Rani Therapeutics Holdings, Inc. announced three new positive preclinical studies which support the development of a high-capacity oral biologics device known as the RaniPill® HC, a version of the RaniPill® capsule that is capable of delivering up to a 500%-plus higher drug payload than Rani?s existing oral biologics capsule. Preliminary Data Highlights: Teriparatide Canine Studies: Rani conducted two preclinical studies of the RaniPill® HC containing 40ug of teriparatide. In the first study, two RaniPill® HC capsules were orally administered to 5 awake canine subjects sequentially, with a second RaniPill® HC capsule administered after the deployment of the previous device was confirmed.

In the second study, a single RaniPill® HC capsule was administered to 10 awake canines; RaniPill® HC achieved 18/20 successful drug delivery of teriparatide in the two studies, resulting in a cumulative 90% success rate; Successful drug delivery was confirmed by positive drug signal for teriparatide in serum; Devices used in these studies were separate iterations, and may not comprise all the same components expected in a final version; Preliminary preclinical testing supports the potential for RaniPill® HC to have high reliability. Fe57 Canine Study: Rani also conducted an additional preclinical study of RaniPill® HC containing Fe57 (iron) in 2 canine subjects. The RaniPill® HC containing Fe57 showed a positive drug signal comparable to subcutaneous injection; Initial analysis of drug delivery via the RaniPill® HC shows a potential for mimicking parenteral (subcutaneous) administration.

Anticipated Next Steps & Milestones: Continue preclinical testing of the RaniPill® HC to confirm the preliminary reliability rate and optimize device performance; Introduce RaniPill® HC into the clinic with the initiation of a Phase 1 trial of RT-105 containing adalimumab.