Abeona Therapeutics (ABEO) investor relations material

Key product and clinical updates

• ZevaSkin™ received FDA approval in April 2025 for treating recessive dystrophic epidermolysis bullosa (RDEB) wounds in adults and children.

• Over 50 patients identified for ZevaSkin™ treatment, with more than a dozen at two activated qualified treatment centers (QTCs).

• ZevaSkin™ is the first and only gene therapy approved for large-area wound coverage with a single application, offering multi-year healing and pain relief.

• Clinical trials showed 81% of treated wounds had >50% healing at six months, with significant pain reduction.

• Long-term follow-up demonstrated sustained wound healing for up to eight years after a single treatment.

Commercial launch and patient access

• ZevaSkin™ is priced at $3.1 million per treatment, with strong initial demand and positive payer momentum.

• Two QTCs are operational, with additional centers being activated to meet growing demand.

• Patient support programs, including travel and logistics assistance, are in place to facilitate access.

• The process from patient consult to treatment currently takes three to four months, expected to improve over time.

• Manufacturing capacity is being ramped up to address demand, with a planned GMP shutdown in December.

Market opportunity and financial outlook

• Estimated 750 eligible RDEB patients in the U.S., with an average of two treatment cycles per patient, representing a $4 billion cumulative revenue opportunity.

• Profitability expected by treating more than three patients per month, with projected profitability in the first half of 2026.

• $226 million in cash as of June 30, 2025, providing over two years of operating runway.

• Positive payer coverage trends, including policies from UnitedHealth, Cigna, and Anthem, and agreements with CMS for Medicaid and Medicare reimbursement.

• Demand is outpacing supply, with ongoing efforts to expand manufacturing and treatment center capacity.