1. LAVAL, Quebec, March 08, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) is providing an update on the use of its "at-the market" equity offering program.

    As previously disclosed, Acasti entered into an amended and restated ATM sales agreement on June 29, 2020 (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 its common shares having an aggregate offering price of up to $75 million through the Agents (the "ATM Program"). Pursuant to…

    LAVAL, Quebec, March 08, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) is providing an update on the use of its "at-the market" equity offering program.

    As previously disclosed, Acasti entered into an amended and restated ATM sales agreement on June 29, 2020 (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 its 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 January 27, 2021, Acasti issued an aggregate of 20,159,229 common shares (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US$21.7 million. The ATM Shares were sold at prevailing market prices averaging US$1.0747 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. As a result of the recent ATM sales, Acasti has a total of 200,119,659 common shares issued and outstanding as of March 5, 2021.

    The additional capital raised has strengthened Acasti's balance sheet and will provide the Company with additional flexibility in its ongoing review process to explore and evaluate strategic alternatives.

    About Acasti

    Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

    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 and its review of strategic alternatives.

    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 and quarterly report on Form 10-Q 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:



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  2. New York, Feb. 09, 2021 (GLOBE NEWSWIRE) -- - Tocvan Ventures Corp (CSE:TOC) (FRA:TV3) says maiden drill program at Pilar project shows encouraging mineralization and potential for expansion click here

    - LiteLink Technologies Inc (CSE:LLT) (OTC:LLNKD) (FRA:C0B:FF) completes previously announced private placement for gross proceeds of C$1,005,000 click here

    - Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) (FRA:A1PA) posts fiscal third quarter results as strategic review continues click here

    - HempFusion Wellness Inc (TSE:CBD.U) (OTC:CBDHF) (FRA:8OO) CMO Ola Lessard becomes first two-term president of advocacy group US Hemp Roundtable click here

    - Exro Technologies  Inc (CVE:EXRO) (OTC:EXROF) (FRA:1O2) bolsters…

    New York, Feb. 09, 2021 (GLOBE NEWSWIRE) -- - Tocvan Ventures Corp (CSE:TOC) (FRA:TV3) says maiden drill program at Pilar project shows encouraging mineralization and potential for expansion click here

    - LiteLink Technologies Inc (CSE:LLT) (OTC:LLNKD) (FRA:C0B:FF) completes previously announced private placement for gross proceeds of C$1,005,000 click here

    - Acasti Pharma Inc (NASDAQ:ACST) (CVE:ACST) (FRA:A1PA) posts fiscal third quarter results as strategic review continues click here

    - HempFusion Wellness Inc (TSE:CBD.U) (OTC:CBDHF) (FRA:8OO) CMO Ola Lessard becomes first two-term president of advocacy group US Hemp Roundtable click here

    - Exro Technologies  Inc (CVE:EXRO) (OTC:EXROF) (FRA:1O2) bolsters partnership with SEA Electric to advance its battery control system click here

    - Genprex Inc (NASDAQ:GNPX) announces $25 million registered direct offering priced at-the-market click here

    - American Resources Corporation (NASDAQ:AREC) engages ex-Eli Lilly executive William Smith III to design and build its rare earth and critical mineral purification facilities click here

    - First Cobalt Corp (CVE:FCC) (OTCQX:FTSSF) makes two key corporate appointments to help advance its Iron Creek copper-cobalt project in Idaho click here

    - Milestone Scientific Inc (NYSEAMERICAN:MLSS) signs distribution deals with Atlanta Dental and Nashville Dental for its Wand Single Tooth Anesthesia System click here

    - Esports Entertainment Group Group Inc (NASDAQ:GMBL) (FRA:40Y1) files for a gaming license in New Jersey click here



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  3. LAVAL, Quebec, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) today announced its operating and financial results for the third quarter of fiscal 2021 ended December 31, 2020.

    Recent Events:

    Engaged Oppenheimer & Co. Inc. to Assist in Strategic Review. On September 29, 2020 the Company announced that it had commenced a formal process to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, Acasti engaged Oppenheimer & Co., Inc., as the Company's financial advisor to assist in the process. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome. Acasti expects to devote significant…

    LAVAL, Quebec, Feb. 09, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) today announced its operating and financial results for the third quarter of fiscal 2021 ended December 31, 2020.

    Recent Events:

    Engaged Oppenheimer & Co. Inc. to Assist in Strategic Review. On September 29, 2020 the Company announced that it had commenced a formal process to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, Acasti engaged Oppenheimer & Co., Inc., as the Company's financial advisor to assist in the process. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome. Acasti expects to devote significant time and resources to identifying and evaluating strategic alternatives, however, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value. The Company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by our Board of Directors.

    Third 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 December 31, 2020 was $2.0 million, compared to a loss from operations of $6.1 million for the three months ended December 31, 2019. The change was due mainly to a reduction in R&D, general and administrative expenses, and sales and marketing expenses.
    • Net loss for the three months ended December 31, 2020 was $3.2 million or $0.03 per share, a decrease of $8.9 million from the net loss $12.1 million or $0.14 per share for the three months ended December 31, 2019. The reduction in net loss, resulted primarily from net financial expenses decreasing by $4.7 million to a loss of $1.3 million for the three months ended December 31, 2020, as compared to net financial expenses of $6.0 million for the three months ended December 31, 2019. This is due mostly to a decreased impact from the change in fair value of the derivative warrant liability as compared to the comparative fiscal quarter in 2019, caused by a proportionately higher decrease in the quarter over quarter closing share price partly offset by a reduction in the number of warrants outstanding due to exercises during the prior year.
    • R&D expenses before depreciation, amortization and stock-based compensation expense for the three months ended December 31, 2020 totaled $620 thousand compared to $3.2 million for the three months ended December 31, 2019. The net decrease was mainly attributable to a reduction in research contracts with the reduction in R&D activities as well as a reduction in headcount within the department.
    • General and Administrative expenses before stock-based compensation expenses were $931 thousand for the three-months ended December 31, 2020 and decreased by $262 thousand from $1.2 million for the three months ended December 31, 2019. This decrease is mostly a result of a $251 thousand decrease related to legal and professional fees.
    • Sales and Marketing expenses before stock-based compensation expenses were $488 thousand for the three months ended December 31, 2020 compared to $562 thousand for the three months ended December 31, 2019. The change was related to severances associated to the reduction in headcount in the department of $118 thousand, offset by the reduction in professional fees and other sales activities of $192 thousand as a result of an end to planned pre-launch marketing activities for CaPre.
    • Cash flows Cash, cash equivalents totaled $26.5 million as of December 31, 2020, compared to $14.2 million at March 31, 2020. Acasti believes that existing cash will fully fund the Company's operations through to an eventual completion of the evaluation of strategic options or at least through the next 12 months, but there can be no assurance as to when or whether Acasti will complete any strategic transaction or collaboration. The Company's ability to continue as a going concern is dependent upon its ability to achieve a successful strategic alternative and ultimately generate cashflows to meet its obligations.

    About Acasti

    Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

    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.

    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 and quarterly report on Form 10-Q 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:



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  4. LAVAL, Québec, Jan. 27, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) is providing an update on the use of its "at-the market" equity offering program.

    As previously disclosed, Acasti entered into an amended and restated ATM sales agreement on June 29, 2020 (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 its common shares having an aggregate offering price of up to US$75 million through the Agents (the "ATM Program"). Pursuant to the…

    LAVAL, Québec, Jan. 27, 2021 (GLOBE NEWSWIRE) -- As required pursuant to the policies of the TSX Venture Exchange, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) is providing an update on the use of its "at-the market" equity offering program.

    As previously disclosed, Acasti entered into an amended and restated ATM sales agreement on June 29, 2020 (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 its common shares having an aggregate offering price of up to US$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 August 13, 2020, Acasti issued an aggregate of 82,626,562 common shares (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US$28.5 million. The ATM Shares were sold at prevailing market prices averaging US$0.3445 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. As a result of the recent ATM sales, Acasti has a total of 179,495,705 common shares issued and outstanding as of January 26th, 2021.

    The additional capital raised has strengthened Acasti's balance sheet and will provide the Company with additional flexibility in its ongoing review process to explore and evaluate strategic alternatives.

    About Acasti

    Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

    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 and its review of strategic alternatives.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement and 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 and quarterly report on Form 10-Q 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, Dec. 23, 2020 (GLOBE NEWSWIRE) -- At the request of IIROC, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) wishes to confirm that the Company's management and Board of Directors are unaware of any material change in the Company's operations that would account for the recent increase in market activity.

    About Acasti

    Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia…

    LAVAL, Québec, Dec. 23, 2020 (GLOBE NEWSWIRE) -- At the request of IIROC, Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) wishes to confirm that the Company's management and Board of Directors are unaware of any material change in the Company's operations that would account for the recent increase in market activity.

    About Acasti

    Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

    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.

    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 and quarterly report on Form 10-Q 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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  6. LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.

    Recent Events:

    TRILOGY 1 & 2 Topline Results. The Company's two Phase 3 clinical trials, designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020 and August 31, 2020 respectively, and neither TRILOGY 1 nor TRILOGY 2 independently reached statistical significance, and therefore they did not meet their primary endpoint for lowering triglycerides…

    LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.

    Recent Events:

    TRILOGY 1 & 2 Topline Results. The Company's two Phase 3 clinical trials, designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020 and August 31, 2020 respectively, and neither TRILOGY 1 nor TRILOGY 2 independently reached statistical significance, and therefore they did not meet their primary endpoint for lowering triglycerides. Although the triglyceride reduction in the CaPre arm was one of the largest seen amongst previously conducted triglyceride reduction studies, 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.

    Engaged Oppenheimer & Co. Inc. to Assist in Strategic Review. On September 29, 2020, the Company announced that it had engaged Oppenheimer & Co. Inc. as its financial advisor to assist in the strategic review process. Potential strategic alternatives that may be explored or evaluated as part of this review include, but are not limited to, a merger, business combination or other strategic transaction involving Acasti and/or CaPre. There is no defined timeline for completion of the review process.

    Reduction in Headcount and Discontinuation of Substantially all Commercial and R&D Activities. The Company initiated a plan in September 2020 to reduce personnel and expenses to preserve cash and further reduce its operations consistent with the decision to discontinue substantially all commercialization and research and development activities. The Company expects to devote significant time and resources to identifying and evaluating strategic alternatives, however, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value.

    Jan D'Alvise, Chief Executive Officer of Acasti, commented, "We remain committed to maximizing value for our shareholders, and as previously disclosed, we are actively exploring and evaluating a range of strategic options. We have also taken a number of proactive steps to preserve our cash by reducing staff, discontinuing all commercialization activities and putting R&D activities on hold. This has resulted in certain one-time and non-cash charges as reflected in our financial statements this quarter. While we continue to pursue strategic alternatives, we plan to complete the full data analyses for TRILOGY as contemplated in the Statistical Analysis Plan, including the pooling of the data from TRILOGY 1 and 2. As previously disclosed, we plan to provide an update on the final TRILOGY data when feasible."

    Second 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 September 30, 2020 was $7.8 million, compared to a loss from operations of $6.3 million for the three months ended September 30, 2019. The increase was due mainly to impairment charges of $5.3 million, $3.7 million related to intangible assets and $1.6 million related to production and lab equipment, offset by a reduction in R&D, general and administrative expenses, and sales and marketing expenses.
    • Net loss for the three months ended September 30, 2020 was $6.1 million or $0.06 per share, compared to a net loss of $21.2 million or $0.25 per share for the three months ended September 30, 2019. The reduction in net loss, resulted primarily from net financial expenses decreasing to a gain of $1.9 million for the three months ended September 30, 2020, as compared to net financial expenses of $14.9 million for the three months ended September 30, 2019. This is due mostly to a decreased impact from the change in fair value of the derivative warrant liability as compared to the comparative fiscal quarter in 2019, caused by a proportionately higher decrease in the quarter over quarter closing share price partly offset by a reduction in the number of warrants outstanding due to exercises during the prior year.
    • R&D expenses before depreciation, amortization and stock-based compensation expenses were $0.8 million for the three months ended September 30, 2020, compared to $3.3 million for the three months ended September 30, 2019. The net decrease was mainly attributable to a reduction in salaries and research contracts with the reduction in R&D activities.
    • General and Administrative expenses before stock-based compensation expenses were $1.1 million for the three months ended September 30, 2020, compared to $1.1 million for the three months ended September 30, 2019. This reflects a $0.27 million increase related to legal fees related offset by a decrease of $0.23 million related to salaries, due to a reversal of bonus accruals.
    • Sales and Marketing expenses before stock-based compensation expenses were $0.02 million for the three months ended September 30, 2020, compared to $0.66 million for the three months ended September 30, 2019. The decrease was mostly due to a reduction in professional fees as a result of a reclassification of professional and other expenses to R&D.
    • Cash flows Cash and cash equivalents totaled $11.6 million as of September 30, 2020, compared to $14.2 million at March 31, 2020. Acasti believes that existing cash will fully fund the Company's operations through the second calendar quarter of 2021 or through to an eventual completion of the evaluation of strategic options, but there can be no assurance as to when or whether Acasti will complete any strategic transaction, collaboration or non-dilutive financings. If the Company cannot 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.

    NASDAQ Minimum Bid Price Rule

    On February 28, 2020, Acasti received written notification from the NASDAQ Listing Qualifications Department for failing to maintain a minimum bid price of $1.00 per share for the preceding 30 consecutive business days, as required by NASDAQ Listing Rule 5550(a)(2) – bid price (the "Minimum Bid Price Rule"). Under NASDAQ Listing Rule 5810(c)(3)(A) – compliance period, Acasti initially had 180 calendar days to regain compliance.

    On April 17, 2020, Acasti was informed that NASDAQ had granted temporary regulatory relief related to the Minimum Bid Price Rule due to the COVID-19 pandemic for all NASDAQ-listed companies and therefore extended the deadline for Acasti to regain compliance to November 9, 2020.

    On November 11, 2020, Acasti was further informed that NASDAQ had granted an additional 180 calendar days, or until May 10, 2021, for Acasti to regain compliance with the Minimum Bid Price Rule.

    Retention Agreements

    In connection with its strategic review process, the Company also announces that, upon the recommendation of the Governance and Human Resources Committee of the board of directors, it has entered into retention incentive agreements with Ms. Jan D'Alvise, the Company's President and Chief Executive Officer, and Mr. Pierre Lemieux, the Company's Chief Operating Officer and Chief Scientific Officer (the "Retention Agreements").

    The Retention Agreements provide that the Company will pay Ms. D'Alvise an employment retention incentive of US $100,000 provided that she remains employed with the Company until the earlier of April 30, 2021 or the closing of a merger or like transaction with a third party.

    In addition, the Retention Agreements also provide that the Company will pay each of Ms. D'Alvise and Mr. Lemieux an amount of up to US $125,000 in the event that certain milestones are met in relation to the monetization by the Company of its assets relating to the Company's drug candidate, CaPre.

    The Company also announces the upcoming departure of Mr. Brian Groch, its Chief Commercial Officer, from his position with the Company effective December 31, 2020, until which date he is continuing in his role with Acasti. The Company would like to thank Mr. Groch for his contributions to the Company and wishes him well in his future endeavors.

    About Acasti

    Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

    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; the outcome of the strategic review process to explore and evaluate strategic alternatives to enhance shareholder value; and Acasti's ability to successfully consummate a strategic transaction.

