RedHill Biopharma Ltd. · NASDAQ:RDHL
RedHill Biopharma — Investor Presentation (December 2022)
81 slides from RedHill Biopharma's investor presentation, Dec 15, 2022
Slide 1: RedHill Biopharma Ltd. Corporate Presentation
RedHill Biopharma Ltd. (“RDHL”) Corporate Presentation December 2022
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation does not constitute an offer or invitation to sell or issue, or any solicitation of an offer to subscribe for or acquire any of the Company’s securities or to participate in any investment in the Company. No representation or warranty is made to the accura
Slide 3: Corporate Highlights
Corporate Highlights An emerging U.S. specialty biopharmaceutical company (Nasdaq: RDHL), primarily focused on U.S. commercialization and development of drugs for gastrointestinal (GI) diseases and infectious diseases Strong U.S. Commercial Footprint and Robust Development Pipeline with Multiple Nea
Slide 4: Emerging U.S. Specialty Pharma: Select Programs
Emerging U.S. Specialty Pharma: Select Programsi Commercial Productsii Talicia® (omeprazole magnesium, amoxicillin and rifabutin) - H. pylori infection in adults iii Movantik® (naloxegol) - Opioid-induced constipation (OIC) in adults with chronic non-cancer pain Aemcolo® (rifamycin) - Travelers’ dia
Slide 5: Emerging U.S. Specialty Pharma
Emerging U.S. Specialty Pharmai A leading U.S. specialty pharmaceutical company ii Opaganib GI RHB-107 Oncology/GI RHB-104 Crohn’s disease Opaganib Cholangiocarcinoma Opaganib COVID-19 RHB-102 Gastroenteritis/ Opaganib Oncology support Nuclear - Radiation Injury RHB-102 IBS-D ~115 U.S. Commercial RH
Slide 6: Financial Highlights
Financial Highlightsi RedHill Biopharma Ltd. Nasdaq: RDHL Market Cap (approx.) $18.6 million American Depositary Shares (ADSs) 91.2 million (Representing 912 million ordinary shares outstanding) Cash Balance as of September 30, 2022ii $31.4 million Q3/2022 New Revenues $17.6 million Q3/2022 Gross Ma
Slide 7: Highly Experienced Senior Leadership
Highly Experienced Senior Leadership Dror Ben-Asher, Chief Executive Officer Gilead Raday, Chief Operating Officer P.C.M.I. Ltd. MSc Neurology, MBE Cambridge, Sepal Pharma Adi Frish, Chief Corporate & Business Development Officer Guy Goldberg, Chief Business Officer Y. Ben-Dror, MediGus Eagle Pharma
Slide 8: Board of Directors and Advisory Board
Board of Directors and Advisory Board Board of Directors Dror Ben-Asher, CEO Rick D. Scruggs P.C.M.I. Ltd. Salix, Watson, Oclassen Eric Swenden Ofer Tsimchi Alterphama nv, Lifeline Scientific Danbar, Polysack, Director in several companies Kenneth Reed, MD Alla Felder Dermatologist; Director Minerva
Slide 9: Commercial Operations - Strong U.S. Presence
Commercial Operations - Strong U.S. Presence U.S. Commercial Headquarters (Raleigh, NC) Marketing Market Access Sales Legal Supply Chain Medical Affairs Compliance & Trade & HR & Quality ~115 U.S. commercial organization team members promoting 3 products to thousands of GI, PCPs and other HCPs Promo
Slide 10: Movantik indicated for opioid-induced constipation
Indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain i Movantik® is a registered trademark of AstraZeneca. 10
Slide 11: MOVANTIK Important Safety Information
MOVANTIK® (naloxegol) Important Safety Information MOVANTIK® (naloxegol) is contraindicated in: – Patients with known or suspected gastrointestinal (GI) obstruction and patients at risk of recurrent obstruction, due to the potential for GI perforation – Patients receiving strong CYP3A4 inhibitors (e
Slide 12: Movantik - FDA-Approved for Treatment of OIC
Movantik® (naloxegol) - FDA-Approved for Treatment of Opioid-Induced Constipation (OIC) Treatment of opioid-induced constipation in adults with chronic non-cancer Approved pain, including patients with chronic pain related to prior cancer or its Indication treatment who do not require frequent (e.g.
