Rani Therapeutics Holdings, Inc. · NASDAQ:RANI
Rani Therapeutics — Corporate Update (June 2024)
34 slides from Rani Therapeutics's corporate update, Jun 24, 2024
Slide 1: Rani Therapeutics and ProGen Collaboration
Rani Therapeutics and ProGen Collaboration June 24, 2024 1
Slide 2: Rani Forward-Looking Statements
Rani 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 Ac
Slide 3: ProGen Disclaimer
ProGen Disclaimer This presentation and the accompanying oral statements contain forward-looking statements that are based on the current expectations and beliefs of ProGen Co., Ltd. (“ProGen”). This presentation and the accompanying oral statements regarding matters that are not historical facts, i
Slide 4: Today's Agenda
Today’s Agenda 01 Rani Therapeutics and Progen Introduction & Deal Overview 02 Obesity Strategy 03 Overview of Rani’s Technology Platform 04 Overview of PG-102 05 RT-114 / RPG-102 (Obesity) 06 Q&A 4
Slide 5: Presenters
Presenters Talat Imran Jong Gyun Kim, PhD • Chief Executive Officer, Rani Therapeutics • Chief Executive Officer, ProGen • >15 years experience in Healthcare • >30 years of extensive experience in • Venture capitalist for several Silicon Valley pharmaceutical industry healthcare funds • R&D and stra
Slide 6: Leadership Team
Leadership Team Mir Hashim, PhD Jesper Høiland, Kyung-Hwa Son, PhD Sae Won Kim, PhD • Chief Scientific Officer, • Strategic Advisor, • Chief Development • Chief Scientific Officer, Rani Therapeutics Rani Therapeutics Officer, Progen Progen 6
Slide 7: RaniPill
Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases Rani Therapeutics Clinical-stage biotech focused on Oral Delivery of Biologic Drugs NASDAQ: RANI with Bioavailability Comparable to Parenteral Products TECHNOLOGY: RaniPill • 200 µL Capacity
Slide 8: Rani's Strategic Vision in the 50/50 Partnership with ProGen
Rani’s Strategic Vision in the 50 / 50 Partnership with ProGen PG-102 RaniPill GLP-1/GLP-2 Drug-agnostic oral delivery platform for Long-acting Fc fusion platform for multivalent Deal Rationale: biologics agonists ✓ Targeting optimized delivery + optimized therapeutic Differentiated anti-obesity mec
Slide 9: Rani / ProGen Deal Structure
Rani / ProGen Deal Structure Rani and ProGen have entered into a collaboration agreement for the development and commercialization of a RaniPill capsule containing PG-102 (GLP-1 / GLP-2 dual agonist) for weight management (including obesity). ➢ Rani holds exclusive rights to ➢ No upfront payment com
Slide 10: Obesity Strategy
Obesity Strategy
Slide 11: Obesity is a Fast-Growing Market; Potential for Oral Options
Obesity is a Fast-Growing Market; Potential for Oral Options to Play an Important Role Anti-Obesity Medications Market * Across various therapeutic areas, 120 patients prefer daily pill over current Forecasted to reach injection regimen ** $100B by 2030 100 80 USD, Billions 16x increase 60 40 $6B, s
Slide 12: RaniPill Delivery Technology May Solve for the Shortcomings of Current Orals
RaniPill Delivery Technology May Solve for the Shortcomings of Current Orals in Development Low High API Cost & Restrictive Inconvenient Tolerability Bioavailability Supply Chain Administration Dosing Regimen Risk Issues Requirements Oral chemistry-based Extremely high doses to Restrictive pre-treat
Slide 13: Clear Opportunity in Obesity Landscape for RT-114/RPG-102
Clear Opportunity in Obesity Landscape for RT-114/RPG-102 [7] Max API Dose per Week Semaglutide Pemvidutide (approved) (Ph2) INJECTABLE Only Convenient, Oral, Survodutide Low Dose Option ORAL Liraglutide <5mg Mazdutide (Ph2) (Approved) (Ph2) Dapiglutide (Ph2) 15mg Tirzepatide VK2735 (approved) (Ph2)
Slide 14: Overview of Rani's Technology Platform
Overview of Rani’s Technology Platform
Slide 15: RaniPill Development Progress and Safety
RaniPill Development Progress and Safety Preclinical Clinical 15 Molecules Assessed 3 Phase 1 Studies* antibodies, peptides, and large proteins completed delivered with high bioavailability >7000 Capsules 233 RaniPill Capsules tested in vitro & in vivo administered to 146 humans 60-Day GLP Study 7-D
Slide 16: Demonstrated Equivalent PD to SC through Rani Route of Administration
Demonstrated Equivalent PD to SC through Rani Route of Administration – At Same Dose Objective Body Weight (%) Serum Cholesterol (%) • To evaluate the PK-PD profiles of Triagonist (a unimolecular incretin agonist for GLP-1, GIP and Glucagon receptors) in Group 1 Group 2 Group 1 Group 2 Beagle do
Slide 17: Rani Has Demonstrated Bioavailability Comparable to Subcutaneous Injection
Rani Has Demonstrated Bioavailability Comparable to Subcutaneous Injection in Preclinical and Clinical Studies Mean RaniPill Relative PK Profiles of Single Doses of RT-111 (Oral Ustekinumab Biotherapeutic Bioavailability Biosimilar) vs SC Stelara® Injection Compared to SC* 100 RT-111, 0.75 mg (N=16)
