Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — IPO Roadshow (June 2013)
42 slides from Oramed Pharmaceuticals's IPO roadshow presentation, Jun 17, 2013
Slide 1: Breakthrough Technology for a Brighter Future
Breakthrough Technology for a Brighter Future Issuer Free Writing Prospectus Filed Pursuant to Rule 433 Registration No. 333-187343 June 17, 2013
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: Free Writing Prospectus Statement
Free Writing Prospectus Statement This presentation highlights basic information about us and the offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement (including a prospectus dated March 22, 20
Slide 4: Offering Summary
Issuer Oramed Pharmaceuticals Inc. Exchange / Ticker NASDAQ Capital Market / ORMP Offering Size Approximately $13 million (100% Primary) Over-allotment 15% (100% Primary) Use of Proceeds Clinical development of ORMD-0801 and ORMD-0901, working capital & general corporate purposes Book-Runners Aegis
Slide 5: Oramed: An oral solution
Oramed An oral solution….
Slide 6: Proprietary platform technology for oral delivery of drugs
Has a proprietary platform technology for oral delivery of drugs -- currently available via injection only Flagship product - Oral insulin for Type 2. Product Pipeline includes: + Oral Insulin Capsule (ORMD-0801) + Oral Exenatide Capsule (ORMD-0901; a GLP-1 Analog) + Combination Therapy (ORMD 0801 +
Slide 7: Fate of proteins/peptides in GIT
Fate of proteins/peptides in GIT Protein breakdown, low bioavailability Harsh pH Protease threat Mechanical challenges Absorption barrier
Slide 8: Oramed Technology
Oramed Technology: 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.
Slide 9: Oramed Drug Delivery
ORAMED DRUG DELIVERY Versatile Simple Competent Versatile Supports a wide range of protein sizes and doses Simple Simple blend of ingredients Regulatory competence No NCEs; widely applied pharmacopoeia Oramed Technology
Slide 10: Diabetes: A Global Epidemic
Diabetes: A Global Epidemic
Slide 11: Type 2 Diabetes: A Global Epidemic
http://www.idf.org/home/ Type 2 Diabetes: A Global Epidemic • $471 billion : Estimated total annual economic cost of diabetes worldwide ( IDF, 2012) • $14.5 billion : Estimated total global insulin market (ReportLinker, 2010) Year 171 Million 30 Million 371 Million (IDF Diabetes Atlas, 2012) Type 2
Slide 12: Pipeline Overview
Therapy Indication Preclinical Phase I Phase II (ex-US) Phase II (FDA) Timeline ORMD - 0801 ORMD-0901 Combination Therapy T2DM Q3, ‘13: Phase IIa “sub-study” projected initiation Q2, ’14: Phase IIb multi-center study projected initiation T1DM Q2, ‘14: Phase II (ex-US) multi-center trial projected in
Slide 13: ORMD-0801 Oral Insulin
ORMD-0801 Oral Insulin
Slide 14: Total number of study subjects and administrations
131 1444 Total number of study subjects: Total number of administrations in humans:
Slide 15: ORMD-0801 Type 2 Diabetes
ORMD-0801 Type 2 Diabetes
Slide 16: Portal insulin delivery is physiologic
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 Portal insulin delivery is physiologic. Systemic insulin delivery is not.
Slide 17: Type 2 Diabetes: Stages & Treatment Options
Initial Treatment: • Lifestyle Modification • Diet & Exercise Single & Combination Oral Therapies: • ORMD-0801 • Reduce insulin resistance • Stimulate insulin secretion Final Treatment: • Insulin Replacement ORMD-0801 is not a substitute for insulin injections, but rather a new earlier treatment opt
Slide 18: Unique Initial Indication
Unique Initial Indication + Measurement of blood glucose levels after a fast, here defined as 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 Type 2 diabetics + Main cause: exces
Slide 19: Toxicology studies in rats
* 90 rats, 28-day tox + 14-day post-treatment monitoring + Doses: 3 times greater than human exposure + “Overall, no safety signals were observed in either the PoC studies in Beagle dogs or pigs or the 28-day repeat does toxicity and toxicokinetic studies in Sprague Dawley rats...” (Oramed’s IND App
Slide 20: Preclinical - Dogs
Healthy, non-diabetic, cannulated beagle dogs 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 Time (min) n=4 8 mg insulin 8 mg insulin, no additives 1.5 U NovoRapid ORMD-0801 (A) ORMD-0801 (C) ORMD
Slide 21: Preclinical - Pigs
- NC - Time (min) NC; 4 independent test 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
Slide 22: Phase II Study (ex-US)
Phase II Study (ex-US): Design: Multi-centered, placebo-controlled, randomized, double-blinded, 29 T2DM patient study to evaluate safety and tolerability of one bedtime orally administered ORMD-0801 formulation (2 capsules containing 8 mg insulin each) as well as its effectiveness in providing glyce
