Alaunos acquires Velaris, agrees to ~$350M financing
A stockholder vote would determine preferred conversion and charter changes, while board composition and license terms include additional conditions.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Alaunos Therapeutics, Inc. (TCRT) completed its acquisition of Velaris on October 13, 2026, issuing 105,286 Series B and 33,054 Series C non-voting convertible preferred shares. After stockholder approval and an authorized-share increase, Series B may convert at holders’ option and Series C automatically converts into 1,000 common shares per preferred share, subject to ownership limits. Alaunos agreed to sell 687,789 common shares at $1.4357 each and 243,063 Series C preferred shares at $1,435.70 each for approximately $350 million. The purchase terms expected an October 14, 2026 closing subject to conditions; the company announcement described the financing as completed.
Net proceeds are intended for Velaris research and development, working capital and general corporate purposes. Stockholders will consider conversion, charter changes including a reverse split at a ratio set by the board with Lead Investor consent, and an equity plan. If approved, a Velaris director and Lead Investor designees would hold four of five board seats. Paragon may, at its discretion, terminate licenses if equity does not exceed $200 million at the end of the second full fiscal quarter after closing. Velaris’s candidates are preclinical; company materials project filings in 2027 and proof-of-concept data in 2028.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major point. Forward-looking: it has not happened yet and may not happen.The approximately $350 million financing is expected to fund operations into 2029. 131× market cap
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Paragon’s $200 million equity test may permit license termination.
Insights
Analyzing...
8-K Event Classification
Key Figures
Key Terms
Series B Non-Voting Convertible Preferred Stock financial
beneficial ownership limitations financial
resale registration statement financial
single-digit percentage royalty financial
proof-of-concept medical
ActRIIA-Fc ligand trap technical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much is Alaunos (TCRT) raising in its private placement?
What could cause Paragon to terminate Velaris licenses?
What board changes are tied to TCRT stockholder approval?
AI-generated analysis. How Rhea-AI works. Not financial advice.
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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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 1.01 – Entry into a Material Definitive Agreement.
Agreement and Plan of Merger
On October 13, 2026, Alaunos Therapeutics, Inc., a Delaware corporation (the “Company” or “Alaunos”), acquired Velaris Therapeutics, Inc., a Delaware corporation (“Velaris”), in accordance with the terms of the Agreement and Plan of Merger, dated October 13, 2026 (the “Merger Agreement”), by and among the Company, Valkyrie Merger Sub I, Inc., a Delaware corporation and a wholly owned subsidiary of the Company (“First Merger Sub”), Valkyrie Merger Sub II, LLC, a Delaware limited liability company and wholly owned subsidiary of the Company (“Second Merger Sub”), and Velaris. Pursuant to the Merger Agreement, First Merger Sub merged with and into Velaris, pursuant to which Velaris was the surviving corporation and became a wholly owned subsidiary of the Company (the “First Merger”). Immediately following the First Merger, Velaris merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity (together with the First Merger, the “Merger”). The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
Under the terms of the Merger Agreement, at the closing of the Merger (the “Closing”), the Company issued to the stockholders of Velaris (i) 105,286 shares of Series B Non-Voting Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”) (as described below) and (ii) 33,054 shares of Series C Non-Voting Convertible Preferred Stock, par value $0.001 per share (the “Series C Preferred Stock”) (as described below), each share of which is, in each case, convertible into 1,000 shares of the common stock of the Company, par value $0.001 per share (the “Common Stock”), subject to certain conditions described below. In addition, shares of Series C Preferred Stock issued in respect of outstanding unvested restricted shares of Velaris common stock remain subject to the same vesting terms, and each outstanding option to purchase shares of Velaris common stock was assumed by the Company and converted into an option to purchase shares of Common Stock, with the number of shares and exercise price adjusted based on the exchange ratio in the Merger Agreement.
Reference is made to the discussion of the Series B Preferred Stock and Series C Preferred Stock in Item 5.03 of this Current Report on Form 8-K, which is incorporated into this Item 1.01 by reference.
Pursuant to the Merger Agreement and the Purchase Agreement (as defined below), the Company has agreed to hold a stockholders’ meeting to submit the following matters to its stockholders for their consideration: (i) the approval of the conversion of the Series B Preferred Stock and the Series C Preferred Stock into shares of Common Stock in accordance with the listing rules of The Nasdaq Stock Market LLC (“Nasdaq”) (the “Conversion Proposal”), (ii) the approval of an amendment to the certificate of incorporation of the Company to (A) increase the number of authorized shares of Common Stock to a number sufficient to permit the conversion in full of the Series B Preferred Stock and the Series C Preferred Stock (the “Authorized Share Increase”), (B) change the name of the Company to “Velaris Therapeutics, Inc.”, (C) effect the redomestication of the Company, (D) effect a reverse stock split of the outstanding shares of Common Stock at a ratio to be determined by the Company’s board of directors with the consent of the Lead Investor (as defined below), and (E) make such other changes as are mutually agreeable to the Company and Velaris (the “Charter Amendment Proposal”), and (iii) the approval of a new equity incentive plan (the “Equity Plan Proposal”) (together with the Conversion Proposal and the Charter Amendment Proposal, the “Meeting Proposals”). In connection with these matters, the Company intends to file with the Securities and Exchange Commission (the “SEC”) a proxy statement and other relevant materials.
The Board of Directors of the Company (the “Board”) approved the Merger Agreement and the related transactions, and the consummation of the Merger did not require the approval of the Company stockholders.
The Merger Agreement also provides that, from the Closing until the earliest of the conversion of all outstanding shares of Series B Preferred Stock following stockholder approval of the Conversion Proposal, twelve months following the Closing and the date on which the lead investor in the Financing (the “Lead Investor”) otherwise agrees, the Company will conduct the development of Velaris’s programs in all material respects in accordance with an agreed development plan and operating budget and will not materially deviate from such plan without the consent of the Lead Investor, subject to certain exceptions.
The Merger Agreement further provides that, effective upon stockholder approval of the Conversion Proposal, three directors of the Company will resign from the Board and designees of the Lead Investor will be appointed to fill the resulting vacancies, such that the director designated by Velaris and the designees of the Lead Investor will constitute four of the five members of the Board. The Merger Agreement also requires that any redomestication of the Company provide that each director elected by the holders of the Series B Preferred Stock will be entitled to three votes on each matter presented to the Board.
The foregoing description of the Merger and the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The Merger Agreement has been included to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company or Velaris. The Merger Agreement contains representations, warranties and covenants that the Company and Velaris made to each other as of specific dates. The assertions embodied in those representations, warranties and covenants were made solely for purposes of the Merger Agreement between the Company and Velaris and may be subject to important qualifications and limitations agreed to by the Company and Velaris in connection with negotiating its terms, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the Merger Agreement. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to investors or securityholders, or may have been used for the purpose of allocating risk between the Company and Velaris rather than establishing matters as facts. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the Merger Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures. For the foregoing reasons, no person should rely on the representations and warranties as statements of factual information at the time they were made or otherwise.
Support Agreements
In connection with the execution of the Merger Agreement, the Company entered into stockholder support agreements (the “Support Agreements”) with certain of the Company’s officers and directors (together with affiliated entities). The Support Agreements provide that, among other things, each of the parties thereto has agreed to vote or cause to be voted all of the shares of the Company’s capital stock owned by such stockholder in favor of the Meeting Proposals at the Company stockholders’ meeting to be held in connection therewith, and has granted the Company an irrevocable proxy to vote such shares in accordance therewith. The Support Agreements terminate upon the earliest of nine months following the date thereof, the approval of the Meeting Proposals and the mutual written agreement of the parties thereto.
The foregoing description of the Support Agreements does not purport to be complete and is qualified in its entirety by reference to the form of the Support Agreement, which is provided as Exhibit C to the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.
