HBX Hana Biosciences

Hana Biosciences (AMEX:HBX), a biopharmaceutical company focused on advancing cancer care, reported its results of operations for 2005 and the filing of its annual report on Form 10-K. Hana reported a net loss of $10.0 million, or $0.57 per share for the year ended December 31, 2005, compared to a net loss of $7.3 million, or $0.80 per share, in 2004. Cash used in operations was 8.5 million in 2005. Hana ended 2005 with $17.0 million in cash and cash equivalents, compared to $6.6 million at the end of 2004. Increased investment in research and development, driven by the accelerated clinical development of its three product candidates, resulted in the additional expense throughout 2005. "2005 was a milestone year in advancing our oncology product candidates and enhancing shareholder value," said Mark Ahn, President and CEO of Hana. "With our tightly focused business plan, experienced management team and deep commitment to advancing the care of cancer patients, we will strive to continue meeting and exceeding our objectives to deliver on the promise of emerging medical research." Key Achievements in 2005 Hana achieved several important milestones in the development of its product portfolio during 2005: -- Zensana(TM) (ondansetron oral spray), for the prevention of chemotherapy and radiation-induced, and post-operative nausea and vomiting, completed a pilot trial and first pivotal trial which demonstrated that an 8 mg dose of Zensana(TM) oral spray is statistically bioequivalent to the commercially available 8 mg ondansetron (Zofran(R)) tablet. Additionally, Zensana(TM) can be conveniently administered in multiple doses and was shown to have a similar safety profile to the ondansetron 8 mg tablet. Hana plans to submit a New Drug Application (NDA) to the FDA for Zensana(TM) in 2006, with a targeted commercial launch in 2007. -- Talotrexin (PT-523) is a novel nonpolyglutamatable antifolate drug which has demonstrated enhanced antitumor activity in a broad spectrum of cancers by targeting DHFR to prevent DNA synthesis and inhibit tumor growth. Hana completed and reported results of a Phase I/II trial in NSCLC (non-small cell lung cancer), as well as initiated a Phase I/II study in ALL (acute lymphocytic leukemia). -- IPdR is a novel, orally available, thymidine analogue and prodrug for IUdR, which demonstrated survival advantage in Phase II studies in anaplastic astrocytoma, a type of brain tumor. Hana initiated a Phase I clinical trial for IPdR for the treatment of colorectal, gastric, liver and pancreatic cancers. In addition, Hana's common shares were approved for listing on the American Stock Exchange (AMEX) in September 2005, trading under the symbol HBX. Outlook for 2006 Hana previously announced the following milestones for 2006: -- 1H 06: Announce results from Ph I clinical trials in NSCLC, ALL, and solid tumors -- 1H 06: Initiate Talotrexin Ph II NSCLC, with potential interim results in Q4 06 -- 1H 06: Initiate Talotrexin Phase II trial in other tumor type -- 1H 06: Submit Zensana(TM) NDA under 505(b)(2) registration, with potential US '07 market launch -- 2H 06: Initiate additional Zensana(TM) clinical trials in chemotherapy-induced nausea and vomiting (CINV) -- 2H 06: Initiate additional IPdR Phase I/II trial in glioblastoma multiforme (GBM) and/or neoadjuvant rectal cancer -- 2H 06: Complete IPdR Ph I in gastric, colorectal, pancreatic and liver cancers Hana Biosciences will host a teleconference to discuss the results presented above as well as an overview of 2006 goals at 4:30PM ET on Monday, March 20, 2006. Those interested in hearing management's discussion may join the call by dialing (877) 407-9210. International participants may access the call by dialing (201) 689-8049. Participants may also access a live web-cast of the conference call through the Investor Relations section of Hana's web site at http://www.hanabiosciences.com. A replay will be available for three months following the call by dialing (877) 660-6853 for domestic participants and (201) 612-7415 for international participants and entering 286 for the playback account number and 196499 for the playback access code when prompted. About Hana Biosciences, Inc. Hana Biosciences, Inc. (AMEX:HBX) is a South San Francisco, CA-based biopharmaceutical company that acquires, develops, and commercializes innovative products to advance cancer care. The company is committed to creating value by building a world-class team, accelerating the development of lead product candidates, expanding its pipeline by being the alliance partner of choice, and nurturing a unique company culture. Additional information on Hana Biosciences can be found at www.hanabiosciences.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that could cause Hana's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. Among other things, there can be no assurances that any of Hana's development efforts relating to its product candidates will be successful. Other risks that may affect forward-looking information contained in this press release include the possibility of being unable to obtain regulatory approval of Hana's product candidates, the risk that the results of clinical trials may not support Hana's claims, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2005. Hana assumes no obligation to update these statements, except as required by law.