PHILADELPHIA, Aug. 9, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) announced its financial results for the three months ended June 30, 2013. The net loss (including non-cash effects) was approximately $4,283,000 or $(0.03) per share as compared to a net loss of $3,000,000 or ($0.02) per share for the same three month period in 2012. This Quarter-to-Quarter increase in net loss of approximately $1,283,000 was predominantly caused by:
- a non-cash write-down of existing Alferon N Injection® work in process inventory for $458,000; and
- an increase of approximately $470,000 related to continued efforts to seek regulatory approval (U.S.A. and abroad) of the Ampligen® NDA for Chronic Fatigue Syndrome including costs related to clinical studies, research, raw material production and various GMP validation procedures at our New Brunswick, NJ facility.
Cash, cash equivalents and marketable securities were approximately $32,523,000 at June 30, 2013 as compared to $43,953,000 as of December 31, 2012. Cash, cash equivalents and marketable securities, net of the Margin Loan used for the facility enhancement project at our 43,000 sq. ft. FDA approved New Brunswick facility, was approximately $25,472,000 at June 30, 2013.
Our facility in New Brunswick, NJ produces the active pharmaceutical ingredient for Alferon® and raw materials and drug intermediates for the experimental product Ampligen®. The facility enhancement project is in its final stage with construction complete. The validation phase of the Alferon® manufacturing project is currently underway as we prepare to undertake the Installation Qualification Process phase of the enhancement project. Approximately $7,709,000 has been spent to date on the project. While facility upgrades are intended to enhance the Alferon® manufacturing process, this project has not impacted our capability to manufacture Ampligen® raw materials and drug intermediates. Our overall objectives include our plans to continue seeking approval for commercialization of Ampligen® in the United States and abroad as well as to widen existing commercial therapeutic indications of Alferon N. Injection® presently approved in the United States and Argentina.
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