On March 9, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the fourth quarter and year ended December 31, 2016 (Press release, Sunesis, MAR 9, 2017, View Source [SID1234518055]). Loss from operations for the three months and year ended December 31, 2016 was $8.1 million and $36.5 million, respectively. As of December 31, 2016, cash, cash equivalents and marketable securities totaled $42.6 million. Schedule your 30 min Free 1stOncology Demo! "We are making meaningful progress in advancing our two lead programs, vosaroxin and SNS-062, in areas of unmet need in hematologic malignancies," said Daniel Swisher, Chief Executive Officer of Sunesis. "Our European Marketing Authorization Application is on track; we are working diligently to submit responses this quarter to the Day 180 List of Outstanding Issues and we are preparing to go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April, culminating in a likely CHMP decision by mid-year. We continue, in parallel, to advance active dialogues with potential pharma collaborators toward the goal of supporting a potential market launch of vosaroxin in Europe in the second half of this year."
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Mr. Swisher continued, "Our BTK inhibitor program is advancing as planned. The IND for SNS-062 is now active and we expect to initiate a Phase 1B/2 study in patients with advanced B-cell malignancies in the second quarter. We were encouraged by the data from the Phase 1A Healthy Volunteer study and the level of interest generated at our ASH (Free ASH Whitepaper) 2016 presentation."
Fourth Quarter 2016 and Recent Highlights
Continued Progress with the Marketing Authorization Application (MAA) for Vosaroxin in Europe. In January, Sunesis announced that it had received the Day 180 List of Outstanding Issues from the European Medicines Agency (EMA), issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process. The Company plans to submit its response to the list by the end of the first quarter. In addition, the Company announced that it will go before the Scientific Advisory Group’s Oncology Division (SAG-O) in April, which will assist the CHMP in its evaluation of the MAA. Sunesis anticipates an approval decision on vosaroxin by mid-year.
Announced Active IND for SNS-062 and Trial Initiation Plans in Phase 1B/2 Study in Patients with Advanced B-Cell Malignancies. In January, Sunesis announced that its Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) was active, supporting the initiation of a Phase 1B/2 study to assess the candidate’s safety and efficacy in patients with advanced B-cell malignancies after prior ibrutinib exposure, including in patients with C481S mutations. Phase 1A of the study examined the safety, pharmacodynamics, and pharmacokinetics of SNS-062 and was completed during the fourth quarter of 2016, and the Company plans to begin dosing patients in the Phase 1B/2 study within the first half of 2017.
Announced Poster Presentation on BTK Inhibitor SNS-062 at the AACR (Free AACR Whitepaper) Annual Meeting. Today, Sunesis announced a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2017 Annual Meeting to be held April 1-5 in Washington, D.C. The poster, titled "SNS-062 demonstrates efficacy in chronic lymphocytic leukemia in vitro and inhibits C481S mutated Bruton tyrosine kinase" (Poster Number 22, Abstract Number 1207, Convention Center, Halls A-C, Poster Section 6), details results from an Ohio State University-sponsored preclinical study, conducted in collaboration with Sunesis, that examines the potency of SNS-062 versus ibrutinib and acalabrutinib, specifically relating to the C481S mutation. The results will be presented in a session titled "Reversal of Drug Resistance" on Monday, April 3, 2017 from 8:00 AM to 12:00 PM Eastern Time.
Presentation of Updated Results from the VALOR Trial Evaluating Vosaroxin in AML and Completed Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK Inhibitor SNS-062 at ASH (Free ASH Whitepaper) Annual Meeting. In December 2016, Sunesis presented updated results from the VALOR Trial examining overall survival in patients age 60 years and older with relapsed/refractory acute myeloid leukemia (AML), as well results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent reversible BTK inhibitor SNS-062 at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in San Diego, California. The oral presentation, titled "Durable Overall Survival Benefit in Patients ≥ 60 Years with Relapsed or Refractory AML Treated with Vosaroxin/Cytarabine Vs Placebo/Cytarabine: Updated Results from the Valor Trial" and the poster titled "First-in-Human Phase 1a Study of the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton’s Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects," are available on the Sunesis website at www.sunesis.com.
Completion of $25.9 million Financing. In October, Sunesis announced the completion of an equity financing with net proceeds of $25.9 million. The financing attracted participation from leading biotechnology investors.
Announced Organizational Updates. Today, 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. Dr. Fox brings over 25 years of experience both as a scientist and program leader at leading life science companies. At Sunesis, she and her team will develop and implement strategic research roadmaps to support the advancement of Sunesis’ product portfolio. She obtained her Ph.D. in Biological Chemistry from M.I.T. Pietro Taverna, Ph.D. returns to Sunesis from Astex/Otsuka Pharmaceuticals, where he led the Translational Pharmacology department and was responsible for biomarker strategy and the translation of research insights into optimal clinical development. He holds a Ph.D. from M. Negri Institute for Pharmacological Research in Milan. Additionally, Jennifer Troia was promoted to Vice President, Human Resources. Jennifer brings over 25 years of related HR experience, including at Gilead Sciences, COR Therapeutics, CoMentis and Sunesis.
Financial Highlights
Cash, cash equivalents and marketable securities totaled $42.6 million as of December 31, 2016, as compared to $46.4 million as of December 31, 2015. The decrease of $3.8 million was primarily due to $37 million of net cash used in operating activities and $7.2 million of final payments against notes payable and $0.8 million of principal payments against notes payable, partially offset by net proceeds of $25.9 million from the underwritten offering and $14.8 million in net loan proceeds, and $0.3 million from the sale of our common stock through the Sales Agreement with Cantor and exercise of stock options.
Revenues for the three months and year ended December 31, 2016 were $0.7 million and $2.5 million, as compared to $0.7 million and $3.1 million for the same periods in 2015. The decrease between the periods was primarily due to the extension of the amortization period of our deferred revenue.
Research and development expenses were $4.8 million and $22.9 million for the three months and year ended December 31, 2016, as compared to $7.6 million and $23.7 million for the same periods in 2015. The decrease of $0.8 million in 2016 was primarily due to a decrease of $2.2 million in personnel costs partially offset by increases in professional services, clinical trials and medical affairs expenses.
General and administrative expenses for the three months and year ended December 31, 2016 were $3.9 million and $16 million, as compared to $4.4 million and $18.7 million for the same periods in 2015. The decrease of $2.6 million in 2016 was primarily due to decrease in professional services and personnel costs.
Interest expense was $0.5 million and $1.7 million for the three months and year ended December 31, 2016, as compared to $0.2 million and $0.9 million for the same periods in 2015. The increases in the 2016 periods were primarily due to the increase in the notes payable.
Net other income was $0.2 million in 2016 as compared to $3.6 million in 2015. The 2015 amount was primarily comprised of net non-cash credit for the revaluation of warrants issued in the 2010 Offering.
Cash used in operating activities was $37.0 million for the year ended December 31, 2016, as compared to $38.7 for the same period in 2015. Net cash used in operating activities in 2016 resulted primarily from the net loss of $38.0 million and net adjustment for the non-cash items of $5.2 million offset by changes in operating assets and liabilities of $4.1 million (including $2.4 million related to recognition of deferred revenue under the Royalty Agreement).
Sunesis reported loss from operations of $8.1 million and $36.5 million for the three months and year ended December 31, 2016, as compared to $11.3 million and $39.3 million for the same periods in 2015. Net loss was $8.5 million and $38.0 million for the three months and year ended December 31, 2016, as compared to $11.6 million and $36.7 million for the same periods in 2015.