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HNAB..Hana Biosciences Reports First Quarter 2010 Financial Results
globenewswire

Press Release Source: Hana Biosciences, Inc. On Friday May 14, 2010, 8:30 am

SOUTH SAN FRANCISCO, Calif., May 14, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc., (OTCBB:HNAB - News), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the first quarter ended March 31, 2010, and provided a corporate update.

"During the first quarter of 2010, we continued our focus on the clinical and manufacturing development for Marqibo(R) in relapsed/refractory adult acute lymphoblastic leukemia," said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "We continue to move forward with our submission plans following input received from the Food and Drug Administration during our April pre-New Drug Application meeting. We are confident that the complete rALLy data from the entire 65 patient population, which will be reported in an oral presentation at the 2010 Meeting of the American Society of Clinical Oncology, will provide additional evidence of Marqibo's efficacy."

Recent Clinical and Corporate Highlights

* In April 2010, Hana completed a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, Marqibo(R) for the treatment of relapsed/refractory adult Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL). The purpose of the meeting was to discuss the proposed NDA and to confirm the clinical, non-clinical and manufacturing requirements for the NDA submission. Following the pre-NDA meeting, Hana intends to proceed with its plan to submit a rolling NDA for Marqibo in relapsed/refractory adult Philadelphia chromosome-negative ALL.
* In April 2010, Hana also announced that complete data from its pivotal study of Marqibo in patients with relapsed/refractory adult Philadelphia chromosome-negative ALL, had been accepted for an oral podium presentation at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 4-8, 2010 in Chicago, Illinois. The oral podium presentation (Abstract #6507) entitled, "Phase II Study of Marqibo in Adult Patients with Refractory or Relapsed Philadelphia Chromosome Negative (Ph-) Acute Lymphoblastic Leukemia (ALL)" will be presented in Room E354b at 11:45 a.m. on Monday, June 7.
* In March 2010, Hana announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for the use of menadione to prevent and treat skin rash in patients taking biologic and small molecule epidermal growth factor receptor (EGFR) inhibitors, such as Erbitux(R) and Tarceva(R), for anti-cancer therapy. The U.S. Patent Application Number 11/886,803 is entitled "Vitamin K for Prevention and Treatment of Skin Rash Secondary to Anti-EGFR Therapy" and extends intellectual property protection around menadione into 2026.

First Quarter 2010 Financial Results

The Company reported a net loss of $5.5 million, or $0.07 per share, for the quarter ended March 31, 2010 compared with a net loss of $5.6 million, or $0.17 per share, for the quarter ended March 31, 2009.

Total operating expenses for the quarter ended March 31, 2010, were $4.4 million compared with $5.6 million for the quarter ended March 31, 2009.

Research and development expenses were $3.3 million for the quarter ended March 31, 2010, compared with $4.2 million for the quarter ended March 31, 2009.

General and administrative expenses were $1.1 million for the quarter ended March 31, 2010, compared with $1.4 million for the quarter ended March 31, 2009.

As of March 31, 2010, the Company had cash, cash equivalents and available-for-sale securities of $4.2 million. Cash used in operations was $5.5 million for the quarter. The Company has implemented cost controls to conserve its cash and continues to evaluate both traditional and non-dilutive financing options. With a lower cash burn rate, the Company's current cash resources are sufficient to fund operations through June 2010.

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 timing, progress and anticipated results of Hana's planned NDA filing relating to Marqibo, including whether such NDA submission will be accepted for review or approved by the FDA; statements regarding the potential of Marqibo to replace existing therapies and the expected benefits Marqibo may have for patients with relapsed ALL compared to existing therapies; statements regarding the extent of the Company's intellectual property rights and protections relating to menadione; and statements relating to the period of time for which its existing cash resources are sufficient to fund operations and whether the Company's cost control measures will be sufficient to preserve its cash resources until additional capital is obtained. 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 clinical and regulatory development efforts relating to Marqibo will be successful; that even if an NDA for Marqibo is accepted by the FDA, that it will be approved; that the data of the clinical trials of Marqibo will be sufficient to support approval by the FDA of an NDA for Marqibo; that Hana will have completed all other activities necessary for the filing of an NDA or other submission with the FDA; that the results of the clinical trials of Marqibo will support Hana's claims or beliefs concerning Marqibo's safety and effectiveness; that its existing patent and other intellectual property rights will be adequate; and that Hana will be able to secure the additional capital necessary to fund the activities required to complete the proposed NDA submission and other clinical and regulatory activities relating to Marqibo. Additional risks that may affect such forward-looking statements include Hana's need to raise additional capital to fund its product development programs, including Marqibo, 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, 2009 and in the Company's Form 10-Q for the three month period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.




HANA BIOSCIENCES, INC.

BALANCE SHEETS


March 31,
2010 December 31,
2009
ASSETS (Unaudited)
Current assets:

Cash and cash equivalents $ 4,096,056 $9,570,453
Available-for-sale securities 76,000 68,000
Prepaid expenses and other current assets 104,414 114,067
Total current assets 4,276,470 9,752,520



Property and equipment, net 217,492 252,455
Restricted cash 125,000 125,000
Debt issuance costs 1,018,755 1,193,594
Total assets $5,637,717 $11,323,569



LIABILITIES AND STOCKHOLDERS' DEFICIT

Current liabilities:

Accounts payable and accrued liabilities $3,416,775 $4,027,075
Other short-term liabilities 27,382 43,586
Total current liabilities 3,444,157 4,070,661
Notes payable, net of discount 22,836,344 22,597,050
Other long-term liabilities 6,224 6,540
Warrant liabilities 2,104,666 2,145,511
Total long term liabilities 24,947,234 24,749,101
Total liabilities 28,391,391 28,819,762






Stockholders' deficit:

Common stock; $0.001 par value:

200,000,000 shares authorized, 79,788,264 and 79,649,976 shares issued and outstanding at March 31, 2010 and December 31, 2009, respectively 79,788 79,650
Additional paid-in capital 117,779,666 117,572,373
Accumulated other comprehensive income (16,000) (24,000)
Accumulated deficit (140,597,128) (135,124,216)
Total stockholders' deficit (22,753,674) (17,496,193)
Total liabilities and stockholders' deficit $5,637,717 $11,323,569




HANA BIOSCIENCES, INC.
STATEMENT OF OPERATIONS
AND COMPREHENSIVE LOSS
(Unaudited)



Three Months Ended
March 31,

2010 2009



Operating expenses:

General and administrative $1,170,895 $1,377,600
Research and development 3,258,545 4,192,483
Total operating expenses 4,429,440 5,570,083



Loss from operations (4,429,440) (5,570,083)



Other income (expense):

Interest income 267 11,582
Interest expense (1,084,584) (727,007)
Other expense, net -- (4,907)
Change in fair market value of warrant liabilities 40,845 664,060



Total other expense (1,043,472) (56,272)



Net loss $ (5,472,912) $ (5,626,355)
Net loss per share, basic and diluted $ (0.07) $ (0.17)
Weighted average shares used in computing net loss per share, basic and diluted 79,782,118 32,449,739



Comprehensive loss:

Net loss $ (5,472,912) $ (5,626,355)
Unrealized holding gains (losses) arising during the period 8,000 (32,000)



Comprehensive loss $ (5,464,912) $ (5,658,355)

Contact:

Hana Biosciences, Inc.
Investor & Media Contacts:
Investor Relations Team
[phone]
[e-mail]
Burns McClellan
Rebecca Birbach
[phone]
[e-mail]