Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (July 2015)
38 slides from Oramed Pharmaceuticals's investor presentation, Jul 2, 2015
Slide 1: July 2015 Corporate Presentation
Nasdaq: ORMP July 2015 Corporate Presentation
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 m
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
Slide 4: Oramed: An Oral Solution
Oramed An Oral Solution
Slide 5: Fate of proteins/peptides in GIT
Fate of proteins/peptides in GIT Leads to protein breakdown and lack of absorption Harsh pH Protease threat Mechanical challenges Absorption barrier
Slide 6: Oramed POD Technology: Oral Protein and Peptide Delivery
Oramed POD™ Technology: Oral Protein and Peptide Delivery and Absorption Oramed’ s delivery platform protects proteins and enhances their absorption , allowing them to reach the bloodstream via the portal vein, thereby establishing a more physiologic protein gradient when compared to other delivery
Slide 7: Oramed Has Opportunities in Many Large Markets
Insulin GLP - 1 Analog Other Targeting Diabetes Treatment: Oramed has Opportunities in many Large Markets $ 20 billion 2013 global insulin market 1 $ 47 billion projected market for 2020 1 $ 2 + billion 2012 global GLP - 1 market 2 $ 6.6 billion projected for 2018 3 Many patients stop treatment as a
Slide 8: Oral Insulin Administrations To-date
Total number of study subjects : 196 ORMD - 0801 : Oral Insulin Administrations To - date As of October 15 , 2014 0 20 40 60 80 100 120 140 160 180 200 Study Subjects: Breakdown T2DM 50 T1DM 62 Healthy 84 84 62 50 Total number of human doses: 2,063
Slide 9: Type 2 Diabetes (T2DM)
ORMD - 0801 Type 2 Diabetes ( T 2 DM)
Slide 10: Physiologic Insulin Delivery
Physiologic Insulin Delivery Portal insulin delivery is physiologic, while systemic insulin delivery (injected, inhaled, etc.) is not Blood glucose - insulin secretion system forms a 'closed - loop' Peripheral insulin promotes glucose uptake in fat and muscle First - pass hepatic metabolism
Slide 11: Type 2 Diabetes Stages & Treatment Options
IGT Post - prandial hyper - glycemia T 2 DM Phase I Phase II - 12 - 10 - 8 - 6 - 2 0 2 6 8 10 14 b - cell functioning 100 75 50 2 5 0 Phase III Initial Treatment: • Lifestyle Modification • Diet & Exercise Single & Combination Oral Therapies: • Reduce insulin resistance • Stimulate insulin secretion
Slide 12: Unique Initial Indication: Fasting Blood Glucose
Unique Initial Indication (ORMD - 0801 ) Fasting Blood Glucose (FBG): • Measurement of blood glucose levels after a fast (e.g. first thing in the morning) • Effected by liver regulation of glucose and insulin levels in the body during a fast Elevated FBG • Elevated FBG levels are a major issue in T
Slide 13: Trial Results: A Summary
ORMD - 0801 Trial Results: A Summary • 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) • Randomized, double - blind, multi
Slide 14: Phase IIa Results
ORMD - 0801 Phase IIa Results
Slide 15: Phase IIa FDA Study ORA-D-009 Overview
ORMD - 0801 : Phase IIa FDA Study T 2 DM – ORA - D - 009 • 30 T 2 DM patients • US site • In - patient setting • Double blind • Randomized • 1 week of treatment • Primary objective: • Safety and tolerability • Secondary objectives: • Pharmacodynamic effects on mean nighttime glucose • Pharmacokin
Slide 16: Phase IIa Primary Objective: Safety
Phase 2 a: 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 + 16 mg 4 patients
Slide 17: Fasting and Night Time CGM Glucose
Fasting CGM Glucose – mg/DL (1) Placebo (n = 10) ORMD - 0801 8 mg + 8mg (n=10) Difference (ORMD 0801 – placebo) ORMD - 0801 8 mg + 16mg (n=8) Difference (ORMD 0801 – placebo) Last 2 days of data 156.26 (58.62) 126.02 (27.26) - 30.24 136.12 (43.17) - 20.14 All 7 days 154.37 (57.99) 129.27 (27.43) - 2
Slide 18: Phase IIa FDA Study: Safe and Well-Tolerated, Sustained Glucose Reduction
ORMD - 0801 : Phase IIa FDA Study Safe and Well - Tolerated, Sustained Glucose Reduction • 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 the study in any treatment
Slide 19: Proposed Phase IIb FDA Study
ORMD - 0801 : Proposed Phase IIb FDA Study • ~ 180 T 2 DM patients • > 30 US sites • Double blind • Randomized • 28 days of treatment • Primary objective: • Safety: Evaluate the safety of ORMD - 0801 • Efficacy: evaluate the PF effects of ORMD - 0801 on mean nighttime glucose (determined using co
Slide 20: Type 1 Diabetes (T1DM)
ORMD - 0801 Type 1 Diabetes (T 1 DM)
Slide 21: T1DM Overview
T 1 DM – an overview T 1 DM • T 1 DM 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 T 1 DM – approx. 18 - 37 million people worldwide. • The disease was previously on
