SOUTH SAN FRANCISCO, Calif., May 6 /PRNewswire-FirstCall/ --
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today reported
financial results for the first quarter ended March 31, 2009. Total
revenue for the first quarter of 2009 was $0.2 million, with a net
loss of $8.4 million, including $1.9 million of restructuring
charges. As of March 31, 2009, cash, cash equivalents and
marketable securities totaled $4.3 million, with no debt
outstanding. "In the first quarter of this year, we continued to
make significant progress moving voreloxin forward in the clinic,"
said Daniel Swisher, Chief Executive Officer of Sunesis. "This
progress, combined with the recent tranched financing of up to
$43.5 million, positions us well to realize the potential for
voreloxin to be an important new anticancer agent for treating
hematologic and solid tumors." Recent Highlights -- In April,
Sunesis announced the execution of a securities purchase agreement
with accredited investors, including certain members of management,
providing for a private placement, subject to the satisfaction of
conditions, of up to $43.5 million in a tranched financing,
including two tranches of units consisting of convertible preferred
stock and common stock warrants, and a tranche of common stock. The
first tranche for $10.0 million of units closed on April 3
resulting in net proceeds of approximately $8.8 million. The
remainder may be issued by Sunesis, subject to approval by Sunesis'
stockholders, upon the satisfaction of a certain clinical milestone
and Sunesis' common stock trading above a specified floor price or
upon approval by a majority of the investors in the private
placement, among other conditions. -- In April, Sunesis presented
data on voreloxin at the American Association for Cancer Research
(AACR) Annual Meeting in Denver, Colorado. Results from nonclinical
translational research studies identified potent voreloxin activity
in breast cancer biopsies from both ductal and metastatic tumors.
Activity compared favorably with compounds currently in clinical
use for the treatment of breast cancer, including cisplatin and
topoisomerase II inhibitors doxorubicin and etoposide. Data also
established an enhanced sensitivity to voreloxin in BRCA2 mutant
cell lines, indicating that BRCA mutant tumors may be particularly
sensitive to voreloxin. These data complement previous reports of
potent voreloxin activity in biopsies from triple-negative breast
cancers (AACR 2008) and support a rationale for potential future
investigation of voreloxin's clinical activity in breast cancer
patients. -- In March, all three of the Company's voreloxin
abstracts submitted for consideration at the 45th American Society
of Clinical Oncology (ASCO) Annual Meeting to be held in Orlando,
Florida were accepted. Each abstract represents one of the ongoing
clinical trials of voreloxin: single-agent voreloxin in newly
diagnosed elderly acute myeloid leukemia (AML), voreloxin in
combination with cytarabine in relapsed/refractory AML and
single-agent voreloxin in women with platinum-resistant ovarian
cancer. In lieu of a conference call today, Sunesis management will
host a conference call during the ASCO Annual Meeting to discuss
the voreloxin clinical data to be presented at that meeting. Below
are the details of the voreloxin presentations and the conference
call information will be provided via press release several days
prior to the ASCO Annual Meeting, which begins May 29. Saturday May
30, 8:00AM to 12:00PM (poster presentation) Abstract #7048 Title:
"A phase II study of voreloxin as single agent therapy for elderly
patients (pts) with newly diagnosed acute myeloid leukemia (AML)."
Location: Level 2, West Hall C Board #M2 Sunday May 31, 2:00PM to
6:00PM (poster presentation) Abstract #5559 Title: "A phase II
trial of voreloxin in women with platinum-resistant ovarian
cancer." Location: Level 2, West Hall C Board #M18 Monday June 1,
10:30AM (oral presentation) Abstract #7005 Title: "Phase Ib/II
pharmacokinetic/pharmacodynamic (PK/PD) study of combination
voreloxin and cytarabine in relapsed or refractory AML patients."