Lock-up Agreements
Concurrently and in connection with the execution of the Merger Agreement, certain of the executive officers and directors of Velaris and the Company who continue to serve following the Closing entered into lock-up agreements with the Company, pursuant to which each such individual will be subject to a 180-day lock-up on the sale or transfer of shares of Common Stock and preferred stock of the Company held by such individual at the Closing, including those shares received by Velaris stockholders in the Merger, subject to customary exceptions (the “Lock-up Agreements”). The lock-up period will be extended if the resale registration statement described below has not been declared effective by the SEC prior to the end of such 180-day period.
The foregoing description of the Lock-up Agreements does not purport to be complete and is qualified in its entirety by reference to the form of the Lock-up Agreement, which is provided as Exhibit A to the Merger Agreement, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.
Private Placement and Securities Purchase Agreement
On October 13, 2026, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the purchasers named therein (the “Investors”).
Pursuant to the Purchase Agreement, the Company agreed to sell an aggregate of (i) 687,789 shares of Common Stock at a price of $1.4357 per share and (ii) 243,063 shares of Series C Preferred Stock at a price of $1,435.70 per share (together, the “PIPE Securities”), for an aggregate purchase price of approximately $350 million (collectively, the “Financing”). Each share of Series C Preferred Stock is convertible into 1,000 shares of Common Stock, as described below. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series C Preferred Stock are set forth in the Certificate of Designation of Series C Preferred Stock (as defined below).
The Company intends to use the net proceeds from the Financing to fund the research and development of Velaris’s programs and for working capital and general corporate purposes, and has agreed in the PIPE Letter Agreement (as defined below) to certain restrictions on the use of such proceeds.
The closing of the Financing is expected to occur on October 14, 2026 (the “Financing Closing Date”), subject to the satisfaction of customary closing conditions.
The foregoing summary of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the Purchase Agreement, which is filed as Exhibit 10.1 to this Current Report on Form 8-K.
PIPE Letter Agreement
In connection with the Purchase Agreement, the Company entered into a letter agreement with the Lead Investor (the “PIPE Letter Agreement”), pursuant to which the Company agreed to comply with its obligations under the Merger Agreement relating to the reconstitution of the Board following stockholder approval of the Conversion Proposal described above, and not to amend those obligations, or the director election rights of the Series B Preferred Stock, or take any action that would reasonably be expected to prevent, impede or delay such reconstitution, without the consent of the Lead Investor. The PIPE Letter Agreement also provides that, without the consent of the Lead Investor, the Company will not use the proceeds of the Financing to fund the Company’s legacy business in excess of agreed amounts, to redeem or repurchase shares of its capital stock or to repay indebtedness owed to its directors, officers or affiliates.
The foregoing description of the PIPE Letter Agreement does not purport to be complete and is qualified in its entirety by reference to the PIPE Letter Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2026.
Registration Rights Agreement
In connection with the closing of the Financing, the Company will enter into a Registration Rights Agreement (the “Registration Rights Agreement”) with the Investors, which former Velaris stockholders who received shares in the Merger may also join. Pursuant to the Registration Rights Agreement, the Company is required to prepare and file a resale registration statement with the SEC within 30 calendar days following the Financing Closing Date. The Company shall use its commercially reasonable efforts to cause this registration statement to be declared effective by the SEC within five business days of the date the Company is notified by the SEC that the registration statement will not be reviewed (or within 60 calendar days following the initial filing of the registration statement if the SEC reviews the registration statement).
The Company has also agreed to, among other things, indemnify the Investors, their officers, directors, members, employees, partners, managers, stockholders, affiliates, investment advisors and agents 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 Company’s obligations under the Registration Rights Agreement.
The Financing is exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), as a transaction by an issuer not involving a public offering, and Rule 506 of Regulation D promulgated thereunder. The Investors are acquiring the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends will be affixed to the securities issued in this transaction.
The foregoing summary of the Registration Rights Agreement does not purport to be complete and is qualified in its entirety by reference to the form of Registration Rights Agreement, which is filed as Exhibit 10.2 to this Current Report on Form 8-K.
Share Repurchase and Voting Agreement
Concurrently with the execution of the Merger Agreement, the Company entered into a Share Repurchase and Voting Agreement (the “Repurchase Agreement”) with the holders of all of its outstanding Series A-1 Convertible Preferred Stock and Series A-2 Convertible Preferred Stock (together, the “Existing Preferred Stock”), including Robert W. Postma and Jaime W. Vieser, each a director of the Company, and an entity affiliated with Mr. Postma. Pursuant to the Repurchase Agreement, among other things, (i) such holders agreed to convert their shares of Existing Preferred Stock into shares of Common Stock prior to the record date for the stockholders’ meeting described above, to the extent permitted by the beneficial ownership limitations applicable thereto, (ii) such holders agreed to vote all of their shares of the Company’s capital stock in favor of the Meeting Proposals, and (iii) following stockholder approval of the Conversion Proposal, the Company will repurchase all such shares of Common Stock and any remaining shares of Existing Preferred Stock for an aggregate cash amount equal to the liquidation value of the Existing Preferred Stock plus accrued dividends thereon (approximately $1.6 million if stockholder approval is obtained prior to February 2027). Such holders also consented to the Merger and the related transactions and waived certain rights under the certificates of designation of the Existing Preferred Stock. The Repurchase Agreement was approved by a committee of disinterested directors of the Board.
The foregoing summary of the Repurchase Agreement does not purport to be complete and is qualified in its entirety by reference to the form of Repurchase Agreement, which is filed as Exhibit 10.3 to this Current Report on Form 8-K.
Discovery and Option Agreement
Prior to the effective time of the Merger, Velaris entered into a Fusion Protein Discovery and Option Agreement (the “ADOA”) with Paragon Laboratories, Inc. (“Paragon”). Pursuant to the ADOA, Paragon will conduct research programs, overseen by a joint development committee of representatives of each party, directed to the discovery and development of Fc fusion protein candidates, including programs directed to ActRIIA and ActRIIB that were initiated under a prior research letter agreement between Velaris and Paragon, and a program directed to a BMP9/10-sparing ActRIIA fusion protein. The parties may agree to conduct additional research programs under the ADOA. In addition, under the research letter agreement between Velaris and Paragon, as amended on October 13, 2026, Velaris holds options with respect to three research programs directed to antibody candidates, including an anti-PDGF-B monoclonal antibody and a bispecific molecule combining an ActRIIA fusion protein with an anti-PDGF-B antibody, which the parties expect to document in a separate discovery and option agreement.
Velaris has an exclusive option, on a program-by-program basis and exercisable until a specified period following the delivery of the final research deliverables for the applicable program, to obtain an exclusive, worldwide license to develop, manufacture and commercialize the fusion proteins arising from such program, pursuant to a license agreement to be entered into on terms set forth in the ADOA. In consideration for Paragon’s research services, Velaris will pay Paragon a one-time research initiation fee for certain programs, which will become payable following the completion of a qualified financing, and will reimburse Paragon for its development costs, consisting of third-party costs (including a mark-up on certain costs) and a monthly fee for Paragon’s personnel and resources. Velaris may also engage Paragon to perform chemistry, manufacturing and controls activities for a program on a fixed-fee basis. Under each license agreement, Velaris will be obligated to make milestone payments upon the achievement of specified development, regulatory and commercial milestones and to pay a single-digit percentage royalty on net sales of licensed products, subject to customary reductions, until the later of the expiration of specified patent rights and the twelfth anniversary of first commercial sale, on a product-by-product and country-by-country basis. Paragon will also be subject to certain exclusivity obligations with respect to the licensed fusion proteins for a period following the execution of each license agreement.
In addition, Velaris (or, at Paragon’s election, the Company, as Velaris’s parent) will grant Paragon two warrants, each to purchase a number of shares of Common Stock equal to 1.00% of the Company’s outstanding shares on a fully diluted basis (including the shares issued or issuable in the Merger and the Financing), at an exercise price equal to fair market value on the date of grant and with a term of ten years. The first warrant is to be granted 120 days following the Closing and the second warrant twelve months thereafter.
