CHICAGO, Nov. 6 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases, today announced its financial results for the third quarter ended September 30, 2008.
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The net loss available to common shareholders for the three months ended September 30, 2008 was $13.1 million or ($0.34) per share compared to $5.9 million or ($0.21) per share for the same period last year. The increase in the net loss is primarily attributable to $10.0 million of milestone expenses due to Abbott Laboratories as part of the cethromycin licensing agreement that were triggered as a result of the cethromycin new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) at the end of the third quarter.
"We achieved multiple significant milestones in the third quarter including establishing a major partnership, valued at more than $100 million, for the development and commercialization of cethromycin with Wyeth in the Asia Pacific region, and completing our cethromycin NDA submission in community acquired pneumonia," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We believe that these are major accomplishments that significantly enhance the value of our lead drug candidate and underscore our company's emerging role in the large and growing global antibiotics market. We look forward to continuing this momentum through the fourth quarter and into 2009."
The company ended the third quarter of 2008 with cash and cash equivalents totaling $7.8 million including $1.7 million from the sale of its common stock to Wyeth. Cash usage in the third quarter 2008 was approximately $3.0 million.
Anticipated Fourth Quarter 2008 Milestones
In the fourth quarter 2008, we anticipate achieving the following milestones:
Financial Outlook for the Fourth Quarter of 2008
In October 2008, using cash on hand and by accessing the remaining $6.0 million under its expanded credit facility, Advanced Life Sciences paid its $10.0 million milestone obligation to Abbott Laboratories which was triggered upon the submission of the cethromycin NDA in September. The Company has significantly reduced variable expenses associated with the completed NDA submission and expects its fourth quarter 2008 cash requirements to range from $12.8 million to $13.4 million inclusive of the $10.0 million cethromycin NDA submission milestone.
Nasdaq Staff Letter
On October 1, 2008, we received notice from the Nasdaq Listing Qualifications Department stating that the market value of our listed securities was below $35.0 million for 10 consecutive days, and that we were in violation of the requirement for continued listing on the Nasdaq Capital Market under Marketplace Rule 4310(c)(3)(B) (the "Rule"). Nasdaq also informed us that we are not in compliance with either of Marketplace Rules 4310(c)(3)(A) or 4310(c)(3)(C), which together require either minimum stockholders' equity of $2.5 million or net income from continuing operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years for listing eligibility.
We were provided 30 calendar days, or until October 31, 2008, to establish compliance with these continued listing requirements of the Nasdaq Capital Market. This required, at a minimum, that the market value of listed securities of our common stock remained above $35.0 million for a minimum of 10 consecutive business days at anytime prior to October 31, 2008.
We were not compliant with the Rule by October 31, 2008 and received notice from the Nasdaq Listing Qualifications Department stating that we are in violation of the requirement for continued listing on the Nasdaq Capital Market. We intend to appeal this decision with the Nasdaq Listing Qualifications Department. Our securities will remain listed on the Nasdaq Capital Market throughout the appeal process.
Conference Call Today
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Thursday, November 6, 2008 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 http://www.advancedlifesciences.com. Investors may participate in the conference call by dialing 888-680-0893 (domestic) or 617-213-4859 (international). The passcode for the conference call is 80103777. 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=PN3D7M9E4. 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. A replay of the conference call will be available until November 13, 2008. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 96626416.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CAP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2 billion dollars for prescribed antibiotics to treat CAP. CAP is potentially fatal if not treated properly, and the bacteria that cause CAP are developing resistance to current standard of care treatments.
Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.
About Cethromycin
Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria, certain Gram-negative bacteria and atypical organisms associated with respiratory tract infections. In in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin 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 cethromycin 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.
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, cethromycin, is a novel NDA-stage once-a-day oral antibiotic for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at http://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.
CONTACT: Joe Camp of Advanced Life Sciences Holdings, Inc.,
+1-630-754-4352
Web site: http://www.advancedlifesciences.com/
