Rani Therapeutics Holdings, Inc. · NASDAQ:RANI
Rani Therapeutics — Investor Presentation (September 2023)
38 slides from Rani Therapeutics's investor presentation, Sep 7, 2023
Slide 1: Rani Therapeutics Corporate Presentation September 2023
Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases. Rani Therapeutics Corporate Presentation September 2023
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: Rani Therapeutics 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: Rani's Technology Is a Potential Breakthrough For Oral Delivery of Biologics
Rani’s Technology and Approach Is a Potential Breakthrough For The Oral Delivery of Biologics Rani Is Pioneering Oral Biologics with Potential Best In Class Technology Delivery mechanism has potential to deliver a wide range of biologics / large molecules Has demonstrated successful delivery of anti
Slide 5: Substantial Unmet Need for Oral Administration of Biologics
Substantial Unmet Need for Oral Administration of Biologics 76% of patients with injection regimen of every 6 months [1] 38% of patients who self administer injections said they frequently skip doses [3] 88% of patients with injection regimen of every 2 weeks [2] Inconvenience impacts treatment adhe
Slide 6: Rani's Approach: Opportunity, Strategy, Value
Rani’s Approach: Opportunity Strategy Value Combine the efficacy of biologics with the convenience of small molecules Best Therapeutic + Best Delivery Drive internal pipeline programs forward to unlock value of assets and advance platform development Actively pursue partnering the technology with va
Slide 7: Partnered with Celltrion On Two Important Assets
Rani - Confidential Partnered with Celltrion On Two Important Assets 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 techn
Slide 8: Productive Pipeline Across a Variety of Therapeutic Areas
PROGRAM INDICATION(S) INDICATION FORMULATION PRE-CLINICAL PRE-CLINICAL PHASE 1 PHASE 1 PHASE 2 PHASE 2 PHASE 3 NEXT EXPECTED MILSTONE* CORE PROGRAMS RT-102 Osteoporosis Initiate Phase 2 in 2023 RT-111 Psoriasis Initiate Phase 1 in 2023 RT-105 Psoriatic Arthritis Initiate Phase 1 RT-110 Hypo-parathyr
Slide 9: Robust Database to Support Our Technology
Robust Database to Support Our Technology 14 Molecules Assessed antibodies, peptides, and large proteins 3 Pharmacodynamic studies conducted 2 Phase I Studies completed 193 RaniPill Capsules administered in 106 humans* >6800 Capsules tested in vitro & in vivo Preclinical Clinical Well-Tolerated with
Slide 10: Rani's Approach vs Chemical Approach
Rani‘s Approach Designed to deliver any biologic Painless, transenteric injection Highly efficient rout of delivery Bioavailability comparable to a subcutaneous injection Mucosal cell barrier prevents drug absorption Chemical Approach Only applicable to small peptides Highly inefficient delivery Poo
Slide 11: Adverse Events
Adverse Events All RaniPill-related AEs from Subjects Completing RaniPill Arms of Phase 1 studies Adverse Events (N=91) Transient Abdominal Pain* 2 (2%) Burping** 1 (1%) * Abdominal pain classified as mild ** Burping lasted 2 days and was classified as moderate In two Phase 1 studies: RaniPill was w
Slide 12: RaniPill Has Demonstrated High Reliability in Clinical Studies
RaniPill Has Demonstrated High Reliability in Clinical Studies 25% 75% 95% 80% 50% 80% 67% 91% RT-102 PTH Phase 1 Study (Part 1 & Part 2) Approved Oral Formulation of Semaglutide [6] RT-102 Phase 1 Study Demonstrated Drug Delivery Reliability Greater than Delivery Reported in Single-Dose Trial of Cu
Slide 13: Demonstrated Biologic Activity in Preclinical Pharmacodynamic Studies
