Acasti aligns with FDA on GTX-104 Phase 3 safety trial protocol; STRIVE-ON to start Q4 2023

Grace Therapeutics, Inc.

FDA confirmed alignment on STRIVE-ON trial design and dosing regimen for GTX-104 in aSAH patients.
STRIVE-ON will enroll ~100 patients at ~25 US hospitals; primary endpoint is safety vs oral nimodipine.
GTX-104 administered to >150 healthy volunteers with comparable safety to oral nimodipine to date.
Cash runway projected through potential NDA submission in H1 2025.
First patient dosing expected in Q4 2023; NDA submission targeted for first half of 2025.

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