Sunesis Pharmaceuticals Reports Second Quarter 2017 Financial Results and Recent Highlights
“We have made tangible progress under our revised operating plan to focus primarily on our non-covalent BTK inhibitor, SNS-062. With the first patient being dosed, the recent initiation of our Phase 1b/2 study in patients with relapsed chronic lymphocytic leukemia (CLL) and other B-cell malignancies marks an important milestone for the company,” said
Mr. Swisher added, “As we work toward this goal, we will maintain a streamlined operation and a focused investment plan with current cash resources lasting into second quarter of 2018.”
- First Patient Dosed in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. In July, Sunesis announced that the first patient was dosed at the
Dana-Farber Cancer Institutein the Phase 1b/2 dose-escalation and cohort-expansion study evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its oral, reversible, non-covalent BTK-inhibitor, SNS-062, in adults with CLL, small lymphocytic leukemia, Waldenstrom’s macroglobulemia and mantle cell lymphoma. The Phase 1b/2 trial is an open-label, sequential-group study that will enroll up to 124 subjects and is being conducted at five leading sites in the United States.
- Cash, cash equivalents and marketable securities totaled
$22.7 millionas of June 30, 2017, as compared to $42.6 millionas of December 31, 2016. The decrease of $19.9 millionwas primarily due to $20.5 millionof net cash used in operating activities and a debt restructuring payment of $7.6 million, partially offset by $8.2 millionprimarily from sales of common stock through the company’s at the market facility. The Company expects that its current cash resources are sufficient to fund the company into the second quarter of 2018.
- Revenue for the three and six months ended
June 30, 2017was nil and $0.7 million, as compared to $0.6 millionand $1.3 millionfor the same periods in 2016. Revenue in each period was primarily due to deferred revenue recognized related to the Royalty Agreement with Royalty Pharma.
- Research and development expense was
$4.9 millionand $11.1 millionfor the three and six months ended June 30, 2017as compared to $6.6 millionand $12.8 millionfor the same periods in 2016. The decrease of $1.7 millionbetween each of the comparable periods from last year was primarily related to reduced spending on the vosaroxin program.
- General and administrative expense was
$3.7 millionand $7.6 millionfor the three and six months ended June 30, 2017, as compared to $4.0 millionand $8.3 millionfor the same periods in 2016. The decreases of $0.3 million and $0.7 millionbetween the comparable periods in 2016 were primarily due to reduced personnel and commercial expenses.
- Interest expense was
$0.3 millionand $0.8 millionfor the three and six months ended June 30, 2017, as compared to $0.5 million and $0.8 millionfor the same periods in 2016.
- Net other income was
$0.1 millionand $0.2 millionfor the three and six months ended June 30, 2017, as compared to nil and $0.1 millionfor the same periods in 2016. The other income was primarily comprised of interest income from the short-term investments.
- Cash used in operating activities was
$20.5 millionfor the six months ended June 30, 2017, as compared to $20.1 million for the same period in 2016. Net cash used in the 2017 period resulted primarily from the net loss of $18.7 millionand changes in operating assets and liabilities of $3.9 million, partially offset by net adjustments for non-cash items of $2.1 million.
- Sunesis reported loss from operations of
$8.6 millionand $18.1 millionfor the three and six months ended June 30, 2017, as compared to $10.0 millionand $19.9 millionfor the same periods in 2016. Net loss was $8.8 millionand $18.7 millionfor the three and six months ended June 30, 2017, as compared to $10.4 millionand $20.5 millionfor the same periods in 2016.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the 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 with its oral non-covalent BTK-inhibitor, SNS-062, in ibrutinib-resistant chronic lymphocytic leukemia. Sunesis also is supporting investigator-led studies of vosaroxin in acute myeloid leukemia.
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, and the sufficiency of Sunesis’ cash and funding into June 2018. Words such as “continue,” “expect,” “goal,” “look forward,” “promising,” “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 studies for SNS-062, vosaroxin 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 or vosaroxin could be otherwise halted or significantly delayed for various reasons, that Sunesis may not be able to receive regulatory approval of SNS-062 or vosaroxin 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 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 June 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|
|June 30,||December 31,|
|Cash and cash equivalents||$||11,672||$||8,056|
|Prepaids and other current assets||840||643|
|Total current assets||23,523||43,231|
|Property and equipment, net||25||3|
|Deposits and other assets||1,371|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||809||1,434|
|Other accrued liabilities||1,065||1,691|
|Current portion of deferred revenue||-||610|
|Current portion of notes payable||1,667||3,333|
|Total current liabilities||6,990||10,939|
|Non-current portion of notes payable||5,424||11,102|
|Other accrued liabilities||32||169|
|Additional paid-in capital||609,744||599,632|
|Accumulated other comprehensive income (loss)||(9||)||(22||)|
|Total stockholders’ equity||12,473||21,024|
|Total liabilities and stockholders’ equity||24,919||43,234|
|Note 1: The consolidated balance sheet as of December 31, 2016 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2016.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Six months ended
|License and other revenue||$||-||$||610||$||669||$||1,250|
|Research and development||4,941||6,606||11,103||12,815|
|General and administrative||3,671||3,997||7,613||8,292|
|Total operating expenses||8,612||10,603||18,716||21,107|
|Loss from operations||(8,612||)||(9,993||)||(18,047||)||(19,857||)|
|Other income (expense), net||114||23||199||99|
|Unrealized gain (loss) on available-for-sale securities||9||(1||)||13||12|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||21,521||14,493||21,276||14,468|
|Basic and diluted loss per common share||$||(0.41||)||$||(0.72||)||$||(0.88||)||$||(1.44||)|
Investor and Media Inquiries:
Maeve Conneighton Argot Partners212-600-1902 Dan Swisher Sunesis Pharmaceuticals Inc.650-266-3715