[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) [Overview and Key Announcements](index=1&type=section&id=Overview%20and%20Key%20Announcements) 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](index=2&type=chunk)[3](index=3&type=chunk) - 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](index=2&type=chunk)[3](index=3&type=chunk) - 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](index=3&type=chunk) [First Quarter 2026 Corporate Highlights](index=1&type=section&id=First%20Quarter%202026%20Corporate%20Highlights) 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](index=6&type=chunk) - 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](index=6&type=chunk) - 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](index=6&type=chunk) [Financial Performance](index=1&type=section&id=Financial%20Performance) [First Quarter 2026 Financial Results](index=1&type=section&id=First%20Quarter%202026%20Financial%20Results) 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](index=7&type=chunk) - 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](index=8&type=chunk) [Cash Position and Runway](index=2&type=section&id=Cash%20Position%20and%20Runway) 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](index=10&type=chunk) - 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](index=11&type=chunk) - 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](index=12&type=chunk) [Product Pipeline & Clinical Development](index=2&type=section&id=Product%20Pipeline%20%26%20Clinical%20Development) [GTx-104 and STRIVE-ON Trial Details](index=2&type=section&id=GTx-104%20and%20STRIVE-ON%20Trial%20Details) 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](index=13&type=chunk) - 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](index=13&type=chunk) - 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](index=13&type=chunk) [Disease Background: aneurysmal Subarachnoid Hemorrhage (aSAH)](index=3&type=section&id=Disease%20Background%3A%20aneurysmal%20Subarachnoid%20Hemorrhage%20(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](index=14&type=chunk) - aSAH is a relatively rare type of stroke, accounting for approximately **5%** of all strokes, with about **42,500** US patients hospitalized annually[14](index=14&type=chunk) [Grace Therapeutics Asset Portfolio](index=3&type=section&id=Grace%20Therapeutics%20Asset%20Portfolio) 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)](index=3&type=section&id=GTx-104%20(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](index=15&type=chunk) - 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](index=16&type=chunk) - 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](index=16&type=chunk) [GTx-102 (Ataxia-Telangiectasia)](index=3&type=section&id=GTx-102%20(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](index=17&type=chunk) - The FDA has provided guidance on the NDA pathway for GTx-102, including design recommendations for a pivotal efficacy and safety trial[17](index=17&type=chunk) - 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](index=17&type=chunk) [GTx-101 (Postherpetic Neuralgia)](index=3&type=section&id=GTx-101%20(Postherpetic%20Neuralgia)) 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](index=18&type=chunk) - 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](index=18&type=chunk) - 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](index=18&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) [About Grace Therapeutics](index=3&type=section&id=About%20Grace%20Therapeutics) 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](index=19&type=chunk) - 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](index=19&type=chunk) - 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](index=19&type=chunk) [Disclaimers & Financial Statements](index=4&type=section&id=Disclaimers%20%26%20Financial%20Statements) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) 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](index=21&type=chunk) - 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](index=21&type=chunk) - 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](index=21&type=chunk) [Contact Information](index=4&type=section&id=Contact%20Information) 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](index=22&type=chunk) - Investor Relations contact: Mike Moyer, Managing Director, LifeSci Advisors, Phone: **617-308-4306**, Email: mmoyer@lifesciadvisors.com[22](index=22&type=chunk) [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) 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 |

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 Grace Therapeutics, Inc. (Exact name of registrant as specified in its charter) State of Delaware 98-1359336 (State or oth ...

