Clinical Trials and Drug Development - The Phase 3 STRIVE-ON safety trial met its primary endpoint, demonstrating improved clinical outcomes for patients compared to orally administered nimodipine[2] - The company anticipates submitting a New Drug Application (NDA) for GTx-104 in the first half of calendar year 2025[4] - The company is focusing on pre-commercial planning and building a commercial team in anticipation of GTx-104's potential approval[3] Financial Performance - For the third fiscal 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[5] - The net loss for the nine months ended December 31, 2024, was $10,204,000, compared to a net loss of $9,687,000 for the same period in 2023, reflecting an increase of 5.3%[18] - The total loss before income tax benefit for the nine months ended December 31, 2024, was $12,385,000, up from $10,630,000 in the same period of 2023[18] - Basic and diluted loss per share for Q3 2024 was $0.36, compared to $0.21 in Q3 2023, indicating a deterioration in earnings per share[18] Expenses and Cash Flow - Research and development expenses for the quarter were $2.2 million, up from $1.4 million in the same quarter of 2023, primarily due to increased activities for the GTx-104 trial[6] - General and administrative expenses were $1.5 million for the quarter, a slight decrease from $1.6 million in the same quarter of 2023[7] - Research and development expenses for Q3 2024 were $2,194,000, an increase of 52% compared to $1,443,000 in Q3 2023[18] - General and administrative expenses decreased slightly to $1,510,000 in Q3 2024 from $1,600,000 in Q3 2023[18] - As of December 31, 2024, cash and cash equivalents were $11.1 million, a decrease of $11.9 million from $23.0 million at March 31, 2024[8] Assets and Deficits - Total assets decreased to $61.2 million as of December 31, 2024, down from $73.3 million at March 31, 2024[17] - The company’s accumulated deficit increased to $221.3 million as of December 31, 2024, compared to $211.1 million at March 31, 2024[17] Financing Activities - The company secured a private placement financing of up to approximately $30 million, with $15 million received upfront and the potential for an additional $15 million upon warrant exercise[4] Other Financial Metrics - The company reported a foreign exchange loss of $16,000 in Q3 2024, compared to a gain of $3,000 in Q3 2023[18] - Interest and other income, net, decreased to $138,000 in Q3 2024 from $316,000 in Q3 2023[18] - The weighted-average number of shares outstanding increased to 11,506,234 in Q3 2024 from 8,874,872 in the same quarter of the previous year[18] - The income tax benefit for the nine months ended December 31, 2024, was $2,181,000, compared to $943,000 for the same period in 2023[18] - The company did not incur any restructuring costs in Q3 2024, while it had restructuring costs of $1,485,000 in the same period of 2023[18]

Financial Performance - Net loss for the three months ended December 31, 2024, was $4,155,000, compared to a net loss of $2,391,000 for the same period in 2023, representing an increase of 74%[20] - The company reported a basic and diluted loss per share of $0.36 for the three months ended December 31, 2024, compared to $0.21 for the same period in 2023, an increase of 71%[20] - The net loss for the three months ended December 31, 2024, was $4.2 million, or $0.36 per share, compared to a net loss of $2.4 million, or $0.21 per share, for the same period in 2023[170] Assets and Liabilities - Total current assets decreased from $24,010,000 on March 31, 2024, to $11,939,000 on December 31, 2024, a decline of approximately 50%[18] - Cash and cash equivalents decreased from $23,005,000 at the beginning of the period to $11,055,000 at the end of the period, a decrease of 52%[24] - The accumulated deficit increased from $211,119,000 on March 31, 2024, to $221,323,000 on December 31, 2024, an increase of approximately 5%[18] - Total liabilities decreased from $11,557,000 on March 31, 2024, to $9,085,000 on December 31, 2024, a reduction of approximately 21%[18] Research and Development - Research and development expenses for the nine months ended December 31, 2024, were $7,877,000, up