Item 8.01 Other Events.
On May 12, 2021 Regen Biopharma, Inc. (the “Company”) executed a consulting agreement with Biotech Research Group Corporation (the “Consultant”), an FDA Specialist Group and Global Regulatory and Scientific Experts, for the purpose of review and guidance with regard to the planned reinstatement of the Company’s inactive Investigational New Drug applications (INDs) #15376 and #16200 filed with the United States Food and Drug Administration (“FDA”). The securing of the services to be provided to the Company pursuant to this consulting agreement marks the first step taken by the Company with regard to activating the Company’s currently inactive applications to initiate clinical trials.
In December 2015 Company was granted permission by the FDA allowing for initiation of clinical trials of the Company’s HemaXellerate therapy under its IND #15376. HemaXellerate is a personalized immune-modulatory cell therapy that has demonstrated benefit in animal models of aplastic anemia