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Advanced Life Sciences Announces Second Quarter 2009 Financial Results and Financial Outlook
Date:8/11/2009

CHICAGO, Aug. 11 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the second quarter ended June 30, 2009.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

The net loss allocable to common shareholders for the three months ended June 30, 2009 was $2.6 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.4 million or ($0.09) per share for the three months ended June 30, 2008. The decrease in the net loss is due to decreased costs involved in the clinical development of the Company's lead compound, Restanza(TM) (cethromycin).

The Company ended the second quarter of 2009 with cash and cash equivalents totaling $1.0 million. Cash used during the quarter was approximately $2.9 million.

"Advanced Life Sciences today is focused on continuing to pursue approval for Restanza in community acquired pneumonia or CAP and complying with the recommendations by the FDA concerning next steps that can lead to a registration pathway," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Based on the agency's recent communication with the Company, we anticipate that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. We intend to work closely with the agency to design and establish a protocol under a Special Protocol Assessment. We are working on these clinical plans with Wyeth, our development and commercialization partner in the Asia Pacific region, and will also continue to pursue additional collaborations. At the same time, we are also continuing to advance Restanza as a biodefense agent against anthrax, plague and tularemia in our collaborative work with the U.S. government which is fully funding our bioterror countermeasure development program."

Operating Expense Analysis

  • Research and development expenses were $1.3 million for the three months ended June 30, 2009 compared to $1.7 million for the three months ended June 30, 2008.
  • Selling, general and administrative expenses totaled $1.7 million, approximately the same amount as the second quarter of last year.

Business Outlook for 2009

  • Work with the FDA and Wyeth to develop a new clinical protocol to further demonstrate Restanza's efficacy in CAP;
  • Pursue a meeting with the FDA relative to establishing a Special Protocol Assessment for development of Restanza in CAP;
  • Advance negotiations with prospective U.S. and E.U. partners for the development and commercialization of Restanza;
  • Under the Department of Defense (DOD) contract, continue studies and report data emerging from Restanza non-human primate studies in plague and tularemia.

Financial Outlook

To fund ongoing operations in 2009, the Company intends to raise additional capital through commercial partnerships and/or the sale of equity.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Tuesday, August 11, 2009 to discuss the Company's second quarter financial results.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888.680.0860 (domestic) or 617.213.4852 (international). The passcode for the conference call is 88622532. A replay of the conference call will be available until August 18, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 69105186. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=P8EHLRVGT. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

About Restanza

Restanza has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Restanza has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. The Company's lead candidate, cethromycin, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at www.advancedlifesciences.com.

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials, the adequacy of our clinical results, the timing and terms of any commercial partnership, and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.

    ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
    (A Development Stage Company)
                                                   June 30,    December 31,
    CONSOLIDATED BALANCE SHEETS                      2009          2008
    -----------------------------------------------------------------------
    (Unaudited)

    ASSETS

    CURRENT ASSETS:
      Cash and cash equivalents                    $ 998,912     $1,527,108
      Grant receivable                               586,820         63,444
      Prepaid insurance                               47,932        227,313
      Other prepaid expenses and deposits             35,281        143,808
                                               -------------  -------------
        Total current assets                       1,668,945      1,961,673
                                               -------------  -------------

    PROPERTY AND EQUIPMENT:
      Furniture and fixtures                         244,072        244,072
      Laboratory equipment                                 -        159,186
      Computer software and equipment                258,786        258,786
      Leasehold improvements                         505,804        505,804
                                               -------------  -------------

        Total property and equipment-at cost       1,008,662      1,167,848
      Less accumulated depreciation                 (677,543)      (760,329)
                                               -------------  -------------

        Property and equipment-net                   331,119        407,519
                                               -------------  -------------

    OTHER ASSETS:
       Commercial launch materials                 2,760,936              -
       Deferred offering and financing costs          20,348        450,861
       Other long-term assets                         25,006              -
                                               -------------  -------------

        Total other assets                         2,806,290        450,861

    TOTAL ASSETS                                  $4,806,354     $2,820,053
                                               =============  =============

    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

    CURRENT LIABILITIES:
      Accounts payable                            $4,387,982     $1,379,941
      Accrued clinical trial and NDA expenses        112,514        458,260
      Accrued payroll                                451,243        506,537
      Other accrued expenses                         611,095        352,466
      Accrued interest payable                       136,256         72,572
      Short-term lease payable                         8,131          8,468
      Short-term notes payable - related party     2,000,000              -
                                               -------------  -------------