from $2,998,000 in the same period of 2023, an increase of 163%[20] - Research and development expenses for the three months ended December 31, 2024, were $2.2 million, an increase of $751,000 from $1.4 million in the same period in 2023[170] - Research and development expenses for the nine months ended December 31, 2024, totaled $7.9 million, up from $3.0 million in the same period in 2023, reflecting increased activities for the GTx-104 pivotal Phase 3 trial[175] Capital and Funding - The Company raised approximately $7,500 from the 2023 Private Placement, issuing 1,951,371 Common Shares at a price of $1.848 per share[33] - The net proceeds from the 2025 Private Placement were approximately $13,800, intended for clinical trial expenses and product launch preparations for GTx-104[34][35] - The Company plans to raise additional capital to maintain adequate liquidity and fund operations beyond the next 12 months[36] - The company completed a private placement in February 2025, raising approximately $13.8 million in net proceeds[168] Clinical Development - The company has three clinical-stage drug candidates aimed at treating rare and orphan diseases, supported by over 40 granted and pending patents worldwide[91] - GTx-104, an injectable formulation of nimodipine, aims to address significant unmet medical needs in aSAH patients and has shown improved bioavailability with 100% compared to oral forms[110] - The STRIVE-ON trial for GTx-104 met its primary endpoint, demonstrating clinical benefit over orally administered nimodipine, with an NDA submission planned for the first half of 2025[100] - GTx-102, an oral-mucosal betamethasone spray for A-T, is in development with FDA guidance received for a pivotal efficacy and safety trial[101] - The company has deferred the clinical development of GTx-102 and GTx-101 for at least three years to focus resources on GTx-104[96] Market Potential - The total addressable market for aSAH in the U.S. is estimated at approximately $300 million, with around 150,000 annual cases in China and 60,000 in the European Union[117] - GTx-102 has a potential total addressable market of $150 million in the U.S., affecting approximately 4,300 patients annually[133] - GTx-101 has a total addressable market estimated at $2.5 billion, with approximately $200 million for postherpetic neuralgia (PHN) pain and $2.3 billion for non-PHN pain indications[152] Operational Changes - The company implemented a strategic realignment plan in May 2023, resulting in a streamlined workforce and a focus on the development of its lead product candidate GTx-104[31] - The company incurred $1,485 million in restructuring costs during the nine months ended December 31, 2023, primarily due to employee severance costs and legal fees[82] - The company incurred $1.5 million in restructuring costs related to workforce termination announced on May 8, 2023[182] Financial Controls and Compliance - Management concluded that existing disclosure controls and procedures were effective as of December 31, 2024, providing reasonable assurance but not absolute assurance against errors and fraud[209] - No changes were made to internal controls over financial reporting during the quarter ended December 31, 2024, that materially affected internal controls[210] - The company is not currently a party to any legal proceedings likely to have a material adverse effect on its business[212] - There have been no material changes from the risk factors disclosed in the Annual Report[214]

Financial Performance - The company reported a net loss of $3.4 million, or $0.30 per share, for the quarter ended September 30, 2024, compared to a net loss of $3.3 million, or $0.43 per share, for the same period in 2023[6]. - The net loss for the three months ended September 30, 2023, was $3,432,000, compared to a net loss of $3,273,000 for the same period in 2022, indicating an increase in loss of approximately 4.9%[23]. - The company reported a basic and diluted loss per share of $0.30 for the three months ended September 30, 2023, compared to $0.43 for the same period in 2022[23]. Research and Development - Research and development expenses increased to $3.0 million for the quarter, up from $0.5 million in the same quarter of 2023, primarily due to activities related to the GTx-104 pivotal Phase 3 STRIVE-ON safety trial[7]. - Research and development expenses for the three months ended September 30, 2023, were $2,976,000, while general and administrative expenses were $1,855,000[23]. - Patient enrollment in the Phase 3 STRIVE-ON safety trial was completed ahead of schedule, with a data readout expected in the first calendar quarter of 2025[4]. Financial Position - The company had cash and cash equivalents of $15.1 million as of September 30, 2024, a decrease of $7.9 million from $23.0 million as of March 31, 2024, with a projected cash runway into the second calendar quarter of 2026[9]. - As of September 30, 2024, total assets decreased to $65,349,000 from $73,300,000 as of March 31, 2024, representing a decline of approximately 10.2%[19]. - Current assets fell to $16,062,000 from $24,010,000, a decrease of about 33.1%[19]. - Total liabilities decreased to $9,215,000 from $11,557,000, a reduction of approximately 20.2%[19]. - Shareholders' equity decreased to $56,134,000 from $61,743,000, reflecting a decline of about 9.1%[19]. Corporate Developments - The company completed its redomicile to Delaware and rebranded to Grace Therapeutics, with trading under the symbol "GRCE" on Nasdaq effective October 28, 2024[5]. - The company plans to submit a New Drug Application (NDA) to the FDA in the first half of calendar 2025[4]. - A virtual Key Opinion Leader event is scheduled for November 20, 2024, to discuss the treatment landscape for aneurysmal Subarachnoid Hemorrhage (aSAH) patients[10]. Product Information - The addressable market for GTx-104 in the United States is estimated to be approximately $300 million[14]. - GTx-104 is a novel injectable formulation of nimodipine being developed for intravenous infusion in aSAH patients, addressing significant unmet medical needs[13]. Other Financial Metrics - The company experienced a foreign exchange gain of $13,000 for the three months ended September 30, 2023, compared to a loss of $13,000 in the previous year[23]. - The change in fair value of derivative warrant liabilities resulted in a gain of $362,000 for the three months ended September 30, 2023[23]. - General and administrative expenses were $1.9 million for the quarter, an increase of $0.3 million from $1.6 million in the same quarter of 2023[8]. - The weighted average number of shares outstanding increased to 11,506,234 for the three months ended September 30, 2023, compared to 7,552,677 for the same period in 2022[23].

Financial Performance - As of September 30, 2024, total assets decreased to $65,349,000 from $73,300,000 as of March 31, 2024, representing a decline of approximately 10.8%[18] - Cash and cash equivalents decreased to $15,155,000 from $23,005,000, a reduction of about 34.3%[18] - The net loss for the quarter was $3,432,000, compared to a net loss of $3,273,000 for the same quarter in 2023, indicating a year-over-year increase of about 4.9%[20] - Basic and diluted loss per share for the quarter was $0.30, compared to $0.43 for the same quarter in 2023, reflecting a decrease of approximately 30.2%[20] - The net loss for the six months ended September 30, 2024, was $6,049,000, compared to a net loss of $7,296,000 for the same period in 2023, representing a 17.1% improvement[8] - For the three months ended September 30, 2024, the net loss was $3.4 million, or $0.30 per share, an increase of $159 from the net loss of $3.3 million, or $0.43 per share, for the same period in 2023[150] Research and Development - Research and development expenses for the quarter ended September 30, 2024, were $2,976,000, significantly higher than $460,000 for the same period in 2023, marking an increase of approximately 548.7%[20] - Total research and development expenses for the six months ended September 30, 2024, were $5.684 million, compared to $1.5 million for the same period in 2023, reflecting a $4.184 million increase[154] - The company incurred a $4.2 million increase in research and development activities for the GTx-104 pivotal Phase 3 STRIVE-ON trial protocol during