Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (September 2021)
37 slides from Oramed Pharmaceuticals's investor presentation, September 2021
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations September 2021
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, including with respect to clinical trials, milestones and the potential benefits of Oramed's products, an
Slide 3: Oramed Snapshot
Oramed Snapshot ▪ Proprietary oral protein delivery platform ▪ Diabetes first - initially targeting the lucrative insulin market ▪ Robust pipeline leveraging IP portfolio for additional significant market opportunities ▪ Strong financial position – ~$105M1 in cash and investments, no debt ▪ Experien
Slide 4: Proprietary Technology for Oral Drug Delivery
Proprietary Technology for Oral Drug Delivery Proteins and Peptides do Not Survive Oramed Technology Protects Drug Integrity and the Digestive System Increases Absorption pH shield Harsh pH Sensitive enteric coating protects Stomach acidity cleaves capsule contents before entering and shreds protein
Slide 5: Multiple Clinical-Stage Programs
Multiple Clinical-Stage Programs Phase 1 Phase 2 Phase 3 ORMD-0801 (Oral Insulin) Type 1 & 2 Diabetes ORMD-0801 (Oral Insulin) NASH ORMD-0901 (Oral GLP-1) Type 2 Diabetes Exploratory Studies Leptin (T1DM – PD: glucose and glycogen reduction; PK) 5
Slide 6: Diabetes: Millions of diabetics inject insulin today
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Slide 7: 1 in 11 Adults on the Planet Have Diabetes
1 in 11 Adults on the Planet Have Diabetes 10% healthcare In 2019 diabetes expenditure reached WORLD 463 M People live with spent on diabetes US $ 760 billion diabetes PREVALENCE 9.09% 2019 expected increase: +237 every 2045 MILLION 6 SECONDS 1 adult dies from diabetes 4M deaths in 2017 7 https://ww
Slide 8: ORMD-0801: Oral Insulin
ORMD-0801: Oral Insulin
Slide 9: Oral Insulin Mimics the Delivery of Endogenous Insulin
Oral Insulin Mimics the Delivery of Endogenous Insulin 1) ORMD-0801 Injectable Insulin Oral Insulin delivered via POD Current Future To systemic technology circulation 4) First pass metabolism and regulation in the liver 3) Insulin reaches liver via 2) Local absorption portal vein in small intestine
Slide 10: Oral Insulin: Significant Advantages Over Injectable Insulins
Oral Insulin: Significant Advantages Over Injectable Insulins Advantages of ORMD-0801 Oral Insulin Improved Blood Glucose Control Insulin is regulated endogenously in the liver, limiting the amount of excess systemic insulin that can lead to hypo/hyper-glycemic events No Weight Gain Better insulin c
Slide 11: ORMD-0801 for Type 1 & Type 2 Diabetes
ORMD-0801 for Type 1 & Type 2 Diabetes Diabetes inhibits the production of sufficient insulin and causes elevated levels of glucose in the blood TYPE 1 Diabetes TYPE 2 Diabetes ▪ T1DM is autoimmune: The body destroys its own ▪ T2DM is metabolic: The body becomes insulin insulin-producing (beta) cell
Slide 12: ORMD-0801 for Type 1 Diabetes (T1DM)
ORMD-0801 for Type 1 Diabetes (T1DM) Potentially eliminating the need for insulin before each meal T1DM patients are treated with various Oramed oral insulin types of insulin replacement therapy ▪ Long-acting insulin (basal) helps maintain ▪ Easier use and reduced systemic exposure stable insulin le
Slide 13: Phase 2a Trial in T1D Completed
Phase 2a Trial in T1D Completed By directly targeting liver glucose, ORMD-0801 may provide tighter blood sugar regulation and control for the ~1.6M1 Type 1 diabetes patients in the US – potentially reducing the need for multiple daily injections, including mealtime insulin. Oral Insulin Reduces Exog
