SOUTH SAN FRANCISCO, Calif., Nov. 12, 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 nine months ended September 30, 2010, and provided a corporate update.
"During the third quarter of 2010, our focus was on preparation of the 5 modules that make up the NDA submission for Marqibo®" stated Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. "An analysis of data from the Menadione Topical Lotion Phase 1 program showed that it was generally safe and well tolerated. In addition, the dose limiting toxicity and apparent maximum tolerated lotion strength were identified. Our strategy is to seek a partner to enhance and accelerate the continued development of Menadione Topical Lotion."
Recent Clinical and Corporate Highlights:
- Intensive data collection and verification efforts in the third quarter led to completion of the database lock for the primary Phase 2 Marqibo clinical trial in October 2010.
- Completed data analysis of Menadione Topical Lotion Phase 1 study.
- Dr. Robert Spiegel, former Chief Medical Officer of Schering Plough, joined the Hana Board of Directors.
- Obtained stockholder approval of certain amendments to the Company's certificate of incorporation, which led to an adjustment to the Company's recent Convertible Preferred financing transaction to more Company-favorable terms.
- Amended its License Agreement with Tekmira Pharmaceuticals Corporation resulting in an aggregate reduction of $18 million in Hana's potential milestone obligations in exchange for a one-time payment to Tekmira of $5.75 million.
Three Months Ended September 30, 2010 Financial Results
For the three months ended September 30, 2010, the Company reported a net loss of $7.9 million and deemed dividends on preferred stock of $22.1 million, which when combined, resulted in a net loss applicable to common stockholders of $30.0 million, or $1.41 per share. The deemed dividends on preferred stock had an impact of $1.04 per share for the three months ended September 30, 2010. This compares with a net loss of $5.7 million, or a loss per share of $0.70, for the three months ended September 30, 2009. There were no deemed dividends on preferred stock for the three months ended September 30, 2009.
Total operating expenses for the three months ended September 30, 2010, were $10.3 million, including the one-time payment to Tekmira of $5.75 million, compared with $4.4 million for the three months ended September 30, 2009. Research and development expenses were $9.0 million for the three months ended September 30, 2010, compared with $3.5 million for the three months ended September 30, 2009. General and administrative expenses were $1.3 million for the three months ended September 30, 2010, compared with $0.9 million for the three months ended September 30, 2009.
As of September 30, 2010, the Company had cash, cash equivalents and available-for-sale securities of $27.7 million. Cash used in operations was $10.2 million for the three months ended September 30, 2010 compared with $5.2 million for the three months ended September 30, 2009.
Nine Months Ended September 30, 2010 Financial Results
For the nine months ended September 30, 2010, the Company reported a net loss of $19.7 million and deemed dividends on preferred stock of $31.4 million, which when combined, resulted in a net loss applicable to common stockholders of $51.1 million, or $2.48 per share. The deemed dividends on preferred stock had an impact of $1.52 per share for the nine months ended September 30, 2010. This compares with a net loss of $19.1 million, or a loss per share of $2.36, for the nine months ended September 30, 2009. There were no deemed dividends on preferred stock for the nine months ended September 30, 2009.
Total operating expenses for the nine months ended September 30, 2010, were $19.3 million, including the $5.75 million one-time payment to Tekmira, compared with $14.2 million for the nine months ended September 30, 2009. Research and development expenses were $15.0 million for the nine months ended September 30, 2010, compared with $10.7 million for the nine months ended September 30, 2009. General and administrative expenses were $4.3 million for the nine months ended September 30, 2010, compared with $3.5 million for the nine months ended September 30, 2009.
Cash used in operations was $20.6 million for the nine months ended September 30, 2010 compared with $16.0 million for the nine months ended September 30, 2009.
The per share results for all periods have been adjusted to reflect the impact of the Company's 1-for-4 reverse stock split that occurred at the close of business on September 10, 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; and statements regarding the timing, progress and anticipated results of the clinical development, clinical trial and data analysis timelines, development plans and strategies and the anticipated benefits of Menadione Topical Lotion. 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 a partner with which to develop Menadione Topical Lotion. 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, 2009 and in the Company's Form 10-Q for the period ended March 31, 2010. Hana assumes no obligation to update these statements, except as required by law.
