Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (June 2017)
38 slides from Oramed Pharmaceuticals's investor presentation, June 2017
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations June 2017
Slide 2: Safe Harbor
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, and are subject to a number of factors and uncertainties that could cause actual results to differ materi
Slide 3: Oramed Snapshot
Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Insulin first - initially targeting the lucrative insulin market. Additional huge markets in the pipeline ▪ Strong financial position $44M in cash and investments, no debt ▪ Strong management team backed by world- class scientific expert
Slide 4: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
Funneling Huge Injectable Drug Markets to Novel Oral Formulations Insulin GLP-1 Analog Vaccines 2014: 2014: 2014: $24 b $3 b $33 b Flu vaccines Interferon 2011: 2015: $2.9 b $10+ b 4
Slide 5: An Unsolved Challenge: Proteins and Peptides do Not Survive the Digestive System
An Unsolved Challenge: Proteins and Peptides do Not Survive the Digestive System Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier Most therapeutic proteins fail to be absorbed via the intestinal wall (barrier) 5
Slide 6: Oramed Technology Protects Drug Integrity and Increases Absorption
Oramed Technology Protects Drug Integrity and Increases Absorption pH shield for passage through stomach pH sensitive enteric coating protects capsule contents. Capsule dissolves only once in small intestine Protease protection Protease inhibitors stave off and protect the active agent from protease
Slide 7: Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage 7
Slide 8: People on the Planet Have Diabetes
1 in 12 People on the Planet Have Diabetes 1 healthcare Is spent on diabetes in9 WORLD 387 M People living with diabetes In 2015 diabetes expenditure PREVALENCE reached US $ 674 billion 8.3% expected increase +205 every MILLION 6 SECONDS 1 person dies from diabetes 5M deaths in 2015 2014 2035 8 http
Slide 9: Type 1 and Type 2 Diabetes Are Different
Type 1 and Type 2 Diabetes Are Different Diabetes: A metabolic disease in which the body’s inability to produce any or enough insulin causes elevated levels of glucose in the blood TYPE 1 Diabetes TYPE 2 Diabetes ▪ T1DM is autoimmune: The body destroys its ▪ T2DM is metabolic: The body becomes own i
Slide 10: ORMD-0801: Oramed's Flagship Product for Oral Treatment of Diabetes
ORMD-0801: Oramed’s Flagship Product for Oral Treatment of Diabetes >300 >5000 Clean study subjects human doses safety profile 10
Slide 11: The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin
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 To systemic INJECTED INSULIN introduced directly to the circulation bloodstream with only a fraction of it reaching the stomach liver. This can cau
Slide 12: ORMD-0801 Type 1 Diabetes (T1DM)
ORMD-0801 Type 1 Diabetes (T1DM): Potentially eliminating the need for insulin before each meal 12
Slide 13: Oramed: Potentially Replacing Mealtime Therapy
Oramed: Potentially Replacing Mealtime Therapy T1DM patients are treated with 2 types Oramed seeks to replace the mealtime of insulin replacement therapy (bolus) insulin doses ▪ Long-acting insulin (basal) helps maintain ▪ Easier use and reduced systemic stable insulin levels during fasting periods
Slide 14: ORMD-0801: Consistent Lowering of Glucose Levels - Day and Night in Preliminary Study
ORMD-0801: Consistent Lowering of Glucose Levels - Day and Night in Preliminary Study Design: ▪ Monitor glycemic stability of orally administered ORMD-0801 ▪ Uncontrolled T1DM patients ▪ 1 capsule of 8 mg insulin administered before meals, three times daily at mealtime ▪ Continuous glucose monitorin
