What changed in this filing

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Item 1A. Risk Factors

2025-03-27 compared with 2024-03-06 · 498 added, 285 removed, 614 unchanged (56% of the section changed)

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strategic review process may not be successful or timely.

ability to consummate a strategic transaction depends on our ability to retain our employees

required to consummate such transaction.

continue, and in the future expect, to incur losses, and we may need substantial additional

capital in order to satisfy our business objectives.

may be unable to protect our intellectual property rights and we may be liable for infringing

the intellectual property rights of others.

success was primarily dependent on the successful commercialization of our oral insulin capsule.

have limited experience in conducting clinical trials.

can provide no assurance that our products will obtain regulatory approval or that the results

of clinical trials will be favorable.

may not realize a return on the ordinary shares of DNA and Entera and the common stock of

Scilex and BioXcel that we own.

Because we may from time to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to be an investment company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens.

may not realize the full benefit from our distribution license agreement with Medicox.

biotechnology and biopharmaceutical industries are characterized by rapid technological developments

and a high degree of competition.

We may be unable to compete with more substantial enterprises.

policy changes, including pending legislation recently adopted and further proposals still

pending to reform the U.S.

healthcare system, may harm our future business.

face uncertainties related to Oravax’s oral COVID-19 vaccine.

Related to Our Real Estate Investments

Related to the Notes

have lent a substantial amount of funds to Scilex.

In the event that Scilex is unable to

service its obligations under the Note and defaults on such Note, it could have a material

adverse effect on our business.

may have difficulty realizing the full value of the Warrants.

Related to our Common Stock

sales of our common stock by our existing stockholders could adversely affect our stock price.

failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements

could result in the delisting of our common stock.

the market price of our common stock may fluctuate significantly, this may make it difficult

for you to sell your shares of common stock when you want or at prices you find attractive.

Related to JV Agreement

February 7, 2025, we and HTIT entered into a JV Agreement that amending the original agreement

signed on January 22, 2024 or the Supplemental Agreement.

If we fail to complete the transactions

contemplated under the JV Agreement as supplemented by the Supplemental Agreement with HTIT,

if such joint venture is not successful, or if we fail to realize the benefits we anticipate

from such joint venture, we may not be able to capitalize on the full market potential of

our drug products and technology.

may not complete the transactions contemplated by the JV Agreement, as supplemented by the

Supplemental Agreement.

may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our

business and assets will be less diversified following the Spin Off.

Related to Conducting Business in Israel

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

may be difficult to enforce a U.S.

judgment against us or our officers and directors and

to assert U.S.

securities laws claims in Israel.

to tax laws could have a negative effect on us or our stockholders.

business and operations would suffer in the event of computer system failures, cyber-attacks

or deficiencies in our cyber-security.

Related to Our Business

strategic review process may not be successful or timely.

the results of the ORA-D-013-1 Phase 3 trial, we conducted a comprehensive analysis of the data to understand if there is a path forward

for our oral insulin candidate and are working on a protocol for a new Phase 3 clinical trial to be submitted to the FDA.

Concurrently,

we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, including among

others, continuation as a stand-alone business, capital raises, or one or more acquisitions, mergers or business combinations or other

strategic transactions.

Potential counterparties in a strategic transaction involving us may place minimal or no value on our assets.

While we are devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance that this

strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed on attractive

terms or at all.

Additionally, there can be no assurances that any particular course of action, business arrangement or transaction,

or series of transactions, will be pursued, successfully consummated, or lead to any stockholder value.

Any potential transaction would

be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry trends,

the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing to

third parties in a potential transaction with us on reasonable terms.

The process of reviewing alternative strategic paths may be time

consuming, may involve the dedication of significant resources and may require us to incur significant costs and expenses.

It could negatively

impact our ability to attract, retain and motivate employees, and expose us to potential litigation in connection with this process or

any resulting transaction.

If we are not successful in setting forth a new strategic path for the Company, or if our plans are not executed

in a timely fashion, this may cause reputational harm with our stockholders and other stakeholders and the value of our securities may

be adversely impacted.

In addition, speculation regarding any developments related to the review of strategic alternatives and perceived

uncertainties related to the future of the Company could cause our stock price to fluctuate significantly.

There can be no guarantee

that the process of evaluating alternative strategic paths will result in our entering into or completing potential transactions within

the anticipated timing or at all.

for our oral insulin candidate.

We submitted a protocol ORA-D-013-3 titled, “A Double-Blinded, Placebo-controlled, Double Dummy

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

Glycemic Control on One to Three Glucose-lowering Agents” to the FDA on September 12, 2024.

We intend to initiate study during

Concurrently, we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities,

including among others, continuation as a stand-alone business, capital raises, or one or more acquisitions, mergers or business combinations

or other strategic transactions.

Potential counterparties in a strategic transaction involving us may place minimal or no value on our

While we are devoting significant efforts to identify and evaluate potential strategic alternatives, there can be no assurance

that this strategic review process will result in us pursuing any transaction or that any transaction, if pursued, will be completed

on attractive terms or at all.

Additionally, there can be no assurances that any particular course of action, business arrangement or

transaction, or series of transactions, will be pursued, successfully consummated, or lead to any stockholder value.

Any potential transaction

would be dependent on a number of factors that may be beyond our control, including, among other things, market conditions, industry

trends, the interest of third parties in a potential transaction with us, obtaining stockholder approval and the availability of financing

to third parties in a potential transaction with us on reasonable terms.

The process of reviewing alternative strategic paths may be

time consuming, may involve the dedication of significant resources and may require us to incur significant costs and expenses.

negatively impact our ability to attract, retain and motivate employees, and expose us to potential litigation in connection with this

process or any resulting transaction.

If we are not successful in setting forth a new strategic path for the Company, or if our plans

are not executed in a timely fashion, this may cause reputational harm with our stockholders and other stakeholders and the value of

our securities may be adversely impacted.

In addition, speculation regarding any developments related to the review of strategic alternatives

and perceived uncertainties related to the future of the Company could cause our stock price to fluctuate significantly.

no guarantee that the process of evaluating alternative strategic paths will result in our entering into or completing potential transactions

within the anticipated timing or at all.

we are successful in completing a strategic transaction, we may be exposed to other operational and financial risks.

