Item 1. Business
ITEM 1. BUSINESS.
Description of Business
We are currently a pharmaceutical
company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the
oral delivery of therapeutic proteins.
Through our research and development
efforts, we have developed an oral dosage form intended to withstand the harsh environment of the stomach and effectively deliver active
biological insulin or other proteins. The excipients in the formulation are not intended to modify the proteins chemically or biologically,
and the dosage form is designed to be safe to ingest. We plan to continue to conduct clinical trials to show the effectiveness of our
technology.
On January 11, 2023, we
announced that our Phase 3 trial, or the ORA-D-013-1 Phase 3 trial, did not meet its primary and secondary endpoints. As a result, we
terminated both ORA-D-013-1 and ORA-D-013-2 Phase 3 clinical trials. In parallel, we have initiated a comprehensive analysis of the data
to understand if there is a path forward for our oral insulin candidate. We are examining our existing pipeline and have commenced an
evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
Research and Development
Oral insulin
Type 2 Diabetes : We
conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control who were on two or
three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of our oral insulin capsule, ORMD-0801,
compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing the change from
baseline in fasting plasma glucose at 26 weeks. On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its
primary and secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, we also terminated the ORA-D-013-2 Phase 3 trial,
a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their condition with
either diet alone or with diet and metformin.
NASH : In December 2020,
we initiated a double blind, placebo controlled clinical trial of ORMD-0801 for the treatment of non-alcoholic steatohepatitis, or NASH,
in T2D. On September 13, 2022, we reported positive top line results from this trial, demonstrating that ORMD-0801 was safe and well tolerated
at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo. The trial
also evaluated the effectiveness of ORMD-0801 in reducing liver fat content over the 12-week treatment period by observing several independent
measures. All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801. We are currently evaluating our
path forward for ORMD-0801 for NASH.
Oral Vaccine
On March 18, 2021, we entered
into a license agreement, or the Oravax License Agreement, with Oravax, our 63% owned joint venture, pursuant to which we granted to Oravax
an exclusive, worldwide license of our rights in certain patents and related intellectual property relating to our proprietary oral delivery
technology to further develop, manufacture and commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas
Biotech Pvt. Ltd.’s, or Premas’s, proprietary vaccine technology involving a triple antigen virus like particle, or the Oravax
product, which was previously owned by Cystron Biotech LLC, and later acquired by Akers Biosciences Inc., or Akers. Effective January
1, 2022, Oravax transferred its rights and obligations under the Oravax License Agreement to its wholly-owned subsidiary, Oravax Medical
Ltd. For further details regarding the Oravax License Agreement, see note 12 to our audited consolidated financial statements.
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In October 2021, Oravax’s
oral virus-like particle, or VLP, COVID-19 vaccine received clearance from the South African Health Products Regulatory Authority (SAPHRA)
to initiate a Phase 1 trial. On December 14, 2021, Oravax screened and enrolled the first participant in this Phase 1 clinical trial.
The trial protocol was divided into two cohorts each comprised of 12 participants, with a 42-day safety waiting period between cohorts.
Due to several factors, including the fact that many volunteers did not qualify during screening due to prior asymptomatic COVID-19 infection
and other conditions, the rate of enrollment was slower than anticipated and as a result, we added an additional clinical site. On October
11, 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of this trial, meeting primary and secondary endpoints of safety
and immunogenicity. These results included significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune
response to VLP vaccine antigens observed in the majority of the patients dosed, and no safety issues were observed, including mild symptoms.
Cohort B completed dosing on January 5, 2023 and data is expected in the first half of 2023.
On December 29, 2021, Oravax signed a cooperation
and purchase agreement for an initial pre-purchase of 10 million doses of oral COVID-19 vaccines with Tan Thanh Holdings to commercialize
the vaccine in Southeast Asia.
Raw Materials
Our oral insulin capsule is
currently manufactured by Fidelio Healthcare, a diversified European Contract Development and Manufacturing Organization (CDMO) in the
pharmaceutical and healthcare industries.
In July 2010, Oramed Ltd.
entered into the Manufacturing and Supply Agreement with Sanofi-Aventis Deutschland GMBH, or Sanofi-Aventis. According to the agreement,
Sanofi-Aventis supplies Oramed Ltd. with specified quantities of recombinant human insulin to be used for clinical trials.
