EX-99.1 2 a06-11593_1ex99d1.htm EX-99.1

Exhibit 99.1

 

1440 Davey Road

Woodridge, Ill. 60517

(Phone) 630.739.6744

(Fax) 630.739.6754

www.advancedlifesciences.com

 

For Immediate Release

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

 

Advanced Life Sciences Announces First Quarter 2006 Results

 

WOODRIDGE, IL, May 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 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.

 

“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.

 

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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 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 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)

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

 

 

As of
March 31,
2006

 

Year ended
December 31,
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