- Conference Call Scheduled for Today at 5:00 p.m. EDT - SOUTH SAN
FRANCISCO, Calif., April 1 /PRNewswire-FirstCall/ -- Sunesis
Pharmaceuticals, Inc. (NASDAQ:SNSS) today reported financial
results for the fourth quarter and fiscal year ended December 31,
2008. Total revenue for the year ended December 31, 2008 was $5.4
million, with a net loss of $37.2 million. As of December 31, 2008,
cash, cash equivalents and marketable securities totaled $10.6
million, with no outstanding debt. Sunesis Pharmaceuticals
separately announced today 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. Recent Highlights -- Presented interim
clinical data of the Phase 2 voreloxin single-agent REVEAL-1 trial
at the 50th Annual Meeting of the American Society of Hematology,
with a year end update that coincided with the 27th Annual J.P.
Morgan Healthcare Conference in San Francisco. The REVEAL-1 trial
is enrolling newly diagnosed elderly AML patients unlikely to
benefit from standard induction chemotherapy. Schedules A (72 mg/m2
of voreloxin weekly for three weeks) and B (72 mg/m2 of voreloxin
weekly for two weeks) are fully enrolled, and patients are now
being enrolled on Schedule C (72 mg/m2 of voreloxin on days one and
four). In Schedule A, twelve of 29 patients achieved complete
remission (CR) or complete remission without full platelet recovery
(CRp) with a 30-day all-cause mortality of 17%. An update of the
interim data suggests that Schedule B is better tolerated by
patients than Schedule A, while maintaining anti-leukemic activity.
Ten of 35 patients on Schedule B have achieved CR or CRp. In
addition to improved tolerability, the 30-day all-cause mortality
has been reduced to 9%. To date, 16 of the planned 30 patients have
been enrolled in Schedule C. -- Presented interim clinical data of
the Phase 1b/2 trial of voreloxin combined with cytarabine in
relapsed/refractory AML at the 50th Annual Meeting of the American
Society of Hematology, with a year end update that coincided with
the 27th Annual J.P. Morgan Healthcare Conference in San Francisco.
A maximum tolerated dose of 80 mg/m2 of voreloxin was established
for Schedule A (continuous infusion of cytarabine), with 9 CRs or
CRps reported in the Phase 1b dose escalation. Early data show that
six of fourteen evaluable AML patients in first relapse enrolled in
the Phase 2 portion of Schedule A of this trial have achieved CR,
with a preliminary 30-day all-cause mortality of less than 10%. In
addition, one patient who achieved a partial response proceeded to
bone marrow transplant. Enrollment for Schedule A is complete. In
Schedule B (a 2 hour intravenous infusion of cytarabine), the third
dose escalation cohort, with a dose of 90 mg/m2 of voreloxin, is
fully enrolled. Complete remissions have been observed in Schedule
B in both relapsed and treatment refractory patients. Enrollment
into the Phase 2 portion of Schedule B is expected to begin
shortly. -- Presented updated interim data from an ongoing Phase 2
clinical trial of single-agent voreloxin in platinum-resistant
ovarian cancer patients at the 12th Biennial Meeting International
Gynecologic Cancer Society, with a year end update that coincided
with the 27th Annual J.P. Morgan Healthcare Conference in San
Francisco. Three schedules of voreloxin have been studied, 48 mg/m2
given every three weeks (N=65), and 60 mg/m2 (N=37) and 75 mg/m2
(N=35) given every four weeks. Enrollment of this trial completed
late last year. Data from this trial show encouraging durable
anti-tumor activity in the 48 mg/m2 cohort, as measured by GOG
RECIST criteria with partial and complete responses, and
progression-free survival. Some of the patients dosed with 60 mg/m2
or 75 mg/m2 of voreloxin still remain on study and complete and
partial responses have been observed. Voreloxin has generally been
well tolerated at all three dose levels. -- In March 2009, Sunesis
sold to SARcode Corporation all of the company's 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. Sunesis continues to hold a series of secured convertible
notes issued by SARcode having a total principal value of $1
million. -- In January 2009, Sunesis entered into an Agreement for
Termination of Lease and Voluntary Surrender of Premises for its
prior company headquarters at 341 Oyster Point Boulevard in South
San Francisco, CA. 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, and the landlord retained the $0.3
million security deposit it received upon signing of the lease. --
Sunesis filed today a Form 12b-25 with the Securities and Exchange
Commission disclosing its inability to timely file its Annual
Report on Form 10-K for the year ended December 31, 2008 due to the
timing of the placement announced today. Sunesis intends to file
its Annual Report on Form 10-K as soon as practicable, and in any
event within the 15 day extension period afforded by Rule 12b-25
under the Securities Exchange Act of 1934, as amended. As disclosed
in the Form 12b-25, Sunesis expects to receive a "going concern"
opinion from its independent registered public accounting firm when
the Annual Report on Form 10-K is filed, whether or not the private
placement closes. The foregoing disclosure regarding the "going
concern" opinion is required under NASDAQ rules and requires that a
company receiving an audit opinion that expresses doubt about the
ability of the company to continue as a going concern make a public
announcement disclosing the receipt of such opinion. With the
anticipated proceeds from the initial closing of the private
placement announced today, Sunesis believes that it has sufficient
resources to fund its operations at least through the end of 2009.
