What changed in this filing

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Item 1A. Risk Factors

2024-03-06 compared with 2023-03-06 · 844 added, 874 removed, 55 unchanged (97% of the section changed)

An investment in our

securities involves a high degree of risk.

You should consider carefully the following information about these risks, together with the

other information contained in this Annual Report on Form 10-K before making an investment decision.

Our business, prospects, financial

condition and results of operations may be materially and adversely affected as a result of any of the following risks.

The value of our

securities could decline as a result of any of these risks.

You could lose all or part of your investment in our securities.

statements in “Item 1A.

RISK FACTORS.

investment in our securities involves a high degree of risk.

You should consider carefully the following information about these risks,

together with the other information contained in this Annual Report on Form 10-K before making an investment decision.

Our business,

prospects, financial condition and results of operations may be materially and adversely affected as a result of any of the following

The value of our securities could decline as a result of any of these risks.

You could lose all or part of your investment in

our securities.

Some of the statements in “Item 1A.

Risk Factors” are forward-looking statements.

The following risk factors are not the only risk factors

facing the Company.

Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect

our business, prospects, financial condition and results of operations.

Risks Related to Our Business

Our strategic review process may

not be successful or timely.

Following the results of the

ORA-D-013-1 Phase 3 trial, we have initiated a comprehensive analysis of the data to understand if there is a path forward for our oral

insulin candidate.

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.

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

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

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

The process of reviewing alternative

strategic paths may be time consuming, may involve the dedication of significant resources and may require us to incur significant costs

and expenses.

It could negatively impact our ability to attract, retain and motivate employees, and expose us to potential litigation

in connection with this process or any resulting transaction.

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

or if our plans are not executed in a timely fashion, this may cause reputational harm with our stockholders and other stakeholders and

the value of our securities may be adversely impacted.

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

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

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

transactions within the anticipated timing or at all.

If we are successful in

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

Although there can be no assurance

that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic alternatives, the negotiation

and consummation of any such transaction will require significant time on the part of our management and may disrupt our business.

negotiation and consummation of any such transaction may also require more time or greater cash resources than we anticipate and expose

us to other operational and financial risks, including:

The following risk factors

are not the only risk factors facing the Company.

Additional risks and uncertainties not presently known to us or that we currently deem

immaterial may also affect our business, prospects, financial condition and results of operations.

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.

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

there can be no assurance that a strategic transaction will result from the process we have undertaken to identify and evaluate strategic

alternatives, the negotiation and consummation of any such transaction will require significant time on the part of our management and

may disrupt our business.

The negotiation and consummation of any such transaction may also require more time or greater cash resources

than we anticipate and expose us to other operational and financial risks, including:

increased near-term and long-term expenditures;

● exposure to unknown liabilities;

● higher than expected acquisition or integration

● incurrence of substantial debt or dilutive issuances

of equity securities to fund future operations;

● write-downs of assets or goodwill or incurrence

of non-recurring, impairment or other charges;

● increased amortization expenses;

● impairment of relationships with key suppliers

of any acquired business due to changes in management and ownership;

● inability to retain our key employees ;

● possibility of future litigation.

Any of the above risks could

have a material adverse effect on our business, financial condition, and prospects.

Our ability to consummate

a strategic transaction depends on our ability to retain our employees required to consummate such transaction.

Our ability to consummate

a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction, the loss of whose

services may adversely impact the ability to consummate such transaction.

Our cash conservation activities may yield unintended consequences,

such as attrition and reduced employee morale, which may cause remaining employees to seek alternative employment.

Our ability to successfully

complete a strategic transaction depends in large part on our ability to retain certain of our remaining personnel.

If we are unable to

successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation of a strategic alternative

as well as business operations.

We may become involved

in securities and stockholder litigation that could divert management’s attention and harm the Company’s business, and insurance

coverage may not be sufficient to cover all costs and damages.

In the past, securities and

stockholder litigation has often followed certain significant business transactions, such as the sale of a company or announcement of

any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials.

The market price

of our common stock dropped substantially when we announced the results of the ORA-D-013-1 Phase 3 trial.

We may be exposed to such litigation

even if no wrongdoing occurred.

Litigation is usually expensive and diverts management’s attention and resources, which could adversely

affect our business and cash resources and our ability to consummate a potential strategic transaction or the ultimate value our stockholders

receive in any such transaction.

We continue, and in the

future expect, to incur losses .

Successful evaluation and

completion of our remaining development programs and our transition to normal operations are dependent upon obtaining necessary regulatory

approvals from the FDA prior to selling our products within the United States, and foreign regulatory approvals must be obtained to sell

our products internationally.

There can be no assurance that we will receive regulatory approval of any of our product candidates, and

a substantial amount of time may pass before we achieve a level of revenues adequate to support our operations.

We also expect to incur

substantial expenditures in connection with our strategic evaluation process, as well as the regulatory approval process for each of our

current or future product candidates during their respective developmental periods.

Obtaining marketing approval will be directly dependent

on our ability to implement the necessary regulatory steps required to obtain marketing approval in the United States and in other countries.

exposure to unknown liabilities; higher than expected acquisition or integration costs; incurrence of substantial debt or dilutive

issuances of equity securities to fund future operations; write-downs of assets or goodwill or incurrence of non-recurring, impairment

or other charges; increased amortization expenses; impairment of relationships with key suppliers of any acquired business

due to changes in management and ownership; inability to retain our key employees; and possibility of future litigation.

of the above risks could have a material adverse effect on our business, financial condition, and prospects.

ability to consummate a strategic transaction depends on our ability to retain our employees required to consummate such transaction.

ability to consummate a strategic transaction depends upon our ability to retain our employees required to consummate such a transaction,

the loss of whose services may adversely impact the ability to consummate such transaction.

Our cash conservation activities may yield

unintended consequences, such as attrition and reduced employee morale, which may cause remaining employees to seek alternative employment.

Our ability to successfully complete a strategic transaction depends in large part on our ability to retain certain of our remaining

If we are unable to successfully retain our remaining personnel, we are at risk of a disruption to our exploration and consummation

of a strategic alternative as well as business operations.

may become involved in securities and stockholder litigation that could divert management’s attention and harm the Company’s

business, and insurance coverage may not be sufficient to cover all costs and damages.

the past, securities and stockholder litigation has often followed certain significant business transactions, such as the sale of a company

or announcement of any other strategic transaction, or the announcement of negative events, such as negative results from clinical trials.

The market price of our common stock dropped substantially when we announced the results of the ORA-D-013-1 Phase 3 trial.

exposed to such litigation even if no wrongdoing occurred.

