Oramed Pharmaceuticals Inc.

Investor Presentation • Oct 23, 2020

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549

FORM 8-K

CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): October 22, 2020

ORAMED PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

DELAWARE 001-35813 98-0376008 (State or Other Jurisdiction (Commission (IRS Employer

of Incorporation) File Number) Identification No.)

1185 Avenue of the Americas, Third Floor, New York, New York 10036

(Address of Principal Executive Offices) (Zip Code)

844-967-2633

(Registrant's telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which registered
Common Stock, par value \$0.012	ORMP	The Nasdaq Capital Market, Tel Aviv Stock
		Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01. Regulation FD Disclosure.

On October 22, 2020, Oramed Pharmaceuticals Inc. posted to its website an investor presentation, a copy of which is attached hereto as Exhibit 99.1.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99.1 Investor Presentation dated October 22, 2020. (Furnished herewith.)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

ORAMED PHARMACEUTICALS INC.

By: /s/ Nadav Kidron Name: Nadav Kidron

Title: President and CEO

October 22, 2020

Addressing the Multibillion -Dollar Injectable Drug Markets with Oral Formulations October 2020

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, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities, and others, all of which could cause or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no oblicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission, which involve known risks, uncertainties and other factors which may cause the actual results, performance or achievements of the company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Please refer to the company's filings with the Securities and Exchange Commission for a comprehensive list of risk factors that could cause actual results, performance or achievements of the company to differ materially from those expressed or implied in such forward-looking statements. Oramed undertakes no obligation to update or revise any forward-looking statements.

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 over \$45.6M in cash and investments, no debt1
• " Experienced management team backed by world-class scientific experts
• = Multiple value-creation events for 2020
• = NASDAQ/TASE: ORMP

1 As of May 31, 2020

Proprietary Technology for Oral Drug Delivery

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

Therapeutic proteins fail to be absorbed via the intestinal wall (barrier)

Oramed Technology Protects Drug Integrity and Increases Absorption

pH shield

Sensitive enteric coating protects capsule contents before entering small intestine

Protease protection Protease inhibitors protect the active agent

Absorption enhancement

Assists the permeation of proteins/peptides across intestinal membrane and into bloodstream

Multiple Clinical-Stage Programs

Diabetes: Millions ofdiabetics inject insulin today and wish for oral dosage

1 in 11 Adults on the Planet Have Diabetes

ORMD - 0801: Oral Insulin

ORMD-0801 - Flagship Product for Oral Treatment of Diabetes

The Drawbacks of Injected Insulin vs. the Advantages of Oral Insulin

ORMD-0801 for Type 1 & Type 2 Diabetes

============================================================================================================================================================================

TYPE 1 Diabetes

• 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 37 million people worldwide have T1DM
• " Projected Market: \$13 billion by 2023

TYPE 2 Diabetes

• T2DM is metabolic: The body becomes insulin resistant. Injections may be used to make up for the pancreas's inability to create sufficient insulin to keep blood sugar at normal levels
• = 371 million people worldwide need treatment
• " Projected Market: \$59 billion by 2025

ORMD-0801 for Type 1 Diabetes (T1DM)

Potentially eliminating the need for insulin before each meal

T1DM 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 injection or pump

Oramed oral insulin

• · Easier use and reduced systemic exposure
• · Potentially reducing multiple daily injections
• Tighter regulation and control of blood sugar levels by directly targeting liver glucose (TiR), due to portal administration

Phase 2a T1DM Study

Consistent and Accumulative Effect of ORMD-0801 for Treating Type 1 Diabetes

Completed: 180 Patient Phase 2 Study for Type 2 Diabetes

FDA Phase 2 Study

Achieved Every Primary Endpoint with No Drug Related Serious Adverse Events

FDA Phase 2 Study Exploratory Endpoints: CGM Parameters

Completed: 298 Patient Phase 2b Trial

Endpoints

Primary Endpoint	■ Mean change in HbA1c from baseline to Week 12
Secondary Endpoints	· Safety (AEs, hypoglycemic) = Fasting Plasma Glucose (FPG) + CGM · Weight
Dose Finding	= 16 mg/day (8 mg x 2/day) 96 mg/day (32 mg X 3/day) = 16 mg/day (16 mg X 1/day) 32 mg/day (32 mg X 1/day) 트 트 32 mg/day (16 mg X 2/day) 64 mg/day (32 mg X 2/day)	8 mg/day (8 mg X 1/day)

Phase 2b: Primary Endpoint Successfully Met

8 mg - 1/day -0.95 (-0.81 placebo adjusted)

60-70% of the randomized patients were on 2 or more glucose lowering drugs

All Patients were on Metformin

Glucose lowering agents taken in addition to Metformin included: Glibenclamide, Glipizide, Empagliflozin, Pioglitazone, Glimepiride, Dapagliflozin, Sitagliptin, Glibomet, Ertugliflozin

