Oramed Pharmaceuticals Inc.

Regulatory Filings • Aug 5, 2021

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): August 5, 2021

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 August 5, 2021, 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 August 5, 2021 (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

August 5, 2021

Addressing the Multibillion -Dollar Injectable Drug Markets with Oral Formulations August 2021

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 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, and others, 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 date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks affecting Oramed, reference is made to Oramed's reports filed from time with the Securities and Exchange Commission, which involve known and unknown 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 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 "\$105M1 in cash and investments, no debt
• " Experienced management team backed by world-class scientific experts
• · Multiple value-creation events for 2021
• = NASDAQ/TASE: ORMP

paueno

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

1 in 11 Adults on the Planet Have Diabetes

Oral Insulin Mimics the Delivery of Endogenous Insulin

Oral Insulin: Significant Advantages Over Injectable Insulins

Advantages of ORMD-0801 Oral Insulin

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

• · 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 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 Exogenous Insulin Requirements

• · 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
• · Additionally, day and night blood glucose levels were lower compared to control group

Oramed @ 2021

Phase 2 - Completed 180 Patient Trial for T2D

change between Baseline and Week 4 of ORMD-0801 and placebo groups

Oramed © 2021

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

Phase 2b - Completed 298 Patient Trial for T2D

ORMD-0801 Phase 2b Achieved Safety and Primary Endpoints

Primary Endpoint

• · 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 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) ORMD-0801 upheld safety profile previously exhibited in first Phase 2 study • 8 mg 1x/day for patients with baseline A1C >9% showed 1.40 (1.26 placebo adjusted) reduction in A1C > No increase in Serious Adverse Events compared to Placebo Mean A1C Change from Baseline at Week 12 V No increase in Hypoglycemic Events 8mg, 1x Placebo 8 mg, 1x compared to Placebo (Baseline >9%) · 6.1% (5/82) of subjects in placebo -0.14 group compared to 0% (0/15) of subjects in 8mg 1x/day had at least 1 hypoglycemic event No weight gain compared to Placebo at -0.95 Week 12 -1.4

Note: ClinicalTrials.gov Identifier = NCT03467932.

Oramed @ 2021

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:

• V No increase in Adverse Events compared to Placebo
• V No increase in Hypoglycemic Events compared to Placebo
• V No weight gain compared to Placebo

Phase 3Trials: Maximizing ORMD - 0801's Success inthe Market

Two Pivotal Phase 3 Trials will Maximize ORMD-0801's Success in the Market

Two Pivotal Phase 3 Trials will Maximize ORMD-0801's Success in the Market

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

Oramed @ 2021

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
  • HTIT clinical trials of ORMD-0801 underway

■ \$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*

(10.9% of adult population)

prediabetic

(35.7% of adult population)

* Journal of the American Medical Association

Two Ongoing Phase 2 Trials for T2D with NASH

With direct action on the liver, ORMD-0801 has the potential to address ~50% of diabetics suffering from NASH, a population with increased mortality.

	Trial Highlights
	48 Protocols	90 Patients1 Day Treatment	Dose Cohort
	Trial #1: Pilot Study to Assess Efficacy and Safety of ORMD- 0801		Trial #2: Safety & Efficacy of ORMD-0801
Design	Open label, non-randomized, single group, 12-week, once daily treatment in 18 T2D patients with NASH in Israel &EU		Double-blinded, randomized, 2 groups, 12 week, twice daily treatment in 30 T2D patients with NASH in US & Israel
Study Population	Patients with T2D with fat concentration in the liver of moderate steatosis (>8% liver with steatosis)		· Patients with T2D, fat concentration in the liver of moderate steatosis ( >8% liver with steatosis)
Endpoints	Primary: number of treatment-related adverse events Secondary: change in liver fat content (MRI-PDFF) from Baseline to Week 12	Baseline to Week 12	· Primary: number of treatment-related adverse events · Secondary: change in liver fat content (MRI-PDFF) from
Initial Data	Efficacy from first eight patients: 30% relative reduction measured by MRI-PDFF; 6.9±6.8% mean reduction in liver fat content (p value: 0.035) Safety from first eight patients: No drug-related Serious Adverse Events	Initiated in Q4 2020

Note: Clinical in also vientified in 1970 (1974). 1974). 1974). (1) Originaly treated Spatients to be teated (EU). Second rial to treat 30 patents (US, lsael, Final of teach

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

ORMD-0901 Clinical Status

• · IND
• · Bioavailability study

Oral GLP-1 - ORMD-0901

Preserved the biological activity of orally delivered exenatide. ORMD-0901 formulations successfully curbed blood sugar excursions following glucose challenge

X - Novel Oral Covid-19 Company

• = JV:
  • Oramed majority shareholder of Oravax
  • Majority of BoD
• " License:
  • Royalties: 7.5% of net sales
  • Sublicensing: 15%
  • Sales milestone: \$25M \$100M ା
• · Universal COVID vaccine
  • · Triple antigen vaccine expected to be effective against COVID variants

· Manufacturing advantages

• · Ease of scale up
• · Straight-forward tech transfer
• · Manufacturing and COGs optimization
• · Consistent process
• · Safe, non-toxic, and efficacious in preclinical and GLP Tox studies in animals:
  • · No temperature rise, or body weight loss/gain, no adverse events noted in any animal
  • · Significant antibody response, as well as cellular immune response
  • · Showed desired immunological parameters and efficacy
  • · Long term retention of the antibody response in animals, post 150 days
• · Oral format
  • · No needles
  • · Easy to administer at home (no need for professional administration)
  • · No need for low temperature storage (freezer)
  • · Potential for further reduction in side effects (greater safety)

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

David Silberman 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

Michael Rabinowitz - Chief Commercial Officer

Over 2 decades experience in launching and marketing new medications and treatments

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

1 As of August 2, 2021 (unaudited) 2 as of July 14, 2021

THANK YOU www.oramed.com