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Oramed Pharmaceuticals Inc.

ormp · NASDAQ Healthcare
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FY2024 Annual Report · Oramed Pharmaceuticals Inc.
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
 
FORM
10-K
 
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For
the Fiscal Year Ended December 31, 2024
 
or
 
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
Commission
file number 001-35813
 
ORAMED
PHARMACEUTICALS INC.
(Exact
Name of Registrant as Specified in its Charter)
 
Delaware
 
98-0376008
(State or Other Jurisdiction of

Incorporation or Organization)
 
(I.R.S. Employer

Identification No.)
 
 
 
1185 Avenue of the Americas, Third Floor, New York, NY
 
10036
(Address of Principal Executive Offices)
 
(Zip Code)
 
844-967-2633

(Registrant’s Telephone Number, Including Area Code)
 
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
  Nasdaq Capital Market, Tel Aviv Stock Exchange
 
Securities
registered pursuant to Section 12(g) of the Act:
 
None.
(Title
of class)
 
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
 
Yes
☐      No ☒
 
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
 
Yes
☐     No ☒
 
Indicate
by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934
during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing
requirements for the past 90 days.
 
Yes
☒      No ☐
 
Indicate
by check mark whether the registrant has submitted electronically every Interactive Date File required to be submitted pursuant to Rule
405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files).
 
Yes
☒      No ☐
 
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an
emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
 “smaller reporting company” and “emerging growth
company” in Rule 12b-2 of the Exchange Act.
 
Large accelerated filer
☐
Accelerated filer
☐
Non-accelerated filer
☒
Smaller reporting company
☒
 
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. ☐
 
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or
issued its audit report. ☐
 

If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the
filing reflect the correction of an error to previously issued financial statements. ☐
 
Indicate
by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation
received
by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
 
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
 
Yes
☐      No ☒
 
The
aggregate market value of the voting and non-voting common equity held by non-affiliates as of the last business day of the registrant’s
most recently
completed second fiscal quarter was $131,190,607 based on a price of $3.58, being the last price at which the shares of
the registrant’s common stock were
sold on the Nasdaq Capital Market prior to the end of the most recently completed second fiscal
quarter.
 
As
of March 27, 2025, the registrant had 40,850,455 shares of common stock issued and outstanding. 
 
 
 
 

 
 
TABLE
OF CONTENTS
 
Introduction
and Use of Certain Terms
 
ii
Cautionary
Statement Regarding Forward-Looking Statements
 
ii
 
 
 
PART
I
 
 
 
ITEM
1. BUSINESS
 
1
 
ITEM
1A. RISK FACTORS
 
13
 
ITEM
IB. UNRESOLVED STAFF COMMENTS
 
34
 
ITEM
1C. CYBERSECURITY
 
34
 
ITEM
2. PROPERTIES
 
34
 
ITEM
3. LEGAL PROCEEDINGS
 
34
 
ITEM
4. MINE SAFETY DISCLOSURES
 
34
 
 
 
 
PART II
 
 
 
ITEM
5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER
PURCHASES OF EQUITY SECURITIES
 
35
 
ITEM
6. [RESERVED]
 
36
 
ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
 
36
 
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
43
 
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
 
44
 
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
DISCLOSURE
 
45
 
ITEM
9A. CONTROLS AND PROCEDURES
 
45
 
ITEM
9B. OTHER INFORMATION
 
46
 
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
 
46
 
 
 
 
PART
III
 
 
 
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
 
47
 
ITEM
11. EXECUTIVE COMPENSATION
 
51
 
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED
STOCKHOLDER MATTERS
 
64
 
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
 
66
 
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
 
66
 
 
 
 
PART
IV
 
 
 
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
 
67
 
ITEM
16. FORM 10-K SUMMARY
 
73
 
i

 
 
INTRODUCTION
AND USE OF CERTAIN TERMS
 
As
used in this Annual Report on Form 10-K, the terms “we,” “us,” “our,” the “Company,”
and “Oramed” mean Oramed Pharmaceuticals Inc. and
our wholly-owned subsidiaries, unless otherwise indicated. All dollar amounts
refer to U.S. dollars unless otherwise indicated.
 
On
December 31, 2024, the exchange rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS
3.647
to $1.00. Unless indicated otherwise by the context, statements in this Annual Report on Form 10-K that provide the dollar equivalent
of NIS amounts or
provide the NIS equivalent of dollar amounts are based on such exchange rate.
 
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
 
The
statements contained in this Annual Report on Form 10-K that are not historical facts are “forward-looking statements” within
the meaning of
the Private Securities Litigation Reform Act of 1995 and other federal securities laws and the Israeli securities law.
Words such as “expects,” “anticipates,”
“intends,” “plans,” “planned expenditures,”
“believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended
to identify
forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements
as denoted in this Annual
Report on Form 10-K. Additionally, statements concerning future matters are forward-looking statements. We
 remind readers that forward-looking
statements are merely predictions and therefore inherently subject to uncertainties and other factors
and involve known and unknown risks that could cause
the actual results, performance, levels of activity, or our achievements, or industry
results, to be materially different from any future results, performance,
levels of activity, or our achievements, or industry results,
expressed or implied by such forward-looking statements. Such forward-looking statements
appear in “Item 1. Business” and
“Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as elsewhere
in this Annual Report on Form 10-K and include, among other statements, statements regarding the following:
 
 
●
our plan to evaluate potential
strategic opportunities;
 
 
 
 
●
our potential repurchases
of shares of our common stock;
 
 
●
the possibility that the
anticipated benefits of the 2023 Scilex Transaction and 2024 Refinancing (as defined below) are not realized when
expected or at
all, including as a result of the impact of, or problems arising from, the ability of Scilex Holding Company, or Scilex, to repay
the Notes and the ability of the Company to realize the value of the warrants;
 
 
●
our Profit Sharing Loan
Agreement expose us to potential market, liquidity, and execution risks;
 
 
●
the JV Agreement (as defined
herein) includes potential delays and, indemnification liabilities, and the impact of the Spin Off (as defined
below) could affect
our financial position, operations, and ability to realize anticipated benefits from the joint venture, or OraTech and Spin
Off;
 
 
●
our exposure to potential
litigation;
 
 
●
our ability to enhance
value for our stockholders;
 
 
●
the expected development
and potential benefits from our products;
 
 
●
the prospects of entering
into additional license agreements, or other partnerships or forms of cooperation with other companies or medical
institutions;
 
 
●
future milestones, conditions
and royalties under our license agreements;
 
 
●
the potential of the Oravax
Medical Inc., or Oravax, vaccine to protect against the coronavirus, or COVID-19, pandemic;
  
ii

 
 
 
●
our research and development
 plans, including preclinical and clinical trials plans and the timing of enrollment, obtaining results and
conclusion of trials;
 
 
●
our belief that our technology
has the potential to deliver medications and vaccines orally that today can only be delivered via injection;
 
 
●
the competitive ability
of our technology based on product efficacy, safety, patient convenience, reliability, value and patent position;
 
 
●
the potential market demand for our products;
 
 
●
our ability to obtain patent protection for our intellectual
property;
 
 
●
our expectation that our
research and development expenses will continue to be our major expenditure;
 
 
●
our expectations regarding our short- and long-term
capital requirements;
 
 
●
our outlook for the coming
months and future periods, including but not limited to our expectations regarding future revenue and expenses;
and
 
 
●
information with respect to any other plans and strategies
for our business.
 
Although
forward-looking statements in this Annual Report on Form 10-K reflect the good faith judgment of our management, such statements
can
only be based on facts and factors known by us at the time of such statements. Consequently, forward-looking statements are inherently
subject to risks
and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or
anticipated by the forward-looking
statements. Factors that could cause or contribute to such differences in results and outcomes include,
without limitation, those discussed herein, including
those risks described in “Item 1A. Risk Factors,” and expressed from
time to time in our other filings with the Securities and Exchange Commission, or
SEC. In addition, historic results of scientific research,
clinical and preclinical trials do not guarantee that the conclusions of future research or trials would
not suggest different conclusions.
Also, historic results referred to in this Annual Report on Form 10-K could be interpreted differently in light of additional
research,
clinical and preclinical trials results. Readers are urged not to place undue reliance on these forward-looking statements, which speak
only as of
the date of this Annual Report on Form 10-K. Except as required by law, we undertake no obligation to revise or update any
forward-looking statements in
order to reflect any event or circumstance that may arise after the date of this Annual Report on Form
10-K. Readers are urged to carefully review and
consider the various disclosures made throughout the entirety of this Annual Report on
Form 10-K which attempt to advise interested parties of the risks
and factors that may affect our business, financial condition, results
of operations and prospects.
 
iii

 
 
PART
I
 
ITEM
1. BUSINESS.
 
Description
of Business
 
We
are 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.
 
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.
 
On January 11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints. As
a result, we
terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the ORA-D-013-1
Phase 3 trial data and
found that subpopulations of patients with pooled specific parameters, such as body mass index, or BMI, baseline
HbA1c and age, responded well to oral
insulin. Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase
3 (ORA-D-013-3) clinical trial to the U.S. Food and
Drug Administration, or the FDA. We intend to initiate study during 2025. We are
additionally examining our existing pipeline and have commenced an
evaluation process of potential strategic opportunities, with the goal
of enhancing value for our stockholders.
 
On
January 22, 2024, we along with our wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement, or Initial JV Agreement,
with Hefei Tianhui Biotech Co., Ltd. or HTIT, and its subsidiary Technowl Limited or HTIT Sub. OraTech will focus on developing and commercializing
products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities.
 
On
February 7, 2025, we and HTIT entered into a Joint Venture Agreement, or the JV Agreement, amending the Initial JV Agreement signed on
January 22, 2024. To execute the JV Agreement, we formed OraTech Pharmaceuticals, Inc., or OraTech, which will serve as the joint venture
entity. We
currently hold 100% of OraTech shares. OraTech was formed to advance the development and commercialization of oral insulin,
combining our proprietary
technology and funding with HTIT’s manufacturing capabilities. Through this partnership, OraTech will
have the technology, resources, and production
capacity to bring oral insulin to market. The agreement also outlines the spin-off of
 OraTech, or the Spin Off, requiring regulatory filings and the
distribution of the majority of OraTech’s shares held by us to our
 shareholders. Both we and HTIT agreed to a 120-day lock-up period post-listing,
restricting share sales.
 
The
Initial Closing, set for April 30, 2025, or the Initial Closing, includes an investment of $40,000,000 by HTIT and $7,500,000 by us into
OraTech . Additionally, we will transfer all our intellectual property rights to OraTech. The second closing, contingent on the listing
of OraTech’s shares on
Nasdaq, involves a $20,000,000 investment by HTIT and an additional $7,500,000 investment by us, or the
Second Closing. It is expected to close by May
31, 2025, but no later than September 1, 2025. Upon completion of the Initial Closing
and the Second Closing, both HTIT and we will receive OraTech
shares, resulting in ownership of 50% for each of HTIT and us, excluding
 the impact of the contemplated distribution of OraTech shares to our
shareholders.
 
As
 part of the JV Agreement, HTIT will receive $20,000,000 at the Initial Closing and $10,000,000 at the Second Closing under a supply
agreement
with OraTech.
 
1

 
 
2023
Scilex Transaction and 2024 Refinancing
 
2023
Scilex Transaction
 
On
September 21, 2023, we entered into and consummated transactions, or, collectively, the 2023 Scilex Transaction, with Scilex, pursuant
to
which Scilex issued to us:
 
 
a.
A senior secured
promissory note, or the Tranche A Note, with a principal amount of $101,875,000, maturing on March 21, 2025 and bearing
interest of
SOFR plus 8.5%, payable in-kind. Scheduled principal payments are due on December 21, 2023, March 21, 2024, June 21, 2024,
September
21, 2024, and December 21, 2024, with the balance due on March 21, 2025. In January 2025, we extended Tranche A Note
maturity from
March 21, 2025 to December 31, 2025. As per the Tranche A Note terms, if the Tranche A Note is not repaid in full on or prior
to
March 21, 2024, an exit fee of approximately $3,056,000 was. Since the Tranche A Note was not repaid by March 21, 2024, we are
entitled
to the above-mentioned exit fee at the maturity date of the Tranche A Note. As of March 27, 2025, Scilex has repaid
$69,200,000 of the
amount due under the Tranche A Note and refinanced $25,000,000 as part of the 2024 Refinancing (as defined
below).
 
 
b.
Warrants
to purchase up to 4,500,000 shares of Scilex common stock with an exercise price of $0.01 per share,
 or the Closing Penny
Warrants, and four additional warrants, or the Subsequent Penny Warrants, each
 for 2,125,000 shares of Scilex common stock with an
exercise price of $0.01 per share. The Closing
Penny Warrants vested on September 21, 2023, and each of the Subsequent Penny Warrants
vested on
each of March 19, 2024, June 17, 2024, September 15, 2024 and December 14, 2024. The Closing Penny
 Warrants and the
Subsequent Penny Warrants shall become exercisable on the earliest of (i) March
14, 2025 and (ii) the date on which the Tranche A Note has
been repaid in full. As of March 27, 2025,
the Closing Penny Warrants and the Subsequent Penny Warrants are fully vested.
 
On
October 30, 2024, we exercised 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants that were exercisable at
such time. As a result, we hold 6,500,000 shares of common stock of Scilex.
 
 
c.
Transferred warrants, or
the Transferred Warrants, to purchase 4,000,000 shares of Scilex common stock with an exercise price of $11.50 per
share, fully exercisable
and expiring on November 10, 2027. On September 20, 2024, we sold the Transferred Warrants for consideration of
$300,000 (see below).
As a result, as of March 27, 2025 we do not hold any Transferred Warrants.
 
On
September 20, 2024, we and Scilex entered into an extension agreement, or the Extension Agreement, to extend the due date of the September
21, 2024 payment under the Tranche A Note. Pursuant to the Extension Agreement, Scilex paid us $2,000,000 on September 23, 2024, which
payment is to
be applied as follows: (i) $1,700,000 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300,000 to
purchase the Transferred
Warrants as mentioned above.
 
2024
Refinancing
 
On
October 7, 2024, we and certain institutional investors, or the Note B Holders, entered into certain agreements with Scilex, pursuant
to which
the Note B Holders purchased in a registered offering, or the 2024 Refinancing, (i) a new tranche B of senior secured convertible
notes of Scilex in the
aggregate principal amount of $50,000,000, or the Tranche B Notes, which Tranche B Notes are convertible into
shares of Scilex common stock and (ii)
warrants, or the Tranche B Warrants, to purchase up to 7,500,000 shares of Scilex common stock,
or Tranche B Warrants. We purchased 50% of Tranche B
Note and Tranche B Warrants and therefore hold an aggregate principal amount of
$25,000,000 under the Tranche B Note and 3,750,000 Tranche B
Warrants.
 
Scilex
received from us, in consideration for our part in Tranche B Notes and the Tranche B Warrants issued to us, an exchange and reduction
of
the principal outstanding balance under the Tranche A Note of $22,500,000.
 
2

 
 
Royalty
Purchase Agreement
 
In
addition, on October 8, 2024, we and certain institutional investors, or the RPA Purchasers, entered into a Purchase and Sale Agreement
or the
RPA with Scilex and Scilex Pharmaceuticals Inc., or Scilex Pharma. Pursuant to the RPA, the RPA Purchasers acquired the right
 to receive, in the
aggregate, 8% of net sales worldwide for 10 years of certain purchase receivables, or the Purchased Receivables with
respect to ZTlido (lidocaine topical
system) 1.8%, SP-103 (lidocaine topical system) 5.4%, and any related, improved, successor, replacement
or varying dosage forms of the foregoing. We
acquired the right to receive 50% of the Purchased Receivables, as more fully described
in the RPA and therefore hold the right to receive 4% royalties.
 
In
consideration for our interest in the Purchased Receivables, we exchanged and reduced $2,500,000 of the principal balance under the Tranche
A
Note.
 
Following the refinancing as described above, on October 8, 2024, Scilex
used $12,500,000 of the net proceeds from the proceeds of the Tranche
B Note for the repayment of the outstanding balance under the Tranche
A Note.
 
ZTLido
Rest of the World Binding Agreement
 
In
addition, on October 8, 2024, we and certain other institutional investors and Scilex entered into a binding term sheet, or the ROW License
Term Sheet, regarding a license and development agreement, or the Lido License Agreement, with respect to services, compositions, products,
dosages and
formulations comprising lidocaine, including without limitation, the product and any future product defined as a “Product”
under Scilex Pharma’s existing
(i) Product Development Agreement, dated as of May 11, 2011, with Oishi Koseido Co., Ltd., or Oishi,
and Itochu Chemical Frontier Corporation, or
Itochu, as amended, and (ii) the associated Commercial Supply Agreement, dated February
16, 2017, between Scilex, Oishi and Itochu, as amended.
 
Subject
to determination of a final structure for the transactions contemplated by the ROW License Term Sheet, we anticipate that we and such
institutional investors will hold the Lido License Agreement through a joint venture, RoyaltyVest, Inc., or RoyaltyVest.
 
In
consideration for the rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term
Sheet, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200,000
per year toward
expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products
rights for the development, out-
licensing, commercialization of any Product outside of the United States and other territories, other
than certain excluded designated territories , or the
ROW Territory, and (c) each of RoyaltyVest and Scilex will receive 50% percent
of the net revenue (less expenses) generated from any Product in the
ROW Territory. The term sheet is subject to entering into a definitive
agreement (signed on February 22, 2025, see below) and subject to the consent of
Oishi and Itochu to the Lido License Agreement.
 
Tranche
B Note Consent
 
On January 2, 2025, we and other Tranche B noteholders entered into
deferral and consent agreements with Scilex or the Tranche B Consent,
deferring Scilex’s first amortization payment under the Tranche
B Note to October 8, 2026. In consideration, we received approximately $877,000 and
2,500,000 shares of Scilex common stock.
 
In
addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
 
1.
Scilex
and the Tranche B Noteholders agreed to a 10-year, assignable 4% royalty on global net sales
of Gloperba and Elyxyb in certain
territories outside of the United States , or RoW, of which,
we are entitled to 2% royalties. Gloperba, an oral liquid colchicine formulation for
gout,
and Elyxyb, an oral solution for acute migraine treatment, represent key assets in Scilex’s
portfolio. The definitive agreement was
signed on February 28, 2025.
 
2.
The
Tranche B Noteholders have the option to fund up to 50% of the cash purchase price for RoW
product rights to Gloperba and Elyxyb
(excluding Elyxyb in Canada) and will receive proportional
revenues from commercialization and licensing.
 
3

 
 
Tranche
A Note Maturity Date Extension Amendment
 
On
January 21, 2025, we entered into an amendment to the Tranche A Note, or the Tranche A Extension Amendment, extending the maturity date
from March 21, 2025, to December 31, 2025 or the Extended Maturity Date. Interest will continue to accrue and be payable on the Extended
Maturity Date.
In consideration of the extension, we received 3,250,000 shares of Scilex common stock.
 
Lidocaine
License Agreement
 
As
part of the ROW License Term Sheet, on February 22, 2025, we, through its 50% ownership in RoyaltyVest, entered into a license agreement
with Scilex. Under this agreement, RoyaltyVest acquired exclusive rights to develop, manufacture, and commercialize lidocaine-based products,
including
ZTlido (lidocaine topical system 1.8%) and SP-103, in the ROW Territory. As part of the arrangement, RoyaltyVest and Scilex
will each receive 50% of the
net profits from the commercialization of these products. Given our 50% ownership in RoyaltyVest, we effectively
holds a 25% in the profits generated
under this agreement.
 
BioXcel
 
In order to diversify our investments as a part of our use of cash
strategy, on
March 4, 2025, we participated in a registered direct offering by
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), or BioXcel, acquiring 2,000,000
shares of BioXcel’s common stock and accompanying warrants to purchase
up to an additional 2,000,000 shares. The shares and warrants
were purchased at a combined offering price of $3.50 per share and warrant, representing
50% of the total 4,000,000 shares issued in
the offering. The warrants have an exercise price of $4.20 per share, are immediately exercisable, and will
expire five years from the
date of issuance.
 
BioXcel
is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology.
Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.
 
As of March 27, 2025, we have sold 869,992 shares and continues to
hold 1,130,008 shares of BioXcel common stock.
 
Real Estate Transactions
 
Additionally, as a part of
our cash management strategy, we have engaged in certain real estate transactions.
 
In January 2025, we
entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800,000
(approximately $1,586,000). The transaction is structured in installments, and as of March 27, 2025, we have paid approximately $1,210,000
toward the
acquisition price. Under the agreement, the developer is responsible for executing all development-related activities,
and we and the developer will share
the profits upon the future sale of the property.
 
On March 24, 2025, we
 entered into a loan agreement to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of
$22,650,000. The
loan has a one-year maturity and is secured by a first-ranking mortgage on a property valued at approximately $800,000,000,
providing
significant collateral coverage. The loan bears an annual interest rate of 12%.
 
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 or 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. In 2023,
we completed an analysis
of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such
as BMI,
baseline HbA1c and age, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant,
reduction in
HbA1c. Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase 3 (ORA-D-013-3) clinical
trial to the FDA. We intend
to initiate this study during 2025. We are additionally examining our existing pipeline and have commenced
an evaluation process of potential strategic
opportunities, with the goal of enhancing value for our stockholders.
 
4

 
 
Joint
Venture Agreement: As mentioned above, on February 7, 2025, we entered into JV Agreement with HTIT. The collaboration combines our
POD technology with HTIT’s manufacturing capabilities, creating a synergy. This integration of technology and manufacturing expertise
will enable us to
ensure consistent, high-quality production at scale, setting new standards for oral protein delivery.
 
OraTech
is backed by a substantial capital and operational commitment. These resources support the initiation of a Phase 3 clinical trial in
the U.S.
As mentioned above, by leveraging insights from prior clinical studies, we have strategically designed this refined Phase 3
trial to focus on key patient
subpopulations that we believe have the highest potential to demonstrate efficacy.
 
Oral
Vaccine
 
On
March 18, 2021, we entered into a license agreement with Oravax, a 63% owned joint venture to commercialize oral vaccines for COVID-19
and other novel coronaviruses based on Premas Biotech Pvt. Ltd.’s proprietary vaccine technology involving a triple antigen virus
like particle.
 
In
 October 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of a Phase 1 clinical trial, meeting primary or 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 virus like particle vaccine antigens observed in the majority of the patients dosed, and no safety
issues were observed, including mild
symptoms. Cohort B completed dosing in January 2023. Cohort B measured Immunoglobulin G, or IGG,
against the spike (S) protein, showing positive
IGG in approximately 55% of the patients dosed. We are currently evaluating our path
forward for Oravax’s oral vaccines for COVID-19.
 
Impact
of Current Events
 
On October 7, 2023, the State of Israel was attacked by Hamas, a group
designated as a terrorist organization by the United States, and the State of
Israel subsequently declared war on Hamas. Since that time,
Israel has been engaged in a multi-front armed conflict with combatants located in Gaza, the
West Bank, Syria, Iran, Lebanon and Yemen.
The situation in the region remains volatile and the possibility of renewed conflicts persist. As of March 27,
2025, we believe that there
is no immediate risk to our business operations related to these events. For further information, see “Item 1A. Risk Factors,”
under “We are affected by the political, economic and military risks of having operations in Israel.”
 
Real
Estate Investments
 
On November 7, 2024, our Board of Directors, or the Board, approved
investments of up to $10,000,000 in real estate assets. This decision
aligns with our strategic approach to capital allocation, leveraging
 opportunities in the current real estate market where we have identified attractive
investment prospects. With interest rates expected
to decline and valuations presenting favorable entry points, the Board believes these investments could
provide long-term value appreciation
and potential income streams, further strengthening our financial position. As we continues to evaluate our business
strategy, including
 potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value. On
February
13, 2025, the Board approved increasing the real estate investments to up to $30,000,000.
 
Diabetes
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, approximately 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. According to the
American Diabetes Association, or ADA, in 2023, the United States there
were approximately 37 million people with diabetes. Diabetes is a leading cause
of blindness, kidney failure, heart attack, stroke and
amputation.
 
5

 
 
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 26 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 140 patents, eight of which were issued during the year ended December 31, 2024, 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.
 
6

 
 
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, 2024, Entera had not paid any royalties to Oramed Ltd. During the years
ended December 31, 2024 and 2023, we did not sell any of DNA’s
ordinary shares. As of December 31, 2024, we held approximately
 1.4% of DNA’s outstanding ordinary shares and approximately 0.3% of Entera’s
outstanding ordinary shares.
 
HTIT
 
On
November 30, 2015, we entered into a Technology License Agreement, or TLA, with 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 $37,500,000, of which $3,000,000 was payable immediately,
$8,000,000 will be paid subject to our entry into certain agreements with certain third
parties, and $26,500,000 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, 2024, we received aggregate milestone
payments of $20,500,000 out of the aggregate amount of $37,500,000.
 
On
August 21, 2020, we received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA.
 
Pursuant
to the terms of the JV Agreement, each of us, HTIT and HTIT Sub, irrevocably released and waived (i) any claims and demands against
each
other party in connection with the TLA; and (ii) all rights, obligations and liabilities set out and arising with respect to the performance
of the TLA.
 
HTIT
has submitted a Marketing Authorization Application to China’s regulators for the oral insulin capsule in China. Since the TLA was novated
to OraTech, OraTech is expected to receive royalties from any future sales in China
 
7

 
 
Oravax
License
 
On
 March 18, 2021, we entered into a license agreement, or the Oravax License Agreement, with Oravax, a 63% owned joint venture to
commercialize
oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt. Ltd.’s proprietary vaccine technology involving
a
triple antigen virus like particle, or the Oravax product.
 
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 $25,000,000 to $100,000,000, 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 $1,500,000. Akers Biosciences
Inc. contributed $1,500,000 in cash to Oravax and a license agreement to the Oravax product.
 
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 $15,000,000 in developmental
milestones, $2,000,000 of which were
received by Oramed in 2022, and up to 15% royalties on gross sales. Medicox will also be responsible
for gaining regulatory approval in the Republic of
Korea. This agreement was assigned to OraTech.
 
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.
 
8

 
 
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.
 
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.
 
9

 
 
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.
 
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.
 
10

 
 
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 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 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. 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.
 
11

 
 
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.
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 386 peer-reviewed
 manuscripts (H-index 124) and several hundreds of scientific abstracts and he is
considered a key opinion leader in Type 2 Diabetes.
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.
 
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 under-resourced populations. Dr. Peters has consulted for many
entities, including the FDA, the Centers for Disease Control and Prevention and
the National Institutes of Health 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 an Endocrine Society
Laureate
Award for Public Service.
 
12

 
 
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, 2024, we have contracted with thirteen individuals for employment or consulting arrangements. Of our staff, four are
senior management, three are
engaged in research and development work, and the remaining six 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.
 
ITEM
1A. RISK FACTORS.
 
An
investment in our securities involves a high degree of risk. You should consider carefully the following information about these risks,
together with the other information contained in this Annual Report on Form 10-K before making an investment decision. Our business,
prospects,
financial condition and results of operations may be materially and adversely affected as a result of any of the following
risks. The value of our
securities could decline as a result of any of these risks. You could lose all or part of your investment in
our securities. Some of the statements in “Item
1A. Risk Factors” are forward-looking statements. The following risk factors
are not the only risk factors facing the Company. Additional risks and
uncertainties not presently known to us or that we currently deem
immaterial may also affect our business, prospects, financial condition and results of
operations.
 
Summary
Risk Factors
 
Risks
Related to Our Business
 
●
Our
strategic review process may not be successful or timely.
 
●
Our
ability to consummate a strategic transaction depends on our ability to retain our employees
required to consummate such transaction.
 
●
We
continue, and in the future expect, to incur losses, and we may need substantial additional
 capital in order to satisfy our business
objectives.
 
13

 
 
●
We
may be unable to protect our intellectual property rights and we may be liable for infringing
the intellectual property rights of others.
 
●
Our
success was primarily dependent on the successful commercialization of our oral insulin capsule.
 
●
We
have limited experience in conducting clinical trials.
 
●
We
can provide no assurance that our products will obtain regulatory approval or that the results
of clinical trials will be favorable.
 
●
We
may not realize a return on the ordinary shares of DNA and Entera and the common stock of
Scilex and BioXcel that we own.
 
 
●
Because we may from time to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to
be an investment company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens.
 
●
We
may not realize the full benefit from our distribution license agreement with Medicox.
 
●
The
biotechnology and biopharmaceutical industries are characterized by rapid technological developments
and a high degree of competition.
We may be unable to compete with more substantial enterprises.
 
●
Healthcare
policy changes, including pending legislation recently adopted and further proposals still
pending to reform the U.S. healthcare
system, may harm our future business.
 
●
We
face uncertainties related to Oravax’s oral COVID-19 vaccine.
 
Risks
Related to Our Real Estate Investments
 
Risks
Related to the Notes
 
●
We
have lent a substantial amount of funds to Scilex. In the event that Scilex is unable to
service its obligations under the Note and defaults
on such Note, it could have a material
adverse effect on our business.
 
●
We
may have difficulty realizing the full value of the Warrants.
 
Risks
Related to our Common Stock
 
●
Future
sales of our common stock by our existing stockholders could adversely affect our stock price.
 
●
Our
failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements
 could result in the delisting of our
common stock.
 
●
As
the market price of our common stock may fluctuate significantly, this may make it difficult
for you to sell your shares of common stock
when you want or at prices you find attractive.
 
Risks
Related to JV Agreement
 
●
On
February 7, 2025, we and HTIT entered into a JV Agreement that amending the original agreement
signed on January 22, 2024 or the
Supplemental Agreement. If we fail to complete the transactions
contemplated under the JV Agreement as supplemented by the Supplemental
Agreement with HTIT,
if such joint venture is not successful, or if we fail to realize the benefits we anticipate
from such joint venture, we
may not be able to capitalize on the full market potential of
our drug products and technology.
 
●
We
may not complete the transactions contemplated by the JV Agreement, as supplemented by the
Supplemental Agreement.
 
●
We
may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our
business.
 
●
Our
business and assets will be less diversified following the Spin Off.
 
14

 
 
Risks
Related to Conducting Business in Israel
 
●
We
are affected by the political, economic and military risks of having operations in Israel.
 
●
It
may be difficult to enforce a U.S. judgment against us or our officers and directors and
to assert U.S. securities laws claims in Israel.
 
General
Risk Factors
 
●
Changes
to tax laws could have a negative effect on us or our stockholders.
 
●
Our
business and operations would suffer in the event of computer system failures, cyber-attacks
or deficiencies in our cyber-security.
 
Risks
Related to Our Business
 
Our
strategic review process may not be successful or timely.
 
Following
the results of the ORA-D-013-1 Phase 3 trial, we conducted a comprehensive analysis of the data to understand if there is a path
forward
for our oral insulin candidate. We submitted a protocol ORA-D-013-3 titled, “A Double-Blinded, Placebo-controlled, Double Dummy
Multi-center
Randomized, Phase 3 Study to Evaluate the efficacy and safety in subjects with Type 2 Diabetes Mellitus with Inadequate
Glycemic Control on One to
Three Glucose-lowering Agents” to the FDA on September 12, 2024. We intend to initiate study during
2025. Concurrently, we are examining our existing
pipeline and have commenced an evaluation process of potential strategic opportunities,
including among others, continuation as a stand-alone business,
capital raises, or one or more acquisitions, mergers or business combinations
 or other strategic transactions. Potential counterparties in a strategic
transaction involving us may place minimal or no value on our
assets. While we are devoting significant efforts to identify and evaluate potential strategic
alternatives, there can be no assurance
that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be
completed
on attractive terms or at all. Additionally, there can be no assurances that any particular course of action, business arrangement or
transaction, or
series of transactions, will be pursued, successfully consummated, or lead to any stockholder value. Any potential transaction
would be dependent on a
number of factors that may be beyond our control, including, among other things, market conditions, industry
trends, the interest of third parties in a
potential transaction with us, obtaining stockholder approval and the availability of financing
to third parties in a potential transaction with us on reasonable
terms. The process of reviewing alternative strategic paths may be
time consuming, may involve the dedication of significant resources and may require us
to incur significant costs and expenses. It could
negatively impact our ability to attract, retain and motivate employees, and expose us to potential litigation
in connection with this
process or any resulting transaction. If we are not successful in setting forth a new strategic path for the Company, or if our plans
are
not executed in a timely fashion, this may cause reputational harm with our stockholders and other stakeholders and the value of
our securities may be
adversely impacted. In addition, speculation regarding any developments related to the review of strategic alternatives
and perceived uncertainties related
to the future of the Company could cause our stock price to fluctuate significantly. There can be
no guarantee that the process of evaluating alternative
strategic paths will result in our entering into or completing potential transactions
within the anticipated timing or at all.
 
If
we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.
 
Although
there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic
alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management and
may disrupt our
business. The negotiation and consummation of any such transaction may also require more time or greater cash resources
than we anticipate and expose us
to other operational and financial risks, including: increased near-term and long-term expenditures;
exposure to unknown liabilities; higher than expected
acquisition or integration costs; incurrence of substantial debt or dilutive
issuances of equity securities to fund future operations; write-downs of assets or
goodwill or incurrence of non-recurring, impairment
or other charges; increased amortization expenses; impairment of relationships with key suppliers of
any acquired business
due to changes in management and ownership; inability to retain our key employees; and possibility of future litigation. Any
of the
above risks could have a material adverse effect on our business, financial condition, and prospects.
 
15

 
 
Our
 ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such
transaction.
 
Our
ability to consummate a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction,
the
loss of whose services may adversely impact the ability to consummate such transaction. Our cash conservation activities may yield
 unintended
consequences, such as attrition and reduced employee morale, which may cause remaining employees to seek alternative employment.
 Our ability to
successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining
 personnel. If we are unable to
successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation
of a strategic alternative as well as business
operations.
  
We
may become involved in securities and stockholder litigation that could divert management’s attention and harm the Company’s
business, and insurance coverage may not be sufficient to cover all costs and damages.
 
In
the past, securities and stockholder litigation has often followed certain significant business transactions, such as the sale of a company
or
announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials.
The market price of
our common stock dropped substantially when we announced the results of the ORA-D-013-1 Phase 3 trial. We may be
exposed to such litigation even if
no wrongdoing occurred. Litigation is usually expensive and diverts management’s attention and
resources, which could adversely affect our business and
cash resources and our ability to consummate a potential strategic transaction
or the ultimate value our stockholders receive in any such transaction.
 
We
continue, and in the future expect, to incur losses.
 
Successful
 evaluation and completion of our remaining development programs and our transition to normal operations are dependent upon
obtaining
necessary regulatory approvals from the FDA prior to selling our products within the United States, and foreign regulatory approvals
must be
obtained to sell our products internationally. There can be no assurance that we will receive regulatory approval of any of our
product candidates, and a
substantial amount of time may pass before we achieve a level of revenues adequate to support our operations.
We expect to incur substantial expenditures
in connection with our research and development programs, our strategic evaluation process,
as well as the regulatory approval process with FDA and other
agencies for each of our current or future product candidates during their
respective developmental periods. Obtaining marketing approval will be directly
dependent on our ability to implement the necessary regulatory
steps required to obtain marketing approval in the United States and in other countries. We
cannot predict the outcome of these activities.
 
Based
on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding
level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior
to such time. If there
are unexpected increases in our operating expenses, we may need to seek additional financing during the next 12
months.
 
We
may need substantial additional capital in order to satisfy our business objectives.
 
To
date, we have financed our operations principally through offerings of securities and we may require substantial additional financing
at various
intervals in order to implement any potential strategic alternative, to continue our remaining or potential future research
 and development programs,
including significant requirements for operating expenses including intellectual property protection and enforcement,
for pursuit of regulatory approvals,
and for commercialization of our remaining or future products. We can provide no assurance that
additional funding will be available on a timely basis, on
terms acceptable to us, or at all. In the event that we are unable to obtain
such financing, we may not be able to implement the actions we decide to take as
part of our strategic review process, and we will not
be able to fully develop and commercialize our technology or pursue new technology. Our future
capital requirements will depend upon
many factors, including:
 
 
●
the results of our strategic
review process and any new strategic direction we decide to take;
 
 
●
continued scientific progress
in our research and development programs;
 
 
●
costs and timing of conducting
clinical trials and seeking regulatory approvals and patent prosecutions;
 
 
●
competing technological
and market developments;
 
 
●
our ability to establish
additional collaborative relationships; and
 
 
●
effects of commercialization
activities and facility expansions if and as required.
 
16

 
 
If
we cannot secure adequate financing when needed, we may be required to delay, scale back or eliminate one or more of our existing or
planned
courses of action or research and development programs, or to enter into license or other arrangements with third parties to
commercialize products or
technologies that we would otherwise seek to develop ourselves and commercialize ourselves. In such event,
our business, prospects, financial condition
and results of operations may be adversely affected as we may be required to scale-back,
eliminate, or delay development efforts or product introductions
or enter into royalty, sales or other agreements with third parties
in order to commercialize our products.
 
We
have a history of losses and can provide no assurance as to our future operating results.
 
We do not have sufficient revenues from our research and development
activities to fully support our operations. Consequently, we have incurred
net losses since inception. We currently have only licensing
revenues and no product revenues, and may not succeed in developing or commercializing any
products which could generate product revenues.
We do not expect to have any products on the market for several years. In addition, development of our
product candidates requires a process
of pre-clinical and clinical testing, during which our products could fail. For example, in January 2023, the ORA-D-
013-1 Phase 3 trial
did not meet its primary or secondary endpoints. We may not be able to enter into agreements with one or more companies experienced
in
 the manufacturing and marketing of therapeutic drugs and, to the extent that we are unable to do so, we will not be able to market our
 product
candidates. Eventual profitability will depend on our success in developing, manufacturing, and marketing our product candidates
 or in pursuing a
successful strategic alternative. As of December 31, 2024 and 2023, we had working capital of approximately $137,536,000
 and approximately
$109,370,000, respectively, and stockholders’ equity of approximately $146,265,000 and approximately $163,821,000,
 respectively. See “Item 7.
Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
 
We
rely upon patents to protect our technology.
 
The
patent position of biopharmaceutical and biotechnology firms is generally uncertain and involves complex legal and factual questions.
We do
not know whether any of our current or future patent applications will result in the issuance of any patents. Even issued patents
 may be challenged,
invalidated or circumvented. Patents may not provide a competitive advantage or afford protection against competitors
 with similar technology.
Competitors or potential competitors may have filed applications for, or may have received patents and may obtain
additional and proprietary rights to
compounds or processes used by or competitive with ours. In addition, laws of certain foreign countries
do not protect intellectual property rights to the
same extent as do the laws of the United States.
 
Patent
litigation is widespread in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to
form
strategic alliances, conduct clinical testing or manufacture and market any products under development. If challenged, our patents
may not be held valid.
We could also become involved in interference proceedings in connection with one or more of our patents or patent
applications to determine priority of
invention. If we become involved in any litigation, interference or other administrative proceedings,
we will likely incur substantial expenses and the
efforts of our technical and management personnel will be significantly diverted. In
addition, an adverse determination could subject us to significant
liabilities or require us to seek licenses that may not be available
on favorable terms, if at all. We may be restricted or prevented from manufacturing and
selling our products in the event of an adverse
determination in a judicial or administrative proceeding or if we fail to obtain necessary licenses.
 
17

 
 
We
may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others.
 
Our
ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies. We currently hold several
pending patent applications in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan and China for our technologies covering
 oral
administration of insulin and other proteins and oral administration of exenatide and proteins and 140 patents issued by the United
States and various other
countries’ patent offices that cover a part of our technology, which allows for the oral delivery of proteins;
patents issued by various patent offices that
cover part of our technology for the oral delivery of exenatide; and patents issued by
patent offices for treating diabetes. Further, we rely on a combination
of trade secrets and non-disclosure and other contractual agreements
and technical measures to protect our rights in our technology. We depend upon
confidentiality agreements with our officers, directors,
 employees, consultants, and subcontractors, as well as collaborative partners, to maintain the
proprietary nature of our technology.
 These measures may not afford us sufficient or complete protection, and others may independently develop
technology similar to ours,
otherwise avoid our confidentiality agreements, or produce patents that would materially and adversely affect our business,
prospects,
financial condition and results of operations. We believe that our technology is not subject to any infringement actions based upon the
patents of
any third parties; however, our technology may in the future be found to infringe upon the rights of others. Others may assert
infringement claims against
us or against companies to which we have licensed our technology, and if we should be found to infringe upon
their patents, or otherwise impermissibly
utilize their intellectual property, our ability to continue to use our technology could be
materially restricted or prohibited. If this event occurs, we may be
required to obtain licenses from the holders of this intellectual
property, enter into royalty agreements, or redesign our products so as not to utilize this
intellectual property, each of which may
prove to be uneconomical or otherwise impossible. Licenses or royalty agreements required in order for us to use
this technology may
not be available on terms acceptable to us, or at all. These claims could result in litigation, which could materially adversely affect
our
business, prospects, financial condition and results of operations. Further, we may need to indemnify companies to which we licensed
our technology in the
event that such technology is found to infringe upon the rights of others.
 
 
Our
commercial success will also depend significantly on our ability to operate without infringing the patents and other proprietary rights
of third
parties. Patent applications are, in many cases, maintained in secrecy until patents are issued. The publication of discoveries
in the scientific or patent
literature frequently occurs substantially later than the date on which the underlying discoveries were made
and patent applications are filed. In the event of
infringement or violation of another party’s patent, we may be prevented from
pursuing product development or commercialization. See “Item 1. Business
—Description of Business— Intellectual Property
and Patents.”
 
Our
success was primarily dependent on the successful commercialization of our oral insulin capsule.
 
The
 successful commercialization of our principal product, the oral insulin capsule, was crucial for our success. On January 12, 2023, we
announced top-line results from the phase 3 trial of our oral insulin capsule, which did not meet its primary or secondary endpoints,
and indicated that we
expect to discontinue oral insulin clinical activities for T2D. At present, following the results of the ORA-D-013-1
 Phase 3 trial, we conducted a
comprehensive analysis of the data and found that subpopulations of patients with pooled specific parameters
responded well to oral insulin. Based on this
analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. . Concurrently,
we are examining our existing pipeline and have commenced
an evaluation process of potential strategic opportunities. Even if we succeed
in commencing a new clinical trial for our oral insulin capsule, there are a
variety of risks and uncertainties related to its development.
Principally, these risks include the following:
 
 
●
Future clinical trial results
may show the same results as the ORA-D-013-1 Phase 3 trial;
 
 
●
Future clinical trial results
may be inconsistent with previous preliminary testing results and data from our earlier trials may be inconsistent
with clinical
data;
 
18

 
 
 
●
Even if our oral insulin
capsule is shown to be safe and effective for its intended purposes in future clinical trials, we may face significant or
unforeseen
difficulties in obtaining or manufacturing sufficient quantities or at reasonable prices;
 
 
●
Our ability to complete
the development and commercialization of the oral insulin capsule for our intended use is significantly dependent
upon our ability
to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for,
and
the manufacturing, marketing and distribution of, the oral insulin capsule on a worldwide basis;
 
 
●
Even if our oral insulin
capsule is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no
guarantee that
there will be market acceptance of our product; and
 
 
●
Our competitors may develop
therapeutics or other treatments which are superior or less costly than our own with the result that our products,
even if they are
successfully developed, manufactured and approved, may not generate significant revenues.
 
Our
business may be seriously harmed if our analysis does not produce positive results, if we are unable to find a path forward to continue
development of our oral insulin capsule, if we are unsuccessful in realizing new strategic opportunities or dealing with any of these
risks, or if we are
unable to successfully commercialize our oral insulin capsule for some other reason.
 
We
have limited experience in conducting clinical trials.
 
Clinical
 trials must meet FDA and foreign regulatory requirements. We have limited experience in designing, conducting and managing the
preclinical
 trials and clinical trials necessary to obtain regulatory approval for our product candidates in any country. In the past, we entered
 into
agreements with Integrium LLC and other consultants to assist us in designing, conducting and managing our various clinical trials
in the United States,
Europe and Israel. Any failure of a consultant to fulfill their obligations could result in significant additional
costs as well as delays in designing, consulting
and completing clinical trials on our products.
  
Our
clinical trials may encounter delays, suspensions or other problems.
 
We
may encounter problems in clinical trials that may cause us or the FDA or foreign regulatory agencies to delay, suspend or terminate
our
clinical trials at any phase. These problems could include the possibility that we may not be able to conduct clinical trials at
our preferred sites, enroll a
sufficient number of patients for our clinical trials at one or more sites or begin or successfully complete
clinical trials in a timely fashion, if at all. For
example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19
vaccine in South Africa was slower than anticipated 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, and
as a result we had to add an additional clinical site.
Furthermore, we, the FDA or foreign regulatory agencies may suspend clinical trials at any time if we
or they believe the subjects participating
in the trials are being exposed to unacceptable health risks or if we or they find deficiencies in the clinical trial
process or conduct
of the investigation. If clinical trials of any of the product candidates fail, we will not be able to market the product candidate which
is
the subject of the failed clinical trials. The FDA and foreign regulatory agencies could also require additional clinical trials,
which would result in increased
costs and significant development delays. Our failure to adequately demonstrate the safety and effectiveness
of a pharmaceutical product candidate under
development could delay or prevent regulatory approval of the product candidate and could
have a material adverse effect on our business, prospects,
financial condition and results of operations. For example, see “Item
1. Business—Description of Business— Research and Development” regarding the
results of the ORA-D-013-1 Phase 3 trial
that did not meet its primary or secondary endpoints. Finally, the COVID-19 pandemic impacted clinical trials
generally in recent years,
and we experienced approximately six months of delays in clinical trials due to slow-downs of recruitment for trials generally
related
to COVID-19. We may experience further delays in site initiation and patient enrollment, failures to comply with study protocols, delays
in the
manufacture of our product candidates for clinical testing and other difficulties in starting or competing our clinical trials.
 
19

 
 
Initial
success in the completed and ongoing early-stage clinical trials does not ensure success in later stage trials, regulatory approval or
commercial viability of a product.
 
Positive
results in a clinical trial may not be replicated in subsequent or confirmatory trials. Additionally, success in preclinical work or
early stage
clinical trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval
will be obtained. Any of our
product’s failure to show sufficient efficacy in patients with the targeted indication, or if such
 studies are discontinued for any other reason, could
negatively impact our development and commercialization goals for these products
 and our stock price could decline. Many companies in the
biopharmaceutical industry have suffered significant setbacks in advanced clinical
trials due to lack of efficacy or adverse safety profiles, notwithstanding
promising results in earlier trials. As a result, preliminary
and interim data should be viewed with caution until the final data are available. We have
invested in clinical studies of medicines
that have not met the primary clinical endpoints in their Phase 3 studies or have been discontinued for other
reasons. For example, in
January 2023, we reported that ORA-D-013-1 trial did not meet its primary or secondary endpoint. Even if later stage clinical
trials
are successful, regulatory authorities may delay or decline approval of our product candidates.
 
There
are a number of factors that could cause a clinical study to fail or be delayed, including: (i) the clinical study may produce negative
or
inconclusive results; (ii) regulators may require that we hold, suspend or terminate clinical research for noncompliance with regulatory
requirements; (iii)
we, our partners, the FDA or foreign regulatory authorities could suspend or terminate a clinical study due to adverse
side effects of a product on subjects
or lack of efficacy in the trial; (iv) we, or our partners, may decide, or regulators may require
us, to conduct additional preclinical testing or clinical studies;
(v) change in rates of enrollment and dropout among clinical trial
participants; (vi) differences in the size and type of the patient populations; (vii) changes
in and adherence to the dosing regimen
and other clinical trial protocols; and (viii) people who enroll in the clinical study may later drop out due to adverse
events, a perception
 they are not benefiting from participating in the study, fatigue with the clinical study process or personal or other issues. The
occurrence
of any of these events could result in significant costs and expense, have an adverse effect on our business, financial condition and
results of
operations and/or cause our stock price to decline or experience periods of volatility.
 
Clinical
trials of our products conducted by third parties may encounter delays, suspensions or other problems and are outside of our
control.
 
Third
parties who conduct clinical trials of our products may encounter problems that may cause delays, suspensions or other problems at any
phase. These problems could include the possibility that they may not be able to conduct clinical trials at their preferred sites, enroll
a sufficient number of
patients for their clinical trials at one or more sites or begin or successfully complete clinical trials in a
timely fashion, if at all. For example, the rate of
enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South
Africa was slower than anticipated 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, and as a result we had to
add an additional clinical site. In addition,
these third parties are not controlled by us and may conduct these trials in a manner in which we disagree or
which may prove to be unsuccessful.
Furthermore, domestic or foreign regulatory agencies may suspend clinical trials at any time if they believe the
subjects participating
in the trials are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial process or conduct of
the
investigation. If such clinical trials conducted by third parties fail, it could have a material adverse effect on our business,
prospects, financial condition and
results of operations.
 
20

 
 
We
can provide no assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable.
 
The
testing, marketing and manufacturing of any of our products will require the approval of the FDA or regulatory agencies of other countries.
We cannot predict with any certainty the amount of time necessary to obtain regulatory approvals, including from the FDA or other foreign
regulatory
authorities, and whether any such approvals will ultimately be granted. In any event, review and approval by the regulatory
bodies is anticipated to take a
number of years. Preclinical and clinical trials may reveal that one or more of our products are ineffective
or unsafe, in which event further development of
such products could be seriously delayed or terminated. For example, in January 2023,
we announced that our ORA-D-013-1 Phase 3 trial did not meet its
primary or secondary endpoints. As a result, we decided to terminate
our ORA-D-013-2 Phase 3 trial, conducted a comprehensive analysis of the data and
found that subpopulations of patients with pooled specific
parameters, responded well to oral insulin. Based on this analysis, we submitted a protocol for a
new Phase 3 clinical trial to the FDA.
Moreover, obtaining approval for certain products may require the testing on human subjects of substances whose
effects on humans are
not fully understood or documented. Delays in obtaining necessary regulatory approvals of any proposed product and failure to
receive
such approvals would have an adverse effect on the product’s potential commercial success and on our business, prospects, financial
condition and
results of operations. In addition, it is possible that a product may be found to be ineffective or unsafe due to conditions
 or facts which arise after
development has been completed and regulatory approvals have been obtained. In this event we may be required
to withdraw such product from the
market. See “Item 1. Business—Description of Business—Government Regulation.”
 
We
are dependent upon third party suppliers of our raw materials and for other services.
 
We
are dependent on outside vendors for our entire supply of the oral insulin capsules and do not currently have any long-term agreements
in
place for the supply of oral insulin capsules, which is still necessary if we decide to continue development of these projects. While
we believe that there are
numerous sources of supply available, if the third party suppliers were to cease production, or otherwise fail
to supply us with quality raw materials in
sufficient quantities on a timely basis and we were unable to contract on acceptable terms
for these services with alternative suppliers, our ability to
produce our products and to conduct testing and clinical trials would be
materially adversely affected.
 
We
rely on suppliers, vendors, outsourcing partners, alliance partners and other third parties to research, develop, manufacture, commercialize,
co-
promote and sell our products, manage certain marketing, IT, data and other business unit and functional services and meet their contractual,
regulatory and
other obligations. Using these third parties poses a number of risks, such as: (i) they may not perform to our standards
or legal requirements, for example,
in relation to the outsourcing of significant clinical development activities for innovative medicines
to some CROs; (ii) they may not produce reliable
products; (iii) they may not perform in a timely manner; (iv) they may not maintain
confidentiality of our proprietary information; (v) they may incur a
significant cyberattack or business disruption; (vi) they may be
 subject to government orders or mandates that require them to give priority to the
government and set aside pre-existing commercial orders;
(vii) disputes may arise with respect to ownership of rights to technology developed with our
partners; and (viii) disagreements could
cause delays in, or termination of, the research, development or commercialization of the product or result in
litigation or arbitration.
The failure of any critical third party to meet its obligations; to adequately deploy business continuity plans in the event of a crisis;
and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on
our operations and
results. In addition, if these third parties violate, or are alleged to have violated, any laws or regulations, including
the local pharmaceutical code, the U.S.
Foreign Corrupt Practice Act of 1977, the U.K. Bribery Act of 2010, the EU’s General Data
Protection Regulations, and other similar laws and regulations,
during the performance of their obligations for us, we could suffer financial
and reputational harm or other negative outcomes, including possible legal
consequences.
  
We
may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own.
 
DNA’s
ordinary shares are traded on the Tel Aviv Stock Exchange and Entera’s ordinary shares and Scilex’s and BioXcel’s common
stock are
traded on the Nasdaq Stock Market, which are subject to market fluctuations. In addition, the shares of Scilex, DNA and Entera
 have historically
experienced low trading volume compared to the level of shares we hold. As a result, there is no guarantee that we
will be able to resell those shares at the
prevailing market prices or that we will realize a positive return on such shares.
 
Because we may from time
to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be
deemed to be an investment
company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens.
 
Currently, we believe that either we are not within the definition
 of “Investment Company” as the term is defined under the  Investment
Company Act of 1940, or the 1940 Act, or, alternatively,
we may rely on one or more of the 1940 Act’s exemptions. As of December 31, 2024, we held
approximately 1.4% of DNA’s outstanding
 ordinary shares, approximately 0.3% of Entera’s outstanding ordinary shares, and beneficially own
approximately 15.7% of BioXcel’s
outstanding common stock. Further, we hold the Tranche A Note and Tranche B Note and in consideration of deferring
Scilex’s first
amortization payment under the Tranche B Note to October 8, 2026, we received, in addition to a nominal payment, 2,500,000 shares of
Scilex
Common Stock.  We have also investments in real estate and real estate lending transactions as described elsewhere in this Annual
Report. In order
not to be regulated as an investment company under the 1940 Act, unless we can qualify for an exclusion,
we must ensure that we are engaged primarily in
a business other than investing, reinvesting or trading in securities and that our activities
do not include investing, reinvesting, owning, holding or trading
“investment securities” constituting more than 40% of our
total assets (exclusive of U.S. government securities and cash items) on an unconsolidated basis.
We intend to continue to conduct our
operations and ongoing investments into DNA, BioXcel, Entera and Scilex and our real estate transaction in a manner
that will exempt us
from the registration requirements of the 1940 Act. If we were to be deemed to be an investment company because of our investments,
we would be required to register as an investment company under the 1940 Act. Alternatively, to continue qualifying for the
exemption, we could be
required to dispose of the securities holdings or other investments, which could have a material adverse effect
on our business, results of operations and
financial condition. The 1940 Act places significant restrictions on the capital structure
and corporate governance of a registered investment company and
materially restricts its ability to conduct transactions with affiliates.
Compliance with the 1940 Act could also increase our operating costs. Such changes
could have a material adverse effect on our business,
results of operations and financial condition.
 
21

 
 
We
may not realize the full benefit from our distribution license agreement with Medicox.
 
Our
distribution license agreement with Medicox provides that Medicox will comply with agreed distribution targets and will purchase ORMD-
0801
at an agreed upon transfer price per capsule and pay us up to $15,000,000 in developmental milestones, $2,000,000 of which have already
been
received by us. If we are not successful in finding a mutually agreed way to continue our collaboration following the results of
the ORA-D-013-1 Phase 3
trial, or if Medicox is not successful in independently advancing the oral insulin candidate, we may not realize
the benefits from this collaboration.
 
We
are highly dependent upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our
products.
 
Our
long-term strategy is to ultimately seek a strategic commercial partner, or partners, such as large pharmaceutical companies, with extensive
experience in the development, commercialization, and marketing of insulin applications and/or other orally digestible drugs. Such planned
 strategic
partnership, or partnerships, may provide a marketing and sales infrastructure for our products as well as financial and operational
support for global
clinical trials, post marketing trials, label expansions and other regulatory requirements concerning future clinical
development in the United States and
elsewhere. We currently lack the resources to manufacture any of our product candidates on a large
scale and we have no sales, marketing or distribution
capabilities. In the event we are not able to enter into a collaborative agreement
with a partner, or partners, on commercially reasonable terms, or at all, we
may be unable to commercialize our products, which would
have a material adverse effect upon our business, prospects, financial condition and results of
operations. 
 
