Abeona Therapeutics(ABEO) GlobeNewswire·2025-03-20 11:30Core Viewpoint - Abeona Therapeutics is making significant progress with its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) aimed at treating recessive dystrophic epidermolysis bullosa (RDEB), with a target action date set for April 29, 2025 [1][6]. Financial Results - For the full year 2024, Abeona reported a net loss of 1.55 loss per common share, compared to a net loss of 2.53 loss per common share in 2023 [7][11]. - Research and development expenses increased to 31.1 million in 2023, primarily due to increased headcount for manufacturing capacity expansion [7][11]. - General and administrative expenses rose to 19.0 million in 2023, attributed to costs associated with commercial launch preparations [7][11]. Cash Position and Runway - As of December 31, 2024, the company had cash, cash equivalents, short-term investments, and restricted cash totaling 52.6 million a year earlier [4][5]. - Abeona estimates that its current financial resources are sufficient to fund operations into 2026, not accounting for potential revenue from pz-cel sales or proceeds from a Priority Review Voucher (PRV) [5]. Regulatory and Development Updates - The FDA has accepted the BLA resubmission for pz-cel and discussions are ongoing regarding post-marketing requirements and the draft label [2][6]. - Abeona plans to treat its first patient with pz-cel in the third quarter of 2025, pending FDA approval [1][6]. - The company is actively preparing for commercialization, including onboarding treatment centers and engaging payers to ensure patient access [6]. Intellectual Property - Abeona has obtained two additional patents for pz-cel, extending patent protection for its use in treating RDEB to June 2037 and for its packaging and transport system to July 2040 [6]. Conference Call - A conference call to discuss financial results and company updates is scheduled for March 20, 2025, at 8:30 a.m. ET [8].