Rani Therapeutics Holdings, Inc. · NASDAQ:RANI
Rani Therapeutics — Investor Presentation (February 2024)
37 slides from Rani Therapeutics's investor presentation, Feb 5, 2024
Slide 1: Rani Therapeutics Corporate Presentation February 2024
Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases. Rani Therapeutics Corporate Presentation February 2024 NASDAQ: RANI
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
Slide 3: Management team
Mir Hashim, Ph.D. Chief Scientific Officer Talat Imran Chief Executive Officer Eric Groen General Counsel Svai Sanford Chief Financial Officer Rani Therapeutics is a public, clinical-stage biotech company developing a platform technology for the oral delivery of biologic drugs. Betsy Gutierrez Vice
Slide 4: Our mission is to end painful injections
Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases FOCUS: TECHNOLOGY: PIPELINE: DISCOVERY: Oral Delivery of Biologic Drugs with Bioavailability Comparable to Parenteral Products GO HC 3mg Capacity Solid Drug Formulation 200 µL Capacity Liqui
Slide 5: Development Pipeline
RT-XXX refers to the RaniPill™ capsule containing a biologic in a proprietary Rani formulation * Clinical timelines are subject to potential regulatory agency review delays ** Partnered with Celltrion, Inc. Celltrion grants Rani a license and drug supply for the drug and has a right of first negotia
Slide 6: Development Pipeline
RT-XXX refers to the RaniPill™ capsule containing a biologic in a proprietary Rani formulation * Clinical timelines are subject to potential regulatory agency review delays ** Partnered with Celltrion, Inc. Celltrion grants Rani a license and drug supply for the drug and has a right of first negotia
Slide 7: RT-111 Phase 1 Study Data
RT-111 Phase 1 Study Data
Slide 8: Study Overview
Study Overview A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of RT-111 – RaniPill Capsule Containing Ustekinumab (CT-P43) – Administered Orally to Healthy Volunteers Objective To assess safety, tolerability and PK of Ustekinumab delivered via Oral RaniPill Study Popu
Slide 9: Study Groups and Design
Study Groups Control Group: 0.50 mg Stelara SC (N=15) RT-111 Group: 0.50 mg CT-P43 in RaniPill (N=20) RT-111 Group: 0.75 mg CT-P43 in RaniPill (N=20) Protocol Participants were given a single dose of the study drug (SC or Oral) after an overnight fast Blood samples were collected at various time poi
Slide 10: Pharmacokinetics
Pharmacokinetics
Slide 11: PK Profiles of Oral Ustekinumab vs SC Stelara
PK Profiles of Oral Ustekinumab Biosimilar (RT-111) vs SC Stelara Injection Group Cmax (ng/mL) Tmax (days) AUC0-t (day.ng/mL) SC 0.5mg (N=15) 56 ± 4 10 ± 0.8 1,566 ± 130 RT-111 0.5mg (N=19) 67 ± 7 3.1 ± 0.2 1,315 ± 150 RT-111 0.75mg (N=16) 92 ± 8 3.3 ± 0.2 1,814 ± 165 Pharmacokinetic Parameters Data
Slide 12: Safety & Tolerability
Safety & Tolerability
Slide 13: Adverse Events
Adverse Events SC, 0.50 mg (N=15) RT-111, 0.50 mg (N=20) RT-111, 0.75 mg (N=20) All 1 2 0 Drug-Related Abdominal Bloating 0 1 (5%) 0 Injection Site Rash/Reaction 1 (6.7%) 0 0 RaniPill-Related Burning Sensation in stomach* N/A 1 (5%) 0 Incidence of Adverse Events *Burning sensation in stomach perceiv
Slide 14: Incidence of Anti-Drug Antibodies
Incidence of Anti-Drug Antibodies (ADAs) Stelara SC 0.50 mg N=15 RT-111 0.50 mg N=20 RT-111 0.75 mg N=20 Drug Signal Detected N=15 N=19 N=16 Number of ADA Positive Cases Total ADA Positive* N 4 2 6 % 27% 11% 38% Incidence of ADAs *ADA positive post dosing, increase in titer compared to pre-dose leve
