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Business Update
Commercial Launch of Zevaskyn® On-Track; First Patient to be Treated in 3Q25
Abeona Therapeutics, Inc. (NASDAQ:ABEO) is continuing to advance the commercial launch of Zevaskyn® (prademagene zamikeracel) following its approval by the U.S. FDA in April 2025. Since the approval, the company has activated two Qualified Treatment Centers (QTCs): Ann & Robert H. Lurie Children’s Hospital of Chicago and Lucile Packard Children’s Hospital Stanford. We anticipate additional centers being activated before the end of 2025.
The first patient at Lurie Children’s has already been biopsied and is anticipated to receive Zevaskyn before the end of the third quarter of 2025. The company has indicated strong interest from the patient community, as approximately 12 patients at the two activated QTC’s have been identified as good candidates for Zevaskyn treatment. In addition, approximately 36 other ‘high-priority’ patients have been identified at various other treatment centers around the country. Thus, we view the initial demand for Zevaskyn to be very strong. Abeona is continuing to guide that 10-14 patients will be treated in 2025 and the company remains on track to have the manufacturing capacity to treat 10 patients/month by mid-2026.
Thus far, 100% of submitted prior authorization requests have been approved. United Healthcare, which is the largest insurance provider in the U.S., published a coverage policy for Zevaskyn that is consistent with the FDA label with no other restrictions. Abeona has entered into the National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare and Medicaid Services (CMS) to get expedited coverage and reimbursement for Zevaskyn across all 51 state Medicaid programs and Puerto Rico. Overall, we view the insurance and reimbursement landscape to be very favorable thus far for the company.
Beacon Therapeutics Exercises Option for AAV204 Capsid
In July 2024, Abeona announced that Beacon Therapeutics has exercised its option to license Abeona’s patented AAV204 capsid for use in potential gene therapies for retinal diseases that result in blindness. Under terms of the agreement, Abeona will receive an undisclosed upfront license payment with additional payments upon the achievement of certain development, regulatory, and sales milestones, along with tiered royalties on worldwide net sales for licensed products incorporating AAV204.
Financial Update
On August 14, 2025, Abeona announced financial results for the second quarter of 2025. The company’s second quarter 2025 results include the reclassification of certain manufacturing and development costs from R&D to G&A. The company reported $0.4 million of license revenue in the second quarter of 2025 compared to $0 for the second quarter of 2024. As a reminder, Abeona will record revenue from the sale of Zevaskyn at the time the patient has surgery to receive the product. R&D expenses in the second quarter of 2025 were $5.9 million compared to $9.2 million for the second quarter of 2024. The decrease was primarily due to costs capitalized into inventory and select costs reclassified as G&A. G&A costs in the second quarter of 2025 were $17.1 million compared to $8.6 million for the second quarter of 2024. The increase was primarily due to increased headcount and professional costs associated with the commercial launch of Zevaskyn.
Abeona exited the second quarter of 2025 with approximately $225.9 million, which included net proceeds from the sale of the PRV. We estimate that the company has sufficient capital to fund operations for the next two years, which does not take into account any revenues from the sale of Zevaskyn. As of August 8, 2025, the company had approximately 51.3 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 67.0 million.
Conclusion
Everything appears to be going according to plan for the commercial launch of Zevaskyn and the company was very upbeat about the near-term prospects for the treatment. Abeona is continuing to guide for 10-14 patients to be treated in 2025, and with the announcement that there are upwards of 50 identified patients that would be good candidates for treatment it appears that the initial interest in the product is very strong. We look forward to updates as the first patients are treated and the company begins to recognize revenue from the sale of Zevaskyn. We have modestly increased our expectations for Zevaskyn in the early part of the commercial launch, which has increased our valuation to $14 per share.
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