EX-99.1 2 a06-23258_2ex99d1.htm EX-99

Exhibit 99.1

1440 Davey Road

Woodridge, IL  60517

(Phone) 630.739.6744

(Fax) 630.739.6754

www.advancedlifesciences.com

For Immediate Release

Investor Relations Contact: Edward P. Flavin (630) 739-6744 Ext. 211

Advanced Life Sciences Announces Third Quarter 2006 Results

WOODRIDGE, IL, November 7, 2006/PRNewswire/: — 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 third quarter ended September 30, 2006.  The net loss available to common shareholders for the three months ended September 30, 2006 was $6.9 million or ($0.24) per share compared to $2.3 million or ($0.15) per share for the three months ended September 30, 2005.  The increase in the net loss reflects increased development expenses related to cethromycin pivotal Phase III clinical trial costs.

“We are focused on completing our pivotal phase III trials in community acquired pneumonia (CAP),” said Michael T. Flavin, Ph.D., Chairman and Chief Executive Officer of Advanced Life Sciences.  “We have achieved our goal of initiating clinical sites in four distinct geographies and look forward to assembling and filing our NDA for the CAP indication next year.”

The Company ended the third quarter of 2006 with cash and cash equivalents totaling $32.0 million.  Cash used during the third quarter was approximately $7.1 million.

Operating Expense Analysis

·                  Research and development expenses increased $4.8 million to $5.7 million for the three months ended September 30, 2006 from $0.9 million for the three months ended September 30, 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 $0.3 million to $1.5 million for the three months ended September 30, 2006 from $1.2 million for the three months ended September 30, 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.

Third Quarter 2006 Product Candidate Highlights

Advanced Life Sciences is developing cethromycin, a second generation once-a-day ketolide antibiotic in response to the emerging antibiotic resistance observed in the treatment of CAP.  Cethromycin has been tested in approximately 3,800 human subjects during clinical trials.

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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 address the need for antibiotics that overcome bacterial resistance, yet retain a favorable safety profile.  The primary endpoint for the trials is clinical cure rate non-inferiority and the secondary endpoint is bacteriological cure rate.

Pipeline Progress and Upcoming Milestones

In the cethromycin clinical program, the Company initiated approximately 75 new clinical sites, including 70 sites in Europe and 5 in North America.  A total of approximately 200 clinical sites have been initiated in Europe, North America, Latin America and South Africa.

In September of 2006, the Company sponsored a satellite symposium entitled “Community Acquired Pneumonia: New Insights for an Old Problem” and presented phase II and phase III cethromycin clinical data at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in CAP and bronchitis in San Francisco.  Along with its collaborator, the U.S. Army Medical Research Institute of Infectious Diseases, the Company also presented cethromycin preclinical data in anthrax models.

In September of 2006, the Company presented data on ALS-357 at the 232nd American Chemical Society meeting in San Francisco.

In October of 2006, the Company presented and conducted an oral “Meet the Presenter” discussion of phase II and phase II/III cethromycin clinical data in sinusitis at the 44th Annual Meeting of the Infectious Disease Society of America (IDSA) in Toronto.

The Company also initiated a pre-NDA animal study with Battelle to measure the efficacy of cethromycin to treat inhalation anthrax post-exposure for prophylaxis.

The Company anticipates the following upcoming milestones in the clinical development of cethromycin:

·                  Complete cethromycin pivotal Phase III clinical trials.

·                  Advance discussions with prospective partners regarding a commercialization partnership for cethromycin.

·                  File NDA for cethromycin in CAP.

Financial Guidance for the Fourth Quarter of 2006

The Company expects its fourth quarter 2006 cash requirements to range between $7.0 and $8.0 million.  Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, November 8, 2006 to discuss the Company’s third 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 www.advancedlifesciences.com.  Alternatively, callers may participate in the conference call by dialing 866-700-5192 (domestic) or 617-213-8833 (international).  The passcode for the conference call is 86403289.  A replay of the conference call will be available until December 9, 2006.  Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 10108693.

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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 second generation 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.

