Conatus Pharmaceuticals Reports First Quarter 2019 Financial Results and Program Updates
May 02 2019 - 4:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced
financial results for the first quarter ended March 31, 2019, and
provided updates on its development programs.
Program Updates The company is currently
conducting two double-blind, placebo-controlled Phase 2b clinical
trials in collaboration with Novartis – the EmricasaN, a Caspase
inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate
emricasan, a first-in-class pan-caspase inhibitor, in patients with
liver cirrhosis caused by nonalcoholic steatohepatitis (NASH).
- The ENCORE-LF (for Liver Function) clinical trial, initiated in
the second quarter of 2017, has enrolled approximately 210 patients
with stable decompensated NASH cirrhosis. The primary endpoint is
event-free survival, which is a composite of all-cause mortality,
new decompensation events, or ≥4 points progression in Model for
End-stage Liver Disease (MELD) score. Enrollment was completed in
the first quarter of 2019. Top-line results triggered by reaching a
prespecified number of events are expected in mid-2019.
- The ENCORE-PH (for Portal Hypertension) clinical trial,
initiated in the fourth quarter of 2016, enrolled 263 patients with
compensated or early decompensated NASH cirrhosis and severe portal
hypertension. The trial’s primary endpoint was change in mean
hepatic venous pressure gradient (HVPG) from baseline to Week 24 in
any of three emricasan dosing groups compared with placebo.
Top-line results were reported in December 2018 showing HVPG trends
consistently favoring emricasan compared with placebo in the
overall population but not meeting the primary endpoint. The
greatest improvement was observed in patients with a baseline HVPG
of 16 mmHg or higher. Week 24 results from the ENCORE-PH clinical
trial were detailed in a late-breaker oral presentation at The
International Liver Congress™ 2019, the Annual Meeting of the
European Association for the Study of the Liver (EASL) in Vienna,
Austria, on April 13, 2019. The associated abstract was also
selected by EASL for inclusion in the “Best of ILC” summary slide
deck highlighting the most noteworthy contributions to the
scientific program at this year’s meeting. A copy of the
presentation is available in the Investors section of the Conatus
website at www.conatuspharma.com.Patients had the option to
continue on their assigned doses of treatment or placebo in a
double-blind 24-week extension period. Results following the
extension period are expected in mid-2019 and will include longer
term safety, liver function and clinical outcomes, but there will
be no additional HVPG measurements.
During the first quarter of 2019, the company announced top-line
results from a third double-blind, placebo-controlled Phase 2b
clinical trial, the ENCORE-NF (for NASH Fibrosis) clinical trial in
patients with biopsy-confirmed NASH and liver fibrosis. The trial’s
primary endpoint was a ≥1 CRN fibrosis stage improvement with no
worsening of steatohepatitis compared with placebo at week 72. The
trial did not meet the primary endpoint.
The company announced in March 2019 the selection of its first
internally developed product candidate, CTS-2090, an orally active
inhibitor of caspase 1. Caspase 1 occupies a uniquely central
position in the NLRP3 inflammasome pathway and blocks activation of
the potent inflammatory cytokine IL-1β. Blocking IL-1β is a
clinically validated approach to treating inflammatory diseases,
with several injectable biologic products using that mechanism of
action already on the market. CTS-2090 is currently in preclinical
development and IND-enabling studies, with an initial clinical
trial planned to begin by the first half of 2020. The company plans
to pursue rare autoinflammatory diseases as initial clinical
targets for CTS-2090.
Financial Results The net loss was $4.7 million
for the first quarter of 2019 compared with a net loss of $5.0
million for the first quarter of 2018.
Total revenues were $7.0 million for the first quarter of 2019
compared with $9.7 million for the first quarter of 2018. Total
revenues consisted of collaboration revenues related to the
Novartis agreement. The decrease in total revenues was primarily
due to lower emricasan-related research and development expenses
resulting in corresponding lower revenues related to the Novartis
agreement.
Research and development expenses were $9.4 million for the
first quarter of 2019 compared with $12.1 million for the first
quarter of 2018. The decrease in research and development expenses
was primarily due to lower spending related to the ENCORE-PH
clinical trial and manufacturing activities, partially offset by
higher spending related to the ENCORE-LF clinical trial.
