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Phase 1b/2 Trial of Vecabrutinib in 400 mg Cohort; Clinical Update at Upcoming ASH Annual Meeting
Sunesis to Host Conference Call Today at 4:30 PM Eastern Time
SOUTH SAN FRANCISCO, Calif., Nov. 12, 2019 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the quarter ended September 30, 2019. Loss from operations for the three and nine months ended September 30, 2019 was $6.0 million and $17.9 million. As of September 30, 2019, the Company had cash and cash equivalents, restricted cash and marketable securities of $38.3 million.
“We continue to advance our Phase 1b/2 trial of vecabrutinib in patients with B-cell malignancies with the goal of identifying our recommended dose and studying vecabrutinib in defined patient populations in the Phase 2 portion of the study. We are currently in the 400mg cohort as the safety and pharmacokinetic data to date support continued dose escalation,” said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. “As announced last week, we will be presenting a poster at the ASH Annual Meeting in December that provides an update on the Phase 1b/2 trial of vecabrutinib, and we look forward to sharing the new findings. We also recently presented exciting preclinical pharmacology data for our first-in-class PDK1 inhibitor, SNS-510, at the AACR-NCI-EORTC conference. The equity offering we completed in July strengthened our cash position and extends our runway through key milestones for the Company.”
Recent Highlights
Financial Highlights
Conference Call Information
Sunesis will host a conference today at 4:30 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 4059849. 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 developing novel targeted inhibitors for the treatment of hematologic and solid cancers. Sunesis has built an experienced 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 its oral non-covalent BTK inhibitor vecabrutinib. Vecabrutinib is currently being evaluated in a Phase 1b/2 study in adults with chronic lymphocytic leukemia and other B-cell malignancies that have progressed after prior therapies.
For additional information on Sunesis, please visit www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
Forward-Looking Statements
This press release contains forward-looking statements, including statements related to Sunesis’ continued development of vecabrutinib, including the timing of Phase 1b/2 trial of vecabrutinib and the therapeutic potential of vecabrutinib, further development and potential of its kinase inhibitor pipeline, and sufficiency of its cash resources and financial position. Words such as “expect,” “will,” “look forward,” 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. These and other risk factors are discussed under "Risk Factors" in Sunesis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 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. | |||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||||
AND COMPREHENSIVE LOSS | |||||||||||||||||
(In thousands, except per share amounts) | |||||||||||||||||
Three months ended September 30, |
Nine months ended September 30, |
||||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||||
(Unaudited) | (Unaudited) | ||||||||||||||||
Revenue: | |||||||||||||||||
License and other revenue | $ | - | $ | - | $ | - | $ | 237 | |||||||||
Total revenues | - | - | - | 237 | |||||||||||||
Operating expenses: | |||||||||||||||||
Research and development | 3,534 | 3,587 | 10,465 | 11,314 | |||||||||||||
General and administrative | 2,507 | 2,690 | 7,469 | 8,873 | |||||||||||||
Total operating expenses | 6,041 | 6,277 | 17,934 | 20,187 | |||||||||||||
Loss from operations | (6,041 | ) | (6,277 | ) | (17,934 | ) | (19,950 | ) | |||||||||
Interest expense | (71 | ) | (291 | ) | (443 | ) | (859 | ) | |||||||||
Other income, net | 170 | 63 | 334 | 191 | |||||||||||||
Net loss | (5,942 | ) | (6,505 | ) | (18,043 | ) | (20,618 | ) | |||||||||
Unrealized gain on available-for-sale securities | - | 1 | - | 7 | |||||||||||||
Comprehensive loss | $ | (5,942 | ) | $ | (6,504 | ) | $ | (18,043 | ) | $ | (20,611 | ) | |||||
Basic and diluted loss per common share: | |||||||||||||||||
Net loss | $ | (5,942 | ) | $ | (6,505 | ) | $ | (18,043 | ) | $ | (20,618 | ) | |||||
Shares used in computing basic and diluted loss per common share | 105,070 | 36,095 | 78,969 | 34,956 | |||||||||||||
Basic and diluted loss per common share | $ | (0.06 | ) | $ | (0.18 | ) | $ | (0.23 | ) | $ | (0.59 | ) |
SUNESIS PHARMACEUTICALS, INC. | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands) | ||||||||
September 30,
|
December 31, | |||||||
2019 | 2018 | |||||||
(Unaudited) | (1 ) | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 19,733 | $ | 13,696 | ||||
Restricted cash | 5,500 | - | ||||||
Marketable securities | 13,080 | - | ||||||
Prepaids and other current assets | 2,236 | 1,504 | ||||||
Total current assets | 40,549 | 15,200 | ||||||
Property and equipment, net | 5 | 11 | ||||||
Operating lease right-of-use asset | 954 | - | ||||||
Deposits and other assets | 102 | 113 | ||||||
Total assets | $ | 41,610 | $ | 15,324 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 770 | $ | 1,393 | ||||
Accrued clinical expense | 544 | 500 | ||||||
Accrued compensation | 1,177 | 943 | ||||||
Other accrued liabilities | 398 | 1,091 | ||||||
Notes payable | 5,460 | 7,396 | ||||||
Operating lease liability - current | 545 | - | ||||||
Total current liabilities | 8,894 | 11,323 | ||||||
Other liabilities | 13 | 8 | ||||||
Operating lease liability - long term | 409 | - | ||||||
Total liabilities | 9,316 | 11,331 | ||||||
Stockholders’ equity: | ||||||||
Convertible preferred stock | 11,763 | 20,998 | ||||||
Common stock | 11 | 4 | ||||||
Additional paid-in capital | 698,032 | 642,460 | ||||||
Accumulated deficit | (677,512 | ) | (659,469 | ) | ||||
Total stockholders’ equity | 32,294 | 3,993 | ||||||
Total liabilities and stockholders’ equity | $ | 41,610 | $ | 15,324 | ||||
Note 1: The consolidated balance sheet as of December 31, 2018 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, 2018. |
Investor and Media Inquiries: Maeve Conneighton Argot Partners 212-600-1902 |
Willie Quinn Sunesis Pharmaceuticals Inc. 650-266-3716 |