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Advanced Life Sciences Announces Second Quarter 2008 Financial Results

CHICAGO, Aug. 14 /PRNewswire-FirstCall/ -- 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 respiratory diseases, today announced its financial results for the second quarter ended June 30, 2008.


The net loss for the three months was $3.4 million or ($0.09) per share compared to $10.6 million or ($0.37) per share for the three months ended June 30, 2007. The improvement in the net loss reflects lower development expenses related to the cethromycin pivotal Phase III clinical program, which was completed in November 2007.

"Recognizing the increased need for new drugs to address emerging bacterial resistance, our team has worked intensely this quarter to finalize our NDA submission for cethromycin in the community acquired pneumonia indication and advancing our pre-commercial objectives," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We also made substantial progress with our biodefense initiatives and pipeline programs."

The company ended the second quarter of 2008 with cash and cash equivalents totaling $9.1 million, having used approximately $3.5 million in the quarter.

Operating Expense Analysis

* Research and development expenses were $1.7 million for the three

months ended June 30, 2008 compared to $8.8 million for the three

months ended June 30, 2007. The decrease in R&D expense is related

to lower clieholders $(7,028,546) $(21,042,108) $(108,106,926)

Net loss per share available to

common shareholders - basic and

diluted $(0.18) $(0.74)

Weighted average shares

outstanding - basic and diluted 38,502,987 28,290,865

nical development and manufacturing costs associated

with the Company's lead product, cethromycin.

* Selling, general and administrative expenses totaled $1.7 million

compared to $1.8 million for the second quarter of last year.

Recent Achievements

* Incorporated knowledge gained in April meetings with FDA to optimize

cethromycin NDA for the community acquired pneumonia (CAP)


* Progressed negotiations with prospective partners for the

commercialization of cethromycin;

* Announced U.S. Department of Defense DTRA contract to study

cethromycin in tularemia, plague and melioidosis for up to

$3.8 million;

* Submitted funding proposal to Department of Health & Human Services

to expand the application of cethromycin as a broad spectrum medical

countermeasure. If awarded, the contract would further support

advanced development for cethromycin to combat Category A and B

bioterror threats such as inhalation anthrax, tularemia, plague and


* Published data in Journal of Antimicrobial Chemotherapy showing

potent cethromycin in vitro CA-MRSA activity;

* Opened enrollment and began screening patients in dose-escalating

study to assess the safety, tolerability, and preliminary efficacy

of ALS-357 topically administered to patients with cutaneous

metastatic melanoma;

* Announced collaboration with UK Ministry of Defence for study of

ALS-886 as a treatment for lung tissue damage.

Business Outlook and Goals for the Third Quarter of 2008

* Submit electronic NDA package for cethromycin in the CAP indication

to the FDA;

* Advance negotiations with prospective partners for the

commercialization of cethromycin;

* Present posters and meet with National Advisory Board for

cethromycin at the October 25-28 ICAAC/IDSA conference in

Washington, DC;

* Under the DTRA contract, expand advanced studies of cethromycin as a

broad spectrum medical countermeasure;

* Continue preparing for commercial launch of cethromycin through

manufacturing, market research, medical education, and pricing

strategy activities;

* Dose first patient in ALS-357 PhaseI/II melanoma trial.

Financial Guidance for the Third Quarter of 2008

Advanced Life Sciences expects its third quarter 2008 cash requirements to fall in the range of $3.4 million and $3.7 million, leaving a cash balance of $5.4 million to $5.7 million as of September 30, 2008. Management believes that this cash balance will be sufficient to allow the Company to progress to the period in which it submits the NDA for cethromycin in the CAP indication to the FDA. To fund ongoing operations including the payment of any milestone payment due to Abbott Laboratories in connection with the submission of the cethromycin NDA, the Company intends to raise additional capital in 2008 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 14, 2008 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 Alternatively, callers may participate in the conference call by dialing 888-713-4218 (domestic) or 617-213-4870 (international). The passcode for the conference call is 89533387. A replay of the conference call will be available until August 21, 2008. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 77812086. 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 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 Community Acquired Pneumonia (CAP)

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CAP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2 billion dollars for prescribed antibiotics to treat CAP. CAP is potentially fatal if not treated properly, and the bacteria that cause CAP are developing resistance to current standard of care treatments.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

About Cethromycin

Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.

