SOUTH SAN FRANCISCO, Calif., Nov. 13, 2009 (GLOBE NEWSWIRE) -- Hana Biosciences (OTCBB:HNAB) announced today financial results for the three and nine months ended September 30, 2009.
"Highlights of the past couple months include completion of a financing with top tier biotechnology investors and intensive preparation for our presentation of top-line data from the pivotal Marqibo rALLy trial at the American Society of Hematology Annual Meeting in December," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We are confident that the data will augment the interim data presented at ASCO 2009 and further demonstrate the potential for Marqibo to provide meaningful clinical benefit in adults with acute lymphoblastic leukemia in second relapse. The financing and pivotal data will support our ongoing New Drug Application regulatory activities for Marqibo."
Three Months Ended September 30, 2009 Financial Results
The Company reported a net loss of $5.7 million (including non-cash expenses), or $0.17 per share, for the three months ended September 30, 2009, compared to $5.2 million (including non-cash expenses), or $0.16 per share, for the same period in 2008. These amounts include a net loss from other expenses of $1.2 million for the three months ended September 30, 2009, compared to a net gain of $0.2 million from other income for the three months ended September 30, 2008. The change 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 September 30, 2009 was $3.6 million, compared to $4.3 million for the three months ended September 30, 2008. The decrease in research and development costs was primarily due to decreased spending for the clinical development of menadione and decreased personnel costs when compared to 2008.
General and administrative expenses totaled $0.8 million for the three months ended September 30, 2009, compared with $1.0 million for the three months ended September 30, 2008. The decrease is due primarily to decreased personnel related expenses.
Cash used in operations was $5.2 million for the three months ended September 30, 2009.
Nine Months Ended September 30, 2009 Financial Results
Hana reported a net loss of $19.1 million (including non-cash expenses), or $0.59 per share, for the nine months ended September 30, 2009, compared to a net loss of $16.1 million, or $0.50 per share, for the same period in 2008. These amounts include a net loss from other expenses of $4.9 million for the nine months ended September 30, 2009, compared to a net gain of $1.6 million from other income for the nine months ended September 30, 2008. The change 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 nine months ended September 30, 2009 was $11.4 million, compared with $13.0 million for the nine months ended September 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 $2.8 million for the nine months ended September 30, 2009, compared with $4.6 million for the nine months ended September 30, 2008. The decrease is due primarily to decreased personnel related expenses.
Recent Corporate Achievements
* Hana completed a private placement of units of its
securities, consisting of shares of common stock and warrants.
The Company realized total gross cash proceeds of
approximately $12.4 million. Net proceeds of the offering
will be used to support completion of the Marqibo(R) clinical
program in adult patients with Philadelphia chromosome negative
acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma
in second relapse or who failed two prior lines of treatment.
The proceeds will also support the Company's planned regulatory
activities related to Marqibo including New Drug Application
preparation and submission.
* Hana entered into a clinical trial agreement (CTA) with the
Center for Cancer Research (CCR) at the National Cancer
Institute (NCI) for the co-development of Marqibo in
refractory pediatric cancer. The five-year CTA with the
CCR will initially focus on a Phase 1 trial to evaluate
the safety, preliminary efficacy, pharmacokinetic profile,
and optimal dose of weekly Marqibo in children and
adolescents with refractory cancer. Following the Phase 1
trial, the Company and the CCR will plan a Phase 2 trial
in pediatric ALL, the most common cancer of childhood.
About Hana Biosciences, Inc.
