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

Core Insights - Abeona Therapeutics Inc. reported financial results and operational progress for Q3 2025, highlighting the anticipated launch of ZEVASKYN and its growing patient demand [1][2][3] Financial Performance - As of September 30, 2025, the company had $207.5 million in cash, cash equivalents, restricted cash, and short-term investments, which is expected to fund operations for over two years [3][6] - R&D spending for Q3 2025 was $4.2 million, a decrease from $8.9 million in Q3 2024, primarily due to costs capitalized into inventory [7] - SG&A expenses increased to $19.3 million in Q3 2025 from $6.4 million in Q3 2024, reflecting increased headcount and costs associated with the ZEVASKYN launch [7] - The net loss for Q3 2025 was $(5.2) million, or $(0.10) per share, compared to a net loss of $(30.3) million, or $(0.63) per share, in Q3 2024 [8][14] Product Development and Launch - The launch of ZEVASKYN has been scaled to meet patient needs, with the first anticipated patient treatment shifted to Q4 2025 due to an optimized release assay [2][4] - Patient demand for ZEVASKYN has more than doubled, with approximately 30 eligible patients identified at the first two Qualified Treatment Centers (QTCs) [4] - The company has activated three QTCs, including Children's Hospital Colorado, and is onboarding additional centers across the U.S. [4] - Coverage decisions from major commercial health plans have been made, covering approximately 60% of all RDEB patients, indicating early market acceptance [4] Strategic Initiatives - The pipeline program ABO-503 has been selected for the FDA Rare Disease Endpoint Advancement Pilot Program, enhancing communication and collaboration with the FDA [2][5] - The management team has been strengthened with the appointment of James A. Gow, MD, as Senior Vice President, Head of Clinical Development & Medical Affairs [5] Balance Sheet Highlights - Total assets as of September 30, 2025, were $231.1 million, up from $108.9 million as of December 31, 2024 [16][17] - Current liabilities totaled $22.2 million, with total liabilities at $59.9 million [16][17]