EX-99.1 2 a07-8737_1ex99d1.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

Advanced Life Sciences Announces Fourth Quarter and Full Year
 2006 Results

Enrollment in first of two pivotal phase III trials for cethromycin completed

WOODRIDGE, IL, March 21, 2007/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 fourth quarter and full year ended December 31, 2006.

The net loss allocable to common shareholders for the three months ended December 31, 2006 was $5.9 million or ($.21) per share compared to a net loss allocable to common shareholders of $2.6 million or ($.15) per share for the three months ended December 31, 2005.  The net loss allocable to common shareholders for the full year 2006 was $20.7 million or ($.78) per share compared to a net loss allocable to common shareholders of $6.6 million or ($.49) per share for 2005.  The increase in the net loss for both periods is due to increasing costs involved in the ongoing clinical development of the Company’s lead compound cethromycin.

“During 2006, Advanced Life Sciences initiated 200 clinical sites in 16 countries and made substantial progress in the enrollment of our two phase III clinical trials for cethromycin in community acquired pneumonia (CAP),” said Michael T. Flavin, Ph.D., chairman and chief executive officer of the Company.  “In addition, during this past year, we set the stage for a timely and robust NDA submission and commercial partnership negotiations to insure a successful market launch of cethromycin. The competitive landscape has narrowed due to patent expirations and regulatory changes, creating an increased market opportunity for cethromycin.”

“We are looking forward to the achievement of key clinical and commercial milestones in 2007,” continued Dr. Flavin.  “In conjunction with this we are pleased to announce the completion of enrollment for one of our two pivotal phase III clinical trials and we expect enrollment in our second trial to finish in the near future,”

The Company ended 2006 with cash, cash equivalents and investments totaling approximately $27.1 million.  Cash used was $5.0 million in the fourth quarter and $21.8 million for the full year period.

-MORE-




Operating Expense Analysis 2006 versus 2005:

·                  Research and development expense.  Total research and development expense increased $14.1 million to approximately $17.2 million for the twelve months ended December 31, 2006 from approximately $3.1 million for the twelve months ended December 31, 2005.  The increase in R&D expense is related to ongoing clinical trials associated with the Company’s lead product cethromycin.

·                  General and administrative expense.  General and administrative expense increased $2.2 million to $5.5 million for the twelve months ended December 31, 2006.  Incremental costs as we operated as a public company for a full year totaled $1.7 million, representing an increase of $1.1 million over the previous year.  Marketing expenses totaled $557,000, an increase of $487,000 over the previous year, which was the result of an expanded presence at key scientific conferences held throughout 2006.  The remaining increase of $613,000 was primarily attributable to overall expenses of additional personnel hired throughout the year as well as higher patent protection costs for our proprietary portfolio of compounds.

Fourth Quarter Expense Analysis 2006 versus 2005:

·                  Research and development expense.  Total research and development expense increased $4.1 million to approximately $5.6 million for the three months ended December 31, 2006 from approximately $1.5 million for the three months ended December 31, 2005.  The increase in R&D expense is related to ongoing clinical trials associated with the Company’s lead product cethromycin.

·                  General and administrative expense.  General and administrative expense increased $0.3 million to $1.5 million for the three months ended December 31, 2006 from approximately $1.2 million for the three months ended December 31, 2005.  This increase is mainly due to increased personnel costs and increased costs associated with operating as a public company.

Operational and Financial 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 previously been tested in approximately 4,400 human subjects during clinical trials, and the Company has initiated pivotal phase III clinical trials for the treatment of mild-to-moderate CAP.

Advanced Life Sciences accomplished the following milestones in the first quarter of 2007:

·                  Completed enrollment of approximately 500 patients in cethromycin Phase III pivotal trial CL-06 in Europe, Israel and South America

·                  Initiated a formal competitive process with prospective commercial partners to assist in the sales and marketing activities associated with cethromycin

-MORE-




·                  Received FDA Orphan Drug designation for the use of cethromycin in the prophylactic treatment of patients exposed to inhalation anthrax

·                  Completed successful non-human primate pharmacokinetic studies to support cethromycin dosing selection in inhalation anthrax

·                  Completed dosing portion of anthrax efficacy study under FDA’s animal rule comparing cethromycin to ciprofloxacin and placebo

·                  Successfully manufactured batches of cethromycin active pharmaceutical ingredient and final dosage form at scale to support the CMC section of the NDA submission

·                  Engaged key expert advisors and Octagon Research as resources in the anticipated NDA submission for cethromycin

·                  Continued preparation of ALS-357 clinical supplies and began to identify clinical trial sites for our Phase I/II in-transit metastatic melanoma trial.

