Conatus Pharmaceuticals Reports Third Quarter 2016 Financial Results and Program Updates
09 November 2016 - 8:05AM
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, 2016, and provided
updates on its clinical development programs.
Financial ResultsThe net loss for the third
quarter of 2016 was $6.9 million compared with $6.1 million for the
third quarter of 2015. The net loss for the first nine months of
2016 was $20.6 million compared with $18.1 million for the first
nine months of 2015.
Research and development expenses were $4.8 million for the
third quarter of 2016 compared with $4.1 million for the third
quarter of 2015. Research and development expenses were $13.8
million for the first nine months of 2016 compared with $12.1
million for the first nine months of 2015. The increases in
research and development expenses for the third quarter and first
nine months were primarily due to the progression of the company’s
ENCORE program.
General and administrative expenses were $2.1 million for the
third quarter of 2016 compared with $2.0 million for the third
quarter of 2015. The increase in general and administrative
expenses for the third quarter was primarily due to higher
personnel costs and consulting fees. General and administrative
expenses were $6.9 million for the first nine months of 2016
compared with $6.0 million for the first nine months of 2015. The
increase in general and administrative expenses for the first nine
months was primarily due to higher personnel costs and higher
consulting, legal and accounting fees.
Cash, cash equivalents and marketable securities were $31.1
million at September 30, 2016, compared with $36.5 million at
December 31, 2015. The company believes current financial resources
are sufficient to maintain operations for at least the next 12
months.
Program UpdatesConatus is developing its lead
compound, emricasan, for the treatment of patients with chronic
liver disease. The company recently initiated:
- ENCORE-PH: A randomized, double-blind,
placebo-controlled Phase 2b clinical trial initiated in November
2016 evaluating the effect of emricasan in reducing hepatic venous
pressure gradient (HVPG) in patients with compensated or early
decompensated liver cirrhosis caused by nonalcoholic
steatohepatitis (NASH), and severe portal hypertension confirmed by
HVPG of ≥12 mmHg at baseline. Results after 24 weeks of twice-daily
treatment with emricasan or placebo are expected in 2018.
Conatus has two additional ongoing emricasan Phase 2b clinical
trials:
- POLT-HCV-SVR: A randomized, double
blind, placebo-controlled Phase 2b clinical trial initiated in May
2014 evaluating potential improvements in Ishak Fibrosis Score 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.
Results after two years of twice-daily treatment with emricasan or
placebo are expected in the first half of 2018.
- ENCORE-NF: A randomized, double blind,
placebo-controlled Phase 2b clinical trial initiated in January
2016 evaluating potential improvements in fibrosis and
steatohepatitis in patients with fibrosis caused by NASH. Results
after 18 months of twice-daily treatment with emricasan or placebo
are expected in 2018.
The company plans to initiate the following additional emricasan
clinical trials as resources permit:
- ENCORE-LF: A planned randomized,
double-blind, placebo-controlled clinical trial, expected to begin
in the first half of 2017, to evaluate the effect of emricasan on
liver function and to collect chronic administration safety
information in NASH cirrhosis patients.
- ENCORE-XT: Planned extensions to
continue treatment for a total of at least two years in patients
completing the ENCORE-PH and ENCORE-LF trials, with continued
monitoring for efficacy, safety, clinical outcomes and
health-related quality of life.
During the third quarter, the company announced the acceptance
of abstracts for four posters – two addressing clinical results and
two addressing preclinical results with emricasan – to be presented
at The Liver Meeting®, the annual meeting of the American
Association for the Study of Liver Diseases (AASLD) in Boston
November 11-15, 2016. Two of the posters were accepted as
“Presidential Posters of Distinction,” indicating review scores
that place them within the top 10 percent of all posters submitted.