We have purchased, pursuant
to separate agreements with third parties, the raw materials required for the manufacturing of our oral capsule. We generally depend upon
a limited number of suppliers for the raw materials. Although alternative sources of supply for these materials are generally available,
we could incur significant costs and disruptions if we need to change suppliers. The termination of our relationships with our suppliers
or the failure of these suppliers to meet our requirements for raw materials on a timely and cost-effective basis could have a material
adverse effect on our business, prospects, financial condition and results of operations.
Market Overview
Diabetes is a disease in which
the body does not produce or properly use insulin. Insulin is a hormone that causes sugar to be absorbed into cells, where the sugar is
converted into energy needed for daily life. The cause of diabetes is attributed both to genetics (type 1 diabetes, or T1D) and, most
often, to environmental factors such as obesity and lack of exercise (T2D). According to the International Diabetes Federation, or IDF,
an estimated 537 million adults (20-79 years) worldwide suffered from diabetes in 2021 and the IDF projects this number will increase
to 783 million by 2045. Also, according to the IDF, in 2021, an estimated 6.7 million people died from diabetes. According to the American
Diabetes Association, or ADA, in the United States there were approximately 37.3 million people with diabetes, or 11.3% of the United
States population in 2019. Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and amputation.
Impact of COVID-19
We do not expect any material
impact on our development timeline and our liquidity due to COVID-19. However, we experienced approximately six months of delays in clinical
trials due to slow-downs of recruitment for trials generally. On the other hand, Oravax continues to develop its oral vaccine, the demand
for which may be reduced if COVID-19 continues to abate. We continue to assess the effect on our operations by monitoring the status of
COVID-19.
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Intellectual Property and Patents
We own a portfolio of patents
and patent applications covering our technologies, and we are aggressively protecting these technology developments on a worldwide basis.
We maintain a proactive intellectual
property strategy, which includes patent filings in multiple jurisdictions, including the United States and other commercially significant
markets. We hold 37 patent applications currently pending, with respect to various compositions, methods of production and oral administration
of proteins and exenatide. Expiration dates for pending patents, if granted, will fall between 2026 and 2039.
We hold 112 patents, twenty
of which were issued during the fiscal year ended December 31, 2022, including patents issued by the United States, Swiss, German, French,
U.K., Italian, Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian, Canadian, Hong Kong,
Chinese, European and Indian patent offices that cover a part of our technology, which allows for the oral delivery of proteins; patents
issued by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norwegian,
Spanish, Swedish, Swiss, U.K., Israeli, New Zealand, South African, Russian, Brazilian and Japanese patent offices that cover part of
our technology for the oral delivery of exenatide; and patents issued by the European, Austrian, Belgian, Denmark, French, German, Irish,
Italian, Luxembourg, Monaco, Netherlands, Norway, Spanish, Swedish, Swiss, U.K. and Japanese patent offices for treating diabetes.
Consistent with our strategy
to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding foreign
counterparts of such applications. We believe that our success will depend on our ability to obtain patent protection for our intellectual
property.
Our patent strategy is as
follows:
● Aggressively
protect all current and future technological developments to assure strong and broad protection by filing patents and/or continuations
in part as appropriate,
● Protect
technological developments at various levels, in a complementary manner, including the base technology, as well as specific applications
of the technology, and
● Establish
comprehensive coverage in the United States and in all relevant foreign markets in anticipation of future commercialization opportunities.
Trademarks and Trade Secrets
We have trademark applications
pending in Israel, with Corresponding international trademark applications in Australia, Brazil, Canada, China, Colombia, the European
Union, India, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mexico, New Zealand, Norway, Oman, Philippines, Russia, Singapore, Switzerland,
Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, U.S.A., Uzbekistan and Vietnam.
We also rely on trade secrets
and unpatentable know-how that we seek to protect, in part, by confidentiality agreements. Our policy is to require our employees, consultants,
contractors, manufacturers, outside scientific collaborators and sponsored researchers, our Board, technical review board and other advisors,
to execute confidentiality agreements upon the commencement of employment or consulting relationships with us. These agreements provide
that all confidential information developed or made known to the individual during the course of the individual’s relationship with
us is to be kept confidential and not disclosed to third parties except in specific limited circumstances. We also require signed confidentiality
or material transfer agreements from any company that is to receive our confidential information. In the case of employees, consultants
and contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall be assigned
to us as the exclusive property of the Company. There can be no assurance, however, that all persons who we desire to sign such agreements
will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our
trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.
