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 (sHTG) (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 first quarter
of fiscal 2021 ended June 30, 2020.
Corporate Highlights:
- Finalized and submitted TRILOGY 2 Statistical Analyses Plan
(“SAP”) to the FDA on July 31, 2020
- Provided business update, on June 29, 2020, in which the
Company identified “Triglyceride Normalization” phenomenon prior to
patient randomization and treatment as likely contributor to
unusually high placebo effect in TRILOGY 1; post-hoc analyses
revealed a rapid, significant and sustained reduction in TG levels
between screening (during qualification) and the time of patient
randomization (prior to patients starting on either drug or
placebo); meaningful efficacy trend for CaPre was observed after
correcting for the unexpectedly large placebo response in the
original analysis
- Received a Notice of Allowance for second composition of matter
patent to be awarded by the Canadian Intellectual Property Office,
expanding the Company’s existing claims to include any composition
containing EPA and DHA, where at least 50% of the composition
consists of phospholipids.
- Received a notice of issuance of a composition of matter patent
to be awarded by the Intellectual Property Office in Hong Kong
granting claims for any composition containing EPA and DHA, where
at least 50% of the composition consists of phospholipids
- TRILOGY 2 topline results expected on or about August 31,
2020
- Update on the timing for reporting the key secondary and
exploratory endpoints from both TRILOGY 1 and TRILOGY 2 trials, and
pooled results from both studies, will be provided after TRILOGY 2
results are reported
As previously reported, the Company, along with
the academic Principal Investigator (PI) of the study, Dariush
Mozaffarian M.D., Dr.P.H., and external clinical and statistical
experts, conducted rigorous post-hoc analysis of TRILOGY 1 data.
These analyses revealed a rapid, significant and sustained
reduction in TG levels between screening (during qualification) and
the time of patient randomization (prior to patients starting on
either drug or placebo), which Acasti refers to as
“Pre-randomization Triglyceride (TG) Normalization.” This
artefactual phenomenon affected both treatment groups, but was much
greater in the placebo group, resulting in the large placebo effect
and significant underestimation of the post-randomization treatment
effect of the active drug, CaPre. The post-hoc analyses of
the primary endpoint using a revised, single point baseline value
from Week 0 (Visit 4) corrected for a significant amount of the
pre-randomization TG reduction in subjects that were most affected
by the normalization phenomenon, and a meaningful efficacy trend
for CaPre was observed.
The Company provided all of the TRILOGY 1
background information and accompanying data to the U.S. Food and
Drug Administration (FDA) in a Type C briefing package, which was
filed on April 29, 2020. As previously disclosed, the FDA provided
Acasti with a written response to the Company’s Type C Meeting
request and briefing package, and confirmed that pivotal efficacy
analyses for TRILOGY 2 will be performed on the full Intent to
Treat (ITT) population, as contemplated in the original Statistical
Analysis Plan (SAP), and they supported the conduct of post-hoc
analyses in TRILOGY 1 for exploratory purposes.
After reviewing feedback from the FDA and from
key experts including Dr. Mozaffarian, Acasti finalized the SAP for
TRILOGY 2, and submitted it to the FDA on July 31, 2020. The
Company remains blinded to the TRILOGY 2 data, and remains on track
to report topline TG data on or about August 31, 2020. An
update on the timing for reporting the key secondary and
exploratory endpoints from both the TRILOGY 1 and TRILOGY 2 trials,
as well as pooled results from both studies, will be provided after
TRILOGY 2 results are reported.
Jan D’Alvise, President and CEO of Acasti,
commented, “With the TRILOGY 2 SAP finalized and now submitted to
the FDA, we continue to advance the process towards unblinding of
our TRILOGY 2 clinical data. We believe if TRILOGY 2 can achieve
statistical significance, and if the pooled efficacy results with
TRILOGY 1 using the Intent to Treat population also reaches
significance, we can proceed with our Pre-NDA meeting where we
intend to discuss with the FDA the use of this data to support an
NDA filing. We look forward to the unblinding of TRILOGY 2 data and
reporting our findings, concurrent with a conference call update on
or about August 31, 2020.”
As of June 30, 2020, Acasti had cash and cash
equivalents totaling $12.1 million, compared to $16.0 million as of
June 30, 2019. The Company believes it is sufficiently funded
through the first calendar quarter of 2021, based on management’s
current projections.
First Quarter of Fiscal 2021 Financial
Results (US dollars):
The consolidated financial statements have been
prepared in accordance with generally accepted accounting
principles in the United States of America (“U.S. GAAP”).
- Loss from operations for the three months
ended June 30, 2020 was $4.1 million, compared to a loss from
operations of $8.0 million for the three months ended June 30,
2019. The decrease was due mainly to a reduction in research
contract expenses as the Phase 3 clinical program for CaPre was
nearing completion.
