Amendment does not purport to be complete and is subject to, and qualified in its entirety by, the complete text of each of the Employment Agreement Amendments and the Separation Agreement Amendment, a copy of which is filed with this Current Report on Form 8-K as Exhibit 10.7, Exhibit 10.8 and Exhibit 10.9, respectively.
| Item 7.01. | Other Events. |
Press Release
On June 1, 2026, Rallybio and Avenzo issued a joint press release announcing the execution of the Merger Agreement. The press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference, except that the information contained on the websites referenced in the press release is not incorporated herein by reference.
Investor Presentation and Conference Call Script
On June 1, 2026, representatives of Rallybio and Avenzo will hold a conference call to investors, which investor presentation and conference call script are furnished as Exhibits 99.2 and 99.3 hereto, respectively, and incorporated herein by reference.
The information contained in this Item 7.01, including 99.1, 99.2 and 99.3, is deemed to have been furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and is not incorporated by reference into any filing under the Securities Act or the Exchange Act.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit |
Exhibit Description | |
| 2.1+ | Agreement and Plan of Merger and Reorganization, dated May 31, 2026, by and among Rallybio Corporation, Farmington Merger Sub, Inc., and Avenzo Therapeutics, Inc. | |
| 10.1 | Form of Rallybio Support Agreement. | |
| 10.2 | Form of Avenzo Support Agreement. | |
| 10.3 | Form of Lock-Up Agreement. | |
| 10.4 | Form of CVR Agreement. | |
| 10.5 | Form of Subscription Agreement. | |
| 10.6 | Form of Registration Rights Agreement. | |
| 10.7 | Amendment to Second Amended and Restated Employment Agreement, effective as of May 31, 2026, between Rallybio Corporation and Stephen Uden. | |
| 10.8 | Amendment to Employment Agreement, effective as of May 31, 2026, between Rallybio Corporation and Jonathan Lieber. | |
| 10.9 | Amendment to Separation Agreement, effective as of May 31, 2026, between Rallybio Corporation and Steven Ryder. | |
| 99.1 | Joint Press Release, issued on June 1, 2026. | |
| 99.2 | Investor Presentation, dated June 1, 2026. | |
| 99.3 | Conference Call Script, dated June 1, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
| + | Registrant has omitted schedules and exhibits pursuant to Item 601(b)(2) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request. |
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the structure and intended tax treatment of the proposed Merger; expectations regarding the ownership structure of the combined company; the expected management team of the combined company; expectations regarding the structure, size, timing and completion of the Concurrent Financing; the potential of Rallybio stockholders to receive consideration pursuant to the CVRs; and other statements that are not historical fact. These forward-looking statements are made as of the date they were first issued, and were based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. There can be no assurance that future developments affecting Rallybio, Avenzo or the Contemplated Transactions will be those that have been anticipated.
Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Rallybio’s and Avenzo’s control. Rallybio’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) the risk that the conditions to the Closing are not satisfied; (ii) uncertainties as to the timing of the consummation of the proposed Merger and the ability of each of Rallybio and Avenzo to consummate the proposed Merger; (iii) risks related to Rallybio’s ability to manage its operating expenses and its expenses associated with the proposed Merger pending Closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or regulatory entity necessary to consummate the proposed Merger; (v) the risk that as a result of adjustments to the Exchange Ratio, Rallybio’s stockholders and Avenzo’s stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Rallybio Common Stock relative to the value suggested by the Exchange Ratio; (vii) unexpected costs, charges or expenses resulting from the proposed Contemplated Transactions; (viii) the risk that the Concurrent Financing is not consummated; (ix) the potential for the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the Merger Agreement and the other agreements entered into in connection therewith; and (x) the possibility that holders of CVRs may never receive any proceeds therefrom. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section titled “Risk Factors” in Rallybio’s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each filed with the SEC, and in other filings that Rallybio makes and will make with the SEC in connection with the proposed merger, including the Proxy Statement (as defined below). You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Rallybio expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Rallybio or Avenzo.
Participants in the Solicitation
This Current Report on Form 8-K relates to the proposed Merger and other Contemplated Transactions involving Rallybio and Avenzo and may be deemed to be solicitation material in respect of the proposed Merger and other Contemplated Transactions. In connection with the proposed Merger and other Contemplated Transactions, Rallybio will file relevant materials with the SEC, including the Form S-4 that will contain a proxy statement (the “Proxy Statement”) and prospectus. This communication is not a substitute for the Form S-4, the Proxy Statement or for any other document that Rallybio may file with the SEC and or send to Rallybio’s stockholders in connection with the proposed Merger. Rallybio, Avenzo, and their respective directors and certain of their executive officers may be considered participants in the solicitation of proxies from Rallybio’s stockholders with respect to the proposed Merger and other Contemplated Transactions under the rules of the SEC. Information about the directors and executive officers of Rallybio is set forth in its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 16, 2026, and in subsequent documents filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will also be included in the Form S-4, the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of this document as described below. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF RALLYBIO ARE URGED TO READ THE FORM S-4, THE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT RALLYBIO, THE PROPOSED MERGER AND OTHER CONTEMPLATED TRANSACTIONS AND RELATED MATTERS.
No Offer or Solicitation
This Current Report on Form 8-K does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transactions herein or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act and otherwise in accordance with applicable law. BEFORE MAKING ANY VOTING DECISION, INVESTORS
AND SECURITY HOLDERS OF RALLYBIO ARE URGED TO READ THE FORM S-4, THE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT RALLYBIO, THE PROPOSED MERGER AND THE CONTEMPLATED TRANSACTIONS AND OTHER RELATED MATTERS.
Additional Information and Where to Find It
Investors and security holders will be able to obtain free copies of the Form S-4, the Proxy Statement and other documents filed by Rallybio with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed by Rallybio with the SEC will also be available free of charge on Rallybio’s website at investors.rallybio.com, or by contacting Rallybio’s Investor Relations at investors@rallybio.com.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| RALLYBIO CORPORATION | ||||||
| Date: June 1, 2026 | By: | /s/ Jonathan I. Lieber | ||||
| Name: | Jonathan I. Lieber | |||||
| Title: | Chief Financial Officer and Treasurer | |||||
Exhibit 99.1
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Rallybio Corporation and Avenzo Therapeutics Announce Merger Agreement to Advance Next-Generation Oncology Therapies and $215 Million Concurrent Private Placement
Combined company to operate as Avenzo Therapeutics, advancing a leading portfolio of next-generation oncology therapies, including small molecules and antibody-drug conjugates
Concurrent oversubscribed private placement financing of $215 million with participation from leading syndicate of healthcare institutional investors and mutual funds
Private placement financing expected to fund operations into late 2028, and support advancement through multiple clinical milestones
Companies to hold joint conference call on Monday, June 1, 2026 at 8:30 a.m. ET
NEW HAVEN, Conn. & SAN DIEGO, Calif. – June 1, 2026 – Rallybio Corporation (Nasdaq: RLYB) (“Rallybio”) and Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology therapies, today announced that they have entered into a definitive agreement pursuant to which Rallybio will acquire Avenzo through a merger transaction (the “Merger”). Upon completion of the Merger, the combined company is expected to operate under the name Avenzo Therapeutics, Inc. and is expected to trade on Nasdaq under the ticker symbol “AVZO”.
In connection with the Merger, Avenzo entered into subscription agreements for a concurrent oversubscribed private placement financing of $215 million in gross proceeds (the “Financing” and, together with the Merger, the “Transaction”). The Financing included participation from new investors including a leading mutual fund, Blackstone Multi-Asset Investing, accounts advised by T. Rowe Price Investment Management, Inc., a leading life sciences fund, Vivo Capital, Affinity Asset Advisors, ADAR1 Capital Management, and existing investors including OrbiMed, SR One, Foresite Capital, Surveyor Capital (a Citadel company), Longwood Fund, New Enterprise Associates, Deep Track Capital, Sands Capital, Lilly Asia Ventures, Sofinnova Investments, and other institutional investors. The combined company expects its cash balance at closing to fund operations into late 2028 and support advancement of its four clinical-stage programs through multiple clinical milestones, including updated Phase 1 data across the pipeline, initial clinical data for the combination of AVZO-023 and AVZO-021 with fulvestrant, and the initiation of multiple Phase 2 studies across the pipeline.
