Oramed Pharmaceuticals Inc. · NASDAQ:ORMP

Oramed Pharmaceuticals — Investor Presentation (August 2023)

41 slides from Oramed Pharmaceuticals's investor presentation, August 2023

  1. Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations

    Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations August 2023 Oramed Pharmaceuticals Inc. © 2023

  2. Slide 2: Safe Harbor

    Safe Harbor This presentation contains forward-looking statements. For example, we are using forward-looking statements when we discuss clinical trials, including the timing thereof and potential approvals of products, catalysts and milestones, pipeline and the potential benefits of products, includ

  3. Slide 3: Oramed Snapshot

    Oramed Snapshot COMPANY OVERVIEW SIGNIFICANT PIPELINE, IP, AND CATALYSTS • Proprietary oral protein delivery platform • Robust pipeline leveraging IP portfolio for additional significant market opportunities • Diabetes first - initially targeting the lucrative insulin market • 88 granted patents, 35

  4. Slide 4: Proprietary Technology for Oral Drug Delivery

    Proprietary Technology for Oral Drug Delivery Proteins and Peptides do Not Oramed Technology Protects Drug Survive the Digestive System Integrity and Increases Absorption Harsh pH pH shield Stomach acidity cleaves and shreds protein Sensitive enteric coating protects capsule contents before entering

  5. Slide 5: Multiple Clinical-Stage Programs

    Multiple Clinical-Stage Programs PHASE 1 PHASE 2 PHASE 3 ORMD-0801 (Oral Insulin) Diabetes ORMD-0801 (Oral Insulin) NASH ORMD-0901 (Oral GLP-1) Oravax’s Oral Covid-19 Vaccine Phase 1 Trials Ongoing Oramed Pharmaceuticals Inc. © 2023 4

  6. Slide 6: Diabetes: Millions of diabetics inject insulin today

    Diabetes: Millions of diabetics inject insulin today and wish for oral dosage Oramed Pharmaceuticals Inc. © 2023 5

  7. Slide 7: 1 in 10 Adults Globally Have Diabetes

    1 in 10 Adults Globally Have Diabetes WORLD WP EUR In 2021 diabetes 537 M SEA MAC ~10% expenditure reached People live with diabetes MENA AFR Healthcare spent US $ 966 billion SACA on diabetes PREVALENCE 10% +246 Million Expected increase Every 5 SECONDS 2021 1 adult dies from diabetes 2045 6.7M dea

  8. Slide 8: ORMD-0801: Oral Insulin

    ORMD-0801: Oral Insulin Oramed Pharmaceuticals Inc. © 2023 7

  9. Slide 9: Oral Insulin Mimics the Delivery of Endogenous Insulin

    Oral Insulin Mimics the Delivery of Endogenous Insulin Injectable Insulin Oral Insulin Current Future First pass metabolism ORMD-0801 delivered and regulation in the liver via POD technology Insulin reaches liver Local absorption in via portal vein small intestine Injectable insulin is introduced di

  10. Slide 10: Oral Insulin: Significant Advantages Over Injectable Insulins

    Oral Insulin: Significant Advantages Over Injectable Insulins 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 control prevents cells from absorbin

  11. 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 • T1D is autoimmune: The body destroys its own insulin- • T2D is metabolic: The body becomes insulin resistant. Injections

  12. Slide 12: ORMD-0801 for Type 1 Diabetes (T1D)

    ORMD-0801 for Type 1 Diabetes (T1D) T1D PATIENTS ARE TREATED WITH VARIOUS ORAMED ORAL INSULIN TYPES OF INSULIN REPLACEMENT THERAPY Long-acting insulin (basal) helps maintain stable Easier use and reduced systemic exposure insulin levels during fasting periods Potentially reducing multiple daily inje

  13. 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

  14. Slide 14: Phase 2 – Completed 180 Patient Trial for T2D

    Phase 2 – Completed 180 Patient Trial for T2D 33 US Sites 180 Patients 28 Day Treatment 2 Dose Groups 28 Day Treatment ¹ Design Double-blind, randomized, placebo-controlled, 4 week, once daily (3 capsules) treatment Enrolled patients with T2D who (1) are being treated by diet and exercise, (2) are u

