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 first quarter
of fiscal 2020 ended June 30, 2019. All amounts are in Canadian
dollars.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “Our TRILOGY Phase 3 trials in patients with
severe hypertriglyceridemia (triglyceride blood levels from 500
mg/dL to 1500 mg/dL) continue to progress, and we remain on track
to report topline TRILOGY 1 results in December 2019, and topline
TRILOGY 2 results in January 2020. Importantly, both of our TRILOGY
studies have achieved 100% patient randomization, and 68% of the
patients have now completed their 6-month plan. Topline results
will include a readout of the primary endpoint, which is intended
to show CaPre’s overall impact on lowering triglycerides (TGs)
after 12 weeks compared to placebo. The placebo used in the TRILOGY
trials is cornstarch, which is inert, and consequently is expected
to have a neutral effect on key biomarkers of patients in the
placebo group. The TRILOGY studies are designed to provide at least
90% statistical power to detect a difference of at least a 20%
decrease from baseline in TGs between CaPre and placebo. We have
shared the statistical analysis plan (SAP) for the analysis and
reporting of the TRILOGY results with the FDA, and will finalize it
prior to final database lock. Subject to any input from the FDA,
Acasti is currently planning that the topline TRILOGY results will
include the primary endpoint of TG reduction at Week 12 compared to
placebo. Safety and tolerability (e.g. overall adverse events (AE)
and serious AE rate, any discontinuation due to AEs, and AEs of
special interest such as gastrointestinal events) will also be
reported.”
The Company currently expects that topline
results will not include any secondary or exploratory endpoints.
The important secondary and exploratory endpoint results are
expected to follow shortly after the release of the topline results
of TRILOGY 2, currently anticipated in late January 2020. According
to the SAP, the primary endpoint must first be positive with
statistical significance prior to analyzing the secondary and
exploratory endpoints. These endpoints will then be analyzed in the
following order: 1) additional TG secondary endpoints, including TG
reduction at Week 26, which is intended to show CaPre’s persistence
of effect, TG reduction in various subgroups to show consistency of
effect (such as patients stratified with baseline qualifying TG
levels of ≤750 mg/dL vs. >750 mg/dL), and a comparison of TG
reduction in patients using and not using statins at baseline; 2)
Non-HDL-C; 3) VLDL-C; 4) HDL-C; 5) LDL-C and HbA1c. Physician
investigators determined if patients with high LDL-C and/or high
HbA1c levels at screening should be put on standard therapy, and if
so, they were stabilized prior to being randomized into TRILOGY.
Results for both LDL-C and HbA1c will then require subgroup
analyses, which are done by combining diabetic patients and
separately patients with high LDL-C from both studies to reach
adequate statistical power to detect a difference if one exists,
and therefore potentially show any incremental benefit of CaPre
above and beyond the standard of care. Acasti expects that the
remaining secondary and exploratory endpoints along with various
additional subgroup analyses should be completed before the end of
March 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 at key scientific meetings in the
first half of 2020. The Company will communicate more
information in the months ahead on how and when all of the TRILOGY
results will be reported once the SAP is finalized.
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. These trials showed not only a significant
reduction of triglycerides, but also indicated that CaPre may have
a positive effect on other major lipid markers such as VLDL, LDL-C,
and HDL-C, as well as HbA1c in patients with diabetes. As
previously disclosed, we believe our Phase 3 trial is well designed
to meet our primary endpoint due to the fact the patients enrolled
have higher baseline triglyceride levels (above 500 mg/dl) versus
our Phase 2 studies, where most had baseline triglycerides
significantly below 500 mg/dl. Additionally, the patients
randomized to CaPre in TRILOGY all received 4 grams per day and
will 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, which is important
given the favorable dose response we saw in our Phase 2 studies.
Assuming our TRILOGY trials replicate our Phase 2 data, we believe
CaPre has the potential to provide an attractive alternative to
current therapies, and thus improve the lives of the millions of
patients with cardiometabolic disease. Finally, we continue to
expand our patent estate in more key jurisdictions, and believe we
have built a highly defensible IP portfolio covering all of the
important markets.”
At June 30, 2019, Acasti had $25.4 million of
cash, cash equivalents and marketable securities, which funds the
Company beyond completion of our Phase 3 trials, including funding
to initiate work on the NDA, assuming the TRILOGY Phase 3 program
is successful, as well as expanded business and US commercial
launch activities. In addition, the Company reported that
approximately $8.1 million in proceeds had been received from the
recent exercise of warrants since July 1, 2019, which further
extends the runway through June of 2020.
Recent Developments:
- On April 1, 2019, the Company announced the
publication of a CaPre® bioavailability study, entitled “A
Single-dose, Comparative Bioavailability Study of a Formulation
Containing OM3 as Phospholipid (PL) and Free Fatty Acid (FFA) to an
Ethyl Ester (EE) Formulation in the Fasting and Fed States,” which
was published in the March 2019 issue of Journal of Clinical
Therapeutics (Clinical Therapeutics 41 (2019) pp. 426-444), a
leading peer-reviewed journal in the field of clinical pharmacology
and therapeutics. The study found that among subjects within the
fasting state, CaPre® demonstrated greater bioavailability of EPA
and DHA as compared to "esterified" pharmaceutical omega-3s derived
from fish oils. CaPre’s superior absorption profile could represent
a significant clinical advantage, since taking it with a low-fat
meal represents a healthier and more realistic regimen for patients
with HTG who must follow a restricted low-fat diet.
