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Grace Therapeutics, Inc. filings document material events, operating updates and governance matters for a late-stage biopharma company advancing GTx-104. Form 8-K disclosures cover quarterly results, corporate presentations, the GTx-104 New Drug Application, the FDA Complete Response Letter, and the chemistry, manufacturing and controls and non-clinical subjects cited in that regulatory correspondence.
The filing record also includes disclosures on patent protection for “Nimodipine Parenteral Administration,” exercises and expirations of common warrants issued in private placements, exhibit-based press releases, and amendments to executive letter agreements and compensation arrangements.
Grace Therapeutics (GRCE) filed its quarterly report for the quarter ended September 30, 2025. The company reported a net loss of $0.9 million (basic and diluted loss per share of $0.06) for the quarter and a six‑month net loss of $4.3 million (loss per share of $0.27).
Cash and cash equivalents were $16.9 million as of September 30, 2025. Operating cash outflow totaled $4.9 million for the six months. Total liabilities were $3.8 million, with derivative warrant liabilities declining to $0.2 million from $1.1 million at March 31, 2025. Stockholders’ equity stood at $62.8 million. The company states existing cash is sufficient to sustain planned operations for at least 12 months from the statements’ issuance.
Development remains centered on GTx‑104 (IV nimodipine) for aneurysmal subarachnoid hemorrhage: the NDA was accepted with a PDUFA target date of April 23, 2026. Subsequent to quarter end, Grace received $4.0 million in gross proceeds from 2023 warrant exercises. Shares outstanding were 14,128,562 as of November 13, 2025.
Grace Therapeutics reported securing approximately $4.0 million in cash proceeds from recent exercises of common warrants originally issued in a September 2023 private placement.
The Company also disclosed that 1,190,927 of those common warrants have expired, as the 60th day after the U.S. Food and Drug Administration’s acceptance for review of the Company’s New Drug Application for GTx-104 has passed. GTx-104 is a clinical-stage, injectable formulation of nimodipine being developed for I.V. infusion to address unmet needs in aneurysmal subarachnoid hemorrhage.
Grace Therapeutics announced that the U.S. Patent and Trademark Office issued Patent No. 12,414,943, titled "Nimodipine Parenteral Administration." The method-of-use patent, published on September 16, 2025 and issued on September 18, 2025, covers the dosing regimen for intravenous administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104 and extends patent protection for GTx-104 to 2043. GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to treat aneurysmal subarachnoid hemorrhage patients. The company attached a press release as Exhibit 99.1 to this Current Report.
Grace Therapeutics announced that the U.S. Patent and Trademark Office issued Patent No. 12,414,943, titled "Nimodipine Parenteral Administration." The method-of-use patent, published on September 16, 2025 and issued on September 18, 2025, covers the dosing regimen for intravenous administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104 and extends patent protection for GTx-104 to 2043. GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to treat aneurysmal subarachnoid hemorrhage patients. The company attached a press release as Exhibit 99.1 to this Current Report.
Grace Therapeutics announced that the U.S. Patent and Trademark Office issued Patent No. 12,414,943, titled "Nimodipine Parenteral Administration." The method-of-use patent, published on September 16, 2025 and issued on September 18, 2025, covers the dosing regimen for intravenous administration of nimodipine used in the Phase 3 STRIVE-ON safety trial for GTx-104 and extends patent protection for GTx-104 to 2043. GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to treat aneurysmal subarachnoid hemorrhage patients. The company attached a press release as Exhibit 99.1 to this Current Report.
Grace Therapeutics reported that the U.S. Food and Drug Administration has accepted its New Drug Application for GTx-104 for formal review. GTx-104 is a novel, injectable formulation of nimodipine being developed for intravenous infusion to treat aneurysmal subarachnoid hemorrhage, a condition with significant unmet medical need.
The FDA has set a Prescription Drug User Fee Act, or PDUFA, target decision date of April 23, 2026 for the NDA. This step means the application passed the initial filing review and will now undergo a full regulatory assessment, but it does not represent an approval or guarantee of approval.
Grace Therapeutics, Inc. Schedule 13G/A reports that Nantahala Capital Management, LLC and its principals Wilmot B. Harkey and Daniel Mack together may be deemed beneficial owners of 1,404,032 shares of Grace Therapeutics common stock, representing 9.99% of the class as of June 30, 2025. The reported position is held by funds and separately managed accounts under Nantahala's control and includes 225,831 shares that may be acquired within sixty days through the exercise of warrants. The filing shows no sole voting or dispositive power; all voting and dispositive authority is reported as shared among the reporting persons.
Grace Therapeutics, Inc. furnished a press release announcing its financial results for the three months ended June 30, 2025. The press release is attached to this report as Exhibit 99.1, and an Inline XBRL cover page is provided as Exhibit 104. The company states that the information in Item 2.02, including Exhibit 99.1, is furnished and not deemed "filed" for purposes of Section 18 of the Exchange Act, which limits the filing liabilities for this disclosure.
The Form 8-K identifies the issuer as Grace Therapeutics (trading as GRCE on The Nasdaq Stock Market) and is signed by Chief Executive Officer Prashant Kohli. The Form itself does not include the detailed financial line items in-line; those figures are conveyed in the attached press release exhibit.
Grace Therapeutics (GRCE) is a clinical‑stage company focused on reformulated drugs for rare and orphan diseases. The company reports $20.0 million in cash and cash equivalents and 13,828,562 shares outstanding, and states its existing cash is expected to sustain operations for at least 12 months. The company completed a private placement that generated net proceeds of $13.7 million.
Grace submitted a New Drug Application for its lead candidate, GTx-104, an intravenous nimodipine formulation. Its pivotal Phase 3 STRIVE-ON trial met the primary safety endpoint versus oral nimodipine: a 19% reduction in patients experiencing clinically significant hypotension (28% vs 35%). Other reported advantages included higher dose intensity (54% ≥95% vs 8%), a 29% relative increase in favorable 90‑day modified Rankin outcomes, favorable pharmacoeconomic measures, and comparable adverse event rates. The trial arms had eight deaths on the GTx-104 arm vs four on oral nimodipine; the company reports no deaths were determined to be related to study drug.
For the quarter, net loss was $3.36 million (loss per share $0.21). Research and development spending fell following completion of the pivotal trial. The company carries derivative warrant liabilities whose fair‑value movements affected results and has multiple outstanding warrants that could dilute equity. Management notes additional financing will be required to advance other candidates.
Grace Therapeutics (NASDAQ:GRCE) filed an 8-K announcing the submission of a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine. The drug candidate is being developed as an IV infusion treatment for patients with aneurysmal subarachnoid hemorrhage. This represents a significant regulatory milestone in the company's drug development pipeline.
Grace Therapeutics, Inc. (NASDAQ: GRCE) filed a Form 8-K on 23 June 2025 under Item 2.02 to furnish – not file – its financial results for the fiscal year ended 31 March 2025.
The filing itself contains no numerical data; instead, it attaches a press release (Exhibit 99.1) that presumably holds the detailed results. Management explicitly states that the furnished information is exempt from Section 18 liability and will not be incorporated into other SEC filings unless specifically referenced.
No additional items (e.g., acquisitions, capital raises, leadership changes) were disclosed. Consequently, investors must review Exhibit 99.1 to evaluate revenue, earnings, cash position, or guidance. Until those figures are consulted, the market impact of this disclosure remains indeterminate.