[Company Announcement and Executive Summary](index=1&type=section&id=Company%20Announcement) [Fiscal Year 2025 Overview](index=1&type=section&id=Fiscal%20Year%202025%20Overview) 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](index=2&type=chunk)[3](index=3&type=chunk) - 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](index=2&type=chunk)[3](index=3&type=chunk) 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](index=2&type=section&id=2025%20Corporate%20Highlights) [Key Corporate Achievements](index=2&type=section&id=Key%20Corporate%20Achievements) 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](index=10&type=chunk) - 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](index=10&type=chunk) - A private placement financing was completed, totaling approximately **$30 million** in potential gross proceeds, including approximately **$15 million** in initial upfront funding[10](index=10&type=chunk) - 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](index=10&type=chunk) [Fiscal Year 2025 Financial Results](index=2&type=section&id=Fiscal%20Year%202025%20Financial%20Results) [FY2025 Financial Performance Summary](index=2&type=section&id=FY2025%20Financial%20Performance%20Summary) 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](index=5&type=chunk) - 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](index=6&type=chunk) [Financing Activities and Cash Runway](index=2&type=section&id=Financing%20Activities%20%26%20Cash%20Runway) 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](index=12&type=chunk) [Product Pipeline Overview](index=3&type=section&id=Grace%20Therapeutics%20Asset%20Portfolio) [GTx-104 for Aneurysmal Subarachnoid Hemorrhage (aSAH)](index=3&type=section&id=GTx-104%20for%20aSAH) 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](index=3&type=section&id=STRIVE-ON%20Trial%20Results) 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](index=13&type=chunk) - 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](index=13&type=chunk) - 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](index=13&type=chunk) [aSAH Disease Background](index=3&type=section&id=aSAH%20Disease%20Background) 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](index=14&type=chunk) - Its primary cause is the rupture of a cerebral aneurysm, leading to bleeding into the subarachnoid space on the brain's surface[14](index=14&type=chunk) [GTx-104 Product Profile](index=3&type=section&id=GTx-104%20Product%20Profile) 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](index=15&type=chunk) - 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](index=16&type=chunk) - 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](index=16&type=chunk) [Other Pipeline Assets](index=4&type=section&id=Other%20Pipeline%20Assets) 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)](index=4&type=section&id=GTx-102%20for%20Ataxia-Telangiectasia%20(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](index=17&type=chunk) - The FDA has provided guidance on GTx-102's NDA pathway, including the design of a single pivotal efficacy and safety trial[17](index=17&type=chunk) [GTx-101 for Postherpetic Neuralgia (PHN)](index=4&type=section&id=GTx-101%20for%20Postherpetic%20Neuralgia%20(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](index=18&type=chunk) - Further development of GTx-101 has been deprioritized to focus on GTx-104 development, with potential for licensing or sale[18](index=18&type=chunk) [About Grace Therapeutics](index=4&type=section&id=About%20Grace%20Therapeutics) [Company Profile](index=4&type=section&id=Company%20Profile) 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](index=19&type=chunk) - 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](index=19&type=chunk) - 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](index=19&type=chunk) [Consolidated Financial Statements](index=6&type=section&id=Consolidated%20Financial%20Statements) [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) 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](index=7&type=section&id=Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) 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](index=5&type=section&id=Legal%20%26%20Investor%20Information) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) 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](index=21&type=chunk) - 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](index=21&type=chunk) [Contact Information](index=5&type=section&id=Contact%20Information) 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](index=22&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 Grace Therapeutics, Inc. (Exact name of registrant as specified in its charter) State of Delaware 98-1359336 (State or other juri ...

