SOUTH SAN FRANCISCO, Calif., Aug. 13, 2010 (GLOBE NEWSWIRE) -- Hana Biosciences Inc. (OTCBB:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today reported financial results for the three and six months ended June 30, 2010, and provided a corporate update.
"The second quarter of 2010 was transformational for Hana," stated Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "The Company had a number of important and encouraging events occur but the most significant was the completion of a substantial financing. This financing provides the resources necessary to aggressively pursue the completion of our NDA submission and approval process for Marqibo®, our lead product candidate. We are focused, energized and optimistic about Hana's future."
Recent Clinical and Corporate Highlights:
-- Completed a financing for up to $100 million with $40 million funded on June 7, 2010.
-- Completed clinical/non-clinical and manufacturing pre-NDA meetings with the FDA for Marqibo.
-- Presented complete RALLY clinical trial data of Marqibo in advanced, relapsed/refractory, adult acute lymphoblastic leukemia at the 2010 American Society of Clinical Oncology Annual Meeting.
-- A U.S. patent was issued for menadione topical lotion in treating skin rash in patients taking biologic and small molecule epidermal growth factor inhibitors, such as Erbitux ® and Tarceva ®, for anti-cancer therapy.
Three Months Ended June 30, 2010 Financial Results
For the three months ended June 30, 2010, the Company reported a net loss of $6.3 million and deemed dividends on preferred stock of $9.3 million, which when combined, resulted in a net loss applicable to common stockholders of $15.6 million, or $0.19 per share. The deemed dividends on preferred stock had an impact of $0.11 per share for the three months ended June 30, 2010. This compares with a net loss of $7.9 million, or a loss per share of $0.24, for the three months ended June 30, 2009. There were no deemed dividends on preferred stock for the three months ended June 30, 2009.
Total operating expenses for the three months ended June 30, 2010, were $4.6 million, compared with $4.2 million for the three months ended June 30, 2009. Research and development expenses were $2.7 million for the three months ended June 30, 2010, compared with $3.0 million for the three months ended June 30, 2009. General and administrative expenses were $1.9 million for the three months ended June 30, 2010, compared with $1.2 million for the three months ended June 30, 2009.
As of June 30, 2010, the Company had cash, cash equivalents and available-for-sale securities of $37.9 million. Cash used in operations was $4.9 million for the three months ended June 30, 2010 compared with $5.3 million for the three months ended June 30, 2009.
Six Months Ended June 30, 2010 Financial Results
For the six months ended June 30, 2010, the Company reported a net loss of $11.8 million and deemed dividends on preferred stock of $9.3 million, which when combined, resulted in a net loss applicable to common stockholders of $21.1 million, or $0.26 per share. The deemed dividends on preferred stock had an impact of $0.12 per share for the six months ended June 30, 2010. This compares with a net loss of $13.5 million, or a loss per share of $0.42, for the six months ended June 30, 2009. There were no deemed dividends on preferred stock for the six months ended June 30, 2009.
Total operating expenses for the six months ended June 30, 2010, were $9.0 million compared with $9.8 million for the six months ended June 30, 2009. Research and development expenses were $6.0 million for the six months ended June 30, 2010, compared with $7.2 million for the six months ended June 30, 2009. General and administrative expenses were $3.0 million for the six months ended June 30, 2010, compared with $2.6 million for the six months ended June 30, 2009.
Cash used in operations was $10.4 million for the six months ended June 30, 2010 compared with $10.8 million for the six months ended June 30, 2009.
