Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (October 2020)
42 slides from Oramed Pharmaceuticals's investor presentation, Oct 22, 2020
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations October 2020
Slide 2: Safe Harbor
2 Safe Harbor Certain statements contained in this material are forward - looking statements . These forward - looking statements are based on the current expectations of the management of Oramed only, including with respect to clinical trials, milestones and the potential benefits of Oramed's produ
Slide 3: Oramed Snapshot
3 Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Diabetes first - initially targeting the lucrative insulin market ▪ Robust pipeline leveraging IP portfolio for additional significant market opportunities ▪ Strong financial position over $45.6M in cash and investments, no debt 1 ▪ Ex
Slide 4: Proprietary Technology for Oral Drug Delivery
4 Proprietary Technology for Oral Drug Delivery Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier Therapeutic proteins fail to be absorbed via the intestinal wall (barrier) Proteins and Peptides do Not Survive the Digestiv
Slide 5: Multiple Clinical-Stage Programs
5 Phase 2 Phase 3 Multiple Clinical - Stage Programs ORMD - 0801 (Oral Insulin) Type 1 & 2 Diabetes ORMD - 0801 (Oral Insulin) NASH ORMD - 0901 (Oral GLP - 1) Type 2 Diabetes Phase 1 Exploratory Studies Leptin (T1DM – PD: glucose and glycogen reduction; PK)
Slide 6: Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Slide 7: Diabetes prevalence and cost worldwide
7 1 in 1 1 Adults on the Planet Have Diabetes every 6 SECONDS 1 adult dies from diabetes 4M deaths in 2017 https://www.idf.org/e - library/epidemiology - research/diabetes - atlas/159 - idf - diabetes - atlas - ninth - edition - 2019.html WORLD 463 M People live with diabetes PREVALENCE 9 . 09 % 20
Slide 8: ORMD-0801: Oral Insulin
ORMD - 0801: Oral Insulin
Slide 9: ORMD-0801 - Flagship Product for Oral Treatment of Diabetes
9 ORMD - 0801 - Flagship Product for Oral Treatment of Diabetes >900 study subjects >10,000 human doses No Serious Drug - Related Adverse Events
Slide 10: The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin
10 The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin ENDOGENOUS INSULIN produced by the pancreas and delivered to the body via the liver portal vein liver small intestine stomach To systemic circulation Oral insulin , like natural insulin, is delivered first to the liver, resultin
Slide 11: ORMD-0801 for Type 1 & Type 2 Diabetes
11 TYPE 1 Diabetes TYPE 2 Diabetes ▪ T 1 DM is autoimmune: The body destroys its own insulin - producing (beta) cells, leaving patients completely dependent on external insulin sources ▪ 10 % of diabetics have T 1 DM: Up to 37 million people worldwide have T 1 DM ▪ Projected Market: $ 13 billion by
Slide 12: ORMD-0801 for Type 1 Diabetes
12 ▪ Long - acting insulin (basal) helps maintain stable insulin levels during fasting periods ▪ Rapid - acting insulin (bolus) prior to each meal to stabilize blood sugar ▪ Administration is via injection or pump ▪ Easier use and reduced systemic exposure ▪ Potentially reducing multiple daily injec
Slide 13: Phase 2a T1DM Study: Effect of ORMD-0801 for Type 1 Diabetes
13 Decreased x use of rapid - acting insulin x levels of post - meal glucose x levels of daytime glucose Phase 2a T1DM Study Consistent and Accumulative Effect of ORMD - 0801 for Treating Type 1 Diabetes Blood glucose levels lower day and night compared to control group Evaluate change in exogenous
Slide 14: Completed Phase 2 Study for Type 2 Diabetes
14 Completed: 180 Patient Phase 2 Study for Type 2 Diabetes 33 US sites 28 day treatment 1 Dose (nightly) 180 patients
Slide 15: FDA Phase 2 Study Achieved Every Primary Endpoint
15 FDA Phase 2 Study Achieved Every Primary Endpoint with No Drug Related Serious Adverse Events Nighttime CGM Glucose Median mg/dl change Nighttime CGM Glucose Mean mg/dl change Nighttime CGM Glucose Mean % change * Indicates Statistically Significant Difference versus Placebo (p - Value<0.05) Last
Slide 16: FDA Phase 2 Study Exploratory Endpoints: CGM Parameters
