Full Press Release Details
| Investor and Media Inquiries: | ||
| David Pitts Argot Partners 212-600-1902 | Eric Bjerkholt Sunesis Pharmaceuticals Inc. 650-266-3717 |
Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2015 Financial
Results and Recent Highlights
Sunesis to Host Conference Call Today at 11:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., March 10, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the fourth
quarter and year ended December 31, 2015. Loss from operations for the three months and year ended December 31, 2015 was $11.3 million and $39.3 million, respectively. As of December 31, 2015, cash, cash equivalents and marketable
securities totaled $46.4 million.
In the fourth quarter, we achieved a top 2015 corporate milestone with the submission and validation of our
Marketing Authorization Application in Europe for vosaroxin to treat relapsed/refractory AML, said Daniel Swisher, Chief Executive Officer of Sunesis. We are committed to bringing this important new therapy to a patient population with
so few options. We will be providing updates later this year on the progress in Europe and in other major regions, including North America.
Mr. Swisher added: Another key milestone for Sunesis is the progress of our pipeline of kinase inhibitors representing targeted new approaches to
the treatment of cancer. Soon, we expect to initiate clinical development of SNS-062, our differentiated non-covalent BTK inhibitor with a European Phase 1A clinical trial in healthy volunteers, followed by a Phase 1B/2 in B-cell malignancy patients
later this year. We also look forward to seeing data from the ongoing multi-arm combination study for the Takeda-partnered pan-RAF inhibitor, TAK-580, and to advancing our PDK-1 inhibitor, SNS-229, through IND-enabling toxicology studies to an
Fourth Quarter 2015 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, March 10th 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 49218884. 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 improving the lives of people with cancer and is currently pursuing regulatory approval in Europe for its lead product candidate,
vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older. In addition, the company is advancing its kinase-inhibitor pipeline of novel targeted therapies into the clinic.
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 progress and potential approval of vosaroxin by the EMA, clinical development of SNS-062;
Sunesis overall strategy in Europe and other major regions and plans to gain marketing approval of vosaroxin in the U.S., the design, conduct and results of clinical trials, including the
expected progress in its kinase inhibitor pipeline, and potential advancements of SNS-229 to an IND, the need for and the role of vosaroxin as a potential new treatment option, , and the sufficiency of Sunesis cash resources. Words such
as expect, look forward, 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 receive regulatory approval of vosaroxin 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, including its pipeline of kinase inhibitors, 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 other product candidates, 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 and other product
candidates. 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, 2015, Sunesis Annual Report on Form 10-K for the year
ended December 31, 2015, 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, | ||||||||
| 2015 | 2014 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 25,387 | $ | 22,186 | ||||
| Marketable securities | 21,043 | 20,795 | ||||||
| Prepaids and other current assets | 558 | 1,223 | ||||||
| Total current assets | 46,988 | 44,204 | ||||||
| Property and equipment, net | 14 | 42 | ||||||
| Deposits and other assets | ||||||||
| Total assets | $ | 47,002 | $ | 44,246 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,453 | $ | 3,177 | ||||
| Accrued clinical expense | 1,954 | 3,112 | ||||||
| Accrued compensation | 1,606 | 2,287 | ||||||
| Other accrued liabilities | 2,711 | 3,087 | ||||||
| Current portion of deferred revenue | 2,441 | 3,418 | ||||||
| Current portion of notes payable | 7,834 | 9,257 | ||||||
| Warrant liability | 3,543 | |||||||
| Total current liabilities | 18,999 | 27,881 | ||||||
| Non-current portion of deferred revenue | 610 | 2,563 | ||||||
| Non-current portion of notes payable | ||||||||
| Commitments | ||||||||
| Stockholders equity (deficit): | ||||||||
| Convertible preferred stock | 16,459 | |||||||
| Common stock | 9 | 7 | ||||||
| Additional paid-in capital | 570,309 | 536,499 | ||||||
| Accumulated other comprehensive loss | (11 | ) | (7 | ) | ||||
| Accumulated deficit | (559,373 | ) | (522,697 | ) | ||||
| Total stockholders equity (deficit) | 27,393 | 13,802 | ||||||
| Total liabilities and stockholders equity (deficit) | $ | 47,002 | $ | 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
thousands, except per share amounts)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Note 2) | |||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 670 | $ | 896 | $ | 3,061 | $ | 5,734 | ||||||||
| Total revenues | 670 | 896 | 3,061 | 5,734 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 7,628 | 5,968 | 23,701 | 27,665 | ||||||||||||
| General and administrative | 4,382 | 6,082 | 18,662 | 23,112 | ||||||||||||
| Total operating expenses | 12,010 | 12,050 | 42,363 | 50,777 | ||||||||||||
| Loss from operations | (11,340 | ) | (11,154 | ) | (39,302 | ) | (45,043 | ) | ||||||||
| Interest expense | (234 | ) | (311 | ) | (939 | ) | (1,719 | ) | ||||||||
| Other income (expense), net | (4 | ) | 10,142 | 3,565 | 3,760 | |||||||||||
| Net loss | (11,578 | ) | (1,323 | ) | (36,676 | ) | (43,002 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | (9 | ) | 2 | (4 | ) | (4 | ) | |||||||||
| Comprehensive loss | $ | (11,587 | ) | $ | (1,321 | ) | $ | (36,680 | ) | $ | (43,006 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | $ | (11,578 | ) | $ | (1,323 | ) | $ | (36,676 | ) | $ | (43,002 | ) | ||||
| Diluted | $ | (11,578 | ) | $ | (1,323 | ) | $ | (36,676 | ) | $ | (46,894 | ) | ||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 76,683 | 63,041 | 72,933 | 60,057 | ||||||||||||
| Diluted | 76,683 | 63,041 | 72,933 | 60,510 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.15 | ) | $ | (0.02 | ) | $ | (0.50 | ) | $ | (0.72 | ) | ||||
| Diluted | $ | (0.15 | ) | $ | (0.02 | ) | $ | (0.50 | ) | $ | (0.76 | ) |
Note 2: The consolidated statement of operations and comprehensive loss for the year ended 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.