Financial Highlights -- No material revenue was recorded in the
fourth quarter of 2008, compared to $1.8 million in the fourth
quarter of the prior year. Revenue totaled $5.4 million for the
year ended December 31, 2008, compared to $9.7 million for the year
ended December 31, 2007. The decrease in revenue year-over-year was
primarily due to the conclusion of the research phase of the kinase
inhibitor collaboration with Biogen Idec in June 2008 and lower
amortization of license fees and milestone payments from our
collaboration with Merck & Co., Inc. -- Research and
development (R&D) expense was $4.6 million for the fourth
quarter of 2008, compared to $8.3 million for the same period in
2007. R&D expense for the year ended December 31, 2008 totaled
$26.3 million, compared to $36.1 million in 2007. The
quarter-over-quarter and year-over-year decrease in R&D expense
was primarily due to the termination of discovery research
activities in June 2008 and decrease in clinical trial activities
related to SNS-032 and SNS-314, partially offset by increased
clinical trial activities related to voreloxin. -- General and
administrative (G&A) expense for the fourth quarter of 2008 was
$2.2 million, compared to $2.8 million for the fourth quarter of
2007. For the year ended December 31, 2008, G&A expense was
$11.5 million, compared to $13.6 million in 2007. The
quarter-over-quarter and year-over-year decrease primarily resulted
from reduced headcount resulting from Sunesis' reorganization and
reduction in force in June 2008. -- In the fourth quarter ended
December 31, 2008, Sunesis recorded a $0.4 million additional
restructuring charge relating to the company's reorganization and
reduction in force in June 2008. Cash restructuring costs accounted
for approximately $3.8 million of the total $5.8 million
restructuring charge recorded for the year. -- Sunesis reported a
net loss of $6.9 million for the fourth quarter of 2008 and $37.2
million for the twelve-month period ended December 31, 2008,
compared to a reported net loss of $8.8 million and $38.8 million,
respectively, for the three-month and twelve-month periods ended
December 31, 2007. Conference Call Information Sunesis management
will host a conference call today to review the fourth quarter and
full-year 2008 financial results and the private placement
transaction separately announced today and to provide a general
business update at 5:00 p.m. EDT / 2:00 p.m. PDT. Individual and
institutional investors can access the call via 1-877-874-1567
(U.S. and Canada) or +1- 719-325-4788 (international). 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 http://www.sunesis.com/. The webcast will be
recorded and available for replay on Sunesis' website until April
15, 2009. 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 hematologic and solid 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/. This press release contains
forward-looking statements, including without limitation statements
related to the potential safety, efficacy and commercial potential
of voreloxin; planned additional clinical testing and development
efforts for voreloxin; the timing of enrollment in the ongoing
clinical trials of voreloxin; and the sufficiency of Sunesis' cash
resources. Words such as "contributed," "positive," "potential,"
"believe," "achieved," "interim," "suggests," "improved," "show,"
"encouraging," "well tolerated" 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
the satisfaction of the conditions to the completion of the
financing transaction announced today and Sunesis' need for
additional funding; the risk that Sunesis' development activities
for voreloxin, including enrollment and reporting of results, 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' preclinical studies and clinical
trials may not satisfy the requirements of the FDA or other
