Acasti Pharma Inc. announced that the Company has aligned with the U.S. Food and Drug Administration (FDA) on the protocol for its pivotal Phase 3 trial of GTX-104 and the FDA also provided guidance for a potential GTX-104 New Drug Application (NDA) package. Acasti has all the necessary information from the FDA to initiate its recently named STRIVE-ON (Safety, Tolerability, Randomized, IV and Oral Nimodipine) pivotal Phase 3 trial of GTX -104 to evaluate its safety and tolerability profile relative to oral nimodipine. STRIVE-ON will be a prospective, open-label, randomized (1:1 ratio), parallel group trial of GTX-104 compared with oral nimodipine, in patients hospitalized for aSAH.

Acasti's novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. 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 on the Company's anticipated cash runway, the timing of the planned initiation of the Company's STRIVE-ON trial, anticipated NDA submission with the FDA, GTX-104's potential to bring enhanced treatment options to patients suffering from aSAH, and the anticipated trail design of STRIVE-ON 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: (i) the success and timing of regulatory submissions of the planned Phase 3 safety study for GTX-104; (ii) regulatory requirements or developments and the outcome and timing of the proposed IND application for GTX-104; (iii) changes to clinical trial designs and regulatory pathways; (iv) legislative, regulatory, political and economic developments; and (v) actual costs associated with Acasti's clinical trials as compared to management's current expectations.