PRINCETON, N.J., March 19, 2026 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (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 infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that abstracts discussing the unmet medical needs and the potential benefits of GTx-104 have been accepted for pres ...

Summary of Grace Therapeutics FY Conference Call Company Overview - **Company**: Grace Therapeutics (NasdaqCM:GRCE) - **Focus**: Development of GTx-104 for the treatment of aneurysm subarachnoid hemorrhage (aSAH) - **PDUFA Date**: April 23, 2026, for GTx-104 approval Core Industry Insights - **Disease Context**: aSAH is a critical care condition with high mortality (one-third of patients do not survive) and morbidity (one-third suffer long-term effects) [3][4] - **Current Treatment**: The only FDA-approved drug for aSAH is nimodipine, which is administered orally and has significant limitations, including a dosing burden and poor pharmacokinetics [4][6] GTx-104 Innovation - **Formulation**: GTx-104 is the first aqueous formulation of nimodipine that can be administered via intravenous infusion, addressing the challenges of the oral formulation [5] - **Clinical Advantages**: - Over 90% of patients on oral nimodipine do not receive the full therapeutic dose due to hypotension and other complications [6][7] - IV administration shows better pharmacokinetics, with a 2-3x lower variability compared to oral [7][8] - Improved ICU workload management and reduced complications associated with oral administration [9] STRIVE-ON Study - **Study Design**: Phase 3 safety trial comparing IV GTx-104 to oral nimodipine, involving 100 patients across 30 high-volume academic centers [12][13] - **Primary Endpoint**: Clinically significant hypotension events; IV arm showed almost 20% fewer events compared to oral [15] - **Relative Dose Intensity (RDI)**: 55% of IV patients achieved 95% or higher RDI, compared to only 8% in the oral group [16] - **Efficacy Signals**: Nearly 30% of IV patients showed good functional recovery, with zero bedridden patients at day 90 compared to 15-16% in the oral arm [17][18] Key Opinion Leader (KOL) Feedback - KOLs are enthusiastic about the potential for better hypotension control and higher dose compliance with GTx-104, which may lead to improved patient outcomes [19] Regulatory and Market Strategy - **Regulatory Engagement**: Positive interactions with the FDA leading up to the NDA submission, with no alarming issues raised [23] - **Market Education**: Ongoing efforts to educate healthcare professionals about the limitations of oral nimodipine and the benefits of GTx-104, including two major continuing medical education events attended by 10,000 healthcare professionals [25][26] Market Potential - **Patient Population**: Estimated 45,000 cases of aSAH annually in the U.S., with a focus on severe cases (Hunt and Hess grades 3-5) [32][41] - **Value Proposition**: Emphasis on hemodynamic stability, reliable drug exposure, and reduced ICU workload [33] Pricing Strategy - Ongoing work to determine pricing for GTx-104, considering the current market for oral nimodipine and the need to maximize patient access [34][36] Intellectual Property - **Protection**: Orphan drug designation expected to convert to exclusivity upon approval, with patents extending to 2043 for method of use and 2037 for formulations [43][44] Conclusion - Grace Therapeutics is positioned to potentially transform the treatment landscape for aSAH with GTx-104, addressing significant limitations of current therapies and aiming for a strong market entry following FDA approval.

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 aimed at treating aneurysmal subarachnoid hemorrhage (aSAH) patients [1][4] Company Overview - Grace Therapeutics specializes in drug candidates for rare and orphan diseases, utilizing innovative drug delivery technologies to enhance drug performance, including faster onset of action and reduced side effects [5] - 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. under certain conditions [5] 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 [4] - The product has been administered to over 200 patients and healthy volunteers, demonstrating good tolerance and significantly lower pharmacokinetic variability compared to oral nimodipine [4] 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. [3]

