Acasti Pharma

Acasti Pharma, Inc. is a biopharmaceutical company, which engages in the development and commercialization of pharmaceutical applications of its licensed rights for cardiovascular diseases. It focuses on the research of prescription drugs using omega-3, fatty acids derived from krill oil. The company was founded by Henri Harland and Pierre Lemieux on February 1, 2002 and is headquartered in Laval, Canada.

Earnings data Q3 2021

Earnings data Q4 2021

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Grace Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of pharmaceutical applications of its licensed rights for cardiovascular diseases. It focuses on the research of prescription drugs using omega-3, fatty acids derived from krill oil. The company was founded by Henri Harland and Pierre Lemieux on February 1, 2002, and is headquartered in Princeton, NJ.

LAVAL, QC , May 17, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), announced today that Prashant Kohli, CEO, will be participating in a Company Webcast and Panel Presentation at the Lytham Partners Spring 2023 Investor Conference on Thursday, May 18, 2023. Management will also be conducting one-on-one meetings with investors.

Acasti to Participate in the Lytham Partners Spring 2023 Investor Conference

Company successfully submits GTX-104 Pivotal Phase 3 protocol IND amendment to the FDA with expectation for first patient dosed in calendar Q4 2023 Strategic realignment prioritizes GTX-104 and expects to extend cash runway through a potential New Drug Application (NDA) filing for GTX-104 LAVAL, Québec, May 8, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced the successful submission to the FDA of GTX-104's full protocol of its pivotal Phase 3 Safety Study and implementation of a strategic realignment plan to maximize shareholder value. Prashant Kohli, CEO of Acasti, commented, "We are extremely pleased to execute on this important submission milestone as we advance GTX-104, a critically important drug candidate to the thousands of patients that suffer from subarachnoid hemorrhage without effective treatment options.

Acasti Successfully Submits Pivotal GTX-104 Phase 3 Safety Study Protocol with FDA and Implements Strategic Realignment Plan That Extends Projected Cash Runway Through Calendar Q2 2025

Company expects the first patient to be enrolled during the second half of 2023 LAVAL, QC , April 4, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, specialty pharma company advancing drug candidates for rare and orphan diseases, today announced that it received a Type C written meeting response and clarifying feedback from the United States Food and Drug Administration (FDA) on Acasti's proposed Phase 3 Safety Study for GTX-104. The FDA provided additional comments on the Company's development plan that, pending submission of the final clinical protocol and FDA approval of same, will allow Acasti to proceed with the initiation of a Phase 3 safety clinical trial in aneurysmal Subarachnoid Hemorrhage (aSAH) patients.

Acasti to Proceed with Phase 3 Clinical Safety Study for GTX-104 Following FDA Feedback, and Upon Approval of the Full Study Protocol to be Submitted to the IND

LAVAL, QC , April 4, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage specialty pharma company advancing drug candidates for rare and orphan diseases, today announced the appointment of Prashant Kohli as Acasti's new Chief Executive Officer, succeeding Jan D'Alvise. The parties have mutually agreed to part ways, and Ms.

Acasti Announces Appointment of Prashant Kohli as CEO

LAVAL, QC , March 30, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST) a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Mr. Jean-Marie (John) Canan had tendered his resignation from the Board of Directors of the Company, such resignation to take effect immediately.

Acasti Pharma Inc. Announces the Resignation of a Director

Acasti also confirms no exposure to Silicon Valley Bank ("SVB") or Silvergate Bank LAVAL, Québec, March 13, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST and TSX-V: ACST) a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that it has applied and received approval for a voluntary delisting of its common shares from the TSX Venture Exchange ("TSXV"). The delisting from the TSXV will not affect the Company's listing on the NASDAQ Capital Market (the "NASDAQ").

Acasti Pharma Inc. Centralizes Marketplace for Shares on the Nasdaq with Voluntary Delisting from TSX Venture Exchange

LAVAL, QC, March 8, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced Jan D'alvise, CEO, will present and host one-on-one meetings with investors at the Oppenheimer 33rd Annual Healthcare Conference, held virtually and taking place on March 13-15, 2023.

Acasti Pharma to Participate in Oppenheimer 33rd Annual Healthcare Conference

LAVAL, QC , Feb. 28, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, recognizes and celebrates Rare Disease Day (February 28), as established by the European Organization for Rare Diseases. "Rare diseases impact approximately 300 million patients around the world and are often chronic, progressive and frequently life-threatening," commented Jan D'Alvise, CEO of Acasti Pharma.

Acasti Pharma Recognizes Rare Disease Day

Here is how Acasti Pharma (ACST) and Autolus Therapeutics PLC Sponsored ADR (AUTL) have performed compared to their sector so far this year.

Has Acasti Pharma (ACST) Outpaced Other Medical Stocks This Year?

Acasti Pharma Inc. (NASDAQ:ACST ) Q3 2023 Earnings Conference Call February 14, 2023 1:00 PM ET Company Representatives Jan D'Alvise - President, Chief Executive Officer Brian Ford - Chief Financial Officer Pierre Lemieux - Chief Operating and Scientific Officer, Co-Founder Prashant Kohli - Chief Commercial Officer Robert Blum - Lytham Partners Conference Call Participants Leland Gershell - Oppenheimer Oren Livnat - H.C. Wainwright Operator Good day, and welcome to the Acasti Pharma Reports Third Quarter of Fiscal Year 2023 Financial Results and Business Update Call.

