ACST Acasti Pharma Inc.

0.22
+0.02  (+11%)
Previous Close 0.19
Open 0.2
52 Week Low 0.183
52 Week High 3.08
Market Cap $20,957,856
Shares 96,892,537
Float 77,927,734
Enterprise Value $22,020,933
Volume 15,851,196
Av. Daily Volume 5,445,185
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Drug Pipeline

Drug Stage Notes
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia
Phase 3
Phase 3
Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data August 31, 2020 also did not meet primary endpoint.

Latest News

  1. LAVAL, Québec, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announced that it has appointed seasoned financial executive Brian D. Ford as its Chief Financial Officer, effective September 14, 2020. Mr. Ford assumes the responsibilities formerly held by Jean-Francois Boily, Vice-President, Finance, who recently resigned.

    Brian D. Ford brings over three decades of financial, project management and M&A experience within the healthcare and financial industries. Mr. Ford is an accomplished CPA-CA having served both publicly traded as well as privately owned organizations. Mr. Ford has been responsible for developing business recovery strategies, negotiating M&A transactions, as well…

    LAVAL, Québec, Sept. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announced that it has appointed seasoned financial executive Brian D. Ford as its Chief Financial Officer, effective September 14, 2020. Mr. Ford assumes the responsibilities formerly held by Jean-Francois Boily, Vice-President, Finance, who recently resigned.

    Brian D. Ford brings over three decades of financial, project management and M&A experience within the healthcare and financial industries. Mr. Ford is an accomplished CPA-CA having served both publicly traded as well as privately owned organizations. Mr. Ford has been responsible for developing business recovery strategies, negotiating M&A transactions, as well as managing quarterly and yearly accounting reports. Most recently, Mr. Ford served as Chief Financial Officer and Senior Business Advisor at  a private group of Ontario based medical clinics, including the largest chronic pain management practice in Canada. During his position as CFO and Senior Business Advisor, Mr. Ford significantly improved the Company's performance and was instrumental in preparing the Company for its Initial Public Offering. Prior to that, Mr. Ford served as Chief Financial Officer at Telesta Therapeutics. At Telesta Therapeutics, Mr. Ford helped develop a new business plan and was heavily involved in all capital transactions. Previously, Mr. Ford started his own consulting firm, Petersford Consulting, where he provided clients with finance and business risk services. Mr. Ford began his career at Ernst & Young, working his way to Principal, Business Risk Services, developing essential business plans that evaluated revenue and cost profiles supporting budget planning and understanding drivers of growth, specifically with healthcare companies. Additionally, at Ernst & Young, Mr. Ford participated in and often led teams in due diligence assignments in relation to mergers and acquisitions or the sale of a business, having extensive experience in developing financial forecasts, product and market valuation, and audits of critical accounting and processes. Mr. Ford holds a B.A. in Economics, History, and English from the University of Guelph and has a Graduate Diploma in Accounting from the University of McGill. Mr. Ford is a member of the Ontario Institute of Chartered Accountants.

    Jan D'Alvise, Chief Executive Officer of Acasti, commented, "We are extremely pleased to appoint Brian D. Ford as Chief Financial Officer. Brian brings strong leadership skills, as well as analytical and financial skills that we believe will add significant value. As we explore strategic options and opportunities, we believe Brian's experience in problem solving, strategic transactions, and M&A will prove beneficial. Brian will assume all responsibilities formerly held by Jean-Francois Boily, who recently resigned, as previously announced. We thank Mr. Boily for his contributions to Acasti and wish him well on his future endeavours."

    Brian D. Ford commented, "I'm thrilled to accept the CFO position at Acasti Pharma and look forward to successfully working with the Acasti team. I believe my experience in evaluating strategic opportunities as well as M&A transactions will provide valuable insights for Acasti as we evaluate our options moving forward."

    Forward Looking Statements

    Statements in this press release that are not statements of historical or current fact constitute "forward-looking information" within the meaning of Canadian securities laws and "forward-looking statements" within the meaning of U.S. federal securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti's strategy, future operations, its review of strategic options, potential value for CaPre®prospects and the plans of management.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Special Note Regarding Forward-Looking Statements" section contained in Acasti's latest annual report on Form 10-K, which will be available on EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com and on the investor section of Acasti's website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti's public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti's latest annual report on Form 10-K under the caption "Risk Factors".

    Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. 

    Acasti Contact:

    Jan D'Alvise

    Chief Executive Officer

    Tel: 450-686-4555

    Email: inacastipharma.com

    www.acastipharma.com 

    Investor Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email:  

    Primary Logo

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  2. LAVAL, Québec, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announced that it has filed and mailed the information circular and management proxy statement (the "Circular") for its upcoming annual and special meeting of shareholders to be held on September 30, 2020 (the "Meeting"). The Meeting will take place at 1:00 p.m. Eastern Time, online only, via a virtual meeting portal, through which shareholders of the Company can listen to the Meeting, submit questions and vote online. For more information regarding the Meeting and how to attend and vote at the Meeting, shareholders can consult the Circular, which is available under the Company's profiles on SEDAR at www.sedar.com and on…

    LAVAL, Québec, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announced that it has filed and mailed the information circular and management proxy statement (the "Circular") for its upcoming annual and special meeting of shareholders to be held on September 30, 2020 (the "Meeting"). The Meeting will take place at 1:00 p.m. Eastern Time, online only, via a virtual meeting portal, through which shareholders of the Company can listen to the Meeting, submit questions and vote online. For more information regarding the Meeting and how to attend and vote at the Meeting, shareholders can consult the Circular, which is available under the Company's profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.

    In addition, the board of directors of the Company (the "Board") has resolved to change the record date for the Meeting as indicated in the Circular for the purpose of determining the Company's shareholders which are entitled to receive notice of and to vote at the Meeting from August 26, 2020 to September 8, 2020. Shareholders registered as of September 8, 2020 are entitled to attend and vote at the Meeting. Shareholders who wish to be represented by proxy at the Meeting must, to entitle the person appointed by the proxy to attend and vote, deliver their proxies at the place, in the manner and within the time set forth in the Circular. Shareholders are encouraged to submit their duly completed proxies as soon as possible ahead of the Meeting, as further described in the Circular.

    Stock Option Plan and Equity Plan Amendments

    Subject to the approvals of the TSX Venture Exchange ("TSXV") and of the shareholders of the Company at the Meeting, the Board resolved to amend the Company's stock option plan (the "Stock Option Plan") and equity incentive plan (the "Equity Incentive Plan") for purposes of maintaining a fixed stock option and equity incentive pool that may be granted under both plans, collectively representing 15% of the shares currently outstanding for the two plans combined (the "15% Fixed Pool"). Such renewal approval is consistent with the Company's historical use of plans with a fixed limit set at 15% (and previously 20%) of the then-applicable outstanding shares, as compared to a "rolling" plan, which allows for an automatic increase of the available pool upon an increase in the number of outstanding shares. 

    In accordance with the above, with respect to the Stock Option Plan, the Board resolved to increase the maximum allowable fixed number of common shares of the Company ("Common Shares") that may be issued upon the exercise of all options granted under the Stock Option Plan to 14,533,811 Common Shares, corresponding to the 15% fixed pool, based on the number of Common Shares issued and outstanding as of August 26, 2020.

    In addition to the 15% Fixed Pool applicable to both Company plans, the Equity Incentive Plan is subject to a plan-specific sublimit further limiting the number of Common Shares available under such plan to a maximum 2.5% of the number of Common Shares currently outstanding. Accordingly, the Board of Directors resolved to set the total number of Common Shares reserved for issuance pursuant to awards granted under the Equity Incentive Plan to an aggregate number that for so long as the Common Shares are listed on the TSXV, shall not exceed the lower of (x) 2,422,313 Common Shares (representing 2.5% of the number of Common Shares issued and outstanding as of August 26, 2020), and (y) the number of Common Shares remaining available for issuance under the 15% Fixed Pool, currently representing 14,533,881 Common Shares.

    Additional Company Changes

    The Company also wishes to announce that Jean-François Boily, Vice-President, Finance of the Company, has tendered his resignation to the Company to pursue other business opportunities. Mr. Boily will assist the Company with a smooth and orderly transition of his functions and the Company expects that its existing internal finance team currently in place will be able to assume Mr. Boily's functions going forward. The Company wishes to thank Mr. Boily for his years of service to the Company and wishes him well in his future endeavours.

    Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Acasti Contact:

    Jan D'Alvise

    Chief Executive Officer

    Tel: 450-686-4555

    Email: inacastipharma.com

    www.acastipharma.com

    Investor Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email:

    Primary Logo

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  3. LAVAL, Québec, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc.  ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.

    The Company reported a 30.4% median reduction in triglyceride levels among all patients receiving CaPre, as…

    LAVAL, Québec, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc.  ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced top-line results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its 278 patient Phase 3 TRILOGY 2 study evaluating the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia.

    The Company reported a 30.4% median reduction in triglyceride levels among all patients receiving CaPre, as compared to 30.5% in TRILOGY 1, and a 17.9% median reduction in triglyceride levels among patients receiving placebo at 12 weeks (the Primary Endpoint), as compared to 27.5% in TRILOGY 1. The unadjusted, placebo corrected triglyceride reduction of 12.4% achieved a "p" value of 0.19, which was not statistically significant, and therefore the TRILOGY 2 study did not meet its primary endpoint. As a result, the company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre.   

    CaPre was well tolerated in TRILOGY 2, with a safety profile similar to placebo, and consistent with the Company's previously conducted Phase 2 and 3 studies.

    "Compared to their baseline levels, the observed triglyceride reductions among patients taking CaPre were similar or larger than seen with prior omega-3 therapies," said Dr. Dariush Mozaffarian, Professor at Tufts University and academic PI of the trial. "However, an unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved. We plan to now pool together the results from the two studies to see if we can better understand this phenomenon in post-hoc explorations. We want to thank all of the investigators for their participation, and Acasti for sponsoring the Trilogy program."

    Jan D'Alvise, Chief Executive Officer of Acasti, stated, "We are very disappointed in the outcome of the Trilogy 2 study. Based on what we have seen in the preliminary topline data, we believe TRILOGY 2 was likely not affected by the same "Pre-Randomization Triglyceride Normalization" effect that we saw in TRILOGY 1. While the triglyceride reduction observed in the control arm was less than what was observed in the Trilogy 1 Study, it still remains one of the highest seen amongst the previously conducted triglyceride reduction studies, and may be explained by the excellent background standard of care that is being provided to these patients today." 

    D'Alvise continued, "We extend our sincere gratitude to all of the patients and their families, as well as the investigators who participated in this important trial, and to our employees who have worked tirelessly to develop and evaluate CaPre as a therapeutic for this indication. We especially want to thank Dr. Dariush Mozaffarian, our Principal Investigator, for his expert counsel and support throughout this program. The Acasti team and our clinical advisors will review the full dataset once it is available, and will complete the full data analyses as contemplated in the Statistical Analysis Plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2. Taking into consideration all of the analyses from TRILOGY once completed, we will seek to maximize the value of the  CaPre® asset by continuing to explore a range of options available to us."

    The Company has decided not to host a conference call today as previously disclosed, as there is no additional material information at this time that can be shared beyond what is contained in this press release. The Company and its board of directors has been and will continue to evaluate all strategic options and will provide updates on this process as warranted.

    Forward Looking Statements

    Statements in this press release that are not statements of historical or current fact constitute "forward-looking information" within the meaning of Canadian securities laws and "forward-looking statements" within the meaning of U.S. federal securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti's strategy, future operations, its review of strategic options, potential value for CaPre®, prospects and the plans of management.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Special Note Regarding Forward-Looking Statements" section contained in Acasti's latest annual report on Form 10-K, which will be available on EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com and on the investor section of Acasti's website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti's public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti's latest annual report on Form 10-K under the caption "Risk Factors".

    Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Acasti Contact:

    Jan D'Alvise

    Chief Executive Officer

    Tel: 450-686-4555

    Email:

    www.acastipharma.com

    Investor Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email:  

    Primary Logo

    View Full Article Hide Full Article
  4. LAVAL, Québec, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today provided a business update and announced its operating and financial results for the first quarter of fiscal 2021 ended June 30, 2020.  

    Corporate Highlights:

    • Finalized and submitted TRILOGY 2 Statistical Analyses Plan ("SAP") to the FDA on July 31, 2020
    • Provided business update, on June 29, 2020, in which the Company identified "Triglyceride Normalization…

    LAVAL, Québec, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today provided a business update and announced its operating and financial results for the first quarter of fiscal 2021 ended June 30, 2020.  