Litigation is usually expensive and diverts management’s attention and

resources, which could adversely affect our business and cash resources and our ability to consummate a potential strategic transaction

or the ultimate value our stockholders receive in any such transaction.

continue, and in the future expect, to incur losses .

evaluation and completion of our remaining development programs and our transition to normal operations are dependent upon obtaining

necessary regulatory approvals from the FDA prior to selling our products within the United States, and foreign regulatory approvals

must be obtained to sell our products internationally.

There can be no assurance that we will receive regulatory approval of any of our

product candidates, and a substantial amount of time may pass before we achieve a level of revenues adequate to support our operations.

We expect to incur substantial expenditures in connection with our research and development programs, our strategic evaluation process,

as well as the regulatory approval process with FDA and other agencies for each of our current or future product candidates during their

respective developmental periods.

Obtaining marketing approval will be directly dependent on our ability to implement the necessary regulatory

steps required to obtain marketing approval in the United States and in other countries.

We cannot predict the outcome of these activities.

Based on our current cash

resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding level of expenditures

for at least the next 12 months, although no assurance can be given that we will not need additional funds prior to such time.

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

We will need substantial

additional capital in order to satisfy our business objectives.

To date, we have financed

our operations principally through offerings of securities and we may require substantial additional financing at various intervals in

order to implement any potential strategic alternative, to continue our remaining or potential future research and development programs,

including significant requirements for operating expenses including intellectual property protection and enforcement, for pursuit of regulatory

approvals, and for commercialization of our remaining or future products.

We can provide no assurance that additional funding will be

available on a timely basis, on terms acceptable to us, or at all.

In the event that we are unable to obtain such financing, we may not

be able to implement the actions we decide to take as part of our strategic review process, and we will not be able to fully develop and

commercialize our technology or pursue new technology.

Our future capital requirements will depend upon many factors, including:

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

continued scientific progress in our research and development programs;

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

competing technological and market developments;

our ability to establish additional collaborative relationships;

effects of commercialization activities and facility expansions if and as required.

If we cannot secure adequate

financing when needed, we may be required to delay, scale back or eliminate one or more of our existing or planned courses of action or

research and development programs, or to enter into license or other arrangements with third parties to commercialize products or technologies

that we would otherwise seek to develop ourselves and commercialize ourselves.

In such event, our business, prospects, financial condition

and results of operations may be adversely affected as we may be required to scale-back, eliminate, or delay development efforts or product

introductions or enter into royalty, sales or other agreements with third parties in order to commercialize our products.

We have a history of losses

and can provide no assurance as to our future operating results.

We do not have sufficient

revenues from our research and development activities to fully support our operations.

Consequently, we have incurred net losses 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.

development of our product candidates requires a process of pre-clinical and clinical testing, during which our products could fail.

example, in January 2023, the ORA-D-013-1 Phase 3 trial did not meet its primary and 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, 2022 and 2021,

we had working capital of $151,363,000 and $140,569,000, respectively, and stockholders’ equity of $151,812,000 and $166,453,000,

respectively.

During the year ended December 31, 2022, the four month period ended December 31, 2021 and the year ended August 31, 2021,

we generated revenues of $2,703,000, $904,000 and $2,703,000, respectively.

For the period from our inception on April 12, 2002 through

December 31, 2022, the year ended December 31, 2022, the four month period ended December 31, 2021 and the year ended August 31, 2021,

we incurred net losses of $163,081,000, $126,520,000 and $114,852,000, respectively.

We may never achieve profitability and expect to

incur net losses in the foreseeable future.

Management’s Discussion and Analysis of Financial Condition and Results

of Operations.”

We rely upon patents to

protect our technology.

The patent position of biopharmaceutical

and biotechnology firms is generally uncertain and involves complex legal and factual questions.

We do not know whether any of our current

or future patent applications will result in the issuance of any patents.

Even issued patents may be challenged, invalidated or circumvented.

Patents may not provide a competitive advantage or afford protection against competitors with similar technology.

Competitors or potential

competitors may have filed applications for, or may have received patents and may obtain additional and proprietary rights to compounds

or processes used by or competitive with ours.

In addition, laws of certain foreign countries do not protect intellectual property rights

to the same extent as do the laws of the United States.

Patent litigation is widespread

in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to form strategic alliances,

conduct clinical testing or manufacture and market any products under development.

If challenged, our patents may not be held valid.

could also become involved in interference proceedings in connection with one or more of our patents or patent applications to determine

priority of invention.

If we become involved in any litigation, interference or other administrative proceedings, we will likely incur

substantial expenses and the efforts of our technical and management personnel will be significantly diverted.

In addition, an adverse

determination could subject us to significant liabilities or require us to seek licenses that may not be available on favorable terms,

We may be restricted or prevented from manufacturing and selling our products in the event of an adverse determination in a

judicial or administrative proceeding or if we fail to obtain necessary licenses.

We may be unable to protect

our intellectual property rights and we may be liable for infringing the intellectual property rights of others.

Our ability to compete effectively

will depend on our ability to maintain the proprietary nature of our technologies.

We currently hold several pending patent applications

in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan and China for our technologies covering oral administration of insulin

and other proteins and oral administration of exenatide and proteins and 112 patents issued by the United States, Swiss, German, French,

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

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

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

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

our technology for the oral delivery of exenatide;

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

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

and Japanese patent offices for treating diabetes.

we intend to rely on a combination of trade secrets and non-disclosure and other contractual agreements and technical measures to protect

our rights in our technology.

We intend to depend upon confidentiality agreements with our officers, directors, employees, consultants,

and subcontractors, as well as collaborative partners, to maintain the proprietary nature of our technology.

These measures may not afford

us sufficient or complete protection, and others may independently develop technology similar to ours, otherwise avoid our confidentiality

agreements, or produce patents that would materially and adversely affect our business, prospects, financial condition and results of

We believe that our technology is not subject to any infringement actions based upon the patents of any third parties;

our technology may in the future be found to infringe upon the rights of others.

Others may assert infringement claims against us or against

companies to which we have licensed our technology, and if we should be found to infringe upon their patents, or otherwise impermissibly

utilize their intellectual property, our ability to continue to use our technology could be materially restricted or prohibited.

event occurs, we may be required to obtain licenses from the holders of this intellectual property, enter into royalty agreements, or

redesign our products so as not to utilize this intellectual property, each of which may prove to be uneconomical or otherwise impossible.

Licenses or royalty agreements required in order for us to use this technology may not be available on terms acceptable to us, or at all.

