Rani Therapeutics (RANI) Stifel 2024 Healthcare Conference summary

Technology overview and clinical validation

• RaniPill enables oral delivery of biologics, replacing injections with a swallowable device that activates in the small intestine for drug delivery.

• Completed 15 preclinical and 3 clinical studies, showing bioavailability comparable to subcutaneous and IV injections.

• Platform is protected by nearly 500 filed and pending patents.

• RaniPill comes in two versions: Go (solid, 3 mg payload) and HC (liquid, 200 µL payload), with HC enabling flexible, less frequent dosing.

• Manufacturing is in-house, with capacity for multiple phase I/II studies; scale-up for commercialization will involve pharma partners and contract manufacturers.

Regulatory and market positioning

• RaniPill is a drug-device combination, reviewed by both CDER and CDRH at the FDA.

• Oral biologics have historically gained rapid market share despite lower efficacy, due to patient preference for oral over injectable forms.

• The technology allows dosing comparable to injectables, avoiding the need for excessive active pharmaceutical ingredient (API) seen in other oral formulations.

• Expanded payload capacity of HC version supports over 90 drug candidates and enables weekly or less frequent dosing.

Pipeline and partnerships

• Lead program RT-114 (GLP-1/GLP-2) is a 50/50 partnership with ProGen, targeting obesity with potential for improved tolerability and muscle preservation.

• Early clinical data for PG-102 (GLP-1/GLP-2) show strong weight loss, improved body composition, and favorable tolerability.

• RT-111 (Stelara biosimilar) completed phase I with 84% bioavailability and no serious adverse events; innovative dosing scheme proposed for phase II.

• Celltrion holds supply rights and first negotiation for RT-111 and is in ongoing discussions for further collaborations.

• RT-105 (Humira biosimilar) is deprioritized due to resource allocation, but may advance with partner funding.