    Corporate Highlights:

    • Finalized and submitted TRILOGY 2 Statistical Analyses Plan ("SAP") to the FDA on July 31, 2020
    • Provided business update, on June 29, 2020, in which the Company identified "Triglyceride Normalization" phenomenon prior to patient randomization and treatment as likely contributor to unusually high placebo effect in TRILOGY 1; post-hoc analyses revealed a rapid, significant and sustained reduction in TG levels between screening (during qualification) and the time of patient randomization (prior to patients starting on either drug or placebo); meaningful efficacy trend for CaPre was observed after correcting for the unexpectedly large placebo response in the original analysis
    • Received a Notice of Allowance for second composition of matter patent to be awarded by the Canadian Intellectual Property Office, expanding the Company's existing claims to include any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.
    • Received a notice of issuance of a composition of matter patent to be awarded by the Intellectual Property Office in Hong Kong granting claims for any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids
    • TRILOGY 2 topline results expected on or about August 31, 2020
    • Update on the timing  for reporting the key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and pooled results from both studies, will be provided after TRILOGY 2 results are reported

    As previously reported, the Company, along with the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, conducted rigorous post-hoc analysis of TRILOGY 1 data. These analyses revealed a rapid, significant and sustained reduction in TG levels between screening (during qualification) and the time of patient randomization (prior to patients starting on either drug or placebo), which Acasti refers to as "Pre-randomization Triglyceride (TG) Normalization." This artefactual phenomenon affected both treatment groups, but was much greater in the placebo group, resulting in the large placebo effect and significant underestimation of the post-randomization treatment effect of the active drug, CaPre.  The post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 (Visit 4) corrected for a significant amount of the pre-randomization TG reduction in subjects that were most affected by the normalization phenomenon, and a meaningful efficacy trend for CaPre was observed.

    The Company provided all of the TRILOGY 1 background information and accompanying data to the U.S. Food and Drug Administration (FDA) in a Type C briefing package, which was filed on April 29, 2020. As previously disclosed, the FDA provided Acasti with a written response to the Company's Type C Meeting request and briefing package, and confirmed that pivotal efficacy analyses for TRILOGY 2 will be performed on the full Intent to Treat (ITT) population, as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes.

    After reviewing feedback from the FDA and from key experts including Dr. Mozaffarian, Acasti finalized the SAP for TRILOGY 2, and submitted it to the FDA on July 31, 2020. The Company remains blinded to the TRILOGY 2 data, and remains on track to report topline TG data on or about August 31, 2020.  An update on the timing for reporting the key secondary and exploratory endpoints from both the TRILOGY 1 and TRILOGY 2 trials, as well as pooled results from both studies, will be provided after TRILOGY 2 results are reported. 

    Jan D'Alvise, President and CEO of Acasti, commented, "With the TRILOGY 2 SAP finalized and now submitted to the FDA, we continue to advance the process towards unblinding of our TRILOGY 2 clinical data. We believe if TRILOGY 2 can achieve statistical significance, and if the pooled efficacy results with TRILOGY 1 using the Intent to Treat population also reaches significance, we can proceed with our Pre-NDA meeting where we intend to discuss with the FDA the use of this data to support an NDA filing. We look forward to the unblinding of TRILOGY 2 data and reporting our findings, concurrent with a conference call update on or about August 31, 2020."

    As of June 30, 2020, Acasti had cash and cash equivalents totaling $12.1 million, compared to $16.0 million as of June 30, 2019. The Company believes it is sufficiently funded through the first calendar quarter of 2021, based on management's current projections.

    First Quarter of Fiscal 2021 Financial Results (US dollars):

    The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP").

