(nasd) ADLS $0.99 Advanced Life Sciences Announces First Quarter 2008 Financial Results Wednesday, May 07 2008 - 6:59
$-0.08 (%-7.48)
CHICAGO, May 7 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), 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 first quarter ended March 31, 2008. The net loss available to common shareholders for the three months ended March 31, 2008 was $3.6 million or ($0.09) per share compared to $10.5 million or ($0.37) per share for the three months ended March 31, 2007. The decrease in the net loss reflects lower development expenses related to the cethromycin pivotal Phase III clinical program, which was completed in November 2007.
"Having confirmed the regulatory plans for cethromycin, we are pushing forward aggressively to achieve our partnering and NDA submission goals," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We believe cethromycin can be an important new drug in the treatment of community acquired pneumonia and, if approved, can assist in the emerging battle against drug resistant bacteria."
The company ended the first quarter of 2008 with cash and cash equivalents totaling $12.6 million. Cash used during the first quarter was approximately $5.7 million.
Operating Expense Analysis:
* Research and development expense. Total research and development expense decreased $7.2 million to approximately $1.9 million for the three months ended March 31, 2008 from approximately $9.1 million for the three months ended March 31, 2007. The decrease in R&D expense is related to lower clinical development and manufacturing costs associated with the Company's lead product cethromycin. * General and administrative expense. General and administrative expense increased $0.2 million to $1.7 million for the three months ended March 31, 2008. The increase was attributable to costs associated with cethromycin national advisory board meeting costs and higher compensation and benefit expenses.
Year-to-Date 2008 Achievements:
* Attended the FDA Anti-Infectives Advisory Committee meeting that discussed non-inferiority margins in CAP clinical trials on April 1 and 2, 2008 and held a conference call to provide management's understanding of the Advisory Committee meeting to investors on April 3, 2008; * Conducted a meeting with FDA on April 7, 2008 to discuss the anticipated NDA submission in CAP and provided a summary of the outcome to investors via conference call on April 10, 2008; * Released results of our successful thorough QT study of cethromycin; * Provided regulatory updates to multiple potential partners and advanced negotiations regarding the commercial development of cethromycin as a treatment for CAP; * Met with the national advisory board for cethromycin consisting of thought leaders in the area of respiratory tract infections and antibiotic therapies to confirm the regulatory and development strategy; * Advanced the development of ALS-357: received approval from the Northwestern University Institutional Review Board (IRB) of the protocol for the planned Phase I/II melanoma program.
Remaining Objectives for 2008
* Submit NDA for cethromycin in CAP; * Finalize negotiations with potential commercial partners for cethromycin; * Continue studies with the National Institute of Allergy and Infectious Diseases (NIAID) and the U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID) to explore cethromycin's activity against high-priority bioterror agents for its use as a broad spectrum countermeasure. Submit proposals to the Department of Defense and the Department of Health and Human Services to fund the advanced development of cethromycin in combating bioterror agents such as anthrax, tularemia, plague and Burkholderia pseudomallei; * Initiate enrollment by the end of the summer in Phase I/II dose-escalating study to assess the safety, tolerability, and preliminary efficacy of ALS-357 topically administered to patients with cutaneous metastatic melanoma; * Present cethromycin clinical data at ICAAC in the Fall.
Financial Guidance for 2008
Advanced Life Sciences expects its 2008 cash requirements excluding milestone payments that become due upon NDA filing to fall in the range of $16 million and $17 million. The first quarter cash use of $5.7 million reflects continued NDA submission costs that will curtail substantially in the coming quarters. Accordingly, we expect our quarterly cash use to decrease as we move forward with our operations. The cash used will be applied toward remaining cethromycin NDA submission activities, manufacturing costs, medical communication investments, ALS-357 clinical costs, and general operating expenses. We believe that this cash balance will be sufficient to allow us to progress into a commercial partnership which will support the ongoing funding needs of the Company.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, May 7, 2008 to discuss the Company's financial results for the first quarter.
The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of Advanced Life Sciences' corporate website http://www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888-679-8033 (domestic) or 617-213-4846 (international). The passcode for the conference call is 94054446. Participants may pre-register for the call at: https://www.theconferencingservice.com/prereg/key.process?key=P9JDGPHR6. A telephone replay of the call will also be available for 48 hours. Callers may access the telephone replay by dialing (domestic) 888-286-8010 or 617-801-6888 (international), passcode 36406348.
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 associated with respiratory tract infections, and, again 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 once-a-day oral antibiotic in late-stage development 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 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.
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