Rani Therapeutics Holdings, Inc. · NASDAQ:RANI

Rani Therapeutics — Technical Presentation (December 2022)

22 slides from Rani Therapeutics's technical presentation, Dec 6, 2022

  1. Slide 1: RT-102 Phase I Study Part 2: Repeat-Dose Update

    RT-102 Phase I Study Part 2: Repeat-Dose Update December 2022

  2. Slide 2: Forward-looking statements

    This presentation and the accompanying oral statements contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act. Forward-looking statements ar

  3. Slide 3: Presentation Overview

    Topline results from Part 2 of our RT-102 Phase 1 study Seven-day repeat-dose study in healthy volunteers First repeat-dose study of RaniPill capsule in humans collecting data on: Safety Tolerability Device Reliability Important data For the RT-102 program and Phase 2 plan for 2023 For RaniPill plat

  4. Slide 4: RT-102 Phase 1 Study Design

    RT-102 Phase 1 Study Design Part 1 : Single ascending doses of RT-102 RT-102 Group 1: 20µg (N=15) RT-102 Group 2: 80µg (N=15) Control Group: Forteo® SC 20µg (N=10) Part 2: Repeat-doses of RT-102 Once daily dose of RT-102 20µg for 7 days in healthy and post-menopausal women (N=10) Objective: To Evalu

  5. Slide 5: Part 1 Summary

    Part 1 Summary Safety & Tolerability Both doses of RT-102 were well tolerated No serious adverse events (SAEs) reported in the study No adverse events (AEs) related to RaniPill reported Device Performance Drug delivery success rate of 95% Pharmacokinetics Bioavailability of PTH delivered via RT-102

  6. Slide 6: Part 2: Arvinder Dhalla, PhD

    Part 2: Arvinder Dhalla, PhD Vice President, Clinical Development

  7. Slide 7: Part 2 Study Overview

    Part 2 Study Overview A Phase I Study to Evaluate the Pharmacokinetics of Parathyroid Hormone (1-34) (PTH) Administered Orally via RaniPill™ Capsule Objective To evaluate the safety and tolerability of repeat-doses of RT-102 Study Population Healthy women and Post-menopausal women (N=10) Study Site

  8. Slide 8: Repeat-Dose: Study Procedures

    Repeat-Dose: Study Procedures Fast >8 hrs. Participant Dosed 6 hr. 9 hr. Blood Sample Blood Sample Blood Sample Blood sample Fluoro image taken Participant Dosed Blood Sample Liquids provided Start PK sampling….. Serial fluoroscopic imaging done to determine T=0 Days 1-6 Day 7 Participation in the s

  9. Slide 9: Topline Results

    Topline Results

  10. Slide 10: Study Demographics

    Healthy Women Post-Menopausal N=5 N=5 Age 25.6 years (22 - 35) 60 years (54 - 65) Race % (n/N) % (n/N) Hispanic 20 (1/5) 0 (0/5) White-non-hispanic 20 (1/5) 100 (5/5) Asian 40 (2/5) 0 (0/5) Asian-Pacific Islander 20 (1/5) 0 (0/5) Mean ± SD (Min - Max) Mean ± SD (Min - Max) Weight (kg) 60.6 ± 9.8 (50

  11. Slide 11: Exclusions after Enrollment

    Enrollment was done on a rolling basis to complete ten subjects, total number of participants enrolled were 17 Seven participants did not complete 7 days of dosing due to exclusions per protocol Two participants started menstruation on Day 4 One participant had cannulation issues on Day 7 One partic

  12. Slide 12: Adverse Events

    Adverse Events Adverse Event Incidence PTH-related Constipation* 1 (10%) Diarrhea* 1 (10%) RaniPill-related Abdominal Pain 1 (10%) * Same subject reported both AEs on different days

  13. Slide 13: Daily Drug Delivery by RaniPill with Repeat-Dosing

    Daily Drug Delivery by RaniPill with Repeat-Dosing 25% 50% 80% Drug signal detected in 63 out of 69 deployments* = at least 91% Success Rate # Subject Type Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 1 HW        2 HW        3 HW        4 HW        5 HW        6 PM 

  14. Slide 14: Presence of Food Did Not Impact Device Performance

    On Days 1-6, food was consumed at 3 hrs. after capsule administration to all enrolled subjects During this period, there were a total of 72 successful deployments 35 were recorded before food was consumed (fasted) 37 were recorded after food was consumed (post-prandial) These data suggest that drug

  15. Slide 15: PK Profile of PTH Delivered via RaniPill

    PK Profile of PTH Delivered via RaniPill Drug levels were observed in all 10 subjects on Day 7 = 100% success rate These data corroborate the high bioavailability observed in Part 1 and suggest that RT-102 may be efficacious at doses lower than 20µg Sampling time points are different between RT-102

  16. Slide 16: Repeat Doses of RT-102 Key Takeaways

    Repeat Doses of RT-102 Key Takeaways RT-102 was well tolerated with repeat dosing No SAEs were reported in the study Device remnants were eliminated without sequelae in all subjects RT-102 RaniPill delivered PTH with reliability of >90% Device performance was unaffected by presence of food Cmax comp

  17. Slide 17: Next Steps

    > | Next Steps Talat Imran, CEO \ Rani THERAPEUTICS

  18. Slide 18: Next Steps and Upcoming Potential Milestones

    Pre-IND meeting request Conduct 28-day GLP study Early 2023 Initiate Phase 2 Study 2H 2023 Plan to publish RT-102 Phase 1 Study results Additional 2023 prospective milestones: Initiation of a Phase 1 study of RT-111 containing an ustekinumab biosimilar Initiation of a Phase 1 study of RT-105 contain

  19. Slide 19: Appendix

    Appendix

  20. Slide 20: Study Demographics

    Total Cohort (N=17) Completed Dosing (N=10) Healthy Women Post-menopausal Healthy Women Post-menopausal N=11 N=6 N=5 N=5 Age 28 years (22 - 49) 58.8 years (53 - 65) 25.6 years (22 - 35) 60 years (54 - 65) Race % (n/N) % (n/N) % (n/N) % (n/N) Hispanic 18.2 (2/11) 0 (0/6) 20 (1/5) 0 (0/5) White-non-hi

  21. Slide 21: Adverse Events

    Adverse Events Adverse Event All Enrolled Participants (N=17) Participants Completed 7 days (N=10) PTH-related Constipation* 1 (5.9%) 1 (10%) Diarrhea* 1 (5.9%) 1 (10%) Headache 1 (5.9%) 0 RaniPill-related Abdominal Pain 2 (11.8%) 1 (10%) Burping 1 (5.9%) 0 * Same subject reported both AEs on differ

  22. Slide 22: Device Performance with Repeat Doses

    Device Performance with Repeat Doses Data from 10 participants who completed the 7-day repeat-dosing Drug signal detected in 63 out of 69 deployments* At least 91% Success Rate Data from all 17 participants Drug signal detected in 82 out of 93 deployments* At least 88% Success Rate *Deployment confi

Rani Therapeutics Holdings — Technical Presentation (December 2022) on 6ix