    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 and quarterly report on Form 10-Q 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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  7. MONTREAL, Nov. 5, 2020 /CNW Telbec/ - Cannara Biotech Inc. ("Cannara" or the "Company") (CSE:LOVE) (OTCQB:LOVFF) (FRA: 8CB) today announced the appointment of Donald Olds as a Director on the Company's board of directors.

    "Don is well recognized within the Montreal business community as a leader both within the life science sector and beyond. We are delighted that he is bringing his experience and integrity to Cannara," said Zohar Krivorot, President and Chief Executive Officer of Cannara. "Don's knowledge regarding how board's create impact beyond governance, and his insights on collaborating with growth companies make him an ideal contributor to Cannara."

    Donald Olds is an experienced life sciences executive, entrepreneur and director with significant experience raising capital for private and public technology companies. Most recently, he was President and Chief Executive Officer of Montreal-based NEOMED Institute, a position he held until the successful closing of a merger with Vancouver-based CDRD. He has held multiple executive positions as Chief Executive Officer, Chief Operations Officer and Chief Financial Officer of private and public life science and technology companies and began his business career as a commercial, corporate and investment banker working across a variety of industry verticals. Mr. Olds has significant corporate governance experience as a board member and chair of both for profit and not for profit organizations. He is currently lead director at Goodfood Markets (TSX:FOOD), director of Acasti Pharma (NASDAQ:ACST), Chair of Aifred Health, past Chair of Oxfam Quebec and director of private Presagia Corp. He holds a master's in business administration and a master's in sciences from McGill University.

    "We would also like to take this opportunity to announce that Lennie Ryer is departing from the Company and we wish him good fortune in his future endeavors," added Mr. Krivorot. "Lennie will continue to provide transition services to the company for a period of 12 months."

    Nicholas Sosiak, Cannara's Senior Vice-President of Finance and Operations, who has been with the Company since April 2019, has been appointed as Interim Chief Financial Officer. Nicholas is a Chartered Professional Accountant and started his career at KPMG in the audit practice, mostly focused on the public sector. Following his tenure as an auditor, he joined Dundee 360 Real Estate Corporation, a subsidiary of Dundee Corporation and a publicly traded company listed on the TSX, as Vice-President of Finance and Accounting where he was responsible for overseeing the company's finance and governance function in addition to managing finances of large-scale real estate development projects like the Queen Elizabeth Hotel and Four Seasons Private Residences. Nicholas has true passion and understanding of the Cannabis industry.

    About Cannara Biotech Inc.

    Cannara Biotech Inc. (CSE:LOVE) (OTCQB:LOVFF) (FRA: 8CB) has built one of the largest indoor cannabis cultivation facilities (625,000 square feet) in Canada and the largest in Quebec. Leveraging Quebec's low electricity costs, Cannara Biotech Inc.'s facility will produce premium-grade indoor cannabis and cannabis-derivative products for the Quebec and Canadian markets.

    The CSE nor its Regulation Services Provider accepts responsibility for the adequacy or accuracy of this release.

    Cautionary Statement Regarding "Forward-Looking" Information

    This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

    SOURCE Cannara Biotech Inc.

    Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/November2020/05/c7245.html

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  8. LAVAL, Québec, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST, TSXV:ACST), announces the voting results for the matters listed in its management information circular and proxy statement dated August 31, 2020 (the "Circular") held at its Annual and Special Meeting of Shareholders on September 30, 2020 (the "AGM").

    For further information on the voting results of the resolution passed during the AGM, please refer to the Report of Voting Results available on SEDAR at www.sedar.com.

    Election of Directors

    At the AGM, the following individuals were elected as directors of the Corporation for the ensuing year: Roderick N. Carter, Jean-Marie (John) Canan, Jan D'Alvise and Donald Olds.

    Appointment

    LAVAL, Québec, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Corporation") (NASDAQ:ACST, TSXV:ACST), announces the voting results for the matters listed in its management information circular and proxy statement dated August 31, 2020 (the "Circular") held at its Annual and Special Meeting of Shareholders on September 30, 2020 (the "AGM").

    For further information on the voting results of the resolution passed during the AGM, please refer to the Report of Voting Results available on SEDAR at www.sedar.com.

    Election of Directors

    At the AGM, the following individuals were elected as directors of the Corporation for the ensuing year: Roderick N. Carter, Jean-Marie (John) Canan, Jan D'Alvise and Donald Olds.

    Appointment of Auditors

    At the AGM, KPMG LLP were appointed as the Corporation's auditors for the ensuing fiscal year and the directors were authorized to fix their remuneration.

    Advisory Vote on the Compensation of Named Executive Officers

    At the AGM, shareholders passed an advisory (non-binding) resolution approving the compensation of the Corporation's named executive officers.

    Advisory Vote on the Frequency of Future Shareholder "say-on-pay" Votes

    At the AGM, shareholders passed an advisory (non-binding) resolution approving the option of having an advisory (non-binding) vote approving the compensation of the Corporation's named executive officers once every year.

    Amendments to the Corporation Stock Option Plan and Equity Incentive Plan

    At the AGM, disinterested shareholders approved amendments to the Corporation's stock option plan, as more particularly described in the Circular.

    At the AGM, disinterested shareholders also approved amendments to the Corporation's equity incentive plan, as more particularly described in the Circular.

    The amendments to the Stock Option Plan and the Equity Incentive Plan are subject to TSX-V final approval.

    Adoption of Amended & Restated General By-Law

    At the AGM, shareholders passed a resolution to approve, ratify and confirm the adoption of the amended and restated general by-law of the Corporation, as more particularly described in the Circular.

    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.

    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 latest quarterly report on Form 10-Q, which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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

    U.S. Contact:

    Crescendo Communications, LLC

    Tel: 212-671-1020

    Email:

    Primary Logo

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  9. LAVAL, Québec, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces the Company has commenced a formal process to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, the Company has engaged Oppenheimer & Co., Inc., as its financial advisor to assist in the process. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome. The Company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the Company's Board of Directors.

    In the meantime, the Company and its clinical advisors plan to complete…

    LAVAL, Québec, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces the Company has commenced a formal process to explore and evaluate strategic alternatives to enhance shareholder value. Towards this end, the Company has engaged Oppenheimer & Co., Inc., as its financial advisor to assist in the process. There can be no assurance of a successful outcome from these efforts, or of the form or timing of any such outcome. The Company does not intend to make any further disclosures regarding the strategic review process unless and until a specific course of action is approved by the Company's Board of Directors.

    In the meantime, the Company and its clinical advisors plan to complete the full data analyses as contemplated in the Statistical Analysis Plan for TRILOGY 2, including the secondary and exploratory endpoints, and the pooling of the data from TRILOGY 1 and 2.

    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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  10. 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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  11. 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

    View Full Article Hide Full Article
  12. 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

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  13. 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:

     

    Primary Logo

    View Full Article Hide Full Article
  14. 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

    View Full Article Hide Full Article
  15. Identifies "Triglyceride Normalization" phenomenon prior to patient randomization and treatment as likely contributor to unusually high placebo effect in TRILOGY 1

    Acasti management to host conference call at 1 PM ET today

    LAVAL, Quebec, June 29, 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 and TRILOGY Phase 3 Clinical Program update, and announced its operating and financial results for the fiscal…

    Identifies "Triglyceride Normalization" phenomenon prior to patient randomization and treatment as likely contributor to unusually high placebo effect in TRILOGY 1

    Acasti management to host conference call at 1 PM ET today

    LAVAL, Quebec, June 29, 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 and TRILOGY Phase 3 Clinical Program update, and announced its operating and financial results for the fiscal year ended March 31, 2020.

    The Company also reported a phenomenon that it refers to as "Pre-Randomization Triglyceride (TG) Normalization" that occurred between the screening and randomization periods of the study (during qualification), and prior to patients starting on drug or placebo.  A summary of the post-hoc data analyses and audit findings for TRILOGY 1 can be found below, and in the Business Section of the Company's annual report on Form 10-K, which will be filed with the Securities and Exchange Commission today, and will be available on the Company's website.

    Recent Corporate Highlights:

    • Reported topline results for TRILOGY 1 Phase 3 trial of CaPre in January 2020
    • Completed clinical site and central lab audits in fiscal Q4
    • Meeting request filed with the Food and Drug Administration (FDA) to discuss TRILOGY 1 post-hoc data analysis, with request to get input on proposed revisions to the pre-specified Statistical Analysis Plan (SAP) for the TRILOGY 2 Phase 3 trial of CaPre
    • Submitted briefing package with TRILOGY 1 data to FDA on April 29, 2020
    • Written response received from the FDA and reported on June 19, 2020
    • TRILOGY 2 topline results still expected in calendar Q3

    TRILOGY 1 Post-Hoc Review Highlights:

    • Rigorous post-hoc analysis of the data conducted by the Company, the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts
    • 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 TG Normalization"
    • Pre-Randomization TG Normalization affected both treatment groups, but was much greater in the placebo group, resulting in a significant underestimation of the post-randomization treatment effect of the active drug, CaPre
    • Company conducted post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 (Visit 4) which corrected for a significant amount of the pre-randomization TG reduction in subjects that were most affected by this normalization phenomenon
    • Meaningful efficacy trend for CaPre observed, after correcting for the unexpectedly large placebo response in the original analysis

    TRILOGY 1 Summary:

    The Company released topline results from its TRILOGY 1 Phase 3 trial in January 2020, reporting a 30.5% median reduction in triglyceride levels among patients receiving CaPre at 12 weeks, and a 42.2% median reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks. Additionally, the Company reported a 36.7% median reduction in triglyceride levels among patients receiving CaPre at 26 weeks. Despite positive results in the CaPre arm, TRILOGY 1 did not reach statistical significance due to an unusually large placebo response of 27.5% and 28.0% median reductions in triglyceride levels at 12 and 26 weeks, respectively. The safety profile of CaPre in TRILOGY 1 was similar to placebo, as there was no significant difference in treatment-related serious adverse events in the trial.

    The protocol for TRILOGY 1 and 2 had input from and was approved by the FDA, and followed essentially the same standard design as has been used by all other companies running trials in sHTG. There were some slight differences in the TRILOGY 1 patient population as compared to previous studies with other omega-3 therapeutics in sHTG, but none that were believed to have contributed to the significant placebo effect. As previously reported, despite monitoring activities conducted throughout the TRILOGY 1 trial to ensure adherence to the protocol and to detect potential protocol violations, Acasti subsequently identified some unexpected and inconsistent findings that the Company believes may have negatively contributed to the unusual placebo effect. These findings were further explored via a comprehensive and rigorous post-hoc review of the data by the Company, the academic Principal Investigator (PI) of the study, Dariush Mozaffarian M.D., Dr.P.H., and external clinical and statistical experts, as well as audits of the central blood testing laboratory and certain clinical sites, which were conducted by an independent team of auditors.

    This post-hoc analysis of the TRILOGY 1 data revealed a rapid, significant and sustained reduction in TG levels during the patient qualification period, which took place between screening and the time of patient randomization (that is, prior to patients starting on either drug or placebo). Acasti refers to this phenomenon as "Pre-Randomization TG Normalization." This phenomenon, which to our knowledge has not been reported in any other TG studies, resulted in an artefactual overestimation of TG reduction in both treatment groups. However, the Pre-Randomization TG Normalization was much greater in the placebo group as compared to the CaPre group, resulting in a significant underestimation of the post-randomization treatment effect of CaPre in TRILOGY 1, and further compromising the ability of the study to detect a clinically significant drug treatment effect.

    TG values are normally quite variable, and it is expected that the intra-individual TG variation in subjects on a healthy, low fat National Cholesterol Education Program (NCEP) diet may be 10% or greater (going in either direction) within a one to two week period. Thus, it is standard practice to include 2 or 3 pre-randomization TG measurements in the determination of the baseline for the calculation of the primary endpoint. The pre-randomization reduction in TGs across all subjects in TRILOGY 1 was about 20%, with 25% of all subjects experiencing a reduction equal to or greater than 38%. The median Pre-Randomization TG Normalization reached 30% or more in 12 out of 54 sites (or in 22% of all randomizing sites), in all, much greater than the 10% variation that would have been expected based on physiological variability. In addition, natural variability would have resulted in both increases and decreases in individual levels which would largely offset each other, limiting aggregate variability below 10%. The magnitude of pre-randomization reduction in TG levels seen in TRILOGY 1 indicated a largely unidirectional variability, which was not likely due solely to physiological intra-individual variation, and therefore is considered to be artefactual.

    The unexpected and large magnitude of this Pre-Randomization TG Normalization phenomenon resulted in about 40% of all randomized and eligible subjects having TG levels at randomization (Visit 4 or "Week 0") that fell below the protocol specified average qualification lower threshold of ≥ 500 mg/dL for patients with sHTG.

    Based on the above observations, we believe that the Pre-Randomization TG Normalization substantially impacted the outcome of TRILOGY 1, and the ability of the study to accurately determine the therapeutic impact of CaPre as measured by the pre-specified primary endpoint. Specifically, we believe that the use of an average of 3 values for the calculation of the baseline TG levels corresponding to time points during Qualification (e.g. at Week minus 2, and Week minus 1 prior to randomization), and Week 0 (at randomization), resulted in an overestimation of the TG reduction, particularly in the placebo group – with significant TG reduction occurring in many patients even before either drug or placebo were started.

    The Company conducted post-hoc analyses of the primary endpoint using a revised, single point baseline value from Week 0 (Visit 4), the date of randomization, which is referred to as the "Revised Baseline." Furthermore, only those subjects meeting the protocol-specified TG threshold of ≥ 500 mg/dL and ≤ 1500 mg/dL at Week 0 were included in this post-hoc analyses.

    This revised approach for calculating the baseline TG levels corrected for a significant amount of the pre-randomization TG reduction in the subjects that were most affected by this normalization phenomenon. After patients with TG values <500 mg/dL and >1500 mg/dL on the date of randomization were removed, a total of 143 subjects remained (originally N = 242), including 42 subjects in the placebo group (originally N = 69), and 101 subjects remained in the CaPre group (originally N = 173), and were included in the post-hoc analyses representing 61% and 58% of all randomized subjects, respectively.

    In this post-hoc analysis of subjects with TG levels meeting the protocol specified TG threshold of >500 mg/dL and <1500mg/dL at Week 0, subjects receiving CaPre showed a 28.1% median reduction in TG compared to a 15.4% median reduction among subjects receiving placebo after 12 weeks (this represents the primary endpoint, and a non-adjusted absolute difference of 12.7%; p = 0.29). As compared to the original analysis, the Revised Baseline attenuated the placebo response by approximately 12 percentage points (from -27.5% to -15.4%), while the response in the CaPre arm remained mostly unaffected (reduced from -30.0% to -28.1%). After 26 weeks of double-blind treatment, the efficacy of CaPre showed good persistency of effect with a 32.6% median reduction compared with a 14.6% median reduction in the placebo group, reaching a non-adjusted difference of -18.0%, which trended toward statistical significance (p = 0.089). As compared to the original analysis, the Revised Baseline attenuated the placebo response at 26 weeks by approximately 13 percentage points (from -28.0% to -14.6%), while the response in the CaPre arm remained mostly unaffected (reduced from -36.7% to -32.6%). The median TG reductions seen with CaPre using this post-hoc methodology compare favorably to those of previous published studies of other FDA approved drugs for sHTG.

