<SEC-DOCUMENT>0001144204-11-047268.txt : 20110815
<SEC-HEADER>0001144204-11-047268.hdr.sgml : 20110815
<ACCEPTANCE-DATETIME>20110815162806
ACCESSION NUMBER:		0001144204-11-047268
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20110815
ITEM INFORMATION:		Results of Operations and Financial Condition
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110815
DATE AS OF CHANGE:		20110815

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:		111036792

	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: 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-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 August 15, 2011, Adeona Pharmaceuticals, Inc., a Nevada corporation (the &#8220;Registrant") issued the attached press release that included financial information for its second fiscal quarter ended June 30, 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: 0.8pt" align="left"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Exhibit 99.1 Press Release issued by Adeona Pharmaceuticals, Inc. dated August 15, 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 Second Quarter 2011 Financial Results</font></div>

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<div style="DISPLAY: block; MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt; TEXT-ALIGN: justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman"><font style="DISPLAY: inline; FONT-WEIGHT: bold">Ann Arbor, MI, August 15, 2011 &#8211;</font> Adeona Pharmaceuticals, Inc. (AMEX:AEN - News), a developer of innovative medicines for serious central nervous system diseases, today reported its second quarter 2011 financial results for the period ended June 30, 2011, as well as updates since the beginning of the second quarter.</font></div>

