CONATUS PHARMACEUTICALS INC. (NASDAQ:CNAT) Files An 8-K Other Events
Item8.01 Other Events.
On May 3, 2017, Conatus Pharmaceuticals Inc. (Conatus) announced
that Novartis Pharma AG (Novartis) has exercised its option to an
exclusive license for the global development and
commercialization of emricasan, Conatus first-in-class,
orally-active pan-caspase inhibitor, under terms of an Option,
Collaboration and License Agreement (the Collaboration Agreement)
entered into with Novartis in December 2016. Subject to usual and
customary conditions, including required anti-trust approvals,
the license will become effective upon the Companys receipt of a
$7 million option exercise payment, expected in mid-2017. The
option exercise by Novartis followed notification by Conatus of
the initiation of the Phase 2b ENCORE-LF (for Liver Function)
randomized, double-blind, placebo-controlled clinical trial
evaluating emricasan in patients with decompensated liver
cirrhosis caused by nonalcoholic steatohepatitis (NASH).
Conatus believes that with the $50 million upfront payment
received in December 2016 to the Collaboration Agreement, the $15
million received in exchange for a convertible promissory note
issued to Novartis in February 2017 to an investment agreement
entered into with Novartis in December 2016, the anticipated $7
million option exercise payment, and Novartis bearing 50% of the
costs of Conatus four ongoing Phase 2b emricasan clinical trials
after the license becomes effective, Conatus will have sufficient
financial resources to maintain operations and ongoing clinical
development activities through the end of 2019.
The ENCORE-LF clinical trial is expected to be conducted at
approximately 90 clinical sites, and is designed to evaluate
dosing, efficacy and safety of emricasan in approximately 210
patients with decompensated NASH cirrhosis. Patients will be
randomized 1:1:1 to receive 5 mg of emricasan, 25 mg of emricasan
or placebo twice daily for at least 48 weeks. The primary
endpoint is event-free survival for each treatment group compared
with the placebo group. For the purposes of the trial, events are
defined as all-cause mortality, new decompensation events, or a
progression of 4 points in the Model for End-stage Liver Disease
(MELD) score. Key secondary endpoints include safety and
tolerability, MELD and Child-Pugh scores, liver transplantation
rates, liver metabolic function using the BreathID Methacetin
Breath Test, and health-related quality of life.
Conatus is conducting three ongoing EmricasaN, a Caspase
inhibitOR, for Evaluation (ENCORE) clinical trials designed to
evaluate emricasan treatment in various NASH patient populations:
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ENCORE-LF, in decompensated NASH cirrhosis, with top-line results expected in 2019; |
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ENCORE-NF (for NASH Fibrosis), a randomized, double-blind, placebo-controlled Phase 2b clinical trial, initiated in the first quarter of 2016, evaluating potential improvements in fibrosis and steatohepatitis in approximately 330 patients with NASH fibrosis. Based on anticipated completion of enrollment, top-line results after 18 months of twice-daily treatment with emricasan or placebo are expected in the first half of 2019; and |
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ENCORE-PH (for Portal Hypertension), a randomized, double-blind, placebo-controlled Phase 2b clinical trial, initiated in the fourth quarter of 2016, evaluating dosing, efficacy and safety of emricasan in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. In April 2017, Conatus amended the ENCORE-PH clinical trial protocol to integrate a six-month treatment extension period for clinical outcomes, rather than conduct a separate extension trial. Top-line results for the primary endpoint after the first six months of twice-daily treatment with emricasan or placebo are expected in 2018. |
Conatus is conducting a fourth ongoing clinical trial in
hepatitis C virus (HCV) patients:
|
POLT-HCV-SVR, a randomized, double-blind, placebo-controlled Phase 2b clinical trial, initiated in the second quarter of 2014, evaluating potential improvements in fibrosis 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. Top-line results after two years of twice-daily treatment with emricasan or placebo are 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.
Conatus also expects to announce independent pipeline development
opportunities in 2017.
* * *
This Current Report on Form 8-K 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 option exercise payment being received by Conatus and the
license becoming effective in mid-2017; the sufficiency of
current financial resources and anticipated payments and expense
reimbursements to maintain operations and ongoing clinical
development activities through the end of 2019; the details of
and the timelines to announce results from the ENCORE-LF,
ENCORE-NF, ENCORE-PH and POLT-HCV-SVR clinical trials; the
possibility that results from ongoing trials will support the
design of Phase 3 clinical trials; and plans to announce pipeline
development opportunities in 2017. 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: Conatus ability
to successfully enroll patients in and complete its ongoing
clinical trials; the license becoming effective and Novartis
continuing development and commercialization of emricasan;
Conatus reliance on third parties to conduct its clinical trials,
including the enrollment of patients, and to manufacture its
clinical drug supplies of emricasan; potential adverse side
effects or other safety risks associated with emricasan that
could delay or preclude its approval; results of future clinical
trials of emricasan; Conatus ability to obtain additional
financing in order to develop other pipeline opportunities; and
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.
About CONATUS PHARMACEUTICALS INC. (NASDAQ:CNAT)
Conatus Pharmaceuticals Inc. is a biotechnology company. The Company focuses on the development and commercialization of medicines to treat liver disease. The Company operates through commercialization and development of pharmaceutical products segment. The Company is engaged in developing emricasan, which is an orally active pan-caspase protease inhibitor for the treatment of patients with chronic liver disease. Emricasan has the potential to interrupt the progression of liver disease and provide treatment options in multiple areas of liver disease. Emricasan is designed to slow or halt the progression of chronic liver disease caused by fibrosis and cirrhosis. Emricasan works by inhibiting caspases, which are a family of related enzymes that plays as modulators of critical cellular functions, including functions that result in apoptosis and inflammation. CONATUS PHARMACEUTICALS INC. (NASDAQ:CNAT) Recent Trading Information
CONATUS PHARMACEUTICALS INC. (NASDAQ:CNAT) closed its last trading session down -0.28 at 8.11 with 527,937 shares trading hands.
