Trial Met the Primary Endpoint and Provides Evidence of GTx-104 Clinical Benefit Compared to Orally Administered Nimodipine New Drug Application (NDA) Submission Expected in the First Half of 2025 PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (NASDAQ:GRCE), formerly Acasti Pharma Inc. (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address sig ...

PRINCETON, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Nasdaq: ACST) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs, today announced that Chief Executive Officer Prashant Kohli will participate the fol ...

Summary of Grace Therapeutics KOL Event on GTX-one 104 Company Overview - **Company Name**: Grace Therapeutics (formerly Acasti) [4][3] - **Product Focus**: GTX-one 104, a novel injectable formulation of nimodipine, in late-stage clinical development [3][4] Industry Context - **Target Indication**: Aneurysmal subarachnoid hemorrhage (ASAH) [4] - **Current Treatment Landscape**: Nimodipine is the only FDA-approved drug for neuroprotection in ASAH, available only in oral formulations [16][24] Key Points Discussed Clinical Development and Trials - **Pivotal Phase III Trial**: The STRIGON trial for GTX-one 104 was fully enrolled in September 2024, with data readout expected in Q1 2025 [4] - **Market Opportunity**: GTX-one 104 aims to address significant unmet needs in ASAH treatment, particularly due to limitations of current oral formulations [4][24] Disease Overview - **Prevalence and Impact**: Approximately 2% to 8% of the population has aneurysms, with a global incidence of ASAH around 6 per 100,000 person-years [9][10] - **Mortality Rates**: Pre-hospital mortality for aneurysm rupture is between 22% and 26%, with an additional 20% mortality for those reaching the hospital [11] Challenges with Current Treatment - **Limitations of Oral Nimodipine**: - Requires frequent dosing (60 mg every 4 hours) which can lead to hypotension in 25% of patients [32][30] - Many patients (30%) present with dysphagia, complicating oral administration [33] - Gastrointestinal intolerance affects up to 80% of patients, leading to complications like diarrhea [35] - Less than half of patients receive the full 21-day course, impacting outcomes [36] Advantages of GTX-one 104 - **Intravenous Formulation Benefits**: - Provides guaranteed drug exposure and allows for titratable dosing, addressing hypotension and absorption issues [42][39] - Flexibility in administration, especially for patients unable to take oral medications [40][42] - Consistent bioavailability, reducing variability in patient response [62] Clinical Implications - **Potential for Improved Outcomes**: Consistent exposure to nimodipine is linked to better functional outcomes, particularly in patients with higher-grade ASAH [39][45] - **Integration into Clinical Practice**: The introduction of GTX-one 104 could enhance treatment protocols in neurocritical care settings, where titratable IV medications are preferred [56][57] Additional Considerations - **Regulatory Pathway**: Approval of GTX-one 104 will require a review process by pharmacy and therapeutics committees, assessing clinical benefits and cost-effectiveness [43][44] - **Future Research**: Comparative studies may be necessary to establish the efficacy of GTX-one 104 against existing treatments [52][54] Conclusion - **Strategic Importance**: GTX-one 104 represents a significant advancement in the treatment of ASAH, addressing critical limitations of current therapies and potentially improving patient outcomes in a high-mortality condition [45][46]

Exhibit 99.1 Grace Therapeutics Announces Second Fiscal Quarter 2025 Financial Results, Provides Business Update STRIVE-ON Data Readout Expected First Calendar Quarter 2025; NDA Submission on Track for 1H Calendar 2025 Completed Corporate Re-Branding, Connecting Company to Rich Scientific Legacy of Grace Therapeutics Announced Completion of Patient Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 Hosting Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage November 20, 2024 Proj ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share GRCE Nasdaq Stock Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Comm ...