Hana Biosciences, Inc. is a biopharmaceutical company dedicated to developing and commercializing new, differentiated cancer therapies designed to improve and enable current standards of care. The company's lead product candidate, Marqibo(R), potentially treats acute lymphoblastic leukemia and lymphomas. The Company has additional pipeline opportunities some of which, 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
Forward-Looking Statement
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 use of proceeds from Hana's recently-completed financing, expected data and results from the rALLy study, as well as the timing, progress and anticipated results of the clinical development, regulatory processes, potential clinical trial initiations, potential NDA filings and commercialization efforts of Hana's product candidates; and statements regarding the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies. 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 the results of the rALLy study will be sufficient to support an NDA filing for Marqibo, or that even if filed, such NDA will be approved by the FDA. In addition, there is no assurance 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
September 30, December 31,
2009 2008
------------- --------------
ASSETS (Unaudited)
Current assets:
Cash and cash equivalents $ 2,960,891 $ 13,999,080
Available-for-sale securities 104,000 128,000
Prepaid expenses and other
current assets 189,819 131,663
------------- --------------
Total current assets 3,254,710 14,258,743
Property and equipment, net 272,709 400,168
Restricted cash 125,000 125,000
Debt issuance costs 1,240,478 1,361,356
------------- --------------
Total assets $ 4,892,897 $ 16,145,267
============= ==============
LIABILITIES AND STOCKHOLDERS'
DEFICIT
Current liabilities:
Accounts payable and accrued
liabilities $ 3,187,397 $ 4,225,863
Other short-term liabilities 54,744 61,341
Warrant liabilities, short-term -- 1,450,479
------------- --------------
Total current liabilities 3,242,141 5,737,683
------------- --------------
Notes payable, net of discount 22,382,347 16,851,541
Warrant liabilities, long-term 3,899,699 --
Other long-term liabilities 11,732 41,775
------------- --------------
Total long term liabilities 26,293,778 16,893,316
------------- --------------
Total liabilities 29,535,919 22,630,999
------------- --------------
Commitments and contingencies:
Stockholders' deficit:
Common stock; $0.001 par value:
100,000,000 shares authorized,
32,583,004 and 32,386,130
shares issued and outstanding
at September 30, 2009 and
December 31, 2008, respectively 32,583 32,386
Additional paid-in capital 105,441,995 104,431,469
Accumulated other comprehensive
income 12,000 36,000
Accumulated deficit (130,129,600) (110,985,587)
------------- --------------
Total stockholders' deficit (24,643,022) (6,485,732)
------------- --------------
Total liabilities and
stockholders' deficit $ 4,892,897 $ 16,145,267
============= ==============
HANA BIOSCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
---------------------------- ----------------------------
2009 2008 2009 2008
------------ ------------ ------------ ------------
Operating expenses:
General and
admini-
strative $ 796,127 $ 973,414 $ 2,838,653 $ 4,623,889
Research
and
develop-
ment 3,643,014 4,347,265 11,367,715 13,031,060
------------ ------------ ------------ ------------
Total
operating
expenses 4,439,141 5,320,679 14,206,368 17,654,949
Loss from
operations (4,439,141) (5,320,679) (14,206,368) (17,654,949)
------------ ------------ ------------ ------------
Other income
(expense):
Interest
income 470 39,997 12,626 271,361
Interest
expense (935,993) (254,569) (2,496,143) (756,211)
Other
expense,
net -- (8,516) (4,908) (51,380)
Gain (loss)
on
derivative
liability (292,111) 382,152 (2,449,220) 2,199,833
Realized
loss on
marketable
securities -- -- -- (108,000)
------------ ------------ ------------ ------------
Total
other
income
(expense) (1,227,634) 159,064 (4,937,645) 1,555,603
------------ ------------ ------------ ------------
Net loss $(5,666,775) $ (5,161,615) $(19,144,013) $(16,099,346)
============ ============ ============ ============
Net loss
per share,
basic
and
diluted $ (0.17) $ (0.16) $ (0.59) $ (0.50)
============ ============ ============ ============
Weighted
average
shares
used in
computing
net loss
per share,
basic
and
diluted 32,580,138 32,385,366 32,494,165 32,265,010
============ ============ ============ ============
Comprehensive
loss:
Net loss $(5,666,775) $ (5,161,615) $(19,144,013) $(16,099,346)
Unrealized
holdings
gains
(losses)
arising
during
the period (20,000) (20,000) (24,000) (128,000)
Less:
reclassification
adjustment
for losses
included
in net
loss -- -- -- 108,000
------------ ------------ ------------ ------------
Comprehensive
loss $ (5,686,775) $ (5,181,615) $(19,168,013) $(16,119,346)
============ ============ ============ ============