What changed in this filing

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Item 1. Business

2025-03-27 compared with 2024-03-06 · 287 added, 277 removed, 383 unchanged (60% of the section changed)

5 unchanged sentences

the dosage form is designed to be safe to ingest.

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

As a result, we terminated

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

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

3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass index, or BMI, baseline HbA1c and

age, responded well to oral insulin.

Based on this analysis, we are working on a protocol for a new Phase 3 clinical trial to be submitted

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.

August 7, 2023, we entered into a Stock Purchase Agreement, as subsequently amended on August 9, 2023 and August 21, 2023, or the Sorrento

SPA, with Sorrento Therapeutics, Inc., or Sorrento, to acquire certain equity securities of Scilex owned by Sorrento, or the Purchased

Securities, for a purchase price of $105 million.

Sorrento and its affiliated debtor, Scintilla Pharmaceuticals, Inc., or Scintilla and

together with Sorrento, the Debtors, are in Chapter 11 bankruptcy proceedings.

August 9, 2023, we entered into a Senior Secured, Super-Priority Debtor-in-Possession Loan and Security Agreement, or the Senior DIP

Loan Agreement, with the Debtors in the principal amount of $100 million, which included a non-refundable closing fee of $450,000 paid

in full out of the proceeds.

This amount was subsequently drawn in full by the Debtors and was intended to be used by us as a credit

for the consideration for the Purchased Securities, with an additional $5,000,000 in cash to be paid by us at closing.

Thereafter, we

and Sorrento continued discussions and negotiations relating to the sale contemplated under the Sorrento SPA.

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

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

September 21, 2023, or the Closing Date, we entered into and consummated the transactions, or, collectively, the Transaction, contemplated

by a Securities Purchase Agreement, or the Scilex SPA, with Scilex and Acquiom Agency Services LLC.

Pursuant to the Scilex SPA, in exchange

for Scilex assuming Sorrento’s outstanding obligations under the Senior DIP Loan Agreement, or the DIP Assumption, and for the

ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento,

Scilex (i) issued to us (A) a Senior Secured Promissory Note due 18 months from the date of issuance in the principal amount of $101,875,000,

or the Note, which includes accrued and unpaid interest of $875,000 under the Senior DIP Loan Agreement and $1,000,000 of fees added

to the principal amount of the Note, (B) a warrant to purchase up to an aggregate of 4,500,000 shares of common stock of Scilex, par

value $0.0001 per share, or the Scilex Common Stock, and containing certain restrictions on exercisability, or the Closing Penny Warrant,

and (C) warrants to purchase up to an aggregate of 8,500,000 shares of Scilex Common Stock, or the Subsequent Penny Warrants, and, together

with the Closing Penny Warrant, the Penny Warrants, each with an exercise price of $0.01 per share and each with certain restrictions

on exercisability, and (ii) caused certain outstanding warrants to purchase up to an aggregate of 4,000,000 shares of Scilex Common Stock

with an exercise price of $11.50 per share to be transferred to us, or the Transferred Warrants and together with the Penny Warrants,

the Warrants.

In addition, on the Closing Date, Scilex reimbursed $1,910,000 of the Company’s Transaction expenses pursuant to

the Scilex SPA.

to the terms of the Scilex SPA, Scilex agreed to certain restrictions on additional issuances of equity securities.

In connection with

the Transaction, we and Sorrento mutually agreed to terminate the Sorrento SPA and to release all claims we and Sorrento may have against

one another, and Scilex completed the acquisition of the Purchased Securities.

Secured Promissory Note

Note matures on March 21, 2025 or upon an uncured event of default, subject to certain mandatory prepayments, and bears interest at a

rate per annum equal to Term SOFR (as defined in the Note) plus 8.5% (subject to a Term SOFR floor of 4.0%), to be paid in-kind, by being

capitalized and added to the principal amount of the Note on a monthly basis.

The Scilex SPA provides for principal payments of (i) $5

million on December 21, 2023, (ii) $15 million on March 21, 2024, and (iii) $20 million on each of June 21, 2024, September 21, 2024,

and December 21, 2024, and for the entire remaining principal balance of the Note to be paid on March 21, 2025.

If the Note is not repaid

in full on or prior to March 21, 2024, an exit fee equal to $3,056,250 shall be payable upon repayment of the Note in full.

Note constitutes senior secured indebtedness of Scilex and is guaranteed by all existing or future formed, direct and indirect, domestic

subsidiaries of Scilex and is secured by a first priority security interest in and liens on all of the assets of Scilex, subject to customary

and mutually agreed permitted liens and except for certain specified exemptions.

prepayments under the Note are required following the earlier of (a) April 1, 2024 and (b) the date upon which certain of Scilex’s

outstanding indebtedness is repaid in full.

