Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Oramed NASH Webinar: Phase 2 Trial Results of ORMD-0801 (November 2022)
29 slides from Oramed Pharmaceuticals's conference presentation, Nov 17, 2022
Slide 1: Webinar Highlighting Phase 2 Clinical Trial of ORMD-0801 for NASH
Webinar Hosted by Oramed Pharmaceuticals Highlighting Detailed Safety and Efficacy Data from Its Positive Phase 2 Clinical Trial of ORMD-0801 for NASH Featuring key opinion leader discussion on the current treatment landscape NOVEMBER 17, 2022 11:00 EST Oramed Pharmaceuticals Inc. © 2022
Slide 2: Forward Looking Statements
Forward Looking Statements • Forar Forward Looking Statements This presentation contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential safety and efficacy of ORMD-0801 to reduce liver fat content in T2D patients with NASH, the timing o
Slide 3: Agenda
Agenda Josh Hexter, Chief Operating and Business Officer, Welcome and introduction Oramed Pharmaceuticals Opening remarks Nadav Kidron, CEO, Oramed Pharmaceuticals Dr. Yaron Ilan, Director of the Department of Overview of NASH Medicine at the Hebrew University-Hadassah Medical Center Presentation of
Slide 4: Meet our Speakers
Meet our Speakers Professor Yaron Ilan, M.D. Joel Neutel, M.D. Dr. Yaron Ilan is the Director of the Department of Dr. Neutel serves as Director of Research at the Orange Medicine at the Hebrew University-Hadassah County Research Center in Orange County, California and at Medical Center. Dr. Ilan se
Slide 5: Oramed Snapshot
Oramed Snapshot COMPANY OVERVIEW SIGNIFICANT PIPELINE, IP, AND CATALYSTS • Proprietary oral protein delivery platform • Robust pipeline leveraging IP portfolio for additional significant market opportunities • Diabetes first - initially targeting the lucrative insulin market • 88 granted patents, 35
Slide 6: Non Alcoholic Fatty Liver Disease: A global epidemic
Non Alcoholic Fatty Liver Disease: A global epidemic Clinical Gastroenterology and Hepatology December 2021 Oramed Pharmaceuticals Inc. © 2022 5
Slide 7: Fatty Liver Progression
Fatty Liver Progression NALF: Non alcoholic fatty liver disease NASH: Non alcoholic steatohepatitis https://ivtd.research.vub.be/en/nafld-nash-modelling Oramed Pharmaceuticals Inc. © 2022 6
Slide 8: Increased risk of cirrhosis and liver cancer
Increased risk of cirrhosis and liver cancer Int. J. Mol. Sci. 2021, 22(9), 4495; https://doi.org/10.3390/ijms22094495 Oramed Pharmaceuticals Inc. © 2022 7
Slide 9: NAFLD Market
NAFLD Market Oramed Pharmaceuticals Inc. © 2022 8
Slide 10: Treatment Landscape
Treatment Landscape There are no FDA- or EMA-approved medications to treat NASH Multiple mechanisms - multiple drugs Oramed Pharmaceuticals Inc. © 2022 9
Slide 11: NASH: The Unmet Need
NASH: The Unmet Need ➢ Safety is a major concern with chronic therapy ➢ Multiple mechanisms implies the need for combination therapy Oramed Pharmaceuticals Inc. © 2022 10
Slide 12: ORMD-0801 Phase 2 Trial Study Results
ORMD-0801 Phase 2 Trial Study Results A Double-Blind, Randomized, Placebo- controlled, Multicenter Study to Assess the Safety and Efficacy of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH) November 2022 Oramed Pharmaceuticals Inc. © 2022
Slide 13: Introduction
Introduction • Primary Objective is to evaluate the safety of oral insulin in patients with nonalcoholic steatohepatitis (NASH) and type 2 DM • Secondary Objective is to assess whether oral insulin may be effective in reducing liver fat content in patients with NASH and type 2 DM • Exploratory outco
