Core Insights - 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) patients [1][5][6] - The company will be represented by CEO Prashant Kohli at the Craig-Hallum 16th Annual Alpha Select Conference on November 18, 2025, in New York [1][2] Company Overview - Grace Therapeutics specializes in drug candidates for rare and orphan diseases, utilizing novel drug delivery technologies to enhance drug performance, including faster onset of action and reduced side effects [6] - 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 [6] Product Details - GTx-104 is designed for IV infusion in aSAH patients, addressing significant unmet medical needs and potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients [5] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and lower pharmacokinetic variability compared to oral nimodipine [5] Industry Context - Aneurysmal subarachnoid hemorrhage (aSAH) is a rare type of stroke, accounting for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. [4]

Financial Performance - The company reported a net loss of $0.9 million, or $0.06 per share, for Q2 2026, a decrease of $2.5 million from a net loss of $3.4 million, or $0.30 per share, in Q2 2025[6] - As of September 30, 2025, Grace Therapeutics reported cash and cash equivalents of $16.862 million, a decrease from $22.133 million as of March 31, 2025, representing a decline of approximately 24%[21] - The net loss for the three months ended September 30, 2025, was $0.938 million, compared to a net loss of $3.432 million for the same period in 2024, indicating a 73% improvement year-over-year[22] - The company reported a basic and diluted loss per share of $0.06 for the three months ended September 30, 2025, compared to $0.30 for the same period in 2024, showing a significant improvement[22] - Total liabilities decreased to $3.758 million from $5.383 million, a reduction of approximately 30%[21] Research and Development - Research and development expenses decreased to $0.6 million in Q2 2026 from $3.0 million in Q2 2025, primarily due to the completion of the STRIVE-ON trial[7] - Research and development expenses for the three months ended September 30, 2025, were $0.568 million, down from $2.976 million in the same period of 2024, a reduction of approximately 81%[22] - Grace Therapeutics is focused on the development of GTx-102, which aims to provide clinical benefits for patients with A-T, with a Phase 3 trial expected to commence soon[20] Drug Development and Regulatory Status - FDA accepted the NDA for GTx-104 for aSAH treatment, with a PDUFA target date of April 23, 2026[4] - The STRIVE-ON trial showed a 19% reduction in clinically significant hypotension for patients treated with GTx-104 compared to oral nimodipine[12] - GTx-104 has received Orphan Drug Designation from the FDA, granting seven years of marketing exclusivity upon NDA approval[4] - The company anticipates the potential of its GTx-104 drug candidate to enhance treatment options for patients suffering from aSAH, with ongoing regulatory submissions expected to impact future performance positively[20] Financial Position and Assets - Cash and cash equivalents were approximately $20.0 million as of October 31, 2025, following $4.0 million in funding secured from warrant exercises[5] - Total assets decreased to $66.576 million from $71.993 million, reflecting a reduction of about 7.5%[21] Intellectual Property - The company holds five patents on the composition of GTx-104, providing protection until 2037, with a new patent extending protection for the IV dosing regimen to 2043[4] - Grace Therapeutics continues to evaluate its intellectual property strategy to protect its drug candidates and enhance its market position[20] Market Performance - GTx-104 has been administered to over 200 patients and was well tolerated, showing lower pharmacokinetic variability compared to oral nimodipine[14] - The company estimates a cash runway through at least the next twelve months, potentially extending into Q2 2027 if all common warrants are exercised[11] - The company has reported a change in fair value of derivative warrant liabilities, resulting in a gain of $1.427 million for the three months ended September 30, 2025, compared to a gain of $0.362 million in the same period of 2024[22]