Advanced Life Sciences completed the following activities in 2006:

Cethromycin Milestones—

·                  Initiated 200 clinical sites in 16 countries and enrolled patients in two pivotal phase III clinical trials with cethromycin in CAP

·                  Hosted an infectious disease and hepatology expert panel call and webcast series to discuss antimicrobial drug development

·                  Began investigating the use of cethromycin in the prophylactic treatment of inhalation anthrax in non-human primates

·                  Sponsored a satellite symposium on CAP treatment options and presented data on cethromycin in CAP, bronchitis and anthrax in five posters and one oral presentation at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)

·                  Presented key clinical data in sinusitis in two posters which were selected for an oral summary presentation at the 44th Annual Infectious Disease Society of America (IDSA) conference

·                  Engaged DSM and Cardinal Health as manufacturing partners for cethromycin.

Corporate and Scientific Milestones—

·                  Elected Theron (Ted) Odlaug, Ph.D., a pharmaceutical industry veteran with extensive commercial and regulatory experience, to our board of directors

·                  Completed the sale of our interest in the HIV drug Calanolide A to the government of Sarawak, Malaysia

-MORE-




·                  Raised gross proceeds of $36 million in our March, 2006 equity offering

·                  Presented data on the ALS-357/melanoma analogue program at the 232nd American Chemical Society National Meeting.

2007 Operational and Financial Guidance:

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

·                  Release of top-line data from cethromycin pivotal phase III CAP clinical program in June of 2007

·                  Complete a partnership agreement with a commercial partner to support the launch and sales of cethromycin

·                  Report top-line efficacy data from prophylactic treatment of anthrax post-exposure in primate study in the second quarter of 2007

·                  Submit a new drug application (NDA) for cethromycin in CAP.

Advanced Life Sciences anticipates cash requirements of $15.0 million for first half 2007 operating activities.

With the current cash on hand, we believe we have sufficient financial resources to complete the cethromycin clinical trial program during the first half of 2007.  In order to fund our post-NDA cethromycin development costs, we intend to consummate a commercial partnership in the second half of 2007 to support marketing, commercialization and general corporate activities.

Conference Call Details:

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Thursday, March 22, 2007 to discuss the Company’s fourth 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 at www.advancedlifesciences.com.  Alternatively, callers may participate in the conference call by dialing 866-356-3377 (domestic) or 617-597-5392 (international).  The passcode for the conference call is 35320290.  A replay of the conference call will be available until April 22, 2007.  Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 70415045.

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 including CAP.

-MORE-




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)

 

 

 

 

 

Year Ended December 31 ,

 

CONSOLIDATED BALANCE SHEETS

 

2006

 

2005

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

27,054,947

 

$

4,749,932

 

Investments - available for sale

 

 

10,475,000

 

Accounts receivable - related party

 

 

6,160

 

Prepaid insurance

 

380,083

 

362,241

 

Prepaid clinical trial expenses

 

2,364,512

 

4,500

 

Other prepaid expenses and deposits

 

273,572

 

113,763

 

 

 

 

 

 

 

Total current assets

 

30,073,114

 

15,711,596

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

250,308

 

147,275

 

Laboratory equipment

 

142,928

 

142,928

 

Computer software and equipment

 

231,022

 

187,771

 

Leasehold improvements

 

182,839

 

40,646

 

 

 

 

 

 

 

Total property and equipment—at cost

 

807,097

 

518,620

 

Less accumulated depreciation

 

(398,486

)

(267,372

)

 

 

 

 

 

 

Property and equipment—net

 

408,611

 

251,248

 

 

 

 

 

 

 

OTHER LONG-TERM ASSETS:

 

 

 

 

 

Deferred financing costs

 

26,502

 

53,004

 

Other assets

 