Location: Level 2, West Hall F1 -- In March, Sunesis sold to
SARcode Corporation all of its interest in patents and know-how
related to the LFA-1 inhibitors program previously licensed to
SARcode for a total cash consideration of $2 million that will be
recorded as revenue in the second quarter of 2009. Sunesis
continues to hold a series of secured convertible notes issued by
SARcode having a total principal value of $1 million. -- In
January, Sunesis entered into an Agreement for Termination of Lease
and Voluntary Surrender of Premises for its prior company
headquarters. In consideration of the early termination of the
existing lease agreement, Sunesis agreed to pay the lessor an
aggregate fee of $2.2 million, thus substantially reducing its
future financial liabilities. Financial Highlights -- Revenues for
the three months ended March 31, 2009 decreased to $0.2 million
compared to $2.3 million for the same period in 2008. The decrease
was primarily due to the conclusion of the research phase of the
kinase inhibitor collaboration with Biogen Idec in June 2008. --
Research and development expense decreased by $4.4 million, or 51
percent, to $4.3 million for the three months ended March 31, 2009,
from $8.7 million for the same period in 2008. This decrease was
primarily due to the termination of substantially all discovery
research activities in June 2008. -- General and administrative
expense for the first quarter of 2009 was $2.4 million compared to
$3.3 million for the same period in 2008. The decrease was
primarily due to reduced administrative headcount as a result of
our June 2008 restructuring. -- Restructuring charges of $1.9
million were recorded in the three months ended March 31, 2009,
including $1.3 million for lease termination activities and $0.6
million for employee severance and related benefit costs related to
a restructuring in March 2009. -- Sunesis reported a net loss of
$8.4 million for the quarter ended March 31, 2009, compared to a
reported net loss of $9.6 million for the same period in 2008.
About Voreloxin Voreloxin 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. Voreloxin both intercalates
DNA and inhibits topoisomerase II, resulting in
replication-dependent, site-selective DNA damage, G2 arrest and
apoptosis. Voreloxin is currently being evaluated in a Phase 2
clinical trial (known as the REVEAL-1 trial) in previously
untreated elderly AML patients and in a Phase 1b/2 clinical trial
combining voreloxin with cytarabine for the treatment of patients
with relapsed/refractory AML, as well as in an ongoing Phase 2
single-agent trial in platinum-resistant ovarian cancer. 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 Leukemia and Lymphoma Society
estimates that over 13,000 new cases of AML were diagnosed and
approximately 9,000 deaths from AML occurred in the U.S. during
2007. AML is generally a disease of older adults, and the median
age of a patient diagnosed with AML is about 67 years. A majority
of elderly patients are not considered candidates for standard
induction therapy or decline therapy, resulting in an acute need
for new treatment options. About Ovarian Cancer In the United
States, ovarian cancer remains the leading cause of death from
gynecologic malignancies and is the fifth leading cause of cancer
death overall in women behind lung, breast, colorectal and
pancreatic cancers. According to the American Cancer Society, in
2008 there were an estimated 21,650 new cases and more than 15,000
deaths from ovarian cancer in the U.S. alone. Following frontline
treatment, recurrence rates among ovarian cancer patients are high.
