CHICAGO, Aug. 8 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation, today announced its financial results for the second quarter ended June 30, 2007.
(Logo: http://www.newscom.com/cgi-bin/prnh/20050428/CGTH039LOGO)
The net loss for the three months ended June 30, 2007 was $10.6 million or ($0.37) per share compared to $4.6 million or ($0.16) per share for the three months ended June 30, 2006. The higher net loss reflects increased development expenses related to regulatory and manufacturing initiatives for cethromycin, as well as ongoing costs related to the clinical trials of the drug.
“The goal of our two pivotal Phase III clinical trials of cethromycin has been to support regulatory approval. In late June, we announced positive results from Trial CL-06, the first of the two Phase III studies designed to assess the safety and efficacy of cethromycin for the treatment of community acquired pneumonia (CAP). In that study, cethromycin not only achieved its primary and secondary efficacy endpoints compared to Biaxin(R) (clarithromycin), but it also demonstrated a favorable safety profile as expected with the incidence of adverse events not being statistically different between cethromycin and Biaxin,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences.
“We believe the strong clinical cure rates and safety profile achieved in Trial CL-06 validate our dosing strategy, as well as endorse our current regulatory and commercial partnering pathway,” continued Dr. Flavin. “To date we have enrolled more than 1,000 patients in the two studies and have surpassed our enrollment target of 500 patients for Trial CL-05, the second pivotal Phase III trial. We eagerly anticipate the results from that study and will report the data as soon as it is compiled and confirmed by the independent CRO. Based on the latest information we have received from our CRO, a comprehensive release of top-line data is expected to occur in the Fall.”
Dr. Flavin concluded, “An estimated 5.6 million cases of CAP occur annually in the U.S., resulting in an estimated total annual spend of $2 billion for prescribed antibiotics. With rates of penicillin and macrolide resistance currently approaching 60% and 40%, respectively, there is a critical need for new antibiotics that can overcome resistance and ultimately replace the macrolides as front-line therapies. We believe that cethromycin, if approved, would address this growing need. Therefore, we continue to advance it towards NDA submission.”
The company ended the second quarter of 2007 with cash totaling $13.5 million.
Operating Expense Analysis
-- Research and development expenses were $8.8 million for the three months ended June 30, 2007 compared to $3.6 million for the three months ended June 30, 2006. This increase was the result of additional development expenses associated with the Phase III clinical trials and NDA-related expenses for cethromycin. -- Selling, general and administrative expenses were $1.8 million in the second quarter of 2007 compared to $1.3 million for the same period in 2006. This increase was due primarily to the development of medical education programs, higher compensation costs for existing personnel and increased costs associated with Sarbanes-Oxley compliance. Second Quarter Achievements -- Released positive data from Trial CL-06, the first of two pivotal Phase III clinical trials for the use of cethromycin in CAP, which met primary and secondary endpoints as guided by the FDA; -- Progressed negotiations with multiple prospective partners regarding the commercial development of cethromycin as a treatment for CAP; -- Released positive data from non-human primate study for inhalation anthrax indication, which demonstrated that cethromycin was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of care, Cipro(R) (ciprofloxacin), which demonstrated 90% protection; -- Completed API manufacturing and initiated stability testing to satisfy FDA’s CMC requirements for the upcoming cethromycin NDA submission; -- Advanced development of ALS-357 with clinical materials manufactured and placed on stability for the melanoma program; and -- Formed National Advisory Board for Cethromycin consisting of 10 thought leaders in the area of respiratory tract infections and antibiotic therapies. Business Outlook for the Second Half 2007 -- Release data from Trial CL-05, the second of two pivotal Phase III clinical trials for the use of cethromycin in CAP; -- Advance negotiations with potential commercial partners for cethromycin; -- Present 11 posters on cethromycin at The American Society for Microbiology’s 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago -- September 17 - 20 and the 45th Annual Meeting of the Infectious Disease Society of America (IDSA) in San Diego -- October 4 - 7; -- Host satellite symposium on current treatment options for drug-resistant CAP at the ICAAC Conference; -- Conduct further NDA submission activities and pre-launch medical education programs relating to cethromycin as a treatment for CAP; -- Finalize and initiate clinical sites for the Phase I/II study of ALS-357 as a treatment for melanoma; -- Expand collaborations 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; and -- Establish and convene additional meetings with the National Advisory Board for Cethromycin.
Financial Guidance for the Second Half of 2007
Advanced Life Sciences expects its third quarter 2007 cash requirements to fall in the range of $6.5 million and $7.5 million leaving a cash balance of $6.0 to $7.0 million as of September 30, 2007. We believe that this cash balance will be sufficient to allow us to progress through the period in which we report comprehensive top-line data from our Phase III cethromycin program in the Fall. To fund ongoing operations, the Company intends to raise additional capital in the fourth quarter of 2007 through a commercial partnership and/or the sale of equity, if available at terms acceptable to us, which cannot be assured.
Conference Call Details
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Thursday, August 9, 2007 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 Advanced Life Sciences’ corporate website http://www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888-873-4896 (domestic) or 617-213-8850 (international). The passcode for the conference call is 16007877. 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 88970844.