Slide 14: Phase 2 – Completed 180 Patient Trial for T2D
Phase 2 – Completed 180 Patient Trial for T2D Trial Highlights 33 US Sites 180 Patients 28 Day Treatment 2 Dose Groups1 Design • Double-blind, randomized, placebo-controlled, 4 week, once daily (3 capsules) treatment • Patients with T2D who (1) are being treated by diet and exercise, (2) are untreat
Slide 15: Phase 2 Trial Demonstrated No Drug Related Serious Adverse Events and Promising Efficacy
Phase 2 Trial Demonstrated No Drug Related Serious Adverse Events and Promising Efficacy on CGM Parameters 1st Primary Endpoint 2nd Exploratory Endpoints • Achieved primary endpoint and showed significant positive effects • ORMD-0801 showed promising reductions in mean 24-hour, fasting, and • Safe/w
Slide 16: Phase 2b – Completed 298 Patient Trial for T2D
Phase 2b – Completed 298 Patient Trial for T2D Trial Highlights 34 US Sites1 298 Patients1 90 Day Treatment 7 Dose Groups Design • Double-blind, randomized, placebo-controlled, 12-week, once/twice/or three times daily treatment • Patients with T2D who are taking metformin only (at least 1500 mg or m
Slide 17: ORMD-0801 Phase 2b Achieved Safety and Primary Endpoints
ORMD-0801 Phase 2b Achieved Safety and Primary Endpoints Primary Endpoint • Achieved primary efficacy endpoint in reduction in A1C at Week 12 • The 8 mg once-daily and twice-daily arms achieved statistically significant values at Week 12 vs. Placebo (p-value 0.028 and 0.029, respectively) Mean Place
Slide 18: ORMD-0801 Phase 2b Exhibited Strong A1C Lowering Activity at 8 mg 1x/Day Dose
ORMD-0801 Phase 2b Exhibited Strong A1C Lowering Activity at 8 mg 1x/Day Dose Significant A1C lowering with 8 mg, 1x/day dose • 8 mg 1x/day showed 0.95 (0.81 placebo adjusted) reduction in A1C (p=0.028) ORMD-0801 upheld safety profile previously • 8 mg 1x/day for patients with baseline A1C >9% showe
Slide 19: FDA Phase 2b Trial Results - Primary Endpoint Successfully Met
FDA Phase 2b Trial Results - Primary Endpoint Successfully Met Safe and well tolerated Significant HbA1c lowering with 1X/daily treatment: ✓No increase in Adverse Events compared to Placebo FDA BLA Pathway: ✓No increase in Hypoglycemic Events compared to Placebo • Confirmatory Phase 3 Study ✓No weig
Slide 20: Phase 3 Trials: Maximizing ORMD-0801's Success in the Market
Phase 3 Trials: Maximizing ORMD-0801’s Success in the Market
Slide 21: Two Pivotal Phase 3 Trials: ORA-D-013-1
Two Pivotal Phase 3 Trials will Maximize ORMD-0801’s Success in the Market 1 ORA-D-013-1 Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Two or Three Oral Glucose-Lowering Agents Patient Type • 675 subjects • US-based Double Blind, Double Dummy, 1:1:1 randomization Design & 8 mg 1x/day
Slide 22: Two Pivotal Phase 3 Trials: ORA-D-013-2
Two Pivotal Phase 3 Trials will Maximize ORMD-0801’s Success in the Market 2 ORA-D-013-2 Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Metformin Monotherapy Patient Type • 450 subjects (~30% naïve patients to 1L therapy - metformin) • US, Euro
Slide 23: ORMD-0801's Robust Clinical Development Program Towards Anticipated Approval
ORMD-0801’s Robust Clinical Development Program has Paved the way Towards Anticipated Approval 2021 2022 2023 2024 T2D Phase 3 ORA-D-013-1 study CSR Ongoing Prep BLA Anticipated T2D Phase 2b study & File ORMD-0801 Completed FDA Approval T2D Phase 3 ORA-D-013-2 study in 2024 Development Ongoing CSR O
Slide 24: 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) - HTIT clinical tria