regulatory agencies; and risks related to the conduct of Sunesis'
clinical trials and manufacturing. These and other risk factors are
discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly
Report on Form 10-Q for the quarter ended September 30, 2008,
Current Report on Form 8-K anticipated to be filed on the date of
this press release 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. SUNESIS and the logo are trademarks of Sunesis
Pharmaceuticals, Inc. Investor Contact: Sunesis Pharmaceuticals,
Inc. Eric Bjerkholt 650-266-3717 Media Contact: Sunesis
Pharmaceuticals, Inc. Dan Weinseimer 650-266-3739 SUNESIS
PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS December 31
December 31 2008 2007 ---- ---- ASSETS (Note 1) Current assets:
Cash and cash equivalents $6,296,942 $11,726,126 Marketable
securities 4,321,844 35,957,933 Prepaids and other current assets
934,429 945,583 ------- ------- Total current assets 11,553,215
48,629,642 Property and equipment, net 612,241 4,238,498 Assets
held-for-sale 470,547 - Deposits and other assets 147,826 377,798
------- ------- Total assets $12,783,829 $53,245,938 ===========
=========== LIABILITIES AND STOCKHOLDERS' EQUITY Current
liabilities: Accounts payable and other accrued liabilities
$4,207,923 $4,515,426 Accrued compensation 537,215 2,225,868
Current portion of deferred rent 1,409,513 - Current portion of
deferred revenue 27,083 1,227,031 Current portion of equipment
financing - 953,940 --- ------- Total current liabilities 6,181,734
8,922,265 Non current portion of equipment financing - 1,352,684
Non-current portion of deferred rent 110,919 1,576,734 -------
--------- Total liabilities 6,292,653 11,851,683 Commitments
Stockholders' equity: Common stock 3,441 3,437 Additional paid-in
capital 322,671,604 320,579,240 Deferred stock-based compensation -
(251,601) Accumulated other comprehensive income 7,841 69,262
Accumulated deficit (316,191,710) (279,006,083) ------------
------------ Total stockholders' equity 6,491,176 41,394,255
--------- ---------- Total liabilities and stockholders' equity
$12,783,829 $53,245,938 =========== =========== Note 1: The
consolidated balance sheet at December 31, 2007 has been derived
from the audited financial statements at that date included in the
Company's Form 10-K for the fiscal year ended December 31, 2007.
SUNESIS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS
Three months ended Twelve months ended December 31, December 31,
------------------ ------------------- 2008 2007 2008 2007 ----
---- ---- ---- Revenue: Collaboration revenue $12,500 $1,796,708
$4,917,340 $9,163,513 License revenue - 250,000 500,000 500,000 ---
------- ------- ------- Total revenues 12,500 2,046,708 5,417,340
9,663,513 Operating expenses: Research and development 4,617,239
8,268,413 26,285,294 36,060,470 General and administrative
2,195,211 2,820,543 11,524,198 13,569,578 Restructuring and
impairment charges 393,158 345,426 5,782,903 1,563,274 -------
------- --------- --------- Total operating expenses 7,205,608
11,434,382 43,592,395 51,193,322 Loss from operations (7,193,108)
(9,387,674) (38,175,055) (41,529,809) Interest income 60,649
661,381 929,114 2,971,666 Interest expense (17,224) (57,631)
(171,308) (209,885) Other income, net 222,551 5,949 231,622 7,108
------- ----- ------- ----- Net loss $(6,927,132) $(8,777,975)
$(37,185,627) $(38,760,920) =========== =========== ============
============ Basic and diluted loss per share $(0.20) $(0.26)
$(1.08) $(1.20) Shares used in computing basic and diluted loss per
share 34,404,578 34,336,345 34,387,177 32,340,203 DATASOURCE:
Sunesis Pharmaceuticals, Inc. CONTACT: Investor Contact, Eric
Bjerkholt, +1-650-266-3717, or Media Contact, Dan Weinseimer,
+1-650-266-3739, both of Sunesis Pharmaceuticals, Inc. Web Site:
http://www.sunesis.com/
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