Acasti Pharma Reports Second Quarter FY 2018 Financial Results

LAVAL, QUEBEC -- (Marketwired) -- 11/13/17 -- Acasti Pharma Inc. (NASDAQ: ACST)(TSX VENTURE: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced its operating and financial results for the quarter ended September 30, 2017, which is the second quarter of Acasti's fiscal year 2018. All amounts are in Canadian dollars.

"Acasti met several key milestones in the second quarter, advancing our Phase 3 clinical program to evaluate CaPre in patients with severe hypertriglyceridemia. We are building the value of CaPre as a potentially best-in-class prescription omega-3 product that addresses a very large market opportunity," said Jan D'Alvise, president and CEO of Acasti. "We continue on schedule to begin site activation in our CaPre Phase 3 program before year-end, and to begin treatment of the first patients in early 2018."

Key Second Quarter FY 2018 and Recent Developments:

--  Advanced Phase 3 program for CaPre: Acasti obtained important
    confirmation from the U.S. Food and Drug Administration on its
    Chemistry, Manufacturing, and Controls (CMC) plan and on the clinical
    trial design supporting Acasti's Phase 3 program. In parallel with the
    clinical trial planning, several lots of CaPre were manufactured under
    cGMP, providing Acasti with the CaPre and placebo inventory necessary to
    support the activation of Phase 3 clinical trial sites by the end of
    2017. Additional clinical trial lots of CaPre are planned to be
    manufactured in 2018 to support completion of the Phase 3 program in
    2019. In addition, Acasti is working with one of the biopharmaceutical
    industry's largest global clinical research organizations to prepare for
    site activation and to conduct the Phase 3 trials for CaPre.
--  Named principal investigator for Phase 3 program: Acasti announced that
    Dariush Mozaffarian, M.D., Dr.P.H., will be the principal investigator
    to oversee the Phase 3 clinical program for CaPre. Dr. Mozaffarian is a
    cardiologist and epidemiologist serving as the Dean of the Friedman
    School of Nutrition Science & Policy and the Jean Mayer Chair and
    Professor of Nutrition at Tufts University. His widely published
    research focuses on how lifestyle and diets such as those rich in omega-
    3s can influence cardiometabolic health. Dr. Mozaffarian is a recognized
    opinion leader often consulted to help develop new and effective
    policies to improve health and wellness.
--  New directors elected at recent AGM: At Acasti's Annual and Special
    Meeting of Shareholders in August 2017, Richard P. Schottenfeld and
    Katherine Crewe were elected as new directors of Acasti. Mr.
    Schottenfeld and Ms. Crewe have extensive investment and pharmaceutical
    industry expertise, respectively, complementing the existing members of
    the Acasti board.

Second Quarter and Year-to-Date FY 2018 Financial Results(1):

--  Net loss for the quarter ended September 30, 2017 was $4.5 million or
    $0.31 loss per share, compared to a net loss of $2.3 million or $0.22
    loss per share for the quarter ended August 31, 2016. The higher net
    loss was primarily due to the increase in both research and development
    expenses (R&D) and general and administrative (G&A) expenses and an
    increase in net financial expenses driven primarily by interest expense
    and the transition of a foreign exchange gain in the prior period to a
    foreign exchange loss in the current period. The net loss for the six
    months ended September 30, 2017 was $7.3 million or $0.49 loss per
    share, compared to a net loss of $5.5 million or $0.51 loss per share
    for the six months ended August 31, 2016, also driven by increased R&D
    and G&A expenses.
--  R&D expenses were $3.3 million for the quarter ended September 30, 2017,
    up from $1.6 million in the quarter ended August 31, 2016. The $1.7
    million increase was primarily attributable to a $0.9 million increase
    in research contracts combined with a $0.6 million increase in
    professional fees to execute on Acasti's clinical development strategy.
    The increased research contract expense primarily resulted from
    activities associated with Acasti's clinical research organization and
    contract manufacturing partners to prepare for the Phase 3 clinical
    program. R&D expenses were $5.3 million for the six months ended
    September 30, 2017, up from $4.0 million in the six months ended August
    31, 2016, resulting primarily from increased professional fees combined
    with expenses related to the expansion of Acasti's full-time R&D
    leadership.
--  G&A expenses were $1.0 million for the quarter ended September 30, 2017,
    up from $0.9 million for the quarter ended August 31, 2016. The net
    increase was mainly attributable to $0.1 million in professional
    expenses to support public company activities and filings. G&A expenses
    were $1.9 million for the six months ended September 30, 2017, up from
    $1.4 million for the six months ended August 31, 2016. The $0.5 million
    increase was primarily attributable to increased professional and legal
    fees and an increase in expenses related to the added full-time
    executive and accounting staff.
--  Cash flows - As previously disclosed, with cash and cash equivalents of
    $5.3 million as of September 30, 2017, if Acasti does not raise
    additional funds, there exists a material uncertainty that casts
    substantial doubt about the company's ability to continue as a going
    concern and therefore realize its assets and discharge its liabilities
    in the normal course of business. Management has a reasonable
    expectation that the company should be able to raise additional funds in
    the third quarter to help finance the advancement of its CaPre Phase 3
    program.



( 1 The interim unaudited financial statements and the MD&A for the quarter
)   ended September 30, 2017 are available on SEDAR at http://www.sedar.com/
    on EDGAR at http://www.sec.gov/edgar.shtml and on the investor section
    of Acasti's website at http://www.acastipharma.com/

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 allows for better absorption 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 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; and Acasti's ability to fund its continued operations.

The forward-looking statements contained in this press 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 report on Form 20-F and most recent management's discussion and analysis (MD&A), which 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. 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 20-F and most recent MD&A.

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.

Contacts:
Acasti Contact:
Jan D'Alvise
Chief Executive Officer
450-686-4555
[e-mail]
www.acastipharma.com

Media Contact:
Jessica Dyas
Canale Communications
619-849-5385
[e-mail]

Investor Relations Contact:
Glen Akselrod
Bristol Capital Ltd.
[phone] ext 10
[e-mail]