    The subgroup of subjects with Revised Baseline TG levels above 750 mg/dL at Visit 4 (Week 0) represented 41% of the subjects retained in the post-hoc analyses.  Within this group, the median TG reduction in the subjects receiving CaPre was larger as would be expected, reaching 36.3% and 43.0% at Week 12 and Week 26, respectively. In comparison, the median TG reduction for the placebo group was 11.8% at Week 12 and 14.4% at Week 26, resulting in non-adjusted differences of 24.5% and 28.6% respectively in favor of CaPre (p = 0.22 and 0.15, respectively). 

    Not surprisingly, a post-hoc power calculation revealed that these substantially smaller sample sizes resulted in reduced statistical power to detect a treatment difference of 20% as specified in the original Statistical Analysis Plan (SAP). However, the Company believes that these post-hoc results suggest clinical relevance even if statistical significance was not demonstrated, as it is plausible that the trend revealed in the post-hoc analysis may have achieved statistical significance with a larger sample size.

    In summary, the post-hoc analyses of TRILOGY 1 data using the Week 0 (Visit 4) value as a Revised Baseline in subjects with TG ≥ 500 mg/dL and ≤ 1500 mg/dL at Week 0, showed a strong trend towards correcting for the unexpectedly large placebo response observed in the original analysis, without major changes in the CaPre response observed, and we believe allows for a clearer understanding of the impact on the TG primary endpoint, and the potential therapeutic effect of CaPre. However, the median difference in TG levels between CaPre and placebo from the TRILOGY 1 post-hoc analyses still fell short of reaching statistical significance at the Week 12 primary endpoint in this patient adjusted sample.

    "The originally observed large reduction in TG in the placebo group was extremely unusual," said Dr. Mozaffarian, PI of the TRILOGY study. "For unclear reasons, perhaps regression to the mean, many of the patients in the placebo group experienced large reductions in TG even before being randomized.  Use of the single baseline TG value at the time of randomization, in a post-hoc analysis, greatly attenuated and appears to explain much of this unusual placebo response.  We look forward to the results of TRILOGY 2, which will further clarify the TG lowering effects of CaPre."

    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. 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. Consistent with the Company's prior disclosures, and depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to submitting a New Drug Application (NDA). Acasti and its expert advisors are now carefully considering the FDA's comments on the TRILOGY 1 data and will conduct further post-hoc analysis based on their feedback.

    Jan D'Alvise, president and CEO of Acasti, commented, "We made steady progress throughout fiscal 2020 by completing our TRILOGY Phase 3 trials in fiscal Q4, and advancing other important pre-commercialization activities, including scale-up of our manufacturing, NDA preparation, and certain partnering and market development objectives. While our initial topline results from TRILOGY 1 were disappointing due to the unusually large placebo effect, we now have a better understanding of the unusual "Pre-Randomization TG Normalization effect" that contributed significantly to the TRILOGY 1 outcome. We are carefully considering the FDA's comments on the TRILOGY 1 data, and are conducting further post-hoc analysis based on their feedback. Acasti will now finalize the Statistical Analysis Plan (SAP) for TRILOGY 2, which we plan to submit to the FDA by the end of July. We continue to remain blinded to the TRILOGY 2 data, and we continue to estimate that we should be able to report topline data by the end of August 2020. The key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials would still be expected as soon as possible after the unblinding of TRILOGY 2 results."

    D'Alvise continued, "In parallel with all of the TRILOGY activities in Fiscal 2020, we continued to make good progress on the preparation of our NDA package, and plans for commercial launch in the United States, assuming we are successful in gaining regulatory approval for CaPre. At the same time, we continued to strengthen our intellectual property portfolio. We are pleased to have been awarded additional composition of matter and method of use patents in Canada, United States, Mexico, China, Hong Kong, Chile, and Israel since the start of fiscal 2020. We believe all of these patents and pending patent applications increase potential commercial opportunities for CaPre, including through possible licensing and partnership opportunities. We are committed to building a global portfolio of patents to ensure long-lasting and comprehensive intellectual property protection, and to safeguard potentially valuable market expansion opportunities."

    As of March 31, 2020, Acasti had cash, cash equivalents and short-term investments totaling $14.2 million, compared to $25.8 million as of March 31, 2019. The Company believes it is sufficiently funded into the first calendar quarter of 2021, based on management's current projections.

    Other Developments:

    • On April 20, 2020, Acasti announced receiving a Notice of Allowance for its second composition of matter patent to be awarded by the Canadian Intellectual Property Office. This new patent expands the Company's existing claims to include any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.
    • On April 30, 2020, Acasti reported receiving 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.

    Fiscal Year 2020 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 year ended March 31, 2020 was $24.4 million, compared to a loss from operations of $34.4 million for the year ended March 31, 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 year ended March 31, 2020 was $25.5 million or $0.30 per share, compared to a net loss of $39.4 million or $0.73 per share for the year ended March 31, 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 to the change in fair value of the warrant derivative liability.
    • R&D expenses before depreciation, amortization and stock-based compensation expenses were $13.2 million for the year ended March 31, 2020, compared to $26.9 million for the year ended March 31, 2019. The $13.6 million decrease was mainly attributable to a $14.4 million decrease in research contracts, partially offset by an increase in salaries and benefits due to increased headcount and related benefits. The lower research contract expense is primarily attributed to the Phase 3 clinical trial program nearing completion.
    • General and Administrative expenses before stock-based compensation expenses were $4.6 million for the year ended March 31, 2020, an increase of $1.3 million from $3.3 million for the year ended March 31, 2019. This increase was mainly attributable to a $0.45 million increase associated with the Company's insurance policies, as well as an increase of $0.83 million in corporate, accounting and legal fees associated with the implementation of a new ERP system, and the conversion of the financial reporting from IFRS to U.S. GAAP.  
    • Sales and Marketing expenses before stock-based compensation expenses were $2.4 million for the year ended March 31, 2020, compared to $0.42 million for the year ended March 31, 2019. The increase is in line with the planned increased headcount in the commercial team to support expanded business and market development activities.
    • Cash flows – Cash and cash equivalents and short-term investments totaled $14.2 million as of March 31, 2020, compared to $25.8 million for the year ended March 31, 2019. As stated above, Acasti believes that existing cash will fully fund the Company's operations into 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.

    Capital Markets Update:

    Acasti provided an update on recent distributions under its previously adopted "at-the-market" equity offering program (the "ATM Program"), as required pursuant to the policies of the TSX Venture Exchange. Since the last distributions under the ATM program reported on February 14, 2020, Acasti issued an aggregate of 2,278,936 common shares (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US$ 1.8 million. The ATM Shares were sold at prevailing market prices averaging US$ 0.81 per share. No securities were sold through the facilities of the TSX Venture Exchange or, to the knowledge of the Company, in Canada. The ATM Shares were sold pursuant to a U.S. registration statement on Form F-3 (No. 333-223464) as made effective on March 16, 2018, as well as an at-the-market issuance sales agreement dated February 14, 2019 among Acasti and B. Riley FBR, Inc. In addition, 81,925 common shares of the Company were issued over the NASDAQ Stock Market on December 13, 2019 for additional aggregate gross proceeds to the Company of US$167,946.25, which issuance was unintentionally omitted from the press release dated February 14, 2020 referenced above.

    Conference Call

    Acasti will host a conference call today, June 29, 2020 at 1:00 PM Eastern Time to discuss the Company's financial results for the year ended March 31, 2020, as well as provide an update on the TRILOGY Phase 3 program for CaPre.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company's News and Investors section of the website: https://www.acastipharma.com/investors/.

    A webcast replay will be available on the Company's News and Investors section of its website (https://www.acastipharma.com/investors/) through September 29, 2020. A telephone replay of the call will be available approximately one hour following the call, through July 6, 2020, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 35330.

    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:

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  16. LAVAL, Québec, June 19, 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, today announced that the FDA has provided Acasti with a written response to its Type C Meeting request and briefing package.

    The FDA 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…

    LAVAL, Québec, June 19, 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, today announced that the FDA has provided Acasti with a written response to its Type C Meeting request and briefing package.

    The FDA 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. Consistent with the Company's prior disclosures, and depending on the outcome of TRILOGY 2, an additional clinical study may still be needed prior to an NDA submission.

    Acasti and its expert advisors are carefully considering the FDA's comments on the TRILOGY 1 data and will conduct further post-hoc analysis based on their feedback. Concurrent with reporting the Company's year-end financial results and investor conference call on June 29, 2020, the Company will provide more information on TRILOGY 1 post-hoc analyses conducted to date in a detailed update to shareholders along with the plan for the unblinding and reporting of the TRILOGY 2 results.

    Conference Call

    The Company will host a conference call at 1:00 PM Eastern Time on Monday, June 29, 2020 to discuss the Company's financial results for the year ended March 31, 2020, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company's News and Investors section of the website: https://www.acastipharma.com/investors/.

    A webcast replay will be available on the Company's News and Investors section of the website (https://www.acastipharma.com/investors/) through September 29, 2020. A telephone replay of the call will be available approximately one hour following the call, through July 6, 2020, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 35330.

    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.

    About Acasti Pharma

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti may need to conduct at least one additional clinical trial 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" 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 (HTG); 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 "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

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  17. FDA response expected on or before June 30, 2020

    Acasti also received notice of issuance of a Composition of Matter Patent in Hong Kong

    LAVAL, Quebec, April 30, 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, today announced that it submitted its briefing package on April 29, 2020 to the Food and Drug Administration (FDA) for review. The Company is currently awaiting comments, and expects a formal response from the FDA on or before June 30, 2020.

    As previously reported, Acasti filed its meeting…

    FDA response expected on or before June 30, 2020

    Acasti also received notice of issuance of a Composition of Matter Patent in Hong Kong

    LAVAL, Quebec, April 30, 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, today announced that it submitted its briefing package on April 29, 2020 to the Food and Drug Administration (FDA) for review. The Company is currently awaiting comments, and expects a formal response from the FDA on or before June 30, 2020.

    As previously reported, Acasti filed its meeting request at the end of March, and this briefing package is now intended to provide the FDA with a review of the relevant TRILOGY 1 data and audit findings, with the objective to gain alignment on the interpretation of the TRILOGY 1 results and implications for TRILOGY 2. The Company will also seek the FDA's input on Acasti's proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and hopefully reach agreement on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 to support an NDA filing.  Acasti continues to remain blinded to the TRILOGY 2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees.

    Jan D'Alvise, President and CEO of Acasti Pharma, commented, "We have submitted our briefing package to the FDA for their review, and are now awaiting their formal response. We remain optimistic that we may still have a viable path toward filing an NDA. We look forward to the FDA's feedback on our briefing package, and expect that they will provide valuable guidance on the next steps to be taken towards the unblinding of TRILOGY 2. We will provide more information about our TRILOGY 1 findings, and the FDA's response to our briefing package and our questions after we get it."

    Acasti also announced today that it has received notice of issuance of a composition of matter patent to be awarded by the Intellectual Property Office in Hong Kong. This new patent grants claims for any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.

    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.

    About Acasti Pharma

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti may need to conduct at least one additional clinical trial 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" 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 (HTG); the timing and outcome of our requested meeting with the FDA; 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 "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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
  18. LAVAL, Québec, April 20, 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, today announced that it has received a Notice of Allowance for its second composition matter patent to be awarded by the Canadian Intellectual Property Office. This new patent expands the Company's existing claims to include any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.

    Pierre Lemieux, PhD, Acasti's Chief Operating Officer and Chief Scientific Officer, commented…

    LAVAL, Québec, April 20, 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, today announced that it has received a Notice of Allowance for its second composition matter patent to be awarded by the Canadian Intellectual Property Office. This new patent expands the Company's existing claims to include any composition containing EPA and DHA, where at least 50% of the composition consists of phospholipids.

    Pierre Lemieux, PhD, Acasti's Chief Operating Officer and Chief Scientific Officer, commented, "This notice of Allowance for a composition of matter patent builds upon similar patents previously awarded in the United States and Mexico, expanding the scope of our composition claims. Strengthening our IP portfolio is central to our business strategy as we move forward with commercial launch planning, assuming we are successful in gaining regulatory approval for CaPre."

    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.

    About Acasti Pharma

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti may need to conduct at least one additional clinical trial 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" 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 (HTG); and Acasti's ability to obtain regulatory approval for CaPre.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml, 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 20-F and most recent MD&A.

    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

    U.S. Contact:

    David Waldman
    President
    Crescendo Communications, LLC Tel: 212-671-1020
    Email:

    Source: Acasti Pharma, Inc.

    Primary Logo

    View Full Article Hide Full Article
  19. LAVAL, Québec, April 01, 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, today announced that it has filed its meeting request with the Food and Drug Administration (FDA). The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results.  The Company will also seek the FDA's input on Acasti's proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and agree on a plan for pooling the data from TRILOGY…

    LAVAL, Québec, April 01, 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, today announced that it has filed its meeting request with the Food and Drug Administration (FDA). The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results.  The Company will also seek the FDA's input on Acasti's proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and agree on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing.  Acasti remains blinded to the TRILOGY2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees. As previously noted, upon submission of the meeting request, Acasti anticipates meeting with the FDA in the second half of June.

    Jan D'Alvise, President and CEO of Acasti Pharma, commented, "We are pleased to have completed the TRILOGY 1 clinical site and central lab audits as planned, including additional post-hoc analyses, and to have submitted our meeting request to the FDA on schedule. We believe the FDA meeting will provide essential guidance as we prepare to unblind and conduct the topline analysis of the TRILOGY 2 data. We look forward to meeting with the FDA and providing further updates as they unfold."

    Annual Stock Option Grants

    Acasti also announced today the annual grant of stock options to its employees, executives and directors, and the amendment of its stock option plan (the "Stock Option Plan"). The stock options were granted by the Board of Directors as part of the Company's annual performance review in accordance with the Company's Long-Term Incentive Program (LTIP). On March 31, 2020, an aggregate of 3,836,000 stock options were granted to certain employees, executives and directors of the Company under the Company's Stock Option Plan. Subject to the terms and conditions of the Stock Option Plan, options granted to directors will vest in equal monthly installments over a period of 12 months and options granted to executives and employees will vest in equal quarterly installments over a period of 36 months. Each option will entitle the holder to purchase one common share of Acasti at a price of CDN$0.53, until March 31, 2030.

    Subject to the approvals of the TSX Venture Exchange and of shareholders at the Company's next annual and special meeting, on March 31, 2020, the Board of Directors amended the Stock Option Plan in order to reduce the minimum vesting period applicable for grants to directors from 18 months on a quarterly basis to 12 months on a monthly basis.

    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.

    About Acasti Pharma

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti may need to conduct at least one additional clinical trial 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" 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 (HTG); and the timing and outcome of our requested meeting with the FDA.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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
  20. Patent upheld in Japan following opposition filings and subsequently allowed

    Completes TRILOGY 1 audits and accelerates plans to submit FDA meeting request by the end of March

    LAVAL, Québec, March 11, 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, today announced that it has received a Notice of Allowance for an additional composition of matter and method of use patent from the US Patent and Trademark Office (USPTO), the 4th patent to be awarded in the U.S., and a Notice of Allowance for…

    Patent upheld in Japan following opposition filings and subsequently allowed

    Completes TRILOGY 1 audits and accelerates plans to submit FDA meeting request by the end of March

    LAVAL, Québec, March 11, 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, today announced that it has received a Notice of Allowance for an additional composition of matter and method of use patent from the US Patent and Trademark Office (USPTO), the 4th patent to be awarded in the U.S., and a Notice of Allowance for a composition of matter and method of use patent awarded by the Mexican Patent Office, the 3rd patent to be awarded in Mexico.  These new patents broaden the Company's existing claims to include any composition containing EPA and DHA where at least 50% of the composition consists of phospholipids. These new patents further strengthen the intellectual property position of CaPre. In addition, Acasti also received a favorable decision issued by the Japan Patent Office following an opposition proceeding filed by a third party against its divisional application, confirming its validity. This decision resulted in the allowance of Acasti's second major patent in Japan.

