Reports over $52 million of cash-on-hand with
Company now fully funded beyond completion of the TRILOGY Phase 3
studies
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, today provided a business update and
announced its operating and financial results for the fiscal second
quarter ended September 30, 2018. All amounts are in Canadian
dollars.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “Following our recent capital raises in the U.S.
and Canada, I am pleased to report as of November 1, we had over
$52 million of cash on hand. Based on management’s current
projections, we are now fully funded to complete our TRILOGY Phase
3 studies. This capital will also enable us to initiate work on our
New Drug Application (NDA) assuming our Phase 3 is successful. It
will also fund expanded business development activities, and allow
us to initiate several important prelaunch marketing programs in
the U.S.”
Acasti’s two TRILOGY Phase 3 studies remain on
track to complete enrollment this year. As of October 31, 2018,
TRILOGY had surpassed 90% enrollment with greater than >50% of
patients randomized at more than 150 clinical sites across the
U.S., Canada, and Mexico. The Company continues to project that the
studies will be completed on schedule in the second half of
calendar 2019, with topline results targeted to report before the
end of calendar 2019.
The recent results of Amarin’s REDUCE-IT outcome
trial demonstrated a meaningful reduction in major adverse CV
events (MACE) in the patient population treated with Vascepa as
compared to placebo. Acasti believes that these results further
validate the importance of therapeutic omega-3 (OM3) products for
patients with elevated triglycerides (TGs), and together with Astra
Zeneca’s pending STRENGTH trial, could hold the potential to expand
the addressable market to the roughly 36 million patients with high
triglycerides (blood levels between 200 – 499 mg/dL)1.
”We remain confident that CaPre has the
potential to become the best-in-class OM3 for the treatment of
severe hypertriglyceridemia (blood levels above 500 mg/dL) based on
the data from our earlier trials, and we are currently seeking to
replicate and expand on this data in our TRILOGY Phase 3 program,”
further commented Ms. D’Alvise. “An important differentiator of
CaPre versus other therapeutic OM3 products is that unlike our
competitors, CaPre does not require a fatty meal to improve
bioavailability and absorption. We believe that CaPre’s proprietary
formulation combining both EPA and DHA, delivered as a mixture of
free fatty acids and bound to phospholipids, makes them more
readily absorbed by the body. Consequently, we believe patients
taking CaPre can remain on their physician recommended low fat diet
and still get full efficacy benefit. Furthermore, we believe it is
the combination of EPA, DHA and phospholipids in CaPre’s
composition that is responsible for CaPre’s “trifecta effect”. In
our prior studies, CaPre showed a significant reduction of
triglycerides (TG) and non-high-density lipoprotein cholesterol
(non-HDL-C) levels in the blood of patients with mild to severe
HTG, and showed no safety concerns. Unlike other OM3 therapeutic
products, CaPre also showed the potential to reduce LDL-C (“bad
cholesterol”). We believe that the phospholipids in CaPre not only
help to improve the absorption, distribution, and metabolism of
OM3s, but could also decrease the synthesis of LDL-C in the liver,
impede cholesterol absorption, and stimulate lipid secretion from
bile. CaPre has also shown the potential to increase high-density
lipoprotein cholesterol (HDL-C), at the therapeutic dose of 4
grams/day in our Phase 2 studies. Furthermore, patients in our
Phase 2 studies showed a significant reduction of HbA1c, indicating
that CaPre, again due to its unique OM3/phospholipid composition,
may improve long-term glucose metabolism.”
Recent Developments:
- On September 24, 2018, the Company announced that Mr.
Jean-François Boily was appointed as the Vice President of Finance
and Mrs. Linda O’Keefe, the Company’s former Chief Financial
Officer, announced her retirement.
- On October 11, 2018, the Company announced the closing of its
underwritten public offering in the United States of 19,090,000
Common Shares (which includes the exercise in full by the
underwriters of their over-allotment option to purchase 2,490,000
additional Common Shares, at the same public offering price of
US$1.00 per Common Share for gross proceeds to the Company of $24.7
million (US$19.1 million) generating net proceeds to the Company of
approximately $22.5 million (US$17.4 million).