Slide 15: Summary
Summary RT-111 was well-tolerated No SAEs Oral delivery of Ustekinumab biosimilar via RaniPill with High Bioavailability No meaningful difference in ADA development via Rani route of delivery compared to SC injection
Slide 16: RT-111 Oral Ustekinumab Target Product Profile
RT-111 Oral Ustekinumab Target Product Profile
Slide 17: Psoriasis Competitive Landscape – Select Injectables
Rani - Confidential Psoriasis Competitive Landscape – Select Injectables(1) Significant Potential Opportunity to Capture Portion of Psoriasis Market Based on Improvement in Convenience and Potential Improved Efficacy Humira Cosentyx Taltz Tremfya Skyrizi Stelara Potential RaniPill Opportunity Admini
Slide 18: Psoriasis Competitive Landscape – Select Orals
Rani - Confidential Psoriasis Competitive Landscape – Select Orals(2) Significant Potential Opportunity to Capture Portion of Psoriasis Market Based on Improvement in Convenience and Potential Improved Efficacy Otezla Sotyktu JNJ-2113*** (PTG-200) Potential RaniPill Opportunity Frequency BID Daily Q
Slide 19: Historical Data Shows Opportunity with Higher Loading Doses
Historical Data Shows Potential Opportunity to Improve Efficacy and Safety with Higher Loading Doses Dose Groups One 45mg dose One 90mg dose Four weekly 45mg dose Four weekly 90mg dose 75 PASI Score 52% 59% 67% 81% 90 PASI Score 23% 30% 44% 52% Patients with at least 1 AE 90% 81% 78% 68% Ustekinumab
Slide 20: Historical Data Shows Opportunity with Higher Loading Doses
Historical Data Shows Potential Opportunity to Improve Efficacy and Safety with Higher Loading Doses Dose Groups One 45mg dose One 90mg dose Four weekly 45mg dose Four weekly 90mg dose 75 PASI Score 52% 59% 67% 81% 90 PASI Score 23% 30% 44% 52% Patients with at least 1 AE 90% 81% 78% 68% Ustekinumab
Slide 21: Historical Data Shows Opportunity with Higher Loading Doses
Historical Data Shows Potential Opportunity to Improve Efficacy and Safety with Higher Loading Doses Dose Groups One 45mg dose One 90mg dose Four weekly 45mg dose Four weekly 90mg dose 75 PASI Score 52% 59% 67% 81% 90 PASI Score 23% 30% 44% 52% Patients with at least 1 AE 90% 81% 78% 68% Ustekinumab
Slide 22: RaniPill Could Enable Higher Loading Phase Doses
The RaniPill Could Enable Higher Loading Phase Doses with the Convenience of Oral Administration Simulated RaniPill+Ustekinumab Loading Dose Serum Concentrations at 12 Weeks Potential to reach PASI 75 = 81% at Week 12 Daily Oral Administration with RaniPill Could Deliver Higher Loading Dose Regimen
Slide 23: Current Stelara Maintenance Phase
Current Stelara Maintenance Phase Concentration (µg/ml) Days Current maintenance dosing for Stelara is 1 injection every 12 weeks Infrequency of injection results in serum concentrations falling below therapeutic levels Target Therapeutic Concentration = .7 µg/ml Simulation based on ustekinumab publ
Slide 24: RaniPill + Ustekinumab Proposed Maintenance Dosing
RaniPill + Ustekinumab Proposed Maintenance Dosing Concentration (µg/ml) Days Proposed RaniPill Dosing Target Therapeutic Concentration RaniPill may enable increased frequency of dosing which translates to: Lower peak-to-trough variability Tighter banding of therapeutic concentrations Simulation bas
Slide 25: Target Dosing: RaniPill + Ustekinumab
