Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST –
TSX-V: 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 (HTG) (triglyceride blood levels from
500 mg/dL to 1500 mg/dL), today announced that on February 28,
2020, it received written notification from the Nasdaq Listing
Qualifications Department (“Nasdaq”) for failing to maintain a
minimum bid price of U.S.$1.00 per share for the last 30
consecutive business days, as required by Nasdaq Listing Rule
5550(a)(2) – bid price (the “Minimum Bid Price Rule”).
The Nasdaq notification has no immediate effect
on the listing of Acasti Pharma’s shares. Under Nasdaq Listing Rule
5810(c)(3)(A) – compliance period, Acasti Pharma has 180 calendar
days, or until August 26, 2020, to regain compliance. If at any
time over this period the bid price of Acasti Pharma’s shares
closes at U.S.$1.00 per share or more for a minimum of ten (10)
consecutive business days, Nasdaq will provide written confirmation
of compliance and the matter will be closed.
If Acasti Pharma does not regain compliance
within the initial 180-day period, but otherwise meets the
continued listing requirements for market value of publicly-held
shares and all other initial listing standards for the Nasdaq
Listing Rule 5505 – Capital Market criteria, except for the Minimum
Bid Price Rule, Acasti Pharma may be eligible for an additional 180
calendar days to regain compliance. If Acasti Pharma is not granted
additional time, then its shares will be subject to delisting, at
which time Acasti Pharma may appeal the delisting determination to
a Nasdaq Hearings Panel.
Acasti Pharma intends to evaluate all available
options to resolve the deficiency and regain compliance with the
Minimum Bid Price Rule.
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, which allows for better absorption into the body.
Acasti believes that EPA and DHA are more efficiently transported
by phospholipids sourced from krill oil than the EPA and DHA
contained in fish oil that are transported either by triglycerides
(as in dietary supplements) or as ethyl esters in other
prescription omega-3 drugs, which must then undergo additional
digestion before they are ready for transport in the bloodstream.
Clinically, the phospholipids may not only improve the absorption,
distribution, and metabolism of omega-3s, but they may also
decrease the synthesis of LDL cholesterol in the liver, impede or
block cholesterol absorption, and stimulate lipid secretion from
bile. In two Phase 2 studies, CaPre achieved a statistically
significant reduction of triglycerides and non-HDL cholesterol
levels in patients across the dyslipidemia spectrum from patients
with mild to moderate hypertriglyceridemia (patients with TG blood
levels between 200mg/dl and 500mg/dl) to patients with severe
hypertriglyceridemia (those with TG levels above 500mg/dl).
Furthermore, in the Phase 2 studies, CaPre demonstrated the
potential to actually reduce LDL, or “bad cholesterol”, as well as
the potential to increase HDL, or “good cholesterol”, especially at
the therapeutic dose of 4 grams/day. The Phase 2 data also showed a
significant reduction of HbA1c at a 4-gram dose, suggesting that
due to its unique omega-3/phospholipid composition, CaPre may
actually improve long-term glucose metabolism. Acasti’s TRILOGY
Phase 3 program is currently underway, as noted above.
About Acasti Pharma
Acasti Pharma is a biopharmaceutical innovator
advancing a potentially best-in-class cardiovascular drug, CaPre,
for the treatment of hypertriglyceridemia, a chronic condition
affecting an estimated one third of the U.S. population. 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. The
company is developing CaPre in a Phase 3 clinical program in
patients with severe hypertriglyceridemia, a market that includes 3
to 4 million patients in the U.S. The potential exists to expand
the treatable market in the United States to the approximately 50
million people with TGs above 150 mg/dl, given the recent FDA
approval of expanded labeling for VASCEPA based on the recent
positive REDUCE-IT outcome study results. Acasti may need to
conduct at least one additional clinical trial to support FDA
approval of a supplemental New Drug Application to expand CaPre’s
indications to this segment. Acasti’s strategy is to commercialize
CaPre in the U.S. and the company is pursuing development and
distribution partnerships to market CaPre in major countries around
the world. 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 information” within the meaning of Canadian
securities laws and “forward-looking statements” within the meaning
of U.S. federal 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 labeled 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.
Forward-looking statements in this press release include, but are
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 licensing negotiations; CaPre’s
potential to become the “best-in-class” cardiovascular drug for
treating severe Hypertriglyceridemia (HTG), Acasti’s ability to
commercially launch CaPre and to fund its continued operations,
CaPre’s potential to meet or exceed the target primary endpoint of
reducing triglycerides by 20% compared to placebo, Acasti’s ability
to report topline results for TRILOGY 2 within the contemplated
timing as well as Acasti’s ability to report key secondary and
exploratory endpoints from both TRILOGY studies within the
contemplated timing, and Acasti’s ability to file an NDA based on
the TRILOGY studies.
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.
Acasti Contact:Jan
D’AlviseChief Executive OfficerTel: 450-686-4555Email:
info@acastipharma.com www.acastipharma.com
Investor
Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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