ACST Acasti Pharma Inc.

0.48
-0.06  -12%
Previous Close 0.54
Open 0.54
52 Week Low 0.171
52 Week High 1.22
Market Cap $46,053,023
Shares 96,892,537
Float 77,927,734
Enterprise Value $22,020,933
Volume 16,257,476
Av. Daily Volume 11,604,806
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Drug Pipeline

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

Latest News

  1. LAVAL, Québec, July 29, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces a reminder that it will host a business update conference call on Wednesday, August 4th at 1:00 PM ET to discuss the planned acquisition of Grace Therapeutics, Inc. ("Grace"), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases, as well as topics related to the annual and special meeting of shareholders. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to .

    The conference call will be available via telephone by dialing…

    LAVAL, Québec, July 29, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces a reminder that it will host a business update conference call on Wednesday, August 4th at 1:00 PM ET to discuss the planned acquisition of Grace Therapeutics, Inc. ("Grace"), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases, as well as topics related to the annual and special meeting of shareholders. Investors and other interested parties are invited to submit questions to management prior to the call's start via email to .

    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. The conference call will also be webcasted and is available at https://www.webcaster4.com/Webcast/Page/2210/42244, 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 Thursday, November 04, 2021. A telephone replay of the call will be available approximately one hour following the call, through Wednesday, August 11, 2021, 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: 42244.

    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.

    Additional Information and Where to Find It

    In connection with the merger, Acasti filed with the Securities and Exchange Commission ("SEC") a registration statement on Form S-4 on June 30, 2021 (as amended on July 13, 2021) that includes the preliminary prospectus/proxy statement relating to the merger. On July 15, 2021, the registration statement was declared effective by the SEC and Acasti filed the final prospectus/proxy statement in connection with the merger with the SEC, which contains important information about the merger and related matters. The prospectus/proxy statement will be mailed to Acasti shareholders and is accessible on Acasti's EDGAR and SEDAR profiles. INVESTORS AND SECURITY HOLDERS OF ACASTI ARE URGED TO CAREFULLY READ THE ENTIRE PROSPECTUS/PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO SUCH DOCUMENTS)  BEFORE MAKING ANY VOTING DECISION WITH RESPECT TO THE MERGER BECAUSE IT CONTAINS IMPORTANT INFORMATION ABOUT THE MERGER AND THE PARTIES TO THE MERGER.

    Acasti shareholders can obtain a free copy of the prospectus/proxy statement, as well as other relevant filings containing information about Acasti and the merger, including materials incorporated by reference into the prospectus/proxy statement, without charge at the SEC's website (www.sec.gov) or from Acasti by contacting Acasti's Secretary at 3009 boul. de la Concorde East, Suite 102 Laval, Québec, Canada H7E 2B5, telephone: (450) 686-4555.

    No Offer or Solicitation

    This document is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

    Participants in the Solicitation

    Acasti and Grace and certain of their respective directors, executive officers and employees may be deemed to be participants in the solicitation of Acasti proxies in respect of the merger. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to Acasti shareholders in connection with the merger is set forth in the prospectus/proxy statement. Copies of the prospectus/proxy statement may be obtained free of charge from the SEC or Acasti, as described in the preceding paragraph.

    Cautionary Statement Regarding Forward-Looking Statements

    This document contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information as defined under applicable Canadian securities legislation (collectively, "forward-looking statements"). These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Acasti, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "estimate," "plan," "believe," "anticipate," "intend," "look forward," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance.

    Forward-looking statements contained in this document may include, without limitation, statements regarding the proposed merger between Acasti and Grace; the timing and financial and strategic benefits thereof; the expected impact of the transaction on the cash balance of Acasti following the merger; Acasti's future strategy, plans and expectations after the merger; and the anticipated timing of clinical trials and approvals for, and the commercial potential of, Acasti's products and pipeline product candidates and those of its subsidiaries (including Grace, if the merger is completed). Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including the failure to receive, on a timely basis or otherwise, the required approvals by Acasti shareholders or Grace stockholders, as applicable, in connection with the merger; the risk that a condition to closing of the merger may not be satisfied; the possibility that the anticipated benefits of the proposed merger may not be fully realized or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of the businesses of Acasti and Grace will be greater than expected; the ability of the companies following the merger to commercialize drug candidates in line with the companies' expectations; the ability to retain and hire key personnel and maintain relationships with customers, key opinion leaders, suppliers or other business partners; the impact of legislative, regulatory, competitive and technological changes; and other risk factors relating to the companies' businesses and the biopharmaceutical industry, as detailed from time to time in Acasti's reports filed with the SEC and the Canadian Securities Administrators, which you are encouraged to review. Investors should not place undue reliance on forward-looking statements.

    For a discussion of the factors that may cause Acasti's, Grace's or the combined company's actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, and for a discussion of risks associated with the ability of Acasti and Grace to complete the merger and the effect of the merger on the business of Acasti, Grace and the combined company, see the section titled "Risk Factors" in the prospectus / proxy statement.