These claims could result in litigation, which could materially adversely affect our business, prospects, financial condition and results

of operations.

Further, we may need to indemnify companies to which we licensed our technology in the event that such technology is found

to infringe upon the rights of others.

Our commercial success will

also depend significantly on our ability to operate without infringing the patents and other proprietary rights of third parties.

applications are, in many cases, maintained in secrecy until patents are issued.

The publication of discoveries in the scientific or patent

literature frequently occurs substantially later than the date on which the underlying discoveries were made and patent applications are

In the event of infringement or violation of another party’s patent, we may be prevented from pursuing product development

or commercialization.

Business—Description of Business— Intellectual Property and Patents.”

Our success was primarily

dependent on the successful commercialization of our oral insulin capsule.

The successful commercialization

of our principal product, the oral insulin capsule, was crucial for our success.

On January 12, 2023, we announced top-line results from

the phase 3 trial of our oral insulin capsule, which did not meet its primary or secondary endpoints, and indicated that we expect to

discontinue oral insulin clinical activities for T2D.

At present, following the results of the ORA-D-013-1 Phase 3 trial, we have initiated

a comprehensive analysis of the data to understand if there is a path forward for our oral insulin candidate.

Concurrently, we are examining

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

Even if our analysis results in a

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

Principally, these

risks include the following:

on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding

level of expenditures for at least the next 12 months, although no assurance can be given that we will not need additional funds prior

to such time.

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

will 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

at various intervals in order to implement any potential strategic alternative, to continue our remaining or potential future research

and development programs, including significant requirements for operating expenses including intellectual property protection and enforcement,

for pursuit of regulatory approvals, and for commercialization of our remaining or future products.

We can provide no assurance that

additional funding will be available on a timely basis, on terms acceptable to us, or at all.

In the event that we are unable to obtain

such financing, we may not be able to implement the actions we decide to take as part of our strategic review process, and we will not

be able to fully develop and commercialize our technology or pursue new technology.

Our future capital requirements will depend upon

many factors, including:

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.

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

planned courses of action or research and development programs, or to enter into license or other arrangements with third parties to

commercialize products or technologies that we would otherwise seek to develop ourselves and commercialize ourselves.

In such event,

our business, prospects, financial condition and results of operations may be adversely affected as we may be required to scale-back,

eliminate, or delay development efforts or product introductions or enter into royalty, sales or other agreements with third parties

in order to commercialize our products.

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.”

rely upon patents to protect our technology.

patent position of biopharmaceutical and biotechnology firms is generally uncertain and involves complex legal and factual questions.

We do not know whether any of our current or future patent applications will result in the issuance of any patents.

Even issued patents

may be challenged, invalidated or circumvented.

Patents may not provide a competitive advantage or afford protection against competitors

with similar technology.

Competitors or potential competitors may have filed applications for, or may have received patents and may obtain

additional and proprietary rights to compounds or processes used by or competitive with ours.

In addition, laws of certain foreign countries

do not protect intellectual property rights to the same extent as do the laws of the United States.

litigation is widespread in the biopharmaceutical and biotechnology industry and we cannot predict how this will affect our efforts to

form strategic alliances, conduct clinical testing or manufacture and market any products under development.

If challenged, our patents

may not be held valid.

We could also become involved in interference proceedings in connection with one or more of our patents or patent

applications to determine priority of invention.

If we become involved in any litigation, interference or other administrative proceedings,

we will likely incur substantial expenses and the efforts of our technical and management personnel will be significantly diverted.

addition, an adverse determination could subject us to significant liabilities or require us to seek licenses that may not be available

on favorable terms, if at all.

We may be restricted or prevented from manufacturing and selling our products in the event of an adverse

determination in a judicial or administrative proceeding or if we fail to obtain necessary licenses.

may be unable to protect our intellectual property rights and we may be liable for infringing the intellectual property rights of others.

ability to compete effectively will depend on our ability to maintain the proprietary nature of our technologies.

We currently hold several

pending patent applications in the United States, Canada, Brazil, Europe, India, Hong Kong, Japan and China for our technologies covering

oral administration of insulin and other proteins and oral administration of exenatide and proteins and 117 patents issued by the United

States and various other countries’ patent offices that cover a part of our technology, which allows for the oral delivery of proteins;

patents issued by various patent offices that cover part of our technology for the oral delivery of exenatide;

and patents issued by

patent offices for treating diabetes.

Further, we rely on a combination of trade secrets and non-disclosure and other contractual agreements

and technical measures to protect our rights in our technology.

We depend upon confidentiality agreements with our officers, directors,

employees, consultants, and subcontractors, as well as collaborative partners, to maintain the proprietary nature of our technology.

These measures may not afford us sufficient or complete protection, and others may independently develop technology similar to ours,

otherwise avoid our confidentiality agreements, or produce patents that would materially and adversely affect our business, prospects,

financial condition and results of operations.

We believe that our technology is not subject to any infringement actions based upon the

patents of any third parties;

however, our technology may in the future be found to infringe upon the rights of others.

Others may assert

infringement claims against us or against companies to which we have licensed our technology, and if we should be found to infringe upon

their patents, or otherwise impermissibly utilize their intellectual property, our ability to continue to use our technology could be

materially restricted or prohibited.

If this event occurs, we may be required to obtain licenses from the holders of this intellectual

property, enter into royalty agreements, or redesign our products so as not to utilize this intellectual property, each of which may

prove to be uneconomical or otherwise impossible.

Licenses or royalty agreements required in order for us to use this technology may

not be available on terms acceptable to us, or at all.

These claims could result in litigation, which could materially adversely affect

our business, prospects, financial condition and results of operations.

Further, we may need to indemnify companies to which we licensed

our technology in the event that such technology is found to infringe upon the rights of others.

commercial success will also depend significantly on our ability to operate without infringing the patents and other proprietary rights

of third parties.

Patent applications are, in many cases, maintained in secrecy until patents are issued.

The publication of discoveries

in the scientific or patent literature frequently occurs substantially later than the date on which the underlying discoveries were made

and patent applications are filed.

In the event of infringement or violation of another party’s patent, we may be prevented from

pursuing product development or commercialization.

Business—Description of Business— Intellectual Property

and Patents.”

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

successful commercialization of our principal product, the oral insulin capsule, was crucial for our success.

On January 12, 2023, we

announced top-line results from the phase 3 trial of our oral insulin capsule, which did not meet its primary or secondary endpoints,

and indicated that we expect to discontinue oral insulin clinical activities for T2D.