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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">As of August 1, 2011, 140 of 150 patients have been enrolled in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting MS. The randomized, double-blind, placebo-controlled clinical trial is currently underway at 15 centers in the United States and should complete enrollment before the end of 2011.</font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Our ongoing Phase II clinical trial of Trimesta (estriol) for relapsing-remitting MS in women has received over $8 million in total grant awards and should support the clinical trial to its completion.</font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">We are planning to sponsor a separate randomized, double-blind, placebo-controlled clinical trial to evaluate Trimesta&#8217;s effect on cognition in female MS patients.</font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In April 2011, clinical study results were presented that demonstrated the cognitive function of the placebo group, on average, declined over six months in comparison to patients managed with <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font>, a medical food. 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 style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Based on the results of our clinical study, we are developing <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> as a medical food for the dietary management of zinc deficiency associated with Alzheimer's disease. <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font> is a proprietary, once-daily, gastroretentive, sustained-release, oral tablet formulation of zinc and cysteine.</font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">In July 2011, we acquired exclusive access to two statistically significant clinical studies that demonstrated a reduction in the duration and severity of symptoms associated with the common cold while taking a particular zinc lozenge.</font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Based on the reduction of common cold symptoms shown in these two clinical studies conducted by Ananda S. Prasad, M.D., Ph.D., we intend to commercialize a similar oral zinc lozenge as a homeopathic over-the-counter (OTC) drug under the brand name <font style="DISPLAY: inline; FONT-STYLE: italic">wellZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: super">TM</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">.</font></font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Our wholly owned subsidiary, Adeona Clinical Laboratory<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">,</font> reported total net revenues of $355,562 for the three months ended June 30, 2011. This revenue reflects an approximate 9% increase from the first quarter ended March 31, 2011<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">.</font></font></div>
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<div style="MARGIN-LEFT: 0pt; TEXT-INDENT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Our cash position was substantially strengthened during the second quarter as a result of a financing we completed in April 2011<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">.</font> The sale of approximately 1.69 million shares of common stock at $2.0725 per share in a registered direct offering provided gross proceeds of approximately $3.5 million.</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 three and six months ended June 30, 2011 were $355,562 and $678,700, respectively, compared to $2,194,888 and $2,254,927, for the same periods in 2010. For the three and six months ended June 30, 2010, total net revenues included $2,125,000 from the flupirtine sublicense fee with Meda AB. Laboratory revenues for the three and six months ended June 30, 2011 increased&#160;&#160;409% to $355,562 and 422% to $678,700, respectively, from $69,888 and $129,927, for the same periods in 2010. These significant changes resulted from an increase in the client base and the expansion of in-house diagnostic testing services 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">Total costs and expenses for the three and six months ended June 30, 2011 were $1,275,064 and $3,024,776, respectively, compared to $1,221,605 and $2,370,003, for the same periods in 2010.</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 and six months ended June 30, 2011, were $694,281 and $1,967,817, respectively, compared to $662,627 and $1,398,456, for the same periods in 2010. For the three and six months ended June 30, 2011, general and administrative expenses include a non-cash charge relating to stock-based compensation expense of $51,614 and $810,324, respectively, compared to $32,460 and $183,607 for the same periods in 2010. The stock-based compensation expense for the six months ended June 30, 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 and six months ended June 30, 2011, were $301,142 and $545,000, respectively, compared to $132,406 and $237,825, for the same periods in 2010. These increases are 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, including salary and supply costs.</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 expenses for the three and six months ended June 30, 2011, were $760,393 and $1,520,280, respectively, compared to $6,499 and $7,336 of other income, for the same periods in 2010. For the three and six months ended June 30, 2011, other expense included $759,610 and $1,569,467, respectively, relating to the estimated fair value of the warrants associated with the January 2011 and April 2011 financings, adjusted for the change in their fair value at June 30, 2011. Other income for the six months ended June 30, 2011 included $62,996 relating to the settlement of accounts payable previously accrued in prior periods.</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 June 30, 2011, was $1,679,895 or $0.06 per share compared to net income of $979,782 or $0.05 for the same period in 2010. The net loss for the six months ended June 30, 2011, was $3,866,356 or $0.15 per share compared to $107,740 or $0.00 per share for the same period in 2010.</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">As of June 30, 2011, Adeona had approximately $8.4 million in cash compared to approximately $2.6 million on December 31, 2010. As of July 31, 2011, we had approximately $8.1 million in cash, cash equivalents and investment in debt securities. Our 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;During the second quarter of 2011, we achieved several operational and clinical milestones that should position us well for future growth and increased shareholder value. In the next several months, we anticipate initiating three clinical trials under INDs and making two products commercially available<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">,</font>&#8221; stated James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer. &#8220;On the drug development side, we look forward to reporting the completion of patient enrollment in the Trimesta MS trial and to the initiation of a new clinical trial to evaluate Trimesta&#8217;s effect on cognitive loss observed in MS patients. We are also very excited to initiate drug trials for our ALS and Alzheimer&#8217;s clinical programs. In addition, we are preparing for the commercial launch of <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: super">TM</font>, our medical food for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease, and <font style="DISPLAY: inline; FONT-STYLE: italic">wellZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: super">TM</font>, to reduce symptoms associated with the common cold.&#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-WEIGHT: bold; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">Adeona Second Quarter 2011 Investor Conference 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 will hold its second quarter 2011 investor conference call this afternoon, Mon<font style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman">day, August 15, 2011, at 2:00pm (EDT)</font>. James S. Kuo, M.D., M.B.A., Adeona&#8217;s Chief Executive Officer, will host the call. Adeona will be joined by special guest, Ananda S. Prasad, M.D., Ph.D., a Distinguished Professor of Internal Medicine at Wayne State University School of Medicine, an Adeona Scientific Advisory Board member and the Principal Investigator of two separate clinical studies that evaluated a particular zinc lozenge for reducing symptoms of the common cold. Dr. Prasad will share his expertise in utilizing zinc lozenges to combat symptoms of the common cold and will take questions about his research. 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 color="#0000ff" style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; TEXT-DECORATION: underline">http://www.videonewswire.com/event.asp?id=81780</font>. If you are unable to participate during the live conference call, the webcast will be available for replay at the same URL (<font color="#0000ff" style="DISPLAY: inline; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; TEXT-DECORATION: underline">http://www.videonewswire.com/event.asp?id=81780</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 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 focused on 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. Adeona is developing, or has partnered the development of, drug product candidates to treat multiple sclerosis, fibromyalgia, amyotrophic lateral sclerosis (ALS) and Alzheimer&#8217;s disease. The Company is currently preparing to make the following products commercially available: <font style="DISPLAY: inline; FONT-STYLE: italic">reaZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: super">TM</font>, a medical food for the dietary management of zinc deficiency associated with Alzheimer&#8217;s disease, and <font style="DISPLAY: inline; FONT-STYLE: italic">wellZin</font><font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: super">TM</font>, a homeopathic over-the-counter drug for reducing symptoms associated with the common cold. Adeona also operates a wholly owned clinical reference laboratory, Adeona Clinical Laboratory, that provides a broad array of chemistry and microbiology diagnostic tests. For more information, please visit Adeona&#8217;s website at <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.adeonapharma.com</font><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">.</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 and wellZin for the common cold,&#160;our intent to further commercialize development of reaZin or wellZin, our ability to obtain INDs in a timely manner for some of our drug candidates, increases in our planned cash expenditures that allow our cash position to meet our planned needs for the next 12 month, the ability of grant funding to support our MS clinical trial, and anticipated enrollment and timing of our ongoing MS clinical trial or our planned Alzheimer&#8217;s, ALS or MS cognition clinical trials. 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, wellZin for the common cold or AEN-100 as a treatment for Alzheimer&#8217;s, the failure of reaZin or wellzin to be accepted for either use, failure of future clinical trials of any of our drug candidates to be enrolled in and completed in the anticipated time or to achieve the desired results<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman">,</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 style="DISPLAY: inline; FONT-FAMILY: Times New Roman">.</font></font></div>

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