UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ Title of each class Trading Symbol(s) Name of each exchange on which registered Common Shares, no par value per share ACST NASDAQ Stock Market 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, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ Title of each class Trading Symbol(s) Name of each exchange on which registered Common Shares, no par value per share ACST NASDAQ Stock Market Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☐ 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 ...

Acasti Pharma Inc. (NASDAQ:ACST) Q4 2020 Earnings Conference Call June 29, 2020 10:30 AM ET Company Participants Alexandra Botie - IR, Crescendo Communications, LLC Jan D’Alvise - President and CEO Pierre Lemieux - COO, Chief Scientific Officer and Co-Founder Brian Groch - Chief Commercial Officer Jean-François Boily - VP, Finance Conference Call Participants Leland Gershell - Oppenheimer & Co. Mayank Mamtani - B. Riley FBR, Inc. Andre Uddin - Mackie Research Capital Corporation Nathan Weinstein - Aegis Cap ...

[Part I](index=7&type=section&id=PART%20I) [Business](index=7&type=section&id=Item%201.%20Business) Acasti Pharma develops CaPre for severe hypertriglyceridemia, progressing its TRILOGY Phase 3 program through a 505(b)(2) regulatory pathway - Acasti's lead product candidate, **CaPre**, is an **OM3 phospholipid therapeutic** being developed for **severe hypertriglyceridemia (sHTG)**, a condition affecting an estimated **three to four million people** in the United States[13](index=13&type=chunk) - The company is conducting the **TRILOGY Phase 3 program**, consisting of two pivotal studies (**TRILOGY 1 and TRILOGY 2**), to evaluate CaPre's safety and efficacy in approximately **500 patients**[66](index=66&type=chunk) - The **TRILOGY 1 trial** did not meet its primary endpoint due to an unusually large placebo effect, with a **30.5% median TG reduction** in the CaPre group versus **27.5%** in the placebo group at **12 weeks**[74](index=74&type=chunk) - Acasti is pursuing a **505(b)(2) regulatory pathway** to leverage the extensive safety data of the approved drug **LOVAZA**, which could streamline CaPre's development and reduce costs and risks[94](index=94&type=chunk) [About CaPre and Hypertriglyceridemia](index=9&type=section&id=About%20CaPre%20and%20Hypertriglyceridemia) Hypertriglyceridemia, linked to cardiovascular disease, is targeted by CaPre, an OM3 fatty acid composition from krill oil offering potentially superior absorption - Elevated TG levels (**≥ 200 mg/dL**) are associated with a greater risk of **coronary artery disease and pancreatitis**; studies suggest that lowering TG levels may reduce these risks[20](index=20&type=chunk) - **CaPre** is composed of **OM3 fatty acids (EPA and DHA)** from krill oil, delivered as a combination of **phospholipid esters and free fatty acids**, which may allow for more efficient absorption compared to fish oil-based OM3 ethyl ester drugs like **LOVAZA and VASCEPA**[22](index=22&type=chunk) [Potential Market and Competition](index=10&type=section&id=Potential%20Market%20and%20Competition) The U.S. market for OM3 therapeutics for HTG exceeded $1.65 billion in 2019, with significant unmet needs due to dissatisfaction with existing treatments - The U.S. market for **OM3 therapeutics for HTG** was valued at more than **$1.65 billion** as of August 2019, with significant growth potential following Amarin's expanded label for **VASCEPA**[25](index=25&type=chunk)[28](index=28&type=chunk) - Physician market research indicates **100%** of those interviewed believe there is a moderate to high unmet medical need for treating HTG, citing dissatisfaction with current OM3s due to insufficient TG lowering, negative LDL-C effects, and absorption issues with low-fat meals[31](index=31&type=chunk) - Key competitors include GlaxoSmithKline's **LOVAZA** (now with generic versions) and Amarin's **VASCEPA**; Amarin's VASCEPA has gained significant market share, reaching about **64% by dollars** as of August 2019[114](index=114&type=chunk)[35](index=35&type=chunk) [Clinical and Nonclinical Data](index=13&type=section&id=Clinical%20and%20Nonclinical%20Data) Clinical