Advanced Life Sciences Announces Fourth Quarter And Full Year 2005 Results

WOODRIDGE, Ill., March 14 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation, today announced its financial results for the fourth quarter and full year ended December 31, 2005. The net loss for the three months ended December 31, 2005 was $2.6 million or ($.15) per share compared to a net loss of $25.3 million or ($7.29) per share for the three months ended December 31, 2004. The net loss for the full year 2005 was $6.6 million or ($.49) per share compared to a net loss of $27.4 million or ($13.27) per share for 2004. The decrease in the net loss for both periods is due to the $24.5 million in-process research & development charge the Company took in the fourth quarter of 2004, reflecting its establishment of a license agreement with Abbott Laboratories for cethromycin.

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Michael T. Flavin, Ph.D., chairman and chief executive officer of the Company, noted, "Advanced Life Sciences continued to make excellent progress during 2005. We completed our IPO to provide the capital required to advance the clinical development of our lead product, cethromycin and we launched our pivotal phase III clinical trials for cethromycin in the fourth quarter. With the closing of our recent $33.6 million private financing, we have strengthened our financial position and broadened our shareholder base."

The Company ended 2005 with cash, cash equivalents and investments totaling approximately $15.2 million.

Operating Expense Analysis 2005 versus 2004: -- Research and development expense. Total research and development expense decreased 88% to approximately $3.1 million for the twelve months ended December 31, 2005 from approximately $25.7 million for the twelve months ended December 31, 2004. The total expense realized in 2004 of $25.7 million includes an in-process research and development charge totaling approximately $24.5 million related to the cethromycin license. Excluding this non-recurring expense, total research and development expenditures increased by approximately $1.9 million in 2005. -- General and administrative expense. General and administrative expense increased 96% to approximately $3.2 million for the year ended December 31, 2005 from $1.6 million for the year ended December 31, 2004. Of the approximate $1.6 million increase in administrative expense, approximately $776,000 related to one-time stock option expense and compensation charges paid in connection with the completion of the Company's IPO. 2005 Operational and Financial Highlights:

Advanced Life Sciences is developing cethromycin, a novel once-a-day ketolide antibiotic, in response to the emerging antibiotic resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has previously been tested by Abbott in approximately 3,800 human subjects during clinical trials, and the Company has initiated pivotal phase III clinical trials for the treatment of mild-to-moderate CAP.

Advanced Life Sciences completed the following activities in 2005: -- Launched pivotal phase III clinical trials with cethromycin in CAP -- Received FDA guidance regarding its cethromycin regulatory and development plan -- Established presence with key thought leaders in the infectious disease field at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) conference -- Engaged Quintiles as its clinical research organization for cethromycin clinical development -- Completed tablet manufacturing and clinical site distribution of cethromycin with Cardinal Health -- Elected Scott Meadow, an experienced healthcare financier, and Richard Reck, formerly a partner with KPMG, to its board of directors. Mr. Meadow was also elected as chairman of the board compensation committee, while Mr. Reck was elected chairman of the board audit committee -- Raised net proceeds of $28.7 million in its August, 2005 IPO.

Advanced Life Sciences recently raised net proceeds of approximately $33.6 million in a private placement in March, 2006. Additionally, the Company engaged Montridge, LLC, a financial healthcare investor relations firm, and continued a comprehensive IR program.

2006 Financial and Operational Guidance:

The Company anticipates the following upcoming milestones in the clinical development of cethromycin:

-- Completion of pivotal phase III clinical trials in 2006 -- Submission of NDA for the CAP indication in the first quarter of 2007 -- Advancement of discussions with potential commercial partners for cethromycin.

Advanced Life Sciences expects to invest between $22 million and $25 million in the cethromycin program and supporting operations over 2006. The Company anticipates cash requirements of between $3.5 million and $4 million for first quarter 2006 operating activities. With the current cash on hand, the Company believes it has sufficient financial resources to complete the cethromycin clinical trial program in CAP and file its NDA with the FDA. Advanced Life Sciences is on track to initiate 200 clinical sites in the Northern and Southern Hemispheres to recruit 1,000 total subjects in its pivotal phase III CAP clinical trials for cethromycin during 2006.