Voluntary prepayments may be made at Scilex’s discretion;

provided that, if made prior

to the one-year anniversary of the Closing Date, Scilex will also be required to pay a customary 50% interest make-whole on the portion

of the Note so prepaid.

Note includes customary events of default, upon which the Note will bear interest at a default rate of Term SOFR plus 15.0%, which shall

be payable in-kind, by being capitalized and added to the principal amount of the Note on a monthly basis.

If the Note is accelerated

upon an event of default, Scilex is required to repay the principal amount of the Note at a mandatory default rate of 125% of such principal

amount (together with 100% of accrued and unpaid interest thereon and all other amounts due in respect of the Note).

the obligations under the Note are repaid in full, we have the right to designate one non-voting observer, to attend meetings of the

board of directors and committees of Scilex and its subsidiaries.

Currently, David Silberman, our Chief Financial Officer, is the observer.

to the terms of the Scilex SPA, we received the first principal payment of $5 million on December 21, 2023.

The next principal payment

in the amount of $15 million is expected to be paid on March 21, 2024.

Closing Penny Warrant will be exercisable upon the earliest of (i) March 14, 2025, (ii) the date on which the Note has been repaid in

full and (iii) the Management Sale Trigger Date (as defined therein), if any, and will expire on the date that is the fifth anniversary

of the issuance date.

For purposes of the Closing Penny Warrant (as well as the Subsequent Penny Warrants), the Management Sale Trigger

Date is generally the first date that either Dr.

Henry Ji, Scilex’s Executive Chairperson, or Mr.

Jaisim Shah, Scilex’s Chief

Executive Officer and President and a member of Scilex’s Board of Directors, engages in certain sales or other similar transfers

of shares of Scilex Common Stock or other of Scilex’s or any of its subsidiaries’ securities, subject to certain exceptions

as are customary for lock-up agreements executed by directors and officers in connection with financings or similar transactions.

exercise price of the Closing Penny Warrant is $0.01 per share, subject to adjustment.

were issued four Subsequent Penny Warrants, each for 2,125,000 shares of Scilex Common Stock, which shall vest and become exercisable

on the date that is the later of (i) March 19, 2024, June 17, 2024, September 15, 2024 or December 14, 2024, respectively, or the Subsequent

Penny Warrant Vesting Date, and (ii) the earliest of (A) March 14, 2025, (B) the date on which the Note has been repaid in full and (C)

the Management Sale Trigger Date (as defined therein), if any.

Each Subsequent Penny Warrant will expire on the date that is the fifth

anniversary of the issuance date;

provided that, if the Note is repaid in full prior to the Subsequent Penny Warrant Vesting Date applicable

to such Subsequent Penny Warrant, such Subsequent Penny Warrant will expire on the date the Note is repaid in full.

We may exercise the

Penny Warrants by means of a “cashless exercise.”

Penny Warrants may not be exercised if we, together with our affiliates, would beneficially own in excess of 9.9% of the number of shares

of Scilex Common Stock outstanding immediately after giving effect to such exercise;

provided, that we may increase or decrease such

limitation upon 61 days’ prior notice to Scilex.

Transferred Warrants are listed on the Nasdaq Capital Market, or Nasdaq, have an exercise price of $11.50 per share, are fully exercisable,

and expire on November 10, 2027.

Rights Agreement

connection with the Scilex SPA, on September 21, 2023, we entered into a registration rights agreement with Scilex, pursuant to which

Scilex granted us certain registration rights applicable to the resale of the shares underlying the Warrants and agreed to pay liquidated

damages equal to the product of 2.0% multiplied by the sum of (x) the aggregate principal amount outstanding under the Note and (y) the

aggregate Exercise Price (as defined in the Closing Penny Warrant) of the Closing (capped at 12%) of the aggregate subscription amount.

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.

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.

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,

we are working on a protocol for a new Phase 3 clinical trial to be submitted to the FDA.

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 :

On January 22, 2024, Oramed and its wholly-owned subsidiary, Oramed Ltd., entered into a Joint Venture Agreement,

or the JV Agreement, with HTIT Biotech and Technowl Limited, a wholly-owned indirect subsidiary of HTIT Biotech, or HTIT Sub, and together

with HTIT Biotech, HTIT, pursuant to which, subject to the terms and conditions set forth in the JV Agreement, the parties will establish

a joint venture, or the JV, based on Oramed’s oral drug delivery technology.

JV will focus on the development and worldwide commercialization of innovative products based on Oramed’s oral insulin and POD™

(Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies.

The parties intend for the JV to use the

protocol we are currently working on to initiate a Phase 3 oral insulin trial in the United States.

and HTIT will initially hold equal shares in the JV, with each owning 50% of the equity.

The board of directors will initially consist

of equal representation from HTIT and Oramed.

