Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the third quarter ended September 30, 2011.
Net loss for the three and nine months ended September 30, 2011 was
$5.0 million and $11.4 million, respectively. As of September 30,
2011, cash, cash equivalents and marketable securities totaled
$41.8 million. On October 19, 2011, after the close of the quarter,
Sunesis announced that it had entered into a $25.0 million tranched
loan facility, pursuant to which it received the initial $10.0
million tranche at closing.
"Sunesis' recently announced tranched loan facility provides us
with capital and access to capital which is minimally dilutive and
substantially funds the company through to completion of the Phase
3 VALOR trial, regardless of outcome at the trial's interim
analysis," said Daniel Swisher, Chief Executive Officer of Sunesis.
"This flexibility provides greater fiscal certainty as we focus on
rigorous execution of the VALOR trial and approach its mid-2012
interim analysis. It is through this focus that the company is
meeting its target enrollment schedule for VALOR, with over 100
sites in 14 countries actively recruiting patients in an
underserved cancer setting." Mr. Swisher added, "While we continue
to direct our resources and attention to vosaroxin, during the
third quarter, our partner Millennium advanced MLN2480, a pan-Raf
kinase inhibitor discovered through Sunesis' kinase inhibitor
program, into a Phase I trial in patients with solid tumors."
Third Quarter 2011 and Recent Highlights
- Secured $25.0 million tranched loan facility.
In October, Sunesis announced that it had entered into a $25.0
million tranched loan facility led by Oxford Finance and partnered
with Silicon Valley Bank and Horizon Technology Finance
Corporation. Under the terms of the loan agreement, Sunesis
received $10.0 million at closing, with the remaining $15.0 million
available to draw at Sunesis' discretion following the planned
interim analysis of the VALOR trial by an independent Data and
Safety Monitoring Board (DSMB), which is expected in mid-2012,
provided the trial continues or is stopped early for efficacy and
provided further that Sunesis is compliant with the terms and
conditions of the related loan agreement.
- Updated leukemia-free survival, increased to 25
months. At the company's analyst meeting in October,
Sunesis announced leukemia-free survival (LFS) data from its Phase
2 cytarabine/vosaroxin trial in first relapsed and primary
refractory acute myeloid leukemia (AML). The LFS was updated to 25
months, an increase from the previously reported 14.5 months.
- Initiated Phase 1 Trial of MLN2480 initiated in
advanced solid tumors. In September, Sunesis announced the
initiation of a Phase 1 clinical trial of MLN2480, an oral,
investigative drug selective for pan-Raf kinase inhibition, which
is being studied in patients with relapsed or refractory solid
tumors. The trial is being sponsored by Millennium Pharmaceuticals,
Inc., which is developing MLN2480 in oncology in collaboration with
Sunesis.
- Issued important U.S. patent covering vosaroxin use in
leukemia.In August, 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 Sunesis' pivotal, Phase 3 VALOR trial.
The patent provides coverage through 2026, and corresponding
applications are pending in other major markets, including Europe,
Japan, Australia and Canada.
- 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
trial 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 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.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $41.8
million as of September 30, 2011, compared to $53.4 million as of
December 31, 2010. Including the net loan proceeds received in
October, the September 30, 2011 balance would have been $51.5
million.
- Total revenue for the three and nine months ended September 30,
2011 were $1.0 million and $5.0 million, as compared to nil and
$27,000 for the same periods in 2010. Revenue in the third quarter
of 2011 related to the recognition of deferred revenue from the
sale of certain intellectual property rights following the
repayment by SARcode of three promissory notes originally issued to
Sunesis in March 2006. Revenue for the nine month period in 2011
also included the $4.0 million upfront payment from Millennium
received in April 2011.
- Research and development expenses increased to $6.2 million and
$16.2 million for the three and nine months ended September 30,
2011, as compared to $3.5 million and $9.6 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, as well as increased drug manufacturing
activities and personnel costs.