data shows CaPre significantly reduces triglycerides, has no negative LDL-C effect, potentially increases HDL-C, and offers superior bioavailability without a food effect - **Phase 2 trials (COLT and TRIFECTA)** showed **CaPre** significantly lowered TGs, had no deleterious effect on LDL-C, and showed potential to increase HDL-C, a combination referred to as the "**trifecta effect**"[46](index=46&type=chunk)[56](index=56&type=chunk) - A **Bridging Study** demonstrated that **CaPre** has better bioavailability than **LOVAZA** in a fasting state and a comparable safety profile under fed (high-fat meal) conditions, supporting the **505(b)(2) regulatory pathway**[49](index=49&type=chunk) - Unlike competitors, **CaPre's absorption** is not meaningfully affected by the fat content of a meal, which is a significant clinical advantage for HTG patients on a low-fat diet[51](index=51&type=chunk)[54](index=54&type=chunk) - Nonclinical studies in mice suggest **CaPre** may promote insulin secretion, a mechanism different from metformin, and showed more robust effects on certain beneficial metabolites (like **PDX**) compared to icosapent ethyl (**VASCEPA**)[41](index=41&type=chunk)[43](index=43&type=chunk) [TRILOGY Phase 3 Program](index=20&type=section&id=TRILOGY%20Phase%203%20Program) TRILOGY Phase 3's first trial failed its primary endpoint due to a high placebo response; TRILOGY 2 results are pending, and an additional study may be required - **TRILOGY 1** topline results showed a **30.5% median TG reduction** for **CaPre** versus a **27.5% reduction** for placebo at **12 weeks**, failing to reach statistical significance due to the unexpectedly large placebo effect[74](index=74&type=chunk) - Post-hoc analysis identified a "**Pre-Randomization TG Normalization**" phenomenon, where TG levels dropped significantly before patients even started the drug or placebo; correcting for this showed a stronger therapeutic effect for **CaPre**, though still not statistically significant[80](index=80&type=chunk)[87](index=87&type=chunk) - The **FDA** confirmed that pivotal analysis for **TRILOGY 2** must be performed on the full **Intent to Treat (ITT) population** as originally planned; depending on TRILOGY 2's outcome, an additional study may be needed for an **NDA submission**[92](index=92&type=chunk)[17](index=17&type=chunk) - Topline results for the **TRILOGY 2 trial** are expected by the end of **August 2020**[18](index=18&type=chunk)[78](index=78&type=chunk) [Intellectual Property and Commercialization Strategy](index=26&type=section&id=Intellectual%20Property%20and%20Commercialization%20Strategy) Acasti expands its global patent portfolio for its HTG composition, planning an independent U.S. launch for CaPre and seeking partnerships for ex-U.S. markets - The company has filed patent applications in over **20 jurisdictions** and currently holds more than **20 issued or allowed patents** for its "**Concentrated Therapeutic Phospholipid Composition**" to treat HTG[100](index=100&type=chunk) - Acasti's commercialization strategy involves launching **CaPre** itself in the **U.S. market** while seeking regional or country-specific strategic partners for commercialization outside the United States[110](index=110&type=chunk) [Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from COVID-19, going concern doubts, CaPre's uncertain Phase 3 outcome, third-party reliance, intense competition, and potential NASDAQ delisting - There is substantial doubt about the company's ability to continue as a **going concern**, as it has incurred operating losses since inception and will require additional capital to fund operations beyond **January 2021**[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) - The company's prospects depend entirely on the success of **CaPre**, its only drug candidate; the **TRILOGY 1 trial** did not reach statistical significance, making the outcome of the **TRILOGY 2 trial** critical and uncertain[197](index=197&type=chunk)[176](index=176&type=chunk) - Acasti relies on **third-party CROs** to conduct its clinical trials and on **third-party manufacturers** to produce **CaPre**, exposing it to risks of non-performance, delays, and compliance