HTIT will contribute to the JV $70 million in cash, while Oramed will contribute $20 million

(comprised of $10 million in cash and $10 million in shares of Oramed common stock that will be subject to certain registration rights)

and will transfer intellectual property related to its oral insulin and POD™ technology, as well as other assets in the Oramed

HTIT will have an option to invest additional funds into the JV up to an aggregate amount of $20 million, thereby increasing

its equity holdings and board representation.

Oramed will be entitled to receive a 3% royalty on gross revenues of the JV generated from

Oramed related assets.

consummation of the JV Agreement is subject to and contingent upon the parties entering into additional agreements within a three-month

period, including an asset transfer agreement for the transfer of Oramed’s intellectual property to the JV, a commercial supply

agreement for the manufacture and supply of products by HTIT to the JV, as well as other documents and agreements to regulate the relationship

of the parties and the JV to be formed pursuant to the JV Agreement.

There is no assurance that the parties will complete and sign these

additional agreements within the agreed timeline or at all.

If such agreements are not signed within the agreed timeframe, then either

party may apply a 30-day extension, after which the JV Agreement may be terminated and voided by either party.

Thereafter, the consummation

of the JV transaction is further subject to the satisfaction or waiver of certain other closing conditions within a three-month period

following the completion of the aforesaid ancillary agreements.

If the closing conditions are not met within the agreed timeframe, then

either party may apply a 30-day extension, after which the JV Agreement may be terminated and voided by either party.

In addition, completion

of the transactions contemplated under the JV Agreement is subject to the satisfaction or waiver of customary and certain other closing

On September 13, 2022, we reported positive top line results from a double blind, placebo controlled clinical trial of ORMD-0801 for

the treatment of non-alcoholic steatohepatitis, or NASH, in T2D, demonstrating that ORMD-0801 was safe and well tolerated at 8 mg twice

daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo.

The trial also evaluated

the effectiveness of ORMD-0801 in reducing liver fat content over the 12-week treatment period by observing several independent measures.

All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801.

We are currently evaluating our path forward

for ORMD-0801 for NASH.

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.

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

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

Acquisition and License

December 2023, we executed and completed an agreement with PeriTech Pharma Ltd., or PeriTech, acquiring the rights to their film-forming

technology tailored for the delivery of topical/dermatology agents.

This includes a once-daily over-the-counter treatment for hemorrhoids.

The PeriTech pipeline extends its potential applications to include indications such as pruritus ani, anal warts, anal fissures and herpes

have entered into an exclusive licensing agreement with Genomma Lab Internacional S.A.B.

de C.V, or Genomma Labs, pursuant to which we

granted Genomma Labs the development and commercialization rights to the PeriTech pipeline, in exchange for a royalty based on net sales.

of Current Events

October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas.

Israel has been in an ongoing

state of war with Hamas since that time.

Following the attack by Hamas, Hezbollah has also launched attacks against Israel and Israel

has been responding to these attacks with targeted air strikes.

It is possible that other terrorist organizations, including Palestinian

military organizations in the West Bank, as well as other hostile countries, such as Iran, will join the hostilities.

As of March 6,

2024, we believe that there is no immediate risk to our business operations related to these events.

For further information, see “Item

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

oral insulin capsule for clinical trials was manufactured by Fidelio Healthcare, a diversified European Contract Development and Manufacturing

Organization (CDMO) in the pharmaceutical and healthcare industries.

July 2010, Oramed Ltd.

entered into the Manufacturing and Supply Agreement with Sanofi-Aventis Deutschland GMBH, or Sanofi-Aventis.

to the agreement, Sanofi-Aventis supplies Oramed Ltd.

with specified quantities of recombinant human insulin to be used for clinical

have purchased, pursuant to separate agreements with third parties, the raw materials required for the manufacturing of our oral capsule.

We generally depend upon a limited number of suppliers for the raw materials.

Although alternative sources of supply for these materials

are generally available, we could incur significant costs and disruptions if we need to change suppliers.

The termination of our relationships

with our suppliers or the failure of these suppliers to meet our requirements for raw materials on a timely and cost-effective basis

could have a material adverse effect on our business, prospects, financial condition and results of operations.

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.

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According to the International Diabetes

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

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.

Also, according to the IDF, in 2021, an estimated 6.7 million people died from diabetes.

According to the American Diabetes Association, or ADA, in the United States there were approximately 37.3 million people with diabetes,

or 11.3% of the United States population in 2019.

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

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2026 and 2039.

hold 117 patents, eight of which were issued during the fiscal year ended December 31, 2023, including patents issued by the United States,

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,

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patent strategy is as follows:

● Aggressively

protect all current and future technological developments to assure strong and broad protection

by filing patents and/or continuations in part as appropriate,

technological developments at various levels, in a complementary manner, including the base

technology, as well as specific applications of the technology, and

comprehensive coverage in the United States and in all relevant foreign markets in anticipation

of future commercialization opportunities.

