8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2009

ADVANCED LIFE SCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

Delaware	000-51436	30-0296543
(State or other jurisdiction	(Commission	(I.R.S. Employer
of incorporation)	File Number)	Identification No.)
1440 Davey Road
Woodridge, Illinois		60517
(Address of principal executive offices)		(Zip Code)

(630) 739-6744

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02.      Results of Operations and Financial Condition.*

On August 11, 2009, Advanced Life Sciences Holdings, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2009.  A copy of the press release is attached hereto as Exhibit 99.1.

Item 9.01.      Financial Statements and Exhibits.

(d)           Exhibits:

99.1*       Press Release dated August 11, 2009.

*     The information furnished under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	ADVANCED LIFE SCIENCES HOLDINGS, INC.
Dated:   August 11, 2009	By:	/s/ Michael T. Flavin
	Name:	Michael T. Flavin, Ph.D.
	Title:	Chairman and Chief Executive Officer

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Exhibit Index

Exhibit No.	Description
99.1*	Press Release dated August 11, 2009.

*       The information furnished under Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

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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 Second Quarter 2009 Financial Results and Financial Outlook

CHICAGO, IL, August 11, 2009/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 second quarter ended June 30, 2009.

The net loss allocable to common shareholders for the three months ended June 30, 2009 was $2.6 million or ($0.06) per share compared to a net loss allocable to common shareholders of $3.4 million or ($0.09) per share for the three months ended June 30, 2008.  The decrease in the net loss is due to decreased costs involved in the clinical development of the Company’s lead compound, Restanza™ (cethromycin).

The Company ended the second quarter of 2009 with cash and cash equivalents totaling $1.0 million.  Cash used during the quarter was approximately $2.9 million.

“Advanced Life Sciences today is focused on continuing to pursue approval for Restanza in community acquired pneumonia by complying with the FDA’s recommendations concerning next steps that can lead to registration,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “Based on the agency’s recent communication with the Company, we anticipate that an additional well-controlled clinical study designed to demonstrate efficacy in a more severe CAP population will likely be required for the approval of Restanza. We intend to work closely with the agency to confirm this understanding and design and establish a protocol under a Special Protocol Assessment. We are working on these clinical plans with Wyeth, our development and commercialization partner in the Asia Pacific region, and will also continue to pursue additional collaborations. At the same time, we are also continuing to advance Restanza as a biodefense agent against anthrax, plague and tularemia in our collaborative work with the U.S. government, which funds our biodefense development program.”

Operating Expense Analysis

·Research and development expenses were $1.3 million for the three months ended June 30, 2009 compared to $1.7 million for the three months ended June 30, 2008.

·Selling, general and administrative expenses totaled $1.7 million, approximately the same amount as the second quarter of last year.

Business Outlook for 2009

·Work with the FDA and Wyeth to develop a new clinical protocol to further demonstrate Restanza’s efficacy in CAP;

·Pursue a meeting with the FDA relative to establishing a Special Protocol Assessment for development of Restanza in CAP;

·Advance negotiations with prospective U.S. and E.U. partners for the development and commercialization of Restanza;

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·Under the Department of Defense (DOD) contract, continue studies and report data emerging from Restanza non-human primate studies in plague and tularemia.

Financial Outlook

To fund ongoing operations in 2009, the Company intends to raise additional capital through commercial partnerships and/or the sale of equity.

Conference Call Details

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Tuesday, August 11, 2009 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 888.680.0860 (domestic) or 617.213.4852 (international). The passcode for the conference call is 88622532. A replay of the conference call will be available until August 18, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 69105186. 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=P8EHLRVGT. 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 Restanza

Restanza has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections, and, again in in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Restanza has a mechanism of action that may slow the onset of future bacterial resistance. In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the drug is not yet approved for this or any other indication.

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, cethromycin, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CAP.  For more information, please visit us on the web at www.advancedlifesciences.com.