failures with **cGMP and cGCP regulations**[182](index=182&type=chunk)[187](index=187&type=chunk) - The company faces intense competition from established products like **LOVAZA and VASCEPA**; a recent court ruling invalidating Amarin's patents for **VASCEPA** could lead to generic competition sooner than expected, potentially creating downward pricing pressure for **CaPre**[206](index=206&type=chunk)[209](index=209&type=chunk) - The company has failed to maintain the **NASDAQ's minimum bid price of $1.00 per share** and has until at least **November 9, 2020**, to regain compliance to avoid delisting[291](index=291&type=chunk)[292](index=292&type=chunk) [Properties](index=61&type=section&id=Item%202.%20Properties) Acasti Pharma leases its head office and R&D lab in Québec, owning proprietary manufacturing equipment but relying on third parties for CaPre production - The company leases its head office in **Laval, Québec** and its R&D lab in **Sherbrooke, Québec**[309](index=309&type=chunk) - Acasti does not own a manufacturing facility but owns the proprietary equipment for production and relies on **third-party manufacturers** for **CaPre**[309](index=309&type=chunk) [Legal Proceedings](index=61&type=section&id=Item%203.%20Legal%20Proceedings) The company settled legal claims with its former CEO on May 10, 2019, by issuing 900,000 common shares and reimbursing nominal legal fees - The company settled a legal claim with its former CEO by issuing **900,000 common shares** and reimbursing legal fees[311](index=311&type=chunk) [Part II](index=62&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities](index=62&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Shareholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Acasti's common shares trade on Nasdaq and TSX Venture, with no anticipated cash dividends, and a significant risk of PFIC classification for U.S. tax purposes - Common shares are traded on **The Nasdaq Capital Market** and the **TSX Venture Exchange** under the symbol "**ACST**"[314](index=314&type=chunk) - The company has never paid cash dividends and does not intend to in the foreseeable future, retaining earnings to finance growth[315](index=315&type=chunk) - There is a significant risk that **Acasti** may be classified as a **Passive Foreign Investment Company (PFIC)** for U.S. federal income tax purposes, which could result in unfavorable tax treatment for U.S. shareholders on gains or distributions[304](index=304&type=chunk)[335](index=335&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operation](index=68&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) For FY2020, Acasti reported a $25.5 million net loss, reduced by lower R&D expenses, with $14.2 million in cash, raising going concern doubts and necessitating additional financing Comparative Financial Highlights (in thousands of U.S. dollars) | Metric | Year Ended March 31, 2020 | Year Ended March 31, 2019 | | :--- | :--- | :--- | | **Net Loss** | $(25,513) | $(39,366) | | **Loss Per Share (Basic & Diluted)** | $(0.30) | $(0.73) | | **Non-GAAP Operating Loss** | $(22,315) | $(30,555) | | **Total Assets** | $22,853 | $36,896 | | **Total Shareholders' Equity** | $12,994 | $11,045 | Breakdown of Operating Expenses (in thousands of U.S. dollars) | Expense Category | Year Ended March 31, 2020 | Year Ended March 31, 2019 | | :--- | :--- | :--- | | **Research and Development** | $15,974 | $29,373 | | **General and Administrative** | $5,799 | $4,539 | | **Sales and Marketing** | $2,665 | $494 | - The decrease in net loss for **FY2020** was primarily driven by a **$13.4 million reduction** in R&D expenses as the **TRILOGY Phase 3 clinical program** advanced towards completion[384](index=384&type=chunk)[397](index=397&type=chunk) - As of **March 31, 2020**, cash and cash equivalents totaled **$14.2 million**; management projects these funds will sustain operations into the **first calendar quarter of 2021**, raising substantial doubt about the company's ability to continue as a going concern without additional financing[373](index=373&type=chunk)[406](index=406&type=chunk)[408](index=408&type=chunk) - During the year ended **March 31, 2020**, the company generated **$13.2 