PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Grace Therapeutics reported an increased net loss of $10.2 million for the nine months ended December 31, 2024, with cash decreasing to $11.1 million, supplemented by a $13.8 million private placement Condensed Consolidated Balance Sheet Highlights (in thousands) | | Dec 31, 2024 | Mar 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $11,055 | $23,005 | | Total current assets | $11,939 | $24,010 | | Intangible assets & Goodwill | $49,266 | $49,266 | | **Total assets** | **$61,224** | **$73,300** | | **Liabilities & Equity** | | | | Total current liabilities | $1,971 | $1,684 | | Derivative warrant liabilities | $3,781 | $4,359 | | **Total liabilities** | **$9,085** | **$11,557** | | **Total stockholders' equity** | **$52,139** | **$61,743** | Condensed Consolidated Statements of Loss (in thousands, except per share data) | | Three Months Ended Dec 31 | Nine Months Ended Dec 31 | | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | Research and development expenses, net | ($2,194) | ($1,443) | ($7,877) | ($2,998) | | General and administrative expenses | ($1,510) | ($1,600) | ($5,619) | ($5,106) | | Loss from operating activities | ($3,704) | ($3,043) | ($13,496) | ($9,589) | | **Net loss** | **($4,155)** | **($2,391)** | **($10,204)** | **($9,687)** | | Basic and diluted loss per share | ($0.36) | ($0.21) | ($0.89) | ($1.09) | Condensed Consolidated Statements of Cash Flows Highlights (Nine months ended Dec 31, in thousands) | | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($11,950) | ($10,245) | | Net cash used in investing activities | $0 | ($6,444) | | Net cash provided by financing activities | $0 | $7,359 | | **Net decrease in cash and cash equivalents** | **($11,950)** | **($9,330)** | | Cash and cash equivalents, end of period | $11,055 | $18,545 | - In February 2025, the company completed a private placement raising net proceeds of approximately **$13.8 million**[34](index=34&type=chunk)[35](index=35&type=chunk) - Management believes existing cash, supplemented by these proceeds, is sufficient to fund operations for at least 12 months from the financial statement issuance date[34](index=34&type=chunk)[35](index=35&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company focuses on developing and commercializing products for rare and orphan diseases, prioritizing its lead candidate GTx-104, with recent financial results reflecting increased R&D expenses and a new private placement [Business Overview and Pipeline](index=19&type=section&id=Business%20Overview%20and%20Pipeline) Grace Therapeutics is a clinical-stage pharmaceutical company focused on rare and orphan diseases, strategically prioritizing its lead candidate GTx-104 for commercialization - The company's strategy is to apply new proprietary formulations to approved pharmaceutical compounds to enhance efficacy, reduce side effects, and improve delivery, potentially enabling a shorter path to regulatory approval via the Section 505(b)(2) pathway[89](index=89&type=chunk)[90](index=90&type=chunk) - All three drug candidates have received Orphan Drug Designation (ODD) from the FDA, which provides for seven years of marketing exclusivity in the U.S. post-launch if certain conditions are met[92](index=92&type=chunk) - In May 2023, the company prioritized the development of its lead candidate, GTx-104, to advance it towards commercialization[96](index=96&type=chunk) - Further development of GTx-102 and GTx-101 is contingent on securing additional funding or strategic partnerships[96](index=96&type=chunk) [Recent Developments](index=21&type=section&id=Recent%20Developments) Recent developments include a successful $13.8 million private placement, positive Phase 3 GTx-104 trial results leading to planned NDA submission, and a corporate domestication to Delaware - Completed a private placement in February 2025, raising approximately **$13.8 million** in net proceeds[98](index=98&type=chunk)[99](index=99&type=chunk) - The Phase 3 STRIVE-ON trial for GTx-104 met its primary endpoint, showing clinical benefit compared to oral nimodipine[100](index=100&type=chunk) - An NDA submission to the FDA is planned for the first half of calendar year 2025[100](index=100&type=chunk) - In October 2024, the company changed its jurisdiction to Delaware, changed its name to Grace Therapeutics, Inc., and began trading on Nasdaq under the symbol 'GRCE'[102](index=102&type=chunk)[104](index=104&type=chunk) [GTx-104 Overview (for aSAH)](index=22&type=section&id=GTx-104%20Overview) GTx-104 is an IV nimodipine formulation for aSAH, targeting a $300 million U.S. market, with its Phase 3 trial successfully meeting endpoints and an NDA submission planned for early 2025 - GTx-104 is an injectable nimodipine formulation for aSAH patients, designed to provide **100% bioavailability**, better blood pressure control, and lower variability compared to the oral form[109](index=109&type=chunk)[112](index=112&type=chunk) - The total addressable market for aSAH is estimated at approximately **$300 million** in the U.S., affecting about **42,500 patients annually**[117](index=117&type=chunk)[115](index=115&type=chunk) - The Phase 3 STRIVE-ON trial met its primary endpoint, with GTx-104 showing a **19% reduction** in drug-related hypotension episodes (**28% vs 35%** for oral nimodipine)[128](index=128&type=chunk) - Favorable outcomes were also seen in dose intensity and patient quality of life[128](index=128&type=chunk) [Results of Operations](index=35&type=section&id=Results%20of%20Operations) The company's net loss increased to $4.2 million for Q3 2024 and $10.2 million for the nine-month period, primarily driven by higher R&D expenses for the GTx-104 trial and increased G&A costs Comparison of Operating Results (in thousands) | | Three Months Ended Dec 31 | Nine Months Ended Dec 31 | | :--- | :--- | :--- | | | **2024** | **2023** | **2024** | **2023** | | R&D Expenses | $2,194 | $1,443 | $7,877 | $2,998 | | G&A Expenses | $1,510 | $1,600 | $5,619 | $5,106 | | Restructuring Costs | $0 | $0 | $0 | $1,485 | | **Net Loss** | **($4,155)** | **($2,391)** | **($10,204)** | **($9,687)** | - Research and development expenses increased by **$4.9 million** for the nine months ended Dec 31, 2024, primarily due to increased research activities for the GTx-104 pivotal Phase 3 safety clinical trial[175](index=175&type=chunk) - General and administrative expenses increased by **$513,000** for the nine months ended Dec 31, 2024, mainly due to higher legal, tax, and accounting fees related to the Continuance and Domestication, as well as increased salaries[181](index=181&type=chunk) - The change in fair value of derivative warrant liabilities resulted in a **$1.2 million expense** for the three months ended Dec 31, 2024, compared to a **$125,000 gain** in the prior-year period, primarily due to changes in the company's stock price[183](index=183&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2024, cash and cash equivalents were $11.1 million, with a $13.8 million private placement in February 2025 expected to fund operations for at least 12 months - Cash and cash equivalents were **$11.1 million** as of December 31, 2024[190](index=190&type=chunk) - In February 2025, a private placement was completed, providing net proceeds of approximately **$13.8 million**[191](index=191&type=chunk)[84](index=84&type=chunk) - Net cash used in operating activities for the nine months ended December 31, 2024, was **$12.0 million**, an increase from **$10.2 million** in the prior-year period, driven by increased R&D for the GTx-104 trial[193](index=193&type=chunk) - The company has commitments of **$230,000** to CMOs and **$1.5 million** to CROs for the next twelve months as of December 31, 2024[199](index=199&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Grace Therapeutics is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide the information required by this Item[208](index=208&type=chunk) [Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2024, with no material changes to internal controls over financial reporting during the quarter - Based on an evaluation as of December 31, 2024, management concluded that the company's disclosure controls and procedures were effective[209](index=209&type=chunk) - No material changes were made to the company's internal controls over financial reporting during the quarter ended December 31, 2024[210](index=210&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=41&type=section&id=Item%201.%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 are expected to have a material adverse effect on its business[212](index=212&type=chunk) [Risk Factors](index=42&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 - There have been no material changes from the risk factors disclosed in the company's Annual Report[214](index=214&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=42&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[215](index=215&type=chunk) [Other Information](index=42&type=section&id=Item%205.%20Other%20Information) During the third quarter of 2024, no director or officer of the company adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement - During the three months ended December 31, 2024, no director or officer adopted or terminated a Rule 10b5-1 trading arrangement[218](index=218&type=chunk)