1,452

 

6,062

 

 

 

 

 

 

 

Total other long-term assets

 

27,954

 

59,066

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

30,509,679

 

$

16,021,910

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

1,011,396

 

$

294,816

 

Accrued clinical trial expenses

 

1,410,894

 

83,186

 

Other accrued expenses

 

226,881

 

157,575

 

Accrued interest payable

 

22,756

 

5,334

 

Short-term lease payable

 

19,437

 

14,114

 

Short-term grant payable

 

476,708

 

 

Short-term notes payable - related party

 

2,000,000

 

 

 

 

 

 

 

 

Total current liabilities

 

5,168,072

 

555,025

 

 

 

 

 

 

 

Long-term lease payable

 

20,076

 

13,166

 

Accrued interest payable - related party

 

 

765,514

 

Long-term grant payable

 

23,292

 

500,000

 

Notes payable - net of $11,266 debt discount December 31, 2006 & $22,532 December 31, 2005

 

3,903,734

 

3,892,468

 

Long-term notes payable - related party

 

 

2,000,000

 

 

 

 

 

 

 

Total liabilities

 

9,115,174

 

7,726,173

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES:

 

 

 

 

 

MINORITY INTEREST

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value—60,000,000 shares authorized;

 

 

 

 

 

December 31, 2006 28,282,677 issued and outstanding; December 31, 2005

 

 

 

 

 

17,990,322 shares issued and outstanding;

 

282,827

 

179,903

 

Additional paid-in capital

 

88,370,853

 

54,834,373

 

Deficit accumulated during the development stage

 

(67,259,175

)

(46,718,539

)

 

 

 

 

 

 

Total stockholders’ equity

 

21,394,505

 

8,295,737

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

30,509,679

 

$

16,021,910

 

 




ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

 

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

 

Three months
ended
December 31,

 

Twelve months
ended
December 31,

 

 

 

2006

 

2005

 

2006

 

2005

 

Revenue:

 

 

 

 

 

 

 

 

 

Management fees

 

$

 

$

8,358

 

$

 

$

61,239

 

Grant

 

4,661

 

60,212

 

39,788

 

60,212

 

Royalty—related party

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total revenue and income

 

4,661

 

68,570

 

39,788

 

121,451

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

5,632,428

 

1,516,867

 

17,202,113

 

3,121,616

 

Contracted research and development—

 

 

 

 

 

 

 

 

 

related party

 

 

 

 

 

Selling, general and administrative

 

1,479,881

 

1,159,751

 

5,457,395

 

3,237,997

 

 

 

 

 

 

 

 

 

 

 

Total expenses

 

7,112,309

 

2,676,618

 

22,659,508

 

6,359,613

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(7,107,648

)

(2,608,048

)

(22,619,720

)

(6,238,162

)

 

 

 

 

 

 

 

 

 

 

Other (income) expense:

 

 

 

 

 

 

 

 

 

Interest Income

 

(384,483

)

(174,504

)

(1,651,916

)

(272,216

)

Interest expense

 

118,358

 

138,126

 

511,884

 

478,300

 

Gain on sale of interest in Sarawak-

 

 

 

 

 

 

 

 

 

MediChem Pharmaceuticals Joint Venture

 

(939,052

)

 

(939,052

)

 

 

 

 

 

 

 

 

 

 

 

Net other (income) expense

 

(1,205,177

)

(36,378

)

(2,079,084

)

206,084

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(5,902,471

)

(2,571,670

)

(20,540,636

)

(6,444,246

)

 

 

 

 

 

 

 

 

 

 

Less accumulated preferred dividends for the period

 

43,750

 

43,750

 

175,000

 

175,000

 

 

 

 

 

 

 

 

 

 

 

Net loss allocable to common shareholders

 

$

(5,946,221

)

$

(2,615,420

)

$

(20,715,636

)

$

(6,619,246

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share available to common shareholders

 

$

(0.21

)

$

(0.15

)

$

(0.78

)

$

(0.49

)

 

 

 

 

 

 

 

 

 

 

Weighted average number common shares

 

 

 

 

 

 

 

 

 

outstanding- basic and diluted

 

28,280,651

 

17,990,322

 

26,546,785

 

13,610,694