    "The United States and Mexico represent important markets for Acasti, given the high prevalence of hypertriglyceridemia and the need for an effective, safe and well-absorbing omega-3 therapeutic for the treatment of cardiovascular-related diseases. Furthermore, these patents strengthen the Company's strategic position in these important markets, which could support valuable commercial opportunities in the future. In addition, Acasti's success in upholding its patent in Japan is a yet another confirmation of the strength of our claims and IP portfolio," said Pierre Lemieux, PhD, Acasti's Chief Operating Officer and Chief Scientific Officer.

    Jan D'Alvise, president and CEO of Acasti Pharma, commented, "We have completed the clinical site and central lab audits of the TRILOGY 1 data, including additional post-hoc analyses.  As a result, I am pleased to report that we now expect to submit our FDA meeting request by the end of March. We look forward to reporting further developments, including an update on a meeting date as soon as it has been set."

    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.

    About Acasti Pharma

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti may need to conduct at least one additional clinical trial 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" 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; and CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG).

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

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  21. LAVAL, Québec, Feb. 28, 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 (HTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that on February 28, 2020, it received written notification from the Nasdaq Listing Qualifications Department ("Nasdaq") for failing to maintain a minimum bid price of U.S.$1.00 per share for the last 30 consecutive business days, as required by Nasdaq Listing Rule 5550(a)(2) – bid price (the "Minimum Bid Price Rule").

    The Nasdaq notification…

    LAVAL, Québec, Feb. 28, 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 (HTG) (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that on February 28, 2020, it received written notification from the Nasdaq Listing Qualifications Department ("Nasdaq") for failing to maintain a minimum bid price of U.S.$1.00 per share for the last 30 consecutive business days, as required by Nasdaq Listing Rule 5550(a)(2) – bid price (the "Minimum Bid Price Rule").

    The Nasdaq notification has no immediate effect on the listing of Acasti Pharma's shares. Under Nasdaq Listing Rule 5810(c)(3)(A) – compliance period, Acasti Pharma has 180 calendar days, or until August 26, 2020, to regain compliance. If at any time over this period the bid price of Acasti Pharma's shares closes at U.S.$1.00 per share or more for a minimum of ten (10) consecutive business days, Nasdaq will provide written confirmation of compliance and the matter will be closed.

    If Acasti Pharma does not regain compliance within the initial 180-day period, but otherwise meets the continued listing requirements for market value of publicly-held shares and all other initial listing standards for the Nasdaq Listing Rule 5505 – Capital Market criteria, except for the Minimum Bid Price Rule, Acasti Pharma may be eligible for an additional 180 calendar days to regain compliance. If Acasti Pharma is not granted additional time, then its shares will be subject to delisting, at which time Acasti Pharma may appeal the delisting determination to a Nasdaq Hearings Panel.

    Acasti Pharma intends to evaluate all available options to resolve the deficiency and regain compliance with the Minimum Bid Price Rule.

    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 Pharma

    Acasti Pharma 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 Pharma 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; the timing and the outcome of licensing negotiations;  CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre and to fund its continued operations, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, Acasti's ability to report topline results for TRILOGY 2 within the contemplated timing as well as Acasti's ability to report key secondary and exploratory endpoints from both TRILOGY studies within the contemplated timing, and Acasti's ability to file an NDA based on the TRILOGY studies.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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
  22. LAVAL, Québec, Feb. 14, 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 (HTG) (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 third quarter of fiscal 2020 ended December 31, 2019. All amounts are in Canadian dollars.

    Corporate highlights:

    • Reported topline results in January for the TRILOGY 1 Phase 3 Trial of CaPre:
      • 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among…

    LAVAL, Québec, Feb. 14, 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 (HTG) (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 third quarter of fiscal 2020 ended December 31, 2019. All amounts are in Canadian dollars.

    Corporate highlights:

    • Reported topline results in January for the TRILOGY 1 Phase 3 Trial of CaPre:
      • 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among patients receiving CaPre at 12 and 26 weeks respectively, as well as 42.2% reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks
      • Despite meaningful triglyceride lowering in the CaPre arm, the study did not reach statistical significance due to unusually large placebo effect
      • No treatment-related serious adverse events were reported in the trial
      • Audits and additional post-hoc data analyses are underway into the unexpected and inconsistent findings that may have negatively impacted the results reported in TRILOGY 1
      • Acasti now plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020
    • Released preliminary new data in a diet-induced obesity animal model with preliminary, statistically significant findings showing that CaPre may promote insulin secretion, and showing a significant increase in plasma levels of 17S-HDHA and PDX as compared to metformin and icosapent ethyl
    • Approximately $25.7 million of cash and cash equivalents as at December 31, 2019; fully funded through December 2020 based on current projections.

    Jan D'Alvise, president and CEO of Acasti Pharma, commented, "We are making steady progress with the audit of TRILOGY 1 data and additional post-hoc analyses. This data has been very informative, and provided we have the FDA's support, any learnings we can take from this investigation that may allow us to adjust the Statistical Analysis Plan (SAP) for TRILOGY 2, gives us a better chance of accurately reflecting the clinical value that we see in CaPre. As previously noted, we have confirmed that there is established precedent for the FDA accepting post-hoc analyses of study results, assuming the analyses are transparent, well justified and well supported. We are moving as quickly as possible now to complete this work and secure a meeting with the FDA. Until we have that important meeting, we intend to keep TRILOGY 2 blinded. Consequently, we now anticipate the unblinding of the topline results for TRILOGY 2 sometime in calendar Q3 of 2020, to allow time for the FDA meeting. Accordingly, key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies, would now be expected after the unblinding of TRILOGY 2 results. We are moving as quickly as possible and will provide material updates when available."

    On January 13, 2020 the Company announced preliminary topline results for the primary endpoint (triglyceride reduction at 12 and 26 weeks) from our Phase 3 TRILOGY 1 trial for CaPre. Acasti reported a 30.5% median reduction in triglyceride (TG) levels among all patients receiving CaPre, compared to a 27.5% median reduction in triglyceride levels among patients receiving placebo at 12 weeks. The Company also reported a 42.2% median reduction in TGs among patients receiving CaPre while on background statin therapy at 12 weeks, compared to a 31.5% median reduction in TG levels among patients receiving placebo and on background statin therapy. In addition, the Company reported a 36.7% median reduction in TG levels among patients receiving CaPre at 26 weeks (end of the study), compared to a 28.0% median reduction in TG levels among patients receiving placebo. Both the placebo and CaPre study groups experienced significant reductions in TGs within the first four weeks from baseline, and even though the difference at 12 and 26 weeks was in favor of CaPre, due to the unexpectedly large placebo response, TRILOGY 1 did not reach statistical significance. The safety profile of CaPre in TRILOGY 1 was similar to placebo, as there was no significant difference in treatment-related serious adverse events in the trial.

    The observed reductions in TG levels in the placebo group were far greater than that seen in any previous triglyceride lowering trial with a prescription omega-3. The placebo used in the TRILOGY trials is simple cornstarch, which is a complex carbohydrate with a low glycemic index, and consequently would be expected to have a neutral effect on key biomarkers of patients in the placebo group. In similar previously conducted triglyceride lowering trials involving prescription omega-3 preparations, the placebo responses (using corn oil, olive oil, or vegetable oil) ranged from a change of +16% to -17% across 18 interventions arms, with 14 of 18 arms ranging between +10% to -10%. The Company noted that 5 sites out of the total 54 enrolling sites disproportionately contributed to this unusually high placebo response. These sites accounted for about 36% of the 242 patients enrolled in the TRILOGY 1 study. By comparison, TRILOGY 2 was conducted at 71 sites in Canada, Mexico and the United States with a total of 278 patients enrolled. The 5 sites that are a focus of the TRILOGY 1 investigation also participated in TRILOGY 2, however these sites accounted for only about 12% of the total patients, with the majority of these patients coming from only 3 sites.

    Despite monitoring activities conducted throughout the TRILOGY 1 trial to ensure adherence to the protocol and identify protocol violations, the Company has subsequently identified some unexpected and inconsistent findings that it believes may have negatively contributed to the overall topline results. These findings are now being further explored via a comprehensive and rigorous review of data and patient medical records by an independent team of auditors. To support this effort, the Company, its independent Clinical Research Organization (CRO) that conducted the TRILOGY studies, its principal investigator Dr. Mozaffarian, and other clinical and regulatory advisors, are conducting a thorough review of all data and records from patients taking both CaPre and placebo. This assessment is well underway, and the Company has also determined that a thorough investigation of the data must be completed and reviewed with the FDA, before the Company can report the findings from TRILOGY 1 and the implications for TRILOGY 2.

    Consequently, the Company intends to request a meeting with the FDA to discuss the TRILOGY 1 data, and will seek their guidance about how to conduct the analysis of the TRILOGY 2 data prior to unblinding TRILOGY 2. The Company continues to remain blinded to the TRILOGY 2 data. Upon submission of the meeting request, which is expected to be sent to the FDA in calendar Q2, 2020, the FDA will have 75 days to respond and schedule a meeting. 

    Given the need to complete the audit and review of the TRILOGY 1 data, and obtain FDA feedback, the Company now anticipates the unblinding of the topline results for TRILOGY 2 sometime in calendar Q3 of 2020. Acasti will provide further guidance as to the timing of reporting TRILOGY 2 data based on progress of the audits and feedback from the FDA. Accordingly, key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies, would now be expected as soon as possible after the unblinding of TRILOGY 2 results.

    If the interpretation of the analyses produced as an outcome of the TRILOGY 1 audits and post-hoc data review are supported by the FDA, and if TRILOGY 2 achieves statistical significance, Acasti believes it may still have a viable path forward to file an NDA for CaPre.

    At December 31, 2019, Acasti had $25.7 million of cash, cash equivalents and marketable securities. This capital is expected to also fund the ongoing study investigations, as well as continued work on the NDA. With the Government funding, capital raised through the established at-the-market program (ATM) during Q3, recent exercise of warrants and cash on hand, the Company is sufficiently funded through December 2020, based on management's current projections.

    Recent Developments:

    • On September 9, 2019, Acasti announced that the Corporation was awarded up to $750,000 in non-dilutive and non-repayable funding, as well as technical and business advisory services, from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to apply towards eligible research and development disbursements of the Corporation's unique commercial production platform for CaPre.

    • On September 30, 2019, Acasti announced that 100% of the required total patients for its two Phase 3 studies had been randomized, and nearly 80% of the patients in both studies combined had completed their 6-month plans.

    • On September 30, 2019, Acasti made the determination that the Corporation will migrate from reporting in IFRS to US GAAP effective beginning with Q4, FY'20 (March 31, 2020 year-end) reports.

    • On November 4, 2019, Acasti announced that it had partnered with Aker BioMarine to deliver raw krill oil (RKO) to Acasti, under a two-year, fixed price supply agreement.

    • On November 7, 2019, Acasti announced the publication of a CaPre pharmacokinetics study entitled, "Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers" in a leading peer-reviewed journal, Clinical Therapeutics. The study showed that the bioavailability of CaPre did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.

    • On November 18, 2019, Acasti released preliminary new animal study data which provides additional insights into CaPre's potential mechanism of action in diabetes. The preliminary findings obtained for the diabetes mouse study showed that CaPre may promote insulin secretion as seen by statistically significant results produced in a standard glucose challenge test, thus suggesting a mechanism of action different and unique when compared to metformin, which does not promote insulin secretion.

    • On November 26, 2019, Acasti announced that the last patient completed their final visit in the Corporation's TRILOGY 1 Phase 3 trial of CaPre.

    • On December 23, 2019, Acasti provided an update on the expected delay of topline results into January 2020 for the Corporation's TRILOGY 1 Phase 3 trial of CaPre. The delay was caused by gaps in the data when the dataset was transferred from the Central laboratory to the CRO data management group. When this problem was identified by the CRO data management group, it triggered an immediate hold on the data transfer to the CRO statistical group, and initiated a full quality review by the CRO of the processes and procedures involved at the central testing laboratory. This review was completed in early January 2020, and topline results for TRILOGY 1 were subsequently released on January 13, 2020. A more comprehensive audit of the central laboratory is currently ongoing. 

    • On December 18, 2019, Acasti incorporated a new wholly owned subsidiary named Acasti Innovation AG ("AIAG") under the laws of Switzerland for the purpose of future development of the Corporation's intellectual property and global distribution of its products. AIAG currently does not have any operations. 

    • On January 9, 2020, Acasti announced that the last patient completed their final visit in Acasti's TRILOGY 2 Phase 3 trial of CaPre.

    • On January 13, 2020, Acasti reported topline results for TRILOGY 1, which, despite showing a meaningful reduction of TGs in the CaPre arm, did not reach statistical significance due to an unusually large placebo effect.

    • On February 10, 2020, Acasti provided an update on its TRILOGY 1 and TRILOGY 2 Phase 3 Trials of CaPre. This announcement disclosed that a full investigation was being conducted, including specific site audits, and a full audit of the central testing laboratory involved its TRILOGY 1 Phase 3 trial for CaPre. It also announced that once the full analysis of TRILOGY 1 is completed, that the Company would request a meeting with the FDA to discuss the data and seek guidance on how to modify the statistical analysis plan (SAP) for TRILOGY 2 before unblinding the results. This important decision will push out the reporting of TRILOGY 2 results until calendar Q3 of 2020. 

    Third Quarter Fiscal 2020 Financial Results:

    • Loss from operating activities for the third quarter ended December 31, 2019 was $7.9 million, compared to a loss from operating activities of $10.7 million for the quarter ended December 31, 2018. The decrease was due mainly to a reduction in research contract expenses as the Phase 3 clinical program is getting closer to completion.
       
    • Net loss for the quarter ended was $15.7 million or ($0.18) per share, compared to a net loss of $4.6 million or ($0.07) per share for the quarter ended December 31, 2018. The higher net loss was primarily due to the non-cash financial loss of $7.9 million for the three months ended December 31, 2019, due mostly to the change in fair value of the warrant derivative liability partially offset by a decrease in the number of warrants.

    • R&D expenses before depreciation, amortization and stock-based compensation expenses were $4.2 million for the quarter ended December 31, 2019, compared to $8.8 million for the three months ended December 31, 2018. The $4.6 million decrease was mainly attributable to a $5.6 million decrease in research contracts. The lower research contract expense is primarily attributed to the Phase 3 clinical trial program getting closer to completion.

    • General and Administrative expenses before stock-based compensation expenses were $1.6 million for the three months ended December 31, 2019, an increase of $.8 million from $.76 million for the three months ended December 31, 2018. This increase was mainly attributable to a $.18 million increase associated with the Company's Directors and Officers insurance policy, as well as an increase of $.5 million in corporate, accounting and legal fees.
       
    • Sales and Marketing expenses before stock-based compensation expenses were $.74 million for the three months ended December 31, 2019, compared to $.13 million for the three months ended December 31, 2018. This increase funded additional headcount and marketing expenses for expanded business and market development activities.
       