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Out-Licensed Technology
Entera Bio
In June 2010, our wholly-owned
subsidiary, Oramed Ltd., entered into a joint venture agreement with DNA GROUP (T.R.) Ltd. (formerly D.N.A Biomedical Solutions Ltd.),
or DNA, for the establishment of Entera Bio Ltd., or Entera.
In March 2011, Oramed Ltd.
sold shares of Entera to DNA, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration
for the shares sold to DNA, the Company received, among other payments, ordinary shares of DNA (see also note 3 to our audited consolidated
financial statements).
As part of this agreement,
Oramed Ltd. entered into a patent transfer agreement, or the Patent Transfer Agreement, according to which Oramed Ltd. assigned to Entera
all of its rights to a patent application related to the oral administration of proteins that it has licensed to Entera since August 2010,
in return for royalties of 3% of Entera’s net revenues and a license back of that patent application for use in respect of diabetes
and influenza. As of December 31, 2022, Entera had not paid any royalties to Oramed Ltd. On December 11, 2018, Entera announced that it
had entered into a research collaboration and license agreement with Amgen, Inc., or Amgen. To the extent that the license granted to
Amgen results in net revenues as defined in the Patent Transfer Agreement, Oramed Ltd. will be entitled to the aforementioned royalties.
As part of a consulting agreement with a third party dated February 15, 2011, Oramed Ltd. is obliged to pay this third party royalties
of 8% of the net royalties received in respect of the patent that was sold to Entera in March 2011. During the years ended December 31,
2022, 2021 and four month period ended December 2021, we did not sell any of DNA’s ordinary shares. As of December 31, 2022, we
held approximately 1.4% of DNA’s outstanding ordinary shares and approximately 0.4% of Entera’s outstanding ordinary shares.
HTIT
On November 30, 2015, we entered into a Technology License Agreement,
or TLA, with Hefei Tianhui Incubator of Technologies Co., Ltd., or HTIT, and on December 21, 2015, these parties entered into an Amended
and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016, or the HTIT License
Agreement. According to the HTIT License Agreement, we granted HTIT an exclusive commercialization license in the territory of the People’s
Republic of China, Macau and Hong Kong, related to our oral insulin capsule, ORMD-0801, or the Product. Pursuant to the HTIT License Agreement,
HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities with respect to our technology and ORMD-0801
capsule, and will pay (i) royalties of 10% on net sales of the related commercialized products to be sold by HTIT in the territory, or
Royalties, and (ii) an aggregate of $37.5 million, of which $3 million was payable immediately, $8 million will be paid subject to our
entry into certain agreements with certain third parties, and $26.5 million will be payable upon achievement of certain milestones and
conditions. In the event that we will not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the
final expiration of our patents covering the technology in the territory in 2033, the Royalties rate may be reduced, under certain circumstances,
to 5%. The royalty payment obligation shall apply during the period of time beginning upon the first commercial sale of the Product in
the territory, and ending upon the later of (i) the expiration of the last-to-expire licensed patents in the territory; and (ii) 15 years
after the first commercial sale of the Product in the territory. The HTIT License Agreement shall remain in effect until the expiration
of the royalty term. The HTIT License Agreement contains customary termination provisions. Through December 31, 2022, we received aggregate
milestone payments of $20.5 million out of the aggregate amount of $37.5 million.
On August 21, 2020, we received
a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. We wholly dispute said claims and we are in discussions
with HTIT in an attempt to reach a mutually agreeable solution. We are currently evaluating with HTIT a path forward to continue our collaboration,
following the results of our ORA-D-013-1 Phase 3 trial.