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

Phase 3 trial, we conducted a comprehensive analysis of the data 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 basis;

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.

Our business may be seriously

harmed if our analysis does not produce positive results, if we are unable to find a path forward to continue development of our oral

insulin capsule, if we are unsuccessful in realizing new strategic opportunities or dealing with any of these risks, or if we are unable

to successfully commercialize our oral insulin capsule for some other reason.

We have limited experience

in conducting clinical trials.

Clinical trials must meet

FDA and foreign regulatory requirements.

We have limited experience in designing, conducting and managing the preclinical trials and clinical

trials necessary to obtain regulatory approval for our product candidates in any country.

We have entered into agreements with Integrium

LLC and other consultants to assist us in designing, conducting and managing our various clinical trials in the United States, Europe

Any failure of Integrium LLC or any other consultant to fulfill their obligations could result in significant additional costs

as well as delays in designing, consulting and completing clinical trials on our products.

Our clinical trials may

encounter delays, suspensions or other problems.

We may encounter problems

in clinical trials that may cause us or the FDA or foreign regulatory agencies to delay, suspend or terminate our clinical trials at any

These problems could include the possibility that we may not be able to conduct clinical trials at our preferred sites, enroll

a sufficient number of patients for our clinical trials at one or more sites or begin or successfully complete clinical trials in a timely

fashion, if at all.

For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South Africa was

slower than anticipated due to several factors, including the fact that many volunteers did not qualify during screening due to prior

asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site.

Furthermore, we, the

FDA or foreign regulatory agencies may suspend clinical trials at any time if we or they believe the subjects participating in the trials

are being exposed to unacceptable health risks or if we or they find deficiencies in the clinical trial process or conduct of the investigation.

If clinical trials of any of the product candidates fail, we will not be able to market the product candidate which is the subject of

the failed clinical trials.

The FDA and foreign regulatory agencies could also require additional clinical trials, which would result

in increased costs and significant development delays.

Our failure to adequately demonstrate the safety and effectiveness of a pharmaceutical

product candidate under development could delay or prevent regulatory approval of the product candidate and could have a material adverse

effect on our business, prospects, financial condition and results of operations.

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.

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

development of our oral insulin capsule, if we are unsuccessful in realizing new strategic opportunities or dealing with any of these

risks, or if we are unable to successfully commercialize our oral insulin capsule for some other reason.

have limited experience in conducting clinical trials.

trials must meet FDA and foreign regulatory requirements.

We have limited experience in designing, conducting and managing the preclinical

trials and clinical trials necessary to obtain regulatory approval for our product candidates in any country.

In the past, we entered

into agreements with Integrium LLC and other consultants to assist us in designing, conducting and managing our various clinical trials

in the United States, Europe and Israel.

Any failure of a consultant to fulfill their obligations could result in significant additional

costs as well as delays in designing, consulting and completing clinical trials on our products.

clinical trials may encounter delays, suspensions or other problems.

may encounter problems in clinical trials that may cause us or the FDA or foreign regulatory agencies to delay, suspend or terminate

our clinical trials at any phase.

These problems could include the possibility that we may not be able to conduct clinical trials at

our preferred sites, enroll a sufficient number of patients for our clinical trials at one or more sites or begin or successfully complete

clinical trials in a timely fashion, if at all.

For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19

vaccine in South Africa was slower than anticipated due to several factors, including the fact that many volunteers did not qualify during

screening due to prior asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site.

Furthermore, we, the FDA or foreign regulatory agencies may suspend clinical trials at any time if we or they believe the subjects participating

in the trials are being exposed to unacceptable health risks or if we or they find deficiencies in the clinical trial process or conduct

of the investigation.

If clinical trials of any of the product candidates fail, we will not be able to market the product candidate which

is the subject of the failed clinical trials.

The FDA and foreign regulatory agencies could also require additional clinical trials,

which would result in increased costs and significant development delays.

Our failure to adequately demonstrate the safety and effectiveness

of a pharmaceutical product candidate under development could delay or prevent regulatory approval of the product candidate and could

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

For example, see “Item

Business—Description

of Business— Research and Development During 2022” regarding the results of the ORA-D-013-1 Phase 3 trial that did not meet

its primary and secondary endpoints.

Finally, the COVID-19 pandemic has impacted clinical trials generally.

However, we experienced approximately

six months of delays in clinical trials due to slow-downs of recruitment for trials generally related to COVID-19.

We may experience further

delays in site initiation and patient enrollment, failures to comply with study protocols, delays in the manufacture of our product candidates

for clinical testing and other difficulties in starting or competing our clinical trials.

Initial success in the

completed and ongoing early-stage clinical trials does not ensure success in later stage trials, regulatory approval or commercial viability

of a product.

Positive results in a clinical

trial may not be replicated in subsequent or confirmatory trials.

Additionally, success in preclinical work or early stage clinical trials

does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval will be obtained.

of our product’s failure to show sufficient efficacy in patients with the targeted indication, or if such studies are discontinued

for any other reason, could negatively impact our development and commercialization goals for these products and our stock price could

Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical trials due to lack of

efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.

As a result, preliminary and interim data should

be viewed with caution until the final data are available.

We have invested in clinical studies of medicines that have not met the primary

clinical endpoints in their Phase 3 studies or have been discontinued for other reasons.

For example, in January 2023, we reported

that ORA-D-013-1 trial did not meet its primary or secondary endpoint.

Even if later stage clinical trials are successful, regulatory

authorities may delay or decline approval of our product candidates.

There are a number of factors

that could cause a clinical study to fail or be delayed, including:

(i) the clinical study may produce negative or inconclusive results;

(ii) regulators may require that we hold, suspend or terminate clinical research for noncompliance with regulatory requirements;

we, our partners, the FDA or foreign regulatory authorities could suspend or terminate a clinical study due to adverse side effects of

a product on subjects or lack of efficacy in the trial;

(iv) we, or our partners, may decide, or regulators may require us, to conduct

additional preclinical testing or clinical studies;

(v) change in rates of enrollment and dropout among clinical trial participants;

differences in the size and type of the patient populations;

(vii) changes in and adherence to the dosing regimen and other clinical trial

and (viii) people who enroll in the clinical study may later drop out due to adverse events, a perception they are not benefiting

from participating in the study, fatigue with the clinical study process or personal or other issues.

The occurrence of any of these events

could result in significant costs and expense, have an adverse effect on our business, financial condition and results of operations and/or

cause our stock price to decline or experience periods of volatility.

