[Business Highlights](index=1&type=section&id=First%20Quarter%202026%20Corporate%20Highlights) Grace Therapeutics announced the submission of a New Drug Application (NDA) to the U.S. FDA for its lead candidate, GTx-104, for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH), a key milestone supported by positive Phase 3 STRIVE-ON trial data - Submitted a New Drug Application (NDA) to the FDA for GTx-104 in treating aSAH, based on positive Phase 3 STRIVE-ON trial results[2](index=2&type=chunk)[3](index=3&type=chunk)[6](index=6&type=chunk) - The NDA submission has the potential to trigger the exercise of warrants from a September 2023 private placement, which could provide up to **$7.6 million** in proceeds[6](index=6&type=chunk)[11](index=11&type=chunk) - GTx-104 has received Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity in the U.S. upon approval[6](index=6&type=chunk)[19](index=19&type=chunk) - The FDA has a 60-day period to determine if the NDA is complete and acceptable for filing and formal review[6](index=6&type=chunk) [Financial Performance](index=1&type=section&id=First%20Quarter%202026%20Financial%20Results) For the quarter ended June 30, 2025, Grace Therapeutics reported a net loss of **$3.4 million**, an increase from **$2.6 million** in the prior year, primarily due to changes in derivative warrant liabilities, partially offset by a **$1.8 million** decrease in R&D expenses [Key Financial Metrics](index=1&type=section&id=Key%20Financial%20Metrics) Net loss increased to **$3.4 million**, primarily due to derivative warrant liabilities, partially offset by reduced R&D expenses Q1 2026 vs Q1 2025 Financial Results | Metric | Q1 2026 (ended June 30, 2025) | Q1 2025 (ended June 30, 2024) | | :--- | :--- | :--- | | **Net Loss** | $3.4 million | $2.6 million | | **Loss Per Share** | $0.21 | $0.24 | - The increase in net loss was mainly driven by a **$1.9 million** difference in the change in fair value of derivative warrant liabilities and a **$0.7 million** decrease in income tax benefit[5](index=5&type=chunk) - The higher net loss was partially offset by a **$1.8 million** decrease in R&D expenses and a **$0.1 million** decrease in G&A expenses[5](index=5&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses decreased, with **R&D down $1.8 million** following GTx-104 trial completion, and G&A slightly reduced Operating Expenses Comparison (in millions) | Expense Category | Q1 2026 (ended June 30, 2025) | Q1 2025 (ended June 30, 2024) | Change | | :--- | :--- | :--- | :--- | | **Research & Development** | $0.9 | $2.7 | -$1.8 | | **General & Administrative** | $2.1 | $2.2 | -$0.1 | - R&D expenses decreased by **$1.8 million**, primarily due to a **$1.9 million** reduction in research activities following the completion of the GTx-104 pivotal Phase 3 STRIVE-ON trial[7](index=7&type=chunk) - G&A expenses decreased slightly by **$0.1 million**, resulting from lower professional fees related to the company's 2024 continuance and domestication[8](index=8&type=chunk) [Financial Position and Cash Runway](index=2&type=section&id=Cash%20Runway) The company maintains a cash position of **$20.0 million**, projecting a runway through at least the next twelve months, with potential extension from warrant exercises - As of June 30, 2025, the company held **$20.0 million** in cash and cash equivalents[9](index=9&type=chunk) - Management believes current cash provides a runway through at least the next twelve months, potentially extending into Q2 2027 if all common warrants from the February 2025 and September 2023 private placements are exercised[12](index=12&type=chunk) - The company has potential gross proceeds of **$22.6 million** from the exercise of outstanding warrants (**$15.0 million** from the Feb 2025 placement and **$7.6 million** from the Sep 2023 placement)[10](index=10&type=chunk)[11](index=11&type=chunk) [Clinical Pipeline and Trials](index=2&type=section&id=About%20the%20STRIVE-ON%20Trial) The company's lead asset, GTx-104, demonstrated positive results in the Phase 3 STRIVE-ON trial, meeting its primary endpoint by reducing drug-induced hypotension compared to oral nimodipine, while other pipeline assets have been deprioritized [GTx-104 and the STRIVE-ON Trial](index=2&type=section&id=GTx-104%20and%20the%20STRIVE-ON%20Trial) GTx-104, an injectable nimodipine formulation, met its primary endpoint in the STRIVE-ON trial, significantly reducing hypotension and improving patient outcomes - GTx-104 is a novel, injectable formulation of nimodipine for IV infusion in patients with aSAH, designed to overcome limitations of oral administration[15](index=15&type=chunk)[16](index=16&type=chunk) - The Phase 3 STRIVE-ON trial met its primary endpoint, with GTx-104 showing a **19% reduction** in clinically significant hypotension compared to oral nimodipine (**28% vs. 35%**)[13](index=13&type=chunk) Key Secondary Outcomes from STRIVE-ON Trial (GTx-104 vs. Oral Nimodipine) | Metric | GTx-104 | Oral Nimodipine | | :--- | :--- | :--- | | **Relative Dose Intensity (RDI) ≥ 95%** | 54% of patients | 8% of patients | | **Favorable Functional Outcomes at 90 days** | 29% more patients | Baseline | | **Other Benefits** | Fewer ICU readmissions, ICU days, and ventilator days | Baseline | [Other Pipeline Assets](index=3&type=section&id=Other%20Pipeline%20Assets) Development of GTx-102 and GTx-101 has been deprioritized to focus on GTx-104, with potential licensing or sale opportunities being explored - The development of GTx-102 (for Ataxia-Telangiectasia) and GTx-101 (for postherpetic neuralgia) has been deprioritized to focus resources on the lead asset, GTx-104[17](index=17&type=chunk)[18](index=18&type=chunk) - The company may pursue licensing or sale opportunities for both GTx-102 and GTx-101[17](index=17&type=chunk)[18](index=18&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section provides the unaudited condensed consolidated financial statements for Grace Therapeutics, Inc. as of June 30, 2025, and for the three-month period then ended, including the Balance Sheets and Statements of Loss and Comprehensive Loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet presents the company's financial position, including assets, liabilities, and equity, as of June 30, 2025, and March 31, 2025 Condensed Consolidated Balance Sheets (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $20,005 | $22,133 | | Total current assets | $20,525 | $22,712 | | Total assets | $69,805 | $71,993 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $2,315 | $1,930 | | Total liabilities | $6,255 | $5,383 | | 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) The statement of loss details the company's revenues and expenses, resulting in a net loss for the three months ended June 30, 2025, and 2024 Condensed Consolidated Statements of Loss (in thousands) | Account | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | Research and development expenses | $(955) | $(2,708) | | General and administrative expenses | $(2,135) | $(2,255) | | Loss from operating activities | $(3,090) | $(4,963) | | **Net loss and total comprehensive loss** | **$(3,362)** | **$(2,617)** | | **Basic and diluted loss per share** | **$(0.21)** | **$(0.24)** |

