Abeona Therapeutics (ABEO) investor relations material

Launch progress and operational updates

• Product launch began in December after initial manufacturing and assay optimization delays; momentum is strong with increasing patient interest and treatment slots filling rapidly.

• False positive sterility assay issues were resolved through assay fine-tuning, significantly reducing risk and restoring patient and physician confidence.

• Currently, four treatment centers are active, with plans to expand to five to seven centers this year; demand is growing as more centers and referring physicians engage.

• Manufacturing capacity is at six slots per month, aiming to reach ten by year-end, with infrastructure ready to double capacity if needed.

• Profitability is projected for 2026, with a run rate of three or more patients treated per month expected to achieve this milestone.

Patient journey and market opportunity

• The target population is approximately 750 moderate to severe RDEB patients in the U.S., with an estimated 1,500 treatment opportunities based on average wound coverage needs.

• Patient journey from identification to treatment currently takes four to five months, expected to shrink to about three months as processes streamline.

• High conversion rates are observed among identified patients, with most delays attributed to administrative and insurance clearance steps.

• As more centers gain experience, process harmonization and efficiency are anticipated, especially at the most active sites.

• Social media and community engagement among patients are accelerating demand and referrals.

Demand evolution and future strategy

• Over 50 patients have been identified, with 12 order forms submitted and two patients treated as of the latest update; numbers are steadily increasing.

• Each center is expected to treat one to two patients per month, with capacity and demand both ramping up as more centers are activated.

• Expansion strategy focuses on activating centers of excellence rather than converting smaller referral sites, as patients are accustomed to traveling for specialized care.

• Lifecycle management includes exploring new indications such as post-surgical applications and potential expansion to less severe patient populations.

• Pipeline updates are expected mid-year, with current focus on commercial execution and maintaining fiscal discipline.