What changed in this filing

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Item 1. Business

2026-03-26 compared with 2025-03-27 · 752 added, 640 removed, 30 unchanged (98% of the section changed)

are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform

that allows for the oral delivery of therapeutic proteins.

have developed an oral dosage form intended to withstand the harsh environment of the stomach and effectively deliver active biological

insulin or other proteins.

The excipients in the formulation are not intended to modify the proteins chemically or biologically, and

the dosage form is designed to be safe to ingest.

On January 11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints.

a result, we terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial.

In 2023, we completed an analysis of the ORA-D-013-1

Phase 3 trial data and found that subpopulations of patients with pooled specific parameters, such as body mass index, or BMI, baseline

HbA1c and age, responded well to oral insulin.

Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase

3 (ORA-D-013-3) clinical trial to the U.S.

Food and Drug Administration, or the FDA.

We intend to initiate study during 2025.

additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal

of enhancing value for our stockholders.

January 22, 2024, we along with our wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement, or Initial JV Agreement,

with Hefei Tianhui Biotech Co., Ltd.

or HTIT, and its subsidiary Technowl Limited or HTIT Sub.

OraTech will focus on developing and commercializing

products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities.

February 7, 2025, we and HTIT entered into a Joint Venture Agreement, or the JV Agreement, amending the Initial JV Agreement signed on

January 22, 2024.

To execute the JV Agreement, we formed OraTech Pharmaceuticals, Inc., or OraTech, which will serve as the joint venture

We currently hold 100% of OraTech shares.

OraTech was formed to advance the development and commercialization of oral insulin,

combining our proprietary technology and funding with HTIT’s manufacturing capabilities.

Through this partnership, OraTech will

have the technology, resources, and production capacity to bring oral insulin to market.

The agreement also outlines the spin-off of

OraTech, or the Spin Off, requiring regulatory filings and the distribution of the majority of OraTech’s shares held by us to our

shareholders.

Both we and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.

Initial Closing, set for April 30, 2025, or the Initial Closing, includes an investment of $40,000,000 by HTIT and $7,500,000 by us into

Additionally, we will transfer all our intellectual property rights to OraTech.

The second closing, contingent on the listing

of OraTech’s shares on Nasdaq, involves a $20,000,000 investment by HTIT and an additional $7,500,000 investment by us, or the

Second Closing.

It is expected to close by May 31, 2025, but no later than September 1, 2025.

Upon completion of the Initial Closing

and the Second Closing, both HTIT and we will receive OraTech shares, resulting in ownership of 50% for each of HTIT and us, excluding

the impact of the contemplated distribution of OraTech shares to our shareholders.

part of the JV Agreement, HTIT will receive $20,000,000 at the Initial Closing and $10,000,000 at the Second Closing under a supply agreement

with OraTech.

Scilex Transaction and 2024 Refinancing

Description of Business

We are a pharmaceutical company

engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery

of therapeutic proteins.

In addition, we allocate capital to strategic investments in healthcare and life sciences companies that we

believe complement our long-term business objectives and technology focus.

We have developed an oral

dosage form intended to withstand the harsh environment of the gastrointestinal tract and effectively deliver active insulin or other

The formulation is not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe

We intend to initiate,

in the second half of 2026, a 60-patient, US-based clinical trial designed to validate the robustness of our oral insulin formulation

in defined patient population.

The trial is designed to use the smallest adequately powered patient population expected to obtain such

validation in what we believe to be the shortest time possible, providing a cost-effective approach to generate additional compelling

evidence and refine our patient selection criteria for future potential regulatory submissions.

The trial will be conducted by OraTech.

For additional information,

see note 21 to our consolidated financial statements included in this Annual Report on Form 10-K.

As part of our business strategy,

we continuously review our existing pipeline and evaluate potential strategic opportunities to enhance stockholder value.

in addition to our core pharmaceutical activities, we have made strategic investments in healthcare and life sciences companies and entered

into other investment, financing, and real estate transactions, as further described below.

HTIT JV Agreement

On January 22, 2024, we along

with our wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement, or the Initial JV Agreement, with Hefei Tianhui

Biotech Co., Ltd.

or HTIT, and its subsidiary Technowl Limited or HTIT Sub., to establish OraTech, or the “JV”.

focus on developing and commercializing products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing

capabilities.

On February 7, 2025, we and

HTIT entered into a Joint Venture Agreement or, the “JV Agreement”, amending the Initial JV Agreement, to advance the development

and commercialization of oral insulin by combining our proprietary technology and funding with HTIT’s manufacturing capabilities.

The initial closing did not occur due to HTIT failing to satisfy the closing conditions under the JV Agreement and the supplemental agreement.

Accordingly, on October 23, 2025, we provided notice of termination of the JV Agreement and the supplemental agreement.

Transactions with Scilex

On April 14, 2025, Scilex Holding Company (“Scilex”) effected

a 1-for-35 reverse stock split of its issued and outstanding common stock.

The numbers below reflect the reverse split, except with respect

to the Subsequent Penny Warrants that were outstanding as of the reverse stock split date, which were not adjustable under the reverse

split pursuant to the terms of such warrants.

2023 Scilex Transaction

September 21, 2023, we entered into and consummated transactions, or, collectively, the 2023 Scilex Transaction, with Scilex, pursuant

to which Scilex issued to us:

A senior secured

promissory note, or the Tranche A Note, with a principal amount of $101,875,000, maturing on March 21, 2025 and bearing interest of

SOFR plus 8.5%, payable in-kind.

Scheduled principal payments are due on December 21, 2023, March 21, 2024, June 21, 2024, September

21, 2024, and December 21, 2024, with the balance due on March 21, 2025.

In January 2025, we extended Tranche A Note maturity from

March 21, 2025 to December 31, 2025.

As per the Tranche A Note terms, if the Tranche A Note is not repaid in full on or prior to

March 21, 2024, an exit fee of approximately $3,056,000 was.

Since the Tranche A Note was not repaid by March 21, 2024, we are

entitled to the above-mentioned exit fee at the maturity date of the Tranche A Note.

As of March 27, 2025, Scilex has repaid

$69,200,000 of the amount due under the Tranche A Note and refinanced $25,000,000 as part of the 2024 Refinancing (as defined

to purchase up to 4,500,000 shares of Scilex common stock with an exercise price of $0.01 per share,

or the Closing Penny Warrants, and four additional warrants, or the Subsequent Penny Warrants, each

for 2,125,000 shares of Scilex common stock with an exercise price of $0.01 per share.

Penny Warrants vested on September 21, 2023, and each of the Subsequent Penny Warrants vested on

each of March 19, 2024, June 17, 2024, September 15, 2024 and December 14, 2024.

The Closing Penny

Warrants and the Subsequent Penny Warrants shall become exercisable on the earliest of (i) March

14, 2025 and (ii) the date on which the Tranche A Note has been repaid in full.

As of March 27, 2025,

the Closing Penny Warrants and the Subsequent Penny Warrants are fully vested.

October 30, 2024, we exercised 4,500,000 Closing Penny Warrants and 2,000,000 Subsequent Penny Warrants that were exercisable at

As a result, we hold 6,500,000 shares of common stock of Scilex.

Transferred warrants, or

the Transferred Warrants, to purchase 4,000,000 shares of Scilex common stock with an exercise price of $11.50 per share, fully exercisable

and expiring on November 10, 2027.

On September 20, 2024, we sold the Transferred Warrants for consideration of $300,000 (see below).

As a result, as of March 27, 2025 we do not hold any Transferred Warrants.

September 20, 2024, we and Scilex entered into an extension agreement, or the Extension Agreement, to extend the due date of the September

21, 2024 payment under the Tranche A Note.

Pursuant to the Extension Agreement, Scilex paid us $2,000,000 on September 23, 2024, which

payment is to be applied as follows:

(i) $1,700,000 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300,000 to

purchase the Transferred Warrants as mentioned above.

October 7, 2024, we and certain institutional investors, or the Note B Holders, entered into certain agreements with Scilex, pursuant

to which the Note B Holders purchased in a registered offering, or the 2024 Refinancing, (i) a new tranche B of senior secured convertible

notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Notes, which Tranche B Notes are convertible into

shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants, to purchase up to 7,500,000 shares of Scilex common stock,

or Tranche B Warrants.

We purchased 50% of Tranche B Note and Tranche B Warrants and therefore hold an aggregate principal amount of

$25,000,000 under the Tranche B Note and 3,750,000 Tranche B Warrants.

received from us, in consideration for our part in Tranche B Notes and the Tranche B Warrants issued to us, an exchange and reduction

of the principal outstanding balance under the Tranche A Note of $22,500,000.

Purchase Agreement

addition, on October 8, 2024, we and certain institutional investors, or the RPA Purchasers, entered into a Purchase and Sale Agreement

or the RPA with Scilex and Scilex Pharmaceuticals Inc., or Scilex Pharma.

Pursuant to the RPA, the RPA Purchasers acquired the right

to receive, in the aggregate, 8% of net sales worldwide for 10 years of certain purchase receivables, or the Purchased Receivables with

respect to ZTlido (lidocaine topical system) 1.8%, SP-103 (lidocaine topical system) 5.4%, and any related, improved, successor, replacement

or varying dosage forms of the foregoing.

We acquired the right to receive 50% of the Purchased Receivables, as more fully described

in the RPA and therefore hold the right to receive 4% royalties.

consideration for our interest in the Purchased Receivables, we exchanged and reduced $2,500,000 of the principal balance under the Tranche

Following the refinancing as described above, on October 8, 2024, Scilex

used $12,500,000 of the net proceeds from the proceeds of the Tranche B Note for the repayment of the outstanding balance under the Tranche

Rest of the World Binding Agreement

addition, on October 8, 2024, we and certain other institutional investors and Scilex entered into a binding term sheet, or the ROW License

Term Sheet, regarding a license and development agreement, or the Lido License Agreement, with respect to services, compositions, products,

dosages and formulations comprising lidocaine, including without limitation, the product and any future product defined as a “Product”

under Scilex Pharma’s existing (i) Product Development Agreement, dated as of May 11, 2011, with Oishi Koseido Co., Ltd., or Oishi,

and Itochu Chemical Frontier Corporation, or Itochu, as amended, and (ii) the associated Commercial Supply Agreement, dated February

16, 2017, between Scilex, Oishi and Itochu, as amended.

to determination of a final structure for the transactions contemplated by the ROW License Term Sheet, we anticipate that we and such

institutional investors will hold the Lido License Agreement through a joint venture, RoyaltyVest, Inc., or RoyaltyVest.

consideration for the rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term

Sheet, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200,000

per year toward expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products

rights for the development, out-licensing, commercialization of any Product outside of the United States and other territories, other

than certain excluded designated territories , or the ROW Territory, and (c) each of RoyaltyVest and Scilex will receive 50% percent

of the net revenue (less expenses) generated from any Product in the ROW Territory.

The term sheet is subject to entering into a definitive

agreement (signed on February 22, 2025, see below) and subject to the consent of Oishi and Itochu to the Lido License Agreement.

