Abeona Therapeutics Reports First Quarter 2024 Financial Results and Recent Corporate Progress

Core Viewpoint - Abeona Therapeutics Inc. is focused on addressing FDA's Chemistry Manufacturing and Controls (CMC) deficiencies to resubmit its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel) for recessive dystrophic epidermolysis bullosa (RDEB) in the second half of 2024, following a successful $75 million financing that extends its cash runway into 2026 [1][3][5]. Corporate Highlights - On May 7, 2024, the company closed a $75 million underwritten securities offering with participation from both new and existing investors [2]. - In January 2024, Abeona entered into a $50 million credit facility and received the first tranche of $20 million [2]. Product Development - The FDA issued a Complete Response Letter (CRL) in April 2024 regarding the BLA for pz-cel, citing the need for additional CMC information, but did not request new clinical trials or data [3]. - The company anticipates completing the BLA resubmission in the second half of 2024 and has accepted new long-term safety data for pz-cel for presentation at the Society for Investigative Dermatology Annual Meeting [3]. Commercial Launch Preparations - Abeona is advancing key commercial activities in preparation for a potential U.S. launch of pz-cel, including discussions with treatment sites and building supply chain capabilities [4]. Financial Results - As of March 31, 2024, the company reported cash and cash equivalents totaling $62.7 million, an increase from $52.6 million as of December 31, 2023 [5]. - The net loss for the first quarter of 2024 was $31.6 million, or $1.16 loss per common share, compared to a net loss of $9.1 million, or $0.54 loss per common share, in the same period of 2023 [6][7]. Research and Development Expenses - Research and development expenses for the first quarter of 2024 were $7.2 million, down from $8.0 million in the same period of 2023 [6]. - General and administrative expenses increased to $7.1 million in the first quarter of 2024, compared to $4.0 million in the same period of 2023 [6]. Balance Sheet Overview - Total assets as of March 31, 2024, were $74.8 million, compared to $64.0 million as of December 31, 2023 [17]. - Total liabilities increased to $83.7 million as of March 31, 2024, from $49.2 million as of December 31, 2023 [18].