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Advanced Life Sciences Announces First Quarter 2008 Financial Results

CHICAGO, May 7 /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 first quarter ended March 31, 2008. The net loss available to common shareholders for the three months ended March 31, 2008 was $3.6 million or ($0.09) per share compared to $10.5 million or ($0.37) per share for the three months ended March 31, 2007. The decrease in the net loss reflects lower development expenses related to the cethromycin pivotal Phase III clinical program, which was completed in November 2007.


"Having confirmed the regulatory plans for cethromycin, we are pushing forward aggressively to achieve our partnering and NDA submission goals," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "We believe cethromycin can be an important new drug in the treatment of community acquired pneumonia and, if approved, can assist in the emerging battle against drug resistant bacteria."

The company ended the first quarter of 2008 with cash and cash equivalents totaling $12.6 million. Cash used during the first quarter was approximately $5.7 million.

Operating Expense Analysis:

* Research and development expense. Total research and development

expense decreased $7.2 million to approximately $1.9 million for the

three months ended March 31, 2008 from approximately $9.1 million for

the three months ended March 31, 2007. The decrease in R&D expense is

related to lower clinical development and manufacturing costs associated

with the Company's lead product cethromycin.

* General and administrative expense. General and administrative expense

increased $0.2 million to $1.7 million for the three months ended

March 31, 2008. The increase was attributable to costs associated with

cethromycin national advisory board meeting costs and higher

compensation and benefit expenses.

Year-to-Date 2008 Achievements:

* Attended the FDA Anti-Infectives Advisory Committee meeting that

discussed non-inferiority margins in CAP clinical trials on April 1

and 2, 2008 and held a conference call to provide management's

understanding of the Advisory Committee meeting to investors on April 3,


* Conducted a meeting with FDA on April 7, 2008 to discuss the anticipated

NDA submission in CAP and provided a summary of the outcome to investors

via conference call on April 10, 2008;

* Released results of our successful thorough QT study of cethromycin;

* Provided regulatory updates to multiple potential partners and advanced

negotiations regarding the commercial development of cethromycin as a

treatment for CAP;

* Met with the national advisory board for cethromycin consisting of

thought leaders in the area of respiratory tract infections and

antibiotic therapies to confirm the regulatory and development strategy;

* Advanced the development of ALS-357: received approval from the

Northwestern University Institutional Review Board (IRB) of the protocol

for the planned Phase I/II melanoma program.

Remaining Objectives for 2008

* Submit NDA for cethromycin in CAP;

* Finalize negotiations with potential commercial partners for


* Continue studies 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. Submit proposals to the Department of Defense and the

Department of Health and Human Services to fund the advanced development

of cethromycin in combating bioterror agents such as anthrax, tularemia,

plague and Burkholderia pseudomallei;

* Initiate enrollment by the end of the summer in Phase I/II

dose-escalating study to assess the safety, tolerability, and

preliminary efficacy of ALS-357 topically administered to patients with

cutaneous metastatic melanoma;

* Present cethromycin clinical data at ICAAC in the Fall.

Financial Guidance for 2008

Advanced Life Sciences expects its 2008 cash requirements excluding milestone payments that become due upon NDA filing to fall in the range of $16 million and $17 million. The first quarter cash use of $5.7 million reflects continued NDA submission costs that will curtail substantially in the coming quarters. Accordingly, we expect our quarterly cash use to decrease as we move forward with our operations. The cash used will be applied toward remaining cethromycin NDA submission activities, manufacturing costs, medical communication investments, ALS-357 clinical costs, and general operating expenses. We believe that this cash balance will be sufficient to allow us to progress into a commercial partnership which will support the ongoing funding needs of the Company.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, May 7, 2008 to discuss the Company's financial results for the first quarter.

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of Advanced Life Sciences' corporate website Alternatively, callers may participate in the conference call by dialing 888-679-8033 (domestic) or 617-213-4846 (international). The passcode for the conference call is 94054446. Participants may pre-register for the call at: 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 36406348.

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 respiratory diseases. 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 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)


(Unaudited) 2008 2007



Cash and cash equivalents $12,589,640 $18,324,991

Prepaid insurance 155,953 251,493

Prepaid clinical trial expenses - 926,168

Other prepaid expenses and deposits 93,500 140,359

Total current assets 12,839,093 19,643,011


Furniture and fixtures 227,825 221,417

Laboratory equipment 159,186 159,186

Computer software and equipment 245,812 242,707

Leasehold improvements 502,798 177,253

Total property and equipment-at cost 1,135,621 800,563

Less accumulated depreciation (595,429) (542,032)

Property and equipment-net 540,192 258,531


Other assets 18,750 10,000

Total other assets 18,750 10,000

TOTAL ASSETS $13,398,035 $19,911,542



Accounts payable $1,458,912 $2,685,751

Accrued clinical trial expenses 754,402 2,776,543

Other accrued expenses 463,347 330,441

Accrued interest payable 21,070 22,756

Short-term lease payable 7,538 7,259

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

Total current liabilities 4,705,269 5,822,750

Long-term lease payable 10,824 12,818

Long-term grant payable 500,000 500,000

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

Notes payable 3,915,000 3,915,000

Total liabilities 9,131,093 12,250,568




Common stock, $0.01 par value-60,000,000

shares authorized; 38,502,987 issued and

outstanding at March 31, 2008; 38,502,987

shares issued and outstanding at December 31,

2007 385,030 385,030

Additional paid-in capital 107,007,634 106,859,532

Deficit accumulated during the

development stage (103,125,722) (99,583,588)

Total stockholders' equity 4,266,942 7,660,974



(A Development Stage Company)



Period From


Three months ended (January 1, 1999)

March 31, Through

2008 2007 March 31, 2008


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

Grants - - 1,035,571

Royalty-related party - - 45,238

Total revenue - - 2,241,989


Research and development 1,868,054 9,050,912 76,739,162

Contracted research and

development-related party - - 7,980,299

Selling, general and

administrative 1,726,366 1,548,163 21,658,454

Total expenses 3,594,420 10,599,075 106,377,915

Loss from operations (3,594,420) (10,599,075) (104,135,926)

Net other income:

Interest income (156,641) (306,569) (2,798,657)

Interest expense 104,355 116,434 2,727,505

Gain on sale of interest in

Sarawak Medichem

Pharmaceuticals joint venture - - (939,052)

Net other income (52,286) (190,135) (1,010,204)

Net loss (3,542,134) (10,408,940) (103,125,722)

Less accumulated preferred

stock dividends of

subsidiary for the period 43,750 43,750 1,538,542

Net loss available to

common shareholders $(3,585,884) $(10,452,690) $(104,664,264)

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 28,287,310

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

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