<SEC-DOCUMENT>0001144204-11-018882.txt : 20110331
<SEC-HEADER>0001144204-11-018882.hdr.sgml : 20110331
<ACCEPTANCE-DATETIME>20110331143218
ACCESSION NUMBER:		0001144204-11-018882
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110331
ITEM INFORMATION:		Results of Operations and Financial Condition
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110331
DATE AS OF CHANGE:		20110331

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:		11725362

	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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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">CURRENT REPORT</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Date of Report (date of earliest event reported): <font style="DISPLAY: inline; FONT-WEIGHT: bold">March 31, 2011</font></font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 36pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">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="DISPLAY: block; TEXT-INDENT: 0pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Item 2.02 &#8211; Results of Operations and Financial Condition.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">On March 31, 2011, Adeona Pharmaceuticals, Inc., a Nevada corporation (the &#8220;Registrant") issued the attached press release that included financial information for its fiscal year 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="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: times new roman">&#160;Exhibit 99.1 Press Release issued by Adeona Pharmaceuticals, Inc. dated March 31, 2011.</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">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="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona Reports 2010 Year End Financial Results</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Ann Arbor, MI, March 31, 2011 &#8211;</font> Adeona Pharmaceuticals, Inc. (AMEX:AEN - News), a developer of innovative medicines for serious central nervous system diseases, today reported its financial results for the year ended December 31, 2010, as well as updates since the beginning of the 4<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">th</font> quarter.</font></div>