        Total current liabilities                  7,707,221      2,778,244

    Long-term lease payable                              621          4,350
    Long-term grant payable                          500,000        500,000
    Long-term notes payable - related party                -      2,000,000
    Line of credit                                10,000,000      9,915,000
                                               -------------  -------------

        Total liabilities                         18,207,842     15,197,594
                                               -------------  -------------

    COMMITMENTS AND CONTINGENCIES

    STOCKHOLDERS' EQUITY (DEFICIT):
      Common stock, $0.01 par value-120,000,000
       shares authorized; 50,698,926 issued and
       outstanding at June 30, 2009; 40,810,932
       shares issued and outstanding at
       December 31, 2008                             506,989        408,109
      Additional paid-in capital                 113,331,011    109,601,807
      Deficit accumulated during the
       development stage                        (127,239,488)  (122,387,457)
      Noncontrolling interest in subsidiary                -              -
                                               -------------  -------------

        Total equity (deficit)                   (13,401,488)   (12,377,541)
                                               -------------  -------------

    TOTAL LIABILITIES AND EQUITY (DEFICIT)        $4,806,354     $2,820,053
                                               =============  =============


    ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
    (A Development Stage Company)

    CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
    -------------------------------------------------------------------------

                                                                Period From
                                                                 Inception
                                                                 (January 1,
                   Three months              Six months             1999)
                      ended                    ended               Through
                     June 30,                 June 30,             June 30,
                 2009        2008        2009         2008           2009
            -----------  -----------  -----------  -----------  -------------

    Revenue:
      Management
       fees          $-           $-           $-           $-     $1,161,180
      Grants    706,814            -    1,118,299            -      2,394,700
      Royalty-
       related
       party          -            -            -            -         45,238
               --------  -----------  -----------  -----------  -------------

        Total
         reve-
         nue    706,814            -    1,118,299            -      3,601,118
               --------  -----------  -----------  -----------  -------------

    Expenses:
      Research
       and
       develop-
       ment   1,309,050    1,690,088    2,243,819    3,558,141     92,824,220
      Contr-
       acted
       research
       and
       development-
       related
       party          -            -            -            -      7,980,299
      Selling,
       general
       and
       admin-
       istra-
       tive   1,690,505    1,682,604    3,199,458    3,408,972     30,248,095
              ---------  -----------  -----------  -----------  -------------

        Total
         expe-
         nses 2,999,555    3,372,692    5,443,277    6,967,113    131,052,614
              ---------  -----------  -----------  -----------  -------------


    Loss from
     opera-
     tions   (2,292,741)  (3,372,692)  (4,324,978)  (6,967,113)  (127,451,496)

    Net other
     (income)
     expense:
      Interest
       income    (1,739)     (76,444)      (3,471)    (233,086)    (2,952,333)
      Interest
       expense  258,211      102,664      510,929      207,019      3,659,782
      Other
       (income)
       expense,
       net       19,595            -       19,595            -         19,595
      Gain on
       sale of
       interest
       in
       Sarawak
       Medichem
       Pharmace-
       uticals
       joint
       venture        -            -            -            -       (939,052)
                -------  -----------  -----------  -----------  -------------
    Net other
     (income)
     expense    276,067       26,220      527,053      (26,067)      (212,008)
            -----------  -----------  -----------  -----------  -------------

    Net loss (2,568,808)  (3,398,912)  (4,852,031)  (6,941,046)  (127,239,488)
            -----------  -----------  -----------  -----------  -------------

    Less net
     loss
     attributable
     to the
     noncon-
     trolling
     interest in
     subsidiary       -            -            -            -              -
                -------  -----------  -----------  -----------  -------------

    Net loss
     Attributable
     to Advanced
     Life
     Sciences
     Holdings,
     Inc.    (2,568,808)  (3,398,912)  (4,852,031)  (6,941,046)  (127,239,488)
            -----------  -----------  -----------  -----------  -------------

    Less
     accumulated
     preferred
     stock
     dividends
     of
     subsidiary
     for the
     period      43,750       43,750       87,500       87,500      1,757,292
            -----------  -----------  -----------  -----------  -------------

    Net loss
     Available
     to
     common
     share-
     hold-
     ers    $(2,612,558) $(3,442,662) $(4,939,531) $(7,028,546) $(128,996,780)
            ===========  ===========  ===========  ===========  =============
    Net loss
     per share
     available
     to common
     share-
     holders
     - basic
     and
     diluted     $(0.06)      $(0.09)      $(0.11)      $(0.18)
            ===========  ===========  ===========  ===========


    Weighted
     average
     shares
     outstand-
     ing
     - basic
     and
     diluted 47,077,869   38,502,987   44,443,387   38,502,987



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SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
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