Each license agreement under the ADOA will permit Paragon, in its sole discretion, to terminate the license, with the licensed rights reverting to Paragon, upon the occurrence of certain events, including if (i) the Company’s stockholders’ equity, as determined in accordance with the Nasdaq listing rules, does not exceed $200 million as of the end of the second full fiscal quarter following the Closing, or the Company fails to timely file the periodic report including such balance sheet, or (ii) the Company fails to deliver freely tradeable shares of Common Stock within 120 days following an exercise of the warrants held by Paragon. Paragon may exercise this right within 180 days following the occurrence of such an event, and its right is not affected by any subsequent cure. Until Paragon’s reversion right expires, Velaris may not, without Paragon’s consent, sublicense (other than to contractors), assign or grant a lien on the licensed rights, and upon any reversion Velaris must transfer to Paragon the related data, regulatory filings and assignable third-party agreements and grant Paragon an exclusive license under related Velaris intellectual property, in each case without further consideration.
Velaris may terminate the ADOA or any research program for convenience upon 30 days’ prior written notice, subject to payment of accrued costs and non-cancellable obligations. Each party may terminate the ADOA for the other party’s uncured material breach or insolvency, and Paragon may terminate a research program if it is suspended or delayed for four consecutive months as a result of Velaris’s action or inaction. The ADOA also contains customary provisions relating to intellectual property, confidentiality and indemnification.
The foregoing summary of the ADOA does not purport to be complete and is subject to, and qualified in its entirety by, the ADOA, a copy of which will be filed, with certain confidential portions omitted, as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2026.
Item 2.01 – Completion of Acquisition or Disposition of Assets.
On October 13, 2026, the Company completed its business combination with Velaris. The information contained in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 2.01.
Item 3.02 – Unregistered Sales of Equity Securities.
The information contained in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. The PIPE Securities were offered and sold in transactions exempt from registration under the Securities Act, in reliance on Section 4(a)(2) thereof and Rule 506 of Regulation D thereunder. Each of the Investors represented that it was an “accredited investor,” as defined in Regulation
D, and is acquiring the PIPE Securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. The PIPE Securities have not been registered under the Securities Act and such PIPE Securities may not be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws. 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 shares of Common Stock or any other securities of the Company.
Pursuant to the Merger Agreement, the Company issued shares of Series B Preferred Stock and Series C Preferred Stock to the former stockholders of Velaris. The information contained in Item 2.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02. Such issuances were exempt from registration pursuant to Section 4(a)(2) of the Securities Act and Regulation D promulgated thereunder.
Item 5.02 – Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Directors
In accordance with the Merger Agreement, on October 13, 2026, effective immediately after the effective time of the Second Merger, Peter Harwin was appointed to the Board as a director.
Peter Harwin (Age 40). Mr. Harwin is a Founding Partner at Fairmount Funds Management LLC (“Fairmount”), a healthcare investment firm he co-founded in April 2016. Prior to Fairmount, he was a member of the investment team at Boxer Capital, LLC. Mr. Harwin also serves as chairman of the board of directors of Cogent Biosciences, Inc. (Nasdaq: COGT), Crescent Biopharma, Inc. (Nasdaq: CBIO) and Damora Therapeutics, Inc. (Nasdaq: DMRA), and is a member of the board of directors of Oruka Therapeutics, Inc. (Nasdaq: ORKA). Mr. Harwin previously served as a director of Apogee Therapeutics, Inc. (Nasdaq: APGE) from June 2023 to May 2026, Spyre Therapeutics, Inc. (Nasdaq: SYRE) from June 2023 to May 2026 and Viridian Therapeutics, Inc. (Nasdaq: VRDN) from October 2020 to March 2025. He received a B.B.A. from Emory University.
There are no arrangements or understandings between Mr. Harwin and any other person pursuant to which he was appointed as a director of the Company, other than the Merger Agreement. Funds affiliated with Fairmount, including the Lead Investor, received 105,286 shares of Series B Preferred Stock in the Merger, agreed to purchase 687,789 shares of Common Stock and 68,964 shares of Series C Preferred Stock in the Financing for an aggregate purchase price of approximately $100.0 million, and are party to the PIPE Letter Agreement. Mr. Harwin is also a director of Paragon, the counterparty to the ADOA, which, together with an affiliate, received an aggregate of 26,322 shares of Series C Preferred Stock in the Merger. Each of the foregoing is described in Item 1.01 of this Current Report on Form 8-K, which is incorporated herein by reference. Except as described herein, Mr. Harwin is not a party to any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
Mr. Harwin will be compensated as a director in accordance with the Company’s non-employee director compensation program described in the Company’s Definitive Proxy Statement on Schedule 14A for its 2025 Annual Meeting of Stockholders.
In connection with the Closing, Mr. Harwin was appointed to the Nominating and Corporate Governance Committee of the Board.
Indemnification Agreements
In connection with Mr. Harwin’s appointment as a director, the Company expects to enter into its standard form of indemnification agreement for directors with Mr. Harwin.
Resignation of Directors
In accordance with the Merger Agreement, on October 13, 2026, each of Robert W. Postma, Michael A. Jerman and Jaime W. Vieser delivered resignations that will become effective automatically only upon, and subject to, stockholder approval of the Conversion Proposal. None of the resignations were as a result of a disagreement with the Company on any matter relating to the Company’s operations, policies or practices.
Retention Bonuses
In connection with the Merger, the Board approved, and the Company entered into, a retention bonus letter agreement with Holger Weis, the Company’s Chief Executive Officer, and an retention agreement and an amendment to its consulting agreement with Ferdinand Groenewald, the Company’s Vice President, Finance (together, the “Retention Agreements”), in lieu of any change of control, severance or similar payments or benefits that would otherwise have been payable in connection with the Merger. Pursuant to his letter agreement, Mr. Weis is eligible to receive a one-time cash retention bonus of $206,250 if (i) the Company’s development of ALN1003 is completed
by July 30, 2027, as determined by the Board in good faith, and (ii) Mr. Weis remains continuously employed by the Company through such date. Pursuant to his amended consulting agreement, Mr. Groenewald is eligible to receive a one-time cash retention bonus of $90,000 if he continues to provide services to the Company through the filing of the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2026 and its Quarterly Report on Form 10-Q for the quarter ending March 31, 2027. If earned, each retention bonus will be paid in a lump sum within 30 days following the applicable retention date. If the executive’s employment or services are terminated by the Company without cause prior to the applicable retention date, the retention bonus will be paid, subject to the executive’s execution and non-revocation of a general release of claims; otherwise, the retention bonus will be forfeited if the executive’s employment or services end prior to the applicable retention date. In addition, on October 12, 2026, the compensation committee of the Board approved the grant to Mr. Weis and Mr. Groenewald of options to purchase 50,000 and 10,000 shares of Common Stock, respectively, at an exercise price of $1.4357 per share, which options will vest on the same terms as the applicable retention bonus.
The foregoing summaries of the Retention Agreements do not purport to be complete, and are subject to, and qualified in their entirety by, such agreements, copies of which will be filed with the Company’s Annual Report on Form 10-K for the fiscal year ending December 31, 2026.
Item 5.03 – Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
On October 13, 2026, the Company filed with the Secretary of State of the State of Delaware a Certificate of Designation of Preferences, Rights and Limitations of the Series B Preferred Stock (the “Certificate of Designation of Series B Preferred Stock”) and a Certificate of Designation of Preferences, Rights and Limitations of the Series C Preferred Stock (the “Certificate of Designation of Series C Preferred Stock,” and together with the Certificate of Designation of Series B Preferred Stock, the “Certificates of Designation”) in connection with the Merger and the Financing referenced in Item 1.01 above. The Certificates of Designation provide for the issuance of shares of the Company’s Series B Preferred Stock and Series C Preferred Stock, as applicable.