Slide 13: OIC is a Large and Underserved Market
OIC is a Large and Underserved Marketi 6.2 – 12.4ii million 71% of patients with OIC opioid users in the report little to no benefit U.S. may have OICi from constipation treatmentsiii 15 million U.S. patients with chronic pain are prescribed opioidsiii 50 million U.S. adults with chronic painiv i Be
Slide 14: Constipation is the Most Common Side Effect of Opioid Therapy
Constipation is the Most Common Side Effect of Opioid Therapyi Results from a meta-analysis that included randomized controlled trials of opioid therapy in patients with chronic non-cancer pain:ii 60% 50% Frequency (%) 41% 40% 32% 29% 30% Opioids 20% Placebo 20% 15% 15% 10% 12% 11% 10% 7% 7% 3% 0% V
Slide 15: Movantik is a Once-Daily Oral Therapy Designed to Treat OIC
Movantik® is a Once-Daily Oral Therapy Specifically Designed to Treat OIC Movantik® functions as a peripherally acting mu-opioid receptor antagonist (PAMORA) in tissues such as the bowel, thereby decreasing the constipating effect of opioids while limiting the potential for interference with central
Slide 16: Movantik - the #1 Prescribed Oral PAMORA
Movantik® - the #1 Prescribed Oral PAMORAi Movantik® has best-in-class PAMORA coverage with over 261 million lives covered across all channelsii The #1 prescribed oral PAMORA specifically designed to treat OIC, with over ~3 million prescriptions written since its launch in 2015iii Movantik® is the P
Slide 17: Movantik Acquisition - A Transformative Event for RedHill
Movantik® Acquisition - A Transformative Event for RedHill RedHill acquired the global rights to Movantiki (excluding Europe and Canada) from AstraZeneca in April 2020 • RedHill benefits from the large investment made by AstraZeneca to make Movantik® a brand leader − First oral PAMORA approved in th
Slide 18: Continued Best Coverage in PAMORA Class
Continued Best Coverage in PAMORA Class Movantik® Lives Covered 90% ✓ Best coverage without restrictions in 80% 7 out of 8 out of the PAMORA class for both 70% 10 lives 10 lives Commercial and Government 60% segments 50% 40% ✓ Movantik® retains 86% Preferred 30% Status within Medicare Part D 20% 10%
Slide 19: Movantik nTRx Volume
Movantik®: +6.7% Year-To-Date (YTD)* nTRx Growth YTD* Movantik® nTRx Growth 400,000 +6.7% Growth Movantik nTRx Volume 350,000 300,000 250,000 200,000 350,128 328,009 150,000 100,000 50,000 0 YTD 2021 YTD 2022 *YTD 2022 until September 30, 2022 Source: IQVIA NPA Report (September 2022), Retail/Mail O
Slide 20: Talicia indicated for H. pylori infection
Indicated for the treatment of Helicobacter pylori infection in adults Approved for Marketing by U.S. FDA Following Two Positive Phase 3 Studies Launched in the U.S. 20
Slide 21: Talicia Important Safety Information
Talicia® (omeprazole magnesium, amoxicillin and rifabutin) Important Safety Information Talicia® contains omeprazole, a proton pump inhibitor (PPI), amoxicillin, a penicillin-class antibacterial, and rifabutin, a rifamycin antibacterial. It is contraindicated in patients with known hypersensitivity
Slide 22: Talicia - FDA-Approved for Treatment of H. pylori Infection
Talicia®- FDA-Approved for Treatment of H. pylori Infection in Adults Approved Treatment of H. pylori infection in adults Indication Omeprazole magnesium, amoxicillin and rifabutin 10 mgi/ 250 mg/ 12.5 mg Drug delayed-release capsulesi Approved NDA approved by U.S. FDA in November 2019 - launched in
Slide 23: Talicia Field Promotion Initiated July 2020
Talicia® Field Promotion Initiated July 2020 RedHill’s U.S. sales force promoting Talicia® to approx. 25,000 gastroenterologists, primary care physicians and other healthcare providers Rapid expansion in managed care coverage since launch Talicia® is the Most Prescribed Branded Agent by U.S. Gastroe
Slide 24: Talicia nTRx Volume
Talicia®: 72% Year-To-Date (YTD)* nTRx Growth YTD* Talicia® nTRx Growth 25,000 +72% Growth Talicia nTRx Volume 20,000 15,000 21,146 10,000 12,303 5,000 0 YTD 2021 YTD 2022 *YTD 2022 until September 30, 2022 Source: IQVIA NPA Report (September 2022), Retail/Mail Order/Long-term Care Data 24
