Abeona Therapeutics(ABEO)2025-03-20 11:45Financial Performance - Abeona Therapeutics reported a net loss of 54.2 million in 2023, representing a 17.5% increase in losses[7]. - Research and development expenses increased to 31.1 million in 2023, primarily due to increased headcount for manufacturing capacity expansion[7]. - General and administrative expenses rose to 19.0 million in 2023, reflecting increased costs related to commercial launch preparations[7]. Cash and Assets - Cash, cash equivalents, short-term investments, and restricted cash totaled 52.6 million as of December 31, 2023, indicating a 86.5% increase[5]. - The total assets of Abeona increased to 64.0 million as of December 31, 2023[15]. - The company estimates its current resources are sufficient to fund operations into 2026, excluding potential revenue from pz-cel sales[6]. Product Development and Regulatory Updates - The FDA has set a PDUFA target action date of April 29, 2025, for the review of the pz-cel Biologics License Application (BLA)[3]. - Abeona anticipates treating the first patient with pz-cel in the third quarter of 2025, pending FDA approval[3]. - The company has engaged five treatment centers in the U.S. to become qualified treatment centers for pz-cel[3]. - 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 system to July 2040[3].