Ann Arbor-based Adeona Pharmaceuticals Inc. (AMEX: AEN), a developer of medicines for serious central nervous system diseases, Monday reported its second quarter financial results for the period ended June 30, as well as updates since the beginning of the second quarter.
Updates since the beginning of the second quarter include:
Drug Development Programs
* Multiple Sclerosis — As of Aug. 1, 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. 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. We are planning to sponsor a separate randomized, double-blind, placebo-controlled clinical trial to evaluate Trimesta’s effect on cognition in female MS patients.
* Fibromyalgia — In May 2010, we announced a $17.5 million corporate partnership with Meda AB for the development and commercialization of flupirtine for fibromyalgia. Meda assumed all future development costs and estimates the U.S. market for fibromyalgia to be near $1 billion at the time of potential launch of flupirtine. We are eligible to receive up to $15 million of additional milestone payments and royalties on sales. In its 2010 Annual Report that was publicly disclosed in May 2011, Meda stated that flupirtine for fibromyalgia was in Phase II development.
* Amyotrophic Lateral Sclerosis (ALS) — In June 2011, we announced plans to sponsor a Phase IIb clinical trial for patients suffering from ALS, also known as Lou Gehrig’s disease. The trial is intended to evaluate the safety and efficacy of our proprietary drug candidates, AEN-100, a gastroretentive, sustained-release zinc-based tablet, and AEN-200, a copper tablet, in a multi-center, double-blind, placebo-controlled clinical trial in ALS patients. The trial will be led by the neurological team at the PNA Center for Neurological Research and is based on the center’s hypothesis that giving high doses of zinc to ALS patients may decrease the amount of toxicity from unbound glutamate and prevent neurotoxicity.
* Mild to Moderate Alzheimer’s Disease — After conducting further analyses of the results presented in April 2011 from the clinical study evaluating our medical food, reaZin, an apparent cognitive benefit was observed in older patients. Preparations are underway to conduct a larger clinical study of AEN-100 (our zinc-based drug candidate) under an Investigational New Drug (IND) application in patients with mild to moderate Alzheimer’s disease who are age 70 and over. It is anticipated that the clinical study will enroll just over 100 patients and that the evaluation period will be at least 12 months. The company said it plans develop its proprietary zinc-based tablet, AEN-100, as a drug in parallel with making reaZin available as a medical food. AEN-100 is a proprietary, once-daily, gastroretentive, sustained-release, oral tablet formulation of zinc.
Near-Term Product Development Programs
* Dietary Management of Zinc Deficiency Associated with Alzheimer’s Disease — 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 reaZin, a medical food. 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. Based on the results of our clinical study, we are developing reaZin as a medical food for the dietary management of zinc deficiency associated with Alzheimer’s disease. reaZin is a proprietary, once-daily, gastroretentive, sustained-release, oral tablet formulation of zinc and cysteine.
* Reducing the Duration and Severity of Symptoms Associated with the Common Cold — 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. Based on the reduction of common cold symptoms shown in these two clinical studies conducted by Ananda S. Prasad, M.D., we intend to commercialize a similar oral zinc lozenge as a homeopathic over-the-counter (OTC) drug under the brand name wellZin.
The company’s cash position was substantially strengthened during the second quarter as a result of a financing it completed in April 2011. 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.
As of June 30, the company said it had $8.4 million in cash, which should meet planned operating needs for at least the next 12 months.
The company reported revenue of $355.562 for the quarter ended June 30, down from $2.2 million a year earlier. Revenue for the six months was $678,700, down from $2.3 million in the same six months of 2010. The big decline came from a large license fee paid a year earlier.
The loss for the quarter was $1.7 million or 6 cents a share, vs. net income of $979,782 or 5 cents a share a year earlier. The loss for the six months was $3.9 million or 15 cents a share vs. a loss of $107,740 or less than a penny a share in the first half of 2010.
“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,” said James S. Kuo, Adeona CEO. “In the next several months, we anticipate initiating three clinical trials under INDs and making two products commercially available. 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’s effect on cognitive loss observed in MS patients. We are also very excited to initiate drug trials for our ALS and Alzheimer’s clinical programs. In addition, we are preparing for the commercial launch of reaZin, our medical food for the dietary management of zinc deficiency associated with Alzheimer’s disease, and wellZin, to reduce symptoms associated with the common cold.”
To listen in on a replay of a conference call discussing the results, visit www.videonewswire.com/event.asp?id=81780.
More at www.adeonapharma.com.