Clinical Trials and Drug Development - The Phase 3 STRIVE-ON safety trial met its primary endpoint, demonstrating improved clinical outcomes for patients compared to orally administered nimodipine[2] - The company anticipates submitting a New Drug Application (NDA) for GTx-104 in the first half of calendar year 2025[4] - The company is focusing on pre-commercial planning and building a commercial team in anticipation of GTx-104's potential approval[3] Financial Performance - For the third fiscal quarter ended December 31, 2024, the company reported a net loss of $4.2 million, or $0.36 per share, an increase from a net loss of $2.4 million, or $0.21 per share, for the same period in 2023[5] - The net loss for the nine months ended December 31, 2024, was $10,204,000, compared to a net loss of $9,687,000 for the same period in 2023, reflecting an increase of 5.3%[18] - The total loss before income tax benefit for the nine months ended December 31, 2024, was $12,385,000, up from $10,630,000 in the same period of 2023[18] - Basic and diluted loss per share for Q3 2024 was $0.36, compared to $0.21 in Q3 2023, indicating a deterioration in earnings per share[18] Expenses and Cash Flow - Research and development expenses for the quarter were $2.2 million, up from $1.4 million in the same quarter of 2023, primarily due to increased activities for the GTx-104 trial[6] - General and administrative expenses were $1.5 million for the quarter, a slight decrease from $1.6 million in the same quarter of 2023[7] - Research and development expenses for Q3 2024 were $2,194,000, an increase of 52% compared to $1,443,000 in Q3 2023[18] - General and administrative expenses decreased slightly to $1,510,000 in Q3 2024 from $1,600,000 in Q3 2023[18] - As of December 31, 2024, cash and cash equivalents were $11.1 million, a decrease of $11.9 million from $23.0 million at March 31, 2024[8] Assets and Deficits - Total assets decreased to $61.2 million as of December 31, 2024, down from $73.3 million at March 31, 2024[17] - The company’s accumulated deficit increased to $221.3 million as of December 31, 2024, compared to $211.1 million at March 31, 2024[17] Financing Activities - The company secured a private placement financing of up to approximately $30 million, with $15 million received upfront and the potential for an additional $15 million upon warrant exercise[4] Other Financial Metrics - The company reported a foreign exchange loss of $16,000 in Q3 2024, compared to a gain of $3,000 in Q3 2023[18] - Interest and other income, net, decreased to $138,000 in Q3 2024 from $316,000 in Q3 2023[18] - The weighted-average number of shares outstanding increased to 11,506,234 in Q3 2024 from 8,874,872 in the same quarter of the previous year[18] - The income tax benefit for the nine months ended December 31, 2024, was $2,181,000, compared to $943,000 for the same period in 2023[18] - The company did not incur any restructuring costs in Q3 2024, while it had restructuring costs of $1,485,000 in the same period of 2023[18]

Financial Performance - Net loss for the three months ended December 31, 2024, was $4,155,000, compared to a net loss of $2,391,000 for the same period in 2023, representing an increase of 74%[20] - The company reported a basic and diluted loss per share of $0.36 for the three months ended December 31, 2024, compared to $0.21 for the same period in 2023, an increase of 71%[20] - The net loss for the three months ended December 31, 2024, was $4.2 million, or $0.36 per share, compared to a net loss of $2.4 million, or $0.21 per share, for the same period in 2023[170] Assets and Liabilities - Total current assets decreased from $24,010,000 on March 31, 2024, to $11,939,000 on December 31, 2024, a decline of approximately 50%[18] - Cash and cash equivalents decreased from $23,005,000 at the beginning of the period to $11,055,000 at the end of the period, a decrease of 52%[24] - The accumulated deficit increased from $211,119,000 on March 31, 2024, to $221,323,000 on December 31, 2024, an increase of approximately 5%[18] - Total liabilities decreased from $11,557,000 on March 31, 2024, to $9,085,000 on December 31, 2024, a reduction of approximately 21%[18] Research and Development - Research and development expenses for the nine months ended December 31, 2024, were $7,877,000, up from $2,998,000 in the same period of 2023, an increase of 163%[20] - Research and development expenses for the three months ended December 31, 2024, were $2.2 million, an increase of $751,000 from $1.4 million in the same period in 2023[170] - Research and development expenses for the nine months ended December 31, 2024, totaled $7.9 million, up from $3.0 million in the same period in 2023, reflecting increased activities for the GTx-104 pivotal Phase 3 trial[175] Capital and Funding - The Company raised approximately $7,500 from the 2023 Private Placement, issuing 1,951,371 Common Shares at a price of $1.848 per share[33] - The net proceeds from the 2025 Private Placement were approximately $13,800, intended for clinical trial expenses and product launch preparations for GTx-104[34][35] - The Company plans to raise additional capital to maintain adequate liquidity and fund operations beyond the next 12 months[36] - The company completed a private placement in February 2025, raising approximately $13.8 million in net proceeds[168] Clinical Development - The company has three clinical-stage drug candidates aimed at treating rare and orphan diseases, supported by over 40 granted and pending patents worldwide[91] - GTx-104, an injectable formulation of nimodipine, aims to address significant unmet medical needs in aSAH patients and has shown improved bioavailability with 100% compared to oral forms[110] - The STRIVE-ON trial for GTx-104 met its