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Abeona Therapeutics(ABEO) - 2024 Q4 - Annual Results

Financial Performance - Abeona Therapeutics reported a net loss of $63.7 million for the full year 2024, compared to a net loss of $54.2 million in 2023, representing a 17.5% increase in losses[7]. - Research and development expenses increased to $34.4 million in 2024 from $31.1 million in 2023, primarily due to increased headcount for manufacturing capacity expansion[7]. - General and administrative expenses rose to $29.9 million in 2024 from $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 $98.1 million as of December 31, 2024, up from $52.6 million as of December 31, 2023, indicating a 86.5% increase[5]. - The total assets of Abeona increased to $108.9 million as of December 31, 2024, compared 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].