Amin Makarem

Amin Makarem (Jefferies) inquired about the expected timeline for the 12 ZEVASKYN Product Order Form (ZPOF) patients to receive treatment, the proportion of these ZPOFs from referred patients versus existing Qualified Treatment Center (QTC) patients, and whether the recent treatment delay impacts the company's profitability timeline.

Answer

Madhav Vasanthavada (Chief Commercial Officer, Abeona) explained that the 12 ZPOF patients are at various stages, with some scheduled for biopsy in November 2025 and early 2026, and full treatment expected in the coming months as administrative processes complete. Vishwas Seshadri (CEO, Abeona) added that a generalized timeline is difficult currently but will normalize as more patients are treated, with better metrics expected in Q1 2026. He also clarified that the vast majority of the 12 ZPOFs are from patients already at QTCs. Madhav Vasanthavada (Chief Commercial Officer, Abeona) stated that the company does not foresee a significant impact on the profitability timeline, maintaining the projection for profitability in the first half of 2026.

Amin Makarem of Jefferies inquired about the specifics of the upcoming full data presentation for the VICTORIA-1 PIK3CA wild-type cohort and the benchmarks for success in the PIK3CA mutant population.

Answer

CEO Brian Sullivan explained that the initial data presentation will focus on the primary endpoints, with subgroup analyses to follow at subsequent medical meetings. For the PIK3CA mutant cohort, he outlined two key benchmarks: achieving a statistically significant and clinically meaningful result versus the alpelisib control arm, and also comparing favorably to data from Capivasertib, which he noted is a practical benchmark used by physicians.

Amin Makarem, on behalf of Maury Raycroft at Jefferies, asked for clarification on the timing of the Tivesimig PFS/OS analysis and whether the data release would be a full dataset or a topline summary.

Answer

CEO Thomas Schuetz stated that projecting the exact timing for reaching the 80% event threshold is difficult, but the company anticipates the analysis will read out in Q1 2026. He clarified that the initial release will be a priority dataset including PFS, OS, demographics, and top-line safety, with the full data reserved for a subsequent medical meeting.

Amin Makarem asked how Q3 trends are shaping guidance, about potential headwinds or tailwinds for TAVALISSE and GAVRETO, and about the gross-to-net impact from Medicare Part D changes.

Answer

EVP & Chief Commercial Officer David Santos projected continued double-digit revenue growth but noted the IRA's affordability impact might be less pronounced in the second half of the year. EVP & CFO Dean Schorno confirmed favorable gross-to-net impacts from distribution changes, product mix, and IRA adjustments, expecting some favorability to persist without providing specific figures.