-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, ON/tjwpPVp2rzWc3AWu9Ur54TddPb2Gho76hBtG614RUISgP+p42pe1o/ZXBZMfY vHqJJeZd1lcKGbcT5gM8Cw== 0001132072-09-000225.txt : 20090522 0001132072-09-000225.hdr.sgml : 20090522 20090521170406 ACCESSION NUMBER: 0001132072-09-000225 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090521 DATE AS OF CHANGE: 20090521 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: 09846064 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 8-K 1 s22-9198_8k.htm FORM 8-K, FIRST QUARTER EARNINGS REPORT s22-9198_8k.htm
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  May 15, 2009
 
ADEONA PHARMACEUTICALS INC.
(Exact name of registrant as specified in its charter)


Delaware
 
1-12584
 
13-3808303
(State or other jurisdiction of incorporation)
 
(Commission File No.)
 
(IRS Employer Identification No.)

3930 Varsity Drive, Ann Arbor, Michigan 48106
(Address of principal executive offices)  (Zip Code)
 
Registrant’s telephone number, including area code: (734) 332-7800

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 
Item 2.02.                                Results of Operations and Financial Condition

On May 15, 2009, Adeona Pharmaceuticals Inc. released its financial results for the quarter ended March 31, 2009.  A copy of the Company’s press release is attached hereto as Exhibit 99.1 and is hereby incorporated by reference (the “Press Release”).

The information provided in the response to this Item 2.02 and the accompanying Exhibit 99.1 are being furnished under Item 2.02 of Form 8-K and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of such Section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation by reference language in any such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01.                                Financial Statements and Exhibits

(d)           Exhibits.  The following exhibits are being furnished as part of this Report.

Exhibit Number
Description
   
99.1
Press release regarding earnings issued by Adeona Pharmaceuticals Inc. dated May 15, 2009


 
SIGNATURES
 
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.
 
  ADEONA PHARMACEUTICALS INC.
Date: May 15, 2009 By:  /s/ Steve H. Kanzer                             
  Name:   Steve H. Kanzer
  Its:        Chief Executive Officer
 
 


EXHIBIT INDEX

Exhibit Number
Description
   
99.1
Press release regarding earning issued by Adeona Pharmaceuticals Inc. dated May 15, 2009
 
 
 
 
 
 
EX-99.1 2 s22-9198_ex991.htm PRESS RELEASE RE: EARNINGS, MAY 15, 2009 s22-9198_ex991.htm
 
EXHIBIT 99.1

Adeona Logo
 
Adeona Pharmaceuticals Announces First Quarter 2009 Results
 

Ann Arbor, Michigan, May 15, 2009 -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), a specialty pharmaceutical company dedicated to the awareness, prevention and treatment of subclinical zinc deficiency and chronic copper toxicity in the mature population, today announced its results for its first quarter ended  March 31, 2009.
A conference call has been scheduled for 12:00 noon EDT on May 15, 2009.  In order to participate in the conference call, please call toll free: (877) 675-4751 and international dial-in: (719) 325-4854 passcode 4378978.  A replay of the conference call will be archived for at least 15 days on Adeona’s website at www.adeonapharma.com.
First quarter and recent highlights included:

·  
Analyzed samples obtained from our IRB-approved, 90-subject blinded, prospective, observational study of metal dyshomeostatis in Alzheimer’s disease, Parkinson’s disease and normal subjects conducted during 2007 and 2008;
·  
Focused development efforts on our zinc-based product candidates, including our Zinthionein™ and EyeDaily™ brands and manufacture of zinc-monocysteine complex;
·  
Launched www.copperproof.com, an informational website dedicated to increasing awareness of the potential health effects of chronic copper toxicity, especially in the mature population;
·  
Appointed David A. Newsome, M.D., President of Adeona's subsidiary, HealthMine, Inc.;
·  
Entered into an agreement to acquire Colwell Clinical Laboratories, Inc., an independent Southern California CLIA-certified clinical laboratory;
·  
Adopted a Stock Repurchase Program authorizing the repurchase, from time-to-time of up to $1 million of the Company’s common stock, up to a maximum of four (4) million shares at prices of up to $5.00 per share.