Oravax License
In consideration for the grant
of the license under the Oravax License Agreement, we will receive (i) royalties equal to 7.5% on net sales, as defined in the Oravax
License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related to the license during the
term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based consideration received by Oravax
from a permitted sublicensee and (iii) other payments ranging between $25 million to $100 million, based on certain sales milestones being
achieved by Oravax. The parties further agreed to establish a development and steering committee, which will consist of three members,
of which two members will be appointed by us, that will oversee the ongoing research, development, clinical and regulatory activity with
respect to the Oravax product. In addition, we agreed to buy and Oravax agreed to issue to us 1,890,000 shares of common stock of Oravax,
representing 63% of the common stock of Oravax for the aggregate amount of $1.5 million. Akers contributed $1.5 million in cash to Oravax
and a license agreement to the Oravax product. Nadav Kidron, the Company’s President and Chief Executive Officer, was one of the
former members of Cystron. See note 12 to our audited consolidated financial statements.
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Medicox License
On November 13, 2022, we
entered into a distribution license agreement with Medicox Co., Ltd., or Medicox. an emerging biotech company with a consortium of proven
partnerships in the Republic of Korea. The agreement grants Medicox the exclusive license to apply for regulatory approval and distribute
ORMD-0801 for ten years in the Republic of Korea. Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at
an agreed upon transfer price per capsule. In addition, Medicox will pay Oramed up to $15 million in developmental milestones, $2 million
of which have already been received by Oramed to date, and up to 15% royalties on gross sales. Medicox will also be responsible for gaining
regulatory approval in the Republic of Korea.
We are currently evaluating
with Medicox a path forward to continue our collaboration, following the results of our ORA-D-013-1 Phase 3 trial.
Government Regulation
The Drug Development
Process
Regulatory requirements for
the approval of new drugs vary from one country to another. In order to obtain approval to market our drug portfolio, we need to go through
a different regulatory process in each country in which we apply for such approval. In some cases, information gathered during the approval
process in one country can be used as supporting information for the approval process in another country. As a strategic decision, we
decided to first explore the FDA regulatory pathway. The following is a summary of the FDA’s requirements.
The FDA requires that pharmaceutical
and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or introduction
to the general public. Clinical testing, known as clinical trials or clinical studies, is either conducted internally by life science,
pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.
The process of conducting
clinical trials is highly regulated by the FDA, as well as by other governmental and professional bodies. Below we describe the principal
framework in which clinical trials are conducted, as well as describe a number of the parties involved in these trials.
Protocols . Before commencing
human clinical trials, the sponsor of a new drug or therapeutic product must submit an IND application to the FDA. The application contains,
among other documents, what is known in the industry as a protocol. A protocol is the blueprint for each drug study. The protocol sets
forth, among other things, the following:
●
Who must be recruited as qualified participants,
●
How often to administer the drug or product,
●
What tests to perform on the participants, and
●
What dosage of the drug or amount of the product to give to the participants.
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Institutional Review Board .
An institutional review board is an independent committee of professionals and lay persons which reviews clinical research trials involving
human beings and is required to adhere to guidelines issued by the FDA. The institutional review board does not report to the FDA, but
its records are audited by the FDA. Its members are not appointed by the FDA. All clinical trials must be approved by an institutional
review board. The institutional review board’s role is to protect the rights of the participants in the clinical trials. It approves
the protocols to be used, the advertisements which the company or CRO conducting the study proposes to use to recruit participants, and
the form of consent which the participants will be required to sign prior to their participation in the clinical trials.
Clinical Trials . Human
clinical trials or testing of a potential product are generally done in three stages known as Phase 1 through Phase 3 testing. The names
of the phases are derived from the regulations of the FDA. Generally, there are multiple trials conducted in each phase.
Phase 1 . Phase 1 trials
involve testing a drug or product on a limited number of healthy or patient participants, typically 24 to 100 people at a time. Phase
1 trials determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body. This phase lasts
an average of six months to a year.
Phase 2 . Phase 2 trials
involve testing of no more than 300 participants at a time who may suffer from the targeted disease or condition. Phase 2 testing typically
lasts an average of one to two years. In Phase 2, the drug is tested to determine its safety and effectiveness for treating a specific
illness or condition. Phase 2 testing also involves determining acceptable dosage levels of the drug. Phase 2 trials may be split into
Phase 2a and Phase 2b sub-trials. Phase 2a trials may be conducted with patient volunteers and are exploratory (non-pivotal) trials, typically
designed to evaluate clinical efficacy or biological activity. Phase 2b trials are conducted with patients defined to evaluate definite
dose range and evaluate efficacy. If Phase 2 trials show that a new drug has an acceptable range of safety risks and probable effectiveness,
a company will generally continue to review the substance in Phase 3 trials.
