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"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: . 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.
ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED BALANCE SHEETS March 31, December 31, (Unaudited) 2008 2007 ASSETS CURRENT ASSETS: Cash and cash equivalents $12,589,640 $18,324,991 Prepaid insurance 155,953 251,493 Prepaid clinical trial expenses - 926,168 Other prepaid expenses and deposits 93,500 140,359 Total current assets 12,839,093 19,643,011 PROPERTY AND EQUIPMENT: Furniture and fixtures 227,825 221,417 Laboratory equipment 159,186 159,186 Computer software and equipment 245,812 242,707 Leasehold improvements 502,798 177,253 Total property and equipment-at cost 1,135,621 800,563 Less accumulated depreciation (595,429) (542,032) Property and equipment-net 540,192 258,531 OTHER ASSETS: Other assets 18,750 10,000 Total other assets 18,750 10,000 TOTAL ASSETS $13,398,035 $19,911,542 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $1,458,912 $2,685,751 Accrued clinical trial expenses 754,402 2,776,543 Other accrued expenses 463,347 330,441 Accrued interest payable 21,070 22,756 Short-term lease payable 7,538 7,259 Short-term notes payable - related party 2,000,000 - Total current liabilities 4,705,269 5,822,750 Long-term lease payable 10,824 12,818 Long-term grant payable 500,000 500,000 Long-term notes payable - related party - 2,000,000 Notes payable 3,915,000 3,915,000 Total liabilities 9,131,093 12,250,568 COMMITMENTS AND CONTINGENCIES MINORITY INTEREST - - STOCKHOLDERS' EQUITY: Common stock, $0.01 par value-60,000,000 shares authorized; 38,502,987 issued and outstanding at March 31, 2008; 38,502,987 shares issued and outstanding at December 31, 2007 385,030 385,030 Additional paid-in capital 107,007,634 106,859,532 Deficit accumulated during the development stage (103,125,722) (99,583,588) Total stockholders' equity 4,266,942 7,660,974 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $13,398,035 $19,911,542 ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Period From Inception Three months ended (January 1, 1999) March 31, Through 2008 2007 March 31, 2008 Revenue: Management fees $- $- $1,161,180 Grants - - 1,035,571 Royalty-related party - - 45,238 Total revenue - - 2,241,989 Expenses: Research and development 1,868,054 9,050,912 76,739,162 Contracted research and development-related party - - 7,980,299 Selling, general and administrative 1,726,366 1,548,163 21,658,454 Total expenses 3,594,420 10,599,075 106,377,915 Loss from operations (3,594,420) (10,599,075) (104,135,926) Net other income: Interest income (156,641) (306,569) (2,798,657) Interest expense 104,355 116,434 2,727,505 Gain on sale of interest in Sarawak Medichem Pharmaceuticals joint venture - - (939,052) Net other income (52,286) (190,135) (1,010,204) Net loss (3,542,134) (10,408,940) (103,125,722) Less accumulated preferred stock dividends of subsidiary for the period 43,750 43,750 1,538,542 Net loss available to common shareholders $(3,585,884) $(10,452,690) $(104,664,264) Net loss per share available to common shareholders - basic and diluted $(0.09) $(0.37) Weighted average shares outstanding - basic and diluted 38,502,987 28,287,310
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CONTACT: Company, Joe Camp of Advanced Life Sciences Holdings, Inc.,
+1-630-754-4352, jcamp@advancedlifesciences.com; or Media, Melanie Nimrodi,
+1-312-546-3508,
+1-213-486-6547,
Advanced Life Sciences Holdings, Inc.
Web site: http://www.advancedlifesciences.com/