Clinical trials of our

products conducted by third parties may encounter delays, suspensions or other problems and are outside of our control.

Third parties who conduct

clinical trials of our products may encounter problems that may cause delays, suspensions or other problems at any phase.

These problems

could include the possibility that they may not be able to conduct clinical trials at their preferred sites, enroll a sufficient number

of patients for their clinical trials at one or more sites or begin or successfully complete clinical trials in a timely fashion, if at

For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South Africa was slower than

anticipated due to several factors, including the fact that many volunteers did not qualify during screening due to prior asymptomatic

COVID-19 infection and other conditions, and as a result we had to add an additional clinical site.

In addition, these third parties are

not controlled by us and may conduct these trials in a manner in which we disagree or which may prove to be unsuccessful.

domestic or foreign regulatory agencies may suspend clinical trials at any time if they believe the subjects participating in the trials

are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial process or conduct of the investigation.

If such clinical trials conducted by third parties fail, it could have a material adverse effect on our business, prospects, financial

condition and results of operations.

We can provide no assurance

that our products will obtain regulatory approval or that the results of clinical trials will be favorable.

The testing, marketing and

manufacturing of any of our products will require the approval of the FDA or regulatory agencies of other countries.

We cannot predict

with any certainty the amount of time necessary to obtain regulatory approvals, including from the FDA or other foreign regulatory authorities,

and whether any such approvals will ultimately be granted.

In any event, review and approval by the regulatory bodies is anticipated to

take a number of years.

Preclinical and clinical trials may reveal that one or more of our products are ineffective or unsafe, in which

event further development of such products could be seriously delayed or terminated.

For example, in January 2023, we announced that our

ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints.

As a result, we decided to terminate our ORA-D-013-2 Phase

3 trial and have initiated a comprehensive analysis of the data to understand if there is a path forward for our oral insulin candidate.

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— Research and Development” regarding the results of the ORA-D-013-1 Phase 3 trial

that did not meet its primary or secondary endpoints.

Finally, the COVID-19 pandemic impacted clinical trials generally in recent years,

and we experienced approximately six months of delays in clinical trials due to slow-downs of recruitment for trials generally related

We may experience further delays in site initiation and patient enrollment, failures to comply with study protocols, delays

in the manufacture of our product candidates for clinical testing and other difficulties in starting or competing our clinical trials.

success in the completed and ongoing early-stage clinical trials does not ensure success in later stage trials, regulatory approval or

commercial viability of a product.

results in a clinical trial may not be replicated in subsequent or confirmatory trials.

Additionally, success in preclinical work or

early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful or that regulatory approval

will be obtained.

Any of our product’s failure to show sufficient efficacy in patients with the targeted indication, or if such

studies are discontinued for any other reason, could negatively impact our development and commercialization goals for these products

and our stock price could decline.

Many companies in the biopharmaceutical industry have suffered significant setbacks in advanced clinical

trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results in earlier trials.

As a result, preliminary

and interim data should be viewed with caution until the final data are available.

We have invested in clinical studies of medicines

that have not met the primary clinical endpoints in their Phase 3 studies or have been discontinued for other reasons.

For example, in

January 2023, we reported that ORA-D-013-1 trial did not meet its primary or secondary endpoint.

Even if later stage clinical trials

are successful, regulatory authorities may delay or decline approval of our product candidates.

are a number of factors that could cause a clinical study to fail or be delayed, including:

(i) the clinical study may produce negative

or inconclusive results;

(ii) regulators may require that we hold, suspend or terminate clinical research for noncompliance with regulatory

requirements;

(iii) we, our partners, the FDA or foreign regulatory authorities could suspend or terminate a clinical study due to adverse

side effects of a product on subjects or lack of efficacy in the trial;

(iv) we, or our partners, may decide, or regulators may require

us, to conduct additional preclinical testing or clinical studies;

(v) change in rates of enrollment and dropout among clinical trial

participants;

(vi) differences in the size and type of the patient populations;

(vii) changes in and adherence to the dosing regimen

and other clinical trial protocols;

and (viii) people who enroll in the clinical study may later drop out due to adverse events, a perception

they are not benefiting from participating in the study, fatigue with the clinical study process or personal or other issues.

The occurrence

of any of these events could result in significant costs and expense, have an adverse effect on our business, financial condition and

results of operations and/or cause our stock price to decline or experience periods of volatility.

trials of our products conducted by third parties may encounter delays, suspensions or other problems and are outside of our control.

parties who conduct clinical trials of our products may encounter problems that may cause delays, suspensions or other problems at any

These problems could include the possibility that they may not be able to conduct clinical trials at their preferred sites, enroll

a sufficient number of patients for their clinical trials at one or more sites or begin or successfully complete clinical trials in a

timely fashion, if at all.

For example, the rate of enrollment for our Phase 1 clinical trial for our oral COVID-19 vaccine in South

Africa was slower than anticipated due to several factors, including the fact that many volunteers did not qualify during screening due

to prior asymptomatic COVID-19 infection and other conditions, and as a result we had to add an additional clinical site.

these third parties are not controlled by us and may conduct these trials in a manner in which we disagree or which may prove to be unsuccessful.

Furthermore, domestic or foreign regulatory agencies may suspend clinical trials at any time if they believe the subjects participating

in the trials are being exposed to unacceptable health risks or if they find deficiencies in the clinical trial process or conduct of

the investigation.

If such clinical trials conducted by third parties fail, it could have a material adverse effect on our business,

prospects, financial condition and results of operations.

can provide no assurance that our products will obtain regulatory approval or that the results of clinical trials will be favorable.

testing, marketing and manufacturing of any of our products will require the approval of the FDA or regulatory agencies of other countries.

We cannot predict with any certainty the amount of time necessary to obtain regulatory approvals, including from the FDA or other foreign

regulatory authorities, and whether any such approvals will ultimately be granted.

In any event, review and approval by the regulatory

bodies is anticipated to take a number of years.

Preclinical and clinical trials may reveal that one or more of our products are ineffective

or unsafe, in which event further development of such products could be seriously delayed or terminated.

For example, in January 2023,

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

As a result, we decided to terminate

our ORA-D-013-2 Phase 3 trial, conducted a comprehensive analysis of the data 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.

Business—Description of Business—Government Regulation.”

We are dependent upon third

party suppliers of our raw materials and for other services.

We are dependent on outside

vendors for our entire supply of the oral insulin capsules and do not currently have any long-term agreements in place for the supply

of oral insulin capsules, which is still necessary if we decide to continue development of these projects.

