EX-99.1 4 a10-9781_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

 

 

Company Contact: Joe Camp 630-754-4352

Email: jcamp@advancedlifesciences.com

 

Advanced Life Sciences Announces First Quarter 2010 Financial Results

and Debt Restructuring  Agreements

 

CHICAGO, IL, May 10, 2010/PRNewswire/: — Advanced Life Sciences Holdings, Inc. (OTCBB: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced its financial results for the first quarter ended March 31, 2010.

 

The net loss allocable to common shareholders for the three months ended March 31, 2010 was $2.0 million or ($0.02) per share compared to a net loss allocable to common shareholders of $2.3 million or ($0.06) per share for the three months ended March 31, 2009.  The decrease in the net loss is due to decreased support costs involved in the clinical activities and regulatory review of the Company’s lead compound, Restanza™ (cethromycin).

 

The Company ended the first quarter of 2010 with cash and cash equivalents totaling $2.8 million.  Cash used for operating activities during the quarter was approximately $2.3 million.

 

“Following the successful approval of the measures voted on by our shareholders at our recent shareholder meeting, we are excited to continue to advance our development of Restanza for use as a drug to treat serious community-based infection such as pneumonia and as a broad spectrum countermeasure against key bioterror pathogens,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences.

 

The Company also announced today that it has amended its loan agreement with Leaders Bank to extend the date of maturity by 12 months to January 1, 2012.  In connection with this extension, the Company reduced the amount currently outstanding under the facility from $10 million to $8.5 million and has agreed to further reduce the outstanding balance to $6 million by April 1, 2011.  Advanced Life Sciences has also agreed to increase the interest rate from 8.5% to 10% and to issue 1,000,000 common stock warrants to Leaders Bank.

 

In addition, the Company announced that it has entered into an agreement providing that the $2 million promissory note with Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences, will be exchanged for equity securities of the Company.  The exchange is expected to occur at the same price and time as a contemplated concurrent sale of equity securities and will result in cancellation of the outstanding indebtedness.

 

“We view these two debt restructuring commitments as very positive transactions that will strengthen the Company’s balance sheet and provide financial flexibility as we move forward,” said John L. Flavin, president and chief financial officer of Advanced Life Sciences.  “In addition to reducing the debt on our balance sheet, the steps we have taken will mitigate our annual cash outflows by close to $400,000.”

 

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Operating Expense Analysis

 

·                  Research and development expenses were $0.9 million for the three months ended March 31, 2010, approximately the same as the three months ended March 31, 2009.

 

·                  Selling, general and administrative expenses totaled $1.3 million for the first quarter compared to $1.5 million for the first quarter of last year.

 

First Quarter Achievements

 

·                  Met with the FDA and continued the Special Protocol Assessment (SPA) process for our upcoming CABP clinical program;

 

·                  Responded to BARDA request for information relating to the pending BAA proposal submission;

 

·                  Initiated PK animal studies for the Restanza IV formulation;

 

·                  Reported potent Restanza in vitro data in Burkholderia psuedomallei and Burkholderia mallei, which are important biodefense and global health related pathogens.

 

Conference Call Details

 

Advanced Life Sciences will host a conference call and live webcast at 9:00 a.m. Eastern Time on Monday, May 10, 2010 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 the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 888.680.0893 (domestic) or 617.213.4859 (international). The passcode for the conference call is 91076532. A replay of the conference call will be available until May 17, 2010. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 33440510. Investors are advised to dial into the call at least ten minutes prior to the call to register. Participants may pre-register for the call at
https://www.theconferencingservice.com/prereg/key.process?key=P39XBXM9U. Pre-registrants will be issued a pin number to use when dialing into the live call which will provide quick access to the conference by bypassing the operator upon connection.

 

About Community Acquired Bacterial Pneumonia (CABP)

 

CABP is the sixth most common cause of death in the United States. CABP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae.  Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion for prescribed antibiotics to treat CABP.  CABP is potentially fatal if not treated properly, and the bacteria that cause CABP are developing resistance to current standard of care treatments.

 

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CABP.   As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

 

About Restanza

 

Restanza is a novel, once-a-day, oral antibiotic that is in late stage development for the treatment of CABP and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza’s demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.

 

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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 respiratory diseases. The Company’s lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.

