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Advanced Life Sciences Announces Second Quarter 2009 Financial Results and Financial Outlook
Tuesday, August 11, 2009 9:59 AM


(Source: PRNewswire-FirstCall)trackingCHICAGO, Aug. 11 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (BULLETIN BOARD: 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.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

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(TM) (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 or CAP and complying with the recommendations by the FDA concerning next steps that can lead to a registration pathway," 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 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 is fully funding our bioterror countermeasure 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 Restanza's 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;    --  Under the Department of Defense (DOD) contract, continue studies and       report data emerging from Restanza non-human primate studies in plague       and tularemia.     Financial Outlook   

To fund ongoing operations in 2009, the Company intends to raise additional capital through commercial partnerships and/or the sale of equity.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Tuesday, August 11, 2009 to discuss the Company's second 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 888.680.0860 (domestic) or 617.213.4852 (international). The passcode for the conference call is 88622532. A replay of the conference call will be available until August 18, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 69105186. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at https://www.theconferencingservice.com/prereg/key.process?key=P8EHLRVGT. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

About Restanza

Restanza has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Restanza has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.



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