Abeona Therapeutics Highlights ZEVASKYN Launch Momentum, Revenue Growth at H.C. Wainwright

Key Points

• ZEVASKYN commercial momentum is building: Abeona reported $11.4 million in quarterly net product revenue, up 31% sequentially, and had treated 12 patients across seven qualified centers as of Aug. 13.
• Market access is broad but administrative hurdles remain: Coverage represents more than 95% of commercial lives, with Medicaid coverage in all 50 states, while prior authorizations and single-case agreements continue to slow treatment.
• Abeona sees significant financial and pipeline potential: The company estimates roughly 750 U.S. patients may be eligible for ZEVASKYN, priced at $3.1 million per treatment cycle, and holds $146 million in cash to support the launch and development of additional programs.

Abeona Therapeutics NASDAQ: ABEO highlighted the early commercial progress of ZEVASKYN, its autologous gene-modified cellular sheet therapy for recessive dystrophic epidermolysis bullosa (RDEB), during the H.C. Wainwright 28th Annual conference.

Madhav Vasanthavada, Abeona’s senior vice president and chief commercial officer, said the company has transitioned into a commercial-stage cell and gene therapy company following ZEVASKYN’s approval and launch late last year. The company reported $11.4 million in net product revenue in its most recent quarter, representing 31% quarter-over-quarter growth, according to Vasanthavada.

ZEVASKYN Launch Expands Treatment-Center Network

Abeona said it had commercially treated 12 patients with ZEVASKYN as of Aug. 13 and had onboarded seven qualified treatment centers. The latest site to become active was Cincinnati Children’s, which Vasanthavada described as one of the largest and globally recognized centers in the U.S.

The seven-center network places qualified treatment sites in states where approximately 40% of the addressable patient population lives, he said. Abeona has identified more than 100 potential patients through both qualified centers and community physicians.

The company said it has obtained coverage representing more than 95% of commercial lives and that Medicaid programs in all 50 states cover ZEVASKYN. Vasanthavada said the company had not experienced an ultimate insurance denial for ZEVASKYN coverage.

However, he said administrative processes remain a launch bottleneck. Before treatment, patients generally require confirmation of medical necessity, prior authorization and single-case agreements between treatment centers and payers. Those agreements may encompass reimbursement not only for the product but also for biopsy procedures, surgery and inpatient hospital stays.

According to Vasanthavada, treatment centers are gaining experience as they treat more patients. The time from center activation to treating an initial patient has fallen to as little as two months at some sites, although timelines continue to vary by institution.

Autologous Manufacturing and Clinical Experience

ZEVASKYN is produced from two 8-millimeter punch biopsies taken from a patient. Abeona said its manufacturing process takes about 25 days and can produce up to 12 credit card-sized, gene-modified skin sheets. The sheets are applied surgically to open wound areas.

Vasanthavada said commercial treatments are averaging nine sheets, compared with a maximum of six sheets administered in the clinical-trial setting. ZEVASKYN is sold at a fixed price rather than on a per-sheet basis, with a minimum of four sheets and a maximum of 12 sheets available per treatment cycle.

The company said ZEVASKYN is intended to address the genetic deficiency associated with RDEB and can be used in adult and pediatric patients. Vasanthavada said the youngest commercially treated patient was 2 years old, while the youngest patient in Abeona’s clinical trials was 6 years old.

He said wounds treated in pivotal trials had been open for an average of five years, with some remaining open for as long as 21 years. Abeona reported that a single surgical application demonstrated wound healing and pain reduction in treated areas during clinical studies. The company also cited follow-up data extending as long as 12 years from an early-phase study and five years from its Phase III experience.

Market Opportunity and Financial Position

Abeona estimates there are approximately 1,300 dystrophic epidermolysis bullosa patients in the U.S., including about 750 patients potentially eligible for ZEVASKYN based on moderate-to-severe wound size. The company expects patients may receive about two treatment cycles, with each cycle carrying a wholesale acquisition cost of $3.1 million.

Vasanthavada said Abeona becomes cash-flow positive from ZEVASKYN treatments when it treats more than three patients in a month. The company reported $146 million in cash, which it expects will support the commercial launch and investigational new drug-enabling work for ABO-701.

Pipeline and Partnered Programs

Beyond ZEVASKYN, Abeona highlighted several partnered programs. Ultragenyx has a PDUFA date for UX111 in Sanfilippo syndrome type A, while Taysha is advancing a Rett syndrome program through pivotal studies. Abeona said it could receive clinical, regulatory and commercial milestones, as well as royalties, from those programs.

The company has also licensed its ophthalmology AAV204 capsids to Beacon Therapeutics on a non-exclusive basis for preclinical retinal-disease programs.

In addition, Abeona acquired PSMA-SIR-T, a synthetic immune receptor T-cell technology targeting prostate cancer, earlier this year. Vasanthavada said the preclinical program targets prostate-specific membrane antigen, or PSMA, and that the company aims to bring the therapy into human studies next year.

About Abeona Therapeutics (NASDAQ:ABEO)

Abeona Therapeutics Inc is a biopharmaceutical company focused on developing and commercializing cell and gene therapies for patients with serious and life-threatening genetic diseases. The company's programs are designed to address conditions for which existing treatment options are limited or inadequate.

Abeona's lead product, ZEVASKYN (prademagene zamikeracel, formerly EB-101), is an autologous gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, a rare inherited disorder that causes fragile skin and chronic wounds.

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