Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (December 2022)
42 slides from Oramed Pharmaceuticals's investor presentation, Dec 12, 2022
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations December 2022 Oramed Pharmaceuticals Inc. © 2022
Slide 2: Safe Harbor
Safe Harbor 1 Oramed Pharmaceuticals Inc. © 2022 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 t
Slide 3: Oramed Snapshot
Oramed Snapshot COMPANY OVERVIEW • Proprietary oral protein delivery platform • Diabetes first - initially targeting the lucrative insulin market • NASDAQ/TASE: ORMP COMPANY MANAGEMENT • Experienced management team backed by world - class scientific experts SIGNIFICANT PIPELINE, IP, AND CATALYSTS •
Slide 4: Upcoming Catalysts
4Q’22 1Q’23 2Q’23 Upcoming Catalysts Oral Insulin: Phase 3 - 1 Top Line Data Oravax: Phase 1 Cohort B Data GLP - 1: Bioavailability Study Data 3 Oramed Pharmaceuticals Inc. © 2022 Oral Insulin: Phase 3 - 2 100% Enrollment
Slide 5: Proprietary Technology for Oral Drug Delivery
Proprietary Technology for Oral Drug Delivery Proteins and Peptides do Not Survive the Digestive System Oramed Technology Protects Drug Integrity and Increases Absorption Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier T
Slide 6: 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 5 Oramed Pharmaceuticals Inc. © 2022
Slide 7: Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Oram e Oram e d d Pharma c Pharma c e e ut i ut i c c a l a l s s I I n c n c . . © © 2 2 02 2 022 Diabetes: Millions of diabetics inject insulin today and wish for oral dosage 6
Slide 8: Adults Globally Have Diabetes
Oramed Pharmaceuticals Inc. © 2022 1 in 10 Adults Globally Have Diabetes In 2021 diabetes expenditure reached US $ 966 billion ~10 % Healthcare spent on diabetes +246 Million Expected increase 2021 2045 Every 5 SECONDS 1 adult dies from diabetes 6.7M deaths in 2021 WORLD 537 M People live with diabe
Slide 9: Oral Insulin
Oram e Oram e d d Pharma c Pharma c e e ut i ut i c c a l a l s s I I n c n c . . © © 2 2 02 2 022 ORMD - 0801: Oral Insulin 8
Slide 10: Oral Insulin Mimics the Delivery of Endogenous Insulin
Oral Insulin Mimics the Delivery of Endogenous Insulin ORMD - 0801 is delivered orally with first pass metabolism occurring in the liver, mimicking endogenous insulin regulation before reaching the bloodstream, thus reducing risks and complications associated with injectable insulin and enabling ear
Slide 11: 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 absorb
Slide 12: Oral Insulin for Type 1 & Type 2 Diabetes
ORMD - 0801 for Type 1 & Type 2 Diabetes 11 Oramed Pharmaceuticals Inc. © 2022 TYPE 1 DIABETES • T1D is autoimmune: The body destroys its own insulin - producing (beta) cells, leaving patients completely dependent on external insulin sources • 10% of diabetics have T1D: Up to 54 million people world
Slide 13: Oral Insulin for Type 1 Diabetes (T1D)
ORMD - 0801 for Type 1 Diabetes (T1D) T1D PATIENTS ARE TREATED WITH VARIOUS TYPES OF INSULIN REPLACEMENT THERAPY Long - acting insulin (basal) helps maintain stable insulin levels during fasting periods Rapid - acting insulin (bolus) prior to each meal to stabilize blood sugar Administration is via
Slide 14: Phase 2a Trial in T1D Completed
Phase 2a Trial in T1D Completed 25 T1D patients 7 Days of treatment 3 Times a day (at mealtime) 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
Slide 15: Phase 2 Completed Patient Trial for T2D
Phase 2 – Completed 180 Patient Trial for T2D ¹ Trial only had 1 dose level, but patients were given either a full dose, or 1.5 doses. ² Based on 2 nights of CGM data by comparison of the mean percent change between Baseline and Week 4 of ORMD - 0801 and placebo groups 33 US Sites 180 Patients 28 Da
Slide 16: 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 • Achieved primary endpoint and showed significant positive effects • Safe/well - tolerated with no drug related serious adverse events • Dose groups 1 & 2 are pooled on weighted mean nighttime
Slide 17: Phase 2b Completed Patient Trial for T2D
Phase 2b – Completed 298 Patient Trial for T2D (1) 36 Sites: 2 sites (49 subjects) were excluded due to significant treatment by center interaction; 347 subjects received primary treatment and had baseline A1c (included in ITT); 298 subjects included in primary analysis; 266 included in final analys
Slide 18: 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) 17 Oramed Pharmaceu
Slide 19: Phase 2b Exhibited Strong A1C Lowering Activity
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) • 8 mg 1x/day for patients with baseline A1C >9% showed 1.40 (1.26 placebo adjusted) reduction
Slide 20: FDA Phase 2b Trial Results
FDA Phase 2b Trial Results Primary Endpoint Successfully Met Significant HbA1c lowering with 1X/daily treatment: • No increase in Adverse Events compared to Placebo • No increase in Hypoglycemic Events compared to Placebo • No weight gain compared to Placebo 19 Oramed Pharmaceuticals Inc. © 2022 Gai
Slide 21: Phase 3 Trials: Maximizing Success in the Market
Oram e Oram e d d Pharma c Pharma c e e ut i ut i c c a l a l s s I I n c n c . . © © 2 2 02 2 022 Phase 3 Trials: Maximizing ORMD - 0801’s Success in the Market 20
Slide 22: 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 Patient Type Design & Dosing Trial Endpoints Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Two or Three Oral Glucose - Lowering Agents • 710 subjects • Reached 100% randomization • US - bas
