Full Press Release Details
Sunesis Pharmaceuticals Reports Third Quarter 2014 Financial Results and Recent Highlights
Announces Submission of Letter of Intent to File MAA for Vosaroxin in Relapsed or Refractory AML with the European Medicines Agency
Announces Upcoming Presentations at ASH Annual Meeting, EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics
SOUTH SAN FRANCISCO, Calif., November 10, 2014 Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) today reported financial results for the quarter
ended September 30, 2014. Loss from operations for the three and nine months ended September 30, 2014 was $13.3 million and $33.9 million, respectively. As of September 30, 2014, cash, cash equivalents and marketable securities
totaled $44.7 million.
VALOR represents the largest randomized company-sponsored dataset in the relapsed and refractory AML setting, said
Daniel Swisher, Chief Executive Officer of Sunesis. As we continue to evaluate the study results and share the findings with our investigators, we believe that the vosaroxin and cytarabine combination demonstrates clinically meaningful
outcomes supported by strong response rates and a manageable safety profile. We are committed to working with regulators in making vosaroxin available to clinicians and patients in urgent need of effective new therapies.
Mr. Swisher continued: As an important step forward in the European regulatory process, we announced today the submission of a letter of intent to
file an MAA for vosaroxin in relapsed or refractory AML with the EMA. Further, we are requesting a meeting with the Food and Drug Administration to determine the appropriate regulatory path forward in the U.S., and look forward to presenting the
full results of VALOR at an upcoming scientific meeting. With the upcoming presentations of MLN2480 at ENA, we look forward to continued positive progress across our emerging pipeline of kinase inhibitor product candidates.
Third Quarter 2014 and Recent Highlights
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=0.809,
p=0.02). The VALOR trial also demonstrated a clinically significant benefit in complete remission, or CR, rate (30.1% vs 16.3%, p=0.0000147), the secondary endpoint.
The safety profile of the vosaroxin combination was consistent with that observed in previous company trials, and induction mortality was
balanced between arms. 30-day and 60-day all-cause mortality were comparable between the trial arms (7.9% versus 6.6% and 19.7% versus 19.4%, for the vosaroxin combination versus placebo and cytarabine, respectively).
Financial Highlights
Conference Call Information
Sunesis will host an update
conference call today, November 10th at 10:30 a.m. Eastern Time. The call can be accessed by dialing (877) 280-4954 (U.S. and Canada) or (857) 244-7311 (international), and entering passcode
29531783. 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.
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 estimates there will be 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
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 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 regulatory strategy (including plans to commence a
marketing authorization filing with the EMA), Sunesis preliminary analysis, assessment and conclusions of the results of the VALOR trial, and the efficacy and commercial potential of vosaroxin and clinical progress of other product candidates.
It is possible that such results or conclusions may change based on further analysis of the VALOR data. Words such as approximately, believe, continue, could, determine,
estimate, expect, intends, may, plans, 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, the risk that Sunesis preliminary analysis, assessment and conclusions of the results of the VALOR trial set forth in this release may
change based on further analysis of such data, the risk that Sunesis plans to commence a marketing authorization filing with the EMA may change or such filing may be rejected by the EMA, and the risk that Sunesis clinical studies for
vosaroxin and other product candidates may not lead to regulatory approval. 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,
2013, Sunesis Quarterly Report on Form 10-Q for the Quarter ended June 30, 2014 and Sunesis other filings with the Securities and Exchange Commission, including Sunesis Quarterly Report on Form 10-Q for the quarter ended
September 30, 2014, 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 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
| September 30, 2014 | December 31, 2013 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 20,807 | $ | 15,121 | ||||
| Marketable securities | 23,912 | 24,172 | ||||||
| Prepaids and other current assets | 1,279 | 1,199 | ||||||
| Total current assets | 45,998 | 40,492 | ||||||
| Property and equipment, net | 53 | 23 | ||||||
| Deposits and other assets | 10 | |||||||
| Total assets | $ | 46,051 | $ | 40,525 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 772 | $ | 953 | ||||
| Accrued clinical expense | 3,621 | 4,750 | ||||||
| Accrued compensation | 1,995 | 1,719 | ||||||
| Other accrued liabilities | 3,967 | 1,645 | ||||||
| Current portion of deferred revenue | 3,418 | 7,956 | ||||||
| Current portion of notes payable | 9,859 | 9,018 | ||||||
| Warrant liability | 13,673 | 7,931 | ||||||
| Total current liabilities | 37,305 | 33,972 | ||||||
| Non-current portion of deferred revenue | 3,418 | 3,712 | ||||||
| Non-current portion of notes payable | 1,713 | 9,025 | ||||||
| Commitments | ||||||||
| Stockholders equity (deficit): | ||||||||
| Common stock | 6 | 5 | ||||||
| Additional paid-in capital | 524,992 | 473,509 | ||||||
| Accumulated other comprehensive loss | (9 | ) | (3 | ) | ||||
| Accumulated deficit | (521,374 | ) | (479,695 | ) | ||||
| Total stockholders equity (deficit) | 3,615 | (6,184 | ) | |||||
| Total liabilities and stockholders equity (deficit) | $ | 46,051 | $ | 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 September 30, | Nine months ended September 30, | |||||||||||||||
| 2014 | 2013 | 2014 | 2013 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 854 | $ | 1,989 | $ | 4,838 | $ | 5,967 | ||||||||
| Total revenues | 854 | 1,989 | 4,838 | 5,967 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,939 | 6,957 | 21,697 | 22,008 | ||||||||||||
| General and administrative | 7,226 | 2,807 | 17,030 | 8,140 | ||||||||||||
| Total operating expenses | 14,165 | 9,764 | 38,727 | 30,148 | ||||||||||||
| Loss from operations | (13,311 | ) | (7,775 | ) | (33,889 | ) | (24,181 | ) | ||||||||
| Interest expense | (391 | ) | (695 | ) | (1,408 | ) | (2,294 | ) | ||||||||
| Other income (expense), net | (1,623 | ) | 863 | (6,382 | ) | (946 | ) | |||||||||
| Net loss | (15,325 | ) | (7,607 | ) | (41,679 | ) | (27,421 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | (2 | ) | 9 | (6 | ) | (29 | ) | |||||||||
| Comprehensive loss | $ | (15,327 | ) | $ | (7,598 | ) | $ | (41,685 | ) | $ | (27,450 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | $ | (15,325 | ) | $ | (7,607 | ) | $ | (41,679 | ) | $ | (27,421 | ) | ||||
| Diluted | $ | (15,325 | ) | $ | (8,329 | ) | $ | (41,679 | ) | $ | (27,421 | ) | ||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 60,549 | 51,698 | 59,052 | 51,639 | ||||||||||||
| Diluted | 60,549 | 53,271 | 59,052 | 51,639 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.25 | ) | $ | (0.15 | ) | $ | (0.71 | ) | $ | (0.53 | ) | ||||
| Diluted | $ | (0.25 | ) | $ | (0.16 | ) | $ | (0.71 | ) | $ | (0.53 | ) |