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AIM ImmunoTech Inc.

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Market:
NYSE
Market Cap:
$74.31 m
Price
2.69 USD
Change
0.75%
52 weeks high
14.81
52 weeks low
0.39

Hemispherx Biopharma, Inc. is an immuno-pharma company headquartered in Ocala, Florida and focused on the research and development of therapeutics to treat multiple types of cancers, as well as immune-deficiency disorders. We have established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

Hemispherx’s flagship products include Ampligen® (Rintatolimod), a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, and Alferon N Injection® (Interferon Alfa-N3). Ampligen® represents an RNA being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen® is also being evaluated for the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Alferon N Injection® is approved for a category of STD infection and patients that are intolerant to recombinant interferon in Argentina. Alferon is the only natural-source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional treatment of refractory (resistant to other treatment) or recurring external Condylomata Acuminata/genital warts (GW) in patients 18 years of age or older.

We operate a 30,000 sq. ft. facility in New Brunswick, NJ with the objective of producing Ampligen® and Alferon®. We are committed to a focused business plan oriented toward finding senior co-development partners with the capital and expertise needed to commercialize the many potential therapeutic aspects of Ampligen® and our FDA-approved drug Alferon® N.

Alferon (FDA approved for refractory HPV genital warts) and the experimental therapeutic, Ampligen, the subject of a pending NDA for CFS. Alferon has two formulations. One is high dose, FDA approved, Alferon N, administered intramuscularly or subcutaneously. The other is Alferon LDO, a Low Dose Oral formulation. Both products are manufactured in Hemispherx FDA approved, GMP facility in New Brunswick New Jersey. This facility is presently undergoing a multimillion dollar expansion and upgrade to improve manufacturing efficiency of Alferon and very substantially increase the manufacturing capacity of both Alferon and Ampligen. Hemispherx seeks partners worldwide.
 
A collaborative clinical research effort is intended to utilize Alferon N Injection® for treatment of seriously ill patients hospitalized with either seasonal influenza or pandemic influenza.
Alferon® LDO [Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)] is an experimental low-dose, oral liquid formulation of Natural Alpha Interferon and like Alferon N Injection® should not cause antibody formation, which is a problem with recombinant interferon. It is an experimental immunotherapeutic believed to work by stimulating an immune cascade response in the cells of the mouth and throat, enabling it to bolster systemic immune response through the entire body by absorption through the oral mucosa. Oral interferon could be economically feasible for patients and logistically manageable in development programs in third-world countries primarily affected by influenza and other emerging viruses. Oral administration of Alferon® LDO, with its anticipated affordability, low toxicity, no production of antibodies, and broad range of potential bioactivity, could be a breakthrough treatment or prevention for viral diseases.
 
The commercial focus for Ampligen® includes application as a treatment for Chronic Fatigue Syndrome (“CFS”) and as an influenza and cancer vaccine enhancer (adjuvant) for both therapeutic and preventative vaccine development. Ampligen® represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for New Drug Application (“NDA”) review to treat CFS. Based on the results of published, peer reviewed pre-clinical studies and clinical trials, we believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Over 1,000 patients have participated in the Ampligen® clinical trials representing the administration of more than 90,000 doses of this drug. Ampligen® is an experimental drug currently undergoing clinical development for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”). Over its developmental history, Ampligen® has received various designations, including Orphan Drug Product Designation.
(FDA), Treatment IND (e.g., treatment investigational new drugs, or “Emergency” or “Compassionate” use authorization) with Cost Recovery Authorization (FDA) and “promising” clinical outcome recognition based on the evaluation of certain summary clinical reports (“AHRQ” or Agency for Healthcare Research and Quality). Ampligen® represents the first drug in the class of large (macromolecular) RNA (nucleic acid) molecules to apply for New Drug Application (“NDA”) review. Based on the results of published, peer reviewed pre-clinical studies and clinical trials, we believe that Ampligen® may have broad-spectrum anti-viral and anti-cancer properties. Over 1,000 patients have participated in the Ampligen® clinical trials representing the administration of more than 90,000 doses of this drug.
 
Alferon N Injection® is the registered trademark for our injectable formulation of natural alpha interferon, which is approved by the FDA in 1989 for the treatment of certain categories of genital warts. Alferon® is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. for the intralesional (within lesions) treatment of refractory (resistant to other treatment) or recurring external genital warts in patients 18 years of age or older. Certain types of human papilloma viruses (“HPV”) cause genital warts, a sexually transmitted disease (“STD”). The CDC estimates that approximately twenty million Americans are currently infected with HPV with another six million becoming newly infected each year. The CDC states that HPV is so common, that at least 50% of sexually active men and women get it at some point in their lives. According to a World Health Organization report on HPV, “Genital warts are very common and are highly infectious, and between 90% and 100% are caused by HPV genotypes 6 and 11. Although they do not usually result in death, genital warts cause significant morbidity and entail substantial health care costs.
 

US & Argentina

 
Thomas K. Equels, M.S. J.D.
Chief Executive Officer

THOMAS K. EQUELS, M.S., J.D., was named Chief Executive Officer in February 2016, served as President since August 2015, has been a Director since 2008 and presently serves as Hemispherx’ Executive Vice Chairman.

Adam Pascale, CPA
Chief Financial Officer

ADAM PASCALE was named Chief Financial Officer in February 2016, in addition to his current responsibilities as Chief Accounting Officer.

David R. Strayer, M.D.
Chief Scientific & Medical Officer

DAVID R. STRAYER, M.D. was appointed Chief Scientific Officer in Feburary 2016 and has acted served as our Medical Director since 1986. Dr. Strayer, based upon this experience, is the foremost medical expert on Ampligen in the World.

Peter W. Rodino III, J.D.
Executive Director for Governmental Relations, General Counsel, Secretary

PETER W. RODINO, III, Esq., was named Executive Director for Governmental Relations and General Counsel in October 2016 and Secretary of the Company in November 2016.

Ellen Lintal
Chief Accounting Officer

Ellen Lintal joined Hemispherx in 2018 as SVP of Finance and Control after a long and successful accounting career, including nearly a decade with The National Wild Turkey Federation, where she rose to the position of CFO.

Wayne Springate
Senior Vice President of Operations

WAYNE S. SPRINGATE has served as Senior Vice President of Operations since May 2011 after joining Hemispherx in 2002 as Vice President of Business Development.

Hemispherx Biopharma, Inc.
Phone: 800-778-4042
Email: [email protected]

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Phone: 212-509-4000
Fax: 212-509-5150
Independent Public Accountants: McGladrey & Pullen, LLP