UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2023 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 ______________________________________ A ...

PRINCETON, N.J., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (NASDAQ:ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster outlining its pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405) has been accepted for presentation at the 2024 International Stroke Conference, to be held F ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 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 ______________________________________ ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 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 ______________________________________ Acast ...

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, 2023 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 ...

Financial Data and Key Metrics Changes - The company ended the third fiscal quarter with $31.3 million in cash, cash equivalents, and short-term investments, down from $34.9 million as of September 30, 2022 [9][35] - Research and development expenses for the quarter totaled $2.5 million, an increase from $2.2 million in the same quarter of the previous year [33] - General and administrative expenses decreased to $1.6 million from $1.8 million year-over-year, attributed to reduced professional fees [33] - The net loss for the quarter was $3.9 million, consistent with the previous year's loss of $3.8 million [34] Business Line Data and Key Metrics Changes - GTX-101, a topical spray for postherpetic neuralgia, successfully met all primary outcome measures in its pharmacokinetic study, allowing advancement to the next clinical stage [11][18] - GTX-102 also met all primary outcome measures in its PK bridging study, paving the way for a Phase 3 safety and efficacy trial [19][24] - GTX-104, aimed at treating aneurysmal subarachnoid hemorrhage, is awaiting FDA guidance to initiate its Phase 3 safety study [25][28] Market Data and Key Metrics Changes - The total addressable market for GTX-101 is estimated at $2.5 billion, with $200 million for PHN pain and $2.3 billion for non-PHN pain [18] - The potential addressable market for GTX-102 in Ataxia Telangiectasia is approximately $150 million, affecting around 4,300 patients annually in the U.S. [22] - The market for GTX-104 addresses a critical need in the care of aSAH patients, a condition with high mortality rates and limited treatment options [26] Company Strategy and Development Direction - The company is focused on leveraging its drug delivery capabilities by reformulating and repurposing marketed drugs for orphan indications with significant unmet medical needs [29][30] - All three drug candidates have received orphan drug designation from the FDA, which may facilitate expedited development and market exclusivity [30] - The strategy includes engaging with key opinion leaders and building relationships with major medical centers to prepare for market adoption upon approval [51][52] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming year, anticipating the initiation of Phase 3 studies for GTX-104 and GTX-102 [36] - The company is awaiting FDA guidance on its proposed Phase 3 study designs, which is crucial for moving forward with clinical trials [28] - The management emphasized the importance of addressing the unmet needs of patients with rare diseases through innovative treatments [59] Other Important Information - The company has completed three successful clinical trials, with two reporting results in December 2022 [36] - The company plans to submit a draft protocol to the FDA for GTX-102's Phase 3 study following the final clinical trial report [40] Q&A Session Summary Question: Enrollment timelines and potential timing for GTX-102 - Management is waiting for the final clinical trial report before submitting to the FDA and expects to initiate study startup activities in the second half of the year [40] Question: Clarification on Type C meeting with the FDA for GTX-104 - The company is still waiting for guidance from the FDA and has not yet had the meeting [42][46] Question: Commercial relationships for GTX-104 - The company is building relationships with key opinion leaders and major medical centers to prepare for market adoption [51][52] Question: Update on GTX-101's pharmacodynamics data - The final clinical report is expected in May, and while pharmacodynamics data will be shared, it was not a primary endpoint of the study [56]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-Q ______________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 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 ______________________________________ A ...

Financial Data and Key Metrics Changes - The company reported a net loss of $4.9 million or $0.11 loss per share for the quarter ended September 30, 2022, compared to a net income of $1 million or $0.03 per share for the same quarter in 2021 [30] - Research and development expenses for the quarter totaled $3.3 million, a significant increase from $0.6 million in the same quarter of the previous year, reflecting the focus on advancing clinical programs [29] - General and administrative expenses decreased to $1.6 million from $2.9 million year-over-year, attributed to reduced professional fees [30] Business Line Data and Key Metrics Changes - GTX-104, the most advanced clinical program, is set to initiate a Phase 3 safety study in the first half of 2023, targeting patients with Subarachnoid Hemorrhage (SAH) [8][18] - GTX-102, a novel oral mucosal spray for Ataxia Telangiectasia, has a potential addressable market of approximately $150 million, with top-line results from a PK study expected by year-end [21][22] - GTX-101, a topical bupivacaine spray for Postherpetic Neuralgia, aims to address significant unmet needs in pain management, with a PK study also expected to be completed by the end of 2022 [23][25] Market Data and Key Metrics Changes - The total available market for GTX-104 in the U.S. is estimated to exceed $300 million, with approximately 50,000 patients affected annually by SAH [19] - The market for GTX-102 is estimated at around $150 million, targeting a patient population of about 4,300 in the U.S. [21] - The company’s market research for GTX-101 indicated a strong demand for faster and more convenient pain relief solutions, validating the product's potential in the market [50] Company Strategy and Development Direction - The company aims to leverage drug delivery technologies to reformulate marketed drugs for orphan indications, utilizing the FDA's Section 505(b)(2) regulatory pathway for potentially shorter and less risky approval processes [12][13] - The strategy includes targeting well-understood orphan diseases with little competition, focusing on improving patient outcomes and quality of life [15] - The company is open to potential partnerships for commercialization, particularly in international markets such as Asia and Europe [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to fund operations through at least March 2024, with sufficient capital to advance GTX-104 into Phase 3 and support GTX-102 and GTX-101 [11][31] - The company anticipates rapid adoption of GTX-104 if approved, due to existing relationships with major healthcare centers [36] - Management highlighted the importance of upcoming milestones, including FDA guidance on the Phase 3 study design for GTX-104 [25] Other Important Information - The company completed a Phase 1 PK bridging study for GTX-104, which met all endpoints, indicating a favorable absorption profile compared to oral nimodipine [16][17] - The company has initiated PK studies for GTX-102 and GTX-101, with results expected to inform further clinical development [22][25] Q&A Session Summary Question: What structure does the company plan to deploy for commercializing GTX-104? - Management indicated that the market is concentrated in major healthcare centers, suggesting a small initial sales force of 15 to 20 representatives, with potential for organic growth [34][35] Question: When can the market expect top-line results for GTX-102? - Management confirmed that top-line results for GTX-102 are expected before the end of December 2022 [37][38] Question: What are the expected timelines for filings for each program? - Management outlined that the GTX-104 study is expected to wrap up by the end of 2024, with a filing anticipated in early 2025 [41][42] Question: What is the expected burn rate going forward? - The CFO indicated a long-term burn rate of about $2 million per month, with expectations for an increase as commercialization efforts ramp up [45] Question: What market research has been conducted for GTX-101? - Management shared that primary research indicated a strong unmet need for GTX-101, with positive feedback from over 250 physicians regarding its potential advantages over current treatments [48][49]

Acasti Pharma Inc. (NASDAQ:ACST) Q1 2023 Earnings Conference Call August 11, 2022 1:00 PM ET Company Participants Robert Blum - Lytham Partners, Investor Relations Jan D'Alvise - President & Chief Executive Officer Brian Ford - Chief Financial Officer Pierre Lemieux - Chief Operating & Scientific Officer Prashant Kohli - Vice President, Commercial Operations Conference Call Participants Leland Gershell - Oppenheimer Operator Good day, and welcome to the Acasti Pharma's First Quarter Fiscal Year 2023 Financi ...