Company Achieves Multiple Milestones to Advance Drug Candidate CaPre Towards Phase 3 Trials
LAVAL, QUÉBEC--(Marketwired - June 6, 2017) - Acasti Pharma Inc. (NASDAQ:ACST)(TSX VENTURE:ACST) today announced its operating and financial results for the fiscal year ended March 31, 2017. The company announced on July 15, 2016 that it would transition to a new fiscal year-end in 2017 to better align Acasti with industry comparables and standard quarters. Accordingly, Acasti's fiscal year ended on March 31, 2017 rather than on February 28, 2017. For the purpose of its regulatory filings, Acasti is reporting results for the thirteen-month transition period ended March 31, 2017, reflecting its fourth quarter period covering the four months of December 1, 2016 to March 31, 2017. All amounts are in Canadian dollars.
"We had an extremely productive fourth quarter, firing on all cylinders to set the stage for us to initiate the Phase 3, registration trials for our product candidate CaPre®, for the treatment of patients with severe hypertriglyceridemia," said Jan D'Alvise, president and CEO of Acasti Pharma. "We raised additional capital and achieved critical clinical, regulatory, manufacturing, and other value-building milestones, and we're all keenly focused on advancing CaPre into Phase 3 clinical trials as planned in the second half of this year."
Key Fourth Quarter, Fiscal Year and Recent Developments
Financial Results for the Three-month Period Ended February 28, 2017 Compared to Three-month Period Ended February 29, 20161
Thirteen-month Period Ended March 31, 2017 Compared to the Year Ended February 29, 2016
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 company's strategy is to initially develop and commercialize CaPre for the 3 to 4 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.
Forward-Looking Statements
Statements in this press release that are not statements of historical or current fact constitute "forward-looking statements" within the meaning of the U.S. securities laws and Canadian securities laws. Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of 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," "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. Forward-looking information in this press release includes, but is not limited to, information or statements about Acasti's strategy, future operations, prospects and the plans of management; Acasti's ability to conduct all required clinical and non-clinical trials for CaPre, including the timing and results of those trials; the timing and the outcome of meetings and discussions with the FDA.
The forward-looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement, the "Cautionary Note Regarding Forward-Looking Information" section contained in Acasti's latest Annual 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 www.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 commissions, including, without limitation, risks related to timing and possible difficulties, delays or failures in the Company's Phase 3 program for CaPre; anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of CaPre; ; anticipated studies and submissions to the FDA may not occur as currently anticipated, or at all; outcome study data from two of Acasti's competitors in mild to moderate HTG patients may be negative, which could also negatively affect the market perception of CaPre; difficulties, delays or failures in obtaining regulatory approvals for the initiation of clinical trials or to market CaPre; uncertainties related to the regulatory approval process; failure to achieve Acasti's publicly announced milestones on time; ; Acasti has a history of negative operating cash flow and may never become profitable or be able to sustain profitability; Acasti will have significant additional future capital needs and may not be able to raise additional financing and to meet ongoing capital requirements.
Certain important assumptions by Acasti in making forward-looking statements include, but are not limited to, the successful and timely completion of all required clinical and nonclinical trials that may be necessary for regulatory approval of CaPre; the successful enrollment of patients in clinical trials as projected; the timeline and costs for Acasti's clinical programs are not incorrectly estimated or affected by unforeseen circumstances; ; the company's ability to achieve its publicly announced milestones on time; the company's ability to continue as a going concern; and Acasti's ability to obtain additional capital and financing as needed on favorable terms. Additional information about these assumptions and risks and uncertainties is contained in the AIF and in the company's most recent management's discussion and analysis (MD&A), in each case under the heading "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.
1 The annual audited financial statements and the MD&A are available on SEDAR at www.sedar.com, on EDGAR at www.sec.gov/edgar.shtml and on the investor section of Acasti's website at www.acastipharma.com.
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