By David Bautz, PhD
NASDAQ: ABEO
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Business Update
Momentum Building for Zevaskyn®
Abeona Therapeutics, Inc. (NASDAQ: ABEO) has successfully transitioned to a commercial-stage company following the April 2025 approval of Zevaskyn, although the early launch metrics thus far show that the company is still in the initial rollout phase. The company has treated two patients thus far, one in the fourth quarter of 2025 and another in the first quarter of 2026. Multiple patients have been biopsied this quarter and each is at a different manufacturing stage with treatment expected over the coming weeks.
We view 2026 as a process-validation year as management is focused on establishing treatment workflows that will lead to a steady increase in the number of treated patients as the year progresses. In December 2025, the company added a fourth Qualified Treatment Center (QTC) at The University of Texas Medical Branch (UTMB) in Galveston, TX, to help support increased patient throughput and expand the company’s geographic footprint.
During the conference call, management indicated that they have now identified > 100 patients that are potentially suitable for Zevaskyn treatment. Importantly, policies covering Zevaskyn have been published by all major commercial payers, including United Healthcare, Cigna, Aetna, Anthem, and Blue Cross and Blue Shield. The first patient treated for which the company has received payment ($2.4M) was covered by Medicaid, so net revenues are expected to normalize over time as the payer mix begins to include commercially insured patients.
As 2026 continues, investors should continue to pay attention to biopsy volume growth, the time it takes for a patient to go from biopsy to treatment, the number of patients that the company is able to treat per quarter, how many patients are treated at each QTC per quarter, and the payer mix evolution. We believe the demand for Zevaskyn is there, and as operational efficiencies continue to improve, the number of patients treated and the revenue recognized will continue to increase as the year progresses.
Financial Update
On March 17, 2026, Abeona announced financial results for 2025. The company reported total revenue of $5.8 million for the year ending December 31, 2025. The revenue consisted of $3.4 million in license and other revenues and $2.4 million in net product revenue. License and other revenues are driven by a clinical milestone reached under the October 2020 sublicense agreement with Taysha Gene Therapies for its investigational Rett syndrome gene therapy. The net product revenue is derived from the one patient treated with Zevaskyn in December 2025. That patient was covered by Medicaid, thus we anticipate revenues normalizing over time as patients covered by commercial insurers are treated. R&D expenses in 2025 were $26.8 million compared to $34.4 million for 2024. The decrease was primarily due to the FDA approval of Zevaskyn, which resulted in certain production costs being capitalized into inventory and engineering runs that are no longer classified as R&D. SG&A expenses in 2025 were $65.0 million compared to $29.9 million for 2024. The increase was primarily due to the commercial transition following Zevaskyn’s approval, including $18.6 million in personnel and stock-based compensation and $2.3 million in direct commercialization costs.
Abeona exited 2025 with approximately $191.4 million in cash, cash equivalents, and short-term investments. As of March 11, 2026, the company had approximately 57.1 million shares outstanding and, when factoring in stock options, restricted stock, and warrants, a fully diluted share count of approximately 70.2 million.
Conclusion
Abeona has entered the commercial stage with Zevaskyn, and while we believe the demand is there the company is still clearly in the operational buildout phase rather than the launch ramp phase. This year will be about repeatable execution in terms of patient identification, manufacturing, and treatment delivery. Investors should look for improved metrics in terms of number of patients treated, turnaround time from biopsy to treatment, and increased throughput at each of the QTCs. There are a lot of moving parts to coordinate, but as the company and each QTC get the procedures standardized, we believe the launch ramp phase will begin to initiate toward the end of 2026 and into 2027. We pushed out revenue expectations slightly as we had underestimated the time necessary to reach an inflection point, and while this has caused a slight decrease to our valuation, we are confident in the long-term story and would look at any near-term pullbacks in the stock as buying opportunities. Our valuation now stands at $13 per share.
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