Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2011. Net loss for the three months and year ended December 31,
2011 was $8.7 million and $20.1 million, respectively. As of
December 31, 2011, cash, cash equivalents and marketable securities
totaled $44.1 million.
"Thanks to the continuing successful execution of our strategic
plan, Sunesis today is well positioned to capitalize on the value
of vosaroxin, which we believe is the most advanced and promising
therapy in development for acute myeloid leukemia," said Daniel
Swisher, Chief Executive Officer of Sunesis. "In support of our
future objectives, we have advanced all aspects of our pivotal
vosaroxin program, including enrollment of 260 patients to date in
our Phase 3 VALOR trial, which is progressing toward an interim
analysis in the third quarter of this year; built significant
financial flexibility, having executed a $25 million tranched debt
financing facility in the fourth quarter; and recently expanded our
intellectual property estate, supporting commercial and development
runway to 2030. We also entered into a partnership with Millennium
Pharmaceuticals in March 2011 for the pan-Raf kinase inhibitor
MLN2480, and announced initiation of a Phase 1 study in September
2011."
Mr. Swisher added: "2012 promises to be a transformational year
for Sunesis, as we advance the VALOR trial through the interim
analysis, progress towards regulatory filings and prepare the
market for the planned launch of vosaroxin in AML."
Fourth Quarter 2011 and Recent Highlights
- Announced DSMB Recommendation to Continue VALOR Trial
Based on Safety Review. In
December,Sunesis announced that the independent Data and Safety
Monitoring Board (DSMB) for the VALOR trial completed a planned
periodic safety review and recommended that the trial continue as
planned without changes to study conduct.
- Announced appointment of Dr. Adam R. Craig as Chief
Medical Officer. In February, Sunesis announced the
appointment of Adam R. Craig, M.B.B.S., Ph.D., M.B.A. to the
newly created position of Executive Vice President, Development and
Chief Medical Officer. In this position, Dr. Craig will direct
Sunesis' R&D organization and global development
programs.
- Announced notice of allowance for U.S. patent
application covering vosaroxin compositions. In February,
Sunesis announced that the U.S. Patent and Trademark Office has
issued a Notice of Allowance for U.S. Patent Application No.
12/982,785 claiming certain compositions related to vosaroxin, and
provides patent exclusivity to mid-2030 in the United States.
A family of corresponding patent applications is pending in the
U.S. and internationally.
- Announced participation in Cardiff University sponsored
Phase 2/3 trial. In December, Sunesis announced
participation in a Phase 2/3 randomized, controlled, multicenter
trial evaluating novel treatment regimens, including two regimens
containing vosaroxin, against low dose cytarabine in elderly AML or
high-risk myelodysplastic syndrome (MDS) patients who are not
candidates for intensive chemotherapy. The trial, known as the Less
Intensive 1 (LI-1) Trial, is being sponsored by Cardiff University
and conducted by the United Kingdom's National Cancer Research
Institute Haematological Oncology Study Group under the direction
of Professor Alan K. Burnett. In March 2012, the first patients
were enrolled in this trial.
2012 Key Milestones
- VALOR interim analysis: Sunesis expects the
planned interim analysis of the VALOR trial by the DSMB to occur in
the third quarter of 2012. As previously announced, the DSMB will
meet to examine pre-specified efficacy and safety data sets and
decide whether to 1) stop the trial early for efficacy or for
futility; 2) continue the study to its planned unblinding, expected
in mid-2013; or 3) recommend a one-time "adaptive" sample size
increase with unblinding expected in early 2014.
- European orphan drug designation for
vosaroxin: Sunesis expects a decision from the European
Commission regarding orphan drug designation for vosaroxin for the
treatment of AML.
- Kinase inhibitors programs: Sunesis expects
Millennium Pharmaceuticals, Inc. will present data from the pan-Raf
kinase inhibitor program at the American Association of Cancer
Research meeting in Chicago on April 1, 2012. The company also
expects that other kinase collaboration programs with Biogen Idec
and Millennium will continue to progress toward the clinic.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $44.1
million as of December 31, 2011, as compared to $53.4 million as of
December 31, 2010.
- Revenues for the three months and year ended December 31, 2011
were nil and $5.0 million, as compared to $6,000 and $33,000 for
the same periods in 2010. Revenue in 2011 was comprised of an
upfront payment of $4.0 million that was received from Millennium
in relation to the agreements that the company entered into with
Biogen Idec and Millennium in March 2011, and $1.0 million from the
recognition of deferred revenue related to the sale of certain
intellectual property rights to SARcode, which was recorded
following the repayment of three promissory notes by SARcode in
August 2011.
- Research and development expenses increase to $6.3 million and
$22.6 million for the three months and year ended December 31,
2011, as compared to $4.9 million and $14.4 million for the same
periods in 2010. The increases were primarily due to the ramp-up of
the VALOR trial and related manufacturing and drug supply
activities.
