Sunesis Pharmaceuticals Reports First Quarter 2017 Financial Results and Recent Highlights
“Following recent regulatory developments, our reversible non-covalent BTK inhibitor, SNS-062, is the central focus of our development efforts and resources,” said
Mr. Swisher continued, “With regard to vosaroxin, we plan to continue to advance its development through investigator-sponsored group trials, and will carefully assess business development alternatives to support any future registration-directed studies. We expect that our current cash resources are sufficient to fund the company into June 2018.”
First Quarter 2017 and Recent Highlights
- Announced Withdrawal of Marketing Authorization Application (MAA) for Vosaroxin in
Europeand Shifted Primary Development Focus to Non-Covalent Reversible BTK Inhibitor SNS-062. On May 1st, Sunesis announced the withdrawal of its European Marketing Authorization Application (MAA) for vosaroxin as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. The decision followed recent interactions with the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP), during which the Company made an assessment based on feedback from its rapporteurs and input from its regulatory consultants that the committee was likely to formally adopt a negative opinion and a withdrawal of its application was the best option at this time. The Company also announced its plans to reduce its investment in its AML program and shift an increasing portion of resources to the Company’s kinase inhibitor pipeline, with an emphasis on timely prosecution of SNS-062.
ProgressToward Initiation of a Phase 1b/2 Trial of Non-Covalent Reversible BTK Inhibitor SNS-062 in Patients with B-Cell Malignancies. Sunesis continues to make progress toward the initiation of treatment in a Phase 1b/2 Trial evaluating its unique, proprietary, non-covalent reversible BTK-inhibitor SNS-062 in patients with B-cell malignancies. The Company has activated multiple clinical sites across the U.S., including at U.C. Irvine Cancer Centerand The Ohio State UniversityComprehensive Cancer Center. These sites are beginning to actively identify patients. An additional three top U.S. centers, Dana-Faber Cancer Institute, MD Anderson Cancer Centerand Weill Cornell Cancer Center, expected to be initiated this quarter. Sunesis expects to announce the dosing of the first patient this quarter.
- Announced Poster Presentation on BTK Inhibitor SNS-062 at the AACR Annual Meeting. In March, Sunesis announced a poster presentation at the
American Association for Cancer Research2017 Annual Meeting. The poster, titled “SNS-062 demonstrates efficacy in chronic lymphocytic leukemia in vitro and inhibits C481S mutated Bruton tyrosine kinase” detailed results from The Ohio State University-sponsored preclinical study, conducted in collaboration with Sunesis, that examined the potency of SNS-062 versus ibrutinib and acalabrutinib, specifically relating to the C481S mutation.
Progressin Ongoing Investigator-Sponsored Studies Evaluating Vosaroxin in Patients with Acute Myeloid Leukemia (AML). Sunesis announced today that the Vanderbilt Universitysponsored VITAL (Vosaroxin and Infusional Cytarabine for Frontline Treatment of Acute Myeloid Leukemia) study of vosaroxin in combination with cytarabine in patients with previously untreated AML has progressed from Stage 1 to Stage 2. The single-arm, open-label trial enrolled 17 patients in Stage 1 and, following a one-time interim analysis by the Data Safety Monitoring Board of responses exceeding a pre-defined efficacy threshold, is now proceeding to enrollment in Stage 2. In this stage, the trial will enroll at least 24 additional patients. The study is being expanded to four additional sites including Yale University, UCLA, Medical University of South Carolinaand University of Alabama.
Sunesis also announced today that vosaroxin has been selected as a treatment arm in the Phase 2/3 BIG-1 (Backbone InterGroup-1) trial. BIG-1 is an open label, multicenter phase 2/3 study with multiple randomization phases at different stages of AML treatment that is designed to improve overall survival in younger patients (18 to 60 years). The vosaroxin portion of the trial, which is expected to begin dosing imminently, will enroll up to 200 patients with favorable or intermediate risk AML, who will receive consolidation therapy of intermediate dose cytarabine with vosaroxin. The study is being conducted at multiple French centers, led by the
University Hospitalof Angers under the direction of Professor Norbert Ifrah, and the University Institute of Hematologyat the Hôpital Saint-Louisunder the direction of Professor Hervé Dombret.
