Conatus (CNAT) Posts In Line Q1 Loss , Focus On Emricasan

Conatus Pharmaceuticals Inc. (NASDAQ:CNAT) reported a first-quarter 2016 loss of 35 cents per share in line with the Zacks Consensus Estimate and narrower than the year-ago loss of 38 cents.

With no approved product in Conatus’ portfolio at the moment, the company does not generate revenues yet.

In the first quarter of 2016, research and development expenses were $4.7 million, up almost 21% from the year-ago quarter, reflecting higher external clinical trial and manufacturing costs. General and administrative were $2.6 million, up 23.8% from the year-ago quarter mainly due to higher legal, consulting and accounting fees.

Emricasan in Focus

Conatus’ lead candidate, emricasan, a first-in-class, orally active pan-caspase protease inhibitor, is being developed for the treatment of patients suffering from chronic liver disease.

Currently, emricasan is being studied in a phase II program. These include the POLT-HCV-SVR study (phase IIb) – in post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis 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. Data following two years of twice-daily treatment or placebo are expected in the first half of 2018.

A phase II liver cirrhosis (LC) study evaluating 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 is also ongoing. The company reported positive top-line three-month data from the second stage LC study a couple of days back. Results from the first stage of the LC study were reported this January.

In Jan 2016, Conatus commenced a phase IIb study – ENCORE-NF (EmricasaN, a Caspase inhibitOR, for Evaluation in patients with nonalcoholic steatohepatitis (NASH), and confirmed resultant Fibrosis) study. Results following 18 months of twice-daily treatment or placebo should be out in 2018. In Feb 2016, the FDA granted Fast Track status to emricasan, for the treatment of liver cirrhosis caused by NASH.

ENCORE-NF is the first phase IIb study to be initiated under the ENCORE program. The company also plans to initiate additional studies (ENCORE-PH, ENCORE-LF and ENCORE-XT) on emricasan under the ENCORE program. While the ENCORE-PH study is expected to commence in the second half of 2016, the ENCORE- LF study is anticipated to start in the first half of 2017.

Top-line data from these studies are expected to be out periodically beginning 2018. Positive data from these studies would allow the company to file for an accelerated approval of emricasan in NASH cirrhosis.

Meanwhile, the company expects that its current financial resources will be sufficient to maintain operations and ongoing development activities associated with emricasan for at least the next 12 months.

We are encouraged by the company’s progress with emricasan. Investor focus should remain on updates pertaining to its development.

Conatus is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) , Retrophin, Inc. (NASDAQ:RTRX) and Vital Therapies, Inc. (NASDAQ:VTL) . All three stocks sport a Zacks Rank #1 (Strong Buy).