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Sep 30, 2021
Abeona Therapeutics Q3 2021 Earnings Report
Announced third quarter financial results and business progress.
Key Takeaways
Abeona Therapeutics reported its Q3 2021 financial results, with a net loss of $7.0 million. The company is advancing two late-stage pivotal assets and expects to finish patient accrual for the EB-101 Phase 3 VIITAL™ study in Q1 2022, with top-line data readout in Q3 2022.
Phase 3 VIITAL™ study on track to complete enrollment in first quarter 2022 with final patients identified and under screening
Added gene therapy and biopharmaceutical industry veterans to regulatory and quality teams to prepare for two Biologics License Application (BLA) submissions
Formally settled dispute with REGENXBIO Inc., eliminating uncertainty from arbitration outcome and facilitating planning of resources to reach next value inflection points
Pivotal Transpher A study top-line data readout expected between Q4 2022 and Q2 2023
Abeona Therapeutics
Abeona Therapeutics
Forward Guidance
Abeona is focused on advancing its pipeline of therapies and preparing for BLA filings and commercial launch readiness.
Positive Outlook
- Enrollment completion for Phase 3 VIITAL™ study expected in Q1 2022 with top-line data readout expected in Q3 2022
- Pivotal Transpher A study top-line data readout expected between Q4 2022 and Q2 2023
- Completed dosing seven patients at the highest dose; 2-year neurocognitive data expected in H2 2022 for efficacy evaluation
- Advancing programs toward pre-IND meetings in late-2022
- Exploring various options including strategic partnering of pipeline assets and non-dilutive funding.
Challenges Ahead
- Potential impacts of the COVID-19 pandemic on business, operations, and financial condition
- Risks associated with data analysis and reporting
- The impact of competition
- The ability to secure licenses for any technology that may be necessary to commercialize our products
- The impact of changes in the financial markets and global economic conditions