Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today reported
financial results for the quarter ended March 31, 2012. Net loss
for the three months ended March 31, 2012 was $13.9 million, which
included a non-cash expense of $4.9 million related to the
revaluation of certain warrants. As of March 31, 2012, cash, cash
equivalents and marketable securities totaled $34.9 million.
"Sunesis is highly focused on the successful execution of our
Phase 3 VALOR trial in acute myeloid leukemia as we prepare for
future regulatory and commercial milestones to realize vosaroxin's
significant potential. We have now enrolled 317 patients and remain
on track to conduct a pre-specified interim analysis in the third
quarter," said Daniel Swisher, Chief Executive Officer of Sunesis.
"The recently announced agreement with Royalty Pharma provides us
access to additional capital and confirms the growing interest in
VALOR's adaptive trial design and the market potential of
vosaroxin."
First Quarter 2012 and Recent Highlights
- Continued strong execution of VALOR trial.
Enrollment and execution in the VALOR trial continues to be strong,
with 317 patients enrolled as of yesterday, which remains on track
for the conduct of the interim analysis in the third quarter of
this year.
- Announced $25.0 million vosaroxin royalty agreement
with Royalty Pharma. In March, Sunesis
announced that Royalty Pharma agreed to pay Sunesis $25.0 million,
under certain circumstances related to the successful development
of vosaroxin, to acquire a royalty on future worldwide net sales of
vosaroxin on terms and conditions previously disclosed.
- Granted U.S. patent covering vosaroxin
compositions. In March, the U.S. Patent and Trademark
Office granted Sunesis Patent No. US 8,138,202 B2 covering certain
compositions related to vosaroxin, which provides patent
exclusivity through mid-2030 in the United States. A family of
corresponding patent applications is pending internationally.
- Received orphan drug designation by European
Commission.In April, the European Commission granted
orphan drug designation to vosaroxin for the treatment of acute
myeloid leukemia (AML). The designation provides for 10 years of
marketing exclusivity subsequent to product approval in Europe.
Vosaroxin has previously received orphan drug and fast track
designations from the U.S. Food and Drug
Administration.
- MLN2480, pan-RAF inhibitor, featured in "New Drugs on
the Horizon" at AACR 2012. In April, Millennium
Pharmaceuticals, Inc. presented preclinical data on MLN2480 at the
2012 American Association of Cancer Research Annual Meeting in
Chicago. The data suggest that MLN2480 has therapeutic anti-cancer
activity in both B-Raf mutant and wild-type melanoma tumor models.
- Dosed first patient in Cardiff University sponsored
Less Intensive 1 (LI-1) Trial. In March, patient dosing
began in the Cardiff University sponsored Phase 2/3 randomized,
controlled, multicenter LI-1 Trial, which is 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. N
- VALOR design poster presentation accepted for ASCO
2012. Sunesis will present the poster titled "VALOR, an
adaptive design, pivotal phase III trial of vosaroxin or placebo in
combination with cytarabine in first relapsed or refractory acute
myeloid leukemia" at the 2012 American Society of Clinical Oncology
(ASCO) Annual Meeting in Chicago.
Financial Highlights
- Cash, cash equivalents and marketable securities totaled $34.9
million as of March 31, 2012, as compared to $44.1 million as of
December 31, 2011.
- Total revenue was nil for the three months ended March 31,
2012, as compared to $4.0 million for the same period in 2011.
Revenue in the 2011 period was due to an upfront payment of $4.0
million from Millennium Pharmaceuticals, Inc. as part of the
assignment of licenses for two oncology programs to it in March
2011.
- Research and development expenses increased to $6.6 million for
the three months ended March 31, 2012, as compared to $4.1 million
for the same period in 2011. The increase in 2012 was primarily due
to an increase in clinical and other expenses related to the VALOR
trial.
- General and administrative expenses for the three months ended
March 31, 2012 were $2.2 million, as compared to $2.0 million for
the same period in 2011. The increase in 2012 was primarily due to
higher non-cash stock-based compensation expenses.
- Other expense, net, was $4.8 million for the three months ended
March 31, 2012, as compared to net other income of $3.9 million for
the same period in 2011. Net other expense for the 2012 period was
primarily comprised of a non-cash expense of $4.9 million for the
revaluation of warrants issued in the underwritten offering
completed in October 2010 to their fair value as of March 31, 2012.
- Sunesis reported a net loss of $13.9 million for the three
months ended March 31, 2012, as compared to net income of $1.8
million for the same period in 2011.
