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Sep 30, 2021
Acasti Pharma Q2 2022 Earnings Report
Acasti Pharma's operating and financial results for the second quarter of fiscal 2022 were announced and a business update was provided.
Key Takeaways
Acasti Pharma reported having $50.8 million in cash, cash equivalents and short-term investments as of September 30, 2021, and completed a merger with Grace Therapeutics. Subject enrollment has commenced for a pivotal PK bridging study for GTX-104. Four composition of matter patents granted for GTX-101 and GTX-102.
Successfully completed a merger with Grace Therapeutics, expanding the pipeline with drug candidates focused on rare diseases.
Commenced subject enrollment for a pivotal PK bridging study for GTX-104, assessing its bioavailability compared to oral nimodipine capsules.
Strengthened patent portfolio with four composition of matter patents granted for GTX-101 and GTX-102.
Acasti had $50.8 million of cash, cash equivalents and short-term investments as of September 30, 2021, providing at least two years of operating runway.
Acasti Pharma
Acasti Pharma
Forward Guidance
Acasti anticipates reporting the results of the GTX-104 study during the first half of calendar 2022 and plans to commence a Phase 3 safety study of GTX-104 in the second half of calendar 2022.
Positive Outlook
- GTX-104 has the potential to provide improved bioavailability.
- GTX-104 has the potential to provide lower intra-subject variability compared to oral capsules.
- GTX-104 could result in better management of hypotension in patients with SAH.
- GTX-104 could potentially lead to better outcomes.
- The patents provide protection in important international markets beyond 2036.
Challenges Ahead
- Success and timing of regulatory submissions of the PK bridging study for GTX-104
- Regulatory requirements or developments and the outcome of meetings with the Food and Drug Administration.
- Changes to clinical trial designs and regulatory pathways.
- Legislative, regulatory, political and economic developments.
- The effects of COVID-19 on clinical programs and business operations.