Core Insights - The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for GTx-104, targeting aneurysmal Subarachnoid Hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026 [1][2][3] - GTx-104 is a novel injectable formulation of nimodipine, developed for intravenous infusion, addressing significant unmet medical needs in aSAH patients [1][14] - The Phase 3 STRIVE-ON trial demonstrated positive results, showing improved clinical outcomes and potential pharmacoeconomic benefits for patients treated with GTx-104 compared to oral nimodipine [2][11] Company Highlights - The FDA's acceptance of the NDA for GTx-104 marks a significant milestone for the company, showcasing its ability to execute clinical and corporate goals [2][3] - The company has secured approximately $4.0 million in additional funding through the exercise of common warrants, enhancing its financial position [3][9] - As of October 31, 2025, the company reported cash and cash equivalents of approximately $20.0 million, indicating a solid cash runway [4][10] Financial Performance - For the quarter ended September 30, 2025, the company reported a net loss of $0.9 million, a decrease from a net loss of $3.4 million in the same period of the previous year [5][22] - Research and development expenses significantly decreased to $0.6 million from $3.0 million year-over-year, primarily due to the completion of the STRIVE-ON trial [6][23] - General and administrative expenses increased slightly to $2.0 million, attributed to pre-commercial planning for GTx-104 [7][23] Intellectual Property - The company was granted a new U.S. patent covering the IV dosing regimen for GTx-104, extending its intellectual property protection to 2043 [2][3] - Grace Therapeutics has established a multi-layered intellectual property estate for GTx-104, including five patents on the formulation, providing protection until 2037 [3][17] STRIVE-ON Trial Insights - The STRIVE-ON trial involved 102 patients, comparing GTx-104 with oral nimodipine, and met its primary endpoint with a 19% reduction in clinically significant hypotension incidents [11] - Secondary outcomes favored GTx-104, with 54% of patients achieving a relative dose intensity of 95% or higher compared to only 8% on oral nimodipine [11] - The trial results were well received at the Neurocritical Care annual meeting, highlighting the potential of GTx-104 in improving treatment for aSAH patients [2][3]

Financial Performance - Net loss for the three months ended September 30, 2025, was $938 thousand, compared to a net loss of $3,432 thousand for the same period in 2024, representing a reduction of approximately 72.6%[25] - The company reported a basic and diluted loss per share of $0.06 for the three months ended September 30, 2025, compared to $0.30 for the same period in 2024, reflecting an improvement of 80.0%[25] - The company reported a net loss of $4,301 for the six months ended September 30, 2025, compared to a net loss of $6,049 for the same period in 2024[86] - For the three months ended September 30, 2025, the net loss was $938, a decrease of $2,494 from the net loss of $3,432 for the same period in 2024[169] Expenses - Research and development expenses for the six months ended September 30, 2025, were $1,523 thousand, down from $5,684 thousand in the same period of 2024, a decrease of approximately 73.3%[25] - The company incurred total operating expenses of $2,529 thousand for the three months ended September 30, 2025, down from $4,831 thousand in the same period of 2024, a decrease of approximately 47.7%[25] - Research and development expenses for the three months ended September 30, 2025, were $568, down from $2,976 for the same period in 2024, a decrease of $2,408[173] - General and administrative expenses for the three months ended September 30, 2025, were $1,961, an increase of $106 from $1,855 for the same period in 2024[180] Assets and Liabilities - Total assets decreased from $71,993 thousand as of March 31, 2025, to $66,576 thousand as of September 30, 2025, a decline of approximately 7.4%[23] - The company’s accumulated deficit increased to $224,987 thousand as of September 30, 2025, from $220,687 thousand as of March 31, 2025, an increase of approximately 1.4%[23] - As of September 30, 2025, total assets measured at fair value were $14,969, with treasury bills classified as cash equivalents contributing $14,969[51] - Total liabilities measured at fair value were $201, primarily from derivative warrant liabilities[51] Cash Flow - Cash and cash equivalents decreased from $22,133 thousand at the beginning of the period to $16,862 thousand at the end of the period, a decrease of approximately 24.0%[29] - Net cash used in operating activities for the six months ended September 30, 2025, was $4,944, a decrease of $2,891 compared to $7,835 for the same period in 2024, primarily due to a $4,248 decrease in research and development activities[188] - Net cash used in financing activities for the six months ended September 30, 2025, was $327 related to stock issuance costs from the 2025 Private Placement, with no financing activities reported for the same period in 2024[190] Funding and Capital Raising - The company completed a private placement in February 2025, raising net proceeds of $13,705 thousand to support its operations[34] - The company raised $13,705 in net proceeds from the 2025 Private Placement, which closed on February 11, 2025[60] - The 2023 Private Placement generated net proceeds of $7,338 after deducting fees and expenses[62] - The company plans to raise additional capital to maintain adequate liquidity, as it does not expect to generate revenue from product sales until regulatory approval is obtained[187] Product Development - The company has submitted a New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine, with the FDA establishing April 23, 2026, as the target date for review completion[104] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating well-tolerated results with significantly lower pharmacokinetic variability compared to oral nimodipine[110] - GTx-104 aims to address significant unmet medical needs in aSAH patients, potentially improving patient outcomes through better management of hypotension and reduced dosing errors[118] - GTx-102, another drug candidate, has completed a Phase-1 pharmacokinetic study with no serious adverse events reported, targeting treatment for ataxia-telangiectasia in pediatric patients[110] Market Opportunity - The market opportunity for GTx-104 includes approximately 42,500 aSAH patients in the U.S. annually, with potential estimates suggesting up to 70,000 cases per year[120] - A market research survey indicated an 80% likelihood of adoption for an IV formulation of nimodipine among hospital administrators and critical care physicians, assuming improved bioavailability and safety[121] - GTx-102 has a potential total addressable market of $150 million in the U.S., affecting approximately 4,300 patients per year[145] - GTx-101 has a total addressable market estimated at $2.5 billion, with $200 million for PHN pain and $2.3 billion for non-PHN pain indications[158] Executive Compensation - Mr. DelAversano has an annual base salary of $306,360 and a discretionary bonus of up to 30% of his base salary[216] - Mr. Kumar has an annual base salary of $310,000 and a discretionary bonus of up to 30% of his base salary[216] - Ms. D'Andrea has an annual base salary of $310,000 and a discretionary bonus of up to 30% of her base salary[216] - Mr. Macdonald has an annual base salary of $200,000 and a discretionary bonus of up to 30% of his base salary[216]

