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<SEC-DOCUMENT>0000890163-10-000103.txt : 20100405
<SEC-HEADER>0000890163-10-000103.hdr.sgml : 20100405
<ACCEPTANCE-DATETIME>20100405170544
ACCESSION NUMBER:		0000890163-10-000103
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20100401
ITEM INFORMATION:		Results of Operations and Financial Condition
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20100405
DATE AS OF CHANGE:		20100405

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ADEONA PHARMACEUTICALS, INC.
		CENTRAL INDEX KEY:			0000894158
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				133808303
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-12584
		FILM NUMBER:		10731878

	BUSINESS ADDRESS:	
		STREET 1:		3930 VARSITY DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108
		BUSINESS PHONE:		734-332-7800

	MAIL ADDRESS:	
		STREET 1:		3930 VARSITY DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PIPEX PHARMACEUTICALS, INC.
		DATE OF NAME CHANGE:	20061214

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD PHARMACEUTICALS INC
		DATE OF NAME CHANGE:	19970730

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	SHEFFIELD MEDICAL TECHNOLOGIES INC
		DATE OF NAME CHANGE:	19940606
</SEC-HEADER>
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<FILENAME>s22-9673_8k.htm
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Date of Report (date of earliest event reported): April 1, 2010</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold"><a name="FIS_ENTRY_MATERIAL_AGREEMENT"><!--EFPlaceholder--></a>Item 2.02 &#8211; Results of Operations and Financial Condition.</font></div>