Phase 3 . Phase 3 trials
involve testing large numbers of participants, typically several hundred to several thousand persons. The purpose is to verify effectiveness
and long-term safety on a large scale. These trials generally last two to three years. Phase 3 trials are conducted at multiple locations
or sites. Like the other phases, Phase 3 requires the site to keep detailed records of data collected and procedures performed.
Biological License Application .
The results of the clinical trials for a biological product are submitted to the FDA as part of a Biological License Application, or BLA.
Following the completion of Phase 3 trials, assuming the sponsor of a potential product in the United States believes it has sufficient
information to support the safety and effectiveness of its product, the sponsor will generally submit a BLA to the FDA requesting that
the product be approved for marketing. The application is a comprehensive, multi-volume filing that includes the results of all clinical
trials, information about the drug’s composition, and the sponsor’s plans for producing, packaging and labeling the product.
The FDA’s review of an application can take a few months to many years, with the average review lasting 18 months. Once approved,
drugs and other products may be marketed in the United States, subject to any conditions imposed by the FDA. Approval of a BLA provides
12 years of exclusivity in the U.S. market.
Phase 4 . The FDA may
require that the sponsor conduct additional clinical trials following new drug approval. The purpose of these trials, known as Phase 4
trials, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness. In recent years,
the FDA has increased its reliance on these trials. Phase 4 trials usually involve thousands of participants. Phase 4 trials also may
be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.
European Regulation .
Similar to the U.S., a European sponsor of a biological product may submit a Marketing Approval Application to the European Medicines
Agency, or EMA, for the registration of the product. The approval process in Europe consists of several stages, which together are summed
up to 210 days from the time of submission of the application (net, without periods in which the sponsor provides answers to questions
raised by the agency) following which, a Marketing Approval may be granted. During the approval process, the sponsor’s manufacturing
facilities will be audited in order to assess Good Manufacturing Practice compliance.
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The drug approval process
is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the
illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials.
Other Regulations
Various federal, state and
local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals,
the environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous substances,
including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities.
They include, among others, the U.S. Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act,
the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions
on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation.
The compliance with these and other laws, regulations and recommendations can be time-consuming and involve substantial costs. In addition,
the extent of governmental regulation which might result from future legislation or administrative action cannot be accurately predicted
and may have a material adverse effect on our business, financial condition, results of operations and prospects.
Competition
Competition in the area of
biomedical and pharmaceutical research and development is intense and significantly depends on scientific and technological factors. These
factors include the availability of patent and other protection for technology and products, the ability to commercialize technological
developments and the ability to obtain regulatory approval for testing, manufacturing and marketing. Our competitors include major pharmaceutical,
medical products, chemical and specialized biotechnology companies, many of which have financial, technical and marketing resources significantly
greater than ours. In addition, many biotechnology companies have formed collaborations with large, established companies to support research,
development and commercialization of products that may be competitive with ours. Academic institutions, governmental agencies and other
public and private research organizations are also conducting research activities and seeking patent protection and may commercialize
products on their own or through joint ventures. We are aware of certain other products manufactured or under development by competitors
that are used for the treatment of the diseases and health conditions that we have targeted for product development. We can provide no
assurance that developments by others will not render our technology obsolete or noncompetitive, that we will be able to keep pace with
new technological developments or that our technology will be able to supplant established products and methodologies in the therapeutic
areas that are targeted by us. The foregoing factors could have a material adverse effect on our business, prospects, financial condition
and results of operations. These companies, as well as academic institutions, governmental agencies and private research organizations,
also compete with us in recruiting and retaining highly qualified scientific personnel and consultants.
Competition within our sector
is increasing, so we will encounter competition from existing firms that offer competitive solutions in diabetes treatment solutions.
These competitive companies could develop products that are superior to, or have greater market acceptance, than the products being developed
by us. We will have to compete against other biotechnology and pharmaceutical companies with greater market recognition and greater financial,
marketing and other resources.