Conference Call Details:

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, March 15, 2006 to discuss the Company's fourth quarter financial results.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of Advanced Life Sciences' corporate website at http://www.advancedlifesciences.com . Alternatively, callers may participate in the conference call by dialing 800-322-2803 (domestic) or 617-614-4925 (international). The passcode for the conference call is 38767589. A telephone replay of the call will also be available for 48 hours. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 53133563.

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 inflammation. The Company's lead candidate, cethromycin, is a novel once-a-day ketolide antibiotic in late-stage clinical development for the treatment of respiratory tract infections including CAP.

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. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences' filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED BALANCE SHEETS Year ended December 31, 2005 2004 ASSETS CURRENT ASSETS: Cash & cash equivalents $4,749,932 $194,555 Investments - available for sale 10,475,000 - Accounts receivable - related party 6,160 24,868 Clinical trials supplies - 533,333 Prepaid insurance 362,241 - Prepaid expenses and other 118,263 25,806 Total current assets 15,711,596 778,562 FURNITURE AND EQUIPMENT: Furniture and fixtures 147,275 139,005 Laboratory equipment 142,928 142,928 Computer equipment 111,884 79,146 Leasehold improvements 40,646 40,646 Construction in-progress 75,887 - Total furniture and equipment-at cost 518,620 401,725 Less accumulated depreciation (267,372) (180,807) Furniture and equipment-net 251,248 220,918 OTHER LONG-TERM ASSETS: Deferred financing costs 53,004 15,000 Other assets 6,062 1,452 Total other long-term assets 59,066 16,452 TOTAL ASSETS $16,021,910 $1,015,932 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $294,816 $255,880 Accrued expenses 240,761 185,348 Accrued interest payable 5,334 4,319 Licenses payable - 14,000,000 Notes payable, net of $11,766 debt discount - 2,238,234 Short-term lease payable 14,114 12,070 Total current liabilities 555,025 16,695,851 Long-term lease payable 13,166 27,279 Accrued interest payable - related party 765,514 566,603 Grant payable 500,000 - Notes payable - net of $22,532 debt discount 3,892,468 - Notes payable - related party 2,000,000 2,000,000 Total liabilities 7,726,173 19,289,733 STOCKHOLDERS' EQUITY: Common stock, $0.01 par value- December 31, 2005: 60,000,000 shares authorized; 17,990,322 issued and outstanding; December 31, 2004: 10,604,584 shares issued and outstanding; 179,903 106,046 Series A preferred stock of Advanced Life Sciences Inc., no par value-250,000 shares authorized, issued and outstanding - - Additional paid-in capital 54,834,373 21,894,446 Deficit accumulated during the development stage (46,718,539) (40,274,293) Total stockholders' equity (deficit) 8,295,737 (18,273,801) TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $16,021,910 $1,015,932 ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED STATEMENTS OF OPERATIONS Three months ended Twelve months ended December 31, December 31, 2005 2004 2005 2004 Revenue and Other Income: Management fees $8,358 $61,824 $61,239 $271,644 Grant 60,212 60,212 38,136 Royalty-related party - - - 10,000 Total revenue and other income 68,570 61,824 121,451 319,780 Expenses: Research and development 1,516,867 24,788,749 3,121,616 25,661,868 Selling, general and administrative 1,159,751 451,039 3,237,997 1,649,953 Total expenses 2,676,618 25,239,788 6,359,613 27,311,821 Loss from operations (2,608,048) (25,177,964) (6,238,162) (26,992,041) Interest income (174,504) - (272,216) - Interest expense 138,126 52,354 478,300 194,877 Net other (income) expense (36,378) 52,354 206,084 194,877 Net loss (2,571,670) (25,230,318) (6,444,246) (27,186,918) Less accumulated preferred dividends for the period 43,750 43,750 175,000 175,000 Net loss available to common shareholders $(2,615,420) $(25,274,068) $(6,619,246) $(27,361,918) Basic net loss per share available to common shareholders $(0.15) $(7.29) $(0.49) $(13.27) Weighted average number common shares outstanding - basic and diluted 17,990,322 3,468,835 13,610,694 2,062,351

CONTACT: Investor Relations, Edward P. Flavin of Advanced Life SciencesHoldings, Inc., +1-630-739-6744 Ex 211

Web site: http://www.advancedlifesciences.com/