Full Press Release Details
Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2012 Financial
Results and Recent Highlights
Sunesis to Host Conference Call Today at 11:00AM Eastern Time
FRANCISCO, Calif., (March 13, 2013) Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today reported financial results for the fourth quarter and year ended December 31, 2012. Loss from operations for the three months and year ended
December 31, 2012 was $8.1 million and $34.6 million, respectively. As of December 31, 2012, cash, cash equivalents and marketable securities totaled $71.2 million.
Last year was a transformational year for Sunesis, one which brought us several steps closer to realizing vosaroxin s potential as a new treatment standard in AML, said Daniel Swisher,
Chief Executive Officer of Sunesis. We continue to make progress with the VALOR trial, which has now enrolled 563 patients, and remain on track to both complete the target enrollment of approximately 675 patients in 2013 and unblind the study
and announce top-line results in the first half of 2014. With a strong balance sheet, Sunesis is well funded to conduct VALOR through to data read-out and to prepare for the corresponding regulatory and pre-launch activities for vosaroxin.
Mr. Swisher added: While VALOR moves towards completion, we continue to support the important progress in the NCRI-sponsored LI-1
Phase 2/3 trial and in our kinase inhibitor collaborations with Biogen Idec and Millennium Pharmaceuticals.
Fourth Quarter 2012 and
high-risk myelodysplastic syndrome (MDS) patients, has reached 62 vosaroxin-treated patients as of March 5, 2013. LI-1 is being conducted by the United Kingdom s National Cancer
Research Institute under the direction of Professor Alan K. Burnett, Head of Haematology at Cardiff University.
Kinase Inhibitor Program
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, March 13th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (866) 383-8108 (U.S. and Canada) or (617) 597-5343
(international), and entering passcode 36968092. 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 s target
enrollment is 675 patients at more than 100 leading sites in the U.S., Canada, Europe, South Korea, Australia and New Zealand. The VALOR trial is currently enrolling patients, who are randomized in a ratio of 1:1 to receive either vosaroxin on days
one and four in combination with cytarabine daily for five days, or placebo in combination with cytarabine. The trial s primary endpoint is overall survival. For more information on the VALOR trial, please visit www.valortrial.com.
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. Both the U.S. Food and Drug Administration (FDA) and European Commission have granted orphan drug designation to vosaroxin for the treatment of AML. Additionally, vosaroxin has been granted fast
track designation by the FDA for the potential treatment of relapsed or refractory acute myeloid leukemia in combination with cytarabine.
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 14,590 new cases of AML and approximately 10,370 deaths from AML in the
U.S. in 2013. 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: (i) Sunesis overall strategy, (ii) the design, conduct,
progress, timing and results of the VALOR trial and Sunesis other clinical programs discussed in this release, (iii) the sufficiency of Sunesis financial resources, (iv) the progress of the kinase collaboration programs and (v) the
sufficiency of Sunesis intellectual property estate and the patent exclusivity period for vosaroxin and the MLN2480 pan-Raf inhibitor in the United States and other jurisdictions. Words such as anticipates, continue,
currently, move toward, promising, expected on track, currently, planned, anticipates, supports, continue, potential,
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 September 30, 2012, Sunesis Annual Report on Form 10-K for the year ended
December 31, 2012, when available, and Sunesis 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
| December 31, 2012 | December 31, 2011 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 14,940 | $ | 9,311 | ||||
| Marketable securities | 56,287 | 34,804 | ||||||
| Prepaids and other current assets | 1,705 | 1,550 | ||||||
| Total current assets | 72,932 | 45,665 | ||||||
| Property and equipment, net | 43 | 74 | ||||||
| Deposits and other assets | 42 | 130 | ||||||
| Total assets | $ | 73,017 | $ | 45,869 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 78 | $ | 658 | ||||
| Accrued clinical expense | 5,449 | 2,370 | ||||||
| Accrued compensation | 1,465 | 1,274 | ||||||
| Other accrued liabilities | 2,113 | 1,805 | ||||||
| Current portion of deferred revenue | 7,956 | |||||||
| Current portion of notes payable | 6,610 | |||||||
| Warrant liability | 8,070 | 2,276 | ||||||
| Total current liabilities | 31,741 | 8,383 | ||||||
| Non-current portion of deferred revenue | 11,668 | |||||||
| Non-current portion of notes payable | 17,651 | 9,453 | ||||||
| Non-current portion of deferred rent | 13 | |||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Common stock | 5 | 5 | ||||||
| Additional paid-in capital | 457,011 | 429,142 | ||||||
| Accumulated other comprehensive income (loss) | 38 | 19 | ||||||
| Accumulated deficit | (445,097 | ) | (401,146 | ) | ||||
| Total stockholders equity | 11,957 | 28,020 | ||||||
| Total liabilities and stockholders equity | $ | 73,017 | $ | 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 OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except per share amounts)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| (Unaudited) | (Unaudited) | (Note 2) | ||||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 1,989 | $ | $ | 3,754 | $ | 5,000 | |||||||||
| Total revenues | 1,989 | 3,754 | 5,000 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,589 | 6,326 | 29,185 | 22,563 | ||||||||||||
| General and administrative | 2,473 | 2,159 | 9,175 | 8,303 | ||||||||||||
| Total operating expenses | 10,062 | 8,485 | 38,360 | 30,866 | ||||||||||||
| Loss from operations | (8,073 | ) | (8,485 | ) | (34,606 | ) | (25,866 | ) | ||||||||
| Interest expense | (839 | ) | (259 | ) | (1,855 | ) | (259 | ) | ||||||||
| Other income (expense), net | 4,860 | 4 | (7,490 | ) | 5,984 | |||||||||||
| Net loss | (4,052 | ) | (8,740 | ) | (43,951 | ) | (20,141 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | 41 | (1 | ) | 19 | 34 | |||||||||||
| Comprehensive loss | $ | (4,011 | ) | $ | (8,741 | ) | $ | (43,932 | ) | $ | (20,107 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | (4,052 | ) | (8,740 | ) | (43,951 | ) | (20,141 | ) | ||||||||
| Diluted | (10,352 | ) | (8,740 | ) | (43,951 | ) | (20,141 | ) | ||||||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 51,412 | 46,733 | 48,146 | 46,412 | ||||||||||||
| Diluted | 52,848 | 46,733 | 48,146 | 46,412 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.08 | ) | $ | (0.19 | ) | $ | (0.91 | ) | $ | (0.43 | ) | ||||
| Diluted | $ | (0.20 | ) | $ | (0.19 | ) | $ | (0.91 | ) | $ | (0.43 | ) |
Note 2: The consolidated statement of operations and comprehensive income (loss) for the year ended 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.