Acasti Announces Court Dismissal of Stockholder Litigation
September 30 2022 - 9:00AM
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.
About Acasti
Acasti is a late-stage, specialty pharma company
advancing three clinical stage drug candidates addressing rare and
orphan diseases. Acasti’s novel drug delivery technologies have the
potential to improve the performance of currently marketed drugs by
achieving faster onset of action, enhanced efficacy, reduced side
effects, and more convenient drug delivery—all which could help to
increase treatment compliance and improve patient outcomes.
Acasti’s three lead clinical assets have each
been granted Orphan Drug Designation by the FDA, which provides the
assets with seven years of marketing exclusivity post-launch in the
United States and have additional intellectual property protection
with over 40 granted and pending patents. Acasti’s lead clinical
assets target underserved orphan diseases: (i) GTX-104, an
intravenous infusion targeting Subarachnoid Hemorrhage (SAH), a
rare and life-threatening medical emergency in which bleeding
occurs over the surface of the brain in the subarachnoid space
between the brain and skull; (ii) GTX-102, an oral mucosal spray
targeting Ataxia-telangiectasia (A-T), a progressive,
neurodegenerative genetic disease that primarily affects children,
causing severe disability, and for which no treatment currently
exists; and (iii) GTX-101, a topical spray targeting Postherpetic
Neuralgia (PHN), a persistent and often debilitating neuropathic
pain caused by nerve damage from the varicella zoster virus
(shingles), which may persist for months and even years. For more
information, please visit: https://www.acastipharma.com/en.
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. Private
Securities Litigation Reform Act of 1995, as amended,
Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as
amended, and “forward-looking information” within the meaning of
Canadian securities laws (collectively, “forward-looking
statements”). 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 containing the terms “believes,” “belief,”
“expects,” “intends,” “anticipates,” “estimates”, “potential,”
“should,” “may,” “will,” “plans,” “continue”, “targeted” or other
similar expressions 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 in this press
release are based upon Acasti’s current expectations and involve
assumptions that may never materialize or may prove to be
incorrect. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties,
including, without limitation: (i) the success and timing of
regulatory submissions of the planned Phase 3 safety study for
GTX-104 and Acasti’s other pre-clinical and clinical trials for
GTX-102 and GTX-101; (ii) regulatory requirements or developments
and the outcome of meetings with the FDA; (iii) changes to clinical
trial designs and regulatory pathways; (iv) legislative,
regulatory, political and economic developments; (v) actual costs
associated with Acasti’s clinical trials as compared to
management’s current expectations; and (vi) the effects of COVID-19
on clinical programs and business operations. The foregoing list of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors detailed in documents that
have been and may be filed by Acasti from time to time with the
Securities and Exchange Commission and Canadian securities
regulators. All forward-looking statements contained in this press
release speak only as of the date on which they were made.
Acasti undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
applicable securities laws. Neither NASDAQ, the TSXV nor its
Regulation Services Provider (as that term is defined in the
policies of the TSXV) accepts responsibility for the adequacy or
accuracy of this release.
For more information, please contact:
Acasti
Contact:
Jan D’AlviseChief Executive OfficerTel: 450-686-4555Email:
info@acastipharma.com www.acastipharma.com
Investor
Relations:
Robert BlumLytham Partners, LLCTel:
602-889-9700ACST@lythampartners.com
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