Slide 25: Talicia Coverage Continues to Expand
Talicia® Coverage Continues to Expand Total Talicia® Coverage Stood at Approx. 200 Million American Lives as of September 2022 Talicia® Lives Covered 80% ✓An additional 1.9 million Medicare Part D lives gained coverage in May 2022 70% 7 out of 10 lives 60% ✓Commercial PBM* win improved coverage to 6
Slide 26: H. pylori - Increasing Global Disease
H. pylori - Increasing Global Disease H. pylori infection → Progressive gastro-duodenal damage • H. pylori - a Group I carcinogen and the strongest risk factor for gastric canceri and peptic ulcer disease; Also associated with iron deficiency, B12 deficiency and drug malabsorption - Gastric cancer -
Slide 27: H. pylori Resistance - An Important Public Health Concern
H. pylori Resistance - An Important Public Health Concern WHO: H. pylori ranked as pathogen with FDA: H. pylori identified under the GAIN Act as “high priority” need for new treatments pathogen posing serious threat to public health • February 2017 - WHO • Talicia® received FDA Enterococcus faecium,
Slide 28: Positive Pivotal Phase 3 Study
Positive Pivotal Phase 3 Study Randomized, Double-Blind, Active Comparator, Two-Arm, Pivotal Phase 3 Study (ERADICATE Hp2), Comparing Talicia® Against a Regimen of Amoxicillin and Omeprazole Alone in the Treatment of Confirmed H. pylori Infection in Dyspepsia Patients, Regardless of Ulcer Status Num
Slide 29: Positive Pivotal Phase 3 Study Results
Positive Pivotal Phase 3 Study The ERADICATE Hp2 study met its primary endpoint with a high degree of statistical significance (p<0.0001) p<0.0001 • Top-line results demonstrated 84% eradication 90% 84% of H. pylori with Talicia® vs. 58% in the active comparator arm (p<0.0001) (ITT) 80% • 90% eradic
Slide 30: Resistance Patterns in Pivotal Study
Resistance Patterns in Pivotal Study Demonstrate Zero to Negligible Resistance For Component Antibiotics in Talicia® H. pylori Resistance to Standard-of-Care • H. pylori culture results from patients across 20 U.S. states supported the high resistance of H. pylori to the antibiotics most commonly us
Slide 31: Positive First Phase 3 Study
Positive First Phase 3 Study A Randomized Placebo-Controlled Phase 3 Study (ERADICATE Hp) to Assess the Safety and Efficacy of Talicia® in the Treatment of Confirmed H. pylori Infection in Dyspepsia Patients, Regardless of Ulcer Status Number of Subjects 118 in the U.S. Treatment Duration 14 days -
Slide 32: Strong Protection from Competition and Substitution
Strong Protection from Competition and Substitution • FDA QIDP designation providing eligibility for a total of 8 years of market exclusivity • Talicia® is covered by U.S. patents covering the unique ‘all-in-one’ capsule formulation and distinct PK profile, extending until at least 2034, with additi
Slide 33: Talicia - Large Potential Market Opportunity in the U.S. and WW
Talicia®- Clear Clinical Differentiation Provides Large Potential for Market Opportunity in the U.S. and WW High Prevalence of Diminished Efficacy Current Brand $4.8B Global Market H. pylori of Standard-of-Care - Medications Lack Approx. 60% Clinical Differentiation Over 27M treatments annually WWi:
Slide 34: Aemcolo indicated for travelers' diarrhea
Indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of E. coli in adults Approved for Marketing by U.S. FDA Launched in the U.S. by RedHill - December 2019 34
Slide 35: Aemcolo Important Safety Information
Aemcolo® (rifamycin) - Important Safety Information INDICATION AND IMPORTANT SAFETY INFORMATION Aemcolo® is indicated for the treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli) in adults. Limitations of Use Aemcolo® is not indicated in patients with diarrhea
Slide 36: Launched by RedHill in the U.S. - December 2019