Target Dosing: RaniPill + Ustekinumab Loading Phase Maintenance Phase DAILY 30-days of 7-12mg Daily Dosing Potential for better early-onset clinical efficacy 7-12mg 3-day Monthly Short Course Potential for tighter banding of therapeutic concentration levels MONTHLY Total of 36 pills per year per pat
Slide 26: Advantages of RaniPill Technology in Psoriasis
Advantages of RaniPill Technology in Psoriasis Other Oral Options Less Efficacious than Biologics Otezla, JAK Inhibitors Additional Safety Concerns JAK Inhibitors Inconvenient Dosing BID Dosing Protagonist, Otezla Injectables Inconvenient & Painful to Administer Dosing Regimen not Maximizing Clinica
Slide 27: Rani - Celltrion Supply Agreement Includes ROFN
Rani - Confidential Celltrion Supply Agreement Includes ROFN Potential to Disrupt Billion-Dollar Markets with First Oral Option for Biologic Therapies in Psoriasis and Psoriatic Arthritis Ustekinumab Biosimilar (RT-111) Combining proven, high value drugs with competitive and disruptive technology Tw
Slide 28: Target Product Profile of RaniPill Products
Target Product Profile of RaniPill Products Convenience Dosing Flexibility Patient Preference Of a Pill Efficacy Long Half-Life Safety Of a Monoclonal Antibody More convenient than small molecule Equal or better efficacy compared to injectables Potentially lower AEs than injectable biologics & small
Slide 29: Rani - Thank You
Rani - Confidential Thank You
Slide 30: Additional Updates
Additional Updates
Slide 31: Transenteric Delivery of GLP-1/GIP/Glucagon Elicits Weight Loss in Beagle Dogs
Transenteric Delivery of GLP-1/GIP/Glucagon Molecule Elicits Rapid Weight Loss in Beagle Dogs Objective To evaluate the PK-PD profiles of Blinded Triagonist (a unimolecular incretin agonist for GLP-1, GIP and Glucagon receptors) in Beagle dogs delivered SC or via endoscopically guided transenteric i
Slide 32: Rani - Obesity Market Potential Opportunity
Rani - Confidential Obesity Market Potential Opportunity Significant Potential Opportunity to Capture Portion of Obesity Market Based on Competitive Landscape (5) Wegovy Mounjaro Retatrutide Oral Semaglutide Orfoglipron Danuglipron Potential RaniPill Opportunity Administration SC SC SC Oral Oral Ora
Slide 33: Appendix
Appendix
Slide 34: RT-111 Phase 1 Additional Data
RT-111 Phase 1 Additional Data
Slide 35: Study Demographics – RT-111 Phase 1 Study
Study Demographics – RT-111 Phase 1 Study BMI, Height and Weight data are Mean ± SD 35 SC 0.50 mg RT-111 0.50 mg RT-111 0.75 mg N 15 20 20 Mean Age, years 29.3 (19 - 49) 28.3 (20 - 39) 30 (20 - 58) Race Hispanic 0% (0/15) 25% (5/20) 5% (1/20) White-non-Hispanic 60% (9/15) 35% (7/20) 75% (15/20) Asia
Slide 36: PK Profiles of Oral Ustekinumab Biosimilar vs SC Stelara
PK Profiles of Oral Ustekinumab Biosimilar (RT-111) vs SC Stelara Injection Data are Means ± SEM. Data are pending final QA review. SC 0.50 mg RT-111 0.50 mg RT-111 0.75 mg Cmax (ng/ml) 58 ± 6 67 ± 7 93 ± 12 Tmax (days) 10.2 ± 0.9 3.2 ± 0.2 3.1 ± 0.4 AUC (day*ng/mL) 1,678 ± 112 1,365 ± 142 1,883 ± 1
Slide 37: Footnotes and data sources
(1) Data of third party molecules are from separate studies published or disclosed by such third parties. Data are not from head-to-head studies. For Humira data and PASI 75 at 16 weeks, see tables 17-18 in U.S. prescribing information. For Humira PASI 75 at 48 weeks, see Table 3 of EMA Summary of P
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