Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (December 2014)
40 slides from Oramed Pharmaceuticals's investor presentation, Dec 2, 2014
Slide 1: Corporate Presentation
March 2014 Nasdaq: ORMP December 2014 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 materi
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 ex
Slide 4: Oramed: An Oral Solution
Oramed An Oral Solution
Slide 5: Fate of proteins/peptides in GIT
Harsh pH Protease threat Mechanical challenges Absorption barrier Fate of proteins/peptides in GIT Leads to protein breakdown and lack of absorption
Slide 6: Oramed POD Technology: Oral Protein and Peptide Delivery and Absorption
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 s
Slide 7: Physiologic Insulin Delivery
Physiologic Insulin Delivery l Portal insulin delivery is physiologic, while systemic insulin delivery (injected, inhaled, etc.) is not l Blood glucose - insulin secretion system forms a 'closed-loop' l Peripheral insulin promotes glucose uptake in fat and muscle l First-pass hepatic metabolism extr
Slide 8: Targeting Diabetes Treatment: 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 result o
Slide 9: As of October 15, 2014
As of October 15, 2014 Total number of study subjects: Total number of human doses:
Slide 10: ORMD-0801 Type 2 Diabetes (T2DM)
ORMD-0801 Type 2 Diabetes (T2DM)
Slide 11: ORMD-0801 Treats Diabetes Sooner
T2DM Initial Treatment: • Lifestyle Modification • Diet & Exercise Single & Combination Oral Therapies: • Reduce insulin resistance • Stimulate insulin secretion Final Treatment: • Insulin Replacement (injections) ORMD-0801 is not a substitute for insulin injections, but rather a new earlier treatme
Slide 12: ORMD-0801: Unique Indication T2DM, Fasting Blood Glucose
Fasting Blood Glucose (FBG): Elevated FBG FBG: Stats ORMD-0801: Unique Indication T2DM • Measurement of blood glucose levels after a fast (e.g. first thing in the morning) • Elevated FBG levels are a major issue in T2DM • Main cause: excessive nocturnal glucose production from liver • Approximately
Slide 13: ORMD-0801 Trial Results: A Summary
T2DM Patients Pre-clinical T2DM 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,
Slide 14: ORMD-0801 Phase IIa Results
ORMD-0801 Phase IIa Results
Slide 15: T2DM - ORA-D-009 Objectives Overview
T2DM - ORA-D-009 Objectives Overview ORMD-0801: Phase IIa FDA Study • 30 T2DM 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 • Pharmac
Slide 16: Phase 2a: Primary Objective Safety
Hypoglycemic Events Adverse Events (non treatment related): T2DM - ORA-D-009 Phase 2a: Primary Objective Safety Serious Adverse Events Severe Adverse Events ORMD 0801 Related Adverse Events Placebo 5 patients 7 reported adverse events 8 mg + 8 mg 3 patients 5 reported adverse events 8 mg + 16 mg 4 p
Slide 17: T2DM - ORA-D-009 CGM Glucose Results
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) -25.10 144.
Slide 18: T2DM - ORA-D-009 Safety Conclusions and Efficacy
T2DM - ORA-D-009 Safety Conclusions Efficacy • 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 group • No ORMD-0801 related adverse events obse
Slide 19: Proposed Phase IIb FDA Study Objectives Overview
Objectives Overview T2DM ORMD-0801: Proposed Phase IIb FDA Study • ~180 T2DM 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 (determin
Slide 20: ORMD-0801 Type 1 Diabetes (T1DM)
ORMD-0801 Type 1 Diabetes (T1DM)
Slide 21: T1DM Treatment: ORMD-0801 Oral Insulin and T1DM
T1DM Treatment ORMD-0801 Oral Insulin and T1DM T1DM T1DM - an overview • 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. •
Slide 22: ORMD-0801: T1DM
T1DM 50.75 49.7 DAY NIGHT pretreatment treatment Frequency glucose >200mg/dL 06:00 - 08:59 09:00 - 11:59 12:00 - 13:59 14:00 - 18:59 19:00 - 20:59 21:00 - 23:59 00:00 - 05:59 Time Design: 8 T1DM, monitor glycemic stability of orally administered ORMD-0801 (1 capsule (8 mg insulin) before meals, thre
Slide 23: T1DM - ORA-D-010 Objectives Overview
