Exhibit 99.1
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| 1440 Davey Road |
For Immediate Release
Investor Relations Contact: Edward P. Flavin (630) 739-6744 Ex 211
Advanced Life Sciences Announces Third Quarter 2005 Results
WOODRIDGE, IL, November 7, 2005/PRNewswire/: — Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), 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, 2005. The net loss available to common shareholders for the three months ended September 30, 2005 was $2.3 million or ($.15) per share compared to $0.9 million or ($.55) per share for the three months ended September 30, 2004. The increase in the net loss reflects increased development expenses related to the advancement of cethromycin into pivotal phase III clinical trials and non-recurring expenses resulting from the completion of the Company’s initial public offering (IPO) in August of 2005.
Michael T. Flavin, Ph.D., chairman and chief executive officer of the Company, noted “Advanced Life Sciences continued to make excellent progress during the third quarter of 2005. We completed our IPO to provide the capital required to advance the clinical development of our lead product, cethromycin. Cethromycin is a novel once-a-day ketolide antibiotic in phase III clinical development for the treatment of respiratory tract infections. We are looking forward to initiating pivotal phase III clinical trials for cethromycin in the treatment of community acquired pneumonia (CAP) during the fourth quarter of 2005,” concluded Dr. Flavin.
During the third quarter of 2005, the Company completed its initial public offering of common stock. Net proceeds from the offering, including the exercise of the underwriters’ over-allotment option and after deducting underwriters’ discounts and offering expenses, were approximately $28.7 million. From this amount, the Company made a payment to Abbott Laboratories in the third quarter of $8.0 million according to the license agreement terms for cethromycin.
The Company ended the third quarter of 2005 with cash, cash equivalents and investments totaling $18.9 million.
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Operating Expense Analysis
• Research and development expenses increased $0.6 million to $0.9 million for the three months ended September 30, 2005 from $0.3 million for the three months ended September 30, 2004. This increase was due to additional development expenses related to cethromycin and non-recurring costs associated with the Company’s IPO in August, 2005. In addition, the increase included a non-cash charge of approximately $0.2 million resulting from the options that vested as a result of our IPO, and stock options granted at the time of the IPO.
• General and administrative expenses increased $0.6 million to $1.2 million for the three months ended September 30, 2005 from $0.6 million for the three months ended September 30, 2004.
This increase is primarily attributed to non-recurring expenses incurred as a result of the Company’s IPO in August 2005. In addition, the increase included a non-cash charge of approximately $0.2 million resulting from the options that vested as a result of our IPO, and stock options granted at the time of the IPO.
Third Quarter 2005 Product Candidate Highlights
Advanced Life Sciences is developing cethromycin, a novel once-a-day ketolide antibiotic licensed from Abbott Laboratories 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 intends to conduct pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate CAP.
Based on publicly available data regarding current antibiotics, the Company believes that there is a potential opportunity for further development of cethromycin in the treatment of respiratory tract infections for a number of reasons:
• cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections;
• cethromycin appears to be effective against penicillin- and macrolide-resistant bacteria;
• cethromycin has a mechanism of action, unique to ketolides, that may slow the onset of future resistance; and
• cethromycin has shown in vitro evidence of extended post-antibiotic effects against pathogens commonly seen in respiratory tract infections.
Advanced Life Sciences believes that cethromycin, if approved, would build upon the growing market acceptance of ketolide drugs in the antibiotic marketplace.
The Company completed the following activities in the third quarter:
• Closing of its initial public offering of common stock, raising $28.7 million in net proceeds.
• Completion of tablet manufacturing of cethromycin with Cardinal Health.
• Engagement of Quintiles as its contract research organization for cethromycin clinical development.
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• Continuation of dialogue with FDA regarding the cethromycin development plan and phase III protocols.
• Addition of Scott Meadow, a noted 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.
The Company anticipates the following upcoming milestones in the clinical development of cethromycin:
• Initiate pivotal phase III studies for cethromycin in CAP in the fourth quarter of 2005. Enroll patients over a twelve month period with data from the trial available in the fourth quarter of 2006.
• Establish presence at ICAAC Conference including sponsorship of a booth in December of 2005.
• Advance discussions with Abbott and other companies regarding a commercialization partnership for cethromycin.
Financial Guidance for Fourth Quarter of 2005
The Company expects its fourth quarter, 2005 cash requirements to range between $4.9 and $5.2 million. Of this amount, cethromycin cash requirements are expected to range between $3.4 and $3.7 million including a $2 million milestone payment to Abbott in accordance with the cethromycin license agreement, which was expensed as in-process research and development in the fourth quarter of 2004. General operating cash requirements are expected to be $1.5 million.
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.
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.
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