Abeona Therapeutics® Reports Second Quarter 2025 Financial Results and Corporate Updates

Core Insights - Abeona Therapeutics has received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][4] - The U.S. launch is on track, with the first patient treatment expected in the third quarter of 2025, supported by strong patient interest and positive insurance coverage [1][2] - As of June 30, 2025, the company reported $226 million in cash and equivalents, expected to fund operations for over two years before ZEVASKYN revenue begins [1][5] Recent Developments - ZEVASKYN was approved by the FDA in April 2025 and is now available at Qualified Treatment Centers (QTCs) [4] - Strong demand for ZEVASKYN has been noted, with over a dozen patients identified for treatment and 100% approval of prior authorization requests submitted [4] - The company has established positive coverage with major insurers, including United Healthcare, covering approximately 16% of the U.S. insured population [4] Financial Results - For the second quarter of 2025, Abeona reported a net income of $108.8 million, significantly up from $7.4 million in the same period of 2024 [8] - Research and development expenses decreased to $5.9 million from $9.2 million year-over-year, primarily due to reclassification of costs [7] - Selling, general, and administrative expenses increased to $17.1 million, reflecting the costs associated with the commercial launch of ZEVASKYN [7] Operational Progress - The company is on track to ramp up ZEVASKYN supply capacity to treat up to 10 patients per month by mid-2026 [4] - Abeona has entered into a licensing agreement for the AAV204 capsid for potential gene therapies in ophthalmology [4] - The company secured $155 million from the sale of its Rare Pediatric Disease priority review voucher, awarded upon FDA approval of ZEVASKYN [4]