PHILADELPHIA, Aug. 6, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended June 30, 2010. The net loss (including non-cash expenses) for the 2nd fiscal quarter was approximately $3,676,000 or $0.03 per share compared to a loss of approximately $3,870,000 or $0.04 per share for the same period in 2009. In comparison of fiscal quarters, year 2010 had decreased Research and Development costs and General and Administrative costs were also reduced due to non-recurring financing expense. For the six months ended June 30, 2010, the net loss was approximately $7,720,000 or $0.06 per share as compared to a loss of $6,957,000 or $0.08 per share for the same period in 2009.
Cash, cash equivalents and investments totaled $50,547,000 as of June 30, 2010, reflecting an increase of approximately $9 million since June 30, 2009.
The Company reported progress on several product-related areas including: 1) Successful culmination of a three year research program funded by the National Institute of Infectious Disease of Japan indicating that a nasally delivered flu vaccine, when coupled with Ampligen®, yielded positive results in providing a more robust and longer lasting immune response in non-human primates; 2) In connection with Max Neeman International, a leading clinical research organization in India, the Company obtained approval to begin a Phase II b study from the Indian Drugs Controller General as it works to enroll subjects for the current monsoon season to treat seriously ill hospitalized flu patients evaluating Alferon N Injection®; 3) As a result of the Company's efforts to proceed with Phase II clinical testing of Alferon® LDO (an experimental biologic) for the potential prophylactic treatment of seasonal and / or pandemic influenza, three months of additional product stability data are being compiled and analyzed for submission to the U.S. Food and Drug Administration ("FDA"); and 4) New data on retrovirus presence in Chronic Fatigue Syndrome ("CFS") has been submitted (abstract) for potential presentation at a National Institutes of Health, U.S, workshop in September, 2010 and are being evaluated in connection with a contemplated Phase III confirmatory trial in CFS with Ampligen®, an experimental therapeutic.
In support of these clinical initiatives, the Company's wholly-owned New Brunswick, N.J. manufacturing facility continues to undergo plant renovations coupled with expansion in its overall production capacity. FDA inspections in June, 2010, conducted in accordance with FDA procedures for Therapeutic Biological Products Inspections, provided routine Good Manufacturing Practice ("GMP") coverage and focused on the Company's approved Alferon N Injection® product. No deficiencies were found during the inspections and, accordingly, no FDA-483 Inspectional Observations were issued.
Overall, these clinical, research, and manufacturing programs reflect the breadth of the Company's on-going commitment to develop and further commercialize its various products.
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 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.