Adeona Reports 1st Quarter 2011 Financial Results
ANN ARBOR, Mich., May 16, 2011 /PRNewswire/ -- Adeona Pharmaceuticals, Inc. (AMEX: AEN), 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 1st quarter.
Updates since the beginning of the 1st quarter include:
Zinc Deficiency Associated with Alzheimer's Disease
- Clinical results: Top-line results from our clinical study evaluating reaZin for the dietary management of zinc deficiency associated with Alzheimer's disease were presented at the 63rd Annual Meeting of the American Academy of Neurology in April 2011.
- As prospectively hypothesized, patients administered reaZin demonstrated increased serum zinc levels and decreased serum free copper levels, resulting in statistical significance of the primary outcomes of the clinical study.
- The cognitive function of the placebo group, on average, declined over 6 months in comparison to patients managed with reaZin. The cognitive function trends favoring the patients managed with reaZin were observed in all three standardized cognitive tests utilized in our study and suggest that reaZin may provide an important benefit to the dietary management of zinc deficiency associated with Alzheimer's disease.
- Commercialization plans: Based on the top-line results from this clinical study, we intend to further the commercial development of reaZin as a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease.
- In April 2011, we executed an agreement with TG United, Inc. of Brooksville, Florida, to provide commercial-scale manufacturing for reaZin.
- We will also review the reaZin clinical study results with our scientific advisors to determine what further clinical studies might be warranted to support additional labeling claims.
- 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.
- $409,426 in grant funding from the National Multiple Sclerosis Society was received in March 2011.
- $1,594,553 in grant funding from the National Institutes of Health/National Institute of Neurological Disorders and Stroke was received in May 2011.
- Patient enrollment: 133 of 150 patients have been enrolled in the clinical trial evaluating Trimesta in women suffering from relapsing-remitting MS as of May 1, 2011. The randomized, double-blind, placebo-controlled clinical trial is currently underway at 15 centers in the United States.
- The quarter ended March 31, 2011 represents the first quarter that Adeona Clinical Laboratory achieved profitability since its purchase in July 2009. This milestone resulted from the increase in total net revenues for the three months ended March 31, 2011 that reflects an approximate 438% increase in net laboratory revenues from the three months ended March 31, 2010.
- Our cash position has been strengthened as a result of two financings, which should meet our planned operating needs for at least the next 12 months.
- Completion of the sale of approximately 2.85 million shares of common stock at $1.40 per share to new institutional investors in a registered direct offering for gross proceeds of $4 million in February 2011. Investors also received warrants to purchase approximately 1.42 million shares of common stock at an exercise price of $2.00 per share and are exercisable for a period of 13 months from issuance.
- Completion of the sale of approximately 1.69 million shares of common stock at $2.0725 per share to a new institutional investor in a registered direct offering for gross proceeds of $3.5 million in April 2011. Investors also received warrants to purchase approximately 844,000 shares of common stock at an exercise price of $2.0725 per share and are exercisable for a period of 13 months from issuance.
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