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The net loss allocable to common shareholders for the three months ended September 30, 2009 was $2.9 million or ($0.05) per share compared to a net loss allocable to common shareholders of $13.1 million or ($0.34) per share for the three months ended September 30, 2008. The decrease in the net loss is due to a $10.0 million milestone expense incurred under the license agreement with Abbott in the third quarter of last year as well as decreased costs related to regulatory expenses and development activities involving the Company's lead compound, Restanza(TM) (cethromycin).
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The Company ended the third quarter of 2009 with cash and cash equivalents totaling $4.2 million. Cash used for operations during the quarter was approximately $4.5 million.
"In the third quarter, we continued to advance Restanza on two significant fronts: in community acquired pneumonia (CAP) and as a broad spectrum countermeasure for biodefense," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "In CAP, we are in ongoing discussions with the FDA to identify the scope and protocol design for the additional clinical data that would be required to satisfy the FDA's request for additional efficacy information to complete the clinical development program. In biodefense, we made exciting progress by generating positive pivotal data in anthrax and plague and receiving orphan designation in tularemia and plague."
Dr. Flavin added: "As another indication of the government's interest in Restanza as a biodefense agent, the Company was invited to submit a full proposal in response to a Broad Agency Announcement (BAA) issued by the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services for the advanced development of Restanza as a broad spectrum countermeasure for biodefense. BARDA funding could significantly help to advance Restanza toward approval by the FDA as an important medical countermeasure, and toward consideration by the government for acquisition and stockpiling."
Operating Expense Analysis
Third Quarter Events
Business Goals for 2009
Financial Outlook
To fund ongoing operations in 2010, 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, November 10, 2009 to discuss the Company's third 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 www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888.713.4214 (domestic) or 617.213.4866 (international). The passcode for the conference call is 75545191. A replay of the conference call will be available until November 17, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 79025053. 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=PGFUTHTV6. 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 is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of CAP and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CAP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.
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 respiratory diseases. The Company's lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com.
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. 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. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials, the adequacy of our clinical results, the timing and terms of any commercial partnership, and 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; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.
-- Research and development expenses were $0.9 million for the three months ended September 30, 2009 compared to $11.2 million for the three months ended September 30, 2008. This difference was primarily due to the $10.0 million milestone expense incurred under our license agreement with Abbott in the third quarter of 2008. -- Selling, general and administrative expenses totaled $2.2 million for the three months ended September 30, 2009 compared to $1.8 million for the same period in 2008.
SOURCE Advanced Life Sciences Holdings, Inc.