- Net loss for the three months ended June 30,
2020 was $4.7 million or $0.05 per share, compared to a net loss of
$8.8 million or $0.11 per share for the three months ended June 30,
2019. The decreased net loss is primarily due to the reduction of
research and development expenses as the Phase 3 clinical program
for CaPre was nearing completion, lower net financial expenses, and
the change in fair value of the warrants derivative
liabilities.
- R&D expenses before depreciation,
amortization and stock-based compensation expenses were $1.1
million for the three months ended June 30, 2020, compared to $5.5
million for the three months ended June 30, 2019. The net decrease
was mainly attributable to a reduction in research contract expense
due to the advancement of the Phase 3 clinical trial program, as it
moved closer to completion.
- General and Administrative expenses before
stock-based compensation expenses were $1.3 million for the three
months ended June 30, 2020, an increase of $0.33 million from $0.97
million for the three months ended June 30, 2019. This increase was
mainly attributable to consulting, accounting, and legal fees in
connection with the conversion from IFRS to U.S. GAAP.
- Sales and Marketing expenses before
stock-based compensation expenses were $0.57 million for the three
months ended June 30, 2020, compared to $0.68 million for the three
months ended June 30, 2019. The decrease was mostly due to a
reduction in professional fees as a result of a slowdown in
pre-launch marketing activities pending the results of the TRILOGY
Phase 3 clinical studies are obtained. The decrease was partially
offset by an increase in salaries and benefits as a result of
increased headcount in the commercial team to support expanded
business and market development activities.
- Cash and cash equivalents totaled $12.1
million as of June 30, 2020, compared to $16.0 million at June 30,
2019. As stated above, Acasti believes that current cash will fully
fund the Company’s operations through the first calendar quarter of
2021. Acasti projects that additional funds will be needed in the
future for activities necessary to prepare for the commercial
launch of CaPre if regulatory approval is received, including the
scale-up of its manufacturing operations, the completion of the
potential regulatory NDA submission package (assuming positive
Phase 3 clinical results), and the expansion of business
development and U.S. commercial launch activities. The Company is
working towards development of strategic partner relationships, as
well as actively seeking additional non-dilutive funds in the near
future, but there can be no assurance as to when or whether Acasti
will complete any strategic collaborations or non-dilutive
financings. If the Company does not raise additional funds or find
one or more strategic partners, it may not be able to realize its
assets and discharge its liabilities in the normal course of
business. As a result, there exists substantial doubt about the
Company’s ability to continue as a going concern, and therefore,
realize its assets and discharge its liabilities in the normal
course of business.
Conference
Call
Acasti plans to host a conference call on or
about August 31, 2020 to discuss the TRILOGY 2 topline results, as
well as to provide an update on the timing for the reporting of the
secondary and exploratory endpoints, and the pooled results from
both TRILOGY studies. Details for the call will be provided as we
get closer to announcing TRILOGY 2
results.
ATM Update
On June 29, 2020, Acasti entered into an amended
and restated ATM sales agreement (the “Sales Agreement”) with B.
Riley FBR Inc., Oppenheimer & Co. Inc. and H.C. Wainwright
& Co., LLC (collectively, the “Agents”), to implement an
“at-the-market” equity offering program under which Acasti may
issue and sell from time to time our common shares having an
aggregate offering price of up to $75 million through the Agents
(the “ATM Program”). Pursuant to the ATM Program, as required
pursuant to the policies of the TSX Venture Exchange (“TSXV”),
since the last distributions reported on June 29, 2020, Acasti
issued an aggregate of 4,404,152 common shares (the “ATM Shares”)
over the NASDAQ Stock Market for aggregate gross proceeds to the
Company of $3.5 million. The ATM Shares were sold at prevailing
market prices averaging $0.80 per share. No securities were sold
through the facilities of the TSXV or, to the knowledge of the
Company, in Canada. The ATM Shares were sold pursuant to a U.S.
registration statement on Form S-3 (No. 333-239538) as made
effective on July 7, 2020, as well as the Sales Agreement. Pursuant
to the Sales Agreement, a cash commission of 3.0% on the aggregate
gross proceeds raised was paid to the Agents in connection with
their services.
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
Acasti 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 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;
CaPre’s potential to become the “best-in-class” cardiovascular drug
for treating severe Hypertriglyceridemia; the timing and outcome of
the unblinding of TRILOGY 2; the impact of the “Pre-Randomization
Triglyceride Normalization” phenomenon on TRILOGY 2; and Acasti’s
ability to file an NDA based on the results of its TRILOGY Phase 3
program.
The forward-looking statements contained in this
press release are expressly qualified in their entirety by this
cautionary statement, the “Special Note Regarding Forward-Looking
Statements” section contained in Acasti’s latest annual report on
Form 10-K and quarterly report on Form 10-Q, which are available on
EDGAR at www.sec.gov/edgar/shtml, on SEDAR at www.sedar.com 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 10-K under the caption “Risk Factors”.
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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