Acasti Pharma Inc. (ACST) Q3 2023 Earnings Call Transcript

Company to Host Conference Call Today at 1:00pm ET

Acasti Pharma Reports Third Quarter 2023 Operational Results

Call to be held on Tuesday, February 14th at 1:00 PM Eastern Time LAVAL, QB, Feb. 7, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that it will host a conference call at 1:00 PM Eastern Time on Tuesday, February 14, 2023, to discuss the Company's corporate progress and other developments, as well as financial results for third quarter 2023 ended December 31, 2022. The conference call will be available via telephone by dialing toll free 844-836-8745 for U.S. callers or +1 412-317-6797 for international callers.

Acasti Pharma to Report Third Quarter 2023 Financial Results on Tuesday, February 14, 2023

LAVAL, Québec, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announces that it has received notification from the NASDAQ Listing Qualifications Department ("NASDAQ") that it is eligible for an additional 180 calendar days, or until July 24, 2023, to regain compliance with the minimum $1.00 per share requirement for continued listing.

Acasti Receives Extension to Regain Compliance with NASDAQ Minimum Bid Price Rule

LAVAL, Québec, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced Jan D'Alvise, CEO, will present and host one-on-one meetings with investors at the Lytham Partners Investor Select Conference, taking place virtually on January 31, 2023.

Acasti Pharma to Present at Lytham Partners Investor Select Conference on January 31

Phoenix, Arizona--(Newsfile Corp. - January 17, 2023) - The Stock Day Podcast welcomed Acasti Pharma, Inc. (NASDAQ: ACST), a late-stage specialty pharma company with drug delivery technologies and drug candidates addressing rare and orphan diseases. CEO of the Company, Jan D'Alvise, joined Stock Day host Everett Jolly. Jolly began the interview by asking about the Company's background and current projects.

Acasti Pharma Discusses Positive Clinical Study Results for GTX-101 and GTX-102 and Upcoming Phase 3 Study for GTX-104 with The Stock Day Podcast

LAVAL, Québec, Jan. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced Jan D'alvise, CEO, will present and host one-on-one meetings with investors at the Sidoti January Virtual Investor Conference, taking place on January 18-19, 2023.

Acasti Pharma to Present at Sidoti Virtual Investor Conference on January 18

LAVAL, Québec, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that it will host a conference call on Tuesday, January 10, 2023 at 4:30 p.m. ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102. Both studies successfully met all target outcome measures.

Acasti to Host Conference Call on Tuesday, January 10, 2023 to Discuss Results from Recent Phase 1 PK Studies for GTX-101 and GTX-102 That Met All Outcome Measures

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LAVAL, Québec, Dec. 28, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announces that the preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 met all outcome measures. The objectives of the study were to evaluate the bioavailability, pharmacokinetics, and safety of GTX-102, a novel, concentrated oral-mucosal metered spray of betamethasone in healthy volunteers. This new formulation is intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T) in a pediatric population for which there are currently no FDA-approved therapies. GTX-102 can be sprayed conveniently over the tongue of A-T patients, who often have difficulties swallowing. This PK study was the next step in the proposed 505(b)(2) regulatory pathway for GTX-102.

Acasti Announces Preliminary Topline Results Met All Outcome Measures in the Pharmacokinetic Bridging Study for GTX-102, the Company's Drug Candidate for the Treatment of Ataxia Telangiectasia

Acasti Pharma Inc. (NASDAQ:ACST ) Q2 2023 Earnings Conference Call November 14, 2022 1:00 PM ET Company Participants Robert Blum - Lytham Partners, IR Jan D'Alvise - President & CEO Brian Ford - CFO Prashant Kohli - Chief Commercial Officer Conference Call Participants Leland Gershell - Oppenheimer Sahil Kazmi - B. Riley Securities Operator Good day, and welcome to the Acasti Pharma Second Quarter 2023 Earnings Event Call.

Acasti Pharma Inc. (ACST) Q2 2023 Earnings Call Transcript

Acasti Pharma Reports Second Quarter 2023 Operational Results

LAVAL, Québec, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Jan D'Alvise, President and CEO of Acasti Pharma will be presenting virtually at the Q4 Investor Summit. The Company will be conducting a webcasted presentation and participating in one-on-one meetings with investors.

Acasti Pharma to Present at Q4 Investor Summit

Call to be held on Monday, November 14th at 1:00 PM Eastern Time Call to be held on Monday, November 14th at 1:00 PM Eastern Time

Acasti Pharma to Report Second Quarter 2023 Financial Results on Monday, November 14, 2022

LAVAL, Québec, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announced today that a U.S. court has dismissed the remaining stockholder litigation filed in connection with the Company's acquisition of Grace Therapeutics, Inc. (“Grace”) via merger in August 2021 (the “Merger”). As previously disclosed, four stockholder lawsuits were filed against Acasti and certain of its directors and officers in connection with the Merger, claiming that the Company's public disclosures relating to the Merger misstated or omitted material information and violated Section 14(a) of the U.S. Securities Exchange Act of 1934. Two of the four cases were voluntarily dismissed. The remaining two cases were consolidated before Judge Katherine Polk Failla in the United States District Court for the Southern District of New York. Acasti and the individual defendants filed a motion to dismiss on February 25, 2022. In a 45-page opinion released earlier today, Judge Failla granted the motion to dismiss in its entirety, finding that the consolidated complaint failed to allege any facts showing that Acasti made a materially misleading statement or material omission in its Merger-related disclosures. Accordingly, subject to any appeal that may be taken in response to today's ruling, all four stockholder suits filed in connection with the Merger have now been dismissed.

Acasti Announces Court Dismissal of Stockholder Litigation

LAVAL, Québec, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announced today the voting results from its Annual General and Special Meeting of Shareholders (the “Meeting”) which was held virtually on Wednesday September 28, 2022.

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