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Sep 30, 2024
Acasti Pharma Q2 2025 Earnings Report
Grace Therapeutics reported financial results for Q2 2025 and provided a business update.
Key Takeaways
Grace Therapeutics reported a net loss of $3.4 million, or $0.30 per share for the quarter ended September 30, 2024. The company completed enrollment of its Phase 3 STRIVE-ON safety trial and rebranded to Grace Therapeutics.
Completed enrollment of Phase 3 STRIVE-ON safety trial ahead of schedule.
Anticipate data readout from STRIVE-ON trial in Q1 2025.
NDA submission to the FDA is anticipated in the first half of calendar year 2025.
Rebranded the Company to Grace Therapeutics and redomiciled to the State of Delaware.
Acasti Pharma
Acasti Pharma
Forward Guidance
Grace Therapeutics believes its existing cash and cash equivalents will be sufficient to fund operations into the second calendar quarter of 2026.
Positive Outlook
- STRIVE-ON data readout expected in Q1 2025.
- NDA submission on track for 1H calendar 2025.
- Completed corporate re-branding.
- Completed patient enrollment in pivotal Phase 3 STRIVE-ON safety trial of GTx-104.
- Projected cash runway into second calendar quarter 2026.
Challenges Ahead
- Success and timing of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104 is uncertain.
- Regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTx-104 is uncertain.
- Changes to clinical trial designs and regulatory pathways may occur.
- Legislative, regulatory, political and economic developments may impact results.
- Actual costs associated with Grace Therapeutics clinical trials may differ from management's current expectations.