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]

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 ...

Summary of Grace Therapeutics KOL Event on GTX-one 104 Company Overview - **Company Name**: Grace Therapeutics (formerly Acasti) [4][3] - **Product Focus**: GTX-one 104, a novel injectable formulation of nimodipine, in late-stage clinical development [3][4] Industry Context - **Target Indication**: Aneurysmal subarachnoid hemorrhage (ASAH) [4] - **Current Treatment Landscape**: Nimodipine is the only FDA-approved drug for neuroprotection in ASAH, available only in oral formulations [16][24] Key Points Discussed Clinical Development and Trials - **Pivotal Phase III Trial**: The STRIGON trial for GTX-one 104 was fully enrolled in September 2024, with data readout expected in Q1 2025 [4] - **Market Opportunity**: GTX-one 104 aims to address significant unmet needs in ASAH treatment, particularly due to limitations of current oral formulations [4][24] Disease Overview - **Prevalence and Impact**: Approximately 2% to 8% of the population has aneurysms, with a global incidence of ASAH around 6 per 100,000 person-years [9][10] - **Mortality Rates**: Pre-hospital mortality for aneurysm rupture is between 22% and 26%, with an additional 20% mortality for those reaching the hospital [11] Challenges with Current Treatment - **Limitations of Oral Nimodipine**: - Requires frequent dosing (60 mg every 4 hours) which can lead to hypotension in 25% of patients [32][30] - Many patients (30%) present with dysphagia, complicating oral administration [33] - Gastrointestinal intolerance affects up to 80% of patients, leading to complications like diarrhea [35] - Less than half of patients receive the full 21-day course, impacting outcomes [36] Advantages of GTX-one 104 - **Intravenous Formulation Benefits**: - Provides guaranteed drug exposure and allows for titratable dosing, addressing hypotension and absorption issues [42][39] - Flexibility in administration, especially for patients unable to take oral medications [40][42] - Consistent bioavailability, reducing variability in patient response [62] Clinical Implications - **Potential for Improved Outcomes**: Consistent exposure to nimodipine is linked to better functional outcomes, particularly in patients with higher-grade ASAH [39][45] - **Integration into Clinical Practice**: The introduction of GTX-one 104 could enhance treatment protocols in neurocritical care settings, where titratable IV medications are preferred [56][57] Additional Considerations - **Regulatory Pathway**: Approval of GTX-one 104 will require a review process by pharmacy and therapeutics committees, assessing clinical benefits and cost-effectiveness [43][44] - **Future Research**: Comparative studies may be necessary to establish the efficacy of GTX-one 104 against existing treatments [52][54] Conclusion - **Strategic Importance**: GTX-one 104 represents a significant advancement in the treatment of ASAH, addressing critical limitations of current therapies and potentially improving patient outcomes in a high-mortality condition [45][46]