Treatment options remain limited following relapse, and overall
long-term survival has not changed significantly over the past 40
years, with five-year survival rates at less than 30 percent. 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,
voreloxin, in multiple indications to improve the lives of people
with cancer. For additional information on Sunesis Pharmaceuticals,
please visit http://www.sunesis.com/. SUNESIS and the logo are
trademarks of Sunesis Pharmaceuticals, Inc. This press release
contains forward-looking statements, including without limitation
statements related to the potential safety and efficacy and
commercial potential of voreloxin, the completion of the tranched
financing, the activity of voreloxin in nonclinical studies,
planned additional clinical testing and development efforts, the
timing of clinical trial enrollment and the anticipated
announcement of clinical results. Words such as "continued,"
"significant," "progress," "potential," " activity," established,"
"enhanced," "realize" 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
additional funding, the risk that Sunesis' drug development
activities could be halted significantly or delayed for various
reasons, the risk that Sunesis' clinical trials for voreloxin may
not demonstrate safety or efficacy or lead to regulatory approval,
the risk that preliminary data and trends may not be predictive of
future data or results, the risk that Sunesis' nonclinical studies
and clinical trials may not satisfy the requirements of the FDA or
other regulatory agencies, risks related to the conduct of Sunesis'
clinical trials, including the pace of enrollment, risks related to
the manufacturing of voreloxin and the risk that Sunesis'
proprietary rights may not adequately protect voreloxin. These and
other risk factors are discussed under "Risk Factors" and elsewhere
in Sunesis' Annual Report on Form 10-K/A for the year ended
December 31, 2008, its quarterly report on Form 10-Q for the
quarter ended March 31, 2009 and 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. Investor Contact: Media Contact: Sunesis
Pharmaceuticals, Inc. Sunesis Pharmaceuticals, Inc. Eric Bjerkholt
Dan Weinseimer 650-266-3717 650-266-3739 SUNESIS PHARMACEUTICALS,
INC. CONDENSED CONSOLIDATED BALANCE SHEETS March 31, December 31,
2009 2008 ---------- ----------- ASSETS (unaudited) (Note 1)
Current assets: Cash and cash equivalents $4,280,363 $6,296,942
Marketable securities - 4,321,844 Prepaids and other current assets
763,074 934,429 ---------- ----------- Total current assets
5,043,437 11,553,215 Property and equipment, net 501,751 612,241
Assets held-for-sale 50,427 470,547 Deposits and other assets
96,824 147,826 ---------- ----------- Total assets $5,692,439
$12,783,829 ========== =========== LIABILITIES AND STOCKHOLDERS'
(DEFICIT) EQUITY Current liabilities: Accounts payable and other
accrued liabilities $1,994,735 $2,150,980 Accrued clinical expense
1,794,154 1,865,773 Accrued compensation 845,649 537,215 Accrued
restructuring charges 621,149 191,170 Current portion of deferred
rent - 1,409,513 Current portion of deferred revenue 1,814,583
27,083 ---------- ----------- Total current liabilities 7,070,270
6,181,734 Non current portion of deferred rent 116,339 110,919
Commitments Stockholders' (deficit) equity: Preferred stock - -
Common stock 3,441 3,441 Additional paid-in capital 323,057,535
322,671,604 Accumulated other comprehensive income - 7,841
Accumulated deficit (324,555,146) (316,191,710) ----------
----------- Total stockholders' (deficit) equity (1,494,170)
6,491,176 ---------- ----------- Total liabilities and
stockholders' (deficit) equity $5,692,439 $12,783,829 ==========
=========== Note 1: The condensed consolidated balance sheet as of
December 31, 2008 has been derived from the audited financial
statements at that date included in the Company's Annual Report on
Form 10-K for the year ended December 31, 2008. SUNESIS
PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS Three months ended March 31, ------------------------
2009 2008 ---------- ----------- (unaudited) Revenue: Collaboration
revenue $12,500 $537,500 Collaboration revenue from related party -
1,765,683 License and other revenue 211,547 - ----------
----------- Total revenues 224,047 2,303,183 Operating expenses:
Research and development 4,264,152 8,742,895 General and
administrative 2,355,012 3,266,129 Restructuring charges 1,862,861
320,774 ---------- ----------- Total operating expenses 8,482,025
12,329,798 Loss from operations (8,257,978) (10,026,615) Interest
income 12,812 460,412 Interest expense (612) (59,373) Other income
(expense), net (117,658) 671 ---------- ----------- Net loss
$(8,363,436) $(9,624,905) =========== =========== Basic and diluted
loss per share $(0.24) $(0.28) Shares used in computing basic and
diluted loss per share 34,409,768 34,364,896 DATASOURCE: Sunesis
Pharmaceuticals, Inc. CONTACT: Investors, Eric Bjerkholt, Inc.,
+1-650-266-3717, or Media, Dan Weinseimer, +1-650-266-3739, both of
Sunesis Pharmaceuticals, Inc. Web Site: http://www.sunesis.com/
Copyright
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Sep 2024 to Oct 2024
Sunesis Pharmaceuticals (NASDAQ:SNSS)
Historical Stock Chart
From Oct 2023 to Oct 2024