Full Press Release Details
Sunesis Pharmaceuticals Reports Third Quarter 2015 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at 11:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., November 5, 2015 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the third
quarter ended September 30, 2015. Loss from operations for the three and nine months ended September 30, 2015 was $8.6 million and $28.0 million, respectively. As of September 30, 2015, cash, cash equivalents and marketable securities
totaled $30.5 million.
We continue to work diligently to complete and submit an MAA by year end for approval of vosaroxin in Europe as a treatment
for AML, said Daniel Swisher, Chief Executive Officer of Sunesis. We believe the European market opportunity is significant, and remain encouraged by the strong support from within the international AML investigator community to bring
this important new therapy to a patient population that has seen little improvement in treatment standards in the last 40 years. While this effort remains our central priority, we are also carefully evaluating and refining our plans to gain
marketing approval in the U.S., and working toward key milestones with our kinase inhibitor pipeline, including data at the upcoming AACR-NCI-EORTC Conference followed by an upcoming CTA filing and Phase 1 study for SNS-062 in Europe.
Third Quarter 2015 Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, November 5th at 11:00 a.m. Eastern Time. The call
can be accessed by dialing (877) 771-6242 (U.S. and Canada) or (440) 996-5676 (international) and entering passcode 65529984. 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)
(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 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 AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for the vosaroxin drug
About Sunesis Pharmaceuticals
Sunesis is a 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 estimated timelines for regulatory interactions and
regulatory progress, including the anticipated submission of the MAA for vosaroxin with the EMA, CTA filing for SNS-062 in Europe and plans to gain marketing approval of vosaroxin in the U.S., Sunesis overall strategy, the design, conduct and
results of clinical trials, including the expected progress in its kinase inhibitor pipeline, the need for and the role of vosaroxin as a potential new treatment option, and Sunesis clinical development of vosaroxin, including the analysis of
the results from the VALOR clinical trial, the commercial potential of vosaroxin in Europe and the U.S., and the sufficiency of Sunesis cash resources. Words such as believe, expect, intends,
plan, potential, 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 may not be able to submit timely the MAA to the EMA, the risk
that Sunesis clinical studies for vosaroxin may not lead to regulatory approval in the U.S. or Europe, that Sunesis development activities for vosaroxin could be otherwise halted or significantly delayed for various reasons, the risk
that Sunesis clinical studies for vosaroxin or other product candidates 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, risks related to Sunesis need for substantial additional funding to complete the development and commercialization of vosaroxin, and 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. These and other risk factors are discussed under Risk Factors and elsewhere in Sunesis Quarterly Report on Form
10-Q for the quarter ended June 30, 2015. 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, 2015 | December 31, 2014 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 16,801 | $ | 22,186 | ||||
| Marketable securities | 13,702 | 20,795 | ||||||
| Prepaids and other current assets | 796 | 1,223 | ||||||
| Total current assets | 31,299 | 44,204 | ||||||
| Property and equipment, net | 17 | 42 | ||||||
| Total assets | $ | 31,316 | $ | 44,246 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,790 | $ | 3,177 | ||||
| Accrued clinical expense | 1,909 | 3,112 | ||||||
| Accrued compensation | 1,491 | 2,287 | ||||||
| Other accrued liabilities | 2,652 | 3,087 | ||||||
| Current portion of deferred revenue | 2,441 | 3,418 | ||||||
| Current portion of notes payable | 5,861 | 9,257 | ||||||
| Warrant liability | 3,543 | |||||||
| Total current liabilities | 16,144 | 27,881 | ||||||
| Non-current portion of deferred revenue | 1,221 | 2,563 | ||||||
| Non-current portion of notes payable | 1,893 | |||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Common stock | 8 | 7 | ||||||
| Additional paid-in capital | 559,847 | 536,499 | ||||||
| Accumulated other comprehensive loss | (2 | ) | (7 | ) | ||||
| Accumulated deficit | (547,795 | ) | (522,697 | ) | ||||
| Total stockholders equity | 12,058 | 13,802 | ||||||
| Total liabilities and stockholders equity | $ | 31,316 | $ | 44,246 |
Note 1: The consolidated balance sheet as of December 31, 2014 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, 2014.
SUNESIS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 683 | $ | 854 | $ | 2,391 | $ | 4,838 | ||||||||
| Total revenues | 683 | 854 | 2,391 | 4,838 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,259 | 6,939 | 16,073 | 21,697 | ||||||||||||
| General and administrative | 3,994 | 7,226 | 14,280 | 17,030 | ||||||||||||
| Total operating expenses | 9,253 | 14,165 | 30,353 | 38,727 | ||||||||||||
| Loss from operations | (8,570 | ) | (13,311 | ) | (27,962 | ) | (33,889 | ) | ||||||||
| Interest expense | (233 | ) | (391 | ) | (705 | ) | (1,408 | ) | ||||||||
| Other income (expense), net | 1,782 | (1,623 | ) | 3,569 | (6,382 | ) | ||||||||||
| Net loss | (7,021 | ) | (15,325 | ) | (25,098 | ) | (41,679 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | 3 | (2 | ) | 5 | (6 | ) | ||||||||||
| Comprehensive loss | $ | (7,018 | ) | $ | (15,327 | ) | $ | (25,093 | ) | $ | (41,685 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss | $ | (7,021 | ) | $ | (15,325 | ) | $ | (25,098 | ) | $ | (41,679 | ) | ||||
| Shares used in computing basic and diluted loss per common share | 74,776 | 60,549 | 71,670 | 59,052 | ||||||||||||
| Basic and diluted loss per common share | $ | (0.09 | ) | $ | (0.25 | ) | $ | (0.35 | ) | $ | (0.71 | ) |