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Advanced Life Sciences Holdings, Inc. (ADLS)

Q4 2007 Earnings Call

February 19 2008 10:00 am ET


Joe Camp - Investor Relation

Michael Flavin - Chairman, Chief Executive Officer

John Flavin - President, Director


Angela Larson - SIG

Matt Osborne - Lazard

Jason Butler - Rodman & Renshaw



Good day ladies and gentlemen and welcome to the Fourth Quarter 2007 Advanced Life Sciences Earning Conference Call. My name is Fab, and I will be your coordinator for today. At this time, all participants are in listen-only mode. We will conduct a question-and-answer session towards the end of this conference. (Operator Instruction). As a reminder, this conference is being recorded for replay purposes.

I would now like to turn the presentation over to Mr. Joe Camp, please proceed.

Joe Camp – Investor Relation

Thank you, Fab. Hello every one. Thank you for joining us today for the Advanced Life Sciences financial results conference call for the fourth quarter and full year of 2007. I'd like to again remind everybody that we are web casting today's call. The live and archived web cast of the call maybe found in the Investor Relation section of the Advanced Life Sciences website at Joining me on the call today from Advanced Life Sciences are Dr. Michael Flavin Chairman & Chief Executive Officer and John Flavin, President.

Before we begin today's call, I would like to read a brief Safe Harbor statement. Except for historical information, the statements made in this presentation are forward-looking statements about Advanced Life Sciences Holdings, Incorporated, including statements regarding the clinical trials and regulatory pathway of cethromycin. Forward-looking statements represent our management's judgment regarding future events and are accurate at the time that they are made

The company does not undertake any obligations to update ant forward-looking statement whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; our ability to interpret regulatory developments in the U.S. and foreign countries; and the rate and degree of market acceptance of any future products. These and additional risks and uncertainties are detailed in the Company's filings with the US Securities and Exchange Commission.

I would now like the turn the call over to Dr. Michael Flavin Chairman & CEO of Advanced Life Sciences.

Michael Flavin - Chairman, Chief Executive Officer

Good morning ladies and gentlemen. Thank you for your interest in Advanced Life Sciences and for joining us today on this call to review the company's accomplishments, business developments, and fourth quater and full year financial results.

As I noted in our earnings' call last August, Advanced Life Sciences primary objective as a company since our IPO in August of 2005 was to bring cethromycin to the market as a treatment for community-acquired pneumonia or CAP. In order to address the global challenge of emerging bacterial resistance to the current standard of care drugs and to increase shareholder value in the process.

We are focused on three areas to accomplish this goal. First, the completion of our two pivotal Phase III clinical trials in CAP, second, the assembly and filing of our NDA in a CAP indication and third, the engagement of a commercial partner with an appropriately sized sales force to help us market cethromycin successfully to primary care physicians.

2007 was a year of achievement and promise for Advanced Life Sciences. We made great progress in advancing our lead drug candidate cethromycin as a treatment for mild-to-moderate CAP. Several significant milestones that we accomplished in the past year includes; successfully meeting all endpoints in our two pivotal phase III clinical trials in CAP, achieving positive results in a Thorough QT study of cethromycin, which were announced this morning supporting the cardiac safety of the drug.

Reporting positive efficacy data from the inhalation anthrax primate study, which can help elevate the importance of cethromycin from a regulatory perspective, and potentially augment the label and commercial opportunity for the drug.

Establishing a Blue Chip National Advisory Board, which is assisting us in our ongoing regulatory and medical communication strategies, building on the eight scientific presentations made in 2006 and the 11 presentations made last fall at the ICAAC and IDSA conferences.

Advancing discussions with several potential partners to ensure that we will have a qualified commercial partner to help us bring Cethromycin to the market and raising net proceeds of $18 million in a private placement with both existing and new investors to help us complete the next phase of our corporate objectives, including the consummation of a commercial partnership and NDA submission for Cethromycin as a treatment for CAP.

And we expect this progress to continue throughout 2008. We remained confident in our original course and we grow more excited everyday about the developing market for Cethromycin. Moreover, we believe that the positive results achieved in the Thorough QT study that we announced this morning provides further support to the cardiac safety of Cethromycin and strengthen our upcoming NDA submission.

I just described to you how we successfully completed the first of these goals by completing our clinical program for Cethromycin. Now I will share, why we believe we are in the home stretch for completing the other two goals.

With respect to the NDA and CAP, the remaining work will be to confirm our NDA submission to guidance standing from the upcoming FDA Advisory Committee meeting and the Advanced Life Sciences meeting with the FDA scheduled for early April.

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