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 (triglyceride blood levels from 500
mg/dL to 1500 mg/dL), today provided a business update and
announced its operating and financial results for the second
quarter of fiscal 2020 ended September 30, 2019. All amounts are in
Canadian dollars.
Corporate highlights:
- On track to report topline results for TRILOGY 1 in December
2019 and TRILOGY 2 in January 2020
- More than 90% of randomized patients have completed the
studies
- Data clean-up for TRILOGY 1 is 95% completed
- Plan to present full data set including results for key
secondary and exploratory endpoints of interest such as non-HDL-C,
LDL-C, VLDL, HDL-C and HbA1c at important scientific meetings
beginning in the first quarter of 2020
- Approximately $25.8 million of cash and cash equivalents as at
September 30, 2019; fully funded beyond completion of Phase 3
studies
- Awarded $750,000 in grants from the Government of Canada
- Partnered with Aker BioMarine to provide supply of raw krill
oil to support product launch and commercialization
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “We continue on track to announce our Phase 3
TRILOGY 1 topline results in December 2019 and TRILOGY 2 topline
results in January 2020. We eagerly await the completion of the
results from our two TRILOGY clinical studies for a number of
reasons, including: (a) the large patient population in our Phase 2
trials (675 patients) demonstrated both a significant reduction of
triglycerides and also indicated that CaPre may have a positive
effect on other major lipid markers such as VLDL, LDL-C, and HDL-C
(“Trifecta Effect”), as well as HbA1c in patients with diabetes;
(b) patients enrolled in our Phase 3 trials have higher baseline
triglyceride levels (above 500 mg/dl) versus our Phase 2 studies,
where most had baseline triglycerides significantly below 500
mg/dl; and (c) a favorable dose response was reported in the Phase
2 studies, in which patients received a range of doses (1 gram, 2
grams and 4 grams per day for only 8 to 12 weeks), which we believe
bodes well for our Phase 3 trials, in which all patients randomized
to CaPre received 4 grams per day and will remain on drug for 6
months.”
“Assuming our TRILOGY trials replicate our Phase
2 data, we believe CaPre has the potential to become a
best-in-class omega-3, due to both the Trifecta Effect and greater
bioavailability, especially in patients that follow the standard
physician-recommended, restricted low-fat diet. We believe these
benefits are due to our unique composition of phospholipids, EPA
and DHA as compared to "esterified" pharmaceutical omega-3s derived
from fish oils. Additionally, in all studies conducted to date,
CaPre has shown no negative side effects or safety concerns.”
“We are also ramping up our commercialization
efforts. Most recently, we announced a supply agreement with Aker
BioMarine to provide raw krill oil (RKO) to Acasti, under a
two-year, fixed price supply agreement, which we believe will
ensure an adequate raw material supply to meet our anticipated
needs through at least mid-2021, including scale-up of production
to build future inventory for anticipated commercial launch. At the
same time, we are in active discussions with a number of pharma
companies regarding potential commercialization partnerships in
several countries around the world, and we look forward to
providing further updates if and when developments unfold.”
Both TRILOGY trials have achieved 100% patient
randomization and more than 90% of the patients have now completed
their 6-month plan. As a result, the “last patient, last visit” in
the TRILOGY 1 study remains on track to take place in November with
topline results expected in December 2019 and the “last patient,
last visit” in the TRILOGY 2 study remains on track to take place
in early January with topline results expected towards the end of
January 2020. 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 TRILOGY studies are designed to provide at least 90%
statistical power to detect a difference of at least a 20%
reduction from baseline in TGs between CaPre and placebo. As
previously disclosed, 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,
and has been shown to not interfere with statin absorption and
efficacy.
The Company has shared the statistical analysis
plan (SAP) for the analysis and reporting of the TRILOGY results
with the FDA and will finalize the SAP prior to final database lock
of TRILOGY 1, which Acasti expects to occur shortly. Subject to any
input from the FDA, Acasti currently intends to report topline
TRILOGY results independently for each study as Acasti receives
results and these topline 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. According to
the protocol, physician investigators were to determine 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 at baseline 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
only. 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 Acasti’s
preliminary topline data, the Company will seek to present the full
data set, which will include results for the Company’s key
secondary and exploratory endpoints of interest such as LDL-C,
VLDL, HDL-C and HbA1c at important scientific meetings in the first
half of 2020. The Company will communicate more information in
the weeks ahead on how and when all of the TRILOGY results will be
reported once the SAP is finalized.
Assuming TRILOGY results are positive, the
Company intends to file an NDA by mid-2020 to obtain regulatory
approval for CaPre in the United States, initially for the
treatment of severe HTG. Acasti may pursue the opportunity to
expand CaPre’s indication to the treatment of patients with high
TGs (200 – 500 mg/dl), but this would likely require the completion
of at least one additional clinical study. Acasti continues to plan
for the potential launch of CaPre in the U.S. by the second half of
2021. The Company also continues to strengthen its patent portfolio
along with other intellectual property rights as a part of its
commercialization strategy.