The Transaction has been unanimously approved by the boards of directors of both companies and is expected to close in Q4 2026, subject to certain closing conditions, including the approval by the stockholders of each company, the effectiveness of a registration statement to be filed with the Securities and Exchange Commission (the “SEC”) to register the shares of Rallybio common stock to be issued in connection with the Transaction, and the satisfaction of other customary closing conditions. Rallybio intends to distribute substantially all of its pre-closing net cash to its pre-closing stockholders in connection with the Transaction. Accordingly, following closing, pre-Transaction Rallybio equityholders are expected to own approximately 2.8% of the combined company, and pre-Transaction Avenzo equityholders (inclusive of investors participating in the Financing) are expected to own approximately 97.2% of the combined company, calculated on a treasury stock method basis and assuming Rallybio has no net cash at closing (as a result of the distribution of its pre-closing net cash). In addition, pre-closing Rallybio stockholders will receive contingent value rights (“CVRs”) entitling them to the net cash proceeds received by the combined company from the previously announced sale of interests in Rallybio’s former REV102 program and potential disposition of Rallybio’s other legacy assets.
Transaction Highlights
| • | Pipeline of Four Next-Generation Clinical Stage Oncology Programs: Avenzo has built a portfolio of potentially differentiated targeted small molecules and antibody-drug conjugates (“ADCs”) for various solid tumor indications with significant commercial potential. Avenzo is currently conducting four ongoing U.S.-based studies evaluating its four clinical stage drug candidates: |
| • | Selective CDK portfolio: AVZO-021 and AVZO-023 are selective inhibitors of CDK2 and CDK4, respectively, designed to address the key limitations of approved CDK4/6 inhibitors in hormone receptor-positive (“HR+”)/human epidermal growth factor receptor 2-negative (“HER2-”) breast cancer. AVZO-021 has been studied in 64 total patients as monotherapy and in combination with fulvestrant in a Phase 1 study, demonstrating clinical activity in heavily pretreated patients with HR+/HER2- breast cancer and a generally well tolerated safety profile. Avenzo plans to present updated safety and efficacy results from the Phase 1 portion of the Phase 1/2 study later today at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. AVZO-021 and AVZO-023 are being studied in the Phase 1 portion of the ongoing ORION-1 Phase 1/2 study in HR+/HER2- breast cancer, where AVZO-023 is administered in combination with endocrine therapy, with or without AVZO-021. Avenzo plans to present preliminary, updated data of AVZO-023 in combination with fulvestrant from the Phase 1 portion of the ORION-1 study in late 2026. |
| • | Bispecific ADC portfolio: AVZO-1418, a bispecific ADC targeting EGFR and HER3, has been studied in over 30 patients across multiple solid tumors in the Phase 1 portion of the ongoing AVENTINE-1 Phase 1/2 study, with clinical activity observed across multiple dose levels and solid tumor indications. AVZO-103, a bispecific ADC targeting Nectin4 and TROP2, is currently being evaluated as monotherapy in multiple tumor types, including urothelial cancer, in the Phase 1 portion of the ongoing BEACON-1 Phase 1/2 study. Avenzo plans to present preliminary, updated data from the Phase 1 portion of the AVENTINE-1 study and initial data from the Phase 1 portion of the BEACON-1 study in late 2026. |
| • | Experienced leadership team: The combined company will be led by Dr. Athena Countouriotis, Chair, President and Chief Executive Officer (“CEO”) of Avenzo, with Dr. Mohammad Hirmand, Co-founder and Chief Medical Officer of Avenzo, and an experienced management team that brings deep expertise in oncology drug development. |
| • | Strong capital foundation: Pro-forma cash at closing is expected to fund the combined company through multiple anticipated clinical milestones in 2027 and 2028. |
“This transaction represents a turning point for Avenzo as we transition to a public company and advance our four potentially differentiated, clinical stage programs for patients with cancer,” said Athena Countouriotis, M.D., Chair, President, and CEO of Avenzo. “By combining with Rallybio and securing $215 million in additional capital from a distinguished group of healthcare investors, we believe that we have the resources to advance our pipeline beyond multiple potential data read outs.”
“We are pleased to announce this transaction with Avenzo, which represents a compelling opportunity for Rallybio stockholders to participate in the development of a portfolio of potentially differentiated oncology therapies,” said Stephen Uden, M.D., Co-Founder and CEO of Rallybio. “Rallybio’s Board of Directors and management team are supportive of this transaction and believe the combined company is well positioned to execute on the development of its pipeline under Avenzo’s leadership.”
About the Proposed Transaction
Under the terms of the merger agreement, Rallybio will acquire Avenzo pursuant to the Merger. At the closing of the Merger, Avenzo stockholders will receive newly issued shares of Rallybio common stock, with the exchange ratio to be determined based on the relative valuations of the two companies at closing. Immediately following the closing of the Merger, the combined company will change its name to Avenzo Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “AVZO”.
In connection with the Transaction, a syndicate of leading healthcare institutional investors and mutual funds has committed to invest $215 million in the Financing. The Financing is expected to close immediately prior to the Merger. In connection with the Transaction, certain stockholders of Avenzo and Rallybio have executed support agreements, pursuant to which they have agreed to vote all their shares of capital stock in favor of the Transaction.
Leerink Partners is serving as exclusive financial advisor, and Cooley LLP is serving as legal counsel to Avenzo. Evercore is serving as lead financial advisor, Citizens Capital Markets & Advisory is serving as co-financial advisor, and Ropes & Gray LLP is serving as legal counsel to Rallybio. Leerink Partners, Goldman Sachs & Co. LLC, Piper Sandler, and Guggenheim Securities are serving as placement agents for the Financing. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is serving as legal counsel to the placement agents.
Conference Call Information
Rallybio and Avenzo will host a joint conference call and webcast on June 1, 2026 at 8:30 a.m. ET. Please access the presentation by clicking on the following link: https://edge.media-server.com/mmc/p/5g9r8mq9
About Avenzo Therapeutics
Avenzo Therapeutics is a clinical-stage biotechnology company focused on developing next-generation oncology therapies for patients. Avenzo’s pipeline includes potentially differentiated small molecules and antibody-drug conjugates (“ADCs”). Avenzo’s small molecule inhibitors, AVZO-021 and AVZO-023, are novel, highly potent and selective inhibitors of CDK2 and CDK4, respectively, which are key enzymes involved in cell cycle regulation. AVZO-021 is being studied in a Phase 1/2 study for the treatment of advanced solid tumors and in combinations in HR+/HER2- metastatic breast cancer. AVZO-021 and AVZO-023 are being studied in the ORION-1 Phase 1/2 study for the treatment of HR+/HER2- metastatic breast cancer, where AVZO-023 is administered in combination with endocrine therapy, with or without AVZO-021. Avenzo’s first ADC drug candidate, AVZO-1418, is a potentially differentiated EGFR/HER3 bispecific ADC that is being studied in the AVENTINE-1 Phase 1/2 study for the treatment of advanced solid tumors. Avenzo’s second ADC drug candidate, AVZO-103, is a potentially differentiated Nectin4/TROP2 bispecific ADC that is being studied in the BEACON-1 Phase 1/2 study for the treatment of advanced solid tumors. Avenzo is headquartered in San Diego, California. For more information, visit us at www.avenzotx.com or on LinkedIn.
References and links to websites in this press release have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. The companies are not responsible for the contents of third-party websites.
About Rallybio
Rallybio (NASDAQ: RLYB) is a clinical-stage biotechnology company with a mission to develop and commercialize life-transforming therapies for patients with severe and rare diseases. Rallybio has built a pipeline of promising product candidates aimed at addressing diseases with unmet medical need in areas of complement dysregulation and hematology. Rallybio’s lead program, RLYB116, is a differentiated C5 inhibitor with
the potential to treat diseases of complement dysregulation, with an initial focus on immune platelet transfusion refractoriness and refractory antiphospholipid syndrome. Rallybio’s pipeline also includes RLYB332, a preclinical long-acting anti-matriptase-2 antibody for the treatment of diseases associated with iron overload. Rallybio is headquartered in New Haven, Connecticut. For more information, please visit www.Rallybio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the structure, timing and completion of the proposed Merger; the combined company’s listing on Nasdaq after closing of the proposed Merger; expectations regarding the ownership structure of the combined company; the expected management team of the combined company; expectations regarding the structure, timing and completion of the Financing, including investment amounts from investors, expected proceeds and use thereof, and impact on ownership structure; the combined company’s expected cash position at closing of the proposed Merger and the combined company’s cash runway following the proposed the Transaction, including its ability advance through multiple clinical milestones; the future operations and potential success of the combined company; the nature, strategy and focus of the combined company; the development and commercial potential and potential benefits of any product candidates of the combined company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for commencing clinical trials and announcing data and other clinical results; the potential of Rallybio stockholders to receive cash distributions and consideration pursuant to the CVRs; and other statements that are not historical fact. These forward-looking statements are made as of the date they were first issued, and were based on the then-current expectations, estimates, forecasts, and projections, as well as the beliefs and assumptions of management. There can be no assurance that future developments affecting Rallybio, Avenzo or the proposed Transaction herein will be those that have been anticipated.
Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Rallybio’s and Avenzo’s control. Rallybio’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) the risk that the conditions to closing of the proposed Merger are not satisfied, including the failure to timely obtain stockholder approval for the merger agreement and the transactions contemplated thereby, if at all; (ii) uncertainties as to the timing of the consummation of the proposed Merger and the ability of each of Rallybio and Avenzo to consummate the proposed Merger; (iii) risks related to Rallybio’s ability to manage its operating expenses and its expenses associated with the proposed Merger pending closing; (iv) risks related to the failure or delay in obtaining required approvals from any governmental or regulatory entity necessary to consummate the proposed Merger; (v) the risk that as a result of adjustments to the exchange ratio, Rallybio’s stockholders
and Avenzo’s stockholders could own more or less of the combined company than is currently anticipated; (vi) risks related to the market price of Rallybio’s common stock relative to the value suggested by the exchange ratio; (vii) unexpected costs, charges or expenses resulting from the proposed Transaction; (viii) potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed Merger; (ix) the uncertainties associated with Avenzo’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (x) risks related to the inability of the combined company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (xi) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (xii) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (xiii) risks associated with the possible failure to realize certain anticipated benefits of the proposed Merger, including with respect to future financial and operating results; (xiv) the risk that the Financing is not consummated; (xv) the potential for the occurrence of any event, change or other circumstance or condition that could give rise to the termination of the merger agreement and any agreements entered into in connection therewith; and (xvi) the possibility that holders of CVRs may never receive any proceeds therefrom. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section titled “Risk Factors” in Rallybio’s Annual Report on Form 10-K for the year ended December 31, 2025 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, each filed with the SEC, and in other filings that Rallybio makes and will make with the SEC in connection with the proposed merger, including the Proxy Statement described below under “Additional Information and Where to Find It.” You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Rallybio expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. This communication does not purport to summarize all of the conditions, risks and other attributes of an investment in Rallybio or Avenzo.
Participants in the Solicitation
This communication relates to the proposed Transaction involving Rallybio and Avenzo and may be deemed to be solicitation material in respect of the proposed Transaction. In connection with the proposed Transaction, Rallybio will file relevant materials with the SEC, including a registration statement on Form S-4 (the “Form S-4”) that will contain a proxy statement (the “Proxy Statement”) and prospectus. This communication is not a substitute for the Form S-4, the Proxy Statement or for any other document that Rallybio
may file with the SEC and or send to Rallybio’s stockholders in connection with the proposed Merger. Rallybio, Avenzo, and their respective directors and certain of their executive officers may be considered participants in the solicitation of proxies from Rallybio’s stockholders with respect to the proposed Merger under the rules of the SEC. Information about the directors and executive officers of Rallybio is set forth in Rallybio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, which was filed with the SEC on March 16, 2026, and in subsequent documents filed with the SEC. Additional information regarding the persons who may be deemed participants in the proxy solicitations and a description of their direct and indirect interests, by security holdings or otherwise, will also be included in the Form S-4, the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of this document as described below. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND SECURITY HOLDERS OF RALLYBIO ARE URGED TO READ THE FORM S-4, THE PROXY STATEMENT AND OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT RALLYBIO, THE PROPOSED MERGER AND RELATED MATTERS.
No Offer or Solicitation
This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities nor a solicitation of any vote or approval with respect to the proposed transactions herein or otherwise. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended, and otherwise in accordance with applicable law.
Additional Information and Where to Find It
Investors and security holders will be able to obtain free copies of the Form S-4, the Proxy Statement and other documents filed by Rallybio with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed by Rallybio with the SEC will also be available free of charge on Rallybio’s website at investors.rallybio.com, or by contacting Rallybio’s Investor Relations at investors@rallybio.com.
Avenzo Therapeutics Contact:
Carla Taub
Media Relations
ctaub@avenzotx.com
Rallybio Investor and Media Relations:
Samantha Tracy
Rallybio Corporation
(475) 47-RALLY (Ext. 282)
investors@rallybio.com
Exhibit 99.2 Avenzo Therapeutics Transaction and Company Overview June 1, 2026 1
Disclaimer This presentation and the accompanying slides and oral commentary (this “Presentation”), which have been prepared by Avenzo Therapeutics, Inc. (the “Company” or “Avenzo”), are being delivered and/or presented to a limited number of parties for discussion purposes only, and shall not form the basis for or be relied on in connection with any contract or binding commitment whatsoever. Each recipient agrees (i) to maintain the strict confidentiality of all information that is contained in this Presentation and not already in the public domain and not to photocopy, reproduce or distribute such information in whole or in part to any other persons at any time without the prior written consent of the Company, and (ii) to use this Presentation for information purposes only and not as the basis for any investment decision with respect to the Company. This Presentation has been prepared by the Company based on information and data which the Company considers reliable, but no reliance shall be placed on, and no representation or warranty, express or implied, whatsoever is or will be given by the Company or any of its affiliates, directors, officers, employees or advisers or any other person as to the truth, accuracy, completeness, fairness and reasonableness of the contents of this Presentation. This Presentation may not be all inclusive and does not purport to contain all of the information that may be required to evaluate a possible investment decision with respect to the Company. The recipient agrees and acknowledges that (i) this Presentation is not intended to form the basis of any investment decision by the recipient and does not constitute investment, tax or legal advice, and (ii) the information contained in this Presentation is subject to change, and any such changes may be material. Any liability in respect of the contents of or any omission from this Presentation is expressly excluded. This Presentation contains forward-looking statements. Such statements include, but are not limited to, statements regarding our research, preclinical and clinical development activities, plans and projected timelines for our product candidates, plans regarding regulatory filings, our expectations regarding the relative benefits of our product candidates versus competitive therapies, our expectations regarding the therapeutic and commercial potential of our product candidates, our expectations regarding the completion of the proposed financing and anticipated use of proceeds from the proposed financing. The words “believe,” “may,” “should,” “will,” “estimate,” “promise,” “plan,” “continue,” “anticipate,” “intend,” “expect,” “potential” and similar expressions (including the negative thereof) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: our preclinical studies and clinical trials may not be successful; the U.S. Food and Drug Administration may not agree with our interpretation of the data from clinical trials of our product candidates; we may experience delays in the commencement, enrollment, completion or analysis of clinical testing for our product candidates, or in the reporting of data from such clinical testing; significant issues regarding the adequacy of our clinical trial designs or the execution of our clinical trials may arise, which could result in increased costs and delays, or limit our ability to obtain regulatory approval; our product candidates may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of our product candidates could delay or prevent regulatory approval or commercialization; and we may not be able to obtain additional financing. Additional risks and uncertainties may emerge from time to time, and it is not possible for Avenzo's management to predict all risks and uncertainties. All forward-looking statements contained in this Presentation speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. This Presentation may contain trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this Presentation may be listed without the TM, SM or © or ® symbols, but the Company will assert, to the fullest extent under applicable law, the rights of the owners to these trademarks, service marks, trade names and copyrights. Any securities of the Company to be offered in any transaction contemplated hereby have not been and will not be registered under the Securities Act of 1933, as amended (the “Securities Act”), or any applicable state or foreign securities laws. Any securities to be offered in any transaction contemplated hereby have not been approved or disapproved by the Securities and Exchange Commission, any state securities commission or other United States or foreign regulatory authority, and will be offered and sold solely in reliance on the exemption from the registration requirements provided by Section 4(a)(2) of the Securities Act and rules and regulations promulgated thereunder (including Regulation D) or Regulation S under the Securities Act. This Presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities, in any state or other jurisdiction to any person to whom it is unlawful, prior to registration or qualification under the securities laws of any such jurisdiction or an exemption therefrom, to make such offer or solicitation in such state or jurisdiction. No commitments to invest in the Company will be accepted, and no money is being solicited or will be accepted at this time. This Presentation is being distributed solely for the consideration of sophisticated prospective purchasers who are institutional accredited investors with sufficient knowledge and experience in investment, financial and business matters and the capability to conduct their own due diligence investigation and evaluation in connection with a potential transaction. This Presentation does not purport to summarize all of the conditions, risks and other attributes of an investment in the Company. Information contained herein will be superseded by, and is qualified in its entirety by reference to, any other information that is made available to you in connection with your investigation of the Company. Each prospective purchaser is invited to meet with a representative of the Company and to discuss with, ask questions of, and receive answers from, such representative concerning the Company and the terms and conditions of any potential transaction. The Company is free to conduct the process for any transaction as they in their sole discretion determine (including, without limitation, negotiating with any prospective investors and entering into an agreement with respect to any transaction without prior notice to you or any other person), and any procedures relating to such transaction may be changed at any time without notice to you or any other person. Any indication of interest from prospective purchasers in response to this Presentation involves no obligation or commitment of any kind. This Presentation should not be distributed to any person other than the addressee to whom it was initially distributed. 2
Transaction Highlights • Rallybio to acquire 100% of Avenzo equity interests in reverse-triangular merger with Avenzo surviving the merger as a wholly owned subsidiary of Rallybio TRANSACTION • Rallybio will distribute all legacy net cash STRUCTURE • Post-closing, Rallybio Corporation will be renamed Avenzo Therapeutics, Inc. and trade on Nasdaq under the ticker symbol “AVZO” • In connection with the merger, Avenzo entered into subscription agreements for a concurrent oversubscribed private financing of $215 million in gross proceeds • The financing included participation from new investors including a leading mutual fund, Blackstone Multi-Asset FINANCING Investing, accounts advised by T. Rowe Price Investment Management, Inc., a leading life sciences fund, Vivo Capital, Affinity Asset Advisors, ADAR1 Capital Management, and existing investors including OrbiMed, SR One, Foresite Capital, Surveyor Capital (a Citadel company), Longwood Fund, New Enterprise Associates, Deep Track Capital, Sands Capital, Lilly Asia Ventures, Sofinnova Investments, and other institutional investors • Support advancement of Avenzo’s four clinical-stage programs through multiple clinical milestones, including updated USE OF Phase 1 data across the pipeline, initial clinical data for the combination of AVZO-023 and AVZO-021 with fulvestrant, PROCEEDS and the initiation of multiple Phase 2 studies across the pipeline MANAGEMENT • Avenzo management team, led by co-founders Dr. Athena Countouriotis and Dr. Mohammad Hirmand, will lead the TEAM combined company post closing of transaction 3
Pro Forma Capitalization Table SHARES OWNERSHIP IN PRO OUTSTANDING / IMPLIED VALUATION FORMA COMPANY ISSUED (1) Rallybio 5.8 $15.0 2.83% Avenzo 115.0 300.0 97.17% Concurrent Financing 82.4 215.0 Total 203.2 $530.0 1 Assumes Rallybio will distribute all legacy net cash. Note: All figures in millions. Calculations above are based on Rallybio’s and Avenzo’s outstanding shares as of May 28, 2026, in each case, calculated on a fully-diluted basis, using the treasury stock method, and are subject to change based on the final number of shares of Rallybio and Avenzo outstanding immediately prior to the closing, calculated on a fully-diluted basis, using the treasury stock method. 4 Source: Rallybio and Avenzo Management.
