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Sep 30, 2022
Acasti Pharma Q2 2023 Earnings Report
Acasti Pharma reported financial and operational results for the second quarter ended September 30, 2022.
Key Takeaways
Acasti Pharma reported a net loss of $4.9 million, or $0.11 loss per share, for the second quarter ended September 30, 2022. The company's cash, cash equivalents and short-term investments totaled $34.9 million as of September 30, 2022.
The Company expects to receive guidance from the FDA on its proposed phase 3 study design for GTX-104 by the end of 2022 or early in the first calendar quarter of 2023.
The pharmacokinetic (PK) bridging study for GTX-102 was initiated on September 13, 2022, and topline results are expected before the end of calendar 2022.
The single dose PK study of GTX-101, was initiated on July 26, 2022, in healthy human volunteers and is expected to be completed by the end of calendar 2022.
The Company finished the second fiscal quarter ended September 30, 2022, with $34.9 million in cash, cash equivalents and short-term investments.
Acasti Pharma
Acasti Pharma
Forward Guidance
Acasti Pharma expects to continue advancing its three clinical programs, with key milestones expected in the near term. The company anticipates initiating and enrolling the first patients in its Phase 3 safety study for GTX-104 in the first half of calendar 2023.
Positive Outlook
- On track to initiate and enroll the first patients in Phase 3 safety study for GTX-104 in the first half of calendar 2023.
- GTX-102 PK study is expected to be completed with top line results reported before year end.
- GTX-101 single dose PK study is expected to also be completed with topline results reported by the end of calendar 2022.
- Advancing GTX-104 well into Phase 3.
- Advancing GTX-102 and GTX-101 to key value inflection points.
Challenges Ahead
- Success and timing of regulatory submissions of the planned Phase 3 safety study for GTX-104 and Acasti’s other pre-clinical and clinical trials for GTX-102 and GTX-101.
- Regulatory requirements or developments and the outcome of meetings with the FDA.
- 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.