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Mar 31, 2024
Acasti Pharma Q4 2024 Earnings Report
Acasti Pharma's financial results for the year ended March 31, 2024, were announced, and a business update was provided.
Key Takeaways
Acasti Pharma reported a net loss of $12.9 million for the year ended March 31, 2024. The company's cash and cash equivalents totaled $23.0 million at the end of the fiscal year, which is expected to support operations into the second calendar quarter of 2026.
Patient enrollment in the pivotal STRIVE-ON Phase 3 safety trial for GTX-104 is on track for a potential NDA submission in the first half of calendar 2025.
The company's cash runway is projected into the second calendar quarter of 2026.
Acasti presented an overview of the STRIVE-ON trial at the 2024 International Stroke Conference.
A $7.5 million private placement equity financing was completed in September 2023.
Acasti Pharma
Acasti Pharma
Forward Guidance
Acasti Pharma anticipates continued progress with the STRIVE-ON trial and potential NDA submission for GTX-104 in the first half of calendar 2025. The company believes it has sufficient cash to support operations into the second calendar quarter of 2026.
Positive Outlook
- On-track patient enrollment in STRIVE-ON Phase 3 safety trial.
- Potential NDA submission in 1H calendar 2025.
- Cash runway projected into the second calendar quarter 2026.
- Focus on GTX-104 program.
- Orphan Drug Designation by the FDA provides seven years of market exclusivity.
Challenges Ahead
- Success and timing of regulatory submissions of the Phase 3 safety trial for GTX-104 is uncertain.
- Regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104 are uncertain.
- Changes to clinical trial designs and regulatory pathways could impact results.
- Legislative, regulatory, political and economic developments may pose risks.
- Actual costs associated with Acasti's clinical trials may differ from management's expectations.