Abeona Therapeutics acquires ABO-801 assets for $20M in stock
Abeona Therapeutics Inc. completed its acquisition of substantially all assets related to Ellodi’s APT-1011, now ABO-801, on November 6, 2026, issuing 4,494,383 common shares valued at $20 million with no upfront cash consideration.
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Rhea-AI Filing Summary
Abeona Therapeutics Inc. completed its acquisition of substantially all assets related to Ellodi’s APT-1011, now ABO-801, on November 6, 2026, issuing 4,494,383 common shares valued at $20 million with no upfront cash consideration. Ellodi may receive $30 million upon FDA approval, up to $30 million for sales milestones, and tiered royalties ranging from low to mid teen percentages on net sales.
ABO-801 is a once-daily oral disintegrating tablet candidate for eosinophilic esophagitis. Neither completed Phase 3 study met the prespecified co-primary patient-reported symptom endpoint, though both showed statistically significant improvements in several endoscopic measures. Abeona anticipates starting another Phase 3 study in Q2 2027 and, subject to study initiation and enrollment, expects topline results by the end of 2028.
Abeona also entered a private placement for approximately $30 million, expected to close November 10, 2026, comprising 6,400,000 common shares and pre-funded warrants to purchase 1,600,043 shares. Net proceeds are intended for general corporate purposes, including pipeline development and ZEVASKYN commercialization. Warrant exercises are subject to a 9.99% beneficial-ownership cap, which a holder may increase to 19.99% with 61 days’ prior notice.
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.
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Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- None.
Negative
- Major pointBoth completed Phase 3 studies missed the co-primary patient-reported symptom endpoint.
Filing Explained
Of the 4,494,383 shares Abeona issued to Ellodi, 337,079 are outside the lock-up; the remaining shares are subject to releases on the six-, 12- and 18-month anniversaries, and Abeona agreed to register all shares for resale, subject to stated conditions and limits.
8-K Event Classification
Key Figures
Key Terms
pre-funded warrants financial
Expanded Access Program medical
Orphan Drug designation regulatory
New Drug Application regulatory
patient-reported symptom endpoint medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much is ABEO’s private placement?
What does Ellodi receive under ABEO’s APT-1011 acquisition agreement?
What ownership cap applies to ABEO’s pre-funded warrants?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date
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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 (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d 2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
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
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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.
Asset Purchase Agreement
On November 6, 2026 (the “Closing Date”), Abeona Therapeutics Inc. (the “Company”) entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Ellodi Pharmaceuticals, L.P., a Delaware limited partnership (“Ellodi”), pursuant to which Ellodi sold and assigned to the Company, and the Company purchased and assumed from Ellodi, substantially all assets related to the research, development, manufacture, and commercialization of Ellodi’s clinical-stage development candidate known as APT-1011 (the “Transaction”). APT-1011 is designed to treat eosinophilic esophagitis (EoE), a chronic, progressive inflammatory disease that can cause esophageal strictures, leading to a variety of symptoms including dysphagia and food impaction. APT-1011, which has been evaluated in a Phase 3 clinical trial in healthy volunteers, is an orally disintegrating tablet formulation containing fluticasone propionate as its active pharmaceutical ingredient.
Pursuant to the Asset Purchase Agreement, the Company issued to Ellodi $20 million in value of Company common stock, par value $0.01 per share (the “Common Stock”), which amounted to 4,494,383 shares (the “Upfront Shares”), based on the 20-trading-day volume weighted average price of the Company’s Common Stock ending on the trading day immediately before the Closing Date. No upfront cash consideration is being paid to Ellodi. In addition, the Company is obligated to pay Ellodi (i) payments of $30 million upon FDA approval of a New Drug Application for APT-1011 and up to $30 million upon the achievement of certain sales milestones, and (ii) certain royalty payments based on the net sales of APT-1011 with royalty percentage tiers ranging from low to mid teen percentages. The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last Valid Claim (as defined in the Asset Purchase Agreement) of any transferred patent right that covers such product in such country, (b) expiration of Regulatory Exclusivity for such product in such country, or (c) the seventh anniversary of the first commercial sale of such product in such country.
The issuance of the Upfront Shares has not been registered under Securities Act of 1933, as amended (the “Securities Act”), and were issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Rule 506(b) of Regulation D promulgated thereunder. The Seller has represented that it is an “accredited investor” as defined in Rule 501 of Regulation D and is acquiring the Upfront Shares solely for its own account for investment purposes and not with a view to, or for offer or sale in connection with, any distribution thereof.
