Hana Biosciences Inc. today posted its fourth quarter and year-end financial results for the period ended Dec. 31, 2009, highlighting recent clinical and corporate updates, as well as 2010 objectives.
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. For the full year ended Dec. 31, 2009, Hana reported a net loss of $24.1 million, or $0.57 per share, compared with a net loss of $22.2 million, or $0.69 per share, for the year ended Dec. 31, 2008.
Total operating expenses for the quarter were $5.4 million compared with $6.6 million for the same quarter of 2008. Total operating expenses were $19.6 million for the full year compared with $24.2 million for the year ended December 31, 2008.
“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,” Steven R. Deitcher, M.D., president and CEO of Hana stated in the press release. “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.”
In December 2009, Hana presented positive data from its pivotal phase 2 rALLy clinical trial of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).
Also in December 2009, Hana announced the appointment of Howard Furst, M.D., M.B.A., to its board of directors.
In March 2009, the company announced Craig Carlson as Hana vice president and CFO.
In October 2009, the company completed a $12.4 million private placement of units of its securities consisting of shares of common stock and warrants.
Hana also laid out objectives for 2010, including a pre-New Drug Application (NDA) meeting for Marqibo in the second quarter of 2010, as well as its plans to: 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.