- Important progress made in FDA discussions on development
pathway for CaPre®
- Reverse Stock Split effective October 15, 2015
Acasti Pharma Inc. ("
Acasti" or the
"
Corporation") (NASDAQ:ACST) (TSX-V:APO), an
emerging biopharmaceutical company focused on the research,
development and commercialization of new krill oil-based forms of
omega-3 phospholipid therapies for the treatment and prevention of
certain cardiometabolic disorders, announces its financial and
operating results for the second quarter ended August 31,
2015. All amounts in Canadian dollars.
"Acasti has made important progress in its discussions with the
US Food and Drug Administration (FDA) regarding next steps in the
development plans for CaPre®," highlighted Pierre Lemieux, PhD,
Acasti's Chief Operating Officer. "The FDA has provided
recommendations and guidance and Acasti is working in conjunction
with experts in pharmaceutical drug development to optimize its
regulatory pathway and better align itself with FDA's
perspectives. Acasti remains committed to advancing its
clinical trials as quickly as possible and is continuing its
discussions with the FDA."
Second Quarter Financial Results
- Research and development (R&D) expenses were $1,116,000 for
the quarter, versus $1,803,000 in the prior year
- Adjusted EBITDA1 was negative $(1,485,000) for the quarter,
versus negative $(2,449,000) in the prior year
- Net loss was $(1,241,000) for the quarter, versus a net loss of
$(3,712,000) in the prior year.
The year-over-year variance for both adjusted EBITDA and net
loss were largely due to a decrease in R&D, and General &
Administrative expenses.
Year-to-Date Financial Results
- Research and development (R&D) expenses were $2,462,000 for
the six-month period, compared to $3,022,000 in the prior year
- Adjusted EBITDA was negative $(3,430,000) for the current
year-to-date, versus negative $(4,144,000) in the prior year
- Net loss was $(2,206,000), versus a net loss of $(2,356,000) in
the prior year.
The six-month year-over-year variances are mainly attributable
to the same factors highlighted above for second quarter financial
results.
CaPre® Development
Plan
The FDA has provided Acasti with guidance and recommendations
regarding next steps in the clinical development of CaPre®.
Acasti is incorporating these comments into its development
plan to be better aligned with current FDA views on CaPre® and to
ensure it is well positioned to move towards regulatory
approval. Working with several leading experts in
pharmaceutical drug development, Acasti is also considering
different alternatives to optimize its development plan for
CaPre®. Acasti will continue discussions with the FDA and
upon approval will move forward with its trials.
Acasti intends to pursue CaPre® regulatory pathway under section
505(b)(2)2 of the Federal Food, Drug, and Cosmetic Act and
plans to conduct a pivotal bioavailability bridging study,
comparing CaPre® to an omega-3 prescription drug. The
505(b)(2) approval pathway has been used by many other companies
and Acasti's regulatory and clinical experts believe such a
strategy is best for CaPre®. This should allow Acasti to
further optimize the advancement of CaPre®, including the Phase 3
protocol design, while most importantly benefiting from the
substantial clinical and nonclinical data already available with
another FDA-approved omega-3 prescription drug. In addition,
this should reduce the expected expenses and streamline the overall
CaPre® development program required to support a New Drug
Application (NDA) submission.
FDA discussions are still ongoing and Acasti has prepared a
comprehensive development plan to be reviewed with
them. Execution of the plan will be contingent on FDA
comments. As such, Acasti has not finalized its definitive
Phase 3 program and overall costs and timelines are still
contingent on FDA direction. However, based on preliminary
discussions with them, along with Acasti's intent to do a pivotal
bioavailability bridging study, Acasti believes that a Phase 3
trial could be initiated in the next 18 months.
For the quarter ended August 31, 2015, Acasti had cash and cash
equivalents of $15.8 million, which is sufficient to complete the
pivotal bioavailability bridging study, to initiate the Phase 3
study, and to maintain ongoing working capital requirements.
Acasti has determined that full realization of Onemia® as a leading
medical food requires significant additional investment in sales
and marketing. This would detract Acasti from focusing its
energy and resources on the development of CaPre®. Acasti
expects ongoing sales of Onemia® to be at thresholds similar to
recent quarters and the Corporation will be exploring strategic
alternatives for Onemia®, including licensing opportunities.
Reverse Stock Split Effective October 15,
2015
On September 29, 2015 Acasti announced its decision to
consolidate its issued and outstanding Class A common shares on a
1-for-10 basis in order to comply with NASDAQ minimum Bid Price
Rules. The consolidation will be effective at the open
of trading on October 15, 2015 and the common shares shall begin
trading on the NASDAQ and TSX Venture Exchange on a reverse
split-adjusted basis on such date, which shall result in
approximately 10,661,626 common shares issued and outstanding on a
post-consolidation basis.
