Oramed Pharmaceuticals Inc. · NASDAQ:ORMP

Oramed Pharmaceuticals — Investor Presentation (July 2015)

38 slides from Oramed Pharmaceuticals's investor presentation, July 2015

  1. Slide 1: Corporate Presentation

    Corporate Presentation Nasdaq: ORMP July 2015

  2. 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

  3. Slide 3: Investment Highlights

    Investment Highlights Proprietary technology platform (POD™) for oral delivery of peptides Significant market opportunity: focus on significant medical needs Clinical proof of concept achieved Orally ingestible insulin: US FDA Phase II clinical development Strong product pipeline: potential to expan

  4. Slide 4: Oramed: An Oral Solution

    Oramed An Oral Solution 4

  5. Slide 5: Fate of proteins/peptides in GIT

    Fate of proteins/peptides in GIT Harsh pH Mechanical Protease Absorption challenges threat barrier Leads to protein breakdown and lack of absorption 5

  6. Slide 6: Oramed POD Technology: Oral Protein and Peptide Delivery

    Oramed POD™ Technology: Oral Protein and Peptide Delivery and Absorption Enteric Coating Protease Inhibitors Absorption Enhancers pH sensitive – only degrades in the Protects protein from Assists with translocation of small intestine, thus protecting capsule degradation by proteases active ingredien

  7. Slide 7: Targeting Diabetes Treatment: Opportunities in Many Large Markets

    Targeting Diabetes Treatment: Oramed has Opportunities in many Large Markets $20 billion 2013 global insulin market1 Insulin $47 billion projected market for 20201 $2+ billion 2012 global GLP-1 market2 GLP-1 $6.6 billion projected for 20183 Analog Many patients stop treatment as a result of injectio

  8. Slide 8: ORMD-0801: Oral Insulin Administrations To-date

    ORMD-0801: Oral Insulin Administrations To-date Total number of 200 50 study subjects: 180 160 140 120 62 196 100 80 60 84 40 Total number of 20 human doses: 0 Study Subjects: Breakdown T2DM 50 T1DM 62 2,063 Healthy 84 As of October 15, 2014 8

  9. Slide 9: ORMD-0801 Type 2 Diabetes (T2DM)

    ORMD-0801 Type 2 Diabetes (T2DM) 9

  10. Slide 10: Physiologic Insulin Delivery

    Physiologic Insulin Delivery  Portal insulin delivery is To systemic physiologic, while systemic insulin circulation delivery (injected, inhaled, etc.) is stomach not liver  Blood glucose - insulin secretion system forms a 'closed-loop'  Peripheral insulin promotes glucose uptake in fat and muscl

  11. Slide 11: ORMD-0801 Treats Diabetes Sooner

    T2DM ORMD-0801 Treats Diabetes Sooner: Type 2 Diabetes Stages & Treatment Options Criteria for advancing to next stage: Initial Treatment: AIC not at target < 7.0% • Lifestyle Modification 100 • Diet & Exercise b-cell functioning Single & Combination Oral Therapies: 75 • Reduce insulin resistance •

  12. Slide 12: Unique Initial Indication (ORMD-0801)

    Unique Initial Indication (ORMD-0801) ORMD-0801: Unique Indication • Nighttime dose • Focused on reducing the excessive nocturnal glucose production from the liver Fasting Blood Glucose (FBG): • Measurement of blood glucose levels after a fast (e.g. first thing in the morning) • Effected by liver re

  13. Slide 13: ORMD-0801 Trial Results: A Summary

    T2DM ORMD-0801 Trial Results: A Summary Pre-clinical • Healthy, non-diabetic, cannulated beagle dogs showed a 60-75% drop in blood glucose levels within 30-100 minutes of treatment • No hypoglycemia or adverse events were observed over the three years of testing (in dogs) T2DM Patients ORA-D-004 8 P

  14. Slide 14: ORMD-0801 Phase IIa Results

    ORMD-0801 Phase IIa Results 14

  15. Slide 15: ORMD-0801: Phase IIa FDA Study

    T2DM – ORA-D-009 ORMD-0801: Phase IIa FDA Study Overview • 30 T2DM patients • US site • In-patient setting • Double blind • Randomized • 1 week of treatment Objectives • Primary objective: • Safety and tolerability • Secondary objectives: • Pharmacodynamic effects on mean nighttime glucose • Pharmac