B Note Consent

On January 2, 2025, we and other Tranche B noteholders entered into

deferral and consent agreements with Scilex or the Tranche B Consent, deferring Scilex’s first amortization payment under the Tranche

B Note to October 8, 2026.

In consideration, we received approximately $877,000 and 2,500,000 shares of Scilex common stock.

addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:

and the Tranche B Noteholders agreed to a 10-year, assignable 4% royalty on global net sales

of Gloperba and Elyxyb in certain territories outside of the United States , or RoW, of which,

we are entitled to 2% royalties.

Gloperba, an oral liquid colchicine formulation for gout,

and Elyxyb, an oral solution for acute migraine treatment, represent key assets in Scilex’s

The definitive agreement was signed on February 28, 2025.

Tranche B Noteholders have the option to fund up to 50% of the cash purchase price for RoW

product rights to Gloperba and Elyxyb (excluding Elyxyb in Canada) and will receive proportional

revenues from commercialization and licensing.

A Note Maturity Date Extension Amendment

January 21, 2025, we entered into an amendment to the Tranche A Note, or the Tranche A Extension Amendment, extending the maturity date

from March 21, 2025, to December 31, 2025 or the Extended Maturity Date.

Interest will continue to accrue and be payable on the Extended

Maturity Date.

In consideration of the extension, we received 3,250,000 shares of Scilex common stock.

License Agreement

part of the ROW License Term Sheet, on February 22, 2025, we, through its 50% ownership in RoyaltyVest, entered into a license agreement

Under this agreement, RoyaltyVest acquired exclusive rights to develop, manufacture, and commercialize lidocaine-based products,

including ZTlido (lidocaine topical system 1.8%) and SP-103, in the ROW Territory.

As part of the arrangement, RoyaltyVest and Scilex

will each receive 50% of the net profits from the commercialization of these products.

Given our 50% ownership in RoyaltyVest, we effectively

holds a 25% in the profits generated under this agreement.

In order to diversify our investments as a part of our use of cash

March 4, 2025, we participated in a registered direct offering by BioXcel Therapeutics, Inc.

BTAI), or BioXcel, acquiring 2,000,000

shares of BioXcel’s common stock and accompanying warrants to purchase up to an additional 2,000,000 shares.

The shares and warrants

were purchased at a combined offering price of $3.50 per share and warrant, representing 50% of the total 4,000,000 shares issued in

the offering.

The warrants have an exercise price of $4.20 per share, are immediately exercisable, and will expire five years from the

date of issuance.

On September 21, 2023, we entered into and consummated a series of

transactions, or the “2023 Scilex Transaction”, with Scilex pursuant to which Scilex issued to us:

A senior secured promissory note, or the Tranche

A Note, with a principal amount of $101,875,000, initially maturing on March 21, 2025 and bearing interest of SOFR plus 8.5%, payable

Scheduled principal payments were due quarterly from December 21, 2023, through December 21, 2024, with the remaining balance

due on March 21, 2025.

The maturity was subsequently extended to December 31, 2025, in exchange for 92,858 shares of Scilex common stock.

An exit fee of approximately $3,056,000 became payable when the note was not repaid by March 21, 2024.

Following the Option Agreement

(as defined below), the maturity was subsequently extended to March 31, 2026.

As of March 26, 2026, Scilex had repaid $69,200,000

of the amount due under the Tranche A Note and refinanced $25,000,000 as part of the 2024 Refinancing (as defined below).

As a result, as of March 26, 2026 the outstanding principal balance

of the Tranche A Note is $7,675,000 (approximately $27,884,000 including accrued interest and the exit fee), which is due by March 31,

Warrants to purchase up to 128,572 shares of Scilex

common stock with an exercise price of $0.35 per share, or the Closing Penny Warrants, and additional warrants or, the “Subsequent

Penny Warrants”, for 57,143 shares of Scilex common stock (after giving effect to the reverse stock split) and 6,500,000 shares

of Scilex common stock (which such amount was not adjusted for the reverse stock split pursuant to the terms of such warrants), with an

exercise price of $0.35 and $0.01 per share, respectively.

During 2024, we exercised 128,572 Closing Penny

Warrants and 57,143 Subsequent Penny Warrants.

On July 22, 2025, we entered into an option agreement,

or the Option Agreement, with Scilex, granting Scilex the right to repurchase our remaining 6,500,000 Subsequent Penny Warrants for an

aggregate price of $27,000,000 plus a $1,500,000 fee.

In two separate installments on September 30, 2025 and December 30, 2025, Scilex

exercised its right under the Option Agreement and repurchased all warrants for total proceeds to us of $28,500,000 (including the option

fee) by December 31, 2025.

As of December 31, 2025, we do not hold any Closing Penny Warrants

or Subsequent Penny Warrants.

Transferred warrants to purchase 114,286 shares

of Scilex common stock with an exercise price of $402.5 per share, fully exercisable and expiring on November 10, 2027 or, the “Transferred

On September 20, 2024, we sold the Transferred Warrants for $300,000 (see below).

As a result, as of December 31, 2025 we do not hold any Transferred

2024 Refinancing

On October 7, 2024, we and certain institutional investors, or the

Note B Holders, entered into certain agreements with Scilex, pursuant to which the Note B Holders purchased in a registered offering,

or the 2024 Refinancing, (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000,

or the Tranche B Note, which Tranche B Note is convertible into shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants,

to purchase up to 214,286 shares of Scilex common stock with an exercise price of $36.40.

We purchased 50% of the Tranche B Note and the

Tranche B Warrants, equal to an aggregate principal amount of $25,000,000 under the Tranche B Note and 107,143 Tranche B Warrants.

Scilex received from us, in

consideration for our purchase of the Tranche B Note and the Tranche B Warrants issued to us, an exchange and reduction of the principal

outstanding balance under the Tranche A Note of $22,500,000.

As of March 26, 2026, Scilex

has repaid $13,000,000 of the principal amount outstanding under the Tranche B Note, leaving a remaining principal balance of $12,000,000

with accrued interest of approximately $495,000.

The Tranche B Note matures on October 8, 2026.

Royalty Purchase Agreement

In addition to the Tranche B Note, on October 8, 2024, we and certain

institutional investors, or the RPA Purchasers, entered into a Purchase and Sale Agreement, or the RPA, with Scilex and Scilex Pharmaceuticals

Inc., or Scilex Pharma.

Pursuant to the RPA, we acquired the right to receive 4% royalties on worldwide net sales of ZTLido, SP-103 and

related products for 10 years, in exchange for a reduction of $2,500,000 in the principal balance under the Tranche A Note.

Scilex used $12,500,000 of the net proceeds from the Tranche B Note for the repayment of the outstanding balance under the Tranche A Note.

ZTLido Rest of the World Binding Agreement

On October 8, 2024, we and certain other institutional investors and

Scilex entered into a binding term sheet, or the ROW License Term Sheet, for a license and development agreement relating to ZTlido and

lidocaine products outside the United States.

To implement the atransaction contemplated by the ROW License Term Sheet, we and the other

institutional investors agreed to operate through a joint venture, RoyaltyVest Ltd., or RoyaltyVest, a company incorporated in the British

Virgin Islands.

On February 12, 2025, we were transferred 50% of the issued and outstanding shares of RoyaltyVest.

On February 22, 2025, RoyaltyVest entered into a License Agreement

with Scilex (the “ZTLido License Agreement”).

Under the ZTLido License Agreement, RoyaltyVest acquired exclusive rights to

develop, manufacture, and commercialize lidocaine-based products, including ZTLido (lidocaine topical system 1.8%) and SP-103 (the “Product”),

outside the United States.

As consideration for the rights provided under the ZTLido License Agreement, (a) RoyaltyVest agreed to invest

(whether through cash consideration or in-kind payment through the provision of services) $200,000 per year toward expanding the Product,

(b) Scilex granted 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,

and (c) each of RoyaltyVest and Scilex each receive 50% percent of the net revenue generated from the commercialization of the Produce

outside of the United States.

Tranche B Note Consent

On January 2, 2025, we and

other Tranche B Noteholders entered into deferral and consent agreements with Scilex or the Tranche B Note Consent, deferring Scilex’s

first amortization payment under the Tranche B Note to October 8, 2026.

In consideration, we received approximately $877,000 ($500,000

of the principal amount and $376,903 accrued interest) and 71,249 shares of Scilex common stock.

A part of the consideration

for providing the Tranche B Note Consent, on February 28, 2025, we entered into a Purchase and Sale Agreement with Scilex, Scilex Pharmaceuticals

and certain other Note B Holders, pursuant to which, among other things, the applicable Note B Holders received a royalty in respect

of 4% of worldwide net sales of Gloperba, Elyxyb, and related products, of which we are entitled to 50% of such royalty payments.

RoyaltyVest, the Note B Holders, were provided the option to fund up to 50% of the cash purchase price for certain ex-US (and, as to Elyxyb,

ex-Canada) product rights to Gloperba and Elyxyb and will receive proportional revenues from commercialization and licensing.

31, 2025, RoyaltyVest exercised its option to Ex-U.S.

product rights of Gloperba

for $500,000.

Tranche B Note Deferral and Warrant Agreement

In October 2025, the Company agreed to defer until December 31, 2025,

the amortization payment due from Scilex on October 1, 2025, under the amortization schedule included in the Tranche B Notes.

In consideration

for such deferral, Scilex agreed to issue to us certain warrants to purchase shares of Scilex’s common stock, par value $0.0001

Such commitment as memorialized in a letter agreement entered into with Scilex on December 31, 2025.

The deferred amortization

payment was subsequently paid to us in November 2025.

A warrant to purchase 100,000 shares of Scilex common stock at an exercise price of $20.00 per share, was issued to the Company pursuant

to a Warrant Agreement entered by the Company and Scilex on February 19, 2026.

Scilex Warrant Agreement

In October 2025, we agreed to defer an amortization

payment due from Scilex on October 1, 2025 under the amortization schedule included in the Tranche B Notes.

The deferred amortization

payment was subsequently paid to us in November 2025.

In consideration for this deferral, Scilex agreed to issue to us warrants to purchase

100,000 shares of Scilex’s common stock, par value $0.0001 per share with an exercise price of $20.

The warrants were issued on

February 19, 2026.

For additional information regarding 2023 Scilex Transaction and 2024

Refinancing, see note 4 to our consolidated financial statements included in this Annual Report on Form 10-K.

In order to diversify our

investments as a part of our use of cash strategy, on March 4, 2025, RoyaltyVest, participated in a registered direct offering by BioXcel

Therapeutics, Inc.

BTAI), or BioXcel, acquiring 188,383 shares of BioXcel’s common stock, 3,811,617 pre-funded warrants

and accompanying warrants to purchase up to an additional 4,000,000 shares for a total consideration of $14,000,000.

The warrants have

an exercise price of $4.20 per share, are immediately exercisable, and will expire five years from the date of issuance.

The pre-funded

warrants have an exercise price of $0.001 per share, are immediately exercisable with no expiration date.

is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology.

Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.

