Rani Therapeutics (RANI) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Company direction and priorities

• Focused on transforming biologics delivery from injections to oral administration using proprietary RaniPill technology.

• Lead program RT-114 targets obesity with a GLP-1, GLP-2 dual agonist; RT-111 delivers oral ustekinumab, a first for monoclonal antibodies.

• Strategic emphasis on high-value markets with limited oral options, such as obesity, immunology, and endocrinology.

• Transitioned to high-capacity RaniPill (HC), enabling weekly or monthly dosing and broader drug compatibility.

• Manufacturing processes are phase II ready, with plans to partner with CDMOs for commercial scale.

Technology and clinical validation

• RaniPill uses a proprietary enteric coating to survive stomach acid and deliver drugs via a microsyringe in the small intestine.

• Over 7,000 preclinical tests (4,000 in live animals) and three phase I human studies (140 subjects, 230+ capsules) show strong safety and tolerability.

• Achieves bioavailability of 80–140% compared to subcutaneous injections, far exceeding traditional oral approaches.

• High-capacity version maintains pill size, shifts from solid to liquid drug delivery, and reduces formulation time and cost.

• No additional safety risks anticipated for obese patients; robust safety data supports confidence in new populations.

Obesity program and partnerships

• Lead obesity program uses ProGen’s PG-102, a GLP-1, GLP-2 dual agonist, with weekly or monthly dosing planned.

• Preclinical and early clinical data show strong weight management, tolerability, and superior body composition benefits versus competitors.

• Phase 1a to begin next year, with efficacy data expected in 2026; phase 2 planned as a 12–16 week efficacy study.

• Partnership with ProGen restricts only GLP-1, GLP-2 combinations; open to other collaborations and mechanisms.

• Actively engaged in discussions for additional partnerships, aiming for best-in-class drug products and market segmentation.