Rani Therapeutics Holdings, Inc. · NASDAQ:RANI
Rani Therapeutics — Investor Presentation (September 2021)
30 slides from Rani Therapeutics's investor presentation, Sep 29, 2021
Slide 1: Redefining Oral Biologics
Redefining Oral Biologics September 2021 Exhibit 99.1
Slide 2: Forward-looking statements
This presentation and the accompanying oral statements contain forward-looking statements. Forward-looking statements are based on information available at the time those statements are made or on management's good faith beliefs and assumptions as of that time with respect to future events, and are
Slide 3: Today's Presenters
Today’s Presenters Talat Imran CEO Mir Hashim CSO
Slide 4: Converting injectable biologics into pills: Corporate Summary
Converting injectable biologics into pills $56BN+ initial market opportunity1 targeting multiple markets across multiple diseases 5 internal development programs Initiation of at least two Phase 1 trials expected in 2022; Repeat-dose study expected in 2022 Octreotide Phase 1 completed supporting pla
Slide 5: Patients Prefer Pills
Patients Prefer Pills 88% of RA patients would prefer a daily pill to a bi-weekly injection of Humira 38% of diabetics miss 4+ injections per week Frost & Sullivan research report commissioned by Rani “Patients initiating treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) had a 71%
Slide 6: Rani's Technology
Rani’s Technology Rani THERAPEUTICS Oral BIOlOgIcs © Rani Therapeutics Rani
Slide 7: Rani's Development Approach
Designed for Minimal Discomfort No small intestine pain receptors Absorption similar to injections Upon Deployment Agnostic to payload Designed to accommodate peptides, proteins and antibodies Strong patent position Covering both the platform and drugs in combination with the platform Scalable desig
Slide 8: Development Pipeline
RT-XXX refers to the RaniPill capsule containing a biologic in a proprietary Rani formulation * Each of these indications will require separate trials ** CCHN will have limited opportunity to negotiate for rights within China ***To follow submission and clearance of IND INDICATION(S) FORMULATION PRE
Slide 9: Preclinical & Clinical Experience
Preclinical & Clinical Experience
Slide 10: Preclinical & Clinical Experience
Preclinical & Clinical Experience Preclinical – 10 molecules assessed 4 antibodies, 5 peptides, 1 large protein Awake dogs, anesthetized juvenile pigs Single and repeat-dose studies No serious adverse events observed to date High bioavailability, comparable to parenteral injections Clinical – 3 mole
Slide 11: Safety and Tolerability Study of RaniPill Platform in Humans
Study conducted in 2018 RaniPill device tracked by X-ray imaging RaniPill device without a needle in fasted and fed groups N=10 per group No food effect observed on device functionality RaniPill was well-tolerated by all subjects No serious adverse events were reported Met all safety endpoints Abili
Slide 12: RaniPill Repeat Administration Canine Study
RaniPill Repeat Administration Canine Study Study Overview Histopathology Summary Objective: Evaluate safety and tolerability of once-daily 7 day repeat oral administration of the RaniPill capsule Animal Model: Male and female beagles naïve to all drugs Study Groups: Test Group: Orally administered
Slide 13: Phase I Study with the RaniPill Containing Octreotide
Phase I Study with the RaniPill Containing Octreotide COMPLETED Q4 2019 Subjects Healthy men and women, aged 18-55 years Design Open label, single center (Australia) Test Articles RaniPill Devices: 3 versions with incremental balloon sizes, each containing 100 µg of octreotide 1 Control Arm (N=6) IV