As of March 27, 2025, we have sold 869,992 shares and continues to

hold 1,130,008 shares of BioXcel common stock.

Real Estate Transactions

Additionally, as a part of

our cash management strategy, we have engaged in certain real estate transactions.

In January 2025, we

entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800,000

(approximately $1,586,000).

The transaction is structured in installments, and as of March 27, 2025, we have paid approximately $1,210,000

toward the acquisition price.

Under the agreement, the developer is responsible for executing all development-related activities,

and we and the developer will share the profits upon the future sale of the property.

On March 24, 2025, we

entered into a loan agreement to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of $22,650,000.

loan has a one-year maturity and is secured by a first-ranking mortgage on a property valued at approximately $800,000,000,

providing significant collateral coverage.

As of December 31, 2025,

RoyaltyVest has sold 4,000,000 shares and 2,600,000 warrants for $12,502,000.

As of December 31, 2025, RoyaltyVest continues to hold

1,400,000 warrants and no longer holds any shares of BioXcel common stock.

Alpha Tau Transaction

On April 24, 2025, our wholly-owned

subsidiary, Oramed Ltd entered into a share purchase agreement with Alpha Tau Medical Ltd.

DRTS), or Alpha Tau, a clinical-stage

oncology company developing a proprietary alpha-radiation cancer therapy platform known as Alpha DaRT™.

Pursuant to the agreement,

purchased 14,110,121 ordinary shares, no par value per share, of Alpha Tau in a registered direct offering at a price of

$2.612 per share, for an aggregate purchase price of approximately $36,900,000.

The closing of the transaction occurred on April 28,

In connection with the investment, Oramed Ltd.

has the right and have nominated two directors to Alpha Tau’s board of directors.

In addition, since the share purchase agreement date and until December 31, 2025, we purchased an additional 359,214 shares of Alpha

Tau for an aggregate amount of $1,255,781.

As of December 31, 2025 and March 26, 2026, we hold an aggregate of 14,469,335 ordinary shares

of Alpha Tau, representing approximately 17% of its outstanding share capital.

Concurrently, we and Alpha Tau entered into a

services agreement, or the Service Agreement, pursuant to which we will provide Alpha Tau with investor relations and public relations

As consideration, Alpha Tau agreed to pay us a non-refundable fee of $3,000,000 over three years and to issue to us warrants

to purchase up to 3,237,000 ordinary shares of Alpha Tau at exercise prices ranging from $3.474 to $3.90 per share.

The term of the Services

Agreement is three years, with limited termination rights.

Alpha DaRT™ Platform and Technology

Alpha Tau’s Alpha DaRT platform is designed

to deliver highly localized alpha radiation through intratumoral insertion of radium-224 impregnated sources into solid tumors.

the radium decays, its short-lived daughters are released and disperse while emitting high-energy alpha particles aimed at destroying

tumor cells while sparing surrounding healthy tissue.

This approach potentially offers a novel treatment solution for patients with otherwise

difficult-to-treat cancers where conventional external beam radiation may be limited.

Clinical Development Progress

Alpha Tau is currently conducting an extensive

clinical program with five concurrent FDA-approved trials in the United States, alongside additional trials in France, Italy, Israel,

and planned studies in the UK:

Clinical Trials:

Pivotal Trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy) :

A multi-center pivotal study in patients with recurrent

cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer.

As of January 2026, Alpha Tau targeted completion

of patient recruitment in Q1 2026 and has begun submitting modules of its Modular Pre-Market Approval (PMA) application to the FDA, with

expected completion of the full submission by year-end 2026.

Study (Intratumoral Pancreatic Alpha Combination Trial) :

A multi-center pilot study in newly-diagnosed pancreatic cancer patients

combining Alpha DaRT with chemotherapy.

Alpha Tau reported encouraging data from its first-in-human pancreatic cancer studies in Canada

and Israel, including positive results presented at the 2026 ASCO Gastrointestinal Cancers Symposium.

Alpha Tau is targeting completion

of patient accrual by the end of Q1 2026, with initial results expected by year-end 2026.

Feasibility Study :

A study in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive malignant brain tumor.

Tau announced treatment of its first patient at Ohio State University and expects initial results around the end of Q4 2026.

Prostate Cancer Pilot Study :

A pilot study in patients with locally recurrent prostate cancer.

● Immunocompromised

A multi-center study in immunocompromised patients with cSCC.

In addition, Alpha Tau is engaged in pre-clinical

research partnerships with leading academic institutions including Mayo Clinic, McGill University, Emory University, and MD Anderson

Cancer Center, exploring combinations with immunotherapy.

Alpha Tau has also reported encouraging interim data from a clinical study

in Israel examining the combination of Alpha DaRT with checkpoint inhibitor therapeutics for patients with locally advanced or metastatic

head and neck squamous cell carcinoma, and is exploring the possibility of conducting a sixth U.S.

trial in this indication.

Regulatory and Commercial Progress

In addition to the ongoing FDA engagement for

clinical programs, Alpha Tau has reported that it is anticipating a response from Japan’s Ministry of Health, Labour and

Welfare regarding its application for approval of Alpha DaRT in the treatment of recurrent head and neck cancer, which would mark Alpha

DaRT’s first commercial approval outside of Israel if granted.

On the manufacturing front, Alpha Tau has received

a radioactive materials license for its Hudson, New Hampshire facility and is currently equipping the facility for Alpha DaRT manufacturing

to support commercial readiness and scale-up operations.

Strategic Overview Rationale

Alpha Tau has demonstrated encouraging clinical

progress across multiple difficult-to-treat cancer types, including pancreatic cancer, head and neck cancer, and skin cancer, with interim

data showing disease control and early signals of clinical benefit.

With five concurrent FDA-approved trials in the U.S., ongoing regulatory

dialogue with the FDA, potential near-term regulatory approval in Japan, and advancement toward PMA submission for its pivotal skin cancer

trial, Alpha Tau is entering a critical phase of clinical validation and regulatory progression.

The company’s innovative alpha-radiation

platform, combined with its expanding clinical footprint across multiple solid tumor types and growing manufacturing capabilities, represents

what we believe to be a compelling investment opportunity in the oncology therapeutics space.

Pelthos Therapeutics Inc.

On July 1, 2025, we purchased 150,000 shares of common stock of Pelthos

Therapeutics Inc, or Pelthos, for an aggregate amount of $1,500,000.

Subsequent to December 31, 2025 and through March 26, 2026, we sold

6,577 shares of Pelthos common stock of for aggregate proceeds of approximately $173,000.

Following these sales, we hold 143,423 shares

of Pelthos common stock.

Nano Dimension Ltd.

As of December 31, 2025,

we purchased an aggregate of 5,436,791 ordinary shares, par value NIS 5.00 per share or, “Nano Ordinary Shares”, of Nano

Dimension Ltd., or Nano, for an aggregate amount of approximately $8,501,000.

Subsequent to December 31, 2025 and through March 26, 2026,

we purchased an additional 6,401,939 of Nano ordinary shares for an aggregate purchase price of approximately $12,308,000 and we sold

1,269,987 ordinary shares of Nano for aggregate proceeds of approximately $2,606,000.

Following these transactions, we hold an aggregate

of 10,568,743 Nano ordinary shares, representing approximately 5.02% of its outstanding shares as of March 26, 2026, based on 210,334,767

Nano Ordinary Shares outstanding as of October 14, 2025, as reported in a Report of Foreign Private Issuer on Form 6-K filed with the

SEC on December 4, 2025.

We have, and intend to in the future, engage in discussions with Nano’s

management, members of Nano’s board of directors, and/or other shareholders of Nano concerning, among other things, Nano’s

performance, the market price of the Nano Ordinary Shares relative to the value of Nano’s assets, potential financing options for

Nano, Nano’s business strategy, potential transactions and other issues for the betterment of Nano.

We intend to engage in discussions

with Nano and other shareholders thereof regarding the management of Nano and to recommend changes to the composition of the board of

directors and expect to subsequently have further discussion with Nano’s management and board of directors covering board composition

as well as a broad range of subjects relative to performance, strategic direction, shareholder value and governance of Nano.

Transactions with Lifeward

Secured Promissory Note

On November 14, 2025, in

anticipation of the transactions contemplated by the Lifeward Share Purchase Agreement and the Lifeward Notes Purchase Agreement described

below, we entered into a loan agreement with Lifeward Ltd.

or “Lifeward” pursuant to which we provided Lifeward with a $3,000,000

secured promissory note bearing interest at 15% per annum and maturing on May

14, 2026 , unless earlier repaid or converted in accordance with its terms.

The note is secured by a lien on Lifeward’s cash

and accounts receivable.

principal and accrued interest under the note are convertible into Lifeward ordinary shares at a conversion price of $5.40 per share,

reflecting Lifeward’s 12-for-1 reverse share split effected on February 24, 2026, which adjusted the original conversion price

of $0.45 per share.

On February 12, 2026, we

agreed to provide Lifeward with an additional secured promissory note with an initial principal amount

of $525,000, which may be increased by up to an additional $975,000 , bearing interest at 24%

per annum and secured by a lien on Lifeward’s cash.

As of March 26 ,

2026, we had funded $1,025,000 under this additional note.

outstanding principal and accrued interest under the secured promissory notes are expected to be rolled into the Initial Notes issued

under the Lifeward Notes Purchase Agreement described below.

Lifeward Share Purchase Agreement

On January 12, 2026, we entered into a Share Purchase Agreement or,

the “Lifeward Share Purchase Agreement” with Lifeward and OraTech pursuant to which Lifeward agreed to acquire all of the

outstanding equity interests of OraTech from us or the “Share Purchase Transaction”.

Prior to the closing, we transferred

to Oratech all intellectual property and related assets relating to our POD™ (Protein Oral Delivery) technology platform, together

with cash to fund the next planned clinical trial and related development activities.

As a result, commencing on the closing date of March

25, 2026, research and development expenses will be borne by Oratech.

In consideration for the acquisition of OraTech, Lifeward issued to

(i) Lifeward Ordinary Shares and pre-funded warrants to purchase Lifeward Ordinary Shares representing up to 49.99% of Lifeward’s

fully diluted equity capitalization at closing, subject to adjustments, which such the Lifeward Ordinary Shares issued at closing represented

less than 45.0% of the outstanding Lifeward Ordinary Shares at closing;

(ii) warrants to purchase Lifeward Ordinary Shares equal to the

quotient of Lifeward’s net cash at closing divided by an exercise price of $5.40 per share, reflecting Lifeward’s 12-for-1

reverse share split effected on February 24, 2026 (which adjusted the original exercise price of $0.45 per share), subject to adjustments

or, the “Share Purchase Warrants”;

and (iii) revenue-sharing payments equal to 4% of the net revenue from Lifeward’s

ReWalk Personal Exoskeleton products and related extended warranties for up to 10 years following closing, subject to certain caps and

early termination upon the occurrence of specified events.

The closing of the Share Purchase Transaction was subject to customary

closing conditions, including the approval of Lifeward’s shareholders for the issuance of more than 19.99% of Lifeward Ordinary

Shares in accordance with Nasdaq listing standards.