Holders of Series B Preferred Stock and Series C Preferred Stock are entitled to receive dividends on shares of Series B Preferred Stock and Series C Preferred Stock, as applicable, equal to, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock. Except as otherwise required by law, the Series B Preferred Stock and Series C Preferred Stock do not have voting rights. However, as long as any shares of Series B Preferred Stock or Series C Preferred Stock, as applicable, are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of Series B Preferred Stock or Series C Preferred Stock, as applicable, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock or Series C Preferred Stock, as applicable, (b) alter or amend the applicable Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock or Series C Preferred Stock, as applicable, (d) issue further shares of Series B Preferred Stock or Series C Preferred Stock, as applicable, or increase or decrease (other than by conversion) the number of authorized shares of Series B Preferred Stock or Series C Preferred Stock, as applicable, (e) prior to stockholder approval of the Conversion Proposal and the Authorized Share Increase, amend, waive or modify the Merger Agreement in any manner that would be reasonably likely to prevent, impede or materially delay such approval, or (f) enter into any agreement with respect to any of the foregoing or, for the Series B Preferred Stock, with respect to the following. Furthermore, as long as at least 30% of the originally issued Series B Preferred Stock remains issued and outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of Series B Preferred Stock, (i) consummate a Fundamental Transaction (as defined in the Certificate of Designation of Series B Preferred Stock) or any merger or consolidation of the Company or other business combination in which the stockholders of the Company immediately before such transaction do not hold at least a majority of the capital stock of the Company immediately after such transaction, (ii) increase or decrease the size of the Board, (iii) without the unanimous approval of the Board, adopt, amend or repeal any written delegation of authority, policy, corporate authority matrix or similar document, framework or schedule, (iv) terminate or replace the Company’s independent registered accounting firm, independent compensation consultant or corporate counsel, (v) use the proceeds of the Financing in violation of certain restrictions, or take any action that would constitute a material deviation from the agreed operating plan, or (vi) enter into any agreement with respect to any of the foregoing. In addition, from and after stockholder approval of the Conversion Proposal, for so long as at least 30% of the originally issued Series B Preferred Stock remains outstanding, the holders of the Series B Preferred Stock, voting as a separate class, will be entitled to elect two directors of the Company. The Series B Preferred Stock and Series C Preferred Stock do not have a preference upon any liquidation, dissolution or winding-up of the Company.
Following stockholder approval of the Conversion Proposal and the Authorized Share Increase, each share of Series B Preferred Stock will be convertible, at the option of the holder, into 1,000 shares of Common Stock and each share of Series C Preferred Stock will automatically convert into 1,000 shares of Common Stock, each subject to certain limitations, including that a holder of Series B Preferred Stock or Series C Preferred Stock is prohibited from converting shares of Series B Preferred Stock or Series C Preferred Stock, as applicable, into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 0% and 19.99%) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
If stockholder approval of the Conversion Proposal and the Authorized Share Increase has not been obtained, then beginning six months following the initial issuance of the Series B Preferred Stock or Series C Preferred Stock, as applicable, a holder may require the Company to settle a conversion in cash in an amount equal to the fair value (as defined in the applicable Certificate of Designation, by reference to the trading price of the Common Stock) of the shares of Common Stock that would otherwise have been issuable upon such conversion.
The foregoing descriptions of the Series B Preferred Stock and Series C Preferred Stock do not purport to be complete and are qualified in their entirety by reference to the Certificates of Designation, copies of which are filed as Exhibit 3.1 and Exhibit 3.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
Item 7.01 – Regulation FD Disclosure.
On October 13, 2026, the Company made available a presentation to be used with investors to discuss the Merger and the Financing. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K. On October 13, 2026, the Company also issued a press release announcing the Merger and the Financing. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K, including the information in the presentation and press release attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Current Report on Form 8-K, including the information in the presentation and press release attached as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company under the Securities Act of 1933, as amended.
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, including, but not limited to, statements regarding: the closing of the Financing, if at all, and the anticipated use of proceeds therefrom; stockholder approval of the Meeting Proposals, including the conversion rights of the Series B Preferred Stock and Series C Preferred Stock; the filing of a resale registration statement pursuant to the Registration Rights Agreement and the timing thereof; the development of Velaris’s programs and the Company’s operating plan; the repurchase of the Existing Preferred Stock; and the anticipated activities and obligations under the ADOA, including the grant of warrants thereunder and the potential reversion of licensed rights. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on the Company’s current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, its clinical results and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. The Company may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in the Company’s most recent Annual Report on Form 10-K filed with the SEC, as supplemented by its Quarterly Reports on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither the Company, nor its affiliates, advisors or representatives, undertakes any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.
Additional Information and Where to Find It
In connection with the Meeting Proposals, the Company intends to file with the SEC a proxy statement on Schedule 14A (the “Proxy Statement”) and other relevant materials. The definitive Proxy Statement will be mailed to the Company’s stockholders. INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC WHEN THEY BECOME AVAILABLE, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE MERGER, THE FINANCING AND THE MEETING PROPOSALS. Investors and stockholders may obtain free copies of these documents, when available, at the SEC’s website at www.sec.gov or on the Company’s website at www.alaunos.com.
Participants in the Solicitation
The Company and its directors and executive officers may be deemed to be participants in the solicitation of proxies from the Company’s stockholders in connection with the Meeting Proposals. Information regarding the Company’s directors and executive officers is contained in the Company’s Definitive Proxy Statement on Schedule 14A for its 2025 Annual Meeting of Stockholders and its Annual Report on Form 10-K for the fiscal year ended December 31, 2026. Additional information regarding the participants in the solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the Proxy Statement when it becomes available.
Item 9.01 – Financial Statements and Exhibits.
(d) Exhibits
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2.1(1) |
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Agreement and Plan of Merger, dated October 13, 2026, by and among Alaunos Therapeutics, Inc., Valkyrie Merger Sub I, Inc., Valkyrie Merger Sub II, LLC and Velaris Therapeutics, Inc. |
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3.1 |
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Certificate of Designation of Series B Non-Voting Convertible Preferred Stock |
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3.2 |
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Certificate of Designation of Series C Non-Voting Convertible Preferred Stock |
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10.1 |
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Securities Purchase Agreement, dated as of October 13, 2026, by and among Alaunos Therapeutics, Inc. and each investor listed on Exhibit A thereto |
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10.2 |
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Form of Registration Rights Agreement, by and among Alaunos Therapeutics, Inc. and certain investors signatory thereto |
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10.3 |
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Form of Share Repurchase and Voting Agreement, by and among Alaunos Therapeutics, Inc., Velaris Therapeutics, Inc. and the holders party thereto |
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99.1 |
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Investor Presentation Dated October 2026 |
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99.2 |
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Press Release issued on October 13, 2026 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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(1) Certain schedules and attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to provide, on a supplemental basis, a copy of any omitted schedules and attachments to the Securities and Exchange Commission or its staff upon request.
SIGNATURE
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.