| HANA BIOSCIENCES, INC. | ||
| CONDENSED BALANCE SHEETS | ||
|
September 30, 2010 |
December 31, 2009 |
|
| (Unaudited) | ||
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $8,669,331 | $9,570,453 |
| Available-for-sale, equity securities | 64,000 | 68,000 |
| Available-for-sale, debt securities | 18,981,752 | -- |
| Prepaid expenses and other current assets | 107,074 | 114,067 |
| Total current assets | 27,822,157 | 9,752,520 |
| Property and equipment, net | 135,266 | 252,455 |
| Restricted cash | 125,000 | 125,000 |
| Debt issuance costs | 938,109 | 1,193,594 |
| Total assets | $29,020,532 | $11,323,569 |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
| Current liabilities: | ||
| Accounts payable and accrued liabilities | $4,024,057 | $4,027,075 |
| Other short-term liabilities | 6,479 | 43,586 |
| Total current liabilities | 4,030,536 | 4,070,661 |
| Notes payable, net of discount | 23,188,508 | 22,597,050 |
| Other long-term liabilities | 5,253 | 6,540 |
| Investors' right to purchase future shares of Series A-1 and A-2 preferred stock | 6,239,000 | -- |
| Warrant liabilities, non-current | 692,271 | 2,145,511 |
| Total long term liabilities | 30,125,032 | 24,749,101 |
| Total liabilities | 34,155,568 | 28,819,762 |
| Commitments and contingencies: | ||
| Redeemable convertible preferred stock; $100 par value: | ||
| 10 million shares authorized, 0.4 million and 0 shares issued and outstanding at September 30, 2010 and December 31, 2009, respectively; aggregate liquidation value of $41.5 million and $0 at September 30, 2010 and December 31, 2009, respectively | 30,643,219 | -- |
| Stockholders' deficit: | ||
| Common stock; $0.001 par value: | ||
| 350 million and 200 million shares authorized, 21.2 million and 19.9 million shares issued and outstanding at September 30, 2010 and December 31, 2009, respectively | 21,234 | 19,912 |
| Additional paid-in capital | 119,071,635 | 117,632,111 |
| Accumulated other comprehensive income | (29,532) | (24,000) |
| Accumulated deficit | (154,841,592) | (135,124,216) |
| Total stockholders' deficit | (35,778,255) | (17,496,193) |
| Total liabilities, redeemable, convertible preferred stock and stockholders' deficit | $29,020,532 | $11,323,569 |
| HANA BIOSCIENCES, INC. | ||||
| CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
| (Unaudited) | ||||
| Three Months Ended | Nine Months Ended | |||
| September 30, | September 30, | |||
| 2010 | 2009 | 2010 | 2009 | |
| Operating expenses: | ||||
| General and administrative | $1,253,194 | $932,221 | $4,299,929 | $3,504,895 |
| Research and development | 9,002,798 | 3,506,920 | 14,966,768 | 10,701,473 |
| Total operating expenses | 10,255,992 | 4,439,141 | 19,266,697 | 14,206,368 |
| Loss from operations | (10,255,992) | (4,439,141) | (19,266,697) | (14,206,368) |
| Other income (expense): | ||||
| Interest income | 37,514 | 470 | 38,020 | 12,626 |
| Interest expense | (856,050) | (935,993) | (2,881,369) | (2,496,143) |
| Other expense, net | (3,511) | -- | (3,511) | (4,908) |
| Change in fair value of warrant liabilities | 348,717 | (292,111) | (34,819) | (2,449,220) |
| Change in fair value of investors' right to purchase future shares of Series A-1 and A-2 preferred stock | 2,809,000 | -- | 2,431,000 | -- |
| Total other income (expense) | 2,335,670 | (1,227,634) | (450,679) | (4,937,645) |
| Net loss | $(7,920,322) | $(5,666,775) | $(19,717,376) | $(19,144,013) |
| Deemed dividends attributable to preferred stock | (22,059,541) | -- | (31,366,973) | -- |
| Net loss applicable to common stock | (29,979,863) | -- | (51,084,348) | -- |
| Net loss per share applicable to common stock, basic and diluted | $(1.41) | $(0.70) | $(2.48) | $(2.36) |
| Weighted average shares used in computing net loss per share, basic and diluted | 21,233,804 | 8,145,034 | 20,570,038 | 8,123,541 |
| Comprehensive loss: | ||||
| Net loss | $(7,920,322) | $(5,666,775) | $(19,717,376) | $(19,144,013) |
| Unrealized holdings gains (losses) arising during the period | (13,532) | (20,000) | (5,532) | (24,000) |
| Comprehensive loss | $(7,933,854) | $(5,686,775) | $(19,722,908) | $(19,168,013) |