Launched by RedHill in the U.S. - December 2019 • A rifamycin antibacterial approved by U.S. FDA in Nov. 2018 for the treatment of travelers’ diarrhea caused by noninvasive strains of E. coli in adults • In-licensed U.S. rights from Cosmo Pharmaceuticals N.V. in Oct. 2019 • FDA QIDP designation gran
Slide 37: High Travel Spending Points to Significant Commercial Opportunity
High Travel Spending Per Person in the U.S. Points to Significant Commercial Opportunity Travelers’ diarrhea is a significant market: • Approximately 93 million Americans traveled abroad in 2018, of which 60 million traveled to medium to high risk regionsi • Travelers’ diarrhea may affect up to 70%
Slide 38: Late-Stage Development Pipeline
Late-Stage Development Pipeline Opaganib RHB-107 Nuclear Radiation Injury Animal Rule NDA path being Non-hospitalized symptomatic pursued COVID-19 (and earlier phase studies Phase 2/3 investigating other viral indications) Severe COVID-19 pneumonia Phase 2/3 Oncology Phase 2 Cholangiocarcinoma Phase
Slide 39: Opaganib (ABC294640)
Opaganib (ABC294640)i Late-Stage Investigational New Drug First-in-class, broad-acting, host-directed, orally-administered sphingosine kinase-2 (SK2) inhibitor, targeting viral (including COVID-19), inflammatory (including nuclear radiation injury) and oncological diseases Nuclear radiation injury –
Slide 40: Opaganib - Broad-Acting, Host-Directed SK2 Inhibitor
Opaganib – Broad-Acting, Host-Directed SK2 Inhibitor Targeting Nuclear Radiation Injury and Viral, Inflammatory and Oncological Diseases - Potential first-in-class, orally-administered sphingosine kinase-2 (SK2) inhibitor - Broad-acting agent targeting viral (incl. COVID-19), inflammatory (incl. rad
Slide 41: Opaganib Host-Directed Mechanism of Action
Opaganib’s Host-Directed Mechanism of Action Inhibits Three Enzymes Contributing to Its Broad Antiviral Effect in Addition to Its Anti-Inflammatory and Anti-Thrombotic Effectsi Dihydroceramide Suppression desaturase of autophagy Opaganib Glucosylceramide Endocytosis synthase SARS-CoV-2 Infection and
Slide 42: SK2 - Therapeutic Target for S1P
SK2 – Therapeutic Target for Metabolite Sphingosine-1- Phosphate (S1P) that has Pathological Roles in Various Diseases • Sphingolipids regulate several important signaling transduction processesi • Sphingosine Kinase 1 (SK1) and Sphingosine Kinase 2 (SK2) phosphorylate sphingosine to form Sphingosin
Slide 43: Opaganib COVID-19 Program: Overview
Opaganib COVID-19 Program: Overview ✓ Novel oral drug candidate showing improved viral RNA clearance in patients with severe COVID-19 pneumonia ✓ Significant 70% mortality benefit when given on top of best SoC, as well as improved time to clinical recovery in a prespecified analysis of a Phase 2/3 s
Slide 44: Opaganib Potent Antiviral Activity Against SARS-CoV-2 Variants
Opaganib Demonstrated Potent Antiviral Activity Against SARS-CoV-2 Variants • Opaganib was evaluated in in vitro model of human lung bronchial tissue (EpiAirway™), including positive control of remdesivir: • Opaganib inhibited infectious virus production of SARS-CoV-2 (WA1/2020) in a dose- dependent
Slide 45: Opaganib Global Phase 2/3 Study in Severe COVID-19
Opaganib Global Phase 2/3 Study in Severe COVID-19 Global Phase 2/3 study in patients hospitalized with severe COVID-19 pneumonia • Randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study • 475 Patients randomized 1:1 to receive opaganib or placebo on top of standard-of-car
Slide 46: Opaganib Phase 2/3 - Significant Improvement in Viral Clearance
Opaganib Global Phase 2/3 Study in Severe COVID-19 - Significant Improvement in Viral Clearance ✓ In a prespecified analysis of all Phase 2/3 study patients with positive PCR at screening, opaganib improved median time to viral RNA clearance by at least 4 days • Median of 10 days for viral clearance
Slide 47: Opaganib Phase 2/3 - 70% Mortality Benefit in SoC Subgroup
