October 20, 2014 7:22 AM ET

Biotechnology

Company Overview of Conatus Pharmaceuticals Inc.

Company Overview

Conatus Pharmaceuticals Inc., a biotechnology company, focuses on the development and commercialization of novel medicines to treat liver diseases in the United States. Its products include Emricasan, an orally active pan-caspase protease inhibitor for the treatment of acute-on-chronic liver failure; chronic liver failure; post liver transplant clearance of hepatitis C virus infection with sustained viral response; non-alcoholic steatohepatitis; and nonalcoholic fatty liver disease. The company was founded in 2005 and is headquartered in San Diego, California.

4365 Executive Drive

Suite 200

San Diego, CA 92121

United States

Founded in 2005

22 Employees

Phone:

858-558-8130

Key Executives for Conatus Pharmaceuticals Inc.

Co-Founder
Age: 62
Total Annual Compensation: $419.5K
Co-Founder
Age: 56
Total Annual Compensation: $283.1K
Chief Medical Officer and Senior Vice President of Clinical Research
Age: 52
Total Annual Compensation: $288.4K
Compensation as of Fiscal Year 2013.

Conatus Pharmaceuticals Inc. Key Developments

Conatus Pharmaceuticals Inc. Appoints David T. Hagerty as Executive Vice President, Clinical Development

Conatus Pharmaceuticals Inc. announced the appointment of David T. Hagerty as Executive Vice President, Clinical Development, with oversight responsibility for the company's medical activities including Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Quality Assurance and Drug Safety. Dr. Hagerty has been an independent consultant in clinical development since April 2013. He served as Senior Vice President and Chief Medical Officer at Ardea Biosciences from 2011 to 2013. He is Board Certified in internal medicine and nephrology and has been United Network for Organ Sharing (UNOS) certified as a transplant physician.

Conatus Pharmaceuticals Inc. Initiates Phase 2 Trial in Patients with Liver Cirrhosis and Separate Open Label Phase 2 Trial in Cirrhosis Patients with Portal Hypertension

Conatus Pharmaceuticals Inc. announced the initiation of a Phase 2 clinical trial of its lead drug candidate, emricasan, in patients with liver cirrhosis (LC), and the initiation of a separate exploratory Phase 2 trial in cirrhosis patients with portal hypertension (PH). The Phase 2 LC clinical trial is designed to consist of two phases and enroll approximately 80 subjects at approximately 20 sites in the United States. In the first phase, which is double-blind and placebo-controlled, subjects will be randomized 1:1 to receive either 25 mg of emricasan or placebo orally twice daily for three months. In the second phase, which will be open label, subjects who complete the first phase of the trial, either on treatment or placebo, may receive emricasan for up to an additional three months. Top-line data from the first phase of this trial are expected to be available in the second half of 2015. Inclusion criteria will include clinical, radiological, or biochemical evidence of liver cirrhosis and a Model for End-Stage Liver Disease (MELD) score of 11 to 18 during the screening period. The primary endpoint will be change from baseline in cleaved cytokeratin 18 (cCK18), a mechanism-specific biomarker of apoptosis associated with excessive cell death, which contributes to chronic inflammation. Secondary endpoints will include change from baseline in MELD score and change from baseline in Child-Pugh score, an assessment of the prognosis of chronic liver disease, primarily cirrhosis. The clinical trial will also evaluate other key serum biomarkers and the safety and tolerability of emricasan in the target patient population. The exploratory, open label Phase 2 clinical trial in PH patients is designed to enroll approximately 20 subjects at approximately eight sites in the United States. Inclusion criteria will include clinical, radiological, or biochemical evidence of liver cirrhosis and portal hypertension confirmed by hepatic venous pressure gradient (HVPG) procedure prior to enrollment. Subjects will receive 25 mg of emricasan orally twice daily for 28 days. The primary endpoint will be change from baseline in cCK18 and HVPG. Secondary endpoints will include change from baseline in MELD score and change from baseline in Child-Pugh score. The clinical trial will also evaluate other key serum biomarkers and the safety and tolerability of emricasan in the target patient population. Top-line data from this trial are expected to be available in the third quarter of 2015 and this open label trial may allow for interim data evaluations.

