May 8, 2008
Knobias Clip Report (05-07-2008)
By admin
Submitted By Knobias ClipReport
ADLS: Management Discusses Q1 Results and Udates Progress with Cethromycin
Advanced Life Sciences Holdings, Inc. (ADLS) announced a first quarter loss $3.6 million, or $0.09 per share, compared to $10.5 million, or $0.37 per share, for the same period last year. Analysts had expected a loss of $0.13 per share.
The Company 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, the Company expects its quarterly cash use to decrease as the Company moves 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.
Advanced Life Sciences’ lead candidate, cethromycin, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including Community Acquired Pneumonia (CAP).
CAP is the sixth most common cause of death in the United States. 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.
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.
Chairman and CEO of Advanced Life Sciences, Michael T. Flavin, Ph.D., said in a conference call today, “Having confirmed the regulatory plans for cethromycin, we are pushing forward aggressively to achieve our partnering and NDA submission goals. We plan to submit and NDA for cethromycin in CAP in the third quarter of this year. We will seek to have a partner in place at that time.”
He added, “We believe that our cash will be sufficient to allow us to progress into a commercial partnership that will support the ongoing needs of the company.”
John L. Flavin, President and CFO of Advanced Life Sciences, explained, “Our regulatory progress allows us to advance negotiations with potential partners. Partners are encouraged by the clear regulatory pathway for cethromycin. We are confident that we will be successful in forging an attractive partnership. We are also building the franchise through product differentiation and expanding indications. CAP represents only the beginning of the opportunities ahead for cethromycin.”
“We will also seek further funding from the U.S. Department of Defense and U.S. Department of Health and Human Services to develop cethromycin for biodefense indications.”
He added, “As significant shareholders of Advanced Life Sciences, our management team’s interests are aligned with other shareholders. We are taking the right steps to continue to build value in our franchise and company.”
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