Phase 2b: 8 mg 1/day - HbA1c Change from Baseline at Week 12

FDA Phase 2b Trial Results - Primary Endpoint Successfully Met

Safe and well tolerated

FDA BLA Pathway:

• Confirmatory Phase 3 Study
• · Submission to FDA

Gain 12-year marketing exclusivity upon FDA approval

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

Factors considered by the FDA in a pivotal Phase 3 program

• 1. Efficacy: The study is powered, based on previous Phase 2 data, to include sufficient patients that will provide statistical significance for primary endpoint provided that the drug performs at least equally well in the Phase 3 study as it did in the Phase 2 study.
• 1. Safety: The study has sufficient patients, as determined by the FDA, to demonstrate that the drug is safe in diabetic patients.
• 1. Exposure: The study must show that the drug remains safe in patients exposed to the drug over a period of 6 and 12 months
• 1. Geographic variation: USA, Israel and EU countries

Pivotal Phase 3: Two Protocols

ORA-D-013-1

A Double-Blinded, Placebo-Controlled, Double Dummy, Multi-Center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on One, Two or Three Oral Glucose-Lowering Agents

ORA-D-013-2

A Double-Blinded, Placebo-Controlled, Multi-Center Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects with Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Diet Control Alone or on Diet Control and Metformin Monotherapy

. ORA-D-013-01

• Double Blind, Double Dummy i
• 1:1:1 randomization
  • · 8mg once-daily at night and placebo 45 mins before breakfast
  • 8mg twice-daily at night and 45 mins before breakfast
  • Placebo twice-daily at night and 45 mins before breakfast

= ORA-D-013-02

• Double Blind -
• 1:1 randomization -
  • 8mg at night .
  • " Placebo at night

Pivotal Phase 3: Sample Size

	ORA-D-013-1	ORA-D-013-2
Sample size	675 adult male and female subjects	450 adult male and female subjects
Territory	US-based	US, Eastern and Western European and Israel-based
Number of Sites	75 US sites	36 US sites, 25 ex-US sites

ORA-D-013-1: Primary and Secondary Objectives

Primary Objective

■ To compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c in inadequately controlled T2DM subjects on one, two or three oral glucose-lowering agents.

Secondary Objective

■ To assess the safety of repeat administration of ORMD-0801 in inadequately controlled T2DM subjects on one, two or three oral glucoselowering agents.

ORA-D-013-2: Primary and Secondary Objectives

Primary Objectives

■ Active vs Placebo:

• To evaluate the efficacy of ORMD-0801 compared to placebo in improving glycemic control as assessed by A1c in inadequately controlled T2DM subjects on diet control alone or on diet control and metformin monotherapy over a 26-week treatment period.

Secondary Objectives

· Active vs Placebo:

• To evaluate the efficacy of ORMD-0801 compared to placebo in maintaining glycemic control over a 52-week treatment period.

Pivotal Phase 3: Key Inclusion Criteria

ORA-D-013-1

• HbA1c ≥ 7.5% but ≤ 11.0% at Screening.
• On a stable dose of at least one and up to three of the following oral glucoselowering agents for a 3-month period prior to Screening:
  • Metformin _ |
  • DPP-4 inhibitor -
  • SGLT-2 inhibitor _
  • Thiazolidinedione
  • Sulfonylurea -

ORA-D-013-2

• = HbA1c ≥ 7.5% but ≤ 11.0% at Screening.
• Subjects should be on:
  • Diet and exercise alone for a period of at least 3 months prior to Screening; OR
  • Diet and exercise with a stable dose of metformin only (≥ 1500 mg or MTD) for a period of at least 3 months prior to Screening.

Pivotal Phase 3: Anticipated Clinical Development Timelines

China License Deal: 500M patient potential

• = 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
  • -
• = \$50M Payments + Royalties:
  • \$12M in restricted stock (at premium)
  • \$38M milestone payments
  • = \$33M received to date
  • \$17M expected over the next 2-3 years
  • । Up to 10% royalties on net sales

Chinese diabetes market*

prediabetic

(35.7% of adult population)

* Journal of the American Medical Association

Commercial Positioning

Project Background

Seagrove Partners completed focus groups with 94 - Seagrove Partners completed focus groups with 34
total participants including HCPs, Patients & Payers
in July 2020.

