Oramed Pharmaceuticals Inc. · NASDAQ:ORMP
Oramed Pharmaceuticals — Investor Presentation (December 2021)
38 slides from Oramed Pharmaceuticals's investor presentation, Dec 7, 2021
Slide 1: Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations
Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations December 2021
Slide 2: Safe Harbor
2 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 produ
Slide 3: Oramed Snapshot
3 Oramed © 2021 Oramed Snapshot Company Overview Upcoming Catalysts Key Financial Metrics Company Management ▪ Proprietary oral protein delivery platform ▪ Diabetes first - initially targeting the lucrative insulin market ▪ NASDAQ/TASE: ORMP ▪ Robust pipeline leveraging IP portfolio for additional s
Slide 4: Proprietary Technology for Oral Drug Delivery
4 Proprietary Technology for Oral Drug Delivery Harsh pH Stomach acidity cleaves and shreds protein Protease attack Proteases attack and break down proteins Absorption barrier Therapeutic proteins fail to be absorbed via the intestinal wall (barrier) Proteins and Peptides do Not Survive the Digestiv
Slide 5: Multiple Clinical-Stage Programs
5 Phase 2 Phase 3 Multiple Clinical - Stage Programs ORMD - 0801 (Oral Insulin) Diabetes ORMD - 0801 (Oral Insulin) NASH ORMD - 0901 (Oral GLP - 1) Type 2 Diabetes Phase 1 Exploratory Studies Leptin (T1DM – PD: glucose and glycogen reduction; PK) Oravax’s Oral Covid - 19 Vaccine Clinical Trials to b
Slide 6: Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Diabetes: Millions of diabetics inject insulin today and wish for oral dosage
Slide 7: Adults on the Planet Have Diabetes
7 1 in 1 1 Adults on the Planet Have Diabetes every 6 SECONDS 1 adult dies from diabetes 4M deaths in 2017 https://www.idf.org/e - library/epidemiology - research/diabetes - atlas/159 - idf - diabetes - atlas - ninth - edition - 2019.html WORLD 463 M People live with diabetes PREVALENCE 9 . 09 % 20
Slide 8: ORMD-0801: Oral Insulin
ORMD - 0801: Oral Insulin
Slide 9: Oral Insulin Mimics the Delivery of Endogenous Insulin
9 Oramed © 2021 Oral Insulin Mimics the Delivery of Endogenous Insulin Injectable Insulin Current Injectable insulin is introduced directly to the bloodstream, with only a small fraction reaching the liver, where endogenous insulin is regulated ORMD - 0801 is delivered orally with first pass metabol
Slide 10: Oral Insulin: Significant Advantages Over Injectable Insulins
10 Oramed © 2021 Oral Insulin: Significant Advantages Over Injectable Insulins Advantages of ORMD - 0801 Oral Insulin Ease of Administration Oral delivery benefits diabetic patients with a fear of needles and should improve patient administration and compliance Improved Blood Glucose Control Insulin
Slide 11: ORMD-0801 for Type 1 & Type 2 Diabetes
11 ▪ T1DM is autoimmune: The body destroys its own insulin - producing (beta) cells, leaving patients completely dependent on external insulin sources ▪ 10% of diabetics have T1DM: Up to 46 million people worldwide have T1DM ▪ Projected Market: $24 billion by 2029 ▪ T 2 DM is metabolic: The body bec
Slide 12: ORMD-0801 for Type 1 Diabetes (T1DM)
12 ▪ 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 injection or pump ▪ Easier use and reduced systemic exposure ▪ Potentially reducing multiple daily injec
Slide 13: Phase 2a Trial in T1D Completed
13 Oramed © 2021 Phase 2a Trial in T1D Completed • Oral insulin met primary endpoint of reducing exogenous insulin requirements in Phase 2a T1D study • Oral insulin decreased use of rapid - acting insulin, level of post - meal glucose, and levels of daytime glucose • Additionally, day and night bloo
Slide 14: Completed Phase 2 Patient Trial for T2D