Slide 25: Two Ongoing Phase 2 Trials for T2D with NASH
Two Ongoing Phase 2 Trials for T2D with NASH With direct action on the liver, ORMD-0801 has the potential to address ~50% of diabetics suffering from NASH, a population with increased mortality. Trial Highlights 2 Protocols 48 Patients1 90 Day Treatment 1 Dose Cohort Trial #1: Pilot Study to Assess
Slide 26: ORMD-0901: Oral GLP-1 Analog
ORMD-0901: Oral GLP-1 Analog
Slide 27: GLP-1 Analog: ORMD-0901 for Oral GLP-1 (T2DM)
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 ▪ Bioavailability study ▪ Compelling safety profile ▪ Decreases blood glucose levels ▪ Effectively reduces HbA1c ▪ Preserves beta cell function ▪ Prom
Slide 28: Oral GLP-1 - ORMD-0901
Oral GLP-1 - ORMD-0901 Preclinical: Oral exenatide delivery amounted to a Human (4 healthy volunteers) >50% reduction in mean glucose (similar to SC) n=4 Area (mg/dl)/minutes *102 120 140 ORMD-0901 100 120 150 mg exenatide 80 * 100 Insulin (mU/mL) 60 * * 80 40 60 20 40 0 20 Placebo Exenatide - S.C.
Slide 29: Oravax – Novel Oral Covid-19 Company
– Novel Oral Covid-19 Company The Oravax technology integrates Premas Biotech’s D-Crypt™ technology with an oral delivery platform from Oramed Pharmaceuticals based on their proprietary POD™ delivery technology. ▪ Joint Venture Covid-19 Vaccines - Oramed majority shareholder of Oravax - Majority of
Slide 30: Oravax - Advantages
- Advantages Triple antigen vaccine expected to be effective against COVID variants ▪ Manufacturing Advantages ▪ Oral Format Ease of scale up No needles Straight-forward tech transfer Easy to administer at home (no need for professional administration) Manufacturing and COGs optimization No need for
Slide 31: Anticipated Development Milestones
Anticipated Development Milestones 2021 0801 • T2DM: Phase 3 trials oral insulin • NASH: Phase 2 underway 0901 • Bioavailability Study (T2DM) Initiation & GLP-1 Completion Leptin • Phase I ex-USA Initiation 31
Slide 32: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
Funneling Huge Injectable Drug Markets to Novel Oral Formulations GLP-1 Insulin 2020: 2019: $12 b $34 b Vaccines NASH 2020: 2019: $5.8 b $2.9 b 32
Slide 33: Management Team
Management Team Nadav Kidron, Esq, MBA - CEO & Director Josh Hexter - Chief Operating & Business Many years of business experience as well as Officer corporate law and technology More than 18 years of prominent leadership roles in biotech and pharma Miriam Kidron, PhD - CSO & Director Roy Eldor, MD
Slide 34: Board of Directors
Board of Directors Kevin Rakin - Chairman Arie Mayer Co-Founder and Partner at HighCape Partners; former Managing Director and Chairman of the Board of Merck President of Regenerative Medicine at Shire plc Life Science Israel (formerly Sigma-Aldrich Israel Ltd.) Leonard Sank Nadav Kidron Entrepreneu
Slide 35: Scientific Advisory Board
Scientific Advisory Board Roy Eldor, MD, PhD Director, Diabetes Unit, Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv Medical Center Harold Jacob, MD Chief Medical Officer, NanoVibronix. Previously, Director, Medical Affairs at Given Imaging. Ele Ferrannini, MD, PhD Professor, Intern
Slide 36: Oramed (NASDAQ/TASE: ORMP) Summary
Oramed (NASDAQ/TASE: ORMP) Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations ▪ Proprietary oral protein delivery platform ▪ Diabetes First: Initially targeting the lucrative insulin market; additional markets in the pipeline ▪ Strong financial position with ~$105M 1 i
Slide 37: THANK YOU
THANK YOU www.oramed.com
Oramed Pharmaceuticals — Investor Presentation (September 2021) on 6ix