Full Press Release Details
Sunesis Pharmaceuticals Reports Second Quarter 2012 Financial Results and Highlights
Sunesis to Host Conference Call Today at 10:30AM Eastern Time
SOUTH SAN FRANCISCO, Calif., (August 9, 2012) Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the quarter ended June 30, 2012. Net loss for the three
and six months ended June 30, 2012 was $8.6 million and $22.5 million, respectively. As of June 30, 2012, cash, cash equivalents and marketable securities totaled $29.3 million.
Next month, the independent Data and Safety Monitoring Board will conduct, in its single pre-planned interim analysis, the first efficacy review of the Phase 3 VALOR trial in acute myeloid
leukemia, said Daniel Swisher, Chief Executive Officer of Sunesis. The DSMB will examine pre-specified unblinded efficacy and safety data sets and decide whether to stop the study early for efficacy or futility, continue the study as
planned or implement a one-time sample size adjustment of 225 additional evaluable patients. This important milestone will determine timing of the final outcome of this pivotal study and enable our plans for future regulatory filings and
commercialization of vosaroxin.
Mr. Swisher added: I continue to be pleased with the execution of the VALOR trial. The trial
has now enrolled 391 patients, a figure that reflects broad investigator support across our more than 110 clinical sites, and underlines vosaroxin s potential to change the standard of care in this disease. We have also seen progress in our
kinase inhibitor collaborations during the quarter. These collaborations allow us to leverage the resources of two leading biopharmaceutical companies, Biogen Idec and Millennium Pharmaceuticals, to advance a broader product pipeline while we focus
our resources on vosaroxin and the VALOR trial.
Second Quarter 2012 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, August 9th at 10:30a.m. Eastern Time. The call can be accessed by dialing
(800) 299-7098 (U.S. and Canada) or (617) 801-9715 (international), and entering passcode 49381836. 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 the company s website for two weeks.
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 more than 110 leading sites in the U.S., Canada, Europe, Australia and New Zealand. The VALOR trial is currently enrolling patients,
who are 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 Data and Safety Monitoring Board (DSMB) at the interim analysis to maintain adequate power across a broader range of 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 anti-cancer quinolone derivative (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.
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 estimates there will be approximately 13,780 new cases of AML and 10,200 deaths from AML in the U.S. in 2012. Additionally, it is estimated that the
prevalence of AML across major global markets (U.S., France, Germany, Italy, Spain, United Kingdom, and Japan) is over 50,000. 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
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to the occurrence, result and timing of the DSMB interim analysis,
the design, conduct, progress and results of the VALOR trial and other clinical trials relating to our existing licensing agreements, and vosaroxin s effects, efficacy, safety profile and commercial potential as a single agent and in
combination with cytarabine. Words such as will, provides, examine, determine, decide, continue, plan, estimate, on track 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 development and commercialization of
vosaroxin, the risk that raising funds through lending arrangements may restrict our operations or produce other adverse results, 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, Sunesis Annual Report on Form 10-K for the year ended
December 31, 2011 and Sunesis other filings with the Securities and Exchange Commission, including Sunesis Quarterly Report on Form 10-Q for the quarter ended June 30, 2012, 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
| June 30, 2012 | December 31, 2011 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,743 | $ | 9,311 | ||||
| Marketable securities | 17,531 | 34,804 | ||||||
| Prepaids and other current assets | 1,602 | 1,550 | ||||||
| Total current assets | 30,876 | 45,665 | ||||||
| Property and equipment, net | 58 | 74 | ||||||
| Deposits and other assets | 108 | 130 | ||||||
| Total assets | $ | 31,042 | $ | 45,869 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 393 | $ | 658 | ||||
| Accrued clinical expense | 3,982 | 2,370 | ||||||
| Accrued compensation | 780 | 1,274 | ||||||
| Other accrued liabilities | 2,749 | 1,805 | ||||||
| Current portion of notes payable | 900 | |||||||
| Warrant liability | 6,402 | 2,276 | ||||||
| Total current liabilities | 15,206 | 8,383 | ||||||
| Non-current portion of notes payable | 8,737 | 9,453 | ||||||
| Non-current portion of deferred rent | 13 | |||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Common stock | 5 | 5 | ||||||
| Additional paid-in capital | 430,748 | 429,142 | ||||||
| Accumulated other comprehensive income (loss) | (5 | ) | 19 | |||||
| Accumulated deficit | (423,649 | ) | (401,146 | ) | ||||
| Total stockholders equity | 7,099 | 28,020 | ||||||
| Total liabilities and stockholders equity | $ | 31,042 | $ | 45,869 |
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except per share amounts)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 1,500 | $ | $ | 1,500 | $ | 4,000 | |||||||||
| Total revenues | 1,500 | 1,500 | 4,000 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 8,072 | 5,950 | 14,718 | 10,020 | ||||||||||||
| General and administrative | 2,182 | 1,975 | 4,371 | 3,989 | ||||||||||||
| Total operating expenses | 10,254 | 7,925 | 19,089 | 14,009 | ||||||||||||
| Loss from operations | (8,754 | ) | (7,925 | ) | (17,589 | ) | (10,009 | ) | ||||||||
| Interest expense | (316 | ) | (631 | ) | ||||||||||||
| Other income (expense), net | 491 | (302 | ) | (4,283 | ) | 3,622 | ||||||||||
| Net loss | (8,579 | ) | (8,227 | ) | (22,503 | ) | (6,387 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | (13 | ) | 21 | (24 | ) | 33 | ||||||||||
| Comprehensive loss | $ | (8,592 | ) | $ | (8,206 | ) | $ | (22,527 | ) | $ | (6,354 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | (8,579 | ) | (8,227 | ) | (22,503 | ) | (6,387 | ) | ||||||||
| Diluted | (9,332 | ) | (8,227 | ) | (22,503 | ) | (6,387 | ) | ||||||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 46,953 | 46,295 | 46,873 | 46,095 | ||||||||||||
| Diluted | 47,286 | 46,295 | 46,873 | 46,095 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.18 | ) | $ | (0.18 | ) | $ | (0.48 | ) | $ | (0.14 | ) | ||||
| Diluted | $ | (0.20 | ) | $ | (0.18 | ) | $ | (0.48 | ) | $ | (0.14 | ) |