Oramed Pharmaceuticals Inc.

Investor Presentation • Dec 12, 2022

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): December 12, 2022

ORAMED PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

DELAWARE 001-35813 98-0376008

(State or Other Jurisdiction (Commission File Number) (IRS Employer

of Incorporation) 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 December 12, 2022, 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

Exhibit No.	Description of Document
99.1	Investor Presentation dated December 12, 2022 (Furnished herewith.)
104	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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

December 12, 2022

Addressing the Multibillion - Dollar Injectable Drug Markets with Oral Formulations December 2022 Oramed Pharmaceuticals Inc. © 2022

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, including in each case those of Oravax. These forward-looking statements are based on the current expectations of the management of Oramed only, 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 statements, including 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. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results 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 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.

Oramed Snapshot

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COMPANY OVERVIEW

• Proprietary oral protein delivery platform
• Diabetes first initially targeting the lucrative insulin market
• · NASDAQ/TASE: ORMP

N

KEY FINANCIAL METRICS

• Strong financial position
• · * \$160M¹ in cash and investments
• · No debt

DRAMED

' As of September 30, 2022 (unaudited)

19

SIGNIFICANT PIPELINE, IP, AND CATALYSTS

• Robust pipeline leveraging IP portfolio for additional significant market opportunities
• · 88 granted patents, 35 pending patent applications, worldwide
• Multiple value-creation events for 2023

83

COMPANY MANAGEMENT

· Experienced management team backed by worldclass scientific experts

Upcoming Catalysts

ORAMED

Oramed Pharmaceuticals Inc. © 2022

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Proprietary Technology for Oral Drug Delivery

Oramed Pharmaceuticals Inc. © 2022

ORAMED

Multiple Clinical-Stage Programs

Diabetes: Millions of diabetics inject insulin today and wish for oral dosage

1 in 10 Adults Globally Have Diabetes

Oral Insulin Mimics the Delivery of Endogenous Insulin

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.

(3)

NO WEIGHT GAIN

Better insulin control prevents cells from absorbing excess glucose that can be converted to fat and lead to weight gain

EASE OF ADMINISTRATION

Oral delivery benefits diabetic patients with a fear of needles and should improve patient administration and compliance

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

• · TID is autoimmune: The body destroys its own insulinproducing (beta) cells, leaving patients completely dependent on external insulin sources
• · 10% of diabetics have TID: Up to 54 million people worldwide have TID
• Projected Market: \$24 billion by 2029

TYPE 2 DIABETES

• · T2D 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
• · 483 million people worldwide need treatment
• Projected Market: \$92 billion by 2029

Oramed Pharmaceuticals Inc. © 2022

ORAMED

ORMD-0801 for Type 1 Diabetes (TID)

ORAMED

Oramed Pharmaceuticals Inc. © 2022

Phase 2a Trial in TID Completed

By directly targeting liver glucose, ORMD-0801 may provide tighter blood sugar regulation and control for the ~1.6M' Type I diabetes patients in the US – potentially reducing the need for multiple daily injections, including mealtime insulin.

Phase 2 - Completed 180 Patient Trial for T2D

	US Sites 33	180 Patients Dose Groups 28 Day Treatment Day Treatment 28 2 2
	Design	Double-blind, randomized, placebo-controlled, 4 week, once daily (3 capsules) treatment
	Study Population	Enrolled patients with T2D who (1) are being treated by diet and exercise, (2) are untreated with antications, or (3) are treated with metformin as a monotherapy or in combination with one other arug (excluding insulin)
	Endpoints	· Primary: mean nighttime glucose levels 2 · Secondary: mean 24-hour glucose ', percent change in CGM mean fasting glucose between treatment and run-in; change from baseline to Week 4 of morning fasting c-peptide; percent change in AIC from Baseline to Week 4
	Dose Cohorts	· Placebo: 3x placebo capsules · Active: 16mg (1 dose/capsule) and 24mg (1.5 dose/capsule)
		1 Trial only had 1 dose level, but patients were given either a full dose, or 1.5 doses. 3 Based on 2 nights of CGM data by comparison of the mean percent change between Baseline and Week 4 of ORMB-0801 and placebo groups
ORAMED	Note: ClinicalTrials.gov Identifier = NCT02496000.	Oramed Pharmaceuticals Inc. © 2022

Phase 2 Trial Demonstrated No Drug Related Serious Adverse Events and Promising Efficacy on CGM Parameters

Phase 2b - Completed 298 Patient Trial for T2D

Design					Double-blind, randomized, placebo-controlled, 12-week, once/twice/or three times daily treatment
Study Population		Dapagliflozin, Sitagliptin, Glibomet, Ertugliflozin				Patients with T2D who are taking metformin only (at least 1500 mg or maximally tolerated dose) or metformin in addition to no more than two of the following: Glipizide, Empagliflozin, Pioglitazone, Glimepiride,
Endpoints				· Primary: mean change in A1C from Baseline to Week 12 of treatment period	· Secondary: safety (AES, hypoglycemic events); fasting plasma glucose (FPG) + CGM; weight
	Placebo	8 mg/day	16 mg/day	32 mg/day (32 mg, 1x/day or	64 mg/day	96 mg/day

