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Advanced Life Sciences Announces Third Quarter 2009 Financial Results
Date:11/10/2009

CHICAGO, Nov. 10 /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 third quarter ended September 30, 2009.

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

The net loss allocable to common shareholders for the three months ended September 30, 2009 was $2.9 million or ($0.05) per share compared to a net loss allocable to common shareholders of $13.1 million or ($0.34) per share for the three months ended September 30, 2008. The decrease in the net loss is due to a $10.0 million milestone expense incurred under the license agreement with Abbott in the third quarter of last year as well as decreased costs related to regulatory expenses and development activities involving the Company's lead compound, Restanza(TM) (cethromycin).

The Company ended the third quarter of 2009 with cash and cash equivalents totaling $4.2 million. Cash used for operations during the quarter was approximately $4.5 million.

"In the third quarter, we continued to advance Restanza on two significant fronts: in community acquired pneumonia (CAP) and as a broad spectrum countermeasure for biodefense," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "In CAP, we are in ongoing discussions with the FDA to identify the scope and protocol design for the additional clinical data that would be required to satisfy the FDA's request for additional efficacy information to complete the clinical development program. In biodefense, we made exciting progress by generating positive pivotal data in anthrax and plague and receiving orphan designation in tularemia and plague."

Dr. Flavin added: "As another indication of the government's interest in Restanza as a biodefense agent, the Company was invited to submit a full proposal in response to a Broad Agency Announcement (BAA) issued by the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services for the advanced development of Restanza as a broad spectrum countermeasure for biodefense. BARDA funding could significantly help to advance Restanza toward approval by the FDA as an important medical countermeasure, and toward consideration by the government for acquisition and stockpiling."

Operating Expense Analysis

  • Research and development expenses were $0.9 million for the three months ended September 30, 2009 compared to $11.2 million for the three months ended September 30, 2008. This difference was primarily due to the $10.0 million milestone expense incurred under our license agreement with Abbott in the third quarter of 2008.
  • Selling, general and administrative expenses totaled $2.2 million for the three months ended September 30, 2009 compared to $1.8 million for the same period in 2008.

Third Quarter Events

  • Reported results from a pivotal primate study in which Restanza demonstrated efficacy in treating anthrax infection;
  • Announced results showing Restanza's protective efficacy in a plague pivotal primate study;
  • Received FDA Orphan Drug Designation for Restanza in plague and tularemia;
  • Received complete response letter from FDA for Restanza in CAP.

Business Goals for 2009

  • Complete studies under the Department of Defense (DoD) contract and report data from pivotal primate study measuring Restanza's protective efficacy in tularemia;
  • Attend December 9th FDA Anti-Infective Drugs Advisory Committee meeting that will discuss CAP clinical trial design and endpoints;
  • Work with the FDA and Pfizer (formerly Wyeth) to identify the scope and protocol design for the additional clinical data that would be required to satisfy the FDA's request for additional efficacy information to complete the CAP clinical development program and gain agency approval;
  • Work with the FDA to determine the regulatory package needed for approval in the biodefense indications of anthrax, plague and tularemia;
  • Advance negotiations with prospective U.S. and E.U. partners for the development and commercialization of Restanza.

Financial Outlook

To fund ongoing operations in 2010, 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, November 10, 2009 to discuss the Company's third 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 888.713.4214 (domestic) or 617.213.4866 (international). The passcode for the conference call is 75545191. A replay of the conference call will be available until November 17, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 79025053. 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=PGFUTHTV6. 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 is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of CAP and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CAP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.

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, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP and biodefense pathogens including anthrax, plague and tularemia. 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)


    CONSOLIDATED BALANCE SHEETS                September 30,  December 31,
    (Unaudited)                                     2009          2008
    ----------                                  -----------    ----------

    ASSETS

    CURRENT ASSETS:
      Cash and cash equivalents                  $4,161,612    $1,527,108
      Grant receivable                              334,885        63,444
      Prepaid insurance                             100,371       227,313
      Other prepaid expenses and deposits           114,045       143,808
                                                    -------       -------

               Total current assets               4,710,913     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                        177,253       505,804
                                                    -------       -------

               Total property and
                equipment-at cost                   680,111     1,167,848
      Less accumulated depreciation                (612,042)     (760,329)
                                                   --------      --------

               Property and equipment-net            68,069       407,519
                                                     ------       -------

    OTHER ASSETS:
       Commercial launch materials                2,760,936             -
       Deferred offering and financing costs         16,957       450,861
       Other long-term assets                        25,000             -
                                                     ------           ---

               Total other assets                 2,802,893       450,861
                                                  ---------       -------

    TOTAL ASSETS                                 $7,581,875    $2,820,053
                                                 ==========    ==========

    LIABILITIES AND STOCKHOLDERS'
     EQUITY (DEFICIT)