While we believe that there

are numerous sources of supply available, if the third party suppliers were to cease production, or otherwise fail to supply us with quality

raw materials in sufficient quantities on a timely basis and we were unable to contract on acceptable terms for these services with alternative

suppliers, our ability to produce our products and to conduct testing and clinical trials would be materially adversely affected.

We rely on suppliers, vendors,

outsourcing partners, alliance partners and other third parties to research, develop, manufacture, commercialize, co-promote and sell

our products, manage certain marketing, IT, data and other business unit and functional services and meet their contractual, regulatory

and other obligations.

are dependent upon third party suppliers of our raw materials and for other services.

are dependent on outside vendors for our entire supply of the oral insulin capsules and do not currently have any long-term agreements

in place for the supply of oral insulin capsules, which is still necessary if we decide to continue development of these projects.

we believe that there are numerous sources of supply available, if the third party suppliers were to cease production, or otherwise fail

to supply us with quality raw materials in sufficient quantities on a timely basis and we were unable to contract on acceptable terms

for these services with alternative suppliers, our ability to produce our products and to conduct testing and clinical trials would be

materially adversely affected.

rely on suppliers, vendors, outsourcing partners, alliance partners and other third parties to research, develop, manufacture, commercialize,

co-promote and sell our products, manage certain marketing, IT, data and other business unit and functional services and meet their contractual,

regulatory and other obligations.

Using these third parties poses a number of risks, such as:

(i) they may not perform to our standards or legal

requirements, for example, in relation to the outsourcing of significant clinical development activities for innovative medicines to some

(i) they may not perform to our standards

or legal requirements, for example, in relation to the outsourcing of significant clinical development activities for innovative medicines

to some CROs;

(ii) they may not produce reliable products;

(iii) they may not perform in a timely manner;

(iv) they may not maintain confidentiality

of our proprietary information;

(iv) they may not maintain

confidentiality of our proprietary information;

(v) they may incur a significant cyberattack or business disruption;

(vi) they may be subject to government

orders or mandates that require them to give priority to the government and set aside pre-existing commercial orders;

(vii) disputes may

arise with respect to ownership of rights to technology developed with our partners;

and (viii) disagreements could cause delays in, or

termination of, the research, development or commercialization of the product or result in litigation or arbitration.

The failure of any

critical third party to meet its obligations;

(vi) they may be

subject to government orders or mandates that require them to give priority to the government and set aside pre-existing commercial orders;

(vii) disputes may arise with respect to ownership of rights to technology developed with our partners;

and (viii) disagreements could

cause delays in, or termination of, the research, development or commercialization of the product or result in litigation or arbitration.

The failure of any critical third party to meet its obligations;

to adequately deploy business continuity plans in the event of a crisis;

and/or to satisfactorily

resolve significant disagreements with us or address other factors, could have a material adverse impact on our operations and results.

In addition, if these third parties violate, or are alleged to have violated, any laws or regulations, including the local pharmaceutical

code, the U.S.

and/or to satisfactorily resolve significant disagreements with us or address other factors, could have a material adverse impact on

our operations and results.

In addition, if these third parties violate, or are alleged to have violated, any laws or regulations, including

the local pharmaceutical code, the U.S.

Foreign Corrupt Practice Act of 1977, the U.K.

Bribery Act of 2010, the EU’s General Data Protection Regulations,

and other similar laws and regulations, during the performance of their obligations for us, we could suffer financial and reputational

harm or other negative outcomes, including possible legal consequences.

Any future revenues from

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

Any future revenues from HTIT

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 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.

Accordingly, 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.

If we do not resolve our

dispute with HTIT favorably, we may need to reverse deferred revenue of up to $2 million and may not receive an additional $4 million

in royalties.

On 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 dispute said claims and have been engaged in discussions and exchanges with HTIT in an attempt

to clarify and resolve disagreements between the parties regarding milestone payments and work plan implementation, 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, 2022 and 2021.

In addition, we may not receive an additional $4 million in Royalties if

HTIT is entitled to the full disputed amount of $6 million.

We may not realize a return

on the ordinary shares of DNA and Entera that we own.

DNA’s 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.

In 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

We may not realize the

full benefit from our distribution license agreement with Medicox.

Our distribution license agreement

with Medicox provides that Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer

price per capsule and pay us up to $15 million in developmental milestones, $2 million of which have already been received by us.

the results of the ORA-D-013-1 Phase 3 trial, we are currently evaluating with Medicox a path forward to continue our collaboration.

we are not successful in finding a mutually agreed way to continue our collaboration, or if Medicox is not successful in independently

advancing the oral insulin candidate, we may not realize the benefits from this collaboration.

We are highly dependent

upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our products.

Our long-term strategy is

to ultimately seek a strategic commercial partner, or partners, such as large pharmaceutical companies, with extensive experience in the

development, commercialization, and marketing of insulin applications and/or other orally digestible drugs.

Such planned strategic partnership,

or partnerships, may provide a marketing and sales infrastructure for our products as well as financial and operational support for global

clinical trials, post marketing trials, label expansions and other regulatory requirements concerning future clinical development in the

United States and elsewhere.

We currently lack the resources to manufacture any of our product candidates on a large scale and we have

no sales, marketing or distribution capabilities.

In the event we are not able to enter into a collaborative agreement with a partner,

or partners, on commercially reasonable terms, or at all, we may be unable to commercialize our products, which would have a material

adverse effect upon our business, prospects, financial condition and results of operations.

The biotechnology and biopharmaceutical

industries are characterized by rapid technological developments and a high degree of competition.

We may be unable to compete with more

substantial enterprises.

The biotechnology and biopharmaceutical

industries are characterized by rapid technological developments and a high degree of competition.

As a result, our products could become

obsolete before we recoup any portion of our related research and development and commercialization expenses.

These industries are highly

competitive, and this competition comes both from biotechnology firms and from major pharmaceutical and chemical companies.

Many of these

companies have substantially greater financial, marketing and human resources than we do (including, in some cases, substantially greater

experience in clinical testing, manufacturing and marketing of pharmaceutical products).

We also experience competition in the development

of our products from universities and other research institutions and compete with others in acquiring technology from such universities

and institutions.

We face the risk that new market entrants and existing competition may try to replicate our business model or introduce

a more innovative offering that renders our services less competitive or obsolete.

In addition, our research and development efforts may

target diseases and conditions for which there are existing therapies or therapies that are being developed by our competitors.

any products resulting from our research and development efforts might not be able to compete successfully with others’ existing

and future products.