The
 biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of
competition.
We may be unable to compete with more substantial enterprises.
 
The
biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition.
As a
result, our products could become obsolete before we recoup any portion of our related research and development and commercialization
expenses. These
industries are highly competitive, and this competition comes both from biotechnology firms and from major pharmaceutical
and chemical companies.
Many of these companies have substantially greater financial, marketing and human resources than we do (including,
in some cases, substantially greater
experience in clinical testing, manufacturing and marketing of pharmaceutical products). We also
 experience competition in the development of our
products from universities and other research institutions and compete with others in
acquiring technology from such universities and institutions. We face
the risk that new market entrants and existing competition may
try to replicate our business model or introduce a more innovative offering that renders our
services less competitive or obsolete. In
addition, our research and development efforts may target diseases and conditions for which there are existing
therapies or therapies
that are being developed by our competitors. Further, any products resulting from our research and development efforts might not be
able
to compete successfully with others’ existing and future products. See “Item 1. Business—Description of Business—Competition.”
 
Our
financial position or results could be negatively affected by product liability claims.
 
It
is possible that we will be responsible for potential product liability stemming from product research, development or manufacturing
and may
face an even greater risk if any product candidate that we develop is commercialized. If we cannot successfully defend ourselves
against claims that
products we develop independently or with our partners caused injuries, we could incur substantial liabilities. Regardless
of the merit or eventual outcome
of such claims, any liability claims may result in, among other things, decreased demand for any product
that we may develop, loss of revenues, significant
time and costs to defend the related litigation, initiation of investigations by regulators
and injury to our reputation and significant negative media attention.
On occasion, large judgments have been awarded in class action
lawsuits based on drugs or medical treatments that had unanticipated adverse effects. Our
clinical trials are covered by liability insurance,
but notwithstanding such coverage, our financial position or results could be negatively affected by product
liability claims.
 
22

 
 
We
have limited senior management resources and may be required to obtain more resources to manage our growth.
 
We
expect the expansion of our business, as well as the activities we take as a result of our strategic review process, to place a significant
strain on
our limited managerial, operational and financial resources. We will be required to expand our operational and financial systems
 significantly and to
expand, train and manage our work force in order to manage the expansion of our operations. Our failure to fully
integrate our new employees into our
operations could have a material adverse effect on our business, prospects, financial condition
and results of operations. Our ability to attract and retain
highly skilled personnel is critical to our operations and expansion. We
face competition for these types of personnel from other technology companies and
more established organizations, many of which have
significantly larger operations and greater financial, technical, human and other resources than we
have. We may not be successful in
attracting and retaining qualified personnel on a timely basis, on competitive terms or at all. If we are not successful in
attracting
and retaining these personnel, our business, prospects, financial condition and results of operations will be materially adversely affected.
See
“Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Item 1.
 Business—Description of Business—
Employees.”
 
We
depend upon our senior management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage.
 
We
currently depend upon the efforts and abilities of our senior executives, as well as the services of several key consultants and other
key
personnel, including Dr. Miriam Kidron, our Chief Scientific Officer. The loss or unavailability of the services of any of these
 individuals for any
significant period of time could have a material adverse effect on our business, prospects, financial condition and
results of operations. We do not maintain
“key man” life insurance policies for any of our senior executives. In addition,
recruiting and retaining qualified scientific personnel to perform future
research and development work will be critical to our success.
There is currently a shortage of employees with expertise in developing, manufacturing and
commercialization of products and related
clinical and regulatory affairs, and this shortage is likely to continue. Competition for skilled personnel is intense
and turnover rates
are high. Our ability to attract and retain qualified personnel may be limited. Our inability to attract and retain qualified skilled
personnel
would have a material adverse effect on our business, prospects, financial condition and results of operations.
 
Our
existing and any future joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we
expect from these arrangements. 
 
We
are currently party to certain joint ventures, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize
assets to or in these joint ventures or other joint ventures that we may enter.
 
Our
participation in our existing joint ventures is subject to risks, including the following:
 
 
●
We share approval rights
over certain major decisions affecting the ownership or operation of the joint ventures and any assets owned by the
joint ventures;
 
 
●
We may need to contribute
additional capital in order to preserve, maintain or grow the joint ventures and their investments;
 
 
●
Our joint venture investors
may have economic or other business interests or goals that are inconsistent with our business interests or goals
and that could
affect our ability to fully benefit from the assets owned by the joint ventures;
 
 
●
Our joint venture investors
may be subject to different laws or regulations than us, which could create conflicts of interest;
 
 
●
Our joint ventures may
have license and other agreements with other investors, which we are not party to and have no control over;
 
 
●
Our ability to sell our
interests in, or sell additional assets to, the joint ventures or the joint ventures’ ability to sell additional interests
of, or
assets owned by, the joint ventures when we so desire are subject to the approval rights of the other joint venture investors
under the terms of
the agreements governing the joint ventures; and
 
 
●
Disagreements with our
joint venture investors could result in litigation or arbitration that could be expensive and distracting to management
and could
delay important decisions.
 
23

 
 
Any
of the foregoing risks could have a material adverse effect on our business, financial condition and results of operations. Further,
these,
similar, enhanced or additional risks, including possible risks of the other joint venture investors having licensed assets to
the joint venture, may apply to
any future additional or amended joint ventures that we may enter into. 
 
Healthcare
 policy changes, including pending legislation recently adopted and further proposals still pending to reform the U.S.
healthcare system,
may harm our future business.
 
Healthcare
costs have risen significantly over the past decade. There have been and continue to be proposals by legislators, regulators and third-
party
payors to keep these costs down. Certain proposals, if passed, would impose limitations on the prices we will be able to charge for the
products that
we are developing, or the amounts of reimbursement available for these products from governmental agencies or third-party
payors. These limitations could
in turn reduce the amount of revenues that we will be able to generate in the future from sales of our
products and licenses of our technology.
  
In
2010, the federal government enacted healthcare reform legislation that has significantly impacted the pharmaceutical industry. In addition
to
requiring most individuals to have health insurance and establishing new regulations on health plans, this legislation requires discounts
under the Medicare
drug benefit program and increased rebates on drugs covered by Medicaid. In addition, the legislation imposes an annual
fee, which has increased annually,
on sales by branded pharmaceutical manufacturers. There can be no assurance that our business will
not be materially adversely affected by these increased
rebates, fees and other provisions. In addition, these and other initiatives
in the United States may continue the pressure on drug pricing, especially under
the Medicare and Medicaid programs, and may also increase
regulatory burdens and operating costs. The announcement or adoption of any such initiative
could have an adverse effect on potential
revenues from any product that we may successfully develop. An expansion in government’s role in the U.S.
healthcare industry may
lower the future revenues for the products we are developing and adversely affect our future business, possibly materially.
 
In
September 2017, members of the U.S. Congress introduced legislation with the announced intention to repeal and replace major provisions
of
the Patient Protection and Affordable Care Act, or the ACA. In addition to those efforts, on October 12, 2017, an executive order
was issued that modified
certain aspects of the ACA. Following several years of litigation in the federal courts, in June 2021, the U.S.
Supreme Court upheld the ACA when it
dismissed a legal challenge to the ACA’s constitutionality. Further attempts to repeal or
to repeal and replace the ACA may continue. In addition, various
other healthcare reform proposals have also emerged at the federal and
 state level. We cannot predict what healthcare initiatives, if any, will be
implemented at the federal or state level, or the effect
any future legislation or regulation will have on us.
 
We
are exposed to fluctuations in currency exchange rates.
 
A
considerable amount of our expenses are generated in dollars or in dollar-linked currencies, but a significant portion of our expenses
such as
some clinical trials and payroll costs are generated in other currencies such as NIS and Euro. Most of the time, our non-dollar
assets are not totally offset by
non-dollar liabilities. Due to the foregoing and to the fact that our financial results are measured
in dollars, our results could be adversely affected as a
result of a strengthening or weakening of the dollar compared to these other
currencies. During the years ended December 31, 2019, 2020 and 2021, the
dollar depreciated in relation to the NIS, which raised the
dollar cost of our Israeli based operations and adversely affected our financial results, while
during the year ended December 31, 2022,
2023 and 2024, the dollar increased in relation to the NIS, which reduced the dollar cost of our Israeli based
operations costs. In addition,
our results could also be adversely affected if we are unable to guard against currency fluctuations in the future. Although we
may in
the future decide to undertake foreign exchange hedging transactions to cover a portion of our foreign currency exchange exposure, we
currently do
not hedge our exposure to foreign currency exchange risks. These transactions, however, may not adequately protect us from
future currency fluctuations
and, even if they do protect us, may involve operational or financing costs we would not otherwise incur.
 
24

 
 
We
face uncertainties related to Oravax’s oral COVID-19 vaccine.
 
We
 face uncertainties related to Oravax’s oral COVID-19 vaccine, including uncertainties related to the risk that our continued development
programs may not be successful, commercially viable or receive approval from regulatory authorities. Other companies may produce superior
 or
competitive oral or other products that make Oravax’s oral COVID-19 vaccine not commercially worthwhile. Even if we succeed
 in developing the
product, the demand for any product we may develop may no longer exist, given the fluid nature of the COVID-19 pandemic,
including possible decreased
demand for vaccines due to weaker strains, the need for different vaccines for new variants of the virus
or an end of the pandemic that may render Oravax’s
vaccine obsolete.
 
Risks
Related to Our Real Estate Investments
 
Our
 investments in real estate may expose us to market and liquidity risks that could adversely affect our financial condition and results
 of
operations. On November 7, 2024, our Board approved investments of up to $10,000,000 in real estate assets, and additional investments
 of up to
$20,000,000 On February 13, 2025. While we believe these investments present attractive opportunities, the real estate market
is subject to fluctuations due
to economic conditions, interest rate changes, and other external factors beyond our control. A downturn
in the real estate market or an extended period of
declining property values could negatively impact the returns on our investments.
Additionally, real estate investments tend to be relatively illiquid, which
may limit our ability to quickly exit or reallocate capital
 in response to market changes. Since our approach focuses on entrepreneurial real estate
investments rather than direct property ownership
or management, we are also exposed to risks associated with deal execution, market timing, and the
financial health of investment partners
or counterparties. If any of these risks materialize, they could adversely affect our financial position and ability to
generate anticipated
returns.
 
Risks
Related to the Notes
 
We
have lent a substantial amount of funds to Scilex. In the event that Scilex is unable to service its obligations under the Note and
defaults
on such Note, it could have a material adverse effect on our business.
 
On September 21, 2023, we were issued the Tranche A Note in an aggregate
principal amount of $101,875,000 by Scilex pursuant to the Scilex
SPA. The Note originally matured on March 21, 2025 and is payable in
six principal installments, with the first installment paid on December 21, 2023. In
January 2025, we extended Tranche A Note maturity
from March 21, 2025 to December 31, 2025. Interest under the Note accrues at a fluctuating per
annum interest rate equal to the sum of
(1) the greater of (x) four percent (4%) and (y) Term SOFR (as defined in the Note) and (2) eight and one half
percent (8.5%), payable
in-kind on a monthly basis.
 
On
October 7, 2024, we entered into an agreement to refinance a portion of the Tranche A Note and pay off certain other indebtedness of
Scilex.
We were issued an aggregate principal amount of $25,000,000 under the Tranche B Note and 3,750,000 Tranche B Warrants. In addition,
on October 8,
2024, we entered into the RPA with Scilex to holds the right to receive 4% royalties.
  
There
is no guarantee that Scilex will be able to service its repayment obligations under the Note. Although the Note is secured by a first
priority
security interest in and liens on all of the assets of Scilex and its subsidiaries, no assurance can be made that Scilex will
be able to repay the Tranche A
Note and Tranche B Notes, or the Notes, when due or that we will be able to foreclose on such assets and
recover enough value upon the sale of such assets
to repay the amounts owed to us. In such an event, we could lose all or a substantial
portion of our loan investment. Additionally, Scilex has disclosed in its
periodic reports filed with the SEC that there is substantial
doubt about its ability to continue as a going concern. If Scilex is unable to continue as a going
concern or defaults on the Notes,
we may be unable to recover some or all of the principal amount of the Note, which could have a material adverse effect
on our business,
financial condition and results of operations.
 
We
may have difficulty realizing the full value of the Warrants.
 
The
Closing Penny Warrant will be exercisable upon the earliest of (i) March 14, 2025, (ii) the date on which the Note has been repaid in
full, and
(iii) the Management Sale Trigger Date (as defined therein), if any, and will expire on the date that is the fifth anniversary
of the issuance date. For
purposes of the Penny Warrants, the Management Sale Trigger Date is generally the first date that certain members
of Scilex management engage in certain
sales or other similar transfers of shares of Scilex Common Stock or other of Scilex’s or
any of its subsidiaries’ securities, subject to certain exceptions as
are customary for lock-up agreements executed by directors
and officers in connection with financings or similar transactions.
 
25

 
 
The
Subsequent Penny Warrants will vest and become exercisable on the date that is the later of (i) Subsequent Penny Warrant Vesting Date,
and
(ii) the earliest of (A) March 14, 2025, (B) the date on which the Note has been repaid in full and (C) the Management Sale Trigger
Date, if any. Each
Subsequent Penny Warrant will expire on the date that is the fifth anniversary of the issuance date; provided that,
if the Notes are repaid in full prior to the
Subsequent Penny Warrant Vesting Date applicable to such Subsequent Penny Warrant, such
Subsequent Penny Warrant will expire on the date the Notes
are repaid in full.
 
Because of the foregoing restrictions on exercisability of the Closing
Penny Warrant and the Subsequent Penny Warrants, we may not be able to
exercise the Warrants for shares of Scilex Common Stock at a time
when it would be financially beneficial for us to do so. Accordingly, there is no
guarantee that we will be able to realize the full or
any value of the Warrants.
 
Risks
Related to our Common Stock
 
Future
sales of our common stock by our existing stockholders could adversely affect our stock price.
 
The
market price of our common stock could decline as a result of sales of a large number of shares of our common stock in the market, or
the
perception that these sales could occur. We experienced a significant decline in the market price of our common stock and a significant
increase in trading
volume after announcing the results of our ORA-D-013-1 Phase 3 trial in January 2023. Any strategic decision we make
as a result of our strategic review
process may also negatively affect our common stock price or cause volatility in the market price
of our common stock. Sales of large amounts of our
securities or large variations in trading volume might make it more difficult for
us to sell equity securities in the future at a time and at a price that we deem
appropriate. As of March 27, 2025, we had outstanding
40,850,455 shares of common stock, a large majority of which are freely tradable. Giving effect to
the exercise in full of all of our
outstanding warrants, options and restricted stock units, or RSUs, including those currently unexercisable or unvested, we
would have
outstanding 44,599,618 shares of common stock.
 
Our
issuance of warrants, options and RSUs to investors, employees and consultants may have a negative effect on the trading prices of
our
common stock as well as a dilutive effect.
 
We
have issued and may continue to issue warrants, options, RSUs and convertible notes at, above or below the current market price. As of
March
27, 2025, we had outstanding warrants exercisable for 20,000 shares of common stock at a weighed average exercise price of $4.13
and options exercisable
for 1,548,633 shares of common stock at a weighted average exercise price of $7.09. We also had outstanding RSUs
for 589,781 shares of common stock.
In addition to the dilutive effect of a large number of shares of common stock and a low exercise
price for the warrants and options, there is a potential that
a large number of underlying shares of common stock may be sold in the
open market at any given time, which could place downward pressure on the
trading of our common stock.
  
Because
we will not pay cash dividends in the foreseeable future, investors may have to sell shares of our common stock in order to realize
their
investment.
 
We
have not paid any cash dividends on our common stock and do not intend to pay cash dividends in the foreseeable future. We intend to
retain
future earnings, if any, for reinvestment in the development and expansion of our business. Any credit agreements which we may
 enter into with
institutional lenders or otherwise may restrict our ability to pay dividends. Whether we pay cash dividends in the future
will be at the discretion of our
Board and will be dependent upon our financial condition, results of operations, capital requirements
and any other factors that our Board decides is
relevant.
 
26

 
 
Our
failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of
our
common stock.
 
Our
common stock is currently listed on the Nasdaq Capital Market. In order to maintain this listing, we must satisfy minimum financial and
other
requirements. Nasdaq Listing Rule 5550(a)(2) requires the minimum bid price of our common stock on the Nasdaq Capital Market to
remain above $1.00.
If the bid price of our common stock closes below $1.00 per share for 30 consecutive business days, we would be in
violation of Nasdaq Listing Rule
5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we would have 180 calendar days to
 regain compliance with the minimum bid
requirement.
 
While
we intend to engage in efforts to maintain compliance, and thus maintain our listing, there can be no assurance that we will continue
to meet
all applicable Nasdaq Capital Market requirements in the future, especially in light of any strategic transaction we may choose
to undertake. If our common
stock were removed from listing with the Nasdaq Capital Market, it may be subject to the so-called “penny
stock” rules. The SEC has adopted regulations
that define a “penny stock” to be any equity security that has a market
price per share of less than $5.00, subject to certain exceptions, such as any
securities listed on a national securities exchange, which
is the exception on which we currently rely. For any transaction involving a “penny stock,” unless
exempt, the rules impose
additional sales practice requirements on broker-dealers, subject to certain exceptions. If our common stock were delisted and
determined
to be a “penny stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more
difficult to acquire
or dispose of our common stock on the secondary market.
 
If
our common stock is delisted and there is no longer an active trading market for our shares, it may, among other things: cause stockholders
difficulty in selling our shares without depressing the market price for the shares or selling our shares at all; substantially impair
 our ability to raise
additional funds; result in a loss of institutional investor interest and fewer financing opportunities for us;
and/or result in costly litigation, significant
liabilities and diversion of our management’s time and attention and could have
a material adverse effect on our financial condition, business and results of
operations.
 
A
delisting would also reduce the value of our equity compensation plans, which could negatively impact our ability to retain employees.
 
As
the market price of our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common
stock
when you want or at prices you find attractive.
 
The
price of our common stock is currently listed on the Nasdaq Capital Market and on the Tel Aviv Stock Exchange and constantly changes.
In
recent years, the stock market in general has experienced extreme price and volume fluctuations. We expect that the market price of
our common stock will
continue to fluctuate. These fluctuations may result from a variety of factors, many of which are beyond our control.
For example, we experienced a
significant decline in the market price of our common stock after announcing the results of our ORA-D-013-1
Phase 3 trial in January 2023. These factors
include:
 
 
●
market acceptance of our
new strategy, once determined and announced;
 
 
●
clinical trial results
and the timing of the release of such results;
 
 
●
the amount of cash resources
and our ability to obtain additional funding;
 
 
●
announcements of research
activities, business developments, technological innovations or new products by us or our competitors;
 
 
●
entering into or terminating
strategic relationships;
 
 
●
changes in government regulation;
 
 
●
departure of key personnel;
 
 
●
disputes concerning patents
or proprietary rights;
 
27

 
 
 
●
changes in expense level;
 
 
●
future sales of our equity
or equity-related securities;
 
 
●
public concern regarding
the safety, efficacy or other aspects of the products or methodologies being developed;
 
 
●
activities of various interest
groups or organizations;
 
 
●
media coverage; and
 
 
●
status of the investment
markets.
 
Future
sales of common stock or the issuance of securities senior to our common stock or convertible into, or exchangeable or exercisable
for,
our common stock could materially adversely affect the trading price of our common stock, and our ability to raise funds in new equity
offerings.
 
Future
sales of substantial amounts of our common stock, including pursuant to any strategic opportunity, the ATM Agreement (as defined below),
or other equity-related securities in the public market or privately, or the perception that such sales could occur, could adversely
affect prevailing trading
prices of our common stock and could impair our ability to raise capital through future offerings of equity
or other equity-related securities. We anticipate
that we will need to raise capital through offerings of equity and equity related securities.
We can make no prediction as to the effect, if any, that future
sales of shares of our common stock or equity-related securities, or
the availability of shares of common stock for future sale, will have on the trading price
of our common stock.
 
Our
stockholders may experience significant dilution as a result of any additional financing using our equity securities.
 
To
the extent that we raise additional funds by issuing equity securities, including in connection with any strategic opportunity or pursuant
to the
ATM Agreement, our stockholders may experience significant dilution. Additionally, we may, from time to time or in connection
 with a strategic
alternative, issue additional shares of common stock at a discount from the current trading price of our common stock.
As a result, our stockholders would
experience immediate dilution upon the purchase of any shares of our common stock sold at such discount.
In addition, as opportunities present themselves,
we may enter into financing or similar arrangements in the future, including the issuance
of convertible debt securities, preferred stock or common stock. If
we issue common stock or securities convertible into common stock,
our common stockholders would experience additional dilution and, as a result, our
stock price may decline.
 
Risks
Related to JV Agreement
 
If
we fail to complete the transactions contemplated under the JV Agreement as supplemented by the Supplemental Agreement with HTIT , if
such
joint venture is not successful, or if we fail to realize the benefits we anticipate from such joint venture, we may not be able
to capitalize on the full
market potential of our drug products and technology.
 
In
joint ventures, we share ownership and management of a company with one or more parties who may not have the same goals, strategies,
priorities, business incentives or resources as we do and may compete with us outside the joint venture. Joint ventures are intended
to be operated for the
benefit of all co-owners, rather than for our exclusive benefit. Operating a business as a joint venture often
requires additional organizational formalities as
well as time-consuming procedures for sharing information and making decisions that
must further take into consideration our partners’ interests. In joint
ventures, we are required to foster our relationships with our
co-owners as well as promote the overall success of the joint venture, and if a co-owner
changes, relationships deteriorate or strategic
objectives diverge, our success in the joint venture may be materially adversely affected. Further, because
most of the benefits from
a successful joint venture are shared among the co-owners, we do not receive all the benefits from our successful joint ventures.
 
28

 
 
In
addition, because we share ownership and management with one or more parties, we may have limited control over the actions of a joint
venture, particularly when we own a minority interest. As a result, we may be unable to prevent violations of applicable laws or other
misconduct by a joint
venture, adverse human rights or other impacts or the failure to satisfy contractual obligations by one or more
parties. Moreover, a joint venture may not be
subject to the same financial reporting, corporate governance or compliance approaches
that we follow. To the extent another party makes decisions that
negatively impact the joint venture or internal control issues arise
within the joint venture, we may have to take responsive actions, or we may be subject to
penalties, fines or other punitive actions
or suffer reputational harm for these activities.
 
The
consummation of the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement, is subject to the
satisfaction
or waiver of certain other closing conditions.
 
If
 we do not successfully complete the closing conditions, this may harm our ability to complete the transactions contemplated by the JV
Agreement, as supplemented by the Supplemental Agreement, as well as additional clinical trials and marketing of our oral insulin candidate.
In addition,
this may cause irreparable harm to our financial position and business operations.
 
Furthermore,
there can be no assurances that OraTech will receive the necessary regulatory approvals for the Phase 3 oral insulin trial in the
United
States or that our drug products and our technology will be developed and commercialized successfully. In addition, OraTech will subject
us to a
number of risks including risks relating to the lack of full control of OraTech, potential disagreements with HTIT about how
to manage OraTech that may
result in the delay or termination of the commercialization of our products or product candidates or that
result in costly litigation or arbitration that diverts
management attention and resources, conflicting interests of OraTech, and OraTech
and its business not being profitable.
 
While
we believe that our board representation, voting rights and other contractual rights with respect to OraTech will serve to mitigate some
of
these risks, we may have disagreements with the other directors and HTIT that could impair our ability to influence OraTech to act
in a manner that we
believe is in the best interest of us.
 
We
may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement.
 
Pursuant
to the Supplemental Agreement, the Initial Closing will be April 30, 2025. Subject to the completion and satisfaction of applicable
closing
conditions, the Second Closing shall occur on a date specified in the applicable closing notice, which such date shall be no later than
the fifth
business day after the satisfaction or waiver of the applicable closing conditions, provided, however, that the Second Closing
shall not be consummated
before April 30, 2025 unless the shares of OraTech’s common stock have been approved for listing and trading
on the Nasdaq Stock Market prior to April
30, 2025. In the event the parties fail to consummate the Second Closing on or before April
30, 2025, solely due to the failure of not achieving the Listing,
the parties agreed to consummate the Second Closing on or before May
31, 2025. Notwithstanding the foregoing, the provisions with respect to the Second
Closing may be terminated by either HTIT or us if
the Second Closing has not occurred by September 1, 2025, subject to certain conditions.
 
There
are no assurances that the applicable parties will consummate either the Initial Closing or the Second Closing, of the Spin Off or complete
the closing conditions such closings are subject to. If we do not successfully complete such closings in a timely manner, or at all,
this may harm OraTech’s
ability to complete the transactions contemplated by the JV Agreement and the Supplemental Agreement, which
may in turn cause irreparable harm to our
financial position and business operations.
 
29

 
 
We
may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our business.
 
We
may not be able to achieve the full strategic and financial benefits expected to result from the Spin Off and such benefits may be delayed
or
not occur at all. The Spin Off is designed to enhance strategic and management focus, provide a distinct corporate identity, and allow
us to efficiently
allocate resources and deploy capital. We may not achieve these and other anticipated benefits for a variety of reasons,
including the following:
 
●
the
Spin Off will require significant amounts of management’s time and effort, which may
divert management’s attention from operating and
growing our business;
 
●
following
the Spin Off, OraTech may be more susceptible to economic downturns and other adverse events
than if it was still a part of the
Company;
 
●
following
the Spin Off, our business will be less diversified than prior to the Spin Off;
 
●
following
the Spin Off, our business will experience a loss of scale and access to certain financial,
managerial, and professional resources as
well as product and brand power influence and recognition
with some customers from which we have benefited in the past;
 
●
actions
required to separate the respective businesses could disrupt our operations; and
 
●
if
we fail to achieve some or all of the benefits expected to result from the Spin Off, or if
such benefits are delayed, our business could be
harmed.
 
Until
 the Spin Off occurs, the business of OraTech will remain our business segment. Completion of the Spin Off remains subject to the
satisfaction
or waiver of certain conditions.
 
Potential
indemnification liabilities to HTIT pursuant to the JV Agreement, as supplemented by the Supplemental Agreement could materially and
adversely affect our financial condition, results of operations, and cash flows.
 
The
JV Agreement, as supplemented by the Supplemental Agreement, among other things, provides for indemnification obligations designed to
make the Company and the OraTech financially responsible for certain liabilities that may exist relating to its business activities.
If we and the OraTech are
required to indemnify HTIT under the circumstances set forth in the JV Agreement, as supplemented by the Supplemental
Agreement, we may be subject
to substantial liabilities.
 
We
potentially could have received better terms from unaffiliated third parties than the terms we received in our agreements with OraTech
 
The
agreements we and OraTech entered into in connection with the Spin Off have been negotiated while OraTech is still a part of our business.
The terms of the agreements negotiated in the context of the Spin Off relate to, among other things, the allocation of assets, intellectual
property, liabilities,
rights, and other obligations between OraTech and us, among others. Arm’s-length negotiations between OraTech
and an unaffiliated third-party in another
form of transaction, such as a buyer in a sale of a business transaction, may have resulted
in more favorable terms to the unaffiliated third-party.
 
Our
business and assets will be less diversified following the Spin Off
 
In
connection with the transactions contemplated by the JV Agreement as supplemented by the Supplemental Agreement, on February 7, 2025,
we
entered into that certain Asset Transfer Agreement or the Asset Transfer Agreement with OraTech and Oramed Ltd., pursuant to which,
we and Oramed
Ltd. have agreed to transfer to OraTech all of our and their rights, titles, and interests in the Transferred IP, Business
Contracts, Business Information, and
Regulatory Information (each as defined in the Asset Transfer Agreement and collectively, or the
Transferred Assets), as part of the capital contribution to
be made to OraTech, in consideration for the issuance to us of certain Shares
(as defined in the JV Agreement) in OraTech.
 
If
such Transferred Assets are transferred to OraTech in connection with the Spin Off, OraTech will have all rights, title and interest
in such
Transferred Assets, and we will no longer have all rights, title and interest in such Transferred Assets, meaning that our business
and assets will be less
diversified following the Spin Off, which may in turn affect our operations and our financial position.
 
30

 
 
The
financial position and business operations of the OraTech could be impacted by HTIT’s ability to perform its obligations under
certain contracts
with us.
 
In
connection with the Spin Off, we have entered into a number of agreements with HTIT, including a supply agreement and a license agreement
that govern our ongoing relationship with HTIT. Our success depends, in part, on the maintenance of our ongoing relationship with HTIT,
 HTIT’s
performance of its obligations under these agreements, including HTITs maintenance of the quality of products and services
and certain other trademarks
and intellectual property that we license to HTIT. If we are unable to maintain a good relationship with
HTIT, or if HTIT does not perform its obligations
under our agreements with HTIT, the business of OraTech, its operations and its financial
position may be negatively impacted.
 
The
Spin Off may expose us to potential liabilities arising out of state and federal fraudulent conveyance laws.
 
If
we file for insolvency or bankruptcy within certain timeframes following the Spin Off, a court could deem the Spin Off or certain internal
restructuring transactions undertaken by us in connection therewith to be a fraudulent conveyance or transfer. Fraudulent conveyances
or transfers are
defined to include transfers made or obligations incurred with the actual intent to hinder, delay or defraud current
or future creditors or transfers made or
obligations incurred for less than reasonably equivalent value when the debtor was insolvent,
or that rendered the debtor insolvent, inadequately capitalized
or unable to pay its debts as they become due. In such circumstances,
a court could void the transactions or impose substantial liabilities upon us, which
could adversely affect our financial condition and
 our results of operations. Whether a transaction is a fraudulent conveyance or transfer will vary
depending upon the jurisdiction whose
law is being applied.
 
Risks
Related to Conducting Business in Israel
 
We
are affected by the political, economic and military risks of having operations in Israel.
 
We
have operations in the State of Israel, and we are directly affected by political, economic and security conditions in that country.
Since the
establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors
and a state of hostility,
varying in degree and intensity, has led to security and economic problems for Israel. In addition, acts of
terrorism, armed conflicts or political instability in
the region could negatively affect local business conditions and harm our results
of operations. We cannot predict the effect on the region of any diplomatic
initiatives or political developments involving Israel or
 the Palestinians or other countries and territories in the Middle East. Recent political events,
including political uprisings, social
unrest and regime change, in various countries in the Middle East and North Africa have weakened the stability of those
countries and
territories, which could result in extremists coming to power. In addition, Iran has threatened to attack Israel and is widely believed
to be
developing nuclear weapons. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas
in Gaza and Hezbollah
in Lebanon. This situation has escalated in the past and may potentially escalate in the future to violent events
which may affect Israel and us. On October
7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas.
Israel has been in an ongoing state of war with Hamas since that
time. Following the attack by Hamas, Hezbollah, a terrorist organization
in Lebanon has also launched missile, rocket, and shooting attacks against Israeli
military sites, troops, and Israeli towns in northern
Israel. In response to these attacks, the Israeli army has carried out a number of targeted strikes on sites
belonging to Hezbollah in
southern Lebanon and in October 2024, the Israeli military initiated a ground operation in Lebanon, primarily near the Israel-
Lebanon
border. As of the end of November 2024, Israel entered into a ceasefire agreement with Hezbollah, but there are no guarantees as to whether
the
agreement will hold or whether further hostilities will resume.
 
In
April and October 2024, Iran launched missile and unmanned aerial vehicle, or UAV, attacks on Israel. Most of the missiles and UAVs were
intercepted by Israel’s defense systems, with support from the United States and other countries, including regional allies, preventing
significant damage
and resulting in no casualties. Despite the successful interceptions, the attacks posed an elevated threat to Israel’s
security.
 
31

 
 
In
December 2024, Ba’athist Syria, led by President Bashar al-Assad, collapsed during a major offensive by opposition forces made
up of several
competing rebel groups. In response, the Israeli Defense Forces took control over a United Nations-designated buffer zone
 over Mount Hermon that
separates Israel and Syria. Simultaneously, Israel conducted targeted military strikes against military assets
in Syria, aiming to eliminate any chemical
weapons storage sites that could be used by rebel groups and further weaken Iran’s operational
capabilities in the region. While the transitional government
of Syria has indicated that it is interested in reconstruction and stability
rather than a continuation of conflicts with Israel, there are no guarantees that there
will be no future escalation of hostilities or
that Syria will not permit other neighboring countries to launch attacks at Israel from its territory.
 
It
is possible that other terrorist organizations, including Palestinian military organizations in the West Bank, as well as other hostile
countries,
such as Iran, will join the hostilities. Although we believe that there is no immediate risk to our business operations related
to these events, our business,
prospects, financial condition and results of operations could be materially adversely affected if such
hostilities involving Israel continue or escalate or if
trade or scientific cooperation between Israel and its current partners is interrupted
or curtailed. Moreover, we cannot predict how this war will ultimately
affect Israel’s economy in general, which may involve a
downgrade in Israel’s credit rating by rating agencies (such as the recent downgrade by Moody’s of
its credit rating of Israel
from A1 to A2, in October 2023 and further downgrade to Baa1 with a negative outlook in September 2024, as well as the
downgrade of its
outlook rating from “stable” to “negative”). We may also be targeted by cyber terrorists specifically because
we are an Israeli-related
company.
 
All
adult male and female permanent residents of Israel, unless exempt, may be required to perform military reserve duty annually.
Additionally,
all such residents are subject to being called to active duty at any time under emergency circumstances, and several
hundred thousand Israeli military
reservists were drafted to perform immediate military service during the current war with Hamas
and other hostile elements, such as Hezbollah in Lebanon.
Some of our employees may in the future be obligated to perform annual
military reserve duty, although none were called up for reserves in the current war.
If called up, such persons may be absent from
their positions for a lengthy period of time. We can provide no assurance that such requirements will not
have a material adverse
effect on our business, prospects, financial condition and results of operations in the future, particularly if emergency
circumstances
occur.
 
It
may be difficult to enforce a U.S. judgment against us or our officers and directors and to assert U.S. securities laws claims in Israel.
 
Almost
all of our directors and officers are nationals and/or residents of countries other than the United States. As a result, service of process
upon
us, our Israeli subsidiary and our directors and officers, may be difficult to obtain within the United States. Furthermore, because
the majority of our assets
and investments, and most of our directors and officers are located outside the United States, it may be difficult
for investors to enforce within the United
States any judgments obtained against us or any such officers or directors. Additionally,
it may be difficult to assert U.S. securities law claims in original
actions instituted in Israel. Israeli courts may refuse to hear
a claim based on a violation of U.S. securities laws because Israel is not the most appropriate
forum in which to bring such a claim.
In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is
applicable to such
claim. If U.S. law is found to be applicable, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming
and costly process. Certain matters of procedure will also be governed by Israeli law.
 
32

 
 
Subject
to specified time limitations and legal procedures, under the rules of private international law currently prevailing in Israel, Israeli
courts
may enforce a U.S. judgment in a civil matter, including a judgment based upon the civil liability provisions of the U.S. securities
laws, as well as a
monetary or compensatory judgment in a non-civil matter, provided that the following key conditions are met:
 
 
●
subject to limited exceptions,
the judgment is final and non-appealable;
 
 
●
the judgment was given
by a court competent under the laws of the state in which the court is located and is otherwise enforceable in such
state;
 
 
●
the judgment was rendered
by a court competent under the rules of private international law applicable in Israel;
 
 
●
the laws of the state in
which the judgment was given provides for the enforcement of judgments of Israeli courts;
 
 
●
adequate service of process
has been effected and the defendant has had a reasonable opportunity to present its arguments and evidence;
 
 
●
the judgment and its enforcement
are not contrary to the law, public policy, security or sovereignty of the State of Israel;
 
 
●
the judgment was not obtained
by fraud and does not conflict with any other valid judgment in the same matter between the same parties; and
 
 
●
an action between the same
parties in the same matter was not pending in any Israeli court at the time the lawsuit was instituted in the U.S.
court.
 
If
any of these conditions are not met, Israeli courts will likely not enforce the applicable U.S. judgment.
 
General
Risk Factors
 
Changes
to tax laws could have a negative effect on us or our stockholders.
 
At
any time, the U.S. federal or state income tax laws, or the administrative interpretations of those laws, may be amended. Federal and
state tax
laws are constantly under review by persons involved in the legislative process, the U.S. Internal Revenue Service, the U.S.
Department of the Treasury and
state taxing authorities. Changes to the tax laws, regulations and administrative interpretations, which
may have retroactive application, could adversely
affect us. Our stockholders are encouraged to consult with their tax advisors about
the potential effects that changes in law may have on them and their
ownership of our securities.
 
Our
business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.
 
Despite
the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to
damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or
cyber-intrusions over
the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside
our organization. The risk of a security breach
or disruption, particularly through cyber-attacks or cyber intrusion, including by computer
hackers, foreign governments, and cyber terrorists, has generally
increased as the number, intensity and sophistication of attempted
attacks and intrusions from around the world have increased. If such an event were to
occur and cause interruptions in our operations,
it could result in a material disruption of our product development programs. For example, the loss of
clinical trial data from completed
or ongoing or planned clinical trials could result in delays in our clinical trial efforts and significantly increase our costs
to recover
or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications,
or
inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage
to our reputation, and the
further development of our product candidates could be delayed.
 
33

 
 
We
 also maintain compliance programs to address the potential applicability of restrictions against trading while in possession of material,
nonpublic information generally and in connection with a cyber-security breach. However, a breakdown in existing controls and procedures
around our
cyber-security environment may prevent us from detecting, reporting or responding to cyber incidents in a timely manner and
could have a material adverse
effect on our financial position and value of our stock.
 
Our
management will have significant flexibility in using the net proceeds of any offering of securities.
 
We
intend generally to use the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and
product
development activities, and for general corporate purposes, including general working capital purposes. Our management will have
significant flexibility in
applying the net proceeds of any such offering and we will necessarily be using our capital when we decide
on new strategic initiatives. The actual amounts
and timing of expenditures will vary significantly depending on a number of factors,
including the amount of cash used in our operations and our research
and development efforts. Management’s failure to use these
funds effectively would have an adverse effect on the value of our common stock and could
make it more difficult and costly to raise
funds in the future.
 
Delaware
law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to
you,
and thereby adversely affect existing stockholders.
 
The
Delaware General Corporation Law contains provisions that may have the effect of making more difficult or delaying attempts by others
to
obtain control of the Company, even when these attempts may be in the best interests of stockholders. Delaware law imposes conditions
on certain business
combination transactions with “interested stockholders.” These provisions and others that could be adopted
in the future could deter unsolicited takeovers
or delay or prevent changes in our control or management, including transactions in which
stockholders might otherwise receive a premium for their shares
of common stock over then current market prices. These provisions may
also limit the ability of stockholders to approve transactions that they may deem to
be in their best interests.
 
ITEM
1B. UNRESOLVED STAFF COMMENTS.
 
Not
applicable.
 
ITEM
1C. CYBERSECURITY.
 
The
 Board recognizes the critical importance of maintaining the trust and confidence of our business partners, employees and clinical trial
participants. The Audit Committee is responsible for reviewing our policies with respect to cybersecurity risks and relevant contingent
liabilities and risks
that may be material to the Company, including risks from third parties and business partners.
 
We
generally seek to address cybersecurity risks by implementing security measures on our internal computer systems and ensuring that third
parties and business partners implement similar measures. These security measures include firewalls, intrusion prevention and detection
systems, anti-
malware functionality and access controls, which are evaluated by our external IT consultant and improved through vulnerability
 assessments and
cybersecurity threat intelligence.
 
Our
Chief Operating and Business Officer is responsible for implementing protection measures for our information systems from cybersecurity
threats and promptly responding to any cybersecurity incidents.
 
To
date, risks from cybersecurity threats have not materially affected us and we do not currently believe any risks from cybersecurity threats
are
reasonably likely to affect the Company, including our business strategy, results of operations or financial condition. For further
information, see “Item 1A.
Risk Factors,” under “Our business and operations would suffer in the event of computer
 system failures, cyber-attacks or deficiencies in our cyber-
security.”
 
ITEM
2. PROPERTIES.
 
We
believe that our existing facilities are suitable and adequate to meet our current business requirements. In the event that we should
require
additional or alternative facilities, we believe that such facilities can be obtained on short notice at competitive rates.
 
ITEM
3. LEGAL PROCEEDINGS.
 
From
time to time we may become subject to litigation incidental to our business. We are not currently a party to any material legal proceedings.
 
ITEM
4. MINE SAFETY DISCLOSURES.
 
Not
applicable.
 
34

 
 
PART
II
 
ITEM
 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES.
 
Common
Stock
 
Our
common stock is traded on the Nasdaq Capital Market and on the Tel Aviv Stock Exchange, in each case under the symbol “ORMP.”
 
Holders
 
As
of March 27, 2025, there were 40,850,455 shares of our common stock issued and outstanding held of record by approximately 40 registered
stockholders. We believe that a significant number of stockholders hold their shares of our common stock in brokerage accounts and registered
in the name
of stock depositories and are therefore not included in the number of stockholders of record.
 
Unregistered
Sales of Equity Securities and Use of Proceeds
 
No
unregistered sales of equity securities were made during the three months ended December 31, 2024.
 
Issuer
Purchases of Equity Securities
 
In
June 2024, our Board authorized a stock buyback and retirement program pursuant to which we may, from time to time, repurchase up
to
$20,000,000 in maximum value of our common stock. Share repurchases may be executed through various means, including, without limitation,
open
market transactions, privately negotiated transactions or otherwise in compliance with Rule 10b-18 under the  Exchange
Act. The stock buyback program
does not obligate us to purchase any shares and expires in 12 months. The authorization for the stock
buyback program may be terminated, increased or
decreased by our Board in its discretion at any time.
 
We have repurchased and retired 1,036,976 shares of our common stock
 under this program for approximately $2,494,000, including
approximately $10,000 excise tax, at an average price of $2.36 per share. All
purchases were funded with cash on hand.
 
The
following sets forth information with respect to repurchase and retirement made by the Company of its shares of common stock during the
fourth quarter ended December 31, 2024:
 
Period
 
Total
number of
shares
purchased
   
Average
price paid
per share
   
Total
number of
shares
purchased as
part of
publicly
announced
plans or
programs
   
Approximate
dollar value
of 
shares that
may yet be
purchased
under
the plans or
programs
 
October 1-31, 2024
   
-     
-     
-    $
18,708,193 
November 1-30, 2024
   
252,802    $
2.327     
252,802    $
18,119,189 
December 1-31, 2024
   
244,722    $
2.463     
244,722    $
17,515,906 
Total
   
497,524     
      
497,524     
  
 
35

 
 
ITEM
6. [RESERVED] 
 
ITEM
7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
 
The
 following discussion and analysis of our financial condition and results of operations should be read in conjunction with the audited
consolidated financial statements and the related notes included elsewhere herein and in our audited consolidated financial statements.
 
In
addition to our audited consolidated financial statements, the following discussion contains forward-looking statements that reflect
our plans,
estimates and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements.
 Factors that could cause or
contribute to these differences include those discussed below and elsewhere in this Annual Report on Form
10-K, particularly in “Cautionary Statement
Regarding Forward-Looking Statements” and “Item 1A. Risk Factors.”
 
Overview
of Operations
 
We
are 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.
 
We
have developed an oral dosage form intended to withstand the harsh environment of the gastrointestinal tract and effectively deliver
active
insulin or other proteins. The formulation is not intended to modify the proteins chemically or biologically, and the dosage form
is designed to be safe to
ingest.
 
On
January 11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints. As
a
result, we terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the ORA-D-013-1
Phase 3 trial data
and found that subpopulations of patients with pooled specific parameters, such as BMI, baseline HbA1c and age, responded
well to oral insulin. Based on
this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA. We are additionally
examining our existing pipeline and have commenced
an evaluation process of potential strategic opportunities, with the goal of enhancing
value for our stockholders.
 
As
detailed above, in September 2023, we entered into the 2023 Scilex Transaction, which included a senior secured promissory note (Tranche
A
Note) and warrants. In October 2024, we participated in the 2024 Refinancing, purchasing a portion of the Tranche B Note and acquiring
royalty rights
under a Purchase and Sale Agreement. Additional agreements secured the right to receive royalties from certain products
of Scilex. We believe that these
transactions collectively strengthened our financial position and expanded our commercial interests.
 
36

 
 
Results
of Operations
 
The table and discussion that follows includes a comparison of our
results of operations and liquidity and capital resources for the years ended
December 31, 2024 and 2023. For a comparison of our results
of operations and financial condition for the year ended December 31, 2023 and the year
ended December 31, 2022, see “Item 7. Management’s
Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual
Report on Form 10-K for the year
ended December 31, 2023, filed with the SEC on March 6, 2024.
 
 
 
Year ended 
December 31,
 
 
 
2024
   
2023
 
 
 
 
 
 
 
(dollar amounts in thousands,
except per share data)
 
Revenues
  $
-    $
1,340 
Research and development expenses
   
(6,324)    
(8,971)
Sales and marketing
   
-     
287 
General and administrative expenses
   
(6,457)    
(8,425)
Interest expenses
   
(853)    
(2,037)
Financial income (expenses), net
   
(2,286)    
22,894 
Income (loss) before taxes on income
   
(15,920)    
5,088 
Taxes on income
   
(3,183)    
- 
Net income (loss) for the year
   
(19,103)    
5,088 
 
   
      
  
Net income (loss) attributable to Company’s stockholders
   
(19,060)    
5,525 
Net loss attributable to non-controlling interest
   
(43)    
(437)
Net income (loss) for the year
   
(19,103)    
5,088 
 
   
      
  
Basic income (loss) per share of common stock
  $
(0.48)   $
0.14 
Diluted income (loss) per share of common stock
  $
(0.48)   $
0.14 
 
   
      
  
Weighted average shares of common stock outstanding used in computing basic income (loss) per share of common
stock
   
40,828,380     
40,315,068 
Weighted average shares of common stock outstanding used in computing diluted income (loss) per share of common
stock
   
40,828,380     
40,566,901 
 
Revenues
 
Revenues
consist of proceeds related to the Amended and Restated Technology License Agreement, dated December 21, 2015, between us and
HTIT, or
as further amended by the parties on June 3, 2016 and July 24, 2016, the HTIT License Agreement, that are recognized on a cumulative
basis
when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, through the expected
product submission date
by HTIT of June 2023.
 
We did not recognize revenues for the year ended December 31, 2024,
compared to revenues of approximately $1,340,000 for the year ended
December 31, 2023. The decrease was due to recognition of revenues
through June 30, 2023, the product submission date by HTIT.
  
Research
and Development Expenses
 
Research
and development expenses include costs directly attributable to the conduct of research and development programs, including the cost
of
salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services
related to our clinical trials,
clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development.
All costs associated with research and
development are expensed as incurred.
 
Clinical
trial costs are a significant component of research and development expenses and include costs associated with third-party contractors.
We
outsource a substantial portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators
and other third-
party service providers to assist us with the execution of our clinical trials.
 
Clinical
activities which relate principally to clinical sites and other administrative functions to manage our clinical trials are performed
primarily
by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification,
 screening and
preparation, pre-study visits, training and program management.
 
Clinical
trial and preclinical trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase
of
materials, cost of manufacturing of the oral insulin and exenatide capsules, payments for patient recruitment and treatment, as well
as salaries and related
expenses of research and development staff.
 
37

 
 
Research and development expenses for the year ended December 31, 2024
 decreased by 30% to approximately $6,324,000, compared to
approximately $8,971,000 for the year ended December 31, 2023. The decrease
was mainly due to lower expenses related to our Phase 3 trials that were
terminated and was partially offset by stock-based compensation
expenses and costs related to the new Phase 3 clinical trial preparations.
 
Government
Grants
 
The
Government of Israel encourages research and development projects through the IIA, pursuant to the R&D Law. Under the R&D Law,
a
research and development plan that meets specified criteria is generally eligible for a grant of up to 50% of certain approved research
and development
expenditures. Each plan must be approved by the IIA.
 
From
August 2009 to March 2014, our subsidiary Oramed Ltd. was awarded five government grants amounting to a total net amount of NIS
8,000,000
(approximately $2,214,000 during such period) from the IIA. We used these funds to support further research and development and clinical
trials
of our oral insulin capsule and oral GLP-1 analog candidate during the period from February 2009 to December 2014.
 
In
the years ended December 31, 2024 and 2023, we did not recognize any research and development grants.
 
Under the terms of the grants we had received from the IIA, we were obligated to pay royalties of 3% on all revenues derived from the
sale of the
products developed pursuant to the funded plans, including revenues from licensed ancillary services. Royalties were generally
payable up to a maximum
amount equaling 100% of the grants received (dollar linked) with the addition of interest at an annual rate based
on the SOFR rate. On February 27, 2025,
we paid approximately $2,031,000 to the IIA, and, as result, we are free of our obligations to
the IIA.
 
The
R&D Law generally requires that a product developed under a program be manufactured in Israel. However, when applying for a
grant, the
applicant may declare that part of the manufacturing will be performed outside of Israel or by non-Israeli residents
 and if the IIA is convinced that
performing some of the manufacturing abroad is essential for the execution of the program, it may
still approve the grant. This declaration will be a
significant factor in the determination of the IIA as to whether to approve a
program and the amount and other terms of the benefits to be granted. If a
company wants to increase the volume of manufacturing
outside of Israel after the grant has been approved, it may transfer up to 10% of the company’s
approved Israeli manufacturing
volume, measured on an aggregate basis, outside of Israel after first notifying the IIA thereof (provided that the IIA does
not
object to such transfer within 30 days). In addition, upon the approval of the IIA, a portion greater than 10% of the manufacturing
volume may be
performed outside of Israel. In any case of transfer of manufacturing out of Israel, the grant recipient is required
to pay royalties at an increased rate, which
may be substantial, and the aggregate repayment amount is increased up to 120% or 150%
of the grant received (dollar linked) with the addition of interest
at an annual rate based on the SOFR
rate, depending on the portion of the total manufacturing volume that is performed outside of Israel. The approval we
received from
 the IIA for the License Agreement was subject to payment of increased royalties and an increased ceiling, all in accordance with the
provisions of the R&D Law. The R&D Law further permits the IIA, among other things, to approve the transfer of manufacturing
rights outside of Israel in
exchange for the import of different manufacturing into Israel as a substitute, in lieu of the increased
royalties.
 
The
R&D Law also provides that know-how developed under an approved research and development program and any derivatives thereof may
not
be transferred or licensed to third parties in Israel without the approval of the research committee, which approval may be subject
to the payment of
royalties from the sale. Such approval is not required for the sale or export of any products resulting from such research
or development. The R&D Law
further provides that the know-how developed under an approved research and development program and any
derivatives thereof may not be transferred or
licensed to any third parties outside Israel absent IIA approval which may be granted in
certain circumstances as follows: (a) the grant recipient pays to the
IIA a portion of the sale or license price paid in consideration
for the purchase or license of such IIA-funded know-how or the price paid in consideration
for the sale of the grant recipient itself,
as the case may be, in accordance with certain formulas included in the tracks published under the R&D Law; (b)
the grant recipient
receives know-how from a third party in exchange for its IIA-funded know-how; or (c) such transfer of IIA-funded know-how is made in
the context of IIA approved research and development cooperation projects or consortia.
 
38

 
 
The
R&D Law imposes reporting requirements with respect to certain changes in the ownership of a grant recipient. The R&D Law requires
the
grant recipient to notify the IIA of any change in control of the recipient or a change in the holdings of the means of control of
the recipient that results in a
non-Israeli entity or person becoming an interested party in the recipient, and requires the new non-Israeli
interested party to undertake to the IIA to comply
with the R&D Law. In addition, the rules of the IIA may require the provision
of additional information or representations in respect of certain such events.
For this purpose, “control” is defined as
the ability to direct the activities of a company other than any ability arising solely from serving as an officer or
director of the
company. A person is presumed to have control if such person holds 50% or more of the means of control of a company. “Means of
control”
refers to voting rights or the right to appoint directors or the chief executive officer. An “interested party”
of a company includes a holder of 5% or more of
its outstanding share capital or voting rights, its chief executive officer and directors,
someone who has the right to appoint its chief executive officer or at
least one director, and a company with respect to which any of
the foregoing interested parties holds 25% or more of the outstanding share capital or voting
rights or has the right to appoint 25%
or more of the directors.
 
Failure
 to meet the R&D Law’s requirements may subject us to mandatory repayment of grants received by us (together with interest and
penalties), as well as expose us to criminal proceedings. In addition, the Israeli government may from time to time audit sales of products
which it claims
incorporate technology funded through IIA programs which may lead to additional royalties being payable on additional
products.
  
Sales
and Marketing Expenses
 
Sales
and marketing expenses include the salaries and related expenses of our commercial functions, consulting costs and other general expenses.
 
We did not recognize any
sales and marketing expenses for the year ended December 31, 2024, compared to an income of approximately $287,000
for the year
ended December 31, 2023. The income primarily resulted from the reversal of previously recognized expenses related to forfeited
employee
stock options, following the termination of an executive officer in fiscal year 2023.
 
General
and Administrative Expenses
 
General
and administrative expenses include the salaries and related expenses of our management, consulting expenses, legal and professional
fees, travel expenses, business development expenses, insurance expenses and other general expenses.
 
General and administrative expenses for the year ended December 31,
 2024 decreased by 23% to approximately $6,457,000, compared to
approximately $8,425,000 for the year ended December 31, 2023. This decrease
 was mainly due to the reversal of previously recognized expenses
following the resignation of certain executive officers.
 
Interest
Expenses
 
Interest expenses were approximately $853,000 for the year ended December
31, 2024, compared to approximately $2,037,000 for the year ended
December 31, 2023, since the Short-Term Borrowings (as defined below)
received from Discount Bank Ltd. were terminated during the second quarter of
2024 (see below).
 
Financial
Income, Net
 
Net financial loss was approximately $2,286,000 for the year ended
December 31, 2024, compared to approximately $22,894,000 net financial
income for the year ended December 31, 2023. The change was mainly
due to the revaluation of the investments in Scilex and lower interest income on
deposits.
 
39

 
  
Liquidity
and Capital Resources
 
From our inception through December 31, 2024, we have incurred losses
in an aggregate amount of approximately $176,616,000. During that
period and through December 31, 2024, we have financed our operations
through several private placements of our common stock, as well as public
offerings of our common stock, raising a total of approximately
 $255,384,000, net of transaction costs. During that period, we also received cash
consideration of approximately $28,001,000 from the
exercise of warrants and options. We expect to seek additional financing through similar sources in
the future, as needed. As of December
31, 2024, we had approximately $54,420,000 of available cash and approximately $55,281,000 of short-term bank
deposits. In addition, we
hold various of interest in certain investments, including in Scilex and others, as further detailed in this report.
 
From
inception through December 31, 2024, we have not generated significant revenues from our operations. Although, we have increased the
research and development activities related to the new Phase 3 clinical trial, our research and development activities have been significantly
reduced while
we conducted a strategic review process, following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials. Following
the preparation and
expected initiation of the revised phase 3 trial (ORA-D-013-3) we expect to increase our research and development
expenses, either directly or through
OraTech.
 
Based
on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding
level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior
to such time. If there
are increases in our operating expenses, we may need to seek additional financing during the next 12 months. We
may also need additional funds to realize
the decisions made as part of our strategic review process. We cannot predict the outcome of
these activities. 
 
On
August 8, 2023, we borrowed an aggregate of $99,550,000 pursuant to loan agreements from Israel Discount Bank Ltd., or the Short-Term
Borrowings. The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66%
to 7.38%,
were secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000.
The net proceeds of the
Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment
of principal and interest at each
respective maturity. As of December 31, 2024, we repaid the entire Short-Term Borrowings amount.
 
