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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. plans a virtual 2026 annual meeting on September 17, 2026, for holders of common stock as of the July 20, 2026 record date. Stockholders will vote on electing five directors, an advisory “say‑on‑pay” resolution, ratifying KPMG LLP as auditor for the year ending March 31, 2027, and the advisory frequency of future say‑on‑pay votes, where the Board recommends 1 YEAR.
The Board proposes reelecting five nominees (four of whom are independent) and notes an independent Chair structure. Executive pay is reviewed annually; in fiscal 2026 CEO Prashant Kohli received total compensation of $1,270,820, including salary of $579,000, a 50%‑of‑salary target bonus and stock options. Named executives earned 100% of target bonuses based on corporate milestones tied to the NDA submission and FDA review of lead candidate GTx‑104.
There were 16,274,026 common shares outstanding on the record date, with directors and officers as a group holding 10.84%. Significant holders include Shore Pharma LLC at 11.60%. The company reports a 2026 net loss of 7,793 ($ in 000s) and a total shareholder return value of 63.25 on a fixed $100 investment. A February 2025 private placement raised about $13.5 million, including purchases by related holders, and is reviewed under the related‑party transactions policy.
Grace Therapeutics, Inc. reports receipt of official U.S. FDA Type A meeting minutes regarding the Complete Response Letter for its GTx-104 new drug application. The minutes confirm that the CRL raised only chemistry, manufacturing and controls issues, including contract-manufacturer cGMP compliance and additional leachables and excipient toxicology data, and did not cite clinical safety or efficacy deficiencies or request new clinical trials.
The company plans to resubmit the NDA after addressing all items through a dual-source manufacturing strategy and required non-clinical studies, with remediation at its existing contract manufacturer and parallel technology transfer to a second U.S. site. Supporting this plan, Phase 3 STRIVE-ON data in hospitalized aneurysmal subarachnoid hemorrhage patients showed a 19% relative reduction in clinically significant hypotension with GTx-104 versus oral nimodipine (28% vs 35%), higher dose intensity (54% vs 8% achieving ≥95% of planned dose), fewer ICU and ventilator days, and fewer ICU readmissions, with comparable overall safety. GTx-104 holds FDA Orphan Drug Designation, Grace cites an estimated 42,500 U.S. hospital-treated aSAH patients annually, and it reported $17.0 million of cash and 16,024,026 common shares outstanding as of March 31, 2026.
Grace Therapeutics, Inc. updated its corporate presentation, focusing on GTx-104, a novel intravenous nimodipine for aneurysmal subarachnoid hemorrhage. The FDA issued an April 2026 Complete Response Letter driven by chemistry, manufacturing and controls and contract manufacturer inspection issues, with no clinical deficiencies cited.
A Type A meeting is scheduled to clarify the path to resubmitting the GTx-104 New Drug Application. Phase 3 STRIVE-ON data showed 28% of GTx-104 patients had clinically significant hypotension versus 35% with oral nimodipine capsules, and 54% achieved at least 95% relative dose intensity versus 8% on capsules.
Patients on GTx-104 had 1.5 fewer intensive care unit days on average and 5 fewer days on mechanical ventilation compared with capsules, with overall safety appearing comparable. The company reports orphan drug status for GTx-104, patents extending to 2043, cash of $17.0 M, 16,024,026 common shares outstanding, and fully diluted shares of 23,033,731 as of March 31, 2026.
Grace Therapeutics reported fiscal year 2026 results and updated progress on its lead drug GTx-104. The company recorded a net loss of $7.8 million, or $0.47 per share, for the year ended March 31, 2026, improving from a $9.6 million loss, or $0.79 per share, a year earlier.
Research and development expenses fell to $2.4 million from $9.5 million as its pivotal Phase 3 STRIVE-ON safety trial for GTx-104 was closed out, while general and administrative expenses rose to $8.7 million from $7.2 million, mainly due to legal, due diligence and pre-commercial planning costs.
Grace ended March 31, 2026 with $17.0 million in cash and cash equivalents and expects this to fund operations for at least 12 months. Following an April 2026 Complete Response Letter from the FDA on the GTx-104 NDA, the company has a Type A meeting scheduled to clarify the path to resubmission and continues disciplined pre-commercial planning in anticipation of a potential approval for treating aneurysmal subarachnoid hemorrhage.
Grace Therapeutics files its annual report describing a rare-disease drug pipeline centered on GTx‑104, an IV formulation of nimodipine for aneurysmal subarachnoid hemorrhage. A Phase 3 trial showed a 19% relative reduction in clinically significant hypotension versus oral nimodipine and stronger dose intensity and functional outcomes.
The company submitted a 505(b)(2) NDA for GTx‑104 in June 2025, which the FDA accepted but later rejected in April 2026 via a Complete Response Letter focused on CMC, leachables and cGMP deficiencies at its contract manufacturer, without questioning safety or efficacy. Grace plans a Type A meeting to clarify a resubmission path.
Grace also decided in June 2026 to stop internal funding for its GTx‑102 and GTx‑101 programs and expects first‑quarter fiscal 2027 impairment charges of $9.2 million and $4.3 million, respectively, while continuing to seek licensing or partnership deals for these assets.
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.