Full Press Release Details
| Investor and Media Inquiries: | ||
| David Pitts Argot Partners 212-600-1902 | Dan Swisher Sunesis Pharmaceuticals Inc. 650-266-3715 |
Sunesis Pharmaceuticals Reports First Quarter 2017 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at 2:00 PM Eastern Time
SOUTH SAN FRANCISCO, Calif., May 8, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for
the first quarter ended March 31, 2017. Loss from operations for the three months ended March 31, 2017 was $9.4 million. As of March 31, 2017, cash, cash equivalents and marketable securities totaled $35.2 million.
Following recent regulatory developments, our reversible non-covalent BTK inhibitor, SNS-062, is the central focus of our development efforts and resources, said Daniel Swisher, President and Chief Executive Officer of Sunesis. Data from
SNS-062 s preclinical and healthy volunteer studies suggest a unique drug profile for this next-generation BTK inhibitor and the potential to overcome the key resistance mechanism of ibrutinib. SNS-062 has the potential to address this increasingly well-defined and prevalent unmet need in CLL and other B-cell malignancy patients with C481S mutations, and we look
forward to dosing the first patient in our Phase 1B/2 study this quarter.
Mr. Swisher continued, With regard to vosaroxin, we plan to
continue to advance its development through investigator-sponsored group trials, and will carefully assess business development alternatives to support any future registration-directed studies. We expect that our current cash resources are
sufficient to fund the company into June 2018.
First Quarter 2017 and Recent Highlights
Sunesis also announced today that vosaroxin has been selected as a treatment arm in the Phase 2/3 BIG-1
(Backbone InterGroup-1) trial. BIG-1 is an open label, multicenter phase 2/3 study with multiple randomization phases at different stages of
AML treatment that is designed to improve overall survival in younger patients (18 to 60 years). The vosaroxin portion of the trial, which is expected to begin dosing imminently, will enroll up to 200 patients with favorable or intermediate
risk AML, who will receive consolidation therapy of intermediate dose cytarabine with vosaroxin. The study is being conducted at multiple French centers, led by the University Hospital of Angers under the direction of Professor Norbert Ifrah,
and the University Institute of Hematology at the H pital Saint-Louis under the direction of Professor Herv Dombret.
Financial Highlights
Conference Call Information
Sunesis will host a conference today at 2:00 p.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 13018661. 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 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 advancing its novel kinase-inhibitor pipeline, which
includes its proprietary reversible 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 the continued development and commercialization of vosaroxin, the
timing of our Phase 1b/2 trial of SNS-062, and the sufficiency of Sunesis cash and funding into June 2018. Words such as advance, continue, expect, 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 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 vosaroxin and other product candidates, including SNS-062, the risk that Sunesis clinical
studies for vosaroxin or other product candidates, including SNS-062 or 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 timing or 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
Quarterly Report on Form 10-Q for the quarter ended March 31, 2017 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
| March 31, | December 31, | |||||||
| 2017 | 2016 | |||||||
| (Unaudited) | (1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,470 | $ | 8,056 | ||||
| Marketable securities | 23,706 | 34,532 | ||||||
| Prepaids and other current assets | 714 | 643 | ||||||
| Total current assets | 35,890 | 43,231 | ||||||
| Property and equipment, net | 1 | 3 | ||||||
| Total assets | $ | 35,891 | $ | 43,234 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,647 | $ | 1,871 | ||||
| Accrued clinical expense | 1,351 | 1,434 | ||||||
| Accrued compensation | 1,055 | 2,000 | ||||||
| Other accrued liabilities | 1,782 | 1,691 | ||||||
| Current portion of deferred revenue | 610 | |||||||
| Current portion of notes payable | 4,583 | 3,333 | ||||||
| Total current liabilities | 11,418 | 10,939 | ||||||
| Non-current portion of notes payable | 9,930 | 11,102 | ||||||
| Other accrued liabilities | 226 | 169 | ||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock | 18,808 | 18,808 | ||||||
| Common stock | 2 | 2 | ||||||
| Additional paid-in capital | 602,755 | 599,632 | ||||||
| Accumulated other comprehensive income (loss) | (18 | ) | (22 | ) | ||||
| Accumulated deficit | (607,230 | ) | (597,396 | ) | ||||
| Total stockholders equity | 14,317 | 21,024 | ||||||
| Total liabilities and stockholders equity | 35,891 | 43,234 |
Note 1: The consolidated balance sheet as of December 31, 2016 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, 2016.
SUNESIS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
(In thousands, except per share amounts)
| Three months ended March 31, | ||||||||
| 2017 | 2016 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Revenue: | ||||||||
| License and other revenue | $ | 669 | $ | 640 | ||||
| Total revenues | 669 | 640 | ||||||
| Operating expenses: | ||||||||
| Research and development | 6,162 | 6,209 | ||||||
| General and administrative | 3,942 | 4,295 | ||||||
| Total operating expenses | 10,104 | 10,504 | ||||||
| Loss from operations | (9,435 | ) | (9,864 | ) | ||||
| Interest expense | (484 | ) | (298 | ) | ||||
| Other income (expense), net | 85 | 76 | ||||||
| Net loss | (9,834 | ) | (10,086 | ) | ||||
| Unrealized gain (loss) on available-for-sale securities | 4 | 13 | ||||||
| Comprehensive loss | $ | (9,830 | ) | $ | (10,073 | ) | ||
| Basic and diluted loss per common share: | ||||||||
| Net loss | $ | (9,834 | ) | $ | (10,086 | ) | ||
| Shares used in computing basic and diluted loss per common share | 21,029 | 14,443 | ||||||
| Basic and diluted loss per common share | $ | (0.47 | ) | $ | (0.70 | ) |