SOUTH SAN FRANCISCO, Calif., July 29 /PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) today reported financial results for the second quarter ended June 30, 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."
Recent Highlights
- 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.
Financial Highlights
- Revenues for the three and six months ended June 30, 2009 were $3.5 million and $3.7 million compared to $2.6 million and $4.9 million for the same periods in 2008. Sunesis recognized $2.0 million in the second quarter of 2009 for the sale to SARcode of its interest in the lymphocyte function-associated antigen-1, or LFA-1, patents and related know-how that had previously been the subject of a license agreement with them, and $1.5 million for the Biogen Idec Raf kinase inhibitor milestone referred to above.