primary endpoint, demonstrating clinical benefit over orally administered nimodipine, with an NDA submission planned for the first half of 2025[100] - GTx-102, an oral-mucosal betamethasone spray for A-T, is in development with FDA guidance received for a pivotal efficacy and safety trial[101] - The company has deferred the clinical development of GTx-102 and GTx-101 for at least three years to focus resources on GTx-104[96] Market Potential - The total addressable market for aSAH in the U.S. is estimated at approximately $300 million, with around 150,000 annual cases in China and 60,000 in the European Union[117] - GTx-102 has a potential total addressable market of $150 million in the U.S., affecting approximately 4,300 patients annually[133] - GTx-101 has a total addressable market estimated at $2.5 billion, with approximately $200 million for postherpetic neuralgia (PHN) pain and $2.3 billion for non-PHN pain indications[152] Operational Changes - The company implemented a strategic realignment plan in May 2023, resulting in a streamlined workforce and a focus on the development of its lead product candidate GTx-104[31] - The company incurred $1,485 million in restructuring costs during the nine months ended December 31, 2023, primarily due to employee severance costs and legal fees[82] - The company incurred $1.5 million in restructuring costs related to workforce termination announced on May 8, 2023[182] Financial Controls and Compliance - Management concluded that existing disclosure controls and procedures were effective as of December 31, 2024, providing reasonable assurance but not absolute assurance against errors and fraud[209] - No changes were made to internal controls over financial reporting during the quarter ended December 31, 2024, that materially affected internal controls[210] - The company is not currently a party to any legal proceedings likely to have a material adverse effect on its business[212] - There have been no material changes from the risk factors disclosed in the Annual Report[214]

Financial Performance - The company reported a net loss of $3.4 million, or $0.30 per share, for the quarter ended September 30, 2024, compared to a net loss of $3.3 million, or $0.43 per share, for the same period in 2023[6]. - The net loss for the three months ended September 30, 2023, was $3,432,000, compared to a net loss of $3,273,000 for the same period in 2022, indicating an increase in loss of approximately 4.9%[23]. - The company reported a basic and diluted loss per share of $0.30 for the three months ended September 30, 2023, compared to $0.43 for the same period in 2022[23]. Research and Development - Research and development expenses increased to $3.0 million for the quarter, up from $0.5 million in the same quarter of 2023, primarily due to activities related to the GTx-104 pivotal Phase 3 STRIVE-ON safety trial[7]. - Research and development expenses for the three months ended September 30, 2023, were $2,976,000, while general and administrative expenses were $1,855,000[23]. - Patient enrollment in the Phase 3 STRIVE-ON safety trial was completed ahead of schedule, with a data readout expected in the first calendar quarter of 2025[4]. Financial Position - The company had cash and cash equivalents of $15.1 million as of September 30, 2024, a decrease of $7.9 million from $23.0 million as of March 31, 2024, with a projected cash runway into the second calendar quarter of 2026[9]. - As of September 30, 2024, total assets decreased to $65,349,000 from $73,300,000 as of March 31, 2024, representing a decline of approximately 10.2%[19]. - Current assets fell to $16,062,000 from $24,010,000, a decrease of about 33.1%[19]. - Total liabilities decreased to $9,215,000 from $11,557,000, a reduction of approximately 20.2%[19]. - Shareholders' equity decreased to $56,134,000 from $61,743,000, reflecting a decline of about 9.1%[19]. Corporate Developments - The company completed its redomicile to Delaware and rebranded to Grace Therapeutics, with trading under the symbol "GRCE" on Nasdaq effective October 28, 2024[5]. - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of calendar 2025[4]. - A virtual Key Opinion Leader event is scheduled for November 20, 2024, to discuss the treatment landscape for aneurysmal Subarachnoid Hemorrhage (aSAH) patients[10]. Product Information - The addressable market for GTx-104 in the United States is estimated to be approximately $300 million[14]. - GTx-104 is a novel injectable formulation of nimodipine being developed for intravenous infusion in aSAH patients, addressing significant unmet medical needs[13]. Other Financial Metrics - The company experienced a foreign exchange gain of $13,000 for the three months ended September 30, 2023, compared to a loss of $13,000 in the previous year[23]. - The change in fair value of derivative warrant liabilities resulted in a gain of $362,000 for the three months ended September 30, 2023[23]. - General and administrative expenses were $1.9 million for the quarter, an increase of $0.3 million from $1.6 million in the same quarter of 2023[8]. - The weighted average number of shares outstanding increased to 11,506,234 for the three months ended September 30, 2023, compared to 7,552,677 for the same period in 2022[23].