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Our competition will be determined
in part by the potential indications for which our technology is developed and ultimately approved by regulatory authorities. In addition,
the first product to reach the market in a therapeutic or preventive area is often at a significant competitive advantage relative to
later entrants to the market. Accordingly, the relative speed with which we, or our potential corporate partners, can develop products,
complete the clinical trials and approval processes and supply commercial quantities of the products to the market are expected to be
important competitive factors. Our competitive position will also depend on our ability to attract and retain qualified scientific and
other personnel, develop effective proprietary products, develop and implement production and marketing plans, obtain and maintain patent
protection and secure adequate capital resources. We expect our technology, if approved for sale, to compete primarily on the basis of
product efficacy, safety, patient convenience, reliability, value and patent position.
We anticipated that our oral
insulin capsule would be a competitive diabetes drug because of its anticipated efficacy and safety profile; however, there are other
treatment options for T1D and T2D patients, such as insulin injections, insulin pumps or a combination of diet, exercise and oral medication
which improve the body’s response to insulin or cause the body to produce more insulin.
Scientific Advisory Board
We maintain a Scientific Advisory
Board consisting of internationally recognized scientists who advise us on scientific and technical aspects of our business. The Scientific
Advisory Board meets periodically to review specific projects and to assess the value of new technologies and developments to us. In addition,
individual members of the Scientific Advisory Board meet with us periodically to provide advice in their particular areas of expertise.
The Scientific Advisory Board consists of the following members, information with respect to whom is set forth below: Dr. Roy Eldor, Professor
Ele Ferrannini, Dr. Alexander Fleming, Professor Avram Hershko, Dr. Harold Jacob, Dr. Julio Rosenstock, Dr. Jay Skyler and Dr. Anne Peters.
Dr. Roy Eldor , MD,
PhD , joined the Oramed Scientific Advisory Board in July 2016. He is an endocrinologist, internist and researcher with over twenty
years of clinical and scientific experience. He is currently Director of the Diabetes Unit at the Institute of Endocrinology, Metabolism
& Hypertension at the Tel-Aviv Sourasky Medical Center. Prior to that, Dr. Eldor served as Principal Scientist at Merck Research Laboratories,
Clinical Research – Diabetes & Endocrinology. He previously served as a senior physician in internal medicine at the Diabetes
Unit in Hadassah Hebrew University Hospital in Jerusalem, Israel; and the Diabetes Division at the University of Texas Health Science
Center in San Antonio, Texas. Dr. Eldor is a recognized expert, with over 50 peer reviewed papers and book chapters, and has been a guest
speaker at numerous international forums.
Professor Ele Ferrannini ,
MD , joined the Oramed Scientific Advisory Board in February 2007. He is a past President to the European Association for the
Study of Diabetes (EASD), which supports scientists, physicians and students from all over the world who are interested in diabetes and
related subjects in Europe and performs functions similar to that of the American Diabetes Association in the United States. Professor
Ferrannini has worked with various institutions including the Department of Clinical & Experimental Medicine at the University of
Pisa School of Medicine, and CNR (National Research Council) Institute of Clinical Physiology in Pisa, Italy; and the Diabetes Division,
Department of Medicine at the University of Texas Health Science Center in San Antonio, Texas. He has extensive training in internal medicine
and endocrinology, and has specialized in diabetes trials. Professor Ferrannini has received a Certificate of the Educational Council
for Foreign Medical Graduates from the University of Bologna, and completed a subspecialty in Diabetes and Metabolic Diseases at the University
of Torino, cum laude . He has published over 500 original papers and 50 book chapters and he is a “highly cited researcher,”
according to the Institute for Scientific Information.
Dr. Alexander Fleming,
MD , joined the Oramed Scientific Advisory Board in December 2019. Dr. Fleming, an endocrinologist, is Founder and Executive Chairman
of Kinexum, a strategic advisory firm. From 1986 to 1998, he served at the FDA as a supervisory medical officer in the Division of Metabolism
and Endocrine Drug Products and was responsible for landmark approvals of the first statin, metformin, and other endocrine and metabolic
therapies. He also represented the FDA at the World Health Organization and on multiple expert working groups of the International Conference
on Harmonization (ICH). Dr. Fleming coined the term, Metabesity, which refers to the constellation of major chronic diseases and the aging
process itself, all which share common metabolic root causes and potential preventive therapies. He organized the first Congress on Metabesity
in London in October 2017, followed by annual conferences. In 2020, Dr. Fleming founded the non-profit Kitalys Institute as a means of
producing Metabesity conferences and advancing interventions of any kind that can improve health and healthspan.