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)

ORMD-0801 Phase 2b Exhibited Strong AIC Lowering Activity at 8 mg 1x/Day Dose

| Note: ClinicalTrials.gov Identifier = NCT03467932. ORAMED

Oramed Pharmaceuticals Inc. © 2022

FDA Phase 2b Trial Results Primary Endpoint Successfully Met

ORAMEC

Two Pivotal Phase 3 Trials will Maximize ORMD-0801's Success in the Market: ORA-D-013-1

Patient Type		Type 2 Diabetes Mellitus with Inadequate Glycemic Control on Two or Three Oral Glucose-Lowering Agents
Design & Dosing	· 710 subjects · Reached 100% randomization · US-based Double Blind, Double Dummy, 2:2:1:1 randomization	8 mg 2x/day at night 8 mg 1x/day at night Placebo 2x/day at and placebo 45 mins and 45 mins before night and 45 mins breakfast before breakfast before breakfast
Trial Endpoints	· To evaluate the safety of ORMD-0801 over a 52-week period	· To compare the efficacy of ORMD-0801 to a placebo in improving glycemic control over a 26-week period

ORAMED

Oramed Pharmaceuticals Inc. © 2022

Two Pivotal Phase 3 Trials will Maximize ORMD-0801's Success in the Market: ORA-D-013-2

ಡ Patient Type	Type 2 Diabetes Mellitus with Inadequate Glycemic Control Alone or on Diet Control and Metformin Monotherapy
Design & Dosing	· 450 subjects (including naive patients to 1L therapy - metformin) · Reached over 50% randomization · US, European and Israel-based Double Blind, 1:1 randomization	8mg at night	Placebo at night
Trial Endpoints	· To compare the efficacy of ORMD-0801 to a placebo in improving glycemic control over a 26-week period · To evaluate the safety of ORMD-0801 over a 52-week period

ORAMED

Oramed Pharmaceuticals Inc. © 2022

Oramed Commissioned IQVIA to Perform Market Research in the US, UK and EU

Country	Endos	PCPs	Total
11	19	21	40
शिल	13	12	25
1	14	12	26
	13	12	25
	14	12	26
	15	13	28
Total	88	82	170

◎IQVIA

ORAMED

Note: Sample size selected to ensure appropriate N size to support PMR data analytics

Oramed Pharmaceuticals Inc. © 2022

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

	Willingness to prescribe oral insulin (A)	Willingness to prescribe ORMD- 0801 (B)
Definitely would NOT prescribe	0%	0%	No HCPs listed that they would
Probably would NOT prescribe	2%	1%	definitely not prescribe the product, indicating high interest
Might or might not prescribe	20%	22%
Probably WOULD prescribe	53%	57%
Definitely WOULD prescribe	23%	20%

ORMD-0801 appears to meet physician expectations for an oral insulin given minimal change in their response after seeing the ORMD-0801 profile

=IQVIA

Q: What is your willingness to prescribe oral insulins for T2D patients, if orol insulins were launched in the morket?
Q: What is your willingness to prescribe Product X (ORM

Source: IQVIA market research of treating physicians (n=170 Endos and PCPs) in the US and Europe (UK/EU4), December 2021

ORAMED

ORMD-0801's Robust Clinical Development Program has Paved the way Towards Anticipated Approval

China License Deal: 500M patient potential

South Korea Commercial Distribution Agreement

Agreement:

Exclusive distribution rights to ORMD-0801 in South Korea

South Korean Partner: Medicox Co., Ltd.

• · Medicox (Kosdaq: 054180) is an emerging pharmaceutical R&D company
• . Has built an excellent consortium of partnerships across established leaders in South Korea
• · Responsible for local regulatory approval
• ® 10 year license to commercialize oral insulin in South Korea

1 in 7 South Korean adults have diabetes

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

Phase 2 Trials for T2D with NASH Completed to addetiss suffering from NASH, coppulation with increased mortality.

