SAB Biotherapeutics announced the U.S. Food and Drug Administration has approved five of seven sections required for the Company's pending New Animal Drug Application (NADA) for the company's antibody-generating platform in Transchromosomic (Tc) bovine. SAB is in the process of completing the remaining two sections of the NADA. Upon formal acceptance of the seven-step safety and effectiveness evaluation, the company will use this approval in support of Biologics License Applications (BLAs) with the FDA Center for Biologics Evaluation and Research (CBER) for its hIgG antibody investigational drugs.

SAB continues to work closely with the FDA'sCenter for Veterinary Medicine (CVM) and CBER to establish a NADA approval for the Company's Tc bovine-based antibody-generating platform. In following this regulatory pathway, SAB's proprietary platform will be further protected from any potential future generic competition beyond the 12-year exclusivity timeframe typically granted to newly approved biologics. Other FDA approved human therapeutics for patients have successfully utilized the NADA process.

SAB's Tc Bovine are a unique and proprietary component of SAB's DiversitAb platform that creates exponentially higher amounts of hIgG antibody treatments with preferential pharmacological properties compared to animal-derived or synthetic human monoclonal immunotherapies. Cows are ruminant animals that inherently have a more robust immune response than humans. This response is stimulated when an immunogen specific and exclusive to a target is introduced to SAB's Tc Bovine and boosted further with a specialized formulation and strategy that maintains a high level of antibody production over an extended period of time.

This technology enables batch-to-batch consistency of large amounts of diverse, high-titer, high-avidity hIgG antibodies, which lead to a nearly endless supply of high-potency therapeutics—without the need for human donors. SAB is leveraging its DiversitAb platform to discover and develop product candidates with the potential to be first-in-class or best-in-class against complex targets to treat or prevent diseases with significant unmet medical needs. These include infectious respiratory and gastroenterological diseases, autoimmune disorders, and oncology.

DiversitAb™ is a proven platform with recent regulatory validation, with the FDA granting both Fast Track designation and Breakthrough Therapy designation to SAB-176, an investigational therapeutic for Type A and Type B influenza illness in high-risk patients, including those who have anti-viral resistant strains. SAB also recently announced positive top-line results from the Phase 3 National Institutes of Health's (NIH) ACTIV-2 clinical trial that assessed SAB-185 in non-hospitalized people with COVID-19 who were at high risk for severe outcomes with demonstrated efficacy against the Omicron variant.