In August 2022, Zivo Bioscience, Inc. (the "Company") announced receipt of a letter from the U.S. Department of Agriculture's (USDA) Center for Veterinary Biologics (CVB) affirming that the agency has claimed jurisdiction for reviewing the Company's novel immune-modulating biologic for treating coccidiosis in broiler chickens. Following a comprehensive review of data from several of ZIVO's efficacy studies, MOA studies and manufacturing processes, the CVB verified ZIVO's product is of biological origin and functions through an immune-modulating MOA that has no direct antimicrobial activity, and therefore is subject to their regulatory review. While other products for the control of coccidiosis delivered in feed are regulated by the U.S. FDA's Center for Veterinary Medicine, CVB's jurisdictional announcement removes regulatory ambiguity while providing a path forward for a comprehensive review. Commercialization Strategy The Company continues to actively pursue opportunities to license its product candidates. The Company is currently continuing its ongoing discussions with a major animal health company to potentially license its product candidate. New Study in Poultry Gut Health One of the Company's potential strategic partners intends to begin a new 42-day in vivo study of the Company's novel product candidate for the treatment of coccidiosis in chickens, to validate the efficacy of the active material. The Company anticipates this study will begin in September 2022, with final analysis and results expected in the first quarter of 2023.