Steve H. Kanzer, CPA, JD, Chairman of the Board, President & Chief Executive Officer of Adeona, commented, “During the first quarter of 2009, we analyzed samples from our 90-subject observational study comparing serum markers of metal dyshomeostasis in Alzheimer’s disease, Parkinson’s disease and normal persons.  We found highly statistically significant differences in serum copper status between Alzheimer’s patients and normal subjects, as well as the first evidence of an apparent subclinical zinc deficiency in Alzheimer’s disease patients.  We currently intend to announce such results of this study in the first half July and intend to acquire a CLIA-certified laboratory to develop and launch a series of diagnostic products and services based on such findings.  Our President of our HealthMine subsidiary, David A. Newsome, M.D., pioneered the use of oral zinc therapy for the 17 million U.S. persons with age-related macular degeneration (AMD), such that oral zinc therapy is now the standard of care for AMD.  We see a similar, perhaps more significant opportunity for our oral zinc therapy products in Alzheimer’s disease and its predecessor, mild cognitive impairment (MCI), which together affect an estimated 20% of persons over the age of 65.”
 


Financial Results for First Quarter of 2009
The net loss applicable to common shareholders for the quarter ended March 31, 2009 was $1,113,275, or $0.05 per share, compared to a net loss applicable to common shareholders of $3,089,456, or $0.15 per share, for the comparable period in 2008. The decrease of $1,976,181 in net loss is due to the significant downsizing and cost saving measures initiated at the end of the first quarter of 2008.  Research and development expenses decreased by $1,628,626 for the quarter ended March 31, 2009 as compared to the same period last year. The decrease primarily relates to a decrease of approximately $837,000 associated with the development of our licensed clinical drug candidates, a decrease of approximately $445,000 in stock based compensation charges and a decrease in salaries and related taxes of approximately $296,000. General and administrative expenses decreased by $409,138 for the quarter ended March 31, 2009 as compared to the same period in 2008 which is primarily due to a decrease in salaries and related payroll taxes of approximately $100,000, a decrease in allocated overhead expense of approximately $96,000, a decrease in stock based compensation charges of approximately $71,000 and a decrease in professional fees of approximately $43,000.
At March 31, 2009, Adeona had cash of approximately $5.3 million, compared to approximately $5.9 million at December 31, 2008. The decrease of approximately $567,000 during the first quarter of 2009 is all attributable to net cash used in operations.

About Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc. (AMEX: AEN) is a specialty pharmaceutical company dedicated to the awareness, prevention and treatment of subclinical zinc deficiency and chronic copper toxicity in the mature population. Adeona believes that such conditions may contribute to the progression of important degenerative diseases, including, dry age-related macular degeneration (dry AMD), Alzheimer’s disease (AD) and mild cognitive impairment (MCI) in susceptible persons.  Adeona is also developing a number of late-stage clinical drug candidates for the treatment of rheumatoid arthritis and multiple sclerosis. For further information, please visit, www.adeonapharma.com.

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 designing additional clinical trials for oral dnaJP1, Zinthionein, flupirtine, or Trimesta. 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, regulatory limitations relating to the company’s ability promote or commercialize its products for awareness, prevention, diagnosis or treatment of subclinical zinc deficiency and chronic copper toxicity, to 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’s report on Form 10-K for the year ended December 31, 2008 and any other filings with the SEC.  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.
 
For Further Information Contact:

Steve H. Kanzer, CPA, JD
Chairman and Chief Executive Officer
(734) 332-7800 x39
 
 
 
 
 
 
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-----END PRIVACY-ENHANCED MESSAGE-----