PRINCETON, N.J., June 13, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (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 significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that Chief Executive Officer Prashant Kohli will participate in the upcoming BIO 2025 International Conference, to be held in ...

PRINCETON, N.J., April 09, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (NASDAQ:GRCE) (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 significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced details of the Company's Type C meeting with the U.S. Food and Drug Administration (FDA). The purpose of this meeting was to ...

Company Overview - Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases [7] - The company's lead clinical asset, GTx-104, is an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH) [5][7] Product Development - GTx-104 is designed for intravenous infusion to address significant unmet medical needs in aSAH patients, potentially improving treatment outcomes compared to oral formulations [5][6] - The unique nanoparticle technology of GTx-104 allows for a standard peripheral IV infusion, which may eliminate the need for nasogastric tube administration in unconscious or dysphagic patients [6] - GTx-104 has been administered to over 150 healthy volunteers and demonstrated good tolerance with lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) is a rare and life-threatening condition that accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [4] - The company hosted a virtual key opinion leader (KOL) event discussing the high unmet medical need and current treatment landscape for aSAH patients [2] Regulatory and Commercial Strategy - Grace Therapeutics has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. [7] - The company holds over 40 granted and pending patents, enhancing its intellectual property protection [7] Upcoming Events - The CEO of Grace Therapeutics, Prashant Kohli, will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, to discuss the company's developments [1][2]

Exhibit 99.1 Grace Therapeutics Announces Third Fiscal Quarter 2025 Financial Results, Provides Business Update Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administered Nimodipine; New Drug Application (NDA) Submission Anticipated First Half of Calendar 2025 Secured Private Placement Financing of $15 Million in Upfront Gross Proceeds with the Potential to Receive up to an Additional $15 Million in Potential Warrant Exercise Proceeds for an A ...

Announced Phase 3 STRIVE-ON Safety Trial Met Primary Endpoint and Provided Clinical Benefit Compared to Orally Administered Nimodipine; New Drug Application (NDA) Submission Anticipated First Half of Calendar 2025 Secured Private Placement Financing of $15 Million in Upfront Gross Proceeds with the Potential to Receive up to an Additional $15 Million in Potential Warrant Exercise Proceeds for an Aggregate of Up to Approximately $30 Million in Potential Total Gross Proceeds PRINCETON, N.J., Feb. 13, 2025 (GL ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 Grace Therapeutics, Inc. (Exact name of registrant as specified in its charter) State of Delaware 98-1359336 (State or ...

On Monday, Grace Therapeutics, Inc. GRCE, formerly b, announced topline data from its Phase 3 STRIVE-ON safety trial of GTx-104 compared with oral nimodipine in patients hospitalized with aneurysmal Subarachnoid Hemorrhage (aSAH).aSAH is bleeding over the brain’s surface in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain.The study met its primary endpoint and provides evidence of clinical benefit compared to orally administered nimodipine.The trial ...

Financing led by Nantahala Capital and ADAR1 Partners, LP with participation from new and existing healthcare-focused institutional investors $15 million in upfront gross proceeds with the potential to receive up to an additional $15 million in potential warrant exercise proceeds for an aggregate of up to approximately $30 million in potential total gross proceeds PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE), formerly Acasti Pharma Inc. (Grace Therapeutics or th ...

Core Viewpoint - Grace Therapeutics, Inc. has announced a financing round to raise up to approximately $30 million, aimed at advancing its clinical-stage drug GTx-104 for treating aneurysmal Subarachnoid Hemorrhage (aSAH) patients [1][5][12] Financing Details - The financing is led by Nantahala Capital and ADAR1 Partners, LP, with participation from both new and existing healthcare-focused institutional investors, including Stonepine Capital Management [2] - The financing consists of $15 million in upfront gross proceeds, with the potential for an additional $15 million from warrant exercises, totaling up to approximately $30 million [1][3] - Grace Therapeutics will issue 4,418,292 shares of common stock and accompanying common warrants at a combined purchase price of $3.395 per share [3][4] Use of Proceeds - The upfront net proceeds from the private placement will be utilized for general corporate purposes and to fund the pre-commercial development of GTx-104 [5] Product Overview - GTx-104 is a novel injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients [10][12] - The drug aims to provide a convenient IV delivery method, potentially eliminating the need for nasogastric tube administration and reducing dosing errors [11] Clinical Background - aSAH is a type of stroke that accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [9] - Grace Therapeutics' lead clinical asset, GTx-104, has met its primary endpoint in the Phase 3 STRIVE-ON safety trial, showing clinical benefits over orally administered nimodipine [12]

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 ...