On August 20, 2020 Cytocom, Inc. (Cytocom), a clinical-stage biopharmaceutical company developing novel immune modulating therapies based on proprietary platforms, reported the company and Immune Therapeutics, Inc. (OTC: IMUN; Immune) have entered into an agreement to reacquire the emerging market rights to distribute and market its late-stage investigational drug candidates CYTO-201 and CYTO-401 (Press release, Cytocom, AUG 20, 2020, https://www.prnewswire.com/news-releases/cytocom-inc-announces-agreement-to-reacquire-rights-to-lead-drug-candidate-cyto-201-and-cyto-401-in-emerging-markets-301115965.html [SID1234568903]). The agreement contemplates the execution of certain additional documents and consents in order to complete the assumption of various liabilities from noteholders and other creditors. The company does not anticipate any issues with the closing of this transaction, which is expected by the end of the third quarter 2020.
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As part of the 2014 spin off of Cytocom as a separate company, Immune licensed the rights to make and sell therapeutics containing CYTO-201 and CYTO-401 in over 80 countries, including Brazil and China. Cytocom is now reacquiring this license in exchange for the assumption of up to approximately $5 million of Immune liabilities.
"We are excited by this transaction and the opportunity to pursue the development of these products for indications such as cancer and HIV, not just in the U.S., but in other major markets such as Brazil and China," said Michael Handley, Cytocom CEO. "This agreement is consistent with our renewed strategic focus, and we look forward to advancing efforts to bring these potential new treatment options to patients as quickly as possible."
Cytocom’s lead investigational drug candidate, CYTO-201, an immune modulator, is now being studied in late-stage clinical trials for Crohn’s disease, fibromyalgia, multiple sclerosis and the human immunodeficiency virus (HIV), and is awaiting FDA clearance of an Investigational New Drug Application (IND) for a Phase 2 study in COVID-19. CYTO-401 is being developed as a cancer immunotherapy and antiviral therapy targeting HIV, as well as the H1N1 virus.