Acasti Pharma(ACST) - 2026 Q1 - Quarterly Results

Executive Summary & Business Update Overview and Key Announcements Grace Therapeutics submitted GTx-104 NDA for aSAH to FDA, backed by positive Phase 3 STRIVE-ON data - Grace Therapeutics submitted an NDA to the FDA for GTx-104 for aSAH, marking a significant milestone for the company's clinical and corporate objectives[2][3] - The GTx-104 NDA is supported by positive Phase 3 STRIVE-ON safety trial data, which met its primary endpoint and demonstrated improved clinical outcomes for aSAH patients, along with potential medical and pharmacoeconomic benefits[2][3] - CEO Prashant Kohli stated that GTx-104 could be a potential breakthrough for aSAH patient care, as standard treatments have seen no significant innovation in nearly 40 years[3] First Quarter 2026 Corporate Highlights Q1 highlights include GTx-104 NDA submission to FDA, potential $7.6 million warrant exercises, and Orphan Drug Designation - The company submitted GTx-104's NDA to the FDA, which includes positive data from the Phase 3 STRIVE-ON safety trial, demonstrating GTx-104's clinical benefits over oral nimodipine[6] - The NDA submission may trigger the exercise of warrants from the September 2023 private placement, potentially generating up to $7.6 million at an exercise price of $3.003 per share[6] - GTx-104 has received FDA Orphan Drug Designation, which, if approved, typically grants seven years of marketing exclusivity in the US market, with additional protection from US and international patents[6] Financial Performance First Quarter 2026 Financial Results Grace Therapeutics reported a $3.4 million net loss for Q1 FY2026, an $0.8 million increase year-over-year, driven by derivative warrant liability changes and reduced tax benefits First Quarter 2026 Key Financial Data | Metric | June 30, 2025 ($ in thousands) | June 30, 2024 ($ in thousands) | Change ($ in thousands) | Change Rate | | :--------------------------------- | :----------------------------- | :----------------------------- | :---------------------- | :---------- | | Net Loss | (3,362) | (2,617) | (745) | 28.47% | | Basic and Diluted Loss Per Share | (0.21) | (0.24) | 0.03 | -12.50% | | Research and Development Expenses | (955) | (2,708) | 1,753 | -64.73% | | General and Administrative Expenses | (2,135) | (2,255) | 120 | -5.32% | | Change in Fair Value of Derivative Warrant Liability | (487) | 1,395 | (1,882) | -134.91% | | Income Tax Benefit | — | 724 | (724) | -100.00% | - Research and development expenses decreased by $1.8 million year-over-year, primarily due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial, partially offset by increased professional fees related to NDA preparation and submission[7] - General and administrative expenses decreased by $0.1 million year-over-year, mainly due to reduced legal, accounting, tax, audit, and other professional fees related to the continuation and domestication completed in October 2024, partially offset by increased payroll and benefits and GTx-104 commercial assessment costs[8] Cash Position and Runway As of June 30, 2025, cash and cash equivalents were $20 million, a $2.1 million decrease, with existing funds projected to cover operations for at least twelve months, extending to Q2 2027 upon warrant exercise Cash and Cash Equivalents | Metric | June 30, 2025 ($ in thousands) | March 31, 2025 ($ in thousands) | Change ($ in thousands) | Change Rate | | :----------------- | :----------------------------- | :----------------------------- | :---------------------- | :---------- | | Cash and Cash Equivalents | 20,005 | 22,133 | (2,128) | -9.61% | - Common stock warrants from the February 2025 private placement, if exercised, could generate aggregate proceeds of $15 million at an exercise price of $3.395 per share[10] - Common stock warrants from the September 2023 private placement, if exercised, could generate aggregate proceeds of $7.6 million at an exercise price of $3.003 per share[11] - The company anticipates that its existing cash and cash equivalents will provide a cash runway for at least the next twelve months, extending to the second quarter of 2027 if all warrants are exercised[12] Product Pipeline & Clinical Development GTx-104 and STRIVE-ON Trial Details The STRIVE-ON trial, comparing GTx-104 to oral nimodipine in aSAH patients, met its primary endpoint, showing GTx-104 reduced clinically significant hypotension by 