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Larger losses than 2013
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced financial results for the quarter and nine months ended September 30, 2014, and provided updates on its clinical development programs.
Financial Results:
The net loss for the third quarter of 2014 was $6.4 million compared with $3.3 million for the third quarter of 2013. The net loss for the first nine months of 2014 was $17.0 million compared with $10.5 million for the first nine months of 2013.
Research and development expenses were $4.4 million for the third quarter of 2014 compared with $1.9 million for the third quarter of 2013. Research and development expenses were $11.5 million for the first nine months of 2014 compared with $4.0 million for the first nine months of 2013. The increases in research and development expenses were primarily due to increases in external costs for clinical trials and manufacturing related to emricasan and personnel costs.
General and administrative expenses were $2.0 million for the third quarter of 2014 compared with $1.1 million for the third quarter of 2013. General and administrative expenses were $5.5 million for the first nine months of 2014 compared with $2.5 million for the first nine months of 2013. The increases in general and administrative expenses for the quarter and first nine months were primarily due to additional personnel costs, and for the first nine months also included higher spending on public company obligations.
Cash, cash equivalents and marketable securities were $41.9 million at September 30, 2014, compared with $56.4 million at December 31, 2013. The company is revising its projection for the year-end 2014 balance of cash, cash equivalents and marketable securities from the prior range of between $28 million and $32 million to the mid-$30 million range. The revised projection reflects further development clarity based on progress in clinical trials.
Program Updates:
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), including subsets of patients with liver cirrhosis (LC) and portal hypertension (PH);
– 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).
The company is currently conducting five Phase 2 clinical trials in these various liver disease patient populations.
Hepatic and Renal Impairment Update:
Conatus initiated three clinical trials of emricasan in subjects 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 subjects who may have simultaneous impairment of both liver and kidney function; a Phase 1 trial initiated in January 2014 in subjects with severe renal impairment; and a Phase 1 hepatic impairment trial initiated in April 2014. Preliminary pharmacokinetic (PK) results from the renal impairment and hepatic impairment trials were used to support the design of two recently initiated trials in subjects with liver cirrhosis.
In a late-breaking poster at the recent annual meeting of the American Association for the Study of Liver Diseases (AASLD), Conatus reported key secondary endpoint pharmacodynamic (PD) biomarker results from the hepatic impairment trial.
