Abeona Therapeutics Reports $12M Net Loss in Q1 2025, FDA Approves ZEVASKYN™

Abeona Therapeutics Inc. reported a net loss of $12.0 million for the first quarter of 2025, a significant improvement compared to a net loss of $31.6 million during the same period in 2024. The company did not generate any revenue during the quarter, maintaining a consistent trend from the previous year. Total expenses increased to $19.7 million, up from $14.3 million in the prior year, primarily driven by higher research and development costs, which rose by 38% to $9.9 million, and general and administrative expenses, which increased by 37% to $9.8 million.

The company’s financial position showed a decrease in total assets, which fell to $99.4 million as of March 31, 2025, down from $108.9 million at the end of 2024. Cash and cash equivalents also declined to $15.9 million from $23.4 million. Abeona's accumulated deficit reached approximately $825.3 million, reflecting the ongoing investment in its product development pipeline. The company’s total liabilities decreased to $58.0 million from $64.9 million, largely due to a reduction in warrant liabilities.

Abeona achieved a significant milestone with the FDA's approval of ZEVASKYN™ on April 28, 2025, marking it as the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). This approval is expected to facilitate the commercial launch of ZEVASKYN™, with plans to begin treatments in the third quarter of 2025 through designated Qualified Treatment Centers. The company also entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $155 million, which is anticipated to bolster its financial resources.

Operationally, Abeona has been expanding its manufacturing capabilities to support the anticipated demand for ZEVASKYN™. The company has established a commercial facility in Cleveland, Ohio, and is actively working on its preclinical pipeline, which includes AAV-based gene therapies targeting various ophthalmic diseases. As of March 31, 2025, Abeona had 48.9 million shares of common stock outstanding, reflecting an increase from 45.6 million shares at the end of 2024.

Looking ahead, Abeona anticipates that its existing cash resources, combined with the proceeds from the sale of the Priority Review Voucher and ongoing sales of common stock under its ATM Agreement, will be sufficient to fund operations for at least the next 12 months. However, the company acknowledges the need for additional funding to support its research and development activities and potential commercialization efforts, emphasizing the inherent risks and uncertainties associated with its business model.