Acasti Pharma Inc. announced the successful submission to the FDA of GTX-104's full protocol of its pivotal Phase 3 Safety Study and implementation of a strategic realignment plan to maximize shareholder value. Key strategies being implemented are: Prioritizing resources to Acasti's biggest value driver – GTX-104. Acasti has submitted the full pivotal Phase 3 Safety Study protocol with all supporting documentation.

Pending final feedback and approval from the FDA, the first patient, first dose for the pivotal Phase 3 Safety Study is expected in calendar Fourth Quarter 2023. Strategic transformation of Acasti's operating model to an agile biopharma reflecting its complete focus on GTX-104. In alignment with the operating model, Acasti has brought on a highly experienced new management team with deep subject matter knowledge and direct, hands-on clinical trial experience in aSAH.

Significant extension of the Company's cash runway expected to be sufficient to fund the Company through calendar Second Quarter 2025, facilitating achievement of critical value inflection milestones, including a potential New Drug Application (NDA) filing for GTX-104. Evaluation of strategic alternatives to maximize value of de-prioritized pipeline assets (GTX-102 and GTX-101) including out-licensing or sale. About aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain.

A primary cause of such bleeding is rupture of an aneurysm. Approximately 70% of aSAH patients experience death or dependence, and a third die within one month after the hemorrhage (Becske, 2018). Approximately 50,000 patients are affected by aSAH per year, based on market research conducted by Fletcher Spaght.

About GTX-104, GTX-104 is a clinical stage, novel aqueous formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. GTX-104 provides a more convenient IV delivery of nimodipine in the ICU eliminating the need for nasogastric tube administration of the drug in unconscious or dysphagic patients. Due to IV delivery, GTX-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors.

Further, GTX-104 has the potential to better manage hypotension in aSAH patients. GTX-104 has been dosed in over 150 healthy subjects and was well tolerated with significantly lower inter and intra subject PK variability compared to the oral drug. The addressable market in the United States for GTX-104 is estimated to be about $300 million, based on market research conducted by Fletcher Spaght.