Such shareholder approval was obtained on March 12, 2026.

The closing of the Share

Purchase Transaction took place on March 25, 2026.

In connection with the transaction,

Lifeward agreed to file a resale registration statement with the SEC covering the Lifeward Ordinary Shares issued in the transaction

and those issuable upon exercise of the pre-funded warrants and warrants described above as soon as practicable following closing, but

no later than 75 days after closing, and to use commercially reasonable efforts to have such registration statement declared effective

within 75 days after closing (or 105 days in the event of a full SEC review).

Pre-Funded Warrants and Share Purchase Warrants

The Share Purchase Warrants were immediately exercisable upon issuance

at an initial exercise price of $5.40 per share, reflecting Lifeward’s 12-for-1 reverse share split effected on February 24, 2026

(which adjusted the original exercise price of $0.45 per share), and expire five years from the date of issuance.

The exercise price is

subject to customary anti-dilution adjustments.

The Pre-Funded Warrants have an exercise price of $0.0012 per share

(reflecting the reverse-split adjusted price of the original $0.0001 per share), subject to customary adjustments, and will remain exercisable

until exercised in full.

We may not exercise any portion of the Pre-Funded

Warrants or Share Purchase Warrants to the extent that, after giving effect to such exercise, we and our affiliates would beneficially

own more than 45.0% of the outstanding Lifeward Ordinary Shares.

This limitation will automatically increase to 49.99% once (i) the Investors

no longer hold any Notes and (ii) the Investors have sold all Note Shares issued or issuable upon conversion of the Notes and related

We may increase the beneficial ownership limitation upon at least 61 days’ prior notice to Lifeward;

provided that, for

so long as certain Lifeward warrants outstanding as of the issuance date remain outstanding, any such increase will require Lifeward’s

consent, which may not be unreasonably withheld, conditioned or delayed.

In connection with the execution

of the Lifeward Share Purchase Agreement, we entered into a lock-up agreement for a period of 120 days after the Closing, without the

prior written consent of Lifeward.

Clinical Trial Management Agreement

In connection with the Lifeward Share Purchase Agreement we agreed

to enter into a clinical trial management or, the “Clinical Trial Management Agreement” with Oratech, pursuant to which we

agreed to manage the clinical study of Oratech’s investigational oral insulin capsule product or, the “Study”, including

providing clinical trial management and administrative services through study completion or, the “Services”.

In consideration

for the Services, OraTech will reimburse us for all reasonable out-of-pocket expenses actually incurred by us in providing the Services

and payments made on behalf of OraTech to third parties and vendors, such as clinical sites, if applicable, subject to certain limitations

and maximum payments as set forth in the Clinical Trial Management Agreement.

The Clinical Trial Management Agreement will terminate upon

completion of the Study unless earlier terminated in accordance with the terms set forth therein.

Notes Securities Purchase Agreement

On January 12, 2026, we entered into a Securities

Purchase Agreement or, the “Lifeward Notes Purchase Agreement” with Lifeward and other investors pursuant to which we agreed

to purchase, in a private placement, up to $18,000,000 of senior secured convertible notes issued

by Lifeward, together with accompanying warrants to purchase Lifeward Ordinary Shares.

At the initial closing, which occurred on March 25, 2026, we agreed

to purchase $9,000,000 aggregate principal amount of such notes or, the “Initial Notes”.

The Initial Notes bear interest at

8% per annum, payable semi-annually, and mature three years from the date of issuance.

The Initial Notes are convertible into Lifeward

Ordinary Shares at an initial conversion price of $5.40 per share, reflecting Lifeward’s 12-for-1 reverse share split effected on

February 24, 2026 (which adjusted the original conversion price of $0.45 per share), subject to customary anti-dilution adjustments.

We also agreed to purchase an additional $9,000,000

aggregate principal amount of notes or, the “Additional Notes” and together with the Initial Notes, or, the “Notes”,

together with accompanying warrants, on substantially the same terms as the Initial Notes.

The closing of the Additional Notes is subject

to customary closing conditions and either:

(i) Lifeward achieving at least a 150%

increase in ReWalk unit sales compared to the trailing twelve-month period immediately preceding the Additional Closing;

(ii) the closing price of Lifeward Ordinary Shares equaling or

exceeding $13.80 per share , reflecting Lifeward’s 12-for-1

reverse share split (which adjusted the original $1.15 threshold), for 10 consecutive trading

days immediately prior to the Additional Closing.

The closing of the Initial

Notes was subject to customary closing conditions, including the approval of Lifeward’s shareholders for the issuance of more

than 19.99% of Lifeward Ordinary Shares in accordance with Nasdaq listing standards.

shareholder approval was obtained on March 12, 2026.

In connection with the transaction, Lifeward

agreed to file a resale registration statement with the SEC covering the Lifeward Ordinary Shares issuable upon conversion of the Notes

and exercise of the related warrants within 30 days after the Initial Closing , and to use commercially

reasonable efforts to have the registration statement declared effective within 45 days thereafter

(or 75 days in the event of a full SEC review).

Strategic Overview Rationale

As part of our ongoing portfolio optimization and focus on high potential

innovation, during 2026 we entered into a strategic transaction with Lifeward Ltd.

Under this agreement, we transferred our proprietary

Protein Oral Delivery POD platform, representing years of research to enable oral administration of injectable biologics including its

refined oral insulin program, to Lifeward while retaining responsibility for managing the near-term clinical development program and receiving

a significant equity ownership interest in the combined company.

This transaction aligns us with a revenue generating medical robotics

business with established products such as ReWalk and AlterG, providing near term cash flow and diversified exposure alongside the long

term upside of the POD platform.

we believe that prior execution challenges at Lifeward were driven primarily by strategy and management

rather than the quality of the underlying technology.

With a new strategic direction and leadership team in place, we believe Lifeward

is well positioned to advance the oral insulin program and fully realize the value of its combined technology platforms, ultimately delivering

meaningful growth and shareholder value.

Corner Ally Ventures

On March 1, 2026, our board approved the formation of Corner Ally Ventures

or, the “Fund”, a new venture capital fund focused on investments in Israeli technology companies.

We co-founded the Fund

together with Corner Capital Management, LLC and, together with Ben Shapiro, are expected to serve as a major general partner of the Fund

and to participate in its management and investment decision-making and may be entitled to a share of the Fund’s carried interest.

We also expect to serve as an anchor limited partner and have committed to vest up to $40,000,000 in the Fund, which is expected to be

funded over an anticipated four-year capital call period.

The Fund’s initial closing, subject to a minimum capital commitment of

$75,000,000, is expected to occur in the third quarter of 2026.

Real Estate Investments

On November 7, 2024, our

Board of Directors, or the Board, approved investments of up to $10,000,000 in real estate assets.

This decision aligns with our strategic

approach to capital allocation, leveraging opportunities in the current real estate market where we have identified attractive investment

With interest rates expected to decline and valuations presenting favorable entry points, the Board believes these investments

could provide long-term value appreciation and potential income streams, further strengthening our financial position.

As we continue

to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility

and maximize shareholder value.

On February 13, 2025, the Board approved increasing the real estate investments to up to $30,000,000.

Profit-Sharing Loan Agreement

On September 4, 2024, we

entered into a loan agreement, or the Profit-Sharing Loan Agreement, with Rabi Binyamin 4 Tama 38 Ltd.

or, the “Borrower”,

to finance a real estate project or, the “Rabi Binyamin Project”.

According to the terms of the Profit-Sharing Loan Agreement,

we agreed to loan NIS 5,500,000 (approximately $1,523,000) or, the “Loan Principal”, to the Borrower.

NIS 4,700,000 (approximately

$1,307,000) was loaned upon signing the Profit-Sharing Loan Agreement and an additional NIS 800,000 (approximately $237,000), or the

Additional Payment, will be loaned upon certain milestones.

On October 28, 2025, the Borrower met the milestones and is entitled to the

additional payment.

On September 14, 2025, we loaned an additional NIS 500,000 (approximately

$150,286) to the Borrower or’ the “Additional Loan”.

The Additional Loan bears an annual interest of 6% and shall be

repaid by December 31, 2025.

According to the Additional Loan agreement, we shall be entitled to instruct the Borrower that instead of

repaying the Additional Loan on the maturity date, the principal amount of the loan, as well as any accrued interest up to the date of

such notice, shall be deemed to constitute a loan amount provided by us, as part of the remaining portion of the Profit-Sharing Loan Agreement.

As of December 31, 2025, the Additional Loan had not been repaid.

The maturity date of the Additional Loan was subsequently extended to

June 30, 2026.

Upon completion of the Rabi

Binyamin Project, we are entitled to receive the Loan Principal and the greater of:

(i) 20% annual interest of the Loan Principal and

(ii) 40% of the Rabi Binyamin Project profits.

In January 2025, we entered

into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800,000 ($1,586,000).

transaction was structured as installments payments, and as of December 31, 2025, we had paid the full purchase price.

We intend to pursue

value-enhancing activities in connection with the land, with the goal of increasing its potential return upon future sale.

Ruby Sapphire II Investment

On December 31, 2025, we

entered into agreement and committed to invest NIS 7,000,000 (approximately $2,185,000) as a limited partner in Ruby Capital Investment

Fund Sapphire II, Limited Partnership or, the “Ruby Sapphire II”, an Israeli private investment fund.

Our commitment may

be drawn down over time in accordance with the fund’s partnership agreement, and the investment is subject to the risks inherent

in private investment funds, including illiquidity and the potential loss of invested capital.

As of March 26, 2026, we had funded NIS

1,556,493 (approximately $499,000) under this commitment.

Loan to Hapisga Project

On March 24, 2025, we entered into a loan agreement with Hapisga Project

– New Talpiot Ltd.

to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of up to $22,650,000 or, the

“Hapisga Loan”.

The loan has a one-year maturity, and a caveat was registered on the property reflecting a commitment to register

a first-ranking mortgage on the property which is valued at approximately NIS 3,000,000,000 (approximately $890,000,000), providing significant

collateral coverage.

The loan bears an annual interest rate of 12%.

and Development

We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes,

or T2D, with inadequate glycaemic control who were on two or three oral glucose-lowering agents.

The primary endpoint of the trial was

to evaluate the efficacy of our oral insulin capsule, ORMD-0801, compared to placebo in improving glycaemic control as assessed by HbA1c,

with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks.

On January 11, 2023, we

announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints.

Following the results of the ORA-D-013-1

Phase 3 trial, we also terminated the ORA-D-013-2 Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic

control who were attempting to manage their condition with either diet alone or with diet and metformin.

In 2023, we completed an analysis

of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as BMI,

baseline HbA1c and age, responded well to oral insulin.

These subsets exhibited an over 1% placebo adjusted, statistically significant,

reduction in HbA1c.

Based on this analysis, on September 12, 2024 we submitted a protocol for a revised Phase 3 (ORA-D-013-3) clinical

trial to the FDA.

We intend to initiate this study during 2025.

We are additionally examining our existing pipeline and have commenced

an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.