Also pursuant to the Asset Purchase Agreement, the Upfront Shares will be subject to a staggered lock-up, whereby Seller will not, directly or indirectly, sell, transfer, pledge, hedge, lend, short, encumber or otherwise dispose of any Upfront Shares, with one-third of such Upfront Shares released from the lock-up on each of the 6-month, 12-month and 18-month anniversaries of the Closing (each, a “Lockup Release Date”), provided that 337,079 of the Upfront Shares will not be subject to any lockup but shall remain subject to the securities laws.
The Asset Purchase Agreement contains customary representations, warranties, covenants and indemnification provisions. Both Ellodi and the Company have agreed to indemnify the other party for losses arising from certain breaches of the Asset Purchase Agreement and other specified liabilities. The indemnification provisions are subject to certain limitations with respect to recovery for losses.
The representations, warranties and covenants set forth in the Asset Purchase Agreement have been made only for purposes of the Asset Purchase Agreement and solely for the benefit of the parties thereto. Moreover, certain of those representations and warranties may not be accurate or complete as of any specified date, may be modified in important part by the underlying disclosure schedules that are not filed publicly, may be subject to a contractual standard of materiality different from those generally applicable to Securities and Exchange Commission filings or may have been used for purposes of allocating risk among the parties to the Asset Purchase Agreement, rather than establishing matters of fact. In addition, information regarding the subject matter of the representations, warranties and covenants made in the Asset Purchase Agreement may change after the date of the Asset Purchase Agreement and do not purport to be accurate as of the date of this Current Report on Form 8-K.
In addition, on the Closing Date, the Company entered into a Registration Rights Agreement (the “Ellodi RRA”) with Ellodi pursuant to which, among other things, and subject to certain limitations set forth therein, Ellodi has customary demand registration rights and the Company is obligated to prepare and file a registration statement registering the offer and sale of all of the Upfront Shares. These registration rights are subject to certain conditions and limitations, including the Company’s right to delay or withdraw a registration statement under certain circumstances.
The foregoing summaries of the terms of the Asset Purchase Agreement and the Ellodi RRA are qualified in their entirety by reference to the full text of the Asset Purchase Agreement, a copy of which the Company expects to file as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2026, and the Ellodi RRA, which is filed as Exhibit 4.1 to this Current Report on Form 8-K.
The Company has determined that the Transaction does not constitute the acquisition of a business as defined in Rule 11-01(d) of Regulation S-X.
Private Placement
On November 6, 2026, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with a group of investors (the “Purchasers”) providing for the private placement (the “Private Placement”) to the Purchasers of (i) 6,400,000 shares of Common Stock (the “Private Placement Shares”), and (ii) pre-funded warrants to purchase 1,600,043 shares of Common Stock (the “Pre-Funded Warrants”, and together with the Private Placement Shares, the “Private Placement Securities”), for an aggregate purchase price of approximately $30 million. Each Pre-Funded Warrant has an exercise price of $0.0001 per share of Common Stock. The closing of the Private Placement is expected to occur on November 10, 2026 (the “Private Placement Closing”).
The Pre-Funded Warrants may not be exercised if the aggregate number of shares of the Common Stock beneficially owned by the holder thereof would exceed 9.99% immediately after exercise thereof, which ownership cap may be increased by the holder up to 19.99% upon 61 days’ prior notice.
The Company intends to use the net proceeds from the Private Placement for general corporate purposes, including funding the development of the Company’s product candidate pipeline and supporting commercialization efforts for ZEVASKYN®.
The securities issued to the Purchasers under the Securities Purchase Agreement were offered in reliance on an exemption from registration provided by Section 4(a)(2) of the Securities Act. The Company relied on this exemption from registration based in part on representations made by the Purchasers, including that each of the Purchasers is an “accredited investor”, as defined in Rule 501(a) promulgated under the Securities Act and are acquiring the Private Placement Securities solely for their own account for investment purposes and not with a view to, or for offer or sale in connection with, any distribution thereof.
Morgan Stanley & Co. LLC served as the placement agent in connection with the Private Placement, and the Company has agreed to pay Morgan Stanley & Co. LLC a customary fee plus reimbursement for certain out-of-pocket expenses.
The sale of the securities pursuant to the Securities Purchase Agreement has not been registered under the Securities Act or any state securities laws. The securities may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the securities described herein or therein.
The Company and the Purchasers will enter into a Registration Rights Agreement immediately prior to the Closing (the “Private Placement RRA”), pursuant to which the Company will agree to prepare and file a registration statement with the Securities and Exchange Commission no later than the 15 days following the execution of the Private Placement RRA to register the resale of the shares of Common Stock and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants.
