Abeona Therapeutics (ABEO) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Key product launch and patient access

• ZEVASKYN, an autologous cell therapy for recessive dystrophic epidermolysis bullosa, launched late last year and is now available at seven qualified treatment centers across the U.S., with plans to expand further to minimize patient travel and increase access.

• Patient selection for centers is based on preference, physician relationships, and insurance coverage, with additional centers expressing interest in onboarding.

• Patients are excited about the potential for durable wound healing and reduced pain, while hesitations center on the surgical nature of the therapy and understanding the process, especially among younger patients and parents.

• Coverage is robust, with over 95% of commercial lives and all Medicaid jurisdictions covering ZEVASKYN, though reimbursement timelines remain a bottleneck due to procedural complexities.

• Each center can currently handle one to two patients per month, but capacity is variable and expected to grow as more centers gain experience.

Patient journey and outcomes

• The patient journey includes consultation, prior authorization, financial arrangements, biopsy, a 25-day manufacturing process, and clinical workup before treatment.

• Commercial experience has expanded to treating younger patients, including a two-year-old, and more centers are beginning to treat, supported by a travel assistance program.

• Early feedback from treated patients and physicians highlights significant wound healing and pain reduction, with some key opinion leaders suggesting long-term benefits.

• Five-year follow-up data from clinical trials and up to 12 years from the first patient support the durability of the therapy.

• Manufacturing challenges, such as low yield or out-of-spec batches, are rare and being addressed through process improvements.

Manufacturing, growth, and market opportunity

• Current manufacturing supports six slots per month, with plans to expand to ten per month by 2027 as demand increases and a second suite comes online.

• Growth is expected to be steady quarter-over-quarter as more centers treat patients and foundational steps are prioritized this year.

• The total addressable market in the U.S. is estimated at over $4 billion, with 750 eligible patients likely needing two treatment cycles each at a price point of $3.1 million per cycle.