Conatus Pharmaceuticals Inc. Announces Unaudited Financial Results for the Second Quarter and Six Months Ended June 30, 2014; Provides Update on Clinical Trail Programmers

Conatus Pharmaceuticals Inc. announced unaudited financial results for the second quarter and six months ended June 30, 2014. The net loss for the second quarter of 2014 was $5.3 million compared with $4.9 million for the second quarter of 2013. Net loss applicable to common stockholders was $5,303,024 or $0.34 per diluted share against $223,776 or $0.16 per diluted share for the second quarter of 2013. The net loss for the first six months of 2014 was $10.5 million compared with $7.2 million for the first six months of 2013. Net loss applicable to common stockholders was $10,546,380 or $0.68 per diluted share. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease and acute exacerbations of chronic liver disease, including: Patients with acute-on-chronic liver failure (ACLF); Patients with chronic liver failure (CLF); Post-orthotopic liver transplant (POLT) recipients with reestablished liver fibrosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy (POLT-HCV-SVR); and Patients with nonalcoholic fatty liver disease (NAFLD), including the subset of NAFLD patients with inflammatory and/or fibrotic nonalcoholic steatohepatitis (NASH). Conatus is conducting three clinical trials of emricasan in patients with impaired organ function to support dose selection and prioritization for advancement in its overall clinical development program: a Phase 2b trial initiated in September 2013 in ACLF patients who may have simultaneous impairment of both liver and kidney function; a Phase 1 trial initiated in January 2014 in patients with severe renal impairment; and a Phase 1 trial initiated in April 2014 in patients with various degrees of hepatic impairment. The company confirmed its guidance that top-line pharmacokinetic (PK) data from these three trials are expected in the second half of 2014. The company further announced that it expects to complete dosing in the ACLF trial by year-end 2014. The company does not expect to dose the maximum of 60 patients stipulated in the protocol, but expects that enrollment and results will be sufficient to determine the future direction for the clinical development of emricasan in this critically ill patient population by the end of 2014. The company believes that emricasan may provide meaningful clinical benefit for CLF patients with long-term cirrhosis whose disease symptoms progress in severity over time. Patients with more advanced cirrhosis may include those on the transplant waiting list and those not eligible for the transplant waiting list. The company believes emricasan may help stabilize these patients long enough to get a liver transplant, or improve their condition enough to qualify for a transplant. Dosing and PK information from the severe renal impairment trial and the hepatic impairment trial is expected to support the design of a CLF trial. Initiation of a Phase 2 trial in CLF patients is expected in the second half of 2014. The company initiated a Phase 2b clinical trial in POLT-HCV-SVR patients with fibrosis in May 2014. The placebo-controlled, double-blind (open to sponsor) clinical trial is designed to enroll approximately 60 patients at approximately 15 planned clinical sites in the United States. Patients will be randomized 2:1 to receive either 25 mg of emricasan or placebo orally twice daily for 24 months and will then be followed for another month post-treatment. The primary endpoint in this exploratory proof-of-concept clinical trial is the change in the Ishak Fibrosis Score compared to placebo. The clinical trial will also evaluate other histological markers, key serum biomarkers, and the safety and tolerability of emricasan in the target patient population. Initial open-label data from the POLT-HCV-SVR Phase 2b trial are expected to be available in the first half of 2015. The company initiated a Phase 2 clinical trial of emricasan in patients with NAFLD, including patients with NASH, in March 2014. The trial is intended to confirm the appropriate dosing in this patient population for potential future studies, to expand emricasan's safety database, and to evaluate changes in relevant biomarkers of liver damage. Dosing data from this clinical trial are expected to position the company to be ready to move forward once appropriate Phase 3 endpoints are confirmed and a regulatory approval pathway is established in the NASH population. Announcement of top-line results from the Phase 2 NAFLD/NASH clinical trial is being deferred to the first quarter of 2015.

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