The foregoing summaries of the terms of the Securities Purchase Agreement, the Pre-Funded Warrants, and the Private Placement RRA are qualified in their entirety by reference to the form of Securities Purchase Agreement, form of Pre-Funded Warrant, and form of Private Placement RRA, respectively, which are filed as Exhibits 10.1, 4.2, and 4.3, respectively, to this Current Report on Form 8-K and are incorporated by reference herein.
Item 2.01. Completion of Acquisition or Disposition of Assets.
The information contained above in Item 1.01 is hereby incorporated by reference into this Item 2.01.
Item 3.02. Unregistered Sales of Equity Securities.
The information contained above in Item 1.01 is hereby incorporated by reference into this Item 3.02.
Item 7.01. Regulation FD Disclosure
On November 9, 2026, the Company issued a press release announcing the Transaction. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Also on November 9, 2026, the Company disseminated an investor presentation titled “APT-1011 Clinical Development History.” A copy of the investor presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K. The Company expressly disclaims any obligation to update or revise any of the information contained in the investor presentation. The investor presentation is available on the Company’s website located at www.abeonatherapeutics.com, although the Company reserves the right to discontinue that availability at any time.
The information in Item 7.01 of this Current Report on Form 8-K (including Exhibits 99.1 and 99.2) shall not be deemed “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, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 4.1 | Registration Rights Agreement, dated November 6, 2026, between Abeona Therapeutics Inc. and Ellodi Pharmaceuticals, L.P. | |
| 4.2 | Form of Pre-Funded Warrant to Purchase Common Stock | |
| 4.3 | Form of Registration Rights Agreement, by and among Abeona Therapeutics Inc. and certain investors signatory thereto | |
| 10.1 | Form of Securities Purchase Agreement, by and among Abeona Therapeutics Inc. and certain investors signatory thereto | |
| 99.1 | Press Release dated November 9, 2026 | |
| 99.2 | Investor Presentation titled “APT-1011 Clinical Development History” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
| Abeona Therapeutics Inc. | ||
| (Registrant) | ||
| By: | /s/ Joseph Vazzano | |
| Name: | Joseph Vazzano | |
| Title: | Chief Financial Officer | |
Date: November 9, 2026
Exhibit 99.1
Abeona Therapeutics® Acquires Phase 3-Ready APT-1011, Now ABO-801, and Enters Into Agreement for $30 Million Private Placement
- Adds a once-daily, oral therapy candidate for eosinophilic esophagitis with FDA Orphan Drug and Fast Track Designations –
– ABO-801 acquired for $20 million equity consideration at closing with no upfront cash payment –
– Private placement financing includes leading life sciences investors –
CLEVELAND, November 9, 2026 – Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the acquisition of APT-1011 (now ABO-801), a product candidate for eosinophilic esophagitis (EoE), from Ellodi Pharmaceuticals, and entered into a securities purchase agreement for a $30 million private placement financing. The acquisition, with no upfront cash consideration and the private placement financing, reflects Abeona’s disciplined approach to capital allocation.
“The acquisition of ABO-801 is an important step in building Abeona into a diversified commercial-stage company with multiple opportunities for value inflection, adding an asset with substantial revenue potential in a rapidly growing disease,” said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics. “ABO-801 brings an established clinical foundation, with learnings from two completed Phase 3 studies that inform the design of the planned Phase 3 study. We believe Abeona is well positioned to advance a differentiated and convenient potential treatment for people living with EoE.”
“We are excited to partner with Abeona as ABO-801 advances into its next stage of development. We have strong conviction in the team and the opportunity and believe ABO-801 has the potential to offer a differentiated profile in EoE, supported by once-daily dosing and low systemic exposure,” said Lucian Iancovici, M.D., Partner, TPG.
ABO-801
Overview
Potential to address an important need in EoE. ABO-801 is a once-daily oral disintegrating tablet formulation of fluticasone propionate being developed for EoE, a chronic inflammatory disease of the esophagus characterized by symptoms including difficulty swallowing and food impaction. Approximately 360,000 patients in the United States have been diagnosed with EoE.