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Alaunos Therapeutics, Inc. |
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Date: October 13, 2026 |
By: |
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/s/ Holger Weis |
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Holger Weis |
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Chief Executive Officer |
Transaction & Corporate Overview October 2026 Confidential
Disclaimers and forward-looking statements Disclaimer This presentation has been prepared by Velaris Therapeutics, Inc. (“Velaris” or the “Company”). The information contained herein is provided as of the date hereof, is subject to change without notice, and is based on publicly available information, third-party sources and internally developed data. It does not purport to contain all of the information that may be necessary to evaluate an investment in the Company, is not a recommendation that any person make such an investment, and is for information purposes only. Any opinion or belief expressed herein is based on certain assumptions and limitations and is an expression of present belief only. Nothing herein should be construed as legal, financial, accounting or tax advice. This presentation is confidential and is furnished solely to a limited number of parties for the purpose of evaluating a possible transaction with the Company. By accepting this presentation, the recipient agrees that it and its representatives will use it solely for that purpose, will not distribute, reproduce or disclose it or any of its contents to any other person, and will return or destroy it upon the Company’s request. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the Company’s securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offer of securities will be made only to accredited investors pursuant to definitive transaction documents, which will supersede this presentation in its entirety. Any securities to be offered in any transaction contemplated hereby have not been 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 U.S. 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 EXEMPTIONS FROM THE REGISTRATION REQUIREMENTS PROVIDED BY THE SECURITIES ACT AND RULES AND REGULATIONS PROMULGATED THEREUNDER. Third-party and market data This presentation contains estimates and other information concerning the Company’s industry, its intended markets and the products of third parties, including estimated patient populations in PAH, secondary PH and other pulmonary indications and projected revenue and peak sales for Winrevair. Such information is derived from published literature, industry publications, analyst consensus estimates and the Company’s own internal estimates. The Company has not independently verified it and makes no representation or warranty as to its accuracy, completeness or timeliness. Estimates of patient populations, market size and revenue are inherently uncertain and subject to change. Information regarding third-party approved or investigational products, including Winrevair, imatinib, HS235 and REGN13335, and the clinical data presented for them, is derived from studies conducted by others under different protocols and in different patient populations. No head-to-head trials have been conducted, none of the Company’s product candidates has been evaluated in humans, and no clinical data of the Company are presented herein. Such information is provided for context only and should not be relied upon as evidence of the safety, efficacy or tolerability of any Company product candidate. Forward-looking statements and other information This presentation contains “forward-looking statements” within the meaning of applicable United States securities laws. Except for statements of historical fact, statements herein are forward-looking, including statements regarding: the Company’s business strategy, including its plan to develop therapies for pulmonary arterial hypertension (PAH), secondary pulmonary hypertension (PH) and other pulmonary disease, to expand into indications including PH-HFpEF, PH-ILD, PH-COPD, IPF, PPF and PH-sarcoidosis, and to develop combination therapies; the potential therapeutic benefit, mechanism of action, efficacy, safety, tolerability, dosing, route of administration and differentiation of VLR199, VLR247, VLR258, VLR360, VLR869 and VLR6109, including as compared to approved or investigational therapies; the Company’s discovery, preclinical and IND-enabling activities, the expected timing of IND or CTA filings, the initiation of clinical development in 2027 and proof-of-concept data in 2028; the expected timing and outcome of third-party catalysts; the anticipated benefits of the Company’s $250 million financing and the expectation that it will fund operations through key inflection points; estimated patient populations, market sizes, peak sales and potential value creation; the Company’s relationship with Paragon Laboratories; the composition of the Company’s management team, including the transition of acting officers to permanent roles; and management’s assessment of future plans and operations. Forward-looking statements are often identified by words such as “may”, “will”, “anticipate”, “believe”, “expect”, “intend”, “potential”, “estimate”, “plan”, “designed to” and “goal” or the negatives thereof. They are neither historical facts nor assurances of future performance, and involve known and unknown risks and uncertainties that may cause actual results to differ materially, including: the Company is a preclinical-stage company with a limited operating history that has not initiated any clinical trial; preclinical and animal model results, and the clinical results of third-party products, may not be predictive of results for the Company’s product candidates in humans; risks arising from regulatory feedback, including disagreement by regulatory authorities with the Company’s preclinical data package, proposed trial designs or interpretation of data; the Company’s dependence on Paragon Laboratories and other third parties for discovery, research, manufacturing and development; the Company’s reliance on an acting management team serving in an interim capacity and its ability to recruit and retain permanent personnel; risks that the financing may not be completed on the anticipated terms or at all; risks related to obtaining and protecting patent rights; the Company’s need to raise substantial additional capital; competition from companies with greater resources, including those developing ActRII-Fc and anti-PDGF-B therapies; macroeconomic conditions and changes in law, tariffs, sanctions or export controls; and the general uncertainties of drug development. All forward-looking statements are qualified by these cautionary statements. Although management believes the expectations conveyed herein are reasonable based on information available on the date such statements are made, there can be no assurance they will prove accurate, and actual results could differ materially. The Company undertakes no obligation to update forward-looking statements except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. Trademarks Trade names, trademarks, service marks and logos of other companies appearing in this presentation, including WINREVAIR™, are the property of their respective owners. Such marks may appear without the ® or ™ symbols solely for convenience, and their use is not intended to imply any relationship with, or endorsement or sponsorship of the Company by, the owner. Confidential 1
Transaction highlights Structure: The acquisition of Velaris was structured as a stock-for-stock transaction whereby all of Velaris’ outstanding equity interests were exchanged for a combination of shares of Alaunos common stock and newly created non-voting Series C convertible preferred stock. Financing: Concurrent with the acquisition of Velaris, Alaunos closed a $350 million private placement with a group of institutional accredited investors led by Fairmount and joined by a robust syndicate of dedicated biotechnology investors, as well as additional undisclosed institutional investors. Management and BOD: Peter Harwin from Fairmount is joining the Alaunos Board of Directors. Primary use of Proceeds: The proceeds from the private placement are expected to be primarily used to advance the Velaris pipeline, deliver on the anticipated milestones (POC data for VLR-199 and VLR-360, initial regulatory filings (e.g., IND) for VLR-247 and VLR-258), and to fund business operations. Proceeds may also fund work relating to Alaunos’ legacy preclinical obesity program and are expected to provide cash runway into 2029. Confidential
Capitalization Confidential As of 10/13/2026 Pre-merger Alaunos common stock outstanding (f.d.) 3,797,326 Merger consideration Shares of preferred 138,340 Preferred conversion ratio 1,000 Total common equivalent (Merger) 138,340,000 Concurrent financing Shares of common 687,789 Shares of preferred 243,063 Total common equivalent (Financing) 243,750,789 Deal price ($ per common share) $1.4357 Total capitalization (Common, as converted) 386,856,547 Market cap at deal price $555.41 million Shares of common stock and preferred stock were issued to Velaris security holders in exchange for all of Velaris’ outstanding equity interest. Shares of preferred stock were issued to Velaris shareholders and to investors in the $350 million private placement. Shares of Series C preferred stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership restrictions set by each holder. Please refer to the company’s SEC filings for additional information.
