WOODRIDGE, Ill., Nov. 7 /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 third quarter ended September 30, 2006. The net loss available to common shareholders for the three months ended September 30, 2006 was $6.9 million or ($0.24) per share compared to $2.3 million or ($0.15) per share for the three months ended September 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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“We are focused on completing our pivotal phase III trials in community acquired pneumonia (CAP),” said Michael T. Flavin, Ph.D., Chairman and Chief Executive Officer of Advanced Life Sciences. “We have achieved our goal of initiating clinical sites in four distinct geographies and look forward to assembling and filing our NDA for the CAP indication next year.”
The Company ended the third quarter of 2006 with cash and cash equivalents totaling $32.0 million. Cash used during the third quarter was approximately $7.1 million.
Operating Expense Analysis -- Research and development expenses increased $4.8 million to $5.7 million for the three months ended September 30, 2006 from $0.9 million for the three months ended September 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 $0.3 million to $1.5 million for the three months ended September 30, 2006 from $1.2 million for the three months ended September 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. Third 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 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 favorable safety profile. The primary endpoint for the trials is clinical cure rate non-inferiority and the secondary endpoint is bacteriological cure rate.
Pipeline Progress and Upcoming Milestones
In the cethromycin clinical program, the Company initiated approximately 75 new clinical sites, including 70 sites in Europe and 5 in North America. A total of approximately 200 clinical sites have been initiated in Europe, North America, Latin America and South Africa.
In September of 2006, the Company sponsored a satellite symposium entitled “Community Acquired Pneumonia: New Insights for an Old Problem” and presented phase II and phase III cethromycin clinical data at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in CAP and bronchitis in San Francisco. Along with its collaborator, the U.S. Army Medical Research Institute of Infectious Diseases, the Company also presented cethromycin preclinical data in anthrax models.
In September of 2006, the Company presented data on ALS-357 at the 232nd American Chemical Society meeting in San Francisco.
In October of 2006, the Company presented and conducted an oral “Meet the Presenter” discussion of phase II and phase II/III cethromycin clinical data in sinusitis at the 44th Annual Meeting of the Infectious Disease Society of America (IDSA) in Toronto.
The Company also initiated a pre-NDA animal study with Battelle to measure the efficacy of cethromycin to treat inhalation anthrax post-exposure for prophylaxis.
The Company anticipates the following upcoming milestones in the clinical development of cethromycin:
-- Complete cethromycin pivotal Phase III clinical trials. -- Advance discussions with prospective partners regarding a commercialization partnership for cethromycin. -- File NDA for cethromycin in CAP. Financial Guidance for the Fourth Quarter of 2006
The Company expects its fourth 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, November 8, 2006 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 http://www.advancedlifesciences.com . Alternatively, callers may participate in the conference call by dialing 866-700-5192 (domestic) or 617-213-8833 (international). The passcode for the conference call is 86403289. A replay of the conference call will be available until December 9, 2006. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 10108693.
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) September 30, December 31, CONDENSED CONSOLIDATED BALANCE SHEETS 2006 2005 (Unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $32,042,342 $4,749,932 Investments - available for sale - 10,475,000 Accounts receivable - related party - 6,160 Prepaid insurance 559,318 362,241 Prepaid clinical trials 2,551,799 4,500 Other prepaid expenses and deposits 451,296 113,763 Total current assets 35,604,755 15,711,596 PROPERTY AND EQUIPMENT: Furniture and fixtures 250,307 147,275 Laboratory equipment 142,928 142,928 Computer software and equipment 216,480 187,771 Leasehold improvements 182,839 40,646 Total property and equipment-at cost 792,554 518,620 Less accumulated depreciation (348,331) (267,372) Property and equipment-net 444,223 251,248 OTHER LONG-TERM ASSETS: Deferred financing costs 33,127 53,004 Other assets 1,452 6,062 Total other long-term assets 34,579 59,066 TOTAL ASSETS $36,083,557 $16,021,910 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $557,522 $294,816 Accrued clinical trial expenses 1,205,058 83,186 Other accrued expenses 652,343 157,575 Accrued interest payable - 5,334 Short-term lease payable 21,926 14,114 Total current liabilities 2,436,849 555,025 Long-term lease payable 22,761 13,166 Accrued interest payable - related party - 765,514 Grant payable 500,000 500,000 Notes payable - net of $14,083 debt discount September 30, 2006 & $22,532 December 31, 2005 3,900,917 3,892,468 Notes payable - related party 2,000,000 2,000,000 Total liabilities 8,860,527 7,726,173 STOCKHOLDERS’ EQUITY: Common stock, $0.01 par value-September 30, 2006: 60,000,000 shares authorized; 28,268,899 issued and outstanding; December 31, 2005: 17,990,322 shares issued and outstanding; 282,689 179,903 Series A preferred stock of Advanced Life Sciences Inc., no par value-250,000 shares authorized, issued and outstanding - - Additional paid-in capital 88,297,045 54,834,373 Deficit accumulated during the development stage (61,356,704) (46,718,539) Total stockholders’ equity 27,223,030 8,295,737 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $36,083,557 $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, 1999) Three months ended Nine months ended Through Sept. 30, Sept. 30, Sept. 30, 2006 2005 2006 2005 2006 Revenue and income: Management fees $- $8,502 $- $52,881 $1,161,180 Grant - - 35,127 - 1,030,910 Royalty -- related party - - - - 45,238 Total revenue and income - 8,502 35,127 52,881 2,237,328 Expenses: Research and develop- ment 5,730,269 938,813 11,569,685 1,604,749 43,502,921 Contracted research and develop- ment- related party - - - - 7,980,299 Selling, general and adminis- tra- tive 1,489,502 1,239,674 3,977,514 2,078,246 11,612,632 Total ex- penses 7,219,771 2,178,487 15,547,199 3,682,995 63,095,852 Loss from opera- tions (7,219,771) (2,169,985) (15,512,072) (3,630,114) (60,858,524) Other (income) expense: Interest Income (466,475) (97,712) (1,267,433) (97,712) (1,539,649) Interest expense 120,649 135,925 393,526 340,174 2,037,829 Net other (income) expense (345,826) 38,213 (873,907) 242,462 498,180 Net loss (6,873,945) (2,208,198) (14,638,165) (3,872,576) (61,356,704) Less accumulated preferred dividends for the period 43,750 43,750 131,250 131,250 1,276,042 Net loss available to common share- hold- ers $(6,917,695) $(2,251,948) $(14,769,415) $(4,003,826) $(62,632,746) Basic and diluted net loss per share available to common share- holders $(0.24) $(0.15) $(0.57) $(0.33) Weighted average number common shares outstanding- basic and diluted 28,268,247 14,819,191 25,962,479 12,134,776
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CONTACT: Edward P. Flavin of Advanced Life Sciences Holdings, Inc.,+1-630-739-6744 Ext. 211
Web site: http://www.advancedlifesciences.com/