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If there are unexpected increases in our operating expenses, we may need to seek additional financing during the next 12

will need substantial additional capital in order to satisfy our business objectives.

may need substantial additional capital in order to satisfy our business objectives.

date, we have financed our operations principally through offerings of securities and we may require substantial additional financing

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many factors, including:

results of our strategic review process and any new strategic direction we decide to take;

scientific progress in our research and development programs;

and timing of conducting clinical trials and seeking regulatory approvals and patent prosecutions;

technological and market developments;

ability to establish additional collaborative relationships;

of commercialization activities and facility expansions if and as required.

the results of our strategic

review process and any new strategic direction we decide to take;

continued scientific progress

in our research and development programs;

costs and timing of conducting

clinical trials and seeking regulatory approvals and patent prosecutions;

competing technological

and market developments;

our ability to establish

additional collaborative relationships;

effects of commercialization

activities and facility expansions if and as required.

we cannot secure adequate financing when needed, we may be required to delay, scale back or eliminate one or more of our existing or

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have a history of losses and can provide no assurance as to our future operating results.

do not have sufficient revenues from our research and development activities to fully support our operations.

Consequently, we have incurred

net losses and negative cash flows since inception.

We currently have only licensing revenues and no product revenues, and may not succeed

in developing or commercializing any products which could generate product revenues.

We do not expect to have any products on the market

for several years.

In addition, development of our product candidates requires a process of pre-clinical and clinical testing, during

which our products could fail.

For example, in January 2023, the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints.

We may not be able to enter into agreements with one or more companies experienced in the manufacturing and marketing of therapeutic

drugs and, to the extent that we are unable to do so, we will not be able to market our product candidates.

Eventual profitability will

depend on our success in developing, manufacturing, and marketing our product candidates or in pursuing a successful strategic alternative.

As of December 31, 2023 and 2022, we had working capital of $109,370,000 and $151,363,000, respectively, and stockholders’ equity

of $163,821,000 and $151,812,000, respectively.

During the years ended December 31, 2023 and 2022, we generated revenues of $1,340,000

and $2,703,000, respectively.

For the period from our inception on April 12, 2002 through December 31, 2023, we incurred net losses of

$157,556,000.

We may never achieve profitability and expect to incur net losses in the foreseeable future.

Discussion and Analysis of Financial Condition and Results of Operations.”

We do not have sufficient revenues from our research and development

activities to fully support our operations.

Consequently, we have incurred net losses since inception.

We currently have only licensing

revenues and no product revenues, and may not succeed in developing or commercializing any products which could generate product revenues.

We do not expect to have any products on the market for several years.

In addition, development of our product candidates requires a process

of pre-clinical and clinical testing, during which our products could fail.

For example, in January 2023, the ORA-D-013-1 Phase 3 trial

did not meet its primary or secondary endpoints.

We may not be able to enter into agreements with one or more companies experienced in

the manufacturing and marketing of therapeutic drugs and, to the extent that we are unable to do so, we will not be able to market our

product candidates.

Eventual profitability will depend on our success in developing, manufacturing, and marketing our product candidates

or in pursuing a successful strategic alternative.

As of December 31, 2024 and 2023, we had working capital of approximately $137,536,000

and approximately $109,370,000, respectively, and stockholders’ equity of approximately $146,265,000 and approximately $163,821,000,

respectively.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.”

rely upon patents to protect our technology.

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At present, following the results of the ORA-D-013-1

Phase 3 trial, we conducted a comprehensive analysis of the data to understand if there is a path forward for our oral insulin candidate

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

Concurrently, we are examining our existing

pipeline and have commenced an evaluation process of potential strategic opportunities.

Even if we succeed in commencing a new clinical

trial for our oral insulin capsule, there are a variety of risks and uncertainties related to its development.

Principally, these risks

include the following:

clinical trial results may show the same results as the ORA-D-013-1 Phase 3 trial;

clinical trial results may be inconsistent with previous preliminary testing results and

data from our earlier trials may be inconsistent with clinical data;

if our oral insulin capsule is shown to be safe and effective for its intended purposes in

future clinical trials, we may face significant or unforeseen difficulties in obtaining or

manufacturing sufficient quantities or at reasonable prices;

ability to complete the development and commercialization of the oral insulin capsule for

our intended use is significantly dependent upon our ability to obtain and maintain experienced

and committed partners to assist us with obtaining clinical and regulatory approvals for,

and the manufacturing, marketing and distribution of, the oral insulin capsule on a worldwide

if our oral insulin capsule is successfully developed, commercially produced and receives

all necessary regulatory approvals, there is no guarantee that there will be market acceptance

of our product;

competitors may develop therapeutics or other treatments which are superior or less costly

than our own with the result that our products, even if they are successfully developed,

manufactured and approved, may not generate significant revenues.

Phase 3 trial, we conducted a comprehensive analysis of the data and found that subpopulations of patients with pooled specific parameters

responded well to oral insulin.

Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA.

Concurrently,

we are examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities.

Even if we succeed

in commencing a new clinical trial for our oral insulin capsule, there are a variety of risks and uncertainties related to its development.

Principally, these risks include the following:

Future clinical trial results

may show the same results as the ORA-D-013-1 Phase 3 trial;

Future clinical trial results

may be inconsistent with previous preliminary testing results and data from our earlier trials may be inconsistent with clinical

Even if our oral insulin

capsule is shown to be safe and effective for its intended purposes in future clinical trials, we may face significant or unforeseen

difficulties in obtaining or manufacturing sufficient quantities or at reasonable prices;

Our ability to complete

the development and commercialization of the oral insulin capsule for our intended use is significantly dependent upon our ability

to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and

the manufacturing, marketing and distribution of, the oral insulin capsule on a worldwide basis;

Even if our oral insulin

capsule is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no guarantee that

there will be market acceptance of our product;

Our competitors may develop

therapeutics or other treatments which are superior or less costly than our own with the result that our products, even if they are

successfully developed, manufactured and approved, may not generate significant revenues.

business may be seriously harmed if our analysis does not produce positive results, if we are unable to find a path forward to continue

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As a result, we decided to terminate

our ORA-D-013-2 Phase 3 trial, conducted a comprehensive analysis of the data to understand if there is a path forward for our oral insulin

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

Moreover, obtaining approval for

certain products may require the testing on human subjects of substances whose effects on humans are not fully understood or documented.