Program Discovery IND-enabling Clinical Ligand trap VLR199 IND or CTA 2H27 VLR247 IND or CTA 1H28* VLR258 Monoclonal antibody VLR360 IND or CTA 2H27 VLR869 Bispecific antibody VLR6109 Velaris is developing a pipeline of potentially transformative therapies for pulmonary hypertension and cardiopulmonary disease Initial focus on PAH where Winrevair (sotatercept-csrk) est. peak sales are $8B+ Expand into secondary PH, where there is substantial unmet need and mounting evidence for the utility of PAH drugs approved in these additional indications Develop combination therapies based on the leading biologics for PH Our Goals PAH: pulmonary arterial hypertension; Winrevair is a trademark of Merck; PH: pulmonary hypertension; *$250M financing supports either VLR247 or VLR258 moving into the clinic. Based on positive preclinical data, external catalysts, and additional capital we may advance both into the clinic. The agents listed above are currently under pre-clinical investigation. Their safety and effectiveness have not yet been established by any regulatory authority. Velaris is the 9th company launched with assets developed by Paragon ActRIIA-Fc: same MoA as Winrevair ActRIIA-Fc with BMP-9/10-sparing PDGF-B Undisclosed Undisclosed ActRIIB-Fc with BMP-9/10-sparing Confidential
Source: VisibleAlpha Winrevair’s rapid growth makes it one of the largest cardiopulmonary launches ever Projected Winrevair revenue in PAH Sales (US $M) Confidential Annualizing $2B two years into launch with current label for PAH alone $8B peak sales estimate in PAH alone ~$8B Winrevair is the only approved ActRII-Fc ligand trap for PAH with no other assets in late-stage development with the same MoA
PAH could be the tip of the iceberg in cardiopulmonary disease Large, untapped opportunity awaits in secondary PH and cardiopulmonary indications Estimated number of US patients No. patients (thousands) Secondary PH and cardiopulmonary disease 60-70K 120Ka 180Ka 250K 500Kb 30-50K PAH PH-ILD IPF PPF PH-COPD PH-HFpEF Winrevair established PoC: Confidential ~$8B Peak Sales Estimate a) all IPF & PPF patients exclusive of PH status (reflects Tyvaso development); b) Combined pre- and post-capillary PH subgroup. PAH: Pulmonary Arterial Hypertension. PH-ILD: Pulmonary Hypertension associated with Interstitial Lung Disease. IPF: Idiopathic pulmonary fibrosis. PPF: Progressive Pulmonary Fibrosis. PH-COPD: Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease. HFpEF: heart failure with preserved ejection fraction. Source: Kirson 2011 Curr Med Res Opinion. Jeganathan 2022 ERJ Open. Kacprzak 2023 Diagnostics. Fan 2026 Ann Am Thor Soc. Olson 2021 Adv Ther. Nathan 2024 Eur Resp J. Zhang 2022 Int J COPD; Company estimates
Pulmonary vascular remodeling from imbalanced growth signaling is a shared pathology across PH groups Confidential Interstitial lung disease PH-lung disease (Group 3) PAH (Group 1) (e.g., PH-ILD, PH-COPD, PH-IPF, PH-PPF) PH-HFpEF (Group 2) Healthy PH Left-sided heart failure (e.g., Cpc-PH-HFpEF, Ipc-PH-HFpEF) Distinct etiologies converge on distal pulmonary arterial remodeling Vessels narrow and stiffen, making the heart work harder to push blood through the lungs That remodeling is in part driven by lost signaling balance; pro-proliferative activins overwhelm anti-proliferative BMP-9/10 Ligand traps help restore balance, while PDGF-B inhibition blocks a distinct, complementary proliferative driver PH: pulmonary hypertension, PAH: Pulmonary Arterial Hypertension, PH-ILD: Pulmonary Hypertension associated with Interstitial Lung Disease, IPF: Idiopathic pulmonary fibrosis, PPF: Progressive Pulmonary Fibrosis, PH-COPD: Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease. HFpEF: heart failure with preserved ejection fraction, Ipc: isolated precapillary, Cpc: combined pre- and post-capillary
Anti-PDGF-B is a distinct MoA from Winrevair’s Velaris is pursuing multiple potentially best-in-class therapies with pipeline-in-a-product potential Confidential Multiple ligand trap approaches yield distinct opportunities with potential to improve on Winrevair and command PH market share VLR199 Designed to replicate Winrevair’s clinically proven ActRIIA MoA, with broad ligand activity Potential for dose optimization to improve benefit-risk profile SC autoinjector at launch VLR247 & VLR258 Designed to spare ligands BMP-9, BMP-10, lower risk of hematologic AEs ActRIIA and ActRIIB backbone options to optimize activity Half-life extended for less frequent SC dosing VLR360 Designed to replicate imatinib’s PAH efficacy without off-target kinase side effects Designed to extend half-life for less frequent SC dosing MoA: mechanism of action
VLR199 is designed to replicate Winrevair’s proven pharmacology Confidential ActRIIA extracellular domain, with broad ligand trapping activity Fc domain of human IgG1 BMP-10 BMP-9 Activin A Activin B GDF-8 GDF-11 Anti-proliferative Pro-proliferative VLR199 Inhibitory profile matches Winrevair Winrevair Exemplary VLR199 lead VLR199 designed to preserve the balance of Winrevair across several ligand targets No clinical head-to-head studies have been conducted between VLR199 and Winrevair. As a result, cross-study comparisons cannot be made.
Velaris pipeline is designed to improve on areas where Winrevair may not be fully optimized Confidential Potential Ability to Differentiate Area for optimization Potential Velaris initiatives VLR199 VLR247 VLR258 Dosing Winrevair titrated from 0.3 to 0.7 mg/kg Q3W Comprehensive dose-ranging for optimal benefit-risk tradeoff; ability to improve on AE and tolerability profile Auto-injector development from the outset of clinical studies; improving on vial and syringe profile Dosing frequency improvements from uncommon q3wk schedule Safety Winrevair USPI warning for elevated risk of bleeding (De)tuned BMP9/10 potency to potentially expand the therapeutic window; reduce hematologic AEs, dose limits, and monitoring requirements Activin signaling inhibition leaves multiple avenues for meaningful improvement
ActRIIA extracellular domain (similar to Winrevair) Fc domain of human IgG1 VLR247 Inhibitory profiles for lead spares BMP-9/10 Winrevair HS235 VLR258 exemplary lead VLR258 Both designed to be BMP-9/10-sparing ActRIIB extracellular domain (similar to HS235*) Confidential Velaris is pursuing multiple approaches to optimize activity beyond VLR199 VLR247 & VLR258 inhibit key activin-signaling ligands while sparing BMP-9/10, targets linked to hematological AEs Relative IC50 BMP-9 BMP-10 More ligand sparing 17x 1x 1x 3.5x 13x 19x * HS235 is BMP-9/10-sparing ActRIIB-Fc ligand trap acquired by GSK; now known as GSK6792070. No clinical head-to-head studies have been conducted among Winrevair, HS235, and VLR258. As a result, cross-study comparisons cannot be made.
VLR360 targets PDGF-B, an emerging target with potential as a monotherapy… Confidential VLR360 Anti-PDGF-B activity Potential for greater potency than REGN13335 Fc-modified for half-life extension Potential for less frequent dosing than REGN13335 Highly selective for PDGF-B Potential to avoid off-target effects observed with imatinib VLR360 is a potentially best-in-class mAb targeting PDGF-B* PDGF-B signaling leads to vascular remodeling and progression of PH Imatinib demonstrated promising clinical efficacy, likely due to PDGFR inhibition, but it was limited in PAH by off-target toxicity REGN’s anti-PDGF-B antibody was well tolerated in a recent Phase 1 HV study VLR360 could be developed as a potential monotherapy or in combination with ActRII-Fc ligand traps PDGF: Platelet Derived Growth Factor, Imatinib: an oral tyrosine kinase inhibitor, HV: healthy volunteer; *VLR360 is currently under pre-clinical investigation, and it has not been evaluated in human clinical trials. Source: Hoeper et al., 2013. Circulation. Fredenburgh LE et. al. ERS 2026
…and has been engineered with combination potential in mind Confidential Combinations are foundational to the pulmonary treatment paradigms VLR199 Designed to replicate Winrevair’s proven pharmacology Designed to optimize ActRII-Fc tolerability VLR360 Designed to replicate imatinib’s effects without side effects VLR869 and VLR6109 Undisclosed Additional antibodies, Fc-conjugates VLR199, VLR247, VLR258 optimized as monotherapies; designed to be foundation for high-impact combos
