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), today provided a business update
and announced its financial results for the fiscal year ending
March 31, 2019. All amounts are in Canadian dollars.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “Fiscal 2019 was an eventful year for the
Company as we achieved several key milestones related to our
ongoing Phase 3 clinical trials, which remain on schedule and
within budget. We recently announced that we had achieved 100%
patient randomization in both TRILOGY clinical studies, and more
than 60% of patients have now completed the trial. As a result, we
remain on track to report topline results for our primary endpoint
of lowering triglycerides for TRILOGY 1 in December 2019, and for
TRILOGY 2 in January 2020. In addition to our preliminary topline
data, we will seek to present the full data set, which will include
results for our key secondary and exploratory endpoints of interest
such as LDL-C, VLDL, HDL-C and HbA1c, as a late breaker
presentation at the American College of Cardiology meeting at the
end of March 2020.”
The Company had $34.4 million of cash, cash
equivalents and marketable securities as of March 31, 2019. With
clinical activities now decelerating, management believes Acasti is
sufficiently capitalized beyond completion of the Phase 3 trials.
This includes funding to continue work on the New Drug Application
(NDA) for CaPre, which management plans to submit to the FDA
mid-2020, assuming Phase 3 is successful, as well as on-going
business and US commercial launch activities. Discussions continued
in Q4 with a number of major pharma companies for commercialization
partnerships in key countries around the globe, and management
expects those discussions to gain momentum next year after Phase 3
results are announced, assuming positive results. Management
is also exploring a variety of strategic and non-dilutive funding
options to further extend the Company’s current cash runway.
Jan D’Alvise continued, “Given the positive
results we saw from our Phase 2 trials in a total of 675 patients,
we eagerly await the completion of the results from our two TRILOGY
clinical studies. It is important to note some key differences that
we believe have optimized the design of our TRILOGY studies
compared to our Phase 2 studies. The approximately 500 severe HTG
patients enrolled in our TRILOGY Phase 3 clinical studies all have
much higher baseline triglyceride levels (above 500 mg/dl) versus
our Phase 2 studies, where most had baseline triglycerides
significantly below 500 mg/dl. Typically, the higher the baseline
level, the greater the potential for lowering triglycerides with a
therapeutic omega-3. Furthermore, patients randomized to CaPre in
TRILOGY will receive 4 grams per day and remain on drug for 6
months, while our phase 2 studies included patients receiving a
range of doses from 1 gram, 2 grams and 4 grams per day for only 8
to 12 weeks. We generally saw a dose response in these Phase
2 studies, where the higher the CaPre dose, the greater the
triglyceride reduction. All of these factors give us further
confidence that CaPre has the potential to meet or exceed the
target primary endpoint of reducing triglycerides by 20% compared
to placebo. Given that our two Phase 3 protocols are very similar
in design, this will also enable us to combine data from both
studies to further explore the efficacy of CaPre in a variety of
important patient subgroups, which we hope will further validate
what we refer to as the “Trifecta Effect” that we saw in Phase
2. In addition to hypertriglyceridemia, data from Acasti’s
Phase 2 studies indicated that CaPre may have a positive effect on
other major lipid markers such as VLDL, LDL-C, and HDL-C, diabetes
and other inflammatory diseases, and this is being further explored
in the TRILOGY Phase 3 program. Based on the results, Acasti
may also seek to identify new potential indications for CaPre that
may be appropriate for future studies and claim expansion.”
The CaPre bioavailability bridging study was
recently published in a leading peer reviewed journal, which
illustrated the superior absorption of CaPre compared to LOVAZA, an
omega-3 ethyl ester. Since patients with severe HTG should adhere
to a low-fat diet, these findings suggest preserved exposure and
perhaps retained efficacy, in patients taking CaPre. As a result,
management believes that CaPre has the potential to become the
best-in-class omega-3 for the treatment of severe HTG.
Based on recent third-party outcome data,
management also believes the potential exists to expand CaPre’s
initial indication to the roughly 70 million patients with elevated
triglycerides in the mild to moderate range (e.g. 150 – 499 mg/dl),
although this would likely require at least one additional
study.
Throughout the year, the Company also continued
to expand the IP portfolio for CaPre. In May 2019, Notices of
Allowance for additional patents were received for both composition
of matter and method of use from the Mexican, Chilean and Israeli
Patent Offices. This follows broad composition-of-matter and method
of use claims that were awarded by the European Patent Office
earlier this year. In addition, Acasti just received Notice of
Allowance for its second Chinese patent, which has broadened our
existing claims by covering a composition containing 50-70%
phospholipids. The granting of these additional patents provides
long-term protection of Acasti’s products in important markets,
which management believes will support ongoing global partnering
and licensing activities.
Recent Developments:
- 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.
