Full Press Release Details
Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2016 Financial
Results and Recent Highlights
Sunesis to Host Conference Call Today at 11:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., March 9, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for
the fourth quarter and year ended December 31, 2016. Loss from operations for the three months and year ended December 31, 2016 was $8.1 million and $36.5 million, respectively. As of December 31, 2016, cash, cash
equivalents and marketable securities totaled $42.6 million.
We are making meaningful progress in advancing our two lead programs, vosaroxin
and SNS-062, in areas of unmet need in hematologic malignancies, said Daniel Swisher, Chief Executive Officer of Sunesis. Our European Marketing Authorization Application is on track; we are
working diligently to submit responses this quarter to the Day 180 List of Outstanding Issues and we are preparing to go before the Scientific Advisory Group s Oncology Division (SAG-O) in April,
culminating in a likely CHMP decision by mid-year. We continue, in parallel, to advance active dialogues with potential pharma collaborators toward the goal of supporting a potential market launch of vosaroxin
in Europe in the second half of this year.
Mr. Swisher continued, Our BTK inhibitor program is advancing as planned. The IND for SNS-062 is now active and we expect to initiate a Phase 1B/2 study in patients with advanced B-cell malignancies in the second quarter. We were encouraged by the data from the
Phase 1A Healthy Volunteer study and the level of interest generated at our ASH 2016 presentation.
Fourth Quarter 2016 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, March 9th at 11:00 a.m. Eastern Time. The call can be
accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 59899543. 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 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/refractory AML in combination with cytarabine. Vosaroxin is an investigational drug that has not been approved for use in any jurisdiction.
Vosaroxin s Marketing Authorization Application for relapsed refractory AML is currently under review by the European Medicines Agency, and a regulatory
decision regarding approval is expected in 2017.
The trademark name QINPREZO is conditionally accepted by the FDA and the EMA as the proprietary name for
the vosaroxin drug product candidate.
SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the
enzyme Bruton s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. Unlike other drugs in its class, SNS-062 has a distinct kinase selectivity profile and binds non-covalently
to the BTK enzyme. This alternate binding site potentially provides an opportunity to address the leading resistance mechanism, a mutation in the enzyme s binding site required for covalent binding. In preclinical studies, SNS-062 demonstrated potent activity against Cys-481S mutated B-cell malignancies, and has been studied in healthy subjects in a Phase
1A, randomized, double-blind, placebo-controlled dose-ranging study to investigate the drug s safety, pharmacokinetics, and pharmacodynamics. With the reported successful study outcome, SNS-062 is
proceeding to a Phase 1B/2 study in patients with B-cell malignancies.
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. Currently, the company is focused on 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, as well as advancing its novel kinase-inhibitor pipeline, which includes its proprietary
non-covalent BTK-inhibitor, SNS-062.
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 corporate objectives, the regulatory development,
timing of SNS-062 clinical development, SNS-062 clinical potential, Sunesis response to Day 180 List of Outstanding Issues and the timing thereof, and potential
approval of vosaroxin by the EMA, potential collaborations and ability to commercialize vosaroxin in Europe. Words such as advancing, anticipate, expect, goal, potential,
progress, 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 SNS-062 or vosaroxin in the U.S. or Europe, that Sunesis development activities for SNS-062 or
vosaroxin could be otherwise halted or significantly delayed for various reasons, risks related to Sunesis need for substantial additional funding to complete the development and commercialization of
SNS-062, vosaroxin and other product candidates, the risk that Sunesis clinical studies for SNS-062, 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, 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 SNS-062, vosaroxin and other product
candidates. 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, 2016 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, | ||||||||
| 2016 | 2015 | |||||||
| (Unaudited) | (Note 1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 8,056 | $ | 26,886 | ||||
| Marketable securities | 34,532 | 19,544 | ||||||
| Prepaids and other current assets | 643 | 558 | ||||||
| Total current assets | 43,231 | 46,988 | ||||||
| Property and equipment, net | 3 | 14 | ||||||
| Total assets | $ | 43,234 | $ | 47,002 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,871 | $ | 2,453 | ||||
| Accrued clinical expense | 1,434 | 1,954 | ||||||
| Accrued compensation | 2,000 | 1,606 | ||||||
| Other accrued liabilities | 1,691 | 2,711 | ||||||
| Current portion of deferred revenue | 610 | 2,441 | ||||||
| Current portion of notes payable | 3,333 | 7,834 | ||||||
| Total current liabilities | 10,939 | 18,999 | ||||||
| Non-current portion of deferred revenue | 610 | |||||||
| Non-current portion of notes payable | ||||||||
| Non-current portion of notes payable | 11,102 | |||||||
| Non-current other liabilities | 169 | |||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Convertible preferred stock | 18,808 | 16,459 | ||||||
| Common stock | 2 | 1 | ||||||
| Additional paid-in capital | 599,632 | 570,317 | ||||||
| Accumulated other comprehensive loss | (22 | ) | (11 | ) | ||||
| Accumulated deficit | (597,396 | ) | (559,373 | ) | ||||
| Total stockholders equity | 21,024 | 27,393 | ||||||
| Total liabilities and stockholders equity | 43,234 | 47,002 |
Note 1: The consolidated balance sheet as of December 31, 2015 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, 2015.
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, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Note 2) | |||||||||||||
| Revenue: | ||||||||||||||||
| License and other revenue | $ | 676 | $ | 670 | $ | 2,536 | $ | 3,061 | ||||||||
| Total revenues | 676 | 670 | 2,536 | 3,061 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,815 | 7,628 | 22,881 | 23,701 | ||||||||||||
| General and administrative | 3,934 | 4,382 | 16,115 | 18,662 | ||||||||||||
| Total operating expenses | 8,749 | 12,010 | 38,996 | 42,363 | ||||||||||||
| Loss from operations | (8,073 | ) | (11,340 | ) | (36,460 | ) | (39,302 | ) | ||||||||
| Interest expense | (474 | ) | (234 | ) | (1,721 | ) | (939 | ) | ||||||||
| Other income (expense), net | 10 | (4 | ) | 158 | 3,565 | |||||||||||
| Net loss | (8,537 | ) | (11,578 | ) | (38,023 | ) | (36,676 | ) | ||||||||
| Unrealized gain (loss) on available-for-sale securities | (9 | ) | (9 | ) | (11 | ) | (4 | ) | ||||||||
| Comprehensive loss | $ | (8,546 | ) | $ | (11,587 | ) | $ | (38,034 | ) | $ | (36,680 | ) | ||||
| Basic and diluted loss per common share: | ||||||||||||||||
| Net loss: | ||||||||||||||||
| Basic | $ | (8,537 | ) | $ | (11,578 | ) | $ | (38,023 | ) | $ | (36,676 | ) | ||||
| Diluted | $ | (8,537 | ) | $ | (11,578 | ) | $ | (38,023 | ) | $ | (36,676 | ) | ||||
| Shares used in computing net loss per common share: | ||||||||||||||||
| Basic | 19,285 | 12,781 | 15,688 | 15,688 | ||||||||||||
| Diluted | 19,285 | 12,781 | 15,688 | 15,688 | ||||||||||||
| Net loss per common share: | ||||||||||||||||
| Basic | $ | (0.44 | ) | $ | (0.91 | ) | $ | (2.42 | ) | $ | (2.34 | ) | ||||
| Diluted | $ | (0.44 | ) | $ | (0.91 | ) | $ | (2.42 | ) | $ | (2.34 | ) |
Note 2: The consolidated statement of operations and comprehensive loss for the year ended December 31, 2015 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, 2015.