earnings
confidence high
sentiment positive
materiality 0.75
Acasti Pharma Q1 net loss $4.0M; FDA aligned on Phase 3 GTX-104 trial; cash runway to Q2 2025
Grace Therapeutics, Inc.
2023-Q1 EPS reported
-$0.54
- Net loss $4.0M ($0.54 per share) vs $4.5M ($0.61 per share) year ago.
- Cash and equivalents $21.6M at quarter end; projected runway through Q2 2025 covering potential GTX-104 NDA submission.
- FDA alignment on STRIVE-ON Phase 3 safety trial for GTX-104; first patient dosing expected Q4 2023.
- R&D expenses fell to $1.1M from $2.3M on restructuring; $1.5M severance costs incurred.
- Appointed new CMO, VP Clinical Operations, VP Program Management; expanded Scientific Advisory Board with three key opinion leaders.