Full Press Release Details
Sunesis Pharmaceuticals Reports First Quarter 2016 Financial Results and
to Host Conference Call Today at 11:00 AM Eastern Time
SOUTH SAN FRANCISCO, Calif., May 5, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:
SNSS) today reported financial results for the first quarter ended March 31, 2016. Loss from operations for the three months ended March 31, 2016 was $10.1 million. As of March 31, 2016, cash, cash equivalents and marketable
securities totaled $40.0 million.
The first quarter of 2016 saw several important milestones, including, notably, the advancement of our unique
BTK-inhibitor SNS-062 into the clinic in a Phase 1A study, said Daniel Swisher, Chief Executive Officer of Sunesis. Resistance to available BTK-inhibitors is a growing concern, and SNS-062 s characteristics as a non-covalently
binding inhibitor position it to address this emerging unmet need. Ongoing dose escalation in our Healthy Volunteer Study is proceeding well. We are actively planning for our Phase 1B/2 study in patients with B-cell malignancies to start later this
Mr. Swisher added: We also continue to progress our efforts to bring vosaroxin to market in Europe as an important new treatment
option for patients with relapsed/refractory AML. Our Marketing Authorization Application has now reached the 120-day comment and question time point. With continued regulatory advancement and strong outreach efforts underway, we aim to enter into a
European collaboration later this year to support a market launch in 2017.
First Quarter 2016 and Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host an update conference call today, May 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 96476414. 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 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.
About Sunesis Pharmaceuticals
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 corporate objectives, including the anticipated
progress and potential approval of vosaroxin by the EMA, clinical development of SNS 062, potential ex-US partnership, the expected progress in its kinase inhibitor pipeline, 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 Annual Report on Form 10-K for the year ended December 31, 2015, Sunesis Quarterly Report on Form 10-Q for the quarter
ended March 31, 2016, 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
| March 31, | December 31, | |||||||
| 2016 | 2015 | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 23,858 | $ | 26,886 | ||||
| Marketable securities | 16,158 | 19,544 | ||||||
| Prepaids and other current assets | 701 | 558 | ||||||
| Total current assets | 40,717 | 46,988 | ||||||
| Property and equipment, net | 11 | 14 | ||||||
| Total assets | $ | 40,728 | $ | 47,002 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,581 | $ | 2,453 | ||||
| Accrued clinical expense | 2,185 | 1,954 | ||||||
| Accrued compensation | 929 | 1,606 | ||||||
| Other accrued liabilities | 1,639 | 2,711 | ||||||
| Current portion of deferred revenue | 2,441 | 2,441 | ||||||
| Current portion of notes payable | 7,834 | |||||||
| Warrant liability | ||||||||
| Total current liabilities | 9,775 | 18,999 | ||||||
| Non-current portion of deferred revenue | 610 | |||||||
| Non-current portion of notes payable | 11,685 | |||||||
| Commitments | ||||||||
| Stockholders equity: | ||||||||
| Preferred stock | 16,459 | 16,459 | ||||||
| Common stock | 9 | 9 | ||||||
| Additional paid-in capital | 572,257 | 570,309 | ||||||
| Accumulated other comprehensive loss | 2 | (11 | ) | |||||
| Accumulated deficit | (569,459 | ) | (559,373 | ) | ||||
| Total stockholders equity | 19,268 | 27,393 | ||||||
| Total liabilities and stockholders equity | $ | 40,728 | $ | 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 | ||||||||
| March 31, | ||||||||
| 2016 | 2015 | |||||||
| (Unaudited) | (Unaudited) | |||||||
| Revenue: | ||||||||
| License and other revenue | $ | 640 | $ | 854 | ||||
| Total revenues | 640 | 854 | ||||||
| Operating expenses: | ||||||||
| Research and development | 6,209 | 4,512 | ||||||
| General and administrative | 4,295 | 5,111 | ||||||
| Total operating expenses | 10,504 | 9,623 | ||||||
| Loss from operations | (9,864 | ) | (8,769 | ) | ||||
| Interest expense | (298 | ) | (239 | ) | ||||
| Other income (expense), net | 76 | (120 | ) | |||||
| Net loss | (10,086 | ) | (9,128 | ) | ||||
| Unrealized gain (loss) on available-for-sale securities | 13 | 2 | ||||||
| Comprehensive loss | $ | (10,073 | ) | $ | (9,126 | ) | ||
| Basic and diluted loss per common share: | ||||||||
| Net loss | $ | (10,086 | ) | $ | (9,128 | ) | ||
| Shares used in computing basic and diluted loss per common share | 86,660 | 67,641 | ||||||
| Basic and diluted loss per common share | $ | (0.12 | ) | $ | (0.13 | ) |