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Professor Avram Hershko,
MD, PhD , joined the Oramed Scientific Advisory Board in July 2008. Professor Hershko served as a physician in the Israel Defense
Forces from 1965 to 1967. After a post-doctoral fellowship with Gordon Tomkins at the University of San Francisco from 1969 to 1972, he
joined the faculty of the Haifa Technion becoming a professor in 1980. He is now Distinguished Professor in the Unit of Biochemistry in
the B. Rappaport Faculty of Medicine of the Technion in Haifa, Israel. Professor Hershko’s main research interests concern the mechanisms
by which cellular proteins are degraded, a formerly neglected field of study. Professor Hershko and his colleagues showed that cellular
proteins are degraded by a highly selective proteolytic system. This system tags proteins for destruction by linkage to a protein called
ubiquitin, which had previously been identified in many tissues, but whose function was previously unknown. Subsequent work by Professor
Hershko and many other laboratories has shown that the ubiquitin system has a vital role in controlling a wide range of cellular processes,
such as the regulation of cell division, signal transduction and DNA repair. Professor Hershko was awarded the Nobel Prize in Chemistry
in 2004, jointly with his former PhD student Aaron Ciechanover and their colleague Irwin Rose. His many honors include the Israel Prize
for Biochemistry (1994), the Gairdner Award (1999), the Lasker Prize for Basic Medical Research (2000), the Wolf Prize for Medicine (2001)
and the Louisa Gross Horwitz Award (2001). Professor Hershko is a member of the Israel Academy of Sciences since 2000 and a Foreign Associate
of the U.S. Academy of Sciences since 2003.
Dr. Harold Jacob, MD ,
joined the Oramed Scientific Advisory Board in November 2016. Since 1998, Dr. Jacob has served as the president of Medical Instrument
Development Inc., a company which provides a range of support and consulting services to start-up and early stage companies as well as
patenting its own proprietary medical devices. Since 2011, Dr. Jacob has also served as an attending physician at Hadassah University
Medical Center in Jerusalem, Israel, where he has served as the director of the gastrointestinal endoscopy unit since September 2013.
Dr. Jacob has advised a spectrum of companies in the past and he served as a consultant and then as the Director of Medical Affairs at
Given Imaging Ltd., from 1997 to 2003, a company that developed the first swallowable wireless pill camera for inspection of the intestine.
He has licensed patents to a number of companies including Kimberly-Clark Corporation. Since 2014, Dr. Jacob has served as the Chief Medical
Officer and a director of NanoVibronix, Inc., a medical device company using surface acoustics to prevent catheter acquired infection
as well as other applications, where he served as Chief Executive Officer from 2004 to 2014. He practiced clinical gastroenterology in
New York and served as Chief of Gastroenterology at St. John’s Episcopal Hospital and South Nassau Communities Hospital from 1986
to 1995, and was a Clinical Assistant Professor of Medicine at SUNY from 1983 to 1990. Dr. Jacob founded and served as Editor in Chief
of Endoscopy Review and has authored numerous publications in the field of gastroenterology.
Dr. Julio Rosenstock,
MD , joined the Oramed Scientific Advisory Board in January 2020. Dr. Rosenstock is the Senior Scientific Advisor and Director
of Velocity Clinical Research at Medical City, Dallas, Texas, and a Clinical Professor of Medicine at the University of Texas Southwestern
Medical Center in Dallas, Texas. He is board certified in Internal Medicine, Endocrinology and Metabolism. His clinical and research activities
have focused on exploring novel agents and therapeutic strategies to improve glycemic control, particularly early combination therapies
in Type 2 Diabetes. Over the last 30 years, he has participated in hundreds of clinical trials and has had an active role in the development
of new oral agents, incretin-related therapies and insulin formulations, often acting as a lead clinical investigator and scientific advisor
on the design and reporting of these clinical trials. Dr. Rosenstock has been the author or co-author of 360 peer-reviewed manuscripts
( H-index 119 ) and several hundreds of scientific abstracts. He has also contributed to 13 book chapters on various topics in the
field of diabetes and is considered a key opinion leader in Type 2 Diabetes.