505(b)(2) Regulatory Pathway
The 505(b)(2) regulatory pathway is defined in The Federal Food
Drug and Cosmetics Act as a New Drug Application (NDA) containing
investigations of safety and effectiveness that are being relied
upon for approval and were not conducted by or for the applicant,
and for which the applicant has not obtained a right of reference.
These applications differ from the typical NDA (described under
Section 505(b)(1) of the Act), in that they allow a sponsor to
rely, at least in part, on the FDA's findings of safety and/or
effectiveness for a previously approved drug. A 505(b)(2)
application may be granted 3 to 5 years exclusivity.
Caution Regarding Non-IFRS Financial
Measures
The Corporation uses adjusted financial measures, including
Adjusted EBITDA, to assess its operating performance. These
non-IFRS financial measures are directly derived from the Company's
financial statements and are presented in a consistent manner. The
Company uses these measures for the purposes of evaluating its
historical and prospective financial performance, as well as its
performance relative to competitors. These measures also help the
Company to plan and forecast for future periods as well as to make
operational and strategic decisions. The Company believes that
providing this information to investors, in addition to IFRS
measures, allows them to see the Company's results through the eyes
of management, and to better understand its historical and future
financial performance.
Securities regulations require that companies caution readers
that earnings and other measures adjusted to a basis other than
IFRS do not have standardized meanings and are unlikely to be
comparable to similar measures used by other companies.
Accordingly, they should not be considered in isolation. The
Corporation uses Adjusted EBITDA to measure its performance from
one period to the next without the variation caused by certain
adjustments that could potentially distort the analysis of trends
its operating performance, and because the Corporation believes it
provides meaningful information on the Corporation's financial
condition and operating results. Acasti's method for calculating
adjusted EBITDA may differ from that used by other
corporations.
Acasti obtains its Adjusted EBITDA measurement by adding to net
loss, finance costs, depreciation and amortization and income taxes
and by subtracting finance income. Finance income/costs include
foreign exchange gain (loss) and change in fair value of
derivatives. Acasti also excludes the effects of certain
non-monetary transactions recorded, such as stock-based
compensation, from its Adjusted EBITDA calculation. The Corporation
believes it is useful to exclude this item as it is a non-cash
expense. Excluding this item does not imply it is necessarily
nonrecurring.
About Acasti Pharma Inc.
Acasti is an emerging biopharmaceutical company focused on the
research, development and commercialization of new krill oil-based
forms of omega-3 phospholipid therapies for the treatment and
prevention of certain cardiometabolic disorders, in particular
abnormalities in blood lipids, also known as dyslipidemia. Because
krill feeds on phytoplankton (diatoms and dinoflagellates), it is a
major source of phospholipids and polyunsaturated fatty acids
("PUFAs"), mainly eicosapentaenoic acid ("EPA") and docosahexaenoic
acid ("DHA"), which are two types of omega-3 fatty acids well known
to be beneficial for human health. CaPre®, currently Acasti's only
prescription drug candidate, is a highly purified omega-3
phospholipid concentrate derived from krill oil and is being
developed to help prevent and treat hypertriglyceridemia, which is
a condition characterized by abnormally high levels of
triglycerides in the bloodstream. ONEMIA®, a medical food and
currently Acasti's only commercialized product, is a purified
omega-3 phospholipid concentrate derived from krill oil with lower
levels of phospholipids, EPA and DHA content than CaPre®.
Forward Looking Statements
Statements in this press release that are not statements of
historical or current fact constitute "forward-looking statements"
within the meaning of the U.S. securities laws and Canadian
securities laws. 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," "will," or "plans"
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.
The forward-looking statements contained in this news release
are expressly qualified in their entirety by this cautionary
statement and the "Cautionary Note Regarding Forward-Looking
Information" section contained in Acasti's latest Annual
Information Form, which also forms part of Acasti's latest annual
report on Form 20-F, and which is 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 acastipharma.com (the
"AIF"). 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 other 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. Additional information about these
assumptions and risks and uncertainties is contained in the AIF
under "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.
1 See "Caution Regarding Non-IFRS Financial Measures"
which follows.
2 See note on "505(b)(2) Regulatory Pathway"
CONTACT: Acasti Contact:
John Ripplinger
Investor Relations
+1.450.687.2262
j.ripplinger@acastipharma.com
acastipharma.com
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