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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On April <font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">1</font>, 2010, Adeona Pharmaceuticals, Inc., a Nevada corporation (the &#8220;Registrant") issued the attached press release that included financial information for its fourth quarter ended December 31, 2010. A copy of the press release is attached as Exhibit 99.1 to this Report on Form 8-K. The information contained in the press release is being furnished to the Commission and shall not be deemed incorporated by reference into any of the Registrant&#8217;s registration statements or other filings with the Commission.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">&#160;Exhibit 99.1 Press Release issued by Adeona Pharmaceuticals, Inc. dated April 1, 2010.</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">ANN ARBOR, MI- Adeona Pharmaceuticals, Inc. (AMEX: <font style="DISPLAY: inline; TEXT-DECORATION: underline">AEN</font> - <font style="DISPLAY: inline; TEXT-DECORATION: underline">News</font>), a specialty pharmaceutical company developing new medicines for serious central nervous system diseases announced today that it will hold an investor conference call on Thursday, April 1, 2010, at 9:00 a.m. EDT. James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chairman and Chief Executive Officer, will host the call.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Adeona&#8217;s lead drug candidate is Trimesta (estriol) for multiple sclerosis. The company is considering the development of Trimesta to treat cognitive loss in multiple sclerosis. This regulatory path could possibly expedite Trimesta&#8217;s commercialization. Cognitive loss is considered the leading cause of unemployment in multiple sclerosis and there is currently no FDA-approved therapy for it. Trimesta is the subject of an investigator-initiated, 150-patient, 16-center, clinical trial for the reduction in relapse rates in female relapsing remitting multiple sclerosis patients. This clinical trial is already over 50% enrolled.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Adeona is currently conducting a controlled clinical trial of Zinthionein<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font> ZC, an oral zinc therapy, for the dietary management of Alzheimer&#8217;s disease and mild cognitive impairment in Clearwater, Florida (CopperProof-2). The clinical study seeks to compare Zinthionein<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font> ZC, a patent-pending, once-a-day, gastroretentive, sustained-release zinc, and cysteine tablet, to placebo, as well as a marketed zinc product.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Since initiating this study in December of 2009, Adeona has treated a total of 11 subjects, 9 of whom are currently continuing daily treatment or placebo in Part 2 of the study. In order to expedite enrollment and completion of this study, Adeona plans to expand this clinical trial from a single site, to two additional sites in Florida.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">&#8220;The past month has seen profound changes in Adeona&#8217;s direction,&#8221; stated James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chairman and CEO. "Trimesta is an extremely exciting lead candidate with tremendous potential to transform the care of multiple sclerosis patients. In addition, we believe that dietary management of Alzheimer&#8217;s and mild cognitive impairment patients with Zinthionein<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font> ZC may represent an important and safe treatment option for a disease that affects tens of millions of people in the U.S. alone. We have discussions underway with potential corporate partners for this and other programs that we believe could represent the most efficient commercialization route.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Financial Results for 2009</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Adeona&#8217;s net loss for the year ended December 31, 2009 was approximately $3.7 million, or $0.18 per share, compared to a net loss of approximately $7.2 million or $0.35 per share, for 2008. This decrease of $3.5 million was primarily due to the significant downsizing and cost saving measures taken. For the year ended December 31, 2009, research and development expenses decreased by $3.4 million, primarily related to a decrease associated with the development of our licensed clinical drug candidates, a decrease in stock based compensation charges and a decrease in salaries and related taxes and other across the board cost cutting measures. General and administrative expenses decreased by approximately $100,000, which is primarily due to slight decreases in salaries and related payroll taxes, stock-based compensation charges, alloc
ated overhead and professional fees.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#160;</div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">At December 31, 2009, Adeona had cash of approximately $2.7 million, compared to approximately $5.9 million at December 31, 2008. The decrease of approximately $3.2 million is attributable to net cash used in operations of approximately $2.9 million, plus net cash used in the acquisition of HartLab of approximately $200,000, offset by approximately $25,000 relating to the gain on the sale of certain equipment, plus net cash of approximately $50,000 used in the acquisition of treasury stock.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">About Adeona Pharmaceuticals, Inc.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify">&#160;</div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Adeona (AMEX:AEN) is a pharmaceutical company developing new medicines for serious central nervous systems diseases. Adeona&#8217;s primary strategy is to in-license clinical-stage drug candidates that have already demonstrated a certain level of clinical efficacy and develop them further to either commercialization or a development collaboration. Trimesta (estriol) is an investigational oral drug for the treatment of relapsing remitting multiple sclerosis. A 150-patient, 16-center, randomized, double-blind, placebo-controlled clinical trial is currently underway. Zinthionein<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font> ZC (zinc cysteine) is an oral, gastro-retentive, sustained-release medical food candidate being developed for the dietary management of Alzheimer&#8217;s disease and mild cognitive im
pairment. In December of 2009, Adeona initiated a 60-patient clinical study. Effirma (flupirtine) is a novel centrally-acting investigational oral drug for the treatment of fibromyalgia syndrome. It is ready for a 90-patient proof-of-concept clinical trial. dnaJP1 (hsp peptide) is an investigational oral drug for the treatment of rheumatoid arthritis. It has completed a 160-patient, multi-center, randomized, double-blind, placebo-controlled clinical trial. CD4 Inhibitor 802-2 (cyclic heptapeptide) is an investigational drug for the prevention of severe graft-versus-host disease.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">This release includes forward-looking statements on Adeona's current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding our clinical trials, our establishment of partnerships and our execution of our growth strategy. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking stateme
nts. Important factors that could cause actual results to differ materially from those reflected in Adeona's forward-looking statements include, among others, a failure of Adeona's product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, regulatory limitations relating to the company's ability to promote or commercialize its products for awareness, prevention, diagnosis or treatment of zinc deficiency and chronic copper toxicity, a lack of acceptance of Adeona's product candidates in the marketplace, a failure of the company to become or remain profitable, our inability to obtain the capital necessary to fund the company's research and development activities, a loss of any of the company's key scientists or management personnel, and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2009 and any other filings with the SEC. The information in this release 
is provided only as of the date of this release, and Adeona undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">For Further Information Contact:</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">James S. Kuo, M.D., M.B.A.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Chairman and Chief Executive Officer</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">(734) 332-7800</font></div>

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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
-----END PRIVACY-ENHANCED MESSAGE-----
