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) (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 third quarter
of fiscal 2020 ended December 31, 2019. All amounts are in Canadian
dollars.
Corporate highlights:
- Reported topline results in January
for the TRILOGY 1 Phase 3 Trial of CaPre:
- 30.5% and 36.7% reduction in triglyceride levels, compared with
baseline, among patients receiving CaPre at 12 and 26 weeks
respectively, as well as 42.2% reduction in triglyceride levels
among patients receiving CaPre while on background statin therapy
at 12 weeks
- Despite meaningful triglyceride lowering in the CaPre arm, the
study did not reach statistical significance due to unusually large
placebo effect
- No treatment-related serious adverse events were reported in
the trial
- Audits and additional post-hoc data analyses are underway into
the unexpected and inconsistent findings that may have negatively
impacted the results reported in TRILOGY 1
- Acasti now plans to seek FDA guidance prior to unblinding
TRILOGY 2 data, which is expected to delay reporting of TRILOGY 2
topline results until calendar Q3, 2020
- Released preliminary new data in a
diet-induced obesity animal model with preliminary, statistically
significant findings showing that CaPre may promote insulin
secretion, and showing a significant increase in plasma levels of
17S-HDHA and PDX as compared to metformin and icosapent ethyl
- Approximately $25.7 million of cash
and cash equivalents as at December 31, 2019; fully funded through
December 2020 based on current projections.
Jan D’Alvise, president and CEO of Acasti
Pharma, commented, “We are making steady progress with the audit of
TRILOGY 1 data and additional post-hoc analyses. This data has been
very informative, and provided we have the FDA’s support, any
learnings we can take from this investigation that may allow us to
adjust the Statistical Analysis Plan (SAP) for TRILOGY 2, gives us
a better chance of accurately reflecting the clinical value that we
see in CaPre. As previously noted, we have confirmed that there is
established precedent for the FDA accepting post-hoc analyses of
study results, assuming the analyses are transparent, well
justified and well supported. We are moving as quickly as possible
now to complete this work and secure a meeting with the FDA. Until
we have that important meeting, we intend to keep TRILOGY 2
blinded. Consequently, we now anticipate the unblinding of the
topline results for TRILOGY 2 sometime in calendar Q3 of 2020, to
allow time for the FDA meeting. Accordingly, key secondary and
exploratory endpoints from both TRILOGY 1 and TRILOGY 2 studies,
would now be expected after the unblinding of TRILOGY 2 results. We
are moving as quickly as possible and will provide material updates
when available.”
On January 13, 2020 the Company announced
preliminary topline results for the primary endpoint (triglyceride
reduction at 12 and 26 weeks) from our Phase 3 TRILOGY 1 trial for
CaPre. Acasti reported a 30.5% median reduction in triglyceride
(TG) levels among all patients receiving CaPre, compared to a 27.5%
median reduction in triglyceride levels among patients receiving
placebo at 12 weeks. The Company also reported a 42.2% median
reduction in TGs among patients receiving CaPre while on background
statin therapy at 12 weeks, compared to a 31.5% median reduction in
TG levels among patients receiving placebo and on background statin
therapy. In addition, the Company reported a 36.7% median reduction
in TG levels among patients receiving CaPre at 26 weeks (end of the
study), compared to a 28.0% median reduction in TG levels among
patients receiving placebo. Both the placebo and CaPre study groups
experienced significant reductions in TGs within the first four
weeks from baseline, and even though the difference at 12 and 26
weeks was in favor of CaPre, due to the unexpectedly large placebo
response, TRILOGY 1 did not reach statistical significance. The
safety profile of CaPre in TRILOGY 1 was similar to placebo, as
there was no significant difference in treatment-related serious
adverse events in the trial.
The observed reductions in TG levels in the
placebo group were far greater than that seen in any previous
triglyceride lowering trial with a prescription omega-3. The
placebo used in the TRILOGY trials is simple cornstarch, which is a
complex carbohydrate with a low glycemic index, and consequently
would be expected to have a neutral effect on key biomarkers of
patients in the placebo group. In similar previously conducted
triglyceride lowering trials involving prescription omega-3
preparations, the placebo responses (using corn oil, olive oil, or
vegetable oil) ranged from a change of +16% to -17% across 18
interventions arms, with 14 of 18 arms ranging between +10% to
-10%. The Company noted that 5 sites out of the total 54 enrolling
sites disproportionately contributed to this unusually high placebo
response. These sites accounted for about 36% of the 242 patients
enrolled in the TRILOGY 1 study. By comparison, TRILOGY 2 was
conducted at 71 sites in Canada, Mexico and the United States with
a total of 278 patients enrolled. The 5 sites that are a focus of
the TRILOGY 1 investigation also participated in TRILOGY 2, however
these sites accounted for only about 12% of the total patients,
with the majority of these patients coming from only 3 sites.