the second quarter of 2025[170] Cash Flow and Liquidity - The company incurred a net cash used in operating activities of $7,835,000 for the six months ended September 30, 2024, compared to $8,353,000 for the same period in 2023, a decrease of 6.2%[8] - The company expects its existing cash and cash equivalents to fund operations into the second calendar quarter of 2026[31] - The company believes its cash runway will be sufficient to fund operations into the second calendar quarter of 2026[149] - The company plans to raise additional capital to maintain adequate liquidity beyond the second quarter of 2026[32] Shareholder Equity and Liabilities - Shareholders' equity decreased to $56,134,000 from $61,743,000, a decline of about 9.1%[19] - Total current liabilities increased to $2,674,000 from $1,684,000, an increase of approximately 58.8%[19] - Total liabilities as of September 30, 2024, were $4,359 million, entirely attributed to derivative warrant liabilities measured at fair value[45] Corporate Developments - The company changed its corporate name to Grace Therapeutics, Inc. effective October 28, 2024, with common stock trading under the symbol "GRCE" on Nasdaq[147] - The company has implemented a strategic realignment plan to enhance shareholder value, resulting in a streamlined workforce and focused development on its lead product candidate GTx-104[30] Product Development and Market Potential - GTx-104 is a clinical-stage injectable formulation of nimodipine for IV infusion in aSAH patients, addressing significant unmet medical needs[91] - The total addressable market for aSAH in the U.S. is estimated at approximately $300 million, with around 50,000 patients affected annually[105] - GTx-104 has demonstrated 100% bioavailability compared to approximately 8% for oral nimodipine capsules, significantly reducing dosing variability[109] - The pivotal Phase 3 STRIVE-ON trial for GTx-104 is expected to enroll approximately 100 patients across 25 hospitals in the U.S.[112] - The first patient in the STRIVE-ON trial was enrolled on October 23, 2023, with data readout anticipated in the first quarter of 2025[115] Clinical Trials and Regulatory Plans - The company plans to submit a New Drug Application (NDA) for GTx-104 in the first half of 2025, pending trial results[115] - The company has deferred the clinical development of GTx-102 and GTx-101 for at least three years to prioritize GTx-104[94] Restructuring and Cost Management - The company incurred restructuring costs of $1.5 million in the six months ended September 30, 2023, with no restructuring costs reported for the same period in 2024[161] - The company has $398 million of commitments to contract manufacturing organizations (CMOs) and $3.9 million of commitments to contract research organizations (CROs) for the next twelve months[72] Patents and Intellectual Property - The company has a portfolio of more than 40 granted and pending patents in various jurisdictions worldwide supporting its therapeutic pipeline[86] - The company has three unique clinical-stage drug candidates that have received orphan drug designation (ODD) status, which provides seven years of marketing exclusivity in the U.S. post-launch[87]

Core Viewpoint - Acasti Pharma Inc. is rebranding to Grace Therapeutics, reflecting its historical roots and scientific innovation, with a focus on advancing its lead drug candidate GTx-104 for treating aneurysmal subarachnoid hemorrhage (aSAH) [1][2] Company Overview - Acasti Pharma Inc. will begin trading under the new name Grace Therapeutics on Nasdaq with the symbol "GRCE" starting October 28, 2024 [1] - The company has made significant progress in the clinical development of GTx-104, including full enrollment of the STRIVE-ON trial, with data expected in early 2025 and a New Drug Application (NDA) submission anticipated in the first half of 2025 [2][3] Product Development - GTx-104 is a novel injectable formulation of nimodipine designed for intravenous infusion in aSAH patients, addressing significant unmet medical needs [4][5] - The U.S. addressable market for GTx-104 is estimated to be approximately $300 million based on market research [5] Corporate Strategy - The company has restructured to an agile biopharma model, rebuilt its management team, prioritized its pipeline, divested legacy assets, and re-domiciled to the U.S. as a Delaware corporation [3] - These strategic steps are expected to enhance the company's attractiveness to potential strategic partners and global institutional investors [3] Upcoming Events - A virtual Key Opinion Leader (KOL) event on GTx-104 is scheduled for November 20, 2024, to discuss its application in aSAH [3]