Delays in obtaining necessary regulatory approvals of any proposed product and failure to receive such approvals would have an adverse

effect on the product’s potential commercial success and on our business, prospects, financial condition and results of operations.

In addition, it is possible that a product may be found to be ineffective or unsafe due to conditions or facts which arise after development

has been completed and regulatory approvals have been obtained.

In this event we may be required to withdraw such product from the market.

our ORA-D-013-2 Phase 3 trial, conducted a comprehensive analysis of the data and found that subpopulations of patients with pooled specific

parameters, responded well to oral insulin.

Based on this analysis, we submitted a protocol for a new Phase 3 clinical trial to the FDA.

Moreover, obtaining approval for certain products may require the testing on human subjects of substances whose effects on humans are

not fully understood or documented.

Delays in obtaining necessary regulatory approvals of any proposed product and failure to receive

such approvals would have an adverse effect on the product’s potential commercial success and on our business, prospects, financial

condition and results of operations.

In addition, it is possible that a product may be found to be ineffective or unsafe due to conditions

or facts which arise after development has been completed and regulatory approvals have been obtained.

In this event we may be required

to withdraw such product from the market.

Business—Description of Business—Government Regulation.”

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and reputational harm or other negative outcomes, including possible legal consequences.

future revenues from HTIT are dependent upon third party suppliers and Chinese regulatory approvals.

future revenues from HTIT under the TLA are dependent upon the achievement of certain milestones and conditions, and the success of HTIT

to implement our technology and to manufacture the oral insulin capsule.

Any future revenues from HTIT under the TLA are also dependent

upon the ability of third parties to scale-up one of our oral capsule ingredients and to scale-up the manufacturing process of our capsules.

Our future revenues from royalties from HTIT are further dependent upon the granting of regulatory approvals in the Territory.

if any of the foregoing does not occur, we may not be successful in receiving future revenues from HTIT and may not succeed with our

business plans in China.

we fail to complete the transactions contemplated under the JV Agreement with HTIT, if such joint venture is not successful, or if we

fail to realize the benefits we anticipate from such joint venture, we may not be able to capitalize on the full market potential of

our drug products and technology.

January 22, 2024, we entered into the JV Agreement with HTIT, pursuant to which, subject to the terms and conditions set forth in the

JV Agreement, the parties will establish a JV based on Oramed’s oral drug delivery technology.

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.

we do not successfully complete the ancillary agreements in a timely manner, or at all, this may harm our ability to complete additional

clinical trials and marketing of our oral insulin candidate.

In addition, this may cause irreparable harm to our financial position and

business operations.

there can be no assurances that the JV will receive the necessary regulatory approvals for the Phase 3 oral insulin trial in the United

States or that our drug products and our technology will be developed and commercialized successfully.

In addition, the JV will subject

us to a number of risks including risks relating to the lack of full control of the JV, potential disagreements with HTIT about how to

manage the JV that may result in the delay or termination of the commercialization of our products or product candidates or that result

in costly litigation or arbitration that diverts management attention and resources, conflicting interests of the JV, and the JV and

its business not being profitable.

we believe that our board representation, voting rights and other contractual rights with respect to the JV will serve to mitigate some

of these risks, we may have disagreements with the other directors and HTIT that could impair our ability to influence the JV to act

in a manner that we believe is in the best interest of the Company.

we do not resolve our dispute with HTIT favorably, we may need to reverse deferred revenue of up to $2 million and will not receive an

additional $4 million in royalties.

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

We estimate this

obligation to be between $2 million and $6 million.

While we wholly disputed said claims and are planning to resolve any such claims

as part of our discussions with HTIT, if we are not successful in consummating the JV or resolving the claims as part of the JV, we may

be subsequently required to repay to HTIT up to $2 million, which has been received and has been included in our deferred revenue in

each of the consolidated balance sheets for the years ended December 31, 2023 and 2022.

In addition, we will not receive an additional

$4 million in Royalties if HTIT is entitled to the full disputed amount of $6 million.

may not realize a return on the ordinary shares of DNA and Entera that we own.

ordinary shares are traded on the Tel Aviv Stock Exchange and Entera’s ordinary shares are traded on the Nasdaq Stock Market, both

of which are subject to market fluctuations, and may, at times, have a price below the value on the date we acquired such shares.

addition, the ordinary shares of DNA and Entera have historically experienced low trading volume.

As a result, there is no guarantee

that we will be able to resell the ordinary shares of DNA or Entera at the prevailing market prices or that we will realize a positive

return on such shares.

may not realize a return on the ordinary shares of DNA and Entera and the common stock of Scilex and BioXcel that we own.

ordinary shares are traded on the Tel Aviv Stock Exchange and Entera’s ordinary shares and Scilex’s and BioXcel’s common

stock are traded on the Nasdaq Stock Market, which are subject to market fluctuations.

In addition, the shares of Scilex, DNA and Entera

have historically experienced low trading volume compared to the level of shares we hold.

As a result, there is no guarantee that we

will be able to resell those shares at the prevailing market prices or that we will realize a positive return on such shares.

Because we may from time

to time maintain a significant percentage of our assets in cash and/or securities, we may in the future be deemed to be an investment

company under the Investment Company Act of 1940 resulting in additional costs and regulatory burdens.

Currently, we believe that either we are not within the definition

of “Investment Company” as the term is defined under the Investment Company Act of 1940, or the 1940 Act, or, alternatively,

we may rely on one or more of the 1940 Act’s exemptions.

As of December 31, 2024, we held approximately 1.4% of DNA’s outstanding

ordinary shares, approximately 0.3% of Entera’s outstanding ordinary shares, and beneficially own approximately 15.7% of BioXcel’s

outstanding common stock.

Further, we hold the Tranche A Note and Tranche B Note and in consideration of deferring Scilex’s first

amortization payment under the Tranche B Note to October 8, 2026, we received, in addition to a nominal payment, 2,500,000 shares of Scilex

Common Stock.