    The forward-looking statements reflect management's current knowledge, assumptions, beliefs, estimates and expectations and express management's current view of future performance, results and trends. If any of these risks or uncertainties materializes or any of these assumptions proves incorrect, the results of Acasti, Grace or the combined company could differ materially from the forward-looking statements. All forward-looking statements in this document are current only as of the date on which the statements were made, or in the case of a document incorporated by reference, as of the date of that document. Except as required by applicable law, neither Acasti nor Grace undertakes any obligation to update publicly any forward-looking statements for any reason after the date of this document or to conform these statements to actual results or to changes in expectations.

    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. LAVAL, Québec, July 23, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces it will host a business update conference call on Wednesday, August 4th at 1:00 PM ET to discuss the planned acquisition of Grace Therapeutics, Inc. ("Grace"), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases.

    Acasti plans to provide additional context on the proposed Grace acquisition and its benefits, including Grace's:

    • diversified drug pipeline with multiple, high quality clinical assets;
    • significant addressable market opportunities;
    • three clinical stage assets with a potentially shorter timeline…

    LAVAL, Québec, July 23, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces it will host a business update conference call on Wednesday, August 4th at 1:00 PM ET to discuss the planned acquisition of Grace Therapeutics, Inc. ("Grace"), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases.

    Acasti plans to provide additional context on the proposed Grace acquisition and its benefits, including Grace's:

    • diversified drug pipeline with multiple, high quality clinical assets;
    • significant addressable market opportunities;
    • three clinical stage assets with a potentially shorter timeline to key milestones;
    • efficient and lower-cost clinical and regulatory pathway;
    • and a strong and growing intellectual property portfolio.

    Additionally, management plans to discuss how this acquisition represents a unique opportunity for Acasti and its shareholders to build a new, late-stage specialty pharma company focused on rare diseases, by combining Acasti's extensive drug development, manufacturing, commercialization capabilities and strong balance sheet with Grace's drug delivery technologies and deep product pipeline. Following the merger, Acasti expects to have more than $60 million in cash, which should provide at least two years of operating runway and enable the Company to deliver meaningful catalysts including the completion of development and NDA filing for GTX-104, Grace's lead clinical asset, as well as advance other drug candidates in the Grace pipeline to key, value-enhancing milestones.

    Acasti strongly encourages all investors to vote in advance of the August 26, 2021 annual and special meeting of shareholders, in order to ensure the quorum requirements are met to approve the transaction. In order for shares to be voted at the annual and special meeting, a proxy must be received (whether delivered by mail, telephone or internet) by no later than 5:00 p.m. Eastern Time on August 24, 2021 by Acasti's registrar and transfer agent, Computershare Investor Services Inc., Attention: Proxy Department, 100 University Avenue, 9th Floor, Toronto, Ontario, M5J 2Y1, telephone number: 1-866-732-VOTE (8683), website: www.investorvote.com.

    If investors have any questions regarding the proposals or how to vote, please contact investor relations at .

    Conference Call Instructions

    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. The conference call will also be webcasted and is available at https://www.webcaster4.com/Webcast/Page/2210/42244, 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 Thursday, November 04, 2021. A telephone replay of the call will be available approximately one hour following the call, through Wednesday, August 11, 2021, 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: 42244.

    Nasdaq Update

    Acasti presented a detailed plan of compliance for the NASDAQ Hearings Panel's consideration on June 17, 2021, which included Acasti's commitment to implement a share consolidation, if needed, to evidence compliance with NASDAQ's listing rules. On July 12, 2021, the NASDAQ Hearings Panel issued its decision, which extended the time for Acasti to regain compliance with Listing Rule 5550(a), subject to the following: 1) on or before August 26, 2021, Acasti will hold a shareholders meeting to obtain approval for a share consolidation at a ratio that will allow for long term compliance with Listing Rule 5550(a); and 2) on or before September 10, 2021, Acasti will have regained compliance with Listing Rule 5550(a). The approval by NASDAQ of (i) the continued listing of Acasti's common shares on NASDAQ following the effective time of the merger and (ii) the listing of the Acasti common shares being issued to Grace stockholders in connection with the merger on NASDAQ at or prior to the effective time are conditions to the closing of the merger.

    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.

    Additional Information and Where to Find It

    In connection with the merger, Acasti filed with the Securities and Exchange Commission ("SEC") a registration statement on Form S-4 on June 30, 2021 (as amended on July 13, 2021) that includes the preliminary prospectus/proxy statement relating to the merger. On July 15, 2021, the registration statement was declared effective by the SEC and Acasti filed the final prospectus/proxy statement in connection with the merger with the SEC, which contains important information about the merger and related matters. The prospectus/proxy statement will be mailed to Acasti shareholders and is accessible on Acasti's EDGAR and SEDAR profiles. INVESTORS AND SECURITY HOLDERS OF ACASTI ARE URGED TO CAREFULLY READ THE ENTIRE PROSPECTUS/PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS TO SUCH DOCUMENTS) BEFORE MAKING ANY VOTING DECISION WITH RESPECT TO THE MERGER BECAUSE IT CONTAINS IMPORTANT INFORMATION ABOUT THE MERGER AND THE PARTIES TO THE MERGER.

    Acasti shareholders can obtain a free copy of the prospectus/proxy statement, as well as other relevant filings containing information about Acasti and the merger, including materials incorporated by reference into the prospectus/proxy statement, without charge at the SEC's website (www.sec.gov) or from Acasti by contacting Acasti's Secretary at 3009 boul. de la Concorde East, Suite 102 Laval, Québec, Canada H7E 2B5, telephone: (450) 686-4555.

