PRINCETON, N.J., Nov. 17, 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/present in the upcoming Craig-Hallum 16th Annual Alpha Select Co ...

Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Neurocritical Care Annual Meeting Granted Sixth U.S. Patent Covering IV Dosing Regimen for GTx-104 Princeton, NJ, November 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 aSAH patients, today announced the financ ...

Announced U.S. Food and Drug Administration (FDA) Acceptance for Reviewof New Drug Application (NDA) for GTx-104 FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Neurocritical Care Annual Meeting Granted Sixth U.S. Patent Covering IV Dosing Regimen for GTx-104 PRINCETON, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Grace Therape ...

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 September 30, 2025 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 o ...

STRIVE-ON Results Accepted for Late-Breaking PresentationPRINCETON, N.J., Nov. 11, 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 an abstract of the Company’s Pivotal Phase 3 STRIVE-ON Safety T ...

Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, a novel injectable formulation of nimodipine for I.V. infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [6] - The company has received Orphan Drug Designation from the FDA for its lead clinical asset, GTx-104, which provides seven years of marketing exclusivity post-launch in the U.S. [6] Funding and Financials - The company secured approximately $4.0 million in additional funding through the exercise of common warrants, issuing 1,345,464 new shares at an exercise price of $3.003 per share [1] - The remaining 1,190,927 common warrants from the 2023 private placement have expired following the FDA's acceptance for review of the NDA for GTx-104 [1] Product Development - GTx-104 is being developed to address significant unmet medical needs in aSAH patients, with a PDUFA target date set by the FDA for April 23, 2026, for the NDA review [2] - The NDA submission is supported by positive data from the Phase 3 STRIVE-ON safety trial of GTx-104 [2] Medical Context - aSAH is a type of stroke caused by the rupture of an aneurysm, accounting for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [3] - GTx-104 aims to provide a convenient I.V. delivery method, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients, and has been administered to over 200 patients and healthy volunteers [5] Technology and Advantages - GTx-104 utilizes unique nanoparticle technology to facilitate the aqueous formulation of insoluble nimodipine for standard peripheral I.V. infusion [4] - The intravenous delivery of GTx-104 may lower food effects, drug-to-drug interactions, and dosing errors, while better managing hypotension in aSAH patients [5]

Core Insights - Grace Therapeutics, Inc. presented data from its Pivotal Phase 3 STRIVE-ON Safety Trial for GTx-104, an injectable formulation of nimodipine, at the Neurocritical Care Society annual meeting, highlighting its potential benefits over oral nimodipine in treating aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases, with GTx-104 as its lead clinical asset targeting aSAH [8] - The company 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. [8] Clinical Trial Results - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with the primary endpoint being the incidence of clinically significant hypotension [3] - Results indicated that GTx-104 may deliver neuroprotective effects while reducing hypotensive events compared to oral nimodipine, along with improvements in ICU length of stay and reduced need for mechanical ventilation [3] Market Potential - The standard of care for aSAH has not seen significant innovation in nearly 40 years, positioning GTx-104 as a promising alternative if approved by the FDA [3] - The FDA's review of the New Drug Application (NDA) for GTx-104 is ongoing, with a target date of April 23, 2026 [3] Product Details - GTx-104 utilizes unique nanoparticle technology to facilitate the intravenous infusion of nimodipine, potentially improving patient management in the ICU and reducing complications associated with oral administration [5][6] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerability and lower pharmacokinetic variability compared to oral nimodipine [6]

