Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the fourth quarter and year ended December
31, 2010. Net loss for the three months and year ended December 31,
2010 was $10.1 million and $24.6 million, respectively. As of
December 31, 2010, cash, cash equivalents and marketable securities
totaled $53.4 million, with no debt outstanding.
"This past year was a landmark year for Sunesis, with our lead
program, vosaroxin, moving into a pivotal Phase 3 trial, the VALOR
trial, in acute myeloid leukemia," said Daniel Swisher, Chief
Executive Officer of Sunesis. "Since the beginning of the fourth
quarter, we achieved a number of critical clinical, regulatory,
intellectual property and financial objectives, including the
launch of the VALOR trial. I am pleased with the pace of site
activation and patient enrollment to date. With an improved capital
structure and over $53 million in cash at the end of 2010, Sunesis
is today well positioned to reach our goal of bringing an important
new cancer treatment to patients with an enduring unmet need."
Fourth Quarter 2010 and Recent Highlights
-- Launched Phase 3 VALOR trial of
vosaroxin in AML. In December 2010, Sunesis commenced
enrollment in its VALOR trial, a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial of vosaroxin in combination with
cytarabine, a widely used chemotherapy, in patients with relapsed
or refractory acute myeloid leukemia (AML). The trial is expected
to enroll 450 patients at approximately 100 leading sites in the
United States, Canada, Europe, Australia and New Zealand.
-- Granted FDA fast track designation. In
February 2011, the FDA granted fast track designation to vosaroxin
for the potential treatment of relapsed or refractory AML in
combination with cytarabine, providing for the possibility of a
"rolling submission" for a marketing application and eligibility
for a priority review period by the FDA.
-- Issued important U.S. and European patents covering
vosaroxin clinical formulation. In November 2010, Sunesis
announced that the United States Patent and Trademark Office
(USPTO) had granted U.S. Patent No. 7,829,577, claiming Sunesis'
pharmaceutical compositions of vosaroxin. The patent is scheduled
to expire in March 2025, and could be eligible for patent term
extension beyond this date. Earlier this March, the European Patent
Office (EPO) granted European Patent No. 1725233 covering similar
claims as described above. Corresponding patent applications are
also pending in other major markets throughout the world, including
Japan, Australia and Canada.
-- Presented positive Phase 2 data for vosaroxin in
AML. In November 2010, Robert Stuart, MD, Professor of
Medicine, Division of Hematology/Oncology, Department of Medicine,
Medical University of South Carolina, presented data from Phase 2
clinical trials of vosaroxin in combination with cytarabine in
relapsed/refractory AML and as a single agent in frontline elderly
AML at the Chemotherapy Foundation Symposium XXVIII. Consistent
with results presented at the American Society of Clinical Oncology
Annual Meeting in June 2010, vosaroxin achieved clinically
meaningful complete remission rates balanced with low all-cause
early mortality. Preliminary leukemia-free survival, measured as
time from complete remission to relapse or death, was 14.4 months
(440 days). Median overall survival was 7.1 months, with 14
patients continuing in survival follow up well beyond this
median.
Financial Highlights
-- Cash, cash equivalents and marketable securities totaled
$53.4 million as of December 31, 2010, as compared to $4.3 million
as of December 31, 2009.
-- Revenues for the three months and year ended December 31,
2010 were $6,000 and $33,000, as compared to $12,500 and $3.8
million for the same periods in 2009.
-- Research and development expenses increased to $4.9 million
and $14.4 million for the three months and year ended December 31,
2010, as compared to $2.2 million and $13.2 million for the same
periods in 2009. The increases were primarily due to the launch of
the VALOR trial.
-- General and administrative expenses for the three months and
year ended December 31, 2010 were $1.8 million and $7.0 million, as
compared to $1.9 million and $7.7 million for the same periods in
2009.
-- Sunesis reported net losses of $10.1 million and $24.6
million for the three months and year ended December 31, 2010, as
compared to $4.0 million and $40.2 million for the same periods in
2009. Net loss in each of the periods in 2010 reflect a non-cash
charge of $3.7 million for the revaluation of warrants issued as
part of the underwritten offering in October 2010 to their fair
value as of December 31, 2010. Net loss for 2009 included non-cash
charges of $21.0 million related to the accounting for the private
placement of Sunesis' securities in 2009.
-- Cash used in operations was $4.2 million and $19.4 million
for the three months and year ended December 31, 2010, as compared
to $4.3 million and $20.2 million for the same periods in 2009.
-- In October 2010, Sunesis completed an underwritten offering
of its common stock and warrants to purchase its common stock for
net proceeds of $14.2 million, and during the fourth quarter of
2010, raised net proceeds of $3.1 million through its controlled
equity offering facility with Cantor Fitzgerald & Co.
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 approximately 100 leading sites in the U.S., Canada,
Europe, Australia and New Zealand. The VALOR trial is currently
open for enrollment and patients will be 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 broad range of clinically meaningful and
statistically significant survival outcomes. The trial's primary
endpoint is overall survival. For more information on the
VALOR trial, please visit www.valortrial.com.
