Hana Biosciences reports $5.5 million net loss for first-quarter 2010

May 14 2010

Hana Biosciences Inc., (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.

"During the first quarter of 2010, we continued our focus on the clinical and manufacturing development for Marqibo® in relapsed/refractory adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We continue to move forward with our submission plans following input received from the Food and Drug Administration during our April pre-New Drug Application meeting. We are confident that the complete rALLy data from the entire 65 patient population, which will be reported in an oral presentation at the 2010 Meeting of the American Society of Clinical Oncology, will provide additional evidence of Marqibo's efficacy."

Recent Clinical and Corporate Highlights

• In April 2010, Hana completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo® for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission. Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
   
• In April 2010, Hana also announced that complete data from its pivotal study of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative ALL, had been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois. The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
   
• In March 2010, Hana announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy.  The U.S. Patent Application Number 11/886,803 is entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" and extends intellectual property protection around menadione into 2026.

First Quarter 2010 Financial Results

The Company reported a net loss of $5.5 million, or $0.07 per share, for the quarter ended March 31, 2010 compared with a net loss of $5.6 million, or $0.17 per share, for the quarter ended March 31, 2009. 

Total operating expenses for the quarter ended March 31, 2010, were $4.4 million compared with $5.6 million for the quarter ended March 31, 2009. 

Research and development expenses were $3.3 million for the quarter ended March 31, 2010, compared with $4.2 million for the quarter ended March 31, 2009. 

General and administrative expenses were $1.1 million for the quarter ended March 31, 2010, compared with $1.4 million for the quarter ended March 31, 2009. 

As of March 31, 2010, the Company had cash, cash equivalents and available-for-sale securities of $4.2 million.  Cash used in operations was $5.5 million for the quarter. The Company has implemented cost controls to conserve its cash and continues to evaluate both traditional and non-dilutive financing options. With a lower cash burn rate, the Company's current cash resources are sufficient to fund operations through June 2010.