Abeona Therapeutics Reports Full Year 2023 Financial Results and Announces Completion of FDA Inspections

Core Insights - Abeona Therapeutics Inc. reported its financial results for the full year of 2023 and provided updates on its corporate objectives, particularly regarding the Biologics License Application (BLA) for pz-cel [1][10] Regulatory Updates - The FDA completed a Pre-License Inspection (PLI) of Abeona's Cleveland manufacturing facility for pz-cel, issuing a Form 483 with observations related to process controls [2] - The FDA's review of the pz-cel BLA is ongoing, with a target Prescription Drug User Fee Act (PDUFA) date set for May 25, 2024, and no Advisory Committee meeting planned [2][4] Financial Performance - For the year ended December 31, 2023, Abeona reported license and other revenues of $3.5 million, an increase from $1.4 million in 2022 [7] - Research and development expenses rose to $31.1 million in 2023 from $29.0 million in 2022, primarily due to increased headcount for BLA activities [8] - The net loss attributable to common shareholders for 2023 was $54.2 million, or $2.53 loss per share, compared to a net loss of $43.5 million, or $5.53 loss per share, in 2022 [8] Cash Position and Funding - As of December 31, 2023, the company had cash, cash equivalents, restricted cash, and short-term investments totaling $52.6 million, slightly up from $52.5 million in 2022 [6] - Abeona entered a $50 million credit facility with Avenue Venture Opportunities Fund, L.P., with the first tranche of $20 million funded in January 2024 [5] Commercial Launch Preparations - The company is advancing commercial activities in preparation for a potential U.S. launch of pz-cel, including payer engagement and market research [5]