Rani Therapeutics Holdings, Inc. · NASDAQ:RANI
Rani Therapeutics — Investor Presentation (February 2022)
25 slides from Rani Therapeutics's investor presentation, February 2022
Slide 1: Announcing RaniPill HC
Rani Therapeutics Announcing RaniPill™ HC February 2022
Slide 2: Forward Looking Statements
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
Slide 3: Rani Platforms & Payloads
Rani Platforms & Payloads ~ # OF DRUGS DEVICE CAPACITY SELECT POTENTIAL DRUGS ENABLED • Octreotide • Parathyroid hormone for osteoporosis Current RaniPill™ Up to 3 mg >40 • Parathyroid hormone for hypo capsule • Human growth hormone • Anti TNF-α antibody • Pembrolizumab / Keytruda® RaniPill™ HC • Et
Slide 4: The high payload RaniPill HC will enable delivery of a wider variety of drugs
The RaniPill™ HC The high payload RaniPill™ HC will enable delivery of a wider variety of drugs and significantly expand our market opportunity 4
Slide 5: RaniPill HC Study
RaniPill™ HC Study 5
Slide 6: High Payload System: Study Objectives
High Payload System: Study Objectives • Demonstrate ability to deliver high drug payloads (up to 20 mg) in canines • Verify that the absorption profile of adalimumab delivered via the RaniPill™ HC device is consistent with previously established historical controls with an adalimumab biosimilar 6
Slide 7: RaniPill HC – Adalimumab: Protocol Summary
RaniPill™ HC – Adalimumab: Protocol Summary • Test Device – RaniPill™ HC device without enteric-coated capsule shell or chemical reactants • Test Article & Dose – Adalimumab: 18 mg / 20 mg • Protocol – RaniPill™ HC device inserted directly into the jejunum lumen via a laparotomy – The RaniPill ballo
Slide 8: Study Animal Details
Study Animal Details Animal Animal Animal Animal Animal Animal ID #5074 #5077 #5080 #5042 #5084 Species: Canine Canine Canine Canine Canine Sex: Male Male Female Male Female Weight: 13.1 kg 14.2 kg 11.6 kg 16.7 kg 11.8 kg Adalimumab Dose: 18 mg 18 mg 18 mg 20 mg 20 mg Route of Admin: RaniPill™ HC Ra
Slide 9: PK of Adalimumab ~18 mg Delivered via the RaniPill HC
Pharmacokinetics (PK) of Adalimumab ~18 mg Delivered via the RaniPill™ HC PK Curves of an Adalimumab Biosimilar (2.5 and 5 mg, Historical Data) delivered via the RaniPill capsule in awake canines vs. Adalimumab ~18 mg delivered via RaniPill™ HC All data are means ± Standard Deviation (SD) 14 RaniPil
Slide 10: PK of Adalimumab ~18 mg Delivered via the RaniPill HC (Weight-Normalized)
PK of Adalimumab ~18 mg Delivered via the RaniPill™ HC Weight-Normalized PK Curves of an Adalimumab Biosimilar (2.5 and 5 mg, Historical Data) delivered via the RaniPill capsule vs. Adalimumab ~18 mg delivered via RaniPill™ HC All data are weight-normalized means ± Standard Deviation (SD) 180 RP1020
Slide 11: Adalimumab PK Profiles Delivered via the RaniPill Route
Adalimumab PK Profiles Delivered via the RaniPill Route Dose- and Weight-Normalized PK Curves of an Adalimumab Biosimilar (2.5 and 5 mg, Historical Data) delivered via the RaniPill capsule vs. Adalimumab ~18 mg delivered via RaniPill™ HC 14 • The PK curve of adalimumab Serum Adalimumab (kg.µg/mL/mg)
Slide 12: Historical PK of Oral Adalimumab Biosimilar in Awake Canines
Historical PK of Oral Adalimumab Biosimilar in Awake Canines 8000 IV (N=3) 7000 RaniPill (N=5) Serum Adalimumab Biosimilar 6000 SC (N=3) BIOAVAILABILITY* (%) Concentration (ng/ml) 5000 Adalimumab Dose = 2.5 mg SC 46 ± 3 4000 Rani 49 ± 6 3000 2000 *Formation of anti-adalimumab antibodies in the canin
Slide 13: PK Comparison: RaniPill HC vs Subcutaneous (SC) Controls
PK Comparison: RaniPill™ HC vs Subcutaneous (SC) Controls All data are weight- & dose-normalized means ± SD 14 RaniPill™ HC (n = 3) SC (n = 2) Serum Adalimumab (kg.µg/mL)/mg RP1020 Humira (18 mg) (n(18 = 3)mg) (n = 3) Cmax 6.4 4.1 12 RaniPill™ HC adalimumab (kg.µg/mL)/mg (3.81, 7.24, 8.06) (2.15, 6.
