Conatus Pharmaceuticals Reports 2018 Financial Results and Program Updates
March 08 2019 - 4:05PM
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) today announced
financial results for the fourth quarter and full year ended
December 31, 2018, and provided updates on its development
programs.
Program Updates The company is conducting three
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
fibrosis or cirrhosis caused by nonalcoholic steatohepatitis
(NASH).
- The ENCORE-NF (for NASH Fibrosis) clinical trial, initiated in
the first quarter of 2016, has enrolled approximately 330 patients
with baseline NASH Clinical Research Network (CRN) fibrosis scores
of F1 (up to 20% of enrolled patients), F2, and F3. The primary
endpoint is a biopsy-based one point or greater improvement in NASH
CRN fibrosis score compared with placebo at week 72, with no
worsening of steatohepatitis. The primary endpoint will be
evaluated and can be achieved in either of two prospectively
defined patient populations – the F1/F2/F3 population or the F2/F3
population. Either of these populations may be used in a future
Phase 3 trial. The company believes that the ENCORE-NF analysis
plan has the potential to facilitate discussions with regulatory
authorities regarding its use as a study to support regulatory
approval. Top-line results from ENCORE-NF are expected in the first
half of 2019.
- 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. Post hoc
analyses showed clinically meaningful treatment effects for
emricasan compared with placebo and a trend toward clinical benefit
in the prespecified subpopulation of compensated patients, with the
greatest improvement in compensated patients with baseline HVPG ≥16
mmHg. Patients had the option to continue on their assigned doses
of treatment or placebo in a double-blind 24-week extension period
to evaluate longer term safety, liver function and clinical
outcomes. Results following the extension period are expected in
mid-2019.
In its internal development program, the company has assembled a
proprietary portfolio of orally active molecules that inhibit the
NLRP3 inflammasome pathway and the activation of the potent
inflammatory cytokine IL-1b. Inhibition of IL-1b is a clinically
validated approach to treating inflammatory diseases, with several
injectable biologic products using that mechanism of action already
on the market. The NLRP3 inflammasome pathway is dependent upon
caspase 1, which activates IL-1b. Caspase 1 occupies a uniquely
central position in the inflammasome pathway, and the company has
leveraged its scientific expertise in caspase research and
development to design potent, selective and orally bioavailable
inhibitors of caspase 1. Excess IL-1b has been linked to a variety
of diseases including rare genetic inflammatory diseases, cancer,
liver and other gastrointestinal diseases, and cardiovascular
diseases.
The company is announcing today the selection of its first
internally developed product candidate, CTS-2090, based on its
preclinical profile, including high selectivity for caspase 1, and
drug-like properties. CTS-2090 is currently in preclinical
development and IND-enabling studies, with an initial clinical
trial expected to begin by the first half of 2020. Additional
details will be discussed in the conference call and webcast
scheduled for 4:30 p.m. ET today (information below).
Financial ResultsThe net loss for the fourth
quarter of 2018 was $3.9 million compared with $4.4 million for the
fourth quarter of 2017. The net loss for the full year 2018 was
$18.0 million compared with $17.4 million for the full year
2017.
Total revenues were $7.4 million for the fourth quarter of 2018
compared with $8.8 million for the fourth quarter of 2017, and
$33.6 million for the full year 2018 compared with $35.4 million
for the full year 2017. Total revenues consisted of collaboration
revenues related to the Novartis agreement. The decreases in
revenues for both periods were primarily due to lower
emricasan-related research and development expenses resulting in
corresponding lower revenues related to the Novartis agreement,
partially offset by the effects of adopting the ASC 606 revenue
recognition standard.
Research and development expenses were $8.9 million for the
fourth quarter of 2018 compared with $10.9 million for the fourth
quarter of 2017. Research and development expenses were $41.4
million for the full year 2018 compared with $43.2 million for the
full year 2017. The decreases in both periods were primarily due to
lower costs related to the ENCORE clinical trials, as well as lower
costs related to emricasan manufacturing activities, partially
offset by higher costs related to new product candidate
development.
General and administrative expenses were $2.5 million for the
fourth quarter of 2018 compared with $2.3 million for the fourth
quarter of 2017. General and administrative expenses were $10.5
million for the full year 2018 compared with $9.7 million for the
full year 2017. The increases in general and administrative
expenses for both periods were primarily due to higher personnel
costs and recognition of deferred collaboration costs due to
adoption of the new revenue recognition standard.