Venture Agreement :

As mentioned above, on February 7, 2025, we entered into JV Agreement with HTIT.

The collaboration combines our

POD technology with HTIT’s manufacturing capabilities, creating a synergy.

This integration of technology and manufacturing expertise

will enable us to ensure consistent, high-quality production at scale, setting new standards for oral protein delivery.

is backed by a substantial capital and operational commitment.

These resources support the initiation of a Phase 3 clinical trial in

As mentioned above, by leveraging insights from prior clinical studies, we have strategically designed this refined Phase 3

trial to focus on key patient subpopulations that we believe have the highest potential to demonstrate efficacy.

March 18, 2021, we entered into a license agreement with Oravax, a 63% owned joint venture to commercialize oral vaccines for COVID-19

and other novel coronaviruses based on Premas Biotech Pvt.

Ltd.’s proprietary vaccine technology involving a triple antigen virus

like particle.

October 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of a Phase 1 clinical trial, meeting primary or secondary

endpoints of safety and immunogenicity.

These results included significant antibody response (2-6 fold over baseline) as measured by

multiple markers of immune response to virus like particle vaccine antigens observed in the majority of the patients dosed, and no safety

issues were observed, including mild symptoms.

Cohort B completed dosing in January 2023.

Cohort B measured Immunoglobulin G, or IGG,

against the spike (S) protein, showing positive IGG in approximately 55% of the patients dosed.

We are currently evaluating our path

forward for Oravax’s oral vaccines for COVID-19.

of Current Events

On October 7, 2023, the State of Israel was attacked by Hamas, a group

designated as a terrorist organization by the United States, and the State of Israel subsequently declared war on Hamas.

Since that time,

Israel has been engaged in a multi-front armed conflict with combatants located in Gaza, the West Bank, Syria, Iran, Lebanon and Yemen.

The situation in the region remains volatile and the possibility of renewed conflicts persist.

As of March 27, 2025, we believe that there

is no immediate risk to our business operations related to these events.

For further information, see “Item 1A.

Risk Factors,”

under “We are affected by the political, economic and military risks of having operations in Israel.”

Estate Investments

On November 7, 2024, our Board of Directors, or the Board, approved

investments of up to $10,000,000 in real estate assets.

This decision aligns with our strategic approach to capital allocation, leveraging

opportunities in the current real estate market where we have identified attractive investment prospects.

With interest rates expected

to decline and valuations presenting favorable entry points, the Board believes these investments could provide long-term value appreciation

and potential income streams, further strengthening our financial position.

As we continues to evaluate our business strategy, including

potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value.

13, 2025, the Board approved increasing the real estate investments to up to $30,000,000.

Market Overview

is a disease in which the body does not produce or properly use insulin.

Insulin is a hormone that causes sugar to be absorbed into cells,

where the sugar is converted into energy needed for daily life.

The cause of diabetes is attributed both to genetics (type 1 diabetes,

or T1D) and, most often, to environmental factors such as obesity and lack of exercise (T2D).

According to the International Diabetes

Federation, or IDF, approximately 537 million adults (20-79 years) worldwide suffered from diabetes in 2021 and the IDF projects this

number will increase to 783 million by 2045.

According to the American Diabetes Association, or ADA, in 2023, the United States there

were approximately 37 million people with diabetes.

Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke and

Property and Patents

own a portfolio of patents and patent applications covering our technologies, and we are aggressively protecting these technology developments

on a worldwide basis.

maintain a proactive intellectual property strategy, which includes patent filings in multiple jurisdictions, including the United States

and other commercially significant markets.

We hold 26 patent applications currently pending, with respect to various compositions, methods

of production and oral administration of proteins and exenatide.

Expiration dates for pending patents, if granted, will fall between

2026 and 2039.

hold 140 patents, eight of which were issued during the year ended December 31, 2024, including patents issued by the United States,

Swiss, German, French, U.K., Italian, Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian,

Canadian, Hong Kong, Chinese, European and Indian patent offices that cover a part of our technology, which allows for the oral delivery

patents issued by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco,

Netherlands, Norwegian, Spanish, Swedish, Swiss, U.K., Israeli, New Zealand, South African, Russian, Brazilian and Japanese patent offices

that cover part of our technology for the oral delivery of exenatide;

and patents issued by the European, Austrian, Belgian, Denmark,

French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norway, Spanish, Swedish, Swiss, U.K.

and Japanese patent offices for

treating diabetes.

with our strategy to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding

foreign counterparts of such applications.

We believe that our success will depend on our ability to obtain patent protection for our

intellectual property.

patent strategy is as follows:

On the same date, we entered

into a loan agreement with Tova Chochma Im Nachala Ltd.

or, the “Tova Chochma” in the amount of $5,000,000.

The loan bears

an annual interest rate of 12% with a maturity date of 12 months.

In May 2025, Tova Chochma repaid an amount of $500,000.

can repay the loan at any time.

This loan is also secured by the registration of the caveat for Hapisga Loan.

The loans were granted

by us in April 2025.

Research and Development

Oral Insulin and Strategic

Review Process

Our proprietary flagship

product, an orally ingestible insulin capsule, or ORMD-0801, allows insulin to travel from the gastrointestinal tract via the portal

vein to the bloodstream, revolutionizing the manner in which insulin is delivered.

It enables the passage in a more physiological manner

than current delivery methods of insulin.

We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, with inadequate

glycaemic control who were on two or three oral glucose-lowering agents.

The primary endpoint of the trial was to evaluate the efficacy

of ORMD-0801, compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing

the change from baseline in fasting plasma glucose at 26 weeks.

On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial

did not meet its primary or secondary endpoints.

Following the January 2023

results, we initiated a strategic review process and conducted a comprehensive analysis of the data to understand if there is a path

forward for our oral insulin candidate.

Accordingly, we completed a subpopulation analysis that identified patient groups with specific

parameters (BMI, baseline HbA1c, and age) demonstrating an over 1% placebo-adjusted, statistically significant reduction in HbA1c.

on these findings, on September 12, 2024, we submitted a protocol to the FDA titled, “A Double-Blinded, Placebo-controlled, Double

Dummy Multi-Center Randomized, Phase 3 Study to Evaluate the efficacy and safety in subjects with Type 2 Diabetes Mellitus with Inadequate

Glycemic Control on One to Three Glucose-lowering Agents” or a revised Phase 3 trial (ORA-D-013-3).

We intend on initiating a 60-patient, US-based clinical trial designed

to validate the robustness of our oral insulin formulation in these high-responder populations.

The trial is designed to use the smallest

adequately powered patient population expected to obtain such validation in what we believe to be the shortest time possible, providing

a cost-effective approach to generate additional compelling evidence and refine our patient selection criteria for future potential regulatory

The trial will be conducted by OraTech.

For additional information, see note 21 to our consolidated financial statements

included in this Annual Report on Form 10-K.

Diabetes Market Overview

Diabetes is a disease in

which the body does not produce or properly use insulin.

Insulin is a hormone that causes sugar to be absorbed into cells, where the

sugar is converted into energy needed for daily life.

The cause of diabetes is attributed both to genetics (type 1 diabetes, or T1D)

and, most often, to environmental factors such as obesity and lack of exercise (T2D).

According to the International Diabetes Federation,

or IDF, approximately 589 million adults (20-79 years) worldwide suffered from diabetes in 2024 and the IDF projects this number will

increase to 853 million by 2050.

According to the American Diabetes Association or, the “ADA”, in 2024, the United States

there were approximately 38.5 million people with diabetes.

Diabetes is a leading cause of blindness, kidney failure, heart attack, stroke

and amputation.

Intellectual Property and Patents

We own a portfolio of patents

and patent applications covering our technologies, and we are aggressively protecting these technology developments on a worldwide basis.

We maintain a proactive intellectual

property strategy, which includes patent filings in multiple jurisdictions, including the United States and other commercially significant

We hold 21 patent applications currently pending, with respect to various compositions, methods of production and oral administration

of proteins and exenatide.

Expiration dates for pending patents, if granted, will fall between 2026 and 2039.

We hold 141 patents, one

of which issued during the year ended December 31, 2025, including patents issued by the United States, Swiss, German, French, U.K.,

Italian, Netherlands, Swedish, Spanish, Australian, Israeli, Japanese, New Zealand, South African, Russian, Canadian, Hong Kong, Chinese,

European and Indian patent offices that cover a part of our technology, which allows for the oral delivery of proteins;

patents issued

by the Australian, Canadian, European, Austrian, Belgian, French, German, Irish, Italian, Luxembourg, Monaco, Netherlands, Norwegian,

Spanish, Swedish, Swiss, U.K., Israeli, New Zealand, South African, Russian, Brazilian and Japanese patent offices that cover part of

our technology for the oral delivery of exenatide;

and patents issued by the European, Austrian, Belgian, Denmark, French, German, Irish,

Italian, Luxembourg, Monaco, Netherlands, Norway, Spanish, Swedish, Swiss, U.K.

and Japanese patent offices for treating diabetes.

Consistent with our strategy

to seek protection in key markets worldwide, we have been and will continue to pursue the patent applications and corresponding foreign

counterparts of such applications.

We believe that our success will depend on our ability to obtain patent protection for our intellectual

Our patent strategy is as

Aggressively protect all

5 unchanged sentences

coverage in the United States and in all relevant foreign markets in anticipation of future commercialization opportunities.

and Trade Secrets

have trademark applications pending in Israel, with Corresponding international trademark applications in Australia, Brazil, Canada,

China, Colombia, the European Union, India, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mexico, New Zealand, Norway, Oman, Philippines,

Russia, Singapore, Switzerland, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, U.S.A., Uzbekistan and Vietnam.

also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by confidentiality agreements.

Our policy is to

require our employees, consultants, contractors, manufacturers, outside scientific collaborators and sponsored researchers, our Board,

technical review board and other advisors, to execute confidentiality agreements upon the commencement of employment or consulting relationships

These agreements provide that all confidential information developed or made known to the individual during the course of the

individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances.

We also require signed confidentiality or material transfer agreements from any company that is to receive our confidential information.

In the case of employees, consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering

services to us shall be assigned to us as the exclusive property of the Company.

There can be no assurance, however, that all persons

who we desire to sign such agreements will sign, or if they do, that these agreements will not be breached, that we would have adequate

remedies for any breach, or that our trade secrets or unpatentable know-how will not otherwise become known or be independently developed

by competitors.

June 2010, our wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement with DNA GROUP (T.R.) Ltd.

(formerly D.N.A

Biomedical Solutions Ltd.), or DNA, for the establishment of Entera Bio Ltd., or Entera.

March 2011, Oramed Ltd.

sold shares of Entera to DNA, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera

in July 2018).

In consideration for the shares sold to DNA, the Company received, among other payments, ordinary shares of DNA (see also

note 3 to our audited consolidated financial statements).

part of this agreement, Oramed Ltd.

entered into a patent transfer agreement, or the Patent Transfer Agreement, according to which Oramed

assigned to Entera all of its rights to a patent application related to the oral administration of proteins that it has licensed

to Entera since August 2010, in return for royalties of 3% of Entera’s net revenues and a license back of that patent application

for use in respect of diabetes and influenza.