Financial Performance - The company reported a net loss of approximately $2.3 million, or $0.14 per share, for Q3 2026, a decrease of $1.8 million from a net loss of $4.2 million, or $0.36 per share, in Q3 2025[5]. - The net loss for the three months ended December 31, 2025, was $2.315 million, compared to a net loss of $4.155 million for the same period in 2024, indicating an improvement of approximately 44.5%[20]. - The company reported a basic and diluted loss per share of $0.14 for the three months ended December 31, 2025, compared to $0.36 for the same period in 2024, showing a decrease of approximately 61.1%[20]. Research and Development - Total research and development expenses for Q3 2026 were $0.5 million, down from $2.2 million in Q3 2025, primarily due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON safety clinical trial[6]. - Research and development expenses for the three months ended December 31, 2025, were $462 thousand, significantly lower than $2.194 million for the same period in 2024, a reduction of about 78.9%[20]. - The company anticipates potential clinical benefits from GTx-102 in decreasing symptoms associated with A-T, with a Phase 3 trial planned[18]. Cash and Funding - As of December 31, 2025, cash and cash equivalents were $18.7 million, a decrease of $3.4 million compared to $22.1 million at March 31, 2025[8]. - The company secured approximately $4.0 million in additional funding through the exercise of common warrants at an exercise price of $3.003 per share[4]. - The company plans to utilize its cash reserves for regulatory review, pre-commercial planning, and potential product launch of GTx-104 if approved[10]. - Grace Therapeutics is actively managing its cash runway and exploring opportunities for market expansion and new product development[18]. Assets and Liabilities - Total assets decreased to $68.488 million as of December 31, 2025, down from $71.993 million on March 31, 2025, reflecting a reduction of about 4.3%[19]. - Total liabilities decreased to $3.596 million as of December 31, 2025, down from $5.383 million on March 31, 2025, a decline of about 33.2%[19]. - The accumulated deficit increased to $227.302 million as of December 31, 2025, compared to $220.687 million on March 31, 2025, reflecting an increase of approximately 3%[19]. Product Development and Market Position - The STRIVE-ON trial demonstrated a 19% reduction in clinically significant hypotension for patients treated with GTx-104 compared to oral nimodipine (28% vs. 35%) and showed improved functional outcomes at 90 days[11]. - The company anticipates potential FDA approval of GTx-104 by the PDUFA target date of April 23, 2026, supported by a robust data package from the STRIVE-ON trial[3]. - GTx-104 is positioned to address significant unmet medical needs in aSAH patients, with the standard of care having seen no meaningful innovation in nearly 40 years[3]. - Grace Therapeutics is focused on the development of GTx-104 and GTx-102 drug candidates, with ongoing regulatory submissions and trials expected to impact future performance[18]. - The company has over 40 granted and pending patents, enhancing the long-term market value of GTx-104[16].

Core Viewpoint - Grace Therapeutics is advancing GTx-104, a novel injectable formulation of nimodipine for the treatment of aneurysmal subarachnoid hemorrhage (aSAH), with a PDUFA target date set for April 23, 2026, for FDA review of its NDA submission [1][2]. Company Developments - The company is engaged in pre-commercial planning in anticipation of potential FDA approval for GTx-104, supported by positive results from the STRIVE-ON trial, which demonstrated improved clinical outcomes for aSAH patients [2][4]. - The STRIVE-ON trial results were presented at the Society of Vascular and Interventional Neurology annual meeting in November 2025, highlighting the safety and tolerability of GTx-104 compared to oral nimodipine [5][11]. - The company secured approximately $4.0 million in additional funding through the exercise of common warrants, enhancing its financial position for ongoing operations [5]. Financial Performance - For the quarter ended December 31, 2025, the company reported a net loss of approximately $2.3 million, a decrease from a net loss of $4.2 million in the same quarter of the previous year, primarily due to reduced research and development expenses [4][22]. - Research and development expenses for the same period were $0.5 million, significantly lower than $2.2 million in the prior year, reflecting the completion of the STRIVE-ON trial [6]. - General and administrative expenses increased to $2.0 million, up from $1.5 million, attributed to costs associated with GTx-104 pre-commercial planning [7]. Cash Position - As of December 31, 2025, the company had cash and cash equivalents of $18.7 million, a decrease from $22.1 million at the end of March 2025, indicating a need for careful cash management moving forward [8][10]. Market Context - aSAH is a rare and serious condition that has not seen significant innovation in treatment for nearly 40 years, positioning GTx-104 as a potentially transformative therapy if approved [2][12]. - The company holds a strong patent estate that could enhance the long-term market value of GTx-104, benefiting shareholders [2].

