Full Press Release Details
Reports Financial Results for the First Quarter 2009
SOUTH SAN FRANCISCO, Calif (May 6,
2009) - Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported
financial results for the first quarter ended March 31, 2009.
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
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
May 30, 8:00AM to 12:00PM (poster presentation)
phase II study of voreloxin as single agent therapy for elderly patients (pts)
with newly diagnosed acute myeloid leukemia (AML)."
Level 2, West Hall C
May 31, 2:00PM to 6:00PM (poster presentation)
Title: "A phase II trial of
voreloxin in women with platinum-resistant ovarian cancer."
Location: Level 2, West Hall
June 1, 10:30AM (oral presentation)
pharmacokinetic/pharmacodynamic (PK/PD) study of combination voreloxin and
cytarabine in relapsed or refractory AML patients."
Location: Level 2, West Hall
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.
Acute Myeloid Leukemia
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.
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.
Sunesis Pharmaceuticals
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.
and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
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
| 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 |