As of December 31, 2024, Entera had not paid any royalties to Oramed Ltd.

During the years

ended December 31, 2024 and 2023, we did not sell any of DNA’s ordinary shares.

As of December 31, 2024, we held approximately

1.4% of DNA’s outstanding ordinary shares and approximately 0.3% of Entera’s outstanding ordinary shares.

November 30, 2015, we entered into a Technology License Agreement, or TLA, with HTIT and on December 21, 2015, these parties entered

into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016,

or the HTIT License Agreement.

According to the HTIT License Agreement, we granted HTIT an exclusive commercialization license in the

territory of the People’s Republic of China, Macau and Hong Kong, related to our oral insulin capsule, ORMD-0801, or the Product.

Pursuant to the HTIT License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities

with respect to our technology and ORMD-0801 capsule, and will pay (i) royalties of 10% on net sales of the related commercialized products

to be sold by HTIT in the territory, or Royalties, and (ii) an aggregate of $37,500,000, of which $3,000,000 was payable immediately,

$8,000,000 will be paid subject to our entry into certain agreements with certain third parties, and $26,500,000 will be payable upon

achievement of certain milestones and conditions.

In the event that we will not meet certain conditions, the Royalties rate may be reduced

to a minimum of 8%.

Following the final expiration of our patents covering the technology in the territory in 2033, the Royalties rate

may be reduced, under certain circumstances, to 5%.

The royalty payment obligation shall apply during the period of time beginning upon

the first commercial sale of the Product in the territory, and ending upon the later of (i) the expiration of the last-to-expire licensed

patents in the territory;

and (ii) 15 years after the first commercial sale of the Product in the territory.

The HTIT License Agreement

shall remain in effect until the expiration of the royalty term.

The HTIT License Agreement contains customary termination provisions.

Through December 31, 2024, we received aggregate milestone payments of $20,500,000 out of the aggregate amount of $37,500,000.

August 21, 2020, we received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA.

to the terms of the JV Agreement, each of us, HTIT and HTIT Sub, irrevocably released and waived (i) any claims and demands against each

other party in connection with the TLA;

and (ii) all rights, obligations and liabilities set out and arising with respect to the performance

has submitted a Marketing Authorization Application to China’s regulators for the oral insulin capsule in China.

Since the TLA was novated

to OraTech, OraTech is expected to receive royalties from any future sales in China

March 18, 2021, we entered into a license agreement, or the Oravax License Agreement, with Oravax, a 63% owned joint venture to commercialize

oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt.

Ltd.’s proprietary vaccine technology involving

a triple antigen virus like particle, or the Oravax product.

consideration for the grant of the license under the Oravax License Agreement, we will receive (i) royalties equal to 7.5% on net sales,

as defined in the Oravax License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related

to the license during the term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based

consideration received by Oravax from a permitted sublicensee and (iii) other payments ranging between $25,000,000 to $100,000,000, based

on certain sales milestones being achieved by Oravax.

The parties further agreed to establish a development and steering committee, which

will consist of three members, of which two members will be appointed by us, that will oversee the ongoing research, development, clinical

and regulatory activity with respect to the Oravax product.

In addition, we agreed to buy and Oravax agreed to issue to us 1,890,000

shares of common stock of Oravax, representing 63% of the common stock of Oravax for the aggregate amount of $1,500,000.

Akers Biosciences

contributed $1,500,000 in cash to Oravax and a license agreement to the Oravax product.

November 13, 2022, we entered into a distribution license agreement with Medicox Co., Ltd., or Medicox, an emerging biotech company with

a consortium of proven partnerships in the Republic of Korea.

The agreement grants Medicox the exclusive license to apply for regulatory

approval and distribute ORMD-0801 for ten years in the Republic of Korea.

Medicox will comply with agreed distribution targets and will

purchase ORMD-0801 at an agreed upon transfer price per capsule.

In addition, Medicox will pay Oramed up to $15,000,000 in developmental

milestones, $2,000,000 of which were received by Oramed in 2022, and up to 15% royalties on gross sales.

Medicox will also be responsible

for gaining regulatory approval in the Republic of Korea.

This agreement was assigned to OraTech.

Drug Development Process

requirements for the approval of new drugs vary from one country to another.

In order to obtain approval to market our drug portfolio,

we need to go through a different regulatory process in each country in which we apply for such approval.

In some cases, information

gathered during the approval process in one country can be used as supporting information for the approval process in another country.

As a strategic decision, we decided to first explore the FDA regulatory pathway.

Trademarks and Trade Secrets

We have trademark applications

pending in Israel, with Corresponding international trademark applications in Australia, Brazil, Canada, China, Colombia, the European

Union, India, Indonesia, Japan, Kazakhstan, Korea, Malaysia, Mexico, New Zealand, Norway, Oman, Philippines, Russia, Singapore, Switzerland,

Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, U.S.A., Uzbekistan and Vietnam.

We also rely on trade secrets

and unpatentable know-how that we seek to protect, in part, by confidentiality agreements.

Our policy is to require our employees, consultants,

contractors, manufacturers, outside scientific collaborators and sponsored researchers, our Board, technical review board and other advisors,

to execute confidentiality agreements upon the commencement of employment or consulting relationships with us.

These agreements provide

that all confidential information developed or made known to the individual during the course of the individual’s relationship

with us is to be kept confidential and not disclosed to third parties except in specific limited circumstances.

We also require signed

confidentiality or material transfer agreements from any company that is to receive our confidential information.

In the case of employees,

consultants and contractors, the agreements provide that all inventions conceived by the individual while rendering services to us shall

be assigned to us as the exclusive property of us.

There can be no assurance, however, that all persons who we desire to sign such agreements

will sign, or if they do, that these agreements will not be breached, that we would have adequate remedies for any breach, or that our

trade secrets or unpatentable know-how will not otherwise become known or be independently developed by competitors.

Out-Licensed Technology

We entered into strategic

agreements with Lifeward pursuant to which we agreed to sell all of the outstanding equity interests of OraTech, effectively transferring

all intellectual property and related assets relating to our POD™ (Protein Oral Delivery) technology platform, together with associated

development activities for the oral insulin program.

In consideration, we will receive equity securities of Lifeward, including ordinary

shares and warrants, as well as potential revenue-sharing payments.

In addition, we will continue to support the development of the out-licensed

technology by providing clinical trial management and related services for the oral insulin capsule program.

In June 2010, our wholly-owned

subsidiary, Oramed Ltd., entered into a joint venture agreement with Israel Canada Hotels Ltd (formerly DNA GROUP (T.R.) Ltd.) or DNA,

for the establishment of Entera Bio Ltd., or Entera.

In March 2011, Oramed Ltd.

sold shares of Entera to DNA and retaining 117,000 ordinary shares (after giving effect to Entera’s July 2018 stock split), and,

as part of the consideration, received ordinary shares of DNA.

In connection with the joint venture, Oramed Ltd entered into a patent

transfer agreement pursuant to which it assigned to Entera its rights to a patent application related to the oral administration of proteins

(previously licensed to Entera since August 2010), in return for royalties of 3% of Entera’s net revenues and a license back of

diabetes and influenza indications.

As of December 31, 2025,

Entera had not paid any royalties to Oramed Ltd.

During the years ended December 31, 2025 and 2024, we did not sell any of DNA’s

ordinary shares.

As of December 31, 2025, we held approximately 0.2% of DNA’s outstanding ordinary shares and 0.3% of Entera’s

outstanding ordinary shares.

In 2015-2016, we entered

into an exclusive license agreement with HTIT, as amended or, the “HTIT License Agreement”, granting HTIT commercialization

rights to our oral insulin capsule, ORMD-0801, in the People’s Republic of China, Macau, and Hong Kong.

Under the agreement, HTIT

conducts pre-commercialization and regulatory activities at its own expense and pays us (i) royalties of 10% on net sales (subject to

reduction to 8% if certain conditions are not met, or 5% following patent expiration in 2033), and (ii) milestone payments totaling $37,500,000,

of which we have received $20,500,000.

The royalty payment obligation continues from first commercial sale until the later of (i) patent

expiration in the territory or (ii) 15 years after first commercial sale.

HTIT has submitted a Marketing

Authorization Application to China’s regulators for the oral insulin capsule in China.

Government Regulation

The Drug Development

Regulatory requirements for

the approval of new drugs vary from one country to another.

In order to obtain approval to market our drug portfolio, we need to go through

a different regulatory process in each country in which we apply for such approval.

In some cases, information gathered during the approval

process in one country can be used as supporting information for the approval process in another country.

As a strategic decision, we

decided to first explore the FDA regulatory pathway.

The following is a summary of the FDA’s requirements.

FDA requires that pharmaceutical and certain other therapeutic products undergo significant clinical experimentation and clinical testing

prior to their marketing or introduction to the general public.

Clinical testing, known as clinical trials or clinical studies, is either

conducted internally by life science, pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.

process of conducting clinical trials is highly regulated by the FDA, as well as by other governmental and professional bodies.

we describe the principal framework in which clinical trials are conducted, as well as describe a number of the parties involved in these

Before commencing human clinical trials, the sponsor of a new drug or therapeutic product must submit an IND application to the FDA.

The application contains, among other documents, what is known in the industry as a protocol.

A protocol is the blueprint for each drug

The protocol sets forth, among other things, the following:

The FDA requires that pharmaceutical

and certain other therapeutic products undergo significant clinical experimentation and clinical testing prior to their marketing or

introduction to the general public.

Clinical testing, known as clinical trials or clinical studies, is either conducted internally by

life science, pharmaceutical or biotechnology companies or is conducted on behalf of these companies by CROs.

The process of conducting

clinical trials is highly regulated by the FDA, as well as by other governmental and professional bodies.

Below we describe the principal

framework in which clinical trials are conducted, as well as describe a number of the parties involved in these trials.

Before commencing human clinical trials, the sponsor

of a new drug or therapeutic product must submit an IND application to the FDA.

The application contains, among other documents, what

is known in the industry as a protocol.

A protocol is the blueprint for each drug study.

The protocol sets forth, among other things,

the following:

Who must be recruited as

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or amount of the product to give to the participants.

Institutional

Review Board .

An institutional review board is an independent committee of professionals and lay persons which reviews clinical research

trials involving human beings and is required to adhere to guidelines issued by the FDA.

The institutional review board does not report

to the FDA, but its records are audited by the FDA.

Institutional Review Board .

An institutional review board is an independent committee of professionals and lay persons which reviews clinical research trials involving

human beings and is required to adhere to guidelines issued by the FDA.

The institutional review board does not report to the FDA, but

its records are audited by the FDA.

Its members are not appointed by the FDA.

All clinical trials must be approved by

an institutional review board.

The institutional review board’s role is to protect the rights of the participants in the clinical

It approves the protocols to be used, the advertisements which the company or CRO conducting the study proposes to use to recruit

participants, and the form of consent which the participants will be required to sign prior to their participation in the clinical trials.