Financial Performance - The net loss for the three months ended December 31, 2025, was $2,315,000, a reduction of 45% compared to a net loss of $4,155,000 for the same period in 2024[23]. - The company reported a net loss of $6,615,000 for the nine months ended December 31, 2025, compared to a net loss of $10,204,000 for the same period in 2024[76]. - The effective income tax rate for the nine months ended December 31, 2025, was 0.0%, compared to 17.6% for the same period in 2024, primarily due to a partial valuation allowance against net domestic deferred tax assets[78][79]. - The net loss for the three months ended December 31, 2025, was $2,315, or $0.14 per share, a decrease of $1,840 from a net loss of $4,155, or $0.36 per share, for the same period in 2024[162]. Assets and Liabilities - As of December 31, 2025, total assets decreased to $68,488,000 from $71,993,000 as of March 31, 2025, representing a decline of approximately 4%[21]. - Cash and cash equivalents at the end of the period were $18,672,000, a decrease of 16.6% from $22,133,000 at the beginning of the period[26]. - The accumulated deficit increased to $227,302,000 as of December 31, 2025, from $220,687,000 as of March 31, 2025[21]. - Total trade and other payables decreased from $1,930 as of March 31, 2025 to $1,284 as of December 31, 2025, indicating a reduction of approximately 33.5%[49]. Research and Development - Research and development expenses for the nine months ended December 31, 2025, were $1,985,000, down 75% from $7,877,000 in the same period of 2024[23]. - Clinical development program expenses for the nine months ended December 31, 2025, were $651,000, significantly reduced from $6,977,000 in the same period of 2024[76]. - Total research and development expenses for the nine months ended December 31, 2025, were $1,985, down from $7,877 for the same period in 2024, a decrease of $5,892[167]. - The company reported a $5,892 decrease in research and development expenses due to the completion of the GTx-104 pivotal Phase 3 STRIVE-ON trial[181]. Capital and Financing - The company raised $4,040,000 in gross proceeds from the exercise of common warrants in October 2025[33]. - The Company completed a private placement in February 2025, raising net proceeds of $13,705 from the sale of 3,252,132 shares of Common Stock at $3.395 per share[56]. - In the 2023 Private Placement, the Company raised $7,338 from the sale of 1,951,371 Common Shares at $1.848 per share[58]. - The company plans to raise additional capital to maintain liquidity and fund operations beyond the next 12 months[180]. Strategic Plans and Operations - A strategic realignment plan was implemented in May 2023, resulting in a streamlined organization focused on the development of GTx-104[31]. - The company plans to use existing cash for regulatory review, pre-commercial planning, and product launch for GTx-104, expecting sufficient funds for at least 12 months[34]. - The company has incurred operating losses and negative cash flows since inception, indicating a need for additional capital to fund operations[29]. - The company expects general and administrative expenses to continue increasing as it advances research and development programs and prepares for potential commercial launch of GTx-104[171]. Product Development and Market Potential - The company has submitted a New Drug Application (NDA) for GTx-104, a novel injectable formulation of nimodipine, to the FDA, with a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for review completion[94][115]. - GTx-104 has shown a 19% reduction in clinically significant hypotension incidents compared to oral nimodipine in the Phase 3 STRIVE-ON trial, with rates of 28% for GTx-104 versus 35% for oral nimodipine[114]. - Approximately 42,500 patients in the U.S. are affected by aneurysmal subarachnoid hemorrhage (aSAH) annually, with potential market research suggesting incidence could be as high as 70,000[110]. - The total addressable market for GTx-101, targeting postherpetic neuralgia (PHN), could reach $2.5 billion, with approximately $200 million specifically for PHN pain[151]. Intellectual Property - The company holds over 40 granted and pending patents globally, with the new patent for GTx-104 extending protection to 2043, enhancing its intellectual property position[89][96]. - The 2024 Equity Incentive Plan was approved on September 30, 2024, replacing prior plans, with 1,350,000 shares authorized for issuance and 964,470 shares available for future issuance as of December 31, 2025[64][67]. Financial Reporting and Compliance - The unaudited condensed consolidated financial statements reflect all necessary adjustments for fair presentation as of December 31, 2025, including results for the three and nine months ended December 31, 2025 and 2024[38]. - The Company has not made any changes to its significant accounting policies since the last audited financial statements for the year ended March 31, 2025[40]. - There were no changes to internal controls over financial reporting during the quarter ended December 31, 2025, that materially affected the company's financial reporting[195]. - The company’s disclosure controls and procedures were evaluated as effective as of December 31, 2025, providing reasonable assurance against errors and fraud[194].

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]