Slide 15: Phase IIa FDA Study: Shows Consistent and Accumulative Effect of ORMD-0801
Phase IIa FDA Study: Shows Consistent and Accumulative Effect of ORMD-0801 Blood glucose levels are lower, day and night, compared to control group Reduction in FBG 25 T1DM patients Basal or Bolus Insulin (units) 10.00 Delta Placebo vs ORMD 2 Delta Placebo vs ORMD -10.00 FPG (mg/dl) -3 -30.00 -8 7 d
Slide 16: ORMD-0801: Phase IIa FDA Study Demonstrates Oral Insulin Reduces Exogenous Insulin Requirements
ORMD-0801: Phase IIa FDA Study Demonstrates Oral Insulin Reduces Exogenous Insulin Requirements Safe and well tolerated for the pre-meal dosing regimen in this study. Encouraging trends in key areas vs. placebo: Decreased use of rapid-acting insulin levels of post-meal glucose levels of daytime gluc
Slide 17: ORMD-0801: Better type 2 diabetes (T2DM) treatment
ORMD-0801: Better type 2 diabetes (T2DM) treatment by interacting with the body like natural insulin 17
Slide 18: The Type 2 Diabetes Treatment Paradigm
The Type 2 Diabetes Treatment Paradigm 01 02 03 Stage 1: Stage 2: Stage 3: Initial Treatment Oral Therapies Late-Stage Treatment - Lifestyle modification - Reduce insulin resistance - Insulin (injections) - Diet & exercise - Stimulate insulin secretion 18 ADA guidance: Earlier use of insulin equals
Slide 19: Excessive Production of Glucose at Night: A Significant Challenge in Diabetes Management
Excessive Production of Glucose at Night: A Significant Challenge in Diabetes Management ▪ Excessive nocturnal glucose production by the liver is frequently demonstrated in diabetes patients ▪ Results of high blood sugar are measured by a fasting blood sugar (FBG) test, done after an 8-hour fast. Hi
Slide 20: Simple Oral Administration at Bed Time Managing Diabetes
Simple Oral Administration at Bed Time Managing Diabetes Oramed’s first indication, ORMD-0801, reduces excessive nocturnal glucose production in the liver, by acting the same way that natural insulin does. Key benefits Reduction of Increased patient Slowing down FBG levels compliance via simple the
Slide 21: Phase IIa FDA Study: ORMD-0801 Drug Safe With no Serious Adverse Events
Phase IIa FDA Study: ORMD-0801 Drug Safe With no Serious Adverse Events ▪ 30 T2DM patients ▪ Primary objective: Safety and tolerability ▪ Secondary objective: Pharmacodynamic effects on mean nighttime glucose Fasting CGM Glucose (mg/dL) Nighttime CGM Glucose (mg/dL) Daytime CGM Glucose (mg/dL) Place
Slide 22: Completed: 180 Patient FDA Phase IIb Study
Completed: 180 Patient FDA Phase IIb Study 33 US sites 180 patients 28 day treatment 1 Dose (nightly) 22
Slide 23: Phase IIb FDA Study: ORMD-0801 Endpoints and Objectives
Phase IIb FDA Study: ORMD-0801 Endpoints and Objectives ▪ Safety of ORMD-0801 Primary ▪ Evaluate effect of ORMD-0801 on mean 01 objectives nighttime glucose ▪ Evaluate effect of ORMD-0801 on fasting blood Secondary glucose, morning blood insulin, c-peptide, 02 objectives triglycerides ▪ Evaluate eff
Slide 24: Phase IIb FDA Study: Primary Endpoints Successfully Met
Phase IIb FDA Study: Primary Endpoints Successfully Met Safe and well tolerated oral delivery – No drug related serious adverse events Nighttime CGM Glucose Nighttime CGM Glucose Nighttime CGM Glucose Mean % change Mean mg/dl change Median mg/dl change Placebo 13.70 Placebo Placebo 12.38 Change from
Slide 25: Other Continuous Glucose Monitoring Parameters (Exploratory Objectives)
Other Continuous Glucose Monitoring Parameters (Exploratory Objectives) Fasting Daytime 24 Hours 5AM to 7AM 6AM to 10PM Mean Change from Run-in Period Glucose (mg/dl) Placebo P-value=<0.0001* 15.95 Placebo P-value=<0.0001* Placebo 13.26 P-value=0.0010* 11.88 ORMD-0801 P-value=0.0010* ORMD-0801 ORMD-
Slide 26: HbA1c (Exploratory Objective)