Human clinical trials or testing of a potential product are generally done in three stages known as Phase 1 through Phase

The names of the phases are derived from the regulations of the FDA.

Generally, there are multiple trials conducted in each

Phase 1 trials involve testing a drug or product on a limited number of healthy or patient participants, typically 24 to 100 people

Phase 1 trials determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body.

This phase lasts an average of six months to a year.

Phase 2 trials involve testing of no more than 300 participants at a time who may suffer from the targeted disease or condition.

Phase 2 testing typically lasts an average of one to two years.

In Phase 2, the drug is tested to determine its safety and effectiveness

for treating a specific illness or condition.

All clinical trials must be approved by an institutional

review board.

The institutional review board’s role is to protect the rights of the participants in the clinical trials.

the protocols to be used, the advertisements which we or CRO conducting the study proposes to use to recruit participants, and the form

of consent which the participants will be required to sign prior to their participation in the clinical trials.

Clinical Trials .

clinical trials or testing of a potential product are generally done in three stages known as Phase 1 through Phase 3 testing.

of the phases are derived from the regulations of the FDA.

Generally, there are multiple trials conducted in each phase.

Phase 1 trials

involve testing a drug or product on a limited number of healthy or patient participants, typically 24 to 100 people at a time.

1 trials determine a product’s basic safety and how the product is absorbed by, and eliminated from, the body.

This phase lasts

an average of six months to a year.

trials involve testing of no more than 300 participants at a time who may suffer from the targeted disease or condition.

testing typically lasts an average of one to two years.

In Phase 2, the drug is tested to determine its safety and effectiveness for

treating a specific illness or condition.

Phase 2 testing also involves determining acceptable dosage levels of the drug.

trials may be split into Phase 2a and Phase 2b sub-trials.

Phase 2a trials may be conducted with patient volunteers and are exploratory

(non-pivotal) trials, typically designed to evaluate clinical efficacy or biological activity.

Phase 2b trials are conducted with patients

defined to evaluate definite dose range and evaluate efficacy.

If Phase 2 trials show that a new drug has an acceptable range of safety

risks and probable effectiveness, a company will generally continue to review the substance in Phase 3 trials.

Phase 3 trials involve testing large numbers of participants, typically several hundred to several thousand persons.

is to verify effectiveness and long-term safety on a large scale.

Phase 2a trials may be conducted with patient volunteers and are

exploratory (non-pivotal) trials, typically designed to evaluate clinical efficacy or biological activity.

Phase 2b trials are

conducted with patients defined to evaluate definite dose range and evaluate efficacy.

If Phase 2 trials show that a new drug has an

acceptable range of safety risks and probable effectiveness, a company will generally continue to review the substance in Phase 3

Phase 3 trials

involve testing large numbers of participants, typically several hundred to several thousand persons.

The purpose is to verify effectiveness

and long-term safety on a large scale.

These trials generally last two to three years.

Phase 3 trials are

conducted at multiple locations or sites.

Like the other phases, Phase 3 requires the site to keep detailed records of data collected

and procedures performed.

License Application .

The results of the clinical trials for a biological product are submitted to the FDA as part of a Biological

License Application, or BLA.

Following the completion of Phase 3 trials, assuming the sponsor of a potential product in the United States

believes it has sufficient information to support the safety and effectiveness of its product, the sponsor will generally submit a BLA

to the FDA requesting that the product be approved for marketing.

The application is a comprehensive, multi-volume filing that includes

the results of all clinical trials, information about the drug’s composition, and the sponsor’s plans for producing, packaging

Phase 3 trials are conducted at multiple locations

Like the other phases, Phase 3 requires the site to keep detailed records of data collected and procedures performed.

Biological License Application .

The results of the clinical trials for a biological product are submitted to the FDA as part of a Biological License Application or,

Following the completion of Phase 3 trials, assuming the sponsor of a potential product in the United States believes

it has sufficient information to support the safety and effectiveness of its product, the sponsor will generally submit a BLA to the

FDA requesting that the product be approved for marketing.

The application is a comprehensive, multi-volume filing that includes the

results of all clinical trials, information about the drug’s composition, and the sponsor’s plans for producing, packaging

and labeling the product.

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Approval of a BLA provides 12 years of exclusivity in the U.S.

The FDA may require that the sponsor conduct additional clinical trials following new drug approval.

The purpose of these trials,

known as Phase 4 trials, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness.

In recent years, the FDA has increased its reliance on these trials.

require that the sponsor conduct additional clinical trials following new drug approval.

The purpose of these trials, known as Phase

4 trials, is to monitor long-term risks and benefits, study different dosage levels or evaluate safety and effectiveness.

In recent years,

the FDA has increased its reliance on these trials.

Phase 4 trials usually involve thousands of participants.

4 trials also may be initiated by the company sponsoring the new drug to gain broader market value for an approved drug.

Similar to the U.S., a European sponsor of a biological product may submit a Marketing Approval Application to the European

Medicines Agency, or EMA, for the registration of the product.

The approval process in Europe consists of several stages, which together

are summed up to 210 days from the time of submission of the application (net, without periods in which the sponsor provides answers

to questions raised by the agency) following which, a Marketing Approval may be granted.

During the approval process, the sponsor’s

manufacturing facilities will be audited in order to assess Good Manufacturing Practice compliance.

drug approval process is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including

the severity of the illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical

federal, state and local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental

use of animals, the environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous

substances, including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our

Phase 4 trials also may

be initiated by us sponsoring the new drug to gain broader market value for an approved drug.

European Regulation .

the U.S., a European sponsor of a biological product may submit a Marketing Approval Application to the European Medicines Agency (“EMA”),

for the registration of the product.

The approval process in Europe consists of several stages, which together are summed up to 210 days

from the time of submission of the application (net, without periods in which the sponsor provides answers to questions raised by the

agency) following which, a Marketing Approval may be granted.

During the approval process, the sponsor’s manufacturing facilities

will be audited in order to assess Good Manufacturing Practice compliance.

The drug approval process

is time-consuming, involves substantial expenditures of resources, and depends upon a number of factors, including the severity of the

illness in question, the availability of alternative treatments, and the risks and benefits demonstrated in the clinical trials.

Other Regulations

Various federal, state and

local laws, regulations, and recommendations relating to safe working conditions, laboratory practices, the experimental use of animals,

the environment and the purchase, storage, movement, import, export, use, and disposal of hazardous or potentially hazardous substances,

including radioactive compounds and infectious disease agents, used in connection with our research are applicable to our activities.

They include, among others, the U.S.

Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and

Health Act, the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national

restrictions on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or

federal regulation.

The compliance with these and other laws, regulations and recommendations can be time-consuming and involve substantial

In addition, the extent of governmental regulation which might result from future legislation or administrative action cannot

be accurately predicted and may have a material adverse effect on our business, financial condition, results of operations and prospects.

in the area of biomedical and pharmaceutical research and development is intense and significantly depends on scientific and technological

These factors include the availability of patent and other protection for technology and products, the ability to commercialize

technological developments and the ability to obtain regulatory approval for testing, manufacturing and marketing.

Our competitors include

major pharmaceutical, medical products, chemical and specialized biotechnology companies, many of which have financial, technical and

marketing resources significantly greater than ours.

In addition, many biotechnology companies have formed collaborations with large,

established companies to support research, development and commercialization of products that may be competitive with ours.

institutions, governmental agencies and other public and private research organizations are also conducting research activities and seeking

patent protection and may commercialize products on their own or through joint ventures.

We are aware of certain other products manufactured

or under development by competitors that are used for the treatment of the diseases and health conditions that we have targeted for product

We can provide no assurance that developments by others will not render our technology obsolete or noncompetitive, that

we will be able to keep pace with new technological developments or that our technology will be able to supplant established products

and methodologies in the therapeutic areas that are targeted by us.

The foregoing factors could have a material adverse effect on our

business, prospects, financial condition and results of operations.

These companies, as well as academic institutions, governmental agencies

and private research organizations, also compete with us in recruiting and retaining highly qualified scientific personnel and consultants.

within our sector is increasing, so we will encounter competition from existing firms that offer competitive solutions in diabetes treatment

These competitive companies could develop products that are superior to, or have greater market acceptance, than the products

being developed by us.

We will have to compete against other biotechnology and pharmaceutical companies with greater market recognition

and greater financial, marketing and other resources.

competition will be determined in part by the potential indications for which our technology is developed and ultimately approved by

regulatory authorities.

In addition, the first product to reach the market in a therapeutic or preventive area is often at a significant

competitive advantage relative to later entrants to the market.

Accordingly, the relative speed with which we, or our potential corporate

partners, can develop products, complete the clinical trials and approval processes and supply commercial quantities of the products

to the market are expected to be important competitive factors.

Our competitive position will also depend on our ability to attract and

retain qualified scientific and other personnel, develop effective proprietary products, develop and implement production and marketing

plans, obtain and maintain patent protection and secure adequate capital resources.

We expect our technology, if approved for sale, to

compete primarily on the basis of product efficacy, safety, patient convenience, reliability, value and patent position.

anticipated that our oral insulin capsule would be a competitive diabetes drug because of its anticipated efficacy and safety profile;

however, there are other treatment options for T1D and T2D patients, such as insulin injections, insulin pumps or a combination of diet,

exercise and oral medication which improve the body’s response to insulin or cause the body to produce more insulin.

Advisory Board

maintain a Scientific Advisory Board consisting of internationally recognized scientists who advise us on scientific and technical aspects

of our business.

The Scientific Advisory Board meets to review specific projects and to assess the value of new technologies

and developments to us.

In addition, individual members of the Scientific Advisory Board meet with us to provide advice

in their particular areas of expertise.

The Scientific Advisory Board consists of the following members, information with respect to

whom is set forth below:

Roy Eldor, Professor Ele Ferrannini, Dr.

Alexander Fleming, Professor Avram Hershko, Dr.

Julio Rosenstock,

Jay Skyler and Dr.

Roy Eldor , MD, PhD , joined the Oramed Scientific Advisory Board in July 2016.

He is an endocrinologist, internist and

researcher with over twenty years of clinical and scientific experience.

He is currently Director of the Diabetes Unit at the Institute

of Endocrinology, Metabolism & Hypertension at the Tel-Aviv Sourasky Medical Center.

Prior to that, Dr.

Eldor served as Principal

Scientist at Merck Research Laboratories, Clinical Research – Diabetes & Endocrinology.

He previously served as a senior physician

in internal medicine at the Diabetes Unit in Hadassah Hebrew University Hospital in Jerusalem, Israel;

and the Diabetes Division at the

University of Texas Health Science Center in San Antonio, Texas.

Eldor is a recognized expert, with over 50 peer reviewed papers

and book chapters, and has been a guest speaker at numerous international forums.

Ele Ferrannini , MD , joined the Oramed Scientific Advisory Board in February 2007.