million** from financing activities, primarily from its "**at-the-market**" (**ATM**) program (**$7.0 million net proceeds**) and warrant exercises (**$7.7 million**)[409](index=409&type=chunk)[411](index=411&type=chunk) [Controls and Procedures](index=85&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of March 31, 2020, management concluded that the company's disclosure controls and internal control over financial reporting were effective, with no material changes - Management concluded that as of **March 31, 2020**, the company's disclosure controls and procedures were effective[456](index=456&type=chunk) - Based on an assessment using the **COSO framework**, management concluded that internal control over financial reporting was effective as of **March 31, 2020**[457](index=457&type=chunk) [Part III](index=86&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=86&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) The report details the Board of Directors and senior management, with three of four directors deemed independent, and outlines the company's governance committees and ethical policies - The Board of Directors is composed of **four members**: **Jan D'Alvise** (President & CEO), **Roderick N. Carter** (Chairman), **Jean-Marie (John) Canan**, and **Donald Olds**[461](index=461&type=chunk) - **Three of the four directors** (**Carter, Canan, and Olds**) are considered independent; CEO **Jan D'Alvise** is not independent[528](index=528&type=chunk)[529](index=529&type=chunk) - The **Audit Committee** is chaired by **Jean-Marie Canan**, who is designated as the "**audit committee financial expert**"[474](index=474&type=chunk)[475](index=475&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics**, along with policies for disclosure, insider trading, and whistleblowing to promote ethical conduct[541](index=541&type=chunk)[543](index=543&type=chunk) [Executive Compensation](index=88&type=section&id=Item%2011.%20Executive%20Compensation) Acasti's executive compensation combines base salary, short-term cash bonuses, and long-term stock options, with CEO Jan D'Alvise receiving $2.19 million in FY2020, aligning interests Summary Compensation for Named Executive Officers (Fiscal Year 2020) | Name and Principal Position | Salary ($) | Bonus ($) | Option Awards ($) | Total Compensation ($) | | :--- | :--- | :--- | :--- | :--- | | **Jan D'Alvise**, President and CEO | 410,703 | 154,781 | 1,620,863 | 2,186,347 | | **Pierre Lemieux**, COO | 264,128 | 80,018 | 603,458 | 947,604 | | **Brian Groch**, CCO | 289,615 | 87,000 | 357,461 | 734,106 | - The compensation program consists of base salary, a **Short-Term Incentive Plan (STIP)** with cash bonuses, and a **Long-Term Incentive Plan (LTIP)** with stock options[479](index=479&type=chunk) - Non-executive director compensation for **FY2020** included annual cash retainers and fees totaling **$72,500** for the Chairman, **$50,000** for the Audit Committee Chair, and **$47,500** for the GHR Committee Chair, supplemented by option awards[518](index=518&type=chunk)[520](index=520&type=chunk) - The company has established share ownership guidelines requiring executives and non-employee directors to hold a certain value of company stock, aligning their interests with shareholders[489](index=489&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters](index=97&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Shareholder%20Matters) As of May 31, 2020, directors and executive officers collectively owned 3.8% of common shares; Acuitas Group Holdings, LLC is the only 5%+ beneficial owner, with equity compensation details provided Equity Compensation Plan Information (as of March 31, 2020) | Plan Category | Securities to be Issued Upon Exercise | Weighted-Average Exercise Price | Securities Remaining for Future Issuance | | :--- | :--- | :--- | :--- | | **Equity compensation plans approved by security holders** | 9,936,486 | CAD$1.00 | 1,329,382 | - As of **May 31, 2020**, all directors and executive officers as a group beneficially owned **3.8%** of the company's common shares[525](index=525&type=chunk) - **Acuitas Group Holdings, LLC** is the only known beneficial owner of **5% or more** of the