Despite monitoring activities conducted
throughout the TRILOGY 1 trial to ensure adherence to the protocol
and identify protocol violations, the Company has subsequently
identified some unexpected and inconsistent findings that it
believes may have negatively contributed to the overall topline
results. These findings are now being further explored via a
comprehensive and rigorous review of data and patient medical
records by an independent team of auditors. To support this effort,
the Company, its independent Clinical Research Organization (CRO)
that conducted the TRILOGY studies, its principal investigator Dr.
Mozaffarian, and other clinical and regulatory advisors, are
conducting a thorough review of all data and records from patients
taking both CaPre and placebo. This assessment is well underway,
and the Company has also determined that a thorough investigation
of the data must be completed and reviewed with the FDA, before the
Company can report the findings from TRILOGY 1 and the implications
for TRILOGY 2.
Consequently, the Company intends to request a
meeting with the FDA to discuss the TRILOGY 1 data, and will seek
their guidance about how to conduct the analysis of the TRILOGY 2
data prior to unblinding TRILOGY 2. The Company continues to remain
blinded to the TRILOGY 2 data. Upon submission of the meeting
request, which is expected to be sent to the FDA in calendar Q2,
2020, the FDA will have 75 days to respond and schedule a
meeting.
Given the need to complete the audit and review
of the TRILOGY 1 data, and obtain FDA feedback, the Company now
anticipates the unblinding of the topline results for TRILOGY 2
sometime in calendar Q3 of 2020. Acasti will provide further
guidance as to the timing of reporting TRILOGY 2 data based on
progress of the audits and feedback from the FDA. Accordingly, key
secondary and exploratory endpoints from both TRILOGY 1 and TRILOGY
2 studies, would now be expected as soon as possible after the
unblinding of TRILOGY 2 results.
If the interpretation of the analyses produced
as an outcome of the TRILOGY 1 audits and post-hoc data review are
supported by the FDA, and if TRILOGY 2 achieves statistical
significance, Acasti believes it may still have a viable path
forward to file an NDA for CaPre.
At December 31, 2019, Acasti had $25.7 million
of cash, cash equivalents and marketable securities. This capital
is expected to also fund the ongoing study investigations, as well
as continued work on the NDA. With the Government funding, capital
raised through the established at-the-market program (ATM) during
Q3, recent exercise of warrants and cash on hand, the Company is
sufficiently funded through December 2020, based on management’s
current projections.
Recent Developments:
- On September 9,
2019, Acasti announced that the Corporation was awarded up
to $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 eligible research and development
disbursements of the Corporation’s unique commercial production
platform for CaPre.
- On September 30,
2019, Acasti announced that 100% of the required total
patients for its 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,
2019, Acasti made the determination that the Corporation
will migrate from reporting in IFRS to US GAAP effective beginning
with Q4, FY’20 (March 31, 2020 year-end) reports.
- On November 4,
2019, Acasti announced that it had partnered with Aker
BioMarine to deliver raw krill oil (RKO) to Acasti, under a
two-year, fixed price supply agreement.
- On November 7,
2019, 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.
- On November 18,
2019, Acasti released preliminary new animal study data
which provides additional insights into CaPre’s potential mechanism
of action in diabetes. The preliminary findings obtained for the
diabetes mouse study showed that CaPre may promote insulin
secretion as seen by statistically significant results produced in
a standard glucose challenge test, thus suggesting a mechanism of
action different and unique when compared to metformin, which does
not promote insulin secretion.
- On November 26,
2019, Acasti announced that the last patient completed
their final visit in the Corporation's TRILOGY 1 Phase 3 trial of
CaPre.
- On December 23,
2019, Acasti provided an update on the expected delay of
topline results into January 2020 for the Corporation's TRILOGY 1
Phase 3 trial of CaPre. The delay was caused by gaps in the data
when the dataset was transferred from the Central laboratory to the
CRO data management group. When this problem was identified by the
CRO data management group, it triggered an immediate hold on the
data transfer to the CRO statistical group, and initiated a full
quality review by the CRO of the processes and procedures involved
at the central testing laboratory. This review was completed in
early January 2020, and topline results for TRILOGY 1 were
subsequently released on January 13, 2020. A more comprehensive
audit of the central laboratory is currently ongoing.
- On December 18,
2019, Acasti incorporated a new wholly owned subsidiary
named Acasti Innovation AG (“AIAG”) under the laws of Switzerland
for the purpose of future development of the Corporation’s
intellectual property and global distribution of its products. AIAG
currently does not have any operations.
- On January 9,
2020, Acasti announced that the last patient completed
their final visit in Acasti's TRILOGY 2 Phase 3 trial of
CaPre.