    • Cash flows – Cash and cash equivalents and marketable securities totaled $25.7 million as of December 31, 2019, compared to $28.9 million for the quarter ended December 31, 2018. The decrease was mainly generated by the operating loss partially offset by the net proceeds from the sale of shares through the established ATM program and the recent exercise of warrants. As stated above, Acasti believes that existing cash will fully fund the Company's operations through at least December of 2020. Acasti projects that additional funds will be needed in the future, for activities necessary to prepare for commercial launch, including the scale up of our manufacturing operations, the completion of the potential regulatory (NDA) submission package (assuming positive Phase 3 clinical results), and the expansion of business development and US commercial launch activities. If Acasti does not raise additional funds, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists a material uncertainty about the Acasti's ability to continue as a going concern and to realize its assets and discharge its liabilities in the normal course of business.

    ATM Update

    Acasti also provided an update on recent distributions under its previously adopted ATM program, as required pursuant to the policies of the TSX Venture Exchange. Since the last distributions under the ATM program reported on December 23, 2019, Acasti issued an aggregate of 1,355,798 common shares of the Company (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US$1.4 million. The ATM Shares were sold at prevailing market prices which ranged from US$2.02 per share to US$0.85 per share. No securities were sold through the facilities of the TSX Venture Exchange or, to the knowledge of the Company, in Canada. The ATM Shares were sold pursuant to a U.S. registration statement on Form F-3 (No. 333-223464) as made effective on March 16, 2018, as well as an at-the-market issuance sales agreement dated February 14, 2019 among Acasti and B. Riley FBR, Inc.

    Conference Call

    Acasti will host a conference call today, Friday, February 14, 2020 at 1:00 PM Eastern Time to discuss the Company's financial results for the third quarter ended December 31, 2019, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company's News and Investors section of the website: https://www.acastipharma.com/investors/.

    A webcast replay will be available on the Company's News and Investors section of the website (https://www.acastipharma.com/investors/) through May 14, 2020. A telephone replay of the call will be available approximately one hour following the call, through February 21, 2020, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 33138.

    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 Pharma

    Acasti Pharma 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 Pharma 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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre and to fund its continued operations, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, Acasti's ability to report topline results for TRILOGY 2 within the contemplated timing as well as Acasti's ability to report key secondary and exploratory endpoints from both TRILOGY studies within the contemplated timing, and Acasti's ability to file an NDA based on the TRILOGY studies.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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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  23. LAVAL, Quebec, Feb. 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 (HTG), today announced that it will host a conference call at 1:00 PM Eastern Time on Friday, February 14, 2020 to discuss the Company's financial results for the third quarter ended December 31, 2019, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers…

    LAVAL, Quebec, Feb. 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 (HTG), today announced that it will host a conference call at 1:00 PM Eastern Time on Friday, February 14, 2020 to discuss the Company's financial results for the third quarter ended December 31, 2019, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase 3 trials of CaPre.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company's News and Investors section of the website: https://www.acastipharma.com/investors/.

    A webcast replay will be available on the Company's News and Investors section of the website (https://www.acastipharma.com/investors/) through May 14, 2020. A telephone replay of the call will be available approximately one hour following the call, through February 21, 2020, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 33138. 

    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 Pharma

    Acasti Pharma 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 Pharma 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; the timing and the outcome of licensing negotiations;  CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre and to fund its continued operations, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, Acasti's ability to report topline results for TRILOGY 2 within the contemplated timing as well as Acasti's ability to report key secondary and exploratory endpoints from both TRILOGY studies within the contemplated timing, and Acasti's ability to file an NDA based on the TRILOGY studies.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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
  24. Investigation underway into unexpected and inconsistent findings that may have negatively impacted results reported in TRILOGY 1

    Announces plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020

    LAVAL, Quebec, Feb. 10, 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, or HTG (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that a detailed examination of the Phase 3 TRILOGY…

    Investigation underway into unexpected and inconsistent findings that may have negatively impacted results reported in TRILOGY 1

    Announces plans to seek FDA guidance prior to unblinding TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2 topline results until calendar Q3, 2020

    LAVAL, Quebec, Feb. 10, 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, or HTG (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that a detailed examination of the Phase 3 TRILOGY 1 results for CaPre  is underway, including specific clinical site audits and an audit of the central testing laboratory.

    As previously reported, the Company noted a highly unusual placebo response in its topline triglyceride reduction primary endpoint, far greater than seen in any prior omega-3 triglyceride lowering trials, with 5 sites out of the total 54 enrolling sites disproportionately contributing to this placebo response. These sites accounted for about 36% of the 242 patients enrolled in the TRILOGY 1 study. By comparison, TRILOGY 2 was conducted at 71 sites in Canada, Mexico and the United States that enrolled a total of 278 patients. The 5 sites also participated in TRILOGY 2, however these sites accounted for only 12% of the total patients, with the majority of these patients coming from only 3 sites.

    Despite monitoring activities conducted throughout the TRILOGY 1 trial to ensure adherence to the protocol and identify protocol violations, the Company has subsequently identified some unexpected and inconsistent findings that it believes may have negatively contributed to the overall topline results. These findings are now being further explored via a comprehensive and rigorous review of data and patient medical records by an independent team of auditors. To support this effort, the Company, its independent Clinical Research Organization (CRO) that conducted the TRILOGY studies, its principal investigator Dr. Mozaffarian, and other clinical and regulatory advisors, are conducting a thorough review of all data and records from patients taking both CaPre and placebo. This assessment is well underway, and the Company has also determined that a thorough investigation of the data must be completed and reviewed with the FDA, before the Company can report the findings from TRILOGY 1 and the implications for TRILOGY 2.

    Consequently, the Company intends to request a meeting with the FDA to discuss the TRILOGY 1 data, and will seek their guidance about how to conduct the analysis of the TRILOGY 2 data prior to unblinding TRILOGY 2. The Company continues to remain blinded to the TRILOGY 2 data. Upon submission of the meeting request, which is expected to be sent to the FDA in calendar Q2, 2020, the FDA will have 75 days to review the findings and provide feedback and guidance. 

    Given the need to complete the audit and review of the TRILOGY 1 data, and obtain FDA feedback, the Company now anticipates the unblinding of the topline results for TRILOGY 2 sometime in calendar Q3 of 2020. Acasti will provide further guidance as to the timing of reporting TRILOGY 2 data based on progress of the audits and feedback from the FDA. Accordingly, key secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies, would now be expected as soon as possible after the unblinding of TRILOGY 2 results.

    If the interpretation of the analyses produced as an outcome of the audits and post-hoc data review are supported by the FDA, and if TRILOGY 2 achieves statistical significance, Acasti believes it may still have a viable path forward to file an NDA for CaPre.

    Jan D'Alvise, president and CEO of Acasti Pharma, stated, "Taking into account that the audit is still underway, that the data that we are evaluating is still preliminary, and that any findings will be subject to guidance from the FDA, we look forward to concluding the necessary work, which we hope will help us to better understand the unexpected TRILOGY 1 results. While we regret the additional delay in reporting TRILOGY 2 results, given our initial findings, we believe it is critical to conduct a thorough investigation and evaluation of the TRILOGY 1 results. Any learnings we can take from this investigation that may allow us to proactively adjust the SAP for TRILOGY 2, gives us a better chance of accurately reflecting the clinical value that we believe we still see in CaPre. Moreover, we have confirmed that there is established precedent for the FDA accepting post-hoc analyses of study results, assuming the analyses are transparent, well justified and well supported.  We are moving as quickly as possible to gain a greater understanding of the TRILOGY 1 results, and will provide material updates as we learn more information.  Furthermore, we project that our current cash position will now last through calendar 2020, giving us the necessary runway to complete our extended analysis of the TRILOGY program. We remain fully committed to our goal of gaining NDA approval for CaPre, and appreciate the tremendous support and patience of our shareholders."  

    About CaPre

    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 Pharma

    Acasti Pharma 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 Pharma 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; the timing and the outcome of licensing negotiations;  CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre and to fund its continued operations, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, Acasti's ability to report topline results for TRILOGY 2 within the contemplated timing as well as Acasti's ability to report key secondary and exploratory endpoints from both TRILOGY studies within the contemplated timing, and Acasti's ability to file an NDA based on the TRILOGY studies.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  25. LAVAL, QC, Jan. 13, 2020 /CNW Telbec/ Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (NASDAQ:NEPT) (TSX:NEPT), a health and wellness company focused on extraction, purification and formulation of cannabinoids, would like to provide an update on its non-core investments.

    Neptune Logo - ENGLISH (CNW Group/Neptune Wellness Solutions Inc.)

    In recent months, Neptune sold 1,964,695 shares of Acasti Pharma Inc. (NASDAQ:ACST) for net proceeds of US$4 million as part of a monetizing process for the Company's non-core investments. Neptune still owns 1 million shares in Acasti. The net proceeds are intended to be channeled towards the deployment of Neptune's cannabis 2.0 products.

    About Neptune Wellness Solutions Inc.
    Neptune Wellness Solutions specializes in the extraction, purification and formulation…

    LAVAL, QC, Jan. 13, 2020 /CNW Telbec/ Neptune Wellness Solutions Inc. ("Neptune" or the "Company") (NASDAQ:NEPT) (TSX:NEPT), a health and wellness company focused on extraction, purification and formulation of cannabinoids, would like to provide an update on its non-core investments.

    Neptune Logo - ENGLISH (CNW Group/Neptune Wellness Solutions Inc.)

    In recent months, Neptune sold 1,964,695 shares of Acasti Pharma Inc. (NASDAQ:ACST) for net proceeds of US$4 million as part of a monetizing process for the Company's non-core investments. Neptune still owns 1 million shares in Acasti. The net proceeds are intended to be channeled towards the deployment of Neptune's cannabis 2.0 products.

    About Neptune Wellness Solutions Inc.
    Neptune Wellness Solutions specializes in the extraction, purification and formulation of health and wellness products. The Company has in excess of 100 customers across several verticals including legal cannabis and hemp, nutraceutical and consumer packaged goods. Neptune's wholly owned subsidiary, 9354-7537 Québec Inc., is licensed by Health Canada to process cannabis at its 50,000-square-foot facility located in Sherbrooke, Quebec. The Company also has a 24,000 square-foot facility located in North Carolina to process hemp biomass into extracts. Neptune brings decades of experience in the natural products sector to the legal cannabis and hemp industries. Leveraging its scientific and technological expertise, the Company sees applications for hemp-derived extracts in the U.S. beyond existing markets and product forms and into personal care and home care markets. Neptune's activities also include the development and commercialization of turnkey nutrition solutions and patented ingredients such as MaxSimil® and a variety of marine and seed oils. Its head office is located in Laval, Quebec.

    Forward Looking Statements
    Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. securities laws and Canadian securities laws. Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Neptune 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", "projects", "anticipates", "will", "should" or "plans," or which refer to expectations, projections or other characterizations of future events or circumstances, 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.
    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement and the "Cautionary Note Regarding Forward-Looking Information" section contained in Neptune's latest Annual Information Form (the "AIF"), which also forms part of Neptune's latest annual report on Form 40-F, and which is available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.html and on the investor section of Neptune's website at www.neptunecorp.com. All forward-looking statements in this press release are made as of the date of this press release. Neptune 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 other risks and uncertainties that are described from time to time in Neptune's public securities filings with the Securities and Exchange Commission and the Canadian securities commissions. Additional information about these assumptions and risks and uncertainties is contained in the AIF under "Risk Factors".

    Neither NASDAQ nor the Toronto Stock Exchange accepts responsibility for the adequacy or accuracy of this release.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/neptune-provides-updates-on-non-core-investments-300985887.html

    SOURCE Neptune Wellness Solutions Inc.

    View Full Article Hide Full Article
  26. Reports 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among patients receiving CaPre at 12 and 26 weeks respectively, as well as 42.2% reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks

    Despite positive results in CaPre arm, study did not reach statistical significance
    due to unusually large placebo effect; further analysis is underway

    No treatment-related serious adverse events reported in the trial

    The last patient completed their final visit in the TRILOGY 2 trial late last week,
    topline results expected now by mid-February 2020

    LAVAL, Québec, Jan. 13, 2020 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti or the "Company") (NASDAQ:ACST, TSXV:ACST), a…

    Reports 30.5% and 36.7% reduction in triglyceride levels, compared with baseline, among patients receiving CaPre at 12 and 26 weeks respectively, as well as 42.2% reduction in triglyceride levels among patients receiving CaPre while on background statin therapy at 12 weeks

    Despite positive results in CaPre arm, study did not reach statistical significance
    due to unusually large placebo effect; further analysis is underway

    No treatment-related serious adverse events reported in the trial

    The last patient completed their final visit in the TRILOGY 2 trial late last week,
    topline results expected now by mid-February 2020

    LAVAL, Québec, Jan. 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 (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced topline results for the Primary Endpoint (triglyceride reduction at 12 and 26 weeks) from its Phase 3 TRILOGY 1 trial for the Company's lead product candidate, CaPre.

    The Company reported a 30.5% median reduction in triglyceride levels among all patients receiving CaPre, compared to a 27.5% median reduction in triglyceride levels among patients receiving placebo at 12 weeks. The Company also reported a 42.2% median reduction in triglycerides among patients receiving CaPre while on background statin therapy at 12 weeks, compared to a 31.5% median reduction in triglyceride levels among patients receiving placebo and on background statin therapy. In addition, the Company reported a 36.7% median reduction in triglyceride levels among patients receiving CaPre at 26 weeks (end of the study), compared to a 28.0% median reduction in triglyceride levels among patients receiving placebo. Both the placebo and CaPre study groups experienced significant reductions in triglycerides within the first four weeks from baseline, and even though the difference at 12 and 26 weeks was in favor of CaPre, due to the unexpectedly large placebo response, TRILOGY 1 did not reach statistical significance. The safety profile of CaPre in TRILOGY 1 was similar to placebo, as there were no significant difference in treatment-related serious adverse events in the trial. Results for all of the secondary and exploratory endpoints were delayed as previously reported on December 23, 2019, and are expected to be available by the end of Q1, 2020. 

    The observed reductions in triglyceride levels in the placebo group were far greater than that seen in any previous triglyceride lowering trial with a prescription omega-3. The placebo used in the TRILOGY trials is simple cornstarch, which is a complex carbohydrate with a low glycemic index, and consequently would be expected to have a neutral effect on key biomarkers of patients in the placebo group. In similar previously conducted triglyceride lowering trials involving prescription omega-3 preparations, the placebo responses (using corn oil, olive oil, or vegetable oil) ranged from a change of +16% to -17% across 18 interventions arms, with 14 of 18 arms ranging between +10% to -10%.

    A table summarizing the placebo and active triglyceride lowering results from all of these previous hypertriglyceridemia trials is presented below:

    A Media Snippet accompanying this announcement is available by clicking on the image or link below:

    Given that cornstarch is likely not the root cause for the significant placebo response in TRILOGY 1, the Company is carefully evaluating other possible explanations. The Company has noted that a high placebo response at 5 sites (out of a total of 54 enrolling sites) disproportionately contributed to the overall placebo response, and is being further investigated. A full audit of these sites, including review of all raw data and records from patients taking both CaPre and placebo, will be conducted to identify a possible root cause of the unprecedented placebo effect. This audit is likely to take at least several weeks, with an outcome expected by the end of February 2020. Additional avenues of investigation will include further assessment related to specific continuation or discontinuation of other lipid lowering drugs during screening, and changes in the use of other lipid-lowering medications during the trial. Furthermore, the results of the ongoing TRILOGY 2 trial with CaPre may provide additional important information and insight in this regard. If one or more of these investigations provide a plausible explanation as to what may have influenced the placebo arm, and assuming the primary endpoint reaches statistical significance in TRILOGY 2, the Company may still have a path forward to file an NDA, and would seek a meeting with the FDA as soon as possible to discuss all of the TRILOGY data, investigational findings, and obtain their input and guidance on next steps.