    No Offer or Solicitation

    This document is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

    Participants in the Solicitation

    Acasti and Grace and certain of their respective directors, executive officers and employees may be deemed to be participants in the solicitation of Acasti proxies in respect of the merger. Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies to Acasti shareholders in connection with the merger is set forth in the prospectus/proxy statement. Copies of the prospectus/proxy statement may be obtained free of charge from the SEC or Acasti, as described in the preceding paragraph.

    Cautionary Statement Regarding Forward-Looking Statements

    This document contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and may be forward-looking information as defined under applicable Canadian securities legislation (collectively, "forward-looking statements"). These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Acasti, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "estimate," "plan," "believe," "anticipate," "intend," "look forward," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance.

    Forward-looking statements contained in this document may include, without limitation, statements regarding the proposed merger between Acasti and Grace; the timing and financial and strategic benefits thereof; the expected impact of the transaction on the cash balance of Acasti following the merger; Acasti's future strategy, plans and expectations after the merger; and the anticipated timing of clinical trials and approvals for, and the commercial potential of, Acasti's products and pipeline product candidates and those of its subsidiaries (including Grace, if the merger is completed). Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including the failure to receive, on a timely basis or otherwise, the required approvals by Acasti shareholders or Grace stockholders, as applicable, in connection with the merger; the risk that a condition to closing of the merger may not be satisfied; the possibility that the anticipated benefits of the proposed merger may not be fully realized or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of the businesses of Acasti and Grace will be greater than expected; the ability of the companies following the merger to commercialize drug candidates in line with the companies' expectations; the ability to retain and hire key personnel and maintain relationships with customers, key opinion leaders, suppliers or other business partners; the impact of legislative, regulatory, competitive and technological changes; and other risk factors relating to the companies' businesses and the biopharmaceutical industry, as detailed from time to time in Acasti's reports filed with the SEC and the Canadian Securities Administrators, which you are encouraged to review. Investors should not place undue reliance on forward-looking statements.

    For a discussion of the factors that may cause Acasti's, Grace's or the combined company's actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied in such forward-looking statements, and for a discussion of risks associated with the ability of Acasti and Grace to complete the merger and the effect of the merger on the business of Acasti, Grace and the combined company, see the section titled "Risk Factors" in the prospectus / proxy statement.

    The forward-looking statements reflect management's current knowledge, assumptions, beliefs, estimates and expectations and express management's current view of future performance, results and trends. If any of these risks or uncertainties materializes or any of these assumptions proves incorrect, the results of Acasti, Grace or the combined company could differ materially from the forward-looking statements. All forward-looking statements in this document are current only as of the date on which the statements were made, or in the case of a document incorporated by reference, as of the date of that document. Except as required by applicable law, neither Acasti nor Grace undertakes any obligation to update publicly any forward-looking statements for any reason after the date of this document or to conform these statements to actual results or to changes in expectations.

    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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  3. LAVAL, Québec, June 22, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) today announced its operating and financial results for the fiscal year ended March 31, 2021, and provided an update on its plans to acquire Grace Therapeutics and the ongoing strategic process for CaPre.

    As part of Acasti's formal process to explore and evaluate a range of strategic alternatives to enhance shareholder value, management and the board evaluated dozens of companies and conducted an extensive and thorough due diligence process on several finalist candidates. Acasti's management and board believed that Grace Therapeutics (Grace), a privately held emerging biopharmaceutical company focused on developing innovative…

    LAVAL, Québec, June 22, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) today announced its operating and financial results for the fiscal year ended March 31, 2021, and provided an update on its plans to acquire Grace Therapeutics and the ongoing strategic process for CaPre.

    As part of Acasti's formal process to explore and evaluate a range of strategic alternatives to enhance shareholder value, management and the board evaluated dozens of companies and conducted an extensive and thorough due diligence process on several finalist candidates. Acasti's management and board believed that Grace Therapeutics (Grace), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases, stood out from the field of acquisition targets because of several important factors, including their diversified drug pipeline with multiple, high quality clinical assets; significant addressable market opportunities; three later stage assets with a potentially shorter timeline to key milestones; efficient and low-cost clinical and regulatory pathway; and a strong and growing intellectual property portfolio. Grace's novel drug delivery technologies are designed to enable the rapid development of new therapies that could improve upon currently marketed compounds with known safety profiles. Grace's most advanced drug candidates may also have a fast path to regulatory approval and commercialization via the 505(b)(2) pathway.

    On May 7, 2021, Acasti announced that it had entered into a definitive agreement to acquire Grace and their pipeline of drug candidates addressing critical unmet medical needs ("Proposed Transaction"). The Proposed Transaction has been approved by the boards of directors of both companies and is supported by Grace's shareholders through voting and lock-up agreements with Acasti. The transaction remains subject to approval of Acasti stockholders, as well as applicable stock exchanges.

