Acasti Pharma Q3 2023 Earnings Report
Key Takeaways
Acasti Pharma reported a net loss of $3.9 million for the third quarter ended December 31, 2022, with $31.3 million in cash, cash equivalents, and short-term investments.
The Company anticipates receiving clarifying guidance from the FDA on its proposed phase 3 study design for GTX-104 through a written Type C meeting in the first calendar quarter of 2023.
Preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 announced in December 2022 met all primary outcome measures.
Preliminary topline results announced in December 2022 for the Company’s single-dose PK study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug in the U.S., bupivacaine subcutaneous injectable, met all primary outcome measures for the study.
The Company finished the second fiscal quarter ended December 31, 2022, with $31.3 million in cash, cash equivalents and short-term investments.
Acasti Pharma
Acasti Pharma
Forward Guidance
Management believes that based on current projections, the Company has sufficient capital to fund operations into calendar Q2 of 2024 allowing for the advancement of GTX-104 well into Phase 3 and advancing GTX-102 and GTX-101 to additional important milestones.