Full Press Release Details
| Investor Contact: | Media Contact: | |
| Sunesis Pharmaceuticals, Inc. | Sunesis Pharmaceuticals, Inc. | |
| Eric Bjerkholt | Dan Weinseimer | |
| 650-266-3717 | 650-266-3739 |
Sunesis Reports Financial Results for the Second Quarter 2009
SOUTH SAN FRANCISCO, Calif. (July 29, 2009) Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the second quarter ended
Total revenue for the second quarter of 2009 was $3.5 million, with a net loss of $22.9 million, including non-cash charges of $21.0
million related to the financing completed in April. Loss from operations was $1.9 million for the second quarter and $10.2 million for the first half of 2009. As of June 30, 2009, cash, cash equivalents and marketable securities totaled $7.3
million, with no debt outstanding.
In the second quarter, we completed the initial closing of a tranched financing of up to $43.5 million with a
syndicate of experienced life science investors. We also presented positive new data on all three of our Phase 2 voreloxin studies at ASCO, said Daniel Swisher, Chief Executive Officer of Sunesis. As we finish enrollment of both of our
Phase 2 studies in AML, we are actively planning for an End-of-Phase 2 meeting later this year with the FDA to gain concurrence on our AML registration strategy.
Voreloxin 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.
About Acute Myeloid Leukemia
AML is a 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.
About Ovarian Cancer
In the 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.
About Sunesis Pharmaceuticals
Sunesis 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.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc. All other trademarks appearing in this release are the property of their respective owners.
This 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 enrollment, clinical testing and development efforts, the timing of the End-of-Phase 2 meeting with FDA
and the company s ability to transfer to The NASDAQ Capital Market. Words such as demonstrating, planning, promising, shows 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, the risk that Sunesis proprietary rights may not adequately protect voreloxin and the risk that NASDAQ does not permit Sunesis to transfer to The NASDAQ Capital Market and
that Sunesis may be subject to delisting proceedings. These and other risk factors are discussed under Risk Factors and elsewhere in Sunesis Quarterly Report on Form 10-Q for the quarter ended June 30, 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 based.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| June 30, 2009 | December 31, 2008 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,842,425 | $ | 6,296,942 | ||||
| Marketable securities | 506,619 | 4,321,844 | ||||||
| Accounts receivable | 1,500,000 | |||||||
| Prepaids and other current assets | 404,106 | 934,429 | ||||||
| Total current assets | 9,253,150 | 11,553,215 | ||||||
| Property and equipment, net | 407,725 | 612,241 | ||||||
| Assets held-for-sale | 23,653 | 470,547 | ||||||
| Deposits and other assets | 101,275 | 147,826 | ||||||
| Total assets | $ | 9,785,803 | $ | 12,783,829 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and other accrued liabilities | $ | 2,049,936 | $ | 2,150,980 | ||||
| Accrued clinical expense | 1,321,786 | 1,865,773 | ||||||
| Accrued compensation | 415,007 | 537,215 | ||||||
| Accrued restructuring charges | 59,993 | 191,170 | ||||||
| Current portion of deferred rent | 23,308 | 1,409,513 | ||||||
| Current portion of deferred revenue | 2,083 | 27,083 | ||||||
| Total current liabilities | 3,872,113 | 6,181,734 | ||||||
| Non-current portion of deferred rent | 87,755 | 110,919 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Convertible preferred stock | 56,163,436 | |||||||
| Common stock | 3,442 | 3,441 | ||||||
| Additional paid-in capital | 297,092,539 | 322,671,604 | ||||||
| Accumulated other comprehensive income | 127 | 7,841 | ||||||
| Accumulated deficit | (347,433,609 | ) | (316,191,710 | ) | ||||
| Total stockholders equity | 5,825,935 | 6,491,176 | ||||||
| Total liabilities and stockholders equity | $ | 9,785,803 | $ | 12,783,829 |
Note 1: The condensed consolidated balance sheet as of December 31, 2008 has been derived from the audited
financial statements as of 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 June 30, | Six months ended June 30, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| Collaboration revenue related party | $ | 1,500,000 | $ | 2,544,868 | $ | 1,500,000 | $ | 4,310,551 | ||||||||
| Collaboration revenue other | 12,500 | 46,372 | 25,000 | 583,872 | ||||||||||||
| License and other revenue | 2,000,000 | 2,211,547 | ||||||||||||||
| Total revenues | 3,512,500 | 2,591,240 | 3,736,547 | 4,894,423 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,448,685 | 8,262,604 | 7,712,836 | 17,005,499 | ||||||||||||
| General and administrative | 1,994,903 | 3,235,061 | 4,349,916 | 6,501,190 | ||||||||||||
| Restructuring charges | 532 | 4,876,746 | 1,863,393 | 5,197,520 | ||||||||||||
| Total operating expenses | 5,444,120 | 16,374,411 | 13,926,145 | 28,704,209 | ||||||||||||
| Loss from operations | (1,931,620 | ) | (13,783,171 | ) | (10,189,598 | ) | (23,809,786 | ) | ||||||||
| Interest income | 6,000 | 269,385 | 18,812 | 729,797 | ||||||||||||
| Interest expense | (375 | ) | (54,433 | ) | (987 | ) | (113,806 | ) | ||||||||
| Other income (expense), net | (20,952,469 | ) | (199 | ) | (21,070,126 | ) | 472 | |||||||||
| Net loss | (22,878,464 | ) | (13,568,418 | ) | (31,241,899 | ) | (23,193,323 | ) | ||||||||
| Deemed distribution to preferred stockholders | (26,375,000 | ) | (26,375,000 | ) | ||||||||||||
| Loss attributable to common stockholders | $ | (49,253,464 | ) | $ | (13,568,418 | ) | $ | (57,616,899 | ) | $ | (23,193,323 | ) | ||||
| Basic and diluted loss attributable to common stockholders per common share | $ | (1.43 | ) | $ | (0.39 | ) | $ | (1.67 | ) | $ | (0.67 | ) | ||||
| Shares used in computing basic and diluted loss attributable to common stockholders per common share | 34,412,870 | 34,377,367 | 34,411,327 | 34,371,132 |