We have also investments in real estate and real estate lending transactions as described elsewhere in this Annual

In order not to be regulated as an investment company under the 1940 Act, unless we can qualify for an exclusion,

we must ensure that we are engaged primarily in a business other than investing, reinvesting or trading in securities and that our activities

do not include investing, reinvesting, owning, holding or trading “investment securities” constituting more than 40% of our

total assets (exclusive of U.S.

government securities and cash items) on an unconsolidated basis.

We intend to continue to conduct our

operations and ongoing investments into DNA, BioXcel, Entera and Scilex and our real estate transaction in a manner that will exempt us

from the registration requirements of the 1940 Act.

If we were to be deemed to be an investment company because of our investments,

we would be required to register as an investment company under the 1940 Act.

Alternatively, to continue qualifying for the

exemption, we could be required to dispose of the securities holdings or other investments, which could have a material adverse effect

on our business, results of operations and financial condition.

The 1940 Act places significant restrictions on the capital structure

and corporate governance of a registered investment company and materially restricts its ability to conduct transactions with affiliates.

Compliance with the 1940 Act could also increase our operating costs.

Such changes could have a material adverse effect on our business,

results of operations and financial condition.

may not realize the full benefit from our distribution license agreement with Medicox.

distribution license agreement with Medicox provides that Medicox will comply with agreed distribution targets and will purchase ORMD-0801

at an agreed upon transfer price per capsule and pay us up to $15 million in developmental milestones, $2 million of which have already

at an agreed upon transfer price per capsule and pay us up to $15,000,000 in developmental milestones, $2,000,000 of which have already

been received by us.

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participation in our existing joint ventures is subject to risks, including the following:

share approval rights over certain major decisions affecting the ownership or operation of

the joint ventures and any assets owned by the joint ventures;

may need to contribute additional capital in order to preserve, maintain or grow the joint

ventures and their investments;

joint venture investors may have economic or other business interests or goals that are inconsistent

with our business interests or goals and that could affect our ability to fully benefit from

the assets owned by the joint ventures;

joint venture investors may be subject to different laws or regulations than us, which could

create conflicts of interest;

joint ventures may have license and other agreements with other investors, which we are not

party to and have no control over;

ability to sell our interests in, or sell additional assets to, the joint ventures or the

joint ventures’ ability to sell additional interests of, or assets owned by, the joint

ventures when we so desire are subject to the approval rights of the other joint venture

investors under the terms of the agreements governing the joint ventures;

● Disagreements

with our joint venture investors could result in litigation or arbitration that could be

expensive and distracting to management and could delay important decisions.

We share approval rights

over certain major decisions affecting the ownership or operation of the joint ventures and any assets owned by the joint ventures;

We may need to contribute

additional capital in order to preserve, maintain or grow the joint ventures and their investments;

Our joint venture investors

may have economic or other business interests or goals that are inconsistent with our business interests or goals and that could

affect our ability to fully benefit from the assets owned by the joint ventures;

Our joint venture investors

may be subject to different laws or regulations than us, which could create conflicts of interest;

Our joint ventures may

have license and other agreements with other investors, which we are not party to and have no control over;

Our ability to sell our

interests in, or sell additional assets to, the joint ventures or the joint ventures’ ability to sell additional interests

of, or assets owned by, the joint ventures when we so desire are subject to the approval rights of the other joint venture investors

under the terms of the agreements governing the joint ventures;

Disagreements with our

joint venture investors could result in litigation or arbitration that could be expensive and distracting to management and could

delay important decisions.

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

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or an end of the pandemic that may render Oravax’s vaccine obsolete.

Related to the Note

Related to Our Real Estate Investments

investments in real estate may expose us to market and liquidity risks that could adversely affect our financial condition and results

of operations.

On November 7, 2024, our Board approved investments of up to $10,000,000 in real estate assets, and additional investments

of up to $20,000,000 On February 13, 2025.

While we believe these investments present attractive opportunities, the real estate market

is subject to fluctuations due to economic conditions, interest rate changes, and other external factors beyond our control.

in the real estate market or an extended period of declining property values could negatively impact the returns on our investments.

Additionally, real estate investments tend to be relatively illiquid, which may limit our ability to quickly exit or reallocate capital

in response to market changes.

Since our approach focuses on entrepreneurial real estate investments rather than direct property ownership

or management, we are also exposed to risks associated with deal execution, market timing, and the financial health of investment partners

or counterparties.

If any of these risks materialize, they could adversely affect our financial position and ability to generate anticipated

Related to the Notes

have lent a substantial amount of funds to Scilex.

1 unchanged sentence

on such Note, it could have a material adverse effect on our business.

September 21, 2023, we were issued the Note in an aggregate principal amount of $101,875,000 by Scilex pursuant to the Scilex SPA.

Note matures on March 21, 2025 and is payable in six principal installments, with the first installment paid on December 21, 2023.

under the Note accrues at a fluctuating per annum interest rate equal to the sum of (1) the greater of (x) four percent (4%) and (y)

Term SOFR (as defined in the Note) and (2) eight and one half percent (8.5%), payable in-kind on a monthly basis.

On September 21, 2023, we were issued the Tranche A Note in an aggregate

principal amount of $101,875,000 by Scilex pursuant to the Scilex SPA.

The Note originally matured on March 21, 2025 and is payable in

six principal installments, with the first installment paid on December 21, 2023.

In January 2025, we extended Tranche A Note maturity

from March 21, 2025 to December 31, 2025.

Interest under the Note accrues at a fluctuating per annum interest rate equal to the sum of

(1) the greater of (x) four percent (4%) and (y) Term SOFR (as defined in the Note) and (2) eight and one half percent (8.5%), payable

in-kind on a monthly basis.

October 7, 2024, we entered into an agreement to refinance a portion of the Tranche A Note and pay off certain other indebtedness of

We were issued an aggregate principal amount of $25,000,000 under the Tranche B Note and 3,750,000 Tranche B Warrants.

on October 8, 2024, we entered into the RPA with Scilex to holds the right to receive 4% royalties.

is no guarantee that Scilex will be able to service its repayment obligations under the Note.