    • Loss from operations for the three months ended June 30, 2020 was $4.1 million, compared to a loss from operations of $8.0 million for the three months ended June 30, 2019. The decrease was due mainly to a reduction in research contract expenses as the Phase 3 clinical program for CaPre was nearing completion.
    • Net loss for the three months ended June 30, 2020 was $4.7 million or $0.05 per share, compared to a net loss of $8.8 million or $0.11 per share for the three months ended June 30, 2019. The decreased net loss is primarily due to the reduction of research and development expenses as the Phase 3 clinical program for CaPre was nearing completion, lower net financial expenses, and the change in fair value of the warrants derivative liabilities.
    • R&D expenses before depreciation, amortization and stock-based compensation expenses were $1.1 million for the three months ended June 30, 2020, compared to $5.5 million for the three months ended June 30, 2019. The net decrease was mainly attributable to a reduction in research contract expense due to the advancement of the Phase 3 clinical trial program, as it moved closer to completion.
    • General and Administrative expenses before stock-based compensation expenses were $1.3 million for the three months ended June 30, 2020, an increase of $0.33 million from $0.97 million for the three months ended June 30, 2019. This increase was mainly attributable to consulting, accounting, and legal fees in connection with the conversion from IFRS to U.S. GAAP.  
    • Sales and Marketing expenses before stock-based compensation expenses were $0.57 million for the three months ended June 30, 2020, compared to $0.68 million for the three months ended June 30, 2019. The decrease was mostly due to a reduction in professional fees as a result of a slowdown in pre-launch marketing activities pending the results of the TRILOGY Phase 3 clinical studies are obtained. The decrease was partially offset by an increase in salaries and benefits as a result of increased headcount in the commercial team to support expanded business and market development activities.
    • Cash and cash equivalents totaled $12.1 million as of June 30, 2020, compared to $16.0 million at June 30, 2019. As stated above, Acasti believes that current cash will fully fund the Company's operations through the first calendar quarter of 2021. Acasti projects that additional funds will be needed in the future for activities necessary to prepare for the commercial launch of CaPre if regulatory approval is received, including the scale-up of its manufacturing operations, the completion of the potential regulatory NDA submission package (assuming positive Phase 3 clinical results), and the expansion of business development and U.S. commercial launch activities. The Company is working towards development of strategic partner relationships, as well as actively seeking additional non-dilutive funds in the near future, but there can be no assurance as to when or whether Acasti will complete any strategic collaborations or non-dilutive financings. If the Company does not raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company's ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business. 

    Conference Call

    Acasti plans to host a conference call on or about August 31, 2020 to discuss the TRILOGY 2 topline results, as well as to provide an update on the timing for the reporting of the secondary and exploratory endpoints, and the pooled results from both TRILOGY studies. Details for the call will be provided as we get closer to announcing TRILOGY 2 results. 

    ATM Update

    On June 29, 2020, Acasti entered into an amended and restated ATM sales agreement (the "Sales Agreement") with B. Riley FBR Inc., Oppenheimer & Co. Inc. and H.C. Wainwright & Co., LLC (collectively, the "Agents"), to implement an "at-the-market" equity offering program under which Acasti may issue and sell from time to time our common shares having an aggregate offering price of up to $75 million through the Agents (the "ATM Program"). Pursuant to the ATM Program, as required pursuant to the policies of the TSX Venture Exchange ("TSXV"), since the last distributions reported on June 29, 2020, Acasti issued an aggregate of 4,404,152 common shares (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of $3.5 million. The ATM Shares were sold at prevailing market prices averaging $0.80 per share. No securities were sold through the facilities of the TSXV or, to the knowledge of the Company, in Canada. The ATM Shares were sold pursuant to a U.S. registration statement on Form S-3 (No. 333-239538) as made effective on July 7, 2020, as well as the Sales Agreement. Pursuant to the Sales Agreement, a cash commission of 3.0% on the aggregate gross proceeds raised was paid to the Agents in connection with their services.  

    About CaPre (omega-3 phospholipid) 

    Acasti's prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil, and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either "free" or bound to phospholipids, which allows for better absorption into the body. Acasti believes that EPA and DHA are more efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by triglycerides (as in dietary supplements) or as ethyl esters in other prescription omega-3 drugs, which must then undergo additional digestion before they are ready for transport in the bloodstream. Clinically, the phospholipids may not only improve the absorption, distribution, and metabolism of omega-3s, but they may also decrease the synthesis of LDL cholesterol in the liver, impede or block cholesterol absorption, and stimulate lipid secretion from bile. In two Phase 2 studies, CaPre achieved a statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients across the dyslipidemia spectrum from patients with mild to moderate hypertriglyceridemia (patients with TG blood levels between 200mg/dl and 500mg/dl) to patients with severe hypertriglyceridemia (those with TG levels above 500mg/dl). Furthermore, in the Phase 2 studies, CaPre demonstrated the potential to actually reduce LDL, or "bad cholesterol", as well as the potential to increase HDL, or "good cholesterol", especially at the therapeutic dose of 4 grams/day. The Phase 2 data also showed a significant reduction of HbA1c at a 4-gram dose, suggesting that due to its unique omega-3/phospholipid composition, CaPre may actually improve long-term glucose metabolism. Acasti's TRILOGY Phase 3 program is currently underway, as noted above.

