On November 3, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2016. Loss from operations for the three months ended September 30, 2016 was $8.5 million (Press release, Sunesis, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219049 [SID1234516331]). As of September 30, 2016, cash, cash equivalents and marketable securities totaled $24.3 million.

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"Since the beginning of the third quarter we have made significant progress in advancing both our vosaroxin and BTK inhibitor programs. In addition, in October, we secured the financial resources from leading life sciences investors which will help us reach several potential value inflection points," said Daniel Swisher, Chief Executive Officer of Sunesis. "The potential milestones include a marketing authorization decision on vosaroxin in Europe, the potential for a corresponding partnership and product launch in this territory, and the initiation and prosecution of a Phase 1B/2 study of SNS-062, our differentiated, non-covalent BTK-inhibitor, in patients with B-cell malignancies."

"The European regulatory review of vosaroxin has now resumed, following our response to the Day 120 List of Questions, and we look forward to receiving the EMA Day 180 List of Outstanding Issues before year-end. We were also pleased to present Phase 1A Healthy Volunteer Study results demonstrating a favorable safety, pharmacokinetic and pharmacodynamic profile for SNS-062 at the ESH Conference on New Concepts in B-Cell Malignancies in September."

Third Quarter 2016 and Recent Highlights

Submission of Responses to the EMA Day 120 List of Questions for the Marketing Authorization Application for Vosaroxin. In October, Sunesis announced that it submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin based on data from the VALOR trial, as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.

Presentation of Dose Escalation Results from the Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK inhibitor SNS-062. In September, Sunesis announced results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’s (ESH) 2nd International Conference on New Concepts in B-Cell Malignancies at the Estoril Congress Centre in Estoril, Portugal. The presentation, titled "A Phase 1A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects: Preliminary Results" is 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 Publication in "Drugs" Detailing Molecular and Pharmacologic Properties of Vosaroxin. In August, Sunesis announced the publication of an article detailing the molecular and pharmacologic properties of vosaroxin as a new therapeutic for acute myeloid leukemia (AML) in the journal Drugs. Vosaroxin is the first quinolone-based topoisomerase II inhibitor studied in clinical trials in oncology. The article, titled "Molecular and Pharmacologic Properties of the Anticancer Quinolone Derivative Vosaroxin: A New Therapeutic for Acute Myeloid Leukemia," is available online and appeared in the September 2016 print issue of Drugs. The authors describe how the unique chemical and pharmacologic characteristics of vosaroxin may contribute to the efficacy and safety profile observed in Sunesis’ Phase 3 VALOR trial in first relapsed or refractory AML.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $24.3 million as of September 30, 2016, as compared to $46.4 million as of December 31, 2015. The decrease of $22.1 million was primarily due to $28.9 million of net cash used in operating activities, $8.0 million of payments against notes payable, partially offset by $14.8 million in net loan proceeds. An additional $25.9 million in net proceeds was raised in the October 2016 equity financing, resulting in pro-forma September 30, 2016 cash, cash equivalents and marketable securities of $50.2 million. This capital is expected to be sufficient to fund operations into 2018.

Revenue for the three and nine months ended September 30, 2016 was $0.6 million and $1.9 million as compared to $0.7 million and $2.4 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 expense was $5.3 million and $18.1 million for the three and nine months ended September 30, 2016 as compared to $5.3 million and $16.1 million for the same periods in 2015. The increase of $2.0 million between the comparable nine month periods was primarily due to an increase in professional services, clinical trials and medical affairs expenses.

General and administrative expense was $3.9 million and $12.2 million for the three and nine months ended September 30, 2016 as compared to $4.0 million and $14.3 million for the same periods in 2015. The decrease of $0.1 million between the comparable three month periods was primarily due to a decrease in personnel expenses. The decrease of $2.1 million between the comparable nine month periods was primarily due to decrease in outside service costs.

Interest expense was $0.5 million and $1.2 million for the three and nine months ended September 30, 2016 as compared to $0.2 million and $0.7 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 nil and $0.1 million for the three and nine months ended September 30, 2016 as compared to net other income of $1.8 million and $3.6 million for the same period in 2015. The decrease in net other income is related to the quarterly re-valuation of warrant liabilities.

Cash used in operating activities was $29.0 million for the nine months ended September 30, 2016, as compared to $29.5 million for the same period in 2015. Net cash used in the 2016 period resulted primarily from the net loss of $29.5 million and changes in operating assets and liabilities of $3.6 million, including the payment of a final fee of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million. Net cash used in the 2015 period resulted primarily from the net loss of $25.1 million and changes in operating assets and liabilities of $5.6 million, partially offset by net adjustments for non-cash items of $1.2 million.

Sunesis reported loss from operations of $8.5 million and $28.4 million for the three and nine months ended September 30, 2016 as compared to $8.6 million and $28.0 million for the same periods in 2015. Net loss was $9.0 million and $29.5 million for the three and nine months ended September 30, 2016, as compared to $7.0 million and $25.1 million for the same periods in 2015.