SOUTH SAN FRANCISCO, Calif., Aug. 14, 2009 (GLOBE NEWSWIRE) -- Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced financial results for the three and six months ended June 30, 2009.
Three Months Ended June 30, 2009 Financial Results:
The Company reported a net loss of $7.9 million (including non-cash expenses), or $0.24 per share, for the three months ended June 30, 2009, compared to $4.7 million (including non-cash expenses), or $0.15 per share, for the same period in 2008. These amounts include a net loss from other expenses of $3.7 million for the three months ended June 30, 2009 compared to a gain of $1.5 million from other income for the three months ended June 30, 2008. The change in other expenses is primarily related to a non-cash accounting charge recorded to increase the value of our warrant liability. The increase in this value is primarily related to an increase in share price for the period.
Research and development expense for the three months ended June 30, 2009 was $3.3 million, compared to $4.4 million for the three months ended June 30, 2008. The decrease in research and development costs was primarily due to decreased spending for clinical development of menadione and Brakiva.
General and administrative expenses totaled $0.9 million for the three months ended June 30, 2009, compared with $1.7 million for the three months ended June 30, 2008. The decrease is due primarily to decreased personnel related expenses.
Cash used in operations was $5.3 million for the three months ended June 30, 2009.
Six Months Ended June 30, 2009 Financial Results:
Hana reported a net loss of $13.5 million (including non-cash expenses), or $0.42 per share, for the six months ended June 30, 2009, compared to a net loss of $10.9 million, or $0.34 per share, for the same period in 2008. These amounts include a net loss from other expenses of $3.7 million for the six months ended June 30, 2009 compared to a gain of $1.4 million from other income for the six months ended June 30, 2008. The change in other expenses is primarily related to a non-cash accounting charge recorded to increase the value of our warrant liability. The increase in this value is primarily related to an increase in share price for the period.
Research and development expense for the six months ended June 30, 2009 was $7.7 million, compared with $8.7 million for the six months ended June 30, 2008. The decrease in research and development costs was primarily due to decreased spending for clinical development of menadione and Brakiva.
General and administrative expenses totaled $2.0 million for the six months ended June 30, 2009, compared with $3.7 million for the six months ended June 30, 2008. The decrease is due primarily to decreased personnel related expenses.
Key Achievements during 2009
* Appointed Thomas J. Tarlow as Vice President Regulatory Affairs and Quality. * Phase 1 data on menadione topical lotion presented at 33rd Hawaii Dermatology Seminar. * Presented at 11th Annual BIO CEO & Investor Conference. * Announced that an Independent Data Monitoring Committee (IDMC) continued to support the acceptable safety profile observed with Marqibo and recommended that the trial continue to completion per protocol. * Announced new positive preliminary efficacy results from a planned interim analysis of the ongoing pivotal rALLy clinical trial evaluating Marqibo. * Presented updated data for Marqibo at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). * Achieved target enrollment of 56 evaluable subjects in the pivotal Phase 2 rALLy clinical trial for the treatment of adult acute lymphoblastic leukemia in second relapse.
"We remain excited about the milestones achieved during 2009 as well as the positive interim results of our rALLy clinical trial," stated John Iparraguirre, Vice President and Chief Financial Officer. "We look forward to continuing the positive momentum into the second half of 2009."
About Hana Biosciences, Inc.
Hana Biosciences, Inc. (Nasdaq:HNAB) is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company has two lead product candidates that target large markets and are in pivotal and/or proof-of-concept clinical trials. Marqibo(r) potentially treats acute lymphoblastic leukemia and lymphomas. Menadione topical lotion is a first-in-class compound for the potential prevention and/or treatment of skin toxicity associated with epidermal growth factor receptor inhibitors. The company has additional pipeline opportunities that, like Marqibo, improve delivery and enhance the therapeutic benefits of well characterized, proven chemotherapies and enable high potency dosing without increased toxicity. Additional information on Hana Biosciences can be found at www.hanabiosciences.com.
