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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, Inc. reported that Carrie D’Andrea will cease serving as Vice President of Clinical Operations and will no longer be employed by the company effective June 5, 2026, a change approved on June 1, 2026.
She is expected to receive severance benefits under a prior letter agreement, subject to a release of claims and continued compliance with non-competition, non-solicitation, and confidentiality obligations. In connection with her departure, D’Andrea entered into a 12‑month Consulting Agreement starting June 5, 2026, under which she will provide services at $250 per hour.
During the consulting term, her stock options granted under the company’s equity plans will continue to vest and remain exercisable while she provides, or is willing to provide, services. She will have 90 days after the consulting agreement ends to exercise any vested options.
ADAR1 Capital Management and affiliates reported beneficial ownership of prefunded and milestone warrants and common stock equal to approximately 1,717,009–1,717,426 shares, representing 9.9% of Grace Therapeutics' common stock on a reported basis. The filing states the share counts reflect warrants and direct holdings and cites 15,474,026 shares outstanding as of February 12, 2026 from the Issuer's Form 10-Q. The Schedule 13G/A clarifies that certain warrants are excluded from the percentage calculations because their exchange/exercise is subject to 9.99% beneficial ownership limitations. The filing is signed by Daniel Schneeberger in his managerial and individual capacities.
Grace Therapeutics, Inc. Schedule 13G/A (Amendment No. 4) reports that AIGH Capital Management LLC, AIGH Investment Partners LLC and Orin Hirschman jointly beneficially own 814,000 shares of Common Stock, representing 4.9% of the class. The filing states the 814,000 shares include 814,000 common shares issuable upon exercise of warrants and exclude 10,742 common shares issuable upon exercise of warrants not currently exercisable due to beneficial ownership limitations on exercise.
Grace Therapeutics, Inc. updated its corporate presentation to highlight regulatory status, clinical data and capital position. The company received an FDA Complete Response Letter for its GTx-104 intravenous nimodipine NDA, driven by chemistry, manufacturing and controls and manufacturing facility issues, with no clinical deficiencies cited. Management plans a Type A FDA meeting and additional leachable and toxicology work, while evaluating manufacturing alternatives. Phase 3 STRIVE-ON data in aneurysmal subarachnoid hemorrhage showed fewer hypotension events, higher relative dose intensity and signals of better 90‑day outcomes and resource use versus oral nimodipine. The deck also notes orphan drug status and patents for GTx-104, additional programs GTx-102 and GTx-101, cash of $18.7 million and potential $15.0 million of gross proceeds from outstanding warrants.
Grace Therapeutics, Inc. reported that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage. The letter cites outstanding Chemistry, Manufacturing, and Controls and non-clinical items, but does not request additional clinical data.
The cited items involve leachables data for product packaging, non-clinical toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturer. Grace plans to request a Type A meeting with the FDA to clarify the path forward and intends to resubmit the application after resolving these issues.
Grace Therapeutics, Inc. received an updated ownership report from ADAR1 Capital Management, ADAR1 Capital Management GP, and Daniel Schneeberger on a Schedule 13G/A. The filing shows beneficial ownership of about 9.9% of the common stock, or roughly 1.65 million shares, including common shares and shares underlying prefunded and milestone warrants as of December 31, 2025. Additional warrant shares are excluded because their exercise is limited by a 9.99% beneficial ownership cap. The reporting persons state the securities are held in the ordinary course of business and not for the purpose of changing or influencing control of the company.
Grace Therapeutics, Inc. reported an updated large shareholder position in this amended Schedule 13G. Nantahala Capital Management, LLC, together with Wilmot B. Harkey and Daniel Mack, may be deemed to beneficially own 1,586,659 shares of common stock, or 9.99% of the class as of December 31, 2025.
This amount includes 408,456 shares that can be acquired within sixty days through warrant exercises. The reporting persons share voting and dispositive power over these shares, and certify that the holdings are in the ordinary course of business and not for the purpose of changing or influencing control of Grace Therapeutics.
Grace Therapeutics reported a net loss of about $2.3 million, or $0.14 per share, for the quarter ended December 31, 2025, improving from a $4.2 million loss a year earlier. The smaller loss mainly reflects a sharp drop in research and development spending after completing the pivotal Phase 3 STRIVE-ON trial of GTx-104.
Research and development expenses fell to $0.5 million from $2.2 million, while general and administrative costs rose to $2.0 million, driven by pre-commercial planning for GTx-104. Cash and cash equivalents were $18.7 million, and the company expects this to fund operations for at least 12 months. The FDA set a PDUFA target date of April 23, 2026 for the GTx-104 NDA in aneurysmal subarachnoid hemorrhage, supported by STRIVE-ON data showing fewer hypotension episodes, higher dose intensity, and better functional outcomes versus oral nimodipine.
Grace Therapeutics reported a smaller net loss while advancing its lead drug GTx-104 toward potential approval. For the quarter ended December 31, 2025, net loss was $2.3 million, or $0.14 per share, improving from $4.2 million a year earlier, mainly as research and development spending declined. For the nine months, net loss narrowed to $6.6 million from $10.2 million. Cash and cash equivalents were $18.7 million and total assets $68.5 million, with minimal liabilities of $3.6 million, leaving stockholders’ equity at $64.9 million. The company completed a $13.7 million net private placement in February 2025 and raised an additional $4.0 million from warrant exercises. GTx-104’s New Drug Application was accepted by the FDA with an April 23, 2026 PDUFA date, following a Phase 3 trial that met its primary endpoint and supported an NDA under the 505(b)(2) pathway.
Grace Therapeutics, Inc. received an amended Schedule 13G/A showing that AIGH Capital Management LLC, AIGH Investment Partners LLC, and Orin Hirschman together report beneficial ownership of 907,217 shares of Common Stock, representing 5.9% of the class as of 12/31/2025.
The filing notes an additional 824,742 common shares are issuable upon exercise of warrants that are not currently exercisable because of beneficial ownership limitations. The reporting persons certify the shares were acquired and are held in the ordinary course of business and not to change or influence control of Grace Therapeutics.