Financial Performance - Acasti reported a net loss of $2.6 million, or $0.24 loss per share, for the quarter ended June 30, 2024, a decrease of $1.4 million from the net loss of $4.0 million, or $0.54 per share, for the same quarter in 2023[4]. - The net loss for Q2 2024 was $2,617,000, an improvement from a net loss of $4,023,000 in Q2 2023[42]. - Basic and diluted loss per share improved to $0.24 in Q2 2024 from $0.54 in Q2 2023[42]. - Loss before income tax recovery decreased to $3,341,000 in Q2 2024 from $4,312,000 in Q2 2023, indicating a positive trend[42]. Research and Development - Total research and development expenses for the quarter were $2.7 million, compared to $1.1 million for the quarter ended June 30, 2023, reflecting an increase of $1.6 million due to heightened research activities for GTX-104[4]. - Research and development expenses increased to $2,708,000 in Q2 2024 from $1,095,000 in Q2 2023, representing a significant rise[41]. General and Administrative Expenses - General and administrative expenses increased to $2.3 million for the quarter ended June 30, 2024, up from $1.9 million for the same period in 2023, primarily due to increased professional fees[5]. - General and administrative expenses rose to $2,255,000 in Q2 2024 compared to $1,874,000 in Q2 2023, indicating an increase[41]. Cash and Assets - As of June 30, 2024, Acasti had cash and cash equivalents of $19.4 million, down from $23.0 million as of March 31, 2024, with a projected cash runway into the second calendar quarter of 2026[5]. - Cash and cash equivalents at June 30, 2024, were $19.4 million, down from $23.0 million as of March 31, 2024, with sufficient cash projected to support operations into the second calendar quarter of 2026[26]. - The total assets decreased to $69.7 million as of June 30, 2024, from $73.3 million as of March 31, 2024[37]. - Total liabilities decreased to $10.4 million as of June 30, 2024, from $11.6 million as of March 31, 2024[38]. Clinical Trials and Drug Development - Acasti surpassed the 50% enrollment milestone in the pivotal Phase 3 STRIVE-ON safety trial of GTX-104, with full enrollment of 100 patients projected for late 2024 to early 2025[3]. - The company anticipates submitting a New Drug Application (NDA) for GTX-104 to the FDA in the first half of calendar 2025[3]. - The company has deprioritized further development of GTX-102 and GTX-101 in favor of focusing on GTX-104[8][9]. - Acasti's GTX-104 is designed to provide an intravenous alternative to oral nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH), a condition affecting approximately 50,000 patients annually in the U.S.[6]. - Acasti's lead clinical asset, GTX-104, has been granted Orphan Drug Designation by the FDA, providing seven years of marketing exclusivity post-launch in the U.S.[11]. Market Potential - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million[7]. - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million[28]. Share Information - The company had 9,399,404 shares issued and outstanding as of June 30, 2024[39]. - The weighted-average number of shares outstanding increased to 10,928,543 in Q2 2024 from 7,435,533 in Q2 2023[42]. Other Income and Tax - Total other income, net, increased to $1,622,000 in Q2 2024 from $142,000 in Q2 2023, showing substantial growth[42]. - Income tax benefit increased to $724,000 in Q2 2024 from $289,000 in Q2 2023, reflecting improved tax recovery[42]. - The company reported a foreign exchange loss of $8,000 in Q2 2024, compared to a gain of $8,000 in Q2 2023[42]. - Change in fair value of derivative warrant liabilities contributed $1,395,000 in Q2 2024, with no contribution in Q2 2023[42].