    About Acasti

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre, for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. The Company is developing CaPre in a Phase 3 clinical program in patients with severe hypertriglyceridemia, a market that includes 3 to 4 million patients in the U.S. The potential exists to expand the treatable market in the United States to the approximately 50 million people with TGs above 150 mg/dl, given the recent FDA approval of expanded labeling for VASCEPA based on the recent positive REDUCE-IT outcome study results. Acasti may need to conduct at least one additional clinical trial to support FDA approval of a supplemental New Drug Application to expand CaPre's indications to this segment. Acasti's strategy is to commercialize CaPre in the U.S. and the Company is pursuing development and distribution partnerships to market CaPre in major countries around the world. For more information, visit www.acastipharma.com.

    Forward Looking Statements

    Statements in this press release that are not statements of historical or current fact constitute "forward-looking information" within the meaning of Canadian securities laws and "forward-looking statements" within the meaning of U.S. federal securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti's strategy, future operations, prospects and the plans of management; Acasti's ability to conduct all required clinical and non-clinical trials for CaPre, including the timing and results of those trials; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia; the timing and outcome of the unblinding of TRILOGY 2; the impact of the "Pre-Randomization Triglyceride Normalization" phenomenon on TRILOGY 2; and Acasti's ability to file an NDA based on the results of its TRILOGY Phase 3 program.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Special Note Regarding Forward-Looking Statements" section contained in Acasti's latest annual report on Form 10-K and quarterly report on Form 10-Q, which are available on EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com and on the investor section of Acasti's website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti's public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti's latest annual report on Form 10-K under the caption "Risk Factors".

    Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Acasti Contact:

    Jan D'Alvise

    Chief Executive Officer

    Tel: 450-686-4555

    Email: inacastipharma.com

    www.acastipharma.com

    Investor Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email:

     

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  5. LAVAL, Québec, July 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced it has completed its revisions to the pre-specified Statistical Analysis Plan (SAP) for the TRILOGY 2 Phase 3 trial of CaPre, and has filed it with the Food and Drug Administration (FDA).

    As previously disclosed, the Company, along with the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical…

    LAVAL, Québec, July 31, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (sHTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced it has completed its revisions to the pre-specified Statistical Analysis Plan (SAP) for the TRILOGY 2 Phase 3 trial of CaPre, and has filed it with the Food and Drug Administration (FDA).

    As previously disclosed, the Company, along with the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, conducted rigorous post-hoc analysis of TRILOGY 1 data. Analysis of the TRILOGY 1 data revealed a rapid, significant and sustained reduction in TG levels between screening (during qualification) and the time of patient randomization (prior to patients starting on either drug or placebo), which Acasti refers to as "Pre-randomization Triglyceride (TG) Normalization." This artefactual phenomenon affected both treatment groups, but was much greater in the placebo group, resulting in the large placebo effect and significant underestimation of the post-randomization treatment effect of the active drug, CaPre.  The post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 (Visit 4) corrected for a significant amount of the pre-randomization TG reduction in subjects that were most affected by the normalization phenomenon, and a meaningful efficacy trend for CaPre was observed.

    The Company provided all of the TRILOGY 1 background information and accompanying data to the FDA in a Type C briefing package, which was filed on April 29, 2020. As previously disclosed, the FDA provided Acasti with a written response to its Type C Meeting request and briefing package, and confirmed that it will require pivotal efficacy analyses for TRILOGY 2 to be performed on the full Intent to Treat (ITT) population, as contemplated in the original Statistical Analysis Plan (SAP), and they supported the conduct of post-hoc analyses in TRILOGY 1 for exploratory purposes. Based on the FDA's feedback and input from key experts including Dr. Mozaffarian, Acasti finalized the Statistical Analysis Plan (SAP) for TRILOGY 2 and has now submitted it to the FDA. The Company remains blinded to the TRILOGY 2 data, and remains on track to report topline TG data on or about August 31, 2020. The key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and pooled results from both studies, are still expected within several weeks following the unblinding of TRILOGY 2 results. 

