PHILADELPHIA, Nov. 9, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced its financial results for the three months ended September 30, 2009. The net loss (including non-cash expenses) for the fiscal quarter was approximately $2,435,000 or $0.02 per share compared to a loss of approximately $3,415,000 or $0.05 per share for the same period in 2008. The decrease in loss was primarily due to 1) lower R&D expenses related to the preparation of the Ampligen(R) NDA and, 2) the effect of reducing G&A expenses pursuant to the cash conservation and cost reduction program implemented by Management in early 2009. The net loss for the nine months ended September 30, 2009 including non-cash expenses was $9,392,000 or $0.09 per share compared to a loss of $9,382,000 or $0.13 per share in 2008.
Cash and cash equivalents were $61,042,000 as of September 30, 2009 reflecting an increase of $54,923,000 since year end 2008. This increase primarily reflects the net proceeds of two equity placements in May, 2009 as well as proceeds derived from an equity financing agreement.
The Company presented new data at the Chronic Fatigue Syndrome (CFS) Advisory Committee to the Department of Health and Human Services (HHS) on October 29, 2009, regarding patient referral patterns in CFS and outlined new collaborative clinical research for the "Longitudinal Study of Gene Expression in CFS". On the seasonal and pandemic influenza prevention front, the Company continued discussions with its Japanese collaborative partners regarding proposed means to enhance the effectiveness of vaccines via its experimental therapeutic, Ampligen(R). In the prophylactic influenza protection area, the Company planned new clinical studies directed at North American clinical sites for Alferon(R) LDO, a new experimental oral formulation of its Food and Drug Administration (FDA) approved biologic, Alferon N Injection(R).
The FDA has not informed the Company as to any outstanding responses required in order to take action on the pending New Drug Application (NDA). The target date for action on the NDA under the Prescription Drug User Fee Act (PDUFA) was extended by the FDA in May, 2009. The Company is finalizing certain responses with respect to third-party based animal toxicology and manufacturing programs it believes should be considered post-approval issues and that do not constitute new or additional FDA requests.
The Company has initiated a $4.4 million capital investment program to upgrade its production facility located in New Brunswick, New Jersey. This facility produces Alferon N Injection(R), a commercial product for the treatment of refractory human papillomavirus (HPV), and the raw materials used to produce its experimental therapeutic drug, Ampligen(R). Both pharmaceutical platforms lend themselves to multiple drug delivery approaches including nasal and sublingual routes.
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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R), Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. 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 50 patents comprising its core intellectual property estate and commercially approved product (Alferon N Injection(R)). 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(R), Alferon(R) 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 under Treatment Investigational New Drugs (IND) conditions. 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. Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.