    CURRENT LIABILITIES:
      Accounts payable                           $1,721,745    $1,379,941
      Accrued clinical trial and
       NDA expenses                                  80,053       458,260
      Accrued payroll                               873,039       506,537
      Other accrued expenses                        685,470       352,466
      Accrued interest payable                       97,771        72,572
      Short-term lease payable                        6,595         8,468
      Short-term notes payable - related party    2,000,000             -
                                                  ---------           ---

               Total current liabilities          5,464,673     2,778,244

    Long-term lease payable                               -         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                 15,964,673    15,197,594
                                                 ----------    ----------

    COMMITMENTS AND CONTINGENCIES

    STOCKHOLDERS' EQUITY (DEFICIT):
      Common stock, $0.01 par value-
       120,000,000 shares authorized;
       75,969,683 issued and
       outstanding at September 30,
       2009; 40,810,932 shares issued
       and outstanding at December 31,
       2008                                         759,697       408,109
      Additional paid-in capital                120,955,240   109,601,807
      Deficit accumulated during the
       development stage                       (130,097,735) (122,387,457)
      Noncontrolling interest in subsidiary               -             -
                                                        ---           ---

               Total equity (deficit)            (8,382,798)  (12,377,541)
                                                 ----------   -----------

    TOTAL LIABILITIES AND EQUITY (DEFICIT)       $7,581,875    $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 ended       Nine months ended          1999)
                    September 30,           September 30,          Through
                 ------------------       -----------------      September 30,
                 2009          2008       2009          2008         2009
                 ----          ----       ----          ----     -------------
    Revenue:
      Management
       Fees         $-            $-          $-            $-     $1,161,180
      Grants   616,940        32,006   1,735,239        32,006      3,011,640
      Royalty-
       related
       party         -             -           -             -         45,238
                   ---           ---         ---           ---         ------
       Total
        rev-
        enue   616,940        32,006   1,735,239        32,006      4,218,058
               -------        ------   ---------        ------      ---------

    Expenses:
      Research
       and
       devel-
       opment  916,241    11,240,032   3,160,061    14,798,173     93,740,462
      Contracted
        research
        and
        development-
        related
        party        -             -           -             -      7,980,299
      Selling,
       general
       and
       admin-
       istra-
       tive  2,201,684     1,828,607   5,401,142     5,237,579     32,449,779
             ---------     ---------   ---------     ---------     ----------
       Total
        expen-
        ses  3,117,925    13,068,639   8,561,203    20,035,752    134,170,540
             ---------    ----------   ---------    ----------    -----------


    Loss
     from
     oper-
     ations (2,500,985)  (13,036,633) (6,825,964)  (20,003,746)  (129,952,482)

    Net other
     (income)
     expense:
      Interest
       income   (5,865)      (51,244)     (9,336)     (284,330)    (2,958,198)
      Interest
       expense 263,272       103,277     774,201       310,296      3,923,054
      Other     99,854             -     119,449             -        119,449
       (income)
       expense,
       net
      Gain
       on
       sale
       of
       interest
       in
       Sarawak
       Medichem
       Pharma-
       ceuticals
       joint
       venture       -             -           -             -       (939,052)
                   ---           ---         ---           ---       --------
    Net
     other
     (income)
     Expense   357,261        52,033     884,314        25,966        145,253
               -------        ------     -------        ------        -------
    Net
     loss   (2,858,246)  (13,088,666) (7,710,278)  (20,029,712)  (130,097,735)
            ----------   -----------  ----------   -----------   ------------

    Less
     net
     loss
     attrib-
     utable
     to the
     non-
     controlling
     interest in
     subsidiary      -             -           -             -              -
                   ---           ---         ---           ---            ---
    Net
     loss
     attributable
     to
     Advanced
     Life
     Sciences
     Holdings,
     Inc.   (2,858,246)  (13,088,666) (7,710,278)  (20,029,712)  (130,097,735)
             ---------    ----------   ---------    ----------    -----------
    Less
     accumulated
     preferred
     stock
     dividends
     of subsidiary
     for the
     period     43,750        43,750     131,250       131,250      1,801,042
                ------        ------     -------       -------      ---------
    Net
     loss
     availa-
     ble
     to
     common
     share-
     hold-
     ers   $(2,901,996) $(13,132,416)$(7,841,528) $(20,160,962) $(131,898,777)
           ===========  ============ ===========  ============  =============

    Net
     loss
     per
     share
     available
     to
     common
     shareholders -
     basic
     and
     diluted    $(0.05)       $(0.34)     $(0.15)       $(0.52)
                ======        ======      ======        ======

    Weighted
     average
     shares
     out-
     standing -
     basic
     and
     dil-
     uted   62,715,539    38,568,464  50,601,036    38,524,972

SOURCE Advanced Life Sciences Holdings, Inc.


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SOURCE Advanced Life Sciences Holdings, Inc.
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