SOUTH SAN FRANCISCO, Calif., March 11 /PRNewswire-FirstCall/ --
Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS), a clinical-stage
biopharmaceutical company focused on the discovery, development and
commercialization of novel small-molecule therapeutics, today
reported financial results for the quarter and fiscal year ended
December 31, 2007. Total revenue for the fourth quarter of 2007 was
$2.0 million, with a net loss of $8.8 million. Total revenue for
the year ended December 31, 2007 was $9.7 million, with a net loss
of $38.8 million. As of December 31, 2007, cash, cash equivalents
and marketable securities totaled $47.7 million, and debt totaled
$2.3 million. Net cash used in operating activities in 2007 was
$34.5 million. Recent Highlights -- This week at the 39th Annual
Meeting on Women's Cancer hosted by the Society for Gynecologic
Oncology in Tampa, Florida, Sunesis presented positive interim
results from the company's ongoing Phase 2 clinical trial of
SNS-595, a novel naphthyridine analog, in advanced
platinum-resistant ovarian cancer patients. -- Sixty-five women
have been enrolled and treated with single-agent SNS-595 at a dose
of 48 mg/m2 administered once every three weeks, with the majority
of these women having been enrolled since October. Forty-five women
have sufficient follow up to yield useful safety results and 35 are
evaluable for best response using GOG-RECIST criteria. -- In this
trial, SNS-595 has demonstrated disease control (defined as stable
disease, partial response or complete response), with 31 of 35 of
evaluable patients having best responses of stable disease or
better. Of the 31 patients with stable disease or better, one
patient had a complete response and four patients had partial
responses (two unconfirmed). -- SNS-595 has been generally well
tolerated in this trial, with a low rate of febrile neutropenia or
other Grade 3/4 adverse events and manageable Grade 1/2 nausea or
vomiting. Based on the drug's observed safety profile and
indications of clinical activity, Sunesis amended the protocol to
explore a higher dose of SNS-595 in this trial. Enrollment has
begun at a dose of 60 mg/m2 over twenty- eight days, and Sunesis
anticipates enrolling approximately 30 patients at this dose in the
third quarter of this year. -- Data from this trial has been
accepted for presentation at the 44th ASCO Annual Meeting. --
Sunesis updated the results from the company's Phase 1 clinical
trial of single-agent SNS-595 in patients with relapsed or
refractory acute leukemias, which had previously been reported at
the 49th Annual Meeting of the American Society of Hematology (ASH)
in Atlanta, Georgia in December 2007. Since the ASH presentation,
an additional patient in this trial has achieved a complete
remission. -- Twelve of 30 patients (43 percent) who received doses
of SNS-595 of 50 mg/m2 or greater on a weekly dose schedule have
now achieved bone marrow blast reductions to less than five
percent, and five of these 12 patients achieved either complete
remission, complete remission without platelet recovery or complete
remission with incomplete recovery of normal hematopoietic blood
elements. -- SNS-595 was generally well tolerated in this trial,
with a dose-limiting toxicity of reversible Grade 3/4 oral
mucositis. -- Based on these promising results, Sunesis continues
to pursue development of SNS-595 in acute myeloid leukemia (AML). A
Phase 1b clinical trial of SNS-595 in combination with cytarabine
in relapsed or refractory AML patients is in progress. Sunesis
plans to begin enrollment in a Phase 2 clinical trial of SNS-595 on
a weekly dose schedule in previously untreated elderly AML patients
in the first half of 2008. Sunesis expects to report data later
this year for both AML clinical trials. -- Results from a
non-clinical study of SNS-032, a potent and selective inhibitor of
cyclin-dependent kinases (CDKs) 2, 7 and 9, were presented at ASH.
