OCALA, Fla., Aug. 15, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American:HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, has announced its financial results for the six months ended June 30, 2018.
The Company has made great progress pursuing Ampligen in combination therapeutic treatments in immuno-oncology. Significant synergistic anti-tumor activity and/or increased median survival has been observed when Ampligen was added to other anti-cancer agents in three pre-clinical studies. As a result, the Company is now working with several top U.S. cancer research centers to initiate Phase 1 and Phase 2 clinical trials combining Ampligen with FDA-approved checkpoint blockade therapies in a variety of solid tumors.
Hemispherx continues to clarify the regulatory pathway for approval of Ampligen to treat CFS in the United States. It expanded its production capabilities in order to provide a reliable supply of Ampligen for all of its clinical and expanded access programs in the U.S., Canada, Europe and commercial program in Argentina. With the ability to produce Ampligen in sizable commercial lots, the Company is laying the foundation for significant revenue growth, as it sees ongoing scientific and medical validation of Ampligen's potential to fill large unmet medical needs in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and a variety of immune-modulated illnesses.
Six Months Ended June 30, 2018 Financial Highlights
As of June 30, 2018, Hemispherx had $4.2 million in cash and cash equivalents, compared to $2.1 million at December 31, 2017. Cash used in operations was $5.2 million for the six months ended June 30, 2018, compared to $5.3 million in the same period in 2017. The net loss was $5.1 million, or $0.13 per share, for the six months ended June 30, 2018, compared to a net loss of $5.0 million, or $0.19 per share, in the same period in 2017.
Ampligen Moving Towards Commercialization
During the quarter, Hemispherx successfully completed the first phase of its Ampligen production plan. The first commercial-sized lot of Ampligen of 8,500 vials passed all required testing for regulatory release for human use. The vials are earmarked for distribution to U.S.-based ME/CFS expanded access programs in Nevada and North Carolina, U.S. clinical trials in immuno-oncology, European and Canadian expanded access programs and for certain testing and validation required for commercial launch in Argentina.
The second commercial-sized lot of Ampligen is currently undergoing release testing and is intended to be available to supply initial demand for Ampligen’s anticipated commercial launch in Argentina, where it is approved for the treatment of severe CFS. The Argentine commercial approval is the first-ever approval of a drug for severe CFS.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.