Company Overview 4 Clinical Stage, Potentially Differentiated Oncology Programs in Blockbuster Opportunities ✓ Phase 1 monotherapy and fulvestrant combination complete, with differentiated profile AVZO-021 ✓ Updated Phase 1 data to be presented at ASCO 2026 CDK2 Inhibitor ✓ Enrolling in combination with AVZO-023 (CDK4i) + fulvestrant in ORION-1 study ✓ ORION-1 Phase 1 fulvestrant combination enrolling AVZO-023 CDK4 Inhibitor ✓ Preliminary, updated Phase 1 fulvestrant combination data anticipated late 2026 ✓ Rapid progress in AVENTINE-1 Phase 1 monotherapy, with >30 patients enrolled across 5 dose cohorts ✓ Responses across multiple doses and different tumor types with strong signal in NSCLC AVZO-1418 EGFR/HER3 ADC ✓ FTD granted in EGFRm TKI-pretreated NSCLC ✓ Preliminary, updated Phase 1 data anticipated in 2H 2026 ✓ BEACON-1 Phase 1 monotherapy ongoing AVZO-103 ✓ FTD granted in post-enfortumab vedotin urothelial cancer NECTIN4/TROP2 ADC ✓ Initial Phase 1 data anticipated in 2H 2026 ✓ Team with deep expertise in oncology development ✓ Cash and cash equivalents of $160 million as of 31-Mar-2026 CORPORATE ✓ Expected proceeds to be primarily used to advance Avenzo’s pipeline through various anticipated milestones ADC: antibody drug conjugate; CDK: cyclin-dependent kinase; EGFRm: EGFR mutant; FTD: Fast Track designation; NSCLC: non-small cell lung cancer; TKI: tyrosine kinase 5 inhibitor
Blockbuster Commercial Opportunities Across the Pipeline AVZO-023 + AVZO-021 AVZO-1418 AVZO-103 CDK4i + CDK2i EGFR/HER3 ADC Nectin4/TROP2 ADC Market Size¹ Market Size² Market Size³ ~$15B ~$16B ~$5B Urothelial Cancer HR+/HER2- NSCLCwt (no AGA) & Breast Cancer EGFRm NSCLC ¹ Based on reported 2025 revenues of FDA approved CDK4/6 inhibitors abemaciclib, palbociclib and ribociclib. ² Based on 2025 estimated revenue of pembrolizumab (anti-PD-1 mAb) per Wall Street research estimates (NSCLCwt (no AGA)), and reported 2025 revenue of osimertinib (EGFRm NSCLC). ³ Based on projected enfortumab vedotin revenue including frontline (1L) urothelial cancer, per Wall Street research estimates. ADC: antibody drug conjugate; AGA: actionable genomic alteration; EGFRm NSCLC: EGFR mutant non-small cell lung cancer; NSCLCwt (no AGA): non-small cell lung cancer 6 without known alteration/mutation
Avenzo Pipeline of Potentially Differentiated Programs Four U.S.-Based Phase 1 Studies Ongoing Across Pipeline PROGRAM/STUDY INDICATION PHASE 1 PHASE 2 AVZO-021 (CDK2i) Monotherapy ± Fulvestrant HR+/HER2- Breast Cancer AVZO-023 (CDK4i): ORION-1 + Fulvestrant HR+/HER2- Breast Cancer + AVZO-021 + Fulvestrant HR+/HER2- Breast Cancer Initiated Q2 2026 AVZO-1418 (EGFR/HER3 ADC): AVENTINE-1 Monotherapy Solid Tumors AVZO-103 (NECTIN4/TROP2 ADC): BEACON-1 Monotherapy Solid Tumors Note: Avenzo in-licensed worldwide rights, excluding Greater China for each program. AVZO-021 and AVZO-023 partnered with Allorion; AVZO-1418 partnered with DualityBio; AVZO-103 partnered with VelaVigo. 7 ADC: antibody drug conjugate; CDK: cyclin-dependent kinase
KEY HIGHLIGHTS • Potentially differentiated with well tolerated safety profile and mPFS of 5.3 months as monotherapy in HR+/HER2- breast cancer • Phase 1 monotherapy and fulvestrant combination complete • Phase 1 study in combination with selective AVZO-023 (CDK4i) + fulvestrant ongoing AVZO-021 Selective CDK2 Inhibitor ANTICIPATED MILESTONES HR+/HER2- Breast Cancer • ASCO 2026: Updated Phase 1 monotherapy and fulvestrant combination data • 2H 2027: Initial Phase 1 data in combination with AVZO-023 (CDK4i) and fulvestrant 8
Evolving HR+/HER2- Breast Cancer Treatment Paradigm HR+/HER2- BC TREATMENT PARADIGM • Pfizer and BeOne focused on displacing CDK4/6i + ET with selective CDK4i; no planned 2L registrational studies CDK4/6i + ET ‒ Limited CDK2i combination potential due to inadequate selectivity BIOMARKER-NEGATIVE BIOMARKER-POSITIVE AVZO-023 + ET ± AVZO-021 • Fragmented with no biomarker-agnostic therapy CDK4i + ET ± CDK2i • Pfizer's atirmociclib Phase 2 data validates selective CDK4i in SERD (ESR1m) 2L; statistically significant PFS improvement (HR 0.60)¹ CDK4/6i + ET AKTi + ET • Atirmociclib and abemaciclib (EMBER-3) confirm CDK4 (PIK3CA/AKT/PTEN) inhibition effective in 2L regardless of biomarker status PI3Ki + ET (PIK3CA) • Avenzo plans to move quickly toward 2L registrational strategy EVEROLIMUS + ET initially given opportunity and currently limited in-class PARPi (BRCA1/2) competition Note: No head-to-head trials have been conducted among the results shown. As a result, cross-trial comparisons cannot be made. ¹ Based on FOURLIGHT-1; a randomized Phase 2 study of atirmociclib + fulvestrant vs fulvestrant or everolimus + exemestane in patients with HR+/HER2- breast cancer whose disease progressed after CDK4/6i-based treatment. ESR: estrogen receptor; ET: endocrine therapy; PARP: poly ADP-ribose polymerase; PI3K: phosphoinositide 3-kinase; PIK3CA: phosphatidylinositol 3-kinase catalytic subunit 9 alpha; PFS: progression free survival; SERD: selective estrogen receptor degrader 2L 1L
AVZO-021 CDK2i Key Areas of Differentiation AVZO-021¹ TEGTOCICLIB BG-68501 INCB123667 Avenzo Pfizer BeOne Incyte Development Stage Phase 1 Phase 1 Deprioritized Phase 3 Phase 1 15% ORR (n=26) 19% ORR (n=16) 3% ORR (n=33) 11% ORR (n=76) 4 6 Efficacy Data 5.3 months PFS 3.5 months PFS² PFS not disclosed PFS not disclosed Dosing QD (14 hour t ) BID (2-3 hour t ) BID BID 1/2 1/2 û CDK1 and CDK9 üûü ~60% nausea and ~60% Selectivity ~50% nausea, ~30% vomiting ~80% nausea, ~50% vomiting ~40% nausea and ~30% vomiting (required scheduled 7 Drivers of GI Toxicity and ~20% diarrhea and ~50% diarrhea² vomiting 4 anti-emetics) CDK6 Selectivity üû Driver of üü 7 Low rates of heme toxicity Dose limiting heme toxicity Hematologic Toxicity Not disclosed Tolerability in Not expected to be well Not disclosed üû tolerated, given high rates of GI Combination with Not focused in breast cancer Ongoing Not well tolerated³ toxicity for BG-68501 and Portfolio CDK4i 5 BGB-43395 Potentially Differentiated CDK4i in Portfolio Not Well Tolerated No CDK4i in Portfolio CDK4i in Portfolio in Combination with CDK2i Note: Information provided in the tables above is for illustrative purposes only and no head-to-head clinical trials have been conducted evaluating these product candidates. Differences exist between study or trial designs and participant characteristics, and caution should be exercised when comparing data across trials. ¹ Patel M et al: ASCO 2026. ORR includes 1 unconfirmed partial response (uPR) on treatment as of data cut-off awaiting confirmatory scan. ² Yap T et al: ASCO 2023. 1 of 3 responders at 500 mg BID, which is higher than MTD of 300 mg BID. Safety includes all grade TEAEs. ³ Yap T et al: ESMO 2024. ⁴ Joshi R et al: ASCO 2025. Excludes uPR who did not confirm. Safety includes all grade TEAEs. BeOne 2025 Investor R&D Day, Jun-2025. ⁵ Yap T et al: SABCS 6 7 2024. Simonelli M et al: ESMO 2024. All grade TEAEs per Lorusso D et al: ESMO 2025. BID selected as RP2D as QD doses associated with increased incidence of GI toxicity. 10 BID: twice daily; GI: gastrointestinal; ORR: overall response rate; PFS: progression free survival; QD: once daily; RP2D: recommended Phase 2 dose; TEAE: treatment emergent adverse event
AVZO-021 Phase 1 Study Design Phase 1 Completed | Data to be Presented at ASCO 2026¹ Part 1a: Monotherapy Dose Escalation / Backfill (N=51²) DESIGN As of 30-Mar-2026 data cut-off, 250 mg QD • Single patient safety population (N=64): N=1 accelerated 220 mg QD • Part 1a monotherapy: N=51 patients titration (20, 40, N=3 with advanced solid tumors 60 mg QD) 180 mg QD followed by BOIN N=7 • Part 1b fulvestrant combination: N=13 patients with HR+/HER2- mBC 150 mg QD • QD administration N=9 • Median (range) follow-up time of 5.9 in 28-day cycles 120 mg QD months (0.03+, 16.49+) N=3 90 mg QD As of 07-May-2026 updated data cut-off, N=4 OBJECTIVES efficacy-evaluable population (N=39): • Evaluate Part 1b: Combination in HR+/HER2- mBC • Patients treated at ≥150 mg QD safety/tolerability (N=13) AVZO-021 (± fulvestrant) with HR+/HER2- and 200 mg QD AVZO-021 + mBC or CCNE1-amplified solid tumors, determine fulvestrant (N=7) with at least 1 evaluable post-baseline scan RP2D/MTD 150 mg QD AVZO-021 + fulvestrant (N=6) ¹ Patel M et al: ASCO 2026. ² Includes accelerated titration 20, 40 and 60 mg QD (n=4) and additional backfill patients treated at 100 mg QD (n=10) and 200 mg QD (n=10). 11 BC: breast cancer; BOIN: Bayesian Optimal Interval; MTD: maximum tolerated dose; QD: once daily; RP2D: recommended Phase 2 dose