Financial Performance - As of September 30, 2024, total assets decreased to $65,349,000 from $73,300,000 as of March 31, 2024, representing a decline of approximately 10.8%[18] - Cash and cash equivalents decreased to $15,155,000 from $23,005,000, a reduction of about 34.3%[18] - The net loss for the quarter was $3,432,000, compared to a net loss of $3,273,000 for the same quarter in 2023, indicating a year-over-year increase of about 4.9%[20] - Basic and diluted loss per share for the quarter was $0.30, compared to $0.43 for the same quarter in 2023, reflecting a decrease of approximately 30.2%[20] - The net loss for the six months ended September 30, 2024, was $6,049,000, compared to a net loss of $7,296,000 for the same period in 2023, representing a 17.1% improvement[8] - For the three months ended September 30, 2024, the net loss was $3.4 million, or $0.30 per share, an increase of $159 from the net loss of $3.3 million, or $0.43 per share, for the same period in 2023[150] Research and Development - Research and development expenses for the quarter ended September 30, 2024, were $2,976,000, significantly higher than $460,000 for the same period in 2023, marking an increase of approximately 548.7%[20] - Total research and development expenses for the six months ended September 30, 2024, were $5.684 million, compared to $1.5 million for the same period in 2023, reflecting a $4.184 million increase[154] - The company incurred a $4.2 million increase in research and development activities for the GTx-104 pivotal Phase 3 STRIVE-ON trial protocol during the second quarter of 2025[170] Cash Flow and Liquidity - The company incurred a net cash used in operating activities of $7,835,000 for the six months ended September 30, 2024, compared to $8,353,000 for the same period in 2023, a decrease of 6.2%[8] - The company expects its existing cash and cash equivalents to fund operations into the second calendar quarter of 2026[31] - The company believes its cash runway will be sufficient to fund operations into the second calendar quarter of 2026[149] - The company plans to raise additional capital to maintain adequate liquidity beyond the second quarter of 2026[32] Shareholder Equity and Liabilities - Shareholders' equity decreased to $56,134,000 from $61,743,000, a decline of about 9.1%[19] - Total current liabilities increased to $2,674,000 from $1,684,000, an increase of approximately 58.8%[19] - Total liabilities as of September 30, 2024, were $4,359 million, entirely attributed to derivative warrant liabilities measured at fair value[45] Corporate Developments - The company changed its corporate name to Grace Therapeutics, Inc. effective October 28, 2024, with common stock trading under the symbol "GRCE" on Nasdaq[147] - The company has implemented a strategic realignment plan to enhance shareholder value, resulting in a streamlined workforce and focused development on its lead product candidate GTx-104[30] Product Development and Market Potential - GTx-104 is a clinical-stage injectable formulation of nimodipine for IV infusion in aSAH patients, addressing significant unmet medical needs[91] - The total addressable market for aSAH in the U.S. is estimated at approximately $300 million, with around 50,000 patients affected annually[105] - GTx-104 has demonstrated 100% bioavailability compared to approximately 8% for oral nimodipine capsules, significantly reducing dosing variability[109] - The pivotal Phase 3 STRIVE-ON trial for GTx-104 is expected to enroll approximately 100 patients across 25 hospitals in the U.S.[112] - The first patient in the STRIVE-ON trial was enrolled on October 23, 2023, with data readout anticipated in the first quarter of 2025[115] Clinical Trials and Regulatory Plans - The company plans to submit a New Drug Application (NDA) for GTx-104 in the first half of 2025, pending trial results[115] - The company has deferred the clinical development of GTx-102 and GTx-101 for at least three years to prioritize GTx-104[94] Restructuring and Cost Management - The company incurred restructuring costs of $1.5 million in the six months ended September 30, 2023, with no restructuring costs reported for the same period in 2024[161] - The company has $398 million of commitments to contract manufacturing organizations (CMOs) and $3.9 million of commitments to contract research organizations (CROs) for the next twelve months[72] Patents and Intellectual Property - The company has a portfolio of more than 40 granted and pending patents in various jurisdictions worldwide supporting its therapeutic pipeline[86] - The company has three unique clinical-stage drug candidates that have received orphan drug designation (ODD) status, which provides seven years of marketing exclusivity in the U.S. post-launch[87]

