Form: 8-K

Current report filing

July 31, 2020

Documents

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________

Form 8-K
_____________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): July 31, 2020  

ACASTI PHARMA INC.
(Exact Name of Registrant as Specified in Charter)

QUEBEC, CANADA 001-35776 98-1359336
(State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number)

 

545 Promenade du Centropolis
Suite 100
Laval, Québec
Canada H7T 0A3 
(Address of Principal Executive Offices) (Zip Code)

450-686-4555
(Registrant's telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

  [   ]   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
  [   ]   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
  [   ]   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
  [   ]   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Shares, no par value per share   ACST   NASDAQ Stock Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). 

 

Emerging growth company [   ]

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [   ]

 
 

Item 7.01. Regulation FD Disclosure.

On July 31, 2020, Acasti Pharma Inc. (“Acasti”) issued a press release announcing that Acasti had completed its revisions to the pre-specified Statistical Analysis Plan (“SAP”) for the TRILOGY 2 Phase 3 trial of CaPre and filed the SAP with the U.S. Food and Drug Administration (the “FDA”). Acasti remains blinded to the TRILOGY 2 data and remains on track to report topline triglyceride data on or about August 31, 2020.

Acasti also announced that it plans to host a conference call on or about August 31, 2020 to discuss the TRILOGY 2 topline results as well as provide an update on the timing for reporting of the secondary and exploratory endpoints and the pooled results from both TRILOGY studies. As a result, Acasti will not 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.

On July 31, 2020, this press release was filed with the Canadian securities regulatory authorities in Canada on the System for Electronic Document Analysis and Retrieval at www.sedar.com. A copy of this press release is filed as exhibit 99.1 hereto.

The information provided under this Item 7.01 (including Exhibit 99.1, attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.   Description
     
99.1   Press Release issued by Acasti Pharma Inc. on July 31, 2020

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  ACASTI PHARMA INC.
     
   
Date: July 31, 2020 By:  /s/ Jan D'Alvise        
    Jan D'Alvise
    Chief Executive Officer