Rani Therapeutics Holdings, Inc. Q4 FY2024 earnings call

• Rani Therapeutics is a clinical stage biotech with RaniPill technology for oral administration of biologics, matching injectable bioavailability. • RaniPill capsule has an enteric coating, self-inflating balloon in small intestine to deliver drug. • Pipeline focus on obesity space, with RT-114 (co-developed with ProGen) and RT-116 (oral semaglutide) programs. • Preclinical data shows RT-116 achieved comparable pharmacokinetics and weight loss to subcutaneous semaglutide, with 107% relative bioavailability. • RT-114 preclinical data shows higher Cmax, earlier Tmax, 111% relative bioavailability, and comparable weight loss. • Financial results: Cash, cash equivalents, and marketable securities at $27.6M as of Dec 31, 2024; contract revenue $1M in 2024; R&D expenses $26.7M in 2024; net loss $56.6M in 2024.

No specific product segments with detailed financial performance and revenue contribution percentages provided in the transcript.

• Cash, cash equivalents, and marketable securities expected to fund operations into Q3 2025. • Primary focus on RT-114 in 2024 due to capital constraints. • Plan to move RT-114 into clinic in mid-2025. • Immunology programs will be advanced when more capital is available.

• Forward-looking statements subject to risks, uncertainties, and assumptions as discussed in SEC filings, including those related to product development, clinical trials, market sizes, and operating performance. Actual results may differ materially from forward-looking statements.

Q: Annabel Samimy asked about the rationale for developing oral semaglutide (RT-116) given competition, costs of Phase 1 trial, and prioritization of programs.

A: Talat Imran said primary focus is RT-114 due to capital constraints, RT-116 is a discovery program to validate delivery, and immunology programs will be advanced when capital is available.

Q: Eka Gigauri asked about variability in RT-114 weight loss compared to subcutaneous PG-102 and details on Phase 1 study for RT-114.

A: Talat Imran said transenteric route is more efficient, Phase 1 will be single and multi-ascending dose in obese non-diabetics, with subsequent Phase 2a study planned.

Q: Julian Harrison asked about tolerability guiding RT-114 clinical development and dosing flexibility.

A: Talat Imran said tolerability is key, oral formulation allows splitting doses to optimize tolerability.

Q: Mitchell Kapoor asked about BD interest and priorities for RaniPill platform.

A: Talat Imran said partnering is a primary focus, interest in obesity, immunology, and rare disease, with ongoing research collaborations.

Q: Chad Yahn asked how ProGen's PG-102 compares to Zealand's GLP-1/GLP-2.

A: Talat Imran said it's hard to compare across studies but ProGen's data is promising and RT-114 can leverage their work.

Q: Xinwei An asked about additional animal studies for RT-114 and confidence in human data.

A: Talat Imran said no additional preclinical work planned, confident in human data based on prior Phase 1 studies.

Q: John Vandermosten asked about ProGen's PG-102 development timeline and RT-114's position.

A: Talat Imran said ProGen is in Phase 2a and plans to file IND, RT-114 can leverage their work for faster clinical studies.