    Jan D'Alvise, Acasti's chief executive officer stated, "We are very excited about the planned acquisition of Grace, as we believe their product portfolio has the potential for delivering better patient solutions with enhanced efficacy, faster onset of action, reduced side effects, and more convenient delivery with the potential to increase patient compliance. The planned merger with Grace will result in the creation of a rare and orphan disease company that we believe will allow us to not only rapidly advance their existing assets through the clinic, but also continue to develop new innovative therapies that leverage Grace's novel drug delivery technologies. Following the merger, we expect to have more than $60 million in cash, which should provide at least two years of operating runway and enable us to complete clinical development and file an NDA for GTX-104, and significantly advance other key drug candidates in the Grace pipeline.

    In connection with the Proposed Transaction, Acasti will acquire Grace's entire therapeutic pipeline consisting of three unique clinical stage and multiple pre-clinical stage assets supported by an intellectual property portfolio consisting of more than 40 granted and pending patents in various jurisdictions worldwide. Grace's product candidates aim to improve clinical outcomes by applying proprietary formulation and drug delivery technologies to existing pharmaceutical compounds to achieve improvements over the current standard of care, or they could provide treatment for diseases with no currently approved therapy. Grace's three lead programs have all received Orphan Drug Designation from the U.S. Food & Drug Administration (FDA), which could provide up to seven years of marketing exclusivity in the United States upon FDA approval of the New Drug Application (NDA), provided that certain conditions are met.

    The Company has posted a presentation summarizing key highlights of the transaction, which is available on both the Acasti and Grace websites.

    D'Alvise continued, "In parallel with progressing the acquisition of Grace, we have received interest and are evaluating a variety of strategic options for CaPre. We remain highly encouraged by the outlook for our overall business prospects and look forward to providing further updates to shareholders on our strategic processes as it relates to both the Grace acquisition as well as our plans for CaPre."

    Conference call and Shareholder Meeting

    As previously disclosed, Acasti plans to file a Form S-4 proxy statement with the U.S. Securities & Exchange Commission (SEC), which will include detailed disclosure regarding the Proposed Transaction in the next few weeks. Following the SEC granting the Form S-4 to be effective, Acasti and Grace management plan to host an investor conference call to further discuss the anticipated benefits of the acquisition and answer investor questions. Acasti will call a shareholder meeting, which will be combined with our FY'21 AGM, to approve the transaction following the public filing of the Form S-4 proxy statement. More information will be provided on the timing and logistics for both events as soon as it is available.

    Nasdaq Communication

    On May 11, 2021, the Company received notice from the Nasdaq Listing Qualifications Department indicating that, based upon the Company's non-compliance with the $1.00 minimum bid price requirement set forth in Nasdaq Listing Rule 5550(a) as of May 10, 2021, the Company's shares were subject to delisting unless the Company timely requests a hearing before the Nasdaq Hearings Panel.

    The Company requested and was granted a hearing before the Nasdaq Hearing Panel on June 17, 2021, which has stayed any further action by Nasdaq pending the conclusion of the hearing process. At the hearing, the Company presented a detailed plan of compliance for the Panel's consideration, including the Company's commitment to implement a share consolidation concurrently with the completion of its proposed acquisition of Grace. Acasti expects to receive the Panel's decision within 30 days of the hearing and is prepared to take definitive action to regain compliance with Nasdaq's minimum bid price rule to ensure the Company's continued listing on Nasdaq.

    Fiscal Year 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 operating activities for the year ended March 31, 2021, was $16.4 million, compared to a loss from operating activities of $24.4 million for the year ended March 31, 2020. The change was due mainly to a reduction in R&D, general and administrative expenses, and sales and marketing expenses.
    • Net loss for the year ended March 31, 2021, was $19.7 million or $0.17 per share, a decrease of $5.8 million from the net loss of $25.5 million or $0.30 per share for the year ended March 31, 2020. The reduction in net loss resulted in part from a decrease in research and development expenses as the TRILOGY Phase 3 clinical program for CaPre was winding down. General and administrative expenses decreased from the comparative period due to decreased stock-based compensation. Sales and marketing expenses also decreased as a result of the termination of any CaPre commercialization activities due to the TRILOGY 2 Phase 3 clinical trial results. Furthermore, operational events related to the TRILOGY outcome resulted in an impairment of equipment, intangible and other assets of $5.7M. The net loss was also impacted from financial expenses of $3.3 million for the year ended March 31, 2021, as compared to net financial expenses of $1.0 million for the year ended March 31, 2020, due mostly to the change in fair value of the warrant derivative liability.
    • R&D expenses before depreciation, amortization and stock-based compensation expenses for the year ended March 31, 2021, totaled $2.9 million compared to $13.2 million for the year ended March 31, 2020. The net decrease was mainly attributable to a reduction in research contracts with the completion of the CaPre R&D activities as well as a reduction in headcount within the department.
    • General and Administration expenses before stock-based compensation expenses for the year ended March 31, 2021, were $4.7 million compared to $4.6 million for the year ended March 31, 2020. This increase was mainly attributable to an increase associated with the Company's insurance policies, as well as an increase in legal fees, which was offset by a decrease in salaries.
    • Sales and Marketing expenses before stock-based compensation expenses were $1.1 million for the year ended March 31, 2021, compared to $2.4 million for the year ended March 31, 2020. The decrease was mostly a result of a reduction in headcount, as well as a reduction in professional fees and other marketing activities resulting from the termination of the planned pre-launch marketing activities for CaPre.
    • Cash flows Cash and cash equivalents totaled $50.9 million as of March 31, 2021, compared to $14.2 million at March 31, 2020.

