Abeona Therapeutics® Reports Third Quarter 2026 Financial Results and ZEVASKYN® Commercial Progress
The ABO-801 acquisition adds a late-stage development asset, while stock consideration and contingent payments form the purchase terms.
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 Summary
Abeona Therapeutics (ABEO) reported third-quarter 2026 net ZEVASKYN revenue of $13.5 million, up 18% from the second quarter.
Net loss narrowed to $4.8 million, or $0.08 per share, from $20.2 million, or $0.35 per share, sequentially. Cash, cash equivalents and short-term investments were $134.9 million at September 30, excluding a $30 million private placement completed after quarter end. Six ZEVASKYN treatments were completed during the quarter, bringing the launch total to 15. The treatment-center network expanded to eight sites. Supplemental Medicare hospital reimbursement status took effect October 1, 2026.
Abeona acquired Phase 3-ready ABO-801 from Ellodi Pharmaceuticals for $20 million in common stock, with no upfront cash payment. Ellodi is eligible for $30 million upon FDA approval, up to another $30 million in sales milestones and tiered royalties ranging from low to mid teen percentages.
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
- Moderate pointZEVASKYN revenue of $13.5 million rose 18% from $11.4 million in the second quarter of 2026.
- Moderate pointSupplemental Medicare hospital reimbursement became effective October 1, 2026, for eligible ZEVASKYN treatments.
- Moderate pointABO-801 acquisition added a Phase 3-ready eosinophilic esophagitis candidate with no upfront cash consideration.
- Moderate point$30 million gross private placement completed after quarter end added funding before fees and expenses. 13% of market cap
- Moderate pointQ3 net loss narrowed to $4.8 million, or $0.08 per share, from $20.2 million, or $0.35, sequentially.
- Moderate pointQ3 operating loss narrowed to $13.001 million from $24.018 million a year earlier.
- Moderate pointNine-month revenue increased to $33.591 million in 2026 from $400,000 in 2025.
- Moderate pointNine-month operating loss narrowed to $49.687 million from $66.537 million a year earlier.
6 minor points
- Minor pointSix ZEVASKYN treatments were completed in Q3 2026, bringing the total since launch to 15.
- Minor pointEight qualified treatment centers expanded geographic access; centers with treatment experience increased from two to four.
- Minor point. Forward-looking: it has not happened yet and may not happen.FAYUVI FDA approval leaves Abeona eligible for commercial milestones and royalties up to 8% on future sales.
- Minor pointQ3 research and development expense fell to $3.7 million from $5.0 million sequentially.
- Minor pointNine-month research and development expense declined to $18.248 million from $20.100 million a year earlier.
- Minor pointTotal liabilities declined to $46.048 million at September 30, 2026, from $60.354 million at December 31, 2025.
Negative
- Moderate point$20 million in common stock issued to Ellodi at acquisition closing dilutes existing holders. 8.4% of market cap
- Moderate pointQ3 cost of sales increased to $5.7 million from $4.2 million sequentially.
- Moderate pointCash and investments declined to $134.9 million at September 30 from $146.8 million at June 30, 2026.
- Moderate pointNine-month net loss of $42.074 million compared with $91.643 million net income a year earlier.
- Moderate pointNine-month selling, general and administrative expense increased to $52.444 million from $46.249 million a year earlier.
6 minor points
- Minor point. Forward-looking: it has not happened yet and may not happen.ABO-801 contingent payments include $30 million upon FDA approval and up to $30 million for specified sales milestones.
- Minor point. Forward-looking: it has not happened yet and may not happen.ABO-801 royalty obligations range from low to mid teen percentages of net sales.
- Minor pointOne Q3 treatment generated no recognized revenue because its batch failed the identity-assay release criterion.
- Minor pointQ3 selling, general and administrative expense rose to $17.1 million from $15.8 million sequentially.
- Minor pointTotal assets fell to $171.924 million at September 30, 2026, from $219.570 million at December 31, 2025.
- Minor pointStockholders’ equity declined to $125.876 million at September 30, 2026, from $159.216 million at December 31, 2025.
Details
Market move: ABEO -4.08% vs previous close. Q3 2026 earnings report
On Nov 9, the day this news came out, the latest delayed price for ABEO is 4.08% below the previous close. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $4.00. Relative volume is elevated at 2.7x what this stock usually trades by this time of day.
