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Dec 31, 2021
Abeona Therapeutics Q4 2021 Earnings Report
Abeona Therapeutics reported its Q4 2021 financial results and provided a business and strategy update.
Key Takeaways
Abeona Therapeutics reported a net loss of $84.9 million for the full year 2021. The company is focusing on EB-101 and expects topline results in Q3 2022. They also plan to reduce operating expenses and extend cash runway to mid-2023.
EB-101 pivotal phase 3 VIITALâ„¢ study in RDEB achieved target enrollment; top-line data expected in third quarter of 2022.
The company gained FDA alignment on CMC requirements for EB-101 including characterization and validation plans.
The company will pursue a strategic partner to take over development activities for ABO-102 for MPS IIIA, while discontinuing development of ABO-101 for MPS IIIB.
The company plans to reduce operating expenses and extend cash runway to mid-2023.
Forward Guidance
Abeona Therapeutics is focused on developing novel cell and gene therapies for patients with rare diseases with no approved treatment options and plans to extend their cash runway.
Positive Outlook
- EB-101 pivotal Phase 3 VIITALâ„¢ study achieved target enrollment.
- Topline results for EB-101 VIITALâ„¢ study expected in Q3 2022.
- Animal proof-of-concept data from preclinical eye programs expected beginning in the second half of 2022.
- Strategic steps announced reflect the operating discipline needed to extend cash runway.
- Focus on EB-101 development.
Challenges Ahead
- Discontinuing development of ABO-101 for MPS IIIB.
- Pursuing strategic partner to take over development activities for ABO-102 for MPS IIIA.
- Potential impacts of the COVID-19 pandemic on business, operations, and financial condition.
- Risks associated with data analysis and reporting.
Historical Earnings Impact
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