earnings
confidence high
sentiment positive
materiality 0.75
Grace Therapeutics reports Q1 net loss $3.4M; submits GTx-104 NDA to FDA
Grace Therapeutics, Inc.
2026-Q1 EPS reported
-$0.21
- Net loss $3.4M ($0.21/sh) vs $2.6M ($0.24/sh) in prior-year quarter; R&D down $1.8M to $0.9M.
- Submitted NDA to FDA for GTx-104 (IV nimodipine) for aneurysmal subarachnoid hemorrhage; based on positive STRIVE-ON Phase 3 trial.
- STRIVE-ON met primary endpoint: 19% reduction in clinically significant hypotension vs oral nimodipine; 54% patients had ≥95% relative dose intensity.
- Cash and equivalents $20.0M; potential warrant exercises of $22.6M ($7.6M + $15.0M) could extend runway into Q2 2027.
- Deprioritized GTx-102 and GTx-101 to focus on GTx-104; may license or sell those assets.
item 2.02item 9.01