Bribery Act of 2010, the EU’s General Data

Protection Regulations, and other similar laws and regulations, during the performance of their obligations for us, we could suffer financial

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

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 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

been received by us.

If we are not successful in finding a mutually agreed way to continue our collaboration following the results of

the ORA-D-013-1 Phase 3 trial, or if Medicox is not successful in independently advancing the oral insulin candidate, we may not realize

the benefits from this collaboration.

are highly dependent upon our ability to enter into agreements with collaborative partners to develop, commercialize and market our products.

long-term strategy is to ultimately seek a strategic commercial partner, or partners, such as large pharmaceutical companies, with extensive

experience in the development, commercialization, and marketing of insulin applications and/or other orally digestible drugs.

strategic partnership, or partnerships, may provide a marketing and sales infrastructure for our products as well as financial and operational

support for global clinical trials, post marketing trials, label expansions and other regulatory requirements concerning future clinical

development in the United States and elsewhere.

We currently lack the resources to manufacture any of our product candidates on a large

scale and we have no sales, marketing or distribution capabilities.

In the event we are not able to enter into a collaborative agreement

with a partner, or partners, on commercially reasonable terms, or at all, we may be unable to commercialize our products, which would

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

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.

biotechnology and biopharmaceutical industries are characterized by rapid technological developments and a high degree of competition.

As a result, our products could become obsolete before we recoup any portion of our related research and development and commercialization

These industries are highly competitive, and this competition comes both from biotechnology firms and from major pharmaceutical

and chemical companies.

Many of these companies have substantially greater financial, marketing and human resources than we do (including,

in some cases, substantially greater experience in clinical testing, manufacturing and marketing of pharmaceutical products).

experience competition in the development of our products from universities and other research institutions and compete with others in

acquiring technology from such universities and institutions.

We face the risk that new market entrants and existing competition may

try to replicate our business model or introduce a more innovative offering that renders our services less competitive or obsolete.

addition, our research and development efforts may target diseases and conditions for which there are existing therapies or therapies

that are being developed by our competitors.

Further, any products resulting from our research and development efforts might not be able

to compete successfully with others’ existing and future products.

Business—Description of Business—Competition.”

Our financial position

or results could be negatively affected by product liability claims.

It is possible that we will

be responsible for potential product liability stemming from product research, development or manufacturing and may face an even greater

risk if any product candidate that we develop is commercialized.

If we cannot successfully defend ourselves against claims that products

we develop independently or with our partners caused injuries, we could incur substantial liabilities.

Regardless of the merit or eventual

outcome of such claims, any liability claims may result in, among other things, decreased demand for any product that we may develop,

loss of revenues, significant time and costs to defend the related litigation, initiation of investigations by regulators and injury to

our reputation and significant negative media attention.

On occasion, large judgments have been awarded in class action lawsuits based

on drugs or medical treatments that had unanticipated adverse effects.

Our clinical trials are covered by liability insurance, but notwithstanding

such coverage, our financial position or results could be negatively affected by product liability claims.

We have limited senior

management resources and may be required to obtain more resources to manage our growth.

We expect the expansion of

our business, as well as the activities we take as a result of our strategic review process, to place a significant strain on our limited

managerial, operational and financial resources.

We will be required to expand our operational and financial systems significantly and

to expand, train and manage our work force in order to manage the expansion of our operations.

Our failure to fully integrate our new

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

financial position or results could be negatively affected by product liability claims.

is possible that we will be responsible for potential product liability stemming from product research, development or manufacturing

and may face an even greater risk if any product candidate that we develop is commercialized.

If we cannot successfully defend ourselves

against claims that products we develop independently or with our partners caused injuries, we could incur substantial liabilities.

of the merit or eventual outcome of such claims, any liability claims may result in, among other things, decreased demand for any product

that we may develop, loss of revenues, significant time and costs to defend the related litigation, initiation of investigations by regulators

and injury to our reputation and significant negative media attention.

On occasion, large judgments have been awarded in class action

lawsuits based on drugs or medical treatments that had unanticipated adverse effects.

Our clinical trials are covered by liability insurance,

but notwithstanding such coverage, our financial position or results could be negatively affected by product liability claims.

have limited senior management resources and may be required to obtain more resources to manage our growth.

expect the expansion of our business, as well as the activities we take as a result of our strategic review process, to place a significant

strain on our limited managerial, operational and financial resources.

We will be required to expand our operational and financial systems

significantly and to expand, train and manage our work force in order to manage the expansion of our operations.

Our failure to fully

integrate our new employees into our operations could have a material adverse effect on our business, prospects, financial condition

and results of operations.

Our ability to attract and retain highly skilled personnel is critical to our operations and expansion.

We face competition for these

types of personnel from other technology companies and more established organizations, many of which have significantly larger operations

and greater financial, technical, human and other resources than we have.

We may not be successful in attracting and retaining qualified

personnel on a timely basis, on competitive terms or at all.

If we are not successful in attracting and retaining these personnel, our

business, prospects, financial condition and results of operations will be materially adversely affected.

Discussion and Analysis of Financial Condition and Results of Operations,” “Item 1.

face competition for these types of personnel from other technology companies and more established organizations, many of which have

significantly larger operations and greater financial, technical, human and other resources than we have.

We may not be successful in

attracting and retaining qualified personnel on a timely basis, on competitive terms or at all.

If we are not successful in attracting

and retaining these personnel, our business, prospects, financial condition and results of operations will be materially adversely affected.

Management’s Discussion and Analysis of Financial Condition and Results of Operations,” “Item 1.

Business—Description of Business—Employees.”

We depend upon our senior

management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage.

We currently depend upon the

efforts and abilities of our senior executives, as well as the services of several key consultants and other key personnel, including

depend upon our senior management and skilled personnel and their loss or unavailability could put us at a competitive disadvantage.

currently depend upon the efforts and abilities of our senior executives, as well as the services of several key consultants and other

key personnel, including Dr.

Miriam Kidron, our Chief Scientific Officer.

The loss or unavailability of the services of any of these individuals for any significant

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

maintain “key man” life insurance policies for any of our senior executives.

In addition, recruiting and retaining qualified

scientific personnel to perform future research and development work will be critical to our success.

There is currently a shortage of

employees with expertise in developing, manufacturing and commercialization of products and related clinical and regulatory affairs, and

this shortage is likely to continue.

Competition for skilled personnel is intense and turnover rates are high.

Our ability to attract

and retain qualified personnel may be limited.

Our inability to attract and retain qualified skilled personnel would have a material adverse

effect on our business, prospects, financial condition and results of operations.

