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Jun 30, 2025
Acasti Pharma Q1 2026 Earnings Report
Reported a wider Q1 2026 net loss primarily due to non-cash warrant revaluation, despite lower R&D and G&A expenses.
Key Takeaways
Acasti Pharma (Grace Therapeutics) posted a Q1 2026 net loss of $3.4M as it submitted an NDA for GTx-104, its IV nimodipine formulation for aSAH. Cash balance was $20M, with a cash runway expected through at least the next 12 months and potentially into Q2 2027 with warrant exercises.
Q1 2026 net loss was $3.4M, or $0.21 per share, compared to $2.6M in Q1 2025.
NDA for GTx-104 was submitted to FDA, supported by positive Phase 3 STRIVE-ON trial results.
Cash and cash equivalents totaled $20.0M as of June 30, 2025.
Weighted-average shares outstanding increased to 15.9M from 10.9M a year earlier.
Forward Guidance
Grace expects FDA response to NDA submission for GTx-104 and may trigger warrant exercises extending cash runway into Q2 2027.
Positive Outlook
- NDA for GTx-104 submitted to FDA for aSAH treatment
- Positive Phase 3 STRIVE-ON trial results support efficacy and safety of GTx-104
- Potential $22.6M in warrant funding could extend cash runway
- GTx-104 has Orphan Drug Designation, offering market exclusivity if approved
- Commercial launch preparations for GTx-104 underway
Challenges Ahead
- Net loss widened due to fair value changes in warrants and tax benefit decline
- No reported revenue for the quarter
- Development of GTx-101 and GTx-102 deprioritized
- Regulatory timelines subject to FDA acceptance and review delays
Historical Earnings Impact
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Avg. Return Before/After Earnings
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