Abeona Therapeutics® Acquires Phase 3-Ready APT-1011, Now ABO-801, and Enters Into Agreement for $30 Million Private Placement

The acquisition has no upfront cash payment but carries equity consideration, potential milestone payments and sales royalties.

Rhea-AI Summary

Abeona Therapeutics (ABEO) acquired EoE candidate APT-1011, now ABO-801, from Ellodi Pharmaceuticals and agreed to a $30 million private placement. EoE is a chronic inflammatory disease of the esophagus. The acquisition requires $20 million in common stock, with no upfront cash payment, plus potential approval and sales milestone payments and royalties.

The financing is expected to provide $30 million in gross proceeds through common shares and pre-funded warrants. ABO-801 has FDA Orphan Drug and Fast Track designations. Neither completed Phase 3 study met its prespecified co-primary patient-reported symptom endpoint, although both showed statistically significant improvements in several endoscopic measures. Abeona anticipates starting another Phase 3 study in mid-2027, with topline results by the end of 2028, subject to study initiation and enrollment timing.

5 points · 0 major

NegativeiHow this balance works

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.

How the balance worksHow Sentiment works

1 major · 7 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointThe ABO-801 acquisition adds an EoE therapy candidate with no upfront cash payment.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Private placement financing is expected to provide $30 million in gross proceeds before fees and expenses. 13% of market cap
• Minor pointABO-801 holds FDA Orphan Drug and Fast Track designations for EoE.
• Minor pointBoth completed Phase 3 studies showed statistically significant improvements in several endoscopic measures.
• Minor point. Forward-looking: it has not happened yet and may not happen.Abeona anticipates initiating another Phase 3 study in mid-2027.

Negative

• Major pointNeither completed Phase 3 study met its prespecified co-primary patient-reported symptom endpoint.
• Moderate pointAcquisition consideration of $20 million in Abeona common stock dilutes existing shareholders. 8.4% of market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.Private placement includes 6,400,000 common shares at $3.75 per share, diluting existing holders.
• Minor point. Forward-looking: it has not happened yet and may not happen.Pre-funded warrants cover up to 1,600,043 shares at $3.7499 per warrant, adding potential dilution.
• Minor point. Forward-looking: it has not happened yet and may not happen.Ellodi is eligible for $30 million upon FDA approval and up to another $30 million upon specified sales milestones.

2 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Ellodi is eligible for tiered net-sales royalties ranging from low to mid teen percentages.
• Minor point. Forward-looking: it has not happened yet and may not happen.Anticipated topline results by the end of 2028 depend on study initiation and enrollment timing.

Key Figures

Acquisition consideration: $20 million in common stock FDA approval payment: $30 million Sales milestone payments: Up to an additional $30 million +5 more

Acquisition consideration

$20 million in common stock

Payable at closing; no upfront cash consideration

FDA approval payment

$30 million

Payment to Ellodi upon FDA approval of ABO-801

Sales milestone payments

Up to an additional $30 million

Payable to Ellodi upon achievement of specified sales milestones

Private placement proceeds

$30 million gross

Before fees and expenses

Common shares in private placement

6,400,000 shares at $3.75 per share

Private placement purchase terms

Pre-funded warrants

Up to 1,600,043 at $3.7499 per warrant

Private placement purchase terms

Phase 3 study enrollment

361 patients combined

Two completed Phase 3 studies

Planned Phase 3 timeline

Initiation in mid-2027; topline results by the end of 2028

Company anticipates these dates, subject to study initiation and enrollment timing

Key Terms

eosinophilic esophagitis, orphan drug designation, fast track designation, co-primary patient-reported symptom endpoint, +1 more

5 terms

eosinophilic esophagitis medical

"being developed for EoE, a chronic inflammatory disease of the esophagus"

A chronic allergic condition in which a type of white blood cell builds up in the tube that carries food from the mouth to the stomach, causing inflammation, difficulty swallowing and chest or throat pain; think of it as sticky residue narrowing a pipe. It matters to investors because prevalence, diagnostic rates and treatment options drive demand for drugs, tests and procedures, and clinical or regulatory news can quickly change revenue and valuation for healthcare companies working on therapies or diagnostics.

orphan drug designation regulatory

"has received Orphan Drug designation from the U.S. Food and Drug Administration"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

fast track designation regulatory

"with FDA Orphan Drug and Fast Track Designations"

Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.

co-primary patient-reported symptom endpoint medical

"neither Phase 3 study met its prespecified co-primary patient-reported symptom endpoint"

A co-primary patient-reported symptom endpoint is one of two or more equally important main outcomes in a clinical trial that come directly from patients’ reports about their symptoms (rather than from laboratory tests or clinician assessments). Each co-primary endpoint is pre-specified, measured with a validated patient-reported outcome (PRO) instrument or questionnaire, and typically must meet its success criterion for the trial to be considered positive; using co-primary endpoints affects trial design and statistical testing because multiple comparisons and timing of measurements are planned in advance. This term applies only to symptom-based outcomes reported by patients and does not include clinician-assessed, objective, or composite endpoints unless those are also defined as separate co-primary PRO symptom measures.

pre-funded warrants financial

"and pre-funded warrants to purchase up to 1,600,043 shares of common stock"

Pre-funded warrants are financial instruments that give investors the right to purchase a company's stock at a set price, but with most or all of the purchase price paid upfront. They function like a coupon or gift card for stock, allowing investors to buy shares later at a fixed price, which can be beneficial if they want to avoid future price increases. This makes them important for investors seeking flexibility and certainty in their investment plans.

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- 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, Nov. 09, 2026 (GLOBE NEWSWIRE) -- 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 mid-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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What are the terms of Abeona's ABO-801 acquisition from Ellodi?

Abeona agreed to issue Ellodi $20 million in common stock, with no upfront cash consideration. Ellodi is also eligible for $30 million upon FDA approval, up to an additional $30 million upon specified sales milestones, and tiered royalties on net sales ranging from low to mid teen percentages.

How much does Abeona expect to raise in its private placement, and at what price?

Abeona expects $30 million in gross proceeds before fees and expenses. The financing includes 6,400,000 common shares at $3.75 per share and pre-funded warrants to purchase up to 1,600,043 common shares at $3.7499 per pre-funded warrant.

How many patients have participated in ABO-801 clinical studies?

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 enrolling a combined 361 patients. An Expanded Access Program also provided longer-term treatment experience involving 265 cumulative participants.