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, 2017, and provided
updates on its development programs.
Program Updates In collaboration with Novartis
under terms of the company’s Option, Collaboration and License
Agreement with Novartis, which was executed in December 2016,
Conatus is conducting four randomized, double-blind,
placebo-controlled Phase 2b clinical trials designed to evaluate
emricasan treatment in various patient populations, including three
EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical
trials in patients with fibrosis or cirrhosis caused by
nonalcoholic steatohepatitis (NASH), and a fourth clinical trial in
POLT-HCV-SVR patients:
- 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 hepatitis C virus (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 Plans
In October 2017, the European Medicines Agency (EMA) granted
Orphan Drug Designation in the European Union to the company’s
pan-caspase inhibitor IDN-7314 for the treatment of primary
sclerosing cholangitis (PSC), a disease affecting bile ducts in the
liver, which can lead to cirrhosis and liver failure. In June 2017,
the U.S. Food and Drug Administration (FDA) granted Orphan Drug
Designation in the United States to IDN-7314 for the treatment of
PSC.
These orphan drug designations were based on previously reported
data with IDN-7314 demonstrating reduction of relevant biomarkers
in two preclinical models of PSC. New results, showing that
IDN-7314 markedly diminished inflammasome activation and reduced
liver injury in a preclinical model of PSC, were presented in
October 2017 at The Liver Meeting®, the annual meeting of the
American Association for the Study of Liver Diseases (AASLD). In a
separate study, IDN-7314 reduced biochemical markers in a new acute
preclinical model of PSC.
Conatus believes the orphan drug designations, along with the
growing body of preclinical data, warrant further evaluation of
IDN-7314 as a potential product candidate in PSC as a component of
its initial pipeline expansion plans. The company’s ongoing
pipeline expansion activities also include:
- 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.
Conatus may pursue the development of product candidates in
liver disease and in other related disease areas.
Financial ResultsThe net loss for the third
quarter of 2017 was $4.0 million compared with $6.9 million for the
third quarter of 2016. The net loss for the first nine months of
2017 was $13.0 million compared with $20.6 million for the first
nine months of 2016.
Total revenues were $9.6 million for the third quarter of 2017
and $26.6 million for the first nine months of 2017, compared with
$0.0 million for the comparable periods in 2016. Total revenues for
both periods in 2017 consisted of collaboration revenue related to
the Option, Collaboration and License Agreement with Novartis.
Research and development expenses were $11.2 million for the
third quarter of 2017 compared with $4.8 million for the third
quarter of 2016. Research and development expenses were $32.3
million for the first nine months of 2017 compared with $13.8
million for the first nine months of 2016. The increases in
research and development expenses were primarily due to the ramp up
of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.
General and administrative expenses were $2.4 million for the
third quarter of 2017 compared with $2.1 million for the third
quarter of 2016. General and administrative expenses were $7.4
million for the first nine months of 2017 compared with $6.9
million for the first nine months of 2016. The increases in general
and administrative expenses were primarily due to higher personnel
costs and professional fees.
Cash, cash equivalents and marketable securities were $85.2
million at September 30, 2017, compared with $77.0 million at
December 31, 2016. Based primarily on lower than expected spending
on in-licensing and internal pipeline development, the company is
now projecting a year-end 2017 balance of between $70 million and
$75 million. The company believes its current and forecasted
financial resources are sufficient to maintain operations and
ongoing emricasan clinical development activities through the end
of 2019, as well as to fund anticipated 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 99505370. 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-NF, the ENCORE-PH, the ENCORE-LF, and the POLT-HCV-SVR
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
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.
CONTACT: Alan EngbringConatus
Pharmaceuticals Inc.(858) 376-2637aengbring@conatuspharma.com
Conatus Pharmaceuticals Inc. |
|
Selected Condensed Financial
Information |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
Statements of
Operations |
|
September 30, |
|
|
September 30, |
|
|
|
2017 |
|
2016 |
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
9,565,890 |
|
|
$ |
- |
|
|
|
$ |
26,572,397 |
|
|
$ |
- |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
11,165,150 |
|
|
|
4,825,421 |
|
|
|
|
32,308,786 |
|
|
|
13,770,371 |
|
|
General
and administrative |
|
|
2,449,382 |
|
|
|
2,069,447 |
|
|
|
|
7,406,591 |
|
|
|
6,883,708 |
|
|
Total operating
expenses |
|
|
13,614,532 |
|
|
|
6,894,868 |
|
|
|
|
39,715,377 |
|
|
|
20,654,079 |
|
|
Loss from
operations |
|
|
(4,048,642 |
) |
|
|
(6,894,868 |
) |
|
|
|
(13,142,980 |
) |
|
|
(20,654,079 |
) |
|
Other
income/expense |
|
|
48,264 |
|
|
|
27,958 |
|
|
|
|
102,970 |
|
|
|
44,140 |
|
|
Net loss |
|
$ |
(4,000,378 |
) |
|
$ |
(6,866,910 |
) |
|
|
$ |
(13,040,010 |
) |
|
$ |
(20,609,939 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share,
basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.31 |
) |
|
|
$ |
(0.46 |
) |
|
$ |
(0.96 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
30,004,037 |
|
|
|
22,410,702 |
|
|
|
|
28,104,199 |
|
|
|
21,527,993 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
Balance Sheets |
|
|
|
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities |
|
|
|
|
|
$ |
85,183,887 |
|
|
$ |
77,015,124 |
|
|
Other receivables |
|
|
|
|
|
|
- |
|
|
|
2,500,000 |
|
|
Prepaid and other current assets |
|
|
|
|
|
|
1,339,208 |
|
|
|
937,436 |
|
|
Total current assets |
|
|
|
|
|
|
86,523,095 |
|
|
|
80,452,560 |
|
|
Property and equipment, net |
|
|
|
|
|
|
204,914 |
|
|
|
261,446 |
|
|
Other assets |
|
|
|
|
|
|
2,538,211 |
|
|
|
1,609,834 |
|
|
Total assets |
|
|
|
|
|
$ |
89,266,220 |
|
|
$ |
82,323,840 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders'
equity |
|
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
|
|
Accounts payable and other accrued expenses |
|
|
|
|
|
$ |
12,748,770 |
|
|
$ |
7,662,796 |
|
|
Current
portion of deferred revenue |
|
|
|
|
|
|
|
19,454,795 |
|
|
|
30,897,192 |
|
|
Note payable |
|
|
|
|
|
|
- |
|
|
|
1,000,000 |
|
|
Total
current liabilities |
|
|
|
|
|
|
|
32,203,565 |
|
|
|
39,559,988 |
|
|
Deferred
revenue, less current portion |
|
|
|
|
|
|
|
12,673,762 |
|
|
|
20,803,762 |
|
|
Convertible note payable |
|
|
|
|
|
|
12,968,493 |
|
|
|
- |
|
|
Deferred
rent |
|
|
|
|
|
|
|
139,392 |
|
|
|
171,544 |
|
|
Stockholders' equity |
|
|
|
|
|
|
31,281,008 |
|
|
|
21,788,546 |
|
|
Total liabilities and stockholders' equity |
|
|
|
|
|
$ |
89,266,220 |
|
|
$ |
82,323,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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