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Key Figures
- Net ZEVASKYN revenue
- $13.5 million; up 18%
- Q3 2026 compared with Q2 2026
- Net loss
- $(4.8) million
- Q3 2026, compared with $(20.2) million in Q2 2026
- Cash, cash equivalents and short-term investments
- $134.9 million
- As of September 30, 2026
- NTAP effective date
- October 1, 2026
- ZEVASKYN status
- Stock consideration at closing
- $20 million
- ABO-801 asset purchase; 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
- ABO-801 specified sales milestones
- PIPE gross proceeds
- $30 million
- Private placement, before fees and expenses
Previous Earnings Reports
-
ZEVASKYN revenue rose sequentially as treatment volume and qualified treatment-center network expanded.
-
ZEVASKYN revenue increased from the prior quarter as treatments and qualified treatment-center sites grew.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pipe financing financial
eosinophilic esophagitis medical
new technology add-on payment regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Q3 net ZEVASKYN revenue of
– 15 ZEVASKYN treatments completed since launch, including six during Q3 –
- QTC network expanded to eight sites; four centers have completed patient treatments –
- ZEVASKYN NTAP status became effective October 1, 2026 –
-
- Separately announced acquisition of Phase 3-ready APT-1011 in eosinophilic esophagitis (EoE) and
CLEVELAND, Nov. 09, 2026 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported third-quarter 2026 financial results and provided an update on the commercial launch of ZEVASKYN.
“Maximizing the opportunity for ZEVASKYN remains our number one priority. During the third quarter, we continued to build the commercial foundation for ZEVASKYN, with expansion of our QTC network and more centers gaining firsthand treatment experience,” said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona Therapeutics. “The acquisition of APT-1011 represents an important step in building Abeona into a diversified commercial-stage company, adding a uniquely differentiated late-stage orphan-drug asset with substantial commercial potential in a rapidly growing disease with high unmet need.”
ZEVASKYN Commercial Update
ZEVASKYN treatment activity increased in the third quarter. Since launch, 15 patient treatments have been completed with ZEVASKYN, including six during the third quarter of 2026.
Broader qualified treatment center (QTC) participation supported increased ZEVASKYN treatment activity. Abeona expanded its national ZEVASKYN QTC network to eight sites during the third quarter, increasing geographic access for eligible patients:
- Children’s Hospital of Philadelphia and the University of Texas Medical Branch completed their first ZEVASKYN patient treatments during the third quarter, increasing the number of QTCs with treatment experience from two to four.
- University of Florida (UF) Health in Gainesville, Florida, was activated in September 2026 as the eighth ZEVASKYN QTC, expanding access for eligible pediatric and adult RDEB patients in Florida and the Southeastern U.S.
- Cincinnati Children’s, one of the largest epidermolysis bullosa treatment centers in the U.S., was activated as a ZEVASKYN QTC in July 2026.
New Technology Add-On Payment (NTAP) status for ZEVASKYN became effective October 1, 2026. Under the Centers for Medicare & Medicaid Services (CMS) fiscal year 2027 Hospital Inpatient Prospective Payment System Final Rule. Under the standard NTAP pathway, qualifying technologies must be new and meaningfully differentiated from existing technologies, meet CMS cost criteria, and demonstrate substantial clinical improvement relative to existing treatments. NTAP provides a pathway for eligible hospitals to receive supplemental reimbursement, in addition to the diagnosis-related group base payment, when treating eligible Medicare beneficiaries with ZEVASKYN. This designation is expected to help support patient access and hospital adoption among eligible Medicare beneficiaries, who represent approximately 10 percent of RDEB patients.
Corporate and Pipeline Developments
Abeona acquired APT-1011, now ABO-801, from Ellodi Pharmaceuticals and announced a
Also announced in a separate press release issued today, Abeona entered into a securities purchase agreement for a private placement of
Ultragenyx secures U.S. FDA approval of FAYUVI™. In September, Ultragenyx Pharmaceutical Inc. received FDA approval of FAYUVI (rebisufligene etisparvovec-hopf) gene therapy for Sanfilippo Syndrome Type A (MPS IIIA). Abeona previously advanced the program before licensing it to Ultragenyx in May 2022. Pursuant to its licensing agreement with Ultragenyx, Abeona is eligible to receive certain commercial milestone payments and tiered royalties of up to 8 percent on future product sales.
