SOUTH SAN FRANCISCO, Calif., Aug. 7 CA-Sunesis-Pharma-ERN
SOUTH SAN FRANCISCO, Calif., Aug. 7 /PRNewswire-FirstCall/ -- Sunesis
Pharmaceuticals, Inc. (Nasdaq: SNSS), a clinical-stage biopharmaceutical
company focused on the development and commercialization of novel oncology
therapeutics, today reported financial results for the quarter ended June 30,
2008.
Total revenue for the second quarter of 2008 was $2.6 million, with a net
loss of $13.6 million, including a $4.9 million net restructuring charge. As
of June 30, 2008, cash, cash equivalents and marketable securities totaled
$28.3 million, and debt totaled $1.8 million.
"We are pleased with the progress of our portfolio, including our most
advanced program, voreloxin. Our trials are enrolling well, and we reported
positive data from our ongoing AML and ovarian cancer trials," said Daniel
Swisher, Sunesis' Chief Executive Officer. "We also strengthened the
leadership of our development team with the addition of two seasoned industry
professionals as we focused our resources on voreloxin. I am confident that
the commitment and talent of the Sunesis team will build on the legacy of past
contributions as we work to aggressively advance voreloxin into and through
late-stage trials."
Recent Highlights
-- In May, Sunesis initiated REVEAL-1 (Response Evaluation of Voreloxin in
Elderly AML), a Phase 2 clinical trial of voreloxin (formerly SNS-595)
in previously untreated elderly patients with acute myeloid leukemia
(AML) who are unlikely to benefit from standard induction therapy. The
primary objective of the REVEAL-1 trial is to evaluate voreloxin's
anti-leukemic activity as a single agent, measured as either complete
remission (CR) or complete remission without full platelet recovery
(CRp). The study will also measure the duration of these responses and
overall survival.
-- In June, Sunesis reported results from two clinical trials of voreloxin
in patients with relapsed/refractory AML at the 13th Congress of the
European Hematology Association.
-- Sunesis presented comparative safety, pharmacokinetic and response
data from its Phase 1 dose-escalating trial of single-agent
voreloxin, evaluating data from older patients (age >/= 60) against
those from younger patients (age < 60). Six patients, including four
age 60 or older and two younger than age 60, achieved CR, CRp or CRi
(complete remission with incomplete recovery of hematopoeitic
elements) when voreloxin was administered at doses of 50 mg/m2 or
greater weekly or 40 mg/m2 twice-weekly. Remissions of up to seven
months have been observed thus far, with two patients undergoing
re-induction with voreloxin following relapse and one patient
undergoing a bone marrow transplant. Overall, voreloxin demonstrated
a similar safety profile in both older and younger patients.
-- Preliminary results were also presented from Sunesis' ongoing
dose-escalating Phase 1b clinical trial evaluating voreloxin in
combination with cytarabine, a current standard of care in patients
with relapsed/refractory AML. Patients enrolled in the trial receive
escalating doses of voreloxin administered on days one and four with
a fixed dose of cytarabine given over five days. Of the twelve
patients then evaluable in the first three cohorts, three patients
had achieved CRs.
-- At the 44th American Society of Clinical Oncology Annual Meeting in
June, Sunesis presented an update of interim data from the company's
ongoing Phase 2 clinical trial of voreloxin in platinum-resistant
ovarian cancer patients.
-- Of 62 women evaluable for best response at a dose of 48 mg/m2 every
21 days, one patient had a CR, five patients had partial responses
(PR) (including one unconfirmed) and 45 patients achieved stable
disease. Forty-eight percent of the 62 evaluable patients achieved
disease control, defined as stable disease for 90 days or more or a
CR or PR. At 48 mg/m2, preliminary median progression free survival
was 13 weeks as of mid-May.
-- The company reported that out of the eight patients then evaluable
for efficacy response at a dose of 60 mg/m2 once every 28 days, one
patient had achieved a PR and 6 patients had stable disease as best
response. Based on indications of clinical activity and voreloxin's
safety profile in this patient population, Sunesis has amended the
protocol for the ongoing Phase 2 clinical trial to increase the dose
to 75 mg/m2 given once every 28 days. The company expects to enroll
approximately 30 patients at this new dose level by the end of this
year.
-- In June, Sunesis announced a corporate realignment to concentrate
financial and human resources on the late-stage development of
voreloxin. In conjunction with the strategic restructuring, Sunesis
wound down its research activities and reduced its workforce by
approximately 60 percent.
-- Ongoing trials of Sunesis' earlier stage candidates, SNS-032 and
SNS-314, continue. Sunesis expects to report additional data from all
three of its clinical programs later this year.
-- Sunesis announced the expansion of its product development leadership
team with the appointment of industry veterans Steven B. Ketchum,
Ph.D., as Senior Vice President, Research and Development and Mary G.
Bolton, M.D., Ph.D., as Vice President, Clinical Development.
-- In June, Sunesis received a $0.5 million milestone payment from Biogen
Idec for preclinical progress against an undisclosed target in the
companies' multi-kinase discovery and development collaboration. In
conjunction with the June reorganization and wind down of research
activities, the research term of this collaboration was amended to end
on June 30, 2008, two months early.
Financial Highlights
-- Collaboration revenue for the three months ended June 30, 2008
decreased to $2.6 million compared to $3.3 million in 2007. The
decrease was primarily due to the fact that in 2007 Sunesis received
from Merck a $1.0 million payment upon the achievement of a preclinical
milestone, as well as research revenue, in the companies' BACE
collaboration, which were partially offset in 2008 by the $0.5 million
milestone from Biogen Idec and the acceleration of research revenue
from Biogen Idec which would have been recognized in the third quarter
except for the termination of the research term of Sunesis'
collaboration with Biogen Idec in June 2008. In addition, research
revenue from Biogen Idec was lower in 2008 compared to 2007 due to a
lower number of Sunesis researchers working on the collaboration.