    Financing Activities

    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 March 8, 2021, Acasti issued an aggregate of 8,255,890 common shares (the "ATM Shares") over the NASDAQ Stock Market for aggregate gross proceeds to the Company of US $5,849,567 million. The ATM Shares were sold at prevailing market prices averaging US $0.71 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 208,375,549 common shares issued and outstanding as of June 22, 2021. During the three-month period ended March 31, 2021, Acasti sold an aggregate of 51,837,057 shares under the ATM Program at an average price per share of $0.6873 for total net proceeds of $34,495,532, and for the year ended March 31, 2021, Acasti sold an aggregate of 117,724,769 shares under the ATM Program at an average price per share of $0.5213 for total net proceeds of $59,332,476. No additional shares have been sold by Acasti under the ATM Program since March 2021.

    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.

    Cautionary Statement Regarding 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, statements relating to the timing and completion of the Proposed Transaction and benefits of the Proposed Transaction; future product development plans and the efficacy of drug candidates; the potential market opportunities and value of drug candidates; other statements regarding future product development and regulatory strategies, including with respect to specific indications; statements regarding expectations of continued NASDAQ listing and compliance; and any other statements regarding Acasti's and Grace's future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance, and Acasti's ability to obtain a further extension from the Panel and its ability to evidence compliance with the Nasdaq Rule within any extension period that may be granted by the Panel.

    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/, 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, May 17, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) today announced that, on May 11, 2021, the Company received notice from the Nasdaq Listing Qualifications Department (the "Staff") indicating that, based upon the Company's non-compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a) (the "Rule") as of May 10, 2021, the Company's securities were subject to delisting unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the "Panel"). The Company has previously disclosed and expected such notification from Nasdaq and believes it has options to regain compliance, preferably in connection with its proposed acquisition of…

    LAVAL, Québec, May 17, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) today announced that, on May 11, 2021, the Company received notice from the Nasdaq Listing Qualifications Department (the "Staff") indicating that, based upon the Company's non-compliance with the $1.00 bid price requirement set forth in Nasdaq Listing Rule 5550(a) (the "Rule") as of May 10, 2021, the Company's securities were subject to delisting unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the "Panel"). The Company has previously disclosed and expected such notification from Nasdaq and believes it has options to regain compliance, preferably in connection with its proposed acquisition of Grace Therapeutics, Inc. ("Grace") as is often done in connection with similar transactions.

    The Company plans to timely request a hearing, which will stay any further action by Nasdaq pending the conclusion of the hearing process. Importantly, Acasti is prepared to take definitive action to regain compliance with the Rule and otherwise ensure the Company's continued listing on Nasdaq. The Company understands that Panel hearings are typically scheduled within 30-45 calendar days of an issuer's request, and in accordance with the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an extension through November 8, 2021 to regain compliance with the Rule.

    At the hearing, the Company will present a detailed plan of compliance for the Panel's consideration, which will include the Company's commitment to implement a share consolidation if needed to evidence compliance with the Rule. Should the Company determine that a share consolidation is necessary or otherwise advisable, the Company would likely take such action concurrent with the completion of its proposed acquisition of Grace.

    The Company plans to issue an update with respect to the Nasdaq hearings process as soon as substantive updates are available.

    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.

    Cautionary Statement Regarding 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, statements relating to Acasti's ability to obtain a further extension from the Panel and its ability to evidence compliance with the Nasdaq Rule within any extension period that may be granted by the Panel.

    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, 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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  5. Grace provides Acasti with a pipeline of rare and orphan disease programs, including 3 clinical stage assets that have received Orphan Drug Designation from the FDA

    Expects lead asset to complete PK Bridging Study in early 2022, with potential to advance directly into a Phase 3 clinical safety trial for Subarachnoid Hemorrhage

    Combination creates a unique rare disease company with innovative drug delivery technologies, and is expected to have ~$64M in cash at closing to advance lead clinical assets

    LAVAL, Québec, May 07, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces it has entered into a definitive agreement to acquire Grace Therapeutics, Inc. ("Grace"), a privately held emerging…

    Grace provides Acasti with a pipeline of rare and orphan disease programs, including 3 clinical stage assets that have received Orphan Drug Designation from the FDA

    Expects lead asset to complete PK Bridging Study in early 2022, with potential to advance directly into a Phase 3 clinical safety trial for Subarachnoid Hemorrhage

    Combination creates a unique rare disease company with innovative drug delivery technologies, and is expected to have ~$64M in cash at closing to advance lead clinical assets

    LAVAL, Québec, May 07, 2021 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ:ACST, TSXV:ACST) announces it has entered into a definitive agreement to acquire Grace Therapeutics, Inc. ("Grace"), a privately held emerging biopharmaceutical company focused on developing innovative drug delivery technologies for the treatment of rare and orphan diseases (the "Proposed Transaction"). Subject to the completion of the Proposed Transaction, Acasti will acquire Grace's pipeline of drug candidates addressing critical unmet medical needs with the potential to deliver significant value to patients and providers. It is anticipated that the cash at closing of about $64 million will be principally used to pursue the clinical development of the first two assets through Phase 3, and further advance earlier pipeline assets into the clinic. The Proposed Transaction has been approved by the boards of directors of both companies and is supported by Grace shareholders through voting and lock-up agreements with the Company. The transaction remains subject to approval of Acasti stockholders, as well as applicable stock exchanges.