    Dariush Mozaffarian, M.D., Dr.P.H., principal investigator for the study, commented, "Compared with baseline, triglyceride levels in subjects receiving CaPre were substantially lower at 12 and 26 weeks in the CaPre arm, with 30.5% and 37.5% lower levels, respectively. However, these reductions were accompanied by larger than expected declines in triglyceride levels in the placebo group, which remain unexplained and highly unusual. Initial analyses suggest no protocol deviations in treatment allocation, capsule contents, laboratory quality control, or mismatched randomization that could explain these highly unusual placebo results. We are continuing to evaluate the data in detail to assess possible explanations. I am also hopeful that TRILOGY 2 topline data, expected in late January 2020, may provide more insight into this unprecedented placebo response seen in TRILOGY 1."

    Jan D'Alvise, president and CEO of Acasti Pharma, stated, "First, we wish to thank the physicians, study professionals, and of course the 242 patients who dedicated their time to participate in this trial. While we are encouraged by the magnitude of reduction in triglyceride levels seen among patients receiving CaPre, the large placebo effect was completely unexpected, and was about double what was seen in all other therapeutic OM3 hypertriglyceridemia trials. Several hypotheses are being investigated now by our clinical team, and by our CRO and Dr. Mozaffarian.  These avenues of investigation are being carefully and rigorously pursued, and we are moving as quickly as possible to try to gain understanding and insight into the large and unexpected placebo response seen in TRILOGY 1. The Company will continue to provide updates on this investigation, as well as topline results for TRILOGY 2 as we get them, to be followed by all secondary and exploratory endpoints for TRILOGY 1 and 2 once the TRILOGY 2 study is completed and fully analyzed."

    Implementation of the TRILOGY 2 study remains on track, with the last patient having completed their final visit late last week. The Company remains blinded to the TRILOGY 2 data.  Given the additional focus of critical resources now on TRILOGY 1, there could be a small delay of a couple weeks in reporting topline results for TRILOGY 2 to mid-February 2020. As previously disclosed, key secondary and exploratory endpoints from both studies, would be expected sometime later in the first quarter of 2020.

    About CaPre

    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.

    About Acasti Pharma

    Acasti Pharma 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 Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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; the timing and the outcome of licensing negotiations;  CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre and to fund its continued operations, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, Acasti's ability to report topline results for TRILOGY 2 in January 2020 as well as Acasti's ability to report key secondary and exploratory endpoints from both TRILOGY studies by the end of the first quarter of 2020, and Acasti's ability to file an NDA based on the TRILOGY studies.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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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  27. Expects to report Trilogy 1 topline results in January 2020
    with topline results for Trilogy 2 still expected by the end of January 2020

    LAVAL, Québec, Dec. 23, 2019 (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 (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that it expects to report its topline results for the TRILOGY 1 pivotal Phase 3 trial of CaPre in January 2020. The reporting of Trilogy 1 was postponed due to an unexpected delay in data processing and transfer from…

    Expects to report Trilogy 1 topline results in January 2020
    with topline results for Trilogy 2 still expected by the end of January 2020

    LAVAL, Québec, Dec. 23, 2019 (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 (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), today announced that it expects to report its topline results for the TRILOGY 1 pivotal Phase 3 trial of CaPre in January 2020. The reporting of Trilogy 1 was postponed due to an unexpected delay in data processing and transfer from the central testing laboratory to the statistical consultants for independent and external validation. Acasti regrets the delay due to factors outside its control, and now anticipates to report topline results in January 2020.  As requested by the Investment Industry Regulatory Organization of Canada (IIROC), due to market volatility, the Company indicates that it has no material update to provide at this time beyond the above timing update and independent and external validation exercise that is underway.

    Implementation of the Trilogy 2 Study remains on track, and the Company continues to expect the last patient to complete their final visit in early January 2020, and expects to report topline results in Trilogy 2 towards the end of January 2020.

    Topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, and any discontinuation due to AEs) will also be reported.  Other important secondary endpoints such as Non-HDL cholesterol, HDL cholesterol, and VLDL may now also be reported with the topline results. As previously disclosed, subgroup analyses of certain key secondary (LDL) and exploratory markers (HbA1c) will be dependent on combining results from both studies, and would be expected sometime later in the first quarter of 2020. 

    NOVEMBER ATM DISTRIBUTION UPDATE

    Acasti also provided an update on its previously adopted at-the-market program (the "ATM Program") for the month of November 2019, as required pursuant to the policies of the TSX Venture Exchange (the "November ATM Distribution"). Pursuant to the November ATM Distribution, Acasti issued an aggregate of 2,628,263 common shares of the Company (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US$5,693,057.27. The ATM Shares were sold at prevailing market prices which ranged from US$2.05 per share to US$2.27 per share. No securities were sold through the facilities of the TSX Venture Exchange or, to the knowledge of the Company, in Canada. The ATM Shares were sold pursuant to a U.S. registration statement on Form F-3 (No. 333-223464) as made effective on March 16, 2018, as well as an at-the-market issuance sales agreement dated February 14, 2019 among Acasti and B. Riley FBR, Inc. The ATM Shares sold pursuant to the November ATM Distribution were the first securities sold by Acasti under the ATM Program.

    About CaPre

    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. 

    About Acasti Pharma

    Acasti Pharma 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 Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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; the timing and the outcome of licensing negotiations;  CaPre'spotential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, Acasti's ability to report to topline results for TRILOGY 1 and TRILOGY 2 in January 2020 and Acasti's ability to fund its continued operations.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  28. LAVAL, Québec, Nov. 26, 2019 (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 (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), announced that the last patient completed their final visit in the Company's TRILOGY 1 pivotal Phase 3 trial of CaPre last week. Topline results for TRILOGY 1 are expected to be reported as planned in December 2019. The Company also expects the last patient to complete their final visit in TRILOGY 2 in early January 2020, with topline results expected towards the…

    LAVAL, Québec, Nov. 26, 2019 (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 (triglyceride blood levels from 500 mg/dL to 1500 mg/dL), announced that the last patient completed their final visit in the Company's TRILOGY 1 pivotal Phase 3 trial of CaPre last week. Topline results for TRILOGY 1 are expected to be reported as planned in December 2019. The Company also expects the last patient to complete their final visit in TRILOGY 2 in early January 2020, with topline results expected towards the end of January 2020. 

    Topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) will also be reported.

    The Company currently expects that topline results will not include any secondary or exploratory endpoints. The important secondary and exploratory endpoint results are expected to be completed before the end of March 2020, and will include: 1) additional TG secondary endpoints, including TG reduction at Week 26, which is intended to show CaPre's persistence of effect, TG reduction in various subgroups to show consistency of effect (such as patients stratified with baseline qualifying TG levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG reduction in patients using and not using statins at baseline; 2) Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c. 

    Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, "We are pleased to report our "last patient, last visit" in TRILOGY 1, and we are nearing completion of TRILOGY 2 with approximately 85% of randomized patients having completed TRILOGY 2. Data clean-up is now 97% and 75% completed for TRILOGY 1 and TRILOGY 2, respectively.  As a result, we are on track to report topline results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020. Assuming these results are positive, we intend to present the full data set at important scientific meetings in the first half of 2020, and file an NDA by mid-2020 to obtain regulatory approval for CaPre in the United States." 

    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.

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, and Acasti's ability to fund its continued operations.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  29. Dover, Delaware--(Newsfile Corp. - November 25, 2019) - Encode Ideas, L.P. Initiates Research on Acasti Pharma, Inc. (NASDAQ:ACST). The full research publication is available here and available on our website at www.encodelp.com.

    Encode Ideas is initiating coverage on Acasti Pharma, Inc. as a high-risk investment idea. Acasti is developing a krill-based omega-3 fatty acid product, CaPre, for the treatment of severe hypertriglyceridemia. Acasti is currently conducting two virtually identical Ph3 studies - Trilogy I and Trilogy II- with CaPre, and expects to report top-line data from the first in December and the second in January. If the primary TG-lowering endpoints are met in both Trilogy studies, assuming an acceptable safety profile, there…

    Dover, Delaware--(Newsfile Corp. - November 25, 2019) - Encode Ideas, L.P. Initiates Research on Acasti Pharma, Inc. (NASDAQ:ACST). The full research publication is available here and available on our website at www.encodelp.com.

    Encode Ideas is initiating coverage on Acasti Pharma, Inc. as a high-risk investment idea. Acasti is developing a krill-based omega-3 fatty acid product, CaPre, for the treatment of severe hypertriglyceridemia. Acasti is currently conducting two virtually identical Ph3 studies - Trilogy I and Trilogy II- with CaPre, and expects to report top-line data from the first in December and the second in January. If the primary TG-lowering endpoints are met in both Trilogy studies, assuming an acceptable safety profile, there is a good probability that CaPre would be approved by FDA in 2021. Although we are optimistic, assuming Ph3 clinical success, about CaPre's commercial potential, we recommend caution to investors heading into the first Trilogy readout in December.

    About us

    Encode Ideas, L.P. is a healthcare focused research firm, founded in 2019, providing institutional quality research and actionable investment and trade ideas. We undertake an intensive research process to identify healthcare companies that are mispriced or underfollowed. This process lends us towards covering predominately micro / small cap securities, where we feel some of the most intriguing risk reward opportunities exist. We are not financial advisors, so please seek proper financial advice before investing in a security we cover. For more information please visit our website at www.encodelp.com.

    Disclosures

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    • Data from a new preclinical mouse study suggests a unique mechanism of CaPre compared to metformin and icosapent ethyl (VASCEPA®) in a diet-induced obesity animal model 

    • Preliminary, statistically significant findings show that CaPre may promote insulin secretion, and showed a significant increase in plasma levels of 17S-HDHA and PDX as compared to metformin and icosapent ethyl 

    • Despite the lower concentration of EPA in CaPre's composition, the actual levels of 18RS-HEPE (a metabolite of EPA) reached in the blood were higher for CaPre than levels produced by icosapent ethyl. 18RS-HEPE and Resolvin E1 are both involved in the resolution of inflammation that is triggered in many chronic diseases including obesity and diabetes.

    LAVAL, Québec, Nov…

    • Data from a new preclinical mouse study suggests a unique mechanism of CaPre compared to metformin and icosapent ethyl (VASCEPA®) in a diet-induced obesity animal model 

    • Preliminary, statistically significant findings show that CaPre may promote insulin secretion, and showed a significant increase in plasma levels of 17S-HDHA and PDX as compared to metformin and icosapent ethyl 

    • Despite the lower concentration of EPA in CaPre's composition, the actual levels of 18RS-HEPE (a metabolite of EPA) reached in the blood were higher for CaPre than levels produced by icosapent ethyl. 18RS-HEPE and Resolvin E1 are both involved in the resolution of inflammation that is triggered in many chronic diseases including obesity and diabetes.

    LAVAL, Québec, Nov. 18, 2019 (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 (HTG), released some preliminary new animal data today which provides additional insights into CaPre's potential mechanism of action in diabetes. In the Company's Phase 2 studies in humans, a statistically significant reduction of hemoglobin A1c (HbA1c) was seen in the 4 gram treatment arm of the COLT study. This is the same dose that is currently being tested in Acasti's TRILOGY Phase 3 program in humans.  This positive HbA1c result In COLT was surprising at the time, and potentially unique to CaPre, as other therapeutic OM3s had previously shown no effect on glucose metabolism in a diabetic or pre-diabetic population. The main objective for this new mechanistic diabetes mouse study was to assess if CaPre acts on glucose and/or insulin in some unique manner, and to compare results head-to-head with icosapent ethyl (VASCEPA), a marketed omega-3 therapeutic, and metformin, a widely prescribed diabetic medication. Acasti collaborated with Professor André Marette, Ph.D. who conducted the study. Dr. Marette, who is the Director of the Pfizer Chair to study the pathogenesis of insulin resistance and cardiometabolic diseases at the University Laval, Quebec, conducted the study for Acasti in a widely used and well accepted animal model in diet-induced obese C57BL6 mice to compare the mechanisms of action of CaPre versus icosapent ethyl and metformin on insulin resistance and type 2 diabetes. A second, still ongoing study will also compare these same drugs in a fatty liver disease animal model. Dr. Marette is a highly regarded researcher of cardiometabolic disease, and he has published numerous papers in prestigious journals such as Nature Medicine.

    The preliminary findings obtained for the diabetes mouse study showed that CaPre may promote insulin secretion as seen by statistically significant results produced in a standard glucose challenge test, thus suggesting a mechanism of action different and unique when compared to metformin, which does not promote insulin secretion. Furthermore, icosapent ethyl showed no effect on insulin or any improvement in glucose metabolism or management.

    Key additional findings from this diabetic mouse study are:           

    • CaPre increased insulin production in association with increased c-peptide levels, suggesting that this effect is linked to greater insulin secretion by ß cells. This was also associated with a tendency for lower glucose responses during a glucose challenge test. CaPre exhibited a dose response, where the higher the dose the more insulin was secreted. 
       
    • Both CaPre and icosapent ethyl significantly increased plasma 18RS-HEPE, (a metabolite of EPA and a precursor of Resolvin E1) as compared to the untreated control and metformin groups. Despite the lower levels of EPA in CaPre's composition, the actual levels of 18RS-HEPE reached in the blood were higher for CaPre than levels produced by icosapent ethyl. Again, a dose response effect was seen with CaPre. 18RS-HEPE and Resolvin E1 are both resolving mediators of OM3s, and particularly EPA, and they are involved in the resolution of inflammation that is triggered in many chronic diseases including obesity and diabetes.
       
    • Both high dose (HED or human equivalent dose of 4 grams/day), and low dose (HED of 2 grams/day) of CaPre significantly increased plasma levels of 17S-HDHA and PDX (two metabolites of DHA) as compared to the untreated control group. The effects of high dose CaPre on PDX was very robust and significant, and much greater than those of icosapent ethyl, which showed virtually no response. Research has shown that increased levels of PDX improves insulin sensitivity in various models of insulin resistance and diabetes by several mechanisms, including by limiting inflammation in metabolic tissues, as well as by enhancing skeletal muscle IL-6 secretion, AMP activated protein kinase (AMPK) activation and glucose uptake, and by enhancing insulin's ability to suppress hepatic glucose production, which is also elevated in diabetic patients.

    Data from the diabetic mouse study are still being compiled and finalized.  The second study underway in a fatty liver/NASH disease model, will further confirm the findings of the diabetes study, and may potentially provide more insight into the mechanism of action of CaPre on the plasma lipid profile, and in fatty liver disease by further comparing the impact of CaPre on plasma TGs, LDL-C and HDL-C, as well as on hepatic lipid accumulation versus that of icosapent ethyl and metformin. Based on the findings from both of these study phases, Acasti and Dr. Marette plan to submit the data to a peer review journal for publication. Acasti may also file additional patents covering unique aspects and applications of this expanded understanding of CaPre's mechanism of action.

    Dr. Marette commented, "Our initial pre-clinical studies with CaPre are very promising. The effect of CaPre on insulin secretion may suggest preservation of beta-cell function early in the development of type 2 diabetes. The robust increase in plasma PDX levels with CaPre treatment is also of marked interest given the pleiotropic action of this key anti-inflammatory and pro-metabolic molecule. We have not seen this in previous studies with other OM3s using similar pre-clinical models of diabetes."

