Abeona Therapeutics (NASDAQ:ABEO) executives said the company is seeing early momentum in the commercial launch of ZEVASKYN, its FDA-approved autologous ex vivo engineered cell therapy for patients with wounds associated with recessive dystrophic epidermolysis bullosa, or RDEB.
Speaking at a Jefferies fireside chat, President and CEO Vish Seshadri said ZEVASKYN was approved by the FDA in April 2025 and that the company began its commercial launch later in the year as it optimized assays and onboarded treatment sites. Abeona has activated six qualified treatment centers, or QTCs, and has seen treatment activity build from the first two activated sites.
Patient Funnel and Treatment Site Ramp
Chief Commercial Officer Madhav Vasanthavada said demand remains strong, with patients being identified both within QTCs and in community physician practices. Abeona previously cited more than 100 identified patients across QTCs and community physicians. Vasanthavada said those identified patients are patients with large chronic wounds that physicians view as immediate candidates for ZEVASKYN.
About 20% of those identified patients are actively pursuing ZEVASKYN treatment, he said. As patients move through the process, the company expects more to enter the QTC funnel.
Executives said the biggest bottlenecks are administrative steps tied to payer interactions and the pace at which QTCs can move patients through the process. Seshadri said the current bottleneck is the QTC network, but Abeona is working to expand the number of active centers and improve patient flow within each site.
The company has communicated a goal of activating five to seven QTCs this year and could reach about 10 QTCs early next year, Seshadri said. He added that the first activated QTCs should be operating at a “cruise control rate” by the start of 2027.
Coverage and Reimbursement
Vasanthavada said Abeona has not seen final payer denials so far. He said more than 95% of commercial insurance coverage policies have been published, and Medicaid baseline coverage has been established across all 50 states.
Still, reimbursement timing can vary. Vasanthavada said negotiations between the institution and payer over payment rates for the product and associated procedures can affect the timeline, particularly for anesthesia, surgery and other procedural components. Seshadri said, based on the company’s early experience, in-state Medicaid appears to be the fastest pathway, followed by commercial insurance, with out-of-state Medicaid the slowest.
Seshadri said roughly 60% of patients have commercial insurance, while about 30% to 35% may be covered by Medicaid.
On retreatment, Vasanthavada said Abeona does not expect the same level of friction because payer coverage and payment rates would already have been established. Seshadri said the company expects a majority of patients to seek a second treatment for previously untreated wounds, noting that patients may not be able to have all wounds treated in one surgery because of wound location and post-application immobilization requirements.
Manufacturing and Capacity
Seshadri said ZEVASKYN manufacturing turnaround time is about 25 days, which is shorter and less variable than the patient journey from entering the funnel to biopsy. He said the company’s focus is on streamlining the upstream process before biopsy rather than materially changing manufacturing time.
Abeona currently has capacity for six manufacturing slots per month, Seshadri said. The company is working with the FDA on converting an RVV manufacturing suite into ZEVASKYN drug product manufacturing, with a goal of reaching 10 slots per month by the fourth quarter. Abeona has also begun certain long-lead activities for additional GMP space, though Seshadri said the company wants to avoid disrupting the current ramp-up.
Ex-U.S. and Pipeline Plans
Seshadri said the nearest ex-U.S. opportunity would likely involve supplying certain markets from Abeona’s Cleveland facility. However, he said Europe and Japan present logistical challenges, including the need to receive a cold-chain biopsy within 24 hours and the 84-hour shelf life of the drug product, along with QP clearance requirements.
He said the company is exploring longer-term options, including potential manufacturing outside the United States with a partner. Seshadri added that Abeona receives frequent inbound interest from ex-U.S. markets seeking access to ZEVASKYN, but said the company is being selective in its strategy.
Abeona also discussed ABO-701, a recently in-licensed asset. Seshadri said the therapy is not a CAR-T, but instead uses SIR-T technology intended to combine native T-cell receptor signaling with direct antigen binding. He said Abeona has been evaluating the asset for two to three years and plans to move into the clinic in the second half of next year, while continuing discussions with the FDA.
Asked about competition for the PSMA target, Seshadri said the company is aiming for a profile that could provide meaningful, durable remission in prostate cancer.
Profitability Milestone
Seshadri reiterated that potential monthly profitability, starting in June, is volume-driven. He said treating more than three patients in a given month would make that month cash-flow positive. Sustaining that level would depend on adding more sites and improving the treatment flow rate at each site.
“It’s just an inevitable phenomena,” Seshadri said, pointing to the expected contribution from more QTCs and better throughput over time.
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.