40

 
 
As of December 31, 2024, our
 total current assets were approximately $143,221,000 and our total current liabilities were approximately
$5,685,000. On December 31,
 2024, we had a working capital surplus of approximately $137,536,000 and an accumulated loss of approximately
$176,616,000. As of December
31, 2023, our total current assets were approximately $162,584,000 and our total current liabilities were approximately
$53,214,000. On
 December 31, 2023, we had a working capital surplus of approximately $109,370,000 and an accumulated loss of approximately
$157,556,000.
The increase in working capital surplus was mainly due an increase in cash and cash equivalents together with a decrease in short-term
borrowings that was partially offset by a decrease in short-term deposits and investments at fair value.
 
During the year ended December
31, 2024, cash and cash equivalents increased to approximately $54,420,000 from approximately $9,055,000 as
of December 31, 2023. The
increase was mainly due to the reasons described below.
 
Operating activities used
cash of approximately $8,412,000 in the year ended December 31, 2024, compared to approximately $10,295,000 used
in the year ended December
31, 2023. Cash used in operating activities consisted mainly of changes in fair value of investments partially offset by net loss
resulting
from research and development and general and administrative expenses.
 
Investing activities provided
cash of approximately $105,817,000 in the year ended December 31, 2024, compared to cash used for investing
activities of approximately
$73,038,000 in the year ended December 31, 2023. Cash provided by investing activities in the year ended December 31, 2024
consisted primarily
of proceeds from short-term deposits and proceeds from repayments by Scilex under the Tranche A Note. Cash used by investing
activities
in the year ended December 31, 2023 is mainly due to our investment in Scilex and the purchase of short-term deposits, partially offset
by the
proceeds of short-term deposits.
 
Financing activities used cash of approximately $52,036,000 in the
 year ended December 31, 2024, compared to cash of approximately
$51,978,000 provided in the year ended December 31, 2023. Cash used for
financing activities in the year ended December 31, 2024, consisted primarily of
repayments of the Short-Term Borrowings and repurchases
of our shares. Cash provided by financing activities in the year ended December 31, 2023,
consisted primarily of the Short-Term Borrowings.
Our primary financing activities for the year ended December 31, 2024, were as follows: 
 
 
●
In
March 2024, we entered into the ATM Agreement with Rodman & Renshaw LLC and StockBlock Securities
LLC as sales agents, or the
Agents, pursuant to which we may issue and sell in transactions that
are deemed to be “at the market” offerings as defined in Rule 415 under
the Securities
Act of 1933, as amended, or the Securities Act, shares of our common stock, par value $0.012 per
share, having a maximum
aggregate offering price of up to $75,000,000 from time to time through the
Agents.
 
Any
sales of shares of common stock pursuant to the ATM Agreement will be made pursuant to an effective shelf registration statement
on
Form S-3 (File No. 333-257926), which was declared effective by the SEC on July 26, 2021, the prospectus contained therein and
 a
prospectus supplement related thereto dated March 18, 2024, filed with the SEC. The Agents may sell our common stock (A) in privately
negotiated transactions with our consent; (B) as block transactions; or (C) by any other method permitted by law deemed to be an
“at the
market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly
on The Nasdaq Capital
Market or sales made into any other existing trading market for our common stock. As of December 31, 2024,
no shares had been issued
under the ATM Agreement.
 
 
●
In
June 2024, our Board authorized a stock buyback program pursuant to which we may, from time to time,
repurchase and retire up to
$20,000,000 in maximum value of our common stock.
 
During the year ended December 31, 2024, we repurchased and retired
 1,036,976 shares of our common stock under this program for
approximately $2,494,000, including approximately $10,000 excise tax, at an
average price of $2.36 per share. All repurchases were funded
with cash on hand.
 
 
●
On August 8, 2023, we borrowed
an aggregate of $99,550,000 pursuant to loan agreements from Israel Discount Bank Ltd., or the Short-Term
Borrowings. The Short-Term
Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66%
to 7.38%, were secured
by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000. The
net proceeds
of the Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment of
principal
and interest at each respective maturity. As of December 31, 2024, we repaid the entire Short-Term Borrowings amount.
 
41

 
 
Trend
Information
 
Following
the results of the Phase 3 trials for our oral insulin capsule candidate, ORMD-0801, we conducted a comprehensive analysis of the data
to understand if there is a path forward for our oral insulin candidate, and we worked on a protocol for a new Phase 3 clinical trial
that was submitted to the
FDA. Conducting this clinical trial, whether independently or as part of OraTech, will require significant
 funds and resources. Concurrently, 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. At this time, we cannot foresee how these strategic decisions will
impact our financial results and operations.
 
Planned
Expenditures
 
In
previous years, we primarily invested in research and development. If we proceed to conduct a new clinical trial for our oral insulin
candidate,
we expect that in the upcoming years our research and development expenses will continue to be our major operating expense;
however, if this clinical trial
is conducted through OraTech, these costs will be borne by Oratech and not by us.
 
 Critical
Accounting Estimates
 
Our significant accounting policies are more fully described in the
notes to our accompanying consolidated financial statements. We believe that
the accounting policy below is critical for one to fully
understand and evaluate our financial condition and results of operations.
 
The
 discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which
 we
prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of our consolidated financial
statements requires us
to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure
of contingent assets and liabilities at the date
of the consolidated financial statements, as well as the reported revenues and expenses
during the reporting periods. On an ongoing basis, we evaluate such
estimates and judgments. We base our estimates on historical experience
 and on various other factors that we believe are reasonable under the
circumstances, the results of which form the basis for making judgments
about the carrying value of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these
estimates under different assumptions or conditions.
 
42

 
 
Investments
at fair value: On September 21, 2023 and on October 7, 2024 we entered into the 2023 Scilex Transaction and 2024 Refinancing,
respectively. We elected the fair value option for each of the components under 2023 Scilex Transaction and 2024 Refinancing in order
 to reduce
operational complexity of bifurcating embedded derivatives. Changes in value are recorded under financial income, net and include
interest income on the
Notes and Royalties received.
 
Determining
the fair value of the components above required significant judgment with regards to the expected repayment date of the Notes which
also
impacts the number of Subsequent Penny Warrants to be issued to us. The total value of the 2023 Scilex Transaction (and of each of its
components)
was valued on a weighted average of the different scenarios.
 
On September 4, 2024, we entered into a loan agreement to finance a
real estate project or the Profit Sharing Loan Agreement. We decided to
designate the Profit Sharing Loan Agreement as a whole under the
fair-value option. The valuation of the Profit Sharing Loan Agreement was based on
various project profit scenarios derived from the appraiser’s
report.
 
ITEM
7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.
 
We
are exposed to a variety of risks, including changes in interest rates, foreign currency exchange rates, changes in the value of our
marketable
securities and inflation.
 
As of December 31, 2024, we had approximately $54,420,000 in cash and
cash equivalents and approximately $55,281,000 in short term bank
deposits.
 
We
aim to preserve our financial assets, maintain adequate liquidity and maximize return while minimizing exposure to market risks. Such
policy
further provides that we should hold most of our current assets in bank deposits. As of today, the currency of our financial assets
is mainly in U.S. dollars.
 
Marketable
securities
 
We
 own 1,701,357 common shares of DNA, 6,500,000 shares of Scilex Common Stock and 117,000 ordinary shares of Entera, which are
presented
in our financial statements as marketable securities. Marketable securities are presented at fair value and their realization is subject
to certain
limitations if sold through the market, and we are therefore exposed to market risk. There is no assurance that at the time
 of sale of the marketable
securities the price per share will be the same or higher, nor that we will be able to sell all of the securities
at once given the volume of securities we hold.
Entera shares and the Closing Penny Warrants are traded on Nasdaq in U.S. dollars, while
DNA shares are traded on the Tel Aviv Stock Exchange in NIS.
We are also exposed to changes in the market price of the Scilex, Entera
and DNA shares and the Closing Penny Warrants, as well as to exchange rates
fluctuations in the NIS currency compared to the U.S. dollar
with respect to the DNA shares.
 
43

 
 
Interest
Rate Risk
 
We
invest a major portion of our cash surplus in bank deposits in banks in Israel. Since the bank deposits typically carry fixed interest
rates,
financial income over the holding period is not sensitive to changes in interest rates, but only the fair value of these instruments.
However, our interest
gains from future deposits may decline in the future as a result of changes in the financial markets.
 
The
Note issued by Scilex is based on the SOFR rate. Our interest income may decline in the future as a result of a change in the SOFR rate.
 
Foreign
Currency Exchange Risk
 
A significant portion of our expenditures, including salaries, clinical
 research expenses, consultants’ fees and office expenses relate to our
operations in Israel. The cost of those Israeli operations,
as expressed in U.S. dollars, is influenced by the extent to which any increase in the rate of
inflation in Israel is not offset (or is
offset on a lagging basis) by a devaluation of the NIS in relation to the U.S. dollar. If the U.S. dollar declines in value in
relation
to the NIS, it will become more expensive for us to fund our operations in Israel. In addition, as of December 31, 2024, we own net balances
in
NIS of approximately $2,078,000. Assuming a 10% appreciation of the NIS against the U.S. dollar, we would experience an exchange rate
 gain of
approximately $231,000, while assuming a 10% devaluation of the NIS against the U.S. dollar, we would experience an exchange rate
 loss of
approximately $189,000.
 
The
exchange rate of the U.S. dollar to the NIS, based on exchange rates published by the Bank of Israel, was as follows:
 
 
 
Year
ended 
December 31,
 
 
 
2024
   
2023
 
Average rate for period
   
3.70     
3.69 
Rate at period-end
   
3.65     
3.63 
 
We
 do not use any currency hedging transactions of options or forwards to decrease the risk of financial exposure from fluctuations in the
exchange rate of the U.S. dollar against the NIS.
 
ITEM
8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.
 
See
Item 15 of this Annual Report on Form 10-K.
 
44

 
 
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.
 
None.
 
ITEM
9A. CONTROLS AND PROCEDURES.
 
Disclosure
Controls and Procedures
 
Our
management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls
and
procedures as of December 31, 2024. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure
controls and procedures are effective.
  
Management’s
Annual Report on Internal Control over Financial Reporting
 
Our
 management, under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and
maintaining
adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act.
The
Company’s internal control over financial reporting is defined as a process designed to provide reasonable assurance regarding
the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with GAAP. Internal
control over financial reporting includes
policies and procedures that:
 
 
●
pertain to the maintenance
of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;
 
 
●
provide reasonable assurance
that transactions are recorded as necessary to permit the preparation of our financial statements in accordance
with GAAP, and that
our receipts and expenditures are being made only in accordance with authorizations of our management and directors;
and
 
 
●
provide reasonable assurance
regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could
have a material
effect on our financial statements.
 
Under
 the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we
evaluated
the effectiveness of our internal control over financial reporting as of December 31, 2024 based on the current framework for Internal
Control-
Integrated Framework (2013) set forth by The Committee of Sponsoring Organizations of the Treadway Commission.
 
Based
on this evaluation, our management concluded that the Company’s internal control over financial reporting was effective as of December
31, 2024 at a reasonable assurance level.
 
45

 
 
Changes
in Internal Control over Financial Reporting
 
There
 were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2024 that have
materially
affected, or are reasonable likely to materially affect, our internal control over financial reporting.
 
ITEM
9B. OTHER INFORMATION.
 
(a)
Disclosure Pursuant to Item 5.03 of Form 8-K. Amendments to Bylaws
 
On March 27, 2025, the Board amended and restated our by-laws, or the
Amended and Restated By-Laws. The Amended and Restated By-
Laws became effective as of March 27, 2025. The changes to the
Amended and Restated By-Laws include (i) in a contested election, a director nominee
shall be elected by a plurality of the
votes cast by the stockholders entitled to vote at the election on such election of directors (an election shall be
considered contested if,
as of the last date on which nominees for director may be submitted in accordance with the Amended and Restated By-laws, the
nominees
for election to the Board of Directors exceed the number of positions on the Board to be filled by election at that meeting); and (ii)
clarification
that the officers of the Company shall be a Chief Executive Officer, a President, a Secretary and a Treasurer. This description
of the amendments to the
Amended and Restated By-Laws is qualified in its entirety by reference to the text of the Amended and
Restated By-Laws filed as Exhibit 3.2 to this
Annual Report on Form 10-K.
 
(b)
Termination of Rule 10b5–1 Trading Arrangements
 
Not
applicable. 
 
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
 
Not
applicable.
 
46

 
 
PART
III
 
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
 
Directors
and Executive Officers
 
The
name and age of each of our directors and executive officers, his or her position with us and the period during which such person has
served
as a director or executive officer of the Company are set forth below.
 
Name
 
Age
 
Position
 
Serving
Since
 
Nadav
Kidron
 
50
  President,
Chief Executive Officer, Director and Chairman (effective as of
June 30, 2022)
 
2006
 
Dr.
Miriam Kidron
 
84
  Chief
Scientific Officer and Director
 
2006
 
Avraham
Gabay
 
40
  Chief
Financial Officer and Treasurer
 
2024
 
Joshua
Hexter
 
54
  Chief
Operating & Business Officer
 
2019
 
Daniel
Aghion
 
43
  Director
 
2024
 
Dr.
Arie Mayer
 
68
  Director
 
2019
 
Yehuda
Reznick
 
77
  Director
 
2024
 
Leonard
Sank
 
59
  Director
 
2007
 
Benjamin
Shapiro
 
41
  Director
 
2023
 
 
Mr.
Derovan, our former Chief Legal Officer and Secretary, ended his service with the Company on March 5, 2024. Mr. Silberman, our former
Chief Financial Officer, Treasurer and Secretary, ended his service with the Company on July 11, 2024.
 
Dr.
Miriam Kidron is Mr. Nadav Kidron’s mother. There are no other directors or officers of the Company who are related by blood or
marriage.
 
Business
Experience
 
The
following is a brief account of the education and business experience during at least the past five years of each of our directors and
of our
executive officers who are not also directors, indicating the principal occupation during that period, and the name and principal
business of the organization
in which such occupation and employment were carried out.
 
Mr.
Nadav Kidron was appointed President, Chief Executive Officer and director in March 2006, and Chairman
of the Board effective as of
June 30, 2022. He is also Chairman of the board of MDG Real Estate Global, Ltd., director of Israel
Advanced Technology Industries organization and until
2016 was a director of Entera Bio Ltd. In 2009, he was a fellow at the Merage Foundation
for U.S.-Israel Trade Programs for executives in the life sciences
field. From 2003 to 2006, he was the managing director of the Institute
of Advanced Jewish Studies at Bar Ilan University. From 2001 to 2003, he was a
legal intern at Wine, Mishaiker & Ernstoff Law Offices
 in Jerusalem, Israel. Mr. Kidron holds an LL.B. and an International MBA from Bar Ilan
University, Israel.
 
We
believe that Mr. Kidron’s qualifications to serve on our Board include his familiarity with the Company as its founder, his experience
in capital
markets, as well as his knowledge and familiarity with corporate management.
 
Dr.
Miriam Kidron was appointed Chief Scientific Officer and director in March 2006. Dr. Kidron is a pharmacologist
and a biochemist with a
Ph.D. in biochemistry. From 1990 to 2007, Dr. Kidron was a senior researcher in the Diabetes Unit at Hadassah
University Hospital in Jerusalem, Israel.
Dr. Kidron was formerly a visiting professor at the Medical School at the University of Toronto
(Canada), and is a member of the American, European and
Israeli Diabetes Associations. Dr. Kidron is a recipient of the Bern Schlanger
Award.
 
We
believe that Dr. Kidron’s qualifications to serve on our Board include her expertise in the Company’s technology, as it is
based on her research,
as well as her experience and relevant education in the fields of pharmacology and diabetes.
 
47

 
 
Mr.
Avraham Gabay was appointed Chief Financial Officer, Treasurer and Secretary in June 2024. Prior to his
appointment, Mr. Gabay served
as interim chief financial officer of BiomX Inc. (NYSE American: PHGE) during 2023. From 2021 until 2023,
Mr. Gabay served as the chief financial
officer at Oravax Inc., a 63% owned subsidiary of the Company. From 2019 until 2021, Mr. Gabay
was the chief financial officer of the Company. From
2015 to 2019, Mr. Gabay served as VP Finance at Orcam Technologies Ltd. From 2014
to 2015, Mr. Gabay provided economic services in the advisory
department of KPMG Israel, a certified public accounting firm, and from
2013 to 2014, he worked in the tax department of the law firm Gornitzky & Co.
In addition, Mr. Gabay serves as a director on the
board of Iintoo Ltd. (TASE: INTO). Mr. Gabay holds a bachelor’s degree in law and accounting (magna
cum-laude) from Tel-Aviv University
and is a certified public accountant in Israel and a member of the Israeli Bar Association.
 
Mr.
Joshua Hexter was appointed Chief Operating and Business Officer in September 2019. Prior to his appointment,
Mr. Hexter served as
Chief Business Officer at BrainsWay Ltd. (Nasdaq/TASE: BWAY) from 2018 to 2019, a commercial stage medical device
 company focused on the
development and sale of non-invasive neuromodulation products. From 2013 to 2018, Mr. Hexter served as Chief Operating
Officer and VP Business
Development of the Company and from 2007 to 2013, Mr. Hexter was a Director or Executive Director of BioLineRx
Ltd. (Nasdaq/TASE: BLRX), a
biopharmaceutical development company dedicated to identifying, in-licensing and developing innovative therapeutic
candidates. Prior to his employment
with BioLineRx, Mr. Hexter was a member of the board of directors and Chief Executive Officer of
Biosensor Systems Design, Inc., a company developing
market-driven biosensors. Mr. Hexter holds a bachelor’s degree from the University
of Wisconsin and a master’s degree in management from Boston
University.
 
Dr.
Daniel Aghion became a director in January 2024. Dr. Aghion has been a neurosurgeon at Memorial Neuroscience Institute
in Florida since
2016, where he treats patients with a wide array of spine disorders, including severe degenerative spine diseases, spine
trauma, cancer in the spine, spine
tumors, peripheral nerve surgery and more. Dr. Aghion holds a Bachelor of Science degree from the
University of Michigan and an MD from the Sackler
School of Medicine at Tel Aviv University. He completed his residency at Rhode Island
Hospital in 2015, and a complex spine fellowship at Johns Hopkins
University in Baltimore in 2016.
 
We
believe that Dr. Aghion’s qualifications to serve on the Board include his extensive practical and academic medical background.
 
Dr.
Arie Mayer became a director in December 2019. Dr. Mayer is currently the Managing Director and Chairman of the
Board of Sigma-Aldrich
Israel Ltd. and has held that position since January 2010. Dr. Mayer has held various roles with Sigma-Aldrich
Israel Ltd. since 1995 and was instrumental
in introducing and developing the Cell Culture and Molecular Biology business for Sigma Aldrich
Israel Ltd. Dr. Mayer holds a Bachelor of Science degree
in chemistry from Hebrew University and a Ph.D. in biochemistry from Israel
Institute of Technology.
 
We
 believe that Dr. Mayer’s qualifications to serve on our Board include his experience as an executive in the biotechnology industry,
 with
knowledge in managing large organizations, as well as his experience and relevant education in the fields of chemistry and biochemistry.
 
Mr.
Yehuda Reznick became a director in April 2024. Mr. Reznick served as an audit partner at Kesselman & Kesselman
CPA, a member of
PricewaterhouseCoopers International Limited, from 1999 until 2014. Prior to joining Kesselman & Kesselman, he was
a tax and audit partner at Shachak,
Peer Reznick CPA for sixteen years. Mr. Reznick currently serves on the board of directors of Oravax
Medical Inc., an affiliate of the Company. Since
2019, Mr. Reznick has also served on the board of directors of Hiron-Trade Investments
 & Industrial Buildings Ltd (TASE: HRON). Mr. Reznick
previously served on the board of directors of Bonus Biogroup Ltd (OTC: BBIXF)
from 2017 to 2023.
 
48

 
 
We
believe that Mr. Reznick’s qualifications to serve on the Board include his extensive operational experience and his business background
and
acumen.
 
Mr.
 Leonard Sank became a director in October 2007. Mr. Sank is a South African entrepreneur and businessman, whose
 interests lie in
entrepreneurial endeavors and initiatives, with over 30 years’ experience of playing significant leadership roles
in developing businesses. Mr. Sank serves
on the boards of a few national businesses and local non-profit charity organizations in Cape
Town, where he resides.
 
We
believe that Mr. Sank’s qualifications to serve on our Board include his years of experience in development stage businesses, as
well as his
experience serving as a director of many entities.
  
Mr.
Benjamin Shapiro became a director in May 2023. Mr. Shapiro is a successful entrepreneur and business professional
who co-founded The
Daily Wire, a successful, industry leading, international media outlet in June 2015. Since May 2015, he has been host
of “The Ben Shapiro Show,” a
popular podcast, and he is the author of numerous New York Times best-selling books. Mr. Shapiro
earned a B.A. in Political Science from UCLA in 2004,
summa cum laude, and a law degree from Harvard Law School in 2007, cum laude.
 
We
believe that Mr. Shapiro’s qualifications to serve on the Board include his extensive operational experience and his business background
and
acumen.
 
 Board
of Directors
 
There
are no agreements with respect to the election of directors. Each director is currently elected for a period of one year at our annual
meeting
of stockholders and serves until the next such meeting and until his or her successor is duly elected or until his or her earlier
resignation or removal. The
Board may also appoint additional directors. A director so chosen or appointed will hold office until the
next annual meeting of stockholders and until his
or her successor is duly elected and qualified or until his or her earlier resignation
or removal.
 
The
Board has determined that Dr. Daniel Aghion, Dr. Arie Mayer, Yehuda Reznick, Leonard Sank and Benjamin Shapiro are independent as
defined
under the rules promulgated by the Nasdaq. Except for Dr. Arie Mayer and Mr. Reznick, each of whom serves on the board of directors of
Oravax,
a company 63% owned by us, none of the independent directors has any material relationship with us besides serving on our Board.
 
We
 have determined that each of the directors is qualified to serve as a director of the Company based on a review of the experience,
qualifications,
attributes and skills of each director. In reaching this determination, we have considered a variety of criteria, including, among other
things:
character and integrity; ability to review critically, evaluate, question and discuss information provided, to exercise effective
business judgment and to
interact effectively with the other directors; and willingness and ability to commit the time necessary to perform
the duties of a director.
 
Board
Meeting Attendance
 
During the year ended December 31, 2024, our Board held six meetings
 and took action by written consent on nine occasions. Except Mr.
Benjamin Shapiro, all of our directors attended at least 75% of the aggregate
number of meetings of the Board and the committees that were held during the
period such director served on the Board. Board members are
encouraged to attend our annual meetings of stockholders.
 
Board
Evaluation Process
 
Our
Board is committed to continuous improvement and conducts a board and committee evaluation process each year, to ensure that our Board
maintains optimal composition and functions effectively.
 
As
part of this process, the members of our Board complete a confidential written assessment of the performance, oversight and composition
of
the Board and its committees that is submitted to the Company secretary. The results are then reported back to the full Board. After
the evaluations, the
Board and management work to improve upon any issues presented during the evaluation process and to identify opportunities
that may lead to further
improvement.
 
49

 
 
Committees
 
Audit
Committee and Audit Committee Financial Expert
 
The
members of our Audit Committee are Dr. Daniel Aghion, Dr. Arie Mayer and Yehuda Reznick. Our Board has determined that Mr. Reznick is
an “audit committee financial expert” as set forth in Item 407(d)(5) of Regulation S-K based on his experience as set forth
above, and that all members of
the Audit Committee are “independent” as defined by the rules of the SEC and the Nasdaq rules
and regulations. The Audit Committee operates under a
written charter that is posted on the “Investors” section of our website,
www.oramed.com. The primary responsibilities of our Audit Committee include:
 
 
●
Overseeing the accounting
and financial reporting processes of the Company and the audits of the financial statements of the Company;
 
 
●
Appointing, compensating
and retaining our registered independent public accounting firm;
 
 
●
Overseeing the work performed
by any outside accounting firm;
 
 
●
Assisting the Board in
fulfilling its responsibilities by reviewing: (i) the financial reports provided by us to the SEC, our stockholders or to the
general
public and (ii) our internal financial and accounting controls;
 
 
●
Reviewing the Company’s
policies with respect to cyber security risks and relevant contingent liabilities and risks that may be material to the
Company;
 
 
●
Recommending, establishing
and monitoring procedures designed to improve the quality and reliability of the disclosure of our financial
condition and results
of operations; and
 
 
●
Reviewing major financial
risk exposures and the steps management has taken to monitor and control such exposures, and discussing the
guidelines and polices
to govern the process by which risk assessment and management is undertaken.
 
Our
Audit Committee met four times and took action by written consent on four occasions during the year ended December 31, 2024.
 
Compensation
Committee
 
The
members of our Compensation Committee are Dr. Daniel Aghion, Yehuda Reznick and Leonard Sank. The Board has determined that all of
the
members of the Compensation Committee are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations.
The Compensation
Committee operates under a written charter that is posted on the “Investors” section of our website, www.oramed.com.
The primary responsibilities of our
Compensation Committee include:
 
 
●
Reviewing, negotiating
and approving, or recommending for approval by our Board the salaries and incentive compensation of our executive
officers;
 
 
●
Administering our equity
based plans and making recommendations to our Board with respect to our incentive-compensation plans and
equity-based plans;
 
 
●
Making recommendations
to our Board with respect to director compensation; and
 
 
●
Authority to exercise all
rights, authority and functions of the Board under our Clawback Policy.
 
The
Compensation Committee meets as often as it deems necessary, without the presence of any executive officer when approving compensation,
except that the Company’s Chief Executive Officer, at the discretion of the Compensation Committee, may be present during the approval
 of, or
deliberations with respect to, the compensation of other executive officers. The Compensation Committee may delegate any authority
granted to it to one or
more subcommittees of the Compensation Committee, in its sole discretion.
 
50

 
 
Our
Compensation Committee met two times and took action by written consent on four occasions during the year ended December 31, 2024.
  
Nominating
Committee
 
The
members of our Nominating Committee are Dr. Arie Mayer and Leonard Sank. The Board has determined that all of the members of the
Nominating
Committee are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations. The Nominating Committee
operates under
a written charter that is posted on the “Investors” section of our website, www.oramed.com. The primary responsibilities
of our Nominating Committee
include:
 
 
●
Overseeing the composition
 and size of the Board, developing qualification criteria for Board members based on background, skills,
experience and diversity,
 and actively seeking, interviewing and screening individuals qualified to become Board members for
recommendation to the Board;
 
 
●
Recommending the composition
of the Board for each annual meeting of stockholders; and 
 
 
●
Reviewing periodically
with the Chairman of the Board and the Chief Executive Officer the succession plans relating to positions held by
directors, and
making recommendations to the Board with respect to the selection and development of individuals to occupy those positions.
 
Our
Nominating Committee met once and took one action by written consent during the year ended December 31, 2024.
 
Code
of Ethics
 
We
have adopted a Code of Ethics and Business Conduct for our senior officers, directors and employees. A copy of the Code of Ethics and
Business Conduct is located at our website at www.oramed.com. We intend to satisfy the disclosure requirement regarding any amendment
to, or a waiver
from, a provision of the Code of Ethics that applies to our Chief Executive Officer, Chief Financial Officer or controller,
or persons performing similar
functions and that relates to the Code of Ethics by posting such information on our website, www.oramed.com.
 
Insider
Trading Policy
 
We
have adopted an insider trading policy, or the Policy, governing the purchase, sale and other transactions in our securities
that applies to our
directors, officers, employees, including part-time and temporary employees, and other covered persons, including
immediate family members and entities
controlled by any of the foregoing persons, as well as by the Company itself.
 
The
Policy prohibits, among other things, insider trading and certain speculative transactions in our securities (including short sales,
buying put
and selling call options and other hedging or derivative transactions in our securities) and establishes a regular blackout
period schedule during which
directors, executive officers, employees, and other covered persons may not trade in the Company’s
securities, as well as certain pre-clearance procedures
that directors and executive officers must observe prior to effecting any transaction
in our securities.
 
The
Company believes that the Policy is reasonably designed to promote compliance with insider trading laws, rules and regulations,
and listing
standards applicable to the Company. A copy of the Policy is filed as Exhibit 19.1 to this Form 10-K.
 
ITEM
11. EXECUTIVE COMPENSATION.
 
Compensation
Discussion and Analysis
 
This
section explains the policies and decisions that shape our executive compensation program, including its specific objectives and elements,
as
it relates to our “named executive officers,” or NEOs.
 
51

 
 
Our
 NEOs for the year ended December 31, 2024 are those three individuals listed in the “Summary Compensation Table” below. The
Compensation Committee believes that our executive compensation is appropriately designed to incentivize our NEOs to work for our long-term
prosperity, is reasonable in comparison with the levels of compensation provided by comparable companies and reflects a reasonable cost.
We believe our
NEOs are critical to the achievement of our corporate goals, through which we can drive stockholder value.
 
The
Compensation Committee of our Board is comprised solely of independent directors as defined by Nasdaq and non-employee directors as
defined
by Rule 16b-3 under the Exchange Act. The Compensation Committee has the authority and responsibility to review and approve the compensation
of our President and Chief Executive Officer and other executive officers. Other information concerning the structure, roles and responsibilities
of our
Compensation Committee is set forth in “Board Meetings and Committees—Compensation Committee” section.
 
Our
executive compensation program and our NEOs’ compensation packages are designed around the following objectives:
 
 
●
attract, hire, and retain
talented and experienced executives;
 
 
●
motivate, reward and retain
executives whose knowledge, skills and performance are critical to our success;
 
 
●
ensure fairness among the
executive management team via recognizing the contributions of each executive to our success;
 
 
●
focus executive behavior
on achievement of our corporate objectives and strategy; and
 
 
●
align the interests of
management and stockholders by providing management with longer-term incentives through equity ownership.
 
The
Compensation Committee reviews the allocation of compensation components regularly to ensure alignment with strategic and operating
goals,
competitive market practices and legislative changes. The Compensation Committee does not apply a specific formula to determine the allocation
between cash and non-cash forms of compensation. Certain compensation components, such as base salaries, benefits and perquisites, are
 intended
primarily to attract, hire, and retain well-qualified executives. Other compensation elements, such as long-term incentive opportunities,
are designed to
motivate and reward performance. Long-term incentives are intended to reward NEOs for our long-term performance and executing
our business strategy,
and to strongly align NEOs’ interests with those of stockholders.
 
With
respect to equity compensation, the Compensation Committee makes awards to executives under our Amended and Restated 2019 Incentive
Plan,
or the 2019 Plan. Executive compensation is paid or granted based on such matters as the Compensation Committee deems appropriate, including
our
financial and operating performance and the alignment of the interests of the executive officers and our stockholders.
 
Elements
of Compensation
 
Our
executive officer compensation program is comprised of: (i) base salary or monthly compensation; (ii) discretionary bonus; (iii) long-term
equity incentive compensation in the form of stock option and RSU grants; and (iv) benefits and perquisites.
 
In
establishing overall executive compensation levels and making specific compensation decisions for our NEOs in the year ended December
31,
2024, the Compensation Committee considered a number of criteria, including the executive’s position, scope of responsibilities,
prior base salary and
annual incentive awards and expected contribution.
 
Generally,
our Compensation Committee reviews and, as appropriate, approves compensation arrangements for the NEOs from time to time but
not less
than once each year. The Compensation Committee also takes into consideration the President and Chief Executive Officer’s recommendations
for
executive compensation of the other NEOs. The President and Chief Executive Officer generally presents these recommendations at the
 time of our
Compensation Committee’s review of executive compensation arrangements.
 
52

 
 
During
the year ended December 31, 2024, the Compensation Committee received consulting services from Aon Solutions UK Limited., or Aon,
with
regard to management compensation. The Compensation Committee engaged the consultant to review the Company’s current compensation
plans for
its management and collect and analyze data regarding management compensation at other companies comparable to the Company,
in order to provide a
competitive compensation benchmark. Aon collected SEC filings data regarding U.S. and Israeli compensation practices
and developed a peer group of the
following U.S. and Israeli companies: ALX Oncology Holdings Inc., AN2 Therapeutics, Inc., Anavex Life
Sciences Corp., Atossa Therapeutics Inc., aTyr
Pharma, Inc., Chimerix, Inc., Compugen Ltd., Fulcrum Therapeutics, Inc., Immunic, Inc.,
Marinus Pharmaceuticals, Inc., MediciNova, Inc., Pluri Biotech
Ltd., Rani Therapeutics, Inc., Relmada Therapeutics, Inc., Rezolute, Inc.,
Vistagen Therapeutics, Inc., vTv Therapeutics Inc. and Zevra Therapeutics, Inc..
Following its review, Aon provided recommendations for
 cash and equity compensation at various percentiles for the Compensation Committee’s
consideration.
 
Base
Salary
 
The
Compensation Committee performs a review of base salaries and monthly compensation for our NEOs from time to time as appropriate. In
determining salaries, the Compensation Committee members also take into consideration the scope of the NEOs’ responsibilities and
independent third-
party market data, such as compensation surveys to industry, individual experience and performance and contribution
 to our clinical, regulatory,
commercial and operational performance. None of the factors above has a dominant weight in determining the
 compensation of our NEOs, and our
Compensation Committee considers the factors as a whole when considering such compensation. In addition,
 our Compensation Committee uses
comparative data regarding compensation paid by peer companies in order to obtain a general understanding
of current trends in compensation practices
and ranges of amounts being awarded by other public companies, and not as part of an analysis
or a formula.
 
We
believe that a competitive base salary and monthly compensation is a necessary element of any compensation program that is designed to
attract and retain talented and experienced executives. We also believe that attractive base salaries can motivate and reward executives
for their overall
performance. Base salary and monthly compensation are established in part based on the individual experience, skills
and expected contributions to our
performance, as well as such executive’s performance during the prior year. Generally, we believe
that executives’ base salaries should be targeted near the
median of the range of salaries for executives in similar positions
with similar responsibilities, experience and performance at comparable companies.
Compensation adjustments are made occasionally based
on changes in an executive’s level of responsibility, company progress or on changed local and
specific executive employment market
conditions.
 
 In
November 2024, our Compensation Committee increased the base salary of our NEOs by 15% (effective July 1, 2024 as it deemed this to be
a
reasonable rate based on, among other factors, such NEO’s responsibilities and the report from Aon, as it determined the salaries
were not in line with
market compensation.
 
Performance
Based Bonus
 
Our
NEOs are eligible to receive discretionary annual bonuses based upon performance. The amount of annual bonus to our NEOs is based on
various factors, including, among others, the achievement of scientific and business goals and our financial and operational performance.
 The
Compensation Committee takes into account the overall performance of the individuals, as well as the overall performance of the Company
over the period
being reviewed and the recommendation of management. For any given year, the compensation objectives vary, but relate
generally to strategic factors
such as developments in our clinical path, the execution of a license agreement for the commercialization
of product candidates, the establishment of key
strategic collaborations, the build-up of our pipeline and financial factors such as
 capital raising. Bonuses are awarded generally based on corporate
performance, with adjustments made within a range for individual performance,
at the discretion of the Compensation Committee. The Compensation
Committee determines, on a discretionary basis, the size of the entire
bonus pool and the amount of the actual award to each NEO. The overall payment is
also based on historic compensation of the NEOs.
 
53

 
 
We
believe that annual bonuses payable based on the achievement of short-term corporate goals incentivize our NEOs to create stockholder
value
and attain short-term performance objectives.
  
Long-Term
Equity Incentive Compensation
 
Long-term
incentive compensation allows the NEOs to share in any appreciation in the value of our common stock. The Compensation Committee
believes
that stock participation aligns executive officers’ interests with those of our stockholders. Equity incentive awards are generally
made at the
commencement of employment and following a significant change in job responsibilities, or to meet other special retention
or performance objectives. The
amounts of the awards are designed to reward past performance and create incentives to meet long-term
objectives. Awards are made at a level expected to
be competitive within the biotechnology industry, as well as with Israeli-based companies.
Awards are made on a discretionary basis and not pursuant to
specific criteria set out in advance. In determining the amount of each
grant, the Compensation Committee also takes into account the number of shares
held by the executive prior to the grant. The vesting
 schedule for NEOs generally provides for annual installments for new grants, though the
Compensation Committee also utilizes quarterly
vesting from time to time, as well as performance-based vesting. The Compensation Committee believes
that time-based vesting encourages
 recipients to build stockholder value over a long period of time and that performance-based vesting encourages
recipients to achieve
goals that benefit the Company.
 
As
part of its engagement in the year ended December 31, 2024 described above, Aon also provided consulting services in connection with
grants
of equity awards to our executive officers. Aon reviewed annual long-term incentive grants at peer companies, as well as such
grants made by companies in
the broader market, based on a blend of Black-Scholes valuations and grants as a percentage of the applicable
company’s capitalization. Following such
consultation, the Compensation Committee is considering alternative models and equity
vehicles for future equity-based grants.
 
Benefits
and Perquisites
 
Generally,
benefits available to NEOs are available to all employees on similar terms and include welfare benefits, paid time-off, life and disability
insurance and other customary or mandatory social benefits in Israel. We provide some of our NEOs with a phone and a company car, which
are customary
benefits in Israel to managers and officers.
 
We
do not believe that the benefits and perquisites described above deviate materially from the customary practice for compensation of executive
officers by other companies similar in size and stage of development in Israel. These benefits represent a relatively small portion of
the executive officers’
total compensation.
 
Say-on-Pay
Vote
 
Our
stockholders approved, on an advisory basis, our executive compensation program at our annual meeting of stockholders held on August
1,
2024. Over 90% of votes cast were voted “for” the compensation of our named executive officers as described in the proxy
statement for last year’s annual
meeting of stockholders. The Compensation Committee did not specifically rely on the results of
 the prior vote in making any compensation-related
decisions during the year ended December 31, 2024.
 
54

 
 
SUMMARY
COMPENSATION TABLE
 
The
following table sets forth the compensation earned by our NEOs for the years ended December 31, 2024 and 2023.
 
Name and Principal Position
 
Year
   
Salary
($) (1)
   
Bonus
($) (1)(2)    
RSUs
and
PSUs
Awards
($) (3)
   
All
Other 
Compensation
($) (1)(4)
   
Total
($)
 
Nadav Kidron
   
2024
     
540,145     
270,767      1,224,760     
62,017      2,097,689 
President,
Chief Executive Officer and Chairman
   
2023
     
462,988     
242,576     
904,920     
48,738      1,659,222 
 
   
 
     
      
      
      
      
  
Dr. Miriam Kidron
   
2024
     
408,104     
155,291     
951,545     
19,607      1,534,547 
Chief
Scientific Officer and director(5)
   
2023
     
347,405     
139,123     
605,480     
17,423      1,109,431 
 
   
 
     
      
      
      
      
  
Avraham Gabay (6)
   
2024
     
119,925     
49,623     
450,084     
28,583     
648,215 
Chief Financial Officer
   
 
     
      
      
      
      
  
 
(1) Amounts paid for Salary,
Bonus and All Other Compensation that were originally denominated in NIS were translated into U.S. Dollars at the then
average exchange
rate for the period.
 
(2) Bonuses were granted at
the discretion of the Compensation Committee.
 
(3) For
RSU and performance stock unit, or PSU, awards, the amounts reflect the grant date fair value, as calculated pursuant to ASC
 Topic 718
“Compensation–Stock Compensation.” The assumptions used to determine
the fair value of the RSU awards are set forth in note 10 to our audited
consolidated financial statements.
Our NEOs will not realize the value of these awards in cash unless and until the awards vest and
the underlying
shares are issued and subsequently sold.
 
On
January 2, 2025, we granted 328,500 PSUs that shall veste upon at the earliest of (1) the closing of a JV transaction with HTIT;
 or (2) the
repayment to us of the value of our principal investment in Scilex plus 10%. We modified 294,000 outstanding PSUs that
were granted, adjusting the
vesting criteria and performance targets. As of March 27, 2025, all PSUs that granted achieved the first
updated performance target.
 
(4) See “All Other Compensation
Table” below.
 
(5) Dr. Kidron receives compensation
from Oramed Ltd. through KNRY, Ltd., or KNRY. See “—Employment and Consulting Agreements” below.
 
(6) Mr. Gabay was appointed
as Chief Financial Officer, effective June 18, 2024.
 
55

 
 
All
Other Compensation Table
 
The
“All Other Compensation” amounts set forth in the Summary Compensation Table above consist of the following:
 
Name
 
Year
   
Automobile-
Related
Expenses
($)
   
Manager’s
Insurance
(1)($)
   
Education
Fund
($)
   
Total
($)
 
Nadav Kidron
   
2024
     
30,505     
25,158     
6,354     
62,017 
 
   
2023
     
21,191     
21,711     
5,836     
48,738 
 
   
 
     
      
      
      
  
Dr. Miriam Kidron
   
2024
     
19,607     
-     
-     
19,607 
 
   
2023
     
17,423     
-     
-     
17,423 
 
   
 
     
      
      
      
  
Avraham Gabay
   
2024
     
8,854     
17,822     
1,907     
28,583 
 
(1) Manager’s insurance
and education funds are customary benefits provided to employees based in Israel. Manager’s insurance is a combination of
severance
savings (in accordance with Israeli law), defined contribution tax-qualified pension savings and disability insurance premiums. An
education
fund is a savings fund of pre-tax contributions to be used after a specified period of time for educational or other permitted
purposes.
 
Employment
and Consulting Agreements
 
On
July 1, 2008, Oramed Ltd. entered into a consulting agreement with KNRY whereby Dr. Miriam Kidron, through KNRY, provides services as
Chief Scientific Officer of both the Company and Oramed Ltd., or the Miriam Kidron Consulting Agreement.
 
The
Miriam Kidron Consulting Agreement is terminable by either party upon 140 days prior written notice. The agreement, as amended, provides
that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the agreement. Pursuant to the agreement,
each of
KNRY and Dr. Miriam Kidron agreed that during the term of the agreement and for a 12-month period thereafter, none of them will
compete with Oramed
Ltd. nor solicit employees of Oramed Ltd. Starting January 1, 2024, Dr. Miriam Kidron receives a monthly consulting
fee of NIS 117,040. Effective as of
July 1, 2024, the monthly consulting fee is NIS 134,550.
 
Effective
November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd., whereby Nadav Kidron, through Shnida Ltd.,
provides
services as President and Chief Executive Officer of the Company. The agreement is terminable by either party upon 140 days prior written
notice.
The agreement provides that Shnida Ltd. will be reimbursed for reasonable expenses incurred in connection with performance of
the agreement. Effective
as of January 1, 2024, Nadav Kidron receives a monthly consulting fee of NIS 96,825. Effective as of July 1,
2024, the monthly consulting fee is NIS
111,349. Pursuant to the agreement, Shnida Ltd. and Nadav Kidron each agree that during the term
of the agreement and for a 12-month period thereafter,
none of them will compete with the Company nor solicit employees of the Company.
 
In
 addition, we, through Oramed Ltd., have entered into an employment agreement with Nadav Kidron, effective as of November 1, 2022,
pursuant
to which, effective as of January 1, 2024, Mr. Kidron receives gross monthly salary of NIS 51,591 in consideration for his services as
President
and Chief Executive Officer of Oramed Ltd. Effective as of July 1, 2024, Mr. Kidron receives gross monthly salary of NIS 59,330
in consideration for his
services as President and Chief Executive Officer of Oramed Ltd. In addition, Mr. Kidron is provided with a
phone and a company car pursuant to the
terms of his agreement.
 
We,
through Oramed Ltd., have entered into an employment agreement with Avraham Gabay as of June 6, 2024, pursuant to which Mr. Gabay was
appointed as Chief Financial Officer, Treasurer and Secretary of the Company and Oramed Ltd., effective June 18, 2024. In accordance
 with the
employment agreement, as amended, Mr. Gabay’s current gross monthly salary is NIS 68,000, and he will be provided with
a company car allowance
pursuant to the terms of his agreement.
 
56

 
 
We
have entered into indemnification agreements with our directors and officers pursuant to which we agreed to indemnify each director and
officer for any liability he or she may incur by reason of the fact that he or she serves as our director or officer, to the maximum
extent permitted by law. 
 
Potential
Payments upon Termination or Change-in-Control
 
We
have no plans or arrangements in respect of remuneration received or that may be received by our NEOs to compensate such officers in
the
event of termination of employment (as a result of resignation or retirement).
 
According
to our NEOs’ employment agreements, upon a termination in connection with a change-in-control that occurs during the period that
is
three months prior and 12 months after the event, the following “double trigger” change-in-control provisions shall apply:
 
 
●
The President and Chief
Executive Officer will be entitled to receive 18 months severance.
 
 
●
All other NEOS will be
entitled to receive 12 months severance.
 
 
●
Severance shall be defined
as base salary plus bonuses over the severance period. For U.S.-based persons, COBRA payments equivalent to
healthcare benefits values
will be provided over the severance period.
 
 
●
Full vesting acceleration
of all outstanding unvested equity incentives.
 
Pension,
Retirement or Similar Benefit Plans
 
We
have no arrangements or plans under which we provide pension, retirement or similar benefits for directors or executive officers. Our
directors
and executive officers may receive stock options, RSUs or restricted shares at the discretion of our Compensation Committee
in the future.
 
Policy
Relating to Recovery of Erroneously Awarded Compensation
 
Our Board has adopted an executive compensation clawback policy, administered by our Compensation Committee, which provides for the
recoupment
(or clawback) from current and former executive officers of certain compensation in the event of an accounting restatement resulting from
material noncompliance with financial reporting requirements under the federal securities laws of the United States. In the event the
Company is required
to prepare an accounting restatement of its financial statements due to the Company’s material non-compliance
with any financial reporting requirement
under the securities laws, the Compensation Committee will require prompt reimbursement or forfeiture
of any excess incentive compensation (as defined
in the clawback policy) received by any covered executive officer during the three completed years immediately preceding the date on which the Company
is required to prepare an accounting restatement.
 
57

 
 
OUTSTANDING
EQUITY AWARDS AT DECEMBER 31, 2024
 
The
following table sets forth information concerning stock options and stock awards held by the NEOs as of December 31, 2024.
 
 
 
Option
Awards
 
 
Stock
Awards
 
Name
 
Number
of
Securities
Underlying 
Unexercised 
Options (#)
Exercisable
 
 
Number
of
Securities
Underlying
Unexercised 
Options (#)
Unexercisable  
 
Option
Exercise
Price
($)
   
Option
Expiration 
Date
 
Number
of
shares 
that
have not 
vested
(#)
 
 
Market
value of 
shares
that
have not
vested
($)
 
Nadav
Kidron
   
49,000(1)
   
- 
   
7.77   
6/30/27
   
  
   
  
 
   
97,000(2)
   
- 
   
8.14   
1/31/28
   
  
   
  
 
   
196,500(3)(4)    
- 
   
3.16   
2/26/29
   
  
   
  
 
   
190,000(5)
   
- 
   
4.80   
1/8/30
   
  
   
  
 
   
150,000(6)
   
  
   
10.40   
2/3/31
   
  
   
  
 
   
53,500(7)
   
53,500(7)    
13.89   
1/3/32
   
  
   
  
 
   
116,127(8)
   
  
   
3.91   
9/17/32
   
  
   
  
 
   
  
   
  
   
    
 
   
792,082(11)(12)(13)(14)(15)(16)   
1,916,838 
 
   
  
   
  
   
    
 
   
  
   
  
Dr.
Miriam
Kidron
   
69,999(17)
   
- 
   
7.77   
6/30/27
   
  
   
  
 
   
47,000(18)
   
- 
   
8.14   
1/31/28
   
  
   
  
 
   
104,000(19)(4)   
- 
   
3.16   
2/26/29
   
  
   
  
 
   
100,000(20)
   
  
   
4.80   
1/8/30
   
  
   
  
 
   
100,000(21)
   
  
   
10.40   
2/3/31
   
  
   
  
 
   
36,000(22)
   
36,000(22)   
13.89   
1/3/32
   
  
   
  
 
   
32,079(23)
   
  
   
3.91   
9/17/32
   
  
   
  
 
   
  
   
  
   
    
 
   
570,085(24)(25)(26)(27)(29)(30)   
1,379,606 
 
   
  
   
  
   
    
 
   
  
   
  
Avraham
Gabay   
  
   
  
   
    
 
   
174,040(31)(32)
   
421,177 
 
(1)
On June 30, 2017, 147,000
options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $7.77 per share; 49,000 of such
options vested on
December 31, 2017 and the remainder vested in two equal installments of 49,000 on each of December 31, 2018 and December
31, 2019,
subject to the Company share price reaching the target of $9.50 and $12.50 per share, respectively. The options expire on June 30,
2027.
As of December 31, 2021, 98,000 of these options were forfeited.
 
(2)
On January 31, 2018, 97,000
options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $8.14 per share; 97,000 of such
options vested in
four equal installments of 24,250 on each of January 1, 2019, January 1, 2020, January 1, 2021 and January 1, 2022. The options
expire
on January 31, 2028.
 
(3)
On February 26, 2019, 196,500
options were granted to Nadav Kidron under the 2008 Plan at an exercise price of $3.16 per share; 196,500 of such
options vested
in four equal installments of 49,125 on each of December 31, 2019, December 31, 2020, December 31, 2021 and December 31, 2022.
The
options expire on February 26, 2029. For additional information, see footnote 5 below.
 
58

 
 
(4)
On September 11, 2019,
these options were canceled and re-granted under the 2019 Plan in the same amounts and under the same terms as the
original grants.
 
(5)
On January 8, 2020, 190,000
options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $4.80 per share. 190,000 of the
options vested in
four equal installments of 47,500 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December 31, 2023.
The options
expire on January 8, 2030.
 
(6)
On February 3, 2021, 150,000
options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $10.40 per share. 112,500 of the
options vested
in four equal installments of 37,500 on each of December 31, 2021, December 31, 2022 and December 31, 2023, and December 31,
2024.
The options expire on February 3, 2031.
 
(7)
On January 3, 2022, 107,000
options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $13.89 per share. 53,500 options
vested in two equal
installments of 26,750 on each of January 1, 2023, January 1, 2024, and the remainder shall vest in two equal installments of
26,750
on January 1, 2025 and January 1, 2026. The options expire on January 3, 2032.
 
(8)
On September 18, 2022,
116,127 options were granted to Nadav Kidron under the Oravax Medical Inc. 2021 Long-Term Incentive Plan at an
exercise price of
$3.91 per share. 116,127 of the options vested in four installments on each of September 18, 2022, December 31, 2022, December
31,
2023 and December 31, 2024. The options expire on September 17, 2032.
 
(9)
On November 13, 2014, 9,788
RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. The
RSUs vested in
two equal installments, each of 4,894 shares, on November 30 and December 31, 2014. The shares of common stock underlying the
RSUs
will be issued upon request of the grantee.
 
(10)
On February 23, 2015, 79,848
RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. The
RSUs vested in
23 installments consisting of one installment of 6,654 shares on February 28, 2015 and 22 equal monthly installments of 3,327
shares
each, commencing March 31, 2015. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
 
(11)
On February 3, 2021, 300,000
RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron.
100,000 RSUs vested
on August 31, 2021 and the remainder shall vest per the following: 100,000 shares shall vest upon our common stock
achieving a specified
price per share, and 100,000 shall vest upon our achievement of certain business objectives.
 
(12)
On January 3, 2022, 63,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. The RSUs
vested in
two equal installments, each of 15,750 shares on January 1, 2023 and on January 1, 2024. The shares of common stock underlying the
RSUs will be issued upon request of the grantee. The remainder shall vest in two equal installments of 15,750 on each of January
1, 2025 and
January 1, 2026.
 
(13)
On July 28, 2022, 126,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. 42,000
RSUs vested
on January 1, 2024. The shares of common stock underlying the RSUs will be issued upon request of the grantee. The remainder shall
vest in two equal installments of 42,000 on each of January 1, 2025 and January 1, 2026.
  
(14)
On April 17, 2023, 279,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. 162,750
RSUs vested
in seven equal quarterly installments of 23,250 starting May 1, 2023 and the remainder of 116,250 shall vest in five equal quarterly
installments of 23,250 starting February 1, 2025.
 
59

 
 
(15)
On January 4, 2024, 329,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. 109,668
RSUs vested
in twelve equal quarterly installments of 27,417 starting January 8, 2024.
 
(16)
On January 4, 2024, 141,000
PSUs representing a right to receive shares of the Company’s common stock were granted to Nadav Kidron. The total
amount of
the PSUs shall vest when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average
of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $691, using the Monte-Carlo
model, based on
the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant.
 
 
(17)
On June 30, 2017, 69,999
options were granted to Dr. Miriam Kidron under the 2008 Plan at an exercise price of $7.77 per share; Such options
vested in three
equal installments of 23,333 on each of December 31, 2017, December 31, 2018 and December 31, 2019. The options have an
expiration
date of June 30, 2027.
 
(18)
On January 31, 2018, 47,000
options were granted to Dr. Miriam Kidron under the 2008 Plan at an exercise price of $8.14 per share; 47,000 of such
options vested
in four equal installments of 11,750 on each of January 1, 2019, January 1, 2020, January 1, 2021 and January 1, 2022. The options
expire on January 31, 2028.
 
(19)
On February 26, 2019, 104,000
options were granted to Dr. Miriam Kidron under the 2008 Plan at an exercise price of $3.16 per share; 104,000 of
such options vested
in four equal installments of 26,000 on each of December 31, 2019, December 31, 2020, December 31, 2021 and December 31,
2022. The
options expire on February 26, 2029. For additional information, see footnote 4 above.
 
(20)
On January 8, 2020, 100,000
options were granted to Dr. Miriam Kidron under the 2019 Plan at an exercise price of $4.80 per share. 100,000 of the
options vested
in four equal installments of 25,000 on each of  December 31, 2020, December 31, 2021, December 31, 2022 and December 31,
2023.
The options expire on January 8, 2030.
 
(21)
On February 3, 2021, 100,000
options were granted to Dr. Miriam Kidron under the 2019 Plan at an exercise price of $10.40 per share. 100,000 of
such options vested
in four equal installments of 25,000 on each of December 31, 2021, December 31, 2022 and December 31, 2023 and December
31, 2024.
The options expire on February 3, 2031.
 
(22)
On January 3, 2022, 72,000
options were granted to Dr. Miriam Kidron under the 2019 Plan at an exercise price of $13.89 per share. 36,000 of such
options vested
in two equal installments of 25,000 on each of January 1, 2023 and January 1, 2024. The remaining 36,000 of the options shall vest
in
two equal installments of 25,000 on each of January 1, 2025 and January 1, 2026. The options expire on January 3, 2032.
 
(23)
On September 18, 2022,
32,079 options were granted to Dr. Miriam Kidron under the Oravax Medical Inc. 2021 Long-Term Incentive Plan at an
exercise price
of $3.91 per share. 32,079 of the options vested in four installments on each of September 18, 2022, December 31, 2022, December
31, 2023 and December 31, 2024. The options expire on September 17, 2032.
 
(24)
On February 3, 2021, 200,000
RSUs, representing a right to receive shares of the Company’s common stock, were granted to Dr. Miriam Kidron.
66,666 RSUs
vested in one installment on August 31, 2021 and the remainder shall vest per the following: 66,667 shares shall vest upon our
common
stock achieving a specified price per share, and 66,667 shall vest upon our achievement of certain business objectives.
 
(25)
On January 3, 2022, 42,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron.
21,000 vested
on two equal installments of 10,500 on each of January 1, 2023 and January 1, 2024. The remaining 21,500 shall vest in two equal
installments of 10,500 on each of January 1, 2025 and January 1, 2026.
 
(26)
On July 28, 2022, 84,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. 28,000
vested
on one installment on January 1, 2024. The remaining 56,000 shall vest in two equal installments of 28,000 on each of January 1,
2025 and
January 1, 2026.
 
60

 
 
(27)
On April 17, 2023, 213,000
RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron.
124,249 RSUs vested
in seven equal quarterly installments of 17,750 starting May 1, 2023 and the remainder of 88,751 shall vest in five equal
quarterly
installments of 17,750 starting February 1, 2025. The shares of common stock underlying the RSUs will be issued upon request of the
grantee.
 