Opaganib Global Phase 2/3 Study in Severe COVID-19 - 70% Mortality Benefit in Opaganib + SoC Subgroup ✓ A prespecified analysis of Phase 2/3 data in severe COVID-19 patients showed a significant 70.2% mortality benefit with opaganib by Day 42 when given on top of the best available SoC, remdesivir a
Slide 48: Opaganib Phase 2 COVID-19 Study - Positive Data
Opaganib Phase 2 COVID-19 Study - Positive Data U.S. Phase 2 study of opaganib in patients hospitalized with COVID-19 pneumonia: Non-powered study of 40 patients, randomized 1:1 to receive opaganib or placebo on top of standard-of-care. Follow up for up to 42 days post treatment initiation Results d
Slide 49: Opaganib - Potent Antiviral Activity Against Multiple Viruses
Opaganib – Novel, Host-Directed, Broad-Acting Agent Demonstrating Potent Antiviral Activity Against Multiple Viruses • RedHill is working with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate opaganib’s utility against a wide range of pathogens • This work includes precl
Slide 50: Opaganib - SK2 Inhibitor Against Radiation Toxicity
Opaganib – An SK2 Selective Inhibitor with Potential Activity Against Radiation Toxicity • In 2015, RedHill in-licensed opaganib from Apogee Biotechnology Corp. • Opaganib (ABC294640) is a proprietary, first-in-class, orally-administered, stable (shelf life over 5 years), for ease of national stockp
Slide 51: Opaganib - A Potential Treatment for GI-ARS
Opaganib – A Potential Treatment for GI-ARS • Acute Radiation Syndrome (ARS) is an acute illness caused by irradiation of the entire body (or most of the body) by a high dose of penetrating radiation in a very short period of time • GI-ARS can occur when the GI tract is exposed to high levels of rad
Slide 52: Opaganib Promise as Radioprotectant in Animal Models
Opaganib Shows Promise as Radioprotectant in Animal Models and Safety in Humans Opaganib: ✓ An advanced clinical stage orally administered; first-in-class patented novel sphingosine kinase 2 inhibitor ✓ Safe in humans, as confirmed in clinical trials and in compassionate use indications in ~ 470 par
Slide 53: SK2 as a Specific Target for Anti-cancer Drugs
SK2 as a Specific Target for Anti-cancer Drugs Why SK2 for Anticancer Therapy? Oncology Development Status ✓ Completed numerous successful pre-clinical • SK2 is an innovative molecular target for studies in various oncology indications anticancer therapy because of its critical role in catalyzing th
Slide 54: Opaganib - Positive Phase 1 Study
Opaganib - Positive Phase 1 Study Phase 1 Clinical study of opaganib in Cancer Patients with Advanced Solid Tumors Study - Open-label, dose-escalation, PK and PD, first-in-human Phase I study with opaganib Design Site - Medical University of South Carolina Subjects - 21 patients with advanced solid
Slide 55: Opaganib - Phase 2a Study for Cholangiocarcinoma
Opaganib - Phase 2a Study for Cholangiocarcinoma Single-arm Phase 2a clinical study evaluating opaganib in patients with advanced, unresectable, intra-hepatic, perihilar and extra-hepatic cholangiocarcinoma Sites Mayo Clinic, MD Anderson, Huntsman Cancer Institute, Emory University Initiated Decembe
Slide 56: RHB-107 (upamostat)
RHB-107 (upamostat) Late-Stage Investigational New Drug First-in-class, broad-acting, host-directed serine protease inhibitor targeting COVID-19, oncological, GI and inflammatory lung diseases Orally-administered, once-daily, small molecule drug -- Phase 2/3 study for COVID-19 in non-hospitalized pa
Slide 57: RHB-107 - Host-Directed S1 Serine Protease Inhibitor
RHB-107 - Broad-Acting, Host-Directed S1 Serine Protease Inhibitor Targeting Oncological, GI and Inflammatory Lung Diseases - First-in-class, orally-administered inhibitor of the S1 family of serine proteases - Broad-acting agent with potential for use in the treatment of cancer, inflammatory lung d
Slide 58: RHB-107 - Phase 2/3 COVID-19 Study
RHB-107 - Phase 2/3 COVID-19 Study Phase 2/3 study with RHB-107 in non-hospitalized patients with symptomatic COVID-19 not requiring supplemental oxygen (Phase 2, Part A completed) ✓ Study design: 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2/3 study ✓ Inn