- Announced Organizational Updates. In March, Sunesis announced two management additions: Judy Fox Ph.D. to the position of Chief Scientific Officer and
Pietro Taverna, Ph.D. to Executive Director, Translational Medicine. In April, Eric Bjerkholt resigned from his position of Chief Financial Officer. Dan Swisher, our Chief Executive Officer, has assumed the CFO responsibilities on an interim basis.
- Cash, cash equivalents and marketable securities totaled
$35.2 millionas of March 31, 2017, as compared to $42.6 millionas of December 31, 2016. The decrease of $7.4 millionwas primarily due to $9.7 millionof net cash used in operating activities offset by $2.2 millionfrom 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 June 2018.
- Revenue for the three months ended
March 31, 2017was $0.7 million, as compared to $0.6 millionfor the same period on 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
$6.2 millionfor the three months ended March 31, 2017and for the same period in 2016, primarily relating to the vosaroxin development program in each period.
- General and administrative expense was
$3.9 millionfor the three months ended March 31, 2017as compared to $4.3 millionfor the same period in 2016. The decrease of $0.4 million in 2016 was primarily due to decrease in personnel expenses and commercial expenses.
- Interest expense was
$0.5 millionfor the three months ended March 31, 2017as compared to $0.3 million and for the same period in 2016. The increase in the 2017 period was primarily due to the increase in the notes payable.
- Net other income was
$0.1 millionfor the three months ended March 31, 2017and for the same period in 2016. The other income was primarily comprised of interest income from the short-term investments.
- Cash used in operating activities was
$9.7 millionfor the three months ended March 31, 2017, as compared to $10.7 million for the same period in 2016. 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
$9.4 millionfor the three months ended March 31, 2017, as compared to $9.9 millionfor the same period in 2016. Net loss was $9.8 millionfor the three months ended March 31, 2017, as compared to $10.1 millionfor the same period in 2016.
Conference Call Information
Sunesis will host a conference today at
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly-experienced cancer drug development organization committed to improving the lives of people with cancer. Currently, the company is focused on advancing its novel kinase-inhibitor pipeline, which includes its proprietary reversible non-covalent BTK-inhibitor, SNS-062.
For additional information on Sunesis, please visit http://www.sunesis.com.
SUNESIS and the logos are trademarks of Sunesis Pharmaceuticals, Inc.
This press release contains forward-looking statements, including statements related to the continued development and commercialization of vosaroxin, the timing of our Phase 1b/2 trial of SNS-062, and the sufficiency of Sunesis’ cash and funding into
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED BALANCE SHEETS|
|March 31,||December 31,|
|Cash and cash equivalents||$||11,470||$||8,056|
|Prepaids and other current assets||714||643|
|Total current assets||35,890||43,231|
|Property and equipment, net||1||3|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accrued clinical expense||1,351||1,434|
|Other accrued liabilities||1,782||1,691|
|Current portion of deferred revenue||-||610|
|Current portion of notes payable||4,583||3,333|
|Total current liabilities||11,418||10,939|
|Non-current portion of notes payable||9,930||11,102|
|Other accrued liabilities||226||169|
|Additional paid-in capital||602,755||599,632|
|Accumulated other comprehensive income (loss)||(18||)||(22||)|
|Total stockholders’ equity||14,317||21,024|
|Total liabilities and stockholders’ equity||35,891||43,234|
|Note 1: The consolidated balance sheet as of December 31, 2016 has been derived from the audited financial statements as of that date included in the Company's Annual Report on Form 10-K for the year ended December 31, 2016.|
|SUNESIS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|AND COMPREHENSIVE LOSS|
|(In thousands, except per share amounts)|
|Three months ended
|License and other revenue||$||669||$||640|
|Research and development||6,162||6,209|
|General and administrative||3,942||4,295|
|Total operating expenses||10,104||10,504|
|Loss from operations||(9,435||)||(9,864||)|
|Other income (expense), net||85||76|
|Unrealized gain (loss) on available-for-sale securities||4||13|
|Basic and diluted loss per common share:|
|Shares used in computing basic and diluted loss per common share||21,029||14,443|
|Basic and diluted loss per common share||$||(0.47||)||$||(0.70||)|
Investor and Media Inquiries:
Maeve Conneighton Argot Partners212-600-1902 Dan Swisher Sunesis Pharmaceuticals Inc.650-266-3715