1 unchanged sentence

priority security interest in and liens on all of the assets of Scilex and its subsidiaries, no assurance can be made that Scilex will

be able to repay the Note when due or that we will be able to foreclose on such assets and recover enough value upon the sale of such

assets to repay the amounts owed to us.

In such an event, we could lose all or a substantial portion of our loan investment.

Additionally,

Scilex has disclosed in its periodic reports filed with the SEC that there is substantial doubt about its ability to continue as a going

If Scilex is unable to continue as a going concern or defaults on the Note, we may be unable to recover some or all of the principal

amount of the Note, which could have a material adverse affect on our business, financial condition and results of operations.

be able to repay the Tranche A Note and Tranche B Notes, or the Notes, when due or that we will be able to foreclose on such assets and

recover enough value upon the sale of such assets to repay the amounts owed to us.

In such an event, we could lose all or a substantial

portion of our loan investment.

Additionally, Scilex has disclosed in its periodic reports filed with the SEC that there is substantial

doubt about its ability to continue as a going concern.

If Scilex is unable to continue as a going concern or defaults on the Notes,

we may be unable to recover some or all of the principal amount of the Note, which could have a material adverse effect on our business,

financial condition and results of operations.

may have difficulty realizing the full value of the Warrants.

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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.

Transferred Warrants are listed on Nasdaq, have an exercise price of $11.50 per share, are fully exercisable, and expire on November

of the foregoing restrictions on exercisability of the Closing Penny Warrant and the Subsequent Penny Warrants, and exercise price of

the Transferred Warrants, we may not be able to exercise the Warrants for shares of Scilex Common Stock at a time when it would be financially

beneficial for us to do so.

Accordingly, there is no guarantee that we will be able to realize the full or any value of the Warrants.

if the Notes are repaid in full prior to the Subsequent Penny Warrant Vesting Date applicable to such Subsequent Penny Warrant, such

Subsequent Penny Warrant will expire on the date the Notes are repaid in full.

Because of the foregoing restrictions on exercisability of the Closing

Penny Warrant and the Subsequent Penny Warrants, we may not be able to exercise the Warrants for shares of Scilex Common Stock at a time

when it would be financially beneficial for us to do so.

Accordingly, there is no guarantee that we will be able to realize the full or

any value of the Warrants.

Related to our Common Stock

sales of our common stock by our existing stockholders could adversely affect our stock price.

The market price of our common

stock could decline as a result of sales of a large number of shares of our common stock in the market, or the perception that these sales

We experienced a significant decline in the market price of our common stock and a significant increase in trading volume

after announcing the results of our ORA-D-013-1 Phase 3 trial in January 2023.

Any strategic decision we make as a result of our strategic

review process may also negatively affect our common stock price or cause volatility in the market price of our common stock.

large amounts of our securities or large variations in trading volume might make it more difficult for us to sell equity securities in

the future at a time and at a price that we deem appropriate.

As of March 6, 2024, we had outstanding 40,519,160 shares of common stock,

a large majority of which are freely tradable.

Giving effect to the exercise in full of all of our outstanding warrants, options and restricted

stock units, or RSUs, including those currently unexercisable or unvested, we would have outstanding 45,487,537 shares of common stock.

market price of our common stock could decline as a result of sales of a large number of shares of our common stock in the market, or

the perception that these sales could occur.

We experienced a significant decline in the market price of our common stock and a significant

increase in trading volume after announcing the results of our ORA-D-013-1 Phase 3 trial in January 2023.

Any strategic decision we make

as a result of our strategic review process may also negatively affect our common stock price or cause volatility in the market price

of our common stock.

Sales of large amounts of our securities or large variations in trading volume might make it more difficult for

us to sell equity securities in the future at a time and at a price that we deem appropriate.

As of March 27, 2025, we had outstanding

40,850,455 shares of common stock, a large majority of which are freely tradable.

Giving effect to the exercise in full of all of our

outstanding warrants, options and restricted stock units, or RSUs, including those currently unexercisable or unvested, we would have

outstanding 44,599,618 shares of common stock.

issuance of warrants, options and RSUs to investors, employees and consultants may have a negative effect on the trading prices of our

common stock as well as a dilutive effect.

We have issued and may continue

to issue warrants, options, RSUs and convertible notes at, above or below the current market price.

As of March 6, 2024, we had outstanding

warrants and options exercisable for 20,000 shares of common stock at a weighted average exercise price of $4.13.

We also had outstanding

RSUs exercisable for 350,761 shares of common stock.

In addition to the dilutive effect of a large number of shares of common stock and

a low exercise price for the warrants and options, there is a potential that a large number of underlying shares of common stock may be

sold in the open market at any given time, which could place downward pressure on the trading of our common stock.

have issued and may continue to issue warrants, options, RSUs and convertible notes at, above or below the current market price.

March 27, 2025, we had outstanding warrants exercisable for 20,000 shares of common stock at a weighed average exercise price of $4.13

and options exercisable for 1,548,633 shares of common stock at a weighted average exercise price of $7.09.

We also had outstanding RSUs

for 589,781 shares of common stock.

In addition to the dilutive effect of a large number of shares of common stock and a low exercise

price for the warrants and options, there is a potential that a large number of underlying shares of common stock may be sold in the

open market at any given time, which could place downward pressure on the trading of our common stock.

we will not pay cash dividends in the foreseeable future, investors may have to sell shares of our common stock in order to realize their

49 unchanged sentences

These factors include:

acceptance of our new strategy, once determined and announced;

trial results and the timing of the release of such results;

amount of cash resources and our ability to obtain additional funding;

● announcements

of research activities, business developments, technological innovations or new products

by us or our competitors;

into or terminating strategic relationships;

in government regulation;

of key personnel;

concerning patents or proprietary rights;

in expense level;

sales of our equity or equity-related securities;

concern regarding the safety, efficacy or other aspects of the products or methodologies

being developed;

of various interest groups or organizations;

of the investment markets.

market acceptance of our

new strategy, once determined and announced;

clinical trial results

and the timing of the release of such results;

the amount of cash resources

and our ability to obtain additional funding;

announcements of research

activities, business developments, technological innovations or new products by us or our competitors;

entering into or terminating

strategic relationships;

changes in government regulation;

departure of key personnel;

disputes concerning patents

or proprietary rights;

changes in expense level;

future sales of our equity

or equity-related securities;

public concern regarding

the safety, efficacy or other aspects of the products or methodologies being developed;

activities of various interest

groups or organizations;

media coverage;

status of the investment

sales of common stock or the issuance of securities senior to our common stock or convertible into, or exchangeable or exercisable for,

our common stock could materially adversely affect the trading price of our common stock, and our ability to raise funds in new equity

sales of substantial amounts of our common stock, including pursuant to any strategic opportunity, the Cantor Equity Distribution Agreement

(as defined below), or other equity-related securities in the public market or privately, or the perception that such sales could occur,

could adversely affect prevailing trading prices of our common stock and could impair our ability to raise capital through future offerings

of equity or other equity-related securities.