19% and demonstrated superior or comparable outcomes in other key metrics - The STRIVE-ON trial was a prospective, randomized, open-label study comparing GTx-104 to oral nimodipine in 102 hospitalized aSAH patients (50 in the GTx-104 arm, 52 in the oral nimodipine arm)[13] - The trial met its primary endpoint, with GTx-104 patients experiencing a 19% reduction in clinically significant hypotension (28% vs 35%) and superior performance in relative dose intensity (RDI ≥ 95%: 54% vs 8%) and 90-day good functional outcomes (29% more patients)[13] - GTx-104 patients had fewer ICU readmissions, ICU days, and ventilator days compared to the oral nimodipine group, with comparable adverse events and no new safety concerns, as all deaths were related to the severity of the patients' underlying conditions[13] Disease Background: aneurysmal Subarachnoid Hemorrhage (aSAH) aSAH is a relatively rare stroke type, accounting for 5% of all strokes, with approximately 42,500 US hospitalizations annually, primarily caused by ruptured brain aneurysms - aSAH is bleeding into the subarachnoid space on the brain's surface, primarily caused by a ruptured brain aneurysm[14] - aSAH is a relatively rare type of stroke, accounting for approximately 5% of all strokes, with about 42,500 US patients hospitalized annually[14] Grace Therapeutics Asset Portfolio Grace Therapeutics' portfolio includes GTx-104, GTx-102, and GTx-101, with GTx-104 as the core focus for aSAH, while further development of GTx-102 and GTx-101 has been deprioritized for potential out-licensing or sale GTx-104 (aSAH) GTx-104 is a novel injectable nimodipine formulation using nanoparticle technology for intravenous infusion, addressing unmet needs in aSAH patients by potentially eliminating nasogastric tube administration, reducing food effects and drug interactions, and better managing hypotension - GTx-104 is a novel injectable formulation of nimodipine, utilizing unique nanoparticle technology for standard peripheral intravenous infusion, designed to address significant unmet medical needs in aSAH patients[15] - GTx-104 offers convenient intravenous administration, potentially eliminating the need for nasogastric tube administration in comatose or dysphagic patients, and may reduce food effects, drug interactions, and medication errors[16] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating good tolerability, significantly reduced inter- and intra-subject pharmacokinetic variability compared to oral nimodipine, and the potential for better management of hypotension in aSAH patients[16] GTx-102 (Ataxia-Telangiectasia) GTx-102 is a novel, concentrated betamethasone oral mucosal spray for neurological symptoms of Ataxia-Telangiectasia (A-T), a condition with no FDA-approved therapies, though its development has been deprioritized to focus on GTx-104 - GTx-102 is a novel, concentrated betamethasone oral mucosal spray designed to improve neurological symptoms of Ataxia-Telangiectasia (A-T), for which there are currently no FDA-approved therapies[17] - The FDA has provided guidance on the NDA pathway for GTx-102, including design recommendations for a pivotal efficacy and safety trial[17] - Further development of GTx-102 has been deprioritized to focus on GTx-104 development, and the company may also consider out-licensing or selling GTx-102[17] GTx-101 (Postherpetic Neuralgia) GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray for Postherpetic Neuralgia (PHN) symptom relief, offering rapid onset and up to eight hours of sustained analgesia, with its development deprioritized to focus on GTx-104 - GTx-101 is a non-narcotic, topical bio-adhesive film-forming bupivacaine spray designed to relieve symptoms in patients with Postherpetic Neuralgia (PHN)[18] - Administered via a metered spray, GTx-101 forms a thin, bio-adhesive topical film on the skin surface, offering a touch-free, non-greasy application with the 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, and the company may also consider out-licensing or selling GTx-101[18] Company Information About Grace Therapeutics Grace Therapeutics is a late-stage biopharmaceutical company focused on developing drug candidates for rare and orphan diseases, leveraging novel drug delivery technologies to enhance existing drug performance - Grace Therapeutics is a late-stage biopharmaceutical company focused on developing drug candidates for rare and orphan diseases[19] - The