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]

Financial Performance - Acasti reported a net loss of $12.9 million, or $1.35 loss per share, for the year ended March 31, 2024, a decrease of $29.5 million from the net loss of $42.4 million, or $5.71 per share, for the year ended March 31, 2023[5]. - For the year ended March 31, 2024, Acasti reported a net loss of $12.9 million, or $1.35 loss per share, a decrease of $29.5 million from the net loss of $42.4 million, or $5.71 per share, for the year ended March 31, 2023[23]. - The net loss for the year ended March 31, 2024, was $12,853,000, compared to a net loss of $42,429,000 for the previous year, indicating an improvement of approximately 69.7%[36]. - Basic and diluted loss per share improved to $(1.35) from $(5.71), representing a reduction of approximately 76.4%[36]. Expenses - Research and development expenses decreased to $4.7 million for the year ended March 31, 2024, compared to $10.0 million for the year ended March 31, 2023[5]. - Research and development expenses decreased to $4.7 million for the year ended March 31, 2024, compared to $10.0 million for the previous year, primarily due to a strategic realignment[23]. - General and administrative expenses were $6.4 million for the year ended March 31, 2024, down from $7.6 million for the year ended March 31, 2023[5]. - General and administrative expenses decreased from $7,614,000 to $6,432,000, a reduction of about 15.5%[36]. - Operating expenses reduced significantly, with research and development expenses decreasing from $9,972,000 to $4,683,000, a reduction of about 53%[36]. - The company incurred restructuring costs of $1,485,000 during the year, which were not present in the previous year[36]. Cash Position - As of March 31, 2024, Acasti had cash and cash equivalents of $23.0 million, compared to $27.9 million as of March 31, 2023, with a projected cash runway extending into the second calendar quarter of 2026[5]. - Acasti's cash and cash equivalents as of March 31, 2024, were $23.0 million, compared to $27.9 million as of March 31, 2023, with sufficient cash to support operations into the second calendar quarter of 2026[23]. Strategic Focus - Patient enrollment in the pivotal STRIVE-ON Phase 3 safety trial for GTX-104 is on track for a potential NDA submission to the FDA in the first half of calendar 2025[2]. - Acasti's strategic realignment in May 2023 has prioritized resources towards GTX-104, resulting in reduced clinical development and administrative costs[5]. - Acasti's strategic realignment in May 2023 prioritized resources towards GTX-104, contributing to the decrease in net loss[23]. - The company has deprioritized further development of GTX-102 and GTX-101 in favor of focusing on GTX-104[27][28]. Market Opportunity - The addressable market for GTX-104 in the United States is estimated to be about $300 million[8]. - GTX-104 is targeting a market estimated at approximately $300 million in the United States, addressing significant unmet medical needs for aSAH[26]. - Approximately 50,000 patients in the United States are affected by aSAH annually, with an estimated 70% experiencing death or dependence[6]. Financing Activities - Acasti completed a $7.5 million private placement equity financing in September 2023, enhancing its balance sheet[3]. - Acasti completed a $7.5 million private placement equity financing in September 2023, enhancing its balance sheet[20]. Other Financial Metrics - Total shareholders' equity decreased to $61,743,000 from $67,955,000 year-over-year, reflecting a decline of approximately 9.5%[35]. - Total liabilities and shareholders' equity amounted to $73,300,000, compared to $79,123,000 in the previous year, indicating a decrease of approximately 7.3%[35]. - Interest income increased to $911,000 from $246,000, reflecting a growth of approximately 269.5%[36]. - The company reported a foreign exchange loss of $16,000, down from $72,000, showing a decrease of approximately 77.8%[36]. - The company conducted a meeting of STRIVE-ON trial investigators in April 2024 to ensure quality data collection[21].

Patient Enrollment in Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104 On-Track for Potential NDA Submission in 1H Calendar 2025Projected Cash Runway into Second Calendar Quarter 2026 PRINCETON, N.J., June 21, 2024 (GLOBE NEWSWIRE) --  Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announc ...

Core Insights - Acasti Pharma Inc. is advancing GTX-104, a novel injectable formulation of nimodipine, targeting aneurysmal subarachnoid hemorrhage (aSAH) with a potential NDA submission to the FDA anticipated in the first half of calendar 2025 [1][2][3] Financial Performance - For the fiscal year ended March 31, 2024, Acasti reported a net loss of $12.9 million, or $1.35 loss per share, a significant decrease from a net loss of $42.4 million, or $5.71 per share, for the previous year [4][24] - Research and development expenses were $4.7 million, down from $10.0 million in the prior year, primarily due to strategic realignment efforts [5] - General and administrative expenses decreased to $6.4 million from $7.6 million, attributed to reduced headcount and restructuring costs [5] Cash Position - As of March 31, 2024, the company had cash and cash equivalents of $23.0 million, down from $27.9 million a year earlier, with a projected cash runway extending into the second calendar quarter of 2026 [6][2] Clinical Development - The STRIVE-ON trial, a pivotal Phase 3 safety trial for GTX-104, is progressing well, with steady patient enrollment since its initiation in October 2023 [2][3] - Acasti hosted a Key Opinion Leader event in October 2023 to discuss GTX-104 as a potential new treatment standard for aSAH [3] Market Opportunity - The addressable market for GTX-104 in the United States is estimated to be approximately $300 million, based on market research [9] - Aneurysmal subarachnoid hemorrhage affects around 50,000 patients annually in the U.S., with significant mortality and dependency rates [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35776 ACASTI PHARMA INC. (Exact name of registrant as specified in its charter) Québec, Canada 98-1359336 (State or other jurisdiction ...