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Hemisphrex Biopharma Announces Fiscal 2010 Year Results

PHILADELPHIA, March 29, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced its financial results for the fiscal year ended December 31, 2010. The net loss for the year (including non-cash effects) was approximately $13,136,000 or ($0.10) per share as compared to a net loss of $7,180,000 or ($0.07) per share in 2009. An adjustment and restatement at December 31, 2009 to record the change of fair value of the liability related to certain warrants issued in May 2009 resulted in a non-cash gain of $6,258,000 in 2009 as compared to a non-cash gain of $879,000 in 2010.  This redeemable warrant liability will continue to be revalued to fair market each fiscal quarter and the resulting non-cash adjustment can have a significant impact on overall net profit or loss of the Company. 

Overall Research and Development ("R&D") costs in 2010 were approximately $7,613,000 as compared to $6,995,000 for the same period in 2009. R&D costs for Ampligen®, an experimental therapeutic, and related expenses were approximately $2,239,000 lower in 2010 primarily due to the additional scientific and regulatory effort spent in 2009 on the preparation and filing of the Ampligen® NDA. Our Chronic Fatigue Syndrome ("CFS") regulatory effort is being actively pursued in the U.S. and through GP Pharm Latinoamerica in certain non-U.S. locations. R&D expenses related to Alferon N Injection® and Alferon® LDO were higher by $2,874,000 in 2010 primarily due to efforts expended to significantly enhance the Alferon® manufacturing process for a potential resumption of commercial sales of Alferon N Injection® in the 2 nd half of year 2011. Also, R&D expenses were incurred to refine new diagnostic approaches designed to more reliably identify patients with CFS and to identify potentially superior biomarkers to monitor therapeutic intervention with Ampligen®. This program is designed to identify specific treatable molecular aspects within the overall CFS disease process in order to improve patient outcomes, and is also expected to have a significant impact on the design of CFS studies with Ampligen®. The time for the Company to respond to the Complete Response Letter on the pending Ampligen® New Drug Application was recently extended by the Food and Drug Administration ("FDA") to November 2011.

Cash, cash equivalents and marketable securities were approximately $44,387,000 as of December 31, 2010. Cash used in operations in 2010 was $11,886,000 compared to $9,297,000 for the same period in 2009.

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