Conatus Pharmaceuticals Reports First Quarter 2018 Financial Results and Program Updates
May 02 2018 - 4:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company
focused on the development of novel medicines to treat liver
disease, today announced financial results for the first quarter
ended March 31, 2018, and provided updates on its development
programs.
Program Updates In April 2018, the company
reported top-line results from its exploratory Phase 2b
POLT-HCV-SVR proof-of-concept clinical trial 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 had successfully achieved a sustained viral response
(SVR) following HCV antiviral therapy. The overall safety profile
after two years of dosing in an immunocompromised patient
population was similar in the emricasan and placebo groups.
Although the trial did not meet its primary endpoint in the
heterogeneous overall trial population, emricasan demonstrated a
significant anti-fibrotic treatment effect in the prespecified
subgroup of patients with advanced fibrosis and early cirrhosis. At
this time, there are no plans to initiate additional clinical
trials on the basis of the POLT-HCV-SVR trial alone.
In the POLT-HCV-SVR clinical trial, a separate patient
population was studied versus the other three Phase 2b clinical
trials in the company’s collaboration with Novartis – the
EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials,
designed to evaluate emricasan in patients with fibrosis or
cirrhosis caused by nonalcoholic steatohepatitis (NASH):
- 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 fourth quarter 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.
In February 2018, the company initiated a Phase 2 post-treatment
follow-up clinical trial to monitor long-term adverse event rates
in patients treated with emricasan or placebo in any of the four
Phase 2b clinical trials.
Financial Results Total revenues were $9.7
million for the first quarter of 2018 compared with $7.0 million
for the first quarter of 2017. Total revenues consisted of
collaboration revenues related to the Novartis agreement. The
increase was primarily due to higher revenue from reimbursable
costs related to the Novartis agreement, as well as the effect of
adoption of the ASC 606 revenue recognition standard.
Research and development expenses were $12.1 million for the
first quarter of 2018 compared with $7.9 million for the first
quarter of 2017. The increase in research and development expenses
was primarily due to the ramp up of the ENCORE-PH and ENCORE-LF
clinical trials and higher spending on new product candidate
development.
General and administrative expenses were $2.7 million for the
first quarter of 2018 compared with $2.8 million for the first
quarter of 2017.
The net loss was $5.0 million for the first quarter of 2018
compared with $3.6 million for the first quarter of 2017.
Cash, cash equivalents and marketable securities were $66.8
million at March 31, 2018, compared with $74.9 million at December
31, 2017, 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 ongoing clinical trials, without
including any potential milestone payments under the Novartis
collaboration, are sufficient to maintain operations through
top-line results from the three ENCORE 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 5286754. 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 Conatus Pharmaceuticals Conatus is a
biotechnology company focused on the development of novel medicines
to treat liver disease. In collaboration with Novartis, 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 inhibitor designed to reduce the activity
of enzymes that mediate inflammation and apoptosis. Conatus
believes that by reducing the activity of these enzymes, caspase
inhibitors have the potential to interrupt the progression of a
variety of diseases. 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 timelines to announce results from
the ENCORE-PH, the ENCORE-NF, and the ENCORE-LF clinical trials;
the projected year-end cash balance; the sufficiency of current
financial resources to maintain operations and ongoing clinical
development activities through 2019, as well as to fund initial
pipeline expansion activities; and caspase inhibitors' potential to
interrupt the progression of a variety of diseases. 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 successfully
enroll patients in and complete its ongoing and planned clinical
trials; Novartis continuing development and commercialization of
emricasan; Conatus’ reliance on third parties to conduct its
clinical trials, including the enrollment of patients, and
manufacture its clinical drug supplies of emricasan; potential
adverse side effects or other safety risks associated with
emricasan that could delay or preclude its approval; results of
future clinical trials of emricasan; Conatus’ ability to obtain
additional financing in order to co-commercialize emricasan or
develop other compounds; 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.
CONTACT: Alan EngbringConatus
Pharmaceuticals Inc.(858) 376-2637aengbring@conatuspharma.com
Conatus Pharmaceuticals Inc. |
|
Selected Condensed Financial
Information |
|
(In thousands, except per share
data) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Statements of
Operations |
|
|
March 31, |
|
|
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
Collaboration revenue |
|
|
$ |
9,737 |
|
|
$ |
6,998 |
|
|
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
|
|
12,081 |
|
|
|
7,926 |
|
|
General
and administrative |
|
|
|
2,713 |
|
|
|
2,763 |
|
|
Total operating
expenses |
|
|
|
14,794 |
|
|
|
10,689 |
|
|
Loss from
operations |
|
|
|
(5,057 |
) |
|
|
(3,691 |
) |
|
Other
income/expense |
|
|
|
39 |
|
|
|
68 |
|
|
Net loss |
|
|
$ |
(5,018 |
) |
|
$ |
(3,623 |
) |
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
|
$ |
(0.17 |
) |
|
$ |
(0.14 |
) |
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
|
30,048 |
|
|
|
26,163 |
|
|
|
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
Balance Sheets |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
$ |
66,751 |
|
|
$ |
74,853 |
|
|
Collaboration receivables |
|
|
5,847 |
|
|
|
3,367 |
|
|
Prepaid and other current assets |
|
|
1,231 |
|
|
|
1,004 |
|
|
Total current assets |
|
|
73,829 |
|
|
|
79,224 |
|
|
Property and equipment, net |
|
|
157 |
|
|
|
179 |
|
|
Other assets |
|
|
2,660 |
|
|
|
2,538 |
|
|
Total assets |
|
$ |
76,646 |
|
|
$ |
81,941 |
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable and other accrued expenses |
|
$ |
15,739 |
|
|
$ |
13,970 |
|
|
Current
portion of deferred revenue |
|
|
|
14,868 |
|
|
|
14,172 |
|
|
Total
current liabilities |
|
|
|
30,607 |
|
|
|
28,142 |
|
|
Deferred
revenue, less current portion |
|
|
|
9,231 |
|
|
|
12,519 |
|
|
Convertible note payable |
|
|
13,343 |
|
|
|
13,158 |
|
|
Deferred
rent |
|
|
|
113 |
|
|
|
126 |
|
|
Stockholders' equity |
|
|
23,352 |
|
|
|
27,996 |
|
|
Total liabilities and stockholders' equity |
|
$ |
76,646 |
|
|
$ |
81,941 |
|
|
|
|
|
|
|
|
|
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