Objectives Overview T1DM - ORA-D-010 ORMD-0801: Phase IIa FDA Study • 24 T1DM 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 T1DM patients • Secondary ob
Slide 24: T1DM - ORA-D-010 Finger Stick Fasting Blood Glucose Prior to Breakfast
T1DM - ORA-D-010 Finger Stick Fasting Blood Glucose Prior to Breakfast ORMD-0801: Phase IIa FDA Study Selected Topline Key Results - Indicating that Insulin Could Possibly be Reduced Further Day 1 Change from Average Run-in Value • Placebo → -27.3 • Active → -29.7 Day 2 Change from Average Run-in Va
Slide 25: T1DM - ORA-D-010 Hypoglycemic Events
T1DM - ORA-D-010 Hypoglycemic Events 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
Slide 26: T1DM - ORA-D-010 Topline Key Results
T1DM - ORA-D-010 ORMD-0801: Phase IIa FDA Study Selected Topline Key Results - Indicating that Insulin Could Possibly be Reduced Further
Slide 27: T1DM - ORA-D-010 Topline Key Results
T1DM - ORA-D-010 ORMD-0801: Phase IIa FDA Study Selected Topline Key Results - Indicating that Insulin Could Possibly be Reduced Further
Slide 28: Safety Conclusions and Efficacy T1DM - ORA-D-010
Safety Conclusions Efficacy T1DM - ORA-D-010 ORMD-0801: Phase IIa FDA Study Proof-of-Concept for ORMD-0801 Oral Insulin to Reduce Exogenous Insulin Requirements • ORMD-0801 oral insulin gel caps were observed to be safe and well-tolerated for the preprandial dosing regimen considered in this study •
Slide 29: ORMD-0901 Oral GLP-1 Analog (T2DM)
ORMD-0901 Oral GLP-1 Analog (T2DM)
Slide 30: GLP-1 Hormone Facts and ORMD-0901 Oral GLP-1
GLP-1: Hormone Facts GLP-1 Analog: Drug Facts ORMD-0901 Oral GLP-1 Oral GLP-1 Analog (Exenatide) • Secreted by the intestine • Has effect on the satiety center in the brain • Has effect on pancreatic β -cells • Good safety profile • Mimics the natural hormone in the body • Decreases blood glucose le
Slide 31: Oral GLP-1 - ORMD-0901: Blunting of glucose excursions in dogs
Oral GLP-1 - ORMD-0901 Blunting of glucose excursions in dogs S.C. AG AG - + + + + Exenatide * * * Glucose Results: Subcutaneous exenatide delivery amounted to a 51% reduction in mean glucose AUC 0-150 , while formulations AG4 and AG3 prompted 43% and 29% reductions, respectively (* p = 0.068, demon
Slide 32: Mean AUC
Mean AUC Placebo: 148.5 ± 30.5 No Nausea Insulin: 180.3 ± 106.3
Slide 33: Pipeline Overview
Phase I Phase II Phase III Timeline ORMD-0801 oral insulin Type 2 diabetes Q4, ‘13: Phase IIa completed Q4, ’14: Phase IIb multi-center study projected initiation Type 1 diabetes Q3, ’14: Phase IIa completed ORMD-0901 oral GLP-1 Type 2 diabetes Q3, ’14: Preclinical/IND studies projected initiation Q
Slide 34: Corporate Overview
Corporate Overview
Slide 35: 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 of
Slide 36: Scientific Advisory Board
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 Derek LeRoith, MD, PhD + Professor of Medicine and Chief of Endocrinology, Diabetes and Bone Disease Unit, Mount Sinai School
Slide 37: Corporate Overview
Corporate Overview* Ticker: NASDAQ: ORMP • $49M raised to date ** • No Debt • Cash and investments: $24.4M • Shares Issued: 10.8M • Fully diluted: 12.8M *** • Strong intellectual property estate • Methods & Compositions for Oral Administration of Proteins • Methods & Compositions for Oral Administra
Slide 38: Anticipated Milestones 2014-2015
ORMD-0801 Oral Insulin ORMD-0901 Oral GLP-1Analog Anticipated Milestones 2014-2015 • Initiation & Completion of IND-enabling studies • Initiation & Completion of Phase Ib ex-US study • Initiation of Phase II multi-site study under US IND T2DM ü Completion of Phase IIa FDA study • Initiation & Comple
Slide 39: 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 40: Breakthrough Technology for a Brighter Future
Breakthrough Technology for a Brighter Future Contact : Nadav Kidron CEO nadav@oramed.com Josh Hexter COO josh@oramed.com
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