    The Company has posted a presentation summarizing key highlights of the transaction, which is available on both the Acasti and Grace websites. Acasti plans to file the required Form S-4 proxy statement with the U.S. Securities & Exchange Commission (SEC), which will include detailed disclosures regarding the transaction. Following the filing of the required Form S-4, Acasti and Grace management plan to host an investor conference call to further discuss the anticipated benefits of the acquisition and answer investor questions. Acasti will call a shareholder meeting to approve the transaction following the public filing of the Form S-4 proxy statement. As the Proposed Transaction moves forward, Acasti continues to evaluate strategic options for value creation from its existing assets.

    In connection with the Proposed Transaction, Acasti will acquire Grace's entire therapeutic pipeline consisting of three unique clinical stage and multiple pre-clinical stage assets supported by an intellectual property portfolio consisting of more than 40 granted and pending patents in various jurisdictions worldwide. Grace's product candidates aim to improve clinical outcomes by applying proprietary formulation and drug delivery technologies to existing pharmaceutical compounds to achieve improvements over the current standard of care or provide treatment for diseases with no currently approved therapy. Grace's three lead programs have all received Orphan Drug Designation1 from the U.S. Food & Drug Administration (FDA), which could provide up to seven years of marketing exclusivity in the United States upon FDA's approval of the New Drug Application (NDA), provided that certain conditions are met.

    Grace's Leading Drug Assets:

    • GTX-104: Subarachnoid Hemorrhage (SAH) – Intravenous Infusion



      • Clinical stage: PK Bridging study results expected Q1‘22; Phase 3 Safety Study expected to start enrollment Q3'22.
      • Product Description: Novel aqueous nanoparticle formulation of water insoluble nimodipine, that enables a continuous peripheral IV infusion for rapid and enhanced bioavailability. Acasti and Grace believe GTX-104 can potentially improve the management of hypotension and vasospasm in SAH patients, thereby improving patient outcomes and potentially preventing death and/or reduce long-term disability.
      • Disease Target: SAH is a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. A primary cause of such hemorrhage is rupture of an aneurysm or ballooning of a weakened blood vessel wall. Notably, 10-15% of SAH patients currently die before reaching hospital and 20% of admitted patients die in hospital2.
      • Target Market: SAH affects approximately 50,000 patients per year in the U.S.3 with an estimated addressable market of over $300 million4. Nimodipine, the current standard of care for SAH, is only available as an oral capsule and liquid solution in the U.S., making drug delivery very difficult particularly when a patient is unconscious. Oral nimodipine also has suboptimal absorption when administered through the gut5.



    • GTX-102: Ataxia-telangiectasia (A-T) - Oral Mucosal Spray



      • Clinical stage: PK Study results expected 2H'22; start of Phase 3 expected 1H'23.
      • Product Description: A novel and convenient oral mucosal spray formulation of betamethasone intended to significantly improve neurological symptoms of A-T, including improving clinical assessments of posture and gait disturbance, and kinetic speech and oculomotor functions. Currently, there are no FDA approved pharmacotherapies for A-T. Acasti and Grace also believe that GTX-102 could ease drug administration for patients experiencing A-T given its application as a more convenient, concentrated and metered betamethasone liquid spray onto the tongue, as these A-T patients typically have difficulty swallowing6.
      • Disease Target: A-T is a progressive, neurodegenerative genetic disease that primarily impacts children causing severe disability, for which no treatment currently exists. A-T affects many parts of the body, including areas of the brain, causing difficulty with motor function and motion. The disease is also associated with weakening of the immune system predisposing patients to infection, and with faulty repair of damaged DNA that may increase the risk of cancer7.
      • Target market: A-T affects approximately 4,300 patients per year in the U.S.8 with an estimated addressable market of approximately $150 million4.



    • GTX-101: Post Herpetic Neuralgia (PHN) - Topical Spray



      • Clinical Stage: Phase 1 results expected 2H'22; start of Phase 2 expected 2H'22.
      • Product Description: A novel, topical bio-adhesive film-forming spray of bupivacaine for the treatment of PHN, which could provide significant benefits over the standard of care, including greater convenience, and faster onset and longer action. GTX-101's metered-dose of bupivacaine spray forms a thin bio-adhesive topical film on the surface of the patient's skin, which enables a touch-free, non-greasy application. No skin sensitivity was reported in its Phase 1 study.
      • Disease Target: PHN is a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles). PHN pain varies from mild to excruciating in severity, and may persist for months and even years, adversely impacting quality of life and leading to social withdrawal and depression. As a result, PHN is often cited as the leading cause of suicide in chronic pain patients over the age of 709.
      • Target market: PHN affects approximately 150,000 patients per year in the U.S.10 with an estimated addressable market of approximately $400 million4. Current treatment of PHN most often consists of oral gabapentin and lidocaine patches, and refractory cases may be prescribed opioids to address persistent pain. Current lidocaine patches used for PHN are suboptimal, as these patches are difficult to use; 40% of patients experience insufficient pain relief, the analgesic effect could take up to 2 weeks, and many patients suffer from skin sensitivity and irritation4. Unlike oral gabapentin and lidocaine patches, Acasti and Grace believe that the biphasic delivery mechanism of GTX-101 has the potential for rapid onset and continuous pain relief for up to eight hours11.