These data demonstrated that SNS-032 induces apoptosis in chronic
lymphocytic leukemia (CLL) cells. Furthermore, SNS-032's in vitro
activity compared favorably with flavopiridol in CLL cells obtained
from patients. SNS-032 currently is in a Phase 1 clinical trial of
patients with relapsed or refractory CLL or multiple myeloma. To
date, the drug has been well tolerated in this trial, and dose
escalation in both indications is expected to be completed this
year. -- Sunesis is continuing enrollment in its Phase 1
dose-escalating trial of SNS-314, a potent and selective inhibitor
of Aurora kinases A, B and C, in advanced solid tumors. To date,
SNS-314 has been well tolerated and no dose-limiting toxicities
have been observed. The company expects to identify a
maximum-tolerated dose in this Phase 1 clinical trial this year. --
In December, Sunesis and the Multiple Myeloma Research Consortium
(MMRC) announced a collaboration to evaluate the preclinical
activity of SNS-032 in multiple myeloma-relevant models and in
primary disease tissue, extending non-clinical studies performed by
Sunesis. -- In February 2008, Sunesis received a milestone payment
from Johnson & Johnson Pharmaceutical Research and Development,
LLC (J&JPRD) triggered by J&JPRD's selection of a compound
targeting the Cathepsin S enzyme as a development candidate
emerging from a collaboration with Sunesis. -- Lesley A. Stolz,
Ph.D., joined Sunesis in November 2007 as Vice President, Corporate
and Business Development. Financial Highlights -- Revenue totaled
$2.0 million and $9.7 million, respectively, for the three months
and year ended December 31, 2007, compared to $2.0 million and
$13.7 million for the three months and year ended December 31,
2006. The decrease in revenue year-over-year was primarily due to
lower milestone payments from Merck & Co., Inc. in 2007
compared to 2006. -- Research and development (R&D) expense was
$8.3 million for the fourth quarter of 2007, compared to $8.5
million for the same period in 2006. R&D expense for the year
ended December 31, 2007 totaled $36.1 million, compared to $35.6
million in 2006. The year-over-year increase in R&D expense was
primarily due to increased clinical trial activity for SNS- 595 and
preclinical program costs, partially offset by lower headcount and
lower R&D expense associated with SNS-032 and SNS-314 due to
reduced research activities in these programs. -- General and
administrative (G&A) expense for the fourth quarter of 2007 was
$2.8 million, compared to $3.4 million for the fourth quarter of
2006. For the year ended December 31, 2007, G&A expense was
$13.6 million, compared to $12.3 million in 2006. The
quarter-over-quarter decrease primarily resulted from lower
professional services expense in 2007 compared to 2006. The
year-over-year increase in G&A expense was primarily due to
increased non-cash stock-based compensation expense, employee- and
office-related expenses. -- In the fourth quarter ended December
31, 2007, Sunesis recorded a $0.3 million additional restructuring
charge as a result of the company's reorganization and reduction in
force in the third quarter of 2007. For the year ended December 31,
2007, an aggregate of $1.6 million in restructuring charges was
recorded. Cash restructuring costs accounted for approximately $1.1
million of the total $1.6 million restructuring charge for the
year. -- Sunesis reported a net loss of $8.8 million for the fourth
quarter of 2007 and of $38.8 million for the twelve-month period
ended December 31, 2007, compared to a reported net loss of $9.0
million and $31.2 million, respectively, for the three-month and
twelve-month periods ended December 31, 2006. -- In 2008, Sunesis
expects net cash used in operating activities of approximately $30
million - $35 million in the absence of any new collaborations,
compared to $34.5 million in 2007. A decrease in net cash used in
operating activities is anticipated primarily due to the
reorganization effected in August of last year, partially offset by
increased costs associated with clinical trial and other
development activities for SNS-595, SNS-032 and SNS-314. Conference
Call Information Sunesis' management will host a conference call to
review the results of the fourth quarter and the 2007 fiscal year
today at 10:30 a.m. EDT. Individual and institutional investors can
access the call via 877-604-9668 (U.S. and Canada) or 719-325-4904
(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/.
Please log on to Sunesis' website several minutes prior to the
start of the presentation to ensure adequate time for any software
download that may be necessary. A replay of the webcast will be
archived on the Sunesis website for two weeks until March 25, 2008.
