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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 |
“We concluded 2019 having made solid progress across our portfolio. Vecabrutinib, our non-covalent BTK inhibitor, demonstrated a very favorable safety profile combined with evidence of clinical activity in patients with and without BTK C481-mutations. We continue to advance and characterize our proprietary PDK1 inhibitor, SNS-510, with findings supporting development in both hematologic and solid tumors. We are also building value in our product pipeline through partnerships. In December, we partnered vosaroxin with Denovo Biopharma and TAK-580 with DOT Therapeutics-1 to advance these programs to the market,” said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. “Looking ahead, we remain on track to complete the Phase 1b dose escalation component of our Phase 1b/2 vecabrutinib trial in the second quarter and to advance SNS-510 to an IND by the end of year.”
Vecabrutinib Phase 1b/2 Clinical Update. Since the presentation of clinical data through cohort 5 at ASH in December 2019, Sunesis has enrolled patients in cohorts 6 and 7 of the ongoing Phase 1b/2 trial of vecabrutinib.
SNS-510, first-in-class PDK1 inhibitor. In October, at the 2019 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Sunesis presented data profiling the oral PDK1 inhibitor SNS-510 showing potent activity in hematologic and solid tumor cancer models. New results of in vitro combination studies indicate that SNS-510 can combine synergistically with several drugs including inhibitors of CDK4/6, KRAS G12C, and BCL2. The IND-enabling program is progressing as planned and an IND filing is targeted for the end of 2020. Partnering TAK-580 and vosaroxin. In December, Sunesis consented to Takeda Oncology’s assignment of our agreement relating to the pan-Raf inhibitor TAK-580 to DOT Therapeutics-1, Inc. (“DOT-1”). Coincident with the transaction, Sunesis and DOT-1 entered into a new agreement covering TAK-580 and DOT-1 paid Sunesis an upfront fee of $2.0 million. Under the new TAK-580 agreement, DOT-1 agreed to pay Sunesis up to $57.0 million in pre-commercialization milestone payments, plus royalties on future sales of TAK-580. Also in December, Sunesis licensed vosaroxin to Denovo Biopharma LLC (“Denovo”). Sunesis received a $0.2 million upfront payment and is eligible to receive up to $57.0 million in regulatory and commercial milestones, plus double-digit royalties on future sales of vosaroxin.
Financial Highlights
Conference Call Information
Sunesis will host a conference call 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 2388763. 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, including its oral non-covalent BTK inhibitor vecabrutinib and first-in-class PDK1 inhibitor SNS-510. 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 and results of the Phase 1b/2 trial of vecabrutinib and the therapeutic potential of vecabrutinib, further development and potential of its kinase inhibitor pipeline, including the timing of the potential IND filing for SNS-510, its ability to receive potential milestone or royalty payments under license and collaboration agreements and the timing of receipt of those payments, 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' Annual Report on Form 10-K for the year ended December 31, 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.
Investor and Media Inquiries: | |
Maeve Conneighton Argot Partners 212-600-1902 | Willie Quinn Sunesis Pharmaceuticals Inc. 650-266-3716 |
SUNESIS PHARMACEUTICALS, INC. | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||
AND COMPREHENSIVE LOSS | ||||||||||||||||
(In thousands, except per share amounts) | ||||||||||||||||
Three months ended December 31, | Twelve months ended December 31, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
(Unaudited) | (Unaudited) | (Unaudited) | (1) | |||||||||||||
Revenue: | ||||||||||||||||
License and other revenue | $ | 2,073 | $ | - | $ | 2,073 | $ | 237 | ||||||||
Total revenues | 2,073 | - | 2,073 | 237 | ||||||||||||
Operating expenses: | ||||||||||||||||
Research and development | 4,947 | 3,301 | 15,412 | 14,615 | ||||||||||||
General and administrative | 2,480 | 2,459 | 9,949 | 11,332 | ||||||||||||
Total operating expenses | 7,427 | 5,760 | 25,361 | 25,947 | ||||||||||||
Loss from operations | (5,354 | ) | (5,760 | ) | (23,288 | ) | (25,710 | ) | ||||||||
Interest expense | (71 | ) | (295 | ) | (514 | ) | (1,154 | ) | ||||||||
Other income, net | 138 | 58 | 472 | 249 | ||||||||||||
Net loss | (5,287 | ) | (5,997 | ) | (23,330 | ) | (26,615 | ) | ||||||||
Unrealized gain on available-for-sale securities | 1 | - | 1 | 7 | ||||||||||||
Comprehensive loss | $ | (5,286 | ) | $ | (5,997 | ) | $ | (23,329 | ) | $ | (26,608 | ) | ||||
Basic and diluted loss per common share: | ||||||||||||||||
Net loss | $ | (5,287 | ) | $ | (5,997 | ) | $ | (23,330 | ) | $ | (26,615 | ) | ||||
Shares used in computing basic and diluted loss per common share | 111,343 | 37,438 | 87,129 | 35,582 | ||||||||||||
Basic and diluted loss per common share | $ | (0.05 | ) | $ | (0.16 | ) | $ | (0.27 | ) | $ | (0.75 | ) | ||||
Note 1: The consolidated statement of operations and comprehensive loss for the year ended 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. | ||||||||||||||||
SUNESIS PHARMACEUTICALS, INC. | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
(In thousands) | |||||||
December 31, | December 31, | ||||||
2019 | 2018 | ||||||
(Unaudited) | (2) | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 12,761 | $ | 13,696 | |||
Restricted cash | 5,500 | - | |||||
Marketable securities | 16,364 | - | |||||
Prepaids and other current assets | 1,697 | 1,504 | |||||
Total current assets | 36,322 | 15,200 | |||||
Property and equipment, net | 3 | 11 | |||||
Operating lease right-of-use asset | 817 | - | |||||
Deposits and other assets | 98 | 113 | |||||
Total assets | $ | 37,240 | $ | 15,324 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 791 | $ | 1,393 | |||
Accrued clinical expense | 521 | 500 | |||||
Accrued compensation | 985 | 943 | |||||
Other accrued liabilities | 1,109 | 1,091 | |||||
Notes payable | 5,465 | 7,396 | |||||
Operating lease liability - current | 545 | - | |||||
Total current liabilities | 9,416 | 11,323 | |||||
Other liabilities | 9 | 8 | |||||
Operating lease liability - long term | 272 | - | |||||
Total liabilities | 9,697 | 11,331 | |||||
Stockholders’ equity: | |||||||
Convertible preferred stock | 11,769 | 20,998 | |||||
Common stock | 11 | 4 | |||||
Additional paid-in capital | 698,562 | 642,460 | |||||
Accumulated other comprehensive income | 1 | - | |||||
Accumulated deficit | (682,800 | ) | (659,469 | ) | |||
Total stockholders’ equity | 27,543 | 3,993 | |||||
Total liabilities and stockholders’ equity | $ | 37,240 | $ | 15,324 | |||
Note 2: 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. | |||||||
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