Demonstrated Biologic Activity in Preclinical Pharmacodynamic Studies Teriparatide (RT-102) Increased Bone Mineral Density in Rat Osteoporotic Model Insulin (RT-104) Induced Rapid Glucose Disposal in Swine Under a Euglycemic Clamp Factor VIII (RT-108) Normalized Coagulopathy in A Canine Model of Hem
Slide 14: Pipeline Programs
Pipeline Programs
Slide 15: RT-102: Positive Phase I Data for Osteoporosis
RT-102: Positive Phase I Data for Osteoporosis Forteo SC 20µg RT-102 20µg RT-102 80µg Cmax (pg/mL) 128 ± 64 98 ± 35.5 971 ± 826 Tmax (minutes) 13 68 60 AUC (pg*h/mL) 126 ± 91 343 ± 123 2600 ± 2410 Relative BA (%) ~300% ~400% PK Parameters PK Profiles of Single Doses of RT-102 Milestones & Anticipate
Slide 16: RT-102 Phase 2 Study Design
Study Design: Phase 2, open-label, dose-finding study of RT-102 Dosing Arms: Forteo SC 20 µg dose (N=25) RT-102 20 µg dose (N=25) Patient Population: Postmenopausal women with osteoporosis defined as BMD T-score ≤-2.5 and ≥-4.0 at either the lumbar spine (L1-L4), femoral neck, and/or total hip, meas
Slide 17: RT-111: Oral Ustekinumab Development
RT-111: Oral Ustekinumab Development RT-111 Capsules 0.5 mg Showed 94% Relative Bioavailability Compared to SC Injection Route Pharmacokinetic Parameters (Mean ± SEM) Cmax (µg/mL) Tmax (day) AUC (day. µg/mL) SC 0.5 mg (n = 5) 0.60 ± 0.05 2.8 ± 0.58 6.01 ± 0.68 RT-111 Capsules 0.5 mg (n=6)
Slide 18: RT-105: Oral Adalimumab Development
RT-105: Oral Adalimumab Development Rani - Confidential Anticipated Next Steps: Adalimumab Delivered via the RaniPill Route of Administration Demonstrated PK Comparable to SC Injection Begin Phase I trial with RaniPill HC Human PK Data of Adalimumab (2.5mg): Endoscopic Injection (IJ)* vs. Subcutaneo
Slide 19: RT-110: Oral Long-Acting PTH for Hypoparathyroidism
RT-110: Oral Long-Acting PTH for Hypoparathyroidism Hypoparathyroidism Market Opportunity: Significant unmet medical need Conventional therapy aimed at short-term symptom management with large doses of oral calcium and active vitamin D as first-line therapy option Market forecast to reach $2.64B by
Slide 20: Discovery Programs
Discovery Programs 20
Slide 21: Strategic Focus Areas Under Preclinical Investigation
Actively Investigating Through Preclinical Work: Strategic Focus Areas Our Technology is Designed to Enable a Broad Set of Opportunities for Asset Development Initial Focus: Endocrinology & Immunology Obesity / Metabolic Diseases Oligonucleotides Fertility Proteins Peptides Antibodies $50BN+* initia
Slide 22: RaniPill HC (High Capacity) Expands the RaniPill Platform
RaniPill HC (High Capacity) Expands the RaniPill Platform Large drug reservoir for increased capacity Dissolvable microneedle Increased Payload of Up to 20mg Enables potential delivery of 90+ additional drug candidates including: Transenteric Delivery of Liquid Drug Minimizes formulation steps requi
Slide 23: Recent Preclinical Studies of RaniPill HC
Study #1: Two RaniPill HC capsules containing 40µg teriparatide were administered to 5 awake canines sequentially (second capsule administered after deployment of previous device was confirmed) Rani - Confidential Recent Preclinical Studies* of RaniPill HC Achieved 18/20 Successful Deployments of Te
Slide 24: RaniPill HC Shows Drug Signal Comparable to SC Injection
Rani - Confidential RaniPill HC Shows Drug Signal Comparable to SC Injection* Initial Analysis of Drug Delivery Via the RaniPill HC Shows Potential for Mimicking Parenteral Administration Routes 24 RaniPill HC Containing Fe57 Showed Positive Drug Signal Comparable to SC Injection PK Curves of Adalim
Slide 25: RaniPill HC Preliminary Data and Next Steps
Preliminary Data* Two Recent Preclinical Studies Showed 18/20 Successful Drug Delivery (90% Success Rate) RaniPill HC Preclinical Study of N=2 Containing Fe57 Showed Positive Drug Signal Comparable to SC Injection RaniPill HC Development On Track with Positive Preclinical Results Next Steps & Antici