PAH Provides a Path to Rapid PoC and Clinical Development
PAH offers Velaris a potentially efficient development path, including a small initial study that could demonstrate PoC Confidential n ≈ 20 - 30 Healthy Volunteers Activin signaling inhibition offers specific PD biomarkers (e.g., FSH) and on-target heme changes Extensive Winrevair precedent enables Velaris to target proven activity levels early in development Design to be informed by Phase 1 data and Winrevair precedent PAH Patients Established hemodynamic endpoints (PVR) allow early signal detection; low placebo PVR responses enable small Phase 2 studies The validated regulatory pathway and Winrevair precedents provide an anticipated clear path for trial design and endpoints Recent examples (e.g. Roivant, Inhibikase, Aerovate) demonstrate the ability to quickly accelerate from Phase 2 into Phase 3 registrational studies Phase 1: PoC Anticipated Efficient Path to Registrational Phase 2/3 Studies VLR199, VLR247, VLR258 will pursue a derisking strategy ahead of registrational studies PVR: pulmonary vascular resistance
Multiple PD markers anticipated to provide early confidence in clinical similarity to Winrevair FSH decrease (in postmenopausal women) Hgb changes BSAP increase Early HV PK/PD data expected to enable dose matching to Winrevair, potentially supporting Winrevair-like activity in Phase 2/3 Activin signaling inhibition reveals biomarker changes in early healthy volunteer studies Confidential Winrevair dose-dependently lowers serum FSH Pbo 0.1 0.3 1.0 3.0 (mpk) Winrevair Source: Ruckle et al., 2009 JBMR (day 8 data); FSH: follicle-stimulating hormone, Hgb: Hemoglobin, BSAP: bone-specific alkaline phosphatase. HV: healthy volunteer
Heart Failure with preserved Ejection Fraction (HFpEF), Group 2 PH, is a blockbuster expansion indication
Activin signaling inhibition is the only PAH MoA to show early signs of efficacy in the larger PH-HFpEF population Confidential PH-HFpEF (Group 2 PH): Results after left-sided heart failure causes progressive, pulmonary vasculature changes comparable to PAH Market size markedly larger than PAH No approved therapies; vasodilator agents cause harm, unable to address both the lung and heart Winrevair is only agent to demonstrate early signs of success: Improved 6MWD Lowered time to clinical worsening Improved key biomarkers in both lung and heart (i.e. PVR, wedge pressure) PH HFpEF: heart failure with preserved ejection fraction
Winrevair is only PAH agent to demonstrate efficacy signal in PH-HFpEF Winrevair advancing to Phase 3 with lower (0.3 mg/kg) dose Velaris has potential to efficiently advance into late-stage studies HFpEF: Winrevair has shown early signs of efficacy in heart failure, a potentially ~10x larger population than PAH Confidential 2024: Approved in PAH Probability of event-free survival Placebo Winrevair Time to death or clinical worsening Phase 3 STELLAR (0.7 mpk) Time (weeks) Placebo Winrevair Time (weeks) % without events 2026: Completed Ph 2 trial in PH-HFpEF Time to clinical worsening Phase 2 CADENCE (0.3 mpk arm) 95% patients on double or triple background therapy HR: 0.16 HR: 0.18 Hoeper et al., 2023 NEJM. Gomberg-Maitland et al., Circulation 2026. 0.3 mg/kg arm. HFpEF: heart failure with preserved ejection fraction
Potential expansion into Group 3 PH and adjacent indications
PAH drugs have demonstrated utility in the large markets of PH-ILD and pulmonary fibrosis Confidential PH-ILD (Group 3) and pulmonary fibrosis share in common underlying lung parenchyma disorder Some PAH drugs have demonstrated efficacy, showing the path, but leaving remaining unmet need Activin signaling inhibition has potential to deliver additional efficacy in these populations Considered one of the most effective in PAH Clear mechanistic rationale Surrogate endpoints offer potential for efficient paths to signal generation and clinical PoC PH PAH: Pulmonary Arterial Hypertension, PH-ILD: Pulmonary Hypertension associated with Interstitial Lung Disease, IPF: Idiopathic pulmonary fibrosis, PPF: Progressive Pulmonary Fibrosis, PH-COPD: Pulmonary Hypertension associated with Chronic Obstructive Pulmonary Disease
PAH drugs have an established path into PH-ILD and pulmonary fibrosis Confidential Prostacyclin sGC PAH Tyvaso Mosliciguat PH-ILD Pulmonary Fibrosis Est. Addressable US Pts 30-50K 60-70K 300K FDA Approval 2009 FDA Approval 2021 Two Positive IPF Ph3s 2025 & 2026 + PPF Ph3 Est. 2027 Potential Indication Expansion Ph1b PVR Data 2024 Deliberately rapid clinical development IPF: idiopathic pulmonary fibrosis, PPF: Progressive pulmonary fibrosis, PVR: pulmonary vascular resistance, 6MWD: 6-minute walk distance
Given Winrevair’s superior efficacy in PAH, evaluating the activin MoA in lung disease is a compelling opportunity Confidential Improvement in exercise capacity TRIUMPH (Tyvaso), STELLAR (Winrevair) For illustrative purposes only; no H2H study was conducted Tyvaso Winrevair Pbo-adj D 6MWD (m) 12 wk 24 wk ISTs and KOLs indicate successful use of Winrevair beyond PAH Clinical interviews, retrospective analyses and case reports for Winrevair in patients with PH or other lung diseases today resemble the early signs that preceded Tyvaso’s expansion Endpoints in these expansion opportunities – similar to PAH – are amenable to early signal detection and efficient derisking (FVC) H2H: head-to-head, IST: investigator-sponsored trial, FVC: forced vital capacity, MoA: mechanism of action. Source: Tyvaso TRIUMPH data (FDA), Winrevair Hoeper et al., 2023 NEJM
Velaris programs expected to enter clinic in 2027 with key clinical PoC data expected in 2028 Confidential 2027 2028 VLR199 (ActIIRA-Fc) IND/CTA (2H) PoC data VLR247 (ActIIRA-Fc BMP9/10 sparing) IND/CTA (1H)* VLR258 (ActIIRB-Fc BMP9/10 sparing) VLR360 (anti-PDGF-B) IND/CTA (2H) PoC data External catalysts Merck Winrevair (ActIIRA-Fc) Phase 3 ongoing (PH-HFpEF) GSK HS235 (ActIIRB-Fc BMP9/10 sparing) Phase 1b/2 data (PAH) Phase 1b/2 data (PH-HFpEF) Phase 3 initiation (PAH) Regeneron REGN13335 (anti-PDGF-B) Phase 2 data (PAH) $350M financing anticipated to provide runway through key inflection points *$250M financing supports either VLR247 or VLR258 moving into the clinic. Based on positive preclinical data, external catalysts, and additional capital we may advance both into the clinic.
Company led by an experienced leadership team Confidential Robert Postma Board member Watermill Asset Management Corporation Holger Weis Chairman Michael Jerman Board member Hollywell Partners Jaime Vieser Board member Brushwood, Castle Hill Asset Management Peter Harwin Incoming Board member Fairmount Board of Directors Management Team Holger Weis, BBA, CPA Chief Executive Officer, Alaunos Michael Henderson, MD President,Velaris CEO Paragon Labs
Alaunos Therapeutics Announces Acquisition of Velaris Therapeutics
Acquisition of Velaris and concurrent oversubscribed $350 million private placement positions the Company to deliver multiple proof-of-concept datasets in pulmonary arterial hypertension
Velaris Therapeutics, the ninth company launched based on Paragon-discovered assets, is advancing a pipeline built to address growth signaling imbalances that drive pulmonary vascular remodeling in PAH and secondary pulmonary hypertension (PH), including PH due to heart failure with preserved ejection fraction
Velaris is developing a broad pipeline of ActRII-Fcs and an anti-PDGF-B antibody, designed to be developed as monotherapies or in combination, across cardiopulmonary indications
The Company is expected to have financial runway into 2029 to support multiple data milestones, including clinical proof-of-concept data for VLR199 in 2028
FORT LAUDERDALE, Fla., October 13, 2026 – Alaunos Therapeutics, Inc. (NASDAQ: TCRT) ("Alaunos" or the “Company”) announced today the completion of the acquisition of Velaris Therapeutics, Inc. (“Velaris”), a privately-held biotechnology company advancing a pipeline of potentially transformative therapies for pulmonary arterial hypertension (“PAH”) and related cardiopulmonary diseases. The acquisition gives the Company a portfolio of ActRII-Fc ligand traps and complementary biologics designed to address the underlying signaling imbalances that drive remodeling of the pulmonary vasculature in multiple cardiopulmonary conditions.