Slide 18: Rani's Approach
Rani’s Approach Designed to deliver any biologic Painless, transenteric injection Highly efficient route of delivery Bioavailability comparable to a subcutaneous injection Mucosal cell barrier prevents drug absorption Chemical Approach _—_— * Only applicable to small peptides PN 0n * Highly ineffici
Slide 19: Overview of PG-102
Overview of PG-102
Slide 20: ProGen
ProGen Our Mission at Progen is to Improve Patients’ Quality of Life with Longer-acting Protein Therapeutics Progen Clinical-stage Biotech Company Developing Next Generation Long-acting, KONEX: 296160 Multi-specific Fusion Protein Therapeutics TECHNOLOGY: • Multi-specific Fc fusion protein NTIG® (Ne
Slide 21: PG-102: Long Acting, Bispecific GLP-1/GLP-2 Dual Agonist for Obesity
PG-102: Long Acting, Bispecific GLP-1/GLP-2 Dual Agonist for the Treatment of Obesity Bispecific GLP-1/GLP-2, with optimized ratio biased toward GLP-1 Heterodimeric Fc Fusion Protein Prolonged Half-Life Rani - Confidential 21
Slide 22: PG-102: An Experimentally-optimized, Biased Agonist
PG-102: An Experimentally-optimized, Biased Agonist Biased agonism provided better weight management & glycemic control Normal mouse model (Q2D, SC) 22
Slide 23: Phase 1a SAD Results Show Good Tolerability
Phase 1a SAD Results Show Good Tolerability Target Population Healthy Subject Safety and Tolerability are a main Administration Single concern with metabolic therapies Dosing Regimen PG-102 vs Placebo due to high discontinuation rates Primary Endpoint Safety / Tolerability / PK N= 8 Subjects per Gro
Slide 24: RT-114 / RPG-102 (Obesity)
RT-114 / RPG-102 (Obesity) Differentiation, Dosing and Development
Slide 25: PG-102 Reduces Body Weight & Improves Body Composition (DIO mice)
PG-102 Reduces Body Weight & Improves Body Composition (DIO mice) Improvement of body composition (fat vs. lean mass loss), under similar weight loss condition (vs. Tirzepatide) (%)(%) 20 composition 4.1-fold 6.4-fold 2.2-fold 2.9-fold +1.6 Fat mass lo body composition 0 Lean mass -1.8 -5.0 -10.1 -8
Slide 26: PG-102 Demonstrated Greater Glycemic Control vs Semaglutide, Tirzepatide and Retatrutide
PG-102 Demonstrated Greater Glycemic Control vs Semaglutide, Tirzepatide and Retatrutide (db/db mice) At the same dosage level (30 nmol/kg), PG-102 exerts greater glycemic control than semaglutide, tirzepatide and retatrutide 12 ** 9 HbA1c (%) 6 ** Normal range of 3 HbA1c 0 0 1 2 3 Months after trea
Slide 27: PG-102: Pharmacokinetic Profile
PG-102: Pharmacokinetic Profile PG-102 shows longer Tmax & higher AUClast → Tolerability & persistence ↑ GLP-1 GLP-1 GLP-1 GLP-2 GLP-1 GLP-2 vs. vs. PK profile (PG-102 vs Dulaglutide1) PK profile (PG-102 vs Tirzepatide2) Poster presentation at the 84th ADA Annual Meeting (June 21-24, 2024, Orlando).
Slide 28: Association between Tmax & Up-titration
Association between Tmax & Up-titration Long Tmax may obviate need of up-titration Time to reaching maximum plasma concentrations after injection or oral administration2 Lixisenatide qd 10 mg qd 20 mg qd Exenatide bid 5 mg bid 10 mg bid PG-102 Oral Semaglutide 3 mg qd 7 mg qd 14 mg qd Liraglutide qd
Slide 29: RT-114/RPG-102 Target Dosing
RT-114/RPG-102 Target Dosing Total of 52 Once a Week Oral Dosing pills per year Potential for Monthly Dosing per patient Key Benefits Targeted: • No painful injections • Potential for better tolerability with more frequent, smaller doses than injectable ➢ Tighter banding of serum concentrations • Po
Slide 30: Clear Opportunity in Obesity Landscape for RT-114/RPG-102
Clear Opportunity in Obesity Landscape for RT-114/RPG-102 [7] Max API Dose per Week Semaglutide Pemvidutide (approved) (Ph2) INJECTABLE Only Convenient, Oral, Survodutide Low Dose Option ORAL Liraglutide <5mg Mazdutide (Ph2) (Approved) (Ph2) Dapiglutide (Ph2) 15mg Tirzepatide VK2735 (approved) (Ph2)
Slide 31: Expected Clinical Development Timeline for RT-114/RPG-102
Expected Clinical Development Timeline for RT-114/RPG-102 2025 2026 Phase 1A and 1C Study Phase 1A 1C Phase 2a Obesity Obese (non-diabetic) (BMI 30- (12 weeks treatment) Study HV (BMI 18-30 kg/m2) Population 39.9 kg/m2) Sample Size 30 40 Design Open-label Open-label ▪ Safety (TEAEs & SAEs) ▪ Safety
Slide 32: Potential Differentiation of RT-114/RPG-102
Potential Differentiation of RT-114/RPG-102 Efficacy • Potential greater fat mass loss & less lean mass loss than competitors • Potential for improved nutrient absorption and nutritional status Safety • Potential less GI side effects (nausea, vomiting, diarrhea) • Eliminate injection site reactions
Slide 33: Q&A
Q&A
Slide 34: References
References [1] Rybelsus U.S. prescribing information, Pharmacokinetics. [2] For Wegovy, see U.S. prescribing information, Dosage and Administration. For oral semaglutide, Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-con
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