Sunesis Reports Financial Results for the Second Quarter 2009
Total revenue for the second quarter of 2009 was $3.5 million, with a net loss of $22.9 million, including non-cash charges of $21.0 million related to the financing completed in April. Loss from operations was $1.9 million for the second quarter and $10.2 million for the first half of 2009. As of June 30, 2009, cash, cash equivalents and marketable securities totaled $7.3 million, with no debt outstanding.
"In the second quarter, we completed the initial closing of a tranched financing of up to $43.5 million with a syndicate of experienced life science investors. We also presented positive new data on all three of our Phase 2 voreloxin studies at ASCO," said Daniel Swisher, Chief Executive Officer of Sunesis. "As we finish enrollment of both of our Phase 2 studies in AML, we are actively planning for an End-of-Phase 2 meeting later this year with the FDA to gain concurrence on our AML registration strategy."
Voreloxin is a first-in-class anticancer quinolone derivative, or AQD, a class of compounds that has not been used previously for the treatment of cancer. Voreloxin both intercalates DNA and inhibits topoisomerase II, resulting in replication-dependent, site-selective DNA damage, G2 arrest and apoptosis. Voreloxin is currently being evaluated in a Phase 2 clinical trial (known as the REVEAL-1 trial) in previously untreated elderly AML patients and in a Phase 1b/2 clinical trial combining voreloxin with cytarabine for the treatment of patients with relapsed/refractory AML, as well as in an ongoing Phase 2 single-agent trial in platinum-resistant ovarian cancer.
About Acute Myeloid Leukemia
AML is a rapidly progressing cancer of the blood characterized by the uncontrolled proliferation of immature blast cells in the bone marrow. The Leukemia and Lymphoma Society estimates that over 13,000 new cases of AML were diagnosed and approximately 9,000 deaths from AML occurred in the U.S. during 2007. AML is generally a disease of older adults, and the median age of a patient diagnosed with AML is about 67 years. A majority of elderly patients are not considered candidates for standard induction therapy or decline therapy, resulting in an acute need for new treatment options.
About Ovarian Cancer
In the United States, ovarian cancer remains the leading cause of death from gynecologic malignancies and is the fifth leading cause of cancer death overall in women behind lung, breast, colorectal and pancreatic cancers. According to the American Cancer Society, in 2008 there were an estimated 21,650 new cases and more than 15,000 deaths from ovarian cancer in the U.S. alone. Following frontline treatment, recurrence rates among ovarian cancer patients are high. Treatment options remain limited following relapse, and overall long-term survival has not changed significantly over the past 40 years, with five-year survival rates at less than 30 percent.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to advancing its lead product candidate, voreloxin, in multiple indications to improve the lives of people with cancer. For additional information on Sunesis Pharmaceuticals, please visit http://www.sunesis.com.
SUNESIS and the logo are trademarks of Sunesis Pharmaceuticals, Inc. All other trademarks appearing in this release are the property of their respective owners.
This press release contains forward-looking statements, including without limitation statements related to the potential safety and efficacy and commercial potential of voreloxin, the completion of the tranched financing, the activity of voreloxin in nonclinical studies, planned additional enrollment, clinical testing and development efforts, the timing of the End-of-Phase 2 meeting with FDA and the company's ability to transfer to The NASDAQ Capital Market. Words such as "demonstrating," "planning," "promising," "shows" 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, risks related to Sunesis' need for additional funding, the risk that Sunesis' drug development activities could be halted significantly or delayed for various reasons, the risk that Sunesis' clinical trials for voreloxin may not demonstrate safety or efficacy or lead to regulatory approval, the risk that preliminary data and trends may not be predictive of future data or results, the risk that Sunesis' nonclinical studies and clinical trials may not satisfy the requirements of the FDA or other regulatory agencies, risks related to the conduct of Sunesis' clinical trials, including the pace of enrollment, risks related to the manufacturing of voreloxin, the risk that Sunesis' proprietary rights may not adequately protect voreloxin and the risk that NASDAQ does not permit Sunesis to transfer to The NASDAQ Capital Market and that Sunesis may be subject to delisting proceedings. These and other risk factors are discussed under "Risk Factors" and elsewhere in Sunesis' Quarterly Report on Form 10-Q for the quarter ended June 30, 2009 and other filings with the Securities and Exchange Commission. Sunesis expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
