- First ZEVASKYN® commercial patient treatment completed in December -
- ZEVASKYN launch momentum building in first quarter 2026 –
-
“2026 is about building a steady cadence of biopsies and treatments,” said
ZEVASKYN (prademagene zamikeracel) updates
- First ZEVASKYN commercial patient treatment completed in December; launch momentum building in first quarter 2026: Following the optimization of a release assay in 2025, ZEVASKYN commercial launch activities commenced in the fourth quarter, with the first patient treatment completed in December prior to a mandatory annual manufacturing facility shutdown. Since resuming manufacturing in late
January 2026 , multiple biopsies have been collected with additional biopsies expected this month. One patient has completed treatment with ZEVASKYN so far in 2026, and other collected biopsies are at various stages in the manufacturing process. - Growing ZEVASKYN treatment experience expected to catalyze further ZEVASKYN demand: Growing ZEVASKYN treatment experience across the initial
Qualified Treatment Center (QTC) network is establishing the institutional workflows and scalable foundation necessary to accelerate patient throughput and streamline the referral-to-treatment timeline. As the RDEB community shares in the positive experiences of the initial ZEVASKYN patients, the Company believes this will continue to catalyze sustained demand for ZEVASKYN. - Abeona expands patient access to ZEVASKYN across
Texas and theGulf Coast region with activation of its newest QTC: In December, the Company announced activation ofThe University of Texas Medical Branch (UTMB), inGalveston, Texas , as the fourth QTC for ZEVASKYN. UTMB is a major academic medical center renowned for its expertise in comprehensive complex skin disease and wound care.
Full Year 2025 Financial Results
Abeona reported total revenue of
Net product revenue reflects the single patient treatment in December. While net product revenue reflects Medicaid coverage for the patient treated in December, the Company expects average net revenues to normalize over time as the payer mix expands to include commercially insured patients. Cash was received from the December treatment in the first quarter 2026.
Cost of sales for 2025 was
Total research and development (R&D) spending for 2025 decreased
Selling, general and administrative (SG&A) expenses for 2025 were
In
Net income was
Cash, cash equivalents and short-term investments totaled
Conference Call Details
The Company will host a conference call and webcast on
About
ZEVASKYN®, Abeona Assist™,
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 successfully commercialize and market ZEVASKYN, including manufacturing sufficient batches of ZEVASKYN to meet demand; the therapeutic potential of ZEVASKYN; whether the unmet need and market opportunity for ZEVASKYN are consistent with the Company’s expectations; continued interest in our rare disease portfolio; our ability to enroll patients in clinical trials; the outcome of future meetings with and inspections by the FDA or other regulatory agencies, including those relating to preclinical programs and to the cGMP manufacturing of ZEVASKYN; the ability to achieve or obtain necessary regulatory approvals for our pre-clinical programs; our ability to execute on our key business priorities; the impact of any changes in the financial markets and global economic conditions, including those resulting from changes to
Consolidated Statements of Operations and Comprehensive Income (Loss) (In thousands, except share and per share amounts) | ||||||||
| For the years ended | ||||||||
| 2025 | 2024 | |||||||
| Revenues: | ||||||||
| Product revenue, net | $ | 2,420 | $ | — | ||||
| License and other revenues | 3,400 | — | ||||||
| Total revenues | 5,820 | — | ||||||
| Costs and expenses: | ||||||||
| Cost of sales | 1,532 | — | ||||||
| Royalties | 1,893 | — | ||||||
| Research and development | 26,812 | 34,360 | ||||||
| Selling, general and administrative | 65,031 | 29,851 | ||||||
| Total costs and expenses | 95,268 | 64,211 | ||||||
| Loss from operations | (89,448 | ) | (64,211 | ) | ||||
| Interest income | 5,556 | 4,246 | ||||||
| Interest expense | (3,740 | ) | (4,208 | ) | ||||
| Change in fair value of warrant and derivative liabilities | 6,139 | (755 | ) | |||||
| Gain from sale of priority review voucher, net | 152,366 | — | ||||||
| Other income, net | 410 | 1,194 | ||||||
| Income (loss) before income taxes | 71,283 | (63,734 | ) | |||||
| Income tax (benefit) expense | 100 | — | ||||||
| Net income (loss) | $ | 71,183 | $ | (63,734 | ) | |||
| Basic income (loss) per common share | $ | 1.34 | $ | (1.55 | ) | |||
| Dilutive income (loss) per common share | $ | 1.01 | $ | (1.55 | ) | |||
| Weighted average number of common shares outstanding: | ||||||||
| Basic | 52,952,917 | 41,048,206 | ||||||
| Dilutive | 66,135,821 | 41,048,206 | ||||||
| Other comprehensive income (loss): | ||||||||
| Change in unrealized gains related to available-for-sale debt securities | 130 | 74 | ||||||
| Comprehensive income (loss) | $ | 71,313 | $ | (63,660 | ) | |||
Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 78,437 | $ | 23,357 | ||||
| Short-term investments | 112,967 | 74,363 | ||||||
| Restricted cash | — | 338 | ||||||
| Accounts receivable, net | 6,147 | — | ||||||
| Inventory | 5,493 | — | ||||||
| Other receivables | 568 | 1,652 | ||||||
| Prepaid expenses and other current assets | 1,294 | 1,143 | ||||||
| Total current assets | 204,906 | 100,853 | ||||||
| Property and equipment, net | 9,921 | 4,430 | ||||||
| Operating lease right-of-use assets | 3,962 | 3,552 | ||||||
| Other assets | 781 | 96 | ||||||
| Total assets | $ | 219,570 | $ | 108,931 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 7,889 | $ | 3,441 | ||||
| Accrued expenses | 8,467 | 6,333 | ||||||
| Current portion of long-term debt | 12,222 | 5,926 | ||||||
| Current portion of operating lease liability | 864 | 823 | ||||||
| Accrued taxes | 126 | — | ||||||
| Other current liabilities | 2 | 64 | ||||||
| Total current liabilities | 29,570 | 16,587 | ||||||
| Long-term operating lease liabilities | 4,069 | 3,262 | ||||||
| Long-term debt | 7,813 | 13,037 | ||||||
| Warrant liabilities | 18,902 | 32,014 | ||||||
| Total liabilities | 60,354 | 64,900 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock - | — | — | ||||||
| Common stock - | 550 | 457 | ||||||
| Additional paid-in capital | 900,603 | 856,824 | ||||||
| Accumulated deficit | (742,075 | ) | (813,258 | ) | ||||
| Accumulated other comprehensive loss | 138 | 8 | ||||||
| Total stockholders’ equity | 159,216 | 44,031 | ||||||
| Total liabilities and stockholders’ equity | $ | 219,570 | $ | 108,931 | ||||
Contacts:Investor and MediaGreg Gin VP, Investor Relations and Corporate CommunicationsAbeona Therapeutics ir@abeonatherapeutics.comInvestorLee M. Stern Meru Advisors lstern@meruadvisors.com
