This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration. Need a new registration confirmation email? Click here
PHILADELPHIA, May 9, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced its financial results for the three months ended March 31, 2014. The net loss (including non-cash effects) was approximately $3,836,000 or $(0.02) per share as compared to a net loss of $3,611,000 or ($0.02) per share for the same three month period in 2013.
Cash, cash equivalents and marketable securities were approximately $21,554,000 at March 31, 2014 as compared to $18,194,000 as of December 31, 2013.
We own and operate a 43,000 sq. ft. FDA approved facility in New Brunswick, NJ that is designed to produce Alferon®, and Ampligen®. In December 2011, our Board of Directors reevaluated and expanded the facility enhancement project that focused on high volume, cost effective manufacturing processes for three products: Alferon N Injection®, Alferon® LDO (a low does oral form of Alferon®) and Ampligen®. The facility enhancement project is in its final stage with construction complete and a Certificate of Approval issued by the city of New Brunswick for the work completed. Approximately $7,107,000 has been spent on this project through March 31, 2014. We are testing our scaled up facility to deliver commercial level quantities of our three products in anticipation of upcoming audits by regulatory bodies.
Our overall objectives include 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. In addition, we collaborate with world-wide government based Biosecurity Units to explore the potentiality of Alferon LDO to neutralize outbreaks of seasonal flu, pandemic flu and MERS (Middle East Respiratory Syndrome).
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen
® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The production of new Alferon® API inventory will not commence until validation phases are complete. While the facility is approved by FDA under the Biological License Application ("BLA") for Alferon®, this status will need to be reaffirmed upon the completion of the facility's enhancements prior to commercial sale of newly produced inventory product. If and when we obtain a reaffirmation of FDA BLA status and have begun production of new Alferon® API, we will need FDA approval as to the quality and stability of the final product to allow commercial sales to resume. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen
® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of the Ampligen
® NDA in the United States and other countries.
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, changes 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. The final results of these efforts could vary materially from Hemispherx's expectations.