Hemispherx BioPharma (HEB)

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Report update and continued coverage: Hemispherx Biopharma, Inc. (NYSE: HEB)

Our alert from yesterday, Hemispherx Biopharma, Inc. (NYSE MKT: HEB) got off to a good start with a quick 20% gain on higher than average trading volume.

Today, Chief Executive Officer, Thomas K. Equels, M.S. J.D. is at Biotech Showcase™ 2018 in San Francisco. Biotech Showcase™ is one of the industry's largest annual healthcare investor conferences. CEO Equels will give a presentation and meet with investors and pharma executives there.

If you watched the CEO interview video with Equels that we discussed yesterday, you know that he is quite enthusiastic about the prospects for HEB and its products. As you read this he is bringing that enthusiasm to pharma executives and investors. The near-term could tell if the networking he does at the conference results in any catalysts. If you missed the video interview, recorded last Tuesday, we’ve included a link to it here.
http://www.ceolive.tv/hemispherx-heb-going-after-multi-billion-dollar-immuno-oncology-market/


Yesterday we highlighted the two HEB products, Alferon N Injection® and Ampligen®. At their New Jersey facility, HEB makes Alferon N Injection®. Alpha Interferon has been FDA approved since 1989 and Hemispherx produces a natural-source, multi-species version made from white blood cells. The other products on the market are recombinant (synthetic), giving HEB a niche market, not only for the treatment of genital warts, but potentially as an alternative to patient that don’t respond to recombinant Alpha Interferon (this application has been approved in Argentina, but not yet in the US).

But, the potential blockbuster at HEB is Ampligen®, and CEO Equels is likely pitching this product at the Biotech Showcase™. Ampligen® is being developed for debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome and the company has a NDA filed with the FDA for that specific application. However, based on the results of published, peer reviewed pre-clinical studies and clinical trials, Ampligen® may have broad-spectrum anti-viral and anti-cancer properties.

If the HEB data is sound, and we believe it is, big pharma will be very interested in a product showing potential in the viral and oncology markets.

Current progress for Ampligen®:

ME/CFS
NDA Active. Company in discussions with FDA to formulate path forward for potential approval.



Vaccine Adjuvant
Phase I/II – Research Collaboration with the University of Alabama.


Ovarian, Colorectal, and Peritoneal Cancers
Phase I/II - Sponsored by University of Pittsburgh.


Colorectal, Melanoma Cancer
Pre-clinical research collaboration with Georgia Regents University.


Renal Cell Carcinoma, Melanoma Cancers
Phase I/II Research Collaboration with Hahnemann University.


Ampligen® has been approved in Argentina for severely debilitated Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients. Hemispherx recently reported that discussions are underway with the U.S. FDA on the next steps regarding a New Drug Application (NDA) for Ampligen® in ME/CFS, which afflicts more than one million people in this country, according to the Centers for Disease Control (CDC). Ampligen® is the only drug to have completed a Phase 3 clinical trial in the U.S. in ME/CFS.


Last year Hemispherx began supplying Ampligen® for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands.


In December, the company’s (CMO) for Ampligen® completed a commercial scale demonstration/engineering manufacturing run. The product will ultimately be used to supply the current approved applications and for use in further clinical studies.


In yesterday’s session HEB shares crossed their 200-day moving average of $.431 in a bullish manner.


The real potential in the Hemispherix products could warrant a much higher market cap.


The Team