Hana Biosciences (AMEX:HBX)
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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.