Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the quarter ended March 31, 2011. Net income
for the three months ended March 31, 2011 was $1.8 million. As of
March 31, 2011, cash, cash equivalents and marketable securities
totaled $48.9 million, with no debt outstanding. This cash balance
does not include $4.0 million received on April 4, 2011 under
Sunesis' previously disclosed oncology kinase inhibitor
collaboration with Millennium Pharmaceuticals, Inc.
The Company also announced that an abstract reviewing the
adaptive design of the VALOR trial has been accepted for
presentation during a poster session at the 2011 American Society
of Clinical Oncology (ASCO) Annual Meeting, which is being held
June 3-7 in Chicago, Illinois.
"Since the beginning of the year, we have achieved a number of
milestones that enhance the prospects for vosaroxin, our lead
program, as well as our earlier-stage pipeline programs," said
Daniel Swisher, Chief Executive Officer of Sunesis. "For vosaroxin,
we made progress on the clinical, regulatory and intellectual
property fronts: the roll-out of our Phase 3 pivotal VALOR trial in
relapsed/refractory AML is progressing well, we received U.S. FDA
Fast Track designation for vosaroxin in AML and an important
European patent has issued. Beyond vosaroxin, our newly formed
oncology kinase inhibitor collaboration with Millennium
Pharmaceuticals highlights the significant potential of our
pipeline programs, including a pan-Raf kinase inhibitor candidate
set for Phase 1 development. This collaboration will ensure these
programs are supported with the capabilities and resources of a
leading global oncology company while we continue to focus our
internal investment on vosaroxin and the ongoing VALOR trial."
First Quarter 2011 and Recent Highlights
-- 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 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.
-- Issued important European patent covering
vosaroxin clinical formulation. In March, the European
Patent Office (EPO) granted European Patent No. 1725233, which
claims pharmaceutical compositions of vosaroxin. A corresponding
patent was issued by the U.S. Patent and Trademark Office in
November 2010, and related applications are also pending in other
major markets throughout the world, including Japan, Australia and
Canada. Sunesis is proceeding to validate this patent in
several member states and the resulting national patents would
expire in March 2025. The company believes this patent, which
covers the formulation currently being used in the VALOR trial, may
provide a significant additional exclusivity period for its
vosaroxin franchise.
-- Received FDA Fast Track designation. In
February, the U.S. Food and Drug Administration (FDA) granted its
Fast Track designation to vosaroxin for the potential treatment of
relapsed or refractory AML in combination with cytarabine. This
designation provides for the possibility of a "rolling submission,"
or submission of individual sections as they become available, for
a marketing application and eligibility for a priority review
period by the FDA.
Financial Highlights
-- Cash, cash equivalents and marketable securities totaled
$48.9 million as of March 31, 2011, as compared to $53.4 million as
of December 31, 2010. The decrease of $4.5 million was primarily
due to $6.7 million of net cash used in operating activities,
partially offset by net proceeds of $2.1 million from sales of
Sunesis' common stock through its facility with Cantor Fitzgerald
& Co. In April 2011, Sunesis received a $4.0 million payment
from Millennium per the terms of the license agreement entered into
by Sunesis and Millennium on March 31, 2011. The company
believes that currently available and accessible funds are
sufficient to fund the company to the planned unblinding of the
VALOR trial.
-- Total revenues for the three months ended March 31, 2011
were $4.0 million, as compared to $13,000 for the same period in
2010. Revenue in the 2011 period was related to the upfront payment
of $4.0 million from Millennium.
-- Research and development expenses increased to $4.1
million for the three months ended March 31, 2011, as compared to
$3.1 million for the same period in 2010. The increase in 2011 was
primarily due to an increase in clinical expenses incurred as a
result of the launch of the VALOR trial.
-- General and administrative expenses for the three months
ended March 31, 2011 were $2.0 million, as compared to $1.6 million
for the same period in 2010. The increase in 2011 was primarily due
to higher legal and marketing costs, including legal costs related
to the recently completed agreements with Biogen Idec and
Millennium, and marketing costs related to the VALOR trial.
-- Other income, net, was $3.9 million for the three months
ended March 31, 2011 as compared to $4,000 for the same period
in 2010. The income in the 2011 period was comprised of a non-cash
credit of $3.6 million for the revaluation of warrants issued in
the October 2010 offering to their fair value as of March 31,
2011, and net foreign exchange gains of $0.3 million.
-- Sunesis reported net income of $1.8 million for the three
months ended March 31, 2011 as compared to a net loss of $4.6
million for the same period in 2010.
ASCO Presentation
The Company will present the poster titled "Adaptive design of
VALOR, a phase III trial of vosaroxin or placebo in combination
with cytarabine for patients with first relapsed or refractory
acute myeloid leukemia" at McCormick Place, Hall A, during the
Trials in Progress Poster Session on Monday, June 6, 2011 from 8:00
a.m. to 12:00 p.m. local time (Poster #48G).
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, the benefits to Sunesis from its
collaboration arrangement with Millennium, the prosecution of
pending foreign patent applications, the sufficiency of Sunesis'
currently available and accessible funds, and vosaroxin's effects,
efficacy and safety profile as a single agent and in combination
with cytarabine. Words such as "progressing," "will," "pending,"
"proceeding," "intends to," "expected," "believe" 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 result 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' 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 March 31, 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) |
|
|
March 31, 2011 |
December 31,
2010 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash
equivalents |
$ 9,914 |
$ 14,223 |
Marketable
securities |
39,002 |
39,173 |
Accounts receivable |
4,000 |
-- |
Prepaids and other
current assets |
1,595 |
1,286 |
Total current assets |
54,511 |
54,682 |
Property and equipment, net |
106 |
116 |
Deposits and other assets |
60 |
60 |
Total assets |
$ 54,677 |
$ 54,858 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 616 |
$ 416 |
Accrued clinical
expense |
1,599 |
1,574 |
Accrued compensation |
493 |
1,013 |
Other accrued
liabilities |
990 |
1,406 |
Warrant liability |
4,539 |
8,154 |
Total current liabilities |
8,237 |
12,563 |
|
|
|
Other liabilities |
40 |
48 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' equity: |
|
|
Common stock |
5 |
5 |
Additional paid-in
capital |
425,563 |
423,262 |
Accumulated other
comprehensive loss |
(3) |
(15) |
Accumulated deficit |
(379,165) |
(381,005) |
Total stockholders' equity |
46,400 |
42,247 |
Total liabilities and stockholders'
equity |
$ 54,677 |
$ 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 March 31, |
|
2011 |
2010 |
|
(Unaudited) |
|
Revenue: |
|
|
Collaboration
revenue |
$ -- |
$ 13 |
License and other
revenue |
4,000 |
-- |
Total revenues |
4,000 |
13 |
|
|
|
Operating expenses: |
|
|
Research and
development |
4,070 |
3,111 |
General and administrative |
2,014 |
1,554 |
Total operating expenses |
6,084 |
4,665 |
|
|
|
Loss from operations |
(2,084) |
(4,652) |
|
|
|
Other income, net |
3,924 |
4 |
Net income (loss) |
$ 1,840 |
$ (4,648) |
|
|
|
Net income (loss) per common share: |
|
|
Basic |
$ 0.04 |
$ (0.65) |
Diluted |
$ 0.04 |
$ (0.65) |
|
|
|
Shares used in computing net income (loss)
per common share: |
|
|
Basic |
45,894 |
7,142 |
Diluted |
47,866 |
7,142 |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals, Inc.
650-266-3717
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