(28)
On April 17, 2023, 53,500
performance-based RSUs representing a right to receive shares of the Company’s common stock were granted to Dr.
Miriam Kidron.
120,000 RSUs vested in one installment on May 26, 2023, upon our common stock achieving a specified price per share. The shares
of
common stock underlying the RSUs will be issued upon request of the grantee.
 
(29)
On January 4, 2024, 295,500
RSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. The
RSUs vested
in twelve equal quarterly installments of 24,625 starting January 8, 2024. The shares of common stock underlying the RSUs will be
issued upon request of the grantee.
 
(30)
On January 4, 2024, 74,000
PSUs representing a right to receive shares of the Company’s common stock were granted to Dr. Miriam Kidron. The
total amount
of the PSUs shall vest when the closing price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an
average
of $4.00 over any 10-trading day period. The total fair value of these PSUs on the date of grant was $691, using the Monte-Carlo
model,
based on the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant.
 
(31)
On June 21, 2024, 140,040
RSUs representing a right to receive shares of the Company’s common stock were granted to Avraham Gabay. 93,360
shall vest
in one installment on June 18, 2026 and 46,680 shall vest in four equal quarterly installments of 11,670 starting September 18, 2026.
  
(32)
On June 20, 2024, the Company
granted 34,000 PSUs representing a right to receive shares of the Company’s common stock to Avraham Gabay.
The total amount
of the PSUs shall vest upon the later of (i) June 18, 2026 and (ii) when the closing price per share of Common Stock of the
Company
on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs on the
date
of grant was $73, using the Monte-Carlo model, based on the quoted closing market share price of $2.21 on the Nasdaq Capital
Market on the date
of grant.
 
On
 January 2, 2025, we granted 1,023,000 RSUs representing a right to receive shares of the Company’s common stock to the Company’s
executive officers. The total amount of the RSUs shall vest in equal quarterly installments of approximately 85,249 over a three year
period starting with
the first quarterly vesting on January 1, 2025. Also on January 2, 2025, we granted 328,500 PSUs representing a
right to receive shares of the Company’s
common stock to our executive officers. The total amount of the PSUs shall vest upon at
the earliest of (1) the closing of OraTech transaction with HTIT; or
(2) the repayment to the Company of the value of its principal investment
in Scilex plus 10%. The total fair value of these PSUs on the date of grant was
$792 based on the quoted closing market share price of
$2.41 on the Nasdaq Capital Market on the date of grant. As of March 27, 2025, all PSUs that were
granted to the Company’s executive
officers achieved the first updated performance target.
 
61

 
 
DIRECTOR
COMPENSATION
 
The
following table provides information regarding compensation earned by, awarded or paid to each person for serving as a director who is
not
an executive officer during the year ended December 31, 2024:
 
 
Name
of Director
 
Fees
Earned or
Paid in Cash
($)
   
Stock
Awards
(1)(2)($)
   
Option
Awards 
(1)(2)($)
   
All
Other 
Compensation
($)
   
Total
($)
 
Daniel
Aghion(6)
   
39,645     
94,992     
-     
-     
134,637 
Dr. Arie
Mayer
   
41,963     
93,987     
-     
-     
135,950 
Yehuda
Reznik(3)
   
29,537     
71,091     
-     
-     
100,628 
Yadin
Rozov(5)
   
1,913     
92,780     
-     
-     
94,693 
Leonard
Sank
   
41,117     
93,987     
-     
-     
135,104 
Benjamin
Shapiro
   
30,000     
83,817     
-     
-     
113,817 
 
(1) As of December 31, 2024,
our non-employee directors then in office held options to purchase shares of our common stock and RSUs as follows:
 
Name of
Director
 
Aggregate
Number
of Shares
Underlying
Stock
Awards
   
Aggregate
Number
of Shares
Underlying
Option
Awards
 
Daniel
Aghion(6)
   
32,204     
- 
Dr.
Arie Mayer(4)
   
55,831     
45,398 
Yehuda
Reznik(3)
   
25,314     
15,398 
Yadin
Rozov(5)
   
-     
- 
Leonard
Sank
   
55,831     
46,773 
Benjamin
Shapiro
   
39,600     
- 
 
(2) The
amounts reflect the grant date fair value, as calculated pursuant to ASC 718, of these option
awards. The assumptions used to determine the fair
value of the option awards are set forth
in note 10 to our audited consolidated financial statements included in the Annual Report.
Our directors will
not realize the value of these awards in cash unless and until these awards
are exercised and the underlying shares subsequently sold.
 
(3) Mr.
Reznik joined the Board effective on April 1, 2024.
 
(4) Includes 15,398 option
awards granted by Oravax for Dr. Mayer’s service as a member of the Board of Directors of Oravax.
 
(5) Mr. Rozov resigned from
the Board on January 17, 2024 and forfeited his unvested RSUs and Options.
 
(6) Mr. Aghion joined the Board
on January 1, 2024.
 
62

 
 
Our
 directors are entitled to reimbursement for reasonable travel and other out-of-pocket expenses incurred in connection with attendance
 at
meetings of our Board. Based on a report provided to the Compensation Committee by Aon in 2023, effective as of January 1, 2024, each
independent
director is entitled to receive as remuneration for his or her service as a member of the Board a sum equal to $30,000 and
a grant of 5,070 RSUs per annum.
The Chairman of our Board is entitled to receive an additional sum equal to $25,500, other than if
the Chairman is an executive officer. The members of
our Audit Committee are each entitled to receive an additional sum equal to $6,000
and a grant of 2,230 RSUs. The members of our Compensation
Committee are each entitled to receive an additional sum equal to $4,500 and
a grant of 1,520 RSUs. The members of our Nominating Committee are each
entitled to receive an additional sum equal to $4,000 and a grant
of 505 RSUs. All cash remuneration is to be paid quarterly after the close of each quarter.
The RSUs vest on April 1, July 1, October
1 and January 1 of each year, subject to Compensation Committee approval each year. Our executive officers did
not receive additional
compensation for service as directors. The Board may award special remuneration to any director undertaking any special services on
behalf
of us other than services ordinarily required of a director.
 
On
January 2, 2025 the Compensation Committee, approved that in addition to the current annual compensation for the board members, a flat
cash
fee of $500 per meeting will be paid to each director for attendance at every meeting beyond six meetings per year, and an additional
$2,000 in cash will be
paid to each director per meeting of over three hours which he or she attends, regardless of the number of meetings.
 
Other
than as described above, we have no present formal plan for compensating our directors for their service in their capacity as directors.
Other
than indicated above, no director received and/or accrued any compensation for his services as a director, including committee
participation and/or special
assignments during the year ended December 31, 2024. In addition, during 2024 the directors granted an aggregate
of 142,500 RSUs that will vest in three
equal annual installments starting January 1, 2025.
 
The
 Company’s Policies and Practices Related to the Grant of Certain Equity Awards Close in Time to the Release of
Material Nonpublic Information
 
We
do not have any formal policy that requires the Company to grant, or avoid granting, equity-based compensation at certain times. We do
not
grant equity awards in anticipation of the release of material nonpublic information that is likely to result in changes to the price
of our common stock, and
do not time the public release of such information based on award grant dates. The timing of any equity grants
 to executive officers or directors in
connection with new hires, promotions, or other non-routine grants is tied to the event giving
 rise to the award (such as an executive officer’s
commencement of employment or promotion effective date).
 
During
the year ended December 31, 2024, there were no equity grants made to our executive officers during any period beginning four business
days before the filing of a periodic report or current report disclosing material non-public information and ending one business day
after the filing or
furnishing of such report with the SEC.
 
63

 
 
ITEM
 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS.
 
Stock
Option Plans
 
Our
Board adopted the 2008 Plan and the 2019 Plan in order to attract and retain quality personnel.
 
The
2008 Plan, which is no longer utilized for new grants, provided for the grant of stock options, restricted stock, RSUs, and stock appreciation
rights, collectively referred to as “awards.” Under the 2008 Plan, as amended, 2,400,000 shares were reserved for the grant
of awards. As of December 31,
2024, options with respect to 2,287,989 shares had been granted, of which 275,673 had been forfeited, 308,804
had been exercised and 1,420,504 have
expired. As of December 31, 2024, 525,824 RSUs had been granted, none of them have vested and the
shares of common stock underlying those RSUs
have not been issued and 34,118 have been forfeited.
 
The
2019 Plan provides for the grant of stock options, restricted stock, RSUs, and stock appreciation rights, collectively referred to as
“awards.”
Under the 2019 Plan, 1,000,000 shares were initially reserved for the grant of awards. On June 29, 2020, and August
3, 2020, respectively, our Board and
stockholders approved to amend and restate the 2019 Plan, the principal change being an increase
in the number of shares of common stock available under
the 2019 Plan from 1,000,000 shares to 3,000,000 shares. On June 30, 2022, our
Board and stockholders approved to amend and restate the 2019 Plan, the
principal change being an increase in the number of shares of
common stock available under the 2019 Plan from 3,000,000 shares to 7,500,000 shares.
Stock options granted under the 2019 Plan may be
either incentive stock options under the provisions of Section 422 of the Code, or non-qualified stock
options. Under the amended 2019
Plan, 7,500,000 shares are reserved for the grant of awards, which may be issued at the discretion of our Board from time
to time. As
of December 31, 2024, options with respect to 1,863,646 shares have been granted, of which 282,043 had been forfeited, 66,978 had been
exercised and none of them were expired. As of December 31, 2024, 4,808,060 RSUs had been granted, of which 290,125 have vested and the
shares of
common stock underlying those RSUs have not been issued and 808,196 have been forfeited. Since the Company had granted options
during the time after
the 2008 Plan allegedly terminated, and out of an abundance of caution, the Company canceled these grants and re-granted
certain of the options under
2019 Plan in the same amounts and under the same terms as the original grants.
 
The
following table sets forth additional information with respect to our equity compensation plans as of December 31, 2024:
 
Plan category
 
Number
of
securities to
be issued
upon
exercise of
outstanding
options,
RSUs and
rights (a)
   
Weight-
average
exercise
price of
outstanding
options,
RSUs and
rights (b)
   
Number
of
securities
remaining
available for
future
issuance
under equity
compensation
plans
(excluding
securities
reflected in
column (a))
(c)
 
Equity compensation plans approved
by security holders
   
3,947,562    $
2.80     
2,148,993 
Equity compensation plans not approved by security
holders
   
-     
-     
- 
Total
   
3,947,562    $
2.80     
2,148,993 
 
Security
Ownership of Certain Beneficial Owners and Management
 
The
following table sets forth certain information regarding the beneficial ownership of our common stock as of March 27, 2025 by: (1) each
person who is known by us to own beneficially more than 5% of our common stock; (2) each of our current directors; (3) each of our NEOs;
and (4) all of
our directors and executive officers as a group. On such date, we had 40,850,455 shares of common stock outstanding.
 
64

 
 
As
used in the table below and elsewhere in this form, the term “beneficial ownership” with respect to a security consists of
sole or shared voting
power, including the power to vote or direct the vote, and/or sole or shared investment power, including the power
to dispose or direct the disposition, with
respect to the security through any contract, arrangement, understanding, relationship or
otherwise, including a right to acquire such power(s) during the 60
days following March 27, 2025. Inclusion of shares in the table does
not, however, constitute an admission that the named stockholder is a direct or indirect
beneficial owner of those shares. Unless otherwise
indicated, (1) each person or entity named in the table has sole voting power and investment power (or
shares that power with that person’s
spouse) with respect to all shares of common stock listed as owned by that person or entity and (2) the address of each
of the individuals
named below is: c/o Oramed Pharmaceuticals Inc., 1185 Avenue of the Americas, Third Floor, New York, New York 10036.
 
 
Name
and Address of Beneficial Owner
 
Number
of
Shares
   
Percentage
of Shares
Beneficially
Owned
 
Nadav Kidron #+
   
3,193,699(1)   
7.6%
Dr. Miriam Kidron #+
   
1,256,332(2)   
3.0%
Avraham Gabay+
   
137,340(3)   
* 
Dr. Daniel Aghion #
   
18,820     
* 
Dr. Arie Mayer #
   
90,634(4)   
* 
Yehuda Reznik#
   
15,560     
* 
Leonard Sank #
   
109,294(5)   
* 
Benjamin Shapiro #
   
1,930,070(6)   
4.7%
 
   
      
  
All current executive officers and directors,
as a group (nine persons)
   
7,533,336(7)   
18.2%
 
   
      
  
Greater than 5% holders
   
      
  
BML Investment Partners, L.P.
   
2,643,907(8)   
6.6%
 
*
Less than 1%
 
#
Director
 
+
NEO
 
(1) Includes 953,884 shares of common stock issuable upon the exercise of
outstanding stock options, 86,791 shares of common stock issuable upon the
vesting of RSUs. Mr. Nadav’s beneficial ownership includes
the 218,603 shares of common stock held by Xiaopeng Li, a former director of the
Company, over which he holds a proxy.
 
(2) Includes 474,999 shares
of common stock issuable upon the exercise of outstanding stock options, 59,625 shares of common stock issuable upon the
vesting
of RSUs, and 610,917 shares of common stock underlying vested RSUs that are issuable upon request.
 
(3) Includes 15,666 shares
of common stock issuable upon the vesting of RSUs.
 
(4) Includes 27,500 shares
of common stock issuable upon the exercise of outstanding stock options and 2,500 shares of common stock issuable upon the
vesting
of RSUs.
 
(5) Includes 44,273 shares
of common stock issuable upon the exercise of outstanding stock options and 2,500 shares of common stock issuable upon the
vesting
of RSUs.
 
(6) Includes 1,666 shares of
common stock issuable upon the vesting of RSUs.
 
(7) Includes 1,677,656 shares
of common stock issuable upon the exercise of options beneficially owned by the referenced persons, 208,997 shares of
common stock
issuable upon the vesting of RSUs and 610,917 shares of common stock underlying vested RSUs that are issuable upon request.
  
(8) Based on Schedule 13G/A,
filed on February 13, 2025. BML Investment Partners, L.P. is a Delaware limited partnership whose sole general partner is
BML Capital
Management, LLC. The managing member of BML Capital Management, LLC is Braden M. Leonard. As a result, Braden M. Leonard is
deemed
to be the indirect owner of the shares held directly by BML Investment Partners, L.P. Despite such shared beneficial ownership, the
reporting
persons disclaim that they constitute a statutory group within the meaning of Rule 13d-5(b)(1) of the Exchange Act. The
address of BML Investment
Partners, L.P. is 65 E Cedar, Suite 2 Zionsville, IN 46077.
 
65

 
 
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
 
During
the years ended December 31, 2024 and 2023, except for compensation arrangements described elsewhere herein, we did not participate in
any transaction, and we are not currently participating in any proposed transaction, or series of transactions, in which the amount involved
exceeded the
lesser of $120,000 or one percent of the average of our total assets at year end for the last two completed years,
and in which, to our knowledge, any of our
directors, officers, five percent beneficial security holders, or any member of the immediate
family of the foregoing persons had, or will have, a direct or
indirect material interest.
 
Our
policy is to enter into transactions with related persons on terms that, on the whole, are no less favorable than those available from
unaffiliated
third parties. Based on our experience in the business sectors in which we operate and the terms of our transactions with
unaffiliated third parties, we
believe that all of the transactions described below met this policy standard at the time they occurred.
All related person transactions are approved by our
Board.
 
The
Board has determined that Dr. Daniel Aghion, Dr. Arie Mayer, Yehuda Reznick, Leonard Sank and Benjamin Shapiro are independent as
defined
under the rules promulgated by Nasdaq.
 
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
 
The aggregate fees billed by Kesselman & Kesselman, Certified Public
Accountants (Isr.), a member of PricewaterhouseCoopers International
Limited, independent registered public accounting firm, for services
rendered to us during the years ended December 31, 2024 and 2023:
 
 
 
2024
   
2023
 
Audit
Fees(1)
  $
124,882    $
132,501 
Audit-Related
Fees(2)
   
1,500     
1,500 
Tax Fees(3)
   
17,986     
31,363 
All
Other Fees
   
-     
- 
Total
Fees
  $
144,368    $
165,364 
 
(1) Amount represents fees
 paid for professional services for the audit of our consolidated financial statements, review of our interim condensed
consolidated
financial statements included in quarterly reports and services that are normally provided by our independent registered public accounting
firm in connection with statutory and regulatory filings or engagements.
 
(2) Represents fees paid for
services rendered in connection with the IIA requirements.
 
(3) Represents fees paid for
tax consulting services.
 
SEC
rules require that before the independent registered public accounting firm are engaged by us to render any auditing or permitted non-audit
related service, the engagement be: (1) pre-approved by our Audit Committee; or (2) entered into pursuant to pre-approval policies and
 procedures
established by the Audit Committee, provided the policies and procedures are detailed as to the particular service, the Audit
Committee is informed of each
service, and such policies and procedures do not include delegation of the Audit Committee’s responsibilities
to management.
 
The
Audit Committee pre-approves all services provided by our independent registered public accounting firm. All of the above services and
fees
were reviewed and approved by the Audit Committee before the services were rendered.
 
66

 
 
PART
IV
 
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
 
 
(a)
Index to Financial Statements
 
The
following consolidated financial statements are filed as part of this Annual Report on Form 10-K:
 
 
 
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name: Kesselman & Kesselman C.P.A.s,
PCAOB ID: 1309 and Auditor Location: Tel Aviv, Israel)
 
F-1
 
 
 
CONSOLIDATED FINANCIAL STATEMENTS:
 
 
Consolidated Balance Sheets
 
F-3
Consolidated Statements of Comprehensive Income (Loss)
 
F-4
Consolidated Statements of Changes in Equity
 
F-5
Consolidated Statements of Cash Flows
 
F-6
Notes to Consolidated financial Statements
 
F-7 - F-43
 
67

 
 
 
 
Report
of Independent Registered Public Accounting Firm
 
To the Board of Directors and Stockholders of
Oramed Pharmaceuticals Inc.
 
Opinion on the Financial Statements
 
We have audited the accompanying consolidated
balance sheets of Oramed Pharmaceuticals Inc. and its subsidiaries (the “Company”) as of December 31,
2024 and 2023, and the
 related consolidated statements of comprehensive income (loss), changes in equity and cash flows for the years then ended,
including the
related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial
statements present
fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results
of its operations and its cash flows
for the years then ended in conformity with accounting principles generally accepted in the United
States of America.
 
Basis for Opinion
 
These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s
consolidated financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board
(United
States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and
the
applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
 
We conducted our audits of these consolidated financial statements
in accordance with the standards of the PCAOB. Those standards require that we plan
and perform the audits to obtain reasonable assurance
about whether the consolidated financial statements are free of material misstatement, whether due to
error or fraud. The Company is not
required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our
audits we
are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion
on the
effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
 
Our audits included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or
fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and
disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis
for our opinion.
 
Critical Audit Matters
 
The critical audit matter communicated below is
 a matter arising from the current period audit of the consolidated financial statements that was
communicated or required to be communicated
to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated
financial statements and
(ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not
alter
in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit
matter below,
providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
 
F-1

 
Investments at fair value
 
As described in Note 4 to the consolidated financial statements, the
Company has approximately $34,808 thousand investments at fair value recorded as of
December 31, 2024 relating to Tranche A note, Tranche
B note, warrants and royalty purchase agreement payment issued to the Company by Scilex
Holding Company. Management applied significant
judgment in estimating the fair value of the investments recorded, which also impacted the results of
operations of the Company by approximately
$4,359 thousand for the change in fair value of such investments in the year ended December 31, 2024. The
fair value estimation involved
the use of significant estimates and assumptions with respect to the repayment dates and amounts of the notes and royalties.
 
The principal considerations for our determination that performing
procedures relating to investments at fair value is a critical audit matter are (i) the high
degree of auditor judgment and subjectivity
in performing procedures relating to the fair value measurement of the investments recorded, due to significant
judgment by management
when developing the estimate; (ii) significant audit effort in evaluating the significant assumptions relating to the repayment
dates
and amounts of the notes and royalties; and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.
 
Addressing the matter involved performing procedures and evaluating
audit evidence in connection with forming our overall opinion on the consolidated
financial statements. These procedures included, among
others (i) reading the related agreements and (ii) testing management’s process for estimating the
fair value of the investments.
Testing management’s process included evaluating the appropriateness of the valuation methods, testing the completeness and
accuracy
of the data provided by management, and evaluating the reasonableness of significant assumptions related to the repayment dates and amounts
of
the notes and royalties. Professionals with specialized skill and knowledge were used to assist in the evaluation of the Company’s
models.
 
/s/ Kesselman & Kesselman
 
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International
Limited
 
Tel Aviv, Israel
March 27, 2025
 
We have served as the Company’s auditor since
2008.
 
Kesselman & Kesselman, 146 Derech Menachem Begin St. Tel-Aviv
6492103, Israel,
P.O Box 50005 Tel-Aviv 6150001 Telephone: +972 -3- 7954555, Fax:+972 -3- 7954556, www.pwc.com/il
 
F-2

 
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED BALANCE SHEETS
In thousands (except share and per share data)
 
 
 
December
31,
 
 
 
2024
   
2023
 
ASSETS
 
 
   
 
 
CURRENT ASSETS:
 
    
  
Cash and
cash equivalents
  $
54,420    $
9,055 
Short-term deposits
(note 2)
   
55,281     
95,279 
Marketable securities
(note 3)
   
3,441     
- 
Investments at fair
value (note 4)
   
28,788     
57,713 
Prepaid
expenses and other current assets
   
1,291     
537 
Total
current assets
   
143,221     
162,584 
 
   
      
  
LONG-TERM ASSETS:
   
      
  
Long-term deposits
   
2     
7 
Investments at fair
value (note 4)
   
7,387     
51,035 
Marketable securities
(note 3)
   
-     
1,807 
Other non-marketable
equity securities (note 5)
   
3,524     
3,524 
Amounts funded in respect
of employee rights upon retirement
   
32     
27 
Property and equipment,
net
   
698     
873 
Operating
lease right of use assets
   
414     
694 
Total
long-term assets
   
12,057     
57,967 
Total
assets
  $
155,278    $
220,551 
 
   
      
  
LIABILITIES AND STOCKHOLDERS’
EQUITY
   
      
  
CURRENT LIABILITIES:
   
      
  
Accounts payable and
accrued expenses (note 6)
  $
5,140    $
1,609 
Short-term borrowings
(note 7)
   
-     
51,013 
Payable to related parties
(note 14b)
   
329     
325 
Operating
lease liabilities
   
216     
267 
Total
current liabilities
   
5,685     
53,214 
 
   
      
  
LONG-TERM LIABILITIES:
   
      
  
Long-term deferred revenues
   
4,000     
4,000 
Employee rights upon
retirement
   
30     
28 
Provision for uncertain
tax position (note 12f)
   
-     
11 
Operating lease liabilities
   
156     
342 
Other
liabilities
   
60     
63 
Total
long-term liabilities
   
4,246     
4,444 
 
   
      
  
COMMITMENTS (note
8)
   
      
  
 
   
      
  
EQUITY
   
      
  
EQUITY ATTRIBUTABLE TO COMPANY’S
STOCKHOLDERS:
   
      
  
Common stock, $ 0.012 par value (60,000,000 authorized shares as of December 31, 2024 and December 31, 2023;
39,919,545 and 40,338,979 shares issued and outstanding as of December 31, 2024 and December 31, 2023,
respectively)
   
480     
485 
Additional paid-in capital
   
322,401     
320,892 
Accumulated deficit
   
(176,616)    
(157,556)
Total stockholders’ equity
   
146,265     
163,821 
Non-controlling interests
   
(918)    
(928)
Total
equity
   
145,347     
162,893 
Total
liabilities and equity
  $
155,278    $
220,551 
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-3

 
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
In thousands (except share and per share data)
 
 
 
Year ended 
December 31,    
Year ended
December 31,  
 
 
2024
   
2023
 
REVENUES
  $
-    $
1,340 
RESEARCH AND DEVELOPMENT EXPENSES
   
(6,324)    
(8,971)
SALES AND MARKETING
   
-     
287 
GENERAL AND ADMINISTRATIVE EXPENSES
   
(6,457)    
(8,425)
OPERATING LOSS
   
(12,781)    
(15,769)
 
   
      
  
INTEREST EXPENSES (note 11b)
   
(853)    
(2,037)
FINANCIAL INCOME (EXPENSES), NET (note 11a)
   
(2,286)    
22,894 
INCOME (LOSS) BEFORE TAX EXPENSES
   
(15,920)    
5,088 
TAX EXPENSES
   
(3,183)    
- 
NET INCOME (LOSS)
  $
(19,103)   $
5,088 
 
   
      
  
NET INCOME (LOSS) ATTRIBUTABLE TO:
   
      
  
COMPANY’S STOCKHOLDERS
   
(19,060)    
5,525 
NON-CONTROLLING INTERESTS
   
(43)    
(437)
NET INCOME (LOSS)
  $
(19,103)   $
5,088 
 
   
      
  
BASIC INCOME (LOSS) PER SHARE OF COMMON STOCK
  $
(0.48)   $
0.14 
DILUTED INCOME (LOSS) PER SHARE OF COMMON STOCK
  $
(0.48)   $
0.14 
 
   
      
  
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC
INCOME (LOSS) PER SHARE OF COMMON STOCK
   
40,828,380     
40,315,068 
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING
DILUTED INCOME (LOSS) PER SHARE OF COMMON STOCK
   
40,828,380     
40,566,901 
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-4

 
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
in thousands
 
Attributable
to Company’s Stockholders
 
 
 
 
   
Additional
   
 
   
Total
   
Non-
   
 
 
 
 
Common Stock
   
paid-in
    Accumulated     stockholders’    
controlling    
Total
 
 
 
Shares
   
$
   
capital
   
deficit
   
equity
   
interests
   
Equity
 
 
 
In thousands    
 
   
 
   
 
   
 
   
 
   
 
 
BALANCE AS OF JANUARY 1, 2024
   
40,339     
485     
320,892     
(157,556)    
163,821     
(928)    
162,893 
STOCK-BASED COMPENSATION
   
618     
7     
3,991     
-     
3,998     
-     
3,998 
STOCK-BASED COMPENSATION OF
SUBSIDIARY
   
-     
      
-     
-     
-     
53     
53 
REPURCHASE AND RETIREMENT OF COMMON
STOCK
   
(1,037)    
(12)    
(2,482)    
       
(2,494)    
      
(2,494)
NET LOSS
   
      
      
      
(19,060)    
(19,060)    
(43)    
(19,103)
BALANCE AS OF DECEMBER 31, 2024
   
39,920     
480     
322,401     
(176,616)    
146,265     
(918)    
145,347 
 
Attributable
to Company’s Stockholders
 
 
 
 
   
Additional
   
 
   
Total
   
Non-
     
 
 
 
Common Stock
   
paid-in
    Accumulated     stockholders’    
controlling    
Total
 
 
 
Shares
   
$
   
capital
   
deficit
   
equity
   
interests
   
Equity
 
 
 
In thousands    
 
   
 
   
 
   
 
   
 
     
 
BALANCE AS OF JANUARY 1, 2023
   
39,564     
476     
314,417     
(163,081)    
151,812     
(656)    
151,156 
SHARES ISSUED FOR SERVICES
   
3     
*     
9     
-     
9     
-     
9 
ISSUANCE OF COMMON STOCK, NET
   
193     
2     
2,426     
-     
2,428     
-     
2,428 
STOCK-BASED COMPENSATION
   
579     
7     
4,040     
-     
4,047     
-     
4,047 
STOCK-BASED COMPENSATION OF
SUBSIDIARY
   
-     
-     
-     
-     
-     
165     
165 
NET INCOME (LOSS)
   
-     
-     
-     
5,525     
5,525     
(437)    
5,088 
BALANCE AS OF DECEMBER 31, 2023
   
40,339     
485     
320,892     
(157,556)    
163,821     
(928)    
162,893 
 
*
Represents an amount of less than $1.
 
The
accompanying notes are an integral part of the consolidated financial statements.
 
F-5

 
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
In thousands
 
 
 
Year ended 
December 31,    
Year ended 
December 31,  
 
 
2024
   
2023
 
CASH FLOWS FROM OPERATING ACTIVITIES:
   
     
 
Net income (loss)
  $
(19,103)   $
5,088 
Adjustments required to reconcile net income (loss) to net cash used in operating activities:
   
      
  
Depreciation
   
193     
196 
Exchange differences, accrued interest on deposits and held to maturity bonds
   
(2,700)    
(2,172)
Changes in fair value of investments
   
7,413     
(16,392)
Stock-based compensation
   
4,053     
4,212 
Shares issued for services
   
-     
9 
Funds in respect of employee rights upon retirement
   
(5)    
(3)
Change in accrued interest on short-term borrowings to maturity
   
(1,463)    
1,463 
Changes in operating assets and liabilities:
   
      
  
Prepaid expenses and other current assets
   
(356)    
852 
Accounts payable, accrued expenses and related parties
   
3,525     
(2,225)
Net changes in operating lease
   
43     
8 
Deferred revenues
   
-     
(1,340)
Liability for employee rights upon retirement
   
2     
7 
Other liabilities
   
(14)    
2 
Total net cash used in operating activities
   
(8,412)    
(10,295)
CASH FLOWS FROM INVESTING ACTIVITIES:
   
      
  
Purchase of property and equipment
   
(18)    
(254)
Purchase of short-term deposits
   
(54,450)    
(91,369)
Proceeds from redemption of short-term deposits
   
97,152     
109,760 
Exercise of Closing Penny Warrants and Subsequent Penny Warrants
   
(65)    
- 
Long-term investments
   
(1,307)    
(99,550)
Proceeds from long-term deposits
   
5     
- 
Proceeds from long-term investments
   
64,500     
5,000 
Proceeds from maturity of held to maturity securities
   
-     
3,375 
Total net cash provided by (used in) investing activities
   
105,817     
(73,038)
CASH FLOWS FROM FINANCING ACTIVITIES:
   
      
  
Proceeds from issuance of common stock, net of issuance costs
   
-     
2,428 
Repurchase and retirement of common stock
   
(2,484)    
- 
Loans received
   
-     
99,550 
Loans repaid
   
(49,550)    
(50,000)
Tax withholdings related to stock-based compensation settlements
   
(2)    
- 
Total net cash provided by (used in) financing activities
   
(52,036)    
51,978 
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS
   
(4)    
(54)
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
   
45,365     
(31,409)
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
   
9,055     
40,464 
CASH AND CASH EQUIVALENTS AT END OF YEAR
  $
54,420    $
9,055 
 
   
      
  
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS:
   
      
  
Interest paid
  $
2,316    $
574 
Interest received
  $
7,376    $
5,156 
(B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:
   
      
  
2024 Refinancing Tranche A
   
(21,575)    
- 
2024 Refinancing Tranche B
   
25,000     
- 
Excise tax for repurchase and retirement of common stock
   
(10)    
- 
Recognition of operating lease right-of-use assets and liabilities
   
58     
- 
Derecognition of right-of-use asset
   
(26)    
- 
Derecognition of lease liability
   
23     
- 
 
The
accompanying notes are an integral part of the consolidated financial statements
 
F-6

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES:
 
a.
General
 
Oramed
 Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company,” unless the context indicates otherwise), a Delaware
corporation, was incorporated on April 12, 2002.
 
On
 February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. to acquire the
provisional
patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes.
 
On
May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged
in
research and development.
 
On March 18, 2021, the Company entered
into a license agreement with Oravax Medical Inc. (“Oravax”) and holds 63% of the issued and
outstanding share capital of
Oravax, on a fully diluted basis, as of the date of issuance. Consequently, Oramed consolidates Oravax in its
consolidated financial statements
since that time.
 
On
July 1, 2024, the Company incorporated a wholly-owned subsidiary in Nevada, Oramed NewCo, Inc. (“OraTech”), which intends
to serve
as the company for the joint venture with Hefei Tianhui Biotech Co., Ltd. (“HTIT”), see note 15 (b)
 
On
January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. As a
result,
the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. As these results are considered a triggering event,
the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use assets in the first quarter
of 2023
and concluded that no impairment was required.
 
In
2023, the Company completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with
pooled specific parameters, such as body mass index (BMI), baseline HbA1c and age, responded well to oral insulin. These subsets exhibited
an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, on September 12, 2024 the Company
submitted protocol ORA-D-013-3 Phase 3 to focus on the subpopulations with the higher probability to show efficacy. The Company intends
to initiate a study during 2025. Moreover, the Company is examining its existing pipeline and has commenced an evaluation process of
potential strategic opportunities, with the goal of enhancing value for the Company’s stockholders.
  
See note 4 regarding 2023 Scilex Transaction
and 2024 Refinancing.
 
See note 7 regarding Short-Term Borrowings.
 
See
note 15 regarding JV Supplemental Agreement.
  
F-7

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
b.
Basis of presentation
 
The
consolidated financial statements included herein have been prepared in accordance with generally accepted accounting principles in the
United States of America (“U.S. GAAP”).
 
c.
Use of estimates in the preparation of financial statements
 
The
preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions
that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the financial statements
date and the
reported revenues and expenses during the reporting periods. Actual results could differ from those estimates.
 
As
applicable to these consolidated financial statements, the most significant estimates and assumptions relate to stock-based compensation
and to
the investments at fair value (for further details, see note 4).
 
d.
Functional currency
 
The
currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the U.S. dollar
(“$” or “dollar”). Therefore, the functional currency of the Company and its subsidiaries is the dollar.
 
Transactions
and balances originally denominated in dollars are presented at their original amounts. Balances in foreign currencies are translated
into dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For foreign transactions
and other
items reflected in the statements of operations, the following exchange rates are used: (1) for transactions – exchange
rates at transaction dates or
average rates and (2) for other items (derived from non-monetary balance sheet items such as depreciation)
 – historical exchange rates. The
resulting transaction gains or losses are carried to financial income or expenses, as appropriate.
 
e.
Repurchase
and retirement of common stock
 
The Company debited the common stock account by the par value of the
shares retired and allocated the excess of the repurchase price over the
par value of the shares to additional paid in capital.
 
F-8

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
f.
Principles of consolidation
 
The
consolidated financial statements include the accounts of the Company and its subsidiaries. All inter-company transactions and balances
have
been eliminated in consolidation.
 
g.
Cash equivalents
 
The
Company considers all short-term, highly liquid investments, which include short-term deposits with original maturities of three months
or
less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash,
to be cash
equivalents.
 
h.
Fair value measurement:
 
The Company measures fair value and
discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that
would be received to sell
an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In
order to increase
 consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes
observable
and unobservable inputs used to measure fair value into three broad levels, which are described as follows:
 
 
Level 1: Quoted
prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy
gives the highest priority to Level 1 inputs.
 
 
 
 
Level 2: Observable prices that
are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability,
either directly
or indirectly.
 
 
 
 
Level 3: Unobservable inputs are
used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3
inputs.
 
F-9

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE
1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
 
h.
Fair
value measurement (continued):
 
The
Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements
were as
follows:
 
 
 
December 31, 2024
 
 
 
Level 1
   
Level 2
   
Level 3
   
Fair Value
 
Assets:
   
     
   
      
 
Marketable Securities
 
    
    
      
 
DNA
   
424     
-     
-     
424 
Entera
   
248     
-     
-     
248 
Scilex
   
2,769     
-     
-     
2,769 
Subsequent Penny Warrants (see note 4)
   
-     
2,772     
-     
2,772 
Warrants Note B (see note 4)
   
-     
-     
548     
548 
Tranche A Note (see note 4)
   
-     
-     
13,714     
13,714 
Tranche B Note (see note 4)
   
-     
-     
15,798     
15,798 
Royalty Purchase Agreement (see note 4)
   
-     
-     
1,976     
1,976 
Profit Sharing Loan Agreement (see note 4 (e))
   
-     
-     
1,367     
1,367 
 
  $
3,441    $
2,772    $
33,403    $
39,616 
 
 
 
December 31,
2023
 
 
 
Level
1
   
Level
2
   
Level
3
   
Fair
Value
 
Assets:
   
     
   
      
 
Marketable Securities
 
    
    
      
 
DNA
   
297     
-     
-     
297 
Entera
   
70     
-     
-     
70 
Transferred Warrants (see note 4)
   
1,440     
-     
-     
1,440 
Closing Penny Warrant (see note 4)
   
-     
9,180     
-     
9,180 
Subsequent Penny Warrants (see note 4)
   
-     
-     
6,502     
6,502 
The Note (see note 4)
   
-     
-     
93,066     
93,066 
 
  $
1,807    $
9,180    $
99,568    $
110,555 
 
As of December 31, 2024, and December
31, 2023, the carrying amounts of cash equivalents, short-term deposits, Short-Term Borrowings (as
defined in Note 7), and accounts payable
approximate their fair values due to the short-term maturities of these instruments.
 
The
amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value.
 
F-10

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE
1 - SIGNIFICANT ACCOUNTING POLICIES (continued):
  
i.
Marketable securities
 
The Company measured the securities
(investments in equity securities of DNA group (T.R.) Ltd. (“DNA”), Entera Bio Ltd. (“Entera”) and Scilex
Holding
Company (“Scilex”) at fair value, with changes in fair value recognized in earnings. The Company intends to exercise these
investments
during 2025, and has classified the marketable securities as short-term accordingly.
 
j.
Other non-marketable equity securities
 
The
Company also invested in non-marketable equity securities, through an investment in a privately held company. This equity investment
does
not have a readily determinable fair value. The investment is measured under the measurement alternative in Accounting Standards
Codification
(“ASC”) 321 “Investments – Equity Securities” to the extent such an investment is not subject
to consolidation or the equity method. Under the
measurement alternative, this equity investment is carried at cost, less any impairment,
 adjusted for changes resulting from observable price
changes in transactions for an identical or similar investment of the same issuer.
The investment would be impaired in accordance with the
provisions of ASC 820 “Fair Value Measurement” if, based on a qualitative
assessment of impairment indicators, the fair value of the investment
is less than its carrying amount. If considered impaired, the difference
between the carrying amount and fair value would be recorded in the
consolidated statement of income (loss). For further details, see
note 5.
 
k.
Investments, at fair value
 
The Company invested in the Tranche A Note (as defined in note 4),
Tranche B Note (as defined in note 4) (collectively the “Notes”), Penny
Warrants and Royalty Purchase Agreement issued by
 Scilex, for which it has elected the fair value option. Under the Fair Value Option
Subsections of ASC Subtopic 825-10, Financial Instruments
– Overall, the Company has the irrevocable option to report financial assets at fair
value on an instrument-by-instrument basis.
 
Scilex
also issued to the Company the Note A Transferred Warrants and Note B Warrants (as defined in note 4) that meet the definition of a
derivative
under ASC 815 “Derivatives and Hedging”. Therefore, the Warrants will be measured at fair value initially and on every reporting
period.
 
The
 Company entered into a loan agreement to finance a real estate project. The Company decided to designate the Profit Sharing Loan
Agreement
(as define in note 4) as a whole under the Fair-Value option in accordance with ASC Topic 825 “Financial Instruments”.
 
Changes
in the fair value are recorded under financial income (expenses), net.
 
l.
Concentration of credit risks
 
Financial instruments that subject the
Company to credit risk consist primarily of cash and cash equivalents, short and long-term deposits, which
are deposited in major financial
institutions, Profit Sharing Loan Agreement, Royalty Purchase Agreement and the Notes. The Company is of the
opinion that the credit risk
in respect of these balances is remote, except for the Profit Sharing Loan Agreement, Royalty Purchase Agreement and
the Notes for which
the Company is of the opinion there is a credit risk, which is reflected in its fair value measurement (for further details, see
note
4).
 
F-11

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
m. Income taxes
 
1.
Deferred
taxes
 
Deferred
taxes are determined utilizing the asset and liability method based on the estimated future tax effects of differences between the
financial
accounting and tax bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax
rates
expected to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based
upon
the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. The
Company has
provided a full valuation allowance with respect to its deferred tax assets. See note 12.
 
Taxes
 that would apply in the event of disposal of investments in the Israeli subsidiary have not been taken into account in computing
deferred
taxes, as it is the Company’s intention to hold this investment, not to realize it.
 
2.
Uncertainty
in income tax
 
The
Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position
for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be
sustained on
audit. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized
upon ultimate
settlement. Such liabilities are classified as long-term, unless the liability is expected to be resolved within 12 months
from the balance sheet
date. The Company’s policy is to include interest and penalties related to unrecognized tax benefits within
income tax expenses.
 
F-12

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
n.
Revenue recognition
 
HTIT
 
On
November 30, 2015, the Company entered into a Technology License Agreement, with HTIT and on December 21, 2015, the 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 (the
“HTIT
License Agreement”).
 
As of December 31, 2024, an aggregate amount of $22,382 was allocated
to the HTIT License Agreement, all of which were received through
December 31, 2024. Through December 31, 2023, the Company recognized
revenue associated with this agreement in the aggregate amount of
$20,382, of which $1,340 was recognized in the year ended December 31,
2023, and deferred the remaining amount of $2,000, which is presented
as long-term deferred revenues on the consolidated balance sheet.
 The Company did not recognize revenue related to the HTIT License
Agreement in the year ended December 31, 2024. See note 15 regarding
the JV Supplemental Agreement.
 
Medicox
 
On
November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co.,
Ltd.
(“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and
distribute ORMD-0801
in the Republic of Korea. For further details, see note 8b.
 
Under
ASC 606 “Revenue from Contracts with Customers,” the Company identified Medicox as a customer and the Medicox License Agreement
as a contract with a customer.
 
The
Company identified a performance obligation in the Medicox License Agreement to stand-ready and provide Medicox with support in its
commercialization
efforts in the Republic of Korea. This performance obligation includes a non-distinct distribution license for ORMD-0801,
which the Company
views a predominant item in the combined performance obligation. The Company concluded that the license is not distinct, as
no party
other than the Company is capable of providing related services to Medicox, and both the license and related services are necessary for
the customer to obtain a regulatory approval in the Republic of Korea. In addition, the agreement covers the terms of future manufacturing
services, that are contingent on the completion and success of the commercialization efforts.
 
The
Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company during the year ended December
31, 2022 and is currently presented under long-term deferred revenues. It also contains variable consideration of contractual milestone
payments
and sales-based royalties.
 
The
Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company
expects to
provide support to Medicox. As of December 31, 2024, this support has not commenced, and no revenue was recognized from the
Medicox
License Agreement.
 
If
Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized
at
a later stage, going forward. The Company notes that its Phase 3 trial did not meet its primary or secondary endpoints (see note 1a.1).
 
If
Medicox chooses to terminate the agreement as a result of the outcome of the Phase 3 trials, the Company will accelerate revenue recognition
and recognize it at such time. 
 
F-13

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
o.
Research and development
 
Research and development expenses include costs directly attributable
to the conduct of research and development programs, including the cost of
salaries, stock-based compensation, employee benefits, the
cost of supplies, the cost of services provided by outside contractors, including services
related to the Company’s clinical trials,
 clinical trial expenses and the full cost of manufacturing drug for use in research and preclinical
development. All costs associated
with research and development are expensed as incurred.
 
Clinical
trial costs are a significant component of research and development expenses and include costs associated with third-party contractors.
The Company outsources a substantial portion of its clinical trial activities, utilizing external entities such as Clinical Research
Organizations
(“CROs”), independent clinical investigators, and other third-party service providers to assist the Company
with the execution of its clinical trials.
For each clinical trial that the Company conducts, clinical trial costs are expensed immediately.
 
p.
Stock-based compensation
 
Equity awards granted to employees are accounted for using the grant
date fair value method. The grant date fair value is determined as follows:
for stock options with an exercise price and only service
conditions using the Black Scholes pricing model, for stock options and restricted stock
units (“RSUs”) with market conditions
using a Monte Carlo model and for RSUs with service conditions based on the grant date share price. The
fair value of share based payment
awards is recognized as an expense over the requisite service period. The expected term is the length of time
until the expected dates
of exercising the award and is estimated using the simplified method due to insufficient specific historical information of
employees’
exercise behavior, unless the award includes a market condition, in which case the contractual term is used. The volatility is based on
a historical volatility, by statistical analysis of the weekly share price for past periods. The Company elected to recognize compensation
cost for
awards granted to employees that have a graded vesting schedule using the accelerated method based on the multiple-option award
approach. For
awards with market conditions, compensation expense is not reversed if the market conditions are not satisfied.
 
The
Company elects to account for forfeitures as they occur. 
 
F-14

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
q.
Income
(loss) per share of common stock
 
Basic net earnings (loss) per common
share are computed by dividing the net earnings (loss) attributable to stockholders for the period by the
weighted average number of shares
of common stock outstanding for each period, including vested RSUs. Outstanding stock options, warrants and
unvested RSUs have been excluded
from the calculation of the diluted loss per share for the year ended December 31, 2024 because all such
securities are anti-dilutive
for the year ended December 31, 2024.
 
For the diluted earnings per share calculation for the year ended December
31, 2023, the weighted average number of shares outstanding during
the year is adjusted for the potential dilution that could occur in
connection with employee share-based payment, using the treasury stock method.
The difference in the denominator results from the dilutive
impact of 251,833 RSUs.
 
The weighted average number of stock
 options, warrants and RSUs excluded from the calculation of diluted income (loss) per share was
4,582,421 and 1,227,506 for the years
ended December 31, 2024 and December 31, 2023, respectively.
 
r.
Leases
 
The
Company leases real estate and cars for use in its operations, which are classified as operating leases. In addition to rent, the leases
may
require the Company to pay directly for fees, insurance, maintenance and other operating expenses.
 
The
 Company determines if an arrangement is a lease at inception. Operating leases are included in operating lease right of use assets and
operating lease liabilities in the consolidated balance sheets. Right of use (“ROU”) assets represent the Company’s
right to use an underlying asset
for the lease term and lease liabilities represent the Company’s obligation to make lease payments
arising from the lease. Operating lease ROU
assets and liabilities are recognized at the commencement date based on the present value
of lease payments over the lease term. The Company
uses its incremental borrowing rate based on the information available at the commencement
date to determine the present value of the lease
payments. Lease expenses are recognized on a straight-line basis over the lease term.
 
The
Company elected the practical expedient to not separate lease and non-lease components for all of its leases.
 
Lease
terms will include options to extend or terminate the lease when it is reasonably certain that the Company will either exercise or not
exercise
the option to renew or terminate the lease.
 
The
Company’s lease agreements have remaining lease terms ranging from 4 months to 2.5 years. Some of these agreements include options
to
extend the leases for up to an additional 5 years and some include options to terminate the leases immediately. See Note 8d.
 
F-15

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 1
- SIGNIFICANT ACCOUNTING POLICIES (continued):
 
s.
New accounting pronouncements
 
Recently
adopted accounting pronouncements
 
In
November 2023, the Financial Accounting Standard Board (the “FASB”) issued Accounting Standards Update (“ASU”)
2023-07 “Segment
Reporting: Improvements to Reportable Segment Disclosures.” This guidance expands public entities’
segment disclosures primarily by requiring
disclosure of significant segment expenses that are regularly provided to the chief operating
decision maker and included within each reported
measure of segment profit or loss, an amount and description of its composition for
other segment items, and interim disclosures of a reportable
segment’s profit or loss and assets. Public entities with a single
 reportable segment are required to provide the new disclosures and all the
disclosures required under ASC 280 “Segment Reporting”.
The Company adopted this standard in the current period retrospectively to all prior
periods presented in its financial statements, see
note 13.
 
Recently
issued accounting pronouncements, not yet adopted
 
In
December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This guidance
is
intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor
requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid
both in
the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for years beginning after December 15, 2024 on a prospective
basis, with the
option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance
to determine the
impact it may have on its consolidated financial statements disclosures.
 
In November 2024, the FASB issued ASU  2024-03 “Income Statement—Reporting
 Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which
requires disclosure about the types of costs and expenses
included in certain expense captions presented on the income statement as well
as disclosures about selling expenses. ASU 2024-03 is effective for
years beginning after December 15, 2026, and interim periods within
years beginning after December 15, 2027, with early adoption permitted, and
may be applied either prospectively or retrospectively. The
Company is currently evaluating this guidance to determine the impact it may have on
its consolidated financial statements disclosures.
 
F-16

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 2
- SHORT-TERM DEPOSITS:
 
Composition:
 
 
 
December
31,
 
 
 
2024
   
2023
 
 
 
Annual
interest rate    
Amount
   
Annual
interest rate    
Amount
 
Dollar deposits
   
5.65-5.75%   
55,281     
6.35-6.81%  $
95,279 
 
NOTE 3
- MARKETABLE SECURITIES:
 
a.
Composition:
 
The
Company’s marketable securities include investments in equity securities of DNA, Entera and Scilex.
 
 
 
December
31,
 
 
 
2024
   
2023
 
Short-term:
   
     
 
DNA (see b below)
  $
424    $
- 
Entera (see c below)
   
248     
- 
Scilex (see d below)
   
2,769     
- 
 
  $
3,441     
- 
Long-term:
   
      
  
DNA (see b below)
  $
-    $
297 
Entera (see c below)
   
-     
70 
Transferred Warrants
(see note 4)
   
-     
1,440 
 
  $
-    $
1,807 
 
b.
DNA
 
DNA’s
ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted prices of the
securities on the measurement date.
 
During
the years ended December 31, 2024 and 2023, the Company did not sell any of DNA’s ordinary shares. As of December 31, 2024, the
Company owns approximately 1.4% of DNA’s outstanding ordinary shares.
 
The
cost of the securities as of both December 31, 2024 and 2023 was $595.
 
c.
Entera
 
Entera ordinary shares have been traded on the Nasdaq Capital Market
since June 28, 2018. The Company measures the investment at fair value
from such date, since it has a readily determinable fair value.
 
F-17

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 3
- MARKETABLE SECURITIES (continued):
 
d.
Scilex
 
Scilex
ordinary shares are traded on the Nasdaq Capital Market. The fair value of those securities is measured at the quoted prices of the securities
on the measurement date.
 
On
November 4, 2024 the Company exercised 6,500,000 of the Penny Warrant to shares. (for more details, see note 4).
 
NOTE 4
- INVESTMENTS, AT FAIR VALUE:
 
2023
Scilex Transaction and 2024 Refinancing
 
2023
Scilex Transaction
 
On
September 21, 2023, the Company entered into and consummated the transactions (collectively, the “2023 Scilex Transaction”)
contemplated
by a securities purchase agreement with Scilex, pursuant to which Scilex issued to the Company: 
 
a.
A senior secured promissory note (the “Tranche A Note”),
with a principal amount of $101,875, maturing on March 21, 2025 and bearing
interest of SOFR plus 8.5%, payable in-kind. Scheduled principal
payments are due on December 21, 2023, March 21, 2024, June 21, 2024,
September 21, 2024, and December 21, 2024, with the balance due
on March 21, 2025. In January 2025, the Company extended Tranche A
Note maturity from March 21, 2025 to December 31, 2025. As per the
Tranche A Note terms, if the Tranche A Note is not repaid in full on or
prior to March 21, 2024, an exit fee of $3,056 is due. Since the
Tranche A Note was not repaid by that date, the Company is entitled to the
above-mentioned exit fee at the maturity date of the Tranche
A Note. As of December 31, 2024, Scilex has repaid $69,200 of the amount due
under the Tranche A Note. See the description of the Extension
Agreement (as defined below).
 
 
 
 
 
The Tranche A Note constitutes senior secured indebtedness of Scilex
and is guaranteed by all existing or future formed, direct and indirect,
domestic subsidiaries of Scilex and is secured by a first priority
 security interest in and liens on all of the assets of Scilex, subject to
customary and mutually agreed permitted liens and except for
certain specified exemptions.
 
 
b.
Warrants to purchase up to 4,500,000 shares of Scilex common stock with an exercise price of $0.01 per share (the “Closing Penny
Warrants”) and four additional warrants (the “Subsequent Penny Warrants”) each for 2,125,000 shares of Scilex common stock with an
exercise price of $0.01 per share. The Closing Penny Warrants were vested on September 21, 2023, and each of the Subsequent Penny
Warrants vested quarterly during 2024. The Closing Penny Warrants and the Subsequent Penny Warrants shall become exercisable on the
earliest of (i) March 14, 2025 and (ii) the date on which the Tranche A Note has been repaid in full.
 
As of December 31, 2024, 4,500,000 Closing Penny Warrants were vested according to the terms of Tranche A Note, 8,500,000 Subsequent
Penny Warrants were vested according to the terms of the Tranche A Note and as per the Extension Agreement (as defined below).
 
According to the Extension Agreement (as defined below), 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants
have become exercisable.
 
On October 30, 2024, the Company exercised 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants that were
exercisable at such time. As a result the Company holds 6,500,000 shares of common stock of Scilex.
 
 
c.
Transferred warrants (the “Transferred Warrants”) to purchase 4,000,000 shares of Scilex common stock with an exercise price of $11.50 per
share, fully exercisable and expiring on November 10, 2027. On September 20, 2024, the Company sold the Transferred Warrants for
consideration of $300 (see below). As a result, as of December 31, 2024 the Company does not hold any Transferred Warrants.
 
F-18

 
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
 
2023
Scilex Transaction and 2024 Refinancing (continued)
 
2023
Scilex Transaction (continued)
 
The
Company accounted for the Transferred Warrants as derivatives measured at fair value.
 
The Company elected the fair value option for the Tranche A Note and
 the Penny Warrants in order to reduce operational complexity of
bifurcating embedded derivatives. Changes in value are recorded under
financial income (expense), net and include interest income on the Tranche
A Note.
 
The
valuation was performed based on several scenarios. Each scenario took into consideration the present value of the Tranche A Note’s
cash
flows (including the exit fee and the prepayment premium) and the Warrants’ value. The total value of the 2023 Scilex Transaction
(and of each of
its components) was valued on a weighted average of the different scenarios.
 
The
discount rate of the Tranche A Note was based on the B- rating zero curve in addition to a risk premium which takes into account the
credit
risk of Scilex and ranged between 112% to 113%.
 
The
fair value of the Transferred Warrants was based on their closing price on the Nasdaq Capital Market. The fair value of the Penny Warrants
was calculated based on the closing price of the Scilex common stock on the Nasdaq Capital Market.
 
On
September 20, 2024, the Company and Scilex entered into an extension agreement (the “Extension Agreement”) to extend the
due date of the
September 21, 2024 payment. Pursuant to the Extension Agreement, Scilex paid to the Company $2,000 on September 23, 2024,
which payment
is to be applied as follows: (i) $1,700 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300 to
purchase the Transferred
Warrants.
 
The
table below represents the fair value composition of the Tranche Note A:
 
 
 
December
31, 2024
   
December
31, 2023
 
 
 
Short
term
   
Long
term
   
Total
   
Short
term    
Long
term
   
Total
 
Tranche Note
A
  $
13,714     
-    $
13,714    $
57,713    $
35,353    $
93,066 
Closing Penny Warrant
   
-     
-     
-     
-    $
9,180    $
9,180 
Subsequent Penny Warrants
  $
2,772     
-    $
2,772     
-    $
6,502    $
6,502 
Transferred Warrants
   
-     
-     
-     
-    $
1,440    $
1,440 
Total
  $
16,486     
-    $
16,486    $
57,713    $
52,475    $
110,188 
 
As
of December 31, 2023, the fair value of the Tranche A Note was less than the aggregate unpaid principal balance (which includes interest
payable on maturity) by $7,801.
 
As of December 31, 2024, the fair value of the Tranche A Note was less than the aggregate unpaid principal
balance (which includes interest
payable on maturity) by $8,114.
 