Six Key Project Objectives:
1. Dieterstand Therapeuth Market for Urgil Investin
3. Desterstand Therapeuthe Market for Urgil Institution Product Uperake
4. Destermine Preferre

Key Findings

• Prescribers value ancillary benefits of existing diabetes medications. In addition to the solid
  A1C lowering impact, HCPs place a high value on weight loss, cardiovascular an
• Positive response with some uncertainty on positioning. The initial response we
  of excitement and stopticism ("too product" for an oral" of Link of and Crail Architer and Cr
• o-Primary care physicians are attractive taget. Most T2 patients are in
  progression of cliabetes and are on high TDD of insulin when the bear and and the tre
  proposition of ORM
• suiln concept and physiologic MOA concept were positively received by Payers. Payers
  nthusiastic about the clinical of an orainsulin for T Postienter stores on the comments
• 0 63% of payers would be "very likely" or "likely" to recommend formulary cover
  members in combination withotheroral agents (metformin. SGLT-2s) or GLP-1s
• ם ning oral insulin as a new class has benefits. Positioning ORMD-0801 as a new class
  tion (vs. being lumped in with insulins) allows more control over rebate levels and le
  sit
• ם se III design can bolster support for coverage at was clear from the FC discussion tha
  ers will rely on outcomes data when determining coverage and relay por limpo
  sures area

Patient Segmentation

First Line Alter Mettormin Defore GLP-1sVSTL-2s)
This Cruine Sche Schop Shorth Scomparable CrillProvement with
Misform of beth Subscull of Warch Welch Wellsworld Tourised Tou

Semilia Valients ville Cruzents of Select Patients

Third Line In Combination with GLP-1s/SGLT-2s

Given the ancillary CV, renal and weight gain benefits of the GLP.
1/SCLT-2 (esses, oral insulin strong strong strong (s).
Llasse, oral insulin reill requires s

4th Line Post GLP-1s/SGLT-2s

With similar (but longer-term) clinical results to today, ORMD-0801
can be positioned as a precursor or "training insulin" particularly in
primary care. The value proposi

NASH Study Leveraging Oral Insulin for Nonalcoholic Fatty Liver Disease

Nonalcoholic Steatohepatitis (NASH)

• " Chronic liver disease caused by excessive fat in liver (MoA not fully known)
• · Leads to fibrosis, cirrhosis and liver failure (death)
• = 25% of adults in the U.S. have NAFLD
• 5% of adults in the U.S. have NASH
  • 37% among patients with T2DM

Status

• Data from initial 8 patients presented at ADA 2020 :
  • Safety:
    • 12-week, once-daily treatment had no SAEs
  • Efficacy:
    • · 30% relative reduction measured by MRI-PDFF
    • 6.9±6.8% mean reduction in liver fat content (p value: 0.035)
• Initiation of 10 additional patients in EU (ongoing)
• Initiation of Double-Blind Placebo-Controlled Study (n=30) in US and Israel (Q4;2020)

ORMD -0901: Oral GLP -1 Analog

GLP-1 Analog: ORMD-0901 for Oral GLP-1 (TD2M)

GLP-1 Analog

• · T2DM medication
• Mimics the natural hormone in the body
• · Compelling safety profile
• Decreases blood glucose levels
• Effectively reduces HbA1c
• Preserves beta cell function
• · Promotes weight loss
• Current therapy via injection only

ORMD-0901 Clinical Status

• . IND
• Bioavailability study

Oral GLP-1 - ORMD-0901

Anticipated Development Milestones

Funneling Huge Injectable Drug Markets to Novel Oral Formulations

Management Team

Nadav Kidron, Esq, MBA - CEO & Director Many years of business experience as well as corporate law and technology

Miriam Kidron, PhD - CSO & Director Senior Researcher at the Diabetes Unit of Hadassah Medical Center for more than 25 years

Avi Gabay, CPA - CFO Extensive experience in corporate financial management

Josh Hexter - Chief Operating & Business Officer More than 18 years of prominent leadership

roles in biotech and pharma

Roy Eldor, MD - Chief Medical Advisor Head of the Diabetes Unit at Tel-Aviv Sourasky Medical Center

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 of public and private companies including Maayan Ventures, Capital Point and Rosetta Green Ltd.

Arie Mayer

Managing Director and Chairman of the Board of Merck Life Science Israel (formerly Sigma-Aldrich Israel Ltd.)

Xiaoming Gao Chairman of HTIT, China

Nadav Kidron CEO, Oramed

Miriam Kidron CSO, Oramed

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

Recognized authority in the metabolic and endocrine fields with extensive FDA experience.

Avram Herskho, MD, PhD; Nobel Laureate

Distinguished professor in the biochemistry unit in the B. Rappaport Facility of Medicine, Technion, Haifa, Israel

Harold Jacob, MD

Chief Medical Officer, NanoVibronix. Previously, Director, Medical Affairs at Given Imaging.

Julio Rosenstock, MD

Director, Dallas Diabetes Research Center, Professor, University of Texas Southwestern Medical Center; Associate Editor, Diabetes Care.

Jay Skyler, MD, MCAP

Professor or Medicine, Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Miami.

Oramed (NASDAQ/TASE: ORMP)

Addressing the Multibillion-Dollar Injectable Drug Markets with Oral Formulations

= Proprietary oral protein delivery platform

1 As of May 31, 2020

THANK YOU www.oramed.com