Item 9A. Controls and Procedures
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