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. (GRCE) has filed a Form S-3 prospectus to register the resale, from time to time, of up to 4,761,904 shares of common stock by existing selling stockholders. These shares were issued in an August 2026 private placement at $2.10 per share that generated approximately $9.1 million in net proceeds for Grace at closing; the company will receive no cash from subsequent resales.
Grace focuses on reformulating approved drugs for rare and orphan diseases using proprietary drug-delivery technologies and follows the Section 505(b)(2) regulatory pathway. Its pipeline includes three clinical-stage candidates that all hold orphan drug designation, supported by more than 79 granted and pending patents. Lead asset GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage, received an FDA Complete Response Letter in April 2026 citing chemistry, manufacturing and controls, nonclinical items, and the cGMP status of a contract manufacturer, but no clinical safety or efficacy deficiencies.
Grace plans to resubmit the GTx-104 NDA after addressing these issues and has begun a dual-source manufacturing strategy, including technology transfer to a second U.S.-based manufacturer. Following a 2023 strategic realignment, the company is concentrating resources on GTx-104 and, as of June 2026, chose not to resume internal development funding for GTx-102 or GTx-101 under its current operating plan.
Grace Therapeutics, Inc. (GRCE) had a Form 4 filed for Opaleye Management Inc., a more-than-ten-percent holder, reporting an open-market purchase of 11,608 shares of common stock on August 14, 2026 at a weighted average price of $2.0853 per share. The shares are held indirectly by Opaleye, L.P., with Opaleye Management Inc. potentially deemed a beneficial owner through its role as investment manager but disclaiming beneficial ownership except to the extent of its pecuniary interest. Following this transaction, 2,760,000 shares are reported as held indirectly by Opaleye, L.P.
Grace Therapeutics, Inc. received an updated ownership report showing that ADAR1 Capital Management, related entities, and Daniel Schneeberger collectively report beneficial ownership of Grace common stock through prefunded and milestone warrants. ADAR1 Capital Management, LLC and Mr. Schneeberger each report beneficial ownership of 1,806,216 shares of common stock underlying these warrants, representing 9.9% of the company’s common stock based on 16,274,026 shares outstanding as of June 30, 2026. ADAR1 Capital Management GP, LLC reports 1,525,757 underlying shares, or 8.6% of the class.
The filing notes that an additional 69,331 underlying shares are excluded from the reported amounts because exchanges or exercises are subject to a 9.99% beneficial ownership limitation. Mr. Schneeberger is identified as a control person of the ADAR1 investment entities and may be deemed to indirectly beneficially own their reported positions.
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.