F-19

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 4
- INVESTMENTS, AT FAIR VALUE (continued):
 
2024
Refinancing
 
In October 2024, the Company entered into the transactions (collectively,
 the “2024 Refinancing”) pursuant to which Scilex issued to the
Company:
 
a.
Convertible Notes SPA
 
The Company entered into a securities purchase agreement (the “Convertible Notes SPA”) with certain institutional
investors (together with the
Company, the “Buyers”) and Scilex to refinance a portion of the Tranche A Note and pay off certain
other indebtedness of Scilex. Pursuant to the
Convertible Notes SPA, the Buyers purchased in a registered offering by Scilex (i) a new
tranche B of senior secured convertible notes of Scilex in
the aggregate principal amount of $50,000 (the “Tranche B Notes”)
 repayable on a quarterly basis for 2 years, which Tranche B Notes are
convertible into shares of Scilex common stock and (ii) warrants
to purchase up to 7,500,000 shares of Scilex common stock (the “Tranche B
warrants”). The Company purchased 50% of Tranche
B Notes and Tranche B Warrants and therefore holds an aggregate principal amount of
$25,000 of the Tranche B Notes and 3,750,000 Tranche
B Warrants.
 
Scilex
received from the Company, in consideration for the Tranche B Notes and the Tranche B Warrants issued to the Company, an exchange and
reduction of the principal outstanding balance under the Tranche A Note of $22,500.
 
b.
Royalty Purchase Agreement
 
The Company and certain institutional investors (together with the Company, the “RPA Purchasers”)
entered into a Purchase and Sale Agreement
(the “Royalty Purchase Agreement”) with Scilex and Scilex Pharmaceuticals Inc.
 (“Scilex Pharma”). Pursuant to the Royalty Purchase
Agreement, the RPA Purchasers acquired the right to receive, in the aggregate,
 8% of net sales worldwide for 10 years (the “Purchased
Receivables”) with respect to ZTlido (lidocaine topical system) 1.8%,
 SP-103 (lidocaine topical system) 5.4%, and any related, improved,
successor, replacement or varying dosage forms of the foregoing. The
Company acquired the right to receive 50% of the Purchased Receivables
and therefore holds the right to receive 4% royalties.
 
In
consideration for its interest in the Purchased Receivables, the Company exchanged and reduced $2,500 of the principal balance under
the
Tranche A Note.
 
c.
ZTlido Rest of the World Binding Agreement
 
The Company and certain other institutional investors and Scilex entered into a binding term sheet (the
“ROW License Term Sheet”), regarding a
license and development agreement (the: “Lido License Agreement”), with
respect to services, compositions, products, dosages and formulations
comprising lidocaine, including without limitation, the product
and any future product defined as a “Product” under Scilex Pharma’s existing (i)
Product Development Agreement, dated
as of May 11, 2011, with Oishi Koseido Co., Ltd. (“Oishi”), and Itochu Chemical Frontier Corporation
(“Itochu”),
as amended, and (ii) the associated Commercial Supply Agreement, dated February 16, 2017, between Scilex, Oishi and Itochu, as
amended.
 
F-20

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 4
- INVESTMENTS, AT FAIR VALUE (continued):
 
2024
Refinancing (continued)
 
c.
ZTLido Rest of the World Binding Agreement (continued):
 
Subject
to determination of a final structure for the transactions contemplated by the ROW License Term Sheet, it is anticipated that the Company
and such institutional investors will hold the Lido License Agreement through a joint venture, RoyaltyVest, Inc. (“RoyaltyVest”).
 
In
consideration for the rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term
Sheet, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200 per
year toward
expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products
 rights for the
development, out-licensing, commercialization of any Product outside of the United States and other territories, other
 than certain excluded
designated territories (the “ROW Territory”), and (c) each of RoyaltyVest and Scilex will receive 50%
percent of the net revenue (less expenses)
generated from any Product in the ROW Territory.
 
The
term sheet is subject to entering into a definitive agreement (see note 15) and subject to the consent of Oishi and Itochu to the Lido
License
Agreement.
 
As of December 31, 2024, the fair value
of the ROW License was immaterial, inter alia, as it remains contingent upon third-party approvals and
the future execution of agreements.
 
The institutional investors who are parties to the Convertible Notes
SPA, Royalty Purchase Agreement and ROW License Term Sheet are all inter-
related.
 
Following the refinancing as described
above, on October 8, 2024, Scilex used $12,500 of the net proceeds from the proceeds of the Tranche B
Note for the partial repayment
of the outstanding balance under the Tranche A Note.
 
The Company elected the fair value option for the Tranche B Note and the Royalty
Purchase Agreement, The Note B Warrants meet the definition
of a derivative, and therefore will be measured at fair value. Changes in
value are recorded under financial income (expense), net and include
interest income on the Tranche B Note.
 
The
valuation of the Tranche B Note’s was performed based on the binomial model, using a discount rate of 110.33%.
Presented below is the
summary of the assumptions and estimates that were used for the valuation:
 
Parameters and Assumptions
 
  
Share Price
  $
0.43 
Conversion Rate
   
1.04 
Floor Rate
   
1.04 
Expected Term
   
1.77 Years 
Volatility
   
61.99%
Risk Free Rate
   
4.16%
 
The fair value of the Note B Warrants was calculated based on Black
and Scholes model.
 
F-21

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 4
- INVESTMENTS, AT FAIR VALUE (continued):
 
2024
Refinancing (continued)
 
c.
ZTLido Rest of the World Binding Agreement (continued):
 
Presented below is the summary of the assumptions and estimates
that were used for the valuation of the Warrants:
 
Parameters and Assumptions
   
  
Share Price
  $
0.43 
Exercise Price
  $
1.04 
Expected Term
   
4.77 Years 
Volatility
   
63.14%
Risk Free Rate
   
4.33%
Dividend Rate
   
0%
 
The
value of the Royalty Purchase Agreement was calculated according to the royalty payment schedule and the aggregation of discounted cash
flows derived from the royalty payments, using a discount rate of 110.33%.
 
As of December 31, 2024, the
fair value of the Tranche B Note was less than the aggregate unpaid principal balance (which includes interest
payable on maturity)
is $9,833.
 
The
table below represents the fair value composition of the Tranche B Note:
 
 
 
December 31, 2024
 
 
 
Short term
   
Long term
   
Total
 
Tranche B Note
  $
11,263    $
4,535    $
15,798 
Warrant
   
-    $
548    $
548 
Royalty Purchase Agreement
  $
1,039    $
937    $
1,976 
Total
  $
12,302    $
6,020    $
18,322 
 
F-22

 
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
 
2024 Refinancing (continued)
 
c.
ZTLido Rest of the World Binding Agreement (continued):
 
The
table below represents the fair value cycle of 2023 Scilex Transaction and 2024 Refinancing Transaction throughout December 31, 2023
and
December 31, 2024:
 
 
 
Tranche A
   
Tranche B
   
Total
 
Balance as of December 31, 2022
 
-   
-   
- 
2023 Scilex Transaction
   
101,875     
-     
101,875 
Cash received from note repayment
   
(5,000)    
-     
(5,000)
Change in fair value
   
13,313     
-     
13,313 
Balance as of December 31, 2023
   
110,188     
-     
110,188 
2024 Refinancing (*)
   
(21,575)    
25,000     
3,425 
Proceeds from the sale of Transferred Warrants
   
(300)    
-     
(300)
Cash received from Tranche A Note repayment
   
(64,200)    
-     
(64,200)
Exercised warrants (**)
   
(6,123)    
-     
(6,123)
Amounts receivable from the royalty agreement (***)
   
-     
(398)    
(398)
Change in fair value
   
(1,504)    
(6,280)    
(7,784)
Balance as of December 31, 2024
   
16,486     
18,322     
34,808 
 
(*)
The amount was recorded as part of the financial income (expenses), net.
 
(**)
On October 30, 2024 the Company exercised 4,500,000 Closing Penny Warrants,
and 2,000,000 Subsequent Penny Warrants into 6,500,000 shares of
common stock of Scilex and as a result, these shares are not part of
the Tranche A Note and presented under fair value investment.
 
(***) The amount is included under prepaid expenses and other current assets.
 
Financial income (expenses) recognized in respect of 2023 Scilex
Transaction and 2024 Refinancing, for the years ended December 31, 2024 and 2023,
were ($4,359) and $13,313, respectively. 
 
F-23

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 4
- INVESTMENTS, AT FAIR VALUE (continued):
 
2024
Refinancing (continued)
 
c.
ZTLido Rest of the World Binding Agreement (continued):
 
The
table below represents the fair value breakdown as of December 31, 2024:
 
 
 
Tranche A Note
   
Tranche B Note
   
Total
 
 
 
Amount
   
Fair Value
   
Amount
   
Fair Value
   
Fair Value
 
The Notes
   
7,675     
13,714     
25,000     
15,798     
29,512 
Warrants
   
6,500     
2,772     
3,750     
548     
3,320 
Royalty Purchase Agreement payment
   
-     
-     
-     
1,976     
1,976 
December 31, 2024
   
-     
16,486     
-     
18,322     
34,808 
 
For
more details see note 15, subsequent events.
 
e.
Profit
Sharing Loan Agreement
 
On
September 4, 2024, the Company entered into a loan agreement (the “Profit Sharing Loan Agreement”) with Rabi Binyamin 4 Tama
38 Ltd.
(the “Borrower”) to finance a real estate project (the “Project”). According to the terms of the Profit
Sharing Loan Agreement, Oramed agreed to
loan NIS 5.5 million ($1,523) (the “Loan Principal”) to the Borrower. NIS 4.7 million
($1,307) was loaned upon signing the Profit Sharing Loan
Agreement and an additional NIS 0.8 million ($216) will be loaned upon certain
milestones which are expected to occur in the first half of 2025.
Upon completion of the Project, the Company is entitled to receive
the Loan Principal and the greater of: (i) 20% annual interest of the Loan
Principal and (ii) 40% of the Project profits.
 
The
Company decided to designate the Profit Sharing Loan Agreement as a whole under the Fair-Value option in accordance with ASC Topic
825
“Financial Instruments”. The valuation of the Profit Sharing Loan Agreement was based on various project
profit scenarios derived from the
appraiser’s report. The Company used the Wang Transform model, a risk-neutral probabilities
method, with an expected term of 4.01 years, a
curve rate of 13.9% and a risk spread of 0.43%.
 
F-24

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 5
- OTHER NON-MARKETABLE EQUITY SECURITIES:
 
On
August 26, 2022, the Company entered into a stock purchase agreement with Diasome Pharmaceuticals, Inc. (“Diasome”), a privately-held
company, pursuant to which the Company purchased shares of Series B preferred stock of Diasome for an aggregate purchase price of
approximately
$2,700. Following the purchase, the Company holds less than 5% of the issued and outstanding stock of Diasome. The stock
purchase agreement
provides the Company with the option to purchase additional preferred shares of stock on a pro rata basis at similar terms to
the terms
and conditions of the current round contingent upon Diasome achieving certain milestones.
 
The Company’s non-marketable equity
 securities are an investment in a company without a readily determinable fair value. The Company
accounts for this investment under the
measurement alternative in ASC 321, whereby the equity investment is recorded at cost, less impairment.
The carrying amount is subsequently
remeasured to its fair value in accordance with the provisions of ASC 820 when observable price changes
occur as of the date the transaction
occurred, or it is impaired. Any adjustments to the carrying amount are recorded in the consolidated statements
of comprehensive income
(loss).
 
During the year ended December 31,
2023, the Company recorded an $824 increase in value due to the closing in June 2023 of a Series C
preferred investment round in
Diasome. The change was recorded using the transaction price of similar securities issued by Diasome, adjusted for
contractual
rights and obligations of the securities held by the Company. During the year ended December 31, 2024, there was no change in the
value of the Diasome investment.
 
NOTE 6
- ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
 
Composition:
 
 
 
December
31,
 
 
 
2024
   
2023
 
Accounts payable
  $
789    $
551 
Payroll and related accruals
   
407     
453 
Income tax
   
3,204     
- 
Accrued liabilities
   
740     
605 
 
  $
5,140    $
1,609 
 
NOTE 7
- SHORT-TERM BORROWINGS:
 
On
August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. (the “Short-Term
Borrowings”). The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging
from 6.66% to
7.38%, and are secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount
of $99,550. The net
proceeds of the Short-Term Borrowings were used to fund the Tranche A Note (for further details, see note 4).
The Short-Term Borrowings are
paid in one payment of principal and interest at each respective maturity. As of December 31, 2024, the
Company repaid the entire Short-Term
Borrowings amount.
 
F-25

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 8
- COMMITMENTS:
 
 
a.
On August 21, 2020, the Company received a letter from HTIT, disputing certain pending payment obligations of HTIT under the
Technology License Agreement (“TLA”). The payment obligation being disputed is $6,000, out of which only an amount of $2,000 has
been received and has been included in deferred revenue in each of the consolidated balance sheets as of the years ended December 31,
2024, and December 31, 2023.
 
On February 7, 2025, the Company and HTIT entered into a JV Agreement (as defined in note 15). Pursuant to the terms of the JV
Agreement, each of the Company, the Subsidiary and HTIT irrevocably released and waived (i) any claims and demands against each
other party in connection with the TLA; and (ii) all rights, obligations and liabilities set out and arising with respect to the performance of
the TLA. For more details see note 15.
 
 
b.
On November 13, 2022, the Company entered the Medicox License Agreement with Medicox.
 
The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the
Republic of Korea. The Medicox License Agreement is for ten years, but the parties have the right to terminate it with a 180 days-notice.
 
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 the Company up to $15,000 in developmental milestones, $2,000 of which were received by the Company in
2022, and up to 15% royalties on gross sales. Medicox will also be responsible for obtaining a regulatory approval in the Republic of
Korea.
 
For the Company’s revenue recognition policy, see note 1m. 
 
 
c.
Grants from the Israel
Innovation Authority (“IIA”)
 
Under
the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so
funded,
up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual
rate based
on SOFR.
 
At
the time the grants were received, successful development of the related projects was not assured. The total amount that was received
through December 31, 2024 was $2,214 ($2,587 including interest). All grants were received before the year ended August 31, 2020 and
recorded as a reduction of research and development expenses at that time.
 
As
of December 31, 2024, the liability to the IIA was $59. The royalty expenses which are related to the funded project were recognized
in cost of revenues in the relevant periods.
 
As
of December 31, 2024, the Company has paid a total amount of $556 to the IIA.
 
For
additional details see note 15.
 
F-26

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 8
- COMMITMENTS (continued):
 
d.
Leases
 
On
August 2, 2020, the Subsidiary entered into a lease agreement for its facilities in Israel. The lease agreement is for a period of 60
months
commencing September 1, 2020. The Subsidiary has the option to extend the period for another 60 months. The annual lease payment,
including
management fees, as of December 31, 2024 is approximately NIS 435 ($119). As security for its obligation under this lease agreement,
 the
Company provided a bank guarantee in an amount equal to three monthly lease payments. For accounting purposes, the lease period is
60 months.
 
On
December 2, 2021, the Subsidiary entered into an addendum (the “Addendum”) to the current lease agreement for its facilities
in Israel. The
Addendum refers to the lease of an additional space of 264 square meters for a period of 60 months commencing February
 1, 2022. The
Subsidiary has the option to extend the period for another 60 months. The annual lease payment, including management fees,
is approximately
NIS 435 ($119). As security for its obligation under the Addendum, the Company provided a bank guarantee in an amount
equal to three monthly
lease payments. For accounting purposes, the lease commenced on February 1, 2022 as the Subsidiary did not have
access to the space until that
date. For accounting purposes, the lease period is 60 months.
 
The
total expenses related to leases were $265 for the year ended December 31, 2024, and $236 for the year ended December 31,
2023.
 
The
 Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s
operating right-of-use assets and operating lease liabilities as of December 31, 2024 and 2023:
 
 
 
December 31,
2024
   
December 31,
2023
 
Operating right-of-use assets
  $
414    $
694 
 
   
      
  
Operating lease liabilities, current
   
216     
267 
Operating lease liabilities long-term
   
156     
342 
Total operating lease liabilities
  $
372    $
609 
 
   
      
  
Weighted Average of Remaining Lease Term
   
      
  
Operating leases
   
1.8     
2.5 
 
   
      
  
Weighted Average Discount Rate
   
      
  
Operating leases
   
3.52%   
3.15%
 
Operating
cash flows from operating lease for the years Ended December 31, 2024 and 2023 were $264 and $267, respectively.
 
Lease
payments for the Company’s right-of-use assets over the remaining lease periods as of December 31, 2024 are as follows:
 
 
 
December 31,
2024
 
 
   
 
2025
  $
225 
2026
   
141 
2027
   
18 
Total undiscounted lease
payments
   
384 
Less: Interest*
   
(12)
Present value of lease liabilities
  $
372 
 
*
Future lease payments were discounted by 3%-7% interest rate.
 
F-27

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 8
- COMMITMENTS (continued):
 
e.
Clinical
Research Organization Services Agreement
 
On
September 23, 2024, the Subsidiary entered into a Clinical Research Organization Services Agreement with a third party, to retain it
as a
clinical research organization (“CRO”). The services covered by the agreement include strategic planning, expert consultation,
data processing,
regulatory, clerical, project management and other research and development services requested by the Company for the
Phase 3 clinical trial. As
consideration for its services, the Company will pay the CRO a total amount of $11,577 during the term of
 the engagement and based on
achievement of certain milestones, of which $775 recognized in research and development expenses through
December 31, 2024.
 
NOTE 9
- STOCKHOLDERS’ EQUITY:
 
The
following are the significant capital stock transactions that took place during the years ended December 31, 2024 and 2023:
 
 
a.
On September 1, 2021, the Company entered into a controlled equity offering agreement (the “Cantor Equity Distribution Agreement”)
with Cantor Fitzgerald & Co., as agent, pursuant to which the Company may issue and sell shares of its common stock having an
aggregate offering price of up to $100,000, through a sales agent, subject to certain terms and conditions. Any shares sold will be sold
pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated July 26, 2021 and prospectus
supplement dated September 1, 2021. The Company paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of
any shares sold through the sales agent under the Cantor Equity Distribution Agreement. As of December 31, 2023 1,971,447 shares were
issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $26,253, no shares were issued in 2024. The
agreement terminated on March 17, 2024.
 
 
b.
On March 18, 2024, the Company entered into an at the market offering (the “StockBlock ATM Agreement”) with Rodman & Renshaw
LLC and StockBlock Securities LLC, as agent, pursuant to which the Company may issue and sell shares of its common stock having an
aggregate offering price of up to $75,000, through a sales agent, subject to certain terms and conditions. Any shares sold will be sold
pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated March 18, 2024 and
prospectus supplement dated September 1, 2021. The Company will pay the sales agent a cash commission of 3.0% of the gross proceeds
of the sale of any shares sold through the sales agent under the StockBlock ATM Agreement. As of December 31, 2024 no shares had
been issued under the StockBlock ATM Agreement.
 
 
c.
As of December 31, 2024, the Company had outstanding warrants exercisable starting February 25, 2020 for 20,000 shares of common
stock at an exercise price of $4.13 per share and expiring on April 15, 2029.
 
F-28

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 9
- STOCKHOLDERS’ EQUITY (continued):
 
The
following table presents the warrant activity for the years ended December 31, 2024 and 2023:
 
 
 
Year
ended December 31,
 
 
 
2024
   
2023
 
 
 
Warrants
   
Weighted-
Average
Exercise
Price
   
Warrants
   
Weighted-
Average
Exercise
Price
 
Warrants outstanding at beginning
of year
   
20,000    $
4.13     
150,705    $
4.71 
Issued
   
-    $
-     
-    $
- 
Exercised
   
-    $
-     
-    $
- 
Expired
   
-    $
-     
(130,705)   $
4.80 
Warrants outstanding
at end of year
   
20,000    $
4.13     
20,000    $
4.13 
Warrants exercisable
at end of year
   
20,000    $
4.13     
20,000    $
4.13 
 
d.
Buyback
program
 
In
June 2024, the Company’s board of directors authorized a stock buyback program pursuant to which the Company may, from time
to time,
repurchase and retire up to $20,000 in maximum value of its common stock. The stock buyback program does not obligate the Company
to
purchase any shares and expires in 12 months. The authorization for the stock buyback program may be terminated, increased or decreased
by the
Company’s board of directors in its discretion at any time.
 
During 2024, the Company repurchased
and retired 1,036,976 shares of its common stock under this program for approximately $2,494, including
$10 excise tax, at an average
price of $2.36 per share. All repurchases were funded with cash on hand.
 
F-29

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 10
- STOCK-BASED COMPENSATION:
 
The
Company makes awards only under the 2019 Plan, under which, the Company had reserved a pool of 7,500,000 shares of the Company’s
common stock which may be issued at the discretion of the board of directors from time to time. Under this 2019 Plan, each option or
RSU is
exercisable into one share of common stock of the Company. The options may be exercised after vesting and in accordance with vesting
schedules
which will be determined by the board of directors for each grant. The maximum term of the options and RSUs is 10 years. 
 
The following are the significant stock
options, RSUs transactions with employees and board members made during the years ended December 31,
2024 and 2023:
 
 
a.
On April 17, 2023, the Company granted an aggregate of 868,500 RSUs representing a right to receive shares of the Company’s common
stock to executive officers and board members of the Company. The RSUs will vest in twelve equal quarterly installments starting May 1,
2023. The total fair value of these RSUs on the date of grant was $1,980, using the quoted closing market share price of $2.28 on the
Nasdaq Capital Market on the date of grant.
 
 
b.
On April 17, 2023, the Company granted an aggregate of 245,500 performance based RSUs (“PSUs”) representing a right to receive
shares of the Company’s common stock to executive officers of the Company. The PSUs vested on May 26, 2023, upon the Company’s
common stock achieving and maintaining a specified price per share. The total fair value of these PSUs on the date of grant was $550,
using the Monte-Carlo model.
 
 
c.
On May 1, 2023, the Company granted an aggregate of 20,000 RSUs representing a right to receive shares of the Company’s common
stock to a new board member. The RSUs will vest in twelve quarterly installments starting May 1, 2023. The total fair value of these
RSUs on the date of grant was $49, using the quoted closing market share price of $2.45 on the Nasdaq Capital Market on the date of
grant.
 
 
d.
On January 4, 2024, the Company granted an aggregate of 941,500 RSUs representing a right to receive shares of the Company’s
common stock to executive officers of the Company. The RSUs will vest in twelve equal quarterly installments starting January 8, 2024.
The total fair value of these RSUs on the date of grant was $2,250 using the quoted closing market share price of $2.39 on the Nasdaq
Capital Market on the date of grant.
 
F-30

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 10
- STOCK-BASED COMPENSATION (continued):
 
 
e.
On January 4, 2024, the Company granted 294,000 PSUs representing a right to receive shares of the Company’s common stock to
executive officers of the Company. The total amount of the PSUs shall vest when the closing price per share of Common Stock of the
Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day period. The total fair value of these PSUs
on the date of grant was $691, using the Monte-Carlo model, based on the quoted closing market share price of $2.39 on the Nasdaq
Capital Market on the date of grant.
 
 
f.
On January 4, 2024, the Company granted an aggregate of 187,610 RSUs representing a right to receive shares of the Company’s
common stock to board members of the Company. 37,610 RSUs will vest in three equal quarterly installments starting April 1, 2024.
150,000 RSUs will vest in three equal annual installments starting January 1, 2025. The total fair value of these RSUs on the date of grant
was $448, using the quoted closing market share price of $2.39 on the Nasdaq Capital Market on the date of grant.
 
 
g.
On January 30, 2024, the Company granted an aggregate of 3,750 RSUs representing a right to receive shares of the Company’s common
stock to board member of the Company. The RSUs will vest in four equal quarterly installments starting April 1, 2024. The total fair
value of these RSUs on the date of grant was $11, using the quoted closing market share price of $2.98 on the Nasdaq Capital Market on
the date of grant.
 
 
h.
On April 17, 2024, the Company granted an aggregate of 29,800 RSUs representing a right to receive shares of the Company’s common
stock to board member of the Company. 7,300 RSUs will vest in three equal quarterly installments starting July 1, 2024. 22,500 RSUs
will vest in three equal annual installments starting January 1, 2025. The total fair value of these RSUs on the date of grant was $69,
using the quoted closing market share price of $2.33 on the Nasdaq Capital Market on the date of grant.
 
 
i.
On June 20, 2024, the Company granted 34,000 PSUs representing a right to receive shares of the Company’s common stock to the
Company’s Chief Financial Officer. The total amount of the PSUs shall vest upon the later of (i) June 18, 2026 and (ii) when the closing
price per share of Common Stock of the Company on the Nasdaq Capital Market reaches an average of $4.00 over any 10-trading day
period. The total fair value of these PSUs on the date of grant was $73, using the Monte-Carlo model, based on the quoted closing market
share price of $2.21 on the Nasdaq Capital Market on the date of grant.
 
 
j.
On June 21, 2024, 140,040 RSUs representing a right to receive shares of the Company’s common stock were granted to executive
officer. 93,360 shall vest in one installment on June, 18 2026 and 46,680 shall vest in four equal quarterly installments starting September
9, 2026. The total fair value of these RSUs on the date of grant was $305, using the quoted closing market share price of $2.18 on the
Nasdaq Capital Market on the date of grant.
 
 
k.
On November 11, 2024, the Company granted an aggregate of 135,000 RSUs representing a right to receive shares of the Company’s
common stock to executive officers of the Company. The RSUs vested on the date of grant. The total fair value of these RSUs on the date
of grant was $321, using the quoted closing market share price of $2.38 on the Nasdaq Capital Market on the date of grant.
 
F-31

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 10
- STOCK-BASED COMPENSATION (continued):
 
 
l.
Options
to employees, directors and non-employees
 
A
summary of the status of the stock options granted to employees and directors as of December 31, 2024 and 2023 and changes during the
years
ended on those dates, is presented below:
 
 
 
Year
ended December 31,
 
 
 
2024
   
2023
 
 
 
Number
of
options
   
Weighted
average
exercise
price
   
Number
of
options
   
Weighted
average
exercise
price
 
 
   
   
$
     
   
$
 
Options
outstanding at beginning of year
   
1,909,676     
8.03     
2,041,676     
8.47 
Changes
during the year:
   
      
      
      
  
Granted
   
-      
-      
-     
- 
Forfeited
   
(49,125)    
13.92     
(132,000)    
14.81 
Expired
   
(199,543)    
13.40     
-     
- 
Exercised
   
-     
-     
-     
- 
Options
outstanding at end of year
   
1,661,008     
7.21     
1,909,676     
8.03 
Options
exercisable at end of year
   
1,442,258     
6.91     
1,479,426     
7.15 
 
Expenses
recognized in respect of stock options granted to employees and directors, for the years Ended December 31, 2024 and 2023, were $213
and $811, respectively.
 
F-32

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In
thousands (except share and per share data)
 
NOTE 10
- STOCK-BASED COMPENSATION (continued):
 
m. Options
to employees, directors and non-employees
 
The
following table presents summary information concerning the options granted to employees and directors outstanding as of December 31,
2024:
 
Exercise prices $
 
Number outstanding    
Weighted
Average
Remaining
Contractual
Life Years
   
Weighted
average
exercise
price $
 
1-6
   
840,500     
4.83     
3.94 
6.23-9.12
   
283,008     
2.80     
7.96 
10.40-20.19
   
537,500     
6.50     
11.94 
 
   
1,661,008     
5.02     
7.21 
 
As
of December 31, 2024, there were $122 of unrecognized compensation costs related to non-vested options previously granted to employees
and
directors. The unrecognized compensation costs are expected to be recognized over a weighted average period of 0.6 years.
 
47,000
options granted to non-employees were outstanding and exercisable as of December 31, 2024 and 2023. The Company recorded no stock-
based
compensation related to non-employees’ awards during the years ended December 31, 2024 and 2023. During the years ended December
31, 2024 and 2023, no options were exercised.
 
As of December 31, 2024, there were
no unrecognized compensation costs related to non-vested options previously granted to non-employees.
 
F-33

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 10
- STOCK-BASED COMPENSATION (continued):
 
m. Options
to employees, directors and non-employees (continued):
 
The
following table presents summary information concerning the options granted to non-employees outstanding as of December 31, 2024:
 
Range of
exercise
prices $
 
Number outstanding
 
Weighted
Average
Remaining
Contractual
Life Years
 
Weighted
Average
Exercise
Price $
3.74-5.08
 
47,000 
4.98 
4.31
  
n.
Restricted
stock units
 
The
following table summarizes the activities for unvested RSUs and PSUs granted to employees and directors for the years ended December
31,
2024 and 2023:
 
 
 
Year
ended 
December 31,
 
 
 
2024
   
2023
 
 
 
Number
of RSUs
 
Outstanding at the beginning
of year
   
1,834,362     
1,561,570 
Changes during the year:
   
      
  
Granted
   
1,792,460     
1,134,000 
Issued
   
(617,542)    
(574,791)
Forfeited
   
(405,945)    
(286,417)
Expired
   
(50,770)    
- 
Outstanding at the
end of the year
   
2,552,565     
1,834,362 
Vested during the
year
   
925,937     
521,625 
Vested and unissued
at year end
   
520,531     
212,136 
 
The
Company recorded compensation expenses related to RSUs of $3,787 for the year ended December 31, 2024 and $3,210 for the year ended
December
31, 2023.
 
As
of December 31, 2024, there were unrecognized compensation costs of $1,630 related to RSUs. The unrecognized compensation costs are
expected
to be recognized over a weighted average period of 0.68 year.
 
F-34

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 10
- STOCK-BASED COMPENSATION (continued):
 
n.
Restricted
stock units (continued):
 
The Company recorded compensation
expenses related to RSUs granted to non-employees of $26 for the year ended December 31, 2023. No
compensation expenses recorded for the
year ended December 31, 2024.
 
As of December 31, 2024, there were
no unrecognized compensation costs related to RSUs.
 
The Company recorded total compensation expenses of $4,053 and $4,212
for the years ended December 31, 2024 and 2023, respectively. $1,998
and $1,718 were included in Research and Development expenses, $2,055
and $2,933 were included in General and Administrative expenses and
$0 and $(440) were included in Sales and Marketing for the years ended
December 31, 2024 and 2023, respectively.
 
For additional information regarding
RSUs and PSUs granted in 2025, see note 15.
 
NOTE 11
- FINANCIAL INCOME AND EXPENSES:
 
a.
Financial income
 
 
 
Year
ended 
December 31,
 
 
 
2024
   
2023
 
Income from interest on deposits
  $
4,128    $
8,016 
Exchange rate differences, net
   
174     
- 
Income from interest on corporate bonds
   
-     
10 
Revaluation of investments, net
   
-     
16,461 
Money Market Interest Income
   
870     
143 
Other
   
67     
- 
 
  $
5,239    $
24,630 
 
b.
Financial expenses
 
 
 
Year
ended 
December 31,
 
 
 
2024
   
2023
 
Exchange rate differences, net
  $
-    $
124 
Bank and broker commissions
   
15     
29 
Revaluation of securities, net
   
3,114     
69 
Revaluation of investments, net (see note 4)
   
4,302     
- 
Fees regarding Scilex transaction
   
94     
1,514 
Interest expenses
   
853     
2,037 
 
  $
8,378    $
3,773 
 
F-35

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 12
- TAXES ON INCOME:
 
Taxes on income included in the consolidated
statements of comprehensive income (loss) represent current taxes due to taxable income of the
Company.
 
a.
Corporate
taxation in the U.S.
 
The
applicable corporate tax rate for the Company is 21%.
 
As of December 31, 2024, the Company has utilized all of its outstanding
 net operating loss (“NOL”). Oravax had an accumulated tax loss
carryforward of approximately $3,386 (as of December 31, 2023,
$3,374). Under U.S. tax laws, subject to certain limitations, carryforward tax
losses originating in tax years beginning after January
1, 2018, have no expiration date, but they are limited to 80% of the company’s taxable
income in any given tax year. Carryforward
tax losses originating in tax years beginning prior to January 1, 2018, expire 20 years after the year in
which incurred.
 
b.
Corporate
taxation in Israel
 
The
Subsidiary is taxed in accordance with Israeli tax laws. The corporate tax rate applicable to 2024 and 2023 is 23%.
 
As
of December 31, 2024, the Subsidiary and Oravax Medical Ltd. had an accumulated tax loss carryforward of approximately $114,000 (as of
December 31, 2023, approximately $102,000). Under the Israeli tax laws, carryforward tax losses have no expiration date.
 
c.
Deferred income taxes
 
 
 
December 31,
 
 
 
2024
   
2023
 
In respect of:
   
     
 
Net operating loss carryforward
  $
26,797    $
27,757 
Research and development expenses
   
1,220     
2,731 
Revaluation of investments
   
5,608     
(2,611)
Other temporary differences
   
2,495     
596 
Less - valuation allowance
   
(36,120)    
(28,473)
Net deferred tax assets
  $
-    $
- 
  
Deferred
taxes are determined based on temporary differences between financial reporting and tax bases of assets and liabilities and are measured
using the enacted tax rates and laws that will be in effect when the differences are expected to reverse.
 
Realization
of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and
carryforwards are expected to be available to reduce taxable income. As the achievement of required future taxable income is uncertain,
the
Company recorded a full valuation allowance.
 
F-36

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 12
- TAXES ON INCOME (continued):
 
d.
Income (Loss) before taxes on income and income taxes included in the consolidated statements of comprehensive income (loss)
 
 
 
Year ended 
December 31,
 
 
 
2024
   
2023
 
Income (loss) before taxes on income:
 
    
  
U.S.
  $
(8,853)   $
11,604 
Outside U.S.
   
(7,067)    
(6,516)
 
  $
(15,920)   $
5,088 
Taxes on income (tax benefit):
   
      
  
Current:
   
      
  
U.S. (*)
   
3,183     
- 
Outside U.S.
   
-     
- 
 
  $
3,183    $
- 
  
(*) Based on anticipated gains from the 2023 Scilex Transaction
and 2024 Refinancing, the Company anticipates taxable income for the year ending
December 31, 2024. As a result, the Company fully
utilized its tax loss carryforward and incurred associated tax expenses. During the year ended
December 31, 2024, the Company recognized
tax expenses of $3,194. Tax provision of $3,194 has been classified to Accounts payable and accrued
expenses.
 
e.
Reconciliation
of the statutory tax benefit to effective tax expense
 
Following
is a reconciliation of the theoretical tax expense, assuming all income is taxed at the regular tax rates applicable to companies in
the
United States, and the actual tax expense:
 
 
 
Year ended 
December 31,
 
 
 
2024
   
2023
 
Income (loss) before income taxes as reported in the consolidated statement of comprehensive income (loss)
  $
(15,920)   $
5,088 
 
   
      
  
Statutory tax (benefit) expense – 21%
   
(3,343)    
1,068 
Increase (decrease) in income taxes resulting from:
   
      
  
Change in the balance of the valuation allowance for deferred tax
   
7,647     
(4,332)
Disallowable deductions
   
(878)    
731 
Influence of different tax rate applicable to the Subsidiary and Oravax Medical Ltd.
   
(219)    
(305)
Prior year adjustments
   
(13)    
2,838 
Uncertain tax position
   
(11)    
- 
Taxes on income for the reported year
  $
3,183    $
- 
  
F-37

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 12
- TAXES ON INCOME (continued):
 
f.
Uncertainty
in Income Taxes
 
ASC
 740, “Income Taxes” requires significant judgment in determining what constitutes an individual tax position as well as assessing
 the
outcome of each tax position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate
of the
effective tax rate and consequently, affect the operating results of the Company. The Company recognizes interest and penalties
related to its tax
contingencies as income tax expense.
 
The
following table summarizes the activity of the Company unrecognized tax benefits:
 
 
 
Year
ended 
December 31,
 
 
 
2024
   
2023
 
Balance at Beginning of Year
  $
11    $
11 
Decrease in uncertain
tax positions for the current year
   
(11)    
- 
Balance at End of
Year
  $
-    $
11 
 
The
Company does not expect unrecognized tax expenses to change significantly over the next 12 months.
 
The
Company is subject to U.S. Federal income tax examinations for the tax years of 2020 through 2023.
 
The
Subsidiary is subject to Israeli income tax examinations for the tax years of 2019 through 2023.
 
g.
Valuation Allowance Rollforward
 
 
 
Year ended
 
 
 
Balance at
beginning
of year
   
Additions
(deductions)    
Balance at
end of
year
 
Allowance in respect of carryforward tax losses:
 
    
    
  
Year ended December 31, 2024
  $
28,473    $
7,647    $
36,120 
Year ended December 31, 2023
   
32,805     
(4,332)    
28,473 
 
F-38

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 13
- SEGMENT REPORTING:
 
The Company’s Chief Executive
Officer, serving as the Chief Operating Decision Maker (CODM), evaluates operational performance and makes
resource allocation decisions
based on net income (loss), which is reported in the consolidated statements of comprehensive income (loss). The
Company has determined
that it operates in a single reportable segment, focused on research and development activities related to its proprietary
products and
technologies.
 
The CODM monitors budgeted versus actual
net income (loss), using this measure to assess segment performance and guide financial planning,
which is consistent with the financial
statements. In addition to its research and development activities, the Company holds financial investments,
including a material investment
in Scilex, see note 4. The CODM monitors these investments separately from operational performance. Income
and expenses related to financial
instruments are reported as finance income (expenses) in the consolidated statements of comprehensive income
(loss), reflecting their
distinct nature from core business operations.
 
NOTE 14
- RELATED PARTY TRANSACTIONS:
 
 
a.
On July 1, 2008, the Subsidiary entered into two consulting agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the
Chief Scientific Officer, whereby the President and Chief Executive Officer and the Chief Scientific Officer, through KNRY, provide
services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either party upon 140 days,
prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable expenses incurred in
connection with performance of the Consulting Agreements and that the monthly consulting fee paid to the President and Chief
Executive Officer and the Chief Scientific Officer is NIS 146,705 ($40) and NIS 106,400 ($29), respectively.
  
Following
the relocation of the President and Chief Executive Officer to the State of Israel, the Company entered into two agreements
with the
President and Chief Executive Officer, replacing his above-mentioned consulting agreement through KNRY, substantially on the
same terms,
in order to allocate his time and services between the Company and the Subsidiary.
 
Effective
as of January 1, 2024, the monthly consulting fee of the Chief Scientific Officer is NIS 117,040 ($32). Effective as of July 1,
2024, the monthly consulting fee of the Chief Scientific Officer is NIS 134,550 ($37). 
 
Effective
November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd. (“Shnida”), whereby the President and
Chief Executive Officer, through Shnida, provides services as President and Chief Executive Officer of the Company. The agreement is
terminable by either party upon 140 days prior written notice. The agreement provides that Shnida will be reimbursed for reasonable
expenses
incurred in connection with performance of the agreement. Effective as of January 1, 2024, the President and Chief Executive
Officer
receives a monthly consulting fee of NIS 96,825 ($26). Effective as of July 1, 2024, the monthly consulting fee of the President
and
Chief Executive Officer is NIS 111,349 ($31). Pursuant to the agreement, Shnida and the President and Chief Executive Officer each
agree
that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit
employees
of the Company.
 
In addition, the Company, through
the Subsidiary, has entered into an employment agreement with the President and Chief Executive
Officer, effective as of November 1,
2022, pursuant to which, effective as of January 1, 2024, the President and Chief Executive Officer
receives gross monthly salary of
NIS 51,591 ($14) in consideration for his services as President and Chief Executive Officer of the
Subsidiary. Effective as of July
1, 2024, the President and Chief Executive Officer receives gross monthly salary of NIS 59,330 ($16) in
consideration for his
services as President and Chief Executive Officer of the Subsidiary. In addition, the President and Chief Executive
Officer is
provided with a phone and a company car pursuant to the terms of his agreement.
 
F-39

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 14
- RELATED PARTY TRANSACTIONS (continued):
 
b.
Balances with related parties:
 
 
 
December 31,
 
 
 
2024
   
2023
 
Accounts payable and accrued expenses - Shnida
  $
175    $
160 
Accounts payable and accrued expenses - KNRY
   
154     
165 
Total payable to related parties
  $
329    $
325 
 
c.
Expenses to related parties:
 
 
 
Year
ended 
December 31,
 
 
 
2024
   
2023
 
KNRY
  $
563    $
486 
Shnida
   
514     
445 
Nadav Kidron (President
and Chief Executive Officer)
  $
297    $
296 
 
NOTE 15
- SUBSEQUENT EVENTS:
 
A.
RSUs
granted
 
On
 January 2, 2025, the Company granted 1,023,000 RSUs representing a right to receive shares of the Company’s common stock to the
Company’s executive officers. The total amount of the RSUs shall vest in equal quarterly installments of approximately 85,249 over
a three year
period starting with the first quarterly vesting on January 1, 2025. The total fair value of these RSUs on the date of grant
was $2,465 based on the
quoted closing market share price of $2.41 on the Nasdaq Capital Market on the date of grant.
 
B.
PSUs
granted
 
On
January 2, 2025, the Company granted 328,500 PSUs representing a right to receive shares of the Company’s common stock to the Company’s
executive officers. The total amount of the PSUs shall vest upon at the earliest of (1) the closing of a joint venture (“JV”)
transaction with HTIT;
or (2) the repayment to the Company of the value of its principal investment in Scilex plus 10%. The total fair
value of these PSUs on the date of
grant was $792 based on the quoted closing market share price of $2.41 on the Nasdaq Capital Market
on the date of grant.
 
F-40

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 15
- SUBSEQUENT EVENTS (continued):
 
 
B.
PSUs granted (continued):
 
The Company modified 294,000 outstanding
PSUs that were granted to the Company’s Executive Officers, adjusting the vesting criteria and
performance targets. The Company
 will recognize stock-based compensation expense equal to the unrecognized grant-date fair value of the
original award plus any incremental
fair value arising from the modification over the remaining requisite service period.
 
As of March 27, 2025, all PSUs that
granted to the Company’s Executive Officers achieved the first updated performance target.
 
C.
Scilex
investment
 
Tranche
B Note Consent
 
On January 2, 2025, the Company and other Tranche B Noteholders entered
into deferral and consent agreements with Scilex (the “Tranche B
Consent”), deferring Scilex’s first amortization payment
under the Tranche B Note to October 8, 2026. In consideration, the Company received
$877 ($555 of the principal amount and $322 accrued
interest), and 2,500,000 Scilex Common Stock shares.
 
In
addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
 
 
●
Scilex and the Tranche B Noteholders agreed to a 10-year, assignable 4% royalty on global net sales of Gloperba and Elyxyb, excluding
Elyxyb sales in Canada, with the Company entitled to 2%. Gloperba, an oral liquid colchicine formulation for gout, and Elyxyb, an oral
solution for acute migraine treatment, represent key assets in Scilex’s portfolio. The agreement was signed on February 28, 2025.
 
●
The Tranche B Noteholders have the option to fund up to 50% of the cash purchase price for Ex-US Product Rights to Gloperba and Elyxyb
(excluding Elyxyb in Canada) and will receive proportional revenues from commercialization and licensing.
 
●
Scilex granted the Tranche B Noteholders exclusive rights to develop and commercialize Elyxyb in Canada, entitling them to 50% of net
revenue.
 
Tranche
A Note Maturity Date Extension Amendment
 
On
January 21, 2025, the Company entered into an amendment to the Tranche A Note (the “Tranche A Extension Amendment”), extending
the
maturity date from March 21, 2025, to December 31, 2025 (the “Extended Maturity Date”). Interest will continue to accrue
and be payable on the
Extended Maturity Date. In consideration of the extension, the Company received 3,250,000 shares of Scilex Common
Stock.
 
Lidocaine
License Agreement
 
As
part of the binding term sheet signed with Scilex under the Tranche B Note, on February 22, 2025, the Company, through its 50% ownership
in
RoyaltyVest, entered into an additional License Agreement with Scilex. Under this agreement, RoyaltyVest acquired exclusive rights
to develop,
manufacture, and commercialize lidocaine-based products, including ZTlido (lidocaine topical system 1.8%) and SP-103, outside
 the United
States. As part of the arrangement, RoyaltyVest and Scilex will each receive 50% of the net profits from the commercialization
of these products.
Given the Company’s 50% ownership in RoyaltyVest, Oramed effectively holds a 25% share in the profits generated
under this agreement.
 
F-41

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 15
- SUBSEQUENT EVENTS (continued):
 
D.
Real
Estate – Castel
 
In January 2025, the Company entered into an agreement to acquire a
parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS
5,800 ($1,586). The transaction is structured in installments,
and as of March 27, 2025, the Company has paid $1,210 toward the acquisition
price. Under the agreement, the developer is responsible
for executing all development-related activities, and the company and the developer will
share the profits upon the future sale of the
property. The Company is currently evaluating the appropriate accounting treatment.
 
E.
JV
Supplemental Agreement
 
On
February 7, 2025, the Company and HTIT entered into a Joint Venture Agreement (the “JV Agreement”), amending the original
agreement
signed on January 22, 2024. The JV was formed to advance the development and commercialization of oral insulin, combining the
Company’s
proprietary technology and funding with HTIT’s manufacturing capabilities. Through this partnership, the JV will
have the technology, resources,
and production capacity to bring oral insulin to market.
 
The
initial closing, set for April 30, 2025, includes an investment of $40,000 by HTIT and $7,500 by the Company into OraTech. Additionally,
the
Company will transfer all its intellectual property rights to OraTech. Upon completion, both HTIT and the Company will receive OraTech
shares.
 
The
second closing, contingent on Nasdaq listing approval, involves a $20,000 investment by HTIT and an additional $7,500 investment by the
Company. It is expected to close by May 31, 2025, but no later than September 1, 2025.
 
The
agreement also outlines the spin-off of OraTech, requiring regulatory filings and the distribution of at least 60% of the Company’s
stake in
OraTech to its shareholders. Both the Company and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.
 
As
part of the JV Agreement, HTIT will receive $20,000 at the initial closing and $10,000 at the second closing under a Supply Agreement
with
OraTech.
 
F.
IIA
Payment
 
on
February 18, 2025, the Company received approval from the Israel Innovation Authority (IIA) to transfer all of its IIA-funded technology
to
OraTech in accordance with the terms of the JV agreement. This approval was granted upon the condition that the Company pays the aggregate
IIA grant amount, plus accrued interest, less all royalties paid to date.
 
On
February 27, 2025, the Company fulfilled its payment obligation by remitting $2,031 to the IIA, and as result the Company has no further
obligations to the IIA.
 
F-42

 
ORAMED
PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
 
NOTE 15
- SUBSEQUENT EVENTS (continued):
 
G. BioXcel
 
On March 4, 2025, the Company, through RoyaltyVest, participated in
a registered direct offering by BioXcel Therapeutics, Inc. (Nasdaq: BTAI)
(“BioXcel”), acquiring 2,000,000 shares of BioXcel’s
 common stock and accompanying warrants to purchase up to an additional 2,000,000
shares. The shares and warrants were purchased at a combined
 offering price of $3.50 per share and warrant, representing 50% of the total
4,000,000 shares issued in the offering. The warrants have
an exercise price of $4.20 per share, are immediately exercisable, and will expire five
years from the date of issuance.
 
BioXcel
is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology.
Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.
 
As of March 27, 2025, the Company, through RoyaltyVest, has sold 869,992
shares and continues to hold 1,130,008 shares of BioXcel common
stock.
 
H. Real
Estate Transactions
 
On March 24, 2025, the Company entered into a loan agreement to finance
a purchase of a real estate asset in Jerusalem Israel in the amount of
$22,650. The loan has a one-year maturity and is secured by a first-ranking
mortgage on a property valued at approximately $800,000, providing
significant collateral coverage. The loan bears an annual interest
rate of 12%.
 
F-43

 
(b) Exhibits
  
3.1
  Composite
Copy of Certificate of Incorporation, as amended as of January 22, 2013, corrected February 8, 2013, as amended as of July 25,
2014, corrected September 5, 2017 and as further amended as of August 3, 2020 (incorporated by reference from our annual report on
Form
10-K filed November 24, 2020)
 
   
3.2*
  Fifth
Amended and Restated By-laws, adopted effective March 27, 2025.
 
   
3.3*
  Fifth Amended and Restated By-laws, adopted effective March 27, 2025 (marked copy).
 
   
4.1
  Specimen Common Stock Certificate (incorporated by reference from our registration statement on Form S-1 filed February 1, 2013).
 
   
4.2*
  Description of Securities.
 
   
10.1+
  Consulting
Agreement by and between Oramed Pharmaceuticals Inc. and Shnida Ltd., entered into as of November 1, 2022, for the services
of Nadav
Kidron (incorporated by reference from our annual report on Form 10-K filed March 6, 2023).
 
   
10.2+
  Amendment,
dated April 27, 2023, to Consulting Agreement by and between Oramed Pharmaceuticals Inc. and Shnida Ltd., entered into as
of November
1, 2022, for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed March 6,
2024).
 
   
10.3+
  Amendment,
dated January 8, 2024, to Consulting Agreement by and between Oramed Pharmaceuticals Inc. and Shnida Ltd., entered into
as of November
1, 2022, for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed March 6,
2024).
 
   
10.4+
  Employment
Agreement by and between Oramed Ltd. and Nadav Kidron, entered into as of November 1, 2022 (incorporated by reference
from our annual
report on Form 10-K filed March 6, 2023).
 
   
10.5+
  Amendment,
dated April 27, 2023, to Employment Agreement by and between Oramed Ltd. and Nadav Kidron, entered into as of
November 1, 2022 (incorporated
by reference from our annual report on Form 10-K filed March 6, 2024).
 
   
10.6+
  Amendment,
dated January 8, 2024, to Employment Agreement by and between Oramed Ltd. and Nadav Kidron, entered into as of
November 1, 2022 (incorporated
by reference from our annual report on Form 10-K filed March 6, 2024).
 
   
10.7+
  Consulting
Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron
(incorporated
by reference from our current report on Form 8-K filed July 2, 2008).
 
   
10.8+
  Amendment,
dated November 13, 2014, to Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1,
2008, for
the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
 
   
10.9+
  Amendment,
dated July 13, 2013, to Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008
for the services
of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
 
   
10.10+
  Amendment,
dated July 21, 2015, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008,
for the
services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2015).
 
   
10.11+
  Amendment,
dated June 27, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008,
for the
services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
 
68

 
 
10.12+
  Amendment,
dated June 30, 2017, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008,
for the
services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 29, 2017).
 
   
10.13+
  Amendment,
dated January 10, 2020, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1,
2008, for
the services of Miriam Kidron (incorporated by reference from our quarterly report on Form 10-Q filed April 6, 2020).
  
10.14+
  Amendment,
dated September 19, 2021, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1,
2008, for
the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 24, 2021).
 
   
10.15+
  Amendment,
dated April 27, 2023, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1,
2008, for the
services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed March 6, 2024).
 
   
10.16+
  Amendment,
dated January 8, 2024, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1,
2008, for the
services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed March 6, 2024).
 
 
10.17*
  Employment
Agreement, dated June 6, 2024, between Oramed Ltd. and Avraham Gabay (incorporated by reference from our quarterly
report on Form
10-Q filed August 4, 2024).
 
   
10.18+
  Representative
 Form of Indemnification Agreements between Oramed Pharmaceuticals Inc. and each of our directors and officers
(incorporated by reference
from our quarterly report on Form 10-Q filed August 14, 2024).
 
10.19+
  Oramed
Pharmaceuticals Inc. Second Amended and Restated 2008 Stock Incentive Plan (incorporated by reference from our definitive
proxy statement
on Schedule 14A filed August 4, 2016).
 
   
10.20+
  Form
of Restricted Stock Unit Notice and Restricted Stock Unit Agreement (incorporated by reference from our annual report on Form 10-
K
filed November 14, 2014).
 
   
10.21+
  Form
of Restricted Stock Unit Notice and Restricted Stock Unit Agreement between the Company and the Chief Scientific Officer or Chief
Executive Officer (incorporated by reference from our annual report on Form 10-K filed November 29, 2017).
 
69

 
 
10.22+
  Form
of Notice of Stock Option Award and Stock Option Award Agreement (incorporated by reference from our current report on Form 8-
K filed
July 2, 2008).
 
   
10.23+
  Oramed
Pharmaceuticals Inc. 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A
filed
August 6, 2019).
 
   
10.24+
  Oramed
Pharmaceuticals Inc. Amended and Restated 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy
statement
on Schedule 14A filed June 30, 2020).
 
   
10.25+
  Amendment
to Oramed Pharmaceuticals Inc. Amended and Restated 2019 Stock Incentive Plan (incorporated by reference from our
definitive proxy
statement on Schedule 14A filed June 2, 2022).
 
   
10.26+
  Form
of Notice of Stock Option Award and Stock Option Award Agreement (incorporated by reference from our annual report on Form 10-
K filed
November 27, 2019).
 
   
10.27+
  Form
of Restricted Stock Unit Notice and Restricted Stock Unit Agreement (incorporated by reference from our annual report on Form 10-
K
filed March 6, 2023).
  
10.28
  Patent
Transfer Agreement, dated February 22, 2011, between Oramed Ltd. and Entera Bio Ltd. (incorporated by reference from our
registration
statement on Form S-1 filed March 25, 2011).
 
   
10.29
  Amended
and Restated Technology License Agreement, dated December 21, 2015, between Hefei Tianhui Incubator of Technologies Co.,
Ltd., Oramed
Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been granted for portions of this document) (incorporated
by reference
from our quarterly report on Form 10-Q filed January 13, 2016).
 
   
10.30
  Amendment to the Amended and Restated Technology License Agreement, dated June 3, 2016, between Hefei Tianhui Incubator of
Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been requested for portions of this
document. The confidential portions will be omitted and filed separately, on a confidential basis, with the Securities and Exchange
Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
 
   
10.31
  Amendment to the Amended and Restated Technology License Agreement, dated July 24, 2016, between Hefei Tianhui Incubator of
Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been requested for portions of this
document. The confidential portions will be omitted and filed separately, on a confidential basis, with the Securities and Exchange
Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
 
   
10.32
  Joint
Venture Agreement, dated January 22, 2024, among Oramed Pharmaceuticals Inc., Oramed Ltd., Hefei Tianhui Biotech Co., Ltd. and
Technowl
Limited (incorporated by reference from our current report on Form 8-K filed January 23, 2024).
 
   
10.33
  At
the Market Offering Agreement, dated March 18, 2024, by and among the Company, Rodman & Renshaw LLC and StockBlock
Securities
LLC. (incorporated by reference from our current report on Form 8-K filed March 18, 2024).
 
   
10.34
  License
Agreement, dated as of March 18, 2021, between the Company, Oramed Ltd. and Oravax Medical Inc. (incorporated by reference
from our
current report on Form 8-K filed March 19, 2021).
 
70

 
 
10.35
  Stockholders
Agreement, dated as of March 18, 2021, between Oramed Pharmaceuticals Inc., Akers Biosciences Inc., Premas Biotech PVT
Ltd., Cutter
Mill Capital LLC, and Run Ridge LLC. (incorporated by reference from our Form 8-K filed March 19, 2021).
 
   
10.36§
  Securities
Purchase Agreement, dated September 21, 2023 by and between Scilex Holding Company and Oramed Pharmaceuticals Inc.
(incorporated
by reference from our current report on Form 8-K filed September 26, 2023).
 
   
10.37
  Senior
 Secured Promissory Note, dated September 21, 2023 issued to Oramed Pharmaceuticals Inc. by Scilex Holding Company
(incorporated by
reference from our current report on Form 8-K filed September 26, 2023).
 
   
10.38
  Warrant
No. ORMP CS-1 to Purchase Common Stock of Scilex Holding Company (incorporated by reference from our current report on
Form 8-K filed
September 26, 2023).
 
   
10.39
  Warrant
No. ORMP CS-2 to Purchase Common Stock of Scilex Holding Company (incorporated by reference from our current report on
Form 8-K filed
September 26, 2023).
 
   
10.40
  Warrant
No. ORMP CS-3 to Purchase Common Stock of Scilex Holding Company (incorporated by reference from our current report on
Form 8-K filed
September 26, 2023).
 
   
10.41
  Warrant
No. ORMP CS-4 to Purchase Common Stock of Scilex Holding Company (incorporated by reference from our current report on
Form 8-K filed
September 26, 2023).
 