In December 2018, the company, at its option, converted the
outstanding principal plus accrued and unpaid interest of the
Novartis note into shares of the company’s common stock. Cash, cash
equivalents and marketable securities were $40.7 million at
December 31, 2018, compared with $74.9 million at December 31,
2017, and a projected year-end 2019 balance, without including any
potential milestone payments under the Novartis collaboration, of
between $10 million and $15 million.
Conference Call and Audio WebcastConatus will
host a conference call and audio webcast at 4:30 p.m. ET 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 3249458. 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 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 expectation and timeline to begin
an initial clinical trial of CTS-2090; the projected year-end cash
balance; emricasan’s potential as a treatment for NASH-driven
chronic liver diseases; and CTS-2090’s potential as a treatment for
chronic diseases involving inflammasome pathways. 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
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
CTS-2090; potential adverse side effects or other safety risks
associated with emricasan or CTS-2090 that could delay or preclude
its approval; results of future clinical trials of emricasan or
CTS-2090; 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 |
|
Twelve Months Ended |
Statements of
Operations |
|
|
December 31, |
|
December 31, |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
|
$ |
7,409 |
|
|
$ |
8,805 |
|
|
$ |
33,586 |
|
|
$ |
35,377 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
8,886 |
|
|
|
10,911 |
|
|
|
41,368 |
|
|
|
43,220 |
|
General
and administrative |
|
|
|
2,528 |
|
|
|
2,301 |
|
|
|
10,495 |
|
|
|
9,707 |
|
Total operating
expenses |
|
|
|
11,414 |
|
|
|
13,212 |
|
|
|
51,863 |
|
|
|
52,927 |
|
Loss from
operations |
|
|
|
(4,005 |
) |
|
|
(4,407 |
) |
|
|
(18,277 |
) |
|
|
(17,550 |
) |
Other
income/expense |
|
|
|
99 |
|
|
|
51 |
|
|
|
267 |
|
|
|
154 |
|
Net loss |
|
|
$ |
(3,906 |
) |
|
$ |
(4,356 |
) |
|
$ |
(18,010 |
) |
|
$ |
(17,396 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
|
$ |
(0.13 |
) |
|
$ |
(0.15 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing |
|
|
|
|
|
|
|
|
|
net loss per share,
basic and diluted |
|
|
|
31,118 |
|
|
|
30,018 |
|
|
|
30,370 |
|
|
|
28,587 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
Balance Sheets |
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
|
$ |
40,692 |
|
|
$ |
74,853 |
|
Collaboration receivables |
|
|
|
|
|
|
3,677 |
|
|
|
3,367 |
|
Prepaid and other current assets |
|
|
|
|
|
|
3,057 |
|
|
|
1,004 |
|
Total
current assets |
|
|
|
|
|
|
47,426 |
|
|
|
79,224 |
|
Property
and equipment, net |
|
|
|
|
|
|
154 |
|
|
|
179 |
|
Other
assets |
|
|
|
|
|
|
1,223 |
|
|
|
2,538 |
|
Total
assets |
|
|
|
|
|
$ |
48,803 |
|
|
$ |
81,941 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable and other accrued expenses |
|
|
|
|
|
$ |
8,446 |
|
|
$ |
13,970 |
|
Current
portion of deferred revenue |
|
|
|
|
|
|
|
10,075 |
|
|
|
14,172 |
|
Total current
liabilities |
|
|
|
|
|
|
|
18,521 |
|
|
|
28,142 |
|
Deferred revenue, less
current portion |
|
|
|
|
|
|
|
2,815 |
|
|
|
12,519 |
|
Convertible
note payable |
|
|
|
|
|
|
- |
|
|
|
13,158 |
|
Deferred rent |
|
|
|
|
|
|
|
68 |
|
|
|
126 |
|
Stockholders' equity |
|
|
|
|
|
|
27,399 |
|
|
|
27,996 |
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
$ |
48,803 |
|
|
$ |
81,941 |
|
|
|
|
|
|
|
|
|
|
|
CONTACT: Alan EngbringConatus
Pharmaceuticals Inc.(858) 376-2637aengbring@conatuspharma.com
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