- On January 13,
2020, Acasti reported topline results for TRILOGY 1,
which, despite showing a meaningful reduction of TGs in the CaPre
arm, did not reach statistical significance due to an unusually
large placebo effect.
- On February 10,
2020, Acasti provided an update on its TRILOGY 1 and
TRILOGY 2 Phase 3 Trials of CaPre. This announcement disclosed that
a full investigation was being conducted, including specific site
audits, and a full audit of the central testing laboratory involved
its TRILOGY 1 Phase 3 trial for CaPre. It also announced that once
the full analysis of TRILOGY 1 is completed, that the Company would
request a meeting with the FDA to discuss the data and seek
guidance on how to modify the statistical analysis plan (SAP) for
TRILOGY 2 before unblinding the results. This important decision
will push out the reporting of TRILOGY 2 results until calendar Q3
of 2020.
Third Quarter
Fiscal 2020 Financial
Results:
- Loss from operating
activities for the third quarter ended December 31, 2019
was $7.9 million, compared to a loss from operating activities of
$10.7 million for the quarter ended December 31, 2018. The decrease
was due mainly to a reduction in research contract expenses as the
Phase 3 clinical program is getting closer to
completion.
- Net loss for the
quarter ended was $15.7 million or ($0.18) per share, compared to a
net loss of $4.6 million or ($0.07) per share for the quarter ended
December 31, 2018. The higher net loss was primarily due to the
non-cash financial loss of $7.9 million for the three months ended
December 31, 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 $4.2 million for the quarter ended December 31, 2019,
compared to $8.8 million for the three months ended December 31,
2018. The $4.6 million decrease was mainly attributable to a $5.6
million decrease in research contracts. The lower research contract
expense is primarily attributed to the Phase 3 clinical trial
program getting closer to completion.
- General and Administrative
expenses before stock-based compensation expenses were
$1.6 million for the three months ended December 31, 2019, an
increase of $.8 million from $.76 million for the three months
ended December 31, 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 $.5 million in
corporate, accounting and legal fees.
- Sales and Marketing
expenses before stock-based compensation expenses were
$.74 million for the three months ended December 31, 2019, compared
to $.13 million for the three months ended December 31, 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 $25.7
million as of December 31, 2019, compared to $28.9 million for the
quarter ended December 31, 2018. The decrease was mainly generated
by the operating loss partially offset by the net proceeds from the
sale of shares through the established ATM program and the recent
exercise of warrants. As stated above, Acasti believes that
existing cash will fully fund the Company’s operations through at
least December of 2020. Acasti projects that additional funds will
be needed in the future, for activities necessary to prepare for
commercial launch, including the scale up of our manufacturing
operations, the completion of the potential regulatory (NDA)
submission package (assuming positive Phase 3 clinical results),
and the expansion of business development 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.
ATM Update
Acasti also provided an update on recent
distributions under its previously adopted ATM program, as required
pursuant to the policies of the TSX Venture Exchange. Since the
last distributions under the ATM program reported on December 23,
2019, Acasti issued an aggregate of 1,355,798 common shares of the
Company (the “ATM Shares”) over the NASDAQ Stock Market for
aggregate gross proceeds to the Company of US$1.4 million. The ATM
Shares were sold at prevailing market prices which ranged from
US$2.02 per share to US$0.85 per share. No securities were sold
through the facilities of the TSX Venture Exchange or, to the
knowledge of the Company, in Canada. The ATM Shares were sold
pursuant to a U.S. registration statement on Form F-3 (No.
333-223464) as made effective on March 16, 2018, as well as an
at-the-market issuance sales agreement dated February 14, 2019
among Acasti and B. Riley FBR, Inc.
Conference
Call
Acasti will host a conference call today,
Friday, February 14, 2020 at 1:00 PM Eastern Time to discuss the
Company’s financial results for the third quarter ended December
31, 2019, as well as an update on the TRILOGY 1 and TRILOGY 2 Phase
3 trials of CaPre.
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 May 14, 2020. A
telephone replay of the call will be available approximately one
hour following the call, through February 21, 2020, 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:
33138.
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, as noted above.
About Acasti Pharma
Acasti Pharma is a biopharmaceutical innovator
advancing a potentially best-in-class cardiovascular drug, CaPre,
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 potential exists to expand
the treatable market in the United States to the approximately 50
million people with TGs above 150 mg/dl, given the recent FDA
approval of expanded labeling for VASCEPA based on the recent
positive REDUCE-IT outcome study results. 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 to fund its continued operations,
CaPre’s potential to meet or exceed the target primary endpoint of
reducing triglycerides by 20% compared to placebo, Acasti’s ability
to report topline results for TRILOGY 2 within the contemplated
timing as well as Acasti’s ability to report key secondary and
exploratory endpoints from both TRILOGY studies within the
contemplated timing, and Acasti’s ability to file an NDA based on
the TRILOGY studies.
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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