- General and administrative expenses for the three and nine
months ended September 30, 2011 were $2.2 million and $6.1 million,
as compared to $1.8 million and $5.2 million for the same periods
in 2010. The increases in 2011 were primarily due to higher legal,
marketing and personnel expenses.
- Net other income was $2.4 million and $6.0 million for the
three and nine months ended September 30, 2011, as compared to $0.2
million for each of the same periods in 2010. Net other income for
the three and nine months ended September 30, 2011 was primarily
comprised of non-cash credits of $2.5 million and $5.7 million,
respectively, for the revaluation of warrants issued in the October
2010 offering to their fair value as of September 30, 2011.
- Sunesis reported a net loss of $5.0 million and $11.4 million
for the three and nine months ended September 30, 2011, as compared
to a net loss of $5.1 million and $14.5 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 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 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 estimates there will be
12,950 new cases of AML and approximately 9,050 deaths from AML in
the U.S. in 2011. 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 through to the completion of the VALOR trial, the
occurrence and timing of the DSMB interim analysis, the
availability of the second tranche under the loan facility with
Oxford Finance LLC, Horizon Technology Finance Corporation and
Silicon Valley Bank, the design, conduct and results of the VALOR
trial, and vosaroxin's effects, efficacy and safety profile as a
single agent and in combination with cytarabine. Words such as
"focus," "provides," "advanced," "continue," "available," planned,"
"support," "will" "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, 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 June 30, 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 September 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) |
|
|
|
|
September 30, |
December 31, |
|
2011 |
2010 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash
equivalents |
$ 11,894 |
$ 14,223 |
Marketable
securities |
29,869 |
39,173 |
Prepaids and other
current assets |
1,770 |
1,286 |
Total current assets |
43,533 |
54,682 |
Property and equipment, net |
82 |
116 |
Deposits and other assets |
60 |
60 |
Total assets |
$ 43,675 |
$ 54,858 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 327 |
$ 416 |
Accrued clinical
expense |
2,762 |
1,574 |
Accrued compensation |
1,019 |
1,013 |
Other accrued
liabilities |
1,281 |
1,406 |
Warrant liability |
2,453 |
8,154 |
Total current liabilities |
7,842 |
12,563 |
|
|
|
Non-current portion of deferred rent |
22 |
48 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' equity: |
|
|
Common stock |
5 |
5 |
Additional paid-in
capital |
428,192 |
423,262 |
Accumulated other
comprehensive income (loss) |
20 |
(15) |
Accumulated deficit |
(392,406) |
(381,005) |
Total stockholders' equity |
35,811 |
42,247 |
Total liabilities and stockholders'
equity |
$ 43,675 |
$ 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 September 30, |
Nine
months ended September 30, |
|
2011 |
2010 |
2011 |
2010 |
|
(Unaudited) |
(Unaudited) |
Revenue: |
|
|
|
|
Collaboration
revenue |
$ -- |
$ -- |
$ -- |
$ 27 |
License and other
revenue |
1,000 |
-- |
5,000 |
-- |
Total revenues |
1,000 |
-- |
5,000 |
27 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and
development |
6,217 |
3,479 |
16,237 |
9,560 |
General and
administrative |
2,155 |
1,804 |
6,144 |
5,220 |
Total operating expenses |
8,372 |
5,283 |
22,381 |
14,780 |
|
|
|
|
|
Loss from operations |
(7,372) |
(5,283) |
(17,381) |
(14,753) |
|
|
|
|
|
Other income (expense), net |
2,358 |
199 |
5,980 |
237 |
Net loss |
$ (5,014) |
$ (5,084) |
$ (11,401) |
$ (14,516) |
|
|
|
|
|
Basic and diluted net loss per common
share |
$ (0.11) |
$ (0.14) |
$ (0.25) |
$ (0.79) |
|
|
|
|
|
Shares used in computing basic and diluted
net loss per common share |
46,714 |
36,970 |
46,304 |
18,451 |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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