Conatus Pharmaceuticals Reports Second Quarter 2016 Financial Results and Program Updates
August 03 2016 - 4:05PM
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 six months ended June 30, 2016, and provided updates on
its clinical development programs.
Financial ResultsThe net loss for the second
quarter of 2016 was $6.5 million compared with $6.1 million for the
second quarter of 2015. The net loss for the first six months of
2016 was $13.7 million compared with $12.0 million for the first
six months of 2015.
Research and development expenses were $4.2 million for the
second quarter of 2016 compared with $4.1 million for the second
quarter of 2015. Research and development expenses were $8.9
million for the first six months of 2016 compared with $8.0 million
for the first six months of 2015. The increases in research and
development expenses were primarily due to higher external
emricasan clinical trial and manufacturing costs.
General and administrative expenses were $2.2 million for the
second quarter of 2016 compared with $2.0 million for the second
quarter of 2015. The quarterly increase in general and
administrative expenses was primarily due to higher personnel costs
and consulting fees. General and administrative expenses were $4.8
million for the first six months of 2016 compared with $4.1 million
for the first six months of 2015. The year-to-date increase in
general and administrative expenses was primarily due to higher
personnel costs and higher consulting, legal and accounting
fees.
Cash, cash equivalents and marketable securities were $30.2
million at June 30, 2016, compared with $36.5 million at December
31, 2015. The company believes current financial resources are
sufficient to maintain operations and ongoing clinical trials for
at least the next 12 months.
Program UpdatesConatus is developing emricasan,
a first-in-class, orally active pan-caspase inhibitor, for the
treatment of patients with chronic liver disease. During the second
quarter, the company announced:
- positive top-line results from the three-month, open-label
second stage of the company’s Phase 2 Liver Cirrhosis clinical
trial, evaluating potential 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;
- a late-breaker oral presentation entitled, “Emricasan
(IDN-6556) orally for three months in patients with cirrhosis and
MELD scores 11-18 improves clinical parameters of cirrhosis in
patients with baseline MELD score ≥15,” delivered at the Annual
Meeting of the European Association for the Study of the Liver
(EASL); and
- a poster entitled, “The potent pan-caspase inhibitor IDN-7314
does not affect tumor growth rate nor does it antagonize the
efficacy of sorafenib in models of hepatocellular carcinoma,” also
presented at the EASL annual meeting.
Conatus has two ongoing emricasan Phase 2 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 nonalcoholic
steatohepatitis (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 on a staggered basis through early 2017 as
resources permit and expects top-line results to be available
periodically beginning in 2018:
- ENCORE-PH: A planned randomized,
double-blind, placebo-controlled clinical trial, expected to begin
in the second half of 2016, to evaluate the effect of emricasan in
reducing hepatic venous pressure gradient (HVPG) in NASH cirrhosis
patients with clinically significant Portal Hypertension and
impaired hepatic function.
- ENCORE-LF: A planned randomized,
double-blind, placebo-controlled clinical trial, expected to begin
in the first half of 2017, to assess long-term Liver Function
endpoints of MELD score and Child-Pugh-Turcotte status, related
serum biomarkers and laboratory parameters associated with liver
function, and will collect chronic administration safety
information in NASH cirrhosis patients.
- ENCORE-XT: A planned eXTension clinical
trial to continue treatment for a total of at least two years in
patients completing other trials of emricasan, with continued
monitoring for efficacy, safety, clinical outcomes and
health-related quality of life.
Conference Call and Audio WebcastConatus will
host a conference call and webcast at 4:30 p.m. Eastern Time today,
August 3, 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 50509324. 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
trial and results from the ENCORE-NF trial; and the trial details
and timelines to initiate and announce results from the ENCORE-PH,
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 |
|
|
Six Months Ended |
|
Statements of
Operations |
|
June 30, |
|
|
June 30, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,246,488 |
|
|
$ |
4,070,127 |
|
|
|
$ |
8,944,950 |
|
|
$ |
7,953,740 |
|
|
General and administrative |
|
|
2,238,134 |
|
|
|
1,994,352 |
|
|
|
|
4,814,261 |
|
|
|
4,075,661 |
|
|
Total operating
expenses |
|
|
6,484,622 |
|
|
|
6,064,479 |
|
|
|
|
13,759,211 |
|
|
|
12,029,401 |
|
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
34,377 |
|
|
|
17,977 |
|
|
|
|
61,355 |
|
|
|
29,396 |
|
|
Interest expense |
|
|
(17,500 |
) |
|
|
(17,500 |
) |
|
|
|
(35,000 |
) |
|
|
(35,000 |
) |
|
Other (expense) income |
|
|
(3,400 |
) |
|
|
6,748 |
|
|
|
|
(10,173 |
) |
|
|
(1,913 |
) |
|
Total other income
(expense) |
|
|
13,477 |
|
|
|
7,225 |
|
|
|
|
16,182 |
|
|
|
(7,517 |
) |
|
Net loss |
|
$ |
(6,471,145 |
) |
|
$ |
(6,057,254 |
) |
|
|
$ |
(13,743,029 |
) |
|
$ |
(12,036,918 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.31 |
) |
|
|
$ |
(0.65 |
) |
|
$ |
(0.69 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
21,542,188 |
|
|
|
19,338,167 |
|
|
|
|
21,085,610 |
|
|
|
17,468,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June
30, |
|
December
31, |
|
Balance Sheets |
|
2016 |
|
|
|
2015 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash, cash equivalents
and marketable securities |
$ |
30,202,528 |
|
|
$ |
36,508,109 |
|
|
Prepaid and other
current assets |
|
876,823 |
|
|
|
1,982,031 |
|
|
Total current assets |
|
31,079,351 |
|
|
|
38,490,140 |
|
|
Property and equipment, net |
|
311,381 |
|
|
|
344,734 |
|
|
Other assets |
|
876,130 |
|
|
|
892,394 |
|
|
Total assets |
$ |
32,266,862 |
|
|
$ |
39,727,268 |
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
Current liabilities |
$ |
3,235,359 |
|
|
$ |
3,982,698 |
|
|
Note payable |
|
1,000,000 |
|
|
|
1,000,000 |
|
|
Deferred
rent |
|
|
|
|
|
|
|
190,377 |
|
|
|
204,224 |
|
|
Stockholders' equity |
|
27,841,126 |
|
|
|
34,540,346 |
|
|
Total liabilities and stockholders' equity |
$ |
32,266,862 |
|
|
$ |
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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