Third Quarter 2026 Financial Results
Net ZEVASKYN revenue for the quarter ended September 30, 2026 was
Cost of sales was
Research and development expenses were
Selling, general and administrative expenses were
Net loss was
Cash, cash equivalents and short-term investments totaled
Conference Call Details
The Company will host a conference call and webcast on November 9, 2026, at 8:30 a.m. ET to discuss the third-quarter financial results, ZEVASKYN commercial progress and the acquisition of ABO-801 and PIPE financing. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 208009 five minutes prior to the start of the call. A live, listen-only webcast can be accessed on the Investors & Media section of Abeona's website at https://investors.abeonatherapeutics.com/events. An archived webcast replay will be available for 30 days following the call.
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,” “expect,” “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 realize the anticipated benefits of the acquisition, including integration, of ABO-801 into our business; 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 obtain, maintain, defend, and enforce patent and other intellectual property protection for ABO-801, and to successfully defend against any third-party challenges to the validity, scope, or enforcement of such patents; our ability to consummate the private placement financing or realize the anticipated benefits from the transaction; 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; our ability to manufacture sufficient batches of ZEVASKYN® to meet demand; our ability to manufacture ZEVASKYN® batches that meet certain product release specifications that were required by FDA at the time of BLA approval and implemented based on a limited clinical dataset; the FDA’s willingness to revise such release specifications to reflect real-world manufacturing experience; our ability to manufacture from provided biopsy material a ZEVASKYN® batch for which revenue may ultimately be recognized, which depends on such factors as qualified treatment centers obtaining biopsy samples from ZEVASKYN® patients of sufficient quality to act as starting material for manufacturing ZEVASKYN®, patient-to-patient variability in cell growth during the ZEVASKYN® manufacturing process, patient health deterioration in close proximity to ZEVASKYN® treatment such that treatment is no longer possible, and expiration of ZEVASKYN®’s 84-hour shelf-life before surgical application of ZEVASKYN® can be performed; our ability to activate additional qualified treatment centers to administer ZEVASKYN® on patients; the ability of qualified treatment centers to enroll patients for treatment or administer ZEVASKYN® on patients; our ability submit an investigational new drug application for ABO-701 and enroll patients in new clinical trials; our ability to access additional financial resources and/or our financial flexibility to reduce operating expenses if required; our ability to obtain additional equity funding from current or new stockholders; the potential impact of unpredicted changes in the structure and/or administration of the United States government or its agencies; our ability to out-license technology and/or other assets, deferring and/or eliminating planned expenditures, restructuring operations and/or reducing headcount, and sales of assets; the dilutive effect that raising additional funds by selling additional equity securities would have on the relative equity ownership of our existing investors, including under our existing at-the-market sale agreement; 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; our ability to manufacture cell and gene therapy products and produce an adequate product supply to support clinical trials and potentially future commercialization; the rate and degree of market acceptance of our product candidates for any indication once approved; our ability to meet our obligations contained in license agreements to which we are party; and macroeconomic uncertainty resulting from changes to U.S. trade policy, including current or future tariffs or other trade restrictions.