16 Daytime 6 AM to 10 PM Fasting 5 AM to 7 AM 24 Hours FDA Phase 2 Study Exploratory Endpoints: CGM Parameters Placebo P - value=<0.0001* 13.26 ORMD - 0801 P - value=< 0.0001 * - 0.32 * Placebo P - value=< 0.0001 * 15.95 Placebo P - value= 0.0010 * 11.88 ORMD - 0801 P - value=< 0.0001 * - 0.41 * ORM
Slide 17: Completed Phase 2b Trial
17 Completed: 298 Patient Phase 2 b Trial 34 US sites* 90 Day treatment 7 Doses 298 Patients* 36 Sites: 2 sites ( 49 subjects) were excluded due to significant treatment by center interaction • 347 subjects received primary treatment and had baseline A 1 c (included in ITT) • 298 subjects included i
Slide 18: Phase 2b Endpoints and Dose Finding
18 Endpoints 01 02 Primary Endpoint ▪ Mean change in HbA 1 c from baseline to Week 12 Secondary Endpoints ▪ Safety (AEs, hypoglycemic) ▪ Fasting Plasma Glucose (FPG) + CGM ▪ Weight Dose Finding ▪ 96 mg/day ( 32 mg X 3 /day) ▪ 32 mg/day ( 32 mg X 1 /day) ▪ 32 mg/day ( 16 mg X 2 /day) ▪ 64 mg/day ( 32
Slide 19: Phase 2b: Primary Endpoint Successfully Met
19 Phase 2b: Primary Endpoint Successfully Met - 0.81 - 0.82 0.25 - 0.36 - 0.54 - 0.53 - 0.45 -1 -0.8 -0.6 -0.4 -0.2 0 0.2 0.4 8mg 8mgx2 16mg 16mgx2 32mg 32mgx2 32mgx3 HbA1c (%) Placebo Adjusted Change from Baseline 8 mg - 1 /day - 0.95 ( - 0.81 placebo adjusted) 60 - 70 % of the randomized patients
Slide 20: Phase 2b: HbA1c Change from Baseline at Week 12
20 Phase 2 b: 8 mg 1 /day – HbA 1 c Change from Baseline at Week 12 -1.6 -1.4 -1.2 -1 -0.8 -0.6 -0.4 -0.2 0 Placebo 8mg 8mg (Baseline >9%) 8 mg ( 1 xday) • 0.95 ( 0.81 placebo adjusted) reduction • p - value : 0.0276 • [ 1.29 A 1 C reduction (Observed Means)] • 1.26 placebo adjusted reduction (Basel
Slide 21: FDA BLA Pathway
21 FDA BLA Pathway: • Confirmatory Phase 3 Study • Submission to FDA x No increase in Adverse Events compared to Placebo x No increase in Hypoglycemic Events compared to Placebo x No weight gain compared to Placebo FDA Phase 2b Trial Results - Primary Endpoint Successfully Met Safe and well tolerate
Slide 22: Pivotal Phase 3 Factors Considered by the FDA
Pivotal Phase 3 Factors considered by the FDA in a pivotal Phase 3 program 1. Efficacy : The study is powered, based on previous Phase 2 data, to include sufficient patients that will provide statistical significance for primary endpoint provided that the drug performs at least equally well in the P
Slide 23: Pivotal Phase 3: Two Protocols
ORA - D - 013 - 1 A Double - Blinded, Placebo - Controlled, Double Dummy, Multi - Center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD - 0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One, Two or Three Oral Glucose - Lowering Agents ORA - D
Slide 24: Pivotal Phase 3: Dosing
Pivotal Phase 3 : Dosing (Selected from P 2 b study data) ▪ ORA - D - 013 - 01 - Double Blind, Double Dummy - 1:1:1 randomization ▪ 8 mg once - daily at night and placebo 45 mins before breakfast ▪ 8 mg twice - daily at night and 45 mins before breakfast ▪ Placebo twice - daily at night and 45 mins
Slide 25: Pivotal Phase 3: Sample Size
25 Pivotal Phase 3 : Sample Size ORA - D - 013 - 2 ORA - D - 013 - 1 450 adult male and female subjects 675 adult male and female subjects Sample size US, Eastern and Western European and Israel - based US - based Territory 36 US sites, 25 ex - US sites 75 US sites Number of Sites
Slide 26: ORA-D-013-1: Primary and Secondary Objectives
26 ORA - D - 013 - 1 : Primary and Secondary Objectives Primary Objective ▪ To compare the efficacy of ORMD - 0801 to placebo in improving glycemic control as assessed by A1c in inadequately controlled T2DM subjects on one, two or three oral glucose - lowering agents. Secondary Objective ▪ To assess
Slide 27: ORA-D-013-2: Primary and Secondary Objectives
27 ORA - D - 013 - 2 : Primary and Secondary Objectives Primary Objectives ▪ Active vs Placebo: - To evaluate the efficacy of ORMD - 0801 compared to placebo in improving glycemic control as assessed by A 1 c in inadequately controlled T 2 DM subjects on diet control alone or on diet control and met
Slide 28: Pivotal Phase 3: Key Inclusion Criteria