Core Insights - Grace Therapeutics, Inc. announced positive topline data from its Phase 3 STRIVE-ON safety trial of GTx-104, demonstrating clinical benefits compared to oral nimodipine in patients with aneurysmal Subarachnoid Hemorrhage (aSAH) [1][2] Trial Results - The trial met its primary endpoint, showing a 19% reduction in clinically significant hypotension incidents for patients receiving GTx-104 (28% vs. 35% for nimodipine) [2] - Adverse events were comparable between GTx-104 and nimodipine, with no new safety issues identified [2] - All deaths in the trial were attributed to the severity of the underlying disease, not the treatment [2] Future Plans - A new drug application submission to the US is anticipated in the first half of 2025 [3] - Grace Therapeutics announced a private placement of approximately $30 million, with $15 million upfront and an additional $15 million possible through investor warrants [3][4] Financial Details - The company will issue 4.42 million common shares and warrants at a combined purchase price of $3.395 [4] - The net proceeds from this placement will be used to fund the development of GTx-104 [4] Market Reaction - Following the announcement, GRCE stock increased by 4.32%, reaching $3.38 [4] - A significant 54% of patients receiving GTx-104 achieved a relative dose intensity of 95% or higher, compared to only 8% for nimodipine [4] - There was a 29% relative increase in favorable outcomes at 90 days follow-up on the modified Rankin scale for patients receiving GTx-104 [4] - Patients on GTx-104 experienced fewer ICU readmissions, ICU days, and ventilator days compared to those on nimodipine [4]

