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- **ZEVASKYN Launch Momentum**: Despite Q4 2025 patient treatment delay, Abeona reports 30 identified candidates (double Q2 levels) and 12 ZPOFs finalized, signaling strong demand.
- **Assay Issue Resolved**: Manufacturing delay caused by a false positive sterility assay was resolved in November, enabling resumed biopsy collections.
- **Broad Payer Coverage**: All major commercial payers and all 51 state Medicaid programs now cover ZEVASKYN, with CMS J-code simplifying claims.
- **Financial Strength**: $207.5 million cash position supports operations for over 2 years, with narrowed net loss to $5.2 million in Q3 2025.

**【CEO Summary Section】**
- Abeona reported significant operational progress in Q3 2025, despite a temporary delay in the first patient treatment for ZEVASKYN due to assay optimization. The first patient treatment is now expected in Q4 2025.
- Patient demand doubled, with 30 identified candidates across 3 Qualified Treatment Centers (QTCs), up from 12 in Q2. Twelve patients have already received ZEVASKYN Product Order Forms (ZPOFs).
- The company remains confident in achieving its 2026 launch goals, citing growing QTC network expansion and broad market access.

**【CTO/CFO Financial Commentary】**
- A manufacturing delay occurred due to a false positive in a rapid sterility assay, requiring retesting and regulatory submissions. The issue was resolved in November 2025, allowing resumption of biopsy collections.
- The company maintains a strong cash position of $207.5 million, sufficient to fund operations for over 2 years without ZEVASKYN revenue.
- R&D expenses decreased by 53% YoY to $4.2 million, while SG&A increased 202% YoY to $19.3 million, reflecting commercial launch costs.

**【CCO Commercial Update】**
- ZEVASKYN achieved broad payer coverage, with all major commercial plans (e.g., UnitedHealthcare, Cigna) and all 51 state Medicaid programs covering the therapy.
- A permanent J-code for ZEVASKYN was established by CMS, effective January 1, 2026, simplifying claims processing.
- The QTC network expanded to 3 sites, including Children's Hospital Colorado, with additional centers in active discussions.

**【CFO Financial Results】**
- Net loss narrowed to $5.2 million (Q3 2025) from $30.3 million (Q3 2024), driven by reduced R&D costs and reclassified expenses.
- Cash, cash equivalents, and investments totaled $207.5 million, providing financial flexibility for the commercial launch.

**【Q&A Highlights】**
- 12 ZPOF patients are progressing through insurance approvals, with some scheduled for biopsy in Q4 2025. The company expects a high conversion rate to treatment.
- Profitability guidance remains unchanged, with plans to achieve positive cash flow in 2026.
- The prior authorization process is streamlined, with no step edits observed, and most payers covering ZEVASKYN to the label.

Abeona Therapeutics Inc. (ABEO) Q3 2025 Earnings Call Transcript

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