- General and administrative expenses for the three months and
year ended December 31, 2011 were $2.2 million and $8.3 million, as
compared to $1.8 million and $7.0 million for the same periods in
2010. The increases of were primarily due to increased personnel
and professional service costs.
- Sunesis reported net losses of $8.7 million and $20.1 million
for the three months and year ended December 31, 2011, as compared
to $10.1 million and $24.6 million for the same periods in 2010.
Net loss for 2011 included net non-cash credits of $5.9 million
related to the revaluation of warrants issued as part of the
underwritten offering in October 2010 to their fair value as of
December 31, 2011. Net loss in each of the periods in 2010
reflect a non-cash charge of $3.7 million for the revaluation of
these warrants to their fair value as of December 31, 2010.
- Cash used in operations was $7.3 million and $22.8 million for
the three months and year ended December 31, 2011, as compared to
$4.2 million and $19.4 million for the same periods in 2010.
- In October 2011, Sunesis entered into a $25.0 million tranched
loan facility. Under the terms of the loan agreement, Sunesis
received $10.0 million upon closing, with the remaining $15 million
available for draw at the company's discretion following the
planned interim analysis of the VALOR trial by the DSMB, subject to
certain conditions specified in the loan agreement.
Conference Call Information
The Company will host a conference call today, March 14th at
10:30 a.m. Eastern Time. The call can be accessed by dialing (866)
362-4666 (U.S. and Canada) or (617) 597-5313 (international), and
entering passcode 99720867. To access the live audio webcast, or
the subsequent archived recording, visit the "Investors and Media -
Calendar of Events" section of the Sunesis website at
www.sunesis.com. The webcast will be recorded and available for
replay on the company's website for two weeks.
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial is expected to enroll 450 evaluable
patients at more than 110 leading sites in the U.S., Canada,
Europe, Australia and New Zealand. The VALOR trial is currently
enrolling patients, who are randomized one to one to receive either
vosaroxin on days one and four in combination with cytarabine daily
for five days, or placebo in combination with cytarabine.
Additionally, the VALOR trial employs an innovative, adaptive trial
design that allows for a one-time sample size adjustment by the
DSMB at the interim analysis to maintain adequate power across a
broader range of survival outcomes. The trial's primary endpoint is
overall survival. For more information on the VALOR trial, please
visit www.valortrial.com.
About Vosaroxin
Vosaroxin is a first-in-class anti-cancer quinolone derivative
(AQD), a class of compounds that has not been used previously for
the treatment of cancer. Vosaroxin both intercalates DNA and
inhibits topoisomerase II, resulting in replication-dependent,
site-selective DNA damage, G2 arrest and apoptosis.
About AML
AML is a rapidly progressing cancer of the blood characterized
by the uncontrolled proliferation of immature blast cells in the
bone marrow. The American Cancer Society estimates there were
12,950 new cases of AML and approximately 9,050 deaths from AML in
the U.S. in 2011. Additionally, it is estimated that the prevalence
of AML across major global markets (U.S., France, Germany, Italy,
Spain, United Kingdom, and Japan) is over 50,000. AML is generally
a disease of older adults, and the median age of a patient
diagnosed with AML is about 67 years. AML patients with relapsed or
refractory disease and newly diagnosed AML patients over 60 years
of age with poor prognostic risk factors typically die within one
year, resulting in an acute need for new treatment options for
these patients.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the
development and commercialization of new oncology therapeutics for
the treatment of solid and hematologic cancers. Sunesis has built a
highly experienced cancer drug development organization committed
to advancing its lead product candidate, vosaroxin, in multiple
indications to improve the lives of people with cancer. For
additional information on Sunesis, please visit
http://www.sunesis.com.
