1. Recent CAP Clinical Trial Experience Michael T. Flavin, Ph.D. Chief Executive Officer

2. 2 Safe Harbor Statement This presentation contains forward-looking statements about Advanced Life Sciences Holdings, Inc., including statements regarding the clinical trials and regulatory pathway of cethromycin. 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. These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

3. 3 CAP: Unmet Medical Need  5 million cases of CAP reported annually in US –80% of cases are mild-to-moderate  6th leading cause of death in the US  Streptococcus pneumoniae resistance rates to penicillin and macrolide antibiotics are currently approaching 60% and 40%, respectively  Overuse of fluoroquinolones contributing to CDAD and class cross resistance

4. 4 New Paradigm in Antibiotic Development  Goals of developing new antibiotics that fill gaps in current treatments –Spectrum/coverage –Emerging resistance to current treatments –Safety issues  Large pharma refocusing drug development in favor of chronic diseases  Smaller biopharma stepping in to advance promising antibiotics  Regulatory clarity and consistency are key factors in ability to develop new antibiotics under new paradigm  FDA recognizes new paradigm –Supportive interaction and effort to clarify regulatory path

5. 5 Cethromycin  In-licensed from a large pharma in 2005  Selected CAP: most serious RTI  Developing cethromycin to treat mild-to-moderate CAP  Met with FDA in December 2005 to confirm NI trial design in CAP  Enrollment in two pivotal phase 3 clinical studies initiated in 2006  Over 1,100 patients enrolled at 200 sites worldwide  Two trials from start to finish: 24 months/$40 million

6. 6 Observations  Clinical trial data analysis takes into account the complete data package including: –Pathogen coverage –Clinical benefits –Safety profile  Non-inferiority trials are a practical method of capturing a wealth of information to demonstrate antimicrobial effectiveness and safety in CAP