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 ...

Drug Development and Pipeline - Acasti completed the acquisition of Grace on August 27, 2021, positioning itself as a late-stage specialty pharmaceutical company focused on rare and orphan diseases[90]. - The company has three advanced drug candidates: GTX-104 for Subarachnoid Hemorrhage (SAH), GTX-102 for Ataxia Telangiectasia (A-T), and GTX-101 for Postherpetic Neuralgia (PHN), all of which have received Orphan Drug Designation (ODD)[95][98]. - Acasti's drug development strategy leverages the 505(b)(2) regulatory pathway, potentially shortening the time to market for reformulated drugs[92]. - The company anticipates starting Phase 3 safety studies for GTX-104 in the first half of 2023, following successful PK bridging study results[98]. - GTX-102's PK bridging study results are expected in the second half of 2022, with Phase 3 initiation planned for the second half of 2023[98]. - GTX-101's single-dose study results are expected in the second half of 2022, with a Multiple Ascending Dose study to follow in 2023[98]. - Acasti's therapeutic pipeline includes three unique clinical stage assets supported by over 40 granted and pending patents worldwide[93]. - GTX-102, a concentrated oral-mucosal spray of betamethasone, aims to improve neurological symptoms of Ataxia Telangiectasia (A-T), a rare genetic disorder affecting approximately 4,300 patients annually in the U.S.[115][117]. - GTX-101, a non-narcotic topical bupivacaine spray, targets postherpetic neuralgia (PHN) with a total addressable market of $2.5 billion, including $200 million for PHN pain[132][135]. Financial Performance - The net loss for the three months ended June 30, 2022, was $4.524 million, an increase of $1.406 million from the net loss of $3.118 million for the same period in 2021[152]. - Research and development expenses for the three months ended June 30, 2022, totaled $2.590 million, a significant increase of $2.121 million compared to $469,000 for the same period in 2021[150]. - Total assets as of June 30, 2022, amounted to $124.931 million, an increase of $64.478 million from $60.453 million as of June 30, 2021[150]. - The company reported total shareholders' equity of $104.403 million as of June 30, 2022, up by $50.946 million from $53.457 million in the previous year[150]. - General and administrative expenses for the three months ended June 30, 2022, totaled $1.919 million, a decrease of $757,000 from $2.676 million for the same period in 2021[161]. - Cash and cash equivalents totaled $38,377 as of June 30, 2022, a net decrease of $2,598 compared to $40,975 at June 30, 2021[168]. - Operating activities used cash of $5,426 for the three months ended June 30, 2022, compared to $3,401 for the same period in 2021[169]. - Total fully diluted shares increased to 50,462,426 as of June 30, 2022, from 49,018,292 as of March 31, 2022[167]. Market Potential - The total addressable market for SAH is estimated at over $300 million in the U.S., with approximately 53,596 individuals experiencing aSAH annually[110]. - The potential total addressable market for A-T treatments is estimated at $150 million based on the number of treatable patients in the U.S.[117]. - Approximately 40% of patients using lidocaine patches experience insufficient pain relief, highlighting the need for alternatives like GTX-101[132]. Clinical Study Results - In a clinical trial, oral liquid betamethasone reduced ataxia symptoms by a median of 13 points (28% decrease) in the intent-to-treat population, with significant results compared to placebo (P = 0.01)[119]. - GTX-102 achieves similar blood levels at only 1/70th the volume of an oral solution of betamethasone, which is crucial for patients with swallowing difficulties[121]. - GTX-101 has shown to be well absorbed through the skin with no evidence of skin irritation in Phase 1 studies, indicating its safety and tolerability[138]. - The company believes that non-opioid products like GTX-101 will be attractive options for PHN pain relief due to faster onset and sustained relief[140]. Regulatory and Compliance - Acasti plans to submit the final PK bridging study report to the FDA in Q3 2022 and expects to initiate the Phase 3 Safety Study in the first half of 2023, which will take approximately 18 months to complete[114]. - The company received a notification from Nasdaq on July 27, 2022, for failing to maintain a minimum bid price of $1.00 per share for 30 consecutive business days, with a compliance deadline of January 23, 2023[146]. - The company has no changes in internal controls over financial reporting that materially affected them during the quarter ended June 30, 2022[215]. - There have been no material changes from the risk factors disclosed in the most recently filed annual report on Form 10-K[218]. Commitments and Obligations - The company has a remaining commitment of $2.8 million under the RKO supply agreement, which is currently disputed with Aker Biomarine Antarctic[190]. - The total contractual obligations as of June 30, 2022, amounted to $6,760, with $3,062 due within one year[188]. - The company has a fixed value commitment of $3.1 million for the RKO supply agreement with Aker to purchase raw krill oil product for CaPre[202].

Acasti Pharma, Inc. (NASDAQ:ACST) Q4 2022 Earnings Conference Call June 21, 2022 1:00 PM ET Company Participants Robert Blum - Investor Relations Jan D'Alvise - President and Chief Executive Officer Brian Ford - Chief Financial Officer Monique Champagne - Vice President, Clinical Affairs Conference Call Participants Leland Gershell - Oppenheimer Operator Good day, and welcome to the Acasti Pharma Fourth Quarter and Fiscal Year 2022 Financial Results Conference Call. All participants will be in listen-only m ...

Acasti Pharma Inc. (NASDAQ:ACST) Q3 2021 Earnings Conference Call February 14, 2022 1:00 PM ET Company Participants David Waldman - Investor Relations Jan D’Alvise - President and Chief Executive Officer Brian Ford - Chief Financial Officer George Kottayil - Chief Operating Officer US Conference Call Participants Sahil Kazmi - B. Riley Securities Alexandra Heller - Oppenheimer Operator Good day, ladies and gentlemen, and welcome to the Acasti Pharma Third Quarter Fiscal 2022, Business Update Conference Cal ...