PHILADELPHIA, May 6, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended March 31, 2011. The net loss for the period was approximately $866,000 or $(0.01) per share as compared to a net loss of $5,380,000 or $(0.04) per share for the same period in 2010. This decrease in net loss of $4,514,000 or 84%, comparing the same three month period in 2011 and 2010, was primarily due to lower operational expenses and a gain of $2,272,000 realized from the sale of the Company's accumulated New Jersey state net operating loss carry forwards. Operating expenses decreased by $473,000 primarily due to lower R&D expenses related to Alferon® LDO and reduced legal expenses due to the settlement of various legal proceedings in 2010. In addition, the quarterly fair value revaluation of the liability related to certain redeemable warrants resulted in a non-cash gain of $301,000, as compared to a non-cash net loss of $(1,336,000) for the same period in 2010.
Cash, cash equivalents and marketable securities were approximately $42,828,000 as of March 31, 2011. Net cash used in operations in the three months ended March 31, 2011 was $1,818,000 compared to $3,925,000 for the same period in 2010.
In December 2010, the FDA granted the Company a one year extension to file a response to the Complete Response Letter based on the submission of new data concerning a potential viral presence in Chronic Fatigue Syndrome ("CFS") and its relationship to the Ampligen® clinical response. As such, the Company is in the process of enlarging the open label CFS trial in the United States to obtain more data on the interrelationship between CFS and retroviruses in the clinical response to Ampligen®, an experimental therapeutic. The results of the studies may provide a new approach to the design and recruitment of CFS patients for therapeutic intervention. In addition, the Company has jointly filed a patent application with Chronix BioMedical ("Chronix") to explore the use of Chronix's DNA "signature" technology using next generation DNA sequencing technology. This technology may prove useful as a companion diagnostic for identifying subsets of patients with potential for heightened therapeutic responsiveness.
The Company continued to move forward with enhancements to its FDA licensed manufacturing facility in New Brunswick, NJ to accommodate larger production volumes of its FDA-approved therapeutic, Alferon N Injection®. Additionally, a second diagnostic kit for influenza was introduced to help accelerate enrollment of our Phase II clinical study of hospitalized flu patients treated with either Alferon N Injection® or placebo.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has 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. The planning, completion, results or submission of clinical trials do not imply that any experimental product will ever be approved commercially for the studied or other treatment indications. Similarly, the resumption of commercial sales of Alferon N Injection® is predicated on certain technical achievements and acceptance by FDA of resulting data reports, which may or may not occur. Similarly, the new diagnostic initiatives of the Company in CFS may need to be validated in wider clinical trials and thus may not necessarily be accepted by the FDA as a basis for evaluating the potential efficacy of Ampligen®.