Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the second quarter ended June 30, 2011. Net
loss for the three and six months ended June 30, 2011 was $8.2
million and $6.4 million, respectively. As of June 30, 2011, cash,
cash equivalents and marketable securities totaled $48.8 million,
with no debt outstanding.
"As vosaroxin's importance within the AML drug development
landscape continues to rise, our focus as a company remains on
successfully prosecuting the VALOR trial, our robust, adaptive
Phase 3 study, and supporting a successful commercialization
strategy," said Daniel Swisher, Chief Executive Officer of Sunesis.
"The VALOR trial now has over 60 active sites in 11 countries, and
is on track to reach the interim analysis in mid-2012 and the
planned unblinding in 2013. In addition to our efforts in advancing
vosaroxin during the quarter, we brought to light the significant
potential of our pipeline programs with the announcement of a new
oncology kinase inhibitor collaboration with Millennium
Pharmaceuticals, which includes a very promising oral, selective
pan-Raf kinase inhibitor ready to enter clinical development."
Second Quarter 2011 and Recent Highlights
- Presented adaptive study design for
vosaroxin Phase 3 VALOR trial in AML at ASCO 2011. In
June, Sunesis presented the adaptive study design for its Phase 3
VALOR trial of vosaroxin in AML at the Trials in Progress Poster
Session of the 2011 American Society of Clinical Oncology (ASCO)
Annual Meeting in Chicago, Illinois. The poster, entitled "Adaptive
design of VALOR, a phase 3 trial of vosaroxin or placebo in
combination with cytarabine for patients with first relapsed or
refractory acute myeloid leukemia," is available on the Sunesis
website at www.sunesis.com.
- Announced collaboration with Millennium Pharmaceuticals
for kinase inhibitors in oncology. In
April, Millennium Pharmaceuticals, Inc. (Millennium), a
wholly-owned subsidiary of Takeda Pharmaceutical Company Limited,
and Sunesis announced a license agreement for the development of
Sunesis' oral, selective pan-Raf kinase inhibitor and one
additional undisclosed kinase inhibitor program in oncology. Under
terms of the agreement, Sunesis received a $4.0 million upfront
payment from Millennium on April 4, 2011 and is eligible to receive
up to approximately $60.0 million in pre-commercial milestone
program payments and royalties on sales of future collaboration
products. Sunesis also retains co-development and co-promotion
rights.
The programs were originally part of Sunesis' 2004 multi-kinase
inhibitor collaboration with Biogen Idec, Inc. Following Biogen
Idec's November 2010 announcement to shift its strategic focus and
spin out or outlicense its oncology assets, Millennium acquired two
of these oncology assets and intends to continue the development of
these assets in collaboration with Sunesis. Biogen Idec and Sunesis
will continue with a more focused collaboration directed towards a
unique preclinical kinase inhibitor program involved in
immunology.
- Received $1.2 million from repayment of notes by
SARcode Bioscience, Inc. On August 8,
2011, SARcode Bioscience, Inc. repaid three promissory notes that
had originally been issued to Sunesis. The total amount received by
Sunesis represents the aggregate principal value of $1.0 million
plus accrued interest. Sunesis had not previously recognized any
revenue related to these notes.
- Issued important U.S. patent covering vosaroxin use in
leukemia.On August 3, 2011, Sunesis announced that it had
been granted a patent by the U.S. Patent and Trademark Office
(USPTO), covering methods of use for vosaroxin at various dose
ranges and schedules for the treatment of leukemia, including the
dose and schedule under evaluation in the pivotal, Phase 3 VALOR
trial. The patent provides coverage through 2026. Additionally, in
June 2011, the USPTO granted Sunesis a patent covering combinations
of vosaroxin with cytarabine, which provides coverage to 2026.
- Announced publication of Phase 1b data of vosaroxin in
relapsed or refractory leukemia. In July, Sunesis
announced the publication of data from a Phase 1b multi-center
study of vosaroxin in relapsed or refractory leukemia in the July
2011 issue of Leukemia. The results show that single-agent
vosaroxin was well-tolerated, with a potent anti-leukemic effect in
patients who had received multiple prior therapies. The Phase 1b
data, along with results from Phase 2 studies of vosaroxin used
alone and in combination with cytarabine in the treatment of acute
myeloid leukemia (AML), support the currently-enrolling VALOR
trial. The Leukemia article and full, published data set are
available online at:
http://www.nature.com/leu/journal/vaop/ncurrent/full/leu2011157a.html.
- Announced publication of nonclinical data of vosaroxin
in acute myeloid leukemia.In May, Sunesis announced the
publication by a leading academic group in Cardiff, United Kingdom
of nonclinical data of vosaroxin in the March 2011 issue of
Haematologica. The results demonstrate vosaroxin's potent cytotoxic
activity in primary patient AML blasts ex vivo when used alone and
synergistic activity when used in combination with cytarabine, a
leading current treatment standard in AML, consistent with prior
observations in preclinical models. The studies also extend
Sunesis' observations in primary breast and ovarian cancer biopsies
that vosaroxin remains active in the absence of p53, a tumor
suppressing protein associated with resistance to chemotherapy. The
Haematologica article and full, published data set are available
online at
http://www.haematologica.org/cgi/content/full/96/3/393.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $48.8
million as of June 30, 2011, compared to $53.4 million as of
December 31, 2010. The decrease of $4.6 million was primarily due
to $8.9 million of net cash used in operating activities, offset by
net proceeds of $4.1 million from sales of Sunesis' common stock
through its facility with Cantor Fitzgerald & Co. Sunesis
believes that currently available and accessible funds are
sufficient to fund the company to the planned unblinding of the
VALOR trial.
