Loading...
•
Dec 31, 2023
Acasti Pharma Q3 2024 Earnings Report
Reported a net loss with ongoing progress in GTX-104 development and STRIVE-ON trial.
Key Takeaways
Acasti Pharma reported a net loss of $2.4 million for the quarter ended December 31, 2023, a decrease of $1.5 million compared to the same period in 2022. The company is focused on its GTX-104 program and the STRIVE-ON Phase 3 trial, with patient enrollment ongoing. Acasti's cash runway is projected to extend into the second calendar quarter of 2026.
Net loss decreased by $1.5 million compared to the same quarter last year.
Patient enrollment in the pivotal STRIVE-ON Phase 3 trial is ongoing and on track for NDA submission.
Cash runway is expected to extend into the second calendar quarter of 2026.
Dosing of first patient in STRIVE-ON trial was announced.
Acasti Pharma
Acasti Pharma
Forward Guidance
Acasti anticipates continued progress with the STRIVE-ON trial and is focused on a potential NDA submission in the first half of 2025. The company believes its current cash resources are sufficient to fund operations into the second calendar quarter of 2026.
Positive Outlook
- STRIVE-ON trial on track for potential NDA submission in the first half of calendar 2025.
- Focus on GTX-104 program to address unmet medical needs for aSAH.
- Cash runway expected to extend into the second calendar quarter of 2026.
- Orphan Drug Designation by the FDA provides seven years of marketing exclusivity post-launch in the United States.
- GTX-104 has the potential to better manage hypotension in aSAH patients.
Challenges Ahead
- Success and timing of regulatory submissions of the Phase 3 safety trial for GTX-104.
- Regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104.
- Changes to clinical trial designs and regulatory pathways.
- Legislative, regulatory, political and economic developments.
- Actual costs associated with Acasti's clinical trials as compared to management's current expectations.