- On October 23, 2018, the Company announced the closing of its
underwritten public offering in Canada of 21,562,000 Common Shares
(which includes the exercise in full by the underwriters of their
over-allotment option to purchase 2,812,500 additional Common
Shares), at the same public offering price of $1.28 per Common
Share for gross proceeds to the Company of $27.6 million generating
net proceeds to the Company of approximately $25.4 million. Based
on management’s current projections, Acasti believes that the total
of approximately $47.9 million in net proceeds from the two October
2018 public offerings, together with existing cash, will fully fund
the Company’s operations beyond the completion of our Phase 3
clinical trials.
Second Quarter
2019 Financial
Results:
- Loss from operating activities for the second
quarter ended September 30, 2018 was $10.4 million, compared to a
loss from operating activities of $4.4 million for the quarter
ended September 30, 2017, which was primarily due to the planned
increase of approximately $6.0 million related to research and
development expenses (“R&D”) for the TRILOGY Phase 3
program.
- Net loss for the second quarter ended
September 30, 2018 was $22.7 million or $0.62 per share, compared
to a net loss of $4.5 million or $0.31 per share for the quarter
ended September 30, 2017. The higher net loss of $18.2 million was
primarily due, in addition to the $6.0 million R&D above, to
$12.2 million in non-cash financial expenses due mostly to an
increase in loss related to the change in fair value of the
derivative warrant liabilities.
- R&D expenses were $9.1 million for the
quarter ended September 30, 2018, up from $3.3 million in the
quarter ended September 30, 2017. The $5.8 million increase was
primarily attributable to a $6.4 million increase in clinical
research contracts offset mainly by a decrease in other
professional fees. The increased contract research expense
primarily resulted from the planned patient enrollment and
randomization activities combined with the contract manufacturing
production activities to support the Phase 3 clinical program.
- General and Administrative expenses were $1.3
million for the quarter ended September 30, 2018, compared to $1.0
million for the quarter ended September 30, 2017. The net increase
was mainly attributable to the expansion of business development
and pre-commercialization activities and a $0.1 million increase in
stock based compensation expenses.
- Cash flows – Cash and cash equivalents totaled
$6.0 million as of September 30, 2018 increased by $0.6 million
compared to the quarter ended September 30, 2017. The increase was
generated from gross proceeds from the May 2018 underwritten public
offering in Canada with the full exercise of the overallotment
option offset with the cash used in operating activities. Based on
management’s current projections, and as stated above, Acasti
believes that the total of approximately $47.9 million in net
proceeds from the two October 2018 public offerings, together with
existing cash, will fully fund the Company’s operations beyond the
completion of our Phase 3 clinical trials. Acasti may need to raise
additional capital in the future to complete the funding of its NDA
preparations, and pre-commercialization activities. If Acasti does
not raise additional funds, it may not be able to realize its
assets and discharge its liabilities in the normal course of
business. As a result, there exists a material uncertainty about
the Acasti’s ability to continue as a going concern and to realize
its assets and discharge its liabilities in the normal course of
business.
Conference Call
Acasti will host a conference call today,
Wednesday, November 14, 2018 at 11:00 AM Eastern Time to discuss
the Company’s financial results for the second quarter ended
September 30, 2018, as well as the Company’s corporate progress and
other developments.
The conference call will be available via
telephone by dialing toll free 877-407-8031 for U.S. callers or +1
201-689-8031 for international callers, or on the Company’s News
and Investors section of the website:
https://www.acastipharma.com/investors/.
A webcast replay will be available on the
Company’s News and Investors section of the website
(https://www.acastipharma.com/investors/) through February 14,
2019. A telephone replay of the call will be available
approximately one hour following the call, through November 28,
2018, and can be accessed by dialing 877-481-4010 for U.S. callers
or +1 919-882-2331 for international callers and entering
conference ID: 39708.
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.
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.
Acasti’s CaPre Phase 3 program is currently underway.
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. 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 addressable market
may expand significantly if omega-3s demonstrate long-term
cardiovascular benefits in on-going third party outcomes studies.
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, 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.
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
1 The American Heart Association Scientific Statement on
Triglycerides and Cardiovascular Disease, 2011
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