Abeona Therapeutics closes $155 million sale of priority review voucher

The closing

Abeona Therapeutics Inc. (Nasdaq: ABEO) announced on July 2, 2025 that it had closed the sale of its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $155 million on June 27, 2025. The company, based in Cleveland, was awarded the voucher by the U.S. Food and Drug Administration in April 2025 in connection with the approval of ZEVASKYN (prademagene zamikeracel).

The closing release gives no buyer, names no financial advisors or legal counsel, and states no fees.

Cash after the sale

Including net proceeds from the sale, the company reported that its unaudited cash, cash equivalents, restricted cash and short-term investments as of June 30, 2025 were approximately $225 million. The figure combines several categories, including restricted cash. The release does not break the total into its parts, does not give a quarterly operating cost or cash use, and does not say how much of the $225 million came from the voucher after costs.

Joe Vazzano, Abeona's Chief Financial Officer, said: "The PRV proceeds, combined with our existing cash, provides Abeona with robust financial flexibility, ensuring over two years of operating capital for sustained growth without the need for further capital infusion and prior to accounting for ZEVASKYN sales." He also said the company anticipates the first ZEVASKYN patient treatment in Q3 2025, with profitability projected for early 2026.

Those are projections by management. The release reports no ZEVASKYN revenue, and the company has not yet treated a commercial patient. The profitability target therefore rests on a launch that, as of the release, had not begun, and the claim of more than two years of capital was set before any sales data existed.

The therapy

ZEVASKYN is described by the company as the first and only U.S. approved autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, or RDEB. The company's 2024 annual report, filed March 20, 2025, explains that RDEB patients have a defect in the COL7A1 gene and cannot produce Type VII collagen, so their skin is fragile and forms open, blistering wounds. Long-term patients can suffer from anemia and are at high risk of aggressive squamous cell carcinomas, infections and premature death. The report says the most severe patients are approximately 20 times more likely to die by 30 years of age than the general population, and that the incidence and prevalence of RDEB are not well defined.

Approval followed a delay. The FDA issued a Complete Response Letter in April 2024 that asked for more information on chemistry, manufacturing and controls. According to the annual report, the letter identified no deficiencies in clinical efficacy or safety data and the FDA did not request new trials. Abeona resubmitted its application in October 2024, and the FDA set a target action date of April 29, 2025. The company's VIITAL study, announced in November 2022, had met both co-primary efficacy endpoints.

Manufacturing and pipeline

ZEVASKYN is produced at the company's integrated cell and gene therapy manufacturing facility in Cleveland, Ohio, which the release says serves as the manufacturing site for commercial production. The company's development portfolio otherwise features adeno-associated virus gene therapies for ophthalmic diseases, using capsids that the annual report says are licensed from the University of North Carolina at Chapel Hill and developed internally. The release says those capsids are being evaluated, not that any has entered a clinical trial.

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