   
10.42
  Warrant
No. ORMP CS-5 to Purchase Common Stock of Scilex Holding Company (incorporated by reference from our current report on
Form 8-K filed
September 26, 2023).
 
   
10.43
  Scilex
Holding Company Specimen Warrant Certificate (incorporated by reference from our current report on Form 8-K filed September
26, 2023).
 
   
10.44
  Registration
Rights Agreement, dated September 21, 2023, by and between Oramed Pharmaceuticals Inc. and Scilex Holding Company
(incorporated by
reference from our current report on Form 8-K filed September 26, 2023).
 
   
10.45§
  Subsidiary
Guarantee, dated September 21, 2023, by and among Oramed Pharmaceuticals, Acquiom Agency Services LLC, Scilex Holding
Company, and
certain subsidiaries of Scilex Holding Company party thereto (incorporated by reference from our current report on Form 8-
K filed
September 26, 2023).
 
   
10.46
  Security
Agreement, dated September 21, 2023, by and among Oramed Pharmaceuticals, Acquiom Agency Services LLC, Scilex Holding
Company, and
certain subsidiaries of Scilex Holding Company party thereto (incorporated by reference from our current report on Form 8-
K filed
September 26, 2023).
 
   
10.47
  Mutual
 Termination and Release Agreement, dated September 21, 2023, by and between Sorrento Therapeutics, Inc. and Oramed
Pharmaceuticals,
Inc. (incorporated by reference from our current report on Form 8-K filed September 26, 2023).
 
71

 
 
10.48+
  Oravax
Medical, Inc. 2021 Long-Term Incentive Plan (incorporated by reference from our annual report on Form 10-K filed March 6,
2023).
 
   
10.49+
  Oravax
Stock Option Agreement (incorporated by reference from our annual report on Form 10-K filed March 6, 2023).
 
 
10.50
  Letter
 Agreement, dated as of September 20, 2024, by and between Oramed Pharmaceuticals Inc. and Scilex Holding Company
(incorporated by
reference from our current report on Form 8-K filed September 23, 2024).
 
   
10.51
  Master
Services Agreement dated September 23, 2024, between Oramed Ltd. and InClin, Inc. (incorporated by reference from our current
report
on Form 8-K filed September 26, 2024).
 
   
10.52
  Securities
Purchase Agreement, dated October 7, 2024, by and between Scilex Holding Company and the investors signatory thereto
(incorporated
by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.53
  Amendment
No. 1 to Scilex-Oramed SPA, dated October 8, 2024, by and between Scilex Holding Company and Oramed Pharmaceuticals
Inc (incorporated
by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.54
  Tranche
B Senior Secured Convertible Note, dated October 8, 2024, issued by Scilex Holding Company to the Company (incorporated by
reference
from our current report on Form 8-K filed October 8, 2024).
 
   
10.55
  Warrant
to Purchase Common Stock, dated October 8, 2024, issued by Scilex Holding Company to the Company (incorporated by
reference from
our current report on Form 8-K filed October 8, 2024).
 
   
10.56
  Purchase
and Sale Agreement, dated October 8, 2024, by and among Scilex Holding Company, Silex Pharmaceuticals Inc. and the
purchasers signatory
thereto (incorporated by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.57
  Security
Agreement, dated October 8, 2024, by and among Scilex Pharmaceuticals Inc., and the purchasers signatory thereto (incorporated
by
reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.58
  Subordination
Agreement, dated October 8, 2024, by and among Scilex Pharmaceuticals Inc., Acquiom Agency Services LLC and other
signatories thereto
(incorporated by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.59
  Consent
and Amendment, dated as of October 8, 2024, by and between Scilex Holding Company and Oramed Pharmaceuticals Inc.
(incorporated by
reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.60
  Subsidiary
Guarantee Amendment, dated October 8, 2024, made by certain of Scilex Holding Company subsidiaries in favor of the holders
of
that certain Tranche A Note (incorporated by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.61
  Amended
and Restated Security Agreement, dated October 8, 2024, by and among Scilex Holding Company, the Subsidiaries of Scilex
Holding Company
party thereto, Oramed Pharmaceuticals Inc. and Acquiom Agency Services LLC (incorporated by reference from our
current report on
Form 8-K filed October 8, 2024).
 
   
10.62
  Rest
of World License Term Sheet, dated October 8, 2024, between Oramed Pharmaceuticals Inc., Scilex Holding Company and the other
parties
signatories thereto (incorporated by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.63
  Agreement
Among Holders, dated October 8, 2024, by and between Oramed Pharmaceuticals Inc., Acquiom Agency Services LLC and the
other signatories
thereto (incorporated by reference from our current report on Form 8-K filed October 8, 2024).
 
   
10.64
  Deferral
and Consent under Tranche B Senior Secured Convertible Note, dated January 2, 2025, by and among Scilex Holding Company,
Oramed Pharmaceuticals
Inc., SCLX Stock Acquisition JV LLC and Acquiom Agency Services LLC (incorporated by reference from our
current report on Form 8-K
filed January 3, 2025).
 
   
10.65
  Amendment
to Senior Secured Promissory Note, dated January 21, 2025, by and among Scilex Holding Company, Oramed Pharmaceuticals
Inc., and
SCLX Stock Acquisition JV LLC (incorporated by reference from our current report on Form 8-K filed January 22, 2025).
 
   
10.66
  Ancillary
 Agreement Completion Protocol and Supplemental Agreement, dated as of February 7, 2025, by and among Oramed
Pharmaceuticals Inc.,
 Oramed NewCo, Inc., Oramed Ltd., Hefei Tianhui Biotech Co., Ltd. and Technowl Limited (incorporated by
reference from our current
report on Form 8-K filed February 11, 2025).
 
72

 
 
10.67
  Form
of Registration Rights Agreement, to be executed by and among Oramed Pharmaceuticals Inc., Oramed NewCo, Inc. and Technowl
Limited
(incorporated by reference from our current report on Form 8-K filed February 11, 2025).
 
   
10.68
  Asset
Transfer Agreement, dated as of February 7, 2025, by and among Oramed Pharmaceuticals Inc., Oramed NewCo, Inc. and Oramed
Ltd (incorporated
by reference from our current report on Form 8-K filed February 11, 2025).
 
   
10.69
  Supply
Agreement, dated as of February 7, 2025, by and among Oramed NewCo, Inc., Hefei Tianhui Biotech Co., Ltd. and Technowl
Limited (incorporated
by reference from our current report on Form 8-K filed February 11, 2025). 
 
   
10.70
  License
Agreement, dated as of February 7, 2025, by and among Oramed NewCo, Inc., Hefei Tianhui Biotech Co., Ltd. and Technowl
Limited (incorporated
by reference from our current report on Form 8-K filed February 11, 2025).
 
   
10.71
  Novation
Agreement and Release, effective as of February 7, 2025, by and among Oramed Pharmaceuticals Inc., Oramed Ltd. Oramed
NewCo Inc.,
and Hefei Tianhui Biotech Co., Ltd (incorporated by reference from our current report on Form 8-K filed February 11, 2025).
 
   
10.72+*
  Amendment, dated November 7, 2024, to Consulting Agreement by and between Oramed Pharmaceuticals Inc. and Shnida Ltd., entered
into as of November 1, 2022, for the services of Nadav Kidron.
 
   
10.73+*
  Amendment, dated November 7, 2024, to Employment Agreement by and between Oramed Ltd. and Nadav Kidron, entered into as of
November 1, 2022.
 
   
10.74+*
  Amendment, dated November 7, 2024, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1,
2008, for the services of Miriam Kidron.
 
   
19.1*
  Oramed Pharmaceuticals Inc. Insider Trading Policy.
 
   
21.1*
  Subsidiaries.
 
   
23.1*
  Consent
of Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited,
an
independent registered public accounting firm.
 
   
31.1*
  Certification Statement of the Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of
1934, as amended.
 
   
31.2*
  Certification Statement of the Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934,
as amended.
 
   
32.1**
  Certification Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350.
 
   
32.2**
  Certification Statement of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
 
   
97.1
  Oramed Pharmaceuticals Inc. Clawback Policy, adopted November 9, 2023 (incorporated by reference from our annual report on Form 10-
K filed March 6, 2024).
 
   
101.1*
  The following financial
statements from the Company’s annual report on Form 10-K for the year ended December 31, 2024, formatted in
XBRL (eXtensible
Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Loss, (iii) Consolidated
Statements
of Changes in Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows and (v) the Notes to Consolidated Financial
Statements, tagged as blocks of text and in detail.
 
   
104.1*
  Cover Page Interactive
Data File (formatted as Inline XBRL and contained in Exhibit 101).
 
*
Filed herewith.
 
**
Furnished herewith.
 
+
Management contract or
compensation plan.
 
§
Certain exhibits and similar
attachments to this agreement have been omitted in accordance with Item 601(a)(5) of Regulation S-K. A copy of any
omitted exhibit
or other attachment will be furnished supplementary to the SEC upon request.
 
ITEM
16. FORM 10-K SUMMARY.
 
None.
 
73

 
 
SIGNATURES
 
Pursuant
to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed
on its behalf by the undersigned, thereunto duly authorized.
 
 
ORAMED PHARMACEUTICALS
INC.
 
 
 
/s/
Nadav Kidron
 
Nadav Kidron,
 
President and Chief Executive
Officer
 
 
 
Date: March 27, 2025
 
Pursuant
to the requirements of the Securities and Exchange Act of 1934, this report has been signed below by the following persons on behalf
of
the registrant and in the capacities and on the dates indicated.
 
/s/
Nadav Kidron
 
March 27,
2025
Nadav Kidron,
 
 
President and Chief Executive
Officer and Director
 
 
(principal executive officer)
 
 
 
 
 
/s/
Avraham Gabay
 
March 27, 2025
Avraham Gabay,
 
 
Chief Financial Officer
 
 
(principal financial and
accounting officer)
 
 
 
 
 
/s/
Daniel Aghion
 
March 27, 2025
Daniel Aghion,
 
 
Director
 
 
 
 
 
/s/
Miriam Kidron
 
March 27, 2025
Miriam Kidron,
 
 
Director
 
 
 
 
 
/s/
Arie Mayer
 
March 27, 2025
Arie Mayer,
 
 
Director
 
 
 
 
 
/s/
Yehuda Reznick
 
March 27, 2025
Yehuda Reznick,
 
 
Director
 
 
 
 
 
/s/
Leonard Sank
 
March 27, 2025
Leonard Sank,
 
 
Director
 
 
 
 
 
/s/
Benjamin Shapiro
 
March 27, 2025
Benjamin Shapiro,
 
 
Director
 
 
 
 
74
 
 

Exhibit 3.2
 
ORAMED PHARMACEUTICALS
INC.
FOURTH AMENDED
AND RESTATED BY-LAWS
ARTICLE I
OFFICES
 
1. The location of the registered
 office of the Corporation, and the name of its registered agent, shall be as set forth in the Certificate of
Incorporation.
 
2. The Corporation shall
in addition to its registered office in the State of Delaware establish and maintain an office or offices at such place or
places as the
Board of Directors may from time to time find necessary or desirable.
 
ARTICLE II
CORPORATE SEAL
 
The Corporation may or may not have a corporate
seal, as may be determined from time to time by the Board of Directors. If adopted, the corporate seal of
the Corporation shall have inscribed
thereon the name of the Corporation and may be in such form as the Board of Directors may determine. Such seal may
be used by causing
it or a facsimile thereof to be impressed, affixed or otherwise reproduced.
 
ARTICLE III
MEETINGS OF STOCKHOLDERS
 
1. All meetings of the stockholders
shall be held at the registered office of the Corporation in the State of Delaware or at such other place, as shall
be determined from
 time to time by the Board of Directors. The Board of Directors may, in its sole discretion, determine that any meeting of the
stockholders
shall not be held at any place, but may instead be held solely by means of remote communication in accordance with Section 211 of the
General Corporation Law of the State of Delaware.
 
2. The annual meeting of
stockholders shall be held on such day and at such time as may be determined from time to time by resolution of the
Board of Directors,
when they shall elect, by majority vote pursuant to Section 5 of this Article III, directors to hold office until the annual meeting of
stockholders held next after their election and their successors are respectively elected and qualified, or until their earlier death,
disqualification, resignation
or removal; provided, however, that in a contested election, a nominee shall be elected by a plurality of
the votes cast by the stockholders entitled to vote at
the election on such election of directors. An election shall be considered
contested if, as of the last date on which nominees for director may be submitted
in accordance with these By-laws, the nominees
for election to the Board of Directors exceeds the number of positions on the Board of Directors to be
filled by election at that meeting.
If an incumbent director is not re-elected, the director shall tender his or her resignation to the Board of Directors. The
Nominating
and Corporate Governance Committee of the Board of Directors (or any future committee the equivalent thereof) will make a recommendation
to the Board of Directors on whether to accept or reject the resignation, or whether other action should be taken. The Board of Directors
will act on the
recommendation of such committee and will publicly disclose its decision within ninety (90) days from the date of the
certification of the election results.
A director who tenders his or her resignation may not participate in any meeting of the Board of
Directors or any committee thereof until the Board of
Directors has determined not to accept his or her resignation. Any other proper
business may be transacted at the annual meeting.
 
3. The holders of at least
one third (1/3) of the stock issued and outstanding and entitled to vote on the subject matter, present in person or
represented by proxy,
shall constitute a quorum at all meetings of the stockholders for the transaction of business, except as otherwise expressly provided
by statute, by the Certificate of Incorporation or by these By-laws. If, however, such holders shall not be present or represented at
any meeting of the
stockholders, the stockholders entitled to vote on the subject matter, present in person or by proxy, shall have power
to adjourn the meeting from time to
time, without notice other than announcement at the meeting (except as otherwise provided by statute).
At such adjourned meeting at which a quorum is
present, any business may be transacted which might have been transacted at the meeting
as originally notified.
 
 

 
 
4. At all meetings of the
stockholders each stockholder having the right to vote on the subject matter shall be entitled to vote in person, or by
proxy, but no
proxy shall be voted or acted upon more than three years after its date, unless the proxy provides for a longer period.
 
5. Unless otherwise provided
in the Certificate of Incorporation, at each meeting of the stockholders each stockholder shall have one vote for each
share of capital
stock having voting power, registered in his or her name on the books of the Corporation at the record date fixed for voting in accordance
with these By-laws, or otherwise determined, with respect to such meeting. Unless a different or minimum vote is required by law or regulation
applicable
to the Corporation or its securities, by the Certificate of Incorporation, by these By-laws or by the rules or regulations
of any stock exchange applicable to
the Corporation, in which case such different or minimum vote shall be the applicable vote on the
matter, all matters coming before any meeting of the
stockholders, including the election of directors, shall be decided by a majority
of the votes cast by the holders of shares of stock present in person or
represented by proxy at such meeting and entitled to vote on
the subject matter, a quorum being present; provided, however, that in a contested election, a
nominee shall be elected by a plurality
of the votes cast by the stockholders entitled to vote at the election on such election of directors. Votes cast shall
include votes “for”
and votes “against” and exclude “abstentions” and “broker non-votes” with respect to the subject matter.
 
6. Notice of each meeting
of the stockholders shall be given to each stockholder entitled to vote thereat not less than ten (10) nor more than sixty
(60) days before
the date of the meeting. Such notice shall state the place, date and hour of meeting, the record date for determining the stockholders
entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the
meeting, the means of
remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and
vote at such meeting and, in the case
of a special meeting, the purpose or purposes for which the meeting is called.
 
7. The Corporation shall
prepare, no later than the tenth (10th) day before each meeting of stockholders, a complete list of the stockholders entitled
to vote
at said meeting (provided, however, if the record date for determining the stockholders entitled to vote is less than ten (10) days before
the date of
the meeting, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date), arranged
in alphabetical order, showing the
address of each stockholder and the number of shares registered in the name of each stockholder. Such
 list shall be open to the examination of any
stockholder, for any purpose germane to the meeting for a period of 10 days ending on the
day before the meeting date, (a) on a reasonably accessible
electronic network, provided that the information required to gain access
to such list is provided with the notice of the meeting, or (b) during ordinary
business hours, at the principal place of business of
the Corporation. In the event that the Corporation determines to make the list available on an electronic
network, the Corporation may
take reasonable steps to ensure that such information is available only to stockholders of the Corporation.
 
8. Special meetings of the
stockholders, for any purpose or purposes, unless otherwise prescribed by statute, may be called by the majority of the
Board of Directors,
but such meetings may not be called by any other person or persons.
 
9. Only such business shall
be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the
Corporation’s notice
of meeting.
 
10. The order of business
at each meeting of stockholders shall be determined by the person presiding over the meeting.
 
11. (a) In order that the
Corporation may determine the stockholders entitled to consent to corporate action by consent and without a meeting of
stockholders, the
Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date
is
adopted by the Board of Directors, and which date shall not be more than ten (10) days after the date upon which the resolution fixing
the record date is
adopted by the Board of Directors. Any stockholder of record seeking to have the stockholders authorize or take corporate
action by consent in lieu of a
meeting of stockholders shall, by written notice delivered to the Secretary of the Corporation at the principal
executive offices of the Corporation, request
that the Board of Directors fix a record date. The written notice must contain the information
set forth in Section 11(b) of this Article III. The Board of
Directors shall promptly, but in all events within ten (10) days after the
date on which such written notice is received by the Secretary of the Corporation,
determine the validity of the request, and if appropriate,
adopt a resolution fixing the record date (unless a record date has previously been fixed by the
Board of Directors pursuant to the first
sentence of this Section 11(a) of Article III). If no record date has been fixed by the Board of Directors pursuant to
the first sentence
of this Section 11(a) of Article III or otherwise within ten (10) days after the date on which such written notice is received by the
Secretary of the Corporation, the record date for determining stockholders entitled to consent to corporate action by consent and without
a meeting, when
no prior action by the Board of Directors is required by applicable law, shall be the first date after the expiration
of such ten (10) day time period on which
a signed consent setting forth the action taken or proposed to be taken is delivered to the
Corporation by delivery to its registered office in Delaware by
hand or by certified or registered mail, return receipt requested, to
its principal place of business or to any officer or agent of the Corporation having
custody of the book in which proceedings of meetings
of stockholders are recorded. If no record date has been fixed by the Board of Directors pursuant to
the first sentence of this Section
11(a) of Article III and prior action by the Board of Directors is required by applicable law, the record date for determining
stockholders
entitled to consent to corporate action by consent and without a meeting shall be at the close of business on the date on which the Board
of
Directors adopts the resolution taking such prior action.
 
2

 
 
(b) Any stockholder’s
notice required by Section 11(a) of Article III must describe the action that the stockholder proposes to take by consent.
For each such
proposal, every notice by a stockholder must state (x) the information required by Section 2 of Article IV and Section 2 of Article V
as
though such stockholder was intending to make a nomination or to bring any such business before a meeting of stockholders and (y) the
text of the proposal
(including the text of any resolutions to be effected by consent and the language of any proposed amendment to these
 By-Laws). In addition to the
foregoing, the notice must state as to the stockholder giving the notice and the beneficial owner, if any,
on whose behalf the notice is given a representation
whether the stockholder or the beneficial owner, if any, intends or is part of a
 group which intends to (x) deliver a proxy statement and/or consent
solicitation statement to stockholders of at least the percentage
of the Corporation’s outstanding capital stock required to effect the action by consent either
to solicit consents or to solicit
proxies to execute consents, and/or (y) otherwise solicit proxies or consents from stockholders in support of the action to be
taken by
consent. The Corporation may require the stockholder of record and/or beneficial owner requesting a record date for proposed stockholder
action
by consent to furnish such other information as it may reasonably require to determine the validity of the request for a record
date.
 
(c) In the event of the delivery,
in the manner provided by this Section 11 of Article III and applicable law, to the Corporation of consent or
consents to take corporate
action and/or any related revocation or revocations, the Corporation shall engage independent inspectors of elections for the
purpose
 of performing promptly a ministerial review of the validity of the consents and any consent revocations. For the purpose of permitting
 the
inspectors to perform such review, no stockholder action by consent and without a meeting shall be effective until such inspectors
have completed their
review, determined that the requisite number of valid and unrevoked consents delivered to the Corporation in accordance
with this Section 11 of Article III
and applicable law have been obtained to authorize or take the action specified in the consents, and
certified such determination for entry in the records of
the Corporation kept for the purpose of recording the proceedings of meetings
of stockholders. Nothing contained in this Section 11(c) of Article III shall in
any way be construed to suggest or imply that the Board
of Directors or any stockholder shall not be entitled to contest the validity of any consent or
revocation thereof, whether before or
after such certification by the independent inspectors, or to take any other action (including, without limitation, the
commencement,
prosecution or defense of any litigation with respect thereto, and the seeking of injunctive relief in such litigation).
 
(d) No stockholder consent
to corporate action without a meeting of stockholders shall be effective to take the corporate action referred to
therein unless, within
sixty (60) days after the first date a consent is delivered in accordance with this Section 11 of Article III, a valid consent or valid
consents signed by a sufficient number of stockholders to take such action are delivered to the Corporation in the manner prescribed in
this Section 11 of
Article III and applicable law, and not revoked.
 
3

 
 
ARTICLE IV
STOCKHOLDER PROPOSALS
 
1. At an annual meeting of
 stockholders, only such stockholder business shall be conducted as shall have been properly brought before the
meeting. To be properly
brought before an annual meeting of stockholders, stockholder business (other than the nominations of persons for election to the
Board
of Directors, which shall be set forth in Article V) must be: (i) specified in the notice of the meeting (or any supplement thereto) given
by or at the
direction of the Board of Directors or any committee thereof, (ii) otherwise properly brought before the meeting by or at
the direction of the Board of
Directors or any committee thereof, or (iii) otherwise properly brought before an annual meeting by a stockholder
(a) who is a stockholder of record of the
Corporation at the time the notice provided for in this Article IV is delivered to, or mailed
and received by, the Secretary of the Corporation, on the record
date for the determination of stockholders of the Corporation entitled
to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the
meeting and (c) complies with the notice procedures
 set forth in this Article IV. In addition, any proposal of stockholder business (other than the
nomination of persons for election to
the Board of Directors) must be a proper matter for stockholder action.
 
2. For business (other than
the nomination of persons for election to the Board of Directors, which shall be governed by Article V herein) to be
properly brought
before the annual meeting by a stockholder, the stockholder or stockholders of record intending to propose the business must deliver a
timely and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
 
(i) to be timely, the advance
notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at
the principal executive
offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first
anniversary
date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date
that is more than thirty
(30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual
meeting of stockholders, including in the
event that no annual meeting was held in the previous year), notice by the proponent stockholder
in order to be timely must be so delivered, or mailed and
received by, the Secretary of the Corporation at the principal executive offices
of the Corporation, not earlier than the close of business on the 120th day
prior to the annual meeting and not later than the close of
business on the later of the 90th day prior to the date of such annual meeting or, if the first
“Public Announcement” (as
hereinafter defined in Section 9 of Article V) of the date of such annual meeting is less than one hundred (100) days prior to
the date
 of such annual meeting, the 10th day following the day on which Public Announcement of the date of such meeting is first made by the
Corporation.
In no event shall any adjournment or postponement of an annual meeting, or the Public Announcement thereof, commence a new time period
(or extend any notice time period) for the giving of a stockholder’s notice as described above;
 
(ii) in addition, to be
timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided
or required
to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business
days
prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed
and received by, the
Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business
days after the record date for the meeting
(in the case of the update and supplement required to be made as of the record date), and not
later than eight (8) business days prior to the date for the
meeting, or if the meeting is adjourned or postponed, on the first practicable
date after any adjournment or postponement thereof (in the case of the update
and supplement required to be made as of ten (10) business
days prior to the meeting or any adjournment or postponement thereof);
 
(iii) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the
Corporation’s books
and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
 
4

 
 
(iv) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of
capital stock or other
securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3
under
the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation
right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares
of capital stock or
other securities of the Corporation or with a price or value derived in whole or in part from the price or value of
any shares of capital stock or other
securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction
or arrangement having characteristics of a long or short
position or ownership interest in any shares of capital stock or other securities
of the Corporation, whether or not any such instrument or right shall be
subject to settlement in the underlying shares of capital stock
 or other securities of the Corporation or otherwise, and any other direct or indirect
opportunity to profit or share in any profit derived
from any increase or decrease in the price or value of shares of capital stock or other securities of the
Corporation directly or indirectly
 owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement,
arrangement, understanding
or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any
shares
 of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding
 or
relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent
stockholder has engaged in
or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the
economic risk of shares of capital stock or other
securities of the Corporation by, manage the risk of share price changes for, or increase
or decrease the voting power of, such proponent stockholder with
respect to shares of capital stock or other securities of the Corporation,
or which provides, directly or indirectly, the opportunity to profit from any increase
or decrease in the price or value of the shares
of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the
shares of any class
or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated
or
separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the
proponent stockholder,
directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or
series of capital stock of the Corporation or any
interests described in clause (d), (g) any proportionate interest in any security of
the Corporation or derivative instruments held, directly or indirectly, by a
general or limited partnership or limited liability company
or similar entity in which a proponent stockholder is a general partner or, directly or indirectly,
beneficially owns any interest in
a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the
manager or managing
member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the
last 12 months in any security of the Corporation (for purposes of these By-Laws, a person shall be deemed to have a “Short Interest”
in a security if such
person, directly or indirectly, though any contract, arrangement, understanding, relationship or otherwise, has
the opportunity to profit or share in any profit
derived from any decrease in the value of the subject security), (i) any direct or indirect
legal, economic or financial interest (including Short Interest) of a
proponent stockholder in the outcome of any (1) vote to be taken
at any annual or special meeting of stockholders of the Corporation or (2) any meeting of
stockholders of any other entity with respect
to any matter that is related, directly or indirectly, to any business proposed by any proponent stockholder
under Article IV, (j) any
direct or indirect legal, economic or financial interest (including Short Interest) in any principal competitor of the Corporation held
by a proponent stockholder, (k) any material pending or threatened action, suit or proceeding (whether civil, criminal, investigative,
administrative or
otherwise) in which a proponent stockholder is, or is reasonably expected to be made, a party or material participant
involving the Corporation or any of its
officers, directors or employees, or any affiliate of the Corporation, or any officer, director
or employee of such affiliate, and (l) any other information
relating to such stockholder and beneficial owner, if any, required to be
disclosed in a proxy statement or other filings required to be made in connection
with solicitations of proxies for the proposal pursuant
to and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended and the
rules and regulations promulgated thereunder;
 
(v) the proponent stockholder
must also disclose to the Corporation, as part of the advance notice, all stock ownership information required by
the immediately preceding
clause (iv) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on
whose
behalf the business proposed to be brought before the annual meeting is being brought, (b) any affiliate or associate (each within the
meaning of
Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner,
(c) any stockholder or
stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute
a filing group for purposes of
Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal
of such business;
 
(vi) the proponent stockholder
must represent to the Corporation, as part of the advance notice, whether the proponent intends individually or
as part of a group, to
(x) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital
stock
required to approve or adopt the proposal, and/or (y) to otherwise solicit proxies in support of such proposal;
 
(vii) the proponent stockholder
 must disclose to the Corporation, as part of its advance notice: (a) a reasonably brief description of the
business desired to be brought
before the meeting, the reasons for conducting such business at the meeting and any material interest of such stockholder
and beneficial
owner, if any, in such business, (b) the text of the proposal or business (including the text of any resolutions proposed for consideration
and
in the event that such business includes a proposal to amend the By-Laws of the Corporation, the language of the proposed amendment),
 and (c) a
reasonably detailed description of all agreements, arrangements and understandings between such proponent and the beneficial
owner, if any, and any other
person or persons (including their names) in connection with the proposal of such business by such stockholder;
 
5

 
 
(viii) the proponent stockholder
must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder
is a holder of record
of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation
entitled
to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the stockholder
business specified in the notice;
 
(ix) the proponent stockholder
must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the
information set forth
in the advance notice; and
 
(x) the proponent stockholder
must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial
and record owners) known
by the proponent stockholder to support the stockholder business to be proposed by the proponent stockholder and, to the extent
known,
the class or series and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
 
3. In addition to the provisions
of Section 2 of this Article IV, a stockholder shall also comply with all applicable requirements of state law and all
applicable requirements
of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth
herein.
 
4. Nothing in these By-laws
shall be deemed to affect any rights of stockholders to request the inclusion of proposals in the Corporation’s proxy
statement
pursuant to Rule 14a-8 under the Securities Exchange Act of 1934, as amended. Subject to Rule 14a-8 and Rule 14a-19 under the Securities
Exchange Act of 1934, as amended, nothing in these By-laws shall be construed to permit any stockholder, or give any stockholder the right,
to include or
have disseminated or described in the Corporation’s proxy statement any nomination of director or directors or any
other business proposal.
 
5. Except as otherwise expressly
 provided in any applicable rule or regulation promulgated under the Securities Exchange Act of 1934, as
amended, only such business (other
than the election of directors as set forth in Article V) shall be conducted at an annual meeting of stockholders as shall
have been brought
before the meeting in accordance with the procedures of this Article IV. Except as otherwise provided by law, the chairperson of the
meeting
shall have the power and duty (i) to determine whether any business proposed to be brought before the meeting was proposed in accordance
with
the provisions of this Article IV (including whether the proponent stockholder solicited (or are part of a group which solicited)
or did not so solicit, as the
case may be, proxies or votes in support of the proponent stockholder’s proposal in compliance with
the proponent stockholder’s representation as required
by clause (vi) of Section 2 of Article IV) and (ii) if any proposed business
was not proposed in compliance with Article IV, to declare that such proposed
business shall not be transacted. Notwithstanding the foregoing
provisions of this Article IV, unless otherwise required by law, if the proponent stockholder
(or a qualified representative of the proponent
 stockholder) does not appear at the annual meeting of stockholders of the Corporation to present the
proposed business, such proposed
business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the
Corporation. For
purposes of this Section 5 of Article IV, to be considered a qualified representative of the proponent stockholder, a person must be a
duly
authorized officer, manager or partner of such proponent stockholder or must be authorized by a writing executed by such proponent
stockholder or an
electronic transmission delivered by such proponent stockholder to act for such proponent stockholder as proxy at the
meeting of stockholders and such
person must produce such writing or electronic transmission, or a reliable reproduction of the writing
 or electronic transmission, at the meeting of
stockholders.
 
6

 
 
ARTICLE V
STOCKHOLDER DIRECTOR NOMINATIONS
 
1. At an annual meeting of
stockholders, only such nominations of persons for the election of directors shall be conducted as shall have been
properly brought before
the meeting. To be properly brought before an annual meeting of stockholders, nominations of persons for election to the Board of
Directors
must be: (i) specified in the notice of the meeting (or any supplement thereto) given by or at the direction of the Board of Directors
or any
committee thereof, (ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors or any committee
thereof, or (iii)
otherwise properly brought before an annual meeting by a stockholder (a) who is a stockholder of record of the Corporation
at the time the notice provided
for in this Article V is delivered to, or mailed and received by, the Secretary of the Corporation, on
the record date for the determination of stockholders of
the Corporation entitled to vote at the meeting, and at the time of the meeting,
(b) who is entitled to vote at the meeting and (c) complies with the notice
procedures set forth in this Article V.
 
2. Notwithstanding anything
in these By-laws to the contrary, for the nomination of persons for election to the Board of Directors to be properly
brought before the
annual meeting by a stockholder, the stockholder or stockholders of record intending to propose such nominations must deliver a timely
and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
 
(i) to be timely, the advance
notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at
the principal executive
offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first
anniversary
date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date
that is more than thirty
(30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual
meeting of stockholders, including in the
event that no annual meeting was held in the previous year), notice by the proponent stockholder
in order to be timely must be so delivered, or mailed and
received by, the Secretary of the Corporation at the principal executive offices
of the Corporation, not earlier than the close of business on the 120th day
prior to the annual meeting and not later than the close of
business on the later of the 90th day prior to the date of such annual meeting or, if the first Public
Announcement of the date of such
annual meeting is less than one hundred (100) days prior to the date of such annual meeting, the 10th day following the
day on which Public
Announcement of the date of such meeting is first made by the Corporation. In no event shall any adjournment or postponement of an
annual
meeting, or the Public Announcement thereof, commence a new time period (or extend any notice time period) for the giving of a stockholder’s
notice as described above;
 
(ii) in addition, to be
timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided
or required
to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business
days
prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed
and received by, the
Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business
days after the record date for the meeting
(in the case of the update and supplement required to be made as of the record date), and not
later than eight (8) business days prior to the date for the
meeting, or if the meeting is adjourned or postponed, on the first practicable
date after any adjournment or postponement thereof (in the case of the update
and supplement required to be made as of ten (10) business
days prior to the meeting or any adjournment or postponement thereof);
 
(iii) in the event that
the number of directors to be elected to the Board of Directors is increased by the Board of Directors, and there is no
Public Announcement
by the Corporation naming all of the nominees for director or specifying the size of the increased Board of Directors at least one
hundred
(100) days prior to the first anniversary of the preceding year’s annual meeting, a stockholder’s notice required by Section
2 of this Article V shall
also be considered timely, but only with respect to nominees for any new positions created by such increase,
if it shall be delivered to, or mailed and
received by, the Secretary of the Corporation at the principal executive offices of the Corporation
not later than the close of business on the 10th day
following the day on which such Public Announcement is first made by the Corporation;
 
(iv) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the
Corporation’s books
and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
 
7

 
 
(v) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of
capital stock or other
securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3
under
the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation
right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares
of capital stock or
other securities of the Corporation or with a price or value derived in whole or in part from the price or value of
any shares of capital stock or other
securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction
or arrangement having characteristics of a long or short
position or ownership interest in any shares of capital stock or other securities
of the Corporation, whether or not any such instrument or right shall be
subject to settlement in the underlying shares of capital stock
 or other securities of the Corporation or otherwise, and any other direct or indirect
opportunity to profit or share in any profit derived
from any increase or decrease in the price or value of shares of capital stock or other securities of the
Corporation directly or indirectly
 owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement,
arrangement, understanding
or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any
shares
 of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding
 or
relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent
stockholder has engaged in
or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the
economic risk of shares of capital stock or other
securities of the Corporation by, manage the risk of share price changes for, or increase
or decrease the voting power of, such proponent stockholder with
respect to shares of capital stock or other securities of the Corporation,
or which provides, directly or indirectly, the opportunity to profit from any increase
or decrease in the price or value of the shares
of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the
shares of any class
or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated
or
separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the
proponent stockholder,
directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or
series of capital stock of the Corporation or any
interests described in clause (d), (g) any proportionate interest in any security of
the Corporation or derivative instruments held, directly or indirectly, by a
general or limited partnership or limited liability company
or similar entity in which a proponent stockholder is a general partner or, directly or indirectly,
beneficially owns any interest in
a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the
manager or managing
member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the
last 12 months in any security of the Corporation, (i) any direct or indirect legal, economic or financial interest (including Short Interest)
of a proponent
stockholder in the outcome of any (1) vote to be taken at any annual or special meeting of stockholders of the Corporation
 or (2) any meeting of
stockholders of any other entity with respect to any matter that is related, directly or indirectly, to any nomination
proposed by any proponent stockholder
under Article V, (j) any direct or indirect legal, economic or financial interest (including Short
Interest) in any principal competitor of the Corporation held
by a proponent stockholder, (k) any material pending or threatened action,
suit or proceeding (whether civil, criminal, investigative, administrative or
otherwise) in which a proponent stockholder is, or is reasonably
expected to be made, a party or material participant involving the Corporation or any of its
officers, directors or employees, or any
affiliate of the Corporation, or any officer, director or employee of such affiliate, and (l) any other information
relating to such stockholder
and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection
with solicitations
of proxies for the election of directors in an election contest pursuant to and in accordance with Section 14(a) of the Securities Exchange
Act of 1934, as amended and the rules and regulations promulgated thereunder (collectively, the information in this clause (v), the “Stockholder
Information”);
 
(vi) the proponent stockholder
must also disclose to the Corporation, as part of the advance notice, all stock ownership information required
by the immediately preceding
clause (v) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on
whose behalf
the nomination proposed to be brought before the annual meeting is made, (b) any affiliate or associate (each within the meaning of Rule
12b-
2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner, and, (c) any stockholder
 or
stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute a filing group
for purposes of
Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal of such nomination;
 
(vii) the proponent stockholder
must represent to the Corporation, as part of the advance notice, whether the proponent or any of its respective
affiliates, associates
or others acting in concert therewith intends individually or as part of a group, to (a) deliver a proxy statement and/or form of proxy
to
holders of at least the percentage of the Corporation’s outstanding capital stock required to elect the nominee and/or (b) to
otherwise solicit proxies in
support of such nomination, including to solicit proxies in support of director nominees other than the Corporation’s
nominees in accordance with Rule
14a-19 under the Securities Exchange Act of 1934, as amended;
 
(viii) the proponent stockholder
 must disclose to the Corporation, as part of the advance notice, as to each person whom the proponent
stockholder proposes to nominate
for election as a director (a) all information about the proposed nominees that would be required to be to be disclosed in a
proxy statement
or other filings required to be made in connection with solicitations of proxies for the election of directors in a contested election
pursuant
to Section 14 of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (including
such person’s written
consent to being named in the proxy statement, including the Corporation’s proxy statement, as a nominee
of the proponent stockholder and to serving as a
director if elected), (b) a complete and accurate description of all direct and indirect
compensation and other material monetary agreements, arrangements
and understandings (whether written or oral) during the past three years,
and any other material relationships, between or among such stockholder and
beneficial owner, if any, and their respective affiliates
and associates, or others acting in concert therewith, on the one hand, and each proposed nominee,
and his or her respective affiliates
and associates, or others acting in concert therewith, on the other hand, including, without limitation all information that
would be
required to be disclosed pursuant to Rule 404 promulgated under Regulation S-K if the stockholder making the nomination and any beneficial
owner on whose behalf the nomination is made, if any, or any affiliate or associate thereof or person acting in concert therewith, were
the “registrant” for
purposes of such rule and such proposed nominee were a director or executive officer of such registrant,
 (c) a completed and signed questionnaire,
representation and agreement and any and all other information required by Section 4 of Article
V, and (d) the Stockholder Information for such person and
any member of the immediate family of such person, or any affiliate or associate
of such person, or any person acting in concert therewith;
 
8

 
 
(ix) the proponent stockholder
must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder
is a holder of record
of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation
entitled
to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the nomination(s)
specified in the notice;
 
(x) the proponent stockholder
must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the
information set forth
in the advance notice; and
 
(xi) the proponent stockholder
must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial
and record owners) known
by the proponent stockholder to support the nomination(s) made by the proponent stockholder and, to the extent known, the
class or series
and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
 
3. Nominations of persons
for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be
elected pursuant
to the Corporation’s notice of meeting (i) by or at the direction of the Board of Directors or any committee thereof or (ii) provided
that the
Board of Directors has determined that directors shall be elected at such meeting, by any stockholder of the Corporation (a)
who is a stockholder of record
of the Corporation at the time the notice provided for in this Article V is delivered to, or mailed and
received by, the Secretary of the Corporation, on the
record date for the determination of stockholders of the Corporation entitled to
vote at the meeting, and at the time of the meeting, (b) who is entitled to
vote at the meeting and (c) complies with the notice procedures
 set forth in this Article V. In the event the Corporation calls a special meeting of
stockholders for the purpose of electing one (1)
or more directors to the Board of Directors, any such proponent stockholder entitled to vote in such election
of directors may nominate
a person or persons (as the case may be) for election to such position(s) as specified in the Corporation’s notice of meeting, if
the
notice required by Section 2 of Article V shall be delivered to, or mailed and received by, the Secretary of the Corporation at the
principal executive offices
of the Corporation no earlier than one hundred and twenty (120) days prior to the special meeting, and no
later than ninety (90) days prior to the special
meeting, or the tenth (10th) day following the day on which the Corporation first makes
a public announcement of the date of the special meeting at which
directors are to be elected. In no event shall the public announcement
of an adjournment or postponement of a special meeting commence a new time
period (or extend any time period) for the giving of a stockholder’s
notice as described above.
 
4. In addition to the requirements
set forth elsewhere in these By-Laws, to be eligible to be a nominee for election or re-election as a director of
the Corporation, such
proposed nominee or a person on such proposed nominee’s behalf must deliver (with respect to a nomination made by a proponent
pursuant
to Section 2 of Article V, in accordance with the time periods for delivery of timely notice under Section 2 of Article V), to the Secretary
of the
Corporation at the principal executive offices of the Corporation a completed and signed questionnaire with respect to the background
and qualifications of
such proposed nominee and the background of any other person or entity on whose behalf the nomination is being made
(which questionnaire shall be
provided by the Secretary of the Corporation upon written request of any stockholder of record identified
by name within ten business days of such written
request) and a written representation and agreement (in the form provided by the Secretary
of the Corporation upon written request of any stockholder of
record identified by name within ten business days of such written request)
that such proposed nominee (i) is not and will not become a party to (a) any
agreement, arrangement or understanding with, and has not
given any commitment or assurance to, any person or entity as to how such proposed nominee,
if elected as a director of the Corporation,
will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation
or (b) any
Voting Commitment that could limit or interfere with such proposed nominee’s fiduciary duties under applicable law, (ii) is not
and will not
become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect
to any direct or indirect
compensation, reimbursement or indemnification in connection with service or action as a director that has not
been disclosed to the Corporation, and (iii)
would be in compliance, if elected as a director of the Corporation, and will comply with,
all applicable publicly disclosed corporate governance, code of
conduct and ethics, conflict of interest, confidentiality, corporate opportunities,
trading and any other policies and guidelines of the Corporation applicable
to directors.
 
9

 
 
5. The Corporation may also
require, as a condition to any such nomination being deemed properly brought before an annual or special meeting,
any proponent stockholder
or proposed nominee to furnish such other information as may reasonably be required by the Corporation to determine the
eligibility of
 such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable stockholder’s
understanding of the independence, or lack thereof, of such nominee.
 
6. In addition, if the proponent
stockholder has provided notice pursuant to Rule 14a-19(b) of the Securities Exchange Act of 1934, as amended,
the proponent stockholder
shall deliver to the Corporation no later than ten (10) days prior to the date of the meeting or any adjournment or postponement
thereof
reasonable evidence that it has complied with the requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended.
 
7. Compliance with the provisions
of this Article V is the sole and exclusive method for stockholders to nominate candidates for election to the
Board of Directors at an
annual or special meeting of stockholders. No person shall be eligible for election as a director of the Corporation at an annual or
special
meeting of stockholders unless nominated in accordance with the procedures set forth in this Article V. The number of nominees that a
proponent
stockholder may nominate for election at an annual or special meeting (or in the case of a proponent stockholder giving the
notice on behalf of a beneficial
owner, the number of nominees a proponent stockholder may nominate for election at the annual or special
meeting on behalf of such beneficial owner)
shall not exceed the number of directors to be elected at such annual or special meeting.
For the avoidance of doubt, a stockholder shall not be entitled to
make additional or substitute nominations at an annual or special meeting
following the expiration of the time periods set forth in these By-Laws. Unless
otherwise required by law, if any proponent stockholder
(i) provides notice pursuant to Rule 14a-19(b) under the Securities Exchange Act of 1934, as
amended, and (ii) subsequently fails to comply
with any requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended, or any other
rules or regulations thereunder,
 then the Corporation shall disregard any proxies or votes solicited for such nominees and such nominations shall be
disregarded. Except
as otherwise provided by law or herein, the chairperson of the meeting shall have the power and duty (i) to determine whether a
nomination
was made in accordance with the provisions of this Article V (including whether the proponent stockholder or any of its respective affiliates,
associates or others acting in concert therewith solicited (or are part of a group which solicited) or did not so solicit, as the case
may be, proxies or votes in
support of the proponent stockholder’s nominee in compliance with the proponent stockholder’s
representation as required by clause (vii) of Section 2 of
Article V) and (ii) if any proposed nomination was not made in compliance with
 Article V, to declare that such nomination shall be disregarded.
Notwithstanding the foregoing provisions of Article V, unless otherwise
required by law, if the proponent stockholder (or a qualified representative of the
proponent stockholder) does not appear at the annual
or special meeting of stockholders of the Corporation to present a nomination, such nomination shall
be disregarded, notwithstanding that
proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 7 of Article V,
to be considered
a qualified representative of the proponent stockholder, a person must be a duly authorized officer, manager or partner of such proponent
stockholder or must be authorized by a writing executed by such proponent stockholder or an electronic transmission delivered by such
 proponent
stockholder to act for such proponent stockholder as proxy at the meeting of stockholders and such person must produce such
 writing or electronic
transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
 
8. In addition to the provisions
of this Article V, a stockholder shall also comply with all applicable requirements of state law and all applicable
requirements of the
Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth herein.
 
9. For purposes of these
By-laws, “Public Announcement” shall mean disclosure in a press release reported by a national news service or in a
document
publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Securities Exchange
Act of 1934, as amended and the rules and regulations promulgated thereunder.
 
10

 
 
ARTICLE VI
DIRECTORS
 
1. The business and affairs
of the Corporation shall be managed under the direction of a Board of Directors, which may exercise all such powers
and authority for
and on behalf of the Corporation as shall be permitted by law, the Certificate of Incorporation or these By-laws. Each of the directors
shall
hold office until the next annual meeting of stockholders and until his or her successor has been elected and qualified or until
his or her earlier death,
disqualification, resignation or removal.
 
2. The Board of Directors
is empowered to appoint a Chairman of the Board of Directors. The Chairman shall act as chairman of all meetings of
the Board of Directors
and as the presiding person at all special and annual meetings of stockholders, unless the Board of Directors shall appoint a different
individual as chairman of any meeting of the Board of Directors or as the presiding person at any special or annual meeting of stockholders,
and the
chairman or presiding person shall have control over the agenda of any such meetings, all in accordance with the provisions of
these By-laws and the
Certificate of Incorporation. The Chairman shall perform such other duties as may from time to time be assigned
to him by the Board of Directors.
 
3. The Board of Directors
may hold their meetings within or outside of the State of Delaware, at such place or places as it may from time to time
determine.
 
4. The number of directors
comprising the Board of Directors shall be such number as may be from time to time fixed exclusively by resolution of
the Board of Directors.
In case of any increase in the number of directors, a majority of the remaining members of the Board of Directors, although such
majority
is less than a quorum, shall have the sole and exclusive power and authority to elect each additional director to fill any newly created
directorship,
to hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified or
his or her earlier death, disqualification,
resignation or removal. No decrease in the number of directors shall shorten the term of any
incumbent director.
 
5. If any directorship becomes
vacant, by reason of death, resignation, disqualification, removal or otherwise, a majority of the directors then in
office, although
less than a quorum, shall have the sole and exclusive authority to fill the vacancy by electing a successor who shall hold office until
the
next annual meeting of stockholders and until his or her successor is elected and qualified or his or her earlier death, resignation,
 disqualification or
removal.
 
6. Any director may resign
at any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any
such resignation
shall take effect upon receipt thereof by the Corporation, or at such later time or date as may be specified therein.
 
11

 
 
ARTICLE VII
COMMITTEES OF DIRECTORS
 
1. The Board of Directors
may designate an Executive Committee and one or more other committees, each such committee to consist of one or
more directors of the
Corporation. The Executive Committee shall have and may exercise all the powers and authority of the Board of Directors in the
management
of the business and affairs of the Corporation (except as otherwise expressly limited by statute), including the power and authority to
declare
dividends and to authorize the issuance of stock, and may authorize the seal of the Corporation to be affixed to all papers which
may require it. Each such
committee shall have such of the powers and authority of the Board of Directors as may be provided from time
to time in resolutions adopted by the Board
of Directors.
 
2. The requirements with
respect to the manner in which the Executive Committee and each such other committee shall hold meetings and take
actions shall be set
forth in the resolutions of the Board of Directors designating the Executive Committee or such other committee.
 
ARTICLE VIII
MEETINGS OF DIRECTORS; ACTION WITHOUT A MEETING
 
1. Regular meetings of the
Board of Directors may be held without notice at such time and place, either within or without the State of Delaware, as
may be determined
from time to time by resolution of the Board of Directors.
 
2. Special meetings of the
Board of Directors shall be held whenever called by the President of the Corporation or the majority of the directors
then in office on
at least 24 hours’ notice to each director. Except as may be otherwise specifically provided by statute, by the Certificate of Incorporation
or by these By-laws, the purpose or purposes of any such special meeting need not be stated in such notice, although the time and place
of the meeting shall
be stated.
 
3. At all meetings of the
Board of Directors, the presence in person of a majority of the total number of directors shall be necessary and sufficient
to constitute
a quorum for the transaction of business, and, except as otherwise provided by statute, by the Certificate of Incorporation or by these
By-laws,
if a quorum shall be present the act of a majority of the directors present shall be the act of the Board of Directors.
 
4. Any action required or
permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a
meeting if all the members
of the Board of Directors or such committee, as the case may be, consent thereto in writing or by electronic transmission and
any consent
may be documented, signed and delivered in any manner permitted by Section 116 of the General Corporation Law of the State of Delaware.
After an action is taken, the consent or consents or electronic transmissions shall be filed with the minutes of proceedings of the Board
of Directors or
committee, in the same paper or electronic form as the minutes are maintained. Any director may participate in a meeting
of the Board of Directors, or any
committee designated by the Board of Directors, by means of a conference telephone or other communications
equipment by means of which all persons
participating in the meeting can hear each other, and participation in a meeting pursuant to this
sentence shall constitute presence in person at such meeting.
 
ARTICLE IX
OFFICERS
 
1. The officers of the Corporation
shall be chosen by the Board of Directors and shall be a Chief Executive Officer, a President, a Secretary and a
Treasurer. The Board
of Directors may also choose one or more Vice Presidents, Assistant Secretaries and Assistant Treasurers, and such other officers as it
shall deem necessary. Any number of offices may be held by the same person.
 
2. The salaries of all officers
of the Corporation shall be fixed by the Board of Directors, or in such manner as the Board of Directors may
prescribe.
 
3. The officers of the Corporation
shall hold office until their successors are elected and qualified, or until their earlier resignation or removal. Any
officer may be
at any time removed from office by the Board of Directors, with or without cause. If the office of any officer becomes vacant for any
reason,
the vacancy may be filled by the Board of Directors.
 
4. Any officer may resign at
any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any
such resignation
shall take effect upon receipt thereof by the Corporation or at such later date as may be specified therein.
 
5. The Chief Executive Officer
shall have general supervision and direction of the business and affairs of the Corporation, subject, however, to the
direction and control
of the Board of Directors. The Chief Executive Officer may sign and execute in the name of the Corporation deeds, mortgages, bond,
contracts
or other instruments. The Chief Executive Officer shall perform all duties incident to the office of the Chief Executive Officer and shall,
when
requested, counsel with and advise the other officers of the Corporation and shall perform such other duties as the Board of Directors
may from time to
time determine.
 
12

 
 
6. The President shall have
such powers and perform such duties as from time to time may be assigned to him by the Chief Executive Officer or
the Board of Directors.
 
7. The Vice Presidents shall
have such powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
 
8. The Secretary shall perform
all duties incident to the office of the Secretary and shall have such powers and duties as may be delegated to him
by the Chief Executive
Officer or the Board of Directors.
 
9. The Assistant Secretary
shall, in case of the absence of the Secretary, perform the duties and exercise the powers of the Secretary, and shall have
such other
powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
 
10. The Treasurer shall have
the custody of the corporate funds and securities, and shall deposit or cause to be deposited under his or her direction
all moneys and
other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors
or pursuant to authority granted by it. He shall render to the Chief Executive Officer and the Board of Directors whenever they may require
it an account of
all his or her transactions as Treasurer and of the financial condition of the Corporation. He shall have such other
powers and duties as may be delegated to
him by the Chief Executive Officer or the Board of Directors.
 
11. The Assistant Treasurer
shall, in case of the absence of the Treasurer, perform the duties and exercise the powers of the Treasurer, and shall
have such other
powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
 
ARTICLE X
FORM OF CERTIFICATES; UNCERTIFICATED SHARES
 
Shares of the capital stock of the Corporation
 may be certificated or uncertificated, as provided under the General Corporation Law of the State of
Delaware. Each stockholder holding
certificated shares of capital stock of the Corporation, upon written request to the transfer agent or registrar of the
Corporation, shall
 be entitled to a certificate representing such shares of capital stock of the Corporation in such form as may from time to time be
prescribed
by the Board of Directors. Any such certificate shall be signed by any two authorized officers of the Corporation, which shall include,
without
limitation, the Chairman of the Board of Directors, the Chief Executive Officer, the President, any Vice President, the Treasurer,
any Assistant Treasurer,
the Secretary and any Assistant Secretary.
 
ARTICLE XI
FISCAL YEAR
 
The fiscal year of the Corporation shall be as
determined from time to time by resolution duly adopted by the Board of Directors.
 
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ARTICLE XII
NOTICES AND WAIVERS
 
1. Whenever by statute, by
the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any director, such
provision shall not
be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States
mail, postage prepaid, directed to such director at his or her address as it appears on the records of the Corporation, and such notice
shall be deemed to be
given at the time when the same shall be thus deposited. Notice of meetings of the Board of Directors may also be
given to any director by telephone or by
electronic transmission, and in the latter event the notice shall be deemed to be given at the
time such notice, addressed to such director at the address
hereinabove provided, is transmitted by facsimile, electronic mail or other
electronic transmission.
 
2. Whenever by statute, by
the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any stockholder, such
provision shall
not be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States
mail, postage prepaid, directed to such stockholder at his or her mailing address as it appears on the records of the Corporation, and
such notice shall be
deemed to be given at the time when the same shall be thus deposited. Such notice may also be given (i) by courier
service, and such notice shall be
deemed to be given upon the earlier of when the notice is received or left at the stockholder’s
address or (ii) by electronic transmission directed to the
stockholder’s electronic mail address as it appears on the records of
the Corporation, and such notice shall be deemed to be given when directed to such
stockholder’s electronic mail address unless
 the stockholder has notified the Corporation in writing or by electronic transmission of an objection to
receiving notice by electronic
mail or such notice is prohibited by Section 232(e) of the General Corporation Law of the State of Delaware. A notice by
electronic mail
will include a prominent legend that the communication is an important notice regarding the Corporation.
 
3. Without limiting the manner
by which notice otherwise may be given effectively to stockholders, any notice to stockholders given by the
Corporation under any provision
of the General Corporation Law of the State of Delaware, the Certificate of Incorporation, or these By-laws shall be
effective if given
by another form of electronic transmission consented to by the stockholder to whom the notice is given. Any such consent shall be
revocable
 by the stockholder by written notice or electronic transmission to the Corporation. Any such consent shall be deemed revoked if (i) the
Corporation is unable to deliver by electronic transmission two (2) consecutive notices given by the Corporation in accordance with such
consent and (ii)
such inability becomes known to the Secretary or an Assistant Secretary or to the transfer agent, or other person responsible
for the giving of notice;
provided, however, the inadvertent failure to discover such inability shall not invalidate any meeting
or other action.
 
4. Notice given pursuant
to Section 3 of this Article XII shall be deemed given: (i) if by facsimile telecommunication, when directed to a number
at which the
stockholder has consented to receive notice; (ii) if by a posting on an electronic network together with separate notice to the stockholder
of
such specific posting, upon the later of (A) such posting and (B) the giving of such separate notice; and (iii) if by any other
form of electronic transmission,
when directed to the stockholder. An affidavit of the Secretary or an Assistant Secretary or of the transfer
agent or other agent of the Corporation that the
notice has been given shall, in the absence of fraud, be prima facie evidence of the
facts stated therein. For purposes of this Article XII, “electronic
transmission” means any form of communication, not directly
involving the physical transmission of paper, including the use of, or participation in, 1 or
more electronic networks or databases (including
 1 or more distributed electronic networks or databases), that creates a record that may be retained,
retrieved and reviewed by a recipient
thereof, and that may be directly reproduced in paper form by such a recipient through an automated process.
 