We anticipate that we will need to raise capital through offerings of equity and equity

related securities.

We can make no prediction as to the effect, if any, that future sales of shares of our common stock or equity-related

securities, or the availability of shares of common stock for future sale, will have on the trading price of our common stock.

sales of substantial amounts of our common stock, including pursuant to any strategic opportunity, the ATM Agreement (as defined below),

or other equity-related securities in the public market or privately, or the perception that such sales could occur, could adversely

affect prevailing trading prices of our common stock and could impair our ability to raise capital through future offerings of equity

or other equity-related securities.

We anticipate that we will need to raise capital through offerings of equity and equity related securities.

We can make no prediction as to the effect, if any, that future sales of shares of our common stock or equity-related securities, or

the availability of shares of common stock for future sale, will have on the trading price of our common stock.

stockholders may experience significant dilution as a result of any additional financing using our equity securities.

the extent that we raise additional funds by issuing equity securities, including in connection with any strategic opportunity or pursuant

to the Cantor Equity Distribution Agreement, our stockholders may experience significant dilution.

Additionally, we may, from time to

time or in connection with a strategic alternative, issue additional shares of common stock at a discount from the current trading price

of our common stock.

As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common

stock sold at such discount.

In addition, as opportunities present themselves, we may enter into financing or similar arrangements in

the future, including the issuance of convertible debt securities, preferred stock or common stock.

If we issue common stock or securities

convertible into common stock, our common stockholders would experience additional dilution and, as a result, our stock price may decline.

to the ATM Agreement, our stockholders may experience significant dilution.

Additionally, we may, from time to time or in connection

with a strategic alternative, issue additional shares of common stock at a discount from the current trading price of our common stock.

As a result, our stockholders would experience immediate dilution upon the purchase of any shares of our common stock sold at such discount.

In addition, as opportunities present themselves, we may enter into financing or similar arrangements in the future, including the issuance

of convertible debt securities, preferred stock or common stock.

If we issue common stock or securities convertible into common stock,

our common stockholders would experience additional dilution and, as a result, our stock price may decline.

Related to JV Agreement

we fail to complete the transactions contemplated under the JV Agreement as supplemented by the Supplemental Agreement with HTIT , if

such joint venture is not successful, or if we fail to realize the benefits we anticipate from such joint venture, we may not be able

to capitalize on the full market potential of our drug products and technology.

joint ventures, we share ownership and management of a company with one or more parties who may not have the same goals, strategies,

priorities, business incentives or resources as we do and may compete with us outside the joint venture.

Joint ventures are intended

to be operated for the benefit of all co-owners, rather than for our exclusive benefit.

Operating a business as a joint venture often

requires additional organizational formalities as well as time-consuming procedures for sharing information and making decisions that

must further take into consideration our partners’ interests.

In joint ventures, we are required to foster our relationships with our

co-owners as well as promote the overall success of the joint venture, and if a co-owner changes, relationships deteriorate or strategic

objectives diverge, our success in the joint venture may be materially adversely affected.

Further, because most of the benefits from

a successful joint venture are shared among the co-owners, we do not receive all the benefits from our successful joint ventures.

addition, because we share ownership and management with one or more parties, we may have limited control over the actions of a joint

venture, particularly when we own a minority interest.

As a result, we may be unable to prevent violations of applicable laws or other

misconduct by a joint venture, adverse human rights or other impacts or the failure to satisfy contractual obligations by one or more

Moreover, a joint venture may not be subject to the same financial reporting, corporate governance or compliance approaches

that we follow.

To the extent another party makes decisions that negatively impact the joint venture or internal control issues arise

within the joint venture, we may have to take responsive actions, or we may be subject to penalties, fines or other punitive actions

or suffer reputational harm for these activities.

consummation of the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement, is subject to the satisfaction

or waiver of certain other closing conditions.

we do not successfully complete the closing conditions, this may harm our ability to complete the transactions contemplated by the JV

Agreement, as supplemented by the Supplemental Agreement, as well as additional clinical trials and marketing of our oral insulin candidate.

In addition, this may cause irreparable harm to our financial position and business operations.

there can be no assurances that OraTech will receive the necessary regulatory approvals for the Phase 3 oral insulin trial in the United

States or that our drug products and our technology will be developed and commercialized successfully.

In addition, OraTech will subject

us to a number of risks including risks relating to the lack of full control of OraTech, potential disagreements with HTIT about how

to manage OraTech that may result in the delay or termination of the commercialization of our products or product candidates or that

result in costly litigation or arbitration that diverts management attention and resources, conflicting interests of OraTech, and OraTech

and its business not being profitable.

we believe that our board representation, voting rights and other contractual rights with respect to OraTech will serve to mitigate some

of these risks, we may have disagreements with the other directors and HTIT that could impair our ability to influence OraTech to act

in a manner that we believe is in the best interest of us.

may not complete the transactions contemplated by the JV Agreement, as supplemented by the Supplemental Agreement.

to the Supplemental Agreement, the Initial Closing will be April 30, 2025.

Subject to the completion and satisfaction of applicable closing

conditions, the Second Closing shall occur on a date specified in the applicable closing notice, which such date shall be no later than

the fifth business day after the satisfaction or waiver of the applicable closing conditions, provided, however, that the Second Closing

shall not be consummated before April 30, 2025 unless the shares of OraTech’s common stock have been approved for listing and trading

on the Nasdaq Stock Market prior to April 30, 2025.