company's novel drug delivery technologies aim to improve the performance of existing drugs, enabling faster onset, enhanced efficacy, reduced side effects, and more convenient drug delivery[19] - Grace Therapeutics' primary clinical assets, including GTx-104, have received FDA Orphan Drug Designation, providing seven years of US market exclusivity, and are protected by over 40 issued and pending patents for additional intellectual property protection[19] Disclaimers & Financial Statements Forward-Looking Statements This press release contains forward-looking statements involving known and unknown risks, uncertainties, and other factors that could cause Grace Therapeutics' actual results to differ materially from historical results or future results expressed or implied by such statements - Statements in this press release constitute "forward-looking statements," involving known and unknown risks, uncertainties, and other factors that could cause actual results to differ materially from expectations[21] - Forward-looking statements are based on Grace Therapeutics' current expectations and assumptions, which may not be realized or prove to be incorrect, and readers should not place undue reliance on these statements[21] - The company undertakes no obligation to update such statements to reflect events or circumstances occurring after the date of their release, unless required by applicable securities laws[21] Contact Information Contact details are provided for Grace Therapeutics CEO Prashant Kohli and Investor Relations via LifeSci Advisors, including phone numbers and email addresses - Grace Therapeutics contact: Prashant Kohli, CEO, Phone: 609-322-1602, Email: info@gracetx.com[22] - Investor Relations contact: Mike Moyer, Managing Director, LifeSci Advisors, Phone: 617-308-4306, Email: mmoyer@lifesciadvisors.com[22] Condensed Consolidated Balance Sheets As of June 30, 2025, Grace Therapeutics' total assets were $69,805 thousand, a decrease from $71,993 thousand on March 31, 2025, driven by reduced cash and cash equivalents, and increased derivative warrant liabilities and trade and other payables Condensed Consolidated Balance Sheets (Unaudited) | (in thousands of USD, except share data) | June 30, 2025 | March 31, 2025 | | :--------------------------------- | :------------ | :------------- | | Assets | | | | Cash and cash equivalents | 20,005 | 22,133 | | Accounts receivable | 20 | 126 | | Prepaid expenses | 500 | 453 | | Total Current Assets | 20,525 | 22,712 | | Equipment, net | 14 | 15 | | Intangible assets | 41,128 | 41,128 | | Goodwill | 8,138 | 8,138 | | Total Assets | 69,805 | 71,993 | | Liabilities and Stockholders' Equity | | | | Trade and other payables | 2,315 | 1,930 | | Total Current Liabilities | 2,315 | 1,930 | | Derivative warrant liability | 1,628 | 1,141 | | Deferred tax liability | 2,312 | 2,312 | | Total Liabilities | 6,255 | 5,383 | | Additional paid-in capital | 293,636 | 293,334 | | Accumulated other comprehensive loss | (6,038) | (6,038) | | Accumulated deficit | (224,049) | (220,687) | | Total Stockholders' Equity | 63,550 | 66,610 | | Total Liabilities and Stockholders' Equity | 69,805 | 71,993 | Condensed Consolidated Statements of Loss and Comprehensive Loss For the three months ended June 30, 2025, Grace Therapeutics reported a net loss of $3,362 thousand, compared to a net loss of $2,617 thousand in the prior year, with the increased loss primarily due to a shift from gain to loss in derivative warrant liability fair value and the absence of an income tax benefit, despite reduced R&D and G&A expenses Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) | (in thousands of USD, except share and per share data) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | | Operating Expenses | | | | Research and development expenses | (955) | (2,708) | | General and administrative expenses | (2,135) | (2,255) | | Loss from Operations | (3,090) | (4,963) | | Foreign exchange gain (loss) | 10 | (8) | | Change in fair value of derivative warrant liability | (487) | 1,395 | | Interest and other income, net | 205 | 235 | | Other (expense) income, net | (272) | 1,622 | | Loss Before Income Tax Benefit | (3,362) | (3,341) | | Income tax benefit | — | 724 | | Net Loss and Total Comprehensive Loss | (3,362) | (2,617) | | Basic and diluted loss per share | (0.21) | (0.24) | | Weighted average shares outstanding | 15,924,522 | 10,928,543 |