Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (April 2019)
44 slides from Oramed Pharmaceuticals's investor presentation, April 2019
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations April 2019
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 Snapshot
Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Diabetes first - initially targeting the lucrative insulin market. Additional huge markets in the pipeline ▪ Strong financial position over $40.8M in cash and investments, no debt1 ▪ Strong management team backed by world-class scientifi
Slide 4: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
Funneling Huge Injectable Drug Markets to Novel Oral Formulations Insulin GLP-1 Analog Vaccines 2014: 2017: 2014: $24 b $6 b $33 b Flu vaccines Interferon 2011: 2015: $2.9 b $10+ b 4
Slide 5: An Unsolved Challenge: Proteins and Peptides do Not Survive the Digestive System
An Unsolved Challenge: Proteins and Peptides do Not Survive the Digestive System Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier Most therapeutic proteins fail to be absorbed via the intestinal wall (barrier) 5
Slide 6: Oramed Technology Protects Drug Integrity and Increases Absorption
Oramed Technology Protects Drug Integrity and Increases Absorption pH shield for passage through stomach pH sensitive enteric coating protects capsule contents. Capsule dissolves only once in small intestine Protease protection Protease inhibitors stave off and protect the active agent from protease
Slide 7: Multiple Clinical-Stage Programs
Multiple Clinical-Stage Programs 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 Exploratory Exploratory Studies Studies Leptin Leptin (T1DM – PD: glucose and glycogen reduction; PK) NASH NASH (T2DM –
Slide 8: Diabetes: Millions of diabetics inject insulin today
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Slide 9: Adults on the Planet Have Diabetes
1 in 11 Adults on the Planet Have Diabetes 1 WORLD healthcare Is spent on diabetes in8 In 2017 diabetes expenditure reached US $ 727 billion 415 M People living with diabetes PREVALENCE 9.09% 2017 expected increase every 2045 +204 6 SECONDS 1 adult dies MILLION from diabetes 4M deaths in 2017 9 http
Slide 10: Type 1 and Type 2 Diabetes Are Different
Type 1 and Type 2 Diabetes Are Different Diabetes: A metabolic disease in which the body’s inability to produce any or enough insulin causes elevated levels of glucose in the blood TYPE 1 Diabetes TYPE 2 Diabetes ▪ T1DM is autoimmune: The body destroys its ▪ T2DM is metabolic: The body becomes insul
Slide 11: ORMD-0801: Oramed's Flagship Product for Oral Treatment of Diabetes
ORMD-0801: Oramed’s Flagship Product for Oral Treatment of Diabetes >300 >5000 Clean study subjects human doses safety profile 11
Slide 12: The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin
The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin ENDOGENOUS INSULIN produced by the pancreas and delivered to the body via the liver To systemic circulation Injected Insulin introduced directly to the bloodstream, with only stomach a fraction of it reaching the liver. This can ca
Slide 13: ORMD-0801 Type 1 Diabetes (T1DM)
ORMD-0801 Type 1 Diabetes (T1DM): Potentially eliminating the need for insulin before each meal
Slide 14: Oramed: Potentially Replacing Mealtime Therapy
Oramed: Potentially Replacing Mealtime Therapy T1DM patients are treated with 2 types of Oramed seeks to replace the mealtime insulin replacement therapy (bolus) insulin doses ▪ Long-acting insulin (basal) helps maintain ▪ Easier use and reduced systemic exposure stable insulin levels during fasting
Slide 15: ORMD-0801: Consistent Lowering of Glucose Levels - Day and Night
ORMD-0801: Consistent Lowering of Glucose Levels - Day and Night in Preliminary Study Frequency glucose >200mg/dL Design: 60 ▪ Monitor glycemic stability Frequency (%) 50 40 of orally administered 30 20 ORMD-0801 6:00 9:00 12:00 14:00 19:00 21:00 00:00 Time 8:59 11:59 13:59 18:59 20:59 23:59 5:59 ▪
Slide 16: Phase IIa FDA Study: Consistent and Accumulative Effect of ORMD-0801
Phase IIa FDA Study: Shows Consistent and Accumulative Effect of ORMD-0801 Blood glucose levels are lower, day and night, compared to control group Reduction in FBG 10.00 0.00 2 25 T1DM patients Basal or Bolus Insulin (units) Delta Basal Delta Placebo vs ORMD Delta Placebo vs ORMD -10.00 -3 Insulin
Slide 17: Phase IIa FDA Study Demonstrates Oral Insulin Reduces Exogenous Insulin Requirements
ORMD-0801: Phase IIa FDA Study Demonstrates Oral Insulin Reduces Exogenous Insulin Requirements Safe and well tolerated for the pre-meal dosing regimen in this study. Encouraging trends in key areas vs. placebo: Decreased use of rapid-acting insulin levels of post-meal glucose levels of daytime gluc
Slide 18: ORMD-0801: Better type 2 diabetes treatment
ORMD-0801: Better type 2 diabetes (T2DM) treatment by interacting with the body like natural insulin
Slide 19: The Type 2 Diabetes Treatment Paradigm
The Type 2 Diabetes Treatment Paradigm 01 02 03 Stage 1: Stage 2: Stage 3: Initial Treatment Oral Therapies Late-Stage Treatment - Lifestyle modification - Reduce insulin resistance - Insulin (injections) - Diet & exercise - Stimulate insulin secretion 19 ADA guidance: Earlier use of insulin equals
Slide 20: Excessive Production of Glucose at Night
Excessive Production of Glucose at Night: A Significant Challenge in Diabetes Management ▪ Excessive nocturnal glucose production by the liver is frequently demonstrated in diabetes patients ▪ Results of high blood sugar are measured by a fasting plasma glucose (FPG) test, done after an 8-hour fast.