    Pierre Lemieux, Ph.D., COO and CSO of Acasti, added, "We are very pleased to collaborate with Dr. Marette. He has been a leader in the omega-3 research field, and especially in elucidating the importance and the role of resolvins and protectins (PDX) in the management of inflammation related to insulin resistance and glucose management in diabetes.  These studies may also further reinforce and explain some of the unique and positive results reported in our Phase 2 human clinical trials. Furthermore, based on this data, we now plan to expand our list of exploratory markers to be evaluated in our TRILOGY Phase 3 program to include the resolvins and protectins such as PDX and other related pro-resolution molecules."

    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. 

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, CaPre's potential mechanism of action in diabetes, and Acasti's ability to fund its continued operations.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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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  30. LAVAL, Québec, Nov. 13, 2019 (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 (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 second quarter of fiscal 2020 ended September 30, 2019. All amounts are in Canadian dollars.

    Corporate highlights:

    • On track to report topline results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020
    • More than 90% of randomized patients have completed the studies

    LAVAL, Québec, Nov. 13, 2019 (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 (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 second quarter of fiscal 2020 ended September 30, 2019. All amounts are in Canadian dollars.

    Corporate highlights:

    • On track to report topline results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020
    • More than 90% of randomized patients have completed the studies
    • Data clean-up for TRILOGY 1 is 95% completed
    • Plan to present full data set including results for key secondary and exploratory endpoints of interest such as non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at important scientific meetings beginning in the first quarter of 2020
    • Approximately $25.8 million of cash and cash equivalents as at September 30, 2019; fully funded beyond completion of Phase 3 studies
    • Awarded $750,000 in grants from the Government of Canada
    • Partnered with Aker BioMarine to provide supply of raw krill oil to support product launch and commercialization

    Jan D'Alvise, president and CEO of Acasti Pharma, commented, "We continue on track to announce our Phase 3 TRILOGY 1 topline results in December 2019 and TRILOGY 2 topline results in January 2020. We eagerly await the completion of the results from our two TRILOGY clinical studies for a number of reasons, including: (a) the large patient population in our Phase 2 trials (675 patients) demonstrated both a significant reduction of triglycerides and also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C ("Trifecta Effect"), as well as HbA1c in patients with diabetes; (b) patients enrolled in our Phase 3 trials have higher baseline triglyceride levels (above 500 mg/dl) versus our Phase 2 studies, where most had baseline triglycerides significantly below 500 mg/dl; and (c) a favorable dose response was reported in the Phase 2 studies, in which patients received a range of doses (1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks), which we believe bodes well for our Phase 3 trials, in which all patients randomized to CaPre received 4 grams per day and will remain on drug for 6 months."

    "Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to become a best-in-class omega-3, due to both the Trifecta Effect and greater bioavailability, especially in patients that follow the standard physician-recommended, restricted low-fat diet. We believe these benefits are due to our unique composition of phospholipids, EPA and DHA as compared to "esterified" pharmaceutical omega-3s derived from fish oils. Additionally, in all studies conducted to date, CaPre has shown no negative side effects or safety concerns."

    "We are also ramping up our commercialization efforts. Most recently, we announced a supply agreement with Aker BioMarine to provide raw krill oil (RKO) to Acasti, under a two-year, fixed price supply agreement, which we believe will ensure an adequate raw material supply to meet our anticipated needs through at least mid-2021, including scale-up of production to build future inventory for anticipated commercial launch. At the same time, we are in active discussions with a number of pharma companies regarding potential commercialization partnerships in several countries around the world, and we look forward to providing further updates if and when developments unfold."

    Both TRILOGY trials have achieved 100% patient randomization and more than 90% of the patients have now completed their 6-month plan. As a result, the "last patient, last visit" in the TRILOGY 1 study remains on track to take place in November with topline results expected in December 2019 and the "last patient, last visit" in the TRILOGY 2 study remains on track to take place in early January with topline results expected towards the end of January 2020. Topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. The TRILOGY studies are designed to provide at least 90% statistical power to detect a difference of at least a 20% reduction from baseline in TGs between CaPre and placebo. As previously disclosed, the placebo used in the TRILOGY trials is cornstarch, which is inert, and consequently is expected to have a neutral effect on key biomarkers of patients in the placebo group, and has been shown to not interfere with statin absorption and efficacy.

    The Company has shared the statistical analysis plan (SAP) for the analysis and reporting of the TRILOGY results with the FDA and will finalize the SAP prior to final database lock of TRILOGY 1, which Acasti expects to occur shortly. Subject to any input from the FDA, Acasti currently intends to report topline TRILOGY results independently for each study as Acasti receives results and these topline results will include the primary endpoint of TG reduction at Week 12 compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) will also be reported.

    The Company currently expects that topline results will not include any secondary or exploratory endpoints. The important secondary and exploratory endpoint results are expected to follow shortly after the release of the topline results of TRILOGY 2, currently anticipated in late January 2020. According to the SAP, the primary endpoint must first be positive with statistical significance prior to analyzing the secondary and exploratory endpoints. These endpoints will then be analyzed in the following order: 1) additional TG secondary endpoints, including TG reduction at Week 26, which is intended to show CaPre's persistence of effect, TG reduction in various subgroups to show consistency of effect (such as patients stratified with baseline qualifying TG levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG reduction in patients using and not using statins at baseline; 2) Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c. According to the protocol, physician investigators were to determine if patients with high LDL-C and/or high HbA1c levels at screening should be put on standard therapy, and if so, they were stabilized prior to being randomized into TRILOGY. Results for both LDL-C and HbA1c will then require subgroup analyses, which are done by combining diabetic patients and separately patients with high LDL-C at baseline from both studies to reach adequate statistical power to detect a difference if one exists, and therefore potentially show any incremental benefit of CaPre above and beyond the standard of care only. Acasti expects that the remaining secondary and exploratory endpoints along with various additional subgroup analyses should be completed before the end of March 2020. In addition to Acasti's preliminary topline data, the Company will seek to present the full data set, which will include results for the Company's key secondary and exploratory endpoints of interest such as LDL-C, VLDL, HDL-C and HbA1c at important scientific meetings in the first half of 2020. The Company will communicate more information in the weeks ahead on how and when all of the TRILOGY results will be reported once the SAP is finalized.

    Assuming TRILOGY results are positive, the Company intends to file an NDA by mid-2020 to obtain regulatory approval for CaPre in the United States, initially for the treatment of severe HTG. Acasti may pursue the opportunity to expand CaPre's indication to the treatment of patients with high TGs (200 – 500 mg/dl), but this would likely require the completion of at least one additional clinical study. Acasti continues to plan for the potential launch of CaPre in the U.S. by the second half of 2021. The Company also continues to strengthen its patent portfolio along with other intellectual property rights as a part of its commercialization strategy.

    At September 30, 2019, Acasti had $25.8 million of cash, cash equivalents and marketable securities, including approximately $8.7 million in proceeds received from the recent exercise of warrants since July 1, 2019, which funds the Company beyond completion of the Phase 3 trials. This capital will fund continued work on the NDA, as well as expanded business and US commercial launch activities. Furthermore, the Company recently announced receiving an award for $750,000 in non-dilutive and non-repayable funding from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP). The Company intends to apply the funding towards the research and development of Acasti's exclusive commercial production platform for CaPre. With the Government funding, recent exercise of warrants and cash on hand, the Company is sufficiently funded until June 2020 based on management's current projections.

    Recent Developments:

    • On August 9, 2019, Acasti announced that the Company participated on a lipid panel entitled "Lipids: Moving Beyond Statins: Omega 3s, Bempedoic, and More," moderated by Harold Bays MD, a key opinion leader within the space during the 2019 BTIG Biotechnology Conference.

    • On September 9, 2019, Acasti announced that the Company was awarded $750,000 in non-dilutive and non-repayable funding, as well as technical and business advisory services, from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to apply towards research and development of the Company's unique commercial production platform for CaPre. With NRC IRAP support, Acasti aims to further expand and enhance its production capabilities for CaPre.

    • On September 30, 2019, Acasti announced that 100% of the required total patients for the two Phase 3 studies had been randomized, and nearly 80% of the patients in both studies combined had completed their 6-month plans.

    • On September 30, Acasti made the determination that the Company will migrate from reporting in IFRS to US GAAP effective beginning with Q4, FY 2020 (March 31, 2020 year-end) reports – see the Company's most recent management's discussion and analysis under the heading "Upcoming Changes in IFRS / Foreign Private Issuer Status".

    • On November 4, 2019, Acasti announced that it had signed a two-year, fixed price supply agreement with Aker BioMarine for raw krill oil (RKO), the starting material for the production of CaPre.

    • On November 7, Acasti announced the publication of a CaPre pharmacokinetics study entitled, "Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers" in a leading peer-reviewed journal, Clinical Therapeutics.  The study showed that the bioavailability of CaPre did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration.

    Second Quarter Fiscal 2020 Financial Results:

    • Loss from operating activities for the second quarter ended September 30, 2019 was $8.7 million, compared to a loss from operating activities of $10.4 million for the quarter ended September 30, 2018. The decrease was due in part to a reduction in research contract expenses as the Phase 3 clinical program is getting closer to completions.
    • Net loss for the quarter ended was $28.3 million or ($0.34) per share, compared to a net loss of $22.7 million or ($0.62) per share for the quarter ended September 30, 2018. The higher net loss was primarily due to the non-cash financial loss of $19.7 million for the three months ended September 30, 2019, due mostly to the change in fair value of the warrant derivative liability partially offset by a decrease in the number of warrants.
    • R&D expenses before depreciation, amortization and stock-based compensation expenses were $4.3 million for the quarter ended September 30, 2019, compared to $8.4 million for the three months ended September 30, 2018. The $4.1 million decrease was mainly attributable to a $4.6 million decrease in research contracts. The lower research contract expense is attributed primarily to the Phase 3 clinical trial program getting closer to completion.
    • General and Administrative expenses before stock-based compensation expenses were $1.5 million for the three months ended September 30, 2019, an increase of $.6 million from $.89 million for the three months ended September 30, 2018. This increase was mainly attributable to a $.18 million increase associated with the Company's Directors and Officers insurance policy, as well as an increase of $.3 million in corporate, accounting and legal fees.
    • Sales and Marketing expenses before stock-based compensation expenses were $.88 million for the three months ended September 30, 2019, compared to $.13 million for the three months ended September 30, 2018. This increase funded additional headcount and marketing expenses for expanded business and market development activities.
    • Cash flows – Cash and cash equivalents and marketable securities totaled $25.8 million as of September 30, 2019, compared to $5.99 million for the quarter ended September 30, 2018. The increase was mainly generated by the net proceeds from the Public Offerings and the recent exercise of warrants. As stated above, Acasti believes that existing cash plus the recent exercise of warrants will fully fund the Company's operations beyond the completion of our Phase 3 clinical trials through at least June of 2020. Acasti will need to raise additional capital in the future to complete the funding of the preparation and filing of our NDA, and US commercial launch activities. If Acasti does not raise additional funds, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists a material uncertainty about the Acasti's ability to continue as a going concern and to realize its assets and discharge its liabilities in the normal course of business.

    Conference Call

    Acasti will host a conference call today, Wednesday, November 13, 2019 at 1:00 PM Eastern Time to discuss the Company's financial results for the second quarter ended September 30, 2019, as well as the Company's corporate progress and other developments.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company's News and Investors section of the website: https://www.acastipharma.com/investors/.

    A webcast replay will be available on the Company's News and Investors section of the website (https://www.acastipharma.com/investors/) through February 13, 2020. A telephone replay of the call will be available approximately one hour following the call, through November 27, 2019, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 56770.

    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.

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, and Acasti's ability to fund its continued operations.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  31. LAVAL, Québec, Nov. 07, 2019 (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 (HTG), today announced the publication as Articles in Press of a CaPre pharmacokinetics study, entitled, "Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers" in a leading peer-reviewed journal, Clinical Therapeutics.  The study publication is available online and can be accessed at: https://www.clinicaltherapeutics.com/article/S0149-2918(19)30499-0/fulltext .

    In this Phase…

    LAVAL, Québec, Nov. 07, 2019 (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 (HTG), today announced the publication as Articles in Press of a CaPre pharmacokinetics study, entitled, "Evaluation of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses in Healthy Volunteers" in a leading peer-reviewed journal, Clinical Therapeutics.  The study publication is available online and can be accessed at: https://www.clinicaltherapeutics.com/article/S0149-2918(19)30499-0/fulltext .

    In this Phase I, open-label, randomized, multiple-dose, single-center, parallel-design study, 42 healthy volunteers received a single dose of CaPre (OM3-PL/FFA) at day 1, followed by multiple oral doses of 1, 2, and 4 grams per day for 14 days. At day 15, all subjects received a high fat breakfast.

    Key findings included:

    • CaPre was well tolerated in healthy subjects when administered as multiple oral doses of 1, 2, and 4 grams per day
    • CaPre's PK parameters appeared to be approximately dose proportional over the 1-4 grams/day dose range
    • The bioavailability of CaPre did not appear to be meaningfully affected by the fat content of the meal consumed before dose administration

    Dr. Robert Hegele, Director of the Blackburn Cardiovascular Genetics Laboratory at Robarts Research Institute and co-author of the study, commented, "Although there are several approved prescription OM3 drugs for the treatment of severe HTG, there is need for a formulation with high bioavailability regardless of fat intake, since a low-fat diet is part of the management of patients with HTG. The study results for CaPre demonstrated greater exposure at higher doses, irrespective of fat content of the meal."

    Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, "We are very pleased to have our study published in a leading peer-reviewed journal.  This study further reinforces the favorable dose response reported in our prior clinical trials. This is important due to the fact patients randomized to CaPre in the TRILOGY trials all received 4 grams per day, compared to our Phase 2 studies that included a range of doses from 1 gram, 2 gram and 4 grams per day.  Moreover, exposure was unaffected by fat content of the meal.  This is an important distinction as current prescription omega-3s on the market are bound to ethyl-esters, which require patients to take their omega-3s with a high fat meal for ideal absorption, despite the fact patients with high triglycerides are advised by physicians to follow a restricted low-fat diet."

    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. 

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, and Acasti's ability to fund its continued operations.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  32. LAVAL, Quebec, Nov. 06, 2019 (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 (HTG), today announced that it will host a conference call at 1:00 PM Eastern Time on Wednesday, November 13, 2019 to discuss the Company's financial results for the second quarter ended September 30, 2019, as well as the Company's corporate progress and other developments.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers…

    LAVAL, Quebec, Nov. 06, 2019 (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 (HTG), today announced that it will host a conference call at 1:00 PM Eastern Time on Wednesday, November 13, 2019 to discuss the Company's financial results for the second quarter ended September 30, 2019, as well as the Company's corporate progress and other developments.

    The conference call will be available via telephone by dialing toll free 844-369-8770 for U.S. callers or +1 862-298-0840 for international callers, or on the Company's News and Investors section of the website: https://www.acastipharma.com/investors/.

    A webcast replay will be available on the Company's News and Investors section of the website (https://www.acastipharma.com/investors/) through February 13, 2020. A telephone replay of the call will be available approximately one hour following the call, through November 27, 2019, and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 56770. 

    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 hypertrigyceridemia (those with TG levels above 500mg/dl). Furthermore, in the Phase 2 studies, CaPre demonstrated the potential to 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.

