8-K/A

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.  20549

FORM 8-K/A

(Amendment No. 1)

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  November 7, 2005

ADVANCED LIFE SCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

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

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

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

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

oPre-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 November 7, 2005, Advanced Life Sciences Holdings, Inc. issued a press release announcing financial results for the third quarter ended September 30, 2005 and financial guidance for the fourth quarter of 2005.  A copy of the press release was furnished as an exhibit to a Current Report on Form 8-K that Advanced Life Sciences filed on November 10, 2005.  The final two pages of the press release were omitted from the exhibit previously furnished.  This amendment to the Current Report on Form 8-K is being filed to furnish the complete press release.

Item 9.01.Financial Statements and Exhibits.

(c)Exhibits:

Exhibit No.	Description
99.1*	Press release, dated November 7, 2005, entitled “Advanced Life Sciences Announces Third Quarter 2005 Results.”

*The information furnished under Item 2.02 of this Current Report on Form 8-K/A, 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.
Date: November 11, 2005	By:	/s/ MICHAEL T. FLAVIN
	Name:	Michael T. Flavin
	Title:	Chairman and Chief Executive Officer

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EXHIBIT INDEX

Exhibit No.	Description
99.1*	Press release, dated November 7, 2005, entitled “Advanced Life Sciences Announces Third Quarter 2005 Results.”

*The information furnished under Item 2.02 of this Current Report on Form 8-K/A, 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, 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 Third Quarter 2005 Results

WOODRIDGE, IL, November 7, 2005/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 third quarter ended September 30, 2005.  The net loss available to common shareholders for the three months ended September 30, 2005 was $2.3 million or ($.15) per share compared to $0.9 million or ($.55) per share for the three months ended September 30, 2004.  The increase in the net loss reflects increased development expenses related to the advancement of cethromycin into pivotal phase III clinical trials and non-recurring expenses resulting from the completion of the Company’s initial public offering (IPO) in August of 2005.

Michael T. Flavin, Ph.D., chairman and chief executive officer of the Company, noted “Advanced Life Sciences continued to make excellent progress during the third quarter of 2005.  We completed our IPO to provide the capital required to advance the clinical development of our lead product, cethromycin.  Cethromycin is a novel once-a-day ketolide antibiotic in phase III clinical development for the treatment of respiratory tract infections.  We are looking forward to initiating pivotal phase III clinical trials for cethromycin in the treatment of community acquired pneumonia (CAP) during the fourth quarter of 2005,” concluded Dr. Flavin.

During the third quarter of 2005, the Company completed its initial public offering of common stock.  Net proceeds from the offering, including the exercise of the underwriters’ over-allotment option and after deducting underwriters’ discounts and offering expenses, were approximately $28.7 million.  From this amount, the Company made a payment to Abbott Laboratories in the third quarter of $8.0 million according to the license agreement terms for cethromycin.

The Company ended the third quarter of 2005 with cash, cash equivalents and investments totaling $18.9 million.

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Operating Expense Analysis

•Research and development expenses increased $0.6 million to $0.9 million for the three months ended September 30, 2005 from $0.3 million for the three months ended September 30, 2004.  This increase was due to additional development expenses related to cethromycin and non-recurring costs associated with the Company’s IPO in August, 2005.  In addition, the increase included a non-cash charge of approximately $0.2 million resulting from the options that vested as a result of our IPO, and stock options granted at the time of the IPO.

•General and administrative expenses increased $0.6 million to $1.2 million for the three months ended September 30, 2005 from $0.6 million for the three months ended September 30, 2004.

This increase is primarily attributed to non-recurring expenses incurred as a result of the Company’s IPO in August 2005.  In addition, the increase included a non-cash charge of approximately $0.2 million resulting from the options that vested as a result of our IPO, and stock options granted at the time of the IPO.

Third Quarter 2005 Product Candidate Highlights

Advanced Life Sciences is developing cethromycin, a novel once-a-day ketolide antibiotic licensed from Abbott Laboratories in response to the emerging antibiotic resistance observed in the treatment of CAP.  Cethromycin has been tested in approximately 3,800 human subjects during clinical trials.  The Company intends to conduct pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate CAP.

Based on publicly available data regarding current antibiotics, the Company believes that there is a potential opportunity for further development of cethromycin in the treatment of respiratory tract infections for a number of reasons:

•cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections;

•cethromycin appears to be effective against penicillin- and macrolide-resistant bacteria;

•cethromycin has a mechanism of action, unique to ketolides, that may slow the onset of future resistance; and

•cethromycin has shown in vitro evidence of extended post-antibiotic effects against pathogens commonly seen in respiratory tract infections.

Advanced Life Sciences believes that cethromycin, if approved, would build upon the growing market acceptance of ketolide drugs in the antibiotic marketplace.

The Company completed the following activities in the third quarter:

•Closing of its initial public offering of common stock, raising $28.7 million in net proceeds.

•Completion of tablet manufacturing of cethromycin with Cardinal Health.

•Engagement of Quintiles as its contract research organization for cethromycin clinical development.

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•Continuation of dialogue with FDA regarding the cethromycin development plan and phase III protocols.

