Announcement • Jan 08

Rani Therapeutics Holdings, Inc. Initiates Phase 1 Study of RT-114 RaniPill®? for the Treatment of Obesity in Collaboration with ProGen

Rani Therapeutics Holdings, Inc. announced the initiation of a Phase 1 clinical trial to evaluate the safety, tolerability, bioavailability, and pharmacokinetics and pharmacokinetics and pharmacodynamics of single and multiple doses of RT-114, an orally administered RaniPill®? capsule containing a GLP-1/GLP-2 dual agonist, PG-102, for the treatment of obesity. PG-102 is a fc-fusion protein conjugated GLP-1/GLP-2 dual agonist in development by ProGen Co. Ltd. ("ProGen"). ProGen recently announced preclinical and clinical data, at the 2025 European Association for the Study of Diabetes (EASD) meeting, demonstrating glucose-lowering effects and meaningful early weight-loss signals by PG-102, reinforcing its potential as a next-generation metabolic therapy. In preclinical testing of RT-114 in animal models, the RaniPill®? delivered PG-102 orally with bioavailability, pharmacokinetics, and weight loss comparable to subcutaneous (SC) injection. Rani has developed the RaniPill®®? capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill®? capsules technology. RT-114 is the subject of a Collaboration Agreement between Rani and ProGen entered into in June 2024. Under the Collaboration Agreement, Rani and ProGen will collaborate to manufacture, develop, seek regulatory approvals for and, if approved, commercialize RT-114 in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans. Under the Collaboration Agreement., Rani and ProGen will be equally shared by Rani and ProGen. The parties share responsibility for the development of RT-114 worldwide, with Rani leading such development for preclinical activities through Phase 1 clinical trials. After initiation of the first Phase 2 clinical trial, Rani will lead development and commercialization of RT-114 in the United States, Canada, Europe and Australia, and ProGen will lead development and commercialization in all other countries.

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