-- In April, Sunesis completed a $10.0 million initial closing of a tranched private placement of up to $43.5 million. The private placement contemplates the sale of up to $15.0 million of units of convertible preferred stock and common stock warrants and up to $28.5 million in common stock to accredited investors, including certain members of management. In the initial closing, $10.0 million of units were sold, resulting in net proceeds of $8.8 million. The remaining units may be issued by Sunesis upon the satisfaction of a clinical milestone and Sunesis' common stock trading above a specified floor price or upon approval by a majority of the investors in the private placement, among other conditions, and the common stock of the private placement may be sold upon approval by the company and a majority of the investors in the private placement, among other conditions. -- At the American Society of Clinical Oncology (ASCO) 2009 Annual Meeting in June, the company presented new data from three ongoing clinical trials demonstrating that voreloxin shows promising safety and efficacy in AML and in platinum-resistant ovarian cancer. These presentations can be found on the Sunesis website at http://www.sunesis.com/products-in-development/presentations.php -- REVEAL-1 (Response Evaluation of VorEloxin in AmL) is a Phase 2 dose regimen optimization study of single agent voreloxin in newly diagnosed elderly AML patients who are unlikely to benefit from standard induction chemotherapy. Interim clinical data from this study continue to show that voreloxin can induce durable complete remissions across several dosing schedules. -- The Phase 1b/2 trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered on days one and four with cytarabine given either as a continuous infusion of 400 mg/m2 daily for five days (CIV Schedule) or as a two hour IV bolus of 1 g/m2 daily for five days (Bolus Schedule). Across both the CIV and Bolus Schedules, a total of 14 patients with primary refractory AML were enrolled and treated with a voreloxin dose of 80 mg/m2 or higher. Five of 14 of these patients achieved a CR or CRp for an overall CR or CRp rate of 36 percent, which compares favorably relative to expected remission rates in this AML population of approximately 10 to 15 percent. In the Bolus Schedule, both first relapse and primary refractory patients are currently being enrolled in Phase 2. -- Updated clinical data from the Phase 2 study of single agent voreloxin in women with platinum-resistant ovarian cancer were also presented at the ASCO 2009 Annual Meeting. Approximately a third of the study patients have also failed prior treatment with Doxil(R). Three dose cohorts of voreloxin have been studied, 48 mg/m2 given every three weeks, 60 mg/m2 given every four weeks and 75 mg/m2 given every four weeks. Across all three dosing cohorts, 74 patients (52%) experienced disease control, defined as an objective response or stable disease for 12 weeks or more. The preliminary median progression free survival (PFS) for each of the three cohorts by increasing dose is 82 days, 84 days, and 109 days, respectively. The preliminary median PFS for the 44 women who were both platinum resistant and also had failed treatment with Doxil(R) is 90 days. -- In July, Sunesis received a $1.5 million milestone payment from Biogen Idec (Nasdaq: BIIB) for the selection of a Raf kinase inhibitor development candidate for the treatment of cancer. Biogen Idec is currently conducting IND-enabling GLP preclinical work. Sunesis retains an option to participate in the co-development and co-promotion of the Raf kinase inhibitor resulting from this collaboration. -- On July 24, 2009, Sunesis applied to transfer the listing of its common stock from The NASDAQ Global Market to The NASDAQ Capital Market. The NASDAQ Capital Market is a continuous trading market that operates in the same manner as The NASDAQ Global Market. All companies listed on The NASDAQ Capital Market must meet certain financial requirements and adhere to NASDAQ's corporate governance standards. Sunesis believes it is in compliance with the minimum stockholders' equity requirement and all other applicable criteria for continued listing on The NASDAQ Capital Market, but for the $1.00 bid price requirement, which has been suspended by NASDAQ through August 2, 2009. If the application is approved, the company will no longer be subject to delisting from NASDAQ as a result of the previously disclosed stockholders' equity deficiency as of December 31, 2008, but it will need to comply with The NASDAQ Capital Markets' continued listing requirements on an ongoing basis.
SOURCE Sunesis Pharmaceuticals, Inc.
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