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Advanced Life Sciences Announces First Quarter 2009 Financial Results and Financial Outlook

CHICAGO, May 12 /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 first quarter ended March 31, 2009.

The net loss allocable to common shareholders for the three months ended March 31, 2009 was $2.3 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.6 million or ($0.09) per share for the three months ended March 31, 2008. The decrease in the net loss is due to decreased costs involved in the clinical development of the Company's lead compound, cethromycin.

The company ended the first quarter of 2009 with cash and cash equivalents totaling $0.5 million. Cash used during the quarter was approximately $1.6 million.

"Our efforts in the first quarter were focused on preparing for the June 2nd FDA advisory committee meeting which will review the cethromycin New Drug Application," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We look forward to the opportunity to present the FDA panel with a compelling rationale for recommending the approval of cethromycin in the treatment of community acquired pneumonia."

Operating Expense Analysis

  • Research and development expenses were $0.9 million for the three months ended March 31, 2009 compared to $1.9 million for the three months ended March 31, 2008.
  • Selling, general and administrative expenses totaled $1.5 million compared to $1.7 million for the first quarter of last year.

First Quarter Achievements

  • Received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee (AIDAC) is scheduled to meet on June 2, 2009, and will discuss the New Drug Application (NDA) for cethromycin, a new once-a-day oral antibiotic for the outpatient treatment of adults with mild-to-moderate community acquired pneumonia (CAP);
  • Notified by the U.S. Department of Defense that it would exercise its option to award the Company $2.0 million under the previously announced contract to further study cethromycin as a potential broad-spectrum medical countermeasure;
  • Presented a poster titled, "Pro-apoptotic Screening of Novel Aza Triterpenoids through Structure-Activity Relationship Investigation," at the 237th American Chemical Society meeting in Salt Lake City, UT; and
  • Provided a corporate update at the 11th Annual BIO CEO & Investor Conference.

Business Outlook for 2009

  • Advance negotiations with prospective U.S. and E.U. partners for the commercialization of cethromycin;
  • Support the regulatory process associated with the FDA's review of the cethromycin NDA and plan for ex-U.S. regulatory filings;
  • Under the DOD contract, continue studies of cethromycin as a broad spectrum medical countermeasure; and
  • Continue preparing for commercial launch of cethromycin.

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, May 12, 2009 to discuss the company's first 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 Alternatively, callers may participate in the conference call by dialing 888.713.4209 (domestic) or 617.213.4863 (international). The passcode for the conference call is 17640677. A replay of the conference call will be available until May 19, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 53463919. 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 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 Cethromycin

Cethromycin 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. Cethromycin 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 cethromycin 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

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.

    (A Development Stage Company)
                                                   March 31,   December 31,
    CONSOLIDATED BALANCE SHEETS                      2009          2008

      Cash and cash equivalents                    $488,632    $1,527,108
      Grant receivable                              134,889        63,444
      Prepaid insurance                             150,148       227,313
      Other prepaid expenses and deposits           123,757       143,808
                                                    -------       -------

               Total current assets                 897,426     1,961,673
                                                    -------     ---------

      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                (645,980)     (760,329)
                                                   --------      --------

               Property and equipment-net           362,682       407,519
                                                    -------       -------

      Deferred offering and financing costs         210,066       450,861
                                                    -------       -------

    TOTAL ASSETS                                 $1,470,174    $2,820,053
                                                 ==========    ==========


      Accounts payable                           $1,816,526    $1,379,941
      Accrued clinical trial and NDA
       expenses                                     112,452       458,260
      Accrued payroll                               735,890       506,537
      Other accrued expenses                        340,259       352,466
      Accrued interest payable                       98,770        72,572
      Short-term lease payable                        8,812         8,468
      Short-term notes payable -
       related party                              2,000,000             -
                                                  ---------           ---

               Total current liabilities          5,112,709     2,778,244

    Long-term lease payable                           2,013         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                 15,614,722    15,197,594
                                                 ----------    ----------


      Common stock, $0.01 par value-60,000,000
       shares authorized; 43,259,241
       issued and outstanding at March 31,
       2009; 40,810,932 shares issued and
       outstanding at December 31, 2008             432,592       408,109
      Additional paid-in capital                110,093,540   109,601,807
      Deficit accumulated during the
       development stage                       (124,670,680) (122,387,457)
      Noncontrolling interest in subsidiary               -             -
                                                        ---           ---

               Total stockholders' equity
                (deficit)                       (14,144,548)  (12,377,541)
                                                -----------   -----------

     (DEFICIT)                                   $1,470,174    $2,820,053
                                                 ==========    ==========

    (A Development Stage Company)


                                                             Period From
                                  Three months ended          Inception
                                       March 31,          (January 1, 1999)
                                  ------------------          Through
                                     2009         2008     March 31, 2009
                                     ----         ----     ---------------
      Management fees                   $-           $-         $1,161,180
      Grants                       411,485            -          1,687,886
      Royalty-related party              -            -             45,238
                                       ---          ---             ------

               Total revenue       411,485            -          2,894,304
                                   -------          ---          ---------

      Research and
       development                 934,769    1,868,054         91,515,170
      Contracted research and
        related party                    -            -          7,980,299
      Selling, general and
       administrative            1,508,953    1,726,366         28,557,590
                                 ---------    ---------         ----------

               Total expenses    2,443,722    3,594,420        128,053,059
                                 ---------    ---------        -----------

    Loss from operations        (2,032,237)  (3,594,420)      (125,158,755)

    Net other (income)
      Interest income               (1,732)    (156,641)        (2,950,594)
      Interest expense             252,718      104,355          3,401,571
      Gain on sale of
       interest in Sarawak
       Pharmaceuticals joint
       venture                           -            -           (939,052)
                                       ---          ---           --------

    Net other (income)
     expense                       250,986      (52,286)          (488,075)
                                   -------      -------           --------

    Net loss                    (2,283,223)  (3,542,134)      (124,670,680)
                                ----------   ----------       ------------

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

    Net loss attributable to
     Advanced Life Sciences
     Holdings, Inc.             (2,283,223)  (3,542,134)      (124,670,680)
                                ----------   ----------       ------------

    Less accumulated preferred
     stock dividends of
     subsidiary for the period      43,750       43,750          1,713,542
                                    ------       ------          ---------

    Net loss available to
     common shareholders       $(2,326,973) $(3,585,884)     $(126,384,222)
                               ===========  ===========      =============

    Net loss per share
     available to common
     shareholders - basic
     and diluted                    $(0.06)      $(0.09)
                                    ======       ======

    Weighted average shares
     outstanding - basic and
     diluted                    41,779,634   38,502,987

SOURCE Advanced Life Sciences Holdings, Inc.
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