Core Insights - Grace Therapeutics, Inc. announced that the abstract of its Pivotal Phase 3 STRIVE-ON Safety Trial for GTx-104 has been accepted for late-breaking presentation at the Society of Vascular and Interventional Neurology annual meeting [1][2] Company Overview - Grace Therapeutics is a late-stage biopharma company focused on developing drug candidates for rare and orphan diseases, with a lead clinical asset, GTx-104, targeting aneurysmal subarachnoid hemorrhage (aSAH) [5] - The company utilizes novel drug delivery technologies aimed at improving the performance of existing drugs, achieving faster onset of action, enhanced efficacy, and reduced side effects [5] Product Details - GTx-104 is a clinical-stage injectable formulation of nimodipine designed for IV infusion in aSAH patients, addressing significant unmet medical needs [4] - The unique nanoparticle technology of GTx-104 allows for an aqueous formulation of insoluble nimodipine, facilitating standard peripheral IV infusion [4] - GTx-104 has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [4] Clinical Trial Information - The STRIVE-ON trial (NCT05995405) focuses on the safety and tolerability of GTx-104 compared to oral nimodipine in patients with aSAH [3] - The oral presentation of the trial results is scheduled for November 21, 2025, at the SVIN annual meeting [2][3] Market Context - Aneurysmal subarachnoid hemorrhage (aSAH) accounts for approximately 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [3]

Company Overview - Grace Therapeutics, Inc. is a late-stage biopharma company focused on developing GTx-104, a novel injectable formulation of nimodipine for I.V. infusion targeting aneurysmal subarachnoid hemorrhage (aSAH) [6] - The company has received Orphan Drug Designation from the FDA for its lead clinical asset, GTx-104, which provides seven years of marketing exclusivity post-launch in the U.S. [6] Funding and Financials - The company secured approximately $4.0 million in additional funding through the exercise of common warrants, issuing 1,345,464 new shares at an exercise price of $3.003 per share [1] - The remaining 1,190,927 common warrants from the 2023 private placement have expired following the FDA's acceptance for review of the NDA for GTx-104 [1] Product Development - GTx-104 is being developed to address significant unmet medical needs in aSAH patients, with a PDUFA target date set by the FDA for April 23, 2026, for the NDA review [2] - The NDA submission is supported by positive data from the Phase 3 STRIVE-ON safety trial of GTx-104 [2] Medical Context - aSAH is a type of stroke caused by the rupture of an aneurysm, accounting for about 5% of all strokes, with an estimated 42,500 hospital-treated patients in the U.S. annually [3] - GTx-104 aims to provide a convenient I.V. delivery method, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients, and has been administered to over 200 patients and healthy volunteers [5] Technology and Advantages - GTx-104 utilizes unique nanoparticle technology to facilitate the aqueous formulation of insoluble nimodipine for standard peripheral I.V. infusion [4] - The intravenous delivery of GTx-104 may lower food effects, drug-to-drug interactions, and dosing errors, while better managing hypotension in aSAH patients [5]

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]