Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2018 Financial Results and Recent Highlights
“We began 2019 by announcing the move into the 100 mg cohort for our Phase 1b/2 trial of vecabrutinib, an important milestone as we continue to believe that 100 – 300 mg will be the potentially therapeutic dose levels,” said
- Announced Advancement into 100mg Cohort. In
January 2019, the Company announced that it had opened the 100 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.
The latest protocol amendment, approved by most sites in
February 2019, allows for upfront enrollment of up to 6 evaluable patients into a cohort, and we have taken advantage of this to allocate additional slots for the 100mg cohort. By studying more patients and collecting more data, we can better characterize vecabrutinib’s profile at this dose level.
- Completion of
$20 MillionFinancing. In January, Sunesis announced the completion of an equity financing with net proceeds of approximately $18.4 million. The financing attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as we explore the potentially active dose levels.
- Presentation of Preliminary Data at the ASH Annual Meeting. In
December 2018, Sunesis presented preliminary data from the Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.
- Cash and cash equivalents totaled
$13.7 millionas of December 31, 2018, as compared to $31.8 millionas of December 31, 2017. The decrease of $18.1 millionwas primarily due to $24.4 millionof net cash used in operating activities, partially offset by $6.3 millionin net proceeds from issuance of common stock.
- Revenue was
$0.2 millionin 2018 as compared to $0.7 millionin 2017, primarily due to deferred revenue related to the Royalty Agreement with RPI Finance Trust, which was fully amortized to revenue in March 2017.
- Research and development expense was
$3.3 millionand $14.6 millionfor the three months and year ended December 31, 2018, as compared to $3.7 millionand $21.5 millionfor the same periods in 2017. The decreases in 2018 were primarily due to the 2017 $2.5 millionBiogen payment, a $2.8 milliondecrease in professional services related to the 2017 vosaroxin regulatory filing with the European Medicines Agency, and a $1.8 milliondecrease in salary and related expenses, partially offset by an increase in clinical expenses of $0.5 millionfor work related to the development of vecabrutinib.
- General and administrative expense was
$2.5 millionand $11.3 millionfor the three months and year ended December 31, 2018, as compared to $2.8 millionand $13.5 millionfor the same periods in 2017. The decreases in 2018 were primarily due to a $1.4 milliondecrease in professional services, a $0.5 milliondecrease in salary and related expenses, and a $0.3 milliondecrease in vosaroxin commercial expenses.
- Interest expense was
$0.3 millionand $1.2 millionfor the three months and year ended December 31, 2018, as compared to $0.3 millionand $1.4 millionfor the same periods in 2017. The decrease in 2018 was primarily due to the decrease in the outstanding notes payable.
- Cash used in operating activities was
$24.4 millionfor the year ended December 31, 2018, as compared to $36.1 millionfor the same period in 2017. Net cash used in operating activities in 2018 resulted primarily from the net loss of $26.6 millionand changes in operating assets and liabilities of $0.6 million, offset by net adjustments for non-cash items of $2.8 million.
- Loss from operations was
$5.8 millionand $25.7 millionfor the three months and year ended December 31, 2018, as compared to $6.4 millionand $34.4 millionfor the same periods in 2017. Net loss was $6.0 millionand $26.6 millionfor the three months and year ended December 31, 2018, as compared to $6.6 millionand $35.5 millionfor the same periods in 2017.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company developing new targeted therapeutics 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. The Company’s proprietary PDK1 inhibitor SNS-510 is in preclinical development. 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. Sunesis is exploring strategic alternatives for vosaroxin, a late-stage investigational product for relapsed or refractory AML. Sunesis also has an interest in the pan-RAF inhibitor TAK-580 which is licensed to Takeda. TAK-580 is in a clinical trial for pediatric low-grade glioma.
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 Sunesis’ cash sufficiency forecast, the continued development of vecabrutinib (SNS-062), 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 planned development of SNS-510 and TAK-580. Words such as “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 the vecabrutinib Phase 1b/2 trial, the risk that Sunesis' clinical or preclinical studies for vecabrutinib, 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 vecabrutinib or SNS-510 could be otherwise halted or significantly delayed for various reasons, that Sunesis may not be able to receive regulatory approval of vecabrutinib, or SNS-510 in the U.S. or
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|Twelve months ended
|License and other revenue||$||—||$||—||$||237||$||669|
|Research and development||3,301||3,674||14,615||21,540|
|General and administrative||2,459||2,760||11,332||13,548|
|Total operating expenses||5,760||6,434||25,947||35,088|
|Loss from operations||(5,760||)||(6,434||)||(25,710||)||(34,419||)|
|Other income, net||58||91||249||357|
|Unrealized gain (loss) on available-for-sale securities||—||(6||)||7||15|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||37,438||31,667||35,582||24,516|
|Basic and diluted loss per common share||$||(0.16||)||$||(0.21||)||$||(0.75||)||$||(1.45||)|
Note 1: The consolidated statement of operations and comprehensive loss for the year ended
|SUNESIS PHARMACEUTICALS, INC.|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|December 31,||December 31,|
|Cash and cash equivalents||$||13,696||$||26,977|
|Prepaids and other current assets||1,504||1,183|
|Total current assets||15,200||32,933|
|Property and equipment, net||11||20|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||500||767|
|Other accrued liabilities||1,091||1,570|
|Total current liabilities||11,323||12,678|
|Additional paid-in capital||642,460||633,436|
|Accumulated other comprehensive loss||—||(7||)|
|Total stockholders’ equity||3,993||21,544|
|Total liabilities and stockholders’ equity||$||15,324||$||34,334|
|Note 2: The consolidated balance sheet as of December 31, 2017 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, 2017.|
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