    Roddy Carter, chairman of Acasti, commented on the transaction, "We have diligently pursued a thorough strategic process to evaluate a range of value-creating alternatives. We believe that combining Grace's innovative research programs and scientific talent with Acasti's financial resources and drug development and commercialization expertise position us to build a portfolio of innovative therapeutics that will address unmet medical needs. The Acasti and Grace boards have approved this transaction, which is also supported by Grace shareholders, and we highly recommend that our shareholders also approve it."

    Jan D'Alvise, chief executive officer of Acasti, stated, "We believe that Grace's assets represent a transformative opportunity for Acasti, as their novel drug delivery technologies used to develop new therapies could improve upon existing compounds with known safety profiles and provide an attractive path to drug development and commercialization. We believe Grace's product portfolio has the potential to provide better patient solutions with enhanced efficacy, faster onset of action, reduced side effects, convenient delivery, and increased patient compliance. For these and other reasons, we are very excited about the therapeutic potential of Grace's pipeline, and we believe there could be significant international licensing and marketing opportunities for these assets."

    Vimal Kavuru, co-founder and chairman of Grace, noted, "Merging with Acasti is a significant opportunity for Grace, as it allows us to partner with an experienced team, well-versed in drug development and commercialization, with a strong commitment to the highest standards of corporate governance. As a result of the merger, we anticipate the combined company will have the financial resources to fund our lead programs to critical value inflection points. Our board of directors have approved the proposed transaction with Acasti, which is also supported by Grace's shareholders."

    "We believe our dedication to bringing new, safe and effective medicines to patient populations where there is significant unmet medical need is shared by the management and board of Acasti. We look forward to a successful future together and driving value for our combined shareholders," noted S. George Kottayil, Ph.D., co-founder and chief executive officer of Grace.

    Management and Operations

    Upon shareholder approval of the Proposed Transaction, the combined companies will be led by Jan D'Alvise as president and chief executive officer, and the corporation will continue to maintain its corporate headquarters in Laval, Quebec, Canada. All Grace employees will transition to Acasti and they will continue to maintain an R&D laboratory and commercial presence in North Brunswick, New Jersey. The new Board of Directors will be composed of 4 representatives from Acasti and 3 from Grace, with more details to be provided in the proxy statement.

    About the Proposed Transaction

    Pending approval by Acasti shareholders as well as applicable stock exchange approvals, Grace will merge with a new wholly owned subsidiary of Acasti. Grace stockholders will receive newly issued Acasti common shares pursuant to an exchange ratio formula set forth in the definitive agreement. Under the terms of the definitive agreement, immediately following the consummation of the Proposed Transaction, Acasti's securityholders on a pro forma basis would own approximately 55% of the combined company's common shares, and Grace's securityholders would own approximately 45% of the combined company's common shares, in each case calculated on a fully-diluted basis, subject to upward adjustments in favor of Acasti based on each company's capitalization and net cash balance as set forth in the definitive agreement, with more details to be provided in the proxy statement. For illustrative purposes, assuming no adjustments for each company's capitalization and net cash balance, and based on 208,375,549 common shares of Acasti currently issued and outstanding, an aggregate of 170,489,086 common shares of Acasti would be issued to Grace stockholders as consideration for the Proposed Transaction.

    In connection with the entering into the definitive agreement, Grace stockholders representing substantially all of the outstanding shares of Grace have entered into voting and lock-up agreements with the Company pursuant to which they have agreed, amongst other things to (i) vote their shares of Grace in favor of the Proposed Transaction, (ii) be subject to lock-up provisions for a period of 12 months (subject to certain exceptions), and (iii) support the election of board nominees through to the 2023 annual general meeting of shareholders.

    The Proposed Transaction is expected to close in calendar Q3 of 2021, immediately following approval by Acasti shareholders, subject to any applicable SEC review and stock exchange approvals, as well as satisfaction of other closing conditions by each company specified in the definitive agreement.

    Acasti will take steps to regain compliance with Nasdaq's minimum bid price requirements in connection with the Proposed Transaction, and if required, would implement a share consolidation.

    Oppenheimer & Co. is acting as Acasti's financial advisor for the Proposed Transaction and Osler, Hoskin & Harcourt, LLP is serving as its legal counsel. William Blair & Company, LLC is serving as financial advisor to Grace, with Reed Smith, LLP serving as its legal counsel.

    The Proposed Transaction is an arm's length transaction in accordance with the policies of the TSX Venture Exchange.

    Selected Financial Information of Grace

    Selected financial information of Grace from its most recent audited annual financial statements is provided below:

     Year Ended December 31, 2020

    (audited)
    Year Ended December 31, 2019

    (audited)
    Assets$1,198,921$2,699,476
    Liabilities*$13,725,563$12,753,123
    RevenuesNilNil
    Net Loss$(2,506,228)$(3,666,329)

    *Grace liabilities will be converted into Grace shares prior to the closing of the transaction, and are already accounted for in the conversion formula and the net cash adjustment.

    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.