AVZO-021 Treatment Emergent Adverse Events (N=64) TEAEs OCCURRING IN ≥10% OF PATIENTS BY GRADE Generally well tolerated MONOTHERAPY AND FULVESTRANT COMBINATION (N=64) a GRADE 1 GRADE 2 GRADE 3 GRADE 4 ALL GRADE Most TEAEs were Grade 1 or 2 N (%) N (%) N (%) N (%) N (%) Any TEAE, n (%) 6 (9) 28 (44) 20 (31) 6 (9) 60 (94) Two patients had TEAEs leading to a treatment discontinuation Nausea 23 (36) 9 (14) 1 (2) 0 33 (52) Fatigue 21 (33) 10 (16) 0 0 31 (48) Most commonly reported TEAEs of Anemia 4 (6) 9 (14) 12 (19) 0 25 (39) nausea, fatigue, anemia and vomiting Vomiting 15 (23) 5 (8) 2 (3) 0 22 (34) • Anemia present at baseline in 10 of Diarrhea 10 (16) 2 (3) 1 (2) 0 13 (20) 12 patients with on-treatment Alopecia 12 (19) 0 0 0 12 (19) Grade 3 anemia Neutrophil count decreased 2 (3) 4 (6) 3 (5) 2 (3) 11 (17) Edema peripheral 8 (13) 1 (2) 1 (2) 0 10 (16) 14 patients with TEAEs leading Platelet count decreased 6 (9) 1 (2) 2 (3) 1 (2) 10 (16) to dose reduction Arthralgia 7 (11) 2 (3) 0 0 9 (14) Constipation 7 (11) 2 (3) 0 0 9 (14) Dose-limiting toxicities: Cough 7 (11) 2 (3) 0 0 9 (14) • Monotherapy: 1 DLT at 250 mg QD of Hypokalemia 2 (3) 5 (8) 2 (3) 0 9 (14) Grade 3 syncope Dizziness 7 (11) 1 (2) 0 0 8 (13) • Fulvestrant combination: 1 DLT at 200 Gastroesophageal reflux disease 3 (5) 4 (6) 0 0 7 (11) mg QD of Grade 4 thrombocytopenia Headache 7 (11) 0 0 0 7 (11) a Note: Data cut-off date 30-Mar-2026. TEAEs by preferred term and maximum grade. No patient reported a Grade 5 TEAE. Additional Grade 4 events: 1 patient at 120 mg QD with hypovolemic shock (not related), 1 patient at 200 mg QD with cholestatic jaundice (not related, leading to treatment discontinuation) and 1 patient at 200 mg QD with neutropenia (related, leading to treatment discontinuation). 12 DLT: dose-limiting toxicity; QD: once daily; TEAE: treatment emergent adverse event
Encouraging Signs of Efficacy in Heavily Pretreated HR+/HER2- mBC • 5.3-month median PFS (95% CI: 1.9, 7.2) across all monotherapy doses in HR+/HER2- mBC patients (n=33) • 85% disease control rate (95% CI: 62.1, 96.8) in HR+/HER2- mBC efficacy evaluable patients treated with ≥150 mg QD monotherapy (n=20) AVZO-021 Monotherapy ≥ 150 mg QD (N=26) AVZO-021 + Fulvestrant (N=13) AVZO-021 Monotherapy ≥ 150 mg QD (N=26) # Treatment ongoing Note: Data cut-off date 07-May-2026, with median follow-up time of 8.4 months (range 0.03 to 16.6+). BC: HR+/HER2- breast cancer; FT: CCNE1-amplified fallopian tube cancer; OC: CCNE1-amplified ovarian cancer; PR: partial response; QD: once daily; TNBC: CCNE1-amplified 13 13 triple negative breast cancer; UC: CCNE1-amplified uterine cancer; uPR: unconfirmed partial response
Duration of Treatment (N=43) • All responders remain on treatment, with 3 patients for ≥48 weeks • Among 34 HR+/HER2- breast cancer patients treated at ≥150 mg QD: − 20 patients were on treatment for ≥24 weeks − 9 patients remain on treatment • Among 7 CCNE1-amplified solid tumor patients treated at ≥150 mg QD: − 3 patients on treatment for ≥24 weeks − 1 patient remains on treatment Note: Data cut-off date 07-May-2026. N=21 patients treated with <150 mg QD monotherapy not shown. * Efficacy evaluable. ACC: adrenal cortical carcinoma; BC: HR+/HER2- breast cancer; EN: endometrial cancer; FT: CCNE1-amplified fallopian tube cancer; OC: CCNE1-amplified ovarian cancer; QD: 14 once daily; TNBC: CCNE1-amplified triple negative breast cancer; UC: CCNE1-amplified uterine cancer
KEY HIGHLIGHTS • Potentially differentiated with high selectivity against CDK6 • Ongoing Phase 1 study (ORION-1) in combination with fulvestrant ± AVZO-021 (CDK2i) AVZO-023 Selective CDK4 Inhibitor ANTICIPATED MILESTONES HR+/HER2- Breast Cancer • Late 2026: Preliminary, updated Phase 1 fulvestrant combination data • 2H 2027: Initial Phase 1 data in combination with AVZO-021 (CDK2i) and fulvestrant 15
AVZO-023 CDK4i Key Areas of Differentiation AVZO-023 ATIRMOCICLIB BGB-43395 GDC-4198 Avenzo Pfizer BeOne Roche Development Stage Phase 1 Phase 3 Phase 3 Phase 1b 4 Phase 1 Efficacy Data 0% ORR (n=4) 3 in mBC Ongoing 24% ORR (n=33)¹ 11% ORR (n=19) Monotherapy ORR of 15% (n=27) ET Combination(s) CDK6 Selectivity üûûû Driver of Hematologic 4 Low rates of heme toxicity ~55% neutropenia (~20% G3+)¹ ~20% neutropenia (~15% G3+)³ ~30% neutropenia (~10% G3+) Toxicity CDK1 / CDK9 / GSK3B üûûû Selectivity 4 Low rates of GI toxicity ~40% diarrhea¹ ~85% diarrhea (~5% G3+)³ ~60% diarrhea Drivers of GI Toxicity Tolerability in NA NA üû Single asset with activity Combination with BG-68501 deprioritized Ongoing Not well tolerated² against CDK4 and CDK2 Portfolio CDK2i Potentially Differentiated CDK2i in Portfolio Not Well Tolerated Fixed Activity Against CDK2i in Portfolio in Combination with CDK4i CDK4 and CDK2 Note: Information provided in the tables above is for illustrative purposes only and no head-to-head clinical trials have been conducted evaluating these product candidates. Differences exist between study or trial designs and participant characteristics, and caution should be exercised when comparing data across trials. ¹ Yap T et al: ESMO Breast 4 2024. ² Yap T et al: ESMO 2024. ³ BeOne 2025 Investor R&D Day, Jun-2025. References data presented from CDK4i + fulvestrant dose escalation. Wander S et al: SABCS 2025. 16 BC: breast cancer; GI: gastrointestinal; ORR: overall response rate
AVZO-023 ORION-1 Phase 1 Study Design N=13 Patients Treated as of 28-Apr-2026 POPULATION DOUBLET: AVZO-023 + FULVESTRANT TRIPLET: • CDK4/6i + ET pretreated AVZO-023 + FULVESTRANT + AVZO-021 HR+/HER2- BC DOSE ESCALATION/BACKFILL (N~60) (N~70) ‒ Doublet: ≤2 prior lines of chemotherapy permitted … ‒ Triplet: ≤1 prior line of … chemotherapy permitted 150 mg BID (N=1) • ECOG 0–1 • Asymptomatic CNS DL3 100 mg BID disease allowed (N=7) DESIGN 75 mg BID • Accelerated titration (N=3) DL2 followed by BOIN 50 mg BID • Response evaluation (N=1) by RECIST v1.1 50 mg BID AVZO-023 + 100 mg QD AVZO-021 + 25 mg BID OBJECTIVES Fulvestrant (N=1) • Evaluate safety/tolerability and determine RP2D/MTD Note: Patients can receive prior CDK4/6i but not prior selective CDK2i, CDK4i or CDK2/4i. BC: breast cancer; BOIN: Bayesian Optimal Interval; CNS: central nervous system; DL: dose level; MTD: maximum tolerated dose; QD: once daily; Under 17 RP2D: recommended Phase 2 dose Evaluation
AVZO-023 Treatment Emergent Adverse Events (N=13) TEAEs OCCURRING IN ≥10% OF PATIENTS BY GRADE Generally well tolerated AVZO-023 + FULVESTRANT (N=13)¹ GRADE 1 GRADE 2 GRADE 3 GRADE 4 ALL GRADE N (%) N (%) N (%) N (%) N (%) Most TEAEs were Grade 1 or 2 Any TEAE, n (%) 2(15) 8 (62) 1(8) 1(8) 12(92) Low incidence and severity of hematologic and gastrointestinal Neutrophil count decreased 0 4 (31) 0 1(8) 5(38) adverse events Anaemia 2(15) 1(8) 0 0 3 (23) No patients had TEAEs leading to Nausea 2(15) 1(8) 0 0 3 (23) treatment discontinuation Blood creatinine increased 2(15) 0 0 0 2(15) 1 patient with DLT at 100 mg BID Decreased appetite 2(15) 0 0 0 2(15) • Grade 3 neutrophil count decreased that led to dose Dysgeusia 2(15) 0 0 0 2(15) interruption for >7 days and Grade 4 recurrence upon Vomiting 2(15) 0 0 0 2(15) rechallenge at same dose Note: Data cut-off date 28-Apr-2026. TEAEs by preferred term and maximum grade. No patient reported a Grade 5 TEAE. ¹ Breast cancer patients (11 of 13) received AVZO-023 + fulvestrant from C1D1. Includes 2 patients treated with AVZO-023 monotherapy. 18 BID: twice daily; DLT: dose-limiting toxicity; TEAE: treatment emergent adverse event
AVZO-023 + Fulvestrant ORION-1 Phase 1 Dose-Escalation Encouraging Signs of Efficacy in HR+/HER2- Breast Cancer at 100 mg BID (N=6) • 5/6 patients continued on treatment as of the data cut-off # Treatment ongoing Note: Data cut-off date 14-May-2026. Efficacy evaluable population includes all treated patients with metastatic HR+/HER2- breast cancer, baseline measurable disease, and at 19 least 1 evaluable post-baseline scan. 3 patients had non-measurable disease at baseline (bone only).
