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Abeona closes $155 million sale of rare pediatric disease priority review voucher

Tickers ABEO

Abeona received gross proceeds of $155 million on June 27, 2025. The company says unaudited cash, cash equivalents, restricted cash and short-term investments were approximately $225 million as of June 30, 2025.

Key facts

Company
Abeona Therapeutics Inc. (NASDAQ: ABEO)
News type
Financings
Primary source
ABEONA THERAPEUTICS INC. Form 8-K filed July 2, 2025 (SEC EDGAR)
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Abeona Therapeutics Inc. (Nasdaq: ABEO) completed the sale of its rare pediatric disease priority review voucher on June 27, 2025, for gross proceeds of $155 million. The company disclosed the closing in a Form 8-K filed July 2, 2025, under Items 2.01, 2.02 and 8.01. The filing names no buyer, no broker and no financial or legal adviser on the sale. Joseph Vazzano, Chief Financial Officer, signed the 8-K.

The voucher and the sale

The FDA awarded the voucher to Abeona on April 28, 2025, under a program meant to encourage development of certain rare pediatric disease products. The company received it when the FDA approved its biologics license application for ZEVASKYN (prademagene zamikeracel). The sale was made under a PRV asset purchase agreement dated May 9, 2025. The 8-K says the full agreement will be filed with the company's quarterly report for the three months ended June 30, 2025, and describes it only in summary.

The 8-K gives the gross price of $155 million. It does not give a net figure after fees, and it does not say whether any part of the price is contingent.

Cash after the sale

The company's press release, filed as Exhibit 99.1, says the reported cash resources include the net proceeds from the sale. On that basis, unaudited cash, cash equivalents, restricted cash and short-term investments were about $225 million at June 30, 2025. The 8-K calls that figure preliminary and based on management estimates, and says it is subject to the company's financial closing procedures. The company's independent accounting firm has given no assurance on it.

The company's annual report for 2024 reports $98.1 million in cash, cash equivalents, restricted cash and short-term investments at December 31, 2024. It also says the company had $4.8 million in net proceeds from common stock sold under an at-the-market program after that date. The annual report says those amounts, combined, would fund operations for the next 12 months, while warning that its liquidity could be affected by its ability to raise more capital.

In the press release, Vazzano said the proceeds, combined with existing cash, provide "robust financial flexibility" and over two years of operating capital without further capital infusion, before any ZEVASKYN sales. That runway is the company's own estimate. The annual report shows why cash matters: net losses were $63.7 million for 2024 and $54.2 million for 2023, the accumulated deficit was $813.3 million at December 31, 2024, and the company had not generated any significant revenues.

The product behind the voucher

ZEVASKYN is an autologous, cell-based gene therapy for recessive dystrophic epidermolysis bullosa, or RDEB, a rare skin disorder that causes wounds. The company's 2024 annual report says the VIITAL study met both co-primary efficacy endpoints, showing statistically significant improvements in wound healing and pain reduction in large chronic wounds. The road to approval was not smooth. The FDA granted priority review in November 2023, then issued a Complete Response Letter in April 2024, citing chemistry, manufacturing and controls information that had to be resolved. The letter did not cite clinical efficacy or safety deficiencies. Abeona resubmitted in October 2024, and the FDA set an April 29, 2025 target date. The 8-K gives no ZEVASKYN sales figure. The press release says the first patient treatment is expected in the third quarter of 2025 and profitability in early 2026. Those dates are the company's own projections.

The voucher sale is a one-time payment and adds no shares, unlike the at-the-market stock sales the company used earlier in 2025.

What comes next

The company's stated next steps are the first commercial treatment with ZEVASKYN, expected in the third quarter of 2025, and the filing of the sale agreement with the June 2025 quarterly report. The 8-K does not describe a new financing, and it does not say how the company will use the proceeds beyond its operating plans.

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