Acasti Pharma Inc. announced that the Company's pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial-NCT05995405) has exceeded the 50% enrollment milestone. The STRIVE-ON trial, a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine in 100 patients hospitalized for aSAH, initiated patient enrollment in October of 2023. Investigators continue to be enthusiastic about the potential of GTX-104 as an IV alternative to oral nimodipine for the treatment of aSAH.

Based on a comprehensive review of enrollment factors, the currently anticipate randomized all 100 patients in late 2024 to early 2025, while staying on track for aSAH. Acasti's lead clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection with over 40 granted and pending patents. Acasti's leadclinical asset, GTX-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.

The forward-looking statements in this press release, including statements regarding the Company's anticipated enrollment and NDA submission schedule for the STRIVE-ON trial, GTX-104's commercial prospects, and GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH are based upon Acasti's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: the success and timing of regulatory submissions of the Phase 3 safety trial for GTX-104; regulatory requirements or developments and the outcome and timing of the proposed NDA application for GTX-104; changes to clinical trial designs and regulatory pathways; legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations. The foregoing list of enrollment factors, the company currently anticipate randomizing all 100 patients in late 2022 to early 2025, while staying On track for a potential NDA submission to the FDA in the first half of calendar 2025.