Slide 22: T1DM Glucose Monitoring Results
Time Frequency (%) Design: 8 T 1 DM, monitor glycemic stability of orally administered ORMD - 0801 ( 1 capsule ( 8 mg insulin) before meals, three times daily). Glucose monitored with continuous, blinded glucose monitor ORMD - 0801 : T 1 DM Glucose (mg// dL ) Mean glucose n= 8 11.5 % Results : Saf
Slide 23: Phase IIa FDA Study ORA-D-010 Overview
ORMD - 0801 : Phase IIa FDA Study • 24 T 1 DM patients • US site • In - patient setting • Double blind • Randomized • Placebo - controlled • 7 days of treatment • Primary objective: • To evaluate the change in exogenous insulin requirements in T 1 DM patients • Secondary objectives: • To evaluate
Slide 24: Phase IIa Topline Key Results
ORMD - 0801 : Phase IIa FDA Study Selected Topline Key Results – Indicating that Insulin Could Possibly be Reduced Further Day 6 • Placebo • No events – 5 ( 50.0 %) • 1 event – 3 ( 30.0 %) • 2 events – 2 ( 20.0 %) • Active • No events – 1 ( 6.7 %) • 1 event – 7 ( 46.7 %) • 2 events – 2 ( 13.3 %) • 3
Slide 25: Phase IIa Topline Key Results: Insulin Use
ORMD - 0801 : Phase IIa FDA Study Selected Topline Key Results – Indicating that Insulin Could Possibly be Reduced Further T 1 DM – ORA - D - 010 -18 -13 -8 -3 2 -60.00 -50.00 -40.00 -30.00 -20.00 -10.00 0.00 10.00 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Delta Basal Insulin Delta Bolus Insulin Del
Slide 26: Proof-of-Concept for Oral Insulin: Summary of Data
T 1 DM – ORA - D - 010 • ORMD - 0801 was observed to be safe and well - tolerated for the preprandial dosing regimen in this study • ORMD - 0801 showed encouraging trends of : • Decreased use of rapid acting insulin vs. placebo • Decreased levels of post - prandial glucose vs. placebo • Decreased
Slide 27: ORMD-0901 Oral GLP-1 Analog (T2DM)
ORMD - 0901 Oral GLP - 1 Analog (T 2 DM )
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 • Has effect on pancreatic β - cells GLP - 1 Analog: Drug Facts • Good safety profile • Mimics the natural hormone in the body • Decreases blood glucose levels – aids
Slide 29: ORMD-0901 Blunting of Glucose Excursions in Dogs
Oral GLP - 1 – ORMD - 0901 Blunting of glucose excursions in dogs Results : Subcutaneous exenatide delivery amounted to a 51 % reduction in mean glucose AUC 0 - 150 , while formulations AG 4 and AG 3 prompted 43 % and 29 % reductions, respectively (* p = 0 . 068 , demonstrating a treatment - related
Slide 30: ORMD-0901 First in Human Study
Mean AUC Placebo: 148.5 30.5 No Nausea Insulin: 180.3 106.3 21% 150 m g exenatide ORMD - 0901 - T 2 DM Study • First in Human • 4 healthy volunteers • Placebo controlled • Pre - prandial ORMD - 0901 placebo 0 20 40 60 80 100 120 140 -50 0 50 100 150 Insulin ( mU /mL) n=4
Slide 31: Pipeline Overview
Pipeline Overview Phase I Phase II Phase III ORMD - 0801 (Oral Insulin) Type 2 Diabetes ORMD - 0801 (Oral Insulin) Type 1 Diabetes ORMD - 0901 (Oral GLP - 1) Type 2 Diabetes Q 1 , ‘ 14 : Phase IIa completed Q 2 , ’ 15 : Phase IIb multi - center study initiated Q 3 , ’ 14 : Phase IIa completed Q 3
Slide 32: Corporate Overview
Corporate Overview
Slide 33: Management and Board of Directors
Management Nadav Kidron, Esq, MBA – CEO & Director Experience in various industries, including 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 – COO, VP Bus. Dev. More than 15 years
Slide 34: Scientific Advisory Board
John Amatruda, MD • Former SVP and Franchise Head of the Diabetes and Obesity Unit at Merck & Co. Michael Berelowitz, MD Chairman of SAB • Former SVP Clinical Development and Medical Affairs, Specialty Care Business at Pfizer Inc. • Strong background in the Diabetes field. Avram Herskho , MD, PhD –
Slide 35: Corporate Overview
Corporate Overview* Ticker: NASDAQ: ORMP • $ 54 M raised to date ** • No Debt • Cash and investments: $ 26.2 M • Shares Issued: 11.5 M • Fully diluted: 14.5 *** • Strong intellectual property estate • Methods & Compositions for Oral Administration of Proteins • Methods & Compositions for Oral Admini
Slide 36: Anticipated Milestones 2015/16
ORMD - 0801 Oral Insulin ORMD - 0901 Oral GLP - 1 Analog Anticipated Milestones 2015 / 16 • Initiation & Completion of IND - enabling studies • Initiation & Completion of Phase Ib ex - US study • Initiation of Phase II multi - site study under US IND T 2 DM x Completion of Phase IIa FDA study x I
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
Slide 38: Contact
Nadav Kidron CEO nadav@oramed.com Josh Hexter COO josh@oramed.com
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