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Dec 31, 2023
Abeona Therapeutics Q4 2023 Earnings Report
Abeona Therapeutics reported full year 2023 financial results and announced completion of FDA inspections.
Key Takeaways
Abeona Therapeutics reported its full year 2023 financial results, highlighting a cash position of $52.6 million as of December 31, 2023, and the completion of FDA inspections for its Cleveland manufacturing facility and clinical trial sites related to pz-cel. The company estimates its current resources will fund operations into the first quarter of 2025.
FDA completed Pre-License Inspection of Abeona’s Cleveland manufacturing facility.
FDA completed inspection of clinical trial sites for pz-cel pivotal Phase 3 VIITAL™ study.
Cash, cash equivalents, restricted cash and short-term investments totaled $52.6 million as of December 31, 2023.
Abeona estimates that its current resources are sufficient to fund operations into the first quarter of 2025.
Abeona Therapeutics
Abeona Therapeutics
Forward Guidance
Abeona estimates that its current cash and cash equivalents, restricted cash and short-term investments, as well as the credit facility with Avenue Venture Opportunities Fund, L.P, are sufficient resources to fund operations into the first quarter of 2025 before accounting for any revenue from commercial sales of pz-cel, if approved, or proceeds from the sale of a Priority Review Voucher, if awarded by the FDA.
Positive Outlook
- Current resources are sufficient to fund operations into the first quarter of 2025.
- Potential for revenue from commercial sales of pz-cel, if approved.
- Potential proceeds from the sale of a Priority Review Voucher, if awarded by the FDA.
- Received a first tranche of $20 million as part of the credit facility with Avenue Venture Opportunities Fund, L.P.
- FDA's review of Abeona's pz-cel BLA is ongoing, with a target PDUFA date of May 25, 2024.
Challenges Ahead
- Operations are dependent on potential revenue from commercial sales of pz-cel, if approved.
- Operations are dependent on potential proceeds from the sale of a Priority Review Voucher, if awarded by the FDA.
- The FDA issued a Form 483 with observations related to process controls.
- Net cash used in operating activities was $37.0 million for the full year of 2023.
- Net loss attributable to common shareholders for the full year ended December 31, 2023 was $54.2 million.