PHILADELPHIA, Aug. 12, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced its financial results for the fiscal quarter ended June 30, 2008. The net loss including non-cash expenses for this period was approximately $2,802,000 or ($0.04) per share compared to a loss of $3,925,000 or ($0.05) per share for the same period in 2007. This reduced net loss of $1,123,000 was basically due to 1) a reduction in R&D costs primarily due to extensive work on the Company's Ampligen New Drug Application (NDA) in 2007. R&D costs were down approximately $1,374,000 in 2008; 2) there were no sales of Alferon N Injection in the second quarter of 2008 as there was no product available for sale due to the shelf life expiration date of the current inventory, as a result, sales where down $196,000; 3) G&A costs increased $247,000 during the second quarter, 2008 primarily due to the non-cash write down of prepaid royalties related to Alferon N Injection; 4) financing and interest expenses were lower by $183,000 due to the retirement of certain Convertible Debentures in June 2007. The loss for the six months ended June 30, 2008 was $5,967,000 or ($0.08) per share compare to a loss of $9,025,000 ($0.13) per share for the same period in 2007.
The Company reported accelerated progress on several of its technology platforms: a) the NDA commercial application for Ampligen(r), as a potential treatment of chronic fatigue syndrome ("CFS") was accepted as complete for substantive review by the FDA on July 7, 2008; b) the Company's commercial partner in Japan, Biken Corporation, and the governmental collaborator the Japanese National Institute of Infectious Diseases ("JIID") reported significant progress in a registration-directed program to utilize Ampligen(r) as an immunohancer in combination with various influenza vaccines; c) the Company completed enrollment of a Phase 2 influenza sero-prevention clinical study in Australia; d) completion/submission of a manuscript on Phase 3 studies of Ampligen(r) in potential treatment of CFS, and completion of a manuscript on Alferon-LDO a potential broad-spectrum antiviral/immunomodulator applied by novel delivery routes (sublingually) in non-human primate models; e) the JIID also reported significant progress in HIV/AIDS vaccine enhancement in an animal model utilizing the Company's immunoenhancement technology.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma 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 issued 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
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.