Slide 23: 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 Patient Type Design & Dosing Trial Endpoints Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Metformin Monotherapy • 450 subjects (including naïve pa
Slide 24: Oramed Commissioned IQVIA to Perform Market Research
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 23 Oramed Pharmaceuticals Inc. © 2022
Slide 25: HCPs Were Receptive to Prescribing Oral Insulins
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) Q: What is your willingness to prescribe oral insulins for T2D patients, if oral in
Slide 26: Robust Clinical Development Program Towards Anticipated Approval
ORMD - 0801’s Robust Clinical Development Program has Paved the way Towards Anticipated Approval ORMD - 0801 DEVELOPMENT Anticipated FDA Approval in 2025 NASH Phase 2 Completed T2D Phase 3 ORA - D - 013 - 2 study Ongoing T2D Phase 3 ORA - D - 013 - 1 study Ongoing Prep BLA & File > 900 Study Subject
Slide 27: China License Deal: 500M Patient Potential
China License Deal: 500M patient potential License: Exclusive right to ORMD - 0801 in Greater China DIABETIC (10.9% of adult population) 114 M PREDIABETIC (35.7% of adult population) 26 Oramed Pharmaceuticals Inc. © 2022 ~388 M $50M PAYMENTS + ROYALTIES: • $12M in restricted stock (at premium) • $38
Slide 28: South Korea Commercial Distribution Agreement
South Korea Commercial Distribution Agreement MILESTONE PAYMENTS + ROYALTIES: • $18M in potential milestone payments • $2M received to date • Up to 15% royalties on gross sales • Medicox to purchase ORMD - 0801 from Oramed at fixed transfer price Agreement: Exclusive distribution rights to ORMD - 08
Slide 29: 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 Phase 2 trial results reported: Safety & Efficacy of ORMD - 0801 Day Treatment Primary endpoint met: ORM
Slide 30: Positive Phase 2 NASH Trial Results
Positive Phase 2 NASH trial results reported: Achieved Safety and Primary Endpoints 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 placebo. Efficacy Data Summary • • Secondary obje
Slide 31: GLP-1 Analog: ORMD-0901 for Oral GLP-1
GLP - 1 Analog: ORMD - 0901 for Oral GLP - 1 (T2D) GLP - 1 Analog T2D medication Mimics the natural hormone in the body Compelling safety profile Decreases blood glucose levels Preserves beta cell function Effectively reduces HbA1c Promotes weight loss ORMD - 0901 Clinical Status IND Bioavailability
Slide 32: Oral GLP-1 ORMD-0901 Preserved Biological Activity
Oral GLP - 1 - ORMD - 0901 Preserved the biological activity of orally delivered exenatide. ORMD - 0901 successfully curbed blood sugar excursions following glucose challenge Preclinical: Oral exenatide delivery amounted to a >50% reduction in mean glucose (similar to SC) Human (4 healthy volunteers
Slide 33: Novel Oral Vaccine Company
| Novel Oral Vaccine Company The Oravax technology integrates Premas Biotech’s D - Crypt Œ technology with an oral delivery platform from Oramed Pharmaceuticals based on their proprietary POD Œ delivery technology. x JOINT VENTURE Oramed is the majority shareholder of Oravax (63%) LICENSE - Royaltie
Slide 34: Oral Vaccine Advantages
| Advantages Ease of scale up Straight - forward tech transfer Manufacturing and COGs optimization Consistent process Triple antigen vaccine expected to be effective against COVID variants No needles Easy to administer at home (no need for professional administration) No need for low temperature sto
Slide 35: Highlighted Milestones
| Highlighted Milestones • Commercialize Oral COVID - 19 Vaccine in Mexico • Drive Business in LATAM • Contribute to oral vaccine’s clinical, regulatory, and commercial activities • Participate in a future investment in Oravax 50/50 Joint Venture with Genomma Lab Collaboration Agreement with Tan Tan
Slide 36: Phase 1 Trial Ongoing
| Phase 1 Trial Ongoing 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 35 Oramed Pharmaceuticals Inc. © 2
Slide 37: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
Funneling Huge Injectable Drug Markets to Novel Oral Formulations 2021: $13.6 b 36 Oramed Pharmaceuticals Inc. © 2022 2019: $34 b 2020: $12 b 2019: $2.9 b
Slide 38: Management Team
Management Team Nadav Kidron, Esq, MBA Chief Executive Officer & Director Entrepreneur whose experience includes decades of senior executive roles in a wide range of industries including business, law and technology Miriam Kidron, PhD Chief Scientific Officer & Director Senior Researcher at the Diab
Slide 39: Board of Directors
Board of Directors 38 Oramed Pharmaceuticals Inc. © 2022 LEONARD SANK Independent Director Entrepreneur and business leader; Director of Macsteel Service Centres SA (Pty) Ltd ARIE MAYER, PH.D Independent Director Managing Director and Chairman of the Board of Merck Life Science Israel NADAV KIDRON,
Slide 40: Scientific Advisory Board
Scientific Advisory Board ELE FERRANNINI, MD, PHD Professor, Internal Medicine, University of Pisa School of Medicine. Past President of the EASD. Alexander Fleming, MD Recognized authority in the metabolic and endocrine fields with extensive FDA experience. AVRAM HERSKHO, MD, PHD; NOBEL LAUREATE Di
Slide 41: Oramed: Addressing the Multibillion-Dollar Injectable Drug Markets
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 40 Oramed Pharmaceuticals Inc. © 2022 Strong financial position with ~$160M 1 in cash an
Slide 42: Thank you
Oram e Oram e d d Pharma c Pharma c e e ut i ut i c c a l a l s s I I n c n c . . © © 2 2 02 2 022 Thank you oramed.com 41
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