Core Insights - Grace Therapeutics, Inc. presented data from its Pivotal Phase 3 STRIVE-ON Safety Trial for GTx-104, an injectable formulation of nimodipine, at the Neurocritical Care Society annual meeting, highlighting its potential benefits over oral nimodipine in treating aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on developing innovative drug delivery technologies for rare and orphan diseases, with GTx-104 as its lead clinical asset targeting aSAH [8] - 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. [8] Clinical Trial Results - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with the primary endpoint being the incidence of clinically significant hypotension [3] - Results indicated that GTx-104 may deliver neuroprotective effects while reducing hypotensive events compared to oral nimodipine, along with improvements in ICU length of stay and reduced need for mechanical ventilation [3] Market Potential - The standard of care for aSAH has not seen significant innovation in nearly 40 years, positioning GTx-104 as a promising alternative if approved by the FDA [3] - The FDA's review of the New Drug Application (NDA) for GTx-104 is ongoing, with a target date of April 23, 2026 [3] Product Details - GTx-104 utilizes unique nanoparticle technology to facilitate the intravenous infusion of nimodipine, potentially improving patient management in the ICU and reducing complications associated with oral administration [5][6] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerability and lower pharmacokinetic variability compared to oral nimodipine [6]

Core Viewpoint - Grace Therapeutics has received a new method of use patent for GTx-104, extending its intellectual property protection until 2043, which enhances the company's market exclusivity and potential value for shareholders [2][3][4]. Intellectual Property and Patent Protection - The U.S. Patent and Trademark Office issued U.S. Patent No. 12,414,943 for the dosing regimen of GTx-104, which is used in the Phase 3 STRIVE-ON safety trial [2]. - Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the composition of nimodipine, providing protection until 2037 [3]. - The new patent on the I.V. dosing regimen strengthens the company's intellectual property position and extends protection to 2043 [3]. Clinical Trial Insights - The STRIVE-ON safety trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with GTx-104 showing a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine (28% vs. 35%) [5]. - Patients receiving GTx-104 had a relative dose intensity (RDI) of 95% or higher in 54% of cases, compared to only 8% for oral nimodipine [5]. - GTx-104 demonstrated fewer ICU readmissions, ICU days, and ventilator days compared to oral nimodipine, with adverse events being comparable between both treatment arms [5]. Product Overview - GTx-104 is a novel injectable formulation of nimodipine developed for I.V. infusion in patients with aSAH, addressing significant unmet medical needs [7][9]. - The unique nanoparticle technology of GTx-104 allows for a standard peripheral I.V. infusion, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients [8]. - GTx-104 has been administered to over 200 patients and healthy volunteers, showing well-tolerated results with lower pharmacokinetic variability compared to oral nimodipine [8]. Market Exclusivity - GTx-104 has received Orphan Drug Designation from the FDA, granting it seven years of marketing exclusivity in the U.S. upon FDA approval of the New Drug Application (NDA) [3][9].

Summary of Grace Therapeutics Conference Call Company Overview - **Company**: Grace Therapeutics, Inc. (NasdaqCM:GRCE) - **Focus**: Development of GTX-104, an intravenous formulation of amlodipine targeting subarachnoid hemorrhage (SAH), a rare disease with high morbidity and mortality rates [2][3][4] Core Points and Arguments - **Current Standard of Care**: Amlodipine, an oral calcium channel blocker, has significant clinical liabilities, including high first-pass metabolism and hypotension issues [2][5][6][9] - **Innovative Solution**: GTX-104 aims to address the shortcomings of oral amlodipine by providing a novel aqueous formulation for intravenous administration, enhancing dose compliance and hypotension management [3][10][19] - **Clinical Trial Success**: The pivotal Phase 3 trial (STRY1) demonstrated: - 20% fewer clinically significant hypotensive events with GTX-104 compared to oral amlodipine - 95% or higher dose compliance in 55% of patients on IV versus only 8% on oral [15][19] - 30% of patients on IV showed good recovery compared to oral [15][18] - **Regulatory Pathway**: The FDA accepted the New Drug Application (NDA) for GTX-104 with a PDUFA goal date of April 23, 2026, following a successful pre-NDA meeting [17][25] Market Potential - **Target Market**: Approximately 50,000 cases of SAH annually in the U.S., treated primarily in about 250 hospitals [20][21] - **Commercial Strategy**: A focused sales force of 15 to 20 individuals will be deployed to market GTX-104, leveraging a strong patent portfolio that includes seven years of market exclusivity and multiple formulation patents extending to 2042 [21][22] Financial Position - **Cash Reserves**: $20 million reported at the end of June, with additional potential proceeds from warrants expected to support operations through the anticipated approval and into revenue generation in 2027 [22][23] Additional Important Insights - **Patient Demographics**: SAH primarily affects younger populations, with an average patient age of less than 60 years and a higher incidence in women [5][17] - **Clinical Need**: The unmet clinical need is significant, as many patients are unconscious and unable to swallow, complicating the administration of oral medications [6][10] - **Pharmaco-economic Benefits**: The IV formulation demonstrated a reduction in ICU length of stay by 1.5 days and a 50% reduction in ICU readmissions compared to oral therapy, highlighting its cost-effectiveness [15][16][19] This summary encapsulates the key points from the Grace Therapeutics conference call, emphasizing the company's innovative approach to treating a critical condition, its strong clinical data, and the promising market opportunity ahead.

