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.
-- 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
-- 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- - - 37,901
Total revenues 2,046,708 1,954,977 9,663,513 13,709,186
development 8,268,413 8,468,763 36,060,470 35,615,536
administrative 2,820,543 3,372,108 13,569,578 12,254,892
charges 345,426 - 1,563,274 -
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
per share 34,336,645 29,386,886 32,340,203 27,758,348the 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.
-- 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
-- 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,
ASSETS (Note 1)
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
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
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 $37,500 $229,167 $1,576,610 $6,353,585
related party 1,759,208 1,725,810 7,586,903 7,317,700
License revenue 250,000 - 500,000 -
|SOURCE Sunesis Pharmaceuticals|
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