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents the company's financial performance and position, including statements and management's analysis [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Presents the unaudited condensed consolidated financial statements, detailing the company's financial position, operational results, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Details the company's assets, liabilities, and equity as of June 30, 2025, and March 31, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | March 31, 2025 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $20,005 | $22,133 | | Total current assets | $20,525 | $22,712 | | Intangible assets | $41,128 | $41,128 | | Goodwill | $8,138 | $8,138 | | **Total assets** | **$69,805** | **$71,993** | | **Liabilities & Equity** | | | | Trade and other payables | $2,315 | $1,930 | | Derivative warrant liabilities | $1,628 | $1,141 | | Total liabilities | $6,255 | $5,383 | | 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=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) Presents the company's net loss and comprehensive loss for the three months ended June 30, 2025 and 2024 Condensed Consolidated Statement of Loss (in thousands, except per share data) | Account | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | Research and development expenses | $(955) | $(2,708) | | General and administrative expenses | $(2,135) | $(2,255) | | **Loss from operating activities** | **$(3,090)** | **$(4,963)** | | Change in fair value of derivative warrant liabilities | $(487) | $1,395 | | Interest and other income, net | $205 | $235 | | **Net loss and total comprehensive loss** | **$(3,362)** | **$(2,617)** | | Basic and diluted loss per share | $(0.21) | $(0.24) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Outlines the cash inflows and outflows from operating, investing, and financing activities for the quarter Condensed Consolidated Statement of Cash Flows (in thousands) | Account | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(1,801) | $(3,596) | | Net cash used in investing activities | $— | $(15) | | Net cash used in financing activities | $(327) | $— | | **Net decrease in cash and cash equivalents** | **$(2,128)** | **$(3,611)** | | Cash and cash equivalents, beginning of period | $22,133 | $23,005 | | **Cash and cash equivalents, end of period** | **$20,005** | **$19,394** | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides additional details and explanations for the figures presented in the financial statements - The company changed its jurisdiction from British Columbia, Canada to Delaware, USA, and changed its name from Acasti Pharma Inc. to Grace Therapeutics, Inc. in October 2024[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - Management believes existing cash and cash equivalents of **$20.0 million** are sufficient to sustain planned operations for at least 12 months from the issuance date of the financial statements, but additional capital will be required beyond that period[33](index=33&type=chunk)[34](index=34&type=chunk) - In February 2025, the company completed a private placement, raising net proceeds of **$13.7 million**[32](index=32&type=chunk)[56](index=56&type=chunk) - Derivative warrant liabilities, related to the 2023 Common Warrants, are measured at fair value on a recurring basis and increased from **$1.14 million** to **$1.63 million** during the quarter, resulting in a charge of **$487 thousand** to the statement of loss[60](index=60&type=chunk)[62](index=62&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Discusses the company's strategic focus on rare diseases, lead product development, and analysis of financial performance and liquidity [Business Overview and Pipeline](index=20&type=section&id=Business%20Overview%20and%20Pipeline) Provides an overview of the company's therapeutic focus, drug delivery technologies, and clinical-stage pipeline candidates - The company focuses on developing and commercializing products for rare and orphan diseases using novel drug delivery technologies to improve existing pharmaceutical compounds[88](index=88&type=chunk) - The therapeutic pipeline consists of three clinical-stage drug candidates: GTx-104 (for aSAH), GTx-102 (for Ataxia-Telangiectasia), and GTx-101 (for Postherpetic Neuralgia)[89](index=89&type=chunk)[95](index=95&type=chunk) - The company utilizes the Section 505(b)(2) regulatory pathway, which may provide a shorter path to approval by leveraging existing data on approved compounds[90](index=90&type=chunk) - Following a strategic realignment in May 2023, the company is prioritizing the development of its lead product candidate, GTx-104, while development of GTx-102 and GTx-101 is contingent on additional funding or partnerships[96](index=96&type=chunk) [GTx-104 Program](index=21&type=section&id=GTx-104%20Program) Details the development status of GTx-104, including NDA submission, Phase 3 trial results, and market potential - On June 25, 2025, the company submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine for patients with aneurysmal subarachnoid hemorrhage (aSAH)[94](index=94&type=chunk) - The pivotal Phase 3 STRIVE-ON trial met its primary endpoint, with patients receiving GTx-104 showing a **19% reduction** in clinically significant hypotension compared to oral nimodipine (28% vs. 35%)[108](index=108&type=chunk) - Additional positive outcomes for GTx-104 included a higher dose intensity (**54% vs. 8%** achieving ≥95% of prescribed dose), a **29% relative increase** in favorable outcomes on the modified Rankin scale, and fewer ICU days and readmissions[111](index=111&type=chunk) - The U.S. market for aSAH affects approximately **42,500 patients annually**, with potential for up to **70,000**, and market research indicates an **80% likelihood of adoption** for an IV nimodipine formulation like GTx-104 among key hospital decision-makers[104](index=104&type=chunk)[105](index=105&type=chunk) [GTx-102 and GTx-101 Programs](index=27&type=section&id=GTx-102%20and%20GTx-101%20Programs) Outlines the development status and future plans for GTx-102 and GTx-101, contingent on funding or partnerships - **GTx-102 (Ataxia Telangiectasia):** This is a novel oral-mucosal spray of betamethasone; the FDA has provided guidance on a single pivotal efficacy trial, with further development contingent on additional funding or a strategic partnership[119](index=119&type=chunk)[131](index=131&type=chunk) - **GTx-101 (Postherpetic Neuralgia):** This is a topical bio-adhesive film-forming bupivacaine spray; development has been deprioritized in favor of GTx-104, with future steps dependent on new funding or a partnership[132](index=132&type=chunk)[144](index=144&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Compares key financial results for the three months ended June 30, highlighting changes in expenses and net loss Comparison of Results for the Three Months Ended June 30 (in thousands) | Account | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development expenses | $955 | $2,708 | $(1,753) | | General and administrative expenses | $2,135 | $2,255 | $(120) | | Change in fair value