Abeona Therapeutics Inc. reported a net loss of $63.7 million for the fiscal year ending December 31, 2024, an increase of 18% from the previous year's loss of $54.2 million. The company's revenues were nil, a significant decline from $3.5 million in 2023, primarily due to the absence of clinical development milestones achieved during the year. Total expenses rose to $64.2 million, up 27% from $50.6 million in 2023, driven by increased research and development costs and general administrative expenses, which surged by 57% to $29.9 million.
In terms of operational developments, Abeona's lead product, prademagene zamikeracel (pz-cel), is currently under review by the U.S. Food and Drug Administration (FDA) following a Biologics License Application (BLA) submission in September 2023. The FDA accepted the BLA for priority review, setting a target action date of May 25, 2024. However, the company received a Complete Response Letter (CRL) in April 2024, indicating that additional information was required to meet Chemistry Manufacturing and Controls (CMC) standards. The company has since resubmitted the BLA and is awaiting further review.
Abeona has also made strategic moves to enhance its manufacturing capabilities, including a lease for additional office space to convert into manufacturing space, which is expected to increase pz-cel production capacity. The company currently operates a Good Manufacturing Practices (cGMP) facility in Cleveland, Ohio, where it has been producing pz-cel for clinical trials. As of December 31, 2024, Abeona employed 136 full-time staff, reflecting its commitment to expanding its operational capacity.
Looking ahead, Abeona's financial outlook remains cautious, with the company indicating that it may need to secure additional funding to support ongoing research and development activities. As of the end of 2024, the company had cash resources of $98.1 million, which it believes will sustain operations for at least the next 12 months. However, the need for further capital raises is anticipated, which could dilute existing shareholders' equity. The company continues to engage with stakeholders to understand market access and pricing strategies for pz-cel, should it receive regulatory approval.
About ABEONA THERAPEUTICS INC.
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