The following accepted abstracts are available on the AASLD website
at www.aasld.org/:
- “Emricasan (IDN-6556) Orally for 6 Months in Patients with
Cirrhosis and Elevated MELD Score Improves Liver Function,” (poster
#2095), to be presented by Catherine Frenette, M.D., Medical
Director of Liver Transplantation at Scripps Clinic, La Jolla, CA,
and a principal investigator in the company’s multicenter Phase 2
Liver Cirrhosis clinical trial of emricasan;
- “Emricasan (IDN-6556) Orally for 6 Months in Patients with
Non-alcoholic Steatohepatitis (NASH) Cirrhosis Decreases the
Progression of MELD score and Improves Liver Function,” (poster
#2099), also to be presented by Dr. Frenette;
- “The pan caspase inhibitor Emricasan improves the hepatic
microcirculatory dysfunction of CCl4-cirrhotic rats leading to
portal hypertension amelioration and cirrhosis regression,” (poster
#2097) to be presented by Jordi Gracia-Sancho, Ph.D., Ramón y Cajal
Researcher in Biomedicine at Barcelona Hepatic Hemodynamic Lab,
IDIBAPS Biomedical Research Institute & CIBEREHD, Barcelona,
Spain; and
- “Circulating microparticles carry apoptosis markers CK-18 and
caspase-3/7 which are reduced by treatment with Emricasan in
subjects with chronic liver diseases,” (poster #2098), to be
presented by Akiko Eguchi, Ph.D., Project Scientist in the
Department of Pediatrics, University of California San Diego, La
Jolla, CA.
Conference Call and Audio WebcastConatus will
host a conference call and webcast at 4:30 p.m. Eastern Time today,
November 8, to discuss quarterly financial results and provide an
update on the company’s development programs. 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 8748956. A live and archived
webcast of the call will be available in the Investors section of
the company’s website at www.conatuspharma.com.
About Conatus
PharmaceuticalsConatus is a biotechnology company focused
on the development and commercialization of novel medicines to
treat liver disease. Conatus is developing emricasan, a
first-in-class, orally active pan-caspase protease inhibitor, for
the treatment of patients with chronic liver disease. 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. For additional information, please visit
www.conatuspharma.com.
Forward-Looking StatementsThis 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 timelines to announce results from the POLT-HCV-SVR,
the ENCORE-NF, and the ENCORE-PH clinical trials; and the trial
details and intent to initiate the ENCORE-LF and ENCORE-XT
trials. 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; 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’ 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 |
|
|
Nine Months Ended |
|
Statements of
Operations |
|
September 30, |
|
|
September 30, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
4,825,421 |
|
|
$ |
4,103,257 |
|
|
|
$ |
13,770,371 |
|
|
$ |
12,056,997 |
|
|
General
and administrative |
|
|
2,069,447 |
|
|
|
1,958,078 |
|
|
|
|
6,883,708 |
|
|
|
6,033,739 |
|
|
Total operating
expenses |
|
|
6,894,868 |
|
|
|
6,061,335 |
|
|
|
|
20,654,079 |
|
|
|
18,090,736 |
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
33,640 |
|
|
|
19,680 |
|
|
|
|
94,995 |
|
|
|
49,076 |
|
|
Interest
expense |
|
|
(17,500 |
) |
|
|
(17,500 |
) |
|
|
|
(52,500 |
) |
|
|
(52,500 |
) |
|
Other
income (expense) |
|
|
11,818 |
|
|
|
(8,391 |
) |
|
|
|
1,645 |
|
|
|
(10,304 |
) |
|
Total other income
(expense) |
|
|
27,958 |
|
|
|
(6,211 |
) |
|
|
|
44,140 |
|
|
|
(13,728 |
) |
|
Net loss |
|
$ |
(6,866,910 |
) |
|
$ |
(6,067,546 |
) |
|
|
$ |
(20,609,939 |
) |
|
$ |
(18,104,464 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.31 |
) |
|
|
$ |
(0.96 |
) |
|
$ |
(0.99 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
22,410,702 |
|
|
|
19,668,287 |
|
|
|
|
21,527,993 |
|
|
|
18,209,871 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
Balance Sheets |
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash, cash equivalents and marketable securities |
$ |
31,063,622 |
|
|
$ |
36,508,109 |
|
|
Prepaid and other current assets |
|
1,137,384 |
|
|
|
1,982,031 |
|
|
Total current assets |
|
32,201,006 |
|
|
|
38,490,140 |
|
|
Property and equipment, net |
|
285,023 |
|
|
|
344,734 |
|
|
Other assets |
|
876,130 |
|
|
|
892,394 |
|
|
Total assets |
$ |
33,362,159 |
|
|
$ |
39,727,268 |
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
Current liabilities |
$ |
3,964,175 |
|
|
$ |
3,982,698 |
|
|
Note payable |
|
1,000,000 |
|
|
|
1,000,000 |
|
|
Deferred
rent |
|
|
|
|
|
|
|
181,637 |
|
|
|
204,224 |
|
|
Stockholders' equity |
|
28,216,347 |
|
|
|
34,540,346 |
|
|
Total liabilities and stockholders' equity |
$ |
33,362,159 |
|
|
$ |
39,727,268 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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
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