This press release contains forward-looking statements,
including statements related to Sunesis' strategy, the sufficiency
of Sunesis' intellectual property estate and the patent exclusivity
period for vosaroxin in the United States and other jurisdictions,
the design, conduct, progress and results of the VALOR trial and
other clinical trials, the occurrence and timing of the DSMB
interim analysis, the sufficiency of Sunesis' financial resources
and availability of the second tranche under the loan facility with
Oxford Finance LLC, Horizon Technology Finance Corporation and
Silicon Valley Bank, vosaroxin's effects, efficacy, safety profile
and commercial potential as a single agent and in combination with
cytarabine, the potential grant of orphan drug designation to
vosaroxin by the European Commission, and the progress of the
kinase collaboration programs. Words such as "continuing,"
"advanced'" "believe," "progressing," "promises," "expects" or
"expected," "will," "provides" or "providing," "future objectives,"
"well-positioned," "plan" or "planned," and similar expressions are
intended to identify forward-looking statements. These
forward-looking statements are based upon Sunesis' current
expectations. Forward-looking statements involve risks and
uncertainties. Sunesis' actual results and the timing of events
could differ materially from those anticipated in such
forward-looking statements as a results of these risks and
uncertainties, which include, without limitation, risks related to
Sunesis' need for substantial additional funding to complete the
development and commercialization of vosaroxin, risks related to
Sunesis' ability to raise the capital that it believes to be
accessible and is required to fully finance the development and
commercialization of vosaroxin, the risk that raising funds through
lending arrangements may restrict our operations or produce other
adverse results, the risk that Sunesis' development activities for
vosaroxin could be otherwise halted or significantly delayed for
various reasons, the risk that Sunesis' clinical studies for
vosaroxin may not demonstrate safety or efficacy or lead to
regulatory approval, the risk that data to date and trends may not
be predictive of future data or results, the risk that Sunesis'
nonclinical studies and clinical studies may not satisfy the
requirements of the FDA or other regulatory agencies, risks related
to the conduct of Sunesis' clinical trials, risks related to the
manufacturing of vosaroxin and supply of the active pharmaceutical
ingredients required for the conduct of the VALOR trial, the risk
of third party opposition to granted patents related to vosaroxin,
and the risk that Sunesis' proprietary rights may not adequately
protect vosaroxin. These and other risk factors are discussed under
"Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form
10-Q for the quarter ended September 30, 2011, Sunesis' Annual
Report on Form 10-K for the year ended December 31, 2011, when
available, and Sunesis' other filings with the Securities and
Exchange Commission. Sunesis expressly disclaims any obligation or
undertaking to release publicly any updates or revisions to any
forward-looking statements contained herein to reflect any change
in the company's expectations with regard thereto or any change in
events, conditions or circumstances on which any such statements
are based.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals,
Inc.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
|
SUNESIS
PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE
SHEETS |
(In
thousands) |
|
|
|
|
December 31, |
December 31, |
|
2011 |
2010 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 9,311 |
$ 14,223 |
Marketable securities |
34,804 |
39,173 |
Prepaids and other current
assets |
1,550 |
1,286 |
Total current assets |
45,665 |
54,682 |
Property and equipment, net |
74 |
116 |
Deposits and other assets |
130 |
60 |
Total assets |
$ 45,869 |
$ 54,858 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 658 |
$ 416 |
Accrued clinical expense |
2,370 |
1,574 |
Accrued compensation |
1,274 |
1,013 |
Other accrued liabilities |
1,805 |
1,406 |
Warrant liability |
2,276 |
8,154 |
Total current liabilities |
8,383 |
12,563 |
|
|
|
Non-current portion of notes payable |
9,453 |
-- |
Non-current portion of deferred rent |
13 |
48 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' equity: |
|
|
Common stock |
5 |
5 |
Additional paid-in capital |
429,142 |
423,262 |
Accumulated other comprehensive income
(loss) |
19 |
(15) |
Accumulated deficit |
(401,146) |
(381,005) |
Total stockholders' equity |
28,020 |
42,247 |
Total liabilities and stockholders'
equity |
$ 45,869 |
$ 54,858 |
|
|
|
|
|
|
Note 1: The consolidated
balance sheet as of December 31, 2010 has been derived from the
audited financial statements as of that date included in the
Company's Annual Report on Form 10-K for the year ended December
31, 2010. |
|
SUNESIS
PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS) |
(In thousands, except
per share amounts) |
|
|
|
|
|
|
Three months ended December 31, |
Year ended
December 31, |
|
2011 |
2010 |
2011 |
2010 |
|
(Unaudited) |
(Unaudited) |
(Note 2) |
Revenue: |
|
|
|
|
Collaboration revenue |
$ - |
$ - |
$ - |
$ 27 |
License and other revenue |
- |
6 |
5,000 |
6 |
Total revenues |
- |
6 |
5,000 |
33 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
6,326 |
4,873 |
22,563 |
14,433 |
General and administrative |
2,159 |
1,785 |
8,303 |
7,005 |
Total operating expenses |
8,485 |
6,658 |
30,866 |
21,438 |
|
|
|
|
|
Loss from operations |
(8,485) |
(6,652) |
(25,866) |
(21,405) |
|
|
|
|
|
Other income (expense), net |
(255) |
(3,419) |
5,725 |
(3,182) |
Net loss |
(8,740) |
(10,071) |
(20,141) |
(24,587) |
Unrealized gain (loss) on available-for-sale
securities |
(1) |
(23) |
34 |
(15) |
Comprehensive loss |
$ (8,741) |
$ (10,094) |
$ (20,107) |
$ (24,602) |
|
|
|
|
|
Basic and diluted loss per common
share: |
|
|
|
|
|
|
|
|
Net loss |
(8,740) |
(10,071) |
(20,141) |
(24,587) |
Shares used in computing basic and diluted
net loss per common share |
46,733 |
43,879 |
46,412 |
24,860 |
Basic and diluted net loss per common
share |
$ (0.19) |
$ (0.23) |
$ (0.43) |
$ (0.99) |
|
|
|
|
|
Note 2: The consolidated
statement of operations for the year ended December 31, 2010 has
been derived from the audited financial statements as of that date
included in the Company's Annual Report on Form 10-K for the year
ended December 31, 2010. |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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