    About Acasti Pharma
    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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. Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third-party outcomes studies. Acasti Pharma 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 Pharma's strategy is to commercialize CaPre in the U.S. and Acasti Pharma 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" 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; and CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG).

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    U.S. Contact:
    Crescendo Communications, LLC
    Tel: 212-671-1020
    Email:

    Primary Logo

    View Full Article Hide Full Article
  33. LAVAL, Québec, Nov. 04, 2019 (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, today announced that it has partnered with Aker BioMarine to deliver krill oil to Acasti, under a two-year, fixed price supply agreement. 

    Raw Krill Oil (RKO) is the starting material used by Acasti to make CaPre, which is then further processed via a series of complex and proprietary extraction and purification manufacturing steps to produce the drug substance for CaPre. This agreement is intended to ensure an adequate…

    LAVAL, Québec, Nov. 04, 2019 (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, today announced that it has partnered with Aker BioMarine to deliver krill oil to Acasti, under a two-year, fixed price supply agreement. 

    Raw Krill Oil (RKO) is the starting material used by Acasti to make CaPre, which is then further processed via a series of complex and proprietary extraction and purification manufacturing steps to produce the drug substance for CaPre. This agreement is intended to ensure an adequate krill oil supply to meet Acasti's anticipated raw material needs through at least mid-2021, including scale-up of production to build future inventory for commercial launch. Furthermore, the parties have agreed to contemplate future commercial collaborations.

    "We have built a state-of-the-art manufacturing operation for CaPre, and it is important for us to continue to maintain long-term relationships with the highest quality suppliers across the entire supply chain, in order to ensure continuous operations and delivery of CaPre according to plan," said Pierre Lemieux, Ph.D. and Acasti's COO/CSO. "Aker BioMarine produces high quality krill oil, which is sustainably harvested and has been certified by the Marine Stewardship Council (MSC). This supply agreement secures a reliable source of high quality starting material for CaPre, which we expect will meet our near-term commercial growth aspirations. In addition, we look forward to collaborating on future projects together."

    "Acasti, with its novel drug product CaPre, represents an exciting growth opportunity for our two organizations," said Tim de Haas, EVP Human Health & Nutrition, Aker BioMarine. "We are pleased to partner with Acasti to support commercialization of the first ever, krill oil-based, prescription drug product, which we believe has the potential to become the best-in-class omega-3 therapeutic for the management of cardiometabolic disorders. We look forward to working with their team on future supply initiatives."

    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.

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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.

    About Aker BioMarine

    Aker BioMarine is a biotech innovator and Antarctic krill-harvesting company, dedicated to improving human and planetary health. The company develops krill-based ingredients for nutraceutical, aquaculture, and animal feed applications. The company's fully transparent value chain stretches from sustainable krill harvesting in pristine Antarctic waters through its Montevideo logistics hub, Houston production plant, and all the way to customers around the world. To learn more about Aker BioMarine, please visit the web site www.akerbiomarine.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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, and Acasti's ability to fund its continued operations. 

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  34. LAVAL, Québec, Oct. 01, 2019 (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, today announced that it will be presenting at the 2019 Cantor Fitzgerald Global Healthcare Conference being held on October 2-4, 2019 at the InterContinental New York Barclay Hotel in New York City. Jan D'Alvise, Chief Executive Officer, is scheduled to present on Wednesday, October 2, 2019 at 7:45 a.m. Eastern Time with one-on-one meetings being held throughout the day.

    About CaPre (omega-3 phospholipid) 

    Acasti's prescription…

    LAVAL, Québec, Oct. 01, 2019 (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, today announced that it will be presenting at the 2019 Cantor Fitzgerald Global Healthcare Conference being held on October 2-4, 2019 at the InterContinental New York Barclay Hotel in New York City. Jan D'Alvise, Chief Executive Officer, is scheduled to present on Wednesday, October 2, 2019 at 7:45 a.m. Eastern Time with one-on-one meetings being held throughout the day.

    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. 

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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.

    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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  35. Nearly 80% of randomized patients have completed the studies

    Data clean-up for TRILOGY 1 is 90% completed

    Plan to present full data set including results for key secondary and exploratory endpoints of interest such as non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific meetings in 2020               

    LAVAL, Quebec, Sept. 30, 2019 (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, today reported additional milestones reached and provided a business update on its clinical trials.

    Pierre Lemieux…

    Nearly 80% of randomized patients have completed the studies

    Data clean-up for TRILOGY 1 is 90% completed

    Plan to present full data set including results for key secondary and exploratory endpoints of interest such as non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific meetings in 2020               

    LAVAL, Quebec, Sept. 30, 2019 (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, today reported additional milestones reached and provided a business update on its clinical trials.

    Pierre Lemieux, Ph.D., COO and CSO of Acasti, commented, "Our TRILOGY Phase 3 trials in patients with severe hypertriglyceridemia (triglyceride blood levels from 500 mg/dL to 1500 mg/dL) continue to progress, and we remain on track to report topline TRILOGY 1 results in December 2019, and topline TRILOGY 2 results in January 2020. Importantly, both of our TRILOGY studies have achieved 100% patient randomization, and nearly 80% of the patients in both studies combined have now completed their 6-month plan. It is important to note that data clean up is approximately 90% complete in TRILOGY 1, bringing us closer to database lock.  We have also progressed TRILOGY 2 and anticipate database lock as planned in January 2020."

    Jan D'Alvise, president and CEO of Acasti, further noted, "Given the positive results we saw from our Phase 2 trials in a total of 675 patients, we eagerly await the completion of the results from our two TRILOGY clinical studies. It is also important to note:

    • patients enrolled in the Phase 3 TRILOGY trials have higher baseline triglyceride levels (above 500 mg/dl) versus our Phase 2 studies, where most had baseline triglycerides significantly below 500 mg/dl;
    • patients randomized to CaPre in the Phase 3 TRILOGY trials all received 4 grams per day and will remain on drug for 6 months, while our Phase 2 studies included patients receiving a range of doses from 1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks with a favorable dose response;
    • the Phase 2 trials also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C, as well as HbA1c in patients with diabetes."

    As previously disclosed, topline results will include a readout of the primary endpoint, which is intended to show CaPre's overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. The placebo used in the TRILOGY trials is cornstarch, which is inert, and consequently is expected to have a neutral effect on key biomarkers of patients in the placebo group. The TRILOGY studies are designed to provide at least 90% statistical power to detect a difference of at least a 20% decrease from baseline in TGs between CaPre and placebo.

    The Company has shared the statistical analysis plan (SAP) for the analysis and reporting of the TRILOGY results with the FDA, and expects to finalize the SAP prior to final database lock. Subject to any input from the FDA, Acasti is currently planning that the topline TRILOGY results will include the primary endpoint of TG reduction at Week 12 compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) will also be reported. 

    The Company currently expects that topline results will not include any secondary or exploratory endpoints. The important secondary and exploratory endpoint results are expected to follow shortly after the release of the topline results of TRILOGY 2, currently anticipated in late January, 2020. According to the SAP, the primary endpoint must first be positive with statistical significance prior to analyzing the secondary and exploratory endpoints. These endpoints will then be analyzed in the following order: 1) additional TG secondary endpoints, including TG reduction at Week 26, which is intended to show CaPre's persistence of effect, TG reduction in various subgroups to show consistency of effect (such as patients stratified with baseline qualifying TG levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG reduction in patients using and not using statins at baseline; 2) Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c.  Physician investigators determined if patients with high LDL-C and/or high HbA1c levels at screening needed to be put on standard therapy, and if so, they were stabilized prior to being randomized into TRILOGY. Results for both LDL-C and HbA1c will then require subgroup analyses, which are done by combining diabetic patients and separately patients with high LDL-C from both studies at baseline to reach adequate statistical power to detect a difference if one exists, and therefore potentially show any incremental benefit of CaPre above and beyond the standard of care. Acasti expects that the remaining secondary and exploratory endpoints along with various additional subgroup analyses should be completed before the end of March 2020.

    In addition to the preliminary topline data, the Company will seek to present the full data set, which will include results for key secondary and exploratory endpoints of interest such as Non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at key scientific meetings in 2020. The Company will communicate more information in the months ahead on how and when all of the TRILOGY results will be reported once the SAP is finalized.

    Jan D'Alvise concluded, "We are well capitalized beyond completion of our Phase 3 trials with over $25 million of cash as of June 30th, plus $8.1 million in additional proceeds from 5.9 million warrants exercised during the period from July 1 to August 12, 2019, which includes funding to progress preparation of the NDA, assuming the TRILOGY Phase 3 program is successful,  as well as expanded business and US commercial launch activities. Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to provide an attractive alternative to current therapies, and thus improve the lives of the millions of patients with cardiometabolic disease."

    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.- 

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third-party outcomes studies. 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; the timing and the outcome of licensing negotiations; CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG), Acasti's ability to commercially launch CaPre, CaPre's potential to meet or exceed the target primary endpoint of reducing triglycerides by 20% compared to placebo, and Acasti's ability to fund its continued operations.

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    View Full Article Hide Full Article
  36. LAVAL, Quebec, Sept. 09, 2019 (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 (HTG), today announced that the Company has been awarded up to $750,000 in non-dilutive and non-repayable funding, as well as technical and business advisory services, from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to apply towards research and development of the Company's unique commercial production platform for CaPre. With NRC IRAP support, Acasti aims to expand and enhance…

    LAVAL, Quebec, Sept. 09, 2019 (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 (HTG), today announced that the Company has been awarded up to $750,000 in non-dilutive and non-repayable funding, as well as technical and business advisory services, from the National Research Council of Canada Industrial Research Assistance Program (NRC IRAP) to apply towards research and development of the Company's unique commercial production platform for CaPre. With NRC IRAP support, Acasti aims to expand and enhance its production capabilities for CaPre.

    "We appreciate the strong support from NRC IRAP since 2015 and we are honored to embark on a new research and development project with them. As we progress toward reporting our TRILOGY topline results, which we anticipate later this year, ramping up our commercial production capabilities is an important next step," said Dr. Pierre Lemieux, PhD Acasti's Co-Founder, Chief Operating and Scientific Officer. "Innovation has been a key factor in Acasti's success, and we look forward to working closely with NRC IRAP to further the technical limits of our manufacturing process in anticipation of full commercialization. Under the leadership of Simon Despins, Director of Process Development and Production at Acasti, the work will be directed towards increasing our production capacity by leveraging our extensive manufacturing expertise and broad patents."

    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.

    About Acasti Pharma

    Acasti is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going outcomes studies (REDUCE-IT and STRENGTH). Acasti may need to conduct at least one additional clinical trial 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" 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; and CaPre's potential to become the "best-in-class" cardiovascular drug for treating severe Hypertriglyceridemia (HTG).

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A.

    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

    U.S. Contact:

    David Waldman
    President
    Crescendo Communications, LLC Tel: 212-671-1020
    Email:

    Primary Logo

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  37. LAVAL, Québec, Sept. 04, 2019 (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, today announced that it will be presenting at the 21st Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC, being held on September 8-10, 2019 at the Lotte New York Palace Hotel in New York City. Jan D'Alvise, Chief Executive Officer, is scheduled to present on Monday, September 9, 2019 at 9:35 a.m. Eastern Time.

    If you are an institutional investor, and would like to attend the…

    LAVAL, Québec, Sept. 04, 2019 (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, today announced that it will be presenting at the 21st Annual Rodman & Renshaw Global Investment Conference, sponsored by H.C. Wainwright & Co., LLC, being held on September 8-10, 2019 at the Lotte New York Palace Hotel in New York City. Jan D'Alvise, Chief Executive Officer, is scheduled to present on Monday, September 9, 2019 at 9:35 a.m. Eastern Time.

    If you are an institutional investor, and would like to attend the Company's presentation, please click on the following link (www.rodmanevents.com) to register for the conference. Once your registration is confirmed, you will be prompted to log into the conference website to request a one-on-one meeting with the Company.

    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. 

    About Acasti Pharma

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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.

    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

    View Full Article Hide Full Article
  38. LAVAL, Quebec, Aug. 28, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Corporation") (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 (HTG), announces the voting results for the matters listed in its management circular dated July 24, 2019 held at its Annual and Special Meeting of Shareholders, in Laval, Canada on August 27, 2019 (the "AGM"). 

    For further information on the voting results of the resolution passed during the AGM, please refer to the Report of Voting Results available on SEDAR. 

    Election of Directors 

    At the AGM, the following individuals…

    LAVAL, Quebec, Aug. 28, 2019 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Corporation") (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 (HTG), announces the voting results for the matters listed in its management circular dated July 24, 2019 held at its Annual and Special Meeting of Shareholders, in Laval, Canada on August 27, 2019 (the "AGM"). 

    For further information on the voting results of the resolution passed during the AGM, please refer to the Report of Voting Results available on SEDAR. 

    Election of Directors 

    At the AGM, the following individuals were elected as directors of the Corporation for the ensuing year: Roderick N. Carter, Jean-Marie (John) Canan, Jan D'Alvise and Donald Olds. 

    Appointment of Auditors 

    At the AGM, KPMG LLP were appointed as the Corporation's auditors for the ensuing fiscal year and the directors were authorized to fix their remuneration. 

    Amendments to the Corporation Stock Option Plan and Equity Incentive Plan 

    At the AGM, disinterested shareholders approved amendments to the Corporation's stock option plan (the "Stock Option Plan") in order to increase the fixed number of common shares (the "Common Shares") that may be issued upon the exercise of all options granted under the plan, from 5,494,209 (representing 15% of the number of Common Shares issued and outstanding, as of June 27, 2018) to 11,719,910 Common Shares (representing 15% of the issued and outstanding Common Shares as of April 9, 2019), which number includes 5,041,628 Common Shares reserved for outstanding options under the Stock Option Plan as at July 23, 2019. 

    At the AGM, disinterested shareholders also approved amendments to the Corporation's equity incentive plan (the "Equity Incentive Plan") in order 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 if, and for so long as the Common Shares are listed on the TSX-V, shall not exceed the lower of (x) 1,953,318 Common Shares (representing 2.5% of the number of Common Shares issued and outstanding as of April 9, 2019), up from 915,701 Common Shares (representing 2.5% of the number of Common Shares issued and outstanding as of June 27, 2018), and (y) 15% of the issued and outstanding Common Shares as of April 9, 2019, representing 11,719,910 Common Shares (up from 5,494,209 Common Shares representing 15% of the number of Common Shares issued and outstanding as of June 27, 2018), which number shall include Common Shares issuable pursuant to options issued under the Stock Option Plan. 

    The amendments to the Stock Option Plan and the Equity Incentive Plan are subject to TSX-V final approval. 

    Ratification of Stock Option Grants 

    At the AGM, disinterested shareholders passed a resolution to approve, ratify and confirm a previous grant of a total of 1,362,900 options to purchase Common Shares of the Corporation to certain directors and officers of the Corporation, as further described in the management proxy circular dated July 24, 2019. 

    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.

    About Acasti Pharma 

    Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular drug, CaPre® (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. Since its founding in 2008, Acasti Pharma 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 addressable market may expand significantly if omega-3s demonstrate long-term cardiovascular benefits in on-going third party outcomes studies. 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 (HTG), Acasti's ability to commercially launch CaPre,  and Acasti's ability to fund its continued operations. 

    The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest annual report on Form 20-F and most recent management's discussion and analysis (MD&A), which are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar/shtml, 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 20-F and most recent MD&A. 

    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

    U.S. Contact:
    Crescendo Communications, LLC
    Tel: 212-671-1020
    Email:

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