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Hana Biosciences Reports Third Quarter 2008 Results

November 13, 2008

SOUTH SAN FRANCISCO, Calif., Nov. 13, 2008 (GLOBE NEWSWIRE) — Hana Biosciences (Nasdaq:HNAB), a biopharmaceutical company focused on strengthening the foundation of cancer care, today announced its financial results and operational highlights for the third quarter ended September 30, 2008.

“During the third quarter of 2008, we continued to achieve significant progress on advancing our pipeline of dose-intensifying and compliance-enhancing oncology product candidates that address sizeable commercial opportunities, as evidenced by the positive results from our two key pipeline candidates, Marqibo and menadione,” said Steven R. Deitcher, M.D., President and Chief Executive Officer of Hana Biosciences. “We expect to build on this progress during the coming months as we continue to focus our investment spending, and we remain on track to achieve multiple near-term milestones, in these highest priority initiatives.”

Third Quarter 2008 Key Achievements

    * Marqibo(r) for adult acute lymphoblastic leukemia (ALL): Hana's    registration-enabling Phase 2 rALLy pivotal clinical trial of    Marqibo (vincristine sulfate injection, OPTISOME(tm)) successfully    achieved the pre-specified protocol requirement of at least 3    complete responses or complete responses without full platelet    recovery among the first 29 evaluable patients to proceed to full    enrollment of 56 patients with ALL in second relapse.  After Hana    completes enrollment of the first 29 patients, the data will be    submitted to the Independent Data Monitoring Committee (IDMC),    which will examine the interim safety results of the trial.  During    the third quarter, Marqibo received orphan drug designation from    the European Medicines Evaluation Agency in adult ALL.  Hana    previously received orphan drug and fast track designations for    Marqibo for adult ALL from the U.S. Food and Drug Administration.    The Company expects the IDMC interim analysis of the rALLy trial,    as well as efficacy and safety updates from the trial during the    first quarter of 2009.   * Menadione Topical Lotion for EGFRI-associated skin rash: Data    presented at the European Society for Medical Oncology Conference    demonstrated that topical menadione did not affect the anti-tumor    effect of erlotinib (Tarceva(r)), an approved epidermal growth    factor receptor inhibitor (EGFRI), in preclinical models.  Other    preclinical data presented at the meeting showed menadione's    ability to restore kinase activity in the presence of specific    kinase inhibitors.  These data indicate that treatment with    menadione may result in restoration of normal cell turnover rates    and prevent skin toxicities that result from inhibition of protein    kinases associated with tumor growth signaling pathways, such as    the tyrosine kinases MEK, CDK and RAF.  Hana is currently    evaluating menadione in a Phase 1 clinical trial for the treatment    and/or prevention of EGFRI associated skin toxicities, and expects    top-line data during the fourth quarter of 2008.  Currently, there    are no FDA-approved products or therapies available to treat these    skin toxicities.   * Alocrest(tm) for solid tumor cancers and lymphomas:  At the    European Society for Medical Oncology Conference, Hana presented    Phase 1 data for Alocrest, the Company's OPTISOME(tm) encapsulated    formulation of vinorelbine tartrate.  Overall, this study achieved    a disease control rate of 47 percent, including three of four    elderly non-small cell lung cancer (NSCLC) subjects who achieved    stable disease.  Of 27 subjects with refractory solid tumors and 3    subjects with NHL evaluable for efficacy, one patient achieved a    Partial Response (unconfirmed) and 13 patients achieved Stable    Disease.  Alocrest was generally well-tolerated with reversible    neutropenia as the most common dose limiting toxicity, and a    maximum tolerated dose comparable to unencapsulated vinorelbine in    heavily pre-treated patients. 

Subsequent Events

    * In November 2008, Hana initiated a Phase 1 trial with Brakiva(tm)    (topotecan liposomes injection, OPTISOME(tm)) in advanced solid    tumors in patients with small cell lung and ovarian cancers.  The    primary objective is to evaluate the safety, tolerability, and to    determine the maximum tolerated dose of Brakiva when administered    to subjects with tumors that have relapsed, are refractory to    standard treatment, or for whom there is no standard therapy    available.  Secondarily, the study will assess the pharmacokinetic    (PK) profile of Brakiva and examine the PK/pharmacodynamic    relationship between measures of exposure and effect.  Data is    expected at the end of 2009. 

Third Quarter 2008 Financial Results

The Company reported a net loss of $5.2 million, or $0.16 per share, for the three months ended September 30, 2008 compared to $5.1 million, or $0.16 per share, for the same period in 2007.

Research and development expense for the quarter ended September 30, 2008 was $4.3 million, compared to $5.7 million for three months ended September 30, 2007. The decrease in research and development costs was primarily due to decreased spending on earlier-stage pipeline programs partially offset by increased spending for clinical development of Marqibo and menadione.

General and administrative expenses totaled $1.0 million for the quarter ended September 30, 2008 compared with $0.5 million for the three months ended September 30, 2007. The increase was primarily due to an increase in employee related stock option expenses.

Cash used in operations was $5.5 million for the quarter ended September 30, 2008. As of September 30, 2008, the Company had cash and cash equivalents and available-for-sale securities of $3.8 million. In October 2007, the Company entered into a $30 million financing commitment with Deerfield Management, a leading healthcare investment fund, to finance ongoing working capital requirements of the development of the Company’s pipeline of product candidates. On October 14, 2008, the Company borrowed $12.5 million under the agreement and on November 5, 2008 requested an additional $2.5 million.

“Our current cash balance along with the funds available through the Deerfield agreement will enable us to deliver valuable Phase 2 clinical data for Marqibo, and to further advance our lead pipeline programs,” said John Iparraguirre, Vice President and Chief Financial Officer.

