Conatus Announces Effectiveness of Exclusive License for Global Development and Commercialization of Emricasan with Receipt o...
July 06 2017 - 3:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced that its
exclusive license with Novartis for the global development and
commercialization of emricasan has become effective under terms of
the Option, Collaboration and License Agreement signed in December
2016. The license became effective on July 5, 2017, upon Conatus’
receipt of a $7 million payment, which followed U.S. Federal Trade
Commission review and expiration of the waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended,
with respect to the Agreement. Emricasan, Conatus’ first-in-class,
orally-active pan-caspase inhibitor, has demonstrated activity
across a broad spectrum of liver diseases, and is currently being
evaluated in four Phase 2b clinical trials as a potential treatment
for liver cirrhosis and fibrosis caused by nonalcoholic
steatohepatitis (NASH) or hepatitis C virus (HCV) infection.
With the secured and anticipated funding provided under the
Novartis agreement, along with the retained net proceeds from an
underwritten public offering of its common stock completed in May
2017, Conatus believes that current financial resources are
sufficient to maintain operations and ongoing clinical development
activities through the end of 2019, as well as to fund anticipated
pipeline expansion activities. Conatus is now projecting a balance
of cash, cash equivalents and marketable securities of between $55
million and $65 million at year-end 2017, compared with a balance
of $77.0 million at year-end 2016.
“We are very pleased to advance to effective license status in
our collaboration with Novartis,” said Conatus co-founder,
President and Chief Executive Officer, Steven J. Mento, Ph.D., “and
we look forward to working together on emricasan’s development,
both as a single agent for NASH cirrhosis and as a component of
potential drug combinations for NASH fibrosis. In parallel, we are
advancing toward a planned announcement later in 2017 of
independent pipeline development opportunities aimed at building
additional long-term value for our shareholders beyond
emricasan.”
Emricasan Clinical DevelopmentConatus is
conducting three randomized, double-blind, placebo-controlled Phase
2b EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical
trials designed to evaluate emricasan treatment in various NASH
patient populations:
- ENCORE-LF (for Liver Function), initiated in the second quarter
of 2017, in approximately 210 patients with decompensated NASH
cirrhosis, with top-line results expected in 2019;
- ENCORE-NF (for NASH Fibrosis), initiated in the first quarter
of 2016, in approximately 330 patients with NASH fibrosis, with
top-line results expected in the first half of 2019; and
- ENCORE-PH (for Portal Hypertension), initiated in the fourth
quarter of 2016, in approximately 240 patients with compensated or
early decompensated NASH cirrhosis and severe portal hypertension,
with top-line results expected in 2018 followed by an integrated
6-month treatment extension period for clinical outcomes.
Conatus is conducting a fourth randomized, double-blind,
placebo-controlled Phase 2b clinical trial in POLT-HCV-SVR
patients:
- POLT-HCV-SVR, initiated in the second quarter of 2014, in
approximately 60 post-orthotopic liver transplant (POLT) recipients
with liver fibrosis or cirrhosis post-transplant as a result of
recurrent HCV infection who have successfully achieved a sustained
viral response (SVR) following HCV antiviral therapy, with top-line
results expected in the first half of 2018.
Results from the four ongoing emricasan clinical trials are
expected to support the design of Phase 3 clinical efficacy and
safety trials.
About Conatus PharmaceuticalsConatus is a
biotechnology company focused on the development and
commercialization of novel medicines to treat liver disease. In
collaboration with Novartis, Conatus is developing its lead
compound, emricasan, for the treatment of patients with chronic
liver disease. Emricasan is a first-in-class, orally active
pan-caspase inhibitor designed to reduce the activity of enzymes
that mediate inflammation and apoptosis. Conatus believes that by
reducing the activity of these enzymes, caspase inhibitors have the
potential to interrupt the progression of a variety of diseases.
For additional information, please visit www.conatuspharma.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of Section
21E of the Securities Exchange Act of 1934, as amended. All
statements other than statements of historical facts contained in
this press release are forward looking statements, including
statements regarding: the sufficiency of current and
anticipated financial resources; the projected year-end cash
balance; future development of emricasan as a single agent or in
combination products; the details of and the timelines to announce
results from the ENCORE-LF, ENCORE-NF, ENCORE-PH and POLT-HCV-SVR
clinical trials; plans to announce pipeline development
opportunities in 2017 and the ability of such opportunities to
generate long-term value for shareholders; the ability of results
from ongoing trials to support the design of Phase 3 clinical
trials; and caspase inhibitors' potential to interrupt the
progression of a variety of diseases. In some cases, you can
identify forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negative of these
terms or other similar expressions. These forward-looking
statements speak only as of the date of this press release and are
subject to a number of risks, uncertainties and assumptions,
including those risks described in Conatus’ prior press releases
and in the periodic reports it files with the Securities and
Exchange Commission. The events and circumstances reflected in
Conatus’ forward-looking statements may not be achieved or occur
and actual results could differ materially from those projected in
the forward-looking statements. Except as required by applicable
law, Conatus does not plan to publicly update or revise any
forward-looking statements contained herein, whether as a result of
any new information, future events, changed circumstances or
otherwise.
CONTACT: Alan Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com
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