Core Insights - Acasti Pharma Inc. has surpassed the 50% enrollment milestone in its pivotal Phase 3 STRIVE-ON safety trial for GTX-104, a novel injectable formulation of nimodipine targeting aneurysmal subarachnoid hemorrhage (aSAH) [1][2][3] - The company anticipates completing patient enrollment by late 2024 to early 2025, with a New Drug Application (NDA) submission to the FDA expected in the first half of 2025 [2][3] - Acasti has projected a cash runway extending into the second quarter of 2026 [1][5] Company Developments - The STRIVE-ON trial is designed to provide an effective intravenous alternative to the current oral nimodipine treatment, which is challenging for aSAH patients due to complications [2][8] - Acasti reported a net loss of $2.6 million for the quarter ended June 30, 2024, a decrease from a net loss of $4.0 million in the same quarter of the previous year [4][18] - Research and development expenses increased to $2.7 million for the quarter ended June 30, 2024, compared to $1.1 million for the same period in 2023, primarily due to the ongoing STRIVE-ON trial [4][5] Financial Performance - General and administrative expenses rose to $2.3 million for the quarter ended June 30, 2024, up from $1.9 million in the same quarter of 2023, attributed to increased professional fees related to a proposed change in incorporation jurisdiction [5] - As of June 30, 2024, Acasti had cash and cash equivalents of $19.4 million, down from $23.0 million as of March 31, 2024 [5][15] - The total assets of the company were reported at $69.7 million as of June 30, 2024, compared to $73.3 million as of March 31, 2024 [16]

Financial Performance - As of June 30, 2024, total current assets decreased to $20,429,000 from $24,010,000 as of March 31, 2024, representing a decline of approximately 15.5%[19] - The net loss for the quarter was $2,617,000, compared to a net loss of $4,023,000 for the same quarter in 2023, reflecting an improvement of approximately 34.8%[27] - The company reported a basic and diluted loss per share of $0.24 for the quarter ended June 30, 2024, compared to $0.54 for the same quarter in 2023[27] - The total stockholders' equity decreased to $59,364,000 as of June 30, 2024, down from $64,010,000 as of June 30, 2023, reflecting a decline of approximately 7%[192] - Acasti Pharma's accumulated deficit increased to $213,736,000 as of June 30, 2024, compared to $202,289,000 as of June 30, 2023, marking an increase of approximately 6%[191] Operating Expenses - Operating expenses for the quarter ended June 30, 2024, included research and development expenses of $2,708,000, up from $1,095,000 in the same period last year, indicating a year-over-year increase of approximately 147%[25] - General and administrative expenses for the three months ended June 30, 2024, were $2.3 million, an increase of $0.4 million from $1.9 million for the same period in 2023[138][139] - Operating expenses for the three months ended June 30, 2024, were $4.963 million, compared to $4.454 million for the same period in 2023, reflecting an increase in research and development expenses[187] Cash Flow and Liquidity - Net cash used in operating activities was $3,596,000 for the three months ended June 30, 2024, compared to $6,240,000 for the same period in 2023, indicating a 42.4% reduction[33] - Cash and cash equivalents at the end of the period were $19,394,000, down from $21,633,000 at the end of June 30, 2023, reflecting a decrease of 10.4%[34] - The company plans to raise additional capital to maintain liquidity and fund operations beyond the second calendar quarter of 2026[39] - The company plans to use the net proceeds from the private placement for clinical trial expenses related to the Phase 3 trial for GTX-104, pre-commercial planning, and working capital[200] Drug Development and Pipeline - The company plans to prioritize the development of its GTX-104 drug candidate, which aims to improve management of hypotension in patients with aneurysmal subarachnoid hemorrhage[10] - The company aims to maximize the value of its de-prioritized drug candidates, GTX-102 and GTX-101, through potential development, licensing, or sale[11] - GTX-104 has been administered to over 150 healthy volunteers and demonstrated significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine[84] - The pivotal Phase 3 STRIVE-ON safety trial for GTX-104 has exceeded the 50% patient enrollment milestone as of June 27, 2024, with potential NDA submission anticipated in the first half of 2025[84] - The company has three clinical-stage drug candidates, with GTX-104 being prioritized for commercialization, while the development of GTX-102 and GTX-101 has been deferred for at least three years[86] Strategic