Full Press Release Details
Sunesis Pharmaceuticals Reports First Quarter 2011 Financial Results
FRANCISCO, Calif., May 12, 2011 Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the quarter ended March 31, 2011. Net income for the three months ended March 31, 2011 was $1.8 million. As
of March 31, 2011, cash, cash equivalents and marketable securities totaled $48.9 million, with no debt outstanding. This cash balance does not include $4.0 million received on April 4, 2011 under Sunesis previously disclosed
oncology kinase inhibitor collaboration with Millennium Pharmaceuticals, Inc.
The Company also announced that an abstract reviewing the
adaptive design of the VALOR trial has been accepted for presentation during a poster session at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting, which is being held June 3-7 in Chicago, Illinois.
Since the beginning of the year, we have achieved a number of milestones that enhance the prospects for vosaroxin, our lead program, as well as our
earlier-stage pipeline programs, said Daniel Swisher, Chief Executive Officer of Sunesis. For vosaroxin, we made progress on the clinical, regulatory and intellectual property fronts: the roll-out of our Phase 3 pivotal VALOR trial in
relapsed/refractory AML is progressing well, we received U.S. FDA Fast Track designation for vosaroxin in AML and an important European patent has issued. Beyond vosaroxin, our newly formed oncology kinase inhibitor collaboration with Millennium
Pharmaceuticals highlights the significant potential of our pipeline programs, including a pan-Raf kinase inhibitor candidate set for Phase 1 development. This collaboration will ensure these programs are supported with the capabilities and
resources of a leading global oncology company while we continue to focus our internal investment on vosaroxin and the ongoing VALOR trial.
First Quarter 2011 and Recent Highlights
The programs were originally part of Sunesis 2004 multi-kinase inhibitor collaboration
with Biogen Idec, Inc. Following Biogen Idec s November 2010 announcement to shift its strategic focus and spin out or outlicense its oncology assets, Millennium acquired two of these oncology assets and intends to continue the development of
these in collaboration with Sunesis. Biogen Idec and Sunesis will continue with a more focused collaboration directed towards a unique preclinical kinase inhibitor program involved in immunology.
Financial Highlights
The Company will present the poster titled Adaptive design of VALOR, a phase III trial of vosaroxin or placebo in combination with cytarabine for patients with first relapsed or refractory acute
myeloid leukemia at McCormick Place, Hall A, during the Trials in Progress Poster Session on Monday, June 6, 2011 from 8:00 a.m. to 12:00 p.m. local time (Poster #48G).
VALOR is a Phase 3, randomized, double-blind, placebo-controlled, pivotal
trial in patients with first relapsed or refractory AML. The trial is expected to enroll 450 evaluable patients at approximately 100 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently open for
enrollment and patients will be randomized one to one to receive either vosaroxin on days one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. Additionally, the VALOR trial employs an
innovative, adaptive trial design that allows for a one-time sample size adjustment by the DSMB at the interim analysis to maintain adequate power across a broad range of clinically meaningful and statistically significant survival outcomes. The
trial s primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.
Vosaroxin 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. Vosaroxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis.
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 American Cancer Society estimated that 12,330 cases of AML were diagnosed and approximately 9,000 deaths from AML occured in the U.S. in 2010.
Additionally, it is estimated that prevalence of AML is approximately 25,000 in the U.S. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. AML patients with relapsed or refractory
disease and newly diagnosed AML patients over 60 years of age with poor prognostic risk factors typically die within one year, resulting in an acute need for new treatment options for these patients.
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, vosaroxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis, please visit
This press release contains forward-looking statements, including statements related to the design, conduct and
results of the VALOR trial, the benefits to Sunesis from its collaboration arrangement with Millennium, the prosecution of pending foreign patent applications, the sufficiency of Sunesis currently available and accessible funds, and
vosaroxin s effects, efficacy and safety profile as a single agent and in combination with cytarabine. Words such as progressing, will, pending, proceeding, intends to,
expected, believe 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 substantial additional funding to complete the development and commercialization of vosaroxin, risks related to Sunesis ability to raise the capital that it believes to be accessible and is required to fully finance the
VALOR trial until its planned unblinding in 2013, the risk that Sunesis development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis clinical studies for vosaroxin may
not demonstrate safety or efficacy or lead to regulatory approval, the risk that data to date and trends may not be predictive of future data or results, the risk that Sunesis nonclinical studies and clinical studies may not satisfy the
requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis clinical trials, risks related to the manufacturing of vosaroxin and supply of the active pharmaceutical ingredients required for the conduct of the
VALOR trial, the risk of third party opposition to granted patents related to vosaroxin, and the risk that Sunesis proprietary rights may not adequately protect vosaroxin. 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, 2010 and Sunesis other filings with the Securities and Exchange Commission, including Sunesis Quarterly Report on Form 10-Q for
the quarter ended March 31, 2011, when available. 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 and the logo are trademarks of Sunesis Pharmaceuticals, Inc.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2011 | December 31, 2010 | |||||||
| ASSETS | (Unaudited) | (Note 1) | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,914 | $ | 14,223 | ||||
| Marketable securities | 39,002 | 39,173 | ||||||
| Accounts receivable | 4,000 | |||||||
| Prepaids and other current assets | 1,595 | 1,286 | ||||||
| Total current assets | 54,511 | 54,682 | ||||||
| Property and equipment, net | 106 | 116 | ||||||
| Deposits and other assets | 60 | 60 | ||||||
| Total assets | $ | 54,677 | $ | 54,858 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 616 | $ | 416 | ||||
| Accrued clinical expense | 1,599 | 1,574 | ||||||
| Accrued compensation | 493 | 1,013 | ||||||
| Other accrued liabilities | 990 | 1,406 | ||||||
| Warrant liability | 4,539 | 8,154 | ||||||
| Total current liabilities | 8,237 | 12,563 | ||||||
| Other liabilities | 40 | 48 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Common stock | 5 | 5 | ||||||
| Additional paid-in capital | 425,563 | 423,262 | ||||||
| Accumulated other comprehensive loss | (3 | ) | (15 | ) | ||||
| Accumulated deficit | (379,165 | ) | (381,005 | ) | ||||
| Total stockholders equity | 46,400 | 42,247 | ||||||
| Total liabilities and stockholders equity | $ | 54,677 | $ | 54,858 |
Note 1: The condensed consolidated balance sheet as of December 31, 2010 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, 2010.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
| Three months ended March 31, | ||||||||
| 2011 | 2010 | |||||||
| (Unaudited) | ||||||||
| Revenue: | ||||||||
| Collaboration revenue | $ | $ | 13 | |||||
| License and other revenue | 4,000 | |||||||
| Total revenues | 4,000 | 13 | ||||||
| Operating expenses: | ||||||||
| Research and development | 4,070 | 3,111 | ||||||
| General and administrative | 2,014 | 1,554 | ||||||
| Total operating expenses | 6,084 | 4,665 | ||||||
| Loss from operations | (2,084 | ) | (4,652 | ) | ||||
| Other income, net | 3,924 | 4 | ||||||
| Net income (loss) | $ | 1,840 | $ | (4,648 | ) | |||
| Net income (loss) per common share: | ||||||||
| Basic | $ | 0.04 | $ | (0.65 | ) | |||
| Diluted | $ | 0.04 | $ | (0.65 | ) | |||
| Shares used in computing net income (loss) per common share: | ||||||||
| Basic | 45,894 | 7,142 | ||||||
| Diluted | 47,866 | 7,142 |