Sunesis Pharmaceuticals Reports First Quarter 2018 Financial Results and Recent Highlights
Sunesis to Host Conference Call Today at
“We remain highly focused on the execution of our Phase 1b/2 trial evaluating our lead program, the non-covalent BTK inhibitor vecabrutinib (SNS-062), to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib, the current standard of care in treating CLL,” said
- Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor Vecabrutinib (SNS-062) in Adults with Chronic Lymphocytic Leukemia (CLL) and other B-Cell Malignancies. Sunesis’ ongoing Phase 1b/2 study is evaluating the safety, pharmacokinetics, pharmacodynamics, and antitumor activity of its potent non-covalent BTK-inhibitor vecabrutinib in adults with CLL and other B cell malignancies. The Phase 1b portion of the study is an open-label, dose-escalation study with the goal of determining the recommended Phase 2 dose. The Phase 2 portion of the study will explore various cohorts of patients; current cohort concepts include ibrutinib-resistant patients with C481 mutations. The trial is enrolling patients who have relapsed/refractory B cell malignancies after at least 2 lines of standard treatment. For indications such as CLL with approved BTK inhibitors, one of those prior treatments must have been a covalent BTK inhibitor. The study is in the 50 mg cohort. Sunesis expects to reach the recommended Phase 2 dose in the fall of 2018.
- Appointed Industry Veteran H. Ward Wolff to the Board of Directors. In
February 2018, H. Ward Wolffwas appointed to the Board of Directors. Ward brings over 40 years of finance and executive leadership experience to the Board, with 20 years of experience in the life sciences sector, most recently having served as Executive Vice President and Chief Financial Officer of Sangamo Therapeutics, Inc.Mr. Wolff is also designated chairman of the company’s Audit Committee.
- Cash, cash equivalents, and marketable securities totaled
$25.4 millionas of March 31, 2018, as compared to $31.8 millionas of December 31, 2017. The decrease of $6.4 millionwas primarily due to $6.6 millionof net cash used in operating activities, partially offset by $0.2 millionin net proceeds from the exercise of stock options. This capital is expected to fund the company into early 2019.
- Revenue for the three months ended
March 31, 2018was $0.2 millionas compared to $0.7 millionfor the same period in 2017. The decrease between the periods was 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
$4.0 millionfor the three months ended March 31, 2018, as compared to $6.2 millionfor the same period in 2017, primarily relating to the vecabrutinib and the vosaroxin development program in each period. The decrease of $2.2 millionwas primarily due to $1.7 milliondecrease in professional services and clinical trials expenses related to higher expenses incurred in the first quarter of 2017 due to the preparation for EMA, and $0.3 milliondecrease in salary and personnel expenses due to lower headcounts.
- General and administrative expense was
$3.4 millionfor the three months ended March 31, 2018, as compared to $3.9 millionfor the same period in 2017. The decrease of $0.5 millionwas primarily due to $0.4 milliondecrease in professional services expenses and $0.1 milliondecrease in commercial expenses as result of higher expenses incurred in the first quarter of 2017 due to the preparation for EMA.
- Interest expense was
$0.3 millionfor the three months ended March 31, 2018, as compared to $0.5 millionfor the same period in 2017. The decrease was primarily due to the decrease in the outstanding notes payable.
- Cash used in operating activities was
$6.6 millionfor the three months ended March 31, 2018, as compared to $9.7 millionfor the same period in 2017. Net cash used in the 2018 period resulted primarily from the net loss of $7.3 millionand changes in operating assets and liabilities of $0.2 million, offset by net adjustments for non-cash items of $0.9 million. Net cash used in the 2017 period resulted primarily from the net loss of $9.8 millionand changes in operating assets and liabilities of $0.9 million, partially offset by net adjustments for non-cash items of $1.0 million.
- Sunesis reported loss from operations of
$7.1 millionfor the three months ended March 31, 2018, as compared to $9.4 millionfor the same period in 2017. Net loss was $7.3 millionfor the three months ended March 31, 2018, as compared to $9.8 millionfor the same period in 2017.
Conference Call Information
Sunesis will host a conference call today at
Sunesis is a biopharmaceutical company developing new 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 that its oral non-covalent BTK-inhibitor vecabrutinib is effective in ibrutinib-resistant chronic lymphocytic leukemia. Vecabrutinib is currently being evaluated in a Phase 1b/2 study in adults with chronic lymphocytic leukemia and other B-cell malignancies who have progressed after prior therapies. Beyond the development of vecabrutinib, the Company has two other kinase inhibitor programs, including the Takeda-partnered pan-RAF inhibitor TAK-580, which is in clinical trials for solid tumors, and Sunesis’ proprietary preclinical PDK1 inhibitor SNS-510, which is in preclinical development with an IND submission planned in 2019. 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 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. Words such as “believe,” “expect,” “look forward,” “potential,” “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.|
|CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||21,365||$||26,977|
|Prepaids and other current assets||1,480||1,183|
|Total current assets||26,878||32,933|
|Property and equipment, net||18||20|
|Deposits and other assets||96||1,381|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||570||767|
|Other accrued liabilities||1,905||1,570|
|Total current liabilities||11,627||12,678|
|Additional paid-in capital||634,528||633,436|
|Accumulated other comprehensive loss||(5||)||(7||)|
|Total stockholders’ equity||15,365||21,544|
|Total liabilities and stockholders’ equity||$||26,992||$||34,334|
|Note 1: The consolidated balance sheet as of December 31, 2017 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2017.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended|
|License and other revenue||$||237||$||669|
|Research and development||3,969||6,162|
|General and administrative||3,359||3,942|
|Total operating expenses||7,328||10,104|
|Loss from operations||(7,091||)||(9,435||)|
|Other income (expense), net||99||85|
|Unrealized gain on available-for-sale securities||2||4|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted|
|loss per common share||34,345||21,029|
|Basic and diluted loss per common share||$||(0.21||)||$||(0.47||)|
|Investor and Media Inquiries:
Sunesis Pharmaceuticals Inc.
Source: Sunesis Pharmaceuticals, Inc.