The VALOR logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8774
About Vosaroxin (Formerly Voreloxin)
Vosaroxin is a first-in-class anticancer quinolone derivative,
or 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 Acute Myeloid Leukemia
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 estimated that 12,330 new
cases of AML will be diagnosed and approximately 9,000 deaths from
AML will occur in the U.S. in 2010. Additionally, it is estimated
that prevalence of AML is approximately 25,000 in the U.S. 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
www.sunesis.com.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
This press release contains forward-looking statements,
including statements related to the sufficiency of Sunesis' cash
resources, the design, conduct and results of the VALOR trial, the
prosecution of patent applications with the EPO and vosaroxin's
effects, efficacy and safety profile as a single agent and in
combination with cytarabine. Words such as "well positioned,"
"expected," "to date," "could," "pending" 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 VALOR trial until
its planned unblinding in 2013, 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,
2010 and Sunesis' other filings with the Securities and Exchange
Commission, including Sunesis' Annual Report on Form 10-K for the
year ended December 31, 2010 when available. 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.
|
SUNESIS
PHARMACEUTICALS, INC. |
CONSOLIDATED BALANCE
SHEETS |
|
|
|
|
December 31, |
December 31, |
|
2010 |
2009 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 14,223,388 |
$ 4,258,715 |
Marketable securities |
39,172,480 |
-- |
Prepaids and other current assets |
1,285,487 |
583,030 |
Total current assets |
54,681,355 |
4,841,745 |
Property and equipment, net |
116,188 |
263,111 |
Deposits and other assets |
59,974 |
64,425 |
Total assets |
$ 54,857,517 |
$ 5,169,281 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 415,802 |
$ 360,300 |
Accrued clinical expense |
1,573,580 |
1,129,226 |
Accrued compensation |
1,013,240 |
728,744 |
Other accrued liabilities |
1,380,409 |
788,559 |
Current portion of deferred rent |
26,267 |
27,943 |
Warrant liability |
8,153,712 |
-- |
Total current liabilities |
12,563,010 |
3,034,772 |
|
|
|
Non-current portion of deferred rent |
47,838 |
74,105 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' equity: |
|
|
Convertible preferred stock |
-- |
60,004,986 |
Common stock |
4,537 |
3,590 |
Additional paid-in capital |
423,262,099 |
298,469,584 |
Accumulated other comprehensive
loss |
(14,726) |
-- |
Accumulated deficit |
(381,005,241) |
(356,417,756) |
Total stockholders' equity |
42,246,669 |
2,060,404 |
Total liabilities and stockholders'
equity |
$ 54,857,517 |
$ 5,169,281 |
|
|
|
Note 1: The consolidated
balance sheet as of December 31, 2009 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, 2009. |
|
|
SUNESIS
PHARMACEUTICALS, INC. |
CONSOLIDATED STATEMENTS
OF OPERATIONS |
|
|
|
|
|
|
Three months ended December 31, |
Year ended
December 31, |
|
2010 |
2009 |
2010 |
2009 |
|
(Unaudited) |
(Unaudited) |
(Note 2) |
Revenue: |
|
|
|
|
Collaboration revenue |
$ -- |
$ 12,500 |
$ 27,083 |
$ 1,550,000 |
License and other revenue |
6,000 |
-- |
6,000 |
2,211,547 |
Total revenues |
6,000 |
12,500 |
33,083 |
3,761,547 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
4,874,007 |
2,178,045 |
14,433,777 |
13,246,859 |
General and administrative |
1,785,201 |
1,864,960 |
7,004,909 |
7,748,243 |
Restructuring charges |
-- |
(18,451) |
-- |
1,915,316 |
Total operating expenses |
6,659,208 |
4,024,554 |
21,438,686 |
22,910,418 |
|
|
|
|
|
Loss from operations |
(6,653,208) |
(4,012,054) |
(21,405,603) |
(19,148,871) |
|
|
|
|
|
Other income (expense), net |
(3,418,614) |
(23,018) |
(3,181,882) |
(21,077,175) |
Net loss |
(10,071,822) |
(4,035,072) |
(24,587,485) |
(40,226,046) |
Deemed distribution to preferred
stockholders |
-- |
(1,188,400) |
-- |
(27,563,400) |
Loss attributable to common stockholders |
$ (10,071,822) |
$ (5,223,472) |
$ (24,587,485) |
$ (67,789,446) |
|
|
|
|
|
Basic and diluted loss attributable to common
stockholders per common share |
$ (0.23) |
$ (0.90) |
$ (0.99) |
$ (11.80) |
|
|
|
|
|
Shares used in computing basic and diluted
loss attributable to common stockholders per common share |
43,879,448 |
5,779,792 |
24,860,212 |
5,746,786 |
|
|
|
|
|
Note 2: The consolidated
statement of operations for the year ended December 31, 2009 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, 2009. |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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