of derivative warrant liabilities | $(487) | $1,395 | $(1,882) | | Income tax benefit | $— | $724 | $(724) | | **Net loss** | **$(3,362)** | **$(2,617)** | **$745** | - The net loss increased by **$745 thousand** year-over-year, primarily due to a **$1.88 million** negative change in the fair value of derivative warrant liabilities and the absence of a **$724 thousand** income tax benefit recorded in the prior year[150](index=150&type=chunk) - Research and development expenses decreased by **$1.75 million**, mainly due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON clinical trial[153](index=153&type=chunk) - General and administrative expenses decreased by **$120 thousand**, primarily due to lower professional fees related to the company's Continuance and Domestication, partially offset by higher salaries and commercial assessment costs for GTx-104[158](index=158&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) Assesses the company's cash position, cash flow activities, and future capital requirements - As of June 30, 2025, the company had cash and cash equivalents of **$20.0 million**, a decrease of **$2.1 million** during the quarter[23](index=23&type=chunk)[163](index=163&type=chunk) - Net cash used in operating activities was **$1.8 million** for the quarter, a decrease from **$3.6 million** in the prior-year quarter, primarily due to lower R&D spending after the completion of the GTx-104 trial[166](index=166&type=chunk) - The company raised net proceeds of **$13.7 million** from a private placement in February 2025[169](index=169&type=chunk) - Management believes existing cash is sufficient to sustain planned operations for at least the next 12 months, but additional capital will be required beyond that timeframe[164](index=164&type=chunk)[165](index=165&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is therefore not required to provide the information for this item - As a smaller reporting company, Grace Therapeutics is not required to provide quantitative and qualitative disclosures about market risk[178](index=178&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Principal Financial Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025 - Based on an evaluation as of June 30, 2025, management concluded that the company's disclosure controls and procedures were effective[179](index=179&type=chunk) - No changes were made to internal controls over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[180](index=180&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) Provides additional required disclosures not covered in the financial information section [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on its business - The company is not currently involved in any legal proceedings that are expected to have a material adverse effect on its business[182](index=182&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes from the risk factors previously disclosed in the company's Annual Report on Form 10-K - No material changes have occurred in the risk factors since the filing of the company's Annual Report[184](index=184&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=37&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[185](index=185&type=chunk) [Other Items (Defaults, Mine Safety, Other Information, Exhibits)](index=37&type=section&id=Other%20Items%20(3,%204,%205,%206)) The company reports no defaults upon senior securities, mine safety disclosures are not applicable, and no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter - The company reports no defaults upon senior securities[186](index=186&type=chunk) - Mine safety disclosures are not applicable to the company[187](index=187&type=chunk) - A list of exhibits filed with the report is provided, including certifications and XBRL data files[189](index=189&type=chunk)

Core Viewpoint - Grace Therapeutics has submitted a New Drug Application (NDA) for GTx-104 to the FDA, which is a significant milestone for the company and is supported by positive results from the Phase 3 STRIVE-ON safety trial, indicating potential clinical benefits for patients with aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] Group 1: NDA Submission and Financial Implications - The NDA submission for GTx-104 could trigger the exercise of up to $7.6 million in warrants from a private placement completed in September 2023, with each warrant exercisable at $3.003 per share [2] - The FDA typically has a 60-day period to assess the completeness of the NDA submission [3] Group 2: Clinical Trial Results - The STRIVE-ON safety trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, meeting its primary endpoint with a 19% reduction in clinically significant hypotension incidents for GTx-104 compared to oral nimodipine (28% vs. 35%) [4] - Additional findings showed that 54% of patients on GTx-104 had a relative dose intensity of 95% or higher, compared to only 8% on oral nimodipine, and 29% more patients had favorable functional outcomes at 90 days [4] Group 3: Product and Market Potential - GTx-104 is a novel injectable formulation of nimodipine designed for IV infusion, addressing significant unmet medical needs in aSAH patients [1][7] - The product has been administered to over 200 patients and health volunteers, demonstrating good tolerance and lower pharmacokinetic variability compared to oral nimodipine [8] - GTx-104 has received Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity upon approval [3][9]

[Business Update and Highlights](index=1&type=section&id=Business%20Update%20and%20Highlights) [CEO's Statement & Strategic Focus](index=1&type=section&id=CEO's%20Statement%20%26%20Strategic%20Focus) The company highlights positive Phase 3 data for GTx-104 and plans an NDA submission by June 2025, supported by recent financing - The New Drug Application (NDA) for GTx-104 is on track for submission to the FDA in the first half of calendar year 2025, with an expected completion by the end of June 2025[2](index=2&type=chunk)[3](index=3&type=chunk) - Secured a private placement financing of **$15 million in upfront gross proceeds**, with the potential for an additional $15 million from warrant exercises to support pre-commercial activities for GTx-104[2](index=2&type=chunk)[3](index=3&type=chunk) - Data from the Phase 3 STRIVE-ON trial provided evidence of **improved clinical outcomes and potential pharmacoeconomic benefits** for GTx-104 compared to oral nimodipine[3](index=3&type=chunk) [2025 Corporate Highlights & Financing](index=2&type=section&id=2025%20Corporate%20Highlights%20%26%20Financing) The company confirmed its NDA data package with the FDA, completed the STRIVE-ON trial, and secured financing to extend its cash runway into Q3 2026 - Held a Type C meeting with the FDA, which confirmed the existing data and regulatory packages are sufficient for an NDA submission for GTx-104[10](index=10&type=chunk) - Completed a private placement financing for up to approximately **$30.0 million in potential total gross proceeds**, consisting of $15.0 million upfront[10](index=10&type=chunk) - The company's current cash and cash equivalents provide a runway into **Q3 2026**, which could extend into Q2 2027 if all common