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Form 6-K Acasti Pharma Inc. For: Apr 12

April 12, 2017 8:06 AM EDT

 
 

SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
 


FORM 6-K
 


REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 under
the Securities Exchange Act of 1934
 
For the month of: April 2017
  
Commission File Number: 001-35776
 
 


ACASTI PHARMA INC.
(Name of Registrant)
 


545 Promende du Centropolis
Suite 100
Laval, Québec
Canada H7T 0A3
(Address of Principal Executive Office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F              Form 40-F  
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  
 
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes               No  
 
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): N/A
 

 
This Report on Form 6-K including the exhibits hereto shall be deemed to be incorporated by reference into Acasti Pharma Inc.’s registration statement on Form S-8 (File No. 333-191383) and to be a part thereof from the date on which this report is furnished, to the extent not superseded by documents or reports subsequently filed or furnished.
 

 
SIGNATURES
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, thereunto duly authorized.
 
 
ACASTI PHARMA INC.
     
Date: April 12, 2017
By:
/s/ Jan D'Alvise                                                                
    Name: Jan D'Alvise
   
Title: Chief Executive Officer
 

EXHIBIT INDEX
Exhibit
Description of Exhibit
   
Press Release dated April 12, 2017
 

 
 
 


Exhibit 99.1
 


Acasti Pharma to Present CaPre Omega-3 Bridging Study Results at National Lipid Association Scientific Sessions

Laval, Québec, CANADA – April 12, 2017 – Acasti Pharma Inc. (NASDAQ:ACST – TSX-V: ACST) today announced that company researchers have been invited to present the CaPre® (omega-3 phospholipid) bridging study results in a poster presentation at the National Lipid Association Scientific Sessions in Philadelphia, May 18-21, 2017. Acasti will present the results of its 'Phase 1, Single-Dose, Comparative Bioavailability Study of CaPre, a novel Omega-3 Derived from Krill Oil and Lovaza® under Fasting and Fed Conditions.'

"The selection of CaPre data for a poster presentation at this key medical meeting underscores the importance of providing the medical community with new information about therapy advancements in the treatment of hypertriglyceridemia," said Pierre Lemieux, Ph.D., Acasti's chief operating officer. "Data to be presented will highlight Acasti's commitment to providing hypertriglyceridemia patients and treating physicians with a well-absorbing omega-3 therapeutic that may also have a positive impact on the major lipids associated with cardiovascular disease risk."
Acasti has successfully completed two Phase 1 and two Phase 2 clinical trials with CaPre for the treatment of hypertriglyceridemia. The outcome of the recent End-of-Phase 2 Meeting with the U.S. Food and Drug Administration confirmed that the Phase 3 program is on track to start late 2017.

About CaPre (omega-3 phospholipid)

Acasti's prescription drug candidate, CaPre, is a highly purified omega-3 phospholipid concentrate derived from krill oil and is being developed to treat severe hypertriglyceridemia, a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. Its omega-3s, principally EPA and DHA, are either "free" or bound to phospholipids that help them to be better absorbed into the body. This allows for enhanced bioavailability and EPA and DHA blood levels compared to the "esterified" fish-oil omega-3 options such as LOVAZA.

About Acasti Pharma

Acasti Pharma is a biopharmaceutical innovator advancing a potentially best-in-class cardiovascular
drug, CaPre (omega-3 phospholipid), for the treatment of hypertriglyceridemia, a chronic condition affecting an estimated one third of the U.S. population. The corporation's strategy is to initially develop and commercialize CaPre for the three to four million patients in the U.S. with severe hypertriglyceridemia. Since its founding in 2008, Acasti Pharma has focused on addressing a critical market need for an effective, safe and well-absorbing omega-3 therapeutic that can make a positive impact on the major blood lipids associated with cardiovascular disease risk. For more information, visit www.acastipharma.com.
 
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Forward Looking Statements

Statements in this press release that are not statements of historical or current fact constitute "forward looking statements" and "forward-looking information" (collectively, "forward-looking statements") within the meaning of the U.S. securities laws and Canadian securities laws, including, without limitation, statements with respect to the proposed initiation of the Phase 3 development program for CaPre and the timing of such development program. 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. Certain important assumptions by Acasti in making forward-looking statements include, but are not limited to, Acasti's ability to obtain additional capital and financing as needed on favorable terms, Acasti's ability to take advantage of business opportunities in the pharmaceutical industry and the receipt of strategic partner support, and Acasti's estimate of the timeline and costs for its development programs not being affected by unforeseen events or circumstances. 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," "will," or "plans" to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release.

The forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement and the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest Annual Information Form, which also forms part of Acasti's latest annual report on Form 20-F, and which is available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml and on the investor section of Acasti's website at acastipharma.com (the "AIF"). 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 other 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 regulators. Additional information about these assumptions and risks and uncertainties is contained in the AIF under "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.

SOURCE: Acasti Pharma Inc.

Acasti Contact:
Jan D'Alvise
Chief Executive Officer
450-686-4555
www.acastipharma.com
 
Media & Investor Contact:
Jessica Dyas
Canale Communications
619-849-5385


 
 
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