Exhibit 99.1 Grace Therapeutics Announces Second Quarter 2026 Financial Results, Provides Business Update Announced U.S. Food and Drug Administration (FDA) Acceptance for Review of New Drug Application (NDA) for GTx-104 FDA Established April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Phase 3 STRIVE-ON Safety Trial Data Presented at 2025 Neurocritical Care Annual Meeting Granted Sixth U.S. Pat ...

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 September 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 o ...

[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 |

Financial Performance - The company reported a net loss of $3,362,000 for the three months ended June 30, 2025, compared to a net loss of $2,617,000 for the same period in 2024, representing an increase in loss of about 28.4%[20] - The company incurred a loss from operating activities of $3,090,000 for the three months ended June 30, 2025, compared to a loss of $4,963,000 for the same period in 2024, showing an improvement of about 37.8%[20] - The effective income tax rate for the three months ended June 30, 2025, was 0.00%, a decrease from 21.67% for the same period in 2024[79] - The company has not generated any revenue and expects to continue incurring significant expenses and operating losses as it advances product candidates through development stages[76] Assets and Liabilities - As of June 30, 2025, the company's total assets decreased to $69,805,000 from $71,993,000 as of March 31, 2025, reflecting a decline of approximately 3.0%[18] - The company's cash and cash equivalents decreased to $20,005,000 as of June 30, 2025, down from $22,133,000 at the beginning of the period, a decline of approximately 9.6%[23] - The total stockholders' equity decreased to $63,550,000 as of June 30, 2025, from $66,610,000 as of March 31, 2025, indicating a decline of approximately 4.0%[18] - Total liabilities measured at fair value were $1,628, primarily from derivative warrant liabilities valued at $1,628[47] Research and Development - Research and development expenses for the three months ended June 30, 2025, were $955,000, a decrease of 64.7% compared to $2,708,000 for the same period in 2024[20] - The company is focused on the development of GTx-104 while planning further development of GTx-102 and GTx-101 contingent on securing additional funding or strategic partnerships[31] Funding and Capital Structure - The company completed a private placement in February 2025, raising net proceeds of $13,705,000 to support its operations[32] - In September 2023, the Company raised net proceeds of $7,338 from a private placement, selling 1,951,371 common shares at $1.848 each[57] - The Company has authorized up to 10,000,000 shares of preferred stock, with none issued or outstanding[50] - The Company has 4,418,292 common warrants from the 2025 Private Placement, exercisable at $3.395 per share[59] Stock-Based Compensation - For the three months ended June 30, 2025, total stock-based compensation expense was $302, compared to $238 for the same period in 2024[70] - As of June 30, 2025, the company had $710 of total unrecognized compensation cost related to non-vested stock options, expected to be recognized over a remaining weighted-average vesting period of 1.42 years[70] - The 2024 Equity Incentive Plan was approved on September 30, 2024, with 1,350,000 shares authorized for issuance and 943,470 shares available for future issuance as of June 30, 2025[68] Cash Flow and Commitments - The company has been operating with significant losses and negative cash flows since inception, indicating ongoing financial challenges[29] - The company had commitments of $185 to contract manufacturing organizations (CMOs) for the next twelve months as of June 30, 2025[82] Derivative Liabilities - The Company’s derivative warrant liabilities are classified as Level 3 inputs, indicating they are measured using unobservable inputs[47] - As of June 30, 2025, the balance of derivative warrant liabilities was $1,628, a decrease from $2,964 as of June 30, 2024, reflecting a change in fair value of $487[62]

[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)

