Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (May 2016)
34 slides from Oramed Pharmaceuticals's investor presentation, May 2016
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations May 2016
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 $39M 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 Special cocktail of protease inhibitors stave off and protect the active
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 2014 diabetes expenditure PREVALENCE reached US $ 612 billion 8.3% expected increase +205 every MILLION 7 SECONDS 1 person dies from diabetes 4.9M deaths in 2014 2014 2035 8 ht
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 ~200 ~2000 Clean study subjects* human doses* safety profile 10 * Total number of study subjects: 196. Total number of human doses: 2,063
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: Better type 2 diabetes (T2DM) treatment
ORMD-0801: Better type 2 diabetes (T2DM) treatment by interacting with the body like natural insulin 12
Slide 13: The Type 2 Diabetes Treatment Paradigm
The Type 2 Diabetes Treatment Paradigm 01 02 03 Stage 1: Stage 2: Stage 3: Initial Treatment Single & Combination Late-Stage Treatment - Lifestyle modification Oral Therapies - Insulin (injections) - Diet & exercise - Reduce insulin resistance - Stimulate insulin secretion 13 ADA guidance: Earlier u
Slide 14: 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 15: 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 16: 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 17: Phase IIa FDA Study: ORMD-0801 Demonstrates Sustained Glucose Reduction
Phase IIa FDA Study: ORMD-0801 Demonstrates Sustained Glucose Reduction Safe and well tolerated Sustained glucose reduction Observed to be safe and well tolerated Dose group showed a pronounced for dosing regimen effect over placebo No hypoglycemic events at any point Sustained reduction obs
Slide 18: Ongoing 180 Patient FDA Phase IIb Study
Ongoing 180 Patient FDA Phase IIb Study <30 US sites 180 patients 28 day treatment 1 time a day at night Primary Safety of ORMD-0801 objectives: Evaluate PD effects of ORMD-0801 on mean night glucose 18
Slide 19: ORMD-0801 Type 1 Diabetes (T1DM)
ORMD-0801 Type 1 Diabetes (T1DM): Potentially eliminating the need for insulin before each meal 19
Slide 20: Oramed: Potentially Superseding Bolus Replacement Therapy
Oramed: Potentially Superseding Bolus Replacement 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 fasti
Slide 21: 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 22: 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 23: 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 24: 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 25: ORMD-0901: Oral GLP-1 Analog
ORMD-0901: Oral GLP-1 Analog 25
Slide 26: 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 Ib ex-US study Q3, 2015 Good safety profile Decreases blood glucose levels Phase IIb US study Q4, 2016
Slide 27: Oral GLP-1 - ORMD-0901
Oral GLP-1 - ORMD-0901 Dogs: Subcutaneous exenatide delivery Human (4 healthy volunteers) amounted to a 51% reduction in mean glucose 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 3 0 Gluc
Slide 28: Rich Pipeline: Multiple Value-Creation Events
Rich Pipeline: Multiple Value-Creation Events Phase I Phase II Phase III Timeline ORMD-0801 Q1, ‘14: Phase IIa completed (Oral Insulin) Q2, ’15: Phase IIb study initiated Type 2 Diabetes Q2, ‘16: Phase IIb study projected topline data release ORMD-0801 (Oral Insulin) Q3, ’14: Phase IIa completed Typ
Slide 29: Corporate Overview: On route to meet unmet market needs
Corporate Overview: On route to meet unmet market needs 29
Slide 30: Oramed (NASDAQ: ORMP): Corporate Overview
Oramed (NASDAQ: ORMP): Corporate Overview1 Financial Highlights Analyst Coverage Intellectual Property Estate $39M cash and Rodman & Renshaw (PT $25) Methods and compositions investments for oral administration of Aegis Capital (PT $18) proteins 13.1M shares outstanding (15.7M fully dilute
Slide 31: Lead Team
Lead Team Board of Directors Management Michael Berelowitz, MD Nadav Kidron, Esq, MBA - CEO & Director Chairman of Oramed SAB Many years of business experience as well as SVP Clinical Development & Medical corporate law and technology Affairs, Pfizer (former) Harold Jacob, MD Miriam Kidron, PhD - CS
Slide 32: Scientific Advisory Board
Scientific Advisory Board Michael Berelowitz, MD Nir Barzilai, MD Chairman of SAB Director for the Institute of Aging Former SVP Clinical Development and Research. Member of Diabetes Research Medical Affairs, Specialty Care Business at Center, Albert Einstein University College Pfizer Inc. of Medici
Slide 33: 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 34: Thank You
THANK YOU www.oramed.com Nadav Kidron Josh Hexter CEO COO [email protected] [email protected]
Oramed Pharmaceuticals — Investor Presentation (May 2016) on 6ix