On May 05, 2016 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the first quarter ended March 31, 2016, and provided updates on its development programs (Filing, Q1, Conatus Pharmaceuticals, 2016, MAY 5, 2016, View Source [SID:1234512021]). After the market close yesterday, the company announced top-line results from the second stage of its Phase 2 Liver Cirrhosis trial. A conference call and webcast are scheduled for 8:00 a.m. ET today, as detailed below, to discuss both the trial results and financial results.

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Financial Results
The net loss was $7.3 million for the first quarter of 2016 compared with $6.0 million for the first quarter of 2015.

Research and development expenses increased to $4.7 million for the first quarter of 2016 from $3.9 million for the first quarter of 2015, primarily due to higher external clinical trial and manufacturing costs. General and administrative expenses increased to $2.6 million for the first quarter of 2016 from $2.1 million for the first quarter of 2015, primarily due to higher legal, consulting and accounting fees.

Cash, cash equivalents and marketable securities were $32.6 million at March 31, 2016, compared with $36.5 million at December 31, 2015. The company believes current financial resources are sufficient to maintain operations and ongoing clinical development activities for at least the next 12 months.

Program Updates
Conatus is developing emricasan, a first-in-class, orally active pan-caspase inhibitor, for the treatment of patients with chronic liver disease. To date in 2016, the company announced:

in January, positive top-line results from the three-month, double-blind, placebo-controlled first stage of the company’s Phase 2 Liver Cirrhosis clinical trial, evaluating potential improvements in Model for End-stage Liver Disease (MELD) score and Child-Pugh-Turcotte status in patients with liver cirrhosis and baseline MELD scores of 11 to 18, and in May, positive top-line results from the three-month, open-label second stage of the Liver Cirrhosis clinical trial;

in January, the initiation of active recruitment in its double-blind, placebo-controlled Phase 2b ENCORE-NF (EmricasaN, a Caspase inhibitOR, for Evaluation in patients with nonalcoholic steatohepatitis (NASH), and confirmed resultant Fibrosis) clinical trial;

in February, U.S. Food and Drug Administration (FDA) Fast Track designation for the development of emricasan in patients with liver cirrhosis caused by NASH;

an oral late-breaker presentation (#LBO5) entitled, "Emricasan (IDN-6556) orally for three months in patients with cirrhosis and MELD scores 11-18 improves clinical parameters of cirrhosis in patients with baseline MELD score ≥15," delivered at The International Liver Congress 2016, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, by Catherine Frenette, M.D., Medical Director of Liver Transplantation at Scripps Clinic, La Jolla, CA, and a principal investigator in the company’s multicenter Phase 2 Liver Cirrhosis clinical trial of emricasan; and

a poster (#FRI-078) entitled, "The potent pan-caspase inhibitor IDN-7314 does not affect tumor growth rate nor does it antagonize the efficacy of sorafenib in models of hepatocellular carcinoma," presented at The International Liver Congress 2016, the Annual Meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, by Patricia C. Contreras, Ph.D., Vice President, Preclinical Development at Conatus and lead author on the poster.
Conatus has two ongoing emricasan Phase 2 clinical trials:

POLT-HCV-SVR: A randomized, double blind, placebo-controlled Phase 2b clinical trial initiated in May 2014 evaluating potential improvements in Ishak Fibrosis Score in 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. Results after two years of twice-daily treatment or placebo are expected in the first half of 2018.

ENCORE-NF: A randomized, double blind, placebo-controlled Phase 2b clinical trial initiated in January 2016 evaluating potential improvements in fibrosis and steatohepatitis in patients with NASH fibrosis. Results after 18 months of twice-daily treatment or placebo are expected in 2018.
The company plans to initiate the following additional emricasan clinical trials on a staggered basis through early 2017 as resources permit and expects top-line results to be available periodically beginning in 2018, which the company believes could position it to advance directly to filing for accelerated approval in NASH cirrhosis:

ENCORE-PH: A planned randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of emricasan in reducing hepatic venous pressure gradient (HVPG) in patients with clinically significant Portal Hypertension and impaired hepatic function in patients with NASH cirrhosis.

ENCORE-LF: A planned randomized, double-blind, placebo-controlled clinical trial to assess long-term Liver Function endpoints of MELD score and Child-Pugh-Turcotte status, related serum biomarkers and laboratory parameters associated with liver function, and will collect chronic administration safety information in patients with NASH cirrhosis. With the continued engagement of the regulatory authorities, the six-month data from the Liver Cirrhosis trial may allow redesign of the ENCORE-LF clinical trial, originally planned as a Phase 2 trial, to qualify as a Phase 3 clinical trial.

ENCORE-XT: A planned eXTension clinical trial to continue treatment for at least an additional 18 months, for a total of at least two years, in patients who complete the ENCORE-PH or ENCORE-LF trials, with continued monitoring for efficacy, safety, clinical outcomes and health-related quality of life.