Slide 1: Opaganib Oral Pill for COVID-19: Phase 2/3 Study Outcomes
Opaganib Oral Pill for COVID-19 PHASE 2/3 STUDY OUTCOMES RedHill Biopharma (NASDAQ: RDHL) Webcast October 7th, 2021 1
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: Opening Remarks
OPENING REMARKS DROR BEN-ASHER, CEO 3
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: Breakthrough Data from the Global Phase 2/3 Study for COVID-19
Breakthrough Data from the Global Phase 2/3 Study for COVID-19 Bottom line: • The new data indicates that oral opaganib, if approved, is a potential game-changer with the potential to save many lives of moderately severe COVID-19 patients who are hospitalized with pneumonia, are getting oxygen suppo
Slide 6: Overview: Opaganib for COVID-19 & Phase 2/3 Study
OVERVIEW: OPAGANIB FOR COVID-19 & PHASE 2/3 STUDY GILEAD RADAY, COO 6
Slide 7: Agenda
Agenda • Overview of Opaganib Oral Pill Development Program • Global Phase 2/3 Study Design & Analysis • Overview of Phase 2/3 Study Results • Phase 2/3 Study Results in Detail • Summary • Q&A 7
Slide 8: Overview of Opaganib Oral Pill
Overview of Opaganib Oral Pill ✓ First-in-class proprietary selective sphingosine kinase-2 (SK2) inhibitor ✓ Dual mechanism of action: antiviral and anti-inflammatory ✓ Opaganib inhibits a host factor and is less likely to be subject to resistance due to viral mutation; demonstrated inhibition of SA
Slide 9: Phase 2/3 Study Results Build Upon Extensive Prior Data
Phase 2/3 Study Results Build Upon & Consistent with Extensive Prior Data ➔ Opaganib shows capacity to save lives of a Phase 2/3 distinct large group of moderately severe COVID-19 Study hospitalized COVID-19 patients 230 people additionally treated with opaganib - totaling 468 overall ➔ Opaganib sho
Slide 10: Global Phase 2/3 - Study Design
Global Phase 2/3 - Study Design Randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study • 475 subjects enrolled with severe COVID-19 pneumonia, requiring high-flow oxygen support (WHO Ordinal Scale 5 at baseline) • Subjects randomized to receive either opaganib or placebo a
Slide 11: Global Phase 2/3 - Study Analysis
Global Phase 2/3 - Study Analysis Preliminary top-line results announced on Sep. 14: • Preliminary top-line data of the study efficacy endpoints showed consistent trends in favor of the opaganib arm but did not achieve statistical significance On Oct. 4 we announced that further analysis demonstrate
Slide 12: Global Phase 2/3 Study - New Results Overview
Global Phase 2/3 Study - New Results Overview* • Mortality: Opaganib treatment resulted in a significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk 2.6) (Sensitivity Analysis: 5/117 vs. 16/134, a significant 64% effic
Slide 13: Global Phase 2/3 - Adherence to Strict Analysis Standards
Global Phase 2/3 - Adherence to Strict Analysis Standards The post-hoc analysis is robust, rigorous and adheres to strict standards of integrity and reliability • FiO2 is a clinically and medically relevant parameter for oxygen requirement & disease severity, irrespective of the device providing the
Slide 14: Further Analysis Details
FURTHER ANALYSIS DETAILS MARK LEVITT, MD, PHD MEDICAL DIRECTOR 14
Slide 15: Patient Demographics and Baseline Characteristics Balanced
Patient Demographics and Baseline Characteristics are Overall Balanced in the Sub-population of Moderately Severe COVID-19 Patients* Opaganib Placebo Parameter Statistics Overall (N=251) (N=117) (N=134) Mean 55.5 55.8 55.7 SD 10.65 13.01 11.95 Age (Years) SE 0.99 1.12 0.75 Median 55.0 58.0 56.0 Sex
Slide 16: Analysis of Potential Confounders
Analysis of Potential Confounders* Confounder Opaganib Placebo Difference Mortality Efficacy continuous noriskfactors 4.60% 11.20% -6.60% 59% Pooled Curr Age Group 1 4.60% 11.50% -6.80% 59% Age: </>median 4.60% 11.50% -6.90% 60% continuous age 4.50% 11.70% -7.20% 62% Cardiovascular Disease (Curr) 4.
Slide 17: Reduction in Mortality by Day 42, By Territory
Reduction in Mortality with Opaganib by Day 42 in Moderately Severe COVID-19 Patients, By Territory, Sensitivity Analysis* Mortality N Mortality N Efficacy (Opaganib) (Opaganib) (Placebo) (placebo) Rate Brazil 2 26 vs. 3 29 26% Colombia 0 4 vs. 1 5 100% Israel 0 15 vs. 2 16 100% Italy 0 17 vs. 2 22
Slide 18: Median Time to Discharge Was Days Shorter with Opaganib
Median Time to Discharge Was 4 Days Shorter with Opaganib vs. Placebo (10 vs. 14)* 1.0 0.8 Discharge Probability 0.6 0.4 0.2 Opaganib Placebo Censored 0.0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 Time to discharge from the hospital (days) Number at Risk Opaganib 117 117 111 98 81
Slide 19: Patients with FiO2 over 60%
Patients with FiO2 over 60% The differences in outcomes in the patients with FiO2 above 60% were variable across sites and territories and were not statistically significant, diluting the benefit demonstrated in the up to 60% FiO2 group. Several reasons might have contributed to this: • Higher disea
Slide 20: Opaganib Oral Pill - Phase 2/3 Safety
Opaganib Oral Pill - Phase 2/3 Safety • We are in the middle of a detailed analysis of the safety data • Topline shows good balance between the arms for the Safety Population of the entire cohort: Opaganib Placebo Event (N=230) (N=233) TEAEs 155 (67.4) 147 (63.1) Serious TEAEs 52 (22.6) 52 (22.3) Gr
Slide 21: Phase 2/3 Safety - Cont.
Opaganib Oral Pill - Phase 2/3 Safety - Cont. • Treatment Emergent Serious Adverse Events (TESAEs) were well balanced with no new signals for opaganib • No imbalances for hepatic, respiratory, cardiac or neuropsychiatric AEs – No imbalances in AEs across the board at the organ system level – More de
Slide 22: Phase 2/3 Safety - Cont.
Opaganib Oral Pill - Phase 2/3 Safety - Cont. • Data mining being performed to look at several other aspects of safety – Preliminary evaluation of potential clinical drug-drug interactions looking clean • More detailed full analysis is being undertaken – Preliminary evaluation of ECGs for QTc effect
Slide 23: Summary Overview: Opaganib Oral Pill for COVID-19
SUMMARY OVERVIEW OPAGANIB ORAL PILL FOR COVID-19 GILEAD RADAY, COO 23
Slide 24: Opaganib Oral Pill for COVID-19: Summary
Opaganib Oral Pill for COVID-19: Summary ✓ 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in moderately severe COVID-19 patients, the majority of hospitalized COVID patients ✓ The p
Slide 25: Thank You! Q&A
Thank You! Q&A RedHill Biopharma Ltd. 21 Ha’arba’a St. Tel-Aviv, 6473921 ,Israel Website: www.RedHillbio.com Email: info@redhillbio.com 25 Tel: +972-3-541-3131