EX-99.1 2 a06-15832_2ex99d1.htm EX-99.1

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 Second Quarter 2006 Results

WOODRIDGE, IL, August 9, 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 second quarter ended June 30, 2006.  The net loss available to common shareholders for the three months ended June 30, 2006 was $4.5 million or ($0.16) per share compared to $1.0 million or ($0.09) per share for the three months ended June 30, 2005.  The increase in the net loss reflects increased development expenses related to cethromycin pivotal Phase III clinical trial costs.

“Advanced Life Sciences had a productive second quarter, making steady progress toward our milestones,” said Michael T. Flavin, Ph.D., Chairman and Chief Executive Officer of Advanced Life Sciences.  “We are focused on enrolling patients in our pivotal Phase III clinical trials for cethromycin and are on track to have approximately 200 clinical sites enrolling patients in the Fall as planned.  Our team is focused on the completion of the trials as we advance cethromycin toward an NDA in 2007.”

The Company ended the second quarter of 2006 with cash and cash equivalents totaling $39.2 million.  Cash used during the second quarter was approximately $5.7 million.

Operating Expense Analysis

·                  Research and development expenses increased $3.2 million to $3.6 million for the three months ended June 30, 2006 from $0.4 million for the three months ended June 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 $0.8 million to $1.3 million for the three months ended June 30, 2006 from $0.5 million for the three months ended June 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.

Second 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 community acquired pneumonia (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 mild safety profile.

Cethromycin Progress and Upcoming Milestones

The Company initiated approximately 51 new clinical sites, including 42 sites in Latin America and South Africa and 9 new sites in North America.  A total of approximately 126 clinical sites have been initiated in these three geographies.  Additionally, we made regulatory submissions in 12 European countries.  We are targeting the start of patient enrollment at 70 sites for the beginning of CAP season in the European region.

In May 2006, the Company initiated cethromycin commercial manufacturing agreements with DSM and Cardinal Health.

Based upon the favorable results of our collaboration with USAMRIID, in July 2006 we initiated a pre-NDA animal study with Battelle for cethromycin as a potential treatment for inhalation anthrax.

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

·                  Complete cethromycin pivotal Phase III clinical trials by year end.

·                  Present data from prior cethromycin clinical trials at key scientific conferences including ICAAC and IDSA.

·                  Sponsor a cethromycin principal investigator meeting in Rome, Italy for physicians enrolling CAP patients in Europe.

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

Financial Guidance for the Third Quarter of 2006

The Company expects its third 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, August 9, 2006 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 www.advancedlifesciences.com.  Alternatively, callers may participate in the conference call by dialing 800-573-4840 (domestic) or 617-224-4326 (international).  The passcode for the conference call is 75880306.  A replay of the conference call will be available until September 9, 2006.  Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 32997825.

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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)

 

 

June 30,
2006

 

December 31,
2005

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

39,167,501

 

$

4,749,932

 

Investments - available for sale

 

 

10,475,000

 

Accounts receivable - related party

 

 

6,160

 

Prepaid insurance

 

104,895

 

362,241

 

Prepaid expenses and other

 

2,721,772

 

118,263

 

Total current assets

 

41,994,168

 

15,711,596

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

174,598

 

147,275

 

Laboratory equipment

 

142,928

 

142,928

 

Computer software and equipment

 

211,984

 

187,771

 

Leasehold improvements

 

40,646

 

40,646

 

Total property and equipment—at cost

 

570,156

 

518,620

 

Less accumulated depreciation

 

(315,101)

 

(267,372)

 

Property and equipment—net

 

255,055

 

 251,248

 

OTHER LONG-TERM ASSETS:

 

 

 

 

 

Deferred financing costs

 

39,753

 

53,004

 

Other assets

 

3,654

 

6,062

 

Total other long-term assets

 

43,407

 

59,066

 

TOTAL ASSETS

 

$

42,292,630

 

$

16,021,910

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

148,528

 

$

294,816

 

Accrued expenses

 

1,668,986

 

240,761

 

Accrued interest payable

 

12,917

 

5,334

 

Short-term lease payable

 

19,798

 

1,850,229

 

Total current liabilities

 

1,850,229

 

555,025

 

Long-term lease payable

 

20,678

 

13,166

 

Accrued interest payable - related party

 

 

765,514

 

Grant payable

 

500,000

 

500,000

 

Notes payable - net of $16,899 debt discount June 30, 2006 & $22,532 December 31, 2005

 

3,898,101

 

3,892,468

 

Notes payable - related party

 

2,000,000

 

2,000,000

 

Total liabilities

 

8,269,008

 

7,726,173

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value—June 30, 2006: 60,000,000 shares authorized; 28,258,899 issued and outstanding; December 31, 2005: 17,990,322 shares issued and outstanding;

 

282,589

 

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

 

88,223,792

 

54,834,373

 

Deficit accumulated during the development stage

 

(54,482,759

)

(46,718,539

)

Total stockholders’ equity (deficit)

 

34,023,622

 

16,021,910

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

42,292,630

 

$

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 June 30,

 

Six months ended June 30,

 

Through

 

 

 

2006

 

2005

 

2006

 

2005

 

June 30, 2006

 

Revenue and income:

 

 

 

 

 

 

 

 

 

 

 

Management fees

 

$

 

$

11,860

 

 

$

44,379

 

$

1,161,180

 

Grant

 

 

 

35,127

 

 

1,030,910

 

Royalty—related party

 

 

 

 

 

45,238

 

Total revenue and income

 

 

11,860

 

35,127

 

44,379

 

2,237,328

 

Expenses:

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

3,579,038

 

348,148

 

5,839,416

 

685,938

 

37,772

 

Contracted research and development—related party

 

 

 

 

 

 

 

7,980,299

 

Selling, general and administrative

 

1,338,842

 

470,828

 

2,488,012

 

838,572

 

10,123,130

 

Total expenses

 

4,917,880

 

818,974

 

8,327,428

 

1,504,508

 

55,876,081

 

Loss from operations

 

(4,917,880

)

(807,114

)

(8,292,301

)

(1,460,129

)

(53,638,753

)

Other (income) expense:

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

(520,100

)

 

(800,958

)

 

(1,073,174

)

Interest expense

 

128,007

 

108,938

 

272,877

 

204,249

 

1,917,180

 

Net other (income) expense

 

(392,093

)

108,938

 

(528,081

)

204,249

 

844,006

 

Net loss

 

(4,525,787

)

(916,052

)

(7,764,220

)

(1,684,378

)

(54,482,759

)

Less accumulated preferred dividends for the period

 

43,750

 

43,750

 

87,500

 

87,500

 

1,232,292

 

Net loss available to common shareholders

 

$

(4,569,537

)

$

(959,802

)

$

(7,851,720

)

$

(1,751,878

)

$

(55,715,051

)

Basic and diluted net loss per share available to common shareholders

 

$

(0.16

)

$

(0.09

)

$

(0.32

)

$

(0.16

)

 

 

Weighted average number common shares outstanding—basic and diluted

 

28,252,354

 

10,826,795

 

24,790,486

 

10,780,148