In the event the parties fail to consummate the Second Closing on or before April

30, 2025, solely due to the failure of not achieving the Listing, the parties agreed to consummate the Second Closing on or before May

Notwithstanding the foregoing, the provisions with respect to the Second Closing may be terminated by either HTIT or us if

the Second Closing has not occurred by September 1, 2025, subject to certain conditions.

are no assurances that the applicable parties will consummate either the Initial Closing or the Second Closing, of the Spin Off or complete

the closing conditions such closings are subject to.

If we do not successfully complete such closings in a timely manner, or at all,

this may harm OraTech’s ability to complete the transactions contemplated by the JV Agreement and the Supplemental Agreement, which

may in turn cause irreparable harm to our financial position and business operations.

may not realize the anticipated benefits from the Spin Off, and the Spin Off could harm our business.

may not be able to achieve the full strategic and financial benefits expected to result from the Spin Off and such benefits may be delayed

or not occur at all.

The Spin Off is designed to enhance strategic and management focus, provide a distinct corporate identity, and allow

us to efficiently allocate resources and deploy capital.

We may not achieve these and other anticipated benefits for a variety of reasons,

including the following:

Spin Off will require significant amounts of management’s time and effort, which may

divert management’s attention from operating and growing our business;

the Spin Off, OraTech may be more susceptible to economic downturns and other adverse events

than if it was still a part of the Company;

the Spin Off, our business will be less diversified than prior to the Spin Off;

the Spin Off, our business will experience a loss of scale and access to certain financial,

managerial, and professional resources as well as product and brand power influence and recognition

with some customers from which we have benefited in the past;

required to separate the respective businesses could disrupt our operations;

we fail to achieve some or all of the benefits expected to result from the Spin Off, or if

such benefits are delayed, our business could be harmed.

the Spin Off occurs, the business of OraTech will remain our business segment.

Completion of the Spin Off remains subject to the satisfaction

or waiver of certain conditions.

indemnification liabilities to HTIT pursuant to the JV Agreement, as supplemented by the Supplemental Agreement could materially and

adversely affect our financial condition, results of operations, and cash flows.

JV Agreement, as supplemented by the Supplemental Agreement, among other things, provides for indemnification obligations designed to

make the Company and the OraTech financially responsible for certain liabilities that may exist relating to its business activities.

If we and the OraTech are required to indemnify HTIT under the circumstances set forth in the JV Agreement, as supplemented by the Supplemental

Agreement, we may be subject to substantial liabilities.

potentially could have received better terms from unaffiliated third parties than the terms we received in our agreements with OraTech

agreements we and OraTech entered into in connection with the Spin Off have been negotiated while OraTech is still a part of our business.

The terms of the agreements negotiated in the context of the Spin Off relate to, among other things, the allocation of assets, intellectual

property, liabilities, rights, and other obligations between OraTech and us, among others.

Arm’s-length negotiations between OraTech

and an unaffiliated third-party in another form of transaction, such as a buyer in a sale of a business transaction, may have resulted

in more favorable terms to the unaffiliated third-party.

business and assets will be less diversified following the Spin Off

connection with the transactions contemplated by the JV Agreement as supplemented by the Supplemental Agreement, on February 7, 2025,

we entered into that certain Asset Transfer Agreement or the Asset Transfer Agreement with OraTech and Oramed Ltd., pursuant to which,

we and Oramed Ltd.

have agreed to transfer to OraTech all of our and their rights, titles, and interests in the Transferred IP, Business

Contracts, Business Information, and Regulatory Information (each as defined in the Asset Transfer Agreement and collectively, or the

Transferred Assets), as part of the capital contribution to be made to OraTech, in consideration for the issuance to us of certain Shares

(as defined in the JV Agreement) in OraTech.

such Transferred Assets are transferred to OraTech in connection with the Spin Off, OraTech will have all rights, title and interest

in such Transferred Assets, and we will no longer have all rights, title and interest in such Transferred Assets, meaning that our business

and assets will be less diversified following the Spin Off, which may in turn affect our operations and our financial position.

financial position and business operations of the OraTech could be impacted by HTIT’s ability to perform its obligations under

certain contracts with us.

connection with the Spin Off, we have entered into a number of agreements with HTIT, including a supply agreement and a license agreement

that govern our ongoing relationship with HTIT.

Our success depends, in part, on the maintenance of our ongoing relationship with HTIT,

HTIT’s performance of its obligations under these agreements, including HTITs maintenance of the quality of products and services

and certain other trademarks and intellectual property that we license to HTIT.

If we are unable to maintain a good relationship with

HTIT, or if HTIT does not perform its obligations under our agreements with HTIT, the business of OraTech, its operations and its financial

position may be negatively impacted.

Spin Off may expose us to potential liabilities arising out of state and federal fraudulent conveyance laws.

we file for insolvency or bankruptcy within certain timeframes following the Spin Off, a court could deem the Spin Off or certain internal

restructuring transactions undertaken by us in connection therewith to be a fraudulent conveyance or transfer.

Fraudulent conveyances

or transfers are defined to include transfers made or obligations incurred with the actual intent to hinder, delay or defraud current

or future creditors or transfers made or obligations incurred for less than reasonably equivalent value when the debtor was insolvent,

or that rendered the debtor insolvent, inadequately capitalized or unable to pay its debts as they become due.

In such circumstances,

a court could void the transactions or impose substantial liabilities upon us, which could adversely affect our financial condition and

our results of operations.

Whether a transaction is a fraudulent conveyance or transfer will vary depending upon the jurisdiction whose

law is being applied.

Related to Conducting Business in Israel

19 unchanged sentences

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.

Although we believe that there is no immediate risk to our business operations related to these events, our business, prospects, financial

condition and results of operations could be materially adversely affected if such hostilities involving Israel continue or escalate

or if trade or scientific cooperation between Israel and its current partners is interrupted or curtailed.

Moreover, we cannot predict

how this war will ultimately affect Israel’s economy in general, which may involve a downgrade in Israel’s credit rating

by rating agencies (such as the recent downgrade by Moody’s of its credit rating of Israel from A1 to A2, as well as the downgrade

of its outlook rating from “stable” to “negative”).