General and administrative expenses were $2.6 million for the
first quarter of 2019 compared with $2.7 million for the first
quarter of 2018.
Cash, cash equivalents and marketable securities were $33.8
million at March 31, 2019, compared with $40.7 million at December
31, 2018, and a projected year-end 2019 balance, without including
any potential milestone payments under the Novartis collaboration,
of between $10 million and $15 million.
About Conatus PharmaceuticalsConatus is a
biotechnology company focused on the development and
commercialization of novel medicines to treat chronic diseases with
significant unmet need. In collaboration with Novartis, Conatus is
developing its lead in-licensed compound, emricasan, for the
treatment of patients with NASH-driven chronic liver diseases.
Conatus is independently developing its lead internally developed
compound, CTS-2090, for the treatment of patients with chronic
diseases involving inflammasome pathways. 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 clinical trials; the plan and timeline to begin an
initial clinical trial of CTS-2090; the initial clinical targets
for CTS-2090; and the projected year-end cash balance. In some
cases, you can identify forward-looking statements by terms such as
“may,” “will,” “should,” “expects,” “plans,” “anticipates,”
“could,” “intends,” “targets,” “projects,” “contemplates,”
“believes,” “estimates,” “predicts,” “potential” or “continues” 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 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 supplies of emricasan and CTS-2090; 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 CTS-2090 or 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.
|
Conatus Pharmaceuticals Inc. |
Selected Condensed Financial
Information |
(In thousands, except per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended |
Statements of
Operations |
|
March 31, |
|
|
2019 |
|
2018 |
|
|
|
|
|
Revenues: |
|
|
|
|
Collaboration
revenue |
|
$ |
7,024 |
|
|
$ |
9,737 |
|
Operating
expenses: |
|
|
|
|
Research
and development |
|
|
9,383 |
|
|
|
12,081 |
|
General
and administrative |
|
|
2,591 |
|
|
|
2,713 |
|
Total operating
expenses |
|
|
11,974 |
|
|
|
14,794 |
|
Loss from
operations |
|
|
(4,950 |
) |
|
|
(5,057 |
) |
Other
income/expense |
|
|
203 |
|
|
|
39 |
|
Net loss |
|
$ |
(4,747 |
) |
|
$ |
(5,018 |
) |
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.14 |
) |
|
$ |
(0.17 |
) |
|
|
|
|
|
Weighted average shares
outstanding used in computing |
|
|
|
|
net loss
per share, basic and diluted |
|
|
33,165 |
|
|
|
30,048 |
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
Balance Sheets |
|
2019 |
|
2018 |
|
|
|
|
|
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
$ |
33,833 |
|
|
$ |
40,692 |
|
Collaboration receivables |
|
|
3,860 |
|
|
|
3,677 |
|
Prepaid
and other current assets |
|
|
2,633 |
|
|
|
3,057 |
|
Total
current assets |
|
|
40,326 |
|
|
|
47,426 |
|
Property
and equipment, net |
|
|
145 |
|
|
|
154 |
|
Other
assets |
|
|
1,707 |
|
|
|
1,223 |
|
Total
assets |
|
$ |
42,178 |
|
|
$ |
48,803 |
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts
payable and other current liabilities |
|
$ |
8,625 |
|
|
$ |
8,446 |
|
Current
portion of deferred revenue |
|
|
8,150 |
|
|
|
10,075 |
|
Total
current liabilities |
|
|
16,775 |
|
|
|
18,521 |
|
Deferred
revenue, less current portion |
|
|
1,576 |
|
|
|
2,815 |
|
Other
long-term liabilities |
|
|
229 |
|
|
|
68 |
|
Stockholders' equity |
|
|
23,598 |
|
|
|
27,399 |
|
Total
liabilities and stockholders' equity |
|
$ |
42,178 |
|
|
$ |
48,803 |
|
|
|
|
|
|
CONTACT: Alan EngbringConatus Pharmaceuticals
Inc.(858) 376-2637aengbring@conatuspharma.com
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