Abeona Therapeutics (NASDAQ:ABEO) reported early commercial momentum for ZEVASKYN in the first quarter of 2026, with executives highlighting new patient treatments, expanded treatment-center activation and a newly licensed prostate cancer cell therapy program during the company’s earnings call.
Chief Executive Officer Dr. Vishwas Seshadri said Abeona has treated five commercial patients with ZEVASKYN since the product’s launch, with manufacturing underway for a sixth patient and additional patients scheduled during the current quarter. Three ZEVASKYN treatments occurred in the first quarter, generating $8.7 million in net product revenue.
ZEVASKYN is Abeona’s treatment for recessive dystrophic epidermolysis bullosa, or RDEB. Seshadri described the product’s launch as the company’s “foundational and primary focus.”
ZEVASKYN Launch Shows Early Uptake
Chief Commercial Officer Dr. Madhav Vasanthavada said one commercial patient was treated in the fourth quarter of 2025, three patients were treated in the first quarter of 2026 and one patient has been treated so far in the second quarter, bringing the total to five treated patients.
Vasanthavada said one additional patient has been biopsied and is currently in manufacturing, while six more patients are expected to be biopsied this quarter. As of the morning of the call, four of those six had scheduled biopsies.
The patients treated to date and those scheduled for biopsies are from Abeona’s first two activated qualified treatment centers, or QTCs, Vasanthavada said. Other QTCs have identified patients and are moving toward biopsy scheduling, which he said should add to ZEVASKYN treatments in coming quarters.
Abeona said it has activated six QTCs, including recently announced activations at NewYork-Presbyterian/Columbia University and Children’s Hospital of Philadelphia. The network spans California, Colorado, Texas and the Gulf Coast, Chicago and the East Coast. The company said it remains on track to reach a total of seven QTCs onboarded this year.
Vasanthavada said the company has identified a near-term pool of more than 100 patients across QTCs and community-based physicians. He also said Abeona is in active conversations with 45 referral physicians.
Payer Coverage Broadens, But Approvals Remain Lengthy
Vasanthavada said initial ZEVASKYN use has included adults and children, including one patient as young as five years old. He said the payer mix includes both commercial and Medicaid insurers, and patients have traveled significant distances, including across state lines, to receive treatment.
Commercially covered lives with published ZEVASKYN policies have reached 95%, Vasanthavada said. However, he noted that Abeona is still navigating lengthy insurance approval processes, particularly for out-of-state Medicaid patients. He said the company has seen no patient attrition and no final payer denials to date.
During the question-and-answer session, Seshadri said the early treated patients have generally been severe cases, as expected, and many would require more than 12 sheets of ZEVASKYN. He said there remains an unmet need even among treated patients, though it is too early to say when or how many may return for additional treatment.
Asked about timing for second-quarter treatments, Seshadri said Abeona had provided visibility into eight patients: one treated, one in manufacturing and six in the biopsy scheduling process. He said patients biopsied after the first week of June could potentially fall into July treatment, but added that “a good chunk” of the patients described should fall into second-quarter treatments.
New Prostate Cancer Cell Therapy Program Licensed
Abeona also announced the in-licensing of ABO-701, a PSMA-directed autologous engineered T-cell therapy for advanced prostate cancer. Seshadri said the therapy targets prostate-specific membrane antigen, a validated target in advanced prostate cancer.
The technology was pioneered by Dr. Preet Chaudhary, founder of Angeles Therapeutics and a professor of medicine at the University of Southern California. Seshadri said the platform is structured to overcome limitations of chimeric antigen receptors and T-cell receptors by directly recognizing membrane antigen while retaining physiologic signaling and regulatory features of a native T-cell receptor.
In preclinical studies, Seshadri said PSMA CAR-T showed deep and durable PSMA-specific antitumor responses in mouse models and “exceptionally modest” cytokine release in vitro. Abeona anticipates filing an investigational new drug application and beginning first-in-human studies in the second half of 2027. The company also expects to hold a pre-IND meeting with the FDA on June 3, 2026.
Seshadri said Abeona has deprioritized its in-house ophthalmology preclinical programs as it focuses on assets aligned with its experience in complex cell and gene therapies. He said the prostate cancer program will be advanced through an external contract development and manufacturing organization, with Abeona’s internal teams remaining focused on ZEVASKYN commercialization.
First-Quarter Financial Results
Chief Financial Officer Joseph Vazzano said Abeona reported total net product revenue of $8.7 million for the first quarter, compared with $2.4 million in the fourth quarter of 2025. All three patients treated in the quarter were commercially insured.
Cost of sales was $2.7 million, compared with $1 million in the prior quarter, reflecting the increase to three ZEVASKYN treatments in the first quarter from one treatment in the fourth quarter.
Research and development expenses were $9.6 million, compared with $9.9 million in the first quarter of 2025. Vazzano said the 2026 figure included a $7 million upfront payment related to the PSMA CAR-T licensing agreement. Excluding that transaction, R&D expenses declined, reflecting the transition of certain manufacturing costs to inventory and engineering runs no longer considered R&D after ZEVASKYN’s approval.
Selling, general and administrative expenses were $19.5 million, up $9.7 million year over year. Vazzano said the increase was expected and reflected commercial infrastructure investment following approval, including $5.4 million in personnel and stock-based compensation and $1.9 million in costs related to engineering runs.
Abeona reported a first-quarter net loss of $17.1 million, or 30 cents per basic and diluted common share, compared with a net loss of $12 million, or 24 cents per share, in the prior-year period. The company ended the quarter with $168.3 million in cash equivalents and short-term investments, down from $191.4 million at the end of 2025.
Vazzano said Abeona expects minimal R&D spending for the PSMA program for the rest of the year, limited to low single-digit millions of dollars. In response to an analyst question, he said the company continues to believe it could achieve monthly profitability starting potentially in June, depending on how upcoming biopsies progress.
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.
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