Core Viewpoint - Grace Therapeutics, Inc. has announced a financing round to raise up to approximately $30 million, aimed at advancing its clinical-stage drug GTx-104 for treating aneurysmal Subarachnoid Hemorrhage (aSAH) patients [1][5][12] Financing Details - The financing is led by Nantahala Capital and ADAR1 Partners, LP, with participation from both new and existing healthcare-focused institutional investors, including Stonepine Capital Management [2] - The financing consists of $15 million in upfront gross proceeds, with the potential for an additional $15 million from warrant exercises, totaling up to approximately $30 million [1][3] - Grace Therapeutics will issue 4,418,292 shares of common stock and accompanying common warrants at a combined purchase price of $3.395 per share [3][4] Use of Proceeds - The upfront net proceeds from the private placement will be utilized for general corporate purposes and to fund the pre-commercial development of GTx-104 [5] Product Overview - GTx-104 is a novel injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aSAH patients [10][12] - The drug aims to provide a convenient IV delivery method, potentially eliminating the need for nasogastric tube administration and reducing dosing errors [11] Clinical Background - aSAH is a type of stroke that accounts for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [9] - Grace Therapeutics' lead clinical asset, GTx-104, has met its primary endpoint in the Phase 3 STRIVE-ON safety trial, showing clinical benefits over orally administered nimodipine [12]

Financing led by Nantahala Capital and ADAR1 Partners, LP with participation from new and existing healthcare-focused institutional investors $15 million in upfront gross proceeds with the potential to receive up to an additional $15 million in potential warrant exercise proceeds for an aggregate of up to approximately $30 million in potential total gross proceeds PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE), formerly Acasti Pharma Inc. (Grace Therapeutics or th ...

Trial Met the Primary Endpoint and Provides Evidence of GTx-104 Clinical Benefit Compared to Orally Administered Nimodipine New Drug Application (NDA) Submission Expected in the First Half of 2025 PRINCETON, N.J., Feb. 10, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (NASDAQ:GRCE), formerly Acasti Pharma Inc. (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address sig ...

PRINCETON, N.J., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) formerly Acasti Pharma Inc. (Nasdaq: ACST) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous (IV) infusion in aneurysmal subarachnoid hemorrhage (aSAH) patients to address significant unmet medical needs, today announced that Chief Executive Officer Prashant Kohli will participate the fol ...

Grace Therapeutics (GRCE) Update / Briefing November 20, 2024 02:00 PM ET Speaker0 Good afternoon and welcome to the Grace Therapeutics KOL event. At this time, all attendees are in a listen only mode. A question and answer session will follow the formal presentations. If you would like to submit a question, you may do so by using the Q and A text box at the bottom of the webcast player. As a reminder, this call is being recorded and a replay will be made available on the Grace Therapeutics website followin ...

Exhibit 99.1 Grace Therapeutics Announces Second Fiscal Quarter 2025 Financial Results, Provides Business Update STRIVE-ON Data Readout Expected First Calendar Quarter 2025; NDA Submission on Track for 1H Calendar 2025 Completed Corporate Re-Branding, Connecting Company to Rich Scientific Legacy of Grace Therapeutics Announced Completion of Patient Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 Hosting Virtual KOL Event on GTx-104 in aneurysmal Subarachnoid Hemorrhage November 20, 2024 Proj ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.0001 per share GRCE Nasdaq Stock Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Comm ...