Slide 26: Obesity/Metabolic: GLP-1 Clinical Study
Obesity/Metabolic: GLP-1 Clinical Study Rani has demonstrated high bioavailability of the GLP-1 agonist exenatide Presented as a late-breaking abstract at the American Diabetes Association Conference 2023 Key Drivers: Large and growing patient population seeking treatment options for obesity Approve
Slide 27: Oligonucleotides: Preliminary Research with ASO
Oligonucleotides: Preliminary Research with ASO Key Drivers: Emerging area of drug development that offers a promising alternative to therapies targeting downstream processes Chemistry attempts at oral delivery have had mixed results in terms of bioavailability Rani Strategy: Provide a safe and effi
Slide 28: Fertility: FSH Preclinical Study
Fertility: FSH Preclinical Study Key Drivers: Rani Strategy: Provide oral option to expand market opportunity even further with minimal manufacturing burden FSH delivered via the RaniPill Yielded Bioavailability Comparable to SC Injection Market Poised for significant growth: IVF services estimated
Slide 29: Anticipated Upcoming Milestones & Progress
Initiate a Phase 2 clinical trial with RT-102 in 2023 Initiate a Phase 1 clinical trial with RT-111 in 2023 Anticipated Upcoming Milestones & Progress Progress development of RaniPill HC towards clinic Evaluate platform further in strategic areas of focus
Slide 30: The RaniPill is Reinventing the Oral Delivery of Biologics
Clinically Demonstrated Bioavailability Comparable To or Better Than Approved Injectable Biologics Potential for Wide Range of Biologic Therapies to be Put into a RaniPill Best Therapeutic + Best Delivery The RaniPill is Reinventing the Oral Delivery of Biologics Platform Technology Differentiated P
Slide 31: Rani - Thank You
Rani - Confidential Thank You
Slide 32: Appendix
Appendix
Slide 33: RT-102 Market Opportunity
RT-102 Market opportunity Oral PTH (1-34) for Treatment of Osteoporosis Significant opportunity for an oral parathyroid hormone option for patients with osteoporosis Current anabolic (bone forming) therapies require daily or monthly injections Global PTH market expected to grow to $2.51B in 2026 at
Slide 34: Daily Dosing Has the Potential for Positive Clinical Impact
Daily Dosing Has the Potential for Positive Clinical Impact Daily Administration of Fractionated Doses Enables Tight Banding and Titration for More Controlled and Potentially More Effective Treatment Regimens Actual data from 45mg SC injections of ustekinumab every 12 Weeks vs simulated data for Dai
Slide 35: Financing & Shareholdings
LA Financing & Shareholdings
Slide 36: Umbrella Partnership C Corporation (Up-C) Structure
Umbrella Partnership C Corporation (Up-C) Rani Therapeutics Holdings, Inc. (PubCo - Parent Company) “Class A Shares” Common Stock “Class B Shares” Common Stock Rani Therapeutics, LLC* (Subsidiary) 1 Class A unit LLC + Class B common = “paired interest” = 1 Class A common [1:1 conversion] 1 non-corre
Slide 37: Financing History
AUGUST 2021 - IPO $ 84.3 million gross proceeds Bank of America Stifel Cantor Fitzgerald & Co. Canaccord Genuity BTIG Financing History AUGUST 2022 - LOAN Aggregate principal amount up to $45.0 million; $30M drawn to date Avenue Capital AUGUST 2022 – ATM Controlled EquitySM Sales Agreement $Up to $1
Slide 38: References
[1] Survey of U.S. Clinicians and Patients on Adoption of Novel Oral Drug Delivery Platform dated June 2, 2021, Frost & Sullivan. The independent third-party survey was commissioned by Rani Therapeutics. Product referenced is Prolia. Prolia patients surveyed (n=103) were aged 18 years or older and p
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