ABO-801 is designed to dissolve rapidly in the mouth and deliver topical corticosteroid therapy directly across the esophagus, with very low systemic exposure. Its once-daily formulation is intended to provide a convenient option for chronic disease management while limiting systemic corticosteroid exposure. ABO-801 has received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of EoE
Extensive clinical foundation. ABO-801 has been evaluated in a 24-patient Phase 1/2a study, a 106-patient Phase 2b dose-ranging study and two completed Phase 3 studies that enrolled a combined 361 patients, with additional longer-term treatment experience through an Expanded Access Program involving 265 cumulative participants. Across the clinical program, ABO-801 has demonstrated histologic and endoscopic activity, with encouraging evidence of symptomatic activity and a favorable safety profile. Although neither Phase 3 study met its prespecified co-primary patient-reported symptom endpoint, both demonstrated statistically significant improvements in several endoscopic measures and yielded important insights that are informing the design of a planned future Phase 3 study. Abeona anticipates initiating the planned Phase 3 study in the second quarter of 2027 and, subject to the timing of study initiation and enrollment, currently anticipates topline results by the end of 2028.
Transaction Terms and Private Placement Financing
Disciplined asset-purchase structure. Under the terms of the asset purchase agreement, Abeona agreed to issue Ellodi $20 million of Abeona common stock, with no upfront cash consideration. Ellodi is also eligible to receive payments of $30 million upon FDA approval of ABO-801 and up to an additional $30 million upon achievement of specified sales milestones. In addition, Ellodi is eligible to receive tiered royalties on net sales of ABO-801 ranging from low to mid teen percentages.
$30 million PIPE financing. Abeona entered into a securities purchase agreement with a group of investors for a private placement of 6,400,000 shares of common stock at a purchase price of $3.75 per share and pre-funded warrants to purchase up to 1,600,043 shares of common stock at a purchase price of $3.7499 per pre-funded warrant, expected to result in $30 million in gross proceeds before fees and expenses.
The financing included participation from leading life sciences investors, including current shareholder Nantahala Capital, along with Marshall Wace, Monashee Investment Management, Perceptive Advisors, TPG, and a group of leading healthcare-focused funds. The Company intends to use the net proceeds from the private placement for general corporate purposes, including funding the development of the Company’s product candidate pipeline and supporting commercialization efforts for ZEVASKYN.
Morgan Stanley is acting as the sole placement agent for the private placement.
The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the Securities Act), or any state or other applicable jurisdiction’s securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions’ securities laws. Abeona has agreed to file a registration statement with the U.S. Securities and Exchange Commission registering the resale of the shares of common stock issued in the private placement no later than the 15th day after the closing of the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful. Any offering of the securities under the resale registration statement will only be made by means of a prospectus.
About
Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company building a portfolio of therapies for rare and serious diseases with multiple opportunities for value creation. The Company’s portfolio includes ZEVASKYN® (prademagene zamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa; ABO-801, a Phase 3-ready product candidate for eosinophilic esophagitis; and ABO-701 (PSMA-SIR-T™), an investigational engineered T-cell therapy targeting PSMA. For more information, visit www.abeonatherapeutics.com.
ZEVASKYN®, Abeona Assist®, Abeona Therapeutics®, and their related logos are trademarks of Abeona Therapeutics Inc.
Forward-Looking Statements
This press release contains certain statements that are forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and that involve risks and uncertainties. We have attempted to identify forward-looking statements by such terminology as “may,” “will,” “believe,” “anticipate,” “intend,” “potential,” and similar words and expressions (as well as other words or expressions referencing future events, conditions or circumstances), which constitute and are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, numerous risks and uncertainties, including but not limited to our ability to consummate the private placement financing or realize the anticipated benefits from the transactions; ABO-801 may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; clinical trials may not confirm any safety, potency or other product characteristics described or anticipated in this press release; our ability to maintain existing and obtain additional regulatory approvals of ZEVASKYN® and any future product candidates; our ability to successfully commercialize and market ZEVASKYN® and any future product candidates, if approved, and the timing of any commercialization and marketing efforts; the potential impact of unpredicted changes in the structure and/or administration of the United States government or its agencies; the dilutive effect that raising additional funds by selling additional equity securities may have on the relative equity ownership of our existing investors,; the outcome of any interactions with the FDA or other regulatory agencies relating to any of our products or product candidates; our ability to continue to secure and maintain regulatory designations for our product candidates; our ability to develop manufacturing capabilities compliant with current good manufacturing practices for our product candidates; and macroeconomic uncertainty resulting from changes to U.S. trade policy, including current or future tariffs or other trade restrictions.
Contacts:
Investor and Media
Greg Gin
VP, Investor Relations and Corporate Communications
Abeona Therapeutics
ir@abeonatherapeutics.com
Investor
Lee M. Stern
Meru Advisors
lstern@meruadvisors.com
Exhibit 99.2
Filing Exhibits & Attachments
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