Abeona Therapeutics(ABEO) - 2025 Q1 - Quarterly Results

FDA Approval and Product Launch - Abeona Therapeutics received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1] - The U.S. launch of ZEVASKYN is underway with the activation of the first Qualified Treatment Center (QTC) at Lurie Children's Hospital, expecting to treat the first patient in Q3 2025 [4] Financial Performance - Cash, cash equivalents, restricted cash, and short-term investments totaled $84.5 million as of March 31, 2025, down from$98.1 million as of December 31, 2024 [7] - The net loss for Q1 2025 was $12.0 million, or$0.24 loss per share, significantly improved from a net loss of $31.6 million, or$1.16 loss per share, in Q1 2024 [9] - Abeona's total assets decreased to $99.4 million as of March 31, 2025, from$108.9 million as of December 31, 2024 [18] Research and Development Expenses - Research and development expenses increased to $9.9 million for Q1 2025, compared to$7.2 million for the same period in 2024, primarily due to increased headcount for ZEVASKYN's commercial launch [8] - General and administrative expenses rose to $9.8 million in Q1 2025 from$7.1 million in Q1 2024, reflecting increased staffing for the ZEVASKYN launch [8] Sales and Market Access - Abeona entered into a sales agreement for a priority review voucher (PRV) for gross proceeds of $155 million, which will fund operations for over two years [6] - Abeona has executed value-based agreements with commercial payer groups covering approximately 100 million commercially-insured lives to ensure broad access to ZEVASKYN [5] - The company is actively discussing further access expansion for ZEVASKYN with multiple commercial and government payers [5]