WOODRIDGE, Ill., May 8 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced its financial results for the first quarter ended March 31, 2007. The net loss for the three months ended March 31, 2007 was $10.4 million or ($.37) per share compared to $3.2 million or ($.15) per share for the three months ended March 31, 2006. The increase in the net loss reflects increased development expenses related to pivotal Phase III clinical trial costs of the Company’s novel once-a-day antibiotic, cethromycin.
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“Advanced Life Sciences continued to make substantial progress in the first quarter of 2007,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “We are nearing the end of our clinical work with cethromycin and are building toward a robust NDA submission. We were pleased to announce last week very positive efficacy data from our non-human primate study in inhalation anthrax. Looking forward, our focus is on the release of top-line data from our pivotal Phase III program in CAP that we expect to occur in June of this year.”
The company ended the first quarter of 2007 with cash, cash equivalents and investments totaling $22.1 million. Cash used during the first quarter was approximately $5.0 million.
Operating Expense Analysis -- Research and development expenses increased $6.8 million to $9.1 million for the three months ended March 31, 2007 from $2.3 million for the three months ended March 31, 2006. This increase was due to additional development expenses directly related to our Phase III clinical trials and NDA-related expenses for cethromycin. -- Selling, general and administrative expenses increased $0.4 million to $1.5 million for the three months ended March 31, 2007 from $1.1 million for the three months ended March 31, 2006. This increase is primarily attributed to higher compensation costs for existing personnel and increased costs associated with Sarbanes-Oxley compliance.
First Quarter 2007 Product Candidate Highlights
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 involved in over 50 clinical studies and has been tested in approximately 4,400 human subjects.
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 new antibiotics that overcome bacterial resistance.
Recent Achievements: -- Demonstrated cethromycin was 100% protective against inhalation anthrax in key non-human primate efficacy study -- Granted Orphan Drug status by the FDA for the use of cethromycin in treatment of inhalation anthrax -- Initiated competitive negotiation process with prospective commercialization partners to assist with the launch of cethromycin
The company anticipates the following upcoming milestones in the development of cethromycin:
-- Release of data from pivotal Phase III clinical program in CAP in June -- Continue preparation of NDA submission package and pre-launch medical communication programs -- Advancement of negotiations with multiple prospective commercialization partners
Financial Guidance for Second Quarter of 2007
The company expects its second quarter 2007 cash requirements to range between $7.5 and $8.5 million.
Conference Call Details:
Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, May 9, 2007 to discuss the company’s first 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 800-659-1942 (domestic) or 617-614-2710 (international). The passcode for the conference call is 13856687. 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 99601128.
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.
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. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences’ filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY (A Development Stage Company) March 31, December 31, CONDENSED CONSOLIDATED BALANCE SHEETS 2007 2006 (Unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $22,050,237 $27,054,947 Prepaid insurance 222,957 380,083 Prepaid clinical trial expenses 2,857,597 2,364,512 Other prepaid expenses and deposits 272,116 273,572 Total current assets 25,402,907 30,073,114 PROPERTY AND EQUIPMENT: Furniture and fixtures 250,979 250,308 Laboratory equipment 159,662 142,928 Computer software and equipment 255,241 231,022 Leasehold improvements 177,253 182,839 Total property and equipment -- at cost 843,135 807,097 Less accumulated depreciation (446,574) (398,486) Property and equipment -- net 396,561 408,611 OTHER LONG-TERM ASSETS: Deferred financing costs 19,876 26,502 Other assets 1,452 1,452 Total other long-term assets 21,328 27,954 TOTAL ASSETS $25,820,796 $30,509,679 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $5,253,876 $1,011,396 Accrued clinical trial expenses 2,564,432 1,410,894 Other accrued expenses 386,054 226,881 Accrued interest payable -- 22,756 Short-term lease payable 15,778 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 $8,450 debt discount 3,906,550 -- Total current liabilities 14,603,398 5,168,072 Long-term lease payable 18,362 20,076 Long-term grant payable 23,292 23,292 Notes payable - net of $11,266 debt discount -- 3,903,734 Total liabilities 14,645,052 9,115,174 COMMITMENTS AND CONTINGENCIES: Minority Interest -- -- STOCKHOLDERS’ EQUITY: Common stock, $0.01 par value-60,000,000 shares authorized; March 31, 2007 28,287,677 issued and outstanding; December 31, 2006 28,282,677 shares issued and 282,877 282,827 outstanding; Additional paid-in capital 88,560,982 88,370,853 Deficit accumulated during the development stage (77,668,115) (67,259,175) Total stockholders’ equity 11,175,744 21,394,505 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $25,820,796 $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, 1999) Three months ended March 31, Through 2007 2006 March 31, 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 development 9,050,912 2,260,378 58,186,261 Contracted research and development-related party -- -- 7,980,299 Selling, general and administrative 1,548,163 1,149,170 14,640,676 Total expenses 10,599,075 3,409,548 80,807,236 Loss from operations (10,599,075) (3,374,421) (78,565,247) Other (income) expense: Interest Income (306,569) (280,858) (2,230,701) Interest expense 116,434 144,870 2,272,621 Gain on sale of interest in Sarawak Medichem Pharmaceuticals joint venture -- -- (939,052) Net other income (190,135) (135,988) (897,132) Net loss (10,408,940) (3,238,433) (77,668,115) Less accumulated preferred dividends for the period 43,750 43,750 1,363,542 Net loss available to common shareholders $(10,452,690) $(3,282,183) $(79,031,657) Basic and diluted net loss per share available to common shareholders $(0.37) $(0.15) Weighted average number common shares outstanding- basic and diluted 28,287,310 21,290,153
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CONTACT: investors, Edward P. Flavin of Advanced Life Sciences Holdings,Inc., +1-630-739-6744
Web site: http://www.advancedlifesciences.com/
