WOODRIDGE, Ill., May 9 - Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), 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 first quarter ended March 31, 2006. The net loss for the three months ended March 31, 2006 was $3.3 million or ($.15) per share compared to $0.8 million or ($.07) per share for the three months ended March 31, 2005. The increase in the net loss reflects increased development expenses related to cethromycin pivotal Phase III clinical trial costs.
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"Advanced Life Sciences has continued to make excellent progress," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We significantly strengthened our balance sheet in March by completing a PIPE offering of common stock and warrants with net proceeds of $33.6 million which provides us with additional capital for advancing the development of our lead product cethromycin toward commercialization. We have continued to work with our CRO, Quintiles, and as of now, have initiated approximately 75 clinical trial sites in the U.S. and Canada and continue to enroll patients for the trials we are conducting."
The company ended the first quarter of 2006 with cash, cash equivalents and investments totaling $44.9 million. Cash used during the first quarter was approximately $3.9 million.
Operating Expense Analysis
-- Research and development expenses increased $1.9 million to
$2.2 million for the three months ended March 31, 2006 from
$0.3 million for the three months ended March 31, 2005. This increase
was due to additional development expenses directly related to our
Phase III clinical trials for cethromycin.
-- Selling, general and administrative expenses increased $0.7 million to
$1.1 million for the three months ended March 31, 2006 from
$0.4 million for the three months ended March 31, 2005. This increase
is primarily attributed to the public company costs related to
director and officer insurance, director's fees, investor relations
and legal and accounting services.
First Quarter 2006 Product Candidate Highlights
Advanced Life Sciences is developing cethromycin, a novel once-a-day ketolide antibiotic in response to the emerging antibiotic resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 3,800 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 acceptance of ketolide drugs in the antibiotic marketplace and address the growing need for antibiotics that overcome bacterial resistance.
In the first quarter, the company completed its PIPE equity offering of common stock and warrants, raising $33.6 million in net proceeds.
The company anticipates the following upcoming milestones in the clinical development of cethromycin:
-- Continue to initiate site start-ups in both the Northern and Southern
Hemispheres.
-- Conduct investigator meetings and begin CAP patient enrollment in
South Africa and Latin America.
-- Advance discussions with prospective partners regarding a
commercialization partnership for cethromycin.
Financial Guidance for Second Quarter of 2005
The company expects its second quarter 2006 cash requirements to range between $5.25 and $6.0 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 10, 2006 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 866-831-6270 (domestic) or 617-213-8858 (international). The passcode for the conference call is 30576237. A telephone replay of the call will also be available for 48 hours. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 24154081.
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 ketolide 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)
As of Year ended
March 31, December 31,
CONDENSED CONSOLIDATED BALANCE SHEETS 2006 2005
(Unaudited)
ASSETS
CURRENT ASSETS:
Cash & cash equivalents $38,218,131 $4,749,932
Investments - available for sale 6,675,000 10,475,000
Accounts receivable - related party 5,054 6,160
Prepaid insurance 217,082 362,241
Prepaid expenses and other 2,095,201 118,263
Total current assets 47,210,468 15,711,596
FURNITURE AND EQUIPMENT:
Furniture and fixtures 148,985 147,275
Laboratory equipment 142,928 142,928
Computer software & equipment 194,136 187,771
Leasehold improvements 40,646 40,646
Total furniture and equipment -
at cost 526,695 518,620
Less accumulated depreciation (290,323) (267,372)
Furniture and equipment-net 236,372 251,248
OTHER LONG-TERM ASSETS:
Deferred financing costs 46,378 53,004
Other assets 6,534 6,062
Total other long-term assets 52,912 59,066
TOTAL ASSETS $47,499,752 $16,021,910
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $337,782 $294,816
Accrued expenses 1,371,387 240,761
Accrued interest payable 5,493 5,334
Short-term lease payable 14,677 14,114
Total current liabilities 1,729,339 555,025
Long-term lease payable 9,277 13,166
Accrued interest payable - related party 819,096 765,514
Grant payable 500,000 500,000
Notes payable - net of $19,716 debt discount
March 31, 2006 & $22,532 December 31, 2005 3,895,284 3,892,468
Notes payable - related party 2,000,000 2,000,000
Total liabilities 8,952,996 7,726,173
STOCKHOLDERS' EQUITY:
Common stock, $0.01 par value -
March 31, 2006: 60,000,000 shares
authorized; 28,226,763 issued and
outstanding; December 31, 2005: 17,990,322
shares issued and outstanding; 282,268 179,903
Series A preferred stock of
Advanced Life Sciences Inc., no par
value - 250,000 shares authorized, issued
and outstanding - -
Additional paid-in capital 88,221,460 54,834,373
Deficit accumulated during the development
stage (49,956,972) (46,718,539)
Total stockholders' equity
(deficit) 38,546,756 8,295,737
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $47,499,752 $16,021,910
ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY
(A Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended March 31,
2006 2005
Revenue:
Management fees $- $32,519
Grant 35,127 -
Total revenue 35,127 32,519
Expenses:
Research and development 2,260,378 317,790
Selling, general and administrative 1,149,170 367,744
Total expenses 3,409,548 685,534
Loss from operations (3,374,421) (653,015)
Other (income) expense:
Interest Income (280,858) -
Interest expense 144,870 95,311
Net other (income) expense (135,988) 95,311
Net loss (3,238,433) (748,326)
Less accumulated preferred dividends for
the period 43,750 43,750
Net loss available to common shareholders $(3,282,183) $(792,076)
Basic and diluted net loss per share available
to common shareholders $(0.15) $(0.07)
Weighted average number common shares
outstanding - basic and diluted 21,290,153 10,732,978
