| May 11, 2005 |
| HEMISPHERX BIOPHARMA FIRST QUARTER 2005 EARNINGS ANNOUNCED |
…. Net Loss Decreases By 62% in Current Quarter
Philadelphia, PA, Wednesday, May 11, 2005: Hemispherx Biopharma, Inc. (AMEX: HEB) announced a loss (including non-cash losses) for the three months ended March 31, 2005 of $3,055,000 or $0.07 per share compared to losses of $8,042,000 or $0.20 per share for the same period in 2004. The decrease in loss of $4,987,000 or 62% is primarily due to 1) lower costs associated with non-cash financing charges decreased approximately $2,762,000 related to the issuance of convertible debentures 2) lower non-cash stock compensation expenses of $1,769,000 and 3) production/cost of goods sold was lower by $503,000 primarily due to reduced expenditures in the first quarter of 2005 associated with the ramping up of the New Brunswick facility for further production of Alferon N Injection®.
In the first quarter 2005, the Company increased clinical staff by employing additional medical doctors and other highly trained individuals to focus on the preparation of the Ampligen New Drug Application (NDA) for submission to the Food and Drug Administration (FDA). This NDA will include data accumulated from 40,000 administrations of Ampligen to approximately 700 chronic fatigue patients. A treatment protocol continues to enroll patients with chronic fatigue syndrome (CFS).
The Company also reports that the consolidation of the quality assurance laboratory in Rockville, Maryland into the New Brunswick, New Jersey facility has been completed and the Company is in the process of establishing manufacturing operations for Ampligen® raw materials in New Jersey.
Patients also continue to be actively recruited for the Phase IIb study for the experimental treatment of HIV patients to overcome multi-drug resistance, virus mutation and toxicity associated with current antiviral (“HAART”) therapies.
New experimental programs with Alferon LDO are also being launched in both the U.S. and China (Hong Kong) to test its ability to reactivate latent antiviral/immunomodulatory genes.
About Hemispherx
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx’s flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen and Oragens. Alferon is approved for a category of STD infection, and Ampligen and Oragens represent experimental nucleic acids being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS, Hepatitis and SARS. Hemispherx’s platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 150 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP certified manufacturing facilities for its novel pharma product. For more information please visit www.hemispherx.net.
Contact:
Hemispherx Biopharma, Inc.,
Dianne Will, Investor Relations
(518) 398-6222, Fax: (518) 398-6369
HEB's Web Site: 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 AmpligenÒ and Oragensä) 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 AlferonÒ do not imply that the product will ever be specifically approved commercially for these other treatment indications.
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