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 oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at

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, the adequacy of our clinical results, the timing and terms of any commercial partnership, 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.


(A Development Stage Company)

June 30, December 31,





Cash and cash equivalents $9,054,421 $18,324,991

Prepaid insurance 48,527 251,493

Prepaid clinical trial expenses - 926,168

Other prepaid expenses and deposits 89,360 140,359

Total current assets 9,192,308 19,643,011


Furniture and fixtures 232,461 221,417

Laboratory equipment 159,186 159,186

Computer software and equipment 250,104 242,707

Leasehold improvements 502,798 177,253

Total property and

equipment - at cost 1,144,549 800,563

Less accumulated depreciation (659,108) (542,032)

Property and equipment - net 485,441 258,531

OTHER ASSETS 23,018 10,000

TOTAL ASSETS $9,700,767 $19,911,542



Accounts payable $200,976 $2,685,751

Accrued clinical trial and NDA expenses 1,144,749 2,776,543

Other accrued expenses 811,925 330,441

Accrued interest payable 20,391 22,756

Short-term lease payable 7,832 7,259

Short-term notes payable - related

party 2,000,000 -

Total current liabilities 4,185,873 5,822,750

Long-term lease payable 8,751 12,818

Long-term grant payable 500,000 500,000

Long-term notes payable - related party - 2,000,000

Letter of credit 3,915,000 3,915,000

Total liabilities 8,609,624 12,250,568




Common stock, $0.01 par

value-60,000,000 shares authorized;

38,502,987 issued and outstanding

at June 30, 2008 and December 31,

2007 385,030 385,030

Additional paid-in capital 107,230,747 106,859,532

Deficit accumulated during the

development stage (106,524,634) (99,583,588)

Total stockholders' equity 1,091,143 7,660,974


EQUITY $9,700,767 $19,911,542


(A Development Stage Company)



Three months ended June 30,

2008 2007


Management fees $- $-

Grants - -

Royalty-related party - -

Total revenue - -


Research and development 1,690,088 8,833,078

Contracted research and

development-related party - -

Selling, general and administrative 1,682,604 1,810,249

Total expenses 3,372,692 10,643,327

Loss from operations (3,372,692) (10,643,327)

Net other (income) expense:

Interest income (76,444) (214,495)

Interest expense 102,664 116,836

Gain on sale of interest in Sarawak

Medichem Pharmaceuticals joint venture - -

Net other (income) expense 26,220 (97,659)

Net loss (3,398,912) (10,545,668)

Less accumulated preferred stock dividends

of subsidiary for the period 43,750 43,750

Net loss available to common

shareholders $(3,442,662) $(10,589,418)

Net loss per share available to common

shareholders - basic and diluted $(0.09) $(0.37)

Weighted average shares outstanding -

basic and diluted 38,502,987 28,294,380

Period From


Six months ended (January 1, 1999)

June 30, Through

2008 2007 June 30, 2008


Management fees $- $- $1,161,180

Grants - - 1,035,571

Royalty-related party - - 45,238

Total revenue - - 2,241,989


Research and development 3,558,141 17,883,990 78,429,249

Contracted research and

development-related party - - 7,980,299

Selling, general and

administrative 3,408,972 3,358,412 23,341,060

Total expenses 6,967,113 21,242,402 109,750,608

Loss from operations (6,967,113) (21,242,402) (107,508,619)

Net other (income) expense:

Interest income (233,086) (521,064) (2,875,102)

Interest expense 207,019 233,270 2,830,169

Gain on sale of interest in

Sarawak Medichem

Pharmaceuticals joint venture - - (939,052)

Net other (income) expense (26,067) (287,794) (983,985)

Net loss (6,941,046) (20,954,608) (106,524,634)

Less accumulated preferred stock

dividends of subsidiary for the

period 87,500 87,500 1,582,292

Net loss available to common


SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2008 PR Newswire.
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