Slide 21: Simple Oral Administration at Bed Time Managing Diabetes
Simple Oral Administration at Bed Time Managing Diabetes Oramed’s first indication, ORMD-0801, reduces excessive nocturnal glucose production in the liver, by acting the same way that natural insulin does. Key benefits Reduction of Increased patient Slowing down FBG levels compliance via simple the
Slide 22: Phase IIa FDA Study: ORMD-0801 Drug Safe With no Serious Adverse Events
Phase IIa FDA Study: ORMD-0801 Drug Safe With no Serious Adverse Events ▪ 30 T2DM patients ▪ Primary objective: Safety and tolerability ▪ Secondary objective: Pharmacodynamic effects on mean nighttime glucose Fasting CGM Glucose (mg/dL) Nighttime CGM Glucose (mg/dL) Daytime CGM Glucose (mg/dL) Place
Slide 23: Completed: 180 Patient FDA Phase IIb Study
Completed: 180 Patient FDA Phase IIb Study 33 US sites 180 patients 28 day treatment 1 Dose (nightly) 23
Slide 24: Phase IIb FDA Study: ORMD-0801 Endpoints and Objectives
Phase IIb FDA Study: ORMD-0801 Endpoints and Objectives Primary ▪ Safety of ORMD-0801 01 objectives ▪ Evaluate effect of ORMD-0801 on mean nighttime glucose Secondary ▪ Evaluate effect of ORMD-0801 on fasting blood glucose, morning blood 02 objectives insulin, c-peptide, triglycerides ▪ Evaluate eff
Slide 25: Phase IIb FDA Study: Primary Endpoints Successfully Met
Phase IIb FDA Study: Primary Endpoints Successfully Met Safe and well tolerated oral delivery – No drug related serious adverse events Nighttime CGM Glucose Nighttime CGM Glucose Nighttime CGM Glucose Mean % change Mean mg/dl change Median mg/dl change Placebo Change from run-in – 80% trim 13.70 Pla
Slide 26: Other Continuous Glucose Monitoring Parameters
Other Continuous Glucose Monitoring Parameters (Exploratory Objectives) Fasting Daytime 24 Hours 5AM to 7AM 6AM to 10PM Mean Change from Run-in Period Placebo P-value=<0.0001* Glucose (mg/dl) Placebo 15.95 P-value=<0.0001* Placebo 13.26 P-value=0.0010* 11.88 ORMD-0801 ORMD-0801 ORMD-0801 P-value=0.0
Slide 27: HbA1c
HbA1c (Exploratory Objective) Day 29 Statistically significant Change from baseline difference observed in just 29 days Longer treatment duration with ORMD-0801 has the potential for a more significant Placebo positive impact on HbA1c 0.20 ORMD-0801 -0.01* * Indicates comparison to placebo p-Value<0
Slide 28: FDA Phase IIb Study Clearly Demonstrated Safety and Blood Glucose Lowering Efficacy
FDA Phase IIb Study Clearly Demonstrated the Safety and Blood Glucose Lowering Efficacy of ORMD-0801 Safe and well tolerated with no significant Sustained and highly significant glucose reduction hypoglycemic events observed in every glycemic parameter: FDA BLA Pathway: Fasting, Daytime, Nighttime,
Slide 29: Clamp Study
Clamp Study Clamp study to fully characterize exposure-response profiles ▪ Size/Study: 6 T1DM fasting patients, ages 18-50, HbA1c < 10.0% - Glucose (20%) infusion to maintain plasma glucose concentrations at 100-120 mg/dL - Blood samples will be collected every 5-15 minutes over the 4 hours followin
Slide 30: 90-day HbA1c Study
90-day HbA1c Study ▪ Size: ~285 T2DM subjects ▪ Dose: 16 mg/initial dose titrated to 24 mg/dose titrated to 32 mg/dose - Dose Regimen: ▪ X1 (evening) ▪ X2 (evening + before breakfast) ▪ X3 (evening + before breakfast + before lunch) ▪ Primary End Points: - Safety (AEs, hypoglycemic) - HbA1c over 90
Slide 31: ORMD-0801: Anticipated Clinical Development Timelines
ORMD-0801: Anticipated Clinical Development Timelines 2018 2019 2020 2021 2022 2023 2024 Phase 2b 3-month A1C study T2D Phase 3 study CSR CSR Prep NDA T1D clamp study T1D Phase 3 study & File CSR CSR EOP2 Potential prepare approval P3 program by Q1 2024 Recruitment Active Treatment Period 31
