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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Sunesis Pharmaceuticals Inc | NASDAQ:SNSS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 5.32 | 4.72 | 4.75 | 0 | 01:00:00 |
“In the third quarter, we advanced our lead program, a reversible, non-covalent BTK inhibitor, SNS-062, with the ongoing enrollment in our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies,” said Daniel Swisher, Chief Executive Officer of Sunesis. “We will provide a program update at an investor presentation and webcast during the American Society of Hematology Conference in Atlanta, Georgia in December 2017, and to present interim data from the study at a peer-reviewed medical conference in mid-2018. We believe SNS-062 has the potential to overcome the leading resistance pathway to ibrutinib, the predominant standard of care for the treatment of CLL. In addition, in October, we secured the financial resources from leading life science investors extending our operating runway into early 2019.
Mr. Swisher added, “Beyond SNS-062, we have made progress with our proprietary PDK-1 and Takeda-partnered pan-RAF inhibitor programs. We are pleased to announce today the nomination of our PDK1 (phosphatidyl-inositol dependent kinase1) inhibitor, SNS-510, as a Development Candidate and potentially first-to-clinic selective inhibitor in this pathway. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families. In addition, we look forward to announcing future updates from the ongoing clinical studies of our Takeda-partnered TAK-580 program.”
Recent Highlights
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 1071001. 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 future treatment of solid and hematologic cancers. Sunesis has built an experienced cancer drug development organization committed to improving the lives of people with cancer. The Company is focused on advancing its novel kinase-inhibitor pipeline, with an emphasis on establishing proof of concept that its oral non-covalent BTK-inhibitor, SNS-062, is effective in ibrutinib-resistant chronic lymphocytic leukemia. SNS-062 is currently being evaluated in a Phase 1b/2, open-label, sequential-group, dose-escalation and cohort-expansion study in adults with chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia and mantle cell lymphoma that have progressed after prior therapies. Beyond the development of SNS-062, the Company has two other kinase inhibitor programs, including the Takeda-partnered pan-RAF inhibitor TAK-580, which is in solid tumor trials, and its proprietary preclinical PDK1 inhibitor SNS-510, which has completed non-GLP toxicology studies and has been nominated as a Development Candidate. PDK1 is a master kinase that activates other kinases important to cell growth and survival including members of the AKT, PKC, RSK and SGK families.
For additional information on Sunesis, please visit 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 of SNS-062, including the timing of our Phase 1b/2 trial of SNS-062 and the therapeutic potential of SNS-062, further development of its kinase inhibitor pipeline, business development alternatives for vosaroxin, planned development of SNS-510 and the sufficiency of Sunesis’ cash and funding into early 2019. Words such as “continue,” “expect,” “look forward,” “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 related to the timing or conduct of Sunesis' clinical trials, including SNS-062 Phase 1b/2 trial, the risk that Sunesis' clinical or preclinical studies for SNS-062, vosaroxin, SNS-510 or other product candidate 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, that Sunesis' development activities for SNS-062, vosaroxin or SNS-510 could be otherwise halted or significantly delayed for various reasons, that Sunesis may not be able to receive regulatory approval of SNS-062, vosaroxin or SNS-510 in the U.S. or Europe, 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, SNS-510 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, 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 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 | |||||||||
(In thousands) | |||||||||
September 30, | December 31, | ||||||||
2017 | 2016 | ||||||||
(Unaudited) | (1) | ||||||||
ASSETS | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 7,947 | $ | 8,056 | |||||
Marketable securities | 4,506 | 34,532 | |||||||
Prepaids and other current assets | 1,258 | 643 | |||||||
Total current assets | 13,711 | 43,231 | |||||||
Property and equipment, net | 22 | 3 | |||||||
Deposits and other assets | 1,335 | ||||||||
Total assets | $ | 15,068 | $ | 43,234 | |||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 1,541 | $ | 1,871 | |||||
Accrued clinical expense | 765 | 1,434 | |||||||
Accrued compensation | 1,581 | 2,000 | |||||||
Other accrued liabilities | 1,056 | 1,691 | |||||||
Current portion of deferred revenue | - | 610 | |||||||
Current portion of notes payable | 2,500 | 3,333 | |||||||
Total current liabilities | 7,443 | 10,939 | |||||||
Non-current portion of notes payable | 4,652 | 11,102 | |||||||
Other accrued liabilities | 68 | 169 | |||||||
Commitments | |||||||||
Stockholders’ equity: | |||||||||
Preferred stock | 16,540 | 18,808 | |||||||
Common stock | 2 | 2 | |||||||
Additional paid-in capital | 612,595 | 599,632 | |||||||
Accumulated other comprehensive income (loss) | (1 | ) | (22 | ) | |||||
Accumulated deficit | (626,231 | ) | (597,396 | ) | |||||
Total stockholders’ equity | 2,905 | 21,024 | |||||||
Total liabilities and stockholders’ equity | 15,068 | 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 September 30, | Nine months ended September 30, | ||||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (Note 2) | ||||||||||||||
Revenue: | |||||||||||||||||
License and other revenue | $ | - | $ | 610 | $ | 669 | $ | 1,860 | |||||||||
Total revenues | - | 610 | 669 | 1,860 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 6,763 | 5,251 | 17,866 | 18,066 | |||||||||||||
General and administrative | 3,175 | 3,889 | 10,788 | 12,181 | |||||||||||||
Total operating expenses | 9,938 | 9,140 | 28,654 | 30,247 | |||||||||||||
Loss from operations | (9,938 | ) | (8,530 | ) | (27,985 | ) | (28,387 | ) | |||||||||
Interest expense | (288 | ) | (473 | ) | (1,116 | ) | (1,247 | ) | |||||||||
Other income (expense), net | 67 | 49 | 266 | 148 | |||||||||||||
Net Loss | (10,159 | ) | (8,954 | ) | (28,835 | ) | (29,486 | ) | |||||||||
Unrealized gain (loss) on available-for-sale securities | 8 | (6 | ) | 21 | 6 | ||||||||||||
Comprehensive loss | $ | (10,151 | ) | $ | (8,960 | ) | $ | (28,814 | ) | $ | (29,480 | ) | |||||
Basic and diluted loss per common share: | |||||||||||||||||
Net loss | $ | (10,159 | ) | $ | (8,954 | ) | $ | (28,835 | ) | $ | (29,486 | ) | |||||
Shares used in computing basic and diluted loss per common share | 23,678 | 14,503 | 22,106 | 14,480 | |||||||||||||
Basic and diluted loss per common share | $ | (0.43 | ) | $ | (0.62 | ) | $ | (1.30 | ) | $ | (2.04 | ) | |||||
Investor and Media Inquiries:Maeve ConneightonArgot Partners212-600-1902
Dan SwisherSunesis Pharmaceuticals Inc.650-266-3715
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