PHILADELPHIA, Nov. 8, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced its interim financial results for the three months ended September 30, 2007. The net loss for this fiscal quarter was approximately $5,718,000 or $(.08) per share compared to a loss of $3,807,000 or $(.06) per share for the same period in 2006. The $1,911,000 increase in loss was basically due to higher general and administrative expense of $2,232,000, primarily related to non-cash equity-based compensation expense. The results also reflect increased research and development costs of approximately $228,000, primarily related to independent consultants used in preparing and filing the New Drug Application (NDA) for the experimental therapeutic Ampligen(r) (Poly I: Poly C12U) to treat Chronic Fatigue Syndrome (CFS), offset by lower interest and financing costs of approximately $295,000 related to reduced debt and debt discount amortization. In July, the Company announced the retirement of all remaining debt related to convertible debentures issued in 2003 and 2004.
The net loss for the six months ended June 30, 2007 was approximately $14,743,000 or $(.21) per share compared to a loss of $14,807,000 or $(.24) per share for the same period in 2006.
On October 10, 2007, Hemispherx filed an NDA with the FDA for the use of the experimental therapeutic Ampligen(r) in treating CFS, also known as myalgic encephalomyelitis (ME). In addition, the Company is actively engaged in broad-based experimental studies assessing the efficacy of its products Ampligen(r), Alferon N Injection(r) and Alferon LDO against influenza viruses as immune enhancers and/or single agent antivirals, working with various research affiliates of the National Institutes of Health in the U.S. and health agencies in other countries. Peer-reviewed publications in leading medical journals have recently appeared.
"We recently reached the milestone of filing the NDA that is intended make the experimental therapeutic Ampligen(r) the first approved treatment for CFS, a major disease with significant quality-of-life and economic impacts," commented Dr. William A. Carter, Chairman and CEO of Hemispherx. "As we take that years-long initiative to conclusion, we are receiving exciting news from our research partners with Japan's National Institute of Infectious Diseases. Their findings suggest a key additional role for the experimental therapeutic Ampligen(r) in potentially bolstering the ability of health agencies worldwide to combat an avian flu pandemic, when and if such a threat emerges, by co-administering avian flu vaccine with Ampligen(r). This has already proven a pivotal year for Hemispherx, and we are working to push all our initiatives forward in the months ahead."
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a 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) and the experimental therapeutics Ampligen(r), Alferon LDO and Oragens(r). Alferon N Injection(r) is approved for a category of STD infection, and Ampligen(r) and Oragens(r) represent a large portfolio of experimental RNA nucleic acids being developed for globally important viral diseases, severely debilitating disorders and biodefense applications. 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, a fully commercialized product (Alferon N Injection(r)) and a GMP certified manufacturing facility for its novel pharma products. The Company is actively engaged in further expansion of its intellectual property on a world wide basis to reflect the global distribution of the various disorders which its platform technology addresses. 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(r)) 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.