14 Oramed © 2021 Phase 2 – Completed 180 Patient Trial for T2D Note: ClinicalTrials.gov Identifier = NCT02496000. (1) Trial only had 1 dose level, but patients were given either a full dos e, or 1.5 doses (2) Based on 2 nights of CGM data by comparison of the mean percent change between Baseline and
Slide 15: Phase 2 Trial Demonstrated No Drug Related Serious Adverse Events
15 Oramed © 2021 Phase 2 Trial Demonstrated No Drug Related Serious Adverse Events and Promising Efficacy on CGM Parameters 90 7 298 8.48 13.7 12.38 2.01 1.66 - 0.35 Nighttime CGM Glucose Mean % change Nighttime CGM Glucose Mean mg/dl change Nighttime CGM Glucose Median mg/dl change Change from run
Slide 16: Phase 2b Completed Patient Trial for T2D
16 Oramed © 2021 Phase 2 b – Completed 298 Patient Trial for T 2 D Note: ClinicalTrials.gov Identifier = NCT03467932. (1) 36 Sites: 2 sites (49 subjects) were excluded due to significant treat men t by center interaction; 347 subjects received primary treatment and had baseline A1c (included in ITT)
Slide 17: ORMD-0801 Phase 2b Achieved Safety and Primary Endpoints
17 Oramed © 2021 ORMD - 0801 Phase 2b Achieved Safety and Primary Endpoints Note: ClinicalTrials.gov Identifier = NCT03467932. 8 mg, 2 x - 0.81 - 0.82 0.25 - 0.36 - 0.54 - 0.53 - 0.45 -1 -0.8 -0.6 -0.4 -0.2 0 0.2 0.4 A 1 C Change from Baseline 16 mg, 1x/day 8 mg, 1x/day 8 mg, 2x/day 32 mg, 1 x/day 3
Slide 18: ORMD-0801 Phase 2b Exhibited Strong A1C Lowering Activity at 8 mg 1x/Day
18 Oramed © 2021 ORMD - 0801 Phase 2b Exhibited Strong A1C Lowering Activity at 8 mg 1x/Day Dose 90 7 - 0.14 - 0.95 - 1.4 Placebo 8 mg, 1x 8mg, 1x (Baseline >9%) Significant A1C lowering with 8 mg, 1x/day dose • 8 mg 1 x/day showed 0.95 ( 0.81 placebo adjusted) reduction in A 1 C (p= 0.028 ) • 8 mg
Slide 19: FDA BLA Pathway
19 FDA BLA Pathway: • Confirmatory Phase 3 Study • Submission to FDA x No increase in Adverse Events compared to Placebo x No increase in Hypoglycemic Events compared to Placebo x No weight gain compared to Placebo FDA Phase 2b Trial Results - Primary Endpoint Successfully Met Safe and well tolerate
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 Will Maximize ORMD-0801's Success
21 Oramed © 2021 Two Pivotal Phase 3 Trials will Maximize ORMD - 0801’s Success in the Market Source: (1) FDA indicated possible 1L designation based on the ORA - D - 013 - 2 trial in which ~30% of enrolled patients are metformi n treatment naïve Patient Type Design & Dosing Type 2 Diabetes Mellitus
Slide 22: Two Pivotal Phase 3 Trials Will Maximize ORMD-0801's Success
22 Oramed © 2021 Two Pivotal Phase 3 Trials will Maximize ORMD - 0801 ’ s Success in the Market Source: (1) FDA indicated possible 1L designation based on the ORA - D - 013 - 2 trial in which ~30% of enrolled patients are metformi n treatment naïve Patient Type Design & Dosing Type 2 Diabetes Mellit
Slide 23: ORMD-0801's Robust Clinical Development Program
23 Oramed © 2021 ORMD - 0801’s Robust Clinical Development Program has Paved the way Towards Anticipated Approval Note: CSR = Clinical Study Report; SAE = Serious Adverse Event ( 1 ) Includes all clinical studies across all indications, including formulation studies ORMD - 0801 Development Prep BLA
Slide 24: China License Deal: 500M Patient Potential
24 China License Deal: 500M patient potential * Journal of the American Medical Association ▪ License: Exclusive right to ORMD - 0801 in Greater China ▪ Licensee: Hefei Tianhui ("HTIT") Owns with Sinopharm a state - of - the - art GMP API insulin manufacturing facility - HTIT clinical trials of ORMD
Slide 25: Two Ongoing Phase 2 Trials for T2D with NASH
25 Oramed © 2021 Two Ongoing Phase 2 Trials for T 2 D with NASH Note: ClinicalTrials.gov Identifier = NCT02653300 and NCT04618744 . (1) Originally treated 8 patients (Israel), an additional 10 patients to be treated (EU). Second trial to treat 30 patients (U S, Israel). Final statistical analysis wi
