Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced that it
has entered into a $25 million tranched loan facility. Under the
terms of the loan agreement, Sunesis received $10 million upon
closing, with the remaining $15 million available for draw at its
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. Sunesis anticipates using the funds
to support the clinical development activities related to VALOR, 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), as well as other working capital and
general corporate purposes.
"This facility provides additional financial strength and
flexibility with the initial $10 million tranche increasing our
current cash reserves," said Eric Bjerkholt, Senior Vice President
of Corporate Development and Finance and Chief Financial Officer of
Sunesis. "We anticipate that this facility, if fully drawn,
together with our existing cash and investments, will substantially
fund Sunesis' execution of the VALOR trial through data unblinding
regardless of the outcome at the interim analysis. We appreciate
the support of our lender group, their flexibility in structuring a
two-tranched, four-year loan, and their confidence in vosaroxin,
VALOR and Sunesis."
As previously announced, the DSMB will meet to examine
pre-specified efficacy and safety data sets and decide whether to
1) stop the trial early for efficacy or for futility; 2) continue
the study to its planned unblinding, expected in mid-2013; or 3)
recommend a one-time "adaptive" sample size adjustment to a planned
unblinding, expected in early 2014. The $15 million tranche will be
available to Sunesis, at its option, following the interim
analysis, if the DSMB recommends ending the trial early for
efficacy or continuing the study with or without a sample size
adjustment.
The loan facility was led by Oxford Finance and partnered with
Silicon Valley Bank and Horizon Technology Finance Corporation.
Christopher A. Herr, Managing Director at Oxford Finance, said: "We
are pleased to have led this $25 million loan agreement to support
the execution of Sunesis' VALOR trial. Through our diligence
process, we have gained great confidence in the trial's rigorous
design and execution."
The four-year loan facility is structured to have an
interest-only period until February 2013, followed by a 32-months
amortization period. In conjunction with the loan, Sunesis granted
the lenders warrants to purchase an aggregate of 386,100 shares at
an exercise price of $1.30. Additional warrants will be due if the
second tranche is drawn.
About VALOR
VALOR is a Phase 3, multinational, 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 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
About Oxford Finance LLC
Oxford Finance is a specialty finance firm providing senior
secured loans to public and private life sciences and healthcare
services companies worldwide. For over 20 years, Oxford has
delivered flexible financing solutions to its clients, enabling
these companies to maximize their equity by leveraging their
assets. In recent years, Oxford has originated over $1.5 billion in
loans, with lines of credit ranging from $500 thousand to $50
million. Oxford is headquartered in Alexandria, Virginia, with
additional offices in California, Illinois, Massachusetts and North
Carolina. For more information visit www.oxfordfinance.com.
About Horizon Technology Finance
Horizon Technology Finance Corporation (Nasdaq:HRZN) is a
leading specialty finance company that provides secured loans to
venture capital and private equity backed development-stage
companies in the technology, life science, healthcare information
and services, and clean-tech industries. With more than 20 years in
venture lending, the Horizon team has provided over $2 billion in
financing to more than 750 companies. Horizon is headquartered in
Farmington, CT with its regional office in Walnut Creek, CA. To
learn more, call 860-676-8659 or visit
www.horizontechnologyfinancecorp.com.
About Silicon Valley Bank
Silicon Valley Bank is the premier commercial bank for companies
in the technology, life science, venture capital, private equity
and premium wine industries. SVB provides a comprehensive suite of
financing solutions, treasury management, corporate investment and
international banking services to its clients worldwide. Through
its focus on specialized markets and extensive knowledge of the
people and business issues driving them, Silicon Valley Bank
provides a level of service and partnership that measurably impacts
its clients success. Founded in 1983 and headquartered in Santa
Clara, Calif., the company serves clients around the world through
26 U.S. offices and seven international operations. Silicon Valley
Bank is a member of global financial services firm SVB Financial
Group. www.svb.com
This press release contains forward-looking statements,
including statements related to the occurrence and timing of the
DSMB interim analysis and unblinding of the VALOR trial, the
design, conduct and results of the VALOR trial, the sufficiency of
Sunesis' cash resources, and the use of proceeds from the first
tranche and the availability of the second tranche under the loan
facility with Oxford Finance LLC, Horizon Technology Finance
Corporation and Silicon Valley Bank. Words such as "anticipates,"
"may," "provides," will," "planned," "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 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. 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. All other trademarks, trade names and/or service marks
appearing in this release are the property of their respective
owners.
CONTACT: Investor and Media Inquiries:
David Pitts
Argot Partners
212-600-1902
Eric Bjerkholt
Sunesis Pharmaceuticals Inc.
650-266-3717
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