Conference Call Information
Sunesis will host an update conference call today, May 15th at
11a.m. Eastern Time. The call can be accessed by dialing (866)
783-2143 (U.S. and Canada) or (857) 350-1602 (international), and
entering passcode 91964294. 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
Data Safety Monitoring Board (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 will be
approximately 13,780 new cases of AML and 10,200 deaths from AML in
the U.S. in 2012. 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.
The Sunesis Pharmaceuticals, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=8773
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals,
Inc.
This press release contains forward-looking statements,
including statements related to the occurrence and timing of the
DSMB interim analysis, the design, conduct, progress and results of
the VALOR trial and other clinical trials, the sufficiency of
Sunesis' intellectual property estate and the patent exclusivity
period for vosaroxin in the United States and other jurisdictions,
and vosaroxin's effects, efficacy, safety profile and commercial
potential as a single agent and in combination with cytarabine.
Words such as "will," "on track", "focused", "suggests",
"estimates", "provides," "pending," "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 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 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' Annual Report on Form 10-K
for the year ended December 31, 2011 and Sunesis' other filings
with the Securities and Exchange Commission, including Sunesis'
Quarterly Report on Form 10-Q for the quarter ended March 31, 2012,
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
PHARMACEUTICALS, INC. |
CONDENSED CONSOLIDATED
BALANCE SHEETS |
(In
thousands) |
|
|
|
|
March 31, |
December 31, |
|
2012 |
2011 |
ASSETS |
(Unaudited) |
(Note 1) |
Current assets: |
|
|
Cash and cash
equivalents |
$ 5,282 |
$ 9,311 |
Marketable
securities |
29,594 |
34,804 |
Prepaids and other
current assets |
1,855 |
1,550 |
Total current assets |
36,731 |
45,665 |
Property and equipment, net |
66 |
74 |
Deposits and other assets |
118 |
130 |
Total assets |
$ 36,915 |
$ 45,869 |
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 869 |
$ 658 |
Accrued clinical
expense |
2,564 |
2,370 |
Accrued compensation |
580 |
1,274 |
Other accrued
liabilities |
1,513 |
1,805 |
Current portion of notes
payable |
50 |
-- |
Warrant liability |
7,155 |
2,276 |
Total current liabilities |
12,731 |
8,383 |
|
|
|
Non-current portion of notes payable |
9,496 |
9,453 |
Non-current portion of deferred rent |
3 |
13 |
|
|
|
Commitments |
|
|
|
|
|
Stockholders' equity: |
|
|
Common stock |
5 |
5 |
Additional paid-in capital |
429,742 |
429,142 |
Accumulated other comprehensive income |
8 |
19 |
Accumulated deficit |
(415,070) |
(401,146) |
Total stockholders' equity |
14,685 |
28,020 |
Total liabilities and stockholders'
equity |
$ 36,915 |
$ 45,869 |
|
|
|
|
|
|
Note 1: The condensed
consolidated balance sheet as of December 31, 2011 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, 2011. |
|
|
|
SUNESIS
PHARMACEUTICALS, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
(LOSS) |
(In thousands, except
per share amounts) |
|
|
|
|
Three months
ended March 31, |
|
2012 |
2011 |
|
(Unaudited) |
Revenue: |
|
|
License and other
revenue |
$ -- |
$ 4,000 |
Total revenues |
-- |
4,000 |
|
|
|
Operating expenses: |
|
|
Research and
development |
6,646 |
4,070 |
General and
administrative |
2,189 |
2,014 |
Total operating expenses |
8,835 |
6,084 |
|
|
|
Loss from operations |
(8,835) |
(2,084) |
|
|
|
Interest expense |
(315) |
-- |
Other income (expense), net |
(4,774) |
3,924 |
Net income (loss) |
(13,924) |
1,840 |
Unrealized gain (loss) on available-for-sale
securities |
(11) |
12 |
Comprehensive income (loss) |
$ (13,935) |
$ 1,852 |
|
|
|
Net income (loss) per common share: |
|
|
|
|
|
Net income (loss) |
(13,924) |
1,840 |
|
|
|
Shares used in computing net income (loss)
per common share: |
|
|
Basic |
46,793 |
45,894 |
Diluted |
46,793 |
47,866 |
|
|
|
Net income (loss) per common share: |
|
|
Basic |
$ (0.30) |
$ 0.04 |
Diluted |
$ (0.30) |
$ 0.04 |
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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