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 inflammation. The company’s lead candidate, cethromycin, is a novel once-a-day antibiotic in late-stage clinical development for the treatment of respiratory tract infections.
About Cethromycin
Advanced Life Sciences is developing cethromycin, a novel once-a-day antibiotic in response to the emerging bacterial resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 5,000 human subjects during clinical trials.
The company is currently conducting pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate CAP. Advanced Life Sciences believes that cethromycin, if approved, would build upon the growing market opportunity in the antibiotic marketplace and address the critical need for antibiotics that overcome bacterial resistance.
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.
Except for historical information, the statements made in this press release are forward-looking statements about Advanced Life Sciences Holdings, Inc., including statements regarding the clinical trials and regulatory pathway of cethromycin. Forward-looking statements represent our management’s judgment regarding future events and are accurate at the time they are made. 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, capital requirements, and our ability to access capital through partnerships, stock offerings and future revenues; 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) June 30, December 31, CONDENSED CONSOLIDATED BALANCE SHEETS 2007 2006 (Unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $13,450,776 $27,054,947 Prepaid insurance 64,956 380,083 Prepaid clinical trial expenses 2,266,799 2,364,512 Other prepaid expenses and deposits 332,020 273,572 Total current assets 16,114,551 30,073,114 PROPERTY AND EQUIPMENT: Furniture and fixtures 221,417 250,308 Laboratory equipment 159,186 142,928 Computer software and equipment 236,781 231,022 Leasehold improvements 177,253 182,839 Total property and equipment-at cost 794,637 807,097 Less accumulated depreciation (440,365) (398,486) Property and equipment-net 354,272 408,611 OTHER LONG-TERM ASSETS: Deferred financing costs 13,251 26,502 Other assets 1,452 1,452 Total other long-term assets 14,703 27,954 TOTAL ASSETS $16,483,526 $30,509,679 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $4,044,335 $1,011,396 Accrued clinical trial expenses 4,793,241 1,410,894 Other accrued expenses 387,822 226,881 Accrued interest payable 12,917 22,756 Short-term lease payable 11,976 19,437 Short-term grant payable 476,708 476,708 Short-term notes payable - related party 2,000,000 2,000,000 Short-term notes payable - net of $5,633 debt discount 3,909,367 - Total current liabilities 15,636,366 5,168,072 Long-term lease payable 16,583 20,076 Long-term grant payable 23,292 23,292 Notes payable - net of $11,266 debt discount - 3,903,734 Total liabilities 15,676,241 9,115,174 COMMITMENTS AND CONTINGENCIES: Minority Interest - - STOCKHOLDERS’ EQUITY: Common stock, $0.01 par value-60,000,000 shares authorized; June 30, 2007 28,294,677 issued and outstanding; December 31, 2006 28,282,677 shares issued and outstanding; 282,947 282,827 Additional paid-in capital 88,738,121 88,370,853 Deficit accumulated during the development stage (88,213,783) (67,259,175) Total stockholders’ equity 807,285 21,394,505 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $16,483,526 $30,509,679 ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) Period From Inception (January 1, Three months ended Six months ended 1999) June 30, June 30, Through 2007 2006 2007 2006 June 30, 2007 Revenue: Management fees $- $- $- $- $1,161,180 Grants - - - 35,127 1,035,571 Royalty-related party - - - - 45,238 Total revenue - - - 35,127 2,241,989 Expenses: Research and develop- ment 8,833,078 3,579,038 17,883,990 5,839,416 67,019,339 Contracted research and develop- ment - related party - - - - 7,980,299 Selling, general and administr- ative 1,810,249 1,338,842 3,358,412 2,488,012 16,450,925 Total expen- ses 10,643,327 4,917,880 21,242,402 8,327,428 91,450,563 Loss from opera- tions (10,643,327) (4,917,880) (21,242,402) (8,292,301) (89,208,574) Other (income) expense: Interest Income (214,495) (520,100) (521,064) (800,958) (2,445,196) Interest expense 116,836 128,007 233,270 272,877 2,389,457 Gain on sale of interest in Sarawak Medichem Pharmac- euticals joint venture - - - - (939,052) Net other income (97,659) (392,093) (287,794) (528,081) (994,791) Net loss (10,545,668) (4,525,787) (20,954,608) (7,764,220) (88,213,783) Less accumulated preferred dividends for the period 43,750 43,750 87,500 87,500 1,407,292 Net loss available to common share- holders $(10,589,418)$(4,569,537) $(21,042,108) $(7,851,720)$(89,621,075) Basic and diluted net loss per share available to common shareholders $(0.37) $(0.16) $(0.74) $(0.32) Weighted average number common shares outstanding- basic and diluted 28,294,380 28,252,354 28,290,865 24,790,486
Photo: http://www.newscom.com/cgi-bin/prnh/20050428/CGTH039LOGOAP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comAdvanced Life Sciences Holdings, Inc.
CONTACT: Company, Joe Camp, +1-630-754-4352 of Advanced Life SciencesHoldings, Inc.; or media, Melanie Nimrodi, +1-312-546-3508, or investors,Kathy Price, +1-213-486-6547, both of Financial Relations Board, forAdvanced Life Sciences Holdings, Inc.
Web site: http://www.advancedlifesciences.com/