5. Whenever by statute, by
the Certificate of Incorporation or by these By-laws a notice is required to be given, a written waiver thereof, signed by
the person
entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before or after the time stated therein,
shall be
deemed equivalent to notice. Attendance of any stockholder or director at any meeting thereof shall constitute a waiver of notice
of such meeting by such
stockholder or director, as the case may be, except as otherwise provided by statute.
 
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ARTICLE XIII
INDEMNIFICATION
 
1. The Corporation shall
indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party
to any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or
in the
right of the corporation) by reason of the fact that such person is or was a director or officer of the Corporation, or is or was
serving at the request of the
Corporation as a director or officer of another corporation, partnership, joint venture, trust or other
enterprise, against expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlement actually and reasonably
incurred by such person in connection with such action, suit or proceeding if such
person acted in good faith and in a manner such person
reasonably believed to be in or not opposed to the best interests of the Corporation, and, with
respect to any criminal action or proceeding,
had no reasonable cause to believe such person’s conduct was unlawful. The termination of any action, suit or
proceeding by judgment,
order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the
person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of
the Corporation, and,
with respect to any criminal action or proceeding, had reasonable cause to believe that such person’s conduct
was unlawful. Notwithstanding the provisions
of this Section 1, except as otherwise provided in Section 4 of this Article XIII, the Corporation
shall be required to indemnify any person referenced in this
Section 1 in connection with an action, suit or proceeding (or part thereof)
commenced by such person only if the commencement of such action, suit or
proceeding (or part thereof) by the person was authorized in
the specific case by the Board of Directors.
 
2. The Corporation shall
indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party
to any threatened,
pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that
such
person is or was a director or officer of the corporation, or is or was serving at the request of the Corporation as a director or
officer of another corporation,
partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees)
 actually and reasonably incurred by such person in
connection with the defense or settlement of such action or suit if such person acted
in good faith and in a manner such person reasonably believed to be in
or not opposed to the best interests of the Corporation and except
that no such indemnification shall be made in respect of any claim, issue or matter as to
which such person shall have been adjudged to
be liable to the Corporation unless and only to the extent that the Court of Chancery of the State of
Delaware (the “Court of Chancery”)
or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of
liability but
in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which such
Court of
Chancery or such other court shall deem proper.
 
3. Expenses (including attorneys’
 fees) incurred by a present or former officer or director in defending any civil, criminal, administrative or
investigative action, suit
or proceeding shall be paid by the Corporation in advance of the final disposition of such action, suit or proceeding upon receipt of
an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person
is not entitled to be
indemnified by the Corporation as authorized in this Article XIII. Such expenses (including attorneys’ fees)
incurred by employees and agents may be so
paid upon such terms and conditions, if any, as the Corporation deems appropriate.
 
4. The indemnification and
advancement of expenses provided by, or granted pursuant to, the other Sections of this Article XIII shall not be
deemed exclusive of
any other rights to which those seeking indemnification or advancement of expenses may be entitled under any By-law, agreement,
vote of
stockholders or disinterested directors or otherwise, both as to action in such person’s official capacity and as to action in another
capacity while
holding such office.
 
5. The Corporation may, but
shall not be required to, purchase and maintain insurance on behalf of any person who is or was a director, officer,
employee or agent
of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in
any such capacity, or
arising out of such person’s status as such, whether or not the Corporation would have the power to indemnify
such person against such liability under the
provisions of this Article XIII.
 
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6. For purposes of this Article
 XIII, references to “the Corporation” shall include, in addition to the resulting corporation, any constituent
corporation
(including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would
have
had power and authority to indemnify its directors or officers so that any person who is or was a director or officer of such constituent
corporation, or is or
was serving at the request of such constituent corporation as a director or officer of another corporation, partnership,
joint venture, trust or other enterprise,
shall stand in the same position under the provisions of this Article XIII with respect to the
resulting or surviving corporation as such person would have
with respect to such constituent corporation if its separate existence had
continued.
 
7. For purposes of this Article
XIII, references to “other enterprises” shall include employee benefit plans; references to “fines” shall
include any
excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request
of the Corporation” shall include
service as a director or officer of the Corporation which imposes duties on, or involves services
by, such director or officer with respect to an employee
benefit plan, its participants or beneficiaries; and a person who acted
in good faith and in a manner such person reasonably believed to be in the interest of
the participants and beneficiaries of an employee
 benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the
Corporation” as referred
to in this Article XIII.
 
8. The indemnification and
advancement of expenses provided by, or granted pursuant to, this Article XIII shall, unless otherwise provided when
authorized or ratified,
 continue as to a person who has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and
administrators
of such a person.
 
9. If this Article or any
portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall
nevertheless indemnify
 each director or officer to the fullest extent not prohibited by any applicable portion of this Article that shall not have been
invalidated,
or by any other applicable law. If this Article shall be invalid due to the application of the indemnification provisions of another jurisdiction,
then the Corporation shall indemnify each director and officer to the fullest extent under any other applicable law.
 
10. The Corporation may indemnify
 every person who was or is a party or is or was threatened to be made a party to any action, suit, or
proceeding, whether civil, criminal,
administrative or investigative, by reason of the fact that he is or was an employee or agent of the corporation or, while
an employee
or agent of the Corporation, is or was serving at the request of the corporation as an employee or agent or trustee of another corporation,
partnership, joint venture, trust, employee benefit plan or other enterprise, against expenses (including counsel fees), judgments, fines
and amounts paid in
settlement actually and reasonably incurred by him in connection with such action, suit or proceeding, to the extent
permitted by Delaware law.
 
11. The Corporation’s
obligation, if any, to indemnify or to advance expenses to any person serving at its request as a director or officer of another
corporation,
partnership, joint venture, trust or other enterprise shall be reduced by any amount such person may collect as indemnification or advancement
of expenses from such other corporation, partnership, joint venture, trust or other enterprise.
 
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ARTICLE XIV
FORUM SELECTION
 
1. Unless the Corporation
consents in writing to the selection of an alternative forum, the Court of Chancery (or, if and only if the Court of
Chancery lacks subject
matter jurisdiction, any state or federal court located within the State of Delaware) and any appellate court thereof shall be the sole
and exclusive forum for (i) any derivative action, suit, or proceeding brought on behalf of the Corporation, (ii) any action, suit, or
proceeding asserting a
claim of breach of fiduciary duty owed by any current or former director, officer, employee, or stockholder of
the Corporation to the Corporation or the
Corporation’s stockholders or any action asserting a claim for aiding and abetting any
such breach of fiduciary duty, (iii) any action, suit, or proceeding
arising pursuant to any provision of the General Corporation Law
of the State of Delaware or the Certificate of Incorporation or these By-laws (as each
may be amended from time to time), (iv) any claim
as to which the General Corporation Law of the State of Delaware confers jurisdiction upon the Court
of Chancery, or (v) any action, suit,
or proceeding asserting a claim against the Corporation or its current or former directors, officers, employees, or
stockholders governed
by the internal affairs doctrine, in each such case subject to such court having personal jurisdiction over the indispensable parties
named as defendants therein.
 
2. Unless the Corporation
consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district
courts of the
United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the
Securities Act of 1933, as amended.
 
3. Notwithstanding the foregoing,
the provisions of this Article XIV shall not apply to suits brought to enforce any liability or duty created by the
Securities Exchange
Act of 1934, as amended, or any other claim for which the federal courts of the United States have exclusive jurisdiction.
 
4. Any person or entity purchasing
or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice
of the provisions of
this Article XIV. If any provision or provisions of this Article XIV shall be held to be invalid, illegal or unenforceable as applied
to any
person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality
and enforceability of such
provisions in any other circumstance and of the remaining provisions of this Article XIV (including, without
limitation, each portion of any sentence of this
Article XIV containing any such provision held to be invalid, illegal or unenforceable
that is not itself held to be invalid, illegal or unenforceable) and the
application of such provision to other persons or entities and
circumstances shall not in any way be affected or impaired thereby.
  
ARTICLE XV
AMENDMENT OF BY-LAWS
 
The By-laws of the Corporation may be altered,
amended or repealed, and new By-laws may be adopted, by the Board of Directors. In addition, the By-
laws of the Corporation may be altered,
amended or repealed, and new By-laws may be adopted, by the stockholders of the Corporation by the affirmative
vote of the holders of
a majority in voting power of the outstanding shares of capital stock of the Corporation entitled to vote thereon.
 
 
17
 
 

Exhibit 3.3
 
ORAMED PHARMACEUTICALS
INC.
FOURTH AMENDED
AND RESTATED BY-LAWS
 
ARTICLE I
 
OFFICES
 
1. The location of the registered
 office of the Corporation, and the name of its registered agent, shall be as set forth in the Certificate of
Incorporation.
 
2. The Corporation shall
in addition to its registered office in the State of Delaware establish and maintain an office or offices at such place or
places as the
Board of Directors may from time to time find necessary or desirable.
 
ARTICLE II
CORPORATE SEAL
 
The Corporation may or may not have a corporate
seal, as may be determined from time to time by the Board of Directors. If adopted, the corporate seal of
the Corporation shall have inscribed
thereon the name of the Corporation and may be in such form as the Board of Directors may determine. Such seal may
be used by causing
it or a facsimile thereof to be impressed, affixed or otherwise reproduced.
 
ARTICLE III
MEETINGS OF STOCKHOLDERS
 
1. All meetings of the stockholders
shall be held at the registered office of the Corporation in the State of Delaware or at such other place, as shall
be determined from
 time to time by the Board of Directors. The Board of Directors may, in its sole discretion, determine that any meeting of the
stockholders
shall not be held at any place, but may instead be held solely by means of remote communication in accordance with Section 211 of the
General Corporation Law of the State of Delaware.
 
2. The annual meeting
of stockholders shall be held on such day and at such time as may be determined from time to time by resolution of the
Board of Directors,
when they shall elect, by majority vote pursuant to Section 5 of this Article III, directors to hold office until the annual meeting
of
stockholders held next after their election and their successors are respectively elected and qualified, or until their earlier death,
disqualification, resignation
or removal; provided, however, that in a contested election, a nominee shall
be elected by a plurality of the votes cast by the stockholders entitled to vote at
the election on such election of directors. An
election shall be considered contested if, as of the last date on which nominees for director may be submitted
in accordance with
these By-laws, the nominees for election to the Board of Directors exceeds the number of positions on the Board of Directors to be
filled
by election at that meeting. If an incumbent director is not re-elected, the director shall tender his or her resignation to the Board
of Directors.. The
Nominating and Corporate Governance
Committee of the Board of Directors (or any future committee the equivalent thereof) will make a recommendation
to the Board of Directors
on whether to accept or reject the resignation, or whether other action should be taken. The Board of Directors will act on the
recommendation
of such committee and will publicly disclose its decision within ninety (90) days from the date of the certification of the election
results.
A director who tenders his or her resignation may not participate in any meeting of the Board of Directors or any committee
thereof until the Board of
Directors has determined not to accept his or her resignation. Any other proper business may be
transacted at the annual meeting.
 
3. The holders of at least
one third (1/3) of the stock issued and outstanding and entitled to vote on the subject matter, present in person or
represented by proxy,
shall constitute a quorum at all meetings of the stockholders for the transaction of business, except as otherwise expressly provided
by statute, by the Certificate of Incorporation or by these By-laws. If, however, such holders shall not be present or represented at
any meeting of the
stockholders, the stockholders entitled to vote on the subject matter, present in person or by proxy, shall have power
to adjourn the meeting from time to
time, without notice other than announcement at the meeting (except as otherwise provided by statute).
At such adjourned meeting at which a quorum is
present, any business may be transacted which might have been transacted at the meeting
as originally notified.
 

 
 
4. At all meetings of the
stockholders each stockholder having the right to vote on the subject matter shall be entitled to vote in person, or by
proxy, but no
proxy shall be voted or acted upon more than three years after its date, unless the proxy provides for a longer period.
 
5. Unless otherwise provided
in the Certificate of Incorporation, at each meeting of the stockholders each stockholder shall have one vote for each
share of capital
stock having voting power, registered in his or her name on the books of the Corporation at the record date fixed for voting in accordance
with these By-laws, or otherwise determined, with respect to such meeting. Unless a different or minimum vote is required by law or regulation
applicable
to the Corporation or its securities, by the Certificate of Incorporation, by these By-laws or by the rules or regulations
of any stock exchange applicable to
the Corporation, in which case such different or minimum vote shall be the applicable vote on the
matter, all matters coming before any meeting of the
stockholders, including the election of directors, shall be decided by a majority
of the votes cast by the holders of shares of stock present in person or
represented by proxy at such meeting and entitled to vote on
the subject matter, a quorum being present; provided, however, that in a contested election, a
nominee shall
be elected by a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors.
Votes cast shall
include votes “for” and votes “against” and exclude “abstentions” and “broker
non-votes” with respect to the subject matter.
 
6. Notice of each meeting
of the stockholders shall be given to each stockholder entitled to vote thereat not less than ten (10) nor more than sixty
(60) days before
the date of the meeting. Such notice shall state the place, date and hour of meeting, the record date for determining the stockholders
entitled to vote at the meeting, if such date is different from the record date for determining stockholders entitled to notice of the
meeting, the means of
remote communications, if any, by which stockholders and proxy holders may be deemed to be present in person and
vote at such meeting and, in the case
of a special meeting, the purpose or purposes for which the meeting is called.
 
7. The Corporation shall
prepare, no later than the tenth (10th) day before each meeting of stockholders, a complete list of the stockholders entitled
to vote
at said meeting (provided, however, if the record date for determining the stockholders entitled to vote is less than ten (10) days before
the date of
the meeting, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date), arranged
in alphabetical order, showing the
address of each stockholder and the number of shares registered in the name of each stockholder. Such
 list shall be open to the examination of any
stockholder, for any purpose germane to the meeting for a period of 10 days ending on the
day before the meeting date, (a) on a reasonably accessible
electronic network, provided that the information required to gain access
to such list is provided with the notice of the meeting, or (b) during ordinary
business hours, at the principal place of business of
the Corporation. In the event that the Corporation determines to make the list available on an electronic
network, the Corporation may
take reasonable steps to ensure that such information is available only to stockholders of the Corporation.
 
8. Special meetings of the
stockholders, for any purpose or purposes, unless otherwise prescribed by statute, may be called by the majority of the
Board of Directors,
but such meetings may not be called by any other person or persons.
 
9. Only such business shall
be conducted at a special meeting of stockholders as shall have been brought before the meeting pursuant to the
Corporation’s notice
of meeting.
 
10. The order of business
at each meeting of stockholders shall be determined by the person presiding over the meeting.
 
2

 
 
11. (a) In order that the
Corporation may determine the stockholders entitled to consent to corporate action by consent and without a meeting of
stockholders, the
Board of Directors may fix a record date, which record date shall not precede the date upon which the resolution fixing the record date
is
adopted by the Board of Directors, and which date shall not be more than ten (10) days after the date upon which the resolution fixing
the record date is
adopted by the Board of Directors. Any stockholder of record seeking to have the stockholders authorize or take corporate
action by consent in lieu of a
meeting of stockholders shall, by written notice delivered to the Secretary of the Corporation at the principal
executive offices of the Corporation, request
that the Board of Directors fix a record date. The written notice must contain the information
set forth in Section 11(b) of this Article III. The Board of
Directors shall promptly, but in all events within ten (10) days after the
date on which such written notice is received by the Secretary of the Corporation,
determine the validity of the request, and if appropriate,
adopt a resolution fixing the record date (unless a record date has previously been fixed by the
Board of Directors pursuant to the first
sentence of this Section 11(a) of Article III). If no record date has been fixed by the Board of Directors pursuant to
the first sentence
of this Section 11(a) of Article III or otherwise within ten (10) days after the date on which such written notice is received by the
Secretary of the Corporation, the record date for determining stockholders entitled to consent to corporate action by consent and without
a meeting, when
no prior action by the Board of Directors is required by applicable law, shall be the first date after the expiration
of such ten (10) day time period on which
a signed consent setting forth the action taken or proposed to be taken is delivered to the
Corporation by delivery to its registered office in Delaware by
hand or by certified or registered mail, return receipt requested, to
its principal place of business or to any officer or agent of the Corporation having
custody of the book in which proceedings of meetings
of stockholders are recorded. If no record date has been fixed by the Board of Directors pursuant to
the first sentence of this Section
11(a) of Article III and prior action by the Board of Directors is required by applicable law, the record date for determining
stockholders
entitled to consent to corporate action by consent and without a meeting shall be at the close of business on the date on which the Board
of
Directors adopts the resolution taking such prior action.
 
(b) Any stockholder’s
notice required by Section 11(a) of Article III must describe the action that the stockholder proposes to take by consent.
For each such
proposal, every notice by a stockholder must state (x) the information required by Section 2 of Article IV and Section 2 of Article V
as
though such stockholder was intending to make a nomination or to bring any such business before a meeting of stockholders and (y) the
text of the proposal
(including the text of any resolutions to be effected by consent and the language of any proposed amendment to these
 By-Laws). In addition to the
foregoing, the notice must state as to the stockholder giving the notice and the beneficial owner, if any,
on whose behalf the notice is given a representation
whether the stockholder or the beneficial owner, if any, intends or is part of a
 group which intends to (x) deliver a proxy statement and/or consent
solicitation statement to stockholders of at least the percentage
of the Corporation’s outstanding capital stock required to effect the action by consent either
to solicit consents or to solicit
proxies to execute consents, and/or (y) otherwise solicit proxies or consents from stockholders in support of the action to be
taken by
consent. The Corporation may require the stockholder of record and/or beneficial owner requesting a record date for proposed stockholder
action
by consent to furnish such other information as it may reasonably require to determine the validity of the request for a record
date.
 
(c) In the event of the delivery,
in the manner provided by this Section 11 of Article III and applicable law, to the Corporation of consent or
consents to take corporate
action and/or any related revocation or revocations, the Corporation shall engage independent inspectors of elections for the
purpose
 of performing promptly a ministerial review of the validity of the consents and any consent revocations. For the purpose of permitting
 the
inspectors to perform such review, no stockholder action by consent and without a meeting shall be effective until such inspectors
have completed their
review, determined that the requisite number of valid and unrevoked consents delivered to the Corporation in accordance
with this Section 11 of Article III
and applicable law have been obtained to authorize or take the action specified in the consents, and
certified such determination for entry in the records of
the Corporation kept for the purpose of recording the proceedings of meetings
of stockholders. Nothing contained in this Section 11(c) of Article III shall in
any way be construed to suggest or imply that the Board
of Directors or any stockholder shall not be entitled to contest the validity of any consent or
revocation thereof, whether before or
after such certification by the independent inspectors, or to take any other action (including, without limitation, the
commencement,
prosecution or defense of any litigation with respect thereto, and the seeking of injunctive relief in such litigation).
 
(d) No stockholder consent
to corporate action without a meeting of stockholders shall be effective to take the corporate action referred to
therein unless, within
sixty (60) days after the first date a consent is delivered in accordance with this Section 11 of Article III, a valid consent or valid
consents signed by a sufficient number of stockholders to take such action are delivered to the Corporation in the manner prescribed in
this Section 11 of
Article III and applicable law, and not revoked.
 
ARTICLE IV
STOCKHOLDER PROPOSALS
 
1. At an annual meeting of
 stockholders, only such stockholder business shall be conducted as shall have been properly brought before the
meeting. To be properly
brought before an annual meeting of stockholders, stockholder business (other than the nominations of persons for election to the
Board
of Directors, which shall be set forth in Article V) must be: (i) specified in the notice of the meeting (or any supplement thereto) given
by or at the
direction of the Board of Directors or any committee thereof, (ii) otherwise properly brought before the meeting by or at
the direction of the Board of
Directors or any committee thereof, or (iii) otherwise properly brought before an annual meeting by a stockholder
(a) who is a stockholder of record of the
Corporation at the time the notice provided for in this Article IV is delivered to, or mailed
and received by, the Secretary of the Corporation, on the record
date for the determination of stockholders of the Corporation entitled
to vote at the meeting, and at the time of the meeting, (b) who is entitled to vote at the
meeting and (c) complies with the notice procedures
 set forth in this Article IV. In addition, any proposal of stockholder business (other than the
nomination of persons for election to
the Board of Directors) must be a proper matter for stockholder action.
 
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2. For business (other than
the nomination of persons for election to the Board of Directors, which shall be governed by Article V herein) to be
properly brought
before the annual meeting by a stockholder, the stockholder or stockholders of record intending to propose the business must deliver a
timely and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
 
(i) to be timely, the advance
notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at
the principal executive
offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first
anniversary
date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date
that is more than thirty
(30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual
meeting of stockholders, including in the
event that no annual meeting was held in the previous year), notice by the proponent stockholder
in order to be timely must be so delivered, or mailed and
received by, the Secretary of the Corporation at the principal executive offices
of the Corporation, not earlier than the close of business on the 120th day
prior to the annual meeting and not later than the close of
business on the later of the 90th day prior to the date of such annual meeting or, if the first
“Public Announcement” (as
hereinafter defined in Section 9 of Article V) of the date of such annual meeting is less than one hundred (100) days prior to
the date
 of such annual meeting, the 10th day following the day on which Public Announcement of the date of such meeting is first made by the
Corporation.
In no event shall any adjournment or postponement of an annual meeting, or the Public Announcement thereof, commence a new time period
(or extend any notice time period) for the giving of a stockholder’s notice as described above;
 
(ii) in addition, to be
timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided
or required
to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business
days
prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed
and received by, the
Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business
days after the record date for the meeting
(in the case of the update and supplement required to be made as of the record date), and not
later than eight (8) business days prior to the date for the
meeting, or if the meeting is adjourned or postponed, on the first practicable
date after any adjournment or postponement thereof (in the case of the update
and supplement required to be made as of ten (10) business
days prior to the meeting or any adjournment or postponement thereof);
 
(iii) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the
Corporation’s books
and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
 
(iv) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of
capital stock or other
securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3
under
the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation
right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares
of capital stock or
other securities of the Corporation or with a price or value derived in whole or in part from the price or value of
any shares of capital stock or other
securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction
or arrangement having characteristics of a long or short
position or ownership interest in any shares of capital stock or other securities
of the Corporation, whether or not any such instrument or right shall be
subject to settlement in the underlying shares of capital stock
 or other securities of the Corporation or otherwise, and any other direct or indirect
opportunity to profit or share in any profit derived
from any increase or decrease in the price or value of shares of capital stock or other securities of the
Corporation directly or indirectly
 owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement,
arrangement, understanding
or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any
shares
 of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding
 or
relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent
stockholder has engaged in
or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the
economic risk of shares of capital stock or other
securities of the Corporation by, manage the risk of share price changes for, or increase
or decrease the voting power of, such proponent stockholder with
respect to shares of capital stock or other securities of the Corporation,
or which provides, directly or indirectly, the opportunity to profit from any increase
or decrease in the price or value of the shares
of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the
shares of any class
or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated
or
separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the
proponent stockholder,
directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or
series of capital stock of the Corporation or any
interests described in clause (d), (g) any proportionate interest in any security of
the Corporation or derivative instruments held, directly or indirectly, by a
general or limited partnership or limited liability company
or similar entity in which a proponent stockholder is a general partner or, directly or indirectly,
beneficially owns any interest in
a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the
manager or managing
member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the
last 12 months in any security of the Corporation (for purposes of these By-Laws, a person shall be deemed to have a “Short Interest”
in a security if such
person, directly or indirectly, though any contract, arrangement, understanding, relationship or otherwise, has
the opportunity to profit or share in any profit
derived from any decrease in the value of the subject security), (i) any direct or indirect
legal, economic or financial interest (including Short Interest) of a
proponent stockholder in the outcome of any (1) vote to be taken
at any annual or special meeting of stockholders of the Corporation or (2) any meeting of
stockholders of any other entity with respect
to any matter that is related, directly or indirectly, to any business proposed by any proponent stockholder
under Article IV, (j) any
direct or indirect legal, economic or financial interest (including Short Interest) in any principal competitor of the Corporation held
by a proponent stockholder, (k) any material pending or threatened action, suit or proceeding (whether civil, criminal, investigative,
administrative or
otherwise) in which a proponent stockholder is, or is reasonably expected to be made, a party or material participant
involving the Corporation or any of its
officers, directors or employees, or any affiliate of the Corporation, or any officer, director
or employee of such affiliate, and (l) any other information
relating to such stockholder and beneficial owner, if any, required to be
disclosed in a proxy statement or other filings required to be made in connection
with solicitations of proxies for the proposal pursuant
to and in accordance with Section 14(a) of the Securities Exchange Act of 1934, as amended and the
rules and regulations promulgated thereunder;
 
4

 
 
(v) the proponent stockholder
must also disclose to the Corporation, as part of the advance notice, all stock ownership information required by
the immediately preceding
clause (iv) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on
whose
behalf the business proposed to be brought before the annual meeting is being brought, (b) any affiliate or associate (each within the
meaning of
Rule 12b-2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner,
(c) any stockholder or
stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute
a filing group for purposes of
Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal
of such business;
 
(vi) the proponent stockholder
must represent to the Corporation, as part of the advance notice, whether the proponent intends individually or
as part of a group, to
(x) deliver a proxy statement and/or form of proxy to holders of at least the percentage of the Corporation’s outstanding capital
stock
required to approve or adopt the proposal, and/or (y) to otherwise solicit proxies in support of such proposal;
 
(vii) the proponent stockholder
 must disclose to the Corporation, as part of its advance notice: (a) a reasonably brief description of the
business desired to be brought
before the meeting, the reasons for conducting such business at the meeting and any material interest of such stockholder
and beneficial
owner, if any, in such business, (b) the text of the proposal or business (including the text of any resolutions proposed for consideration
and
in the event that such business includes a proposal to amend the By-Laws of the Corporation, the language of the proposed amendment),
 and (c) a
reasonably detailed description of all agreements, arrangements and understandings between such proponent and the beneficial
owner, if any, and any other
person or persons (including their names) in connection with the proposal of such business by such stockholder;
 
(viii) the proponent stockholder
must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder
is a holder of record
of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation
entitled
to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the stockholder
business specified in the notice;
 
(ix) the proponent stockholder
must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the
information set forth
in the advance notice; and
 
(x) the proponent stockholder
must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial
and record owners) known
by the proponent stockholder to support the stockholder business to be proposed by the proponent stockholder and, to the extent
known,
the class or series and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
 
3. In addition to the provisions
of Section 2 of this Article IV, a stockholder shall also comply with all applicable requirements of state law and all
applicable requirements
of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth
herein.
 
4. Nothing in these By-laws
shall be deemed to affect any rights of stockholders to request the inclusion of proposals in the Corporation’s proxy
statement
pursuant to Rule 14a-8 under the Securities Exchange Act of 1934, as amended. Subject to Rule 14a-8 and Rule 14a-19 under the Securities
Exchange Act of 1934, as amended, nothing in these By-laws shall be construed to permit any stockholder, or give any stockholder the right,
to include or
have disseminated or described in the Corporation’s proxy statement any nomination of director or directors or any
other business proposal.
 
5. Except as otherwise expressly
 provided in any applicable rule or regulation promulgated under the Securities Exchange Act of 1934, as
amended, only such business (other
than the election of directors as set forth in Article V) shall be conducted at an annual meeting of stockholders as shall
have been brought
before the meeting in accordance with the procedures of this Article IV. Except as otherwise provided by law, the chairperson of the
meeting
shall have the power and duty (i) to determine whether any business proposed to be brought before the meeting was proposed in accordance
with
the provisions of this Article IV (including whether the proponent stockholder solicited (or are part of a group which solicited)
or did not so solicit, as the
case may be, proxies or votes in support of the proponent stockholder’s proposal in compliance with
the proponent stockholder’s representation as required
by clause (vi) of Section 2 of Article IV) and (ii) if any proposed business
was not proposed in compliance with Article IV, to declare that such proposed
business shall not be transacted. Notwithstanding the foregoing
provisions of this Article IV, unless otherwise required by law, if the proponent stockholder
(or a qualified representative of the proponent
 stockholder) does not appear at the annual meeting of stockholders of the Corporation to present the
proposed business, such proposed
business shall not be transacted, notwithstanding that proxies in respect of such vote may have been received by the
Corporation. For
purposes of this Section 5 of Article IV, to be considered a qualified representative of the proponent stockholder, a person must be a
duly
authorized officer, manager or partner of such proponent stockholder or must be authorized by a writing executed by such proponent
stockholder or an
electronic transmission delivered by such proponent stockholder to act for such proponent stockholder as proxy at the
meeting of stockholders and such
person must produce such writing or electronic transmission, or a reliable reproduction of the writing
 or electronic transmission, at the meeting of
stockholders.
 
5

 
 
ARTICLE V
STOCKHOLDER DIRECTOR NOMINATIONS
 
1. At an annual meeting of
stockholders, only such nominations of persons for the election of directors shall be conducted as shall have been
properly brought before
the meeting. To be properly brought before an annual meeting of stockholders, nominations of persons for election to the Board of
Directors
must be: (i) specified in the notice of the meeting (or any supplement thereto) given by or at the direction of the Board of Directors
or any
committee thereof, (ii) otherwise properly brought before the meeting by or at the direction of the Board of Directors or any committee
thereof, or (iii)
otherwise properly brought before an annual meeting by a stockholder (a) who is a stockholder of record of the Corporation
at the time the notice provided
for in this Article V is delivered to, or mailed and received by, the Secretary of the Corporation, on
the record date for the determination of stockholders of
the Corporation entitled to vote at the meeting, and at the time of the meeting,
(b) who is entitled to vote at the meeting and (c) complies with the notice
procedures set forth in this Article V.
 
2. Notwithstanding anything
in these By-laws to the contrary, for the nomination of persons for election to the Board of Directors to be properly
brought before the
annual meeting by a stockholder, the stockholder or stockholders of record intending to propose such nominations must deliver a timely
and proper advance notice to the Secretary of the Corporation that complies with the following requirements:
 
(i) to be timely, the advance
notice must be in writing and must be delivered to, or mailed and received by, the Secretary of the Corporation at
the principal executive
offices of the Corporation no earlier than one hundred and twenty (120) days, and no later than ninety (90) days, prior to the first
anniversary
date of the prior year’s annual meeting; provided, however, that in the event that the annual meeting is called for a date
that is more than thirty
(30) days before or more than sixty (60) days after such anniversary date (or with respect to any other annual
meeting of stockholders, including in the
event that no annual meeting was held in the previous year), notice by the proponent stockholder
in order to be timely must be so delivered, or mailed and
received by, the Secretary of the Corporation at the principal executive offices
of the Corporation, not earlier than the close of business on the 120th day
prior to the annual meeting and not later than the close of
business on the later of the 90th day prior to the date of such annual meeting or, if the first Public
Announcement of the date of such
annual meeting is less than one hundred (100) days prior to the date of such annual meeting, the 10th day following the
day on which Public
Announcement of the date of such meeting is first made by the Corporation. In no event shall any adjournment or postponement of an
annual
meeting, or the Public Announcement thereof, commence a new time period (or extend any notice time period) for the giving of a stockholder’s
notice as described above;
 
(ii) in addition, to be
timely, a stockholder’s notice shall further be updated and supplemented, if necessary, so that the information provided
or required
to be provided in such notice shall be true and correct as of each of the record date for the meeting and the date that is ten (10) business
days
prior to the meeting or any adjournment or postponement thereof, and such update and supplement shall be delivered to, or mailed
and received by, the
Secretary of the Corporation at the principal executive offices of the Corporation not later than five (5) business
days after the record date for the meeting
(in the case of the update and supplement required to be made as of the record date), and not
later than eight (8) business days prior to the date for the
meeting, or if the meeting is adjourned or postponed, on the first practicable
date after any adjournment or postponement thereof (in the case of the update
and supplement required to be made as of ten (10) business
days prior to the meeting or any adjournment or postponement thereof);
 
(iii) in the event that
the number of directors to be elected to the Board of Directors is increased by the Board of Directors, and there is no
Public Announcement
by the Corporation naming all of the nominees for director or specifying the size of the increased Board of Directors at least one
hundred
(100) days prior to the first anniversary of the preceding year’s annual meeting, a stockholder’s notice required by Section
2 of this Article V shall
also be considered timely, but only with respect to nominees for any new positions created by such increase,
if it shall be delivered to, or mailed and
received by, the Secretary of the Corporation at the principal executive offices of the Corporation
not later than the close of business on the 10th day
following the day on which such Public Announcement is first made by the Corporation;
 
(iv) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, its name and address as they appear on the
Corporation’s books
and of any beneficial owner, if any, and their respective affiliates and associates or others acting in concert therewith;
 
6

 
 
(v) the proponent stockholder
must disclose to the Corporation, as part of the advance notice, (a) the class or series and number of shares of
capital stock or other
securities of the Corporation which are, directly or indirectly, owned of record or beneficially (within the meaning of Rule 13d-3
under
the Securities Exchange Act of 1934, as amended) by such proponent stockholder, (b) any option, warrant, convertible security, stock appreciation
right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any shares
of capital stock or
other securities of the Corporation or with a price or value derived in whole or in part from the price or value of
any shares of capital stock or other
securities of the Corporation or any derivative, synthetic, hedging, swap or similar transaction
or arrangement having characteristics of a long or short
position or ownership interest in any shares of capital stock or other securities
of the Corporation, whether or not any such instrument or right shall be
subject to settlement in the underlying shares of capital stock
 or other securities of the Corporation or otherwise, and any other direct or indirect
opportunity to profit or share in any profit derived
from any increase or decrease in the price or value of shares of capital stock or other securities of the
Corporation directly or indirectly
 owned beneficially by such proponent stockholder, (c) a reasonably detailed description of any proxy, agreement,
arrangement, understanding
or relationship pursuant to which such proponent stockholder has given or received a right to vote, directly or indirectly, any
shares
 of capital stock or other securities of the Corporation, (d) a reasonably detailed description of any agreement, arrangement, understanding
 or
relationship, including any repurchase or similar so-called “stock borrowing” agreement or arrangement, which such proponent
stockholder has engaged in
or is a party to, directly or indirectly, the purpose or effect of which is to mitigate loss to, reduce the
economic risk of shares of capital stock or other
securities of the Corporation by, manage the risk of share price changes for, or increase
or decrease the voting power of, such proponent stockholder with
respect to shares of capital stock or other securities of the Corporation,
or which provides, directly or indirectly, the opportunity to profit from any increase
or decrease in the price or value of the shares
of capital stock or other securities of the Corporation, (e) any rights to dividends or other distributions on the
shares of any class
or series of capital stock of the Corporation, directly or indirectly, owned beneficially by the proponent stockholder that are separated
or
separable from the underlying shares of the Corporation, (f) any performance-related fees (other than an asset based fee) that the
proponent stockholder,
directly or indirectly, is entitled to based on any increase or decrease in the value of shares of any class or
series of capital stock of the Corporation or any
interests described in clause (d), (g) any proportionate interest in any security of
the Corporation or derivative instruments held, directly or indirectly, by a
general or limited partnership or limited liability company
or similar entity in which a proponent stockholder is a general partner or, directly or indirectly,
beneficially owns any interest in
a general partner or is the manager or managing member or, directly or indirectly, beneficially owns any interest in the
manager or managing
member of a limited liability company or similar entity, (h) any Short Interest held by a proponent stockholder presently or within the
last 12 months in any security of the Corporation, (i) any direct or indirect legal, economic or financial interest (including Short Interest)
of a proponent
stockholder in the outcome of any (1) vote to be taken at any annual or special meeting of stockholders of the Corporation
 or (2) any meeting of
stockholders of any other entity with respect to any matter that is related, directly or indirectly, to any nomination
proposed by any proponent stockholder
under Article V, (j) any direct or indirect legal, economic or financial interest (including Short
Interest) in any principal competitor of the Corporation held
by a proponent stockholder, (k) any material pending or threatened action,
suit or proceeding (whether civil, criminal, investigative, administrative or
otherwise) in which a proponent stockholder is, or is reasonably
expected to be made, a party or material participant involving the Corporation or any of its
officers, directors or employees, or any
affiliate of the Corporation, or any officer, director or employee of such affiliate, and (l) any other information
relating to such stockholder
and beneficial owner, if any, required to be disclosed in a proxy statement or other filings required to be made in connection
with solicitations
of proxies for the election of directors in an election contest pursuant to and in accordance with Section 14(a) of the Securities Exchange
Act of 1934, as amended and the rules and regulations promulgated thereunder (collectively, the information in this clause (v), the “Stockholder
Information”);
 
(vi) the proponent stockholder
must also disclose to the Corporation, as part of the advance notice, all stock ownership information required
by the immediately preceding
clause (v) with respect to (a) the beneficial owner or beneficial owners of capital stock of the Corporation, if different, on
whose behalf
the nomination proposed to be brought before the annual meeting is made, (b) any affiliate or associate (each within the meaning of Rule
12b-
2 under the Securities Exchange Act of 1934, as amended) of the proponent stockholder or any such beneficial owner, and, (c) any stockholder
 or
stockholder group with whom the proponent stockholder is acting in concert with, whether or not such persons constitute a filing group
for purposes of
Schedule 13D, and (d) any other person or persons (including their names) in connection with the proposal of such nomination;
 
(vii) the proponent stockholder
must represent to the Corporation, as part of the advance notice, whether the proponent or any of its respective
affiliates, associates
or others acting in concert therewith intends individually or as part of a group, to (a) deliver a proxy statement and/or form of proxy
to
holders of at least the percentage of the Corporation’s outstanding capital stock required to elect the nominee and/or (b) to
otherwise solicit proxies in
support of such nomination, including to solicit proxies in support of director nominees other than the Corporation’s
nominees in accordance with Rule
14a-19 under the Securities Exchange Act of 1934, as amended;
 
7

 
 
(viii) the proponent stockholder
 must disclose to the Corporation, as part of the advance notice, as to each person whom the proponent
stockholder proposes to nominate
for election as a director (a) all information about the proposed nominees that would be required to be to be disclosed in a
proxy statement
or other filings required to be made in connection with solicitations of proxies for the election of directors in a contested election
pursuant
to Section 14 of the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder (including
such person’s written
consent to being named in the proxy statement, including the Corporation’s proxy statement, as a nominee
of the proponent stockholder and to serving as a
director if elected), (b) a complete and accurate description of all direct and indirect
compensation and other material monetary agreements, arrangements
and understandings (whether written or oral) during the past three years,
and any other material relationships, between or among such stockholder and
beneficial owner, if any, and their respective affiliates
and associates, or others acting in concert therewith, on the one hand, and each proposed nominee,
and his or her respective affiliates
and associates, or others acting in concert therewith, on the other hand, including, without limitation all information that
would be
required to be disclosed pursuant to Rule 404 promulgated under Regulation S-K if the stockholder making the nomination and any beneficial
owner on whose behalf the nomination is made, if any, or any affiliate or associate thereof or person acting in concert therewith, were
the “registrant” for
purposes of such rule and such proposed nominee were a director or executive officer of such registrant,
 (c) a completed and signed questionnaire,
representation and agreement and any and all other information required by Section 4 of Article
V, and (d) the Stockholder Information for such person and
any member of the immediate family of such person, or any affiliate or associate
of such person, or any person acting in concert therewith;
 
(ix) the proponent stockholder
must provide a representation to the Corporation, as part of its advance notice, that the proponent stockholder
is a holder of record
of capital stock of the Corporation entitled to vote at the meeting, will continue to be a stockholder of record of the Corporation
entitled
to vote at such meeting through the date of such meeting and intends to appear in person or by proxy at the meeting to propose the nomination(s)
specified in the notice;
 
(x) the proponent stockholder
must provide, as part of its advance notice, a certification by the proponent stockholder of the accuracy of the
information set forth
in the advance notice; and
 
(xi) the proponent stockholder
must provide, as part of its advance notice, the names and addresses of other stockholders (including beneficial
and record owners) known
by the proponent stockholder to support the nomination(s) made by the proponent stockholder and, to the extent known, the
class or series
and number of all shares of capital stock of the Corporation owned beneficially or of record by such other stockholders.
 
3. Nominations of persons
for election to the Board of Directors may be made at a special meeting of stockholders at which directors are to be
elected pursuant
to the Corporation’s notice of meeting (i) by or at the direction of the Board of Directors or any committee thereof or (ii) provided
that the
Board of Directors has determined that directors shall be elected at such meeting, by any stockholder of the Corporation (a)
who is a stockholder of record
of the Corporation at the time the notice provided for in this Article V is delivered to, or mailed and
received by, the Secretary of the Corporation, on the
record date for the determination of stockholders of the Corporation entitled to
vote at the meeting, and at the time of the meeting, (b) who is entitled to
vote at the meeting and (c) complies with the notice procedures
 set forth in this Article V. In the event the Corporation calls a special meeting of
stockholders for the purpose of electing one (1)
or more directors to the Board of Directors, any such proponent stockholder entitled to vote in such election
of directors may nominate
a person or persons (as the case may be) for election to such position(s) as specified in the Corporation’s notice of meeting, if
the
notice required by Section 2 of Article V shall be delivered to, or mailed and received by, the Secretary of the Corporation at the
principal executive offices
of the Corporation no earlier than one hundred and twenty (120) days prior to the special meeting, and no
later than ninety (90) days prior to the special
meeting, or the tenth (10th) day following the day on which the Corporation first makes
a public announcement of the date of the special meeting at which
directors are to be elected. In no event shall the public announcement
of an adjournment or postponement of a special meeting commence a new time
period (or extend any time period) for the giving of a stockholder’s
notice as described above.
 
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4. In addition to the requirements
set forth elsewhere in these By-Laws, to be eligible to be a nominee for election or re-election as a director of
the Corporation, such
proposed nominee or a person on such proposed nominee’s behalf must deliver (with respect to a nomination made by a proponent
pursuant
to Section 2 of Article V, in accordance with the time periods for delivery of timely notice under Section 2 of Article V), to the Secretary
of the
Corporation at the principal executive offices of the Corporation a completed and signed questionnaire with respect to the background
and qualifications of
such proposed nominee and the background of any other person or entity on whose behalf the nomination is being made
(which questionnaire shall be
provided by the Secretary of the Corporation upon written request of any stockholder of record identified
by name within ten business days of such written
request) and a written representation and agreement (in the form provided by the Secretary
of the Corporation upon written request of any stockholder of
record identified by name within ten business days of such written request)
that such proposed nominee (i) is not and will not become a party to (a) any
agreement, arrangement or understanding with, and has not
given any commitment or assurance to, any person or entity as to how such proposed nominee,
if elected as a director of the Corporation,
will act or vote on any issue or question (a “Voting Commitment”) that has not been disclosed to the Corporation
or (b) any
Voting Commitment that could limit or interfere with such proposed nominee’s fiduciary duties under applicable law, (ii) is not
and will not
become a party to any agreement, arrangement or understanding with any person or entity other than the Corporation with respect
to any direct or indirect
compensation, reimbursement or indemnification in connection with service or action as a director that has not
been disclosed to the Corporation, and (iii)
would be in compliance, if elected as a director of the Corporation, and will comply with,
all applicable publicly disclosed corporate governance, code of
conduct and ethics, conflict of interest, confidentiality, corporate opportunities,
trading and any other policies and guidelines of the Corporation applicable
to directors.
 
5. The Corporation may also
require, as a condition to any such nomination being deemed properly brought before an annual or special meeting,
any proponent stockholder
or proposed nominee to furnish such other information as may reasonably be required by the Corporation to determine the
eligibility of
 such proposed nominee to serve as an independent director of the Corporation or that could be material to a reasonable stockholder’s
understanding of the independence, or lack thereof, of such nominee.
 
6. In addition, if the proponent
stockholder has provided notice pursuant to Rule 14a-19(b) of the Securities Exchange Act of 1934, as amended,
the proponent stockholder
shall deliver to the Corporation no later than ten (10) days prior to the date of the meeting or any adjournment or postponement
thereof
reasonable evidence that it has complied with the requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended.
 
7. Compliance with the provisions
of this Article V is the sole and exclusive method for stockholders to nominate candidates for election to the
Board of Directors at an
annual or special meeting of stockholders. No person shall be eligible for election as a director of the Corporation at an annual or
special
meeting of stockholders unless nominated in accordance with the procedures set forth in this Article V. The number of nominees that a
proponent
stockholder may nominate for election at an annual or special meeting (or in the case of a proponent stockholder giving the
notice on behalf of a beneficial
owner, the number of nominees a proponent stockholder may nominate for election at the annual or special
meeting on behalf of such beneficial owner)
shall not exceed the number of directors to be elected at such annual or special meeting.
For the avoidance of doubt, a stockholder shall not be entitled to
make additional or substitute nominations at an annual or special meeting
following the expiration of the time periods set forth in these By-Laws. Unless
otherwise required by law, if any proponent stockholder
(i) provides notice pursuant to Rule 14a-19(b) under the Securities Exchange Act of 1934, as
amended, and (ii) subsequently fails to comply
with any requirements of Rule 14a-19 of the Securities Exchange Act of 1934, as amended, or any other
rules or regulations thereunder,
 then the Corporation shall disregard any proxies or votes solicited for such nominees and such nominations shall be
disregarded. Except
as otherwise provided by law or herein, the chairperson of the meeting shall have the power and duty (i) to determine whether a
nomination
was made in accordance with the provisions of this Article V (including whether the proponent stockholder or any of its respective affiliates,
associates or others acting in concert therewith solicited (or are part of a group which solicited) or did not so solicit, as the case
may be, proxies or votes in
support of the proponent stockholder’s nominee in compliance with the proponent stockholder’s
representation as required by clause (vii) of Section 2 of
Article V) and (ii) if any proposed nomination was not made in compliance with
 Article V, to declare that such nomination shall be disregarded.
Notwithstanding the foregoing provisions of Article V, unless otherwise
required by law, if the proponent stockholder (or a qualified representative of the
proponent stockholder) does not appear at the annual
or special meeting of stockholders of the Corporation to present a nomination, such nomination shall
be disregarded, notwithstanding that
proxies in respect of such vote may have been received by the Corporation. For purposes of this Section 7 of Article V,
to be considered
a qualified representative of the proponent stockholder, a person must be a duly authorized officer, manager or partner of such proponent
stockholder or must be authorized by a writing executed by such proponent stockholder or an electronic transmission delivered by such
 proponent
stockholder to act for such proponent stockholder as proxy at the meeting of stockholders and such person must produce such
 writing or electronic
transmission, or a reliable reproduction of the writing or electronic transmission, at the meeting of stockholders.
 
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8. In addition to the provisions
of this Article V, a stockholder shall also comply with all applicable requirements of state law and all applicable
requirements of the
Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder, with respect to the matters set forth herein.
 
9. For purposes of these
By-laws, “Public Announcement” shall mean disclosure in a press release reported by a national news service or in a
document
publicly filed by the Corporation with the Securities and Exchange Commission pursuant to Section 13, 14 or 15(d) of the Securities Exchange
Act of 1934, as amended and the rules and regulations promulgated thereunder.
 
ARTICLE VI
DIRECTORS
 
1. The business and affairs
of the Corporation shall be managed under the direction of a Board of Directors, which may exercise all such powers
and authority for
and on behalf of the Corporation as shall be permitted by law, the Certificate of Incorporation or these By-laws. Each of the directors
shall
hold office until the next annual meeting of stockholders and until his or her successor has been elected and qualified or until
his or her earlier death,
disqualification, resignation or removal.
 
2. The Board of Directors
is empowered to appoint a Chairman of the Board of Directors. The Chairman shall act as chairman of all meetings of
the Board of Directors
and as the presiding person at all special and annual meetings of stockholders, unless the Board of Directors shall appoint a different
individual as chairman of any meeting of the Board of Directors or as the presiding person at any special or annual meeting of stockholders,
and the
chairman or presiding person shall have control over the agenda of any such meetings, all in accordance with the provisions of
these By-laws and the
Certificate of Incorporation. The Chairman shall perform such other duties as may from time to time be assigned
to him by the Board of Directors.
 
3. The Board of Directors
may hold their meetings within or outside of the State of Delaware, at such place or places as it may from time to time
determine.
 
4. The number of directors
comprising the Board of Directors shall be such number as may be from time to time fixed exclusively by resolution of
the Board of Directors.
In case of any increase in the number of directors, a majority of the remaining members of the Board of Directors, although such
majority
is less than a quorum, shall have the sole and exclusive power and authority to elect each additional director to fill any newly created
directorship,
to hold office until the next annual meeting of stockholders and until his or her successor is elected and qualified or
his or her earlier death, disqualification,
resignation or removal. No decrease in the number of directors shall shorten the term of any
incumbent director.
 
5. If any directorship becomes
vacant, by reason of death, resignation, disqualification, removal or otherwise, a majority of the directors then in
office, although
less than a quorum, shall have the sole and exclusive authority to fill the vacancy by electing a successor who shall hold office until
the
next annual meeting of stockholders and until his or her successor is elected and qualified or his or her earlier death, resignation,
 disqualification or
removal.
 
6. Any director may resign
at any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any
such resignation
shall take effect upon receipt thereof by the Corporation, or at such later time or date as may be specified therein.
 
ARTICLE VII
COMMITTEES OF DIRECTORS
 
1. The Board of Directors
may designate an Executive Committee and one or more other committees, each such committee to consist of one or
more directors of the
Corporation. The Executive Committee shall have and may exercise all the powers and authority of the Board of Directors in the
management
of the business and affairs of the Corporation (except as otherwise expressly limited by statute), including the power and authority to
declare
dividends and to authorize the issuance of stock, and may authorize the seal of the Corporation to be affixed to all papers which
may require it. Each such
committee shall have such of the powers and authority of the Board of Directors as may be provided from time
to time in resolutions adopted by the Board
of Directors.
 
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2. The requirements with
respect to the manner in which the Executive Committee and each such other committee shall hold meetings and take
actions shall be set
forth in the resolutions of the Board of Directors designating the Executive Committee or such other committee.
 
ARTICLE VIII
MEETINGS OF DIRECTORS; ACTION WITHOUT A MEETING
 
1. Regular meetings of the
Board of Directors may be held without notice at such time and place, either within or without the State of Delaware, as
may be determined
from time to time by resolution of the Board of Directors.
 
2. Special meetings of the
Board of Directors shall be held whenever called by the President of the Corporation or the majority of the directors
then in office on
at least 24 hours’ notice to each director. Except as may be otherwise specifically provided by statute, by the Certificate of Incorporation
or by these By-laws, the purpose or purposes of any such special meeting need not be stated in such notice, although the time and place
of the meeting shall
be stated.
 
3. At all meetings of the
Board of Directors, the presence in person of a majority of the total number of directors shall be necessary and sufficient
to constitute
a quorum for the transaction of business, and, except as otherwise provided by statute, by the Certificate of Incorporation or by these
By-laws,
if a quorum shall be present the act of a majority of the directors present shall be the act of the Board of Directors.
 
4. Any action required or
permitted to be taken at any meeting of the Board of Directors or of any committee thereof may be taken without a
meeting if all the members
of the Board of Directors or such committee, as the case may be, consent thereto in writing or by electronic transmission and
any consent
may be documented, signed and delivered in any manner permitted by Section 116 of the General Corporation Law of the State of Delaware.
After an action is taken, the consent or consents or electronic transmissions shall be filed with the minutes of proceedings of the Board
of Directors or
committee, in the same paper or electronic form as the minutes are maintained. Any director may participate in a meeting
of the Board of Directors, or any
committee designated by the Board of Directors, by means of a conference telephone or other communications
equipment by means of which all persons
participating in the meeting can hear each other, and participation in a meeting pursuant to this
sentence shall constitute presence in person at such meeting.
 
ARTICLE IX
OFFICERS
 
1. The officers of the Corporation
shall be chosen by the Board of Directors and shall be a Chief Executive Officer, a President, one or
more Vice
Presidents, a Secretary and a Treasurer. The Board of Directors may also choose one or more Vice
 Presidents, Assistant Secretaries and Assistant
Treasurers, and such other officers as it shall deem necessary. Any number
of offices may be held by the same person.
 
2. The salaries of all officers
of the Corporation shall be fixed by the Board of Directors, or in such manner as the Board of Directors may
prescribe.
 
3. The officers of the Corporation
shall hold office until their successors are elected and qualified, or until their earlier resignation or removal. Any
officer may be
at any time removed from office by the Board of Directors, with or without cause. If the office of any officer becomes vacant for any
reason,
the vacancy may be filled by the Board of Directors.
 
4. Any officer may resign at
any time by giving notice of his or her resignation to the Corporation in writing or by electronic transmission. Any
such resignation
shall take effect upon receipt thereof by the Corporation or at such later date as may be specified therein.
 
5. The Chief Executive Officer
shall have general supervision and direction of the business and affairs of the Corporation, subject, however, to the
direction and control
of the Board of Directors. The Chief Executive Officer may sign and execute in the name of the Corporation deeds, mortgages, bond,
contracts
or other instruments. The Chief Executive Officer shall perform all duties incident to the office of the Chief Executive Officer and shall,
when
requested, counsel with and advise the other officers of the Corporation and shall perform such other duties as the Board of Directors
may from time to
time determine.
 
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6. The President shall have
such powers and perform such duties as from time to time may be assigned to him by the Chief Executive Officer or
the Board of Directors.
 
7. The Vice Presidents shall
have such powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
 
8. The Secretary shall perform
all duties incident to the office of the Secretary and shall have such powers and duties as may be delegated to him
by the Chief Executive
Officer or the Board of Directors.
 
9. The Assistant Secretary
shall, in case of the absence of the Secretary, perform the duties and exercise the powers of the Secretary, and shall have
such other
powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
 
10. The Treasurer shall have
the custody of the corporate funds and securities, and shall deposit or cause to be deposited under his or her direction
all moneys and
other valuable effects in the name and to the credit of the Corporation in such depositories as may be designated by the Board of Directors
or pursuant to authority granted by it. He shall render to the Chief Executive Officer and the Board of Directors whenever they may require
it an account of
all his or her transactions as Treasurer and of the financial condition of the Corporation. He shall have such other
powers and duties as may be delegated to
him by the Chief Executive Officer or the Board of Directors.
 
11. The Assistant Treasurer
shall, in case of the absence of the Treasurer, perform the duties and exercise the powers of the Treasurer, and shall
have such other
powers and duties as may be delegated to them by the Chief Executive Officer or the Board of Directors.
 
ARTICLE X
FORM OF CERTIFICATES; UNCERTIFICATED SHARES
 
Shares of the capital stock of the Corporation
 may be certificated or uncertificated, as provided under the General Corporation Law of the State of
Delaware. Each stockholder holding
certificated shares of capital stock of the Corporation, upon written request to the transfer agent or registrar of the
Corporation, shall
 be entitled to a certificate representing such shares of capital stock of the Corporation in such form as may from time to time be
prescribed
by the Board of Directors. Any such certificate shall be signed by any two authorized officers of the Corporation, which shall include,
without
limitation, the Chairman of the Board of Directors, the Chief Executive Officer, the President, any Vice President, the Treasurer,
any Assistant Treasurer,
the Secretary and any Assistant Secretary.
 
ARTICLE XI
FISCAL YEAR
 
The fiscal year of the Corporation shall be as
determined from time to time by resolution duly adopted by the Board of Directors.
 
ARTICLE XII
NOTICES AND WAIVERS
 
1. Whenever by statute, by
the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any director, such
provision shall not
be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States
mail, postage prepaid, directed to such director at his or her address as it appears on the records of the Corporation, and such notice
shall be deemed to be
given at the time when the same shall be thus deposited. Notice of meetings of the Board of Directors may also be
given to any director by telephone or by
electronic transmission, and in the latter event the notice shall be deemed to be given at the
time such notice, addressed to such director at the address
hereinabove provided, is transmitted by facsimile, electronic mail or other
electronic transmission.
 