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)
27 T2DM 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 IND Bioavailability study GLP - 1 Analog: ORMD - 0901 for Oral GLP - 1 (TD2M) GLP - 1 Analog ORMD - 0901 Clin
Slide 28: Oral GLP-1 ORMD-0901 Preserved the Biological Activity of Orally Delivered Exenatide
28 Oral GLP - 1 - ORMD - 0901 Preserved the biological activity of orally delivered exenatide. ORMD - 0901 successfully curbed blood sugar excursions following glucose challenge ORMD - 0901 formulations Preclinical: Oral exenatide delivery amounted to a >50% reduction in mean glucose (similar to SC)
Slide 29: Oravax Joint Venture: Novel Oral Covid-19 Vaccine
29 Oramed © 2021 ▪ Joint Venture - Oramed is the majority shareholder of Oravax (63%) ▪ License - Royalties: 7.5% of net sales - Sublicensing: 15% - S ales milestone : $25M - $100M – Novel Oral Covid - 19 Company Covid - 19 Vaccines 2021 : $ 13.6 b The Oravax technology integrates Premas Biotech’s D
Slide 30: Oravax Vaccine Advantages
30 Oramed © 2021 - Advantages ▪ No temperature rise, no body weight loss/gain, no adverse events noted in any animal ▪ Significant antibody response, as well as cellular immune response ▪ Long term retention of the antibody response in animals, post 150 days Triple antigen vaccine expected to be eff
Slide 31: Oravax and Genomma Lab Form Joint Venture
31 Oramed © 2021 - Oravax and Genomma Lab Form Joint Venture • Contribute to the oral vaccine ’ s development, clinical, regulatory, and commercial activities • L everage supply chain, partnerships and market presence in LATAM • P articipate in a future investment in Oravax. • 50/50 JV to Develop an
Slide 32: Anticipated Development Milestones
32 Anticipated Development Milestones • Bioavailability Study (T 2 DM) Initiation & Completion • T2DM: Phase 3 trials • NASH: Phase 2 underway • Phase I ex - USA Initiation 0801 oral insulin 0901 GLP - 1 Leptin 2022 2021 0801 oral insulin 0901 GLP - 1 Leptin • T2DM: Topline Data • NASH: Topline Data
Slide 33: Funneling Huge Injectable Drug Markets to Novel Oral Formulations
33 Funneling Huge Injectable Drug Markets to Novel Oral Formulations Covid - 19 Vaccine 2021 : $ 13.6 b GLP - 1 2020: $12 b Insulin 2019: $34 b NASH 2019: $2.9 b Oramed © 2021 Insulin Market: Human Insulin Market Trends and Forecast, 2020 - 2025 - ResearchAndMarkets.com | Business Wire GLP - 1 Marke
Slide 34: Management Team
34 Management Team Nadav Kidron, Esq, MBA - CEO & Director Entrepreneur whose experience includes decades of senior executive roles in a wide range of industries including business, law and technology Miriam Kidron, PhD - CSO & Director Senior Researcher at the Diabetes Unit of Hadassah Medical Cent
Slide 35: Board of Directors
35 Board of Directors Kevin Rakin - Chairman Co - Founder and Partner at HighCape Partners; former President of Regenerative Medicine at Shire plc Leonard Sank Entrepreneur and business leader; Director of Macsteel Service Centres SA (Pty) Ltd Aviad Friedman Director General of Israel’s Housing Mini
Slide 36: Scientific Advisory Board
36 Scientific Advisory Board Roy Eldor, MD, PhD Director, Diabetes Unit, Institute of Endocrinology, Metabolism & Hypertension, Tel - Aviv Medical Center Ele Ferrannini, MD, PhD Professor, Internal Medicine, University of Pisa School of Medicine. Past President of the EASD Alexander Fleming, MD Reco
Slide 37: Oramed (NASDAQ/TASE: ORMP) Summary
37 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 ~ $17
Slide 38: Thank You
THANK YOU www.oramed.com
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