	· Open label, 90-day treatment , N = 9 T2D patients with NASH, 8mg x2/ x1 morning · Efficacy: 30% relative reduction measured by MRI-PDFF; 6.9±6.8% mean reduction in liver fat content (p value: 0.035) · Safety: No drug-related serious adverse events
	32 90 Day Treatment Patients
	Positive Phase 2 trial results reported: Safety & Efficacy of ORMD-0801
Design	· 32 T2D patients with NASH Double-blind, randomized, placebo- · 8mg x1/ x1 morning & 8mg x1/ x1 night controlled, multi-center study 90-day treatment · US and Israel
Study Population	32 Patients with T2D, fat concentration in the liver of moderate steatosis ( >8% liver with steatosis)
Endpoints Reached	Primary endpoint met: ORMD-0801 was safe and well tolerated with no treatment-related adverse events Secondary endpoint met: Showed clinically meaningful reduction of liver fat from baseline at 12 weeks

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 objective of reducing liver fat content in patients with NASH o and T2D Percent Change from Baseline to Week 12 in MR PDFF (%):
  • Liver Segment 3 (left lobe) showed placebo adjusted mean decrease of 1.8 with placebo adjusted median decrease of 5.7 for ORMD-0801
• o Exploratory objective of median change from baseline in Fibroscan fibrosis levels:
  • Median Change from Baseline to Week 12 in Fibrosis Median (kPa) showed placebo adjusted median decrease of 1.1 for ORMD-0801.
  • . Median change from Baseline to Week 12 in Steatosis Median (dB/m) showed placebo adjusted median decrease of 29 for ORMD-0801.

Placebo ORMQ-08018 mg BID

29

| Note: ClinicalTrials.gov Identifier = NCT03467932.

RAMED

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

Oral GLP-1 - ORMD-0901

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

Oramed is the majority shareholder of Oravax (63%)

LICENSE

• Royalties: 7.5% of net sales
• Sublicensing: 15%
• Sales milestone: \$25M \$100M

Oramed Pharmaceuticals Inc. © 2022

Oravax | Advantages

Triple antigen vaccine expected to be effective against COVID variants

Oravax | Highlighted Milestones

ORAMED

South Africa

• · Open-label
• · N=24 naive participants (no prior COVID-19 vaccine or infection)
• Endpoints:
  • o Safety & tolerability
  • o Efficacy

ORAMED

• Cohort A (12 participants) positive data received Q3 2022
• · Cohort B (12 participants) data expected Q1 2023

Oramed Pharmaceuticals Inc. © 2022

35

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 Diabetes Unit of Hadassah Medical Center for more than 25 years

Chief Financial Officer Extensive experience in corporate financial

David Silberman, CPA

management

Chief Operating & Business Officer

More than 18 years of prominent leadership roles in biotech and pharma

Netanel Derovan Chief Legal Officer

Josh Hexter

Highly accomplished executive leader, having spent over 20 years in senior legal positions.

Michael Rabinowitz Chief Commercial Officer

Over two decades of experience in launching and
marketing new medications and treatments

Board of Directors

NADAV KIDRON, ESQ, MBA

Chief Executive Officer, President & Chairman

Entrepreneur whose experience includes decades of senior executive roles in a wide range of industries including business, law and technology

ARIE MAYER, PH.D Independent Director

Managing Director and Chairman of the Board of Merck Life Science Israel

LEONARD SANK Independent Director

Entrepreneur and business leader; Director of Macsteel Service Centres SA (Pty) Ltd

YADIN ROZOV Independent Director

Investment professional with experience in capital markets, corporate finance, investment banking, and investment management. Founder and Managing Partner at Terrace Edge Ventures LLC.

MIRIAM KIDRON, PH.D Chief Scientific Officer & Director

Senior Researcher at the Diabetes Unit of Hadassah Medical Center for more than 25 years

Oramed Pharmaceuticals Inc. © 2022

Scientific Advisory Board

ROY ELDOR, MD, PHD	ELE FERRANNINI, MD, PHD	Alexander Fleming, MD
Director, Diabetes Unit, Institute of Endocrinology, Metabolism & Hypertension, Tel-Aviv Medical Center.	Professor, Internal Medicine, University of Pisa School of Medicine, Past President of the EASD.	Recognized authority in the metabolic and endocrine fields with extensive FDA experience.
AVRAM HERSKHO, MD, PHD; NOBEL LAUREATE	HAROLD JACOB, MD	JULIO ROSENSTOCK, MD
Distinguished professor in the biochemistry unit in the B. Rappaport Facility of Medicine, Technion, Haifa, Israel.	Chief Medical Officer, NanoVibronix. Previously, Director, Medical Affairs at Given Imaging.	Director, Dallas Diabetes Research Center, Professor, University of Texas Southwestern Medical Center; Associate Editor, Diabetes Care.
JAY SKYLER, MD, MCAP	ANNE PETERS, MD
Professor of Medicine, Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Miami.	Professor of Medicine at Keck School of Medicine of USC and Director of the USC Clinical Diabetes Programs.

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 · \$160M in cash and investments, no debt · 39M shares outstanding ( -43M fully diluted )
• · Proprietary oral protein delivery platform
• · Strong management team backed by world-class scientific experts
• · Multiple near-term value-creation catalysts for this year
• · Robust IP Portfolio
  • Methods and compositions for oral administration of proteins Methods and compositions for or al administration of exenotide
  • Methods and compositions (insulin + exenatide) Improved protease inhibitors

'As of September 30, 2022 (uncluditied) 4Aa el September 30, 2022