A concurrent private placement of Series C non-voting convertible preferred stock (the “Private Placement”) was led by Fairmount with participation from Venrock Healthcare Capital Partners, certain accounts advised by T. Rowe Price Investment Management, Inc., Wellington Management, Janus Henderson Investors, Access Biotechnology, BB Biotech, Perceptive Advisors, Sirenia Capital Management LP, ADAR1 Capital Management and other leading investment management firms. The private placement resulted in gross proceeds to Alaunos of approximately $350 million and is expected to fund operations into 2029, enabling the generation of key proof-of-concept data sets for VLR199 and VLR360, as well as through initial regulatory filings for VLR247 and VLR258.
Velaris is the ninth company launched based on assets discovered by Paragon. The lead program, VLR199, is an ActRIIA-Fc ligand trap designed to replicate the clinically validated pharmacology of the only approved activin-signaling inhibitor for the treatment of PAH and improve on the existing therapy where it is not fully optimized. Velaris’s pipeline additionally includes VLR247 and VLR258, two ActRII-Fc ligand traps based on ActRIIA and ActRIIB, respectively, engineered to spare ligands BMP-9 and BMP-10, which have been associated with hematologic adverse events. Together, this suite of product candidates is designed to provide significant optionality for Velaris to maximize the potential of activin-signaling inhibition. Velaris is also developing VLR360, an anti-PDGF-B monoclonal antibody targeting a complementary
signaling pathway implicated in PAH. VLR360 and the ActRII-Fcs are designed to be developed as monotherapies or in combination, providing Velaris with the opportunity to address multiple underlying signaling imbalances that drive pulmonary vascular remodeling in PAH and related cardiopulmonary conditions.
“We aim to transform the treatment of pulmonary hypertension, starting with PAH”, said Michael Henderson, MD, President of Velaris. “PAH and secondary pulmonary hypertension, including PH due to heart failure with preserved ejection fraction (PH-HFpEF) and interstitial lung disease (PH-ILD), significantly affect the lives of hundreds of thousands living with these conditions in the United States and even more globally. With these indications sharing the imbalanced growth signaling that drives PAH and mounting evidence demonstrating that effective PAH therapies also have utility in secondary PH, we believe the time is right for Velaris. We’ve built a capital-efficient plan to rapidly achieve proof-of-concept in PAH and demonstrate value. With a pipeline built to provide optionality around ligand traps, to address complementary signaling pathways, and to offer compelling follow-on opportunities beyond PAH, we are excited for this next chapter."
“Since our founding, Alaunos has been committed to advancing innovative therapies designed to improve outcomes for patients,” said Holger Weis, CEO and Chairman of the Board of Directors of Alaunos. “We are pleased to announce the acquisition of Velaris. We believe this transaction and the concurrent private placement provide a strong financial foundation for us to advance an exciting pipeline and offer our stockholders a compelling opportunity to realize value, with proof-of-concept data for VLR199 expected in 2028.”
Management & Organization:
In conjunction with the transaction, Peter Harwin, Founding Partner of Fairmount, will join the Board of Directors for Alaunos.
Alaunos intends to hold a meeting of its stockholders to approve, among other things, the conversion of the non-voting convertible preferred stock issued in the transactions into common stock. Effective upon receipt of that approval, three of Alaunos’ current directors will resign from the Board of Directors and three directors designated by Fairmount will be appointed to fill the resulting vacancies, such that Peter Harwin and the Fairmount designees will constitute four of the five members of the Board of Directors. In addition, following receipt of that approval, the holders of Alaunos’ Series B non-voting convertible preferred stock, voting as a separate class, will be entitled to elect two of Alaunos’ five directors (initially, Peter Harwin and one of the Fairmount designees) for so long as at least 30% of the originally issued Series B non-voting convertible preferred stock remains outstanding.
About the Acquisition and Financing Transaction
The acquisition was approved by the Board of Directors of Alaunos and the Board of Directors and stockholders of Velaris. The closings of the transactions are not subject to the approval of Alaunos’ stockholders. On an as-converted basis and after accounting for these transactions (and without giving effect to any beneficial ownership limitations or reverse stock split), the total number of shares of Alaunos common stock will be approximately 358.59 million.
Cantor is serving as financial advisor to Alaunos. Sichenzia Ross Ference Carmel LLP is serving as legal counsel to Alaunos. Wedbush Securities Inc. is serving as strategic financial advisor to Velaris. Jefferies, TD Cowen, Stifel, UBS Investment Bank, and Wedbush & Co., LLC are serving as the placement agents to Velaris, and Gibson, Dunn & Crutcher LLP is serving as legal counsel to Velaris.
About Alaunos Therapeutics
Alaunos Therapeutics is a biotechnology company focused on developing novel therapeutics. The Company’s obesity and metabolic disorders program is advancing ALN1003, an oral small-molecule candidate being evaluated as a potential differentiated, non-hormonal, non-incretin approach for obesity- and metabolic-disease-relevant biology.
About Velaris Therapeutics
Velaris Therapeutics is a biotechnology company advancing a pipeline of potentially transformative therapies for pulmonary hypertension and related cardiopulmonary diseases. Velaris is developing ActRII-Fc ligand traps and complementary biologics designed to maximize the potential of these classes of therapies. VLR199, with broad ligand activity, is designed to replicate clinically validated pharmacology but improving where it is not fully optimized. VLR247 and VLR258, featuring distinct ActRII extracellular domains, are designed to spare BMP-9 and BMP-10 and lower risk for hematologic adverse events. The pipeline also features VLR360, an anti-PDGF-B monoclonal antibody, which offers a complementary approach that alone or in combination with the ActRII-Fcs is designed to address the signaling imbalances that drive remodeling of the pulmonary vasculature. Velaris’ assets were discovered by Paragon Labs. Velaris is based in Waltham, MA. For more information, visit velaristx.com.
About Paragon Labs
Paragon Laboratories, Inc. (“Paragon Labs” and together with its predecessor, “Paragon”) is a biotechnology company applying cutting-edge science and technology to shape the next generation of novel, best-in-class biologics for major medical needs. Paragon is fueling a pipeline of transformative therapies that are positioned to be rapidly advanced into clinical development. To date, nine companies have been launched based on assets discovered by Paragon. Founded by Fairmount, Paragon is based in Waltham, MA. For more information, please visit www.paragonlabs.com. Follow us on LinkedIn.
Forward-Looking Statements
Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to the Company’s expectations, hopes, beliefs, intentions or strategies regarding the future of the acquired assets, pipeline and business including, without limitation, the anticipated meeting of Alaunos’ stockholders and the expected changes to the composition of the Board of Directors following receipt of stockholder approval, the Company’s ability to achieve the expected benefits or opportunities with respect to its product candidates, including whether the product candidates will achieve clinical proof of concept. In addition, any statements that refer to
projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting the Company will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond the Company’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Alaunos’ stockholders do not approve the conversion of the preferred stock and the related matters to be voted on at the stockholder meeting, and those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s most recent filings with the SEC. Should one or more of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. The Company does not undertake or accept any duty to make any updates or revisions to any forward-looking statements.
Additional Information and Where to Find It
This press release does not constitute a solicitation of any vote or approval. Alaunos intends to file with the U.S. Securities and Exchange Commission (the “SEC”) a proxy statement and other relevant materials in connection with the meeting of its stockholders described above. ALAUNOS’ STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT ALAUNOS, THE MATTERS TO BE VOTED ON AT THE MEETING AND RELATED MATTERS. Stockholders may obtain free copies of the proxy statement and other documents filed by Alaunos with the SEC, when available, through the SEC’s website at www.sec.gov or Alaunos’ website at www.alaunos.com.
Participants in the Solicitation
Alaunos and its directors and executive officers, and Fairmount and its designees to the Board of Directors, may be deemed to be participants in the solicitation of proxies from Alaunos’ stockholders in connection with the matters to be voted on at the meeting. Information regarding Alaunos’ directors and executive officers is included in Alaunos’ Annual Report on Form 10-K for the year ended December 31, 2025, as amended, filed with the SEC. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant materials to be filed with the SEC when they become available.
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