KEY HIGHLIGHTS • Rapid progress in AVENTINE-1 Phase 1 monotherapy study, with >30 patients enrolled across 5 dose cohorts • Responses across multiple doses and different tumor types with strong signal in NSCLC • Fast Track designation granted in EGFRm TKI-pretreated NSCLC AVZO-1418 EGFR/HER3 ADC ANTICIPATED MILESTONES Solid Tumors • 2H 2026: Preliminary, updated Phase 1 data • Mid-2027: Phase 2 initiation • 2H 2027: Updated Phase 1 data 20
EGFR/HER3 ADC Background and Opportunity Pan-Tumor Opportunity, including in Lung Cancer NSCLCwt (NO AGA) EGFRm NSCLC • EGFR and HER3 shown to be highly expressed across multiple solid tumors, IMMUNOTHERAPY OSIMERTINIB ± AMIVANTAMAB + including NSCLC ± CHEMOTHERAPY CHEMOTHERAPY LAZERTINIB • Bispecific ADC leverages avidity for enhanced binding, internalization and tumor-specific cytotoxicity AVZO-1418 • Limited options for patients, especially those in 2L setting with EGFRm and NSCLCwt (no AGA) Standard of Care CHEMOTHERAPY ± DOCETAXEL ± DATO-DXD AMIVANTAMAB RAMUCIRUMAB 21 EGFRm NSCLC: EGFR mutant non-small cell lung cancer; NSCLCwt (no AGA): non-small cell lung cancer without known alteration/mutation 2L+ 1L
AVZO-1418 EGFR/HER3 ADC Key Areas of Differentiation 2 AVZO-1418 (AVENZO)¹ IZA-BREN (BMS/SYSTIMMUNE) EGFRm NSCLC: Phase 2/3 Global Development Phase 1 NSCLCwt³: Phase 1 Stage mUC: Phase 2/3 Format 1+1 2+2 EGFR/HER3 Tuning 4 21.6 nM EGFR | 3.5 nM HER3 1.4 nM EGFR (cetuximab) | 88.4 nM HER3 (KD, nM) DAR 6 | P1021 DAR 8 | Ed-04 DAR / Payload (DualityBio topoisomerase I inhibitor) (topoisomerase I inhibitor) 5 EGFRm NSCLC: ✓ EGFRm NSCLC: 23% ORR (n=22) 5 Clinical Activity NSCLCwt: ✓ NSCLCwt³: 40% ORR (n=20) 6 mUC: ✓ mUC: 33% ORR (n=27) 5 Ongoing, no Grade≥3 neutropenia at ≤4.5 mg/kg Q2W 58% Grade≥3 neutropenia Phase 1 Safety Profile (N=20) (N=107) Prophylactic G-CSF 5 No Yes Required Note: Information provided in the table above is for illustrative purposes only and no head-to-head clinical trials have been conducted evaluating these product candidates. Differences exist between study or trial designs and participant characteristics, and caution should be exercised when comparing data across trials. ¹ Zhou Y et al: AACR 2025. 4 5 6 ² Zhang L et al: ASCO 2023. ³ Excludes EGFR, ALK and ROS1-positive NSCLC (NCT05983432). Internal data on file. Yu H et al: ESMO 2025. Bian X et al: ESMO 2024. EGFRm NSCLC: EGFR mutant non-small cell lung cancer; G-CSF: granulocyte-colony stimulating factor; NSCLCwt (no AGA): non-small cell lung cancer without known 22 alteration/mutation; UC: urothelial cancer
AVZO-1418 AVENTINE-1 Phase 1 Study Design N=32 Patients Treated as of 13-May-2026 POPULATION PEMBROLIZUMAB MONOTHERAPY DOSE • Prior lines of COMBINATION ESCALATION/BACKFILL chemotherapy ≤3 in EGFRm NSCLC, NSCLC W/O AGA, NSCLC W/O AGA, escalation and ≤2 in SCLC, NPC, BTC, UC SCLC, NPC, BTC, UC backfill patients (N~100) (N~35) • ECOG 0–1 6 mg/kg Q2W (N=7) • Asymptomatic CNS disease allowed … DL3 DESIGN 5.0 mg/kg Q2W • Bayesian Optimal Ongoing Interval (BOIN) DL2 4.5 mg/kg Q2W • Response evaluation (N=4) by RECIST v1.1 4 mg/kg Q2W 6 mg/kg Q3W DL1 (N=11) (N=5) OBJECTIVES • Evaluate 2 mg/kg Q2W safety/tolerability and (N=5) determine RP2D/MTD Note: Prior version of protocol allowed for enrollment of CRC, SCCHN, and TNBC tumor types. AGA: actionable genomic alteration; BTC: biliary tract cancer; CNS: central nervous system; CRC: colorectal cancer; MTD: maximum tolerated dose; NPC: nasopharyngeal carcinoma; NSCLC: non-small cell lung cancer; RP2D: recommended Phase 2 dose; SCCHN: squamous cell carcinoma of the Under 23 head and neck; SCLC: small cell lung cancer; TNBC: triple negative breast cancer; UC: urothelial cancer Evaluation
AVZO-1418 Treatment Emergent Adverse Events (N=32) TEAEs OCCURRING IN ≥10% OF PATIENTS BY GRADE Generally well-tolerated at doses up to 4.5 2 mg/kg to 4.5 mg/kg (N=20) 6 mg/kg (N=12) a b mg/kg Q2W (N=20) GRADE 1-2 GRADE 3-4 GRADE 1-2 GRADE 3-4 N (%) N (%) N (%) N (%) • No Grade 3+ neutropenia Nausea 10 (50) 0 8 (67) 0 • 1 patient had TEAE leading to treatment Alopecia 11 (55) 0 6 (50) 0 a Fatigue 9 (45) 0 4 (33) 0 discontinuation Diarrhoea 4 (20) 0 6 (50) 1 (8) • 2 patients had TEAEs leading to dose Vomiting 4 (20) 0 6 (50) 0 reduction Anaemia 3 (15) 0 4 (33) 2 (17) Headache 4 (20) 0 5 (42) 0 Neutrophil count decreased 1 (5) 0 3 (25) 4 (33) 6 mg/kg Q2W/Q3W exceeded MTD (N=12) Stomatitis 2 (10) 0 4 (33) 2 (17) Decreased appetite 5 (25) 0 2 (17) 0 • 2 DLTs at 6 mg/kg Q2W: Grade 3 diarrhea, Hypokalaemia 3 (15) 0 2 (17) 1 (8) and Grade 4 acute Epistaxis 1 (5) 0 4 (33) 0 gastroenteritis/pancytopenia Lymphocyte count decreased 0 3 (15) 0 2 (17) Mucosal inflammation 1 (5) 0 4 (33) 0 • 2 DLTs at 6 mg/kg Q3W: Grade 3 ALT Rash maculo-papular 3 (15) 0 2 (17) 0 increased/pneumonitis, and Grade 4 White blood cell count decreased 0 0 1 (8) 4 (33) neutrophil count decreased Dehydration 3 (15) 0 1 (8) 0 Dermatitis acneiform 2 (10) 0 2 (17) 0 • 2 patients had TEAEs leading to treatment Dizziness 2 (10) 0 2 (17) 0 b,c discontinuation Dry eye 1 (5) 0 3 (25) 0 • 5 patients had TEAEs leading to dose Dyspnoea 2 (10) 0 2 (17) 0 Myalgia 4 (20) 0 0 0 reduction Pyrexia 2 (10) 0 2 (17) 0 a Note: Data cut-off 13-May-2026. TEAEs by preferred term and maximum grade. Additional Grade 4+ TEAEs from 2 to 4.5mg/kg: Grade 4 respiratory failure (unrelated), Grade 5 b cardiorespiratory arrest (unrelated, leading to treatment discontinuation) in 1 patient each. Additional Grade 4+ TEAEs at 6 mg/kg: acute gastroenteritis/pancytopenia (related, c leading to treatment discontinuation) and Grade 5 aspiration (unrelated) in same patient. Grade 3 pneumonitis leading to treatment discontinuation in 1 patient. 24 TEAE: treatment-emergent adverse event; MTD: maximum tolerated dose
