Advanced Life Sciences Holdings reports decrease in net loss for full-year 2009

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 fourth quarter and full year ended December 31, 2009.

The net loss allocable to common shareholders for the three months ended December 31, 2009 was $1.5 million or ($0.02) per share compared to a net loss allocable to common shareholders of $2.8 million or ($0.07) per share for the three months ended December 31, 2008.  The net loss allocable to common shareholders for the full year 2009 was $9.3 million or ($0.16) per share compared to a net loss allocable to common shareholders of $23.0 million or ($0.59) per share for 2008.  The decrease in the net loss for the full year 2009 is due to decreased costs involved in the clinical activities and regulatory review of the Company's lead compound Restanza™.

The Company used approximately $3.1 million in cash in the fourth quarter of 2009 and ended the year with cash totaling $2.8 million.  Cash use for the full year was $12.1 million.  

Dr. Michael Flavin, Chairman and Chief Executive Officer of Advanced Life Sciences, commented: "We are excited about the opportunities that lie ahead in 2010 as we pursue a focused strategy to position Restanza, our once-daily, oral antibiotic, for success on two major fronts: community acquired bacterial pneumonia (CABP) and biodefense. We plan to continue to work with the U.S. Food and Drug Administration (FDA) to complete a Special Protocol Assessment (SPA) that will lay the groundwork for initiating registration studies for development of Restanza in CABP. We are also continuing to work with Pfizer, our Asia-Pacific regional partner, on development and commercialization plans. In the area of biodefense, we plan to capitalize on our 2009 achievements, which included generating strong, positive data in four pivotal animal trials and receiving $3.8 million from the Department of Defense to study Restanza further as a potential broad-spectrum medical countermeasure. In 2010, we have an opportunity to secure additional non-dilutive capital through government development contracts which may also position us advantageously for procurement discussions with Department of Defense and Health and Human Services. We are also pursuing additional corporate partnerships as well as advancing additional formulations for hospital and pediatric indications with the goal of capturing the full value of the Restanza franchise."  

Full Year Expense Analysis, 2009 versus 2008:

• Research and development expense. Total research and development expense decreased $11.2 million to approximately $4.5 million for the year ended December 31, 2009 from approximately $15.7 million for the year ended December 31, 2008.  The decrease in R&D expense is related to reduced development costs associated with Restanza.
• General and administrative expense.  General and administrative expense decreased $0.8 million to $6.3 million for the year ended December 31, 2009 from $7.1 million for the year ended December 31, 2008.  

Fourth Quarter Expense Analysis, 2009 versus 2008:

• Research and development expense. Total research and development expense increased $0.4 million to approximately $1.3 million for the three months ended December 31, 2009 from approximately $0.9 million for the three months ended December 31, 2008.
• General and administrative expense.  General and administrative expense decreased $1.0 million to $0.9 million for the three months ended December 31, 2009 from approximately $1.9 million for the three months ended December 31, 2008.  

Financial Guidance for 2010

On March 10, 2010, the Company filed a Form S-1 registration statement with the Securities and Exchange Commission (SEC) to provide the Company with the flexibility to meet its financing needs for 2010 initiatives.  The Company also terminated its Standby Equity Distribution Agreement (SEDA) with YA Global Investments and has withdrawn the Form S-3 with the SEC that allowed for sales of its common stock through the SEDA.