Abeona Therapeutics Inc. Q3 FY2025 earnings call

• 2025 marked significant operational progress with ZivaSkin commercial launch, though first patient treated shifted to 2025 due to release assay optimization. Conviction in 2026 launch goals remains based on patient demand, treatment center expansion, and market access. • Brian Kevany discussed release assay optimization: a full batch of drug product couldn't be released due to assay issue, temporarily paused biopsy collection, resumed in Nov 2025. • Madhav Vasanthavada highlighted growing patient demand, 12 ZivaSkin product order forms (ZPOFs), QTC network expanded to 3 (including Children's Hospital Colorado), broad market access with commercial payers covering >80% insured lives, Medicaid coverage across all 51 states, and CMS establishing J code for 2026. • Joseph Walter Vazzano mentioned cash position of $207.5M as of 9/30/2025, R&D expenses reduced due to cost reclassification, SG&A expenses increased with commercial launch, and net loss reduced compared to 2024.

No detailed product segment financial performance with revenue contribution % provided as the transcript does not break down financials by product segments.

• Expectation to be a profitable business in the first half of 2026 remains unchanged despite first patient treatment shift. • Anticipate continued progress in ZivaSkin commercial launch with growing patient demand, QTC network expansion, and favorable market access.

• Temporary delay in first patient treatment due to release assay optimization issue. • Mandated FDA shutdown in mid-December for maintenance and equipment recalibration, impacting manufacturing timeline temporarily.

Q: What's the expected timeline for the 12 patients with ZPOFs to receive treatment?

A: Patients are at various stages, some scheduled for biopsy in Nov 2025 and 2026; metrics on time from ZPOF to treatment will be better understood in first quarter of 2026.

Q: Are you still planning on shutting the plant down in December for routine maintenance?

A: Yes, shutdown starts mid-December and takes about a month, from mid-December to early January.

Q: Were there any biopsies collected before the temporary pause that need re-biopsy?

A: No, we paused collecting further biopsies during the optimization pause.

Q: Can you share lead time between receiving ZPOFs and treatment?

A: Expect lead time to reduce over time, currently about 3 months, with processes improving as more patients go through the funnel.

Q: What's the attrition rate among patients with ZPOFs?

A: Anticipate low attrition as patients are motivated, and ZPOFs received show high interest; no significant attrition expected.

Q: Comment on prior authorization process for RDEB patients with large chronic wounds?

A: Prior authorization involves clinical and financial steps, often follows trial inclusion/exclusion criteria, with most payers covering label indications, and denials often overturned with medical necessity letters.

Q: How many biopsies done for 12 patients and dose pass revised criteria?

A: Too early to guide, will discuss in next quarterly call; revenue recognized on day of patient administration.

Q: Number of 30 slated patients on VYJUVEC or failed VYJUVEC?

A: No visibility into exact count, but expect majority are on existing therapies with unmet need.

Q: Why isn't UMass a QTC yet?

A: Different sites have various reasons like financial constraints or trade policy mismatches, not discussing specific site hurdles.