Slide 14: Phase I Primary Endpoints: Safety and Tolerability
Phase I Primary Endpoints: Safety and Tolerability Octreotide-RP capsule was well-tolerated by all subjects No subject had difficulty swallowing the capsule Capsule remnants passed out in all subjects No serious adverse events noted in the study
Slide 15: Pharmacokinetic Data: RT-101 Phase I Study
Pharmacokinetic Data: RT-101 Phase I Study RaniPill delivered Octreotide with high bioavailability Bioavailability = 65%
Slide 16: Canine Model Could Be Predictive of Human PK Data
Canine Model Could Be Predictive of Human PK Data Bioavailability = 78% Bioavailability = 65% HUMAN Preclinical Data from Canine Model May Translate Well to Human Clinical Development CANINE
Slide 17: Additional Human Studies
Additional Human Studies
Slide 18: Endoscopic Intrajejunal Administration in Humans
Objective: to obtain an early read on the PK profile via Rani route in humans Methods: Using an endoscopic approach, an approved drug (commercial formulation) is injected into the jejunal wall (IJ route) to mimic the Rani route of administration We have determined PK of three drugs in these type of
Slide 19: PK Data of Octreotide with Endoscopic Injections vs. Oral RaniPill
PK Data of Octreotide with Endoscopic Injections vs. Oral RaniPill
Slide 20: Endoscopic Intrajejunal Administration of Exenatide in Humans
Endoscopic Intrajejunal Administration of Exenatide (GLP-1 Analog) in Humans IJ (N=5) PK in Healthy Subjects - SC vs. Intrajejunal (IJ) Exenatide dose = 10 mg
Slide 21: Endoscopic Intrajejunal Administration of Anti TNF-α Antibody in Humans
Humira IJ Injection vs Subcutaneous Injection Endoscopic Intrajejunal Administration of Anti TNF-α Antibody in Humans Data are Means ± SD *Back Bay Report 2018, projected peak revenue 2.5mg of Adalimumab Endoscopically Delivered in Humans (Subcutaneous and Intrajejunal) Adalimumab: Phase 1 Initiatio
Slide 22: Additional Preclinical Studies
Additional Preclinical Studies
Slide 23: PK of Oral Adalimumab Biosimilar in Awake Dogs
All data are Means ± SEM PK of Oral Adalimumab Biosimilar in Awake Dogs SC 46 ± 3 Rani 49 ± 6 BIOAVAILABILITY* (%) *Formation of anti-adalimumab antibodies in the canine impacted the accurate determination of bioavailability Adalimumab Dose = 2.5 mg
Slide 24: RT-110/102 - PTH (Teriparatide)
Used in two indications: Osteoporosis (OP) and Hypoparathyroidism (Hypo) (rare disease) Must be injected daily PTH Market has been stable at ~$2.0B Affects ~10M adult patients in the United States Prevalence increasing due to aging population An oral Teriparatide could dramatically increase the mark
Slide 25: PK of Oral Teriparatide in Awake Dogs
PK of Oral Teriparatide at 80 µg in Awake dogs Early Preclinical Data
Slide 26: Insulin PK/PD in Juvenile Swine
Insulin PK/PD in Juvenile Swine Insulin dose = 20 IU
Slide 27: Regulatory Strategy & Key Milestones
Regulatory Strategy & Key Milestones
Slide 28: Regulatory Strategy
Regulatory Strategy RaniPill Master File CBER/ CDER IDE study to evaluate safety & reliability of the RaniPill 40 healthy adults, 18-50 years old Dosing for 8 weeks Using non-drug tracer Clinical Studies for Each Drug Based on Pre-submission Meeting with FDA’s CDRH FDA CDRH Center for Devices and Ra
Slide 29: Key Near Term Milestones
Key Near Term Milestones DEVELOPMENT PROGRAM INDICATION DESCRIPTION PLANNED TIMING* RT-101 NETs / Acromegaly Repeat Dose Platform Study 2022 RT-102 Osteoporosis Initiate Phase 1 Clinical Trial 2022 RT-109 GH Deficiency Initiate Phase 1 Clinical Trial 2022 RT-105 Psoriatic Arthritis Initiate Phase 1
Slide 30: Thank You
wi Thank You -
Rani Therapeutics Holdings — Investor Presentation (September 2021) on 6ix