warrants are exercised[12](index=12&type=chunk) - Received FDA guidance on the design of a single pivotal efficacy and safety trial for GTx-102, which could support a future NDA[10](index=10&type=chunk)[17](index=17&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) [Fiscal Year 2025 Financial Results Summary](index=2&type=section&id=Fiscal%20Year%202025%20Financial%20Results%20Summary) The company's net loss decreased to $9.6 million in FY2025 from $12.9 million in FY2024, driven by a favorable change in warrant liabilities Fiscal Year 2025 vs 2024 Key Metrics | Metric | FY 2025 | FY 2024 | Change | | :--- | :--- | :--- | :--- | | Net Loss | $9.6M | $12.9M | -$3.3M | | Loss Per Share | $0.79 | $1.35 | -$0.56 | | R&D Expenses | $9.5M | $4.7M | +$4.8M | | G&A Expenses | $7.2M | $6.7M | +$0.5M | | Cash & Equivalents (End of Period) | $22.1M | $23.0M | -$0.9M | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Total assets slightly decreased to $72.0 million, while a significant reduction in liabilities boosted total stockholders' equity to $66.6 million Balance Sheet Summary | Account (in thousands) | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,133 | $23,005 | | Total Assets | $71,993 | $73,300 | | Derivative warrant liabilities | $1,141 | $4,359 | | Total Liabilities | $5,383 | $11,557 | | Total Stockholders' Equity | $66,610 | $61,743 | [Consolidated Statements of Loss and Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) The FY2025 net loss improved to $9.6 million, as a positive change in derivative warrant liabilities offset a higher operating loss Statement of Loss Summary | Account (in thousands) | Year Ended March 31, 2025 | Year Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development expenses | $(9,511) | $(4,683) | | Loss from operating activities | $(16,679) | $(12,852) | | Change in fair value of derivative warrant liabilities | $3,218 | $(2,728) | | Net loss | $(9,568) | $(12,853) | | Basic and diluted loss per share | $(0.79) | $(1.35) | [Clinical Pipeline and Market](index=3&type=section&id=Clinical%20Pipeline%20and%20Market) [Lead Asset: GTx-104 for aSAH](index=3&type=section&id=Lead%20Asset%3A%20GTx-104%20for%20aSAH) GTx-104, an injectable nimodipine for aSAH, met its primary endpoint in a Phase 3 trial, showing safety and potential clinical benefits [STRIVE-ON Phase 3 Trial Results](index=3&type=section&id=STRIVE-ON%20Phase%203%20Trial%20Results) The trial met its primary endpoint, showing GTx-104 reduced hypotension and improved dosing intensity and patient outcomes versus oral nimodipine - The trial met its primary endpoint, with GTx-104 patients showing a **19% reduction in clinically significant hypotension** compared to oral nimodipine (28% versus 35%)[13](index=13&type=chunk) - Dosing and outcome measures favored GTx-104, with **54% of patients achieving a relative dose intensity (RDI) of 95% or higher** compared to only 8% on oral nimodipine[13](index=13&type=chunk) - Patients receiving GTx-104 had **fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days** compared to the oral nimodipine arm[13](index=13&type=chunk) [About GTx-104 and aSAH](index=3&type=section&id=About%20GTx-104%20and%20aSAH) GTx-104 is an IV nimodipine formulation targeting the 42,500 annual U.S. aSAH patients, addressing oral administration challenges - aSAH is a type of stroke that affects an estimated **42,500 U.S. hospital treated patients annually**[14](index=14&type=chunk) - GTx-104 is a novel, injectable formulation of nimodipine for IV infusion, potentially eliminating nasogastric tube administration and reducing dosing errors[15](index=15&type=chunk)[16](index=16&type=chunk) [Other Pipeline Assets](index=4&type=section&id=Other%20Pipeline%20Assets) The pipeline includes GTx-102 for A-T with a clear regulatory path, while GTx-101 for PHN has been deprioritized for potential licensing [GTx-102 for Ataxia-Telangiectasia (A-T)](index=4&type=section&id=GTx-102%20for%20Ataxia-Telangiectasia%20(A-T)) GTx-102 is an oral spray for A-T, a condition with no approved therapies, and has a defined pivotal trial design following FDA guidance - GTx-102 is a concentrated oral spray of betamethasone for A-T, for which there are **no FDA-approved therapies**[17](index=17&type=chunk) - The FDA has provided guidance on a path toward an NDA, 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 topical spray for PHN, has been deprioritized to focus resources on GTx-104 and is available for licensing or sale - GTx-101 is a non-narcotic, topical bupivacaine spray designed to treat pain from postherpetic neuralgia (PHN)[18](index=18&type=chunk) - The development of GTx-101 has been **deprioritized to focus on GTx-104**, and the company may license or sell this asset[18](index=18&type=chunk) [Company Information and Disclosures](index=4&type=section&id=Company%20Information%20and%20Disclosures) [About Grace Therapeutics](index=4&type=section&id=About%20Grace%20Therapeutics) Grace Therapeutics is a late-stage biopharma using novel drug delivery for rare diseases, with lead assets granted Orphan Drug Designation - The company is a late-stage biopharma focused on drug candidates for **rare and orphan diseases**[19](index=19&type=chunk) - Lead clinical assets, including GTx-104, have been granted **Orphan Drug Designation** by the FDA, providing seven years of U.S. marketing exclusivity post-launch[19](index=19&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) Forward-looking statements cover cash runway, NDA timing, and commercial prospects, which are subject to significant risks and uncertainties - Statements regarding the company's cash runway, timing of the GTx-104 NDA submission, and future prospects of its drug candidates are forward-looking and involve risks[21](index=21&type=chunk) - Key risks that could affect outcomes include the success and timing of regulatory submissions, changes to regulatory pathways, and broader economic developments[21](index=21&type=chunk)

PART I [Business](index=7&type=section&id=Item%201.%20Business) Grace Therapeutics develops rare disease treatments using novel drug delivery, prioritizing GTx-104 for aSAH with an NDA planned for H1 2025 - The company focuses on applying new proprietary formulations to approved compounds to enhance efficacy and compliance, primarily targeting rare and orphan diseases[20](index=20&type=chunk) - The development strategy utilizes the Section 505(b)(2) regulatory pathway, potentially shortening approval timelines by referencing existing FDA data[22](index=22&type=chunk) - All three clinical-stage drug candidates have received Orphan Drug Designation (ODD), potentially providing **7 years of market exclusivity** upon approval[23](index=23&type=chunk) - The company completed domestication from Canada to Delaware in October 2024, changing its name from Acasti Pharma Inc. to Grace Therapeutics, Inc[156](index=156&type=chunk)[412](index=412&type=chunk) [Our Pipeline](index=7&type=section&id=Our%20Pipeline) The company's pipeline includes three clinical-stage candidates, prioritizing GTx-104 while de-prioritizing GTx-102 and GTx-101 Clinical Pipeline Overview | Drug Candidate | Indication | Development Stage & Key Feature | | :--- | :--- | :--- | | **GTx-104** | Aneurysmal Subarachnoid Hemorrhage (aSAH) | Lead candidate; novel injectable nimodipine. Phase 3 completed, NDA submission planned for H1 2025 | | **GTx-102** | Ataxia-Telangiectasia (A-T) | Oral-mucosal betamethasone spray. Phase 1 PK study completed. Development de-prioritized | | **GTx-101** | Postherpetic Neuralgia (PHN) | Topical bio-adhesive bupivacaine spray. Phase 1 studies completed. Development de-prioritized | [Commercialization Strategy](index=18&type=section&id=Commercialization%20Strategy) Grace Therapeutics plans U.S. commercialization of GTx-104 with a targeted sales force, considering partnerships for other assets - Plan to commercialize GTx-104 in the U.S. with a highly experienced and targeted hospital-based sales force if approved[83](index=83&type=chunk) - May seek commercial partnerships for GTx-104 in territories outside the U.S[83](index=83&type=chunk) - Considering out-licensing or selling GTx-102 and/or GTx-101 for U.S. and/or global markets[83](index=83&type=chunk) [Manufacturing and Supply](index=19&type=section&id=Manufacturing%20and%20Supply) The company relies entirely on third-party Contract Manufacturing Organizations (CMOs) for all drug manufacturing under cGMP - The company does not own any manufacturing facilities and utilizes a network of third-party CMOs for manufacturing its drug candidates[84](index=84&type=chunk) - All lots of drug substance and drug product for clinical supply are manufactured under cGMP, and the company plans to continue relying on CMOs for commercial quantities if a product is approved[85](index=85&type=chunk) [Intellectual Property Portfolio](index=19&type=section&id=Intellectual%20Property%20Portfolio) The company's IP strategy combines orphan drug exclusivity and over 40 patents globally to protect its drug candidates - The IP strategy includes orphan drug designation, which could result in **7 years of U.S. marketing exclusivity**, and a patent estate of over **40 granted and pending patents** globally[86](index=86&type=chunk) - The patent portfolio includes **8 U.S. issued patents** and **4 filed U.S. patent applications**, primarily focused on composition and method-of-use patents[86](index=86&type=chunk) [Government Regulation](index=20&type=section&id=Government%20Regulation) The company is subject to extensive FDA regulation, pursuing the 505(b)(2) pathway, and navigating healthcare and data privacy laws - The company is pursuing the Section 505(b)(2) regulatory approval pathway for its candidates, which allows reliance on existing data for an approved reference drug, potentially shortening the development timeline[100](index=100&type=chunk) - All three clinical-stage product candidates have received Orphan Drug Designation (ODD), which provides benefits like tax credits, user fee waivers, and **7 years of market exclusivity** upon approval[124](index=124&type=chunk)[125](index=125&type=chunk) - The company is subject to various healthcare laws, including the Affordable Care Act (ACA), the Inflation Reduction Act (IRA) which impacts drug pricing and reimbursement, and data privacy laws like HIPAA and GDPR[126](index=126&type=chunk)[130](index=130&type=chunk)[132](index=132&type=chunk) [Human Capital Resources](index=29&type=section&id=Human%20Capital%20Resources) As of March 31, 2025, Grace Therapeutics had six full-time employees, all located in the United States - As of March 31, 2025, the company had a total of **six full-time employees**, all located in the United States[153](index=153&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including GTx-104 dependence, funding needs, development uncertainties, market acceptance, and third-party reliance - **Business Risks:** The company is heavily dependent on the success of its lead drug candidate, GTx-104, and requires additional funding to maintain operations and advance its programs. It has no history of commercializing drugs[162](index=162&type=chunk)[164](index=164&type=chunk)[166](index=166&type=chunk) - **Development & Commercialization Risks:** The company relies on the 505(b)(2) regulatory pathway, which is not guaranteed. Clinical development is lengthy and expensive with uncertain outcomes. Market success depends on physician and payor acceptance, and the company faces significant competition[187](index=187&type=chunk)[191](index=191&type=chunk)[247](index=247&type=chunk) - **Third-Party Dependence Risks:** The company relies on third-party CROs to conduct clinical trials and CMOs for all manufacturing, making it vulnerable to their performance, quality, and regulatory compliance[270](index=270&type=chunk)[272](index=272&type=chunk) - **Tax Risks:** There is a significant risk that the company was classified as a Passive Foreign Investment Company (PFIC) for U.S. tax purposes prior to its domestication, which could have adverse tax consequences for U.S. shareholders. The ability to use Net Operating Loss (NOL) carryforwards is also uncertain[282](index=282&type=chunk)[286](index=286&type=chunk) [Unresolved Staff Comments](index=53&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that there are no unresolved staff comments - Not applicable[301](index=301&type=chunk) [Cybersecurity](index=53&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cybersecurity program overseen by an external IT consultant and Audit Committee, reporting no material incidents - The company's cybersecurity program is managed by an external IT consultant and overseen by the Audit Committee of the Board[304](index=304&type=chunk)[305](index=305&type=chunk) - A Cybersecurity Incident Response Plan is in place to manage potential threats[303](index=303&type=chunk) - The company did not experience any material cybersecurity incidents or threats in the last reporting year[307](index=307&type=chunk) [Properties](index=54&type=section&id=Item%202.%20Properties) The company's principal executive office and operations are located in Princeton, New Jersey - The company's principal executive office is located in Princeton, New Jersey[308](index=308&type=chunk) [Legal Proceedings](index=54&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any legal proceedings that management believes are likely to have a material adverse effect on the business[309](index=309&type=chunk) [Mine Safety Disclosures](index=54&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[310](index=310&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=55&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Grace Therapeutics' common stock trades on Nasdaq under 'GRCE', with 32 holders of record; no cash dividends are anticipated - The company's common stock is traded on the Nasdaq Capital Market under the symbol "GRCE"[312](index=312&type=chunk) - As of June 18, 2025, there were **32 holders of record** of the common stock[312](index=312&type=chunk) - The company does not anticipate paying any cash dividends in the foreseeable future[313](index=313&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=56&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) For FY2025, the company reported a net loss of **$9.6 million**, influenced by R&D increases and a positive change in derivative