Welcome to our dedicated page for Grace Therapeutics SEC filings (Ticker: GRCE), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Grace Therapeutics, Inc. (GRCE) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. Grace Therapeutics is a late-stage biopharma company focused on rare and orphan diseases, and its filings offer detailed information on the development and regulatory status of its lead asset, GTx-104, as well as corporate governance, financing activities, and risk disclosures.
Through current reports on Form 8-K, Grace Therapeutics documents material events such as the submission and FDA acceptance for review of its New Drug Application (NDA) for GTx-104, the establishment of a Prescription Drug User Fee Act (PDUFA) target date, the issuance of a U.S. method-of-use patent titled “Nimodipine Parenteral Administration,” and additional funding obtained via exercises of common stock warrants. These filings also reference press releases that describe the pivotal Phase 3 STRIVE-ON safety trial of GTx-104 in aneurysmal subarachnoid hemorrhage (aSAH) patients.
Investors can review the company’s definitive proxy statement (DEF 14A) for insight into board structure, annual meeting proposals, executive compensation advisory votes, and the appointment of the independent registered public accounting firm. Periodic reports such as the Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, when accessed via EDGAR, provide broader context on Grace Therapeutics’ financial condition, risk factors, and development programs, including GTx-102 and GTx-101.
On Stock Titan, these filings are supplemented with AI-powered summaries that highlight key points in lengthy documents, helping users quickly understand the implications of new 8-Ks, 10-Ks, and 10-Qs. Real-time integration with EDGAR means that new filings appear promptly, while Form 4 and related insider transaction reports, when available, can help users track equity activity by directors and officers.
This GRCE filings hub is intended for users who want to analyze how Grace Therapeutics reports its clinical progress, intellectual property developments, financing arrangements, and governance decisions in official SEC documents, with AI-generated overviews to make complex regulatory language more accessible.
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.
Grace Therapeutics, Inc. updated its executive employment arrangements by entering into amendments to existing letter agreements with its CEO and four other executive officers. If an executive is terminated by the company without Cause, and there is no Change in Control, the executive will receive accrued obligations plus continued base salary and COBRA benefits for six months, or twelve months in the case of the CEO. Unvested equity awards are forfeited in this scenario.
If an executive is terminated without Cause or resigns for Good Reason in connection with or within twelve months after a Change in Control, the executive will receive accrued obligations plus a cash payment equal to six months (eighteen months for the CEO) of base salary and target bonus, as well as COBRA premiums for the same period. In this Change in Control context, all unvested equity awards held by the executive will fully vest and become exercisable.
Grace Therapeutics, Inc. director Vimal Kavuru reported a grant of stock options on January 8, 2026. He received a stock option to buy 10,000 shares of Grace Therapeutics common stock at an exercise price of $3.8 per share, held in direct ownership. Following this grant, he beneficially owns options for 10,000 shares.
According to the vesting terms, 25% of the option vests on the grant date, and the remaining 75% vests in substantially equal monthly installments on the 30th day of each month until September 30, 2026, provided he continues to serve the company through each vesting date.