ABEO: Sells Priority Review Voucher for $155 Million…

About this update from Abeona Therapeutics Inc.

By David Bautz, PhD NASDAQ:ABEO READ THE FULL ABEO RESEARCH REPORT Business Update First Qualified Treatment Center Activated On May 14, 2025, Abeona Therapeutics, Inc. (NASDAQ:ABEO) announced that the Ann & Robert H. Lurie Children’s Hospital of Chicago has been activated as the first Qualified Treatment Center (QTC) for Zevaskyn™. The hospital has completed all QTC start-up activities and the first patient is likely to be biopsied in July and treated in August. Lurie Children’s is one of the largest North American centers for epidermolysis bullosa and cares for more than 150 affected children and adults. Zevaskyn will be the tenth gene therapy offered at Lurie Children’s. Commercial Launch Underway Following the approval of Zevaskyn on April 29, 2025, Abeona is focused on advancing its commercial launch and identifying patients eligible for treatment. The company reported that since the drug was approved, approximately 30 patients and caregivers have started registering in the Abeona Assist patient services program. Management has guided that between 10-14 patients are expected to be treated, and revenue recognized from those treatments, this year. Manufacturing capacity is expected to be able to handle up to six treatments per month by the end of 2025 and up to 10 treatments per month by mid-2026. PRV Sale Strengthens Balance Sheet On May 12, 2025, Abeona announced that it entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $155 million (our estimate was for $150 million). The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvement Act. With the proceeds from the sale, the company now has sufficient cash to cover more than two years of operating expenses. Financial Update On May 15, 2025, Abeona announced financial results for the first quarter of 2025. The company did not report any revenue in the first quarter of 2025. R&D expenses in the first quarter of 2025 were $9.9 million compared to $7.2 million for the first quarter of 2024. The increase was primarily due to increased headcount related to the scale-up in manufacturing capacity in preparation for the Zevaskyn commercial launch. G&A costs in the first quarter of 2025 were $9.8 million compared to $7.1 million for the first quarter of 2024. The increase was primarily due to increased headcount associated with the planned launch of Zevaskyn. Abeona exited the first quarter of 2025 with approximately $84.5 million. As indicated above, we estimate the company’s cash position following the closing of the PRV sale will be sufficient to fund operations for at least the next two years, not taking into account any revenues from the sale of Zevaskyn. As of May 9, 2025, the company had approximately 51.2 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 67.2 million. Conclusion Abeona is now set to focus on a successful commercial launch of Zevaskyn following its approval and the PRV sale. With approximately 30 patients already entering into the Abeona Assist program, it appears initial interest in being treated with Zevaskyn is quite strong and we look forward to additional updates throughout the year on the number of patients treated and those that are seeking treatment. We had estimated the PRV would sell for $150 million, thus there is no change to our model and our valuation remains at $11 per share. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH  to receive our articles and reports emailed directly to you each morning. Please visit our  website  for additional information on Zacks SCR.  DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE .

View stock analysis, news, and events for Abeona Therapeutics Inc.