warrant liabilities, holding **$22.1 million** cash [Results of Operations](index=57&type=section&id=Results%20of%20Operations) Net loss decreased to **$9.6 million** in FY2025 from **$12.9 million** in FY2024, primarily due to a positive change in derivative warrant liabilities and increased R&D expenses Comparison of Operations (in thousands) | | Year ended March 31, 2025 | Year ended March 31, 2024 | Change | | :--- | :--- | :--- | :--- | | **Net loss** | **$ (9,568)** | **$ (12,853)** | **$ 3,285** | | Loss per share | $ (0.79) | $ (1.35) | $ 0.56 | | R&D expenses, net | $ 9,511 | $ 4,683 | $ (4,828) | | G&A expenses | $ 7,168 | $ 6,684 | $ (484) | | Restructuring costs | $ — | $ 1,485 | $ 1,485 | | Change in fair value of derivative warrant liabilities | $ 3,218 | $ (2,728) | $ 5,946 | - Research and development expenses increased by **$4.8 million**, primarily due to increased activities for the GTx-104 pivotal Phase 3 safety clinical trial[327](index=327&type=chunk) [Liquidity and Capital Resources](index=59&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, cash was **$22.1 million**; a **$13.7 million** private placement in February 2025 is expected to fund operations for at least 12 months Cash Position and Flows (in thousands) | | As of/Year Ended March 31, 2025 | As of/Year Ended March 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $22,133 | $23,005 | | Net cash used in operating activities | $(14,904) | $(12,333) | | Net cash provided by financing activities | $14,032 | $7,359 | - In February 2025, a private placement generated net proceeds of **$13.7 million**[339](index=339&type=chunk)[345](index=345&type=chunk) - The company believes its existing cash will be sufficient to sustain planned operations through at least 12 months from the financial statement issuance date[321](index=321&type=chunk)[339](index=339&type=chunk) [Critical Accounting Policies](index=61&type=section&id=Critical%20Accounting%20Policies) Key accounting policies involve significant judgment, including expensing R&D costs and annually testing intangible assets and goodwill for impairment - Research and development costs are expensed as incurred, with accruals based on estimates of work performed by contractors[355](index=355&type=chunk) - In-process research and development (IPR&D) and goodwill, valued at **$49.3 million** (**68% of total assets**), are tested for impairment annually. Impairment assessment involves highly subjective assumptions[357](index=357&type=chunk)[358](index=358&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=63&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, Grace Therapeutics is not required to provide this information - The company is not required to provide this information as it qualifies as a smaller reporting company[369](index=369&type=chunk) [Financial Statements and Supplementary Data](index=63&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for FY2025 and FY2024, including the auditor's report and notes [Report of Independent Registered Public Accounting Firm](index=71&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP issued an unqualified opinion on the financial statements, identifying the company's going concern ability as a critical audit matter - The auditor, KPMG LLP, issued an unqualified opinion on the financial statements[397](index=397&type=chunk) - A critical audit matter was identified regarding the assessment of the company's ability to continue as a going concern, due to the subjective nature of forecasting future expenses and cash flows[401](index=401&type=chunk)[403](index=403&type=chunk) [Consolidated Financial Statements](index=72&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show total assets of **$72.0 million** and a net loss of **$9.6 million** for FY2025, with **$14.9 million** cash used in operations Key Financial Data (Year Ended March 31, 2025, in thousands) | Metric | FY 2025 | FY 2024 | | :--- | :--- | :--- | | **Balance Sheet:** | | | | Cash and cash equivalents | $22,133 | $23,005 | | Total Assets | $71,993 | $73,300 | | Total Liabilities | $5,383 | $11,557 | | Total Stockholders' Equity | $66,610 | $61,743 | | **Income Statement:** | | | | Net Loss | $(9,568) | $(12,853) | | Basic and Diluted Loss Per Share | $(0.79) | $(1.35) | | **Cash Flow:** | | | | Net cash used in operating activities | $(14,904) | $(12,333) | | Net cash provided by financing activities | $14,032 | $7,359 | [Notes to the Consolidated Financial Statements](index=76&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) The notes detail corporate changes, liquidity risks, accounting policies, intangible assets, and recent financing, including a **$13.7 million** private placement - **(Note 1)** The company completed its domestication from Canada to Delaware in October 2024. Management believes existing cash is sufficient for at least 12 months but will require additional capital beyond that[413](index=413&type=chunk)[419](index=419&type=chunk) - **(Note 6)** Intangible assets (IPR&D) and goodwill totaled **$49.3 million** as of March 31, 2025, with no impairment recognized during the year[462](index=462&type=chunk) - **(Note 8)** The company raised **$13.7 million** in net proceeds from a private placement in February 2025. As of March 31, 2025, derivative warrant liabilities were valued at **$1.1 million**, a significant decrease from **$4.4 million** the prior year[467](index=467&type=chunk)[481](index=481&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=64&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting principles or financial disclosure - None reported[371](index=371&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of March 31, 2025 - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[371](index=371&type=chunk) - Management concluded that as of March 31, 2025, the company's internal control over financial reporting was effective, based on the COSO framework[372](index=372&type=chunk) - The company is a non-accelerated filer and is not required to provide an auditor attestation on internal controls[374](index=374&type=chunk) [Other Information](index=64&type=section&id=Item%209B.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fourth fiscal quarter - No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the fourth fiscal quarter[375](index=375&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=64&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - None[376](index=376&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=65&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[379](index=379&type=chunk) [Executive Compensation](index=65&type=section&id=Item%2011.%20Executive%20Compensation) Information regarding executive and director compensation is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[380](index=380&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=65&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership and equity compensation plans is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[381](index=381&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=65&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information regarding related party transactions and director independence is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[382](index=382&type=chunk) [Principal Accountant Fees and Services](index=65&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the 2025 Proxy Statement - Information is incorporated by reference from the definitive proxy statement for the 2025 annual meeting of stockholders[383](index=383&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=66&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits filed with or incorporated by reference into the Form 10-K, including financial statements and corporate documents - This section contains the list of all exhibits filed with or incorporated by reference into the Form 10-K[386](index=386&type=chunk) [Form 10-K Summary](index=68&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary provided - None[391](index=391&type=chunk)

Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][7] - The company has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. and has over 40 granted and pending patents [7] Product Details - GTx-104 is designed to address significant unmet medical needs in aSAH patients, facilitating a convenient IV delivery method that may eliminate the need for nasogastric tube administration [5][6] - The product has been administered to over 150 healthy volunteers, showing good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage accounts for approximately 5% of all strokes, with an estimated 42,500 patients treated in U.S. hospitals annually [4] - The BIO International Convention, where the CEO will participate, is the largest biotechnology event globally, attracting over 20,000 leaders from various sectors including biopharma and investment [2]

Core Insights - Grace Therapeutics, Inc. is advancing GTx-104, a novel injectable formulation of nimodipine for IV infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][6] - The company has received positive feedback from the FDA regarding the Phase 3 STRIVE-ON safety trial and plans to submit a New Drug Application (NDA) in Q2 2025 [2][3] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on addressing rare and orphan diseases with innovative drug delivery technologies [9] - The lead clinical asset, GTx-104, has received Orphan Drug Designation from the FDA, providing seven years of marketing exclusivity post-launch in the U.S. [9] Clinical Trial Insights - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, meeting its primary endpoint with a 19% reduction in clinically significant hypotension incidents [4] - GTx-104 demonstrated higher relative dose intensity (RDI) with 54% of patients achieving RDI of 95% or higher compared to 8% for oral nimodipine [4] - The trial also showed improved functional outcomes at 90 days, with 29% more patients on GTx-104 achieving favorable results [4] Product Details - GTx-104 utilizes unique nanoparticle technology for aqueous formulation, facilitating IV infusion and potentially eliminating the need for nasogastric tube administration [6][7] - The product aims to lower food effects, drug-to-drug interactions, and dosing errors while better managing hypotension in aSAH patients [8] Market Context - aSAH accounts for about 5% of all strokes, with an estimated 42,500 U.S. hospital-treated patients annually, indicating a significant unmet medical need [5]

Company Overview - Grace Therapeutics, Inc. (formerly Acasti Pharma Inc.) is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases [7] - The company's lead clinical asset, GTx-104, is an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH) [5][7] Product Development - GTx-104 is designed for intravenous infusion to address significant unmet medical needs in aSAH patients, potentially improving treatment outcomes compared to oral formulations [5][6] - The unique nanoparticle technology of GTx-104 allows for a standard peripheral IV infusion, which may eliminate the need for nasogastric tube administration in unconscious or dysphagic patients [6] - GTx-104 has been administered to over 150 healthy volunteers and demonstrated good tolerance with lower pharmacokinetic variability compared to oral nimodipine [6] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) is a rare and life-threatening condition that accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [4] - The company hosted a virtual key opinion leader (KOL) event discussing the high unmet medical need and current treatment landscape for aSAH patients [2] Regulatory and Commercial Strategy - Grace Therapeutics has received Orphan Drug Designation from the FDA for its lead clinical assets, providing seven years of marketing exclusivity post-launch in the U.S. [7] - The company holds over 40 granted and pending patents, enhancing its intellectual property protection [7] Upcoming Events - The CEO of Grace Therapeutics, Prashant Kohli, will participate in the TD Cowen 45th Annual Health Care Conference on March 4, 2025, to discuss the company's developments [1][2]

[Q3 FY2025 Highlights and Business Update](index=1&type=section&id=Grace%20Therapeutics%20Announces%20Third%20Fiscal%20Quarter%202025%20Financial%20Results%2C%20Provides%20Business%20Update) Grace Therapeutics reported positive Phase 3 GTx-104 trial results, plans a 2025 NDA, and secured $30M financing [Key Highlights](index=1&type=section&id=Highlights%20for%20Third%20Quarter%20Fiscal%20Quarter%202025%20and%20Recent%20Weeks) Positive Phase 3 GTx-104 trial results, secured financing, and received FDA guidance for GTx-102 - The Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint and demonstrated **clinical benefit** compared to oral nimodipine for aneurysmal subarachnoid hemorrhage (aSAH) patients[2](index=2&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - The company plans to submit a New Drug Application (NDA) to the FDA for GTx-104 in the **first half of calendar year 2025**[2](index=2&type=chunk)[4](index=4&type=chunk) - Secured a private placement financing for up to **$30 million** in potential gross proceeds, with an initial **$15 million** upfront, yielding **$13.8 million** net proceeds[2](index=2&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) - Received FDA guidance on the design of a single pivotal efficacy and safety trial for GTx-102, which could support a future NDA[4](index=4&type=chunk)[12](index=12&type=chunk) [Financial Results](index=2&type=section&id=Third%20Fiscal%20Quarter%202025%20Financial%20Results) Grace Therapeutics reported a **$4.2M net loss** in Q3 FY2025, driven by increased R&D and derivative liability changes [Financial Summary](index=2&type=section&id=Financial%20Summary) Q3 FY2025 net loss increased to **$4.2M** due to higher R&D and derivative adjustments, with cash at **$11.1M** Q3 FY2025 vs. Q3 FY2024 Financial Performance | Metric | Q3 FY2025 (ended Dec 31, 2024) (in millions) | Q3 FY2024 (ended Dec 31, 2023) (in millions) | Change (in millions) | | :--- | :--- | :--- | :--- | | **Net Loss** | $4.2 | $2.4 | +$1.8 | | **Loss per Share** | $0.36 | $0.21 | +$0.15 | | **R&D Expenses** | $2.2 | $1.4 | +$0.8 | | **G&A Expenses** | $1.5 | $1.6 | -$0.1 | Cash Position | Metric | Dec 31, 2024 (in millions) | Mar 31, 2024 (in millions) | | :--- | :--- | :--- | | **Cash