WOODRIDGE, Ill., Aug. 8 /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 second quarter ended June 30, 2006. The net loss available to common shareholders for the three months ended June 30, 2006 was $4.5 million or ($0.16) per share compared to $1.0 million or ($0.09) per share for the three months ended June 30, 2005. The increase in the net loss reflects increased development expenses related to cethromycin pivotal Phase III clinical trial costs.
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“Advanced Life Sciences had a productive second quarter, making steady progress toward our milestones,” said Michael T. Flavin, Ph.D., Chairman and Chief Executive Officer of Advanced Life Sciences. “We are focused on enrolling patients in our pivotal Phase III clinical trials for cethromycin and are on track to have approximately 200 clinical sites enrolling patients in the Fall as planned. Our team is focused on the completion of the trials as we advance cethromycin toward an NDA in 2007.”
The Company ended the second quarter of 2006 with cash and cash equivalents totaling $39.2 million. Cash used during the second quarter was approximately $5.7 million.
Operating Expense Analysis -- Research and development expenses increased $3.2 million to $3.6 million for the three months ended June 30, 2006 from $0.4 million for the three months ended June 30, 2005. This increase was due to additional development expenses directly related to our Phase III clinical trials for cethromycin. -- Selling, general and administrative expenses increased $0.8 million to $1.3 million for the three months ended June 30, 2006 from $0.5 million for the three months ended June 30, 2005. This increase is primarily attributed to the public company costs related to director and officer insurance, director’s fees, investor relations and legal and accounting services. Second Quarter 2006 Product Candidate Highlights
Advanced Life Sciences is developing cethromycin, a second generation once-a-day ketolide antibiotic in response to the emerging antibiotic resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 3,800 human subjects during clinical trials.
The Company is currently conducting pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate CAP. Advanced Life Sciences believes that cethromycin, if approved, would address the need for antibiotics that overcome bacterial resistance, yet retain a mild safety profile.
Cethromycin Progress and Upcoming Milestones
The Company initiated approximately 51 new clinical sites, including 42 sites in Latin America and South Africa and 9 new sites in North America. A total of approximately 126 clinical sites have been initiated in these three geographies. Additionally, we made regulatory submissions in 12 European countries. We are targeting the start of patient enrollment at 70 sites for the beginning of CAP season in the European region.
In May 2006, the Company initiated cethromycin commercial manufacturing agreements with DSM and Cardinal Health.
Based upon the favorable results of our collaboration with USAMRIID, in July 2006 we initiated a pre-NDA animal study with Battelle for cethromycin as a potential treatment for inhalation anthrax.
The Company anticipates the following upcoming milestones in the clinical development of cethromycin:
-- Complete cethromycin pivotal Phase III clinical trials by year end. -- Present data from prior cethromycin clinical trials at key scientific conferences including ICAAC and IDSA. -- Sponsor a cethromycin principal investigator meeting in Rome, Italy for physicians enrolling CAP patients in Europe. -- Advance discussions with prospective partners regarding a commercialization partnership for cethromycin. Financial Guidance for the Third Quarter of 2006
The Company expects its third quarter 2006 cash requirements to range between $7.0 and $8.0 million.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, August 9, 2006 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 http://www.advancedlifesciences.com . Alternatively, callers may participate in the conference call by dialing 800-573-4840 (domestic) or 617-224-4326 (international). The passcode for the conference call is 75880306. A replay of the conference call will be available until September 9, 2006. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 32997825.
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 second generation once-a-day ketolide antibiotic in late-stage clinical development for the treatment of respiratory tract infections.
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) June 30, December 31, CONDENSED CONSOLIDATED BALANCE SHEETS 2006 2005 (Unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $39,167,501 $4,749,932 Investments - available for sale - 10,475,000 Accounts receivable - related party - 6,160 Prepaid insurance 104,895 362,241 Prepaid expenses and other 2,721,772 118,263 Total current assets 41,994,168 15,711,596 PROPERTY AND EQUIPMENT: Furniture and fixtures 174,598 147,275 Laboratory equipment 142,928 142,928 Computer software and equipment 211,984 187,771 Leasehold improvements 40,646 40,646 Total property and equipment - at cost 570,156 518,620 Less accumulated depreciation (315,101) (267,372) Property and equipment - net 255,055 251,248 OTHER LONG-TERM ASSETS: Deferred financing costs 39,753 53,004 Other assets 3,654 6,062 Total other long-term assets 43,407 59,066 TOTAL ASSETS $42,292,630 $16,021,910 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $148,528 $294,816 Accrued expenses 1,668,986 240,761 Accrued interest payable 12,917 5,334 Short-term lease payable 19,798 14,114 Total current liabilities 1,850,229 555,025 Long-term lease payable 20,678 13,166 Accrued interest payable - related party - 765,514 Grant payable 500,000 500,000 Notes payable - net of $16,899 debt discount June 30, 2006 & $22,532 December 31, 2005 3,898,101 3,892,468 Notes payable - related party 2,000,000 2,000,000 Total liabilities 8,269,008 7,726,173 STOCKHOLDERS’ EQUITY: Common stock, $0.01 par value - June 30, 2006: 60,000,000 shares authorized; 28,258,899 issued and outstanding; December 31, 2005: 17,990,322 shares issued and outstanding; 282,589 179,903 Series A preferred stock of Advanced Life Sciences Inc., no par value - 250,000 shares authorized, issued and outstanding - - Additional paid-in capital 88,223,792 54,834,373 Deficit accumulated during the development stage (54,482,759) (46,718,539) Total stockholders’ equity (deficit) 34,023,622 8,295,737 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $42,292,630 $16,021,910 ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Period From Inception (January 1, Three months ended Six months ended 1999) June 30, June 30, Through 2006 2005 2006 2005 June 30, 2006 Revenue and income: Management fees $- $11,860 $- $44,379 $1,161,180 Grant - - 35,127 - 1,030,910 Royalty-related party - - - - 45,238 Total revenue and income - 11,860 35,127 44,379 2,237,328 Expenses: Research and develop- ment 3,579,038 348,146 5,839,416 665,936 37,772,652 Contracted research and develop- ment - related party - - 7,980,299 Selling, general and administr- ative 1,338,842 470,828 2,488,012 838,572 10,123,130 Total expen- ses 4,917,880 818,974 8,327,428 1,504,508 55,876,081 Loss from opera- tions (4,917,880) (807,114) (8,292,301) (1,460,129) (53,638,753) Other (income) expense: Interest Income (520,100) - (800,958) - (1,073,174) Interest expense 128,007 108,938 272,877 204,249 1,917,180 Net other (income) expense (392,093) 108,938 (528,081) 204,249 844,006 Net loss (4,525,787) (916,052) (7,764,220) (1,664,378) (54,482,759) Less accumulated preferred dividends for the period 43,750 43,750 87,500 87,500 1,232,292 Net loss available to common share- holders $(4,569,537) $(959,802) $(7,851,720) $(1,751,878) $(55,715,051) Basic and diluted net loss per share available to common shareholders $(0.16) $(0.09) $(0.32) $(0.16) Weighted average number common shares outstanding - basic and diluted 28,252,354 10,826,795 24,790,486 10,780,148
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CONTACT: Investor Relations Contact, Edward P. Flavin of Advanced LifeSciences Holdings, Inc., +1-630-739-6744 Ext. 211
Web site: http://www.advancedlifesciences.com//