About Sunesis' Oncology Programs Sunesis has built a portfolio of
product candidates in oncology focused on inhibition of the
cell-cycle and survival signaling. Our lead product candidate,
SNS-595, is a novel naphthyridine analog, structurally related to
quinolones, a class of compounds which has not been used previously
for the treatment of cancer. SNS-595 is a specific DNA intercalator
and topoisomerase II poison, causing replication-dependent
site-selective double-strand DNA damage, irreversible G2 arrest and
rapid apoptosis. A Phase 2 single agent clinical trial of SNS-595
in ovarian cancer and a Phase 1b clinical trial of SNS-595
combination with cytarabine in relapsed/refractory AML are both
ongoing. SNS-032, a potent and selective inhibitor of CDKs 2, 7 and
9, is being evaluated in a Phase 1 clinical trial in patients with
relapsed/refractory CLL or multiple myeloma. SNS-314, a potent and
selective pan-Aurora kinase inhibitor, is being studied in a Phase
1 dose-escalating clinical trial in patients with advanced solid
tumors. In addition, Sunesis is developing novel small molecule
inhibitors of Raf kinase and other protein kinases in collaboration
with Biogen Idec. About Sunesis Pharmaceuticals Sunesis is a
clinical-stage biopharmaceutical company focused on the discovery,
development and commercialization of novel small-molecule
therapeutics for oncology and other serious diseases. Sunesis has
built a broad product candidate portfolio through internal
discovery and in-licensing of novel cancer therapeutics. Sunesis is
advancing its product candidates through in-house research and
development efforts and strategic collaborations with leading
pharmaceutical and biopharmaceutical companies. For further
information on Sunesis Pharmaceuticals, please visit
http://www.sunesis.com/. SUNESIS and the logo are trademarks of
Sunesis Pharmaceuticals, Inc. Safe Harbor Statement This press
release contains forward-looking statements including without
limitation statements related to the potential safety and efficacy
of SNS-595, SNS-032 and SNS-314, planned additional clinical
testing and development efforts, the timing of enrollment in
clinical trials and the announcement of clinical results. Words
such as "look forward," "suggests," "may," "expects," "designed,"
"believe," "appears" 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, the risk that Sunesis' drug discovery
and development activities, including enrollment and reporting of
results, could be halted significantly or delayed for various
reasons, the risk that Sunesis' clinical trials for SNS-595,
SNS-032 and/or SNS-314 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,
risks related to the conduct of Sunesis' clinical trials and
manufacturing of SNS-595, SNS-032 and SNS-314 and risks related to
Sunesis' need for additional funding. 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, 2006 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 PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS December
31, December 31, 2007 2006 ASSETS (Note 1) Current assets: Cash and
cash equivalents $11,726,126 $6,075,449 Marketable securities
35,957,933 57,029,199 Prepaids and other current assets 945,583
1,082,817 Total current assets 48,629,642 64,187,465 Property and
equipment, net 4,238,498 4,728,929 Deposits and other assets
377,798 359,974 Total assets $53,245,938 $69,276,368 LIABILITIES
AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and
other accrued liabilities $4,515,426 $3,439,422 Accrued
compensation 2,225,868 2,323,742 Current portion of deferred
revenue 1,227,031 2,260,478 Current portion of equipment financing
953,940 885,273 Total current liabilities 8,922,265 8,908,915
Non-current portion of deferred revenue - 1,143,159 Non-current
portion of equipment financing 1,352,684 955,695 Deferred rent and
other non-current liabilities 1,576,734 1,464,902 Total liabilities
11,851,683 12,472,671 Commitments Stockholders' equity: Common
stock 3,437 2,944 Additional paid-in capital 320,579,240
298,073,896 Deferred stock-based compensation (251,601) (1,006,604)
Accumulated other comprehensive income (loss) 69,262 (21,376)
Accumulated deficit (279,006,083) (240,245,163) Total stockholders'
equity 41,394,255 56,803,697 Total liabilities and stockholders'
equity $53,245,938 $69,276,368 Note 1: The condensed balance sheet
at December 31, 2006 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, 2006. SUNESIS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS Three months ended Twelve
months ended December 31, December 31, 2007 2006 2007 2006 Revenue:
Collaboration revenue $37,500 $229,167 $1,576,610 $6,353,585
Collaboration revenue from related party 1,759,208 1,725,810
7,586,903 7,317,700 License revenue 250,000 - 500,000 - Grant and
fellowship revenue - - - 37,901 Total revenues 2,046,708 1,954,977
9,663,513 13,709,186 Operating expenses: Research and development
8,268,413 8,468,763 36,060,470 35,615,536 General and
administrative 2,820,543 3,372,108 13,569,578 12,254,892
Restructuring charges 345,426 - 1,563,274 - Total operating
expenses 11,434,382 11,840,871 51,193,322 47,870,428 Loss from
operations (9,387,674) (9,885,894) (41,529,809) (34,161,242)
Interest income 661,381 898,786 2,971,666 3,394,751 Interest
expense (57,631) (44,018) (209,885) (477,643) Other income, net
5,949 1,124 7,108 6,873 Net loss $(8,777,975) $(9,030,002)
$(38,760,920) $(31,237,261) Basic and diluted loss per share
$(0.26) $(0.31) $(1.20) $(1.13) Shares used in computing basic and
diluted loss per share 34,336,645 29,386,886 32,340,203 27,758,348
DATASOURCE: Sunesis Pharmaceuticals CONTACT: investors, Eric
Bjerkholt, SVP, Corporate Development & Finance of Sunesis
Pharmaceuticals, Inc., +1-650-266-3717; or media, Karen L. Bergman,
+1-650-575-1509, or Michelle Corral, +1-415-794-8662, both of BCC
Partners, for Sunesis Pharmaceuticals Web site:
http://www.sunesis.com/
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