Hana Biosciences reports net loss of $5M for fourth quarter 2009

Hana Biosciences Inc., (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the fourth quarter and year ended December 31, 2009, and provided a corporate update.

"In 2009, we made significant advancements towards our goal of initiating submission of a New Drug Application in mid-2010 seeking accelerated approval of Marqibo® in adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "After reporting positive results from our pivotal Phase 2 rALLy trial, we eagerly await our pre-NDA meeting in the second quarter of 2010 and are confident we will be able to submit a New Drug Application for Marqibo in our expected time frame.  In addition, we look forward to receiving and presenting the final results of the rALLy study from all 65 evaluable subjects, to provide additional evidence of Marqibo's effectiveness."

Recent Clinical and Corporate Highlights

Marqibo Clinical Development

• In December 2009, Hana presented positive data at the American Society of Hematology Annual Meeting from its pivotal Phase 2 rALLy clinical trial of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). Results from the rALLy trial demonstrated compelling evidence of single-agent, anti-leukemic activity in a relapsed/refractory, heavily pre-treated, adult population of ALL patients with a universal history of prior exposure to the standard formulation of vincristine sulfate. The analysis of the first 56 evaluable subjects demonstrated an overall response in 36 percent of the subjects and a complete response (CR) or CR with incomplete hematologic recovery in 21 percent of the subjects. The estimated median overall survival in complete responders was 7.3 months.  Fifty percent of the complete responders were able to receive a potentially life-saving stem cell transplant.  Fifty percent of the complete responders had remission durations longer than the duration of their prior remission.  In addition, Marqibo was generally well-tolerated with a low incidence of early death.

Corporate Developments

• In March 2009, Hana announced that Craig Carlson joined the Company and will assume the title of Vice President, Chief Financial Officer effective April 1, 2010. Mr. Carlson has held senior leadership and executive financial management positions for the past 25 years, including positions at two publicly-held healthcare companies.
• In December 2009, Hana appointed Howard Furst, M.D., M.B.A., to its Board of Directors. Dr. Furst has over 20 years of experience in the healthcare industry and is currently a partner at Deerfield Management.
• In October 2009, Hana completed a $12.4 million private placement of units of its securities consisting of shares of common stock and warrants.

Fourth Quarter and Year End 2009 Financial Results

The Company reported a net loss of $5.0 million, or $0.07 per share, for the fourth quarter of 2009 compared with a net loss of $6.1 million, or $0.19 per share, for the fourth quarter of 2008. The Company reported a net loss of $24.1 million, or $0.57 per share, for the year ended December 31, 2009, compared with a net loss of $22.2 million, or $0.69 per share, for the year ended December 31, 2008.

Total operating expenses for the quarter ended December 31, 2009, were $5.4 million compared with $6.6 million for the quarter ended December 31, 2008. Total operating expenses were $19.6 million for the year ended December 31, 2009, compared with $24.2 million for the year ended December 31, 2008.

Research and development (R&D) expenses were $4.3 million for the quarter ended December 31, 2009, compared with $5.4 million for the quarter ended December 31, 2008. R&D expenses were $15.6 million for the year ended December 31, 2009, compared with $18.4 million for the year ended December 31, 2008.

General and administrative (G&A) expenses were $1.1 million for the quarter ended December 31, 2009, compared with $1.2 million for the quarter ended December 31, 2008. G&A expenses were $4.0 million for the year ended December 31, 2009, compared with $5.8 million for the year ended December 31, 2008.

As of December 31, 2009, the Company had cash, cash equivalents and available-for-sale securities of $9.6 million. Cash used in operations was $5.1 million and $21.1 million for the quarter and year ended December 31, 2009. The Company currently has resources available to fund operations to mid-2010.

2010 Objectives

• Hold a pre-New Drug Application (NDA) meeting for Marqibo in the second quarter of 2010;
• Provide menadione intellectual property update in mid-2010;
• Present top-line proof-of-concept data of menadione in mid-2010;
• Initiate rolling NDA submission for Marqibo in adult ALL in mid-2010;
• Initiate Marqibo's pediatric program sponsored by the Center for Cancer Research at the National Cancer Institute in the second half of 2010;
• Initiate Phase 2 randomized trial of menadione in the second half of 2010; and
• Present final Marqibo rALLy data from all 65 patients at a medical conference.