Conatus Pharmaceuticals
Mar 9, 2016

Conatus Pharmaceuticals Reports 2015 Financial Results and Program Updates

SAN DIEGO, March 09, 2016 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year ended December 31, 2015, and provided updates on its clinical development programs.

Financial Results
The net loss for the fourth quarter of 2015 was $6.0 million compared with $5.3 million for the fourth quarter of 2014. The net loss for the full year 2015 was $24.1 million compared with $22.3 million for the full year 2014.

Research and development expenses were $4.2 million for the fourth quarter of 2015 compared with $3.4 million for the fourth quarter of 2014. Research and development expenses were $16.3 million for the full year 2015 compared with $14.9 million for the full year 2014. The full year increase in research and development expenses was primarily due to higher personnel costs and an increase in external costs related to emricasan.

General and administrative expenses were $1.8 million for the fourth quarter of 2015 compared with $1.9 million for the fourth quarter of 2014. General and administrative expenses were $7.8 million for the full year 2015 compared with $7.4 million for the full year 2014. The full year increase in general and administrative expenses was primarily due to higher personnel costs.

Cash, cash equivalents and marketable securities were $36.5 million at December 31, 2015, compared with $37.1 million at December 31, 2014. The company believes current financial resources are sufficient to maintain operations and ongoing clinical development activities through at least the first quarter of 2017.

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


During 2015, the company reported results from five emricasan clinical trials:


Conatus' two most recent cirrhosis trials enrolled and treated patients whose cirrhosis was due to a variety of etiologies, including hepatitis C virus (HCV) infection, alcohol or NASH. Following the FDA's grant of Fast Track designation to the emricasan development program for the treatment of liver cirrhosis caused by NASH, and based on additional communications with the FDA recommending single-etiology clinical trials, the company plans to focus on advancing toward initial registration of emricasan for patients with NASH cirrhosis, with parallel development toward registration of emricasan for patients with NASH fibrosis.

The company also plans to extend the safety database and evaluate the efficacy of emricasan in focused single-etiology trials to address additional patient populations with cirrhosis due to alcohol or HCV for potential expansion of the targeted initial label for emricasan in NASH cirrhosis.

Conatus has three ongoing emricasan Phase 2 clinical trials:


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:


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 48233480. 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.

About Emricasan Clinical Development
To date, emricasan has been studied in over 650 subjects in 16 clinical trials across a broad range of liver disease etiologies and stages of progression. In multiple clinical trials, emricasan has demonstrated statistically significant, rapid and sustained reductions in elevated levels of key biomarkers of apoptosis and inflammation that are implicated in the severity and progression of liver disease. Recent emricasan clinical trial results have demonstrated emricasan's ability to provide significant improvements in clinically important validated surrogate endpoints of portal hypertension and liver function across multiple etiologies in the subgroups of liver cirrhosis patients with highest medical need.

About Conatus Pharmaceuticals
Conatus is a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease. Conatus is developing its lead compound, emricasan, for the treatment of patients with chronic liver disease. Emricasan is a first-in-class, orally active pan-caspase protease inhibitor designed to reduce the activity of enzymes that mediate inflammation and apoptosis. Conatus believes that by reducing the activity of these enzymes, emricasan has the potential to interrupt the disease progression across the spectrum of liver disease. For additional information, please visit www.conatuspharma.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward looking statements, including statements regarding:  the sufficiency of current financial resources; the company's focus on initial registration of emricasan for patients with NASH cirrhosis and parallel development toward registration of emricasan for patients with NASH fibrosis; plans to extend the safety database and evaluate the efficacy of emricasan in focused single-etiology trials to address additional patient populations with cirrhosis due to alcohol or HCV for potential emricasan label expansion; the timelines to announce results from the POLT-HCV-SVR trial, initial results from the second stage of the Liver Cirrhosis trial, and results from the ENCORE-NF trial; the timelines to initiate and announce results from the ENCORE-PH, ENCORE-LF and ENCORE-XT trials; the potential to file for accelerated approval of emricasan in NASH cirrhosis; the size, patient population and treatment duration of each ENCORE trial; the potential redesign of the ENCORE-LF trial as a Phase 3 clinical trial; and emricasan's potential to interrupt the disease progression across the spectrum of liver disease. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including:  Conatus' ability to initiate and successfully complete current and future clinical trials; Conatus' dependence on its ability to obtain regulatory approval for, and then successfully commercialize emricasan, which is Conatus' only drug candidate; Conatus' reliance on third parties to conduct its clinical trials, enroll subjects, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of emricasan, if approved; potential adverse side effects or other safety risks associated with emricasan that could delay or preclude its approval; Conatus' ability to use accelerated approval pathways and/or obtain orphan drug exclusivity for emricasan for any indication; results of current and future clinical trials of emricasan; the potential for competing products to limit the clinical trial enrollment opportunities for emricasan in certain indications; the uncertainty of the FDA's and other regulatory agencies' approval processes and other regulatory requirements; Conatus' ability to fully comply with numerous federal, state and local laws and regulatory requirements applicable to it; Conatus' limited operating history and its ability to operate successfully as a public company; Conatus' ability to obtain additional financing in order to complete the development and commercialization of emricasan; Conatus may use its financial resources faster than it anticipates; and those risks described in Conatus' prior press releases and in the periodic reports it files with the Securities and Exchange Commission. The events and circumstances reflected in Conatus' forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Conatus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Conatus Pharmaceuticals Inc.
Selected Condensed Financial Information
(Unaudited)
         
  Three Months Ended Twelve Months Ended
Statements of Operations December 31, December 31,
   2015   2014   2015   2014 
         
Operating expenses:        
Research and development $  4,240,620  $  3,393,775  $  16,297,617  $  14,908,843 
General and administrative    1,799,346     1,927,569     7,833,085     7,379,339 
Total operating expenses     6,039,966     5,321,344     24,130,702     22,288,182 
Other income (expense):        
Interest income    18,809     9,511     67,885     57,616 
Interest expense    (17,500)    (17,500)    (70,000)    (70,000)
Other expense    (5,505)    (7,018)    (15,809)    (19,325)
Total other expense    (4,196)     (15,007)    (17,924)    (31,709)
Net loss $  (6,044,162) $  (5,336,351) $  (24,148,626) $  (22,319,891)
         
Net loss per share, basic and diluted $  (0.30) $  (0.34) $  (1.30) $  (1.44)
         
Weighted average shares outstanding used in computing        
  net loss per share, basic and diluted    19,834,477     15,550,320     18,617,537     15,478,999 
         
      December 31,
Balance Sheets     2015   2014 
        
Assets       
Current assets:       
Cash, cash equivalents and marketable securities    $  36,508,109  $  37,071,946 
Prepaid and other current assets       1,982,031     796,818 
Total current assets       38,490,140     37,868,764 
Property and equipment, net       344,734     237,066 
Other assets       892,394     342,051 
Total assets    $  39,727,268  $  38,447,881 
        
Liabilities and stockholders' equity        
Current liabilities    $  3,982,698  $  4,175,233 
Note payable       1,000,000     1,000,000 
Deferred rent        204,224      58,699 
Stockholders' equity       34,540,346     33,213,949 
Total liabilities and stockholders' equity    $  39,727,268  $  38,447,881 

 

 

MEDIA:  David Schull
Russo Partners, LLC
(858) 717-2310
David.Schull@RussoPartnersLLC.com

INVESTORS:  Alan Engbring
Conatus Pharmaceuticals Inc.
(858) 376-2637
aengbring@conatuspharma.com