Full Press Release Details
Pharmaceuticals Reports Fourth Quarter and Full-Year 2008
Conference Call Scheduled for Today at 5:00 p.m. EDT --
SOUTH SAN FRANCISCO, Calif (April 1,
2009) - Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today
reported financial results for the fourth quarter and fiscal year
ended December 31, 2008.
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.
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 www.sunesis.com. The
webcast will be recorded and available for replay on Sunesis' website until
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 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.
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.
and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
| 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 |
PHARMACEUTICALS, INC.
STATEMENT OF OPERATIONS
| Three months ended December 31, | Twelve months ended 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 |