Rani Therapeutics Holdings, Inc. Q4 FY2022 earnings call

Milestones - Significant enhancements to RaniPill platform, including RaniPill HC with higher payload and continued improvement in RaniPill GO. - RT-102 Phase 1 study met endpoints, had 92% delivery success rate, well-tolerated. - Partnership with Celltrion for RT-111, with Celltrion supplying ustekinumab biosimilar. - Plan to initiate Phase 2 trial for RT-102 in second half of 2023 and 3 additional Phase 1 studies in 2023. - Feedback from FDA on RT-102 505(b)(2) pathway suitability.

There are no traditional product segments with revenue contribution percentages discussed. The focus is on the RaniPill platform. The RaniPill GO device had a 92% drug delivery success rate in the Phase 1 study of RT-102. The RaniPill HC device is in preclinical studies with potential to target larger market of molecules like pembrolizumab, etanercept, etc.

- Cash, cash equivalents and marketable securities as of Dec 31, 2022 totaled $98.5M, expected to fund operations to mid-2024. ### - Anticipate initiating Phase 2 clinical trial with RT-102 in second half of 2023 and 3 additional Phase 1 studies with pipeline molecules RT-105, RT-110, RT-111. ### - Operating expenses expected to increase 20%-30% in 2023 from 2022.

- Forward-looking statements subject to risks in company filings, including product development, clinical trials, regulatory environment, manufacturing progress, etc., which may cause actual results to differ materially from forward-looking statements.

Q: When you sat down with the FDA, did they provide color on safety database for RaniPill device in 505(b)(2) pathway for RT-102?

A: They didn't in RT-102 context, but prior interactions had ~2000 deployments, 40 subjects over 8 weeks, Phase 2 will reach similar data.

Q: How to think about size of Phase 1 trial for 2023 and RT-102 Phase 2 trial? And RT-111 Phase 1 nuances?

A: Phase 1 trials for 2023 will be similar to RT-102 single dose portion, ~15-20 subjects. RT-111 Phase 1 will be single dose study, no repeat dosing needed, focusing on bioavailability similar to subcutaneous injection.

Q: On RT-102 multiple dose trial, any interventions if patients miss delivery?

A: No interventions, mixed doses managed through higher bioavailability, few failures due to random chance.

Q: What needs to happen before Phase 2 for RT-102?

A: Run 28-day repeat dose GLP study in first half of 2023, complete it, then submit and start Phase 2 in second half.

Q: Celltrion deal implications and RT-111 indication specificity?

A: Celltrion deal not indication specific, implies value of RaniPill platform, potential for Celltrion to take over commercial rights.

Q: Celltrion key requirements in Phase 1 for RT-111 and FDA discussion on RT-102 Phase 2 design?

A: No repeat dosing needed for RT-111 Phase 1, need to show bioavailability similar to Celltrion's CT-P43. For RT-102 Phase 2, discussing doses, biomarkers, 505(b)(2) pathway.

Q: Phase 1 study timeline for 2023 and OpEx comparison 2023 vs 2022?

A: Phase 1 studies relatively short, RT-111 Phase 1 may take longer due to drug half-life. OpEx expected to increase 20%-30% in 2023 from 2022.

Q: Prioritization of RT-111 indication and monoclonals like pembrolizumab?

A: RT-111 indication prioritization to be determined through discussions, immunology a sweet spot for RaniPill HC. Prioritization of monoclonals based on chronic diseases, crowded categories, potential for oral delivery to improve efficacy.

Q: PK profile margin of safety for RT-102 and update on RT-101 program?

A: RT-102 dose selection between 10-40 micrograms to find efficacy and safety sweet spot. RT-101 is working on sustained release formulation for long acting, similar to RT-110 approach, no current report on progress.