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<SEC-DOCUMENT>0000890163-08-000700.txt : 20081114
<SEC-HEADER>0000890163-08-000700.hdr.sgml : 20081114
<ACCEPTANCE-DATETIME>20081114155226
ACCESSION NUMBER:		0000890163-08-000700
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20081114
ITEM INFORMATION:		Results of Operations and Financial Condition
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20081114
DATE AS OF CHANGE:		20081114

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:		081191057

	BUSINESS ADDRESS:	
		STREET 1:		3985 RESEARCH PARK DRIVE
		CITY:			ANN ARBOR
		STATE:			MI
		ZIP:			48108
		BUSINESS PHONE:		734-332-7800

	MAIL ADDRESS:	
		STREET 1:		3985 RESEARCH PARK 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
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November 14, 2008, Adeona Pharmaceuticals, Inc., a Delaware corporation (the
&#8220;Registrant") issued the attached press release that included financial
information for its fiscal quarter ended September 30, 2008. 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
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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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<TYPE>EX-99
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<FILENAME>s11-8893_ex991.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:right;'><b><font size=2>Exhibit 99.1</font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><img src="intimg1.gif"><br> </p>

<p style=' margin-bottom:3pt; margin-top:12pt;text-align:center;'><b><font size=5>Adeona Pharmaceuticals Announces Clinical Update and Third Quarter 2008 Results</font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:center;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Ann Arbor, Michigan, November 14, 2008 -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a pharmaceutical company developing innovative late-stage drug candidates for the treatment of autoimmune and central nervous system (CNS) diseases, today announced its clinical update and results for its third quarter of 2008. </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>A conference call has been scheduled for 4:00pm EST today.  In order to participate in the conference call, please call toll free: (877) 852-6581</font><font size=2>&nbsp;</font><font size=2>and international dial-in: (719) 325-4779.  A replay of the conference call will be archived for at least 15 days on Adeona&#146;s website at www.adeonapharma.com. </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Third quarter and recent accomplishments included:</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt; margin-left:1in;text-align:justify;'><font size=2>&nbsp;</font></p>


<table border="0" cellspacing=0 cellpadding=0 width="94%" style='margin-left:23.4pt;'>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>In-licensed oral, once-daily new chemical entity for the treatment of rheumatoid arthritis (RA) which has completed a 160 patient, multi-center, double-blind, randomized, placebo-controlled Phase II clinical trial for the treatment of rheumatoid arthritis (RA).</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Presentation by our scientific collaborator has presented new findings from a phase IIa clinical trial results using estriol for the treatment of multiple sclerosis at the World Congress on Treatment and Research in Multiple Sclerosis Meeting (ACTRIMS, ECTRIMS and LACTRIMS) in Montreal, Canada. Estriol is the active ingredient in TRIMESTA.</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Presentation by scientific collaborator of Phase II Clinical Findings for Oral dnaJP1 Presented At The American College of Rheumatology (ACR) Annual Meeting.</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0in;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0in;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Announcing that its double-blind, randomized, placebo-controlled phase II clinical trial of oral flupirtine for the treatment of fibromyalgia has received institutional review board (IRB) approval to initiate the clinical trial.</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Completion of a corporate name change to Adeona Pharmaceuticals, Inc.;  Adeona is a Roman goddess of safe return and safe journey.  </font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>
<br>
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


<table border="0" cellspacing=0 cellpadding=0 width="94%" style='margin-left:23.4pt;'>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>33% decrease or $692,000 in net loss for the quarter ended September 30, 2008 as compared to quarter ended September 30, 2007.</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:justify;margin-top:0pt;margin-bottom:0pt'><font size=1>&nbsp;</font></p> </td> </tr>
    <tr >
        <td width="10%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=4><b>&#149;</b></font>                                     </p> </td>
        <td width="89%" valign=top style='padding:0in 5.4pt 0in 5.4pt'>
            <p style='margin-left:0pt;text-indent:0pt;text-align:left;margin-top:0pt;margin-bottom:0pt'><font size=2>Partial realization of cost cutting measures taken in the first half 2008.</font></p> </td> </tr></table>

