Rani Therapeutics (RANI) Canaccord Genuity 44th Annual Growth Conference & Private Company Showcase 2024 summary

Company mission and technology

• Aims to eliminate painful biologic injections using the RaniPill, an oral delivery platform with demonstrated bioavailability comparable to injections for over 90 drug candidates.

• RaniPill HC (High Capacity) can deliver 200 microliters of liquid, enabling weekly or less frequent dosing.

• Strong intellectual property with nearly 500 filed and pending patents.

• Technology proven in 15 preclinical and 3 clinical studies, with over 233 capsules delivered to 150 patients and no safety issues.

• Pill uses a proprietary enteric coating and a dissolvable microneedle for intestinal drug delivery, with no pain or adverse events reported.

Lead program and partnership

• Lead program RT-114 targets obesity, using a GLP-1/GLP-2 dual agonist (PG-102) in partnership with ProGen.

• RT-114 is a 50/50 co-development and co-commercialization partnership; Rani holds rights in North America, Europe, and Australia.

• Clinical development to begin in early 2025, with efficacy data expected by early 2026.

• Phase 1 will test single and multiple ascending doses, with potential for weekly or even monthly dosing.

• ProGen’s ongoing subcutaneous development in Korea informs Rani’s clinical design and dosing strategy.

Competitive landscape and differentiation

• RT-114 is the only oral dual agonist in development, while competitors are mostly injectables or single agonist orals.

• PG-102 shows superior weight loss and tolerability, with minimal adverse events compared to other oral programs.

• RaniPill enables use of the same dose as injectables, avoiding the need for higher active pharmaceutical ingredient (API) amounts.

• Preclinical data indicate significant preservation of lean muscle mass and improved body composition compared to leading competitors.

• Ongoing discussions with major and emerging obesity companies for additional programs and partnerships.