Actionable news
0
All posts from Actionable news
Actionable news in SNSS: Sunesis Pharmaceuticals, Inc.,

Sunesis: Investor And Media Inquiries David Pitts Argot Partners

The following excerpt is from the company's SEC filing.

212-600-1902

Sunesis Pharmaceuticals Inc.

650-266-3717

Sunesis Pharmaceuticals Reports Third Quarter 2015 Financial Results and Recent Highlights

SOUTH SAN FRANCISCO, Calif., November 5, 2015

Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the third quarter ended September 30, 2015. Loss from operations for the three and nine months ended September 30, 2015 was $8.6 million and $28.0 million, respectively. As of September 30, 2015, cash, cash equivale nts and marketable securities totaled $30.5 million.

We continue to work diligently to complete and submit an MAA by year end for approval of vosaroxin in Europe as a treatment for AML, said Daniel Swisher, Chief Executive Officer of Sunesis. We believe the European market opportunity is significant, and remain encouraged by the strong support from within the international AML investigator community to bring this important new therapy to a patient population that has seen little improvement in treatment standards in the last 40 years. While this effort remains our central priority, we are also carefully evaluating and refining our plans to gain marketing approval in the U.S., and working toward key milestones with our kinase inhibitor pipeline, including data at the upcoming AACR-NCI-EORTC Conference followed by an upcoming CTA filing and Phase 1 study for SNS-062 in Europe.

Third Quarter 2015 Highlights

Received European regulatory guidance regarding potential marketing authorization application for Vosaroxin in AML and Announced Expected Submission of MAA Filing before Year End.

In July 2015, Sunesis announced that, following pre-submission advisory meetings to discuss the potential submission of a Marketing Authorization Application (MAA) for vosaroxin in Europe, the company is proceeding with an MAA filing. The MAA will focus on the indication of relapsed/refractory acute myeloid leukemia (AML) in patients age 60 years and older, a population with the greatest medical need and for whom the greatest benefit was observed in the vosaroxin/cytarabine treatment arm of VALOR, the companys pivotal Phase 3 study of vosaroxin in adult patients with relapsed or refractory AML. In October, the company confirmed that it intends to submit an MAA for vosaroxin by the end of 2015.

Announced Poster Presentation of VALOR Responder Survival Analysis at the Chemotherapy Foundation Symposium.

Yesterday, Sunesis announced that results from a responder survival analysis of the VALOR trial were presented in a poster presentation at the 2015 Chemotherapy Foundation Symposium (CFS) in New York City. The analysis examined the impact of complete remission status on overall survival. Results showed that CR status was the strongest independent predictor of overall survival in patients enrolled in the study, regardless of study arm, with median survival for patients in CR lasting more than 12 months longer than patients without a CR. Furthermore, the addition of vosaroxin to cytarabine demonstrated a two-fold increase in CR rate by day 60. The CR benefit conveyed by vosaroxin was consistently beneficial across all pre-specified subgroups, including in patients with the high unmet medical need, such as those over 60 years of age and those with refractory or relapsed disease. The poster presentation, titled Impact of Complete Remission on Overall Survival in Patients with Refractory/Relapsed Acute Myeloid Leukemia Treated with Vosaroxin Plus Cytarabine or Placebo Plus Cytarabine: Responder Analysis for the Phase 3 VALOR Trial, will be available at www.sunesis.com following the conclusion of the symposium.

Announced Presentations at the Upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

Sunesis recently announced that two poster presentations from the companys proprietary kinase inhibitor programs will be presented at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place November 5-9 in Boston, Massachusetts. The presentations on November 8th will include preclinical data from the companys selective PDK1 inhibitors SNS-229 and SNS-510, as well as the companys potent noncovalent second-generation BTK inhibitor, SNS-062.

Announced Oral Presentation of VALOR Analysis at the 77th Annual Meeting of the Japanese Society of Hematology.

In October, Sunesis announced that data from an analysis of the companys VALOR trial, evaluating vosaroxin in older patients with AML, were presented at the AML Clinical Trial Oral Session of the 77th Annual Meeting of the Japanese Society of Hematology (JSH) in Kanazawa, Japan. The data presented at JSH, which show a compelling survival benefit, durable responses and tolerability profile in patients age 60 years...


More