Full Press Release Details
Sunesis Pharmaceuticals Reports First Quarter 2012 Financial Results and Highlights
Sunesis to Host Conference Call Today at 11AM Eastern Time
SOUTH SAN FRANCISCO, Calif., (May 15, 2012) Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the quarter ended March 31, 2012. Net loss for the
three months ended March 31, 2012 was $13.9 million, which included a non-cash expense of $4.9 million related to the revaluation of certain warrants. As of March 31, 2012, cash, cash equivalents and marketable securities totaled $34.9
Sunesis is highly focused on the successful execution of our Phase 3 VALOR trial in acute myeloid leukemia as we prepare for
future regulatory and commercial milestones to realize vosaroxin s significant potential. We have now enrolled 317 patients and remain on track to conduct a pre-specified interim analysis in the third quarter, said Daniel Swisher, Chief
Executive Officer of Sunesis. The recently announced agreement with Royalty Pharma provides us access to additional capital and confirms the growing interest in VALOR s adaptive trial design and the market potential of vosaroxin.
First Quarter 2012 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, May 15th at 11a.m. Eastern Time. The call can be accessed by dialing (866) 783-2143 (U.S. and Canada) or
(857) 350-1602 (international), and entering passcode 91964294. 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
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
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 theoccurrence and timing of the DSMB interim analysis, the
design, conduct, progress and results of the VALOR trial and other clinical trials, the sufficiency of Sunesis intellectual property estate and the patent exclusivity period for vosaroxin in the United States and other jurisdictions, and
vosaroxin s effects, efficacy, safety profile and commercial potential as a single agent and in combination with cytarabine. Words such as will, on track , focused , suggests , estimates ,
provides, pending, expected 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 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 March 31, 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 PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, 2012 | December 31, 2011 | |||||||
| ASSETS | (Unaudited) | (Note 1) | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,282 | $ | 9,311 | ||||
| Marketable securities | 29,594 | 34,804 | ||||||
| Prepaids and other current assets | 1,855 | 1,550 | ||||||
| Total current assets | 36,731 | 45,665 | ||||||
| Property and equipment, net | 66 | 74 | ||||||
| Deposits and other assets | 118 | 130 | ||||||
| Total assets | $ | 36,915 | $ | 45,869 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 869 | $ | 658 | ||||
| Accrued clinical expense | 2,564 | 2,370 | ||||||
| Accrued compensation | 580 | 1,274 | ||||||
| Other accrued liabilities | 1,513 | 1,805 | ||||||
| Current portion of notes payable | 50 | |||||||
| Warrant liability | 7,155 | 2,276 | ||||||
| Total current liabilities | 12,731 | 8,383 | ||||||
| Non-current portion of notes payable | 9,496 | 9,453 | ||||||
| Non-current portion of deferred rent | 3 | 13 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Common stock | 5 | 5 | ||||||
| Additional paid-in capital | 429,742 | 429,142 | ||||||
| Accumulated other comprehensive income | 8 | 19 | ||||||
| Accumulated deficit | (415,070 | ) | (401,146 | ) | ||||
| Total stockholders equity | 14,685 | 28,020 | ||||||
| Total liabilities and stockholders equity | $ | 36,915 | $ | 45,869 |
Note 1: The condensed consolidated balance sheet as of December 31, 2011 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, 2011.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE INCOME (LOSS)
(In thousands, except per share amounts)
| Three months ended March 31, | ||||||||
| 2012 | 2011 | |||||||
| (Unaudited) | ||||||||
| Revenue: | ||||||||
| License and other revenue | $ | $ | 4,000 | |||||
| Total revenues | 4,000 | |||||||
| Operating expenses: | ||||||||
| Research and development | 6,646 | 4,070 | ||||||
| General and administrative | 2,189 | 2,014 | ||||||
| Total operating expenses | 8,835 | 6,084 | ||||||
| Loss from operations | (8,835 | ) | (2,084 | ) | ||||
| Interest expense | (315 | ) | ||||||
| Other income (expense), net | (4,774 | ) | 3,924 | |||||
| Net income (loss) | (13,924 | ) | 1,840 | |||||
| Unrealized gain (loss) on available-for-sale securities | (11 | ) | 12 | |||||
| Comprehensive income (loss) | $ | (13,935 | ) | $ | 1,852 | |||
| Net income (loss) per common share: | ||||||||
| Net income (loss) | (13,924 | ) | 1,840 | |||||
| Shares used in computing net income (loss) per common share: | ||||||||
| Basic | 46,793 | 45,894 | ||||||
| Diluted | 46,793 | 47,866 | ||||||
| Net income (loss) per common share: | ||||||||
| Basic | $ | (0.30 | ) | $ | 0.04 | |||
| Diluted | $ | (0.30 | ) | $ | 0.04 |