PHILADELPHIA, March 15, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced its financial results for the fiscal year ended December 31, 2009. The net loss for the year (including non-cash charges) was approximately $13,438,000 or $0.12 per share as compared to a net loss of $12,219,000 or $0.16 per share in 2008. This $1,219,000 increase in loss was primarily due to increased research and development expenses associated with preparing the New Brunswick, New Jersey manufacturing plant for increased production plus efforts employed in supporting the New Drug Application ("NDA") and employee compensation awards.
Cash and cash equivalents were $58,072,000 as of December 31, 2009 reflecting an increase of $51,953,000 since year end 2008 due primarily to equity financing during 2009. Cash used in operating activities for the year ended December 31, 2009 was $9,297,000 compared to $9,358,000 for the same period in 2008, a reduction of $61,000.
Progress was made in preparing the Company's production facilities, including the Company's contract manufacturer, for various FDA inspections and additional preclinical studies were conducted assessing the potential use of Ampligen®, an experimental therapeutic, and Alferon NTM (FDA approved for a category of sexually transmitted diseases) against influenza and certain other disease conditions. Alferon NTM production is expected to be resumed based on an approximate $4.4 Million investment in various facility improvements in our approximate 43,000 square foot New Jersey manufacturing facility. A Complete Response Letter received on November 25, 2009, from the Food and Drug Administration ("FDA") regarding the pending NDA has prompted a broad internal and external program to design and implement a confirmatory clinical trial in chronic fatigue syndrome ("CFS") and to conduct certain additional preclinical tests.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.