Aggressively protect all

current and future technological developments to assure strong and broad protection by filing patents and/or continuations in part

as appropriate,

Protect technological developments

at various levels, in a complementary manner, including the base technology, as well as specific applications of the technology,

Establish comprehensive

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

and Trade Secrets

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Our policy is to

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

Directors, or our Board, technical review board and other advisors, to execute confidentiality agreements upon the commencement of employment

or consulting relationships with us.

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

during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except

in specific limited circumstances.

We also require signed confidentiality or material transfer agreements from any company that is to

receive our confidential information.

In the case of employees, consultants and contractors, the agreements provide that all inventions

conceived by the individual while rendering services to us shall be assigned to us as the exclusive property of the Company.

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.

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.

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

On December 11,

2018, Entera announced that it had entered into a research collaboration and license agreement with Amgen, Inc., or Amgen.

To the extent

that the license granted to Amgen results in net revenues as defined in the Patent Transfer Agreement, Oramed Ltd.

will be entitled to

the aforementioned royalties.

During the years ended December 31, 2023 and 2022, we did not sell any of DNA’s ordinary shares.

As of December 31, 2023, we held approximately 1.4% of DNA’s outstanding ordinary shares and approximately 0.4% of Entera’s

outstanding ordinary shares.

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

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

to be sold by HTIT in the territory, or Royalties, and (ii) an aggregate of $37.5 million, of which $3 million was payable immediately,

$8 million will be paid subject to our entry into certain agreements with certain third parties, and $26.5 million will be payable upon

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.

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The HTIT License Agreement contains customary termination provisions.

Through December 31, 2023, we received aggregate milestone payments of $20.5 million out of the aggregate amount of $37.5 million.

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.

We wholly disputed

said claims and are planning to resolve any such claims as part of our discussions with HTIT.

“—Research and Development” above regarding the JV Agreement we signed with HTIT to establish the JV, based on Oramed’s

oral drug delivery technology.

The proposed JV will focus on the development and worldwide commercialization of innovative products based

on Oramed’s oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies.

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,

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

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

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.

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

shares of common stock of Oravax, representing 63% of the common stock of Oravax for the aggregate amount of $1.5 million.

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 $1.5 million in cash to Oravax and a license agreement to the Oravax product.

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

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

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

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

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

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

must be recruited as qualified participants,

often to administer the drug or product,

tests to perform on the participants, and

dosage of the drug or amount of the product to give to the participants.

Who must be recruited as

qualified participants,

How often to administer

the drug or product,

What tests to perform on

the participants, and

What dosage of the drug

or amount of the product to give to the participants.

Institutional

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of our business.

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

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 periodically to provide advice

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

in their particular areas of expertise.

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Alexander Fleming, Professor Avram Hershko, Dr.

Harold Jacob, Dr.

Julio Rosenstock, Dr.

Julio Rosenstock,

Jay Skyler and Dr.

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Academy of Sciences since 2003.

Harold Jacob, MD , joined the Oramed Scientific Advisory Board in November 2016.

Since 1998, Dr.

Jacob has served as the president

of Medical Instrument Development Inc., a company which provides a range of support and consulting services to start-up and early stage

companies as well as patenting its own proprietary medical devices.

Since 2011, Dr.

Jacob has also served as an attending physician at

Hadassah University Medical Center in Jerusalem, Israel, where he has served as the director of the gastrointestinal endoscopy unit since

September 2013.

Jacob has advised a spectrum of companies in the past and he served as a consultant and then as the Director of Medical

Affairs at Given Imaging Ltd., from 1997 to 2003, a company that developed the first swallowable wireless pill camera for inspection

of the intestine.

He has licensed patents to a number of companies including Kimberly-Clark Corporation.

Since 2014, Dr.

Jacob has served

as the Chief Medical Officer and a director of NanoVibronix, Inc., a medical device company using surface acoustics to prevent catheter

acquired infection as well as other applications, where he served as Chief Executive Officer from 2004 to 2014.

He practiced clinical

gastroenterology in New York and served as Chief of Gastroenterology at St.

John’s Episcopal Hospital and South Nassau Communities

Hospital from 1986 to 1995, and was a Clinical Assistant Professor of Medicine at SUNY from 1983 to 1990.

Jacob founded and served

as Editor in Chief of Endoscopy Review and has authored numerous publications in the field of gastroenterology.

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

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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, 2023, we have contracted with fifteen individuals for employment or consulting arrangements, including employees of

Of our staff, five are senior management, four are engaged in research and development work, and the remaining six are involved

in corporate and administration work.

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.

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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