Advanced Life Sciences Announces Second Quarter 2010 Financial Results

CHICAGO, Aug. 11 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the second quarter ended June 30, 2010.  

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"We are exhilarated to have achieved agreement with the US Food & Drug Administration on the special protocol assessment (SPA) for Restanza in community acquired bacterial pneumonia (CABP) which provides a clear roadmap to approval and the opportunity to bring this novel antibiotic to the market," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences.  "Capitalizing on this momentum, we intend to redouble our efforts to seek government and pharmaceutical partners who can provide financial, development and commercial support to the oral Restanza CABP program.  At the same time, we plan to advance other valuable aspects of the Restanza franchise, including the IV formulation for hospital use and the biodefense program. As we expand our pipeline to address unmet medical needs in treating life-threatening infections caused by Gram-negative pathogens, we are pleased to have partnered with Dr. Robert Hancock and The University of British Columbia to develop novel antibiotics which will augment our internal R&D efforts in this area."

The net loss allocable to common shareholders for the three months ended June 30, 2010 was $2.1 million or ($0.02) per share compared to a net loss allocable to common shareholders of $2.6 million or ($0.06) per share for the three months ended June 30, 2009.  The decrease in the net loss is due to decreased regulatory and clinical costs involved in the development of the Company's lead antibiotic, Restanza™ (cethromycin).

Cash used for operating activities during the quarter was approximately $1.1 million.  In addition, the Company made a $1.5 million payment to reduce its outstanding debt balance.  The Company ended the second quarter of 2010 with cash and cash equivalents totaling $85,000.  In July, the Company completed a securities offering raising approximately $1.6 million in gross offering proceeds.  As part of this public equity offering, the Company issued unit warrants that are exercisable for shares of common stock and warrants to purchase common stock.  The unit warrants expire under their terms 45 days after the Company's public announcement that the FDA has accepted the Company's SPA.  Accordingly, as a result of yesterday's announcement, the unit warrants will expire and cease to be exercisable at 4:00 p.m. EDT on Friday, September 24, 2010.   Subsequent to this offering closing, unit warrant exercises to date have provided an additional $458,000 in gross proceeds to the Company. 

Operating Expense Analysis

• Research and development expenses decreased by $0.5 million to approximately $0.8 million for the three months ended June 30, 2010 compared to $1.3 million for the three months ended June 30, 2009 due to reduced regulatory and clinical expenses associated with the Restanza development program.  
• Selling, general and administrative expenses were reduced to $1.3 million for the three months ended June 30, 2010 from $1.7 million during the second quarter of last year due to reduced salary and benefit costs and other operating expenses.  

Second Quarter and Recent Achievements

• Announced positive data from an in vitro study assessing Restanza against 30 strains of Burkholderia pseudomallei, further highlighting its ability to address serious bacterial infections that are becoming untreatable due to the increasing public health threat of bacterial resistance to currently marketed antibiotics;
• Announced positive results from in vitro and in vivo studies assessing the efficacy of Restanza against the species of Plasmodium that cause malaria;
• Expanded the collaboration with the U.S. Government to include the evaluation of Restanza's activity against sexually transmitted infections (STI's), such as gonorrhea;
• Announced positive results from preclinical toxicology and pharmacokinetic studies of an intravenous (IV) formulation of Restanza that support its use in a hospital setting;
• Entered into an option agreement with The University of British Columbia (UBC) to develop several antimicrobial peptides;
• Submitted application for FDA Fast Track designation for Restanza in CABP;
• Completed securities offering raising approximately $1.6 million in gross offering proceeds;
• Applied to the U.S. Internal Revenue Service for the Qualifying Discovery Therapeutic Tax grant for Restanza;
• Executed a debt for equity exchange agreement with chairman and CEO Michael T. Flavin, Ph.D. in which the Company's $2.0 million promissory note with Dr. Flavin was exchanged for 47,619,047 shares of the Company's common stock.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 9:00 a.m. Eastern Time on Wednesday, August 11, 2010 to discuss the Company's second 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 88373836. A replay of the conference call will be available until August 18, 2010. Callers may access the telephone replay by dialing 888.286.8010 (domestic) or 617.801.6888 (international), passcode 91902424. 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.pro. 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 CABP 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 CABP, 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 CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.

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.

SOURCE Advanced Life Sciences Holdings, Inc.