Full Press Release Details
Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2014 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at 11:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., March 12, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the fourth
quarter and year ended December 31, 2014. Loss from operations for the three months and year ended December 31, 2014 was $11.2 million and $45.0 million, respectively. As of December 31, 2014, cash, cash equivalents and marketable
securities totaled $43.0 million.
The fourth quarter of 2014 was a focal period for Sunesis and vosaroxin, with unblinding of our Phase 3 VALOR
trial in October and the presentation in December of the full results at the late breaking abstract forum of ASH, said Daniel Swisher, Chief Executive Officer of Sunesis. AML remains a challenging disease, with a striking absence of new
therapeutic treatment options. In this context, we are engaged in active dialogue with regulators in Europe and the U.S. We remain on track to file an MAA in Europe in the second half of 2015, and look forward to providing clarity on our path
forward in the U.S. around mid-year.
Mr. Swisher continued: In addition to VALOR, we are continuing to make progress across our
pipeline, including in our investigator sponsored trials of vosaroxin and our kinase-inhibitor programs.
Fourth Quarter 2014 and Recent
The randomized, double-blind,
placebo-controlled Phase 3 VALOR trial enrolled 711 adult patients with first relapsed or refractory AML at 124 leading sites in 15 countries. Patients were stratified for age, geographic region and disease status and randomized one to one to
receive either vosaroxin and cytarabine or placebo and cytarabine. Patients treated with vosaroxin achieved increased overall survival compared to those treated with placebo (7.5 months vs 6.1 months, HR=0.87), the primary endpoint, but
this difference did not achieve statistical significance (p=0.06). The complete remission (CR) rate, the sole secondary efficacy endpoint in the trial, did demonstrate a significant difference
for the vosaroxin combination arm (30.1% vs 16.3%, p < 0.0001).
In a pre-planned analysis accounting for the stratification factors at
randomization, a significant improvement in overall survival was demonstrated (HR=0.83, p=0.02). The pre-planned analysis of all treatment strata included the following poor-prognosis patient categories: over 60 years old (7.1 months vs 5.0 months,
HR=0.75, p=0.003, n=451), refractory disease (6.7 months vs 5.0 months, HR=0.87, p=0.23, n=301), and early relapsed disease (6.7 months vs 5.2 months, HR=0.77, p=0.04, n=256). Outcomes in patients under 60 years old or with late relapsed disease
were comparable between treatment arms, with no improvement in overall survival. Across all strata, the CR and Composite CR (CR+CRp+CRi) rates were higher in the vosaroxin combination arm.
Given the complexity of interpreting the impact of transplantation therapy, a predefined analysis of overall survival censoring for
hematopoietic stem cell transplantation was planned. In this analysis, patients receiving the vosaroxin combination had a median overall survival of 6.7 months versus 5.3 months for patients receiving placebo and cytarabine (HR=0.81, p=0.02).
Grade 3 or higher non-hematologic adverse events that were more common in the vosaroxin combination arm were gastrointestinal and
infection-related toxicities, consistent with those observed in previous company trials. The rate of serious adverse events was 55.5% in the vosaroxin combination arm compared to 35.7% in the placebo and cytarabine arm. All-cause mortality was
comparable between the treatment arms (7.9% vs 6.6% for 30-day and 19.7% vs 19.4% for 60-day).
Four-week and eight-week mortality were 0%
and 14%, respectively. Infection related toxicities were the most common Grade 3 adverse events. Grade 3 mucositis was observed in 11 patients (30%).
Medicines Agency (EMA). In November 2014, Sunesis announced that it had submitted a letter of intent describing its intention to file an Marketing Authorization Application (MAA)
with the European Medicines Agency (EMA) seeking marketing authorization of vosaroxin plus cytarabine for the treatment of relapsed or refractory AML. The letter of intent initiates the process for the assignment of a Rapporteur and Co-Rapporteur,
who are two appointed members of the Committee for Human Medicinal Products (CHMP). The CHMP is the committee responsible for preparing the EMA s opinions on questions concerning human medicines. The Rapporteur and Co-Rapporteur will assess the
MAA and provide the CHMP with the result of their analysis, which will be the basis of the conclusions of the CHMP. Sunesis expects to file its MAA in the second half of 2015.
Financial Highlights
Conference Call Information
Sunesis will host an update
conference call today, March 12th at 11:00 a.m. Eastern Time. The call can be accessed by dialing (877) 415-3181 (U.S. and Canada) or (857) 244-7324 (international), and entering passcode 78358079. 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
About QINPREZO (vosaroxin)
QINPREZO (vosaroxin) is an anti-cancer quinolone derivative (AQD), a class of compounds that has not been used previously for the treatment of cancer.
Preclinical data demonstrate that QINPREZO 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 QINPREZO for the treatment of AML. Additionally, QINPREZO has been granted fast track designation by the FDA for the potential treatment of relapsed or refractory AML in combination with cytarabine.
QINPREZO is an investigational drug that has not been approved for use in any jurisdiction.