HbA1c (Exploratory Objective) Day 29 Statistically significant Change from baseline difference observed in just 29 days Longer treatment duration with ORMD-0801 has the potential for a more significant positive impact on HbA1c Placebo 0.20 ORMD-0801 -0.01* * Indicates comparison to placebo p-Value<0
Slide 27: FDA Phase IIb Study Clearly Demonstrated the Safety and Blood Glucose Lowering Efficacy of ORMD-0801
FDA Phase IIb Study Clearly Demonstrated the Safety and Blood Glucose Lowering Efficacy of ORMD-0801 Safe and well tolerated with no Sustained and highly significant glucose significant hypoglycemic event reduction observed in every glycemic parameter: Fasting, Daytime, Nighttime, 24 hr HbA1c showed
Slide 28: China License Deal: 500M patient potential
China License Deal: 500M patient potential ▪ License: Exclusive right to ORMD-0801 in Greater China Chinese diabetes market* ▪ Licensee: Hefei Tianhui ("HTIT") diabetic Owns with Sinopharm a state-of-the-art GMP API 114M (12% of adult population) insulin manufacturing facility ▪ $50M Payments + Roya
Slide 29: ORMD-0901: Oral GLP-1 Analog
ORMD-0901: Oral GLP-1 Analog 29
Slide 30: GLP-1 Analog: ORMD-0901 for Oral GLP-1 (T2DM)
GLP-1 Analog: ORMD-0901 for Oral GLP-1 (TD2M) GLP-1 Analog ORMD-0901 Clinical Status ▪ T2DM medication ▪ IND-enabling tox studies in process ▪ Mimics the natural hormone in the body ▪ Phase II US study H2-2017 projected ▪ Good safety profile initiation ▪ Decreases blood glucose levels ▪ Does not cau
Slide 31: Oral GLP-1 - ORMD-0901
Oral GLP-1 - ORMD-0901 Dogs: Oral exenatide delivery amounted to a Human (4 healthy volunteers) >50% reduction in mean glucose (similar to SC) Area (mg/dl)/minutes *102 120 ORMD-0901 100 n=4 140 150 mg exenatide Insulin (mU/mL) 80 * 120 60 100 * * 80 40 60 20 40 0 20 Placebo Exenatide - S.C. AG 4 AG
Slide 32: Rich Pipeline: Multiple Value-Creation Events
Rich Pipeline: Multiple Value-Creation Events Phase I Phase II Phase III Timeline ORMD-0801 (Oral Insulin) Q2, ’16: Phase IIb study completed Type 2 Diabetes ORMD-0801 (Oral Insulin) Q3, ’14: Phase IIa completed Type 1 Diabetes ORMD-0901 (Oral GLP-1) H2-’17: IND/ Clinical study projected initiation
Slide 33: Corporate Overview: On route to meet unmet market needs
Corporate Overview: On route to meet unmet market needs 33
Slide 34: Oramed (NASDAQ: ORMP): Corporate Overview
Oramed (NASDAQ: ORMP): Corporate Overview1 Financial Highlights Analyst Coverage Intellectual Property Estate ▪ $44.8M cash and ▪ Rodman & Renshaw (PT $25) ▪ Methods and compositions investments for oral administration of ▪ Aegis Capital (PT $18) proteins ▪ 13.2M shares outstanding (15.7M fully dilu
Slide 35: Management Team
Management Team Board of Directors Nadav Kidron, Esq, MBA - CEO & Director David Slager Many years of business experience as well as corporate Founder and Chairman of Regals law and technology Capital; former Chairman and Portfolio Manager of Attara Capital; Vice Miriam Kidron, PhD - CSO & Director
Slide 36: Scientific Advisory Board
Scientific Advisory Board Roy Eldor, MD, PhD Oramed CMA, Director of the Diabetes Unit Harvey L. Katzeff, MD at the Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv Sourasky Medical Senior Director in Cardiovascular, Center Metabolic, Endocrinology and Renal Division, Covance. Former
Slide 37: Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations ▪ Proprietary platform for oral delivery of drugs, proven in clinical studies ▪ Initially targeting the lucrative insulin market. Additional huge markets in the pipeline ▪ Strong lead team backed by globally pr
Slide 38: Thank You
THANK YOU www.oramed.com Nadav Kidron Josh Hexter CEO COO nadav@oramed.com josh@oramed.com
Oramed Pharmaceuticals — Investor Presentation (June 2017) on 6ix