Conatus Pharmaceuticals Reports Third Quarter 2018 Financial Results and Program Updates
November 01 2018 - 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 nine months ended September 30, 2018, and provided
updates on its clinical development programs.
Program Updates The company is conducting three
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 fibrosis or cirrhosis caused by
nonalcoholic steatohepatitis (NASH).
- The ENCORE-PH (for Portal Hypertension) clinical trial,
initiated in the fourth quarter of 2016, has enrolled approximately
240 patients with compensated or early decompensated NASH cirrhosis
and severe portal hypertension. The primary endpoint is the mean
change in hepatic venous pressure gradient (HVPG) for each of three
treatment groups compared with placebo at week 24. ENCORE-PH
remains on track with prior guidance, with top-line results
expected in the current quarter followed by an integrated 24-week
treatment extension period for clinical outcomes.
- The ENCORE-NF (for NASH Fibrosis) clinical trial, initiated in
the first quarter of 2016, has enrolled approximately 330 patients
with NASH fibrosis. The primary endpoint is a one point or greater
improvement in NASH Clinical Research Network (CRN) fibrosis score
compared with placebo at week 72, with no worsening of
steatohepatitis. ENCORE-NF enrolled patients with baseline NASH CRN
fibrosis scores of F1 (up to 20% of enrolled patients), F2, and F3.
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 as described 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, is expected to enroll approximately 210
patients with decompensated NASH cirrhosis. The primary endpoint is
event-free survival, with an event-driven stopping point. All
subjects will be treated for a minimum of 48 weeks. Guidance
for the ENCORE-LF clinical trial has been updated, with top-line
results previously expected in the second half of 2019 now expected
in mid-2019.
During the third quarter, the company announced the publication
of results from preclinical studies of emricasan, demonstrating
improvements in portal hypertension and survival in mouse models of
secondary biliary cirrhosis. In October, the company announced
accepted abstracts for two oral presentations and a poster at The
Liver Meeting®, the annual meeting of the American Association for
the Study of Liver Diseases (AASLD) in San Francisco November 9-13,
2018. In addition, the company will be meeting with institutional
investors at the Stifel 2018 Healthcare Conference in New York on
Tuesday, November 13, 2018.
Financial ResultsThe net loss for the third
quarter of 2018 was $4.6 million compared with $4.0 million for the
third quarter of 2017. The net loss for the first nine months of
2018 was $14.1 million compared with $13.0 million for the first
nine months of 2017.
All revenues were related to the company’s collaboration with
Novartis. Total revenues were $7.7 million for the third quarter of
2018 compared with $9.6 million for the third quarter of 2017.
Total revenues were $26.2 million for the first nine months of 2018
compared with $26.6 million for the first nine months of 2017. The
decreases in revenues for both periods were primarily due to lower
emricasan-related research and development expenses resulting in
corresponding lower revenues from Novartis, partially offset by the
effects of adopting the ASC 606 revenue recognition standard.
Research and development expenses were $9.7 million for the
third quarter of 2018 compared with $11.2 million for the third
quarter of 2017. The decrease in research and development expenses
was primarily due to lower spending related to the ENCORE-NF and
ENCORE-PH clinical trials and manufacturing activities, partially
offset by higher spending related to the ENCORE-LF clinical trial.
Research and development expenses were $32.5 million for the first
nine months of 2018 compared with $32.3 million for the first nine
months of 2017. The increase in research and development expenses
was primarily due to higher spending related to the ENCORE-LF and
ENCORE-PH clinical trials and new product candidate development,
partially offset by lower spending related to the ENCORE-NF
clinical trial and manufacturing activities.
General and administrative expenses were $2.7 million for the
third quarter of 2018 compared with $2.4 million for the third
quarter of 2017. General and administrative expenses were $8.0
million for the first nine months of 2018 compared with $7.4
million for the first nine months of 2017. The increases in general
and administrative expenses for both periods were primarily due to
higher personnel costs.
Cash, cash equivalents and marketable securities were $49.6
million at September 30, 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 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 5773926. 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 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 clinical trials; the potential for the ENCORE-NF
clinical trial to serve as a study to support regulatory approval;
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 anticipated
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.
Conatus Pharmaceuticals
Inc. |
Selected Condensed Financial
Information |
(In thousands, except per share
data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
Statements of
Operations |
|
September
30, |
|
September
30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
7,666 |
|
|
$ |
9,566 |
|
|
$ |
26,177 |
|
|
$ |
26,572 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
9,664 |
|
|
|
11,165 |
|
|
|
32,482 |
|
|
|
32,309 |
|
General
and administrative |
|
|
2,660 |
|
|
|
2,449 |
|
|
|
7,967 |
|
|
|
7,406 |
|
Total operating
expenses |
|
|
12,324 |
|
|
|
13,614 |
|
|
|
40,449 |
|
|
|
39,715 |
|
Loss from
operations |
|
|
(4,658 |
) |
|
|
(4,048 |
) |
|
|
(14,272 |
) |
|
|
(13,143 |
) |
Other
income/expense |
|
|
69 |
|
|
|
48 |
|
|
|
168 |
|
|
|
103 |
|
Net loss |
|
$ |
(4,589 |
) |
|
$ |
(4,000 |
) |
|
$ |
(14,104 |
) |
|
$ |
(13,040 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.46 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing |
|
|
|
|
|
|
|
|
net loss
per share, basic and diluted |
|
|
30,190 |
|
|
|
30,004 |
|
|
|
30,118 |
|
|
|
28,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
Balance Sheets |
|
|
|
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
|
|
|
|
$ |
49,620 |
|
|
$ |
74,853 |
|
Collaboration receivables |
|
|
|
|
|
|
4,109 |
|
|
|
3,367 |
|
Prepaid
and other current assets |
|
|
|
|
|
|
3,170 |
|
|
|
1,004 |
|
Total
current assets |
|
|
|
|
|
|
56,899 |
|
|
|
79,224 |
|
Property
and equipment, net |
|
|
|
|
|
|
124 |
|
|
|
179 |
|
Other
assets |
|
|
|
|
|
|
1,119 |
|
|
|
2,538 |
|
Total
assets |
|
|
|
|
|
$ |
58,142 |
|
|
$ |
81,941 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and other accrued expenses |
|
|
|
|
|
$ |
11,099 |
|
|
$ |
13,970 |
|
Current
portion of deferred revenue |
|
|
|
|
|
|
12,661 |
|
|
|
14,172 |
|
Total
current liabilities |
|
|
|
|
|
|
23,760 |
|
|
|
28,142 |
|
Deferred
revenue, less current portion |
|
|
|
|
|
|
3,962 |
|
|
|
12,519 |
|
Convertible note payable |
|
|
|
|
|
|
13,718 |
|
|
|
13,158 |
|
Deferred
rent |
|
|
|
|
|
|
84 |
|
|
|
126 |
|
Stockholders' equity |
|
|
|
|
|
|
16,618 |
|
|
|
27,996 |
|
Total
liabilities and stockholders' equity |
|
|
|
|
|
$ |
58,142 |
|
|
$ |
81,941 |
|
|
|
|
|
|
|
|
|
|
CONTACT: Alan EngbringConatus
Pharmaceuticals Inc.(858) 376-2637aengbring@conatuspharma.com
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