28 Pivotal Phase 3 : Key Inclusion Criteria ORA - D - 013 - 1 ▪ HbA 1 c ≥ 7.5 % but ≤ 11.0 % at Screening. ▪ On a stable dose of at least one and up to three of the following oral glucose - lowering agents for a 3 - month period prior to Screening: - Metformin - DPP - 4 inhibitor - SGLT - 2 inhibito
Slide 29: Pivotal Phase 3: Anticipated Clinical Development Timelines
29 Prep NDA & File Pivotal Phase 3 : Anticipated Clinical Development Timelines 2018 2020 2021 2022 Phase 2b 3 - month A1C study T2D Phase 3 study T 2 D Phase 3 study EOP 2 prepare P 3 program Potential approval by Q 1 2024 CSR CSR 2023 2019 2024 CSR
Slide 30: China License Deal
30 China License Deal: 500 M patient potential * Journal of the American Medical Association ▪ License: Exclusive right to ORMD - 0801 in Greater China ▪ Licensee: Hefei Tianhui ("HTIT") Owns with Sinopharm a state - of - the - art GMP API insulin manufacturing facility - HTIT clinical trials of ORM
Slide 31: Seagrove Partners commercial focus groups
31 Seagrove Partners completed focus groups with 94 total participants including HCPs, Patients & Payers in July 2020 . Project Background Key Findings Patient Segmentation Possible Positioning and SWOT Ancillary “ Base ” Package Ancillary “ Upside ” Package Commercial Positioning
Slide 32: NASH Study: Leveraging Oral Insulin for Nonalcoholic Fatty Liver Disease
NASH Study Leveraging Oral Insulin for Nonalcoholic Fatty Liver Disease 32 Nonalcoholic Steatohepatitis (NASH) ▪ Chronic liver disease caused by excessive fat in liver (MoA not fully known) ▪ Leads to fibrosis, cirrhosis and liver failure (death) ▪ 25 % of adults in the U.S. have NAFLD ▪ 5 % of adul
Slide 33: ORMD-0901: Oral GLP-1 Analog
ORMD - 0901: Oral GLP - 1 Analog
Slide 34: GLP-1 Analog: ORMD-0901 for Oral GLP-1
34 ▪ T 2 DM medication ▪ Mimics the natural hormone in the body ▪ Compelling safety profile ▪ Decreases blood glucose levels ▪ Effectively reduces HbA 1 c ▪ Preserves beta cell function ▪ Promotes weight loss ▪ Current therapy via injection only ▪ IND ▪ Bioavailability study GLP - 1 Analog: ORMD - 0
Slide 35: Oral GLP-1 ORMD-0901 Preserved Biological Activity
35 Oral GLP - 1 - ORMD - 0901 Preserved the biological activity of orally delivered exenatide. ORMD - 0901 successfully curbed blood sugar excursions following glucose challenge ORMD - 0901 formulations Preclinical: Oral exenatide delivery amounted to a > 50 % reduction in mean glucose (similar to S
Slide 36: Anticipated Development Milestones
36 Anticipated Development Milestones • Bioavailability Study (T 2 DM) Initiation & Completion • T 2 DM: Initiate Phase 3 • NASH: Initiate Phase 2 • Phase I ex - USA Initiation 0801 0901 Leptin 2020
Slide 37: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
37 Funneling Huge Injectable Drug Markets to Novel Oral Formulations Vaccines 2011 : $ 2.9 b GLP - 1 2017: $6 b Insulin 2014 : $ 24 b NASH 2016: $138 m
Slide 38: Management Team
38 Management Team Nadav Kidron, Esq, MBA - CEO & Director Many years of business experience as well as corporate law and technology Miriam Kidron, PhD - CSO & Director Senior Researcher at the Diabetes Unit of Hadassah Medical Center for more than 25 years Josh Hexter - Chief Operating & Business O
Slide 39: Board of Directors
39 Board of Directors Kevin Rakin - Chairman Co - Founder and Partner at HighCape Partners; former President of Regenerative Medicine at Shire plc Leonard Sank Entrepreneur and business leader; Director of Macsteel Service Centres SA (Pty) Ltd Aviad Friedman Director of public and private companies
Slide 40: Scientific Advisory Board
40 Scientific Advisory Board Roy Eldor, MD, PhD Director, Diabetes Unit, Institute of Endocrinology, Metabolism & Hypertension, Tel - Aviv Medical Center Ele Ferrannini, MD, PhD Professor, Internal Medicine, University of Pisa School of Medicine. Past President of the EASD Alexander Fleming, MD Reco
Slide 41: Oramed (NASDAQ/TASE: ORMP)
41 Oramed (NASDAQ/TASE: ORMP) Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations ▪ Proprietary oral protein delivery platform ▪ Primary Indication: Insulin - initially targeting the lucrative insulin market; additional markets in the pipeline ▪ Strong financial posit
Slide 42: Thank You
THANK YOU www.oramed.com
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