PHILADELPHIA, May 7, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended March 31, 2010. The net loss (including non-cash expenses) for the fiscal quarter was approximately $4,044,000 or $0.03 per share compared to a loss of approximately $3,087,000 or $0.04 per share for the same period in 2009. Increased research and development costs were associated with the effort towards launch of Alferon® N Phase II tests; activity preparatory for new clinical trials of Alferon® LDO and Ampligen®, both experimental therapeutics, along with an increase in overall general and administrative costs.
Cash, cash equivalent and short-term investments were $51,723,000 as of March 31, 2010.
As previously announced, in collaboration with Max Neeman International, we have begun the process to undertake a clinical research effort to test the ability of Alferon N Injection® to improve the treatment of seriously ill patients hospitalized with seasonal or pandemic influenza. Also, the Company has formed an independent Data Monitoring Committee ("DMC") to oversee our various drug development programs. The DMC is expected to perform interim reviews of the clinical data to insure safety of patients in clinical trials and evaluate various efficacy parameters with the different experimental therapeutics in our technology platform.
Retrospective analyses of patient samples from the completed Phase III trial of Ampligen® in potential treatment of Chronic Fatigue Syndrome ("CFS") continued in collaboration with the Whittemore Peterson Institute; these studies are expected to provide a new perspective on the design of a confirmatory Phase III study in this disorder. The samples are being analyzed for the presence of XMRV, a novel retrovirus, reported to be found in approximately two-thirds of CFS patients.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® represents experimental nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents 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. Further, the commencement of clinical trials in mid to late 2010 by Max Neeman in India is its target date but cannot be guaranteed due to a variety of risk factors outside of the parties control and should be regarded only as a forward looking estimate.