Hemispherx Biopharma (NYSEMKT:HEB) announces the filing of its Quarterly Report and its financial results for the nine months ended September 30, 2016. The net loss was approximately $6,329,000 or $(0.30) per share as compared to a net loss of $12,093,000 or ($0.62) per share for the same nine month period in 2015. Cash, cash equivalents and marketable securities were approximately $8,009,000 at September 30, 2016 as compared to $8,910,000 as of December 31, 2015.
Hemispherx Biopharma recently made changes to its senior management team and implemented austerity measures which included the reduction of executive compensation and elimination of non-essential contractors and personnel. These measures have resulted in a significant reduction in costs and expenses. The Company is now focusing on commercial success by seeking co-development partners and working closely with the research and regulatory communities to bring disease fighting technologies to the world.
In the middle of this quarter, on August 18, 2016, we received approval of our New Drug Application (“NDA”) from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”) for commercial sale of rintatolimod (U.S. tradename: Ampligen®) in the Argentine Republic for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”). The product will be marketed by GP Pharm, our commercial partner in Latin America. We believe that rintatolimod is the first drug to receive approval for this indication anywhere in the world.
Conference Call Information
Hemispherx will host a conference call at 11:00 a.m. Eastern Standard Time (EST) on Tuesday, November 15, 2016 to provide a general business update. Hemispherx will respond to various stockholder questions submitted prior to the call.
An audio replay of the conference call will be available on the Company’s website approximately one hour following the conclusion of the call.
| Date: | Tuesday, November 15, 2016 |
| Time: | 11:00 a.m. EST |
| Dial-in numbers: | 800-346-7359 (domestic) |
| 973-528-0008 (international) | |
| Conference number: | 27781 |
| Questions: | ir@hemispherx.net by 6:00 AM EST on Monday, November 14, 2016 |
| Audio Replay: | http://ir.hemispherx.net/Events_Presentations |
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® and the experimental therapeutics rintatolimod (tradenames Ampligen® or Rintamod®) and Alferon® LDO. Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Rintatolimod and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The FDA approval of Alferon N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company’s Alferon N approval in Argentina includes the use of Alferon N Injection (under the pending brand name “Naturaferon”) for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. Rintamod® has received approval in the Argentine Republic to treat severe cases of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). It will be marketed by GP Pharm, Hemispherx’s commercial partner in Latin America. 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.