Slide 23: Total number of patients, efficacy and safety
+ Total number of patients: 38 + Efficacy + Showed relevant clinical impact + Safety + Good safety profile + Safe and well tolerated by all patients + No SAEs MBrnea
Slide 24: Phase II Study (ex-US) Results
Results: Safety: • First extended exposure to ORMD-0801 proved safe and tolerable. • No serious adverse events reported. • No cumulative effects were observed. • Only two hypoglycemic events were recorded - both were mild. Efficacy: • Reduced glycemia & inflammatory markers • Percentage of patients
Slide 25: Upcoming Trial (under FDA IND)
Upcoming Trial (under FDA IND)
Slide 26: ORMD-0801 Type 1 Diabetes
ORMD-0801 Type 1 Diabetes
Slide 27: ORMD-0801 T1DM fasting glucose
Subject # Rate of glucose change (mg/dL*hr -1 ) 2 43.7 3 -0.7 4 -15.5 5 10.9 6 -6.1 7 -28.7 8 -18.4 9 5.5 ID: -10 -5 Time (min) ID: -14 -10 -6 -2 Time (min) Expected rate of increase in fasting blood glucose concentrations among T1DM upon insulin withdrawal: 45.1 ± 9.7 mg/dL·hr-1 (Clement et al, 200
Slide 28: ORMD-0801 T1DM glucose frequency
Frequency glucose >200mg/dL DAY NIGHT pretreatment treatment ê 11.5% 50.75 58.3 49.7 DAY NIGHT pretreatment treatment 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: 7 T1DM, monitor glycemic stability of one orally administered ORMD-0801
Slide 29: ORMD-0901 Oral Exenatide T2DM
ORMD-0901 Oral Exenatide T2DM
Slide 30: Oral Exenatide (GLP-1 Analog)
Oral Exenatide (GLP-1 Analog)
Slide 31: Oral exenatide preclinical results
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, demonstrating a treatment-related trend for the sample size). ORMD-
Slide 32: ORMD-0901 first in human
preprandial Phase 1 4 Healthy Placebo-control 150 m g exenatide Time (min) -50 n=4 ORMD-0901 placebo FIRST IN HUMAN NO NAUSEA ORMD-0901 T2DM
Slide 33: Corporate Overview
Oramed Corporate Overview
Slide 34: Management team
31 Nadav Kidron, Esq., MBA - Chief Executive Officer & Director • Experience in various industries, Including corporate law and technology • Advisory Board member - EnteraBio, Trendlines Group Miriam Kidron, PhD - CSO & Director • Senior Researcher at the Diabetes Unit of Hadassah Medical Center for
Slide 35: Scientific Advisory Board
Scientific Advisory Board Chairman of SAB: Michael Berelowitz, MD Prof. Derek LeRoith, MD, PhD • Professor of Medicine and Chief of Endocrinology, Diabetes and Bone Disease Unit, Mount Sinai School of Medicine, NY. Prof. John Amatruda, MD • The Former Senior Vice President and Franchise Head of the
Slide 36: Intellectual Property
Intellectual Property: Five primary worldwide patents • Methods and Compositions for Oral Administration of Proteins (2 unique types) – Expire 2026 & 2028 – Approval granted in Israel, Japan, Australia and New Zealand – Pending in multiple jurisdictions, including the US • Methods and Compositions f
Slide 37: Financial Overview 2013
Financial Overview 2013* * As of June 1, 2013 Ticker: NASDAQ: ORMP • $20.7M raised to date • No Debt • Cash and investments: $4.2M • Shares Issued: 7.2M • Fully diluted: 9.5M** ** Including outstanding 0.9M options and 1.5M warrants. *** Including the shares of D.N.A Biomedical Solutions Ltd.
Slide 38: Capitalization Structure
33 Capitalization Outstanding % Outstanding Common Stock 7,226,423 75.35% Stock Options 857,158 8.94% Warrants 1,506,410 15.71% Fully-diluted Shares Outstanding 9,589,991 100% Capitalization Structure
Slide 39: Anticipated Use of Proceeds 2013-2015
• Anticipated 2013 expenditures (Q3-Q4): $2.5M • Anticipated 2014 expenditures (Q1-Q4): $8M Anticipated Use of Proceeds 2013-2015
Slide 40: In Summary
In Summary Orally ingestible insulin capsule entering Phase 2 clinical development under the US FDA IND Product pipeline with the potential to expand to other indications Proprietary technology platform for oral delivery of peptides World-leading scientific team Strong IP Clear proof of concept Sign
Slide 41: Upcoming milestones for ORMD-0801 and ORMD-0901
ORMD-0801 (Oral Insulin): * Initiation and completion of Phase Ila (T2DM) ¢ Initiation of Pllb multi-site study under US IND (T2DM) Initiation of Pll multi-site ex-US study (T1DM) ORMD-0901 (Oral Exenatide): e Filing pre-IND * Initiation of IND-enabling studies ¢ Initiation of Pll ex-US multi-center
Slide 42: Breakthrough Technology for a Brighter Future
Breakthrough Technology for a Brighter Future Contact : Nadav Kidron CEO [email protected]