Plans and Management - A strategic realignment plan was implemented in May 2023, resulting in a streamlined workforce and a focus on the development of GTX-104[37] - The company implemented a strategic realignment plan in May 2023, which included engaging a new management team and streamlining research and development activities[199] - The management team has significant experience in drug formulation, clinical development, and regulatory affairs, enhancing the company's capabilities in advancing its drug candidates[88] Market Potential - Approximately 50,000 individuals experience aSAH each year in the U.S., with a total addressable market of approximately $300 million[96] - The incidence of aSAH is approximately six per 100,000 person years, with a mortality rate of about 29% at five years post-hemorrhage[95] - GTX-102 targets a total addressable market of $150 million in the U.S., affecting approximately 4,300 patients per year[106] - The total addressable market for GTX-101 is estimated to be as large as $2.5 billion, with approximately $200 million for PHN pain and $2.3 billion for non-PHN pain indications[119] Financing Activities - The company raised approximately $7,500,000 from a private placement on September 24, 2023, to fund clinical trial expenses for GTX-104 and other corporate purposes[38] - A private placement on September 24, 2023, raised approximately $7.3 million after fees, selling 1,951,371 Class A common shares at $1.848 each[149] - The company anticipates the need for additional financing to support its operations and development programs[172] Legal and Compliance - The company has no reserves or liabilities accrued for legal proceedings as of June 30, 2024, but believes it has established appropriate legal reserves[74] - A settlement agreement with Aker BioMarine resulted in the transfer of all rights and assets related to the CaPre product, with no liability recorded[152]

Group 1 - Acasti Pharma (ACST) is currently ranked 6 in the Zacks Sector Rank among 1026 companies in the Medical group, indicating strong performance relative to peers [1] - The Zacks Rank for Acasti Pharma is 2 (Buy), suggesting a positive outlook based on earnings estimates and revisions [1] - The Zacks Consensus Estimate for ACST's full-year earnings has increased by 11.6% in the past quarter, reflecting improved analyst sentiment [2] Group 2 - Acasti Pharma has returned 5.9% year-to-date, outperforming the average return of 4.6% for Medical companies [2] - In comparison, Cigna (CI) has shown a year-to-date return of 9.7% and also holds a Zacks Rank of 2 (Buy) [2] - Acasti Pharma belongs to the Medical - Generic Drugs industry, which is ranked 86 in the Zacks Industry Rank, with an average gain of 8.2% year-to-date, indicating slight underperformance relative to its industry [3] Group 3 - Cigna operates in the Medical - HMOs industry, currently ranked 175, which has declined by 6.1% year-to-date [3] - Both Acasti Pharma and Cigna are highlighted as stocks to watch for continued solid performance in the Medical sector [3]

Core Viewpoint - Acasti Pharma Inc. has announced that its pivotal Phase 3 STRIVE-ON safety trial for GTX-104 has surpassed the 50% enrollment milestone, indicating strong progress in addressing the unmet medical needs for aneurysmal subarachnoid hemorrhage (aSAH) [1][2] Company Overview - Acasti is a late-stage biopharma company focused on developing drug candidates for rare and orphan diseases, with GTX-104 being its lead clinical asset targeting aSAH [6] - The company utilizes novel drug delivery technologies aimed at improving the performance of existing medications, achieving faster onset of action, enhanced efficacy, and reduced side effects [6] GTX-104 Development - GTX-104 is a novel injectable formulation of nimodipine designed for intravenous infusion in aSAH patients, addressing significant unmet medical needs [4][5] - The drug aims to provide a convenient IV delivery method, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients, and has shown promise in managing hypotension [5] Clinical Trial Progress - The STRIVE-ON trial is a randomized, open-label study comparing GTX-104 with oral nimodipine in 100 hospitalized aSAH patients, with safety as the primary endpoint [1][2] - Patient enrollment began in October 2023, and the company anticipates completing the randomization of all patients by late 2024 to early 2025, with a potential NDA submission to the FDA in the first half of 2025 [2] Market Potential - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million, based on market research [5] - Aneurysmal subarachnoid hemorrhage affects around 50,000 patients annually in the U.S., with significant mortality and dependency rates [3]