Conference Call

Hana Biosciences’ management will host a conference call discussion today, November 13, 2008, at 5:00pm ET, 2:00pm PT.

    Date:                        Thursday, November 13, 2008  Time:                        5:00pm ET, 2:00pm PT  Dial-in (U.S. and Canada):   (877) 407-8031  Dial-in (International):     (201) 689-8031  Webcast:                     www.hanabiosciences.com 

A replay of this call will be available for one week by dialing (877) 660-6853 U.S./Canada and (201) 612-7415 for International participants. When prompted, enter Account Number #286 and Conference ID #301599. An archived version of the webcast will also be available via the company’s website for 14 days following the call.

About Hana Biosciences, Inc.

Hana Biosciences, Inc. (Nasdaq:HNAB) is a South San Francisco, CA-based biopharmaceutical company focused on acquiring, developing, and commercializing innovative products to strengthen the foundation of cancer care. The company is committed to creating value by building a best-in-class team, accelerating the development of lead product candidates, expanding its pipeline by being an alliance partner of choice, and nurturing a unique company culture. Further 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. 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, 2007 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                              (Unaudited)                                            September 30,   December 31,                                               2008            2007                                           -------------  -------------   ASSETS  Current assets:  Cash and cash equivalents                $   3,743,357  $  20,795,398  Available-for-sale securities                   72,000         96,000  Prepaid expenses and other current   assets                                        738,491        489,293                                           -------------  -------------   Total current assets                        4,553,848     21,380,691   Property and equipment, net                    445,436        432,529  Restricted cash                                125,000        125,000  Debt issuance costs                          1,395,296      1,423,380                                           -------------  -------------  Total assets                             $   6,519,580  $  23,361,600                                           =============  =============   LIABILITIES AND STOCKHOLDERS' EQUITY   (DEFICIT)  Current liabilities:  Accounts payable                         $     270,311  $   1,682,739  Accrued other expenses                         187,330        496,239  Accrued personnel related expenses             637,600        763,050  Leased equipment: short-term                    48,085         13,919  Accrued clinical development costs           2,092,441      1,156,011                                           -------------  -------------   Total current liabilities                   3,235,767      4,111,958                                           -------------  -------------   Notes payable                                2,189,716      2,025,624  Warrant liabilities                          2,032,523      4,232,355  Leased equipment: long-term                     58,680         33,861                                           -------------  -------------  Total long term liabilities                  4,280,919      6,291,840                                           -------------  -------------  Total liabilities                            7,516,686     10,403,798  Commitments and contingencies   Stockholders' equity (deficit):  Common stock; $0.001 par value:   100,000,000 shares authorized,   32,386,130 and 32,169,553 shares issued   and outstanding at September 30, 2008   and December 31, 2007, respectively            32,386         32,170  Additional paid-in capital                 103,903,612    101,843,390  Accumulated other comprehensive loss           (20,000)      (104,000)  Accumulated deficit                       (104,913,104)   (88,813,758)                                           -------------  -------------  Total stockholders' equity (deficit)          (997,106)    12,957,802                                           -------------  -------------  Total liabilities and stockholders'   equity (deficit)                        $   6,519,580  $  23,361,600                                           =============  =============                          HANA BIOSCIENCES, INC.    CONDENSED STATEMENTS OF OPERATIONS AND OTHER COMPREHENSIVE LOSS                              (Unaudited)                       Three Months Ended         Nine Months Ended                         September 30,             September 30,                   ------------------------  --------------------------                      2008          2007         2008          2007                   -----------  -----------  ------------  ------------  License revenue  $        --  $ 1,150,000  $         --  $  1,150,000   Operating   expenses:  General and   administrative      973,414      481,155     4,623,889     6,553,502  Research and   development       4,347,265    5,730,859    13,031,060    17,442,556                   -----------  -----------  ------------  ------------  Total operating   expenses          5,320,679    6,212,014    17,654,949    23,996,058   Loss from   operations       (5,320,679)  (5,062,014)  (17,654,949)  (22,846,058)                   -----------  -----------  ------------  ------------   Other income   (expense):  Interest income       39,997      265,307       271,361       972,932  Interest expense    (254,569)      (1,138)     (756,211)       (3,807)  Other expense,   net                 (8,516)      (42,418)      (51,380)      (61,057)  Gain or loss on   derivative          382,152           --     2,199,833            --  Realized loss on   marketable   securities               --     (260,000)     (108,000)     (436,000)                   -----------  -----------  ------------  ------------  Total other   income (expense)    159,064      (38,249)    1,555,603       472,068   Net loss         $(5,161,615) $(5,100,263) $(16,099,346) $(22,373,990)                   ===========  ===========  ============  ============  Net loss per   share, basic   and diluted     $     (0.16) $     (0.16) $      (0.50) $      (0.75)                   ===========  ===========  ============  ============   Weighted average   shares used in   computing net   loss per share,   basic and   diluted          32,385,366   31,197,295    32,265,010    29,958,487                   ===========  ===========  ============  ============  Comprehensive   loss:  Net loss         $(5,161,615) $(5,100,263) $(16,099,346) $(22,373,990)  Unrealized   holdings gains   (losses) arising   during the   period              (20,000)          --      (128,000)     (456,000)  Less:   reclassification   adjustment for   losses included   in net loss              --           --       108,000       436,000                   -----------  -----------  ------------  ------------   Comprehensive   loss            $(5,181,615) $(5,100,263) $(16,119,346) $(22,393,990)                   ===========  ===========  ============  ============ 

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 CONTACT:  Hana Biosciences           Investor & Media Contacts:           Investor Relations Team           (650) 588-6641           investor.relations@hanabiosciences.com            Invigorate Communications           Gregory Gin           (908) 376-7737           ggin@invigoratepr.com 




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