  16. Slide 16: Phase 2a: Primary Objective Safety

    T2DM – ORA-D-009 Phase 2a: Primary Objective Safety Hypoglycemic Events 0 Serious Adverse Events 0 Severe Adverse Events 0 ORMD 0801 Related Adverse Events 0 Adverse Events (non treatment related): Placebo 5 patients 7 reported adverse events 8 mg + 8 mg 3 patients 5 reported adverse events 8 mg + 1

  17. Slide 17: Phase IIa

    T2DM – ORA-D-009 Phase IIa Mean fasting blood glucose concentrations (CGM) Fasting CGM Placebo (n = 10) ORMD-0801 Difference ORMD-0801 Difference Glucose – mg/DL (1) 8 mg + 8mg (n=10) (ORMD 0801 – placebo) 8 mg + 16mg (n=8) (ORMD 0801–placebo) Last 2 days of data 156.26 (58.62) 126.02 (27.26) -30.24

  18. Slide 18: ORMD-0801: Phase IIa FDA Study

    T2DM – ORA-D-009 ORMD-0801: Phase IIa FDA Study Safe and Well-Tolerated, Sustained Glucose Reduction Safety Conclusions • ORMD-0801 oral insulin gel caps were observed to be safe and well-tolerated for the dosing regimen considered in this study • No hypoglycemic events occurred at any point during

  19. Slide 19: ORMD-0801: Proposed Phase IIb FDA Study

    T2DM ORMD-0801: Proposed Phase IIb FDA Study Overview • ~180 T2DM patients • >30 US sites • Double blind • Randomized • 28 days of treatment Objectives • Primary objective: • Safety: Evaluate the safety of ORMD-0801 • Efficacy: evaluate the PF effects of ORMD-0801 on mean nighttime glucose (determin

  20. Slide 20: ORMD-0801 Type 1 Diabetes (T1DM)

    ORMD-0801 Type 1 Diabetes (T1DM) 20

  21. Slide 21: T1DM – an overview

    T1DM T1DM – an overview T1DM • T1DM is an autoimmune disease – the body destroys its own insulin-producing cells leaving patients completely dependent on external insulin sources • 5-10% of diabetes cases are T1DM – approx. 18-37 million people worldwide. • The disease was previously only seen in ch

  22. Slide 22: ORMD-0801: T1DM

    T1DM ORMD-0801: T1DM Mean glucose n=8 Frequency glucose >200mg/dL 300 58 51 50  11.5% Glucose (mg//dL) 280 38 Pretreatment 260 Treatment 240 220 Day Night Frequency (%) 200 60 180 50 Day Night 40 Pretreatment Treatment 30 20 6:00 9:00 12:00 14:00 19:00 21:00 00:00 Results: Safe, well tolerated, 8:5

  23. Slide 23: ORMD-0801: Phase IIa FDA Study

    T1DM – ORA-D-010 ORMD-0801: Phase IIa FDA Study Overview • 24 T1DM patients • US site • In-patient setting • Double blind • Randomized • Placebo-controlled • 7 days of treatment Objectives • Primary objective: • To evaluate the change in exogenous insulin requirements in T1DM patients • Secondary ob

  24. Slide 24: Hypoglycemic Events

    T1DM – ORA-D-010 ORMD-0801: Phase IIa FDA Study Selected Topline Key Results – Indicating that Insulin Could Possibly be Reduced Further Hypoglycemic Events Day 6 Placebo Hypo ORMD-0801 Delta FPG • Placebo • No events – 5 (50.0%) 40 40 • 1 event – 3 (30.0%) 30 30 • 2 events – 2 (20.0%) • Active 20 2

  25. Slide 25: ORMD-0801: Phase IIa FDA Study Topline Results

    T1DM – ORA-D-010 ORMD-0801: Phase IIa FDA Study Selected Topline Key Results – Indicating that Insulin Could Possibly be Reduced Further 10.00 2 0.00 Basal or Bolus Insulin (units) Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Delta Placebo vs ORMD Delta Placebo vs ORMD -10.00 -3 FPG (mg/dl) -20.00 -8 -

  26. Slide 26: Proof-of-Concept for ORMD-0801 Oral Insulin

    T1DM – ORA-D-010 ORMD-0801: Phase IIa FDA Study Proof-of-Concept for ORMD-0801 Oral Insulin to Reduce Exogenous Insulin Requirements SUMMARY OF DATA • ORMD-0801 was observed to be safe and well-tolerated for the preprandial dosing regimen in this study • ORMD-0801 showed encouraging trends of: • Dec