Drug Development and Clinical Trials - The company has three clinical-stage drug candidates targeting rare and orphan diseases, supported by over 40 granted and pending patents[21] - GTx-104, an injectable formulation of nimodipine, has been administered to over 200 patients and shows significantly lower pharmacokinetic variability compared to oral nimodipine[35] - The Phase 3 STRIVE-ON trial demonstrated a 19% reduction in clinically significant hypotension for GTx-104 compared to oral nimodipine (28% vs. 35%)[42] - 54% of patients receiving GTx-104 achieved a relative dose intensity of 95% or higher, compared to only 8% for oral nimodipine[44] - GTx-104 demonstrated a bioavailability of 100% compared to only 7.2% for oral nimodipine capsules, allowing for a significantly lower dosage to achieve comparable pharmacokinetics[49] - The Phase 1 PK trial results indicated no serious adverse events for GTx-104, with plasma concentrations showing less variability compared to oral administration[48] - GTx-102 is being developed as the first potential therapy for ataxia-telangiectasia in pediatric patients, with a successful Phase-1 pharmacokinetic study[26] - The company aims to address significant unmet medical needs in rare diseases by utilizing already approved drugs with established safety profiles[23] - The company plans to submit a New Drug Application (NDA) for GTx-104 in the first half of 2025[45] - The NDA for GTx-104 is anticipated to be filed in Q2 2025, based on positive feedback from the FDA regarding the Phase 3 STRIVE-ON safety trial[53] - The company plans to commercialize GTx-104 with a targeted hospital-based sales force upon receiving regulatory approval[83] - The development of GTx-101 has been deprioritized in favor of GTx-104, pending additional funding or strategic partnerships[82] - The company intends to seek FDA approval for GTx-104 through the 505(b)(2) regulatory pathway, which may involve additional clinical trials if not permitted[188] - Clinical development is lengthy and expensive, with uncertain outcomes, and failures can occur at any stage of the clinical trial process[191] - The company may struggle to recruit sufficient patients for clinical trials, which is critical for timely completion and success[195] - Significant adverse events during clinical trials could lead to challenges in recruitment and retention, potentially delaying regulatory approval[200] - The unpredictability of future clinical trial results may result in failure to obtain regulatory approval, significantly harming the company's business[198] Market Opportunities and Financial Projections - The market opportunity for GTx-104 includes approximately 42,500 annual aSAH patients in the U.S., with estimates suggesting up to 70,000 cases[38] - GTx-104 has the potential to provide orphan drug exclusivity for seven years if approved, translating into estimated savings of approximately $4.3 million for the lead drug candidate[23] - GTx-102, a novel oral-mucosal spray of betamethasone, has a potential total addressable market of $150 million in the U.S., targeting approximately 4,300 patients with A-T[59] - GTx-101, a topical bupivacaine spray, targets a total addressable market of $2.5 billion, with $200 million specifically for PHN pain indications[76] - The market opportunities for GTx-104 may be smaller than estimated, adversely affecting operational results and business prospects[206] Regulatory Environment and Compliance - The company’s drug candidates have received orphan drug designation (ODD) status, which may lead to tax credits of up to 25% of clinical development costs[23] - The FDA's orphan status designation for all clinical pipeline drug candidates could result in 7 years of marketing exclusivity in the U.S. and 10 years in Europe, contingent on receiving final marketing authorizations[86] - The company relies on trade secrets and regulatory protections, including orphan drug status and data exclusivity, to maintain its proprietary position[87] - Compliance with current Good Manufacturing Practices (cGMP) is mandatory for manufacturing drug products, with the FDA conducting regular inspections[109] - The FDA may impose post-approval commitments, including additional clinical studies, which could affect the commercial success of a drug[105] - The FDA closely regulates drug marketing and promotion, with penalties for non-compliance that can significantly impact commercial operations[110] - NDA holders must submit annual reports and report adverse drug experiences to comply with regulatory requirements[111] - The CREATES Act allows generic developers to sue brand manufacturers for access to samples necessary for FDA testing, addressing delays in generic product entry[112] - The Hatch-Waxman Act provides abbreviated approval pathways for follow-on pharmaceutical products, facilitating market entry for generics[113] - A new chemical entity (NCE) receives five years of regulatory exclusivity post-approval, preventing ANDA or 505(b)(2) applications for the same active moiety during this