PHILADELPHIA, Nov. 10, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced its financial results for the fiscal quarter ended September 30, 2008. The net loss including non-cash expenses for this period was approximately $3,415,000 or ($0.05) per share compared to a loss of $5,718,000 or ($0.08) per share for the same period in 2007. This reduced net loss of $2,303,000 was primarily due to 1) a reduction in R&D costs due to successful filing of the Company's Ampligen(r) New Drug Application (NDA) and designation that the application was "complete" for review purposes by the FDA; related R&D costs were down approximately $1,146,000 in 2008; and 2) G&A costs decreased $1,833,000 primarily due to lower stock compensation expense in 2008. The loss for the nine months ended September 30, 2008 was $9,382,000 or ($0.13) per share compared to a loss of $14,743,000 ($0.21) per share for the same period in 2007. Cash used in operating activities for the nine months ending September 30, 2008 decreased 35% compared to the same period in 2007.
Four features of the Company's specialty pharma platform, highlighted at recent medical meetings, followed the general theme "Focus on Commercial Success": 1) presentations at two conferences focused on various initiations, including Ampligen as a potential treatment of CFS; a) October 21, 2008, 48th Annual Inter Science Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and b) October 28, 2008, Annual Bio Investor Forum and October 29, 2008, Interagency Federal Committee on CFS (www.hhs.gov/advcomcfs/) focused on various initiatives as potential treatment of CFS; 2) the October 27, 2008 23rd Annual Biotherapy Conference focused on cancer vaccine enhancement strategies with special reference to solid tumors (e.g., ovarian cancer) through a collaboration with (Advanced Immune Technologies); 3) the September 17, 2008, Third European Influenza Conference, focused on infectious disease vaccine (e.g., seasonal influenza) enhancement strategies through collaboration with the National Institute of Infectious Diseases of Japan (JIID). The TLR3 agonist, experimental immunotherapeutic (Ampligen(r)) added to influenza vaccines as a nasal adjuvant induced a wide spectrum cross protection against different serotypes including highly pathogenic H5N1 avian influenza virus; and 4) the September 3, 2008, Biopharm America Conference, focused on special programs in pandemic readiness including Alferon LDO, a new experimental oral formulation of the Company's FDA approved biologic, Alferon N, designed to combat emerging epidemics especially within the Pacific Rim.
Overall, the recent responses to the various Company (and its affiliates) public presentations suggest an incremental interest in the various pharmaceutical platforms of the Company.
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 50 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.