Adeona Pharmaceuticals Announces Third Quarter 2009 Results and Achievements

ANN ARBOR, MI--(Marketwire - November 17, 2009) - Adeona Pharmaceuticals, Inc. (AMEX: AEN), a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population, today announced its results for its third quarter ended September 30, 2009 as well as recent achievements.

A webcast has been scheduled for 9:00 AM EST. Participants my view the audio/visual presentation by either pasting the following link into their browser, http://www.visualwebcaster.com/event.asp?id=64101

United States participants wishing to join the call telephonically may dial toll free 888-812-8536 (913-312-0376 for international participants) and enter the passcode 5272415 which will provide audio only.

A recording of the audio/visual webcast will be maintained on the Company’s website for at least 30 days following the webcast.

Third quarter and recent highlights included:

-- Announcement of the launch of its CopperProof™ Test Panel for evaluating copper and zinc status in Alzheimer’s disease and cognitive impairment patients; -- Announcement of the publication of results of a 160 Patient Phase 2 Clinical Trial of Oral dnaJP1 for Rheumatoid Arthritis; -- Completion of the acquisition of HartLab LLC (“HartLab”), an independent Chicago-area CLIA-certified clinical reference laboratory; -- Announcement of the formation of the initial specialty sales and marketing force for its CopperProof™ test panel; -- Announcement of IRB Approval to initiate a clinical trial of Once- Daily Oral Zinthionein™ ZC GS-150 in Alzheimer’s patients; -- Presentation of the results of our CopperProof-1 Study, an Adeona sponsored 90 subject prospective, blinded, observational clinical study evaluating copper and zinc status in Alzheimer’s patients, Parkinson’s patients and normal subjects, at the 2009 International Conference on Alzheimer’s Disease (ICAD) in Vienna, Austria; and -- Completion of the reincorporation of Adeona to Nevada from Delaware. 

Max Lyon, President & Chief Executive Officer of Adeona, commented, “We are pleased with our progress in the third quarter and are particularly excited about the recent launch of our CopperProof™ test panel for helping physicians determine if their Alzheimer’s and cognitive impairment patients have copper and zinc metabolic imbalances. Our acquisition of HartLab in July, gives us the opportunity to enter the market with the only comprehensive diagnostic test panel available for this purpose. Based on the new data we presented at the ICAD conference, combined with the existing peer reviewed data available, we believe that the comprehensive determination of copper and zinc status combined with the appropriate follow on therapeutic actions could have a significant impact on the progression of these diseases. We believe our recently announced clinical study with Zinthionein ZC will robustly demonstrate the value of this patent pending gastro-retentive, sustained release oral high dose zinc therapy in the Alzheimer’s and cognitive impairment populations, which we plan to launch in the first quarter of 2010.”

Financial Results for Third Quarter of 2009

The net loss for the quarter ended September 30, 2009 was $626,075 or $0.03 per share. Of this, $325,662 was attributable to research and development expenses and $351,646 was attributable to general and administrative expenses.

The net loss for the nine months ended September 30, 2009 was $2,617,608, or $0.12 per share, compared to a net loss of $6,290,008, or $0.31 per share, for the comparable period in 2008. This decrease of $3,672,400 in net loss was 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 $2,937,120 for the nine months ended September 30, 2009 as compared to the same period last year. The decrease primarily relates to a decrease associated with the development of our licensed clinical drug candidates, a decrease in stock based compensation charges and a decrease in salaries and related taxes. General and administrative expenses decreased by $832,655 for the nine months ended September 30, 2009 as compared to the same period in 2008, which is primarily due to a decrease in salaries and related payroll taxes, a decrease in stock based compensation charges, a decrease in allocated overhead and a decrease in professional fees.

At September 30, 2009, Adeona had cash of approximately $3.5 million, compared to approximately $5.9 million at December 31, 2008. The decrease of approximately $2.4 during the nine months ended September 30, 2009 is attributable to net cash used in operations of approximately $2.2 million, plus net cash used in the acquisition of HartLab of approximately $196,000. The decrease in cash for the quarter ended September 30, 2009 is approximately $890,000 and is attributable to net cash used in operations of approximately $704,000 and net cash used in the acquisition of HartLab of approximately $196,000, offset by proceeds from the exercise of outstanding options.