    About Grace

    Grace Therapeutics is an emerging biopharmaceutical company focused on rare and orphan diseases with high unmet medical needs. Grace's strategy is to improve clinical outcomes using novel drug delivery technologies to approved pharmaceutical compounds and achieve enhanced efficacy, faster onset of action, reduced side effects, convenient delivery, and increased patient compliance. Grace has a therapeutic pipeline of three unique clinical stage programs, several preclinical assets, and a robust intellectual property portfolio of over 40 granted and pending patent applications.

    Important Additional Information Will be Filed with the SEC

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. The Proposed Transaction will be submitted to the shareholders of Acasti for their consideration. Acasti will also prepare and file a Registration Statement on Form S-4 that will include a prospectus/proxy statement for Acasti's shareholders. Acasti plans to mail its shareholders a proxy statement in connection with the proposed transaction. Acasti may also file other documents with the Securities and Exchange Commission (the "SEC") regarding the proposed transaction. INVESTORS AND SECURITYHOLDERS ARE URGED TO READ THE PROSPECTUS/PROXY STATEMENT AND ANY OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.

    Investors and securityholders may obtain free copies of the prospectus/proxy statement and other documents containing important information about Acasti, Grace and the Proposed Transaction once such documents are filed with the SEC through the website maintained by the SEC at www.sec.gov. Copies of the documents filed with the SEC by Acasti will be available free of charge on Acasti's website at http://www.acastipharma.com/ under the tab "Investor Relations" or by contacting Acasti by e-mail at , or by phone at (450) 686-4555.

    Participants in the Solicitation

    Acasti and Grace and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the shareholders of Acasti in connection with the Proposed Transaction. Information about the directors and executive officers of Acasti is set forth in Acasti's definitive proxy statement for Acasti's 2020 annual meeting of shareholders filed with the SEC on September 9, 2020. That document can be obtained free of charge from the sources indicated above. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the prospectus/proxy statement and other relevant materials to be filed with the SEC when they become available.

    References:

    1. The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition, which is one that affects less than 200,000 persons in the United States or meets cost recovery provisions of the Orphan Drug Act. The status helps incentivize the development of therapies to treat unmet medical needs by providing a company with seven years of exclusivity rights once a drug reaches market.
    2. Rinkel G. 2016
    3. Becske T. et al 2018
    4. Fletcher Spaght Inc., Market Research Report
    5. Soppi V. et al 2007
    6. Lefton-Greif 2000
    7. U.S. National Cancer Institute, Ataxia-Telangiectasia (2015)
    8. National Organization for Rare Disorders, Ataxia-Telangiectasia (2015)
    9. Hess et al 1990
    10. CDC Morbidity and Mortality Weekly Report (2008)
    11. Grace GTX-101 Phase 1 Study Report

    Cautionary Statement Regarding 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, Grace and the combined company 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, the expected timetable for completing the Proposed Transaction and benefits of the Proposed Transaction; future product development plans and projected timelines for the initiation and completion of preclinical and clinical trials; the potential for the results of ongoing preclinical or clinical trials and the efficacy of drug candidates; the potential market opportunities and value of drug candidates; other statements regarding future product development and regulatory strategies, including with respect to specific indications; the combined company's plans, objectives, future opportunities for the combined company; future financial performance and operating results; sufficiency of capital resources to fund operating requirements; and any other statements regarding Acasti's and Grace's future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance.

    These statements are subject to numerous risks and uncertainties, many of which are beyond Acasti's or Grace's control, which could cause actual results to differ materially from the results expressed or implied by the statements. These risks and uncertainties include, but are not limited to: failure to obtain the required votes or approvals of Acasti's and/or Grace's shareholders; failure to obtain any applicable stock exchange approvals; the timing to consummate the proposed transaction; conditions to closing of the proposed transaction may not be satisfied or that the closing of the proposed transaction otherwise does not occur; the risk that as a result of adjustments to the exchange ratio, Grace stockholders could own less of the combined company than is currently anticipated; the risk that a regulatory approval that may be required for the proposed transaction is not obtained or is obtained subject to conditions that are not anticipated; the diversion of management time on transaction-related issues; the ultimate timing, outcome and results of integrating the operations of Acasti and Grace; the effects of the business combination of Acasti and Grace following the consummation of the proposed transaction, including the combined company's future financial condition, results of operations, strategy and plans; the combined company's need for, and the availability of, substantial capital in the future to fund its operations and research and development activities; the combined company's ability to continue to successfully progress research and development efforts and to create effective, commercially-viable products; the success of the combined company's product candidates in completing pre-clinical or clinical testing and being granted regulatory approval to be sold and marketed in the United States or elsewhere; results of any litigation, settlements and investigations; actions by third parties, including governmental agencies; global economic conditions; ability to effectively identify and enter new markets; governmental regulations; and ability to retain management and field personnel.

    Additional information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in Acasti's SEC filings. Acasti's filings may be obtained by contacting Acasti or the SEC or through Acasti's web site at http://www.acastipharma.com or through the SEC's Electronic Data Gathering and Analysis Retrieval System (EDGAR) at http://www.sec.gov. The foregoing list of risk factors is not exhaustive. These risks, as well as other risks associated with the proposed transaction will be more fully discussed in the prospectus/proxy statement that will be included in the Registration Statement on Form S-4 that will be filed with the SEC in connection with the proposed transaction. Each of Acasti and Grace does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

    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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