  27. Slide 27: ORMD-0901 Oral GLP-1 Analog (T2DM)

    ORMD-0901 Oral GLP-1 Analog (T2DM) 27

  28. Slide 28: Oral GLP-1 Analog (Exenatide)

    Oral GLP-1 Analog (Exenatide) GLP-1: Hormone Facts • Secreted by the intestine • Has effect on the satiety center in the brain ORMD-0901 • Has effect on pancreatic β-cells Oral GLP-1 • Pre-IND package submitted GLP-1 Analog: Drug Facts to the US FDA Q3 2013 • Good safety profile • IND-enabling tox s

  29. Slide 29: Oral GLP-1 – ORMD-0901: Blunting of glucose excursions in dogs

    Oral GLP-1 – ORMD-0901 Blunting of glucose excursions in dogs *102 120 Methods: 100  Healthy, fasting, cannulated Area (mg/dl)/minutes dogs 80 *  Single dose ORMD-0901 60 * * formulation  Administered 30 minutes 40 pre-glucose challenge  Blood samples collected every 20 15 minutes 0 Exenatide -

  30. Slide 30: ORMD-0901 - T2DM First in Human Study

    ORMD-0901 - T2DM Study • First in Human • 4 healthy volunteers • Placebo controlled • Pre-prandial ORMD-0901 Mean AUC n=4 140 Placebo: 120 148.530.5 Insulin (mU/mL) 100 150 mg No Nausea 80 exenatide Insulin: 60 180.3106.3 40  21% 20 placebo 0 -50 0 50 100 150 30

  31. Slide 31: Pipeline Overview

    Pipeline Overview Phase I Phase II Phase III Timeline Q1, ‘14: Phase IIa completed ORMD-0801 (Oral Insulin) Q2, ’15: Phase IIb multi-center study Type 2 Diabetes initiated ORMD-0801 (Oral Insulin) Q3, ’14: Phase IIa completed Type 1 Diabetes ORMD-0901 (Oral GLP-1) Q3, ’14: Preclinical/IND studies in

  32. Slide 32: Corporate Overview

    Corporate Overview 32

  33. Slide 33: Management

    Management Nadav Kidron, Esq, MBA – CEO & Director Experience in various industries, including corporate law and technology Board of Directors Michael Berelowitz, MD Miriam Kidron, PhD – CSO & Director • Chairman of Oramed SAB Senior Researcher at the Diabetes Unit of Hadassah • SVP Clinical Develop

  34. Slide 34: Scientific Advisory Board

    Scientific Advisory Board Michael Berelowitz, MD Chairman of SAB Derek LeRoith, MD, PhD • Former SVP Clinical Development and • Professor of Medicine and Chief of Medical Affairs, Specialty Care Business Endocrinology, Diabetes and Bone at Pfizer Inc. Disease Unit, Mount Sinai School of • Strong bac

  35. Slide 35: Corporate Overview

    Corporate Overview* Ticker: NASDAQ: ORMP Nadav Special • $54M raised to date ** Kidron Situation 7% Fund • No Debt 4% Regals Fund • Cash and investments: $26.2M 8% • Shares Issued: 11.5M Leonard Sank • Fully diluted: 14.5*** 4% •Strong intellectual property estate Guangxi Public Wuzhou • Methods & C

  36. Slide 36: Anticipated Milestones 2015/16

    Anticipated Milestones 2015/16 T2DM  Completion of Phase IIa FDA study ORMD-0801  Initiation & Completion of Phase IIb multi-site Oral Insulin study under US IND T1DM  Completion of Phase IIa FDA study ORMD-0901 • Initiation & Completion of IND-enabling studies Oral GLP-1Analog • Initiation & Com

  37. Slide 37: Summary

    Summary Proprietary technology platform (POD™) for oral delivery of peptides Significant market opportunity: focus on significant medical needs Clinical proof of concept achieved Orally ingestible insulin: US FDA Phase II clinical development Strong product pipeline: potential to expand to other ind

  38. Slide 38: Nadav Kidron, CEO; Josh Hexter, COO

    Nadav Kidron Josh Hexter CEO COO nadav@oramed.com josh@oramed.com

Oramed Pharmaceuticals — Investor Presentation (July 2015) on 6ix