Slide 59: RHB-107 - Positive Phase 2 COVID-19 Study
RHB-107 – Positive Phase 2 COVID-19 Study Phase 2 (Part A) study in non-hospitalized COVID-19: ✓ The study was designed to evaluate safety for dose selection and provide preliminary assessment of parameters to be used for efficacy evaluation (Part B) ✓ 61 patients were enrolled and randomizedi on a
Slide 60: RHB-204
RHB-204 Investigational new drug Targeting pulmonary nontuberculous Mycobacteria (NTM) disease - with Orphan Drug designation, QIDP designation, including Fast-Track development status U.S. Phase 3 Study Ongoing 60
Slide 61: RHB-204 - Targeting First-Line Pulmonary NTM Disease
RHB-204 - Targeting First-Line Pulmonary NTM Disease Planned - Pulmonary nontuberculous mycobacteria (NTM) disease caused by Indication Mycobacterium avium Complex (MAC) - Proprietary, stand-alone, oral treatment containing a fixed-dose, all-in-one The Product combination of clarithromycin, clofazim
Slide 62: RHB-204 for Pulmonary NTM - Background and Epidemiology
RHB-204 for Pulmonary NTM - Background and Epidemiology • Difficult to treat infection with no FDA-approved first-line standard-of-care • NTM are a ubiquitous bacteria, mostly non-pathogenic but can cause human diseasei • Pulmonary manifestations account for 80-90% of NTM associated diseasei • Appro
Slide 63: RHB-204 - CleaR-MAC Phase 3 Study Ongoing
RHB-204 - CleaR-MAC Phase 3 Study Ongoing A Phase 3 study intended to assess the efficacy and safety of RHB-204 as a first-line, stand- alone treatment for pulmonary NTM infections caused by MAC - Multi-center, randomized, double-blind, two-part, placebo-controlled, parallel-group Phase 3 study; 3:2
Slide 64: RHB-104
RHB-104 Investigational new drug Combination therapy targeting MAP bacteria for treatment of Crohn’s disease and potentially other autoimmune diseases Positive First Phase 3 Study in Crohn’s Disease - Study Successfully Met Its Primary Endpoint and Key Secondary Endpoints Potential MAPi Diagnostic P
Slide 65: The Link between Crohn's Disease and MAP
The Link between Crohn’s Disease and MAP Growing evidence that intracellular mycobacteria play a crucial role in Crohn’s disease • MAP (mycobacterium avium subsp. paratuberculosis) is the causative agent of Johne’s disease, an infectious disease in cattle, clinically and pathologically similar to Cr
Slide 66: RHB-104 for Crohn's - Product and Market Overview
RHB-104 for Crohn’s - Product and Market Overview Planned Treatment of Crohn’s disease in adult patients Indication Patent-protected combination of 3 antibiotics (clarithromycin, clofazimine and The product rifabutin) in a single oral capsule with potent intracellular, antimycobacterial and anti-inf
Slide 67: RHB-104 Positive First Phase 3 Study in Crohn's
RHB-104 Positive First Phase 3 Study in Crohn’s - Met Primary Endpoint and Key Secondary Endpoints Multi-center, randomized, double-blind, placebo-controlled, parallel group study (MAP US study) to assess efficacy and safety of orally-administered, fixed-dose combination RHB-104 in subjects with mod
Slide 68: RHB-104 Crohn's Disease Phase 3 - Positive Results
RHB-104 Crohn’s Disease Phase 3 - Positive Results The MAP US Phase 3 study met its primary and key secondary endpoints, demonstrating meaningful, consistent and statistically significant clinical activity of orally-administered RHB-104 as an add-on to standard-of-care treatments RHB-104 (n= 166) Pl
Slide 69: RHB-104 Crohn's Disease Phase 3 - Positive Results
RHB-104 Crohn’s Disease Phase 3 - Positive Results Additional Endpoints Met: ✓ Durable remission weeks 16-52: statistically significant benefit in durable remission on all visits, weeks 16-52, demonstrating an improvement of 100% over placebo ✓ Maintenance of remission: analysis of maintenance of re
Slide 70: RHB-104 Crohn's Disease Phase 3 - Positive Results