period[117] - Pediatric exclusivity can extend exclusivity or patent protection by six months if pediatric data is submitted in response to FDA requests[123] - Orphan Drug Exclusivity grants seven years of exclusivity for drugs treating rare diseases, with specific incentives for development[124] Financial Condition and Capital Requirements - As of March 31, 2025, the company had cash and cash equivalents of $22.0 million, a decrease from $23.0 million as of March 31, 2024[164] - The company is heavily dependent on the success of its lead drug candidate, GTx-104, with significant risks associated with its development and regulatory approval[162] - The company incurred operating losses and negative cash flows from operations since inception, relying on public offerings, private placements, and research grants for financing[164] - Current assets are projected to support liabilities for at least twelve months, including expenses related to the NDA for GTx-104 and pre-commercial planning[165] - The company plans to raise additional capital primarily through securities offerings and non-dilutive sources to support the commercial launch of GTx-104 if approved[165] - GTx-102 and GTx-101 have been deprioritized, and their development will require additional time and resources, with uncertain outcomes for maximizing their value[163] Organizational Structure and Human Resources - The company has six full-time employees with significant experience in the pharmaceutical and biotech industries, focusing on building a high-performing organization[153] - The company is highly dependent on its executive team, which has significant industry experience but has not been with the company for long, posing risks in retaining key personnel[168] - The company faces challenges in recruiting and retaining qualified personnel due to industry competition and potential failures in clinical studies[168] External Factors and Market Dynamics - The Affordable Care Act significantly impacts the pharmaceutical industry, including changes to reimbursement and healthcare coverage[126] - The Inflation Reduction Act introduces a Medicare inflation rebate scheme and drug price negotiation program starting in 2026[130] - Increasing legislative interest in drug pricing practices may limit commercial opportunities and revenue from approved products[131] - The company faces increased responsibilities and potential penalties under the EU General Data Protection Regulation (GDPR), which can reach up to 4% of global annual turnover or €20 million, whichever is higher[133] - Compliance with emerging AI regulations, such as the EU AI Act, is expected to incur substantial costs in the future[134] - Third-party payors are increasingly reducing reimbursements and implementing cost-containment measures, which could limit or delay product sales[139] - The company is required to report average sales prices for Medicare Part B-covered products, with potential civil monetary penalties for non-compliance[144] - The Inflation Reduction Act (IRA) mandates price negotiations for high Medicare spend drugs starting in 2026, impacting market conditions for product candidates[145] - The company must participate in the Federal Supply Schedule pricing program to be eligible for federal funds under Medicaid and Medicare, affecting pricing strategies[147] - Significant civil monetary penalties may apply if the company submits false pricing data or fails to report required price data timely[148] - The company is subject to healthcare fraud and abuse regulations enforced by federal and state governments, which could impact operations[149] - Unfavorable global economic conditions and geopolitical events, such as trade tensions, could adversely affect the company's financial condition and operations[177] - Legislative changes, such as the Budget Control Act of 2011, have resulted in reductions to Medicare payments, impacting potential revenues[214] - Individual states are increasingly implementing regulations to control pharmaceutical pricing, potentially leading to reduced demand or lower pricing for approved products[216] - There is a trend towards establishing prescription drug affordability boards at the state level, which may set upper payment limits for high-cost drugs[216] - Future healthcare policies aimed at curbing costs could limit the prices charged for approved products, impacting commercial opportunities and revenues[217] - Compliance failures with Medicaid Drug Rebate program obligations could result in additional rebate requirements and penalties, adversely affecting financial condition and growth prospects[219] - The ability to set desired prices for drug products may be constrained by regulatory changes and market pressures[218] - Future revenues of potential customers, suppliers, and collaborators may be impacted by pricing regulations and market dynamics[218] - The availability of capital for the company could be affected by changes in the regulatory environment and pricing pressures[218]

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]