- On February 21, 2019, the Company announced it
had been recognized by the TSX Venture Exchange in its “2019
Venture 50,” a ranking of the strongest companies on TSX Venture
Exchange by share price, trading volume and market
capitalization.
- On April 1, 2019, the Company announced the
publication of the CaPre bioavailability study in the March 2019
issue of Journal of Clinical Therapeutics, a leading peer-reviewed
journal in the field of clinical pharmacology and therapeutics.
Acasti’s open-label, randomized, four-way, cross-over,
bioavailability study compared CaPre, given as a single dose of 4
grams in fasting and fed states, with the approved
hypertriglyceridemia drug LOVAZA (omega-3-acid ethyl esters or
OM3-EE) in 56 healthy volunteers. Among subjects in the fasting
state, CaPre demonstrated better bioavailability than LOVAZA, as
measured by blood levels of EPA and DHA.
- On April 1, 2019, the Company announced it had
reached 100% of the required total randomized patients for TRILOGY
1 with no severe adverse events associated with CaPre and a lower
drop-out rate than anticipated.
- On May 15, 2019, the Company announced that it
has received Notices of Allowance for both composition of matter
and method of use patents by the Mexican, Chilean and the Israeli
Patent Offices. The granted patents are valid until 2030 and relate
to a concentrated phospholipid composition and method of using the
same for modulating blood lipids.
- On June 3, 2019, the Company announced that
its TRILOGY 2 trial achieved 100% patient randomization. The
fact that both studies have reached full randomization means that
the “last patient, last visit” in the TRILOGY 1 trial is on track
to take place in November, and the “last patient, last visit” in
the TRILOGY 2 trial is on track to take place in December. It is
then anticipated to take approximately 1 month for data clean-up
prior to moving to database lock. Once the database is
locked, the Company expects topline results for TRILOGY 1 to be
released in December 2019 and TRILOGY 2 to be released in January
2020.
- On June 24, 2019, the Company announced that
it has received Notice of Allowance from the Chinese Patent Office
for a new patent covering both composition of matter and methods of
using the same for modulating blood lipids. This is the
second patent to be allowed in China, and both patents are
valid until 2030.
Annual FY 2019 Financial Results:
- Net loss for the year ended March 31, 2019 was
$51.6 million or $0.95 per share, compared to a net loss of $21.5
million or $1.23 per share for the year ended March 31, 2018. The
higher net loss was primarily due to the $24 million of planned
increase in research and development expenses (“R&D”) for the
TRILOGY Phase 3 program and $6 million in non-cash, financial
expenses related to increased value of the warrant derivative
liability.
- R&D expenses were $38.4 million for the
year ended March 31, 2019, up from $15.7 million for the year ended
March 31, 2018. The $22.7 million increase was primarily
attributable to a $22.5 million rise in clinical research
contracts. The increased contract research expense primarily
resulted from Phase 3 CRO contract expenses and research contracts
from the planned scale-up of CaPre manufacturing activities for the
year ended March 31, 2019.
- General and Administrative (“G&A”)
expenses were $6.6 million for the year ended March 31,
2019, up from $4.0 million for the year ended March 31, 2018. The
$2.6 million net increase was primarily attributable to $1.0
million in compensation expense paid in shares as a legal
settlement to the former CEO, with the remainder due to increased
professional and legal fees, an increase in salaries and benefits
related to the added full-time business development and
commercialization staff, and pre-launch market development
activities.
- Cash flows. As at March 31, 2019, Acasti had
total cash of $34.4 million, an increase of $26.2 million over last
year, due to net proceeds from the May and October public
offerings, partially offset by the cash used in operating
activities. Acasti believes that the current cash on hand will
fully fund the Company’s operations beyond the completion of the
Phase 3 clinical trials for CaPre. Acasti will need to raise
additional capital in the future to complete the funding of its NDA
preparations and US commercial launch activities, which could be in
the form of dilutive and/or non-dilutive financings. 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.
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 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.
Investor Conference Call
The Company will host a conference call at 1:00
PM Eastern Time today, Wednesday, June 26, 2019, to discuss the
Company’s financial results for the fourth quarter and year-ended
March 31, 2019, 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 September 26,
2019. A telephone replay of the call will be available
approximately one hour following the call, through July 10, 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:
49452.
About Acasti PharmaAcasti
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. Acasti
Pharma 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 Pharma
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 Pharma’s
strategy is to commercialize CaPre in the U.S. and Acasti Pharma is
pursuing development and distribution partnerships to market CaPre
in major countries around the world. For more information, visit
www.acastipharma.com.
Forward Looking
StatementsStatements 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” 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); CaPre’s potential to meet or exceed the
target primary endpoint of reducing triglycerides by 20% compared
to placebo, 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
U.S. Contact:Crescendo Communications,
LLCTel: 212-671-1020Email: ACST@crescendo-ir.com
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