Slide 14: Secondary Objective
Secondary Objective: To assess whether oral insulin may be effective in reducing liver fat content in patients with NASH and type 2 DM. Oramed Pharmaceuticals Inc. © 2022 13
Slide 15: Individual Percent Change in MRI-PDFF Levels at Week 12
Individual Percent Change in MRI-PDFF Levels at Week 12 Mean Levels at Baseline Placebo ORMD-0801 Whole Liver 21.558 15.683 Segment 3 20.617 14.560 Segment 6 22.174 15.828 Segment 8 22.565 16.071 Oramed Pharmaceuticals Inc. © 2022 14
Slide 16: Mean Percent Change in MRI-PDFF Levels at Week 12
Mean Percent Change in MRI-PDFF Levels at Week 12 Mean Levels at Baseline Placebo ORMD-0801 Whole Liver 21.558 15.683 Segment 3 20.617 14.560 Segment 6 22.174 15.828 Segment 8 22.565 16.071 Oramed Pharmaceuticals Inc. © 2022 15
Slide 17: Exploratory Outcomes
Exploratory Outcomes: • Change from baseline at week 12 in FibroScan® Median Steatosis in dB/m Levels • Change from baseline at week 12 in FibroScan® Median Fibrosis in kPa Levels • Change from baseline at weeks 12 and 16 in HbA1c Oramed Pharmaceuticals Inc. © 2022 16
Slide 18: Individual Change in FibroScan Steatosis Median Levels Over Time
Individual Change in FibroScan® Steatosis Median Levels Over Time Median Levels at Baseline Placebo ORMD-0801 335.0 329.0 Oramed Pharmaceuticals Inc. © 2022 17
Slide 19: Median Change in FibroScan Steatosis Median Levels Over Time
Median Change in FibroScan® Steatosis Median Levels Over Time Median Levels at Baseline Placebo ORMD-0801 335.0 329.0 Oramed Pharmaceuticals Inc. © 2022 18
Slide 20: Individual Change in FibroScan Fibrosis Median Levels Over Time
Individual Change in FibroScan® Fribrosis Median Levels Over Time Median Levels at Baseline Placebo ORMD-0801 8.4 8.6 Oramed Pharmaceuticals Inc. © 2022 19
Slide 21: Median Change in FibroScan Fibrosis Median kPa Levels Over Time
Median Change in FibroScan® Fibrosis Median kPa Levels Over Time Median Levels at Baseline Placebo ORMD-0801 8.4 8.6 Oramed Pharmaceuticals Inc. © 2022 20
Slide 22: Mean Change in HbA1c Levels Over Time
Mean Change in HbA1c Levels Over Time Mean Levels at Baseline Placebo ORMD-0801 7.44 7.74 Oramed Pharmaceuticals Inc. © 2022 21
Slide 23: Summary of Results
Summary of Results • Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and placebo. • Secondary Objective of reducing liver fat content in patients with NASH and T2D (Percent Change from Baseline to Week 12 in M
Slide 24: Summary of Results Continued
Summary of Results Continued • Exploratory objective of median change from baseline in FibroScan® at week 12 • Median steatosis levels showed a placebo adjusted median decrease of 29 for ORMD-0801. • Median fibrosis levels showed a placebo adjusted median decrease of 1.1 for ORMD-0801. • Other highl
Slide 25: Key Opinion Leader Discussion
Key Opinion Leader Discussion: Professor Yaron Ilan, M.D. Joel Neutel, M.D. Oramed Pharmaceuticals Inc. © 2022 24
Slide 26: Q&A
Q&A oramed.com Oramed Pharmaceuticals Inc. © 2022 25
Slide 27: Thank you
Thank you oramed.com Oramed Pharmaceuticals Inc. © 2022 26
Slide 28: Appendix
Appendix Oramed Pharmaceuticals Inc. © 2022 27
Slide 29: Proprietary Technology for Oral Drug Delivery
Proprietary Technology for Oral Drug Delivery Proteins and Peptides do Not Oramed Technology Protects Drug Survive the Digestive System Integrity and Increases Absorption Harsh pH pH shield Stomach acidity cleaves and shreds protein Sensitive enteric coating protects capsule contents before entering