- Q2 net ZEVASKYN® revenue increased 31% quarter-over-quarter to
- Five patients treated with ZEVASKYN in Q2 2026 and three treatments in Q3 2026 to-date; since launch, 12 treatments completed –
- Expanding QTC network now includes seven sites nationwide; growing number of QTCs progressing patients through treatment process –
-
Commercial Update
Steady launch-year growth for ZEVASKYN. Commercial execution continued to strengthen during the second quarter of 2026 with five patients treated with ZEVASKYN. In the third quarter of 2026 to-date, three patients have completed treatments. Since launch, 12 patient treatments have been completed. Revenue was not recognized for two patients due to low manufacturing yield or not meeting lot release specifications.
Expanded qualified treatment center (QTC) network and increased patient onboarding. Abeona continues to expand the ZEVASKYN QTC network, and the number of QTCs that have treated patients with ZEVASKYN has increased. Key recent milestones include:
NewYork-Presbyterian/Columbia University Irving Medical Center and Children’s Hospital ofPhiladelphia (CHOP) were activated as QTCs during the second quarter of 2026.- CHOP and
University of Texas Medical Branch (UTMB) have commenced collection of patient biopsies, and CHOP has treated its first patient with ZEVASKYN. - In the third quarter of 2026, Abeona announced the activation of Cincinnati Children's as the newest ZEVASKYN QTC. Cincinnati Children's is one of the largest epidermolysis bullosa treatment centers in the
U.S .
Secured CMS New Technology Add-On Payment (NTAP) status for ZEVASKYN. Effective
Continued engagement raising RDEB community awareness. The Company presented 5-year long-term follow-up data after ZEVASKYN application from the VIITAL Phase 3 clinical study and a case report from the longest follow-up of 12 years from the Phase 1/2a study. Presentations were made at key medical congresses, including the
“Our confidence in ZEVASKYN’s substantial opportunity is reinforced by our launch progress and experience to date as we engage with a growing number of patients and expand our QTC network," said
Second Quarter 2026 Financial Results
Net ZEVASKYN revenue for the quarter ended
Research and development (R&D) 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
About Abeona Therapeutics
Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases. Abeona’s ZEVASKYN® (prademagene zamikeracel) is the first and only autologous cell-based gene therapy for the treatment of wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The Company’s fully integrated cell and gene therapy cGMP manufacturing facility in Cleveland, Ohio, serves as the manufacturing site for ZEVASKYN commercial production. The Company’s development portfolio features ABO-701 (PSMA-SIR-T™), a potentially first-in-class engineered T-cell therapy targeting PSMA, engineered to overcome the core failures of cell therapies in solid tumors. 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 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.
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) | |||||||||||||||
| For the three months ended | For the six months ended | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Revenues: | |||||||||||||||
| Product revenue, net | $ | 11,380 | $ | — | $ | 20,100 | $ | — | |||||||
| License and other revenues | — | 400 | — | 400 | |||||||||||
| Total revenues | 11,380 | 400 | 20,100 | 400 | |||||||||||
| Costs and expenses: | |||||||||||||||
| Cost of sales | 4,177 | — | 6,873 | — | |||||||||||
| Royalties | — | 100 | — | 100 | |||||||||||
| Research and development | 5,021 | 5,943 | 14,576 | 15,884 | |||||||||||
| Selling, general and administrative | 15,835 | 17,149 | 35,337 | 26,935 | |||||||||||
| Total costs and expenses | 25,033 | 23,192 | 56,786 | 42,919 | |||||||||||
| Loss from operations | (13,653 | ) | (22,792 | ) | (36,686 | ) | (42,519 | ) | |||||||
| Interest income | 1,355 | 1,027 | 2,709 | 2,337 | |||||||||||
| Interest expense | (696 | ) | (957 | ) | (1,526 | ) | (1,955 | ) | |||||||
| Change in fair value of warrant liabilities | (7,191 | ) | (5,388 | ) | (1,805 | ) | 1,857 | ||||||||
| Gain from sale of priority review voucher, net | — | 152,366 | — | 152,366 | |||||||||||
| Other (loss) income, net | (6 | ) | 89 | 44 | 230 | ||||||||||
| Income (loss) before income taxes | (20,191 | ) | 124,345 | (37,264 | ) | 112,316 | |||||||||
| Income tax expense | — | 15,512 | 2 | 15,512 | |||||||||||
| Net (loss) income | $ | (20,191 | ) | $ | 108,833 | $ | (37,266 | ) | $ | 96,804 | |||||
| Basic (loss) income per common share | $ | (0.35 | ) | $ | 2.07 | $ | (0.66 | ) | $ | 1.89 | |||||
| Dilutive (loss) income per common share | $ | (0.35 | ) | $ | 1.71 | $ | (0.66 | ) | $ | 1.47 | |||||
| Weighted average number of common shares outstanding: | |||||||||||||||
| Basic | 57,048,385 | 52,524,510 | 56,835,833 | 51,159,240 | |||||||||||
| Dilutive | 57,048,385 | 66,640,620 | 56,835,833 | 65,111,330 | |||||||||||
Condensed Consolidated Balance Sheets (In thousands, except share amounts) (Unaudited) | |||||
| Cash, cash equivalents and short-term investments | $ | 146,826 | $ | 191,404 | |
| Total assets | $ | 179,507 | $ | 219,570 | |
| Total liabilities | $ | 51,449 | $ | 60,354 | |
| Total stockholders' equity | $ | 128,058 | $ | 159,216 | |
| Common stock outstanding | 57,225,919 | 55,043,413 | |||
| Common stock and common stock equivalents* | 71,098,537 | 69,103,212 | |||
| *Common stock and common stock equivalents: | |||||
| Common stock | 57,225,919 | 55,043,413 | |||
| Common stock warrants (pre-funded) | 4,933,489 | 5,113,321 | |||
| Common stock and pre-funded warrants | 62,159,408 | 60,156,734 | |||
| Options to purchase common stock | 168,670 | 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 | 71,098,537 | 69,103,212 | |||
Contacts:Investor and MediaGreg Gin VP, Investor Relations and Corporate CommunicationsAbeona Therapeutics ir@abeonatherapeutics.comInvestorLee M. Stern Meru Advisors lstern@meruadvisors.com