Dr. Jay Skyler, MD,
MCAP, FRCP , joined the Oramed Scientific Advisory Board in January 2020. Dr. Skyler is Professor of Medicine, Pediatrics and Psychology
in the Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami Leonard M. Miller School of Medicine.
He previously held the position of Director of the Division of Endocrinology, Diabetes and Metabolism. In addition, Dr. Skyler is Deputy
Director of Clinical Research and Academic Programs at the Diabetes Research Institute, and an Adjunct Professor of Pediatrics at the
Barbara Davis Center for Childhood Diabetes at the University of Colorado in Denver. Dr. Skyler’s research focuses on the clinical
aspects of diabetes, specifically the conduct of randomized controlled clinical trials. From 1993 to 2015, he was Chairman of the National
Institute of Health (NIDDK)-sponsored Diabetes Prevention Trial–- Type 1 (DPT-1) and its successor Type 1 Diabetes Trial Net, a
nationwide and global network conducting clinical trials to prevent T1D.
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Dr. Anne Peters, MD ,
joined the Oramed Scientific Advisory Board in June 2022. Dr. Peters is Professor of Medicine at the Keck School of Medicine of the University
of Southern California (USC) and Director of the USC Clinical Diabetes Programs. Dr. Peters earned her medical degree from the Pritzker
School of Medicine at the University of Chicago and performed an internal medicine residency at Stanford University and an endocrinology
fellowship at Cedars-Sinai Medical Center. She previously directed the clinical diabetes programs at Cedars-Sinai Medical Center and UCLA
in California. Her research has focused on testing new approaches for diagnosing and treating diabetes and developing systems of care
to improve outcomes in diabetic populations. Dr. Peters is the chair of the Endocrine Society Committee on Diabetes Devices and is on
the EASD/ADA Technology Safety Committee. Additionally, she is a member of the JDRF Panel on Management of Exercise in type 1 Diabetes
and a member of the ABIM Endocrinology Subspecialty Board. Dr. Peters has consulted for many entities, including the FDA, Optum Rx and
CVS/Caremark to help guide the development and use of treatments for diabetes. In addition to being an investigator for more than 40 research
studies, Dr. Peters has published over 200 articles, has written four books, and has given more than 500 lectures locally, nationally,
and internationally. She has been on multiple guideline writing committees for the treatment of both type 1 and type 2 diabetes. She was
a recipient of the ADA Outstanding Physician Clinician Award, the Bernardo Houssay Award from the National Minority Quality Forum and
received a 2021 Endocrine Society Laureate Award for Public Service.
Employees
We believe it is imperative
to attract and retain top talent for all positions in the Company. We seek to make Oramed an inclusive, diverse and safe workplace, with
meaningful compensation, benefits and wellness programs and opportunities.
We have experienced personnel involved in our research and development
programs, as well as appropriate clinical/regulatory, quality assurance and other personnel needed to advance through clinical trials
or have engaged the services of experts in the field for these requirements. As of December 31, 2022, we have contracted with seventeen
individuals for employment or consulting arrangements, including employees of Oravax. Of our staff, six are senior management, four are
engaged in research and development work, and the remaining seven are involved in corporate and administration work.
We provide competitive compensation,
health and retirement programs for our employees. We offer variable pay in the form of bonuses and stock-based compensation for eligible
employees. We also provide our employees with additional benefits such as team-building and educational offsite activities and gym facilities.
We believe that this provides a comprehensive package to engage, motivate and retain our employees as a cohesive unit unified in its goal
to achieve the Company’s strategy and objectives.
Additional Information
Additional
information about us is contained on our Internet website at www.oramed.com. Information on our website is not incorporated by reference
into this report. Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those
reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available
free of charge on our website under “SEC Filings” as soon as reasonably practicable after we electronically file such material
with, or furnish it to, the SEC. Reports filed with the SEC are made available on its website at www.sec.gov and
are also available on the website of the Israeli Securities Authority at www.magna.isa.gov.il or
on the website of the Tel Aviv Stock Exchange at www.tase.co.il. The following corporate governance documents are also posted on our website:
Code of Ethics, Whistleblowing Policy and the charters for each of the Audit Committee, Compensation Committee and Nominating Committee
of our Board.
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