EX-99.1 2 a07-13636_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

Advanced Life Sciences Announces First Quarter 2007 Financial Results

WOODRIDGE, IL, May 8, 2007/PRNewswire/: — Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced its financial results for the first quarter ended March 31, 2007.  The net loss for the three months ended March 31, 2007 was $10.4 million or ($.37) per share compared to $3.2 million or ($.15) per share for the three months ended March 31, 2006.  The increase in the net loss reflects increased development expenses related to pivotal Phase III clinical trial costs of the Company’s novel once-a-day antibiotic, cethromycin.

“Advanced Life Sciences continued to make substantial progress in the first quarter of 2007,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences.  “We are nearing the end of our clinical work with cethromycin and are building toward a robust NDA submission.  We were pleased to announce last week very positive efficacy data from our non-human primate study in  inhalation anthrax. Looking forward, our focus is on the release of top-line data from our pivotal Phase III program in CAP that we expect to occur in June of this year.”

The company ended the first quarter of 2007 with cash, cash equivalents and investments totaling $22.1 million.  Cash used during the first quarter was approximately $5.0 million.

Operating Expense Analysis

·                  Research and development expenses increased $6.8 million to $9.1 million for the three months ended March 31, 2007 from $2.3 million for the three months ended March 31, 2006.  This increase was due to additional development expenses directly related to our Phase III clinical trials and NDA-related expenses for cethromycin.

·                  Selling, general and administrative expenses increased $0.4 million to $1.5 million for the three months ended March 31, 2007 from $1.1 million for the three months ended March 31, 2006. This increase is primarily attributed to higher compensation costs for existing personnel and increased costs associated with Sarbanes-Oxley compliance.

First Quarter 2007 Product Candidate Highlights

Advanced Life Sciences is developing cethromycin, a novel once-a-day antibiotic in response to the emerging bacterial resistance observed in the treatment of community acquired pneumonia (CAP).  Cethromycin has been involved in over 50 clinical studies and has been tested in approximately 4,400 human subjects.

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 opportunity in the antibiotic marketplace and address the critical need for new antibiotics that overcome bacterial resistance.

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Recent Achievements:

·                  Demonstrated cethromycin was 100% protective against inhalation anthrax in key non-human primate efficacy study

·                  Granted Orphan Drug status by the FDA for the use of cethromycin in treatment of inhalation anthrax

·                  Initiated competitive negotiation process with prospective commercialization partners to assist with the launch of cethromycin

The company anticipates the following upcoming milestones in the development of cethromycin:

·                  Release of data from pivotal Phase III clinical program in CAP in June

·                  Continue preparation of NDA submission package and pre-launch medical communication programs

·                  Advancement of negotiations with multiple prospective commercialization partners

Financial Guidance for Second Quarter of 2007

The company expects its second quarter 2007 cash requirements to range between $7.5 and $8.5 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 9, 2007 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 800-659-1942 (domestic) or 617-614-2710 (international).  The passcode for the conference call is 13856687.  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 99601128.

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 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)

 

 

 

March 31,

 

December 31,

 

 

 

2007

 

2006

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

22,050,237

 

$

27,054,947

 

Prepaid insurance

 

222,957

 

380,083

 

Prepaid clinical trial expenses

 

2,857,597

 

2,364,512

 

Other prepaid expenses and deposits

 

272,116

 

273,572

 

 

 

 

 

 

 

Total current assets

 

25,402,907

 

30,073,114

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

250,979

 

250,308

 

Laboratory equipment

 

159,662

 

142,928

 

Computer software and equipment

 

255,241

 

231,022

 

Leasehold improvements

 

177,253

 

182,839

 

 

 

 

 

 

 

Total property and equipment—at cost

 

843,135

 

807,097

 

Less accumulated depreciation

 

(446,574

)

(398,486

)

 

 

 

 

 

 

Property and equipment—net

 

396,561

 

408,611

 

 

 

 

 

 

 

OTHER LONG-TERM ASSETS:

 

 

 

 

 

Deferred financing costs

 

19,876

 

26,502

 

Other assets

 

1,452

 

1,452

 

 

 

 

 

 

 

Total other long-term assets

 

21,328

 

27,954

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

25,820,796

 

$

30,509,679

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

5,253,876

 

$

1,011,396

 

Accrued clinical trial expenses

 

2,564,432

 

1,410,894

 

Other accrued expenses

 

386,054

 

226,881

 

Accrued interest payable

 

 

22,756

 

Short-term lease payable

 

15,778

 

19,437

 

Short-term grant payable

 

476,708

 

476,708

 

Short-term notes payable - related party

 

2,000,000

 

2,000,000

 

Short-term notes payable - net of $8,450 debt discount

 

3,906,550

 

 

 

 

 

 

 

 

Total current liabilities

 

14,603,398

 

5,168,072

 

 

 

 

 

 

 

Long-term lease payable

 

18,362

 

20,076

 

Long-term grant payable

 

23,292

 

23,292

 

Notes payable - net of $11,266 debt discount

 

 

3,903,734

 

 

 

 

 

 

 

Total liabilities

 

14,645,052

 

9,115,174

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES:

 

 

 

 

 

Minority Interest

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value—60,000,000 shares authorized;
March 31, 2007 28,287,677 issued and outstanding; December 31, 2006
28,282,677 shares issued and outstanding;

 

282,877

 

282,827

 

Additional paid-in capital

 

88,560,982

 

88,370,853

 

Deficit accumulated during the development stage

 

(77,668,115

)

(67,259,175

)

 

 

 

 

 

 

Total stockholders’ equity

 

11,175,744

 

21,394,505

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

25,820,796

 

$

30,509,679

 

 




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 March 31,

 

Through

 

 

 

2007

 

2006

 

March 31, 2007

 

Revenue:

 

 

 

 

 

 

 

Management fees

 

$

 

$

 

$

1,161,180

 

Grants

 

 

35,127

 

1,035,571

 

Royalty—related party

 

 

 

45,238

 

 

 

 

 

 

 

 

 

Total revenue

 

 

35,127

 

2,241,989

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

Research and development

 

9,050,912

 

2,260,378

 

58,186,261

 

Contracted research and development—related party

 

 

 

7,980,299

 

Selling, general and administrative

 

1,548,163

 

1,149,170

 

14,640,676

 

 

 

 

 

 

 

 

 

Total expenses

 

10,599,075

 

3,409,548

 

80,807,236

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(10,599,075

)

(3,374,421

)

(78,565,247

)

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

Interest Income

 

(306,569

)

(280,858

)

(2,230,701

)

Interest expense

 

116,434

 

144,870

 

2,272,621

 

Gain on sale of interest in Sarawak Medichem Pharmaceuticals joint venture

 

 

 

(939,052

)

 

 

 

 

 

 

 

 

Net other income

 

(190,135

)

(135,988

)

(897,132

)

 

 

 

 

 

 

 

 

Net loss

 

(10,408,940

)

(3,238,433

)

(77,668,115

)

 

 

 

 

 

 

 

 

Less accumulated preferred dividends for the period

 

43,750

 

43,750

 

1,363,542

 

 

 

 

 

 

 

 

 

Net loss available to common shareholders

 

$

(10,452,690

)

$

(3,282,183

)

$

(79,031,657

)

 

 

 

 

 

 

 

 

Basic and diluted net loss per share available to common shareholders

 

$

(0.37

)

$

(0.15

)

 

 

 

 

 

 

 

 

 

 

Weighted average number common shares outstanding- basic and diluted

 

28,287,310

 

21,290,153