Acasti Pharma Provides Update Following Acquisition of Grace Therapeutics and Regains Compliance with Nasdaq Listing Standards
22 September 2021 - 10:30PM
Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and
TSX-V: ACST), today provided a business update and announced that
the Nasdaq Stock Market (“Nasdaq”) has confirmed to Acasti that the
Company has regained compliance with Nasdaq’s minimum bid price
requirement.
Jan D’Alvise, President and Chief Executive
Officer of Acasti Pharma, commented, “We are pleased to have
regained compliance with the listing requirements for Nasdaq, and
are laser focused on the integration of Grace Therapeutics, which
is progressing seamlessly. We could not be more excited by the
outlook for the business and are working aggressively to advance
our clinical pipeline of late-stage drug candidates focused on rare
diseases that address significant markets with unmet medical needs.
We believe our approach of customizing the formulation of marketed
drugs in new ways—backed by more than 40 granted and patents
pending in various jurisdictions—significantly de-risks our
clinical programs. Specifically, these drug candidates are designed
to achieve faster onset of action, enhanced efficacy, reduced side
effects, and more convenient drug delivery. Our confidence is
further reinforced by the fact that all three of our lead programs
have received Orphan Drug Designation from the U.S. Food & Drug
Administration, which offers a number of regulatory, cost and
timing benefits. We look forward to providing continual updates on
our clinical and regulatory progress in the weeks and months
ahead.”
About Acasti
Acasti is a late-stage specialty pharma company
with drug delivery capability and technologies 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 provide the
assets with seven years of marketing exclusivity post-launch in the
United States and protection by over 40 granted and pending
patents. The lead 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 impacts children
causing severe disability, 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 information” within the meaning of Canadian
securities laws and “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
(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 labelled with the terms “believes,” “belief,” “expects,”
“intends,” “anticipates,” “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.
These forward-looking statements 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 and pre-clinical and clinical
trials; (ii) regulatory requirements or developments; (iii) changes
to clinical trial designs and regulatory pathways; (iv)
legislative, regulatory, political and economic developments, and
(v) the effects of COVID-19 on clinical programs and business
operations. The foregoing review 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 SEC. 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.
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.
Acasti Contact:Jan D’AlviseChief Executive
Officer Tel: 450-686-4555Email:
info@acastipharma.comwww.acastipharma.com
Investor Contact:Crescendo
Communications, LLC Tel: 212-671-1020Email:
ACST@crescendo-ir.com
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