 

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.  Forward-looking statements represent our management’s judgment regarding future events.  The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise.  Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers.  These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

 

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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

 

CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

 

 

March 31,

 

December 31,

 

 

 

2010

 

2009

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash and cash equivalents

 

$

2,787,456

 

$

2,841,801

 

Grant receivable

 

283,526

 

530,219

 

Prepaid insurance

 

122,233

 

111,761

 

Other prepaid expenses and deposits

 

133,520

 

88,535

 

 

 

 

 

 

 

Total current assets

 

3,326,735

 

3,572,316

 

 

 

 

 

 

 

PROPERTY AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

214,380

 

244,072

 

Computer software and equipment

 

258,786

 

258,786

 

Leasehold improvements

 

177,253

 

177,253

 

 

 

 

 

 

 

Total property and equipment—at cost

 

650,419

 

680,111

 

Less accumulated depreciation

 

(606,019

)

(624,158

)

 

 

 

 

 

 

Property and equipment—net

 

44,400

 

55,953

 

 

 

 

 

 

 

OTHER ASSETS:

 

 

 

 

 

Commercial launch materials

 

2,760,936

 

2,760,936

 

Deferred offering and financing costs

 

10,174

 

13,566

 

Other long-term assets

 

25,000

 

25,000

 

 

 

 

 

 

 

Total other assets

 

2,796,110

 

2,799,502

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

6,167,245

 

$

6,427,771

 

 

 

 

 

 

 

LIABILITIES AND EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

549,023

 

$

604,334

 

Accrued payroll

 

416,896

 

664,436

 

Other accrued expenses

 

362,265

 

661,504

 

Accrued interest payable

 

73,194

 

73,194

 

Short-term lease payable

 

 

4,350

 

Line of credit

 

3,000,000

 

 

Short-term grant payable

 

500,000

 

 

 

 

 

 

 

 

Total current liabilities

 

4,901,378

 

2,007,818

 

 

 

 

 

 

 

Long-term grant payable

 

 

500,000

 

Long-term notes payable - related party

 

2,000,000

 

2,000,000

 

Line of credit

 

7,000,000

 

10,000,000

 

 

 

 

 

 

 

Total liabilities

 

13,901,378

 

14,507,818

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

 

 

EQUITY (DEFICIT):

 

 

 

 

 

Common stock, $0.01 par value—120,000,000 shares authorized; 100,372,067 issued and outstanding at March 31, 2010; 84,925,010 shares issued and outstanding at December 31, 2009

 

1,003,721

 

849,250

 

Additional paid-in capital

 

124,789,598

 

122,621,392

 

Deficit accumulated during the development stage

 

(133,527,452

)

(131,550,689

)

Noncontrolling interest in subsidiary

 

 

 

 

 

 

 

 

 

Total equity (deficit)

 

(7,734,133

)

(8,080,047

)

 

 

 

 

 

 

TOTAL LIABILITIES AND EQUITY (DEFICIT)

 

$

6,167,245

 

$

6,427,771

 

 



 

ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

 

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

 

 

 

 

 

 

Period From

 

 

 

 

 

 

 

Inception

 

 

 

 

 

 

 

(January 1, 1999)

 

 

 

Three months ended March 31,

 

Through

 

 

 

2010

 

2009

 

March 31, 2010

 

Revenue:

 

 

 

 

 

 

 

Management fees

 

$

 

$

 

$

1,161,180

 

Grants

 

479,824

 

411,485

 

4,549,416

 

Royalty—related party

 

 

 

45,238

 

 

 

 

 

 

 

 

 

Total revenue

 

479,824

 

411,485

 

5,755,834

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

Research and development

 

864,204

 

934,769

 

95,906,886

 

Contracted research and development—related party

 

 

 

7,980,299

 

Selling, general and administrative

 

1,341,829

 

1,508,953

 

34,713,315

 

 

 

 

 

 

 

 

 

Total expenses

 

2,206,033

 

2,443,722

 

138,600,500

 

 

 

 

 

 

 

 

 

Loss from operations

 

(1,726,209

)

(2,032,237

)

(132,844,666

)

 

 

 

 

 

 

 

 

Net other (income) expense:

 

 

 

 

 

 

 

Interest income

 

(5,435

)

(1,732

)

(2,965,858

)

Interest expense

 

255,989

 

252,718

 

4,441,604

 

Other (income) expense, net

 

 

 

146,092

 

Gain on sale of interest in Sarawak Medichem Pharmaceuticals joint venture

 

 

 

(939,052

)

 

 

 

 

 

 

 

 

Net other (income) expense

 

250,554

 

250,986

 

682,786

 

 

 

 

 

 

 

 

 

Net loss

 

(1,976,763

)

(2,283,223

)

(133,527,452

)

 

 

 

 

 

 

 

 

Less net loss attributable to the noncontrolling interest in subsidiary

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to Advanced Life Sciences Holdings, Inc.

 

(1,976,763

)

(2,283,223

)

(133,527,452

)

 

 

 

 

 

 

 

 

Less accumulated preferred stock dividends of subsidiary for the period

 

43,750

 

43,750

 

1,888,542

 

 

 

 

 

 

 

 

 

Net loss available to common shareholders

 

$

(2,020,513

)

$

(2,326,973

)

$

(135,415,994

)

 

 

 

 

 

 

 

 

Net loss per share available to common shareholders - basic and diluted

 

$

(0.02

)

$

(0.06

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding - basic and diluted

 

92,642,185

 

41,779,634