Core Insights - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, an injectable formulation of nimodipine for IV infusion targeting aSAH patients [1][4] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, with opportunities for one-on-one meetings with institutional investors [2][3] Company Overview - Grace Therapeutics specializes in drug candidates for rare and orphan diseases, with innovative drug delivery technologies aimed at improving drug performance [4] - The lead clinical asset, GTx-104, has received Orphan Drug Designation from the FDA, granting seven years of marketing exclusivity post-launch in the U.S. and additional intellectual property protection with over 40 patents [4] Conference Details - The conference will be held at the Lotte New York Palace Hotel, featuring over 550 company presentations available live or on demand [2] - Prashant Kohli, CEO of Grace Therapeutics, will be available for one-on-one meetings with institutional investors during the event [2]

Core Viewpoint - The FDA has accepted Grace Therapeutics' New Drug Application (NDA) for GTx-104, targeting a Prescription Drug User Fee Act (PDUFA) date of April 23, 2026, for the treatment of aneurysmal Subarachnoid Hemorrhage (aSAH) patients, supported by positive results from the Phase 3 STRIVE-ON safety trial [1][2][3] Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing innovative treatments for rare and orphan diseases, with GTx-104 as its lead clinical asset [9] - The company has received Orphan Drug Designation for GTx-104, which provides seven years of marketing exclusivity in the U.S. upon FDA approval [3] Product Details - GTx-104 is a novel injectable formulation of nimodipine designed for IV infusion in aSAH patients, addressing significant unmet medical needs [7][8] - The unique nanoparticle technology of GTx-104 allows for a standard peripheral IV infusion, potentially improving patient outcomes and convenience [8] Clinical Trial Insights - The STRIVE-ON safety trial involved 102 patients, comparing GTx-104 with oral nimodipine, and demonstrated a 19% reduction in clinically significant hypotension incidents for GTx-104 [4] - Additional findings showed that 54% of GTx-104 patients achieved a relative dose intensity of 95% or higher, compared to only 8% for oral nimodipine [4] - GTx-104 also resulted in fewer ICU readmissions and days compared to oral nimodipine, with comparable adverse events between both treatment arms [4] Market Potential - The standard of care for aSAH has not seen significant innovation in nearly 40 years, positioning GTx-104 as a potential breakthrough treatment if approved [2] - The company believes that its patent estate will protect the market value of GTx-104 beyond the exclusivity period provided by the Orphan Drug Designation [3]

[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)** |

Core Viewpoint - Grace Therapeutics has submitted a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine aimed at treating patients with aneurysmal Subarachnoid Hemorrhage (aSAH), supported by positive results from the Phase 3 STRIVE-ON trial [1][2][6]. Company Highlights - The NDA submission for GTx-104 represents a significant milestone for Grace Therapeutics, building on over a decade of research and innovation [2]. - The STRIVE-ON trial demonstrated improved clinical outcomes for aSAH patients treated with GTx-104 compared to oral nimodipine, indicating potential medical and pharmacoeconomic benefits [2][12]. - GTx-104 has received Orphan Drug Designation from the FDA, which provides seven years of marketing exclusivity upon approval [6][18]. Financial Results - For the quarter ended June 30, 2025, the company reported a net loss of $3.4 million, or $0.21 per share, an increase from a net loss of $2.6 million, or $0.24 per share, for the same period in 2024 [4][24]. - Research and development expenses decreased to approximately $0.9 million from $2.7 million year-over-year, primarily due to the completion of the STRIVE-ON trial [5]. - General and administrative expenses were approximately $2.1 million, a slight decrease from $2.2 million in the previous year [7]. Cash Position - As of June 30, 2025, the company had cash and cash equivalents of $20.0 million, down from $22.1 million at the end of March 2025 [8]. - The company believes its current cash runway extends through at least the next twelve months, potentially into the second quarter of 2027 if all common warrants from recent private placements are exercised [11]. STRIVE-ON Trial Details - The STRIVE-ON trial involved 50 patients receiving GTx-104 and 52 patients receiving oral nimodipine, with the primary endpoint showing a 19% reduction in clinically significant hypotension for GTx-104 [12]. - Secondary endpoints indicated that 54% of patients on GTx-104 achieved a relative dose intensity of 95% or higher, compared to only 8% on oral nimodipine [12]. - The trial also reported fewer ICU readmissions and days for patients treated with GTx-104, with no new safety issues identified [12]. Market Context - aSAH is a rare but serious condition accounting for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [13][18]. - The standard of care for aSAH has not seen significant innovation in nearly 40 years, highlighting the potential impact of GTx-104 as a breakthrough treatment [2].

[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)