Core Viewpoint - Grace Therapeutics has received a new method of use patent for GTx-104, extending its intellectual property protection until 2043, which enhances the company's market exclusivity and potential value for shareholders [2][3][4]. Intellectual Property and Patent Protection - The U.S. Patent and Trademark Office issued U.S. Patent No. 12,414,943 for the dosing regimen of GTx-104, which is used in the Phase 3 STRIVE-ON safety trial [2]. - Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the composition of nimodipine, providing protection until 2037 [3]. - The new patent on the I.V. dosing regimen strengthens the company's intellectual property position and extends protection to 2043 [3]. Clinical Trial Insights - The STRIVE-ON safety trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with GTx-104 showing a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine (28% vs. 35%) [5]. - Patients receiving GTx-104 had a relative dose intensity (RDI) of 95% or higher in 54% of cases, compared to only 8% for oral nimodipine [5]. - GTx-104 demonstrated fewer ICU readmissions, ICU days, and ventilator days compared to oral nimodipine, with adverse events being comparable between both treatment arms [5]. Product Overview - GTx-104 is a novel injectable formulation of nimodipine developed for I.V. infusion in patients with aSAH, addressing significant unmet medical needs [7][9]. - The unique nanoparticle technology of GTx-104 allows for a standard peripheral I.V. infusion, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients [8]. - GTx-104 has been administered to over 200 patients and healthy volunteers, showing well-tolerated results with lower pharmacokinetic variability compared to oral nimodipine [8]. Market Exclusivity - GTx-104 has received Orphan Drug Designation from the FDA, granting it seven years of marketing exclusivity in the U.S. upon FDA approval of the New Drug Application (NDA) [3][9].

Summary of Grace Therapeutics Conference Call Company Overview - **Company**: Grace Therapeutics, Inc. (NasdaqCM:GRCE) - **Focus**: Development of GTX-104, an intravenous formulation of amlodipine targeting subarachnoid hemorrhage (SAH), a rare disease with high morbidity and mortality rates [2][3][4] Core Points and Arguments - **Current Standard of Care**: Amlodipine, an oral calcium channel blocker, has significant clinical liabilities, including high first-pass metabolism and hypotension issues [2][5][6][9] - **Innovative Solution**: GTX-104 aims to address the shortcomings of oral amlodipine by providing a novel aqueous formulation for intravenous administration, enhancing dose compliance and hypotension management [3][10][19] - **Clinical Trial Success**: The pivotal Phase 3 trial (STRY1) demonstrated: - 20% fewer clinically significant hypotensive events with GTX-104 compared to oral amlodipine - 95% or higher dose compliance in 55% of patients on IV versus only 8% on oral [15][19] - 30% of patients on IV showed good recovery compared to oral [15][18] - **Regulatory Pathway**: The FDA accepted the New Drug Application (NDA) for GTX-104 with a PDUFA goal date of April 23, 2026, following a successful pre-NDA meeting [17][25] Market Potential - **Target Market**: Approximately 50,000 cases of SAH annually in the U.S., treated primarily in about 250 hospitals [20][21] - **Commercial Strategy**: A focused sales force of 15 to 20 individuals will be deployed to market GTX-104, leveraging a strong patent portfolio that includes seven years of market exclusivity and multiple formulation patents extending to 2042 [21][22] Financial Position - **Cash Reserves**: $20 million reported at the end of June, with additional potential proceeds from warrants expected to support operations through the anticipated approval and into revenue generation in 2027 [22][23] Additional Important Insights - **Patient Demographics**: SAH primarily affects younger populations, with an average patient age of less than 60 years and a higher incidence in women [5][17] - **Clinical Need**: The unmet clinical need is significant, as many patients are unconscious and unable to swallow, complicating the administration of oral medications [6][10] - **Pharmaco-economic Benefits**: The IV formulation demonstrated a reduction in ICU length of stay by 1.5 days and a 50% reduction in ICU readmissions compared to oral therapy, highlighting its cost-effectiveness [15][16][19] This summary encapsulates the key points from the Grace Therapeutics conference call, emphasizing the company's innovative approach to treating a critical condition, its strong clinical data, and the promising market opportunity ahead.

Core Insights - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, an injectable formulation of nimodipine for IV infusion targeting aSAH patients [1][4] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, with opportunities for one-on-one meetings with institutional investors [2][3] Company Overview - Grace Therapeutics specializes in drug candidates for rare and orphan diseases, with innovative drug delivery technologies aimed at improving drug performance [4] - The lead clinical asset, GTx-104, has received Orphan Drug Designation from the FDA, granting seven years of marketing exclusivity post-launch in the U.S. and additional intellectual property protection with over 40 patents [4] Conference Details - The conference will be held at the Lotte New York Palace Hotel, featuring over 550 company presentations available live or on demand [2] - Prashant Kohli, CEO of Grace Therapeutics, will be available for one-on-one meetings with institutional investors during the event [2]