About Adeona Pharmaceuticals, Inc.

Adeona Pharmaceuticals, Inc. (AMEX: AEN) is a specialty pharmaceutical company dedicated to the awareness, diagnosis, prevention and treatment of zinc deficiency and chronic copper toxicity in the mature population. Adeona believes that these conditions may contribute to the progression of debilitating degenerative diseases including Dry Age-Related Macular Degeneration (Dry AMD), Alzheimer’s disease (AD) and mild cognitive impairment (MCI) in susceptible persons. Using Adeona’s proprietary, modified oral zinc delivery technologies, Adeona is preparing to initiate the first clinical trial of oral zinc therapy for the once-a-day dietary management of AD and MCI. 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 our website at www.adeonapharma.com or HartLab’s website at www.hartlab.com.

For further background on the role of zinc and copper imbalance in Alzheimer’s disease and mild cognitive impairment, interested persons are directed to www.copperproof.com and the following references:

1. Sparks D. and Schreurs, B., Trace amounts of copper in water induce beta-amyloid plaques and learning deficits in a rabbit model of Alzheimer’s disease. Proc. Natl. Acad. Sci. (2003) 100: 11065-11069.

2. Sparks DL, Friedland R, Petanceska S, Schreurs BG, Shi J, Perry G, Smith MA, Sharma A, Derosa S, Ziolkowski C, Stankovic G., Trace copper levels in the drinking water, but not zinc or aluminum influence CNS Alzheimer-like pathology, J Nutr Health Aging. (2006 Jul-Aug);10(4):247-54.

3. Deane R, Sagare A, Coma M, Parisi M, Gelein R, Singh I, Zlokovic B, A novel role for copper: Disruption of LRP-dependent brain A? clearance, Neuroscience 2007, Society for Neuroscience (Nov. 2007), Pres. 857.2

4. Kitazawa M, Cheng D, Laferla FM., Chronic copper exposure exacerbates both amyloid and tau pathology and selectively dysregulates cdk5 in a mouse model of AD., J Neurochem. (Mar. 2009); 108(6):1550-60. Epub 2009 Jan 22.

5. Morris MC, Evans DA, Tangney CC, et al., Dietary copper and high saturated and trans fat intakes associated with cognitive decline., Arch Neurol. (2006) 63: 1085-1088.

6. http://www.ewg.org/tapwater/contaminants/contaminant.php?contamcode=1022

7. Committee on Copper in Drinking Water, Copper in Drinking Water, National Research Council, National Academy Press (2000).

8. Squitti R, Bressi F, Paswualetti P, Bonomini C, Ghidoni, R, Binetti G, Casetta E, Moffa F, Ventriglia M, Vernieri F, Rossini P., Longitudinal prognostic value of serum “free” copper in patients with Alzheimer’s disease, Neurology, (Jan. 2009) 72: 50-55.

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 its oral zinc therapies, Zinthionein™ ZC GS-150, dnaJP1, zinc-monosyteine, flupirtine, or Trimesta. Adeona is at an early stage of development and may not ever have any products that generate significant revenue. Adeona’s Hartlab subsidiary is generating modest revenues and its future success will likely depend upon its ability to successfully introduce and market new specialty diagnostic assays to generate additional revenues. 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 to promote or commercialize its products for awareness, prevention, diagnosis or treatment of zinc deficiency and chronic copper toxicity, a lack of acceptance of Adeona’s product candidates in the marketplace, a failure of the company to become or remain profitable, that we will continue to meet the continued listing requirements of the American Stock Exchange (which, unlike other exchanges, does not require us to maintain any minimum bid price with respect our stock but does require us to maintain a minimum of $4 million in stockholders’ equity during the current year, for example), our inability to obtain the capital necessary to fund the company’s 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, Forms 10-Q for quarters ending in 2009 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.