PHILADELPHIA, May 13, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced its financial results for the fiscal quarter ended March 31, 2008. The net loss for this period was approximately $3,165,000 or ($0.04) per share compared to a loss of $5,100,000 or ($0.07) per share for the same period in 2007. This decrease in loss of $1,935,000 was primarily due to lower R&D costs and a reduction in financing costs and interest expense. The R&D costs in 2007 included $1,380,000 in increased Ampligen(r) production costs. Ampligen(r) is an experimental therapeutic with multiple potential applications. Financing costs and interest expense were also lower by $209,000 in 2008 reflecting the effect of paying down all our convertible debentures in June 2007.
On February 8, 2008 representatives of the Company met with the FDA to address 14 preclinical and clinical concerns raised by the FDA in their December 5, 2007 response to the Company's Ampligen(r) (Poly I: Poly C12U) NDA filing. This meeting resolved certain concerns and the five remaining filing related issues have now been addressed by the Company's filing of amendments to its NDA on April 25, 2008. These amendments, now completely filed electronically, should allow the Agency reviewers to evaluate more efficiently the statistical efficacy/safety conclusions of the Company's NDA for the use of Ampligen(r) in potential treatment of Chronic Fatigue Syndrome (CFS).
Progress was also made on two other major Technology Platforms of the Company: Ampligen(r) as an experimental immune enhancer of vaccines, and Alferon N, the Company's FDA approved parenteral antiviral, as a potential low dose orally bioactive broad-spectrum product. First, specific progress with Ampligen(r) was made through ongoing collaborations with the Japanese National Institutes of Health, the Japanese Ministry of Health and the Company's commercial partner in Japan, Biken, the commercial arm of Osaka University. Novel vaccines were created against "Bird Flu" (H5N1 Avian Influenza Virus) utilizing mucosal delivery routes which successfully delivered broad-spectrum cross protection against various strains of virus in non-human primates.
Secondly, collaboration studies done in the Netherlands (ViroClinics) in other non-human primates now suggest a potential role for Alferon LDO as a new therapeutic approach to pandemics. Alferon LDO is now poised for clinical trials against seasonal influenza epidemics. Meetings with prospective partners are ongoing to conduct clinical trials in the Pacific Rim countries and elsewhere. The opportunity for Alferon LDO is being reinforced by new reports of severe side effects secondary to Tamiflu, the present standard of care, by both the FDA and Japanese health authorities. Also, Tamiflu resistant strains of flu virus are now raising concerns on a world wide basis.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced biopharmaceutical 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(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(r) and Oragens(r). Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids 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 in excess of 90 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). 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
Contact: Hemispherx Biopharma, Inc. Dianne Will, Investor Relations (518) 398-6222, Fax: (618) 398-6369 HEB's Web Site: 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(r), Alferon LDO and Oragens) 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(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications; Similarly, the completion of NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.