  15. Slide 15: Phase 2 Trial Demonstrated No Drug Related Serious Adverse Events

    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 daytime

  16. Slide 16: Phase 2b – Completed 298 Patient Trial for T2D

    Phase 2b – Completed 298 Patient Trial for T2D 34 US Sites ¹ 298 Patients ¹ 90 Day Treatment 7 Dose Groups 28 Day Treatment 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 max

  17. Slide 17: ORMD-0801 Phase 2b Achieved Safety and Primary Endpoints

    ORMD-0801 Phase 2b Achieved Safety and Primary Endpoints • 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) Oramed Pharmaceuticals Inc.

  18. 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 ORMD-0801 upheld safety profile previously exhibited in first Phase 2 study • 8 mg 1x/day showed 0.95 (0.81 placebo adjusted) reduction in A1C (p=0.028) No increase in Seriou

  19. Slide 19: FDA Phase 2b Trial Results

    FDA Phase 2b Trial Results Primary Endpoint Successfully Met Safe and well Significant HbA1c tolerated lowering with 1X/daily treatment: FDA BLA Pathway: • Confirmatory Phase 3 Study • No increase in Adverse Events compared to Placebo • Submission to FDA • No increase in Hypoglycemic Events compared

  20. Slide 20: Phase 3 Trials: Maximizing ORMD-0801's Success in the Market

    Phase 3 Trials: Maximizing ORMD-0801’s Success in the Market Oramed Pharmaceuticals Inc. © 2023 19

  21. 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: ORA-D-013-1 1 Patient Type Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Two or Three Oral Glucose-Lowering Agents • 710 subjects • Reached 100% randomization • US-based 8 mg 1x/day at night 8 mg 2x/day at nig

  22. 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: ORA-D-013-2 1 Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control Patient Type and Metformin Monotherapy • 450 subjects (including naïve patients to 1L therapy - metformin) • Re

  23. Slide 23: Oramed Commissioned IQVIA to Perform Market Research in the US, UK and EU

    Oramed Commissioned IQVIA to Perform Market Research in the US, UK and EU Note: Sample size selected to ensure appropriate N size to support PMR data analytics Oramed Pharmaceuticals Inc. © 2023 22

  24. Slide 24: HCPs Were Receptive to Prescribing Oral Insulins and ORMD-0801, If Approved

    HCPs Were Receptive to Prescribing Oral Insulins and ORMD-0801, If Approved Most of the prescribers (85%+) were willing to prescribe oral insulins or ORMD-0801, if approved Future Willingness to Prescribe (n=170) Willingness to prescribe oral Willingness to prescribe ORMD- insulin (A) 0801 (B) Defin

  25. Slide 25: 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 2021 2022 2023 2024 T2D Phase 3 ORA-D-013-1 study Prep BLA DATA CSR Ongoing & File Anticipated FDA ORMD-0801 Approval in DEVELOPMENT T2D Phase 3 ORA-D-013-2 study DATA CSR 2025 Ongoing NASH Phase 2 DA

  26. Slide 26: China License Deal: 500M patient potential

    China License Deal: 500M patient potential License: Exclusive right to ORMD-0801 in Greater China DIABETIC PREDIABETIC 114M ~388M (10.9% of adult population) (35.7% of adult population) LICENSEE: HEFEI TIANHUI ("HTIT") $50M PAYMENTS + ROYALTIES: Owns with Sinopharm a state-of-the-art GMP API • $12M

  27. Slide 27: South Korea Commercial Distribution Agreement

    South Korea Commercial Distribution Agreement Agreement: Exclusive distribution rights to ORMD-0801 in South Korea 1 in 7 South Korean adults have diabetes South Korean Partner: Medicox Co., Ltd. • Medicox (Kosdaq: 054180) is an emerging MILESTONE PAYMENTS + ROYALTIES: pharmaceutical R&D company • H

  28. Slide 28: Phase 2 Trials for T2D with NASH Completed

    Phase 2 Trials for T2D with NASH Completed With direct action on the liver, ORMD-0801 has the potential to address diabetics suffering from NASH, a population with increased mortality. Positive clinical results in completed pilot study of NASH* • Open label, 90-day treatment , N = 9 T2D patients wit

