Acasti Pharma(ACST) - 2025 Q4 - Annual Results

Company Announcement and Executive Summary Fiscal Year 2025 Overview Grace Therapeutics reported significant FY2025 clinical and corporate progress, including positive GTx-104 Phase 3 data, FDA NDA agreement, and $15 million upfront financing - Grace Therapeutics achieved significant progress in FY2025, including positive Phase 3 STRIVE-ON trial data for GTx-104 and agreement with the FDA on NDA submission[2][3] - The NDA for GTx-104 is planned for submission to the FDA in the first half of calendar year 2025, anticipated by the end of June[2][3] Private Placement Details | Financing Type | Upfront Gross Proceeds (million USD) | Potential Warrant Exercise Proceeds (million USD) | Total Potential Gross Proceeds (million USD) | | :------------- | :--------------------- | :-------------------------------- | :----------------------------- | | Private Placement | $15 | Up to an additional $15 | Up to approximately $30 | Fiscal Year 2025 Corporate Highlights Key Corporate Achievements FY2025 saw key achievements including a GTx-104 FDA Type C meeting, successful STRIVE-ON trial completion, private financing, and GTx-102 NDA guidance - A Type C meeting with the FDA provided feedback on GTx-104's STRIVE-ON trial and NDA submission, with the company believing existing data and regulatory filings are sufficient for NDA submission[10] - The STRIVE-ON trial was successfully completed, with GTx-104 meeting its primary endpoint and other metrics supporting or being comparable to GTx-104[10] - A private placement financing was completed, totaling approximately $30 million in potential gross proceeds, including approximately $15 million in initial upfront funding[10] - Written responses were received from the FDA regarding a GTx-102 Phase 1 meeting, providing guidance on the design of a single pivotal efficacy and safety trial to support an NDA[10] Fiscal Year 2025 Financial Results FY2025 Financial Performance Summary FY2025 net loss decreased due to favorable derivative warrant liability changes and lower restructuring costs, despite increased R&D and G&A expenses FY2025 Financial Highlights (thousand USD) | Metric | FY2025 | FY2024 | Change (FY25 vs FY24) | | :------------------------------------------ | :----- | :----- | :-------------------- | | Net Loss | $(9,568) | $(12,853) | $(3,285) Decrease | | Basic and Diluted Loss Per Share | $(0.79) | $(1.35) | $(0.56) Decrease | | Net Research and Development Expenses | $(9,511) | $(4,683) | $(4,828) Increase | | General and Administrative Expenses | $(7,168) | $(6,684) | $(484) Increase | | Cash and Cash Equivalents (as of March 31) | $22,133 | $23,005 | $(872) Decrease | - The decrease in net loss is primarily attributed to a approximately $6 million difference in the fair value change of derivative warrant liabilities and a $1.5 million reduction in restructuring costs, partially offset by a $4.8 million increase in net research and development expenses, a $0.5 million increase in general and administrative expenses, and a $0.2 million decrease in net interest and other income[5] - Research and development expenses increased by $4.8 million, mainly due to increased R&D activities for the pivotal Phase 3 safety clinical trial of GTx-04[6] Financing Activities and Cash Runway Two private placements in 2025 and 2023 secured upfront funds and potential warrant exercise proceeds, extending the company's cash runway Potential Gross Proceeds from Warrant Exercises | Private Placement Date | Exercise Price Per Share | Potential Gross Proceeds (million USD) | Expiration Date | | :--------------------- | :----------------------- | :----------------------- | :--------- | | February 2025 | $3.395 | $15 | 60th day after FDA approval of GTx-104 NDA or September 25, 2028 (whichever is earlier) | | September 2023 | $3.003 | $7.6 | 60th day after FDA acceptance of GTx-104 NDA or five years from issuance (whichever is earlier) | - The company's current cash and cash equivalents are expected to fund operations into the third quarter of calendar year 2026, extending to the second quarter of calendar year 2027 if all common stock warrants issued in the February 2025 and September 2023 private placements are exercised by investors[12] Product Pipeline Overview GTx-104 for Aneurysmal Subarachnoid Hemorrhage (aSAH) GTx-104, a novel injectable nimodipine for aSAH, addresses unmet needs via IV infusion, showing positive Phase 3 STRIVE-ON trial results STRIVE-ON Trial Results STRIVE-ON trial met its primary endpoint, reducing clinically significant hypotension by 19% with GTx-104, showing comparable safety - The STRIVE-ON trial met its primary endpoint, with a 19% reduction in clinically significant hypotension in GTx-104 patients (28% vs 35% for oral nimodipine)[13] - GTx-104 demonstrated superior or comparable performance in relative dose intensity (54% of patients with RDI ≥ 95% vs 8% for oral nimodipine) and good functional outcomes at 90 days (29% more patients)[13] - Adverse events were comparable between both groups, with no new safety concerns identified for GTx-104, and all deaths attributed to the severity of patients' underlying conditions[13] aSAH Disease Background aSAH is a severe stroke type caused by ruptured cerebral aneurysms, affecting about 42,500 US hospitalized patients annually - aSAH is a relatively uncommon stroke type, accounting for approximately 5% of all strokes and affecting about 42,500 hospitalized patients in the US annually[14] - Its primary cause is the rupture of a cerebral aneurysm, leading to bleeding into the subarachnoid space on the brain's surface[14] GTx-104 Product Profile GTx-104 is a novel injectable nimodipine for aSAH, offering convenient IV delivery via nanoparticle technology, potentially improving patient management - GTx-104 is a novel injectable formulation of nimodipine, administered via intravenous infusion for aSAH patients, utilizing nanoparticle technology to enable an aqueous formulation[15] - Its advantages include convenient intravenous administration, potential elimination of nasogastric tube administration, reduced food effects and drug interactions, and better management of hypotension in aSAH patients[16] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating good tolerability and significantly reduced inter- and intra-subject pharmacokinetic variability compared to oral nimodipine[16] Other Pipeline Assets Grace Therapeutics' pipeline includes GTx-102 for A-T and GTx-101 for PHN, with GTx-101 development deprioritized for GTx-104 focus GTx-102 for Ataxia-Telangiectasia (A-T) GTx-102 is a novel betamethasone oral spray for A-T neurological symptoms, with FDA guidance provided for its NDA pathway - GTx-102 is a novel, concentrated betamethasone oral mucosal spray designed to improve neurological symptoms of Ataxia-Telangiectasia (A-T), a condition with no currently FDA-approved therapies[17] - The FDA has provided guidance on GTx-102's NDA pathway, including the design of a single pivotal efficacy and safety trial[17] GTx-101 for Postherpetic Neuralgia (PHN) GTx-101, a non-narcotic topical bupivacaine spray for PHN, has been deprioritized to focus on GTx-104, with potential for licensing - GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray for the relief of Postherpetic Neuralgia (PHN) symptoms, with potential for rapid onset and up to eight hours of sustained analgesia[18] - Further development of GTx-101 has been deprioritized to focus on GTx-104 development, with potential for licensing or sale[18] About Grace Therapeutics Company Profile Grace Therapeutics is a late-stage biopharmaceutical company focused on rare diseases, using novel drug delivery to enhance existing therapies, with key assets holding Orphan Drug Designation - Grace Therapeutics is a late-stage biopharmaceutical company focused on rare and orphan diseases[19] - The company's novel drug delivery technologies aim to enhance the performance of existing drugs, enabling faster onset, enhanced efficacy, reduced side effects, and more convenient drug delivery[19] - Grace Therapeutics' lead clinical assets, including GTx-104, have received FDA Orphan Drug Designation, providing seven years of market exclusivity upon US approval and additional intellectual property protection[19] Consolidated Financial Statements Consolidated Balance Sheets The balance sheets show a slight asset decrease, significant liability reduction from lower derivative warrant and deferred tax liabilities, and increased stockholders' equity Consolidated Balance Sheet Highlights (thousand USD) | Metric | March 31, 2025 | March 31, 2024 | | :-------------------------- | :------------- | :------------- | | Total Assets | $71,993 | $73,300 | | Total Liabilities | $5,383 | $11,557 | | Total Stockholders' Equity | $66,610 | $61,743 | | Cash and Cash Equivalents | $22,133 | $23,005 | | Derivative Warrant Liability | $1,141 | $4,359 | | Deferred Tax Liability | $2,312 | $5,514 | Consolidated Statements of Loss and Comprehensive Loss Consolidated statements show a reduced net loss in FY2025, driven by positive derivative warrant liability changes and income tax benefits, despite higher operating expenses Consolidated Income Statement Highlights (thousand USD) | Metric | Year Ended March 31, 2025 | Year Ended March 31, 2024 | | :------------------------------------------ | :------------------------ | :------------------------ | | Net Research and Development Expenses | $(9,511) | $(4,683) | | General and Administrative Expenses | $(7,168) | $(6,684) | | Restructuring Costs | $0 | $(1,485) | | Loss from Operations | $(16,679) | $(12,852) | | Change in Fair Value of Derivative Warrant Liability | $3,218 | $(2,728) | | Income Tax Benefit | $3,199 | $1,832 | | Net Loss and Total Comprehensive Loss | $(9,568) | $(12,853) | | Basic and Diluted Loss Per Share | $(0.79) | $(1.35) | Legal and Investor Information Forward-Looking Statements This section provides a legal disclaimer, cautioning readers about inherent risks and uncertainties in forward-looking statements - Statements in the press release that are not historical facts constitute "forward-looking statements" and are subject to known and unknown risks and uncertainties[21] - Readers are cautioned not to place undue reliance on these statements, which are valid only as of the date of the press release, and the company undertakes no obligation to update them[21] Contact Information Contact information is provided for Grace Therapeutics CEO and investor relations via LifeSci Advisors - Contact details are provided for Grace Therapeutics (Prashant Kohli, CEO) and Investor Relations (LifeSci Advisors, Mike Moyer)[22]