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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adoption of "<font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>" as the new trademark for Adeona&#8217;s zinc and cysteine-based oral tablet (formerly called Zinthionein) currently under development as a prescription medical food for the dietary management of Alzheimer's disease and mild cognitive impairment.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Completion of the treatment phase of the pivotal clinical trial evaluating the zinc and cysteine-based product candidate, <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin&#8482; </font>in patients with Alzheimer's disease and mild cognitive impairment. Results from this clinical trial are expected to be presented at the 63<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">rd</font> Annual Meeting of the American Academy of Neurology in April of 2011 by Lead Principal Investigator, Diana Pollock, M.D.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Receipt of an additional $409,426 in grant funding from the National Multiple Sclerosis Society for the clinical trial evaluating Adeona&#8217;s drug candidate, Trimesta&#8482; (oral estriol).</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Enrollment of 127 of 150 patients (85%) in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting multiple sclerosis, as of March 2, 2011. The randomized, double-blind, placebo-controlled clinical trial is currently underway at 15 centers in the United States. We anticipate full enrollment by the second half of 2011.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Execution of an agreement for the sale of approximately 2.85 million shares of common stock at $1.40 per share to new institutional investors in a registered direct offering for gross proceeds of $4 million. Investors also received warrants to purchase approximately 1.42 million shares of common stock at an exercise price of $2.00 per share and are exercisable for a period of 13 months.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Appointment of George J. Brewer, M.D., the Morton S. and Henrietta Sellner Emeritus Professor of Human Genetics and Internal Medicine at the University of Michigan, as Senior Vice President of Research &amp; Development, following the unexpected passing of David A. Newsome, M.D.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Execution of an agreement with Dr. Prasad providing access to clinical data from a 50 patient, 12-month, randomized, double-blind, placebo-controlled clinical trial that evaluated the prevention of infections in the elderly who were treated with an oral zinc therapy or matching placebo. The results at 12 months demonstrated a 67% reduction in the incidence of infection between the two groups (88 infections in the placebo group versus 29 infections in the zinc treated group) (p &lt; 0.001).</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Termination of the dnaJP1 (hsp peptide) clinical development program as of March 31, 2011. While data from a Phase II clinical trial previously reported in November 2009 demonstrated safety and tolerability in patients with rheumatoid arthritis, the decision to discontinue this program was driven by strategic considerations as well as clinical and market potential.</font></div>
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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Total net revenues for the year ended December 31, 2010 were $3,164,512, compared to $103,089 for the year ended December 31, 2009. Total net revenues for the year ended December 31, 2010 consisted of $2,125,000 as a result of the Meda AB sublicense agreement of flupirtine for fibromyalgia during the second quarter of 2010, $550,553 of net laboratory revenues from the first full year of operations at Adeona Clinical Laboratory and $488,959 of grant revenues from the Qualifying Therapeutic Discovery Project Program to support Adeona&#8217;s Alzheimer&#8217;s disease and multiple sclerosis programs currently in clinical testing. Total net revenues for the year ended December 31, 2009 consisted of $103,089 of net laboratory revenues from Adeona Clinical Laboratory. Since purchasing Adeona Clinical Laboratory in July of 2009, the client base has increased and the in-house diagnostic testing services have been expanded to include a full array of microbiology testing.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">The net loss for the year ended December 31, 2010 was $1,711,159, or $0.08 per share, compared to $3,731,405, or $0.18 per share, for the year ended December 31, 2009. The decrease in net loss is the result of increased revenues for the year ended December 31, 2010, that included license revenue, increased laboratory revenue and grant revenue.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">&#8220;We continued to make significant progress in the clinical development of our product candidates for Alzheimer&#8217;s disease and multiple sclerosis during 2010. We anticipate reporting results from patients who have completed their 6 month follow-up in the Alzheimer&#8217;s disease clinical study in April of 2011, and, if the clinical results are positive, we intend to further our commercialization efforts of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> as a prescription medical food. We also expect completion of enrollment in the multiple sclerosis clinical trial during the second half of 2011,&#8221; stated James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer. &#8220;We achieved these clinical milestones while also increasing our revenues from various sources and carefully managing our operating expenses.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Dr. Kuo added, &#8220;With the addition of the net proceeds from the financing in January of 2011, we believe our current cash position should meet our planned operating needs for at least the next 12 months.&#8221;</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona will hold its 2010 year end investor conference call today, <font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Thursday, March 31, 2011, at 4:30pm EDT</font>. James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer, will host the call. Interested parties should call toll free<font style="DISPLAY: inline; FONT-WEIGHT: bold">&#160;</font>1-800-860-2442 (U.S.) or 1-866-605-3852 (Canada), or from outside North America +1 412-858-4600, fifteen minutes before the start of the call to register and identify themselves as registrants of the &#8216;Adeona&#8217; Conference Call. Any registered caller on the toll free line may ask to be placed in the queue for the Question &amp; Answer session. The call will be simulcast on the web at <font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; TEXT-DECORATION: underline">http://www.videonewswire.com/event.asp?id=77882</font>. If you are unable to participate during the live call, the webcast will be available for replay at <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.adeonapharma.com</font> for 30 days after the call.</font></div>

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

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</div>

<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona is a pharmaceutical company developing innovative medicines for the treatment of serious central nervous system diseases. The Company&#8217;s strategy is to license product candidates that have demonstrated a certain level of clinical efficacy and develop them to a stage that results in a significant commercial collaboration. Currently, Adeona is developing the following product candidates: a prescription medical food for Alzheimer&#8217;s disease, and drugs for multiple sclerosis, fibromyalgia and age-related macular degeneration. For more information, please visit Adeona&#8217;s website at <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.adeonapharma.com</font>.</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-STYLE: italic; FONT-FAMILY: Times New Roman">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 cash on hand being sufficient to fund operations for the next 12 months, the expected results from the reaZin clinical&#160;&#160;study and potential commercialization efforts related thereto, and our expected completion of enrollment in our multiple sclerosis clinical trial in the anticipated time period. 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 statements. 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 our clinical trials to be completed on time or to achieve desired results, a failure to successfully commercialize products or a failure of our clinical reference laboratory to continue to grow and achieve revenue or a failure by us or our strategic partners to successfully commercialize products and other factors described in Adeona's report on Form 10-K for the year ended December 31, 2010 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="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">For further information, please contact:</font></div>

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

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

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

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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
