Exhibit 99.1

 

 

1440 Davey Road

Woodridge, IL 60517

(Phone) 630.739.6744

(Fax) 630.739.6754

www.advancedlifesciences.com

 

 

Company Contact: Joe Camp 630-754-4352

Email: jcamp@advancedlifesciences.com

 

Advanced Life Sciences Announces Second Quarter 2009 Financial Results and Financial Outlook

 

CHICAGO, IL, August 11, 2009/PRNewswire/: —

Advanced Life Sciences Holdings, Inc. (OTCBB: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the second quarter ended June 30, 2009.

 

The net loss allocable to common shareholders for the three months ended June 30, 2009 was $2.6 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.4 million or ($0.09) per share for the three months ended June 30, 2008.  The decrease in the net loss is due to decreased costs involved in the clinical development of the Company’s lead compound, Restanza™ (cethromycin).

 

The Company ended the second quarter of 2009 with cash and cash equivalents totaling $1.0 million.  Cash used during the quarter was approximately $2.9 million.

 

“Advanced Life Sciences today is focused on continuing to pursue approval for Restanza in community acquired pneumonia by complying with the FDA’s recommendations concerning next steps that can lead to registration,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “Based on the agency’s recent communication with the Company, we anticipate that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. We intend to work closely with the agency to confirm this understanding and design and establish a protocol under a Special Protocol Assessment. We are working on these clinical plans with Wyeth, our development and commercialization partner in the Asia Pacific region, and will also continue to pursue additional collaborations. At the same time, we are also continuing to advance Restanza as a biodefense agent against anthrax, plague and tularemia in our collaborative work with the U.S. government, which funds our biodefense development program.”

 

Operating Expense Analysis

 

·                  Research and development expenses were $1.3 million for the three months ended June 30, 2009 compared to $1.7 million for the three months ended June 30, 2008.

 

·                  Selling, general and administrative expenses totaled $1.7 million, approximately the same amount as the second quarter of last year.

 

Business Outlook for 2009

 

·                  Work with the FDA and Wyeth to develop a new clinical protocol to further demonstrate Restanzas efficacy in CAP;

 

·                  Pursue a meeting with the FDA relative to establishing a Special Protocol Assessment for development of Restanza in CAP;

 

·                  Advance negotiations with prospective U.S. and E.U. partners for the development and commercialization of Restanza;

 

-MORE-

 


The following information was filed by Advanced Life Sciences Holdings, Inc. (ADLS) on Tuesday, August 11, 2009 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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