Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (February 2014)
41 slides from Oramed Pharmaceuticals's investor presentation, Feb 12, 2014
Slide 1: Breakthrough Technology for a Brighter Future
Breakthrough Technology for a Brighter Future February 2014
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 Overview
Oramed Overview Proprietary Protein Oral Delivery (POD™) platform technology For the oral delivery of drugs that are currently only available via injection Product Pipeline Proof of Concept established in preclinical and clinical trials Publicly traded - NASDAQCM:ORMP Founded in 2006 by its scientif
Slide 4: Agenda Overview
Agenda Overview Oral Administration Diabetes Oramed Pipeline Corporate Overview The Challenge The Oramed Solution Statistics and Market Oral Insulin Oral GLP-1 Analog Management Team Scientific Advisory Board Intellectual Property Financials
Slide 5: Oramed: An Oral Solution
Oramed An Oral Solution
Slide 6: 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 7: Oramed POD Technology: The Solution
Oramed POD™ Technology: The Solution 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 systems. Protease Inhibitors Enteric
Slide 8: Oramed POD Technology: Versatile, Simple, Competent
Versatile Supports a wide range of protein sizes and doses Simple Simple blend of ingredients Versatile Simple Competent Regulatory competence No NCEs; widely applied pharmacopoeia Oramed POD™ Technology
Slide 9: Potential Oramed Technology Applications: Opportunities & Market
Insulin GLP-1 Analog Other Potential Oramed Technology Applications: Opportunities & Market $15+ billion 2012 global insulin market $32 billion projected market for 2018 $2+ billion 2012 global GLP-1 market Many patients stop treatment as a result of injection-related side effects Vaccines : $24 bil
Slide 10: Diabetes: A Global Epidemic
Diabetes: A Global Epidemic
Slide 11: Diabetes Population and Cost
POPULATION • 371 million : Number of diabetics worldwide • 25.8 million in the US - projected to 44.1 million by 2034 • Type 2 diabetes accounts for about 90% of diabetes cases COST • $ 471 billion : estimated annual global economic burden - includes direct medical costs, disability, reduced product
Slide 12: Oramed Pipeline
Oramed Pipeline
Slide 13: ORMD-0801 Oral Insulin
ORMD-0801 Oral Insulin
Slide 14: Study subjects and human doses as of Nov 12, 2013
As of Nov 12, 2013 Total number of study subjects: Total number of human doses:
Slide 15: Portal insulin delivery is physiologic
Portal insulin delivery is physiologic. Systemic insulin delivery 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 extracts 80% of secreted insulin l Systemic exposure is minimized
Slide 16: ORMD-0801 Type 2 Diabetes (T2DM)
ORMD-0801 Type 2 Diabetes (T2DM)
Slide 17: Type 2 Diabetes: Stages & Treatment Options
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 18: 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) • Effected by liver regulation of glucose and insulin levels in the body during a fast • Elevated FBG levels are a major issue i
Slide 19: ORMD-0801: Preclinical - Dogs
T2DM Time (min) n=4 8 mg insulin ORMD-0801: Preclinical - Dogs • 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 ORMD-0801 (C) ORMD-0801 (A)
Slide 20: ORMD-0801: Preclinical - Pigs
T2DM - NC - Time (min) NC; 4 independent test sessions ORMD-0801; 10 independent sessions Fasting n=2 Pre-prandial Time (min) -20 n=3 NC; 6 independent test sessions ORMD-0801; 5 independent sessions 8 mg insulin ORMD-0801: Preclinical - Pigs No hypoglycemia or adverse events were observed
Slide 21: 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 22: ORMD-0801 Phase 2a Results
ORMD-0801 Phase 2a Results
Slide 23: ORMD-0801: Phase 2a FDA Study
T2DM ORMD-0801: Phase 2a FDA Study Overview: • 30 T2DM patients • US site • In-patient setting • Double blind • Randomized • 1 week of treatment End Points: • Primary end point: • Safety and tolerability • Secondary end points: • Pharmacodynamic effects on mean night time glucose • Pharmacokinetics
Slide 24: Phase 2a Results: Safety
T2DM Phase 2a Results: Safety No Serious Adverse Events The study clearly shows that ORMD-0801 is safe and well tolerated
Slide 25: ORMD-0801 Type 1 Diabetes (T1DM)
ORMD-0801 Type 1 Diabetes (T1DM)
Slide 26: T1DM overview and ORMD-0801 oral insulin
-— _————————— *TLDM 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 children, but the m
Slide 27: 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 28: ORMD-0901 Oral GLP-1 Analog (T2DM)
ORMD-0901 Oral GLP-1 Analog (T2DM)
Slide 29: GLP-1 Hormone Facts, Analog Drug Facts, ORMD-0901
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 30: 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 31: ORMD-0901 - T2DM First in Human Study
Mean AUC Placebo: 148.5 ± 30.5 No Nausea Insulin: 180.3 ± 106.3 21% 150 m g exenatide Time (min) -50 n=4 ORMD-0901 placebo ORMD-0901 - T2DM Study • First in Human • 4 healthy volunteers • Placebo controlled • Pre-prandial
Slide 32: Pipeline Overview
Therapy Indication Phase I Phase II Phase III/ Market Timeline ORMD - 0801 Oral Insulin T2DM Q4, ‘13: Phase 2a completed Q2/3, ’14: Phase 2b multi-center study projected initiation T1DM Q1, ’14: Phase 2a projected initiation Q1, ’15: Phase 2b multi-center study projected initiation ORMD-0901 Oral GL
Slide 33: Corporate Overview
Corporate Overview
Slide 34: Management
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 35: Scientific Advisory Board
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 John Amatruda, MD + Former SVP and Franchise Head of the Diabetes and Obesity Unit at Merck & Co. E
Slide 36: Intellectual Property: Five Primary Worldwide Patent Families
Intellectual Property: Five Primary Worldwide Patent Families Methods and Compositions for Oral Administration of Proteins (Platform Technology) + Expire 2026 & 2028 + Approved or Granted in Israel, Japan (both types), EU, Russia, China, Canada, Australia, New Zealand and South Africa + Pending in m
Slide 37: Financial Overview
Financial Overview* Ticker: NASDAQ: ORMP • $43M raised to date ** • No Debt • Cash and investments: $23.8M • Shares Issued: 9.7M • Fully diluted: 11.9M *** * As of January 14, 2014 ** Including the shares of D.N.A Biomedical Solutions Ltd. *** Including outstanding 0.9M options and 1.5M warrants
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 1b ex-US study • Initiation of Phase 2 multi-site study under US IND T2DM • Completion of Phase 2a FDA study • Initiation & Completi
Slide 39: Analyst Coverage
Analyst Firm Raghuram Selvaraju Aegis Capital Corp. Graig Suvannavejh MLV & Co. Analyst Coverage Oramed is followed by the analysts listed below: Please note that any opinions, estimates or forecasts regarding Oramed's performance made by these analysts are theirs alone and do not represent opinions
Slide 40: In Summary
In Summary • Product pipeline with the potential to expand to other indications • Proprietary technology platform (POD™) for oral delivery of peptides • Clear proof of concept • Strong IP • Orally ingestible insulin capsule in Phase 2 clinical development under the US FDA • Significant market opport
Slide 41: 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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