•Addition of Scott Meadow, a noted healthcare financier, and Richard Reck, formerly a partner with KPMG, to its board of directors.  Mr. Meadow was also elected as chairman of the board compensation committee while Mr. Reck was elected chairman of the board audit committee.

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

•Initiate pivotal phase III studies for cethromycin in CAP in the fourth quarter of 2005.  Enroll patients over a twelve month period with data from the trial available in the fourth quarter of 2006.

•Establish presence at ICAAC Conference including sponsorship of a booth in December of 2005.

•Advance discussions with Abbott and other companies regarding a commercialization partnership for cethromycin.

Financial Guidance for Fourth Quarter of 2005

The Company expects its fourth quarter, 2005 cash requirements to range between $4.9 and $5.2 million.  Of this amount, cethromycin cash requirements are expected to range between $3.4 and $3.7 million including a $2 million milestone payment to Abbott in accordance with the cethromycin license agreement, which was expensed as in-process research and development in the fourth quarter of 2004.  General operating cash requirements are expected to be $1.5 million.

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.

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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

CONDENSED CONSOLIDATED BALANCE SHEETS

(unaudited)

	As of September 30, 2005			Year ended December 31, 2004
ASSETS
CURRENT ASSETS:
Cash & cash equivalents	$	9,481,827		$	194,555
Investments	9,375,000			—
Accounts receivable - related party	3,664			24,868
Clinical trials supplies	533,333			533,333
Prepaid insurance	459,039			—
Prepaid expenses and other	59,634			25,806
Total current assets	19,912,497			778,562
FURNITURE AND EQUIPMENT:
Furniture and fixtures	140,849			139,005
Laboratory equipment	142,928			142,928
Computer equipment	81,465			79,146
Leasehold improvements	40,646			40,646
Construction in-progress	23,255			—
Total furniture and equipment—at cost	429,143			401,725
Less accumulated depreciation	(235,643		)	(180,807		)
Furniture and equipment—net	193,500			220,918
OTHER LONG-TERM ASSETS:
Deferred financing costs	59,629			15,000
Other assets	4,782			1,452
Total other long-term assets	64,411			16,452
TOTAL ASSETS	$	20,170,408		$	1,015,932
LIABILITIES AND STOCKHOLDERS’ DEFICIT
CURRENT LIABILITIES:
Accounts payable	$	182,413		$	255,880
Accrued expenses	251,144			185,348
Accrued interest payable	3,946			4,319
Licenses payable	2,000,000			14,000,000
Notes payable - net of $11,766 debt discount	—			2,238,234
Short-term lease payable	13,573			12,070
Total current liabilities	2,451,076			16,695,851
Long-term lease payable	16,903			27,279
Accrued interest payable - related party	715,787			566,603
Grant payable	500,000			—
Notes payable - net of $11,766 debt discount in 2004 and $25,349 in 2005	3,889,651			—
Notes payable - related party	2,000,000			2,000,000
Total liabilities	9,573,417			19,289,733
STOCKHOLDERS’ DEFICIT:
Common stock, $0.01 par value—September 30, 2005: 60,000,000 shares authorized;
17,990,328 issued and outstanding; December 31,: 2004:
10,604,584 shares issued and outstanding;	179,893			106,046
Series A preferred stock of Advanced Life Sciences Inc., no par value— 250,000 shares authorized, issued and outstanding	—			—
Deferred compensation	—			(23,219		)
Additional paid-in capital	54,563,967			21,917,665
Deficit accumulated during the development stage	(44,146,869		)	(40,274,293		)
Total stockholders’ deficit	10,596,991			(18,273,801		)
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT	$	20,170,408		$	1,015,932

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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

	Three months ended September 30,						Nine months ended September 30,
	2005			2004			2005			2004
Revenue:
Management fees	$	8,502		$	64,983		$	52,881		$	209,820
Grant	—			—			—			38,136
Royalty—related party	—			10,000			—			10,000
Total revenue	8,502			74,983			52,881			257,956
Expenses:
Research and development	938,813			302,133			1,604,749			873,119
Selling, general and administrative	1,239,674			559,829			2,078,246			1,198,914
Total expenses	2,178,487			861,962			3,682,995			2,072,033
Loss from operations	(2,169,985		)	(786,979		)	(3,630,114		)	(1,814,077		)
Other income (expense):
Interest Income	97,712			—			97,712			—
Interest expense	(135,925		)	(46,134		)	(340,174		)	(142,523		)
Net other income (expense)	(38,213		)	(46,134		)	(242,462		)	(142,523		)
Net loss	(2,208,198		)	(833,113		)	(3,872,576		)	(1,956,600		)
Less accumulated preferred dividiends for the period	43,750			43,750			131,250			131,250
Net loss available to common shareholders	$	(2,251,948	)	$	(876,863	)	$	(4,003,826	)	$	(2,087,850	)
Basic and diluted net loss per share available to common shareholders	$	(0.15	)	$	(0.55	)	$	(0.33	)	$	(1.31	)
Weighted average number common shares outstanding- basic and diluted	14,819,191			1,588,397			12,134,776			1,588,222

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