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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

September 30,

 

December 31,

 

 

 

2006

 

2005

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

32,042,342

 

$

4,749,932

 

Investments - available for sale

 

 

10,475,000

 

Accounts receivable - related party

 

 

6,160

 

Prepaid insurance

 

559,318

 

362,241

 

Prepaid clinical trials

 

2,551,799

 

4,500

 

Other prepaid expenses and deposits

 

451,296

 

113,763

 

 

 

 

 

 

 

Total current assets

 

35,604,755

 

15,711,596

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

250,307

 

147,275

 

Laboratory equipment

 

142,928

 

142,928

 

Computer software and equipment

 

216,480

 

187,771

 

Leasehold improvements

 

182,839

 

40,646

 

 

 

 

 

 

 

Total property and equipment—at cost

 

792,554

 

518,620

 

Less accumulated depreciation

 

(348,331

)

(267,372

)

 

 

 

 

 

 

Property and equipment—net

 

444,223

 

251,248

 

 

 

 

 

 

 

OTHER LONG-TERM ASSETS:

 

 

 

 

 

Deferred financing costs

 

33,127

 

53,004

 

Other assets

 

1,452

 

6,062

 

 

 

 

 

 

 

Total other long-term assets

 

34,579

 

59,066

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

36,083,557

 

$

16,021,910

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

557,522

 

$

294,816

 

Accrued clinical trial expenses

 

1,205,058

 

83,186

 

Other accrued expenses

 

652,343

 

157,575

 

Accrued interest payable

 

 

5,334

 

Short-term lease payable

 

21,926

 

14,114

 

 

 

 

 

 

 

Total current liabilities

 

2,436,849

 

555,025

 

 

 

 

 

 

 

Long-term lease payable

 

22,761

 

13,166

 

Accrued interest payable - related party

 

 

765,514

 

Grant payable

 

500,000

 

500,000

 

Notes payable - net of $14,083 debt discount September 30, 2006 & $22,532 December 31, 2005

 

3,900,917

 

3,892,468

 

Notes payable - related party

 

2,000,000

 

2,000,000

 

 

 

 

 

 

 

Total liabilities

 

8,860,527

 

7,726,173

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value—September 30, 2006: 60,000,000 shares authorized; 28,268,899 issued and outstanding; December 31, 2005: 17,990,322 shares issued and outstanding;

 

282,689

 

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

 

88,297,045

 

54,834,373

 

Deficit accumulated during the development stage

 

(61,356,704

)

(46,718,539

)

 

 

 

 

 

 

Total stockholders’ equity

 

27,223,030

 

8,295,737

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

36,083,557

 

$

16,021,910

 

 




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 September 30,

 

Nine months ended September 30,

 

Through

 

 

 

2006

 

2005

 

2006

 

2005

 

September 30, 2006

 

Revenue and income:

 

 

 

 

 

 

 

 

 

 

 

Management fees

 

$

 

$

8,502

 

$

 

$

52,881

 

$

1,161,180

 

Grant

 

 

 

35,127

 

 

1,030,910

 

Royalty—related party

 

 

 

 

 

45,238

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenue and income

 

 

8,502

 

35,127

 

52,881

 

2,237,328

 

 

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

5,730,269

 

938,813

 

11,569,685

 

1,604,749

 

43,502,921

 

Contracted research and development—related party

 

 

 

 

 

7,980,299

 

Selling, general and administrative

 

1,489,502

 

1,239,674

 

3,977,514

 

2,078,246

 

11,612,632

 

 

 

 

 

 

 

 

 

 

 

 

 

Total expenses

 

7,219,771

 

2,178,487

 

15,547,199

 

3,682,995

 

63,095,852

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(7,219,771

)

(2,169,985

)

(15,512,072

)

(3,630,114

)

(60,858,524

)

 

 

 

 

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

 

 

Interest Income

 

(466,475

)

(97,712

)

(1,267,433

)

(97,712

)

(1,539,649

)

Interest expense

 

120,649

 

135,925

 

393,526

 

340,174

 

2,037,829

 

 

 

 

 

 

 

 

 

 

 

 

 

Net other (income) expense

 

(345,826

)

38,213

 

(873,907

)

242,462

 

498,180

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(6,873,945

)

(2,208,198

)

(14,638,165

)

(3,872,576

)

(61,356,704

)

 

 

 

 

 

 

 

 

 

 

 

 

Less accumulated preferred dividends for the period

 

43,750

 

43,750

 

131,250

 

131,250

 

1,276,042

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss available to common shareholders

 

$

(6,917,695

)

$

(2,251,948

)

$

(14,769,415

)

$

(4,003,826

)

$

(62,632,746

)

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share available to common shareholders

 

$

(0.24

)

$

(0.15

)

$

(0.57

)

$

(0.33

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number common shares outstanding- basic and diluted

 

28,268,247

 

14,819,191

 

25,962,479

 

12,134,776