<SEC-DOCUMENT>0001144204-11-030331.txt : 20110517
<SEC-HEADER>0001144204-11-030331.hdr.sgml : 20110517
<ACCEPTANCE-DATETIME>20110516182246
ACCESSION NUMBER:		0001144204-11-030331
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110516
ITEM INFORMATION:		Results of Operations and Financial Condition
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110517
DATE AS OF CHANGE:		20110516

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:		11849192

	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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<TYPE>8-K
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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; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">On May 16, 2011, Adeona Pharmaceuticals, Inc., a Nevada corporation (the &#8220;Registrant") issued the attached press release that included financial information for its first fiscal quarter ended March 31, 2011. 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">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-STYLE: italic; FONT-FAMILY: Times New Roman">-- Trimesta<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">TM</font> Clinical Trial Receives $2 Million in New Grant Funding --</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, May 16, 2011 &#8211;</font> Adeona Pharmaceuticals, Inc. (AMEX:AEN - News), a developer of innovative medicines for serious central nervous system diseases, today reported its first quarter 2011 financial results for the three month period ended March 31, 2011, as well as updates since the beginning of the 1<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">st</font> quarter.</font></div>

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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Clinical results: Top-line results from our clinical study evaluating <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease were 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 2011.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">As prospectively hypothesized, patients administered <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> demonstrated increased serum zinc levels and decreased serum free copper levels, resulting in statistical significance of the primary outcomes of the clinical study.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">The cognitive function of the placebo group, on average, declined over 6 months in comparison to patients managed with <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>. The cognitive function trends favoring the patients managed with <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> were observed in all three standardized cognitive tests utilized in our study and suggest that <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> may provide an important benefit to the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Commercialization plans: Based on the top-line results from this clinical study, we intend to further the commercial development of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> as a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In April 2011, we executed an agreement with TG United, Inc. of Brooksville, Florida, to provide commercial-scale manufacturing for <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">We will also review the <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> clinical study results with our scientific advisors to determine what further clinical studies might be warranted to support additional labeling claims.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Grant funding: Our ongoing clinical trial of Trimesta (estriol) for relapsing-remitting multiple sclerosis (MS) in women has received grant awards from two organizations that should support the clinical trial to its completion.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">$409,426 in grant funding from the National Multiple Sclerosis Society was received in March 2011.</font></div>
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<div align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">$1,594,553 in grant funding from the National Institutes of Health/National Institute of Neurological Disorders and Stroke was received in May 2011.</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">General and administrative expenses for the three months ended March 31, 2011 were $1,273,536, compared to $742,021 for the same period in 2010. For the three months ended March 31, 2011, general and administrative expenses include a non-cash charge relating to stock-based compensation expense of $758,710, compared to $151,148 for the same period in 2010. The stock-based compensation expense for the three months ended March 31, 2011 includes a one-time charge of $397,767 relating to the modification of certain stock options, prior to expiration, held by a member of the Board of Directors.</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">Costs of laboratory services for the three months ended March 31, 2011 were $243,858, compared to $105,419 for the same period in 2010. This increase is primarily the result of increased costs associated with the increased client base and expansion of in-house diagnostic testing services to include a full array of microbiology testing at Adeona Clinical Laboratory.</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">Other expense for the three months ended March 31, 2011 was $759,887, compared to $7,029 of other income for the same period in 2010. For the three months ended March 31, 2011, other expense included $809,857 relating to the estimated fair value of the warrants associated with the February 2011 financing, adjusted for the change in their fair value at March 31, 2011.</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 three months ended March 31, 2011 was $2,186,461 or $0.09 per share, compared to $1,087,522 or $0.05 per share for the same period in 2010. The increase in net loss is primarily attributable to the warrant liability and the one-time charge relating to the modification of certain stock options, and would have been negligible if these charges had not occurred.