The Hana Biosciences, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=3290
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are often, but not always, made through the use of words or phrases such as "anticipates," "expects," "plans," "believes," "intends," and similar words or phrases. These forward-looking statements include without limitation, statements regarding the timing progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential IND and NDA filings and commercialization efforts of Hana's product candidates; statements regarding the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding the availability of additional capital, including capital subject to Hana's existing loan facility; and statements regarding Hana's efforts to enter into strategic collaborations regarding the development or commercialization of its product candidates. 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 other product candidates will be successful, that Hana will be able to obtain regulatory approval of any of its product candidates, and that the results of clinical trials will support Hana's claims or beliefs concerning the effectiveness of its product candidates. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs to completion, Hana's reliance on third-party researchers to develop its product candidates, and its lack of experience in developing and commercializing pharmaceutical products. Additional risks are described in the company's Annual Report on Form 10-K for the year ended December 31, 2008 filed with the Securities and Exchange Commission. Hana assumes no obligation to update these statements, except as required by law.
HANA BIOSCIENCES, INC.
CONDENSED BALANCE SHEETS
June 30, December 31,
2009 2008
------------ ------------
ASSETS (Unaudited)
Current assets:
Cash and cash equivalents $ 8,190,250 $ 13,999,080
Available-for-sale securities 124,000 128,000
Prepaid expenses and other current assets 55,405 131,663
------------ ------------
Total current assets 8,369,655 14,258,743
Property and equipment, net 310,574 400,168
Restricted cash 125,000 125,000
Debt issuance costs 1,286,141 1,361,356
------------ ------------
Total assets $ 10,091,370 $ 16,145,267
============ ============
LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities:
Accounts payable and accrued liabilities $ 3,559,038 $ 4,225,863
Other short-term liabilities 53,508 61,341
Warrant liabilities, short-term 2,927,761 1,450,479
------------ ------------
Total current liabilities 6,540,307 5,737,683
------------ ------------
Notes payable, net of discount 22,176,876 16,851,541
Other long-term liabilities 28,726 41,775
Warrant liabilities, non-current 679,827 --
------------ ------------
Total long term liabilities 22,885,429 16,893,316
------------ ------------
Total liabilities 29,425,736 22,630,999
------------ ------------
Commitments and contingencies:
Stockholders' deficit:
Common stock; $0.001 par value:
100,000,000 shares authorized,
32,451,184 and 32,386,130 shares
issued and outstanding at June 30,
2009 and December 31, 2008,
respectively 32,451 32,386
Additional paid-in capital 105,064,006 104,431,469
Accumulated other comprehensive income 32,000 36,000
Accumulated deficit (124,462,823) (110,985,587)
------------ ------------
Total stockholders' deficit (19,334,366) (6,485,732)
------------ ------------
Total liabilities and stockholders'
deficit $ 10,091,370 $ 16,145,267
============ ============
HANA BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
-------------------------- --------------------------
2009 2008 2009 2008
------------ ------------ ------------ ------------
Operating
expenses:
General and
administrative $ 934,637 $ 1,749,555 $ 2,042,526 $ 3,650,475
Research and
development 3,262,507 4,419,464 7,724,701 8,683,796
------------ ------------ ------------ ------------
Total
operating
expenses 4,197,144 6,169,019 9,767,227 12,334,271
Loss from
operations (4,197,144) (6,169,019) (9,767,227) (12,334,271)
------------ ------------ ------------ ------------
Other income
(expense):
Interest
income 574 60,457 12,156 231,365
Interest
expense (833,142) (252,477) (1,560,149) (501,641)
Other expense,
net -- (36,802) (4,907) (42,864)
Gain (loss)
on derivative (2,821,169) 1,827,611 (2,157,109) 1,817,681
Realized loss
on marketable
securities -- (108,000) -- (108,000)
------------ ------------ ------------ ------------
Total other
income
(expense) (3,653,737) 1,490,789 (3,710,009) 1,396,541
Net loss $ (7,850,881) $ (4,678,230) $(13,477,236) $(10,937,730)
============ ============ ============ ============
Net loss per
share, basic
and diluted $ (0.24) $ (0.15) $ (0.42) $ (0.34)
============ ============ ============ ============
Weighted
average
shares used
in computing
net loss per
share, basic
and diluted 32,451,184 32,227,195 32,450,465 32,204,171
============ ============ ============ ============
Comprehensive
loss:
Net loss $ (7,850,881) $ (4,678,230) $(13,477,236) $(10,937,730)
Unrealized
holdings
gains
(losses)
arising
during the
period 28,000 (28,000) (4,000) (4,000)
Less:
reclassi-
fication
adjustment
for losses
included in
net loss -- 108,000 -- 108,000
------------ ------------ ------------ ------------
Comprehensive
loss $ (7,822,881) $ (4,598,230) $(13,481,236) $(10,833,730)
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