Slide 32: China License Deal: 500M patient potential
China License Deal: 500M patient potential ▪ License: Exclusive right to ORMD-0801 in Greater China Chinese diabetes market* ▪ Licensee: Hefei Tianhui ("HTIT") Owns with Sinopharm a state-of-the-art GMP API insulin diabetic manufacturing facility 114M (10.9% of adult population) - IND approved for o
Slide 33: ORMD-0901: Oral GLP-1 Analog
ORMD-0901: Oral GLP-1 Analog
Slide 34: GLP-1 Analog: ORMD-0901 for Oral GLP-1
GLP-1 Analog: ORMD-0901 for Oral GLP-1 (TD2M) GLP-1 Analog ORMD-0901 Clinical Status ▪ T2DM medication ▪ IND ▪ Mimics the natural hormone in the body ▪ PK/Dose study – Q1 2019 ▪ Good safety profile ▪ Phase II US study – Projected 2020 ▪ Decreases blood glucose levels ▪ Does not cause hypoglycemia ▪
Slide 35: Oral GLP-1 - ORMD-0901
Oral GLP-1 - ORMD-0901 Dogs: Oral exenatide delivery amounted to a Human (4 healthy volunteers) >50% reduction in mean glucose (similar to SC) n=4 Area (mg/dl)/minutes *102 120 150 ORMD-0901 150 mg exenatide 100 Insulin (mU/mL) * 80 100 60 * * 40 20 50 0 Placebo Exenatide - S.C. AG 4 AG 3 0 Glucose
Slide 36: NASH Study
NASH Study Nonalcoholic Steatohepatitis (NASH) ▪ Chronic liver disease caused by excessive fat in liver (MoA not fully known) ▪ Leads to fibrosis, cirrhosis and liver failure (death) ▪ ~12% of US adult population has NASH ▪ Liver transplants due to NASH have increased 700% (2001-09) Status ▪ Approva
Slide 37: Anticipated Development Milestones
Anticipated Development Milestones 2019 2020 • Q4: HbA1c Study Completion • Prepare and initiate Phase III 0801 0801 • Interim NASH Exploratory Study program T1D and T2D Completion • NASH Exploratory Study Initiation and Completion 0901 • P1 PK Study Initiation and 0901 • P2 PK Study Initiation Comp
Slide 38: Corporate Overview
Corporate Overview: On route to meet unmet market needs
Slide 39: Oramed (NASDAQ: ORMP): Corporate Overview
Oramed (NASDAQ: ORMP): Corporate Overview Financial Highlights Analyst Coverage Intellectual Property Estate ▪ $40.8M cash and investments1 ▪ H.C. Wainwright ▪ Methods and compositions for ▪ 17.4M shares outstanding ▪ Aegis Capital oral administration of proteins (22M fully diluted)1 ▪ FBR & Co. ▪ M
Slide 40: Management Team
Management Team Nadav Kidron, Esq, MBA - CEO & Director Many years of business experience as well as Mark Hasleton, PhD - VP Business corporate law and technology Development Over 15 years Pharma / Biotech experience including Medical, Marketing, R&D and Miriam Kidron, PhD - CSO & Director Business
Slide 41: Board of Directors
Board of Directors Kevin Rakin - Chairman Aviad Friedman Co-Founder and Partner at HighCape Partners; former Director of public and private companies including President of Regenerative Medicine at Shire plc Maayan Ventures, Capital Point and Rosetta Green Ltd. David Slager Xiaopeng Li Founder and C
Slide 42: Scientific Advisory Board
Scientific Advisory Board Roy Eldor, MD, PhD Robert R. Henry, MD Oramed CMA, Director of the Diabetes Unit at Professor of Medicine in the Division of Endocrinology & Metabolism, the Institute of Endocrinology, Metabolism & Department of Medicine at the University of California, San Diego. Chief Hyp
Slide 43: Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations ▪ Proprietary oral protein delivery platform ▪ Insulin first - initially targeting the lucrative insulin market. Additional huge markets in the pipeline ▪ Strong financial position over $40.8M in cash and inves
Slide 44: Thank You
THANK YOU www.oramed.com Nadav Kidron Mark Hasleton, PhD CEO VP, Business Development nadav@oramed.com mark@oramed.com
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