Abeona Therapeutics (NASDAQ:ABEO) executives said the commercial launch of ZEVASKYN is gaining momentum after an early manufacturing-related delay, outlining progress on treatment center activation, patient onboarding, and capacity expansion during remarks at the Leerink Partners Global Healthcare Conference.
Launch progress and early assay remediation
Chief Executive Officer Vish Seshadri said the company’s approval came in late April of last year, but the initial commercial rollout did not accelerate until December after Abeona addressed an issue related to a rapid sterility assay used to release product with an 84-hour shelf life. The company had been unable to release product for the first patient planned for August and worked with the FDA on assay optimization before moving forward.
According to Seshadri, the signal leading to false positives could be generated by patients’ cultured cells and appear similar to microbial contamination. He said feasibility and revalidation work has “vastly reduced the probability” of false positives, though he added that real-world experience across more manufacturing runs will provide the clearest empirical evidence. Abeona said it believes recurrence is “very unlikely,” while acknowledging it is difficult to predict exactly how many successful runs will occur before another potential event.
Target population and market opportunity
The company said its initial commercial focus is on moderate to severe recessive dystrophic epidermolysis bullosa (RDEB) patients, which Seshadri described as a genetically well-defined population typically treated at centers of excellence with multidisciplinary teams and operating room access. Based on a claims analysis at these centers and discussions with physicians, Abeona estimated roughly 750 moderate to severe RDEB patients in the U.S. that fit its target profile.
Seshadri added that, given wound size in this population, Abeona anticipates an average of two ZEVASKYN treatments to achieve substantial wound coverage—implying approximately 1,500 treatment opportunities. He also noted that moderate to severe patients face higher risks of complications such as squamous cell carcinoma, underscoring the perceived urgency for treatments that can provide substantial coverage.
Patient journey and factors affecting timing
Chief Commercial Officer Madhav Vasanthavada said the end-to-end process from patient identification to treatment—when revenue is recognized—is currently taking about four to five months, but the company expects that timeframe to shrink. He outlined the steps as in-person consultation at a qualified treatment center, placement of an order form, insurance and financial clearance, scheduling for a biopsy, and then a predictable 25-day manufacturing period before product application.
Vasanthavada said variability is concentrated in the “upstream” period before biopsy collection, driven by referral logistics and payer processes. He noted that payers often require documentation to establish medical necessity, including letters of medical necessity and other materials such as wound images and mutation information. Seshadri added that the sequencing can vary by site, with some centers preferring to complete more insurance verification before submitting an order form.
In an “ideal” scenario, Vasanthavada said the company expects a roughly 90-day (about three-month) process from order to treatment, with the manufacturing timeline itself representing about a month of that period. He said sites are already becoming more efficient as templates and processes are established with particular payers, but he did not give a specific date by which all centers would consistently reach the three-month target.
Demand indicators, treatment centers, and capacity
On demand, management said physicians have identified roughly 50 patients, and that number is increasing. Vasanthavada referenced a previously communicated figure of 12 order forms and said patients are moving through the multistep process. Abeona also said it has treated two commercial patients so far—one in December and one in January—and expects additional treatments based on biopsies already taken and others scheduled.
The company said it has qualified four treatment centers—Lurie Children’s Hospital (Chicago), Lucile Packard Children’s Hospital Stanford, Children’s Hospital Colorado, and UTMB—with most initial cadence coming from the first two initiated sites. Vasanthavada said the company expects a high conversion rate among the initially identified patients, describing the primary question as “when” rather than “if,” given the severity of their wounds and practical family scheduling considerations.
Regarding expansion, Seshadri reiterated a goal of activating five to seven qualified treatment centers during 2026, calling that target “imminent” and “on track.” He said more centers have expressed interest, but Abeona intends to pace onboarding alongside manufacturing capacity growth. Vasanthavada said the company does not expect to convert most referring sites into treatment centers, citing infrastructure needs and the established pattern of patients traveling to centers of excellence for care.
On manufacturing, Seshadri said Abeona is currently operating at six slots per month and aims to ramp to about 10 per month in the second half of the year by hiring and training additional staff. He said a gating factor had been the conversion of a GMP suite used for vector manufacturing, but the company has now produced sufficient vector supply that could support two to three years of operations, freeing the suite for conversion. Longer term, he said the company has identified space and designs to expand from 10 to 20 slots, though that would require an 18-month lead time after initiating the project.
Lifecycle management and profitability comments
Looking beyond the initial moderate to severe population, Seshadri said one area of interest is use following hand surgery for pseudosyndactyly, where digits fuse and can re-fuse after surgical separation. He also said expansion to less severe patients could be driven by a desire to treat recurrent wounds earlier to prevent them from becoming chronic.
Finally, management addressed the company’s prior guidance toward profitability in 2026. Seshadri said that treating “anything north of three patients a month” would generate profits for the company and added that Abeona is “not far from that,” with the company still expecting to reach that level potentially by the second quarter as momentum builds.
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.