company's voting securities[525](index=525&type=chunk) [Principal Accounting Fees and Services](index=102&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) For FY2020, Acasti incurred CAD$437,210 in fees from KPMG LLP for audit, audit-related, and tax services, all pre-approved by the Audit Committee Auditor Fees (Fiscal Years 2020 & 2019) | Fee Category | FY 2020 (CAD$) | FY 2019 (CAD$) | | :--- | :--- | :--- | | **Audit Fees** | 308,160 | 403,500 | | **Audit-Related Fees** | 82,390 | 53,000 | | **Tax Fees** | 46,660 | 28,100 | | **All Other Fees** | 0 | 0 | | **Total** | **437,210** | **484,600** | [Part IV](index=103&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=103&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section presents consolidated financial statements for FY2020 and FY2019, along with an index of all exhibits filed, including corporate governance documents and certifications - This section includes the company's consolidated financial statements and a list of all exhibits filed with the report, including corporate governance documents and material contracts[564](index=564&type=chunk)[565](index=565&type=chunk) [Financial Statements](index=106&type=section&id=Financial%20Statements) [Consolidated Financial Statements](index=106&type=section&id=Consolidated%20Financial%20Statements) Audited consolidated financial statements for FY2020 and FY2019, prepared under U.S. GAAP, show a $25.5 million net loss for FY2020, with the auditor expressing substantial doubt about going concern Consolidated Balance Sheet Highlights (as of March 31, in thousands of U.S. dollars) | Account | 2020 | 2019 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $14,240 | $16,871 | | **Total current assets** | $16,079 | $27,966 | | **Total assets** | $22,853 | $36,896 | | **Total current liabilities** | $7,395 | $13,668 | | **Total liabilities** | $9,859 | $25,851 | | **Total shareholders' equity** | $12,994 | $11,045 | Consolidated Statement of Loss (for the year ended March 31, in thousands of U.S. dollars) | Account | 2020 | 2019 | | :--- | :--- | :--- | | **Loss from operations** | $(24,438) | $(34,406) | | **Financial expenses** | $(1,075) | $(4,960) | | **Net loss** | $(25,513) | $(39,366) | | **Loss per share** | $(0.30) | $(0.73) | Consolidated Statement of Cash Flows (for the year ended March 31, in thousands of U.S. dollars) | Account | 2020 | 2019 | | :--- | :--- | :--- | | **Net cash used in operating activities** | $(22,944) | $(24,787) | | **Net cash from (used in) investing activities** | $8,138 | $(9,442) | | **Net cash from financing activities** | $13,176 | $45,690 | | **Net (decrease) increase in cash** | $(2,631) | $10,448 | - The independent auditor's report expresses substantial doubt about the company's ability to continue as a **going concern** due to recurring operating losses and negative cash flows[579](index=579&type=chunk) - The company retrospectively adopted **U.S. GAAP** and changed its reporting currency from Canadian dollars to U.S. dollars, with comparative figures adjusted accordingly[580](index=580&type=chunk)[581](index=581&type=chunk)

Acasti Pharma Inc. (NASDAQ:ACST) Q3 2020 Results Conference Call February 14, 2020 1:00 PM ET Company Participants David Waldman - IR Jan D’Alvise - President and CEO Pierre Lemieux - COO, Chief Scientific Officer and Co-Founder Brian Groch - Chief Commercial Officer Jean-François Boily - VP, Finance Conference Call Participants Leland Gershell - Oppenheimer Toby Ma - Mackie Research Operator Ladies and gentlemen, Hello and thank you all for your patience and for joining today’s Acasti Pharma Third Quarter ...

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Acasti Pharma, Inc. (NASDAQ:ACST) Q4 2019 Earnings Conference Call June 26, 2019 1:00 PM ET Company Participants David Waldman - Crescendo Communications Jan D'Alvise - President and CEO Pierre Lemieux - COO and Chief Scientific Officer and Co-Founder Brian Groch - Chief Commercial Officer Jean-François Boily - VP, Finance Conference Call Participants Andre Uddin - Mackie Research Capital Tony Pollock - Aegis Capital Operator Greetings, and welcome to the Acasti Pharma Fourth Quarter and Year End Fiscal 201 ...