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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. has a significant shareholder group reporting beneficial ownership of its common stock. As of June 30, 2026, Nantahala Capital Management, LLC, together with Wilmot B. Harkey and Daniel Mack, may be deemed to beneficially own 1,178,203 shares of common stock, representing 6.75% of the outstanding class. These shares are held by funds and separately managed accounts under Nantahala’s control and are all issuable within sixty days upon exercise of convertible securities. The reporting persons have no sole voting or dispositive power but share voting and dispositive power over the same 1,178,203 shares.
Grace Therapeutics, Inc. reported results for the three months ended June 30, 2026 and provided an update on its GTx-104 program. Net loss was $15.8 million, or $0.91 per share, compared with $3.4 million, or $0.21 per share, a year earlier, driven largely by a $13.5 million impairment of in-process R&D for GTx-101 and GTx-102 after these programs were deprioritized.
Research and development expense declined to $0.7 million and general and administrative expense to $1.7 million, reflecting reduced GTx-104 clinical and pre-commercial activities. The company reassessed GTx-104 following an FDA Complete Response Letter focused on CMC and non-clinical items and concluded no impairment was required. As of August 11, 2026, cash and cash equivalents were $22.2 million; management believes this will fund planned operations, including work to address the CRL and dual-source manufacturing strategy for GTx-104, through the end of calendar 2028.
Grace Therapeutics, Inc. reported a first-quarter net loss of $15.8M, sharply higher than a year earlier, driven mainly by a $13.5M impairment of in-process R&D for de-prioritized programs GTx-102 and GTx-101. Core operating expenses declined, with research and development at $0.7M and general and administrative at $1.7M.
The company is now concentrated on lead asset GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage. After an April 2026 FDA Complete Response Letter focused on CMC and nonclinical items, Grace is pursuing a dual-source manufacturing strategy and preparing an NDA resubmission.
Cash and cash equivalents were $13.8M at June 30, 2026, supplemented by an August 2026 private placement yielding ~$9.1M, bringing cash to $22.2M. Management believes this funds planned operations, including CRL remediation, through at least the end of calendar 2028, though additional capital will be needed for ongoing operations beyond that horizon.
Grace Therapeutics, Inc., a Delaware biotechnology corporation with no revenues, filed a notice of an exempt securities offering. The company is relying on Rule 506(b) of Regulation D for a private equity offering. It reports a total amount sold of $9,999,998 in equity securities, with $0 remaining to be sold, and a first sale date of August 4, 2026. Craig-Hallum Capital Group is listed under sales compensation, and the company discloses $0 in finders' fees.
Opaleye Management Inc., Opaleye, L.P., and James Silverman report beneficial ownership of Grace Therapeutics, Inc. common stock on a Schedule 13G. The Fund directly holds 2,748,392 shares of common stock, and the Adviser and Mr. Silverman may be deemed to beneficially own these shares through their roles with the Fund.
This position represents 13.07% of the outstanding common stock, based on 21,035,930 shares outstanding as of August 5, 2026, which includes shares issued in an August 4, 2026 private placement in which Opaleye, L.P. participated. Voting and dispositive power over the 2,748,392 shares is reported as shared, with no sole voting or dispositive power.
Grace Therapeutics, Inc. completed a private placement of 4,761,904 shares of common stock at $2.10 per share, generating approximately $10 million in gross proceeds from institutional and accredited investors. Craig-Hallum Capital Group LLC acted as placement agent. The shares were issued under Section 4(a)(2) and Rule 506 exemptions, and the company will file a resale registration statement, using reasonable best efforts to have it declared effective within specified SEC review timelines and to keep it effective until the shares are sold or freely tradable under Rule 144. The company agreed to bear related registration expenses and accepted near-term restrictions on additional equity issuance, reverse stock splits and new registration statements, subject to exceptions.
Grace Therapeutics expects net proceeds, together with existing cash, to extend its cash runway to the end of calendar 2028 and intends to use the funds to support manufacturing and regulatory work for its lead asset, GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH). aSAH accounts for about 5% of strokes and an estimated 42,500 U.S. hospital-treated patients annually. GTx-104 has been administered to over 200 patients and volunteers, has Orphan Drug Designation with potential seven years of U.S. marketing exclusivity, and is supported by an intellectual property estate of 52 granted and pending patents as the company pursues an NDA resubmission and a dual-source manufacturing strategy.
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.