- Total revenue for the six months ended June 30, 2011 was $4.0
million as compared to $27,000 for the same period in 2010. Revenue
in the first half of 2011 was due to the upfront payment of $4.0
million from Millennium.
- Research and development expenses increased to $6.0 million and
$10.0 million for the three and six months ended June 30, 2011, as
compared to $3.0 million and $6.1 million for the same periods in
2010. The increases in 2011 were primarily due to increases in
clinical expenses incurred as a result of the ramp-up of the VALOR
trial and drug manufacturing activities.
- General and administrative expenses for the six months ended
June 30, 2011 were $4.0 million, as compared to $3.4 million for
the same period in 2010. The increase between the six month periods
was primarily due to higher legal and marketing costs.
- Net other expense was $0.3 million for the second quarter of
2011 and net other income was $3.6 million for the first half of
2011, The net other income in the six month period was primarily
comprised of a net non-cash credit of $3.2 million for the
revaluation of warrants issued in the October 2010 offering to
their fair value as of June 30, 2011 and net foreign exchange gains
of $0.3 million.
- Sunesis reported a net loss of $8.2 million and $6.4 million
for the three and six months ended June 30, 2011, as compared to a
net loss of $4.8 million and $9.4 million for the same periods in
2010.
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
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
cases of AML were diagnosed and approximately 9,000 deaths from AML
occurred 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 design, conduct and results of
the VALOR trial, vosaroxin's effects, efficacy and safety profile
as a single agent and in combination with cytarabine, the benefits
to Sunesis from its collaboration arrangement with Millennium and
the sufficiency of Sunesis' currently available and accessible
funds to the planned unblinding of the VALOR trial. Words such as
"focus," "on track," planned," "potential," "promising,"
"demonstrate," "will" "believes," "expected" 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 March 31, 2011,
Sunesis' Annual Report on Form 10-K for the year ended December 31,
2010 and Sunesis' other filings with the Securities and Exchange
Commission, including Sunesis' Quarterly Report on Form 10-Q for
the quarter ended June 30, 2011, 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. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(In
thousands) |
|
|
|
|
June 30, |
December 31, |
|
2011 |
2010 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash equivalents |
$ 7,574 |
$ 14,223 |
Marketable securities |
41,258 |
39,173 |
Prepaids and other current assets |
1,440 |
1,286 |
Total current assets |
50,272 |
54,682 |
Property and equipment, net |
94 |
116 |
Deposits and other assets |
60 |
60 |
Total assets |
$ 50,426 |
$ 54,858 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 329 |
$ 416 |
Accrued clinical expense |
2,401 |
1,574 |
Accrued compensation |
758 |
1,013 |
Other accrued liabilities |
1,700 |
1,406 |
Warrant liability |
4,913 |
8,154 |
Total current liabilities |
10,101 |
12,563 |
|
|
|
Non-current portion of deferred rent |
31 |
48 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' equity: |
|
|
Common stock |
5 |
5 |
Additional paid-in capital |
427,663 |
423,262 |
Accumulated other comprehensive income
(loss) |
18 |
(15) |
Accumulated deficit |
(387,392) |
(381,005) |
Total stockholders' equity |
40,294 |
42,247 |
Total liabilities and stockholders'
equity |
$ 50,426 |
$ 54,858 |
|
|
|
Note 1: The condensed
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. |
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS |
(In thousands, except
per share amounts) |
|
|
|
|
|
|
Three months ended June 30, |
Six
months ended June 30, |
|
2011 |
2010 |
2011 |
2010 |
|
(Unaudited) |
(Unaudited) |
Revenue: |
|
|
|
|
Collaboration revenue |
$ -- |
$ 14 |
$ -- |
$ 27 |
License and other revenue |
-- |
-- |
4,000 |
-- |
Total revenues |
-- |
14 |
4,000 |
27 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
5,950 |
2,970 |
10,020 |
6,081 |
General and administrative |
1,975 |
1,862 |
3,989 |
3,416 |
Total operating expenses |
7,925 |
4,832 |
14,009 |
9,497 |
|
|
|
|
|
Loss from operations |
(7,925) |
(4,818) |
(10,009) |
(9,470) |
|
|
|
|
|
Other income (expense), net |
(302) |
34 |
3,622 |
38 |
Net loss |
$ (8,227) |
$ (4,784) |
$ (6,387) |
$ (9,432) |
|
|
|
|
|
Basic and diluted net loss per common
share |
$ (0.18) |
$ (0.44) |
$ (0.14) |
$ (1.04) |
|
|
|
|
|
Shares used in computing basic and diluted
net loss per common share |
46,295 |
10,912 |
46,095 |
9,038 |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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