We may also be targeted by cyber terrorists specifically

because we are an Israeli-related company.

adult male permanent residents of Israel, unless exempt, may be required to perform military reserve duty annually.

Additionally, all

such residents are subject to being called to active duty at any time under emergency circumstances, and several hundred thousand Israeli

military reservists were drafted to perform immediate military service during the current war with Hamas and other hostile elements,

such as Hezbollah in Lebanon.

Some of our employees may in the future be obligated to perform annual military reserve duty, although

none were called up for reserves in the current war.

If called up, such persons may be absent from their positions for a lengthy period

We can provide no assurance that such requirements will not have a material adverse effect on our business, prospects, financial

condition and results of operations in the future, particularly if emergency circumstances occur.

we received grants from the Israel Innovation Authority of the Israeli Ministry of Economy and Industry we are subject to ongoing restrictions.

received royalty-bearing grants from the Israel Innovation Authority of the Israeli Ministry of Economy and Industry, or IIA, for research

and development programs that meet specified criteria.

We did not recognize any grants in the years ended December 31, 2023 and December

We do not expect to receive further grants from the IIA in the future.

The terms of the IIA grants limit our ability to transfer

know-how developed under an approved research and development program outside of Israel, regardless of whether the royalties were fully

Following the attack by Hamas, Hezbollah, a terrorist organization

in Lebanon has also launched missile, rocket, and shooting attacks against Israeli military sites, troops, and Israeli towns in northern

In response to these attacks, the Israeli army has carried out a number of targeted strikes on sites belonging to Hezbollah in

southern Lebanon and in October 2024, the Israeli military initiated a ground operation in Lebanon, primarily near the Israel-Lebanon

As of the end of November 2024, Israel entered into a ceasefire agreement with Hezbollah, but there are no guarantees as to whether

the agreement will hold or whether further hostilities will resume.

April and October 2024, Iran launched missile and unmanned aerial vehicle, or UAV, attacks on Israel.

Most of the missiles and UAVs were

intercepted by Israel’s defense systems, with support from the United States and other countries, including regional allies, preventing

significant damage and resulting in no casualties.

Despite the successful interceptions, the attacks posed an elevated threat to Israel’s

December 2024, Ba’athist Syria, led by President Bashar al-Assad, collapsed during a major offensive by opposition forces made

up of several competing rebel groups.

In response, the Israeli Defense Forces took control over a United Nations-designated buffer zone

over Mount Hermon that separates Israel and Syria.

Simultaneously, Israel conducted targeted military strikes against military assets

in Syria, aiming to eliminate any chemical weapons storage sites that could be used by rebel groups and further weaken Iran’s operational

capabilities in the region.

While the transitional government of Syria has indicated that it is interested in reconstruction and stability

rather than a continuation of conflicts with Israel, there are no guarantees that there will be no future escalation of hostilities or

that Syria will not permit other neighboring countries to launch attacks at Israel from its territory.

is possible that other terrorist organizations, including Palestinian military organizations in the West Bank, as well as other hostile

countries, such as Iran, will join the hostilities.

Although we believe that there is no immediate risk to our business operations related

to these events, our business, prospects, financial condition and results of operations could be materially adversely affected if such

hostilities involving Israel continue or escalate or if trade or scientific cooperation between Israel and its current partners is interrupted

or curtailed.

Moreover, we cannot predict how this war will ultimately affect Israel’s economy in general, which may involve a

downgrade in Israel’s credit rating by rating agencies (such as the recent downgrade by Moody’s of its credit rating of Israel

from A1 to A2, in October 2023 and further downgrade to Baa1 with a negative outlook in September 2024, as well as the downgrade of its

outlook rating from “stable” to “negative”).

We may also be targeted by cyber terrorists specifically because

we are an Israeli-related company.

adult male and female permanent residents of Israel, unless exempt, may be required to perform military reserve duty annually.

Additionally, all such residents are subject to being called to active duty at any time under emergency circumstances, and several

hundred thousand Israeli military reservists were drafted to perform immediate military service during the current war with Hamas

and other hostile elements, such as Hezbollah in Lebanon.

Some of our employees may in the future be obligated to perform annual

military reserve duty, although none were called up for reserves in the current war.

If called up, such persons may be absent from

their positions for a lengthy period of time.

We can provide no assurance that such requirements will not have a material adverse

effect on our business, prospects, financial condition and results of operations in the future, particularly if emergency

circumstances occur.

may be difficult to enforce a U.S.

23 unchanged sentences

laws, as well as a monetary or compensatory judgment in a non-civil matter, provided that the following key conditions are met:

to limited exceptions, the judgment is final and non-appealable;

judgment was given by a court competent under the laws of the state in which the court is

located and is otherwise enforceable in such state;

judgment was rendered by a court competent under the rules of private international law applicable

laws of the state in which the judgment was given provides for the enforcement of judgments

of Israeli courts;

service of process has been effected and the defendant has had a reasonable opportunity to

present its arguments and evidence;

judgment and its enforcement are not contrary to the law, public policy, security or sovereignty

of the State of Israel;

judgment was not obtained by fraud and does not conflict with any other valid judgment in

the same matter between the same parties;

action between the same parties in the same matter was not pending in any Israeli court at

the time the lawsuit was instituted in the U.S.

subject to limited exceptions,

the judgment is final and non-appealable;

the judgment was given

by a court competent under the laws of the state in which the court is located and is otherwise enforceable in such state;

the judgment was rendered

by a court competent under the rules of private international law applicable in Israel;

the laws of the state in

which the judgment was given provides for the enforcement of judgments of Israeli courts;

adequate service of process

has been effected and the defendant has had a reasonable opportunity to present its arguments and evidence;

the judgment and its enforcement

are not contrary to the law, public policy, security or sovereignty of the State of Israel;

the judgment was not obtained

by fraud and does not conflict with any other valid judgment in the same matter between the same parties;

an action between the same

parties in the same matter was not pending in any Israeli court at the time the lawsuit was instituted in the U.S.

any of these conditions are not met, Israeli courts will likely not enforce the applicable U.S.

52 unchanged sentences

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 1A. Risk Factors