</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">As of March 31, 2011, Adeona had approximately $6.1 million in cash compared to approximately $2.6 million on December 31, 2010. As of April 30, 2011, we had approximately $8.9 million in cash, including net proceeds of approximately $3.25 million from the April 2011 financing. O</font>ur cash position should allow us to meet our currently planned operating needs for at least the next 12 months.</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;I believe the operational and clinical milestones we achieved during the first quarter of 2011 should position us for future growth and increased shareholder value<font style="DISPLAY: inline">,</font>&#8221; stated James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer. &#8220;We are encouraged that Adeona Clinical Laboratory has expanded its operations into a profitable business subsidiary. With the top-line results from our Alzheimer&#8217;s clinical study reported and a commercial-scale manufacturer of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> in place, we continue to advance our prescription medical food towards commercialization. We are anticipating the review of the <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> clinical results with our scientific advisors and intend to identify a pathway that could provide for additional labeling claims. At the same time, we look forward to reporting the completion of patient enrollment in the Trimesta MS trial and to <font style="DISPLAY: inline">exploring new opportunities that could expand our MS clinical program.</font>&#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 1<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">st</font> quarter 2011 investor conference call tomorrow, <font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Tuesday, May 17, 2011, at 1:00pm (EDT)</font>. James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer, will host the call. The Company will be joined by special guest, Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology, and Lead Principal Investigator of the multi-center clinical trial evaluating Adeona&#8217;s Trimesta (estriol) drug candidate for multiple sclerosis (MS) in women. Dr. Voskuhl is the investigator who discovered that the female sex hormone, estriol, could suppress MS-like symptoms in a mouse model of the disease.&#160;&#160;This preclinical research led to a 10-patient clinical study that showed an 82% decrease in brain lesions over a six month period. This clinical study was followed by a 150-patient, randomized, double-blind, placebo-controlled clinical trial of Trimesta that is currently underway at 15 centers in the United States. Dr. Voskuhl&#8217;s preclinical and clinical work has been scientifically reviewed and awarded over $8 million in grant funding by organizations such as the National Institutes of Health, the National Multiple Sclerosis Society and other third party groups. In addition to providing an update of the Trimesta clinical trial, Dr. Voskuhl will share insights into her proposed new mechanism to treat MS patients and will take questions about her research.</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">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; COLOR: #0000ff; TEXT-DECORATION: underline">http://www.videonewswire.com/event.asp?id=79592</font>. If you are unable to participate during the live conference call, the webcast will be available for replay at the same URL (<font style="DISPLAY: inline; COLOR: #0000ff; TEXT-DECORATION: underline">http://www.videonewswire.com/event.asp?id=79592</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-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, or has partnered the development of, the following product candidates: a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease, and drugs to treat multiple sclerosis, fibromyalgia, age-related macular degeneration and rheumatoid arthritis. 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," "could," "potential," &#8220;positions,&#8221; "continue," "expects," "anticipates," "intends," "plans," "believe," "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 the use of reaZin for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease,<font style="DISPLAY: inline">&#160;</font>our intent to further commercialize development of reaZin as a prescription&#160;&#160;medical food, <font style="DISPLAY: inline">grant awards supporting the Trimesta clinical trial to its completion, the grant award further expanding the MS program, the milestones that were achieved positioning us for future growth and increased shareholder value, our cash position allowing us to meet our planned needs for the next 12 months, the identification of a pathway for additional labeling claims, the potential effects of slowing the progression of the disease , our ability to produce a new, effective oral therapy for multiple sclerosis and the anticipated enrollment</font>. 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, our failure to successfully commercialize reaZin for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease, the failure of reaZin to be accepted for the dietary management of zinc deficiency associated with&#160;&#160;Alzheimer&#8217;s disease,&#160;&#160;failure of future clinical trials studying&#160;&#160;reaZin to have favorable results, a lack of funding for the Trimesta program despite the recent grants, our failure to successfully commercialize a new oral therapy for multiple sclerosis, <font style="DISPLAY: inline">a failure of our Trimesta clinical trial to complete enrollment in the anticipated time period </font>or to achieve desired results, our inability to increase shareholder value despite achieving our milestones, our ability to initiate additional clinical programs for multiple sclerosis, <font style="DISPLAY: inline">the availability of additional financial and other resources and the allocation of resources among different potential uses,</font> 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-SIZE: 10pt; FONT-FAMILY: Times New Roman">For further information, please contact:</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">James S. Kuo, M.D., M.B.A.</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">734-332-7800</font></div>

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