Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the
closing of two previously disclosed financings. Royalty Pharma has
invested $25.0 million under its royalty arrangement with Sunesis,
and, in a separate transaction, a syndicate of lenders have funded
the second tranche of $15.0 million under their $25.0 million loan
facility with the company.
The loan facility, announced in October 2011, is led by Oxford
Finance and partnered with Silicon Valley Bank and Horizon
Technology Finance Corporation. The transaction with Royalty Pharma
was first announced in March 2012.
Both financings were triggered by the decision to implement a
one-time, 225-patient sample size increase to Sunesis' VALOR trial,
a Phase 3, multinational, randomized, double-blind,
placebo-controlled, pivotal clinical trial of vosaroxin in
combination with cytarabine in first relapsed or refractory acute
myeloid leukemia (AML). Sunesis currently holds all worldwide
commercial rights to its vosaroxin product.
Sunesis anticipates using the funds to support the clinical
development activities related to VALOR as well as other working
capital and general corporate purposes.
"These financings, together with our existing cash and
investments, will fund Sunesis' execution of the VALOR trial
through full data readout in the first half of 2014," said Eric
Bjerkholt, Executive Vice President, Corporate Development and
Finance, Chief Financial Officer of Sunesis. "The strength of our
balance sheet enables us to prosecute VALOR to unblinding and
continue preparations for related regulatory filings and commercial
launch. We appreciate the support of Royalty Pharma and our lender
group, and their continued confidence in vosaroxin, VALOR and
Sunesis."
About VALOR
VALOR is a Phase 3, randomized, double-blind,
placebo-controlled, pivotal trial in patients with first relapsed
or refractory AML. The trial's target enrollment is 675 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. 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. Both the
U.S. Food and Drug Administration (FDA) and European Commission
have granted orphan drug designation to vosaroxin for the treatment
of acute myeloid leukemia. Additionally, vosaroxin has been
granted fast track designation by the FDA for the potential
treatment of relapsed or refractory acute myeloid leukemia in
combination with cytarabine.
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 sufficiency of Sunesis' cash
and investments to fund the company's operations and the VALOR
trial through its planned unblinding in the first half of 2014,
Sunesis' expectations regarding the completion and anticipated use
of proceeds from the disclosed financings and the design, conduct,
progress and results of the VALOR trial. Words such as
"anticipates," "will," "enables," "continued" 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' Quarterly Report on Form
10-Q for the quarter ended June 30, 2012, Sunesis' Annual Report on
Form 10-K for the year ended December 31, 2011 and Sunesis' other
filings with the Securities and Exchange Commission. 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.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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