| ABEONA THERAPEUTICS INC. AND SUBSIDIARIES | ||||||||||||||||
| Condensed Consolidated Statements of Operations | ||||||||||||||||
| (In thousands, except share and per share amounts) | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| For the three months ended September 30, | For the nine months ended September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product revenue, net | $ | 13,491 | $ | — | $ | 33,591 | $ | — | ||||||||
| License and other revenues | — | — | — | 400 | ||||||||||||
| Total revenues | 13,491 | — | 33,591 | 400 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of sales | 5,713 | 488 | 12,586 | 488 | ||||||||||||
| Royalties | — | — | — | 100 | ||||||||||||
| Research and development | 3,672 | 4,216 | 18,248 | 20,100 | ||||||||||||
| Selling, general and administrative | 17,107 | 19,314 | 52,444 | 46,249 | ||||||||||||
| Total costs and expenses | 26,492 | 24,018 | 83,278 | 66,937 | ||||||||||||
| Loss from operations | (13,001 | ) | (24,018 | ) | (49,687 | ) | (66,537 | ) | ||||||||
| Interest income | 2,263 | 1,672 | 4,972 | 4,009 | ||||||||||||
| Interest expense | (557 | ) | (901 | ) | (2,083 | ) | (2,856 | ) | ||||||||
| Change in fair value of warrant liabilities | 6,507 | 2,760 | 4,702 | 4,617 | ||||||||||||
| Gain from sale of priority review voucher, net | — | — | — | 152,366 | ||||||||||||
| Other (loss) income, net | (2 | ) | 129 | 42 | 359 | |||||||||||
| (Loss) income before income taxes | (4,790 | ) | (20,358 | ) | (42,054 | ) | 91,958 | |||||||||
| Income tax expense (benefit) | 18 | (15,197 | ) | 20 | 315 | |||||||||||
| Net (loss) income | $ | (4,808 | ) | $ | (5,161 | ) | $ | (42,074 | ) | $ | 91,643 | |||||
| Basic (loss) income per common share | $ | (0.08 | ) | $ | (0.10 | ) | $ | (0.74 | ) | $ | 1.76 | |||||
| Dilutive (loss) income per common share | $ | (0.08 | ) | $ | (0.10 | ) | $ | (0.74 | ) | $ | 1.35 | |||||
| Weighted average number of common shares outstanding: | ||||||||||||||||
| Basic | 57,858,292 | 54,242,507 | 57,180,398 | 52,198,290 | ||||||||||||
| Dilutive | 57,858,292 | 54,242,507 | 57,180,398 | 65,780,650 | ||||||||||||
| ABEONA THERAPEUTICS INC. AND SUBSIDIARIES | ||||||
| Condensed Consolidated Balance Sheets | ||||||
| (In thousands, except share amounts) | ||||||
| (Unaudited) | ||||||
| September 30, 2026 | December 31, 2025 | |||||
| Cash, cash equivalents and short-term investments | $ | 134,941 | $ | 191,404 | ||
| Total assets | $ | 171,924 | $ | 219,570 | ||
| Total liabilities | $ | 46,048 | $ | 60,354 | ||
| Total stockholders' equity | $ | 125,876 | $ | 159,216 | ||
| Common stock outstanding | 57,168,018 | 55,043,413 | ||||
| Common stock and common stock equivalents* | 70,973,871 | 69,103,212 | ||||
| *Common stock and common stock equivalents: | ||||||
| Common stock | 57,168,018 | 55,043,413 | ||||
| Common stock warrants (pre-funded) | 4,933,489 | 5,113,321 | ||||
| Common stock and pre-funded warrants | 62,101,507 | 60,156,734 | ||||
| Options to purchase common stock | 101,905 | 176,019 | ||||
| Conversion option to redeem common stock | 614,251 | 614,251 | ||||
| Warrants to purchase common stock | 8,156,208 | 8,156,208 | ||||
| Total common stock and common stock equivalents | 70,973,871 | 69,103,212 | ||||
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 were Abeona’s third-quarter 2026 ZEVASKYN revenue and earnings?
Abeona reported $13.5 million in net ZEVASKYN revenue and a net loss of $4.8 million, or $0.08 per basic and diluted share. Revenue increased 18% from the second quarter of 2026, when revenue was $11.4 million and net loss was $20.2 million, or $0.35 per share.
What did Abeona pay to acquire ABO-801 from Ellodi?
Abeona issued $20 million of common stock at closing, 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 ranging from low to mid teen percentages of net sales.
Why did Abeona not recognize revenue for one ZEVASKYN treatment in Q3 2026?
Revenue was not recognized for one third-quarter treatment because the associated batch did not meet the release criterion for the identity assay. This issue had previously been disclosed in August 2026.
How does ZEVASKYN’s NTAP status affect hospital reimbursement?
ZEVASKYN’s New Technology Add-On Payment status provides eligible hospitals a pathway to supplemental reimbursement beyond the diagnosis-related group base payment for eligible Medicare beneficiaries. Abeona expects the designation to support access and hospital adoption among these beneficiaries, who represent approximately 10 percent of patients with recessive dystrophic epidermolysis bullosa.
What contributed to Abeona’s nine-month earnings difference from 2025?
The nine months ended September 30, 2025 included a $152.366 million net gain from the sale of a priority review voucher, while the corresponding 2026 period had no such gain. Abeona recorded a $42.074 million net loss for the 2026 period, compared with $91.643 million net income in 2025.