On March 7, 2018 – 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 fourth quarter and full year ended December 31, 2017, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, MAR 7, 2018, View Source [SID1234524502]).
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Program Updates
In collaboration with Novartis, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including one clinical trial in patients whose transplanted livers were damaged by recurrent hepatitis C virus (HCV), and three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH):
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 second quarter of 2018;
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 the second half of 2018 followed by an integrated treatment extension period for clinical outcomes;
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-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 the second half of 2019.
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.
Pipeline Expansion Plans
Conatus may pursue the development of product candidates in liver disease and in other related disease areas. The company’s ongoing pipeline expansion activities include:
evaluation of the potential for the company’s pan-caspase inhibitor IDN-7314 as a treatment for primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure.
internal development of new preclinical product candidates leveraging its expertise with the caspase inhibition technology platform, and
evaluation for potential in-licensing or acquisition of external clinical-stage product candidates consistent with its product development and regulatory expertise.
Financial Results
Total revenues were $8.8 million for the fourth quarter of 2017 compared with $0.8 million for the fourth quarter of 2016, and $35.4 million for the full year 2017 compared with $0.8 million for the full year 2016. Total revenues consisted of collaboration revenues related to the Novartis agreement. The increases in revenues were a result of having a full fourth quarter and a full year of collaboration revenues in 2017 compared with 13 days of collaboration revenues in 2016.
Research and development expenses were $10.9 million for the fourth quarter of 2017 compared with $6.5 million for the fourth quarter of 2016. Research and development expenses were $43.2 million for the full year 2017 compared with $20.3 million for the full year 2016. The fourth quarter increase in research and development expenses was primarily due to the ramp up of the ENCORE-PH and ENCORE-LF clinical trials and new compound development. The full year increase in research and development expenses was primarily due to the ramp up of the ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials and new compound development.
General and administrative expenses were $2.3 million for the fourth quarter of 2017 compared with $3.5 million for the fourth quarter of 2016. General and administrative expenses were $9.7 million for the full year 2017 compared with $10.3 million for the full year 2016. The decrease in general and administrative expenses was primarily due to consulting and legal fees related to the execution of the Novartis agreement in December 2016.
The net loss for the fourth quarter of 2017 was $4.4 million compared with $9.1 million for the fourth quarter of 2016. The net loss for the full year 2017 was $17.4 million compared with $29.7 million for the full year 2016.
Cash, cash equivalents and marketable securities were $74.9 million at December 31, 2017, compared with $77.0 million at December 31, 2016, and a projected year-end 2018 balance of between $35 million and $40 million. The company believes that current financial resources, together with the anticipated reimbursements for 50% of the costs for the four ongoing clinical trials, without including any potential milestone payments under the Novartis collaboration, are sufficient to maintain operations through top-line results from all four Phase 2b clinical trials by the end of 2019, as well as to fund initial pipeline expansion activities.
Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 7095658. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.