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, the adequacy of our clinical results, the timing and terms of any commercial partnership, 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;

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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)

	June 30,			December 31,
	2009			2008
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	998,912		$	1,527,108
Grant receivable	586,820			63,444
Prepaid insurance	47,932			227,313
Other prepaid expenses and deposits	35,281			143,808
Total current assets	1,668,945			1,961,673
PROPERTY AND EQUIPMENT:
Furniture and fixtures	244,072			244,072
Laboratory equipment	—			159,186
Computer software and equipment	258,786			258,786
Leasehold improvements	505,804			505,804
Total property and equipment—at cost	1,008,662			1,167,848
Less accumulated depreciation	(677,543		)	(760,329		)
Property and equipment—net	331,119			407,519
OTHER ASSETS:
Commercial launch materials	2,760,936			—
Deferred offering and financing costs	20,348			450,861
Other long-term assets	25,006			—
Total other assets	2,806,290			450,861
TOTAL ASSETS	$	4,806,354		$	2,820,053
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
CURRENT LIABILITIES:
Accounts payable	$	4,387,982		$	1,379,941
Accrued clinical trial and NDA expenses	112,514			458,260
Accrued payroll	451,243			506,537
Other accrued expenses	611,095			352,466
Accrued interest payable	136,256			72,572
Short-term lease payable	8,131			8,468
Short-term notes payable - related party	2,000,000			—
Total current liabilities	7,707,221			2,778,244
Long-term lease payable	621			4,350
Long-term grant payable	500,000			500,000
Long-term notes payable - related party	—			2,000,000
Line of credit	10,000,000			9,915,000
Total liabilities	18,207,842			15,197,594
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS’ EQUITY (DEFICIT):
Common stock, $0.01 par value—120,000,000 shares authorized; 50,698,926 issued and outstanding at June 30, 2009; 40,810,932 shares issued and outstanding at December 31, 2008	506,989			408,109
Additional paid-in capital	113,331,011			109,601,807
Deficit accumulated during the development stage	(127,239,488		)	(122,387,457		)
Noncontrolling interest in subsidiary	—			—
Total equity (deficit)	(13,401,488		)	(12,377,541		)
TOTAL LIABILITIES AND EQUITY (DEFICIT)	$	4,806,354		$	2,820,053

See notes to unaudited consolidated financial statements.

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 June 30,						Six months ended June 30,						Through
	2009			2008			2009			2008			June 30, 2009
Revenue:
Management fees	$	—		$	—		$	—		$	—		$	1,161,180
Grants	706,814			—			1,118,299			—			2,394,700
Royalty–related party	—			—			—			—			45,238
Total revenue	706,814			—			1,118,299			—			3,601,118
Expenses:
Research and development	1,309,050			1,690,088			2,243,819			3,558,141			92,824,220
Contracted research and development–related party	—			—			—			—			7,980,299
Selling, general and administrative	1,690,505			1,682,604			3,199,458			3,408,972			30,248,095
Total expenses	2,999,555			3,372,692			5,443,277			6,967,113			131,052,614
Loss from operations	(2,292,741		)	(3,372,692		)	(4,324,978		)	(6,967,113		)	(127,451,496		)
Net other (income) expense:
Interest income	(1,739		)	(76,444		)	(3,471		)	(233,086		)	(2,952,333		)
Interest expense	258,211			102,664			510,929			207,019			3,659,782
Other (income) expense, net	19,595			—			19,595			—			19,595
Gain on sale of interest in Sarawak Medichem Pharmaceuticals joint venture	—			—			—			—			(939,052		)
Net other (income) expense	276,067			26,220			527,053			(26,067		)	(212,008		)
Net loss	(2,568,808		)	(3,398,912		)	(4,852,031		)	(6,941,046		)	(127,239,488		)
Less net loss attributable to the noncontrolling interest in subsidiary	—			—			—			—			—
Net loss attributable to Advanced Life Sciences Holdings, Inc.	(2,568,808		)	(3,398,912		)	(4,852,031		)	(6,941,046		)	(127,239,488		)
Less accumulated preferred stock dividends of subsidiary for the period	43,750			43,750			87,500			87,500			1,757,292
Net loss available to common shareholders	$	(2,612,558	)	$	(3,442,662	)	$	(4,939,531	)	$	(7,028,546	)	$	(128,996,780	)
Net loss per share available to common shareholders - basic and diluted	$	(0.06	)	$	(0.09	)	$	(0.11	)	$	(0.18	)
Weighted average shares outstanding - basic and diluted	47,077,869			38,502,987			44,443,387			38,502,987

See notes to unaudited consolidated financial statements.