AVZO-1418 Phase 1 Monotherapy Dose-Escalation Encouraging Trend and Deepening Tumor Reductions over Time across Tumor Types (N=18) • In 18 efficacy evaluable patients, 9 remain on treatment including 5 responders • Responders across multiple tumor types and multiple dose cohorts • 2/3 responding patients at 6 mg/kg dose reduced to 4 mg/kg prior to response 5 of 18 responders # Treatment ongoing Note: Data cut-off date 13-May-2026. Efficacy-evaluable population includes patients with baseline measurable disease treated with AVZO-1418 who had at least 1 evaluable post- baseline scan. Patient with urothelial cancer treated at 6 mg/kg Q2W is ongoing with PR, which was confirmed subsequent to data cut-off date. * Patient with NSCLC-wt with 0% change from baseline was treated at 4.5 mg/kg Q2W. CRC: colorectal cancer; NPC: nasopharyngeal cancer; NSCLC-wt: non-small cell lung cancer without known alteration/mutation; NSCLC-EGFRm: EGFR mutant non-small cell lung 25 cancer; PR: partial response; SCCHN: squamous cell carcinoma of the head and neck; TNBC: triple negative breast cancer; UC: urothelial cancer; uPR: unconfirmed partial response
AVZO-1418 Phase 1 Monotherapy Dose-Escalation Encouraging Signs of Efficacy in NSCLC Across Multiple Doses (N=10) • In 10 efficacy evaluable patients, 8 remain on treatment including 4 responders • 1/2 responding patients at 6 mg/kg dose reduced to 4 mg/kg prior to response 4 of 10 responders # Treatment ongoing Note: Data cut-off date 13-May-2026. Efficacy-evaluable population includes patients with NSCLC with baseline measurable disease treated with AVZO-1418 who had at least 1 evaluable post-baseline scan. * Patient with NSCLC-wt with 0% change from baseline was treated at 4.5 mg/kg Q2W. NSCLC-wt: non-small cell lung cancer without known alteration/mutation; NSCLC-EGFRm: EGFR mutant non-small cell lung cancer; PR: partial response; uPR: unconfirmed 26 partial response
KEY HIGHLIGHTS • BEACON-1 Phase 1 monotherapy study ongoing • Fast Track designation granted in post-enfortumab vedotin urothelial cancer AVZO-103 Nectin4/TROP2 ADC ANTICIPATED MILESTONES Solid Tumors • 2H 2026: Initial Phase 1 data • Mid-2027: Phase 2 initiation • 2H 2027: Updated Phase 1 data 27
AVZO-103 Phase 1 Study Design Monotherapy Dose Escalation Ongoing POPULATION MONOTHERAPY DOSE PEMBROLIZUMAB COMBINATION • ECOG 0–1 ESCALATION/BACKFILL DOSE ESCALATION SOLID TUMORS¹, INCL. mUC mUC • Asymptomatic CNS (N~80) (N~35) disease allowed … DESIGN • Bayesian Optimal DL3 Interval (BOIN) 4.0 mg/kg Q3W • Response evaluation by RECIST v1.1 DL2 2.5 mg/kg Q3W (N=3) OBJECTIVES DL1 • Evaluate 1.5 mg/kg Q3W safety/tolerability and (N=3) determine RP2D/MTD ¹ Includes solid tumors known to express high Nectin4: urothelial cancer, TNBC, non-squamous EGFRm and non-squamous NSCLC with no actionable genomic alteration, SCCHN and cervical cancer. CNS: central nervous system; MTD: maximum tolerated dose; mUC: metastatic urothelial cancer; NSCLC: non-small cell lung cancer; RP2D: Under 28 recommended Phase 2 dose; SCCHN: head and neck squamous cell carcinoma; TNBC: triple negative breast cancer Evaluation
Anticipated Milestones PROGRAM ANTICIPATED MILESTONE ESTIMATED TIMING AVZO-021 • Updated Phase 1 monotherapy and fulvestrant combination data • ASCO 2026 CDK2 Inhibitor AVZO-023 • Preliminary, updated ORION-1 Phase 1 data in combination with fulvestrant • Late 2026 CDK4 Inhibitor AVZO-023 + -021 • Initial ORION-1 Phase 1 data in combination with fulvestrant • 2H 2027 CDK4 + CDK2 Inhibitors • Preliminary, updated AVENTINE-1 Phase 1 data • 2H 2026 AVZO-1418 • Phase 2 initiation • Mid-2027 EGFR/HER3 ADC • Updated AVENTINE-1 Phase 1 data • 2H 2027 • Initial BEACON-1 Phase 1 data • 2H 2026 AVZO-103 • Phase 2 initiation • Mid-2027 NECTIN4/TROP2 ADC • Updated BEACON-1 Phase 1 data • 2H 2027 29
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Exhibit 99.3
Avenzo Therapeutics and Rallybio Corporation
Merger Agreement + Concomitant Private Placement Announcement
Webcast Call Transcript
Date: June 1, 2026
Time: 8:30 AM ET
CORPORATE PARTICIPANTS
Dr. Stephen Uden, M.D., Co-Founder and Chief Executive Officer, Rallybio Corporation
Dr. Athena Countouriotis, M.D., Chair, President and Chief Executive Officer, Avenzo Therapeutics, Inc.