Core Viewpoint - Acasti Pharma Inc. is rebranding to Grace Therapeutics, reflecting its historical roots and scientific innovation, with a focus on advancing its lead drug candidate GTx-104 for treating aneurysmal subarachnoid hemorrhage (aSAH) [1][2] Company Overview - Acasti Pharma Inc. will begin trading under the new name Grace Therapeutics on Nasdaq with the symbol "GRCE" starting October 28, 2024 [1] - The company has made significant progress in the clinical development of GTx-104, including full enrollment of the STRIVE-ON trial, with data expected in early 2025 and a New Drug Application (NDA) submission anticipated in the first half of 2025 [2][3] Product Development - GTx-104 is a novel injectable formulation of nimodipine designed for intravenous infusion in aSAH patients, addressing significant unmet medical needs [4][5] - The U.S. addressable market for GTx-104 is estimated to be approximately $300 million based on market research [5] Corporate Strategy - The company has restructured to an agile biopharma model, rebuilt its management team, prioritized its pipeline, divested legacy assets, and re-domiciled to the U.S. as a Delaware corporation [3] - These strategic steps are expected to enhance the company's attractiveness to potential strategic partners and global institutional investors [3] Upcoming Events - A virtual Key Opinion Leader (KOL) event on GTx-104 is scheduled for November 20, 2024, to discuss its application in aSAH [3]

Financial Performance - Acasti reported a net loss of $2.6 million, or $0.24 loss per share, for the quarter ended June 30, 2024, a decrease of $1.4 million from the net loss of $4.0 million, or $0.54 per share, for the same quarter in 2023[4]. - The net loss for Q2 2024 was $2,617,000, an improvement from a net loss of $4,023,000 in Q2 2023[42]. - Basic and diluted loss per share improved to $0.24 in Q2 2024 from $0.54 in Q2 2023[42]. - Loss before income tax recovery decreased to $3,341,000 in Q2 2024 from $4,312,000 in Q2 2023, indicating a positive trend[42]. Research and Development - Total research and development expenses for the quarter were $2.7 million, compared to $1.1 million for the quarter ended June 30, 2023, reflecting an increase of $1.6 million due to heightened research activities for GTX-104[4]. - Research and development expenses increased to $2,708,000 in Q2 2024 from $1,095,000 in Q2 2023, representing a significant rise[41]. General and Administrative Expenses - General and administrative expenses increased to $2.3 million for the quarter ended June 30, 2024, up from $1.9 million for the same period in 2023, primarily due to increased professional fees[5]. - General and administrative expenses rose to $2,255,000 in Q2 2024 compared to $1,874,000 in Q2 2023, indicating an increase[41]. Cash and Assets - As of June 30, 2024, Acasti had cash and cash equivalents of $19.4 million, down from $23.0 million as of March 31, 2024, with a projected cash runway into the second calendar quarter of 2026[5]. - Cash and cash equivalents at June 30, 2024, were $19.4 million, down from $23.0 million as of March 31, 2024, with sufficient cash projected to support operations into the second calendar quarter of 2026[26]. - The total assets decreased to $69.7 million as of June 30, 2024, from $73.3 million as of March 31, 2024[37]. - Total liabilities decreased to $10.4 million as of June 30, 2024, from $11.6 million as of March 31, 2024[38]. Clinical Trials and Drug Development - Acasti surpassed the 50% enrollment milestone in the pivotal Phase 3 STRIVE-ON safety trial of GTX-104, with full enrollment of 100 patients projected for late 2024 to early 2025[3]. - The company anticipates submitting a New Drug Application (NDA) for GTX-104 to the FDA in the first half of calendar 2025[3]. - The company has deprioritized further development of GTX-102 and GTX-101 in favor of focusing on GTX-104[8][9]. - Acasti's GTX-104 is designed to provide an intravenous alternative to oral nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH), a condition affecting approximately 50,000 patients annually in the U.S.[6]. - Acasti's lead clinical asset, GTX-104, has been granted Orphan Drug Designation by the FDA, providing seven years of marketing exclusivity post-launch in the U.S.[11]. Market Potential - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million[7]. - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million[28]. Share Information - The company had 9,399,404 shares issued and outstanding as of June 30, 2024[39]. - The weighted-average number of shares outstanding increased to 10,928,543 in Q2 2024 from 7,435,533 in Q2 2023[42]. Other Income and Tax - Total other income, net, increased to $1,622,000 in Q2 2024 from $142,000 in Q2 2023, showing substantial growth[42]. - Income tax benefit increased to $724,000 in Q2 2024 from $289,000 in Q2 2023, reflecting improved tax recovery[42]. - The company reported a foreign exchange loss of $8,000 in Q2 2024, compared to a gain of $8,000 in Q2 2023[42]. - Change in fair value of derivative warrant liabilities contributed $1,395,000 in Q2 2024, with no contribution in Q2 2023[42].