- On April 15, 2019, the Company announced that
its two on-going Phase 3 TRILOGY trials (TRILOGY 1 and TRILOGY 2)
have exceeded a combined 89% patient randomization, and more than
40% of the patients in both trials have completed their 6-month
treatment plan. This means that the “last patient in” to the
TRILOGY 1 trial, will complete the trial by November. With the
expected approximate 1 month of data clean-up following the “last
patient out”, topline results for TRILOGY 1 are expected in
December.
- 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 4, 2019, the Company
announced that its TRILOGY 2 trial studying CaPre in patients with
severe hypertriglyceridemia achieved 100% patient
randomization. Additionally, the Company announced that its
two on-going Phase 3 TRILOGY trials (TRILOGY 1 and TRILOGY 2)
exceeded the target of a combined 500 randomized patients, and more
than 60% of the patients in both trials had already completed their
6-month treatment plan.
- On June 24, 2019, the Company announced that
it has received a Notice of Allowance for its second patent to be
awarded in the People’s Republic of China. This new patent
expands the Company’s existing claims and is valid until
2030. This patent also covers methods for the treatment and
prevention of cardiovascular diseases, metabolic syndrome,
inflammation, neurodevelopmental and neurodegenerative
diseases.
First Quarter
Fiscal 2020 Financial
Results:
- Loss from operating activities for the first
quarter ended June 30, 2019 was $10.6 million, compared to a loss
from operating activities of $9.9 million for the quarter ended
June 30, 2018. The approximately $0.7 million increase was related
to an increased level of spending to support US market development
and commercial prelaunch activities, and increase in insurance
expense offset by the planned deceleration of clinical Phase 3
program.
- Net loss for the first quarter ended June 30,
2019 was $11.8 million or $0.15 per share, compared to a net loss
of $7.4 million or $0.23 per share for the quarter ended June 30,
2018. The higher net loss of $4.3 million was primarily due to a
$1.1 million financial loss during the quarter ended June 30, 2019,
as compared to a financial gain of $2.5 million for the quarter
ended June 30, 2018. Financial loss was due mostly to the change in
fair value of the warrant derivative liability, which was a
non-cash item, partially offset by a decrease in financing fees.
Also contributing to the net loss was the formation of the
commercial leadership team during the second quarter of fiscal year
2019 to support expanded business and market development
activities, additional administrative fees incurred in connection
with the implementation of a new ERP system, increased insurance
costs and accounting and legal fees.
- R&D expenses before depreciation,
amortization and stock-based compensation expense were $7.4 million
for the quarter ended June 30, 2019, down from $8.1 million in the
quarter ended June 30, 2018. The $0.7 million decrease was
primarily attributable to a $0.6 million decrease in clinical
research contracts and $0.2 million decrease in legal fees for
contracting and due diligence, partially offset by an increase in
salaries and benefits of $0.1 million due to higher headcount. The
lower research contract expense is primarily attributed to the
advancement of the Phase 3 clinical trial program, as it nears
completion.
- General and Administrative expenses before
stock-based compensation expense were $1.3 million for the quarter
ended June 30, 2019, compared to $0.9 million for the quarter ended
June 30, 2018. The net increase was mainly due to a $0.2 million
rise in expenses associated with increased insurance expense, which
also increased our insurance expense, as well increased legal fees
and salaries and benefits due to higher headcount.
- Sales and Marketing expenses before
stock-based compensation expense were $0.9 million for the three
months ended June 30, 2019 compared to nil for the three months
ended June 30, 2018. This increase funded additional
headcount and marketing expenses for expanded business and market
development activities.
- Cash flows – Cash and cash equivalents and
marketable securities totaled $25.4 million as of June 30, 2019,
which decreased by $9.0 million compared to March 31, 2019. The
decrease was primarily due to the Company’s cash used in operating
activities of $9.2 million. As stated above, Acasti believes
that existing cash plus the recent exercise of warrants will fully
fund the Company’s operations beyond the completion of our Phase 3
clinical trials through at least June of 2020. Acasti will need to
raise additional capital in the future to complete the funding of
the preparation and filing of our NDA, 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,
Wednesday, August 14, 2019 at 1:00 PM Eastern Time to discuss the
Company’s financial results for the first quarter ended June 30,
2019, as well as the Company’s corporate progress and other
developments.
The conference call will be available via
telephone by dialing toll free 844-369-8770 for U.S. callers or +1
862-298-0840 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 November 14,
2019. A telephone replay of the call will be available
approximately one hour following the call, through August 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:
52892.
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.
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, 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
Investor
Contact:
Crescendo Communications, LLCTel:
212-671-1020Email: ACST@crescendo-ir.com
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