PHILADELPHIA, Nov. 8, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended September 30, 2010. The net loss (including non-cash expenses) for the 3rd fiscal quarter was approximately $3,254,000 or $0.02 per share compared to a loss of approximately $2,435,000 or $0.02 per share the same period in 2009.
Increases in Research & Development costs ($635,000) and General & Administrative costs ($574,000) were partially offset by an increase in investment income of $420,000. The increased R&D spending is related in part to the Alferon N Injection® Phase IIb seasonal influenza clinical trial underway in India and development of Alferon® LDO product for potential clinical trials. The change in G&A costs relates to the non-cash write-down of $293,000 from a stock revaluation analysis prior to the stock distribution regarding 2009's Employee Wage Or Hours Reduction Program, and higher legal costs of $188,000. The increase in expenses were offset by interest and investment income derived from a diverse portfolio of securities.
As of September 30, 2010, the Company had approximately $48,261,000 in cash, cash equivalents and marketable securities. Cash used in operating activities since December 31, 2009 was $10,070,000.
In the nine months ended September 30, 2010, the Company had a net loss, including non-cash expenses, of $10,974,000 compared to a net loss of $9,392,000 for the same period in 2009. The net loss per share was $0.08 for 2010 and $0.09 for 2009. Overall the increase in costs relate to clinical, research, and manufacturing programs that reflect the breadth of the Company's on-going commitment to develop and further commercialize its various products. The Company's New Brunswick, New Jersey FDA approved facility continues to undergo a series of structural and functional upgrades in anticipation of production targeted for 2011.
The Indian site selection process was completed and we obtained approval to begin the study from the Indian Drugs Controller General on July 13, 2010. We began enrolling subjects in September, 2010, and will continue to enroll subjects for this clinical study through the end of monsoon season (September) and into the winter's flu season. Currently we have four operational Clinical Investigative Sites, with the potential to open up to six more sites, through a collaboration with Max Neeman International, a large clinical research organization ("CRO").
On August 11, 2010, Hemispherx won a $188 million judgment in U.S. Federal Court (Southern District of Florida), ending our six-year litigation battle against Johannesburg Consolidated Investments and former JCI officers R.B. Kebble and H.C. Buitendag. Kebble and Buitendag were found to have engaged in fraud damaging Hemispherx. We intend to pursue collection of the judgment awarded, in the United States and South Africa.
On August 24, 2010, we announced that as a result of court mediation proceedings, we had entered into a written agreement in principle with the Court-appointed lead plaintiffs to settle all of the currently pending securities class actions consolidated in the U.S. District Court for the Eastern District of Pennsylvania. Assuming the agreement receives final approval by the Court, the settlement will be paid from our existing insurance coverage and will not result in the payment of any funds by us.
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 progress of clinical trials by Max Neeman International in India cannot be guaranteed due to a variety of risk factors outside of the parties' control and any statements regarding the plans for those trials should be regarded only as a forward looking estimate.