PRESENTATION
Dr. Stephen Uden, Co-Founder and Chief Executive Officer, Rallybio Corporation
“Thank you and good morning. Before we begin, I’d like to remind you that this discussion will contain forward-looking statements based upon the current expectations of Rallybio and Avenzo, which include, but are not limited to, statements regarding the expected timing, completion, effects and intended outcomes for the proposed transactions, and our future expectations, plans and prospects for the combined company, including clinical development matters, use of proceeds, expected cash runway and expected milestones. Such statements represent management’s judgment and intention as of today and involve assumptions, risks and uncertainties.
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Except to the extent required by law, we do not undertake any obligation to update any forward-looking statements. We also caution you against placing undue reliance on any forward-looking statements.
Further, as indicated on these slides, Rallybio intends to file a registration statement and accompanying proxy statement and prospectus with the Securities and Exchange Commission relating to the proposed transactions. Please be advised to read, when available, these and other relevant documents filed with the SEC. Please refer to the accompanying slides for more details on these forward-looking statements.
I will now turn the conference over to Dr. Athena Countouriotis, Chair, President and Chief Executive Officer of Avenzo Therapeutics.”
Dr. Athena Countouriotis, M.D., Chair, President and Chief Executive Officer, Avenzo Therapeutics, Inc.
“Thank you Stephen, and good morning everyone. I want to thank the team at Rallybio for all the work they have done to get to today, and for their belief in our team and our mission. At Avenzo, our mission is to improve the lives of people living with cancer, by delivering next-generation therapies that improve upon today’s standard of care.
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With this announcement, we are excited to share the Avenzo story more broadly, and to outline our plans to advance what we believe is a differentiated pipeline of small molecules and antibody drug-conjugates that are progressing across four Phase 1 clinical trials in various solid tumor indications.
Avenzo Therapeutics was founded in the fall of 2022 by myself and Dr. Mohammad Hirmand, our Chief Medical Officer, after the acquisition of Turning Point Therapeutics by Bristol Myers Squibb. Between Mohammad and myself, we have been fortunate to develop multiple small molecules and antibody-drug conjugates, or ADCs, within oncology, which are now marketed. Our Avenzo team is approximately 60 team members, with deep expertise in oncology drug development, and whom I have had the pleasure of working with for many years across different companies.
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Our strategy at Avenzo parallels that of Turning Point, with respect to how we’ve assembled a clinical-stage oncology pipeline of potentially differentiated programs that address areas of significant unmet need, with Avenzo having exclusive rights outside of Greater China. Today, that pipeline consists of four programs spanning small molecules and ADCs, all of which are now being advanced in Phase 1 studies in the U.S.
Our approach in building the pipeline was to identify potentially differentiated programs with strong biologic rationale and significant commercial potential, where we could utilize our expertise in drug development to rapidly advance each program to treat patients with unmet needs. We’re excited about the pipeline we’ve assembled and believe we are well positioned to advance these programs across multiple clinical milestones as a result of this transaction.
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Our pipeline includes two highly selective cyclin-dependent kinase, or CDK, inhibitors: AVZO-021, our selective CDK2 inhibitor and AVZO-023, our selective CDK4 inhibitor, as well as two bispecific ADCs: AVZO-1418, our bispecific ADC targeting EGFR and HER3, and AVZO-103, our bispecific ADC targeting Nectin4 and TROP2. All four of our programs are being evaluated in ongoing Phase 1 studies conducted by our team in the United States, while our partners are in parallel advancing their respective drug candidates within Greater China, either as part of our study, or in their own China-based study. We are truly excited about the potential of each of our agents as monotherapy and/or in combinations, such as the combination of AVZO-021 and AVZO-023 with endocrine therapy in hormone receptor-positive, HER2-negative breast cancer.
Later today at the American Society of Clinical Oncology conference in Chicago, we are presenting updated data from the ongoing Phase 1 study of AVZO-021 in HR-positive, HER2-negative breast cancer. We have treated 64 patients in total across monotherapy and in combination with fulvestrant, and continue to believe these data support a differentiated profile given our CDK2 inhibitor’s tolerability and clinical activity, including the emerging progression free survival data of 5.3 months in patients with HR-positive, HER2-negative metastatic breast cancer with a median of 4 prior therapies in the metastatic setting treated with AVZO-021 monotherapy.
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In addition, we recently treated the first patient with the triplet combination of AVZO-021, with our selective CDK4 inhibitor, AVZO-023, and fulvestrant in the Phase 1 portion of the ORION-1 study. Beyond the triplet, the ORION-1 study is also evaluating the doublet combination of AVZO-023 and endocrine therapy in patients with previously treated HR+/HER2- metastatic breast cancer.
We are encouraged by the initial profile of our selective CDK4 inhibitor, including its tolerability, specifically its lack of diarrhea which is often difficult for patients, and emerging clinical activity and look forward to sharing updated data from the ORION-1 study later this year.
As for our two bispecific ADC programs, AVZO-1418 is our most advanced ADC, targeting both EGFR and HER3. We have already dosed over 30 patients since initiating the Phase 1 portion of the AVENTINE-1 study in mid-2025. We are encouraged by the initial clinical data, where clinical activity was observed across multiple tumor types, with a potentially differentiated tolerability profile especially in terms of hematologic adverse events. Last in our pipeline is our fourth clinical stage program, AVZO-103, a bispecific ADC targeting both Nectin4 and TROP2. This is in the early stages of the ongoing Phase 1 portion of the BEACON-1 study, and we look forward to sharing clinical data from both of our ADC programs later this year.
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With the additional $215 million expected to be raised as part of this transaction, in addition to the current cash on our balance sheet, we expect to have sufficient runway into late 2028 to advance our clinical-stage programs through multiple clinical milestones, including updated Phase 1 data across the pipeline, initial clinical data for the combination of AVZO-023 and AVZO-021 with fulvestrant, and the initiation of multiple Phase 2 studies. We look forward to sharing more about our later stage development plans with you over time.
I want to conclude my remarks by thanking all of the Avenzo team members, especially my co-founder Dr. Mohammad Hirmand, and our Chief Financial and Chief Business Officer Scott Lipman, for your tireless efforts to get to today. I know we all work incredibly hard for our team and the patients we serve. I also want to thank our Series A and Series B investors who have supported us over the past four years, and to our new investors – we look forward to working with you following the close of this transaction. I truly look forward to Avenzo being a public company, and to many more calls with all of you. Thank you again for your support.
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I will now hand the call back to the operator. Operator you can now conclude the call.”
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