Abeona Therapeutics (NASDAQ:ABEO) executives said the company is seeing growing patient demand for ZEVASKYN, an autologous cell-based gene therapy approved in April 2025 for adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB), while outlining early commercial traction, reimbursement progress, manufacturing capacity plans, and full-year 2025 financial results.
Launch progress and early patient throughput
Chief Executive Officer Dr. Vish Seshadri said ZEVASKYN’s commercial launch was delayed until the fourth quarter of 2025 as the company optimized a sterility test required for product release. Abeona treated its first commercial patient in December 2025, a milestone Seshadri described as the start of broader launch execution in 2026, with a focus on establishing a consistent cadence of biopsies, manufacturing, product delivery, and treatments.
Qualified treatment centers and patient funnel
All patient treatments and biopsies to date have come from the first two of four qualified treatment centers (QTCs): Lurie Children’s Hospital in Chicago and Lucile Packard Children’s Hospital at Stanford. Seshadri said the remaining two activated QTCs—Children’s Hospital of Colorado and the University of Texas Medical Branch (UTMB) in Galveston—are beginning to schedule patients into upcoming biopsy slots.
Vasanthavada emphasized that onboarding new QTCs is a multi-step process that can take several months, requiring institutional approvals and the establishment of operational components including a master service agreement, trade policy, clinical training, and registry protocols with IRB approvals. He said two QTCs have started treating patients and the other two have patients moving through the administrative process to schedule biopsies.
In addition to the four activated QTCs, management said it is actively working toward onboarding five additional centers in various stages, with a goal of having at least seven QTCs active by the end of 2026. On the Q&A portion of the call, Vasanthavada said one additional center is “imminent” and the company hopes to announce it in the coming quarter. Management also indicated that, due to the length of the onboarding process, some potential sites could spill into next year even as the company targets seven activated sites within the year.
Executives said they are building a geographically dispersed footprint to support patient access and reduce logistical issues, including potential Medicaid paperwork when patients cross state borders. Vasanthavada described a three-pronged demand approach:
- Prioritize patients already seen at activated QTCs.
- Drive referrals from community physicians who have identified motivated and eligible patients.
- Add new QTCs that can contribute their own pools of patients as they come online.
On capacity at treatment centers, management said sites have communicated that one patient per month is a cadence they can “definitely” do, with some sites indicating potential for two patients per month. In a separate response, Vasanthavada said certain institutions have suggested they could reach up to three patients per month depending on experience and resource allocation, though management expects one or two patients per month per site in the foreseeable future.
Demand identification, reimbursement, and timing
Vasanthavada said Abeona previously reported nearly 50 potentially eligible patients identified across initial QTCs and community-based physicians, and that the number has now grown to more than 100 after the company deployed a field team to engage community physicians.
Management said the speed from identification to treatment has varied in the early launch phase. Vasanthavada estimated an average process of roughly four to five months from consult and patient intent to treatment, including about 25 days of manufacturing time, and said the timeline should improve as sites and payers gain experience. Executives also noted that the timing of when a site submits a “start form” varies, which can make standardized measurement more difficult.
On coverage, Vasanthavada said no payers have denied insurance coverage for ZEVASKYN so far, and he said the company has not seen patient attrition during the early funnel. He also said major commercial payers, including UnitedHealthcare, Cigna, Aetna, Anthem, and most Blue Cross Blue Shield plans, have published coverage policies representing roughly 80% of commercially covered lives. In addition, he said ZEVASKYN has baseline coverage across Medicaid programs in all 50 states. Management highlighted that CMS established a permanent HCPCS J-code effective Jan. 1, 2026, which Abeona expects will help streamline billing and reimbursement for QTCs.
In response to a question on pre-authorization, Vasanthavada said payers are using a mix of clinical criteria, including references to trial inclusion and exclusion criteria given the product’s cost. He said physicians have been able to address certain requirements through letters of medical necessity, citing examples such as age-related criteria and factors related to squamous cell carcinoma considerations. Management said these requirements have not ultimately prevented reimbursement, though they can add steps.
Manufacturing updates and capacity expansion
Chief Technical Officer Brian Kevany said the company had “a very healthy dialogue” with the FDA around the rapid sterility lot release assay issue that contributed to the delayed launch and that management is confident in the resolution reached with the agency. Seshadri added that Abeona has worked to reduce the probability of future false positives and is pursuing next-generation rapid sterility development as part of lifecycle management efforts.
Kevany said the manufacturing facility is currently running at a cadence of six patients per month and is developing capacity to reach 10 patients per month, a target the company has previously discussed achieving during the second half of the year. Management said the expansion is on track and aligns with the onboarding of additional QTCs.
Financial results and cash position
Chief Financial Officer Joe Vazzano reported total revenue of $5.8 million for the year ended Dec. 31, 2025, including $3.4 million in license and other revenue and $2.4 million in net product revenue. The license revenue was primarily driven by a $3 million clinical milestone achieved in the fourth quarter under a sublicense agreement for Rett syndrome with Taysha Gene Therapies.
Vazzano said net product revenue reflected the December patient treatment, which involved a Medicaid patient. He noted Abeona expects average net revenues to normalize over time as the payer mix expands to include more commercially insured patients, and said payment for that treatment was received in the first quarter of 2026.
Cost of sales for 2025 was $1.5 million, primarily related to the first commercial treatment and costs associated with an August production batch that was not released due to technical challenges tied to the FDA-mandated sterility assay. Vazzano said the company expects gross margins to increase significantly as volumes rise and economies of scale improve production costs.
R&D spending in 2025 decreased by $7.6 million to $26.8 million compared to $34.4 million in 2024, which Vazzano attributed primarily to the FDA approval and the post-approval capitalization of certain production costs into inventory. SG&A expenses rose to $65 million, up $35.1 million year over year, reflecting Abeona’s commercial transition after approval, including $18.6 million in personnel and stock-based compensation and $2.3 million in direct commercialization costs, as well as certain costs shifting from R&D to SG&A.
The company recorded a $152.4 million gain on the sale of a rare pediatric disease priority review voucher, which it sold in May 2025 and received payment for in June. Net income was $71.2 million for 2025, or $0.34 per basic and $1.01 per diluted share, compared with a net loss of $63.7 million in 2024. Abeona ended 2025 with $191.4 million in cash, cash equivalents, and short-term investments.
Looking ahead, management said R&D drivers include the FDA-required registry study and pipeline development, while also noting a shift of certain activities from R&D to SG&A as the company operates as a commercial-stage business.
About Abeona Therapeutics (NASDAQ:ABEO)
Abeona Therapeutics is a clinical‐stage biopharmaceutical company focused on the development and commercialization of gene and cell therapies for severe, life‐threatening rare diseases and oncology indications. Founded in 2014 and headquartered in Cleveland, Ohio, Abeona leverages proprietary viral and non‐viral delivery platforms to correct or compensate for underlying genetic deficiencies. The company’s research efforts target pediatric neurodegenerative disorders as well as debilitating dermatologic conditions with high unmet medical need.
The company’s lead clinical programs include separate AAV‐based gene therapies for CLN1 and CLN3 forms of neuronal ceroid lipofuscinosis, alongside an ex vivo autologous cell therapy for recessive dystrophic epidermolysis bullosa.