<p style=' margin-bottom:0pt; margin-top:0pt; margin-left:0.5in;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Nicholas Stergis, Chief Executive Officer of Adeona, commented, &#147;During the third quarter, we have made substantial progress in realigning our business focus through the in-licensing of dnaJP1, an oral tolerogenic molecule which has already completed a 160 patient, double-blind, placebo-controlled phase II clinical trial for the treatment of rheumatoid arthritis (RA).  Oral dnaJP1 has been derived from a family of heat shock proteins (hsps) which have been shown to be elevated in the synovial joint fluid of RA patients.&nbsp; We are focused on designing additional clinical trials for this molecule.&#148; </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><b><font size=2>Financial Results for Third Quarter 2008 </font></b></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>The net loss applicable to common shareholders for the quarter ended September 30, 2008 was $1,428,839, or $0.07 per share. Of the net loss applicable to common stockholders for the quarter, $863,272 was attributable to research and development expenses and $606,685 was attributable to general and administrative expenses. Research and development expenses for the three months ended September 30, 2008 decreased by approximately $710,000 as compared to the third quarter of 2007.  The decrease is primarily due to a decrease of $575,000 associated with payments related to the development of our licensed clinical drug candidates, a decrease in salaries and related taxes of approximately $198,000, offset by an increase of approximately $80,000 in stock based compensation charges.  </font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>The net loss applicable to common shareholders for the nine months ended September 30, 2008 was $6,290,008, or $0.31 per share, compared to a net loss applicable to common shareholders of $19,142,602, or $1.12 per share, for the comparable period in 2007, representing a decrease of $12,852,594.  The decrease is primarily attributable to a non-cash charge of $12,409,722 taken during the first quarter of 2007 related to the acquisition of Effective Pharmaceuticals, Inc.  The total of the non-cash charge was reflected through equal and offsetting adjustments to additional paid-in-capital with no net impact on stockholders&#146; equity.  Research and development expenses increased by $86,473 for the nine months ended September 30, 2008 as compared to the same period last year. Of this increase approximately $242,000 related to stock based compensation charges and $111,000 related to an increase in allocated
overhead, offset by a decrease of approximately $254,000 in salaries and payroll taxes. General and administrative expenses decreased by $609,271 for the nine months ended September 30, 2008 as compared to the same period in 2007 which is primarily due to a decrease in stock-based compensation expense of approximately $734,000 and a decrease in professional fees of </font></p>

<p style=' margin-bottom:0pt; margin-top:5pt;text-align:justify;'><font size=2>&nbsp;</font></p>
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:5pt; margin-top:5pt;text-align:justify;'><font size=2>$122,000, offset by an increase in salaries and related payroll taxes of approximately $175,000 and an increase in allocated overhead of approximately $71,000.</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>At September 30, 2008, Adeona had cash of approximately $6.4 million, compared to approximately $11.5 million at December 31, 2007. The decrease of approximately $5.1 million during the first nine months of 2008 is attributable to net cash used in operations of approximately $4.1 million, and $900,000 that we elected to use to repay our outstanding equipment notes payable in full in order to eliminate further monthly interest payments as well as the security interest on our $2.0 million in equipment and leasehold improvements primarily relating to our cGMP pharmaceutical production facility in Ann Arbor, Michigan. The cash spend for the quarter ended September 30, 2008 is approximately $1.0 million which was all attributable to net cash used in operations.  </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>We implemented significant downsizing and cost saving measures announced March 11, 2008 in order to preserve our capital.  We are able to realize the effects of the cost cutting measures through a decrease in operating expense of $1.7 million or 53% and a decrease in cash used in operations of approximately $794,000 or 44% as compared to the first quarter of 2008 when the cost reductions were initiated. </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><b><font size=2>About Adeona Pharmaceuticals, Inc. </font></b></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>Adeona Pharmaceuticals, Inc. is a specialty pharmaceutical company that is developing proprietary, late-stage drug candidates for the treatment of neurologic and fibrotic diseases.  Adeona&#146;s strategy is to exclusively in-license proprietary, clinical-stage drug candidates and to complete the further clinical testing, manufacturing and regulatory requirements and seek marketing authorizations.  Adeona is focused on treatments for rheumatoid arthritis, multiple sclerosis, dry age related macular degeneration (AMD), and fibromyalgia. For further information, please visit, www.adeonapharma.com.  </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our products. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties and include statements regarding designing additional clinical trials for Oral dnaJP1. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. 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, a lack of acceptance of Adeona's product candidates in the marketplace, a failure of the company to become or remain profitable, Adeona's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors described in Adeona&#146;s report </font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>&nbsp;</font></p>
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<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:justify;'><font size=2>on Form 10-Q for the quarter ended September 30, 2008.  No forward-looking statements can be guaranteed and actual results may differ materially from such statements. 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></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>For Further Information Contact:</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Nicholas Stergis</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Chief Executive Officer</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>(734) 332-7800</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Redington, Inc. (Investor Relations)</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>Thomas Redington</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>203-222-7399</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>www.redingtoninc.com</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>


<p style=' margin-bottom:0pt; margin-top:0pt;text-align:left;'><font size=2>&nbsp;</font></p>

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