He is a past President to the European

Association for the Study of Diabetes (EASD), which supports scientists, physicians and students from all over the world who are interested

in diabetes and related subjects in Europe and performs functions similar to that of the American Diabetes Association in the United

Professor Ferrannini has worked with various institutions including the Department of Clinical & Experimental Medicine at

the University of Pisa School of Medicine, and CNR (National Research Council) Institute of Clinical Physiology in Pisa, Italy;

Diabetes Division, Department of Medicine at the University of Texas Health Science Center in San Antonio, Texas.

He has extensive training

in internal medicine and endocrinology, and has specialized in diabetes trials.

Professor Ferrannini has received a Certificate of the

Educational Council for Foreign Medical Graduates from the University of Bologna, and completed a subspecialty in Diabetes and Metabolic

Diseases at the University of Torino, cum laude .

He has published over 500 original papers and 50 book chapters and he is a “highly

cited researcher,” according to the Institute for Scientific Information.

Alexander Fleming, MD , joined the Oramed Scientific Advisory Board in December 2019.

Fleming, an endocrinologist, is Founder

and Executive Chairman of Kinexum, a strategic advisory firm.

From 1986 to 1998, he served at the FDA as a supervisory medical officer

in the Division of Metabolism and Endocrine Drug Products and was responsible for landmark approvals of the first statin, metformin,

and other endocrine and metabolic therapies.

He also represented the FDA at the World Health Organization and on multiple expert working

groups of the International Conference on Harmonization (ICH).

Fleming coined the term, Metabesity, which refers to the constellation

of major chronic diseases and the aging process itself, all which share common metabolic root causes and potential preventive therapies.

He organized the first Congress on Metabesity in London in October 2017, followed by annual conferences.

Fleming founded

the non-profit Kitalys Institute as a means of producing Metabesity conferences and advancing interventions of any kind that can improve

health and healthspan.

Avram Hershko, MD, PhD , joined the Oramed Scientific Advisory Board in July 2008.

Professor Hershko served as a physician in

the Israel Defense Forces from 1965 to 1967.

After a post-doctoral fellowship with Gordon Tomkins at the University of San Francisco

from 1969 to 1972, he joined the faculty of the Haifa Technion becoming a professor in 1980.

He is now Distinguished Professor in the

Unit of Biochemistry in the B.

Rappaport Faculty of Medicine of the Technion in Haifa, Israel.

Professor Hershko’s main research

interests concern the mechanisms by which cellular proteins are degraded, a formerly neglected field of study.

Professor Hershko and

his colleagues showed that cellular proteins are degraded by a highly selective proteolytic system.

This system tags proteins for destruction

by linkage to a protein called ubiquitin, which had previously been identified in many tissues, but whose function was previously unknown.

Subsequent work by Professor Hershko and many other laboratories has shown that the ubiquitin system has a vital role in controlling

a wide range of cellular processes, such as the regulation of cell division, signal transduction and DNA repair.

Professor Hershko was

awarded the Nobel Prize in Chemistry in 2004, jointly with his former PhD student Aaron Ciechanover and their colleague Irwin Rose.

many honors include the Israel Prize for Biochemistry (1994), the Gairdner Award (1999), the Lasker Prize for Basic Medical Research

(2000), the Wolf Prize for Medicine (2001) and the Louisa Gross Horwitz Award (2001).

Professor Hershko is a member of the Israel Academy

of Sciences since 2000 and a Foreign Associate of the U.S.

Academy of Sciences since 2003.

Julio Rosenstock, MD , joined the Oramed Scientific Advisory Board in January 2020.

Rosenstock is the Senior Scientific Advisor

and Director of Velocity Clinical Research at Medical City, Dallas, Texas, and a Clinical Professor of Medicine at the University of

Texas Southwestern Medical Center in Dallas, Texas.

He is board certified in Internal Medicine, Endocrinology and Metabolism.

and research activities have focused on exploring novel agents and therapeutic strategies to improve glycemic control, particularly early

combination therapies in Type 2 Diabetes.

Over the last 30 years, he has participated in hundreds of clinical trials and has had an active

role in the development of new oral agents, incretin-related therapies and insulin formulations, often acting as a lead clinical investigator

and scientific advisor on the design and reporting of these clinical trials.

Rosenstock has been the author or co-author of 386 peer-reviewed

manuscripts ( H-index 124 ) and several hundreds of scientific abstracts and he is considered a key opinion leader in Type 2 Diabetes.

He has also contributed to 13 book chapters on various topics in the field of diabetes and is considered a key opinion leader in Type

Jay Skyler, MD, MCAP, FRCP , joined the Oramed Scientific Advisory Board in January 2020.

Skyler is Professor of Medicine,

Pediatrics and Psychology in the Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Miami Leonard

Miller School of Medicine.

He previously held the position of Director of the Division of Endocrinology, Diabetes and Metabolism.

In addition, Dr.

Skyler is Deputy Director of Clinical Research and Academic Programs at the Diabetes Research Institute, and an Adjunct

Professor of Pediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado in Denver.

research focuses on the clinical aspects of diabetes, specifically the conduct of randomized controlled clinical trials.

2015, he was Chairman of the National Institute of Health (NIDDK)-sponsored Diabetes Prevention Trial–- Type 1 (DPT-1) and its

successor Type 1 Diabetes Trial Net, a nationwide and global network conducting clinical trials to prevent T1D.

Anne Peters, MD , joined the Oramed Scientific Advisory Board in June 2022.

Peters is Professor of Medicine at the Keck School

of Medicine of the University of Southern California (USC) and Director of the USC Clinical Diabetes Programs.

Peters earned her

medical degree from the Pritzker School of Medicine at the University of Chicago and performed an internal medicine residency at Stanford

University and an endocrinology fellowship at Cedars-Sinai Medical Center.

She previously directed the clinical diabetes programs at

Cedars-Sinai Medical Center and UCLA in California.

Her research has focused on testing new approaches for diagnosing and treating diabetes

and developing systems of care to improve outcomes in diabetic under-resourced populations.

Peters has consulted for many

entities, including the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health to help guide the development

and use of treatments for diabetes.

In addition to being an investigator for more than 40 research studies, Dr.

Peters has published

over 200 articles, has written four books, and has given more than 500 lectures locally, nationally, and internationally.

been on multiple guideline writing committees for the treatment of both type 1 and type 2 diabetes.

She was a recipient of the ADA Outstanding

Physician Clinician Award, the Bernardo Houssay Award from the National Minority Quality Forum and received an Endocrine Society Laureate

Award for Public Service.

believe it is imperative to attract and retain top talent for all positions in the Company.

We seek to make Oramed an inclusive, diverse

and safe workplace, with meaningful compensation, benefits and wellness programs and opportunities.

have experienced personnel involved in our research and development programs, as well as appropriate clinical/regulatory, quality assurance

and other personnel needed to advance through clinical trials or have engaged the services of experts in the field for these requirements.

As of December 31, 2024, we have contracted with thirteen individuals for employment or consulting arrangements.

Of our staff, four are

senior management, three are engaged in research and development work, and the remaining six are involved in corporate and administration

provide competitive compensation, health and retirement programs for our employees.

We offer variable pay in the form of bonuses and

stock-based compensation for eligible employees.

We also provide our employees with additional benefits such as team-building and educational

offsite activities and gym facilities.

We believe that this provides a comprehensive package to engage, motivate and retain our employees

as a cohesive unit unified in its goal to achieve the Company’s strategy and objectives.

information about us is contained on our Internet website at www.oramed.com.

Information on our website is not incorporated by reference

into this report.

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those

reports filed or furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available

free of charge on our website under “SEC Filings” as soon as reasonably practicable after we electronically file such material

with, or furnish it to, the SEC.

Reports filed with the SEC are made available on its website at www.sec.gov and are also available on

the website of the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the Tel Aviv Stock Exchange at www.tase.co.il.

The following corporate governance documents are also posted on our website:

Code of Ethics, Whistleblowing Policy and the charters for

each of the Audit Committee, Compensation Committee and Nominating Committee of our Board.

Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Occupational Safety and Health Act,

the National Environmental Policy Act, the Toxic Substances Control Act, and Resources Conservation and Recovery Act, national restrictions

on technology transfer, import, export, and customs regulations, and other present and possible future local, state, or federal regulation.

The compliance with these and other laws, regulations and recommendations can be time-consuming and involve substantial costs.

the extent of governmental regulation which might result from future legislation or administrative action cannot be accurately predicted

and may have a material adverse effect on our business, financial condition, results of operations and prospects.

We face intense competition in pharmaceutical

research and development from major pharmaceutical companies, specialized biotechnology firms, academic institutions, and governmental

agencies—many with substantially greater financial, technical, and marketing resources.

Competition is determined by scientific

and technological capabilities, patent protection, speed to market, regulatory approval, and ability to commercialize products.

entities also compete with us for qualified scientific personnel and consultants.

In the diabetes treatment sector specifically,

we compete against well-established and rapidly evolving therapeutic options including insulin injections, insulin pumps, oral medications

that improve insulin response or production, and the increasingly dominant GLP-1 receptor agonists (both injectable and oral formulations),

as well as lifestyle interventions.

The widespread adoption of GLP-1s for diabetes and weight management represents significant competitive

First-to-market products typically hold significant competitive advantages.

Our competitive position depends on our ability

to attract talent, develop effective proprietary products, obtain patent protection, and secure adequate capital.

If approved, we expect

our oral insulin capsule to compete primarily on efficacy, safety, patient convenience, and patent position.

Competitors may develop superior

products or achieve greater market acceptance.

There can be no assurance that our technology will not be rendered obsolete or noncompetitive,

or that we can keep pace with technological developments, any of which could materially adversely affect our business, prospects, financial

condition, and results of operations.

We believe it is imperative

to attract and retain top talent for all positions in the Company.

We seek to make Oramed an inclusive, diverse and safe workplace, with

meaningful compensation, benefits and wellness programs and opportunities.

We have experienced personnel

involved in our research and development programs, as well as appropriate clinical/regulatory, quality assurance and other personnel

needed to advance through clinical trials or have engaged the services of experts in the field for these requirements.

As of December

31, 2025, we have contracted with thirteen individuals for employment or consulting arrangements.

Of our staff, four are senior management,

three are engaged in research and development work, and the remaining six are involved in corporate and administration work.

We provide competitive compensation,

health and retirement programs for our employees.

We offer variable pay in the form of bonuses and stock-based compensation for eligible

We also provide our employees with additional benefits such as team-building and educational offsite activities and gym facilities.

We believe that this provides a comprehensive package to engage, motivate and retain our employees as a cohesive unit unified in its

goal to achieve the Company’s strategy and objectives.

Additional Information

Additional information about

us is contained on our Internet website at www.oramed.com.

Information on our website is not incorporated by reference into this report.

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and amendments to those reports filed or

furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, are available free of charge

on our website under “SEC Filings” as soon as reasonably practicable after we electronically file such material with, or

furnish it to, the SEC.

Reports filed with the SEC are made available on its website at www.sec.gov and are also available on the website

of the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the Tel Aviv Stock Exchange at www.tase.co.il.

The following

corporate governance documents are also posted on our website:

Code of Ethics, Whistleblowing Policy and the charters for each of the

Audit Committee, Compensation Committee and Nominating Committee of our Board.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business