-- Research and development expense decreased by $1.4 million, or 15
percent, to $8.3 million for the three months ended June 30, 2008 from
$9.7 million for the same period in 2007. This decrease is primarily
due to (i) a $0.5 million decrease in clinical trial activity related
to SNS-314 and (ii) a $2.1 million decrease in expenses under the
company's other kinase inhibitors program, partially offset by (iii) a
$1.1 million increase in voreloxin expenses and (iv) a $0.1 million
increase in SNS-032 expenses, in both cases due to increased clinical
trial activities.
-- General and administrative expense for the second quarter of 2008 was
$3.2 million compared to $4.0 million for the second quarter 2007. This
decrease resulted primarily from reduced headcount compared to the
2007 quarter and a decrease in personnel- and office-related expenses.
-- In the second quarter of 2008, Sunesis recorded a net restructuring
charge of $4.9 million, comprised of $5.6 million related to the June
restructuring, partially offset by the reversal of a $0.7 million
charge for the August 2007 restructuring. Approximately $3.2 million of
this charge represented cash expenses and the majority of these
expenses will be paid in the third quarter of 2008. An additional
restructuring charge, currently estimated at approximately
$7.0 million, is expected to be incurred in the third quarter of 2008
after Sunesis' former research and development facility has been
completely vacated.
-- Sunesis reported a net loss of $13.6 million for the quarter ended June
30, 2008 compared to a reported net loss of $9.8 million for the
three-month period ended June 30, 2007.
-- Cash used in operating activities was $18.7 million for the six months
ended June 30, 2008, compared to $17.1 million for the same six-month
period in 2007.
Conference Call Information
Sunesis' management will host a conference call to review the results of
the second quarter and to provide an update on its business today at
11:00 a.m. ET/8:00 a.m. PT. Individual and institutional investors can access
the call via (877) 340-7912 (U.S. and Canada) or (719) 325-4871
(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. The webcast will be recorded
and available for replay on the company's website until August 21, 2008.
About Sunesis Pharmaceuticals
Sunesis is a clinical-stage 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.
Safe Harbor Statement
This press release contains forward-looking statements, including without
limitation statements related to the potential safety and efficacy and
commercial potential of voreloxin (formerly SNS-595), planned additional
clinical testing and development efforts, the timing of clinical trial
enrollment, the anticipated announcement of clinical results and the timing
and amount of future restructuring charges. Words such as "will," "work to,"
"estimated," "expects" 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 could be
halted significantly or delayed for various reasons, the risk that Sunesis'
clinical trials for voreloxin, SNS-032 and 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, including the pace of enrollment, risks related to the
manufacturing of Sunesis' product candidates, risks related to Sunesis' need
for additional funding and the risk that Sunesis' proprietary rights may not
adequately protect the company's product candidates. 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, 2007, its quarterly report
on Form 10-Q for the quarter ended March 31, 2008 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 Statements of Operations
Three months ended Six months ended
June 30, June 30,
2008 2007 2008 2007
(unaudited)(unaudited)
Revenue:
Collaboration
revenue$2,591,240 $3,270,265$4,894,423$5,536,531
License revenue -- - 250,000
Total revenues 2,591,2403,270,265 4,894,423 5,786,531
Operating expenses:
Research and
development 8,262,6049,697,46217,005,49919,004,940
General and
administrative3,235,0614,044,194 6,501,190 7,340,341
Restructuring
charges 4,876,746- 5,197,520 -
Total operating
expenses 16,374,411 13,741,65628,704,20926,345,281
Loss from
operations (13,783,171) (10,471,391) (23,809,786) (20,558,750)
Interest income 269,385 743,928 729,797 1,513,554
Interest expense (54,433) (44,308) (113,806) (96,351)
Other income
(expense), net (199) 188 472 927
Net loss$(13,568,418) $(9,771,583) $(23,193,323) $(19,140,620)
Basic and diluted
loss per share $(0.39) $(0.31) $(0.67) $(0.63)
Shares used in
computing basic
and diluted
loss per share 34,377,367 31,175,93334,371,13230,321,338
Sunesis Pharmaceuticals, Inc.
Consolidated Balance Sheets
June 30 December 31
2008 2007
ASSETS (unaudited) (Note 1)
Current assets:
Cash and cash equivalents $9,480,277 $11,726,126
Marketable securities 18,864,27535,957,933
Prepaids and other current
assets 845,895 945,583
Total current assets29,190,44748,629,642
Property and equipment, net860,764 4,238,498
Assets held-for-sale 1,375,313 -
Deposits and other assets 377,798 377,798
Total assets $31,804,322 $53,245,938
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable and other
accrued liabilities $7,072,536$4,515,426
Accrued compensation 1,478,649 2,225,868
Current portion of deferred
revenue - 1,227,031
Current portion of equipment
financing 1,410,667 953,940
Total current liabilities9,961,852 8,922,265
Non current portion of equipment
financing 390,747 1,352,684
Deferred rent liabilities1,564,671 1,576,734
Total liabilities 11,917,27011,851,683
Commitments
Stockholders' equity:
Common stock 3,440 3,437
Additional paid-in capital 322,122,902 320,579,240
Deferred stock-based compensation (50,906) (251,601)
Accumulated other comprehensive
income 11,02269,262
Accumulated deficit (302,199,406) (279,006,083)
Total stockholders' equity 19,887,05241,394,255
Total liabilities and stockholders'
equity$31,804,322 $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.
SOURCE Sunesis Pharmaceuticals, Inc.