  29. Slide 29: Positive Phase 2 NASH trial results reported

    Positive Phase 2 NASH trial results reported: Achieved Safety and Primary Endpoints Median change in Fibroscan Fibrosis in kPa Levels Safety Data Summary • Primary objective of safety met with no serious adverse events and no difference in the incidence rate of adverse events between ORMD-0801 and p

  30. Slide 30: GLP-1 Analog: ORMD-0901 for Oral GLP-1 (T2D)

    GLP-1 Analog: ORMD-0901 for Oral GLP-1 (T2D) GLP-1 Analog ORMD-0901 Clinical Status T2D medication IND Mimics the natural hormone in the body Bioavailability study Compelling safety profile Decreases blood glucose levels Preserves beta cell function Effectively reduces HbA1c Promotes weight loss Ora

  31. Slide 31: 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) Area (mg/dl)/minutes *10 2 Area (mg/dl)/minutes *10 2 Preserved the biological activity of orally delivered ORMD-0901 exenatide. ORMD-0901 successfull

  32. Slide 32: Novel Oral Vaccine Company

    | Novel Oral Vaccine Company The Oravax technology integrates Premas Biotech’s D- Crypt™ technology with an oral delivery platform from x Oramed Pharmaceuticals based on their proprietary POD™ delivery technology. JOINT VENTURE Oramed is the majority shareholder of Oravax (63%) 2021 LICENSE $13.6 b

  33. Slide 33: 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 low

  34. Slide 34: Highlighted Milestones

    | Highlighted Milestones 50/50 Joint Venture with Genomma Lab Collaboration Agreement with Tan Tanh Holdings • Commercialize Oral COVID-19 Vaccine in Mexico • Pre-purchase of 10 million oral COVID-19 vaccines • Drive Business in LATAM • TTH to commercialize Oral COVID-19 Vaccine in • Contribute to o

  35. Slide 35: Phase 1 Trial Ongoing

    | Phase 1 Trial Ongoing Oral Format South Africa Open-label N=24 naive participants (no prior COVID-19 vaccine or infection) Endpoints: Safety & tolerability Efficacy Cohort A (12 participants) positive data received Q3 2022 Cohort B (12 participants) data expected Q1 2023 Oramed Pharmaceuticals Inc

  36. Slide 36: Funneling Huge Injectable Drug Markets to Novel Oral Formulations

    Funneling Huge Injectable Drug Markets to Novel Oral Formulations 2020: 2019: $12 b $34 b 0801 oral insulin 2021: 2019: $13.6 b $2.9 b Oramed Pharmaceuticals Inc. © 2023 35

  37. Slide 37: Management Team

    Management Team Nadav Kidron, Esq, MBA Josh Hexter Chief Executive Officer & Director Chief Operating & Business Officer Entrepreneur whose experience includes decades of More than 18 years of prominent leadership senior executive roles in a wide range of industries roles in biotech and pharma inclu

  38. Slide 38: Board of Directors

    Board of Directors ARIE MAYER, PH.D BEN SHAPIRO MIRIAM KIDRON, PH.D Independent Director Independent Director Chief Scientific Officer & Director Managing Director and Chairman of the Entrepreneur and business professional Senior Researcher at the Diabetes Unit of Board of Merck Life Science Israel

  39. Slide 39: Scientific Advisory Board

    Scientific Advisory Board ALEXANDER FLEMING, MD AVRAM HERSKHO, MD, PHD; NOBEL ANNE PETERS, MD LAUREATE Recognized authority in the metabolic Professor of Medicine at Keck School and endocrine fields with extensive Distinguished professor in the of Medicine of USC and Director of FDA experience. bioc

  40. Slide 40: Oramed (NASDAQ/TASE: ORMP)

    Oramed (NASDAQ/TASE: ORMP) Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations Diabetes First: Initially targeting the lucrative insulin market; additional markets in the pipeline Strong financial position with ~$150.2M1 in cash and investments, no debt – ~40.2M2 shares

  41. Slide 41: Thank you

    Thank you oramed.com Oramed Pharmaceuticals Inc. © 2023

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