Conatus Pharmaceuticals Reports 2017 Financial Results and Program Updates
March 07 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
fourth quarter and full year ended December 31, 2017, and provided
updates on its development programs.
Program Updates In collaboration with Novartis,
Conatus is conducting four randomized, double-blind,
placebo-controlled Phase 2b clinical trials designed to evaluate
emricasan treatment in various patient populations, including one
clinical trial in patients whose transplanted livers were damaged
by recurrent hepatitis C virus (HCV), and three EmricasaN, a
Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in
patients with fibrosis or cirrhosis caused by nonalcoholic
steatohepatitis (NASH):
- POLT-HCV-SVR, initiated in the second quarter of 2014, in
approximately 60 post-orthotopic liver transplant (POLT) recipients
with liver fibrosis or cirrhosis post-transplant as a result of
recurrent HCV infection who have successfully achieved a sustained
viral response (SVR) following HCV antiviral therapy, with top-line
results expected in the second quarter of 2018;
- 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 second half 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.
Results from the four ongoing emricasan clinical trials are
expected to support the design of Phase 3 clinical efficacy and
safety trials.
Pipeline Expansion PlansConatus may pursue the
development of product candidates in liver disease and in other
related disease areas. The company’s ongoing pipeline expansion
activities include:
- evaluation of the potential for the company’s pan-caspase
inhibitor IDN-7314 as a treatment for primary sclerosing
cholangitis (PSC), a disease affecting bile ducts in the liver,
which can lead to cirrhosis and liver failure.
- internal development of new preclinical product candidates
leveraging its expertise with the caspase inhibition technology
platform, and
- evaluation for potential in-licensing or acquisition of
external clinical-stage product candidates consistent with its
product development and regulatory expertise.
Financial ResultsTotal revenues were $8.8
million for the fourth quarter of 2017 compared with $0.8 million
for the fourth quarter of 2016, and $35.4 million for the full year
2017 compared with $0.8 million for the full year 2016. Total
revenues consisted of collaboration revenues related to the
Novartis agreement. The increases in revenues were a result of
having a full fourth quarter and a full year of collaboration
revenues in 2017 compared with 13 days of collaboration revenues in
2016.
Research and development expenses were $10.9 million for the
fourth quarter of 2017 compared with $6.5 million for the fourth
quarter of 2016. Research and development expenses were $43.2
million for the full year 2017 compared with $20.3 million for the
full year 2016. The fourth quarter increase in research and
development expenses was primarily due to the ramp up of the
ENCORE-PH and ENCORE-LF clinical trials and new compound
development. The full year increase in research and development
expenses was primarily due to the ramp up of the ENCORE-NF,
ENCORE-PH and ENCORE-LF clinical trials and new compound
development.
General and administrative expenses were $2.3 million for the
fourth quarter of 2017 compared with $3.5 million for the fourth
quarter of 2016. General and administrative expenses were $9.7
million for the full year 2017 compared with $10.3 million for the
full year 2016. The decrease in general and administrative expenses
was primarily due to consulting and legal fees related to the
execution of the Novartis agreement in December 2016.
The net loss for the fourth quarter of 2017 was $4.4 million
compared with $9.1 million for the fourth quarter of 2016. The net
loss for the full year 2017 was $17.4 million compared with $29.7
million for the full year 2016.
Cash, cash equivalents and marketable securities were $74.9
million at December 31, 2017, compared with $77.0 million at
December 31, 2016, 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 four ongoing clinical trials, without
including any potential milestone payments under the Novartis
collaboration, are sufficient to maintain operations through
top-line results from all four Phase 2b clinical trials by the end
of 2019, as well as to fund initial pipeline expansion
activities.
Conference Call and Audio WebcastConatus 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 7095658. 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 POLT-HCV-SVR, the ENCORE-PH, the ENCORE-NF, and the ENCORE-LF
clinical trials; evaluation of IDN-7314 and other potential product
candidates; 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 |
(Unaudited) |
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Three Months Ended |
|
|
Twelve Months Ended |
Statements of
Operations |
|
December 31, |
|
|
December 31, |
|
|
2017 |
|
2016 |
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
8,804,399 |
|
|
$ |
799,046 |
|
|
|
$ |
35,376,796 |
|
|
$ |
799,046 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
10,911,660 |
|
|
|
6,523,261 |
|
|
|
|
43,220,446 |
|
|
|
20,293,632 |
|
General
and administrative |
|
|
2,300,243 |
|
|
|
3,453,474 |
|
|
|
|
9,706,834 |
|
|
|
10,337,182 |
|
Total operating
expenses |
|
|
13,211,903 |
|
|
|
9,976,735 |
|
|
|
|
52,927,280 |
|
|
|
30,630,814 |
|
Loss from
operations |
|
|
(4,407,504 |
) |
|
|
(9,177,689 |
) |
|
|
|
(17,550,484 |
) |
|
|
(29,831,768 |
) |
Other
income/expense |
|
|
51,101 |
|
|
|
54,187 |
|
|
|
|
154,071 |
|
|
|
98,327 |
|
Net loss |
|
$ |
(4,356,403 |
) |
|
$ |
(9,123,502 |
) |
|
|
$ |
(17,396,413 |
) |
|
$ |
(29,733,441 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.35 |
) |
|
|
$ |
(0.61 |
) |
|
$ |
(1.31 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing |
|
|
|
|
|
|
|
|
|
net loss per share,
basic and diluted |
|
|
30,018,172 |
|
|
|
25,994,155 |
|
|
|
|
28,586,625 |
|
|
|
22,649,911 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December
31, |
Balance Sheets |
|
|
|
|
|
2017 |
|
2016 |
|
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Assets |
|
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Current assets: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
|
$ |
74,853,247 |
|
|
$ |
77,015,124 |
|
Other receivables |
|
|
|
|
|
|
3,366,585 |
|
|
|
2,500,000 |
|
Prepaid and other current assets |
|
|
|
|
|
|
1,004,198 |
|
|
|
937,436 |
|
Total current assets |
|
|
|
|
|
|
79,224,030 |
|
|
|
80,452,560 |
|
Property and equipment, net |
|
|
|
|
|
|
178,649 |
|
|
|
261,446 |
|
Other assets |
|
|
|
|
|
|
2,538,211 |
|
|
|
1,609,834 |
|
Total assets |
|
|
|
|
|
$ |
81,940,890 |
|
|
$ |
82,323,840 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable and other accrued expenses |
|
|
|
|
|
$ |
13,970,271 |
|
|
$ |
7,662,796 |
|
Current
portion of deferred revenue |
|
|
|
|
|
|
|
14,172,076 |
|
|
|
30,897,192 |
|
Note payable |
|
|
|
|
|
|
- |
|
|
|
1,000,000 |
|
Total
current liabilities |
|
|
|
|
|
|
|
28,142,347 |
|
|
|
39,559,988 |
|
Deferred
revenue, less current portion |
|
|
|
|
|
|
|
12,518,667 |
|
|
|
20,803,762 |
|
Convertible note payable |
|
|
|
|
|
|
13,157,534 |
|
|
|
- |
|
Deferred
rent |
|
|
|
|
|
|
|
126,030 |
|
|
|
171,544 |
|
Stockholders' equity |
|
|
|
|
|
|
27,996,312 |
|
|
|
21,788,546 |
|
Total liabilities and stockholders' equity |
|
|
|
|
|
$ |
81,940,890 |
|
|
$ |
82,323,840 |
|
|
|
|
|
|
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|
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