Planned Enrollment targets achieved in both
TRILOGY studies with over 74% of patients randomized at more than
150 clinical sites
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 third
quarter ended December 31, 2018. All amounts are in Canadian
dollars.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “We continue to make rapid progess on our
TRILOGY Phase 3 trials, and based on current trends we remain on
track to report topline results by the end of this year.
Importantly, we achieved our enrollment targets in December 2018,
however additional patients will continue to be enrolled through
the first calendar quarter of 2019 to attain final randomization
targets as needed. We now have more than 74% of patients
randomized at more than 150 clinical sites across the U.S., Canada,
and Mexico. Following our recent capital raises in the U.S. and
Canada, as of December 31, 2018 we have over $45.6 million of cash
on hand, and based on management’s projections, we are funded
beyond completion of our Phase 3 trials, including funding to
initiate work on our New Drug Application (NDA) assuming our Phase
3 is successful, as well as expanded business and US commercial
launch activities.”
“I am also pleased to report we recently
announced a Certificate for a European Patent has been issued by
the European Patent Office that is valid until 2030. This patent
contains broad claims, and is in addition to our 20 plus patents
allowed in major countries around the rest of the world, which
provide us with equivalent claims and strong protection in each of
our key markets. We believe that CaPre’s proprietary and patented
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. As a result, CaPre does not require a fatty
meal to improve bioavailability and absorption unlike currently
marketed prescription omega-3s, which we believe would allow
patients taking CaPre to remain on their physician recommended low
fat diet and still get full efficacy benefit. The phospholipids in
CaPre may not only help to improve the absorption, distribution,
and metabolism of omega-3s, but could also decrease the synthesis
of LDL-C in the liver, impede cholesterol absorption, and stimulate
lipid secretion from bile. Given these combined benefits, we
believe the combination of EPA, DHA and phospholipids in CaPre’s
composition contribute to CaPre’s potential “trifecta effect,” by:
(a) lowering triglycerides; (b) reducing non-high-density
lipoprotein cholesterol (non-HDL-C) levels including LDL-C (“bad
cholesterol”); and (c) increasing high-density lipoprotein
cholesterol (HDL-C) (“good cholesterol”), as demonstrated at the
therapeutic dose of 4 grams/day in our Phase 2 studies. In
addition, patients in our Phase 2 studies showed a significant
reduction of HbA1c, indicating that CaPre, again due to its unique
omega-3/phospholipid composition, may improve long-term glucose
metabolism. As a result, we remain confident CaPre has the
potential to become the best-in-class omega-3 for the treatment of
severe hypertriglyceridemia (blood levels above 500 mg/dL).”
Recent Developments:
- 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
CDN$1.28 per Common Share for gross proceeds to the Company of
$27.6 million (US$ 21.3 million) generating net proceeds to the
Company of approximately $25.4 million (US$ 19.6 million).
- On January 9, 2019, the Company announced a
Certificate for a European Patent had been issued by the European
Patent Office. The granted patent is valid until 2030 and relates
to a concentrated phospholipid composition and method of using the
same for modulating blood lipids. This patent was validated in
Belgium, Switzerland, Germany, Denmark, Spain, Finland, France,
United Kingdom, Italy, Netherlands, Norway, Portugal and
Sweden.
- As of February 12, 2019, more
than 74% of the required total patients for the two studies have
been randomized, and more than 24% of patients who had previously
been randomized in the TRILOGY program have already completed their
6 month treatment plans. This progress further supports
management’s confidence in announcing topline results before
the end of calendar 2019.
Third Quarter Fiscal
2019 Financial
Results:
- Loss from operating activities for the third
quarter ended December 31, 2018 was $10.7 million, compared to a
loss from operating activities of $5.2 million for the quarter
ended December 31, 2017. The approximately $5.5 million increase
was related to the planned research and development expenses
(“R&D”) for the TRILOGY Phase 3 program.
- Net loss for the third quarter ended December
31, 2018 was $4.6 million or $0.07 per share, compared to a net
loss of $6.1 million or $0.40 per share for the quarter ended
December 31, 2017. The lower net loss of $1.5 million was primarily
due to a $7.0 million increase in financial income due mostly to a
gain related to the reduction in value of the warrant derivative
liability offset primarily from the $5.3 million increase in
planned R&D expenses.
- R&D expenses were $9.6 million for the
quarter ended December 31, 2018, up from $4.3 million in the
quarter ended December 31, 2017. The $5.3 million increase was
primarily attributable to a $5.8 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 $1.2
million for the quarter ended December 31, 2018, compared to $0.9
million for the quarter ended December 31, 2017. The net increase
was mainly due to the expansion of the administrative staff and
business development and US commercial launch activities.
- Cash flows – Cash and cash equivalents of
$28.9 million and marketable securities of $16.7 million totaled
$45.6 million as December 31, 2018 increased by $37.4 million
compared to the quarter ended December 31, 2017. The increase was
generated from gross proceeds from the May 2018 underwritten public
offering in Canada and the two October public offerings with the
full exercise of the overallotment options 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 public
offerings, together with existing cash, will fully fund the
Company’s operations beyond the completion of our Phase 3 clinical
trials. Acasti will need to raise additional capital in the future
to complete the funding of its NDA preparations, and US commercial
launch 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,
Thursday, February 14, 2019 at 1:00 PM Eastern Time to discuss the
Company’s financial results for the fiscal third quarter ended
December 31, 2018, as well as the Company’s corporate progress and
other developments.
The conference call will be available via
telephone by dialing toll free 866-682-6100 for U.S. callers or +1
862-298-0702 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 May 14, 2019. A
telephone replay of the call will be available approximately one
hour following the call, through February 28, 2019, 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:
42051.
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
hypertrigyceridemia (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.
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 https://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.comwww.acastipharma.com
Investor Contact:Crescendo Communications,
LLCTel: 212-671-1020Email: ACST@crescendo-ir.com
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