RHB-104 Crohn’s Disease Phase 3 - Positive Results Effects of concomitant immunomodulators and corticosteroids: Remission at week 26 concomitant meds subgroup analyses demonstrated the impact of RHB-104 as an add-on therapy to a variety of standard-of-care agents despite not being prospectively powe
Slide 71: RHB-104 Crohn's Disease Phase 3 - Endoscopic Response
RHB-104 Crohn’s Disease Phase 3 - Positive Results Endoscopic response: ✓ Endoscopy was voluntary in the study ✓ In a small subset of patients (n=35) in whom endoscopy was performed, results showed meaningful improvement in endoscopic healing (Simple Endoscopic Score for Crohn's Disease (SES-CD)) at
Slide 72: RHB-104 Median Fecal Calprotectin
RHB-104 Crohn’s Disease Phase 3 - Positive Results Median Fecal Calprotectin ✓ Marked and continuous decline of calprotectin inflammatory marker in the RHB-104 active arm from baseline through week 52 RHB-104 Placebo 400 346.5 355.4 350 333.6 314 300 ∆143 276.5 ∆211 250 ∆115 Median 200 189.8 161.1 1
Slide 73: RHB-104 % High Fecal Calprotectin
RHB-104 Crohn’s Disease Phase 3 - Positive Results % High Fecal Calprotectin** ✓ Proportion of high calprotectin declined significantly in the RHB-104 active arm from baseline through week 52 (weeks 12, 26 and 52) RHB-104 Placebo P*=0.0001 P*=0.0017 P*=0.0026 90 80 77.9 72.9 72.6 69.9 67.5 70 ∆25.2%
Slide 74: RHB-104 - Multiple Barriers to Entry
RHB-104 - Multiple Barriers to Entry • Robust global patent portfolio covering RHB-104, with additional claims being pursued • Potential 3 years exclusivity for treatment of Crohn’s disease • Limited availability of clofazimine (distributed by the World Health Organization (WHO) and Novartis) and ge
Slide 75: RHB-104 - Our Plans
RHB-104 - Our Plans Possible progress in MAP diagnostic technology may enable advancement towards a confirmatory study in MAP positive moderate-severe Crohn’s patients Planned confirmatory trial design, pending regulatory input: • Relatively small study in 100-150 MAP positive moderate-severe patien
Slide 76: RHB-102
RHB-102i Investigational new drug A bi-modal extended release, once-daily, ondansetron RHB-102 24 mg - Positive Results from a U.S. Phase 3 Study for Gastroenteritis/Gastritis - Met Primary Endpoint RHB-102 12 mg - Positive Results from a U.S. Phase 2 Study for IBS-D Met Primary Endpoint i Bekinda®
Slide 77: RHB-102 24 mg: Gastroenteritis & Gastritis - First Phase 3 Results
RHB-102 24 mg: Gastroenteritis & Gastritis - Positive First Phase 3 Results A Randomized, Double-Blind, Placebo Controlled, Parallel Group Phase 3 Study (GUARD study) to Assess the Safety and Efficacy of RHB-102i 24 mg for the Treatment of Acute Gastroenteritis & Gastritis The Product Patent-protect
Slide 78: RHB-102 24 mg: Gastroenteritis & Gastritis Phase 3 Results
RHB-102 24 mg: Gastroenteritis & Gastritis Positive Phase 3 Results A Randomized, Double-Blind, Placebo Controlled, Parallel Group Phase 3 Study (“GUARD”) to Assess Safety and Efficacy of RHB-102 24 mg for Treatment of Acute Gastroenteritis & Gastritis - The Phase 3 GUARD study successfully met its
Slide 79: RHB-102 12 mg: IBS-D Positive Phase 2 Results
RHB-102 12 mg: IBS-D Positive Phase 2 Results A Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel Group Phase 2 Clinical Study Designed to Evaluate the Safety and Efficacy of RHB-102 12 mg in Patients Suffering from Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) The Product Patent-
Slide 80: RHB-102 12 mg: IBS-D Positive Phase 2 Results
RHB-102 12 mg: IBS-D Positive Phase 2 Results A Randomized, Double-Blind, Placebo-Controlled, 2-Arm Parallel Group Phase 2 Clinical Study Designed to Evaluate the Safety and Efficacy of RHB-102 12 mg in Patients Suffering from Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) - Primary endpoint:
Slide 81: Thank You!
Thank You! RedHill Biopharma Ltd. 21 Ha’arba’a St. Tel-Aviv, 6473921, Israel Website: www.RedHillbio.com Email: [email protected] Tel: +972-3-541-3131
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