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®, 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 period ended June 30, 2010. Hana assumes no obligation to update these statements, except as required by law.
| HANA BIOSCIENCES, INC. | ||
| CONDENSED BALANCE SHEETS | ||
|
June 30, 2010 |
December 31, 2009 |
|
| ASSETS | (Unaudited) | |
| Current assets: | ||
| Cash and cash equivalents | $37,820,075 | $9,570,453 |
| Available-for-sale securities | 76,000 | 68,000 |
| Prepaid expenses and other current assets | 119,187 | 114,067 |
| Total current assets | 38,015,262 | 9,752,520 |
| Property and equipment, net | 177,463 | 252,455 |
| Restricted cash | 125,000 | 125,000 |
| Debt issuance costs | 963,906 | 1,193,594 |
| Total assets | $39,281,631 | $11,323,569 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
| Current liabilities: | ||
| Accounts payable and accrued liabilities | $3,491,426 | $4,027,075 |
| Other short-term liabilities | 11,022 | 43,586 |
| Total current liabilities | 3,502,448 | 4,070,661 |
| Notes payable, net of discount | 23,042,679 | 22,597,050 |
| Other long-term liabilities | 5,742 | 6,540 |
| Investors' right to purchase future shares of Series A-1 and A-2 preferred stock | 9,048,000 | -- |
| Warrant liabilities, non-current | 1,040,991 | 2,145,511 |
| Total long term liabilities | 33,137,412 | 24,749,101 |
| Total liabilities | 36,639,860 | 28,819,762 |
| Commitments and contingencies: | ||
| Convertible preferred stock; $100 par value: | ||
|
10,000,000 shares authorized, 400,000 and 0 shares issued and outstanding at June 30, 2010 and December 31, 2009, respectively; aggregate liquidation value of $100.8 million and $0 at June 30, 2010 and December 31, 2009, respectively |
29,898,219 | -- |
| Stockholders' deficit: | ||
| Common stock; $0.001 par value: | ||
|
200,000,000 shares authorized, 84,844,815 and 79,649,976 shares issued and outstanding at June 30, 2010 and December 31, 2009, respectively |
84,845 | 79,650 |
| Additional paid-in capital | 119,595,976 | 117,572,373 |
| Accumulated other comprehensive income | (16,000) | (24,000) |
| Accumulated deficit | (146,921,269) | (135,124,216) |
| Total stockholders' deficit | (27,256,448) | (17,496,193) |
| Total liabilities, convertible preferred stock and stockholders' deficit | $39,281,631 | $11,323,569 |
| HANA BIOSCIENCES, INC | ||||
| CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| (Unaudited) | ||||
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||
| 2010 | 2009 | 2010 | 2009 | |
| Operating expenses: | ||||
| General and administrative | $1,875,840 | $1,195,073 | $3,046,735 | $2,572,673 |
| Research and development | 2,705,425 | 3,002,071 | 5,963,970 | 7,194,554 |
| Total operating expenses | 4,581,265 | 4,197,144 | 9,010,705 | 9,767,227 |
| Loss from operations | (4,581,265) | (4,197,144) | (9,010,705) | (9,767,227) |
| Other income (expense): | ||||
| Interest income | 238 | 574 | 506 | 12,156 |
| Interest expense | (940,735) | (833,142) | (2,025,319) | (1,560,149) |
| Other expense, net | -- | -- | -- | (4,907) |
| Change in fair value of warrant liabilities | (424,379) | (2,821,169) | (383,535) | (2,157,109) |
| Change in fair value of investors' right to purchase future shares of Series A-1 and A-2 preferred stock | (378,000) | -- | (378,000) | -- |
| Total other expense | (1,742,876) | (3,653,737) | (2,786,348) | (3,710,009) |
| Net loss | $(6,324,141) | $(7,850,881) | $(11,797,053) | $(13,477,236) |
| Dividends attributable to preferred shares | (9,307,431) | -- | (9,307,431) | -- |
| Net loss applicable to Common Stock | (15,631,572) | -- | (21,104,484) | -- |
| Net loss per share, basic and diluted | $(0.19) | $(0.24) | $(0.26) | $(0.42) |
| Weighted average shares used in computing net loss per share, basic and diluted | 82,066,490 | 32,451,184 | 80,930,614 | 32,450,465 |
| Comprehensive loss: | ||||
| Net loss | $(6,324,141) | $(7,850,881) | $(11,797,053) | $(13,477,236) |
| Unrealized holdings gains (losses) arising during the period | -- | 28,000 | 8,000 | (4,000) |
| Comprehensive loss | $(6,324,141) | $(7,822,881) | $(11,789,053) | $(13,481,236) |