At September 30, 2019, Acasti had $25.8 million
of cash, cash equivalents and marketable securities, including
approximately $8.7 million in proceeds received from the recent
exercise of warrants since July 1, 2019, which funds the Company
beyond completion of the Phase 3 trials. This capital will fund
continued work on the NDA, as well as expanded business and US
commercial launch activities. Furthermore, the Company recently
announced receiving an award for $750,000 in non-dilutive and
non-repayable funding from the National Research Council of Canada
Industrial Research Assistance Program (NRC IRAP). The Company
intends to apply the funding towards the research and development
of Acasti’s exclusive commercial production platform for CaPre.
With the Government funding, recent exercise of warrants and cash
on hand, the Company is sufficiently funded until June 2020 based
on management’s current projections.
Recent Developments:
- On August 9, 2019, Acasti announced that the
Company participated on a lipid panel entitled “Lipids: Moving
Beyond Statins: Omega 3s, Bempedoic, and More,” moderated by Harold
Bays MD, a key opinion leader within the space during the 2019 BTIG
Biotechnology Conference.
- On September 9, 2019, Acasti announced that
the Company was awarded $750,000 in non-dilutive and non-repayable
funding, as well as technical and business advisory services, from
the National Research Council of Canada Industrial Research
Assistance Program (NRC IRAP) to apply towards research and
development of the Company’s unique commercial production platform
for CaPre. With NRC IRAP support, Acasti aims to further expand and
enhance its production capabilities for CaPre.
- On September 30, 2019, Acasti announced that
100% of the required total patients for the two Phase 3 studies had
been randomized, and nearly 80% of the patients in both studies
combined had completed their 6-month plans.
- On September 30, Acasti made the determination
that the Company will migrate from reporting in IFRS to US GAAP
effective beginning with Q4, FY 2020 (March 31, 2020 year-end)
reports – see the Company’s most recent management’s discussion and
analysis under the heading “Upcoming Changes in IFRS / Foreign
Private Issuer Status”.
- On November 4, 2019, Acasti announced that it
had signed a two-year, fixed price supply agreement with Aker
BioMarine for raw krill oil (RKO), the starting material for the
production of CaPre.
- On November 7, Acasti announced the
publication of a CaPre pharmacokinetics study entitled, “Evaluation
of OM3-PL/FFA Pharmacokinetics After Single and Multiple Oral Doses
in Healthy Volunteers” in a leading peer-reviewed journal, Clinical
Therapeutics. The study showed that the bioavailability of
CaPre did not appear to be meaningfully affected by the fat content
of the meal consumed before dose administration.
Second Quarter
Fiscal 2020 Financial
Results:
- Loss from operating activities for the second
quarter ended September 30, 2019 was $8.7 million, compared to a
loss from operating activities of $10.4 million for the quarter
ended September 30, 2018. The decrease was due in part to a
reduction in research contract expenses as the Phase 3 clinical
program is getting closer to completions.
- Net loss for the quarter ended was $28.3
million or ($0.34) per share, compared to a net loss of $22.7
million or ($0.62) per share for the quarter ended September 30,
2018. The higher net loss was primarily due to the non-cash
financial loss of $19.7 million for the three months ended
September 30, 2019, due mostly to the change in fair value of the
warrant derivative liability partially offset by a decrease in the
number of warrants.
- R&D expenses before depreciation,
amortization and stock-based compensation expenses were $4.3
million for the quarter ended September 30, 2019, compared to $8.4
million for the three months ended September 30, 2018. The $4.1
million decrease was mainly attributable to a $4.6 million decrease
in research contracts. The lower research contract expense is
attributed primarily to the Phase 3 clinical trial program getting
closer to completion.
- General and Administrative expenses before
stock-based compensation expenses were $1.5 million for the three
months ended September 30, 2019, an increase of $.6 million from
$.89 million for the three months ended September 30, 2018. This
increase was mainly attributable to a $.18 million increase
associated with the Company’s Directors and Officers insurance
policy, as well as an increase of $.3 million in corporate,
accounting and legal fees.
- Sales and Marketing expenses before
stock-based compensation expenses were $.88 million for the three
months ended September 30, 2019, compared to $.13 million for the
three months ended September 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 $25.8 million as of September 30,
2019, compared to $5.99 million for the quarter ended September 30,
2018. The increase was mainly generated by the net proceeds from
the Public Offerings and the recent exercise of warrants. 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, November 13, 2019 at 1:00 PM Eastern Time to discuss the
Company’s financial results for the second quarter ended September
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 February 13,
2020. A telephone replay of the call will be available
approximately one hour following the call, through November 27,
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: 56770.
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.comwww.acastipharma.com
Investor
Contact:Crescendo
Communications, LLCTel: 212-671-1020Email:
ACST@crescendo-ir.com
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