The trademark name QINPREZO is conditionally accepted by the
FDA and the EMA as the proprietary name for the vosaroxin drug product candidate.
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 there were approximately 18,860 new cases of AML and approximately 10,460 deaths from AML in the U.S. in 2014. 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
biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential 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 http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to Sunesis overall strategy, the design, conduct, progress,
timing and results of Sunesis clinical trials, the preliminary analysis, assessment and conclusions of the results of the VALOR trial, the commercial potential of vosaroxin, and the sufficiency of Sunesis cash resources and the use of
the proceeds under the loan facility with Oxford Finance LLC, Horizon Technology Finance Corporation and Silicon Valley Bank. Words such as believe, continue, expect, look forward, on
track, potential, seek, will, 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 QINPREZO, 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 QINPREZO, the risk that Sunesis development activities for QINPREZO could be otherwise halted or significantly delayed for various reasons, the risk that Sunesis clinical
studies for QINPREZO 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, risks related to the conduct of Sunesis clinical trials, and the
risk that Sunesis clinical studies for vosaroxin may not lead to regulatory approval. 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, 2014, Sunesis Annual Report on Form 10-K for the year ended December 31, 2014, 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 Sunesis expectations with regard thereto or any change in events, conditions or circumstances on which any
such statements are based.
SUNESIS PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
| December 31, | ||||||||
| 2014 | 2013 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 22,186 | $ | 15,121 | ||||
| Marketable securities | 20,795 | 24,172 | ||||||
| Prepaids and other current assets | 1,223 | 1,199 | ||||||
| Total current assets | 44,204 | 40,492 | ||||||
| Property and equipment, net | 42 | 23 | ||||||
| Deposits and other assets | 10 | |||||||
| Total assets | $ | 44,246 | $ | 40,525 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,177 | $ | 953 | ||||
| Accrued clinical expense | 3,112 | 4,750 | ||||||
| Accrued compensation | 2,287 | 1,719 | ||||||
| Other accrued liabilities | 3,087 | 1,645 | ||||||
| Current portion of deferred revenue | 3,418 | 7,956 | ||||||
| Current portion of notes payable | 9,257 | 9,018 | ||||||
| Warrant liability | 3,543 | 7,931 | ||||||
| Total current liabilities | 27,881 | 33,972 | ||||||
| Non-current portion of deferred revenue | 2,563 | 3,712 | ||||||
| Non-current portion of notes payable | 9,025 | |||||||
| Commitments | ||||||||
| Stockholders equity (deficit): | ||||||||
| Common stock | 7 | 5 | ||||||
| Additional paid-in capital | 536,499 | 473,509 | ||||||
| Accumulated other comprehensive loss | (7 | ) | (3 | ) | ||||
| Accumulated deficit | (522,697 | ) | (479,695 | ) | ||||
| Total stockholders equity (deficit) | 13,802 | (6,184 | ) | |||||
| Total liabilities and stockholders equity (deficit) | $ | 44,246 | $ | 40,525 |
Note 1: The consolidated balance sheet as of December 31, 2013 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, 2013.
SUNESIS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Note 2) | |||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 896 | $ | 1,989 | $ | 5,734 | $ | 7,956 | ||||||||
| Total revenues | 896 | 1,989 | 5,734 | 7,956 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,968 | 6,883 | 27,665 | 28,891 | ||||||||||||
| General and administrative | 6,082 | 2,698 | 23,112 | 10,838 | ||||||||||||
| Total operating expenses | 12,050 | 9,581 | 50,777 | 39,729 | ||||||||||||
| Loss from operations | (11,154 | ) | (7,592 | ) | (45,043 | ) | (31,773 | ) | ||||||||
| Interest expense | (311 | ) | (623 | ) | (1,719 | ) | (2,917 | ) | ||||||||
| Other income (expense), net | 10,142 | 1,038 | 3,760 | 92 | ||||||||||||
| Net loss | (1,323 | ) | (7,177 | ) | (43,002 | ) | (34,598 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | 2 | (12 | ) | (4 | ) | (41 | ) | |||||||||
| Comprehensive loss | $ | (1,321 | ) | $ | (7,189 | ) | $ | (43,006 | ) | $ | (34,639 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | $ | (1,323 | ) | $ | (7,177 | ) | $ | (43,002 | ) | $ | (34,598 | ) | ||||
| Diluted | $ | (1,323 | ) | $ | (8,257 | ) | $ | (46,894 | ) | $ | (34,598 | ) | ||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 63,041 | 54,060 | 60,057 | 52,249 | ||||||||||||
| Diluted | 63,041 | 55,573 | 61,510 | 52,249 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.02 | ) | $ | (0.13 | ) | $ | (0.72 | ) | $ | (0.66 | ) | ||||
| Diluted | $ | (0.02 | ) | $ | (0.15 | ) | $ | (0.76 | ) | $ | (0.66 | ) |
Note 2: The consolidated statement of operations and comprehensive loss for the year ended December 31, 2013 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, 2013.