and Cash Equivalents** | $11.1 | $23.0 | [Business and Asset Portfolio](index=2&type=section&id=Business%20and%20Asset%20Portfolio) Details aSAH and the company's clinical-stage asset portfolio: GTx-104, GTx-102, and deprioritized GTx-101 [About aneurysmal Subarachnoid Hemorrhage (aSAH)](index=2&type=section&id=About%20aneurysmal%20Subarachnoid%20Hemorrhage%20%28aSAH%29) aSAH is a rare, severe stroke from a ruptured brain aneurysm, affecting ~42,500 U.S. patients annually - aSAH is a type of stroke caused by bleeding in the subarachnoid space, often from a ruptured brain aneurysm[9](index=9&type=chunk) - This condition accounts for about **5% of all strokes** and impacts an estimated **42,500 U.S. hospital-treated patients**[9](index=9&type=chunk) [Asset Portfolio Overview](index=2&type=section&id=About%20the%20Grace%20Therapeutics%20Asset%20Portfolio) Clinical portfolio targets unmet medical needs, led by GTx-104 for aSAH, GTx-102 for A-T, and deprioritized GTx-101 [GTx-104](index=2&type=section&id=GTx-104) GTx-104 is a novel IV nimodipine formulation for aSAH, improving oral delivery via nanoparticle technology - GTx-104 is a novel, injectable formulation of nimodipine for IV infusion in aSAH patients, utilizing unique nanoparticle technology[10](index=10&type=chunk) - It offers potential benefits over oral administration, including avoiding nasogastric tubes, lowering food effects and drug interactions, and eliminating potential dosing errors[11](index=11&type=chunk) - GTx-104 has shown significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine[11](index=11&type=chunk) [GTx-102](index=2&type=section&id=GTx-102) GTx-102 is an oral betamethasone spray for A-T, with FDA guidance for a single pivotal trial supporting an NDA - GTx-102 is a concentrated oral spray of betamethasone for Ataxia-Telangiectasia (A-T), a condition with no FDA-approved therapies[12](index=12&type=chunk) - The FDA has provided guidance on the design of a single pivotal trial that could support an NDA submission[12](index=12&type=chunk)[4](index=4&type=chunk) [GTx-101](index=2&type=section&id=GTx-101) GTx-101 is a topical bupivacaine spray for PHN, deprioritized for GTx-104 focus, with potential licensing or sale - GTx-101 is a topical bupivacaine spray designed to treat postherpetic neuralgia (PHN) with a potential for rapid onset and up to **eight hours** of pain relief[13](index=13&type=chunk) - The development of GTx-101 has been deprioritized to focus resources on the lead asset, GTx-104. The company may license or sell GTx-101[13](index=13&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) Overview of Grace Therapeutics as a biopharmaceutical company and the nature of forward-looking statements [About Grace Therapeutics](index=3&type=section&id=About%20Grace%20Therapeutics) Grace Therapeutics is a late-stage biopharma company focused on rare and orphan diseases, using novel drug delivery - The company is a late-stage biopharma firm focused on drug candidates for rare and orphan diseases[14](index=14&type=chunk) - Lead clinical assets, including GTx-104, have been granted FDA Orphan Drug Designation, providing **seven years** of U.S. marketing exclusivity after launch[14](index=14&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) Cautions that forward-looking statements are subject to inherent risks and uncertainties, and actual results may differ - The press release contains forward-looking statements regarding the future prospects of GTx-104 and GTx-102, including NDA submission timing and commercial potential[15](index=15&type=chunk) - Actual results may differ due to risks such as regulatory requirements, changes to clinical trial designs, and legislative or economic developments[15](index=15&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) Presents the company's condensed consolidated balance sheets and statements of loss and comprehensive loss [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of December 31, 2024, total assets decreased to **$61.2M**, driven by reduced cash, with liabilities and equity also declining Balance Sheet Summary | Account | December 31, 2024 (in thousands) | March 31, 2024 (in thousands) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $11,055 | $23,005 | | **Total Assets** | $61,224 | $73,300 | | **Total Liabilities** | $9,085 | $11,557 | | **Total Stockholders' Equity** | $52,139 | $61,743 | [Condensed Consolidated Statements of Loss and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Loss%20and%20Comprehensive%20Loss) Net loss of **$4.2M** for Q3 FY2025 and **$10.2M** for nine months, primarily due to increased R&D expenses Statement of Loss - Three Months Ended | Metric | December 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Research and development expenses | $(2,194) | $(1,443) | | General and administrative expenses | $(1,510) | $(1,600) | | **Net Loss** | **$(4,155)** | **$(2,391)** | | **Basic and diluted loss per share** | **$(0.36)** | **$(0.21)** | Statement of Loss - Nine Months Ended | Metric | December 31, 2024 (in thousands) | December 31, 2023 (in thousands) | | :--- | :--- | :--- | | Research and development expenses | $(7,877) | $(2,998) | | General and administrative expenses | $(5,619) | $(5,106) | | **Net Loss** | **$(10,204)** | **$(9,687)** | | **Basic and diluted loss per share** | **$(0.89)** | **$(1.09)** |

Core Insights - Grace Therapeutics announced that its Phase 3 STRIVE-ON safety trial for GTx-104 met its primary endpoint, showing improved clinical outcomes compared to orally administered nimodipine [1][15] - The company secured a private placement financing of up to $30 million, which will support pre-commercial planning and the potential launch of GTx-104 if approved [2][5] - The New Drug Application (NDA) submission for GTx-104 is anticipated in the first half of 2025, marking a significant step towards addressing unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients [1][2] Financial Highlights - For the 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 [4][19] - Research and development expenses increased to $2.2 million for the quarter, up from $1.4 million in the prior year, primarily due to activities related to the GTx-104 pivotal Phase 3 trial [6][19] - As of December 31, 2024, cash and cash equivalents were $11.1 million, a decrease from $23.0 million at the end of March 2024 [8][19] Product Development - GTx-104 is a novel injectable formulation of nimodipine being developed for IV infusion in aSAH patients, addressing significant unmet medical needs [10][15] - The drug's unique nanoparticle technology allows for a standard peripheral IV infusion, potentially improving delivery and reducing complications associated with oral administration [11][15] - The company is also developing GTx-102, a novel oral-mucosal spray of betamethasone for Ataxia-Telangiectasia, with an NDA submission path outlined by the FDA [12][15] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually, indicating a significant market opportunity for GTx-104 [9][15] - The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, positioning GTx-104 as a potential breakthrough treatment if approved by the FDA [2][5]