    Acasti also announced it plans to host a conference call on or about August 31, 2020 to discuss the TRILOGY 2 topline results, as well as to provide an update on the timing for the reporting of the secondary and exploratory endpoints, and the pooled results from both TRILOGY studies. For this reason, the Company does not plan to host its usual quarterly conference call to discuss the financial results for the first fiscal quarter ended June 30, 2020, but expects to report and file its first fiscal quarter 2021 financial results on August 13, 2020.

    About CaPre (omega-3 phospholipid) 

    Acasti's prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil, and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either "free" or bound to phospholipids, which allows for better absorption into the body. Acasti believes that EPA and DHA are more efficiently transported by phospholipids sourced from krill oil than the EPA and DHA contained in fish oil that are transported either by triglycerides (as in dietary supplements) or as ethyl esters in other prescription omega-3 drugs, which must then undergo additional digestion before they are ready for transport in the bloodstream. Clinically, the phospholipids may not only improve the absorption, distribution, and metabolism of omega-3s, but they may also decrease the synthesis of LDL cholesterol in the liver, impede or block cholesterol absorption, and stimulate lipid secretion from bile. In two Phase 2 studies, CaPre achieved a statistically significant reduction of triglycerides and non-HDL cholesterol levels in patients across the dyslipidemia spectrum from patients with mild to moderate hypertriglyceridemia (patients with TG blood levels between 200mg/dl and 500mg/dl) to patients with severe hypertriglyceridemia (those with TG levels above 500mg/dl). Furthermore, in the Phase 2 studies, CaPre demonstrated the potential to actually reduce LDL, or "bad cholesterol", as well as the potential to increase HDL, or "good cholesterol", especially at the therapeutic dose of 4 grams/day. The Phase 2 data also showed a significant reduction of HbA1c at a 4-gram dose, suggesting that due to its unique omega-3/phospholipid composition, CaPre may actually improve long-term glucose metabolism. Acasti's TRILOGY Phase 3 program is currently underway, as noted above.

    About Acasti

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre, for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. The Company is developing CaPre in a Phase 3 clinical program in patients with severe hypertriglyceridemia, a market that includes 3 to 4 million patients in the U.S. The potential exists to expand the treatable market in the United States to the approximately 50 million people with TGs above 150 mg/dl, given the recent FDA approval of expanded labeling for VASCEPA based on the recent positive REDUCE-IT outcome study results. Acasti may need to conduct at least one additional clinical trial to support FDA approval of a supplemental New Drug Application to expand CaPre's indications to this segment. Acasti's strategy is to commercialize CaPre in the U.S. and the Company is pursuing development and distribution partnerships to market CaPre in major countries around the world. For more information, visit www.acastipharma.com.

    Forward Looking Statements

    Statements in this press release that are not statements of historical or current fact constitute "forward-looking information" within the meaning of Canadian securities laws and "forward-looking statements" within the meaning of U.S. federal securities laws (collectively, "forward-looking statements"). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms "believes," "belief," "expects," "intends," "anticipates," "potential," "should," "may," "will," "plans," "continue", "targeted" or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti's strategy, future operations, prospects and the plans of management; Acasti's ability to conduct all required clinical and non-clinical trials for CaPre, including the timing and results of those trials; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia; the timing and outcome of the unblinding of TRILOGY 2; and Acasti's ability to file an NDA based on the results of its TRILOGY Phase 3 program.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Special Note Regarding Forward-Looking Statements" section contained in Acasti's latest annual report on Form 10-K, which will be available on EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com and on the investor section of Acasti's website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti's public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti's latest annual report on Form 10-K under the caption "Risk Factors".

    Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

    Acasti Contact:

    Jan D'Alvise

    Chief Executive Officer

    Tel: 450-686-4555

    Email: inacastipharma.com

    www.acastipharma.com

    Investor Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email:

     

    Primary Logo

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