Slide 14: Summary
Summary • Using the RaniPill™ HC device, we have demonstrated successful delivery of a high dose (18 mg) of adalimumab in canines • Adalimumab 18 mg administered by the RaniPill™ HC device showed a dose- proportional increase in serum concentrations in comparison to historical controls with an adali
Slide 15: Market Research
Market Research 15
Slide 16: Patient Preference Surveys
Patient Preference Surveys* Every 2 Every Every Every Every 2 Every 3 Every 6 Frequency Daily weeks month month month months months months % Likely to Switch to Daily Pill 87% 88% 74% 73% 75% 77% 64% 76% Over Current Injectable *Data for Entyvio, Simponi, Evenity, Cosentyx, Stelara, and Prolia obtai
Slide 17: Mock-RaniPill Swallow Study Overview
Mock-RaniPill Swallow Study Overview • Objective: To evaluate the ease of swallowability of a mock RaniPill capsule by patients of different ages • Patient Population: Patients currently taking injections of various drugs • Study Design – Three cohorts of patient age groups: 21-50, 51-65, 66-75 year
Slide 18: Swallow Study Results
Swallow Study Results # Study # Prefer # Total successfully # Prefer Pill % Prefer Pill Groups Injection over Enrolled swallowed over Injection over Injection (years) Pill Mock-RP 21-50 50 50 44 88% 6 51-65 50 50 48 96% 2 66-75 50 50 44 88% 6 Total 150 150 136 91% 14 18
Slide 19: Adalimumab: Simulations of Daily Oral RaniPill Dosing
Adalimumab: Simulations of Daily Oral RaniPill Dosing 19
Slide 20: The Power of Daily Dosing
The Power of Daily Dosing • Adalimumab is dosed at 40 mg every 2 weeks, which we hypothesized would be approximately equivalent to a ~2.5 mg daily dose • Using the data from our human endoscopic study (2.5 mg of adalimumab injected intra- jejunally), we commissioned steady-state simulations to model
Slide 21: Steady State PK Simulations of Adalimumab IJ Data: Switching from Subcutaneous
Steady State PK Simulations of Adalimumab Intrajejunal (IJ) Data: Switching from Subcutaneous It is projected that patients currently on adalimumab 40 mg biweekly dosing regimen could switch to the daily RaniPill regimen at any point following the last subcutaneous dose of adalimumab 21
Slide 22: Steady State PK Simulations of Adalimumab IJ Data: Daily Dosing
Steady State PK Simulations of Adalimumab IJ Data: Daily Dosing RT-105 Regimen: daily dosing of 2.5 mg RaniPill, no loading dose • With biweekly adalimumab SC injections at a dose of 40 mg, it takes 28 days to reach target efficacy steady states • With once daily oral RaniPill dose of 2.5 mg, it is
Slide 23: Steady State PK Simulations of Adalimumab IJ Data: Loading Doses
Steady State PK Simulations of Adalimumab IJ Data: Loading Doses • Starting with an initial 40 mg SC loading dose, it is projected to take 7 • With initial 2 week BID (twice daily) RaniPill capsule loading doses, it days to reach target efficacy steady state with the 2.5 mg RaniPill capsule is proje
Slide 24: Our Goal is to Become The First-Line Biologics Company
Our Goal is to Become The First-Line Biologics Company INDICATION STARTING THERAPIES STANDARD INJECTABLES Metformin DPP-4 Basal Insulin & GLP-1 Type 2 Diabetes (oral) (oral) (injections) Teriparatide Denosumab Osteoporosis Bisphosphonates (oral) (injection) (injection) Calcitrol PTH(1-84) Hypoparath
Slide 25: Thank you!
“~ Thank you!
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