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2. Whenever by statute, by
the Certificate of Incorporation or by these By-laws it is provided that notice shall be given to any stockholder, such
provision shall
not be construed to require personal notice, but such notice may be given in writing, by mail, by depositing the same in the United States
mail, postage prepaid, directed to such stockholder at his or her mailing address as it appears on the records of the Corporation, and
such notice shall be
deemed to be given at the time when the same shall be thus deposited. Such notice may also be given (i) by courier
service, and such notice shall be
deemed to be given upon the earlier of when the notice is received or left at the stockholder’s
address or (ii) by electronic transmission directed to the
stockholder’s electronic mail address as it appears on the records of
the Corporation, and such notice shall be deemed to be given when directed to such
stockholder’s electronic mail address unless
 the stockholder has notified the Corporation in writing or by electronic transmission of an objection to
receiving notice by electronic
mail or such notice is prohibited by Section 232(e) of the General Corporation Law of the State of Delaware. A notice by
electronic mail
will include a prominent legend that the communication is an important notice regarding the Corporation.
 
3. Without limiting the manner
by which notice otherwise may be given effectively to stockholders, any notice to stockholders given by the
Corporation under any provision
of the General Corporation Law of the State of Delaware, the Certificate of Incorporation, or these By-laws shall be
effective if given
by another form of electronic transmission consented to by the stockholder to whom the notice is given. Any such consent shall be
revocable
 by the stockholder by written notice or electronic transmission to the Corporation. Any such consent shall be deemed revoked if (i) the
Corporation is unable to deliver by electronic transmission two (2) consecutive notices given by the Corporation in accordance with such
consent and (ii)
such inability becomes known to the Secretary or an Assistant Secretary or to the transfer agent, or other person responsible
for the giving of notice;
provided, however, the inadvertent failure to discover such inability shall not invalidate any meeting
or other action.
 
4. Notice given pursuant
to Section 3 of this Article XII shall be deemed given: (i) if by facsimile telecommunication, when directed to a number
at which the
stockholder has consented to receive notice; (ii) if by a posting on an electronic network together with separate notice to the stockholder
of
such specific posting, upon the later of (A) such posting and (B) the giving of such separate notice; and (iii) if by any other
form of electronic transmission,
when directed to the stockholder. An affidavit of the Secretary or an Assistant Secretary or of the transfer
agent or other agent of the Corporation that the
notice has been given shall, in the absence of fraud, be prima facie evidence of the
facts stated therein. For purposes of this Article XII, “electronic
transmission” means any form of communication, not directly
involving the physical transmission of paper, including the use of, or participation in, 1 or
more electronic networks or databases (including
 1 or more distributed electronic networks or databases), that creates a record that may be retained,
retrieved and reviewed by a recipient
thereof, and that may be directly reproduced in paper form by such a recipient through an automated process.
 
5. Whenever by statute, by
the Certificate of Incorporation or by these By-laws a notice is required to be given, a written waiver thereof, signed by
the person
entitled to notice, or a waiver by electronic transmission by the person entitled to notice, whether before or after the time stated therein,
shall be
deemed equivalent to notice. Attendance of any stockholder or director at any meeting thereof shall constitute a waiver of notice
of such meeting by such
stockholder or director, as the case may be, except as otherwise provided by statute.
 
ARTICLE XIII
INDEMNIFICATION
 
1. The Corporation shall
indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party
to any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an action by or
in the
right of the corporation) by reason of the fact that such person is or was a director or officer of the Corporation, or is or was
serving at the request of the
Corporation as a director or officer of another corporation, partnership, joint venture, trust or other
enterprise, against expenses (including attorneys’ fees),
judgments, fines and amounts paid in settlement actually and reasonably
incurred by such person in connection with such action, suit or proceeding if such
person acted in good faith and in a manner such person
reasonably believed to be in or not opposed to the best interests of the Corporation, and, with
respect to any criminal action or proceeding,
had no reasonable cause to believe such person’s conduct was unlawful. The termination of any action, suit or
proceeding by judgment,
order, settlement, conviction, or upon a plea of nolo contendere or its equivalent, shall not, of itself, create a presumption that the
person did not act in good faith and in a manner which such person reasonably believed to be in or not opposed to the best interests of
the Corporation, and,
with respect to any criminal action or proceeding, had reasonable cause to believe that such person’s conduct
was unlawful. Notwithstanding the provisions
of this Section 1, except as otherwise provided in Section 4 of this Article XIII, the Corporation
shall be required to indemnify any person referenced in this
Section 1 in connection with an action, suit or proceeding (or part thereof)
commenced by such person only if the commencement of such action, suit or
proceeding (or part thereof) by the person was authorized in
the specific case by the Board of Directors.
 
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2. The Corporation shall
indemnify to the maximum extent permitted by law any person who was or is a party or is threatened to be made a party
to any threatened,
pending or completed action or suit by or in the right of the Corporation to procure a judgment in its favor by reason of the fact that
such
person is or was a director or officer of the corporation, or is or was serving at the request of the Corporation as a director or
officer of another corporation,
partnership, joint venture, trust or other enterprise against expenses (including attorneys’ fees)
 actually and reasonably incurred by such person in
connection with the defense or settlement of such action or suit if such person acted
in good faith and in a manner such person reasonably believed to be in
or not opposed to the best interests of the Corporation and except
that no such indemnification shall be made in respect of any claim, issue or matter as to
which such person shall have been adjudged to
be liable to the Corporation unless and only to the extent that the Court of Chancery of the State of
Delaware (the “Court of Chancery”)
or the court in which such action or suit was brought shall determine upon application that, despite the adjudication of
liability but
in view of all the circumstances of the case, such person is fairly and reasonably entitled to indemnity for such expenses which such
Court of
Chancery or such other court shall deem proper.
 
3. Expenses (including attorneys’
 fees) incurred by a present or former officer or director in defending any civil, criminal, administrative or
investigative action, suit
or proceeding shall be paid by the Corporation in advance of the final disposition of such action, suit or proceeding upon receipt of
an undertaking by or on behalf of such director or officer to repay such amount if it shall ultimately be determined that such person
is not entitled to be
indemnified by the Corporation as authorized in this Article XIII. Such expenses (including attorneys’ fees)
incurred by employees and agents may be so
paid upon such terms and conditions, if any, as the Corporation deems appropriate.
 
4. The indemnification and
advancement of expenses provided by, or granted pursuant to, the other Sections of this Article XIII shall not be
deemed exclusive of
any other rights to which those seeking indemnification or advancement of expenses may be entitled under any By-law, agreement,
vote of
stockholders or disinterested directors or otherwise, both as to action in such person’s official capacity and as to action in another
capacity while
holding such office.
 
5. The Corporation may, but
shall not be required to, purchase and maintain insurance on behalf of any person who is or was a director, officer,
employee or agent
of the Corporation, or is or was serving at the request of the Corporation as a director, officer, employee or agent of another corporation,
partnership, joint venture, trust or other enterprise against any liability asserted against such person and incurred by such person in
any such capacity, or
arising out of such person’s status as such, whether or not the Corporation would have the power to indemnify
such person against such liability under the
provisions of this Article XIII.
 
6. For purposes of this Article
 XIII, references to “the Corporation” shall include, in addition to the resulting corporation, any constituent
corporation
(including any constituent of a constituent) absorbed in a consolidation or merger which, if its separate existence had continued, would
have
had power and authority to indemnify its directors or officers so that any person who is or was a director or officer of such constituent
corporation, or is or
was serving at the request of such constituent corporation as a director or officer of another corporation, partnership,
joint venture, trust or other enterprise,
shall stand in the same position under the provisions of this Article XIII with respect to the
resulting or surviving corporation as such person would have
with respect to such constituent corporation if its separate existence had
continued.
 
7. For purposes of this Article
XIII, references to “other enterprises” shall include employee benefit plans; references to “fines” shall
include any
excise taxes assessed on a person with respect to an employee benefit plan; and references to “serving at the request
of the Corporation” shall include
service as a director or officer of the Corporation which imposes duties on, or involves services
by, such director or officer with respect to an employee
benefit plan, its participants or beneficiaries; and a person who acted
in good faith and in a manner such person reasonably believed to be in the interest of
the participants and beneficiaries of an employee
 benefit plan shall be deemed to have acted in a manner “not opposed to the best interests of the
Corporation” as referred
to in this Article XIII.
 
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8. The indemnification and
advancement of expenses provided by, or granted pursuant to, this Article XIII shall, unless otherwise provided when
authorized or ratified,
 continue as to a person who has ceased to be a director or officer and shall inure to the benefit of the heirs, executors and
administrators
of such a person.
 
9. If this Article or any
portion hereof shall be invalidated on any ground by any court of competent jurisdiction, then the Corporation shall
nevertheless indemnify
 each director or officer to the fullest extent not prohibited by any applicable portion of this Article that shall not have been
invalidated,
or by any other applicable law. If this Article shall be invalid due to the application of the indemnification provisions of another jurisdiction,
then the Corporation shall indemnify each director and officer to the fullest extent under any other applicable law.
 
10. The Corporation may indemnify
 every person who was or is a party or is or was threatened to be made a party to any action, suit, or
proceeding, whether civil, criminal,
administrative or investigative, by reason of the fact that he is or was an employee or agent of the corporation or, while
an employee
or agent of the Corporation, is or was serving at the request of the corporation as an employee or agent or trustee of another corporation,
partnership, joint venture, trust, employee benefit plan or other enterprise, against expenses (including counsel fees), judgments, fines
and amounts paid in
settlement actually and reasonably incurred by him in connection with such action, suit or proceeding, to the extent
permitted by Delaware law.
 
11. The Corporation’s
obligation, if any, to indemnify or to advance expenses to any person serving at its request as a director or officer of another
corporation,
partnership, joint venture, trust or other enterprise shall be reduced by any amount such person may collect as indemnification or advancement
of expenses from such other corporation, partnership, joint venture, trust or other enterprise.
 
ARTICLE XIV
FORUM SELECTION
 
1. Unless the Corporation
consents in writing to the selection of an alternative forum, the Court of Chancery (or, if and only if the Court of
Chancery lacks subject
matter jurisdiction, any state or federal court located within the State of Delaware) and any appellate court thereof shall be the sole
and exclusive forum for (i) any derivative action, suit, or proceeding brought on behalf of the Corporation, (ii) any action, suit, or
proceeding asserting a
claim of breach of fiduciary duty owed by any current or former director, officer, employee, or stockholder of
the Corporation to the Corporation or the
Corporation’s stockholders or any action asserting a claim for aiding and abetting any
such breach of fiduciary duty, (iii) any action, suit, or proceeding
arising pursuant to any provision of the General Corporation Law
of the State of Delaware or the Certificate of Incorporation or these By-laws (as each
may be amended from time to time), (iv) any claim
as to which the General Corporation Law of the State of Delaware confers jurisdiction upon the Court
of Chancery, or (v) any action, suit,
or proceeding asserting a claim against the Corporation or its current or former directors, officers, employees, or
stockholders governed
by the internal affairs doctrine, in each such case subject to such court having personal jurisdiction over the indispensable parties
named as defendants therein.
 
2. Unless the Corporation
consents in writing to the selection of an alternative forum, to the fullest extent permitted by law, the federal district
courts of the
United States of America shall be the exclusive forum for the resolution of any complaint asserting a cause of action arising under the
Securities Act of 1933, as amended.
 
3. Notwithstanding the foregoing,
the provisions of this Article XIV shall not apply to suits brought to enforce any liability or duty created by the
Securities Exchange
Act of 1934, as amended, or any other claim for which the federal courts of the United States have exclusive jurisdiction.
 
4. Any person or entity purchasing
or otherwise acquiring any interest in shares of capital stock of the Corporation shall be deemed to have notice
of the provisions of
this Article XIV. If any provision or provisions of this Article XIV shall be held to be invalid, illegal or unenforceable as applied
to any
person or entity or circumstance for any reason whatsoever, then, to the fullest extent permitted by law, the validity, legality
and enforceability of such
provisions in any other circumstance and of the remaining provisions of this Article XIV (including, without
limitation, each portion of any sentence of this
Article XIV containing any such provision held to be invalid, illegal or unenforceable
that is not itself held to be invalid, illegal or unenforceable) and the
application of such provision to other persons or entities and
circumstances shall not in any way be affected or impaired thereby.
 
ARTICLE XV
AMENDMENT OF BY-LAWS
 
The By-laws of the Corporation may be altered,
amended or repealed, and new By-laws may be adopted, by the Board of Directors. In addition, the By-
laws of the Corporation may be altered,
amended or repealed, and new By-laws may be adopted, by the stockholders of the Corporation by the affirmative
vote of the holders of
a majority in voting power of the outstanding shares of capital stock of the Corporation entitled to vote thereon.
 
15
 

Exhibit
4.2
 
DESCRIPTION
OF THE REGISTRANT’S SECURITIES REGISTERED PURSUANT TO SECTION 12 
OF THE SECURITIES EXCHANGE ACT OF 1934
 
The
following description of the securities of Oramed Pharmaceuticals Inc. (the “Company”) is a summary only. This summary is
not complete and is
subject to and qualified by the provisions of the Company’s Certificate of Incorporation, as amended (the “Charter”),
and By-laws, as amended and restated
(the “By-laws”), which are filed as exhibits to the Company’s Annual Report on
Form 10-K for the fiscal year ended August 31, 2020 and the Company’s
Current Report on Form 10-K filed March 27, 2025, respectively,
and are incorporated by reference herein.
 
Common
Stock
 
Pursuant
to the Company’s Charter, the Company is authorized to issue up to sixty million (60,000,000) shares of common stock, par value
$0.012 per
share (the “Common Stock”).
 
The
Common Stock is traded on The Nasdaq Capital Market and the Tel Aviv Stock Exchange, in each case under the symbol “ORMP”.
 
The
holders of shares of Common Stock vote together as one class on all matters as to which holders of Common Stock are entitled to vote.
Except as
otherwise required by applicable law, all voting rights are vested in and exercised by the holders of Common Stock with each
share of Common Stock
being entitled to one vote, including in all elections of directors. The Company does not have a classified board
of directors (the “Board”). Generally, all
matters to be voted on by stockholders must be approved by a majority of the votes
cast by the holders of shares of stock present in person or represented
by proxy at such meeting and entitled to vote on the subject
matter, a quorum being present. However, in the case of a contested election of directors, a
director nominee shall be elected by
a plurality of the votes cast by the stockholders entitled to vote at the election on such election of directors (an election
shall be
considered contested if, as of the last date on which nominees for director may be submitted in accordance with the By-laws, the
nominees for
election to the Board exceed the number of positions on the Board to be filled by election at that meeting).
 
The
holders of Common Stock are entitled to receive ratably such dividends, if any, as may be declared from time to time by the Board out
of legally
available funds therefore. The Company has not declared any dividends on its Common Stock and does not anticipate paying any
dividends on its Common
Stock in the foreseeable future.
 
In
the event of the Company’s liquidation, dissolution or winding up, holders of the Common Stock are entitled to share ratably in
all assets remaining after
payment of liabilities. The Common Stock has no cumulative voting rights and no preemptive or other rights
to subscribe for shares of the Company.
 
There
are no redemption or sinking fund provisions applicable to the Common Stock. All shares of Common Stock currently outstanding are fully
paid and
non-assessable.
 
The
Company is permitted to issue, and has from time to time, issued warrants and options to purchase shares of the Common Stock, as well
as restricted
stock units.
 
 

 
 
The
Company’s bylaws provide that the Court of Chancery of the State of Delaware (the “Court Chancery”) is the exclusive
forum for state law claims for
(i) any derivative action, suit, or proceeding brought on behalf of the Company (ii) any action, suit,
or proceeding asserting a claim of breach of fiduciary
duty owed by any current or former director, officer, employee, or stockholder
of the Company to the Company or the Company’s stockholders or any
action asserting a claim for aiding and abetting any such breach
of fiduciary duty, (iii) any action, suit, or proceeding arising pursuant to any provision of
the General Corporation Law of the State
of Delaware or the Certificate of Incorporation or these By-laws (as each may be amended from time to time),
(iv) any claim as to which
the General Corporation Law of the State of Delaware confers jurisdiction upon the Court of Chancery, or (v) any action, suit, or
proceeding
asserting a claim against the Company or its current or former directors, officers, employees, or stockholders governed by the internal
affairs
doctrine, in each such case subject to such court having personal jurisdiction over the indispensable parties named as defendants
therein. To the fullest
extent permitted by law, the federal district courts of the United States of America shall be the exclusive
forum for the resolution of any complaint asserting
a cause of action arising under the Securities Act of 1933, as amended.
 
Anti-Takeover
Effects of the Company’s Charter and By-Laws
 
In
addition to provisions under Delaware law, the Company’s Charter and By-Laws contain provisions that could have the effect of discouraging
potential
acquisition proposals or making a tender offer or delaying or preventing a change in control, including changes a stockholder
might consider favorable. In
particular, the Charter and/or By-Laws, as applicable, among other things:
 
 
●
provide
the Board with the exclusive authority to call special meetings of the stockholders;
 
 
●
provide
the Board with the ability to alter the By-Laws without stockholder approval and require the affirmative vote of the holders of a
majority
in voting power of the outstanding shares of capital stock of the Company entitled to vote thereon to alter the By-Laws
without Board approval;
 
 
●
provide
rules for stockholder action by written consent, including procedures for a record date to be set by the Board in connection with
such
action, information requirements, the engagement of an independent inspector of election and timing requirements;
 
 
 
 
●
provide
the Board with the exclusive authority to fix the number of directors constituting the whole Board; and
 
 
●
provide
that vacancies on the Board may be filled by a majority of directors in office, although less than a quorum.
 
Such
provisions may have the effect of discouraging a third-party from acquiring the Company, even if doing so would be beneficial to the
Company’s
stockholders. These provisions are intended to enhance the likelihood of continuity and stability in the composition
of the Board and in its policies, and to
discourage some types of transactions that may involve an actual or threatened change in control
of the Company. These provisions are designed to reduce
the Company’s vulnerability to an unsolicited acquisition proposal and
to discourage some tactics that may be used in proxy fights. The Company believes
that the benefits of increased protection of its potential
 ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or
restructure the Company outweigh the disadvantages
of discouraging such proposals because, among other things, negotiation of such proposals could
result in an improvement of their terms.
However, these provisions could have the effect of discouraging others from making tender offers for shares of the
Company’s Common
Stock and, as a consequence, they also may inhibit fluctuations in the market price of the shares of the Company’s Common Stock
that could result from actual or rumored takeover attempts. These provisions also may have the effect of preventing changes in the Company’s
management.
 
 
 

Exhibit 10.72
 
Second Amendment to Consulting Agreement
 
This Second Amendment to Consulting Agreement
(this “Second Amendment”) is entered into as of November 7, 2024 and is effective as of July 1, 2024,
by and between
Oramed Pharmaceuticals Inc., a company incorporated under the laws of the State of Delaware, with an address at 20 Mamilla Ave.,
Jerusalem, Israel 9414904 (the “Company”) and Shnida Ltd., a company incorporated under the laws of the State
of Israel, (company I.D. no. 514519016)
with an address at 32 Eliezer Hagadol Street, Jerusalem (the "Consultant").
 
WHEREAS, the Company
and the Consultant entered into a consulting agreement, effective as of November 1, 2022 and amended as of April 27,
2023 and as of January
8, 2024(the “Consulting Agreement”); and
 
WHEREAS, the Company
and the Consultant desire to amend the terms and conditions of the Consulting Agreement as set forth herein.
 
NOW, THEREFORE, the
Company and the Consultant agree as follows:
 
1.
Amendment to Section 6. Section 6 of the Consulting
Agreement is hereby amended and restated in its entirety to read as follows:
 
Compensation.
 Effective January 1, 2024 (inclusive), the Company shall pay to the Consultant in consideration for
 the performance of the
Consulting Services, a gross monthly amount of NIS 111,348 (the “Consideration”), subject to
the receipt by the Company of an invoice from the
Consultant.
 
2.
Except for the changes and/or additions stated herein, all the other terms of the Consulting Agreement
shall remain valid and bind the parties
without any change. In the case of a contradiction between the provisions of this Second Amendment
 and the provisions of the Consulting
Agreement, the provisions of this Second Amendment shall prevail. Without limiting the generality
of the foregoing, the term “Agreement” as
used in the Consulting Agreement shall be deemed to be the Consulting Agreement
as amended by this Second Amendment.
 
 

 
 
IN WITNESS WHEREOF, the parties
have executed this Third Amendment to Consulting Agreement as of the date written above.
 
ORAMED PHARMACEUTICALS INC.
 
SHNIDA LTD.
 
 
 
 
 
By:  
/s/ Avi Gabay
 
By:  
/s/ Nadav Kidron
Name:
Avi Gabay
 
Name:   Nadav Kidron
Title:
Chief Financial Officer
 
Title:
Chief Executive Officer
 
I hereby confirm that I have read this Second
Amendment, understood its terms and agree to be personally bound by all its terms and provisions.
 
/s/ Nadav Kidron
 
 
Nadav Kidron
 
 
 
 
 

Exhibit 10.73
 
Second Amendment to Employment Agreement
 
This Second Amendment to Employment Agreement
(this “Second Amendment”) is entered into as of November 7, 2024 and is effective as of July 1,
2024, by and between
Nadav Kidron, an individual residing in Jerusalem, Israel (the “Executive”), and Oramed Ltd., a company
incorporated under the
laws of the State of Israel, with an address at 20 Mamilla Ave., Jerusalem, Israel 9414904 (the “Company”).
 
WHEREAS, the Company
and the Executive entered into an employment agreement, effective as of November 1, 2022 and amended as of April
27, 2023 and as of January
8, 2024 (the “Employment Agreement”); and
 
WHEREAS, Company and
the Executive desire to amend the terms and conditions of the Employment Agreement as set forth herein.
 
NOW, THEREFORE, the
Company and the Executive agree as follows:
 
1.
Section 2.1(a) of the Employment Agreement will be amended
and replaced as follows:
 
The Executive shall be entitled to a gross monthly
amount of NIS 59,330 (the “Salary”).
 
2.
Except for the changes and/or additions stated herein, all
the other terms of the Employment Agreement shall remain valid and bind the parties
without any change. In the case of a contradiction
between the provisions of this Second Amendment and the provisions of the Employment
Agreement, the provisions of this Second Amendment
shall prevail. Without limiting the generality of the foregoing, the term “Agreement” as
used in the Employment Agreement
shall be deemed to be the Employment Agreement as amended by this Second Amendment.
 
 

 
 
IN WITNESS WHEREOF, the parties have executed this
third Amendment to Employment Agreement as of the date written above.
 
 
Oramed Ltd.
 
 
 
/s/ Avi Gabay
 
Avi Gabay, CFO
 
 
 
/s/ Nadav Kidron
 
Nadav Kidron
 

Exhibit 10.74
 
AGREEMENT AND AMENDMENT
NO. 10
 
This AGREEMENT AND AMENDMENT
NO. 10 (this “Ninth Amendment”) is made as of November 7, 2024 and is effective as of July 1,
2024, by and between
Oramed Ltd., a company incorporated under the laws of the State of Israel, # 513976712 with an address at Mamilla, 20, Jerusalem,
Israel 9414904 (the “Company”), and KNRY, Ltd., a company incorporated under the laws of the State
of Israel, # 513836502 with an address at 2 Elza
Street, Jerusalem, Israel 93706 (the “Consultant”).
 
WHEREAS:
 
A. The Company and the Consultant are parties to that certain consulting agreement dated as of July 1, 2008, as amended on July 13, 2013, on November
13, 2014, on July 21, 2015, on June 27, 2016, on June 30, 2017, on January 10, 2020, on September 19, 2021, on April 17, 2023 and on January 8, 2024
(collectively, the “Consulting Agreement”), for services to be provided by Dr. Miriam Kidron Israeli I.D. number 9665993 (“Miriam”); and
 
B. The Company and the Consultant wish to amend the Consulting Agreement to revise the terms of the Consultant compensation thereunder.
 
NOW, THEREFORE, in consideration of the premises
and the mutual covenants and agreements herein contained, the parties hereto covenant and
agree as follows:
 
1.
Amendment to Section 6. Section 6 of the Consulting
Agreement is hereby amended and restated in its entirety to read as follows:
 
“Compensation.
 Effective July 1, 2024 (inclusive), the Company shall pay to the Consultant in consideration for the performance of the
Consulting Services,
a gross monthly amount of 134,550 + VAT (the “Consideration”), subject to the receipt by the Company of an invoice
from
the Consultant. Each of the Consultant and Miriam hereby declares that neither of them has, nor shall have in the future, any claims
or demands in
respect of amounts paid prior to May 2008.”
 
2.
Except for the changes and/or additions stated herein, all the other terms of the Consulting Agreement
shall remain valid and bind the parties
without any change. In the case of a contradiction between the provisions of this Ninth Amendment
 and the provisions of the Consulting
Agreement, the provisions of this Ninth Amendment shall prevail. Without limiting the generality
of the foregoing, the term “Agreement” as used
in the Consulting Agreement shall be deemed to be the Consulting Agreement
as amended by this Ninth Amendment.
 
 

 
 
IN WITNESS WHEREOF, the parties
have executed this Ninth Amendment to Consulting Agreement as of the date first written above.
 
ORAMED LTD.
 
KNRY
LTD.
 
 
 
By:  
/s/ Avi Gabay
 
By:
/s/ Miriam Kidron
Name:
Avi Gabay
 
Name: 
Miriam Kidron  
Title: 
Chief Financial Officer
 
 
 
 
 

Exhibit 19.1
 
 
 
ORAMED PHARMACEUTICALS INC.
 
INSIDER TRADING POLICY
 
Effective: March 20, 2025
 
This policy sets forth guidelines
for all Insiders (as defined below) of Oramed Pharmaceuticals Inc. (together with its subsidiaries when the context so
requires, “Oramed”)
with respect to transactions in Oramed securities. This policy arises from Oramed’s responsibilities as a public company whose shares
of common stock are quoted on the Nasdaq Capital Market, or Nasdaq, and on the Tel Aviv Stock Exchange, or TASE, under the symbol “ORMP.”
Failure
to comply with these guidelines could result in a serious violation of the securities laws by you and/or Oramed and can involve
both civil and criminal
penalties. It is important that you review this policy carefully.
 
I.
Reason for Policy
 
Oramed is subject to the insider
trading laws in the United States and Israel. Under United States law, an individual may be subject to fines of up to
$5,000,000 and up
to twenty years in jail for violating the securities laws by engaging in transactions in securities at a time when in possession of material
non-public information. In addition, the U.S. Securities and Exchange Commission (the “SEC”) may seek the imposition of a
civil penalty of up to three
times the profits made or losses avoided from the trading. Insider traders must also disgorge any profits
made and are often subjected to an injunction
against future violations. Violators can also be barred from serving as officers or directors
of public companies. Individuals also may be subjected to civil
liability in private lawsuits. The foregoing penalties are subject to
amendment from time to time.
 
Without regard to the penalties
that may be imposed by others, willful violation of this policy constitutes grounds for dismissal from the Board of Directors
of Oramed
(the “Board”), termination of your employment or, with respect to consultants, representatives or independent contractors,
termination of your
engagement, with Oramed.
 
Insider trading proscriptions
are not limited to trading by the insider alone; it is also illegal to advise others to trade on the basis of material non-public
information
or to share material non-public information with others if you know or should have known that they will use such information to purchase
or
sell Oramed securities. This practice is called “tipping.” Liability in such cases can extend both to the “tippee”—the
person who purchased or sold Oramed
securities based on this material non-public information—and to the “tipper,” the
Insider himself or herself. Even if you are not in possession of material
non-public information regarding Oramed, do not recommend to
any other person that they buy or sell securities of Oramed because your recommendation
could be imputed to Oramed and may be misleading
if you do not have all of the relevant information.
 
Finally, the appearance of insider
trading can cause a substantial loss of confidence in Oramed and its securities on the part of the public and the securities
markets.
This could obviously have an adverse impact on Oramed and its stockholders. Accordingly, avoiding the appearance of engaging in
transactions
on the basis of material non-public information can be as important as avoiding a transaction actually based on such
information. Furthermore, if your
transactions become the subject of scrutiny, they will be viewed after the fact with the benefit of
20/20 hindsight. Accordingly, before engaging in any
transaction you should carefully consider how regulators and others might view your
transaction with such hindsight and, if you have the slightest doubt,
consult with Oramed’s Chief Financial Officer (“CFO”).
 
In the event an Insider
becomes aware of a possible violation of this policy by another Insider, he or she should contact Oramed’s CFO, without delay,
by
telephone at +1 844 967 2633 (U.S.) or +972 2-566-0001 (Israel) or by email at avi@oramed.com.
 
 

 
 
II.
Applicability of Policy
 
1. “Insiders”
Defined. This policy applies to any “Insider” of Oramed, including any (a) member of the Board and officer of Oramed,
(b) employee of
Oramed, including part-time or temporary employees, and (c)  consultant, representative, or independent contractor
 (e.g., accountants, attorneys and
investment bankers) who have access to material non-public information of Oramed. This policy
also applies to family members and other members of an
Insiders’ household as well as family members who do not live in their home
but whose transactions in Oramed securities are directed by or are subject to
the influence or control of the Insider, as well as any
entities that an Insider influences or controls, including any corporations, partnerships or trusts
(collectively, “Controlled Entity”).
Insiders are responsible for the compliance with this policy by such Insider’s family members and Controlled Entities.
 
2. “Access
Insiders” Defined. This policy imposes additional restrictions upon Insiders who may have increased access to material information
concerning
Oramed that has not been disclosed to the public (see below for a definition of “material information”), referred
to as “Access Insiders.” Access Insiders
are: (a)  members of the Board of Oramed, (b) the Chief Executive Officer, Chief
 Financial Officer, presidents, general managers, vice presidents,
controllers, vice controllers, treasurers, corporate secretaries and
accounting personnel of Oramed and (c) the family members and Controlled Entities of
the foregoing persons. Access Insiders are subject
to additional procedures and restrictions described in Section VI below.
 
3. Inside
Information Regarding Other Companies. This policy and the guidelines described herein also apply to material non-public information
relating to
other companies, including Oramed’s customers, vendors or suppliers or companies with which Oramed is considering merger
and acquisition transactions
(“business partners”), when that information is obtained in the course of employment with, or
other services performed on behalf of, Oramed, as well as
other companies that may be impacted by material non-public information regarding
Oramed. Civil and criminal penalties, and termination of employment,
may result from trading on inside information regarding Oramed’s
business partners. All personnel should treat material non-public information about
Oramed’s business partners with the same care
required with respect to information related directly to Oramed.
 
4. Tail
Period. If you are aware of material non-public information when your employment or service terminates, you may not trade in Oramed
securities
until that information has become public or is no longer material.
 
5. Applicability to Oramed. In addition,
Oramed itself must comply with securities laws applicable to its own securities trading activities, and must not
engage in any transaction
involving a purchase or sale of its securities, including any offer to purchase or offer to sell or other disposition of its securities,
when it is in possession of material nonpublic information concerning Oramed, other than in compliance with applicable law, subject to
the policies and
procedures adopted by Oramed and the exceptions listed in Section VII of this policy to the extent applicable.
 
2

 
 
III.
Definition of Material Non-Public Information
 
It is not possible to define all categories of
“material” information. In general, information should be regarded as material if its disclosure would reasonably
be
expected to have an effect (whether positive or negative) on the price of a company’s securities or if there is a likelihood that
it would be considered
important by a reasonable investor in making a decision regarding the purchase or sale of Oramed securities. Both
positive and negative information can be
material, as well as information that forecasts whether an event may or may not occur.
 
Although it may be difficult under this standard
to determine whether certain information is material, there are various categories of information that would
almost always be regarded
as material. Examples of such information are: earnings information and quarterly or annual results; guidance on earnings
estimates; clinical
results; product and research developments; marketing plans; major licensing transactions; government inspections, approvals or other
regulatory actions; status of patent applications; changes in senior management; proposed payment of a dividend or change in dividend
policy; planned
share splits or repurchases; new equity or debt offerings; other events regarding Oramed securities (e.g., defaults on
debt, changes to the rights of security
holders); major changes in accounting policies; collaborations, mergers, acquisitions or divestitures,
and significant litigation matters. Moreover, material
information does not have to be related to a company’s business. For example,
advance knowledge of the contents of a forthcoming article that is expected
to affect the market price of a security can be material.
If any Insider has questions as to the materiality of information, he or she should contact the CFO of
Oramed for clarification.
 
Information is considered “non-public”
unless it has been broadly disseminated in a manner that makes the information available to investors generally and
investors
have had a reasonable time to digest the information. Common examples of broad dissemination include annual, quarterly and current reports
filed with the SEC, earnings releases, press releases and other information that is widely reported in the media. Generally, a “reasonable
time” following
the release of the information to the public would require at least one full Nasdaq trading day after the information
became public.
 
IV.
Prohibited Transactions
 
1. Trading
 while in Possession. Insiders may not engage in a transaction (purchase or sale, including any offer to purchase or offer to sell
 or other
disposition of Oramed’s securities) in Oramed shares or Oramed debt securities, as well as other securities for which Oramed’s
 securities serve as
underlying assets (e.g., options, RSUs or PSUs) (collectively, “Oramed securities”) at any time
between the date on which any material non-public material
information becomes known to the individual, including information regarding
other companies referred to in Section II.3 above, and the close of business
of at least one full Nasdaq trading day after such
information is publicly disclosed. Nasdaq is generally open for trading Monday through Friday. If, for
example, Oramed publicly disclosed
information on a Monday, then you may not trade in Oramed securities until Wednesday.
 
2. Speculative
 Trading. No Insider may engage in transactions of a speculative nature with regard to Oramed securities at any time. All Insiders
 are
prohibited from short-selling Oramed common stock or engaging in transactions involving Oramed-based derivative securities. “Derivative
Securities” are
options, warrants, stock appreciation rights or similar rights whose value is derived from the value of an equity
security, such as Oramed common stock.
This prohibition includes, but is not limited to, trading in Oramed-based put and call option contracts,
transacting in straddles, and the like. However, as
indicated below, holding and exercising options or other derivative securities granted
under Oramed’s employee stock option or equity incentive plans is
not prohibited by this policy.
 
3

 
 
3. Short
Sales. Short sales of Oramed securities (i.e., the sale of a security that the seller does not own) may evidence an expectation on
the part of the seller
that the securities will decline in value, and therefore have the potential to signal to the market that the seller
lacks confidence in Oramed’s prospects. In
addition, short sales may reduce a seller’s incentive to seek to improve Oramed’s
performance. For these reasons, short sales of Oramed securities are
prohibited. In addition, Section 16(c) of the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), prohibits officers and directors from
engaging in short sales. (Short sales
 arising from certain types of hedging transactions are governed by the paragraph below captioned “Hedging
Transactions.”)
 
4. Hedging
Transactions. Hedging or monetization transactions can be accomplished through a number of possible mechanisms, including through
the use
of financial instruments such as prepaid variable forwards, equity swaps, collars and exchange funds. Such hedging transactions
may permit a director,
officer or employee to continue to own Oramed securities obtained through employee benefit plans or otherwise,
but without the full risks and rewards of
ownership. When that occurs, the director, officer or employee may no longer have the same objectives
 as Oramed’s other shareholders. Therefore,
directors, officers and employees are prohibited from engaging in any such transactions.
 
5. Margin
Accounts and Pledged Securities. Securities held in a margin account as collateral for a margin loan may be sold by the broker without
the
customer’s consent if the customer fails to meet a margin call. Similarly, securities pledged (or hypothecated) as collateral
for a loan may be sold in
foreclosure if the borrower defaults on the loan. Because a margin sale or foreclosure sale may occur at a time
when the pledgor is aware of material non-
public information or otherwise is not permitted to trade in Oramed securities, directors, officers
and other employees are prohibited from holding Oramed
securities in a margin account or otherwise pledging Oramed securities as collateral
for a loan. (Pledges of Oramed securities arising from certain types of
hedging transactions are governed by the paragraph above captioned
“Hedging Transactions.”)
 
6. Open
Orders. Any Insider who has placed a limit order or open instruction to buy or sell Oramed securities shall bear responsibility for
canceling such
instructions immediately in the event restrictions are imposed on their ability to trade in accordance with this policy.
 
V.
Open Window and Blackout Periods
 
All Insiders are subject to
the following blackout procedures. If you are an Insider involved in the preparation or review of Oramed’s financial statements
and related public disclosures, Oramed will notify you that you are subject to these blackout procedures. If you have any uncertainty
whether you are
covered by the blackout procedures, please contact the CFO.
 
1. Quarterly
Blackout Periods: Oramed’s announcement of its quarterly financial results almost always has the potential to have a material
effect on the
market for Oramed securities. Therefore, to avoid even the appearance of trading on the basis of material non-public information,
regardless of whether or
not you are aware of any material non-public information, you may not trade in Oramed securities during the period
beginning on the first day following
the end of each fiscal quarter and ending on the day after the first full trading day following the
day on which Oramed's quarterly or annual results are
released in the United States.
 
For example, if Oramed announces
quarterly or annual results before trading begins on a Tuesday, the first time you can buy or sell Oramed securities is the
opening of
the market on Wednesday (assuming you are not aware of other material non-public information at that time). However, if Oramed announces
quarterly or annual results after trading begins on that Tuesday, the first time you can buy or sell Oramed securities is the opening
of the market on
Thursday (assuming you are not aware of other material non-public information at that time).
 
4

 
 
Oramed will endeavor to send
out a notice each quarter setting forth the specific dates for the quarterly “blackout” and “open window” periods
to those
persons to whom the blackout procedures apply.
 
2. Event
Specific Blackout Periods. From time to time, an event may occur that is material to Oramed and is known by only a few Insiders. So
long as the
event remains material and non-public, the persons who are aware of the event, as well as other persons designated by the
CFO, may not trade in Oramed
securities. The existence of an event-specific blackout will not be announced, other than to those who are
aware of the event giving rise to the blackout.
Any person made aware of the existence of an event-specific blackout should not disclose
the existence of the blackout to any other person.
 
3. Prohibited
Transactions: Transactions prohibited during blackout periods include:
 
●
Open
market purchase or sale of Oramed securities;
 
●
Purchase
or sale of Oramed securities through a broker;
 
●
Sales
of the shares upon exercise of Oramed stock options;
 
●
Broker-assisted
cashless exercises of Oramed stock options;
 
●
Switching
existing balances into or out of, or elections with respect to, Oramed’s stock fund in a 401(k) plan or other benefit plans; and
 
●
New
discretionary cash investments in any dividend reinvestment plan of Oramed.
 
4. Hardship
Exceptions: A person who is subject to a blackout period and who has an unexpected and urgent need to sell Oramed securities in order
to
generate funds may, in appropriate circumstances, be permitted to sell Oramed securities even during the blackout period, subject to
approval from the
CFO, after concluding that such person is not in possession of material non-public information. Under no circumstance
 will a hardship exception be
granted during an event-specific blackout period or to a director or an executive officer.
 
5. No
Safe Harbor. It is important to emphasize that the institution of blackout periods is an internal Oramed policy. It does not create
a “safe harbor” or
otherwise insulate a person from the consequences of insider trading, which could include severe criminal
and civil sanctions. Even if a blackout period is
not in effect, at no time may you trade in Oramed securities if you are aware of material
non-public information about Oramed, until at least one full
business day following the public disclosure of such information.
 
VI.
Additional Procedures for Access Insiders
 
1. Pre-clearance.
 
a)
All Access Insiders must inform and receive pre-clearance from Oramed’s CFO whenever they intend
 to execute a transaction in Oramed
securities, including the placing of limit orders, a stock plan transaction (such as an option exercise),
or a gift, loan, pledge, contribution to a trust
or any other transfer, at least three (3) business days in advance of the proposed transaction.
The CFO is under no obligation to approve a trade or
transaction submitted for pre-clearance, and may determine not to permit the trade.
 If pre-clearance is denied, such denial must be kept
confidential by the person requesting pre-clearance. The CFO must inform and receive
pre-clearance for such transactions from the CEO.
 
b)
When obtaining pre-clearance to execute a trade in Oramed securities, such individuals will be responsible
for verifying with the CFO that (i) they
do not possess any material non-public information regarding Oramed, (ii) Oramed has not imposed
any blackout periods or other restrictions on
their ability to engage in trades, and (iii) the transaction would not trigger a “short-swing”
profit disgorgement, as described in Section VI.3 below.
If the individual has not completed the trade within three (3) trading days of
notification of the intention to trade, then the individual must re-
confirm their pre-clearance with Oramed’s CFO that they intend
to execute a trade and the individual must re-verify the non-existence of any
restrictions on such trade.
 
5

 
 
c)
Before each transaction in Oramed securities, each such officer and director should contact the CFO regarding
(a) compliance with Rule 144 under
the Securities Act of 1933, as amended, which contains guidelines for the sale of privately
issued shares and sales by affiliates of Oramed, if such
sales are not covered by an effective registration statement, to the extent applicable,
 and (b) the reporting of purchases, sales, gifts or other
transactions of shares through the filing of Form 4s or other applicable
filings with the SEC.
 
d)
Following execution of any transaction in Oramed securities by an Access Insider who is subject to these
pre-clearance procedures (including
transactions effected pursuant to a trading plan established pursuant to Rule 10b5-1 under the Exchange
Act (“Rule 10b5-1”)), such trade or
transaction must be reported to the CFO on the same day in which such a
transaction occurs. Each such report should include the date of the
transaction, quantity of securities, price and broker-dealer (if any)
through which the transaction was effected.
 
e)
The CFO assumes no responsibility for, and approval from the CFO does not protect the Access Insider from,
the consequences of prohibited
insider trading. Ultimately, you are the one responsible for ensuring compliance with this policy in all
respects. Any internal policy, guideline,
action or general advice of Oramed, the CFO or any other employee or director does not in any
 way constitute legal advice or insulate an
individual from liability under applicable securities laws.
 
2. Section
16 Reporting Requirements. Section 16 of the Exchange Act and the SEC’s rules thereunder require all of Oramed’s executive
officers, directors
and greater than 10% stockholders (collectively, “Section 16 Insiders”) to report their beneficial ownership
 of Oramed’s equity securities and any
subsequent changes in that ownership.
 
a)
A Form 3 must be filed within 10 calendar days of becoming a Section 16 Insider. This report discloses
the reporting person’s beneficial interest in
Oramed’s equity securities and must be filed even if such person does not own
any of Oramed’s equity securities.
 
b)
A Form 4 must be filed to report acquisitions and dispositions of Oramed’s equity securities, including
(i) any open market sale or purchase of
Oramed’s equity securities (including pursuant to a Rule 10b5-1 plan), (ii) any grant, exercise
or conversion of restricted stock or derivative
securities (e.g., stock options), (iii) any transfers to or from indirect forms
of ownership, such as transfers to trusts, (iv) any gifts and (v) any intra-
plan transfers involving Oramed’s equity securities
held under pension or retirement plans. A Form 4 must generally be filed within two business
days of the date of execution of the transaction
(not the settlement date or subsequent closing or delivery date).
 
c)
A Form 5 must be filed within 45 days after Oramed’s fiscal year-end by every individual or entity
who was a Section 16 Insider at any time
during the prior fiscal year to report (i) certain small acquisitions of Oramed’s equity
securities, (ii) certain miscellaneous transactions, such as
inheritances and (iii) any transaction during the last fiscal year that was
required to be reported on a Form 3 or Form 4 but was not reported.
Transactions that may be reported following fiscal year-end on a Form
5 may be reported earlier on a Form 4. Oramed encourages the use of the
Form 4 early reporting option to help prevent transactions from
going unreported following fiscal year-end and to help eliminate the need to file a
Form 5.
 
d)
Under SEC rules, the preparation and filing of Section 16 reports are the sole responsibility of the Section
16 Insider. However, Oramed assists its
directors and executive officers in preparing and filing these forms. Oramed can only facilitate
compliance by directors and executive officers to
the extent they provide Oramed with the required information for making their reports.
Oramed does not assume any legal responsibility in this
regard.
 
6

 
 
3. Short-Swing
Trading. Short-term trading of Oramed securities may be distracting to the person and may unduly focus the person on Oramed’s
short-term
stock market performance instead of Oramed’s long-term business objectives. For these reasons, any Section 16 Insider
who purchases Oramed securities
in the open market may not sell any Oramed securities of the same class during the six months following
the purchase (or vice versa). In addition, under
Israeli law, an Access Insider of Oramed who buys and sells, or sells and buys, Oramed
securities within a three-month period is presumed to have traded
on inside information, unless it can be proven that he or she did not
have any material non-public information at the time of the transaction. Since it would
be very difficult to rebut this presumption, all
such persons are advised to monitor carefully the timing of any purchases and sales of Oramed securities so
as to avoid triggering this
provision of Israeli law. To ensure compliance with short-swing trading requirements, all Section 16 Insiders are required to
obtain pre-clearance
and report trades in accordance with Section VI.1 above.
 
4. Disgorgement
of Profits on Short-Swing Transactions. Under Section 16(b) of the Exchange Act, any profit realized by a Section 16 Insider on a
“short-
swing” transaction (e.g., a non-exempt purchase and sale, or sale and purchase, of Oramed’s equity securities
within a period of less than six months) must
be disgorged to Oramed upon demand by Oramed or a stockholder acting on Oramed’s behalf.
By law, Oramed cannot waive or release any claim it may
have under Section 16(b), or enter into an enforceable agreement to provide indemnification
for amounts recovered under Section 16(b).
 
VII.
Exceptions
 
The only exceptions to the policy are set
forth below. It does not matter that the Insider may have decided to engage in a transaction before learning of the
material non-public
information or that delaying the transaction might result in economic loss. It is also irrelevant that publicly disclosed information
about
Oramed might, even aside from the undisclosed material information, provide a substantial basis for engaging in the transaction.
Additionally, there are no
limits on the size of a transaction that will trigger insider trading liability; relatively small trades have
in the past occasioned investigations and lawsuits.
You simply cannot trade in Oramed securities while in possession of material non-public
information about Oramed. The only exceptions to the policy are
as follows:
 
1. Exercise
of an option, vesting of an RSU or PSU under Oramed’s share option plan. Note that this exception does not include (a) any sale
of stock as part
of a broker-assisted cashless exercise of an option, or any other market sale for the purpose of generating the cash
needed to pay the exercise price of an
option or (b) a subsequent sale of the shares acquired pursuant to the exercise of an equity award
under the Oramed share option plan.
 
2. Bona
fide gifts of securities are not deemed to be transactions for the purposes of this policy. Whether a gift is truly bona fide will depend
on the
circumstances surrounding each gift. The more unrelated the donee is to the donor, the more likely the gift would be considered
“bona fide” and not a
“transaction.” For example, gifts to charities, religious institutions and service organizations
would clearly not be “transactions.” On the other hand, gifts to
dependent children followed by a sale of the “gift”
securities in close proximity to the time of the gift may imply some economic benefit to the donor and,
therefore, make the gift non-bona
fide.
 
7

 
 
3. The
restrictions set forth in the preceding paragraphs shall not apply to sales made pursuant to a Qualified Selling Plan. For purposes of
this exception, a
“Qualified Selling Plan” is a written plan for selling Oramed’s securities which meets each of the
following requirements: (a) the plan is adopted by the
Insider or temporary Insider during a period when the Insider or temporary Insider
is not in possession of material non-public information; (b) the plan is
adhered to strictly by the Insider or temporary Insider; (c)
the plan either (i) specifies the amount of securities to be sold and the date on which the
securities are to be sold, (ii) includes a
written formula or algorithm, or computer program, for determining the amount of securities to be sold and the price
at which and the
date on which the securities are to be purchased or sold, or (iii) does not permit the Insider or temporary Insider to exercise any subsequent
influence over how, when, or whether to effect sales; provided, in addition, that any other person who, pursuant to the plan, does exercise
such influence
must not have been aware of the material non-public information when doing so; (d) the plan includes a representation from
the Insider adopting the plan
that such Insider (i) is not aware of any material nonpublic information about Oramed or its securities
and (ii) is adopting the plan in good faith and not as
part of a plan or scheme to evade the prohibitions of Rule 10b-5 under the Exchange
Act; (e) the plan provides that trading under the plan cannot begin
until the later of (i) 90 days after the adoption of the plan or (ii)
two business days following the disclosure of Oramed’s financial results in a Form 10-Q or
Form 10-K for the fiscal quarter in which
the plan is adopted (such period being referred to as the “cooling-off period”, but, in either case, not to exceed
120 days
following the adoption of the plan, and provided that if the Insider is not a director or officer of Oramed, such cooling-off period shall
be at least
30 days rather than the longer periods set forth above); and (e) at the time it is adopted the plan conforms to all other
requirements of Rule 10b5-1 under the
Exchange Act as then in effect. Rule 10b5-1 provides an affirmative defense from insider trading
liability under the U.S. federal securities laws for trading
plans that meet the above requirements.
 
Oramed requires that the entry
into, modification or termination of any Qualified Selling Plan be approved in writing in advance by the CFO, at least five
(5) business
days prior to the proposed entry into such plan. Qualified Selling Plans generally may not be adopted outside an open window period or
during
a blackout period and may only be adopted when the person adopting the plan is not aware of material non-public information.
 
In accordance with Rule 10b5-1
under the Exchange Act, any change to the amount, price, or timing of the purchase or sale of securities underlying a
Qualified Selling
Plan constitutes termination of the Qualified Plan and the adoption of a new Qualified Selling Plan, which triggers the cooling-off period
described above. No Insider may have more than one Qualified Selling Plan for purchases or sales of securities on the open market during
the same period.
In addition, no Insider may have more than one single-trade Qualified Plan during any 12-month period. A single-trade
plan is one that has the practical
effect of requiring the purchase or sale of securities as a single transaction. With respect to overlapping
Qualified Selling Plans, an Insider may have two
separate plans provided (i) the later-commencing plan does not begin until all trades
have been completed under the first plan or the first plan expires
without execution, and trading during the cooling-off period that would
have applied if the later-commencing plan was adopted on the date the earlier-
commencing plan terminates and (ii) the separate plans satisfy
 all other conditions applicable to Qualified Selling Plans. With respect to overlapping
Qualified Selling Plans, an Insider may have separate
plans for “sell-to-cover” transactions in which an Insider instructs an agent to sell securities in order
to satisfy tax withholding
obligations at the time an equity award vests. Any such additional plan must only authorize qualified “sell-to-cover” transactions.
With respect to single-trade Qualified Selling Plans, an Insider may have a single-trade plan for “sell-to-cover” transactions.
 
VIII. Modifications
to Policy
 
Oramed may at any time change this policy or adopt
such other policies or procedures that it considers appropriate to carry out the purposes of this policy.
Notice of any such change will
be delivered to you by email (or other delivery option in Oramed’s discretion). You will be deemed to have received, be
bound by
and agree to revisions of this policy when such revisions have been delivered to you.
 
IX.
Acknowledgement
 
Please sign the attachment acknowledging
 that you have read and agree to comply with this policy and return it to Oramed’s CFO, by email at
avi@oramed.com. If you have any
questions, please contact Oramed’s CFO.
 
8

 
 
ACKNOWLEDGEMENT
 
Please sign below acknowledging
that you have read and agree to abide by Oramed’s Insider Trading Policy.
 
I received, reviewed and agree to be bound by Oramed’s Insider Trading Policy.
 
Date:                    
 
 
 
 
 
 
Signature
 
 
 
 
 
Name
 
 
 
 
 
Title
 
 
Return this Acknowledgment to the CFO of Oramed.
 
 
 
 
 
 
 
Insider Trading Policy Acknowledgment
 
 
 

Exhibit 21.1
 
SUBSIDIARIES
 
Oramed Ltd. – Incorporated in the State
of Israel
Oramed HK Limited – Incorporated in Hong
Kong
OraTech Pharmaceuticals, Inc. – Incorporated
in State of Nevada (100% owned by Oramed Pharmaceuticals Inc.)
Oravax Medical Inc. – Incorporated in the
State of Delaware (63% owned by Oramed Pharmaceuticals Inc.)
RoyaltyVest, LTD. - Incorporated in the British
Virgin Islands (50% owned by Oramed Pharmaceuticals Inc.)

Exhibit 23.1 
 
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
 
We hereby consent to the incorporation
by reference in the Registration Statements on Form S-8 (Nos. 333-163919, 333-190222, 333-199120, 333-213835,
333-234303, 333-244380 and
333-266105) of Oramed Pharmaceuticals Inc. of our report dated March 27, 2025 relating to the financial statements, which
appears in this
Form 10-K.
 
/s/ Kesselman & Kesselman 
 
Certified Public Accountants (Isr.)
 
A member firm of PricewaterhouseCoopers International Limited
Tel-Aviv, Israel
 
 
 
March 27, 2025
 
 

Exhibit 31.1
 
CERTIFICATION PURSUANT TO RULE 13a-14(a) AND
15d-14(a)
 
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED
 
I, Nadav Kidron, certify that:
 
1.
I have reviewed this Annual Report on Form 10-K of Oramed Pharmaceuticals Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
 
(a) Designed such disclosure controls and procedures, or caused
such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which
this report is being prepared;
 
(b) Designed such internal control over financial reporting,
 or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally
accepted accounting principles;
 
(c) Evaluated the effectiveness of the registrant’s disclosure
 controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed in this report any change in the registrant’s
internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the
registrant ’s internal control over financial reporting; and
 
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
(a) All significant deficiencies and material weaknesses in the
design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s
ability to record, process, summarize and report financial information; and
 
(b) Any fraud, whether or not material, that involves management
or other employees who have a significant role in the registrant’s internal control
over financial reporting.
 
Date: March 27, 2025
By:
/s/ Nadav Kidron
 
 
Nadav Kidron
 
 
President and Chief Executive Officer
 

Exhibit 31.2
 
CERTIFICATION PURSUANT TO RULE 13a-14(a) AND
15d-14(a)
 
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED
 
I, Avraham Gabay, certify that:
 
1.
I have reviewed this Annual Report on Form 10-K of Oramed Pharmaceuticals Inc.;
 
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
 
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
 
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
 
(a) Designed such disclosure controls and procedures, or caused
such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the registrant,
including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which
this report is being prepared;
 
(b) Designed such internal control over financial reporting,
 or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally
accepted accounting principles;
 
(c) Evaluated the effectiveness of the registrant’s disclosure
 controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures,
as of the end of the period covered by this report based on such evaluation; and
 
(d) Disclosed in this report any change in the registrant’s
internal control over financial reporting that occurred during the registrant’s most recent
fiscal quarter (the registrant’s
fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially
affect, the
registrant ’s internal control over financial reporting; and
 
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
 
(a) All significant deficiencies and material weaknesses in the
design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the registrant’s
ability to record, process, summarize and report financial information; and
 
(b) Any fraud, whether or not material, that involves management
or other employees who have a significant role in the registrant’s internal control
over financial reporting.
 
Date: March 27, 2025
By:
/s/ Avraham Gabay
 
 
Avraham Gabay
 
 
Chief Financial Officer
 

Exhibit 32.1
 
CERTIFICATION
 
PURSUANT TO 18 U.S.C. SECTION 1350
 
In connection with the annual
report of Oramed Pharmaceuticals Inc., or the Company, on Form 10-K for the period ended December 31, 2024, as
filed with the Securities
and Exchange Commission on the date hereof, or the Report, I, Nadav Kidron, Chief Executive Officer of the Company, certify,
pursuant
to 18 U.S.C. Section 1350, that to my knowledge:
 
1.
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: March 27, 2025
By:
/s/ Nadav Kidron
 
 
Nadav Kidron
 
 
Chief Executive Officer
 

Exhibit 32.2
 
CERTIFICATION
 
PURSUANT TO 18 U.S.C. SECTION 1350
 
In connection with the annual
report of Oramed Pharmaceuticals Inc., or the Company, on Form 10-K for the period ended December 31, 2024, as
filed with the Securities
and Exchange Commission on the date hereof, or the Report, I, David Silberman, Chief Financial Officer of the Company, certify,
pursuant
to 18 U.S.C. Section 1350, that to my knowledge:
 
1.
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
 
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
Date: March 27, 2025
By:
/s/ Avraham Gabay
 
 
Avraham Gabay
 
 
Chief Financial Officer