Our existing and any future

joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we expect from these arrangements.

We are currently party to

a joint venture, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize assets to or in this

joint venture or other joint ventures that we may enter.

Our participation in our existing

joint venture is subject to risks, including the following:

share approval rights over certain major decisions affecting the ownership or operation of the joint venture and any assets owned by

the joint venture;

may need to contribute additional capital in order to preserve, maintain or grow the joint venture and its 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 venture;

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

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

ability to sell our interest in, or sell additional assets to, the joint venture or the joint venture’s ability to sell additional

interests of, or assets owned by, the joint venture 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 venture;

The loss or unavailability of the services of any of these

individuals for any significant period of time could have a material adverse effect on our business, prospects, financial condition and

results of operations.

We do not maintain “key man” life insurance policies for any of our senior executives.

recruiting and retaining qualified scientific personnel to perform future research and development work will be critical to our success.

There is currently a shortage of employees with expertise in developing, manufacturing and commercialization of products and related

clinical and regulatory affairs, and this shortage is likely to continue.

Competition for skilled personnel is intense and turnover rates

Our ability to attract and retain qualified personnel may be limited.

Our inability to attract and retain qualified skilled

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

existing and any future joint ventures may limit our flexibility with jointly owned investments and we may not realize the benefits we

expect from these arrangements.

are currently party to certain joint ventures, and we may in the future sell or contribute additional assets or acquire, develop or recapitalize

assets to or in these joint ventures or other joint ventures that we may enter.

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.

Any of the foregoing risks

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

Further, these, similar, enhanced

or additional risks, including possible risks of the other joint venture investors having licensed assets to the joint venture, may apply

to any future additional or amended joint ventures that we may enter into.

Healthcare policy changes,

including pending legislation recently adopted and further proposals still pending to reform the U.S.

healthcare system, may harm our

future business.

Healthcare costs have risen

significantly over the past decade.

There have been and continue to be proposals by legislators, regulators and third-party payors to

keep these costs down.

Certain proposals, if passed, would impose limitations on the prices we will be able to charge for the products

that we are developing, or the amounts of reimbursement available for these products from governmental agencies or third-party payors.

These limitations could in turn reduce the amount of revenues that we will be able to generate in the future from sales of our products

and licenses of our technology.

In 2010, the federal government

enacted healthcare reform legislation that has significantly impacted the pharmaceutical industry.

In addition to requiring most individuals

to have health insurance and establishing new regulations on health plans, this legislation requires discounts under the Medicare drug

benefit program and increased rebates on drugs covered by Medicaid.

In addition, the legislation imposes an annual fee, which has increased

annually, on sales by branded pharmaceutical manufacturers.

There can be no assurance that our business will not be materially adversely

affected by these increased rebates, fees and other provisions.

In addition, these and other initiatives in the United States may continue

the pressure on drug pricing, especially under the Medicare and Medicaid programs, and may also increase regulatory burdens and operating

The announcement or adoption of any such initiative could have an adverse effect on potential revenues from any product that we

may successfully develop.

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.

these, similar, enhanced or additional risks, including possible risks of the other joint venture investors having licensed assets to

the joint venture, may apply to any future additional or amended joint ventures that we may enter into.

policy changes, including pending legislation recently adopted and further proposals still pending to reform the U.S.

healthcare system,

may harm our future business.

costs have risen significantly over the past decade.

There have been and continue to be proposals by legislators, regulators and third-party

payors to keep these costs down.

Certain proposals, if passed, would impose limitations on the prices we will be able to charge for the

products that we are developing, or the amounts of reimbursement available for these products from governmental agencies or third-party

These limitations could in turn reduce the amount of revenues that we will be able to generate in the future from sales of our

products and licenses of our technology.

2010, the federal government enacted healthcare reform legislation that has significantly impacted the pharmaceutical industry.

to requiring most individuals to have health insurance and establishing new regulations on health plans, this legislation requires discounts

under the Medicare drug benefit program and increased rebates on drugs covered by Medicaid.

In addition, the legislation imposes an annual

fee, which has increased annually, on sales by branded pharmaceutical manufacturers.

There can be no assurance that our business will

not be materially adversely affected by these increased rebates, fees and other provisions.

In addition, these and other initiatives

in the United States may continue the pressure on drug pricing, especially under the Medicare and Medicaid programs, and may also increase

regulatory burdens and operating costs.

The announcement or adoption of any such initiative could have an adverse effect on potential

revenues from any product that we may successfully develop.

An expansion in government’s role in the U.S.

healthcare industry may lower the future revenues for the

products we are developing and adversely affect our future business, possibly materially.

In September 2017, members

Congress introduced legislation with the announced intention to repeal and replace major provisions of the Patient Protection

and Affordable Care Act, or the ACA.

In addition to those efforts, on October 12, 2017, an executive order was issued that modified certain

aspects of the ACA.

healthcare industry may

lower the future revenues for the products we are developing and adversely affect our future business, possibly materially.

September 2017, members of the U.S.

Congress introduced legislation with the announced intention to repeal and replace major provisions

of the Patient Protection and Affordable Care Act, or the ACA.

In addition to those efforts, on October 12, 2017, an executive order

was issued that modified certain aspects of the ACA.

Following several years of litigation in the federal courts, in June 2021, the U.S.

Supreme Court upheld the ACA when

it dismissed a legal challenge to the ACA’s constitutionality.

Further attempts to repeal or to repeal and replace the ACA may continue.

In addition, various other healthcare reform proposals have also emerged at the federal and state level.

We cannot predict what healthcare

initiatives, if any, will be implemented at the federal or state level, or the effect any future legislation or regulation will have on

We are exposed to fluctuations

in currency exchange rates.

A considerable amount of our

expenses are generated in dollars or in dollar-linked currencies, but a significant portion of our expenses such as some clinical trials

and payroll costs are generated in other currencies such as NIS and Euro.

Most of the time, our non-dollar assets are not totally offset

by non-dollar liabilities.

Due to the foregoing and to the fact that our financial results are measured in dollars, our results could

be adversely affected as a result of a strengthening or weakening of the dollar compared to these other currencies.

During the years ended

December 31, 2017, 2019, 2020 and 2021, the dollar depreciated in relation to the NIS, which raised the dollar cost of our Israeli based

operations and adversely affected our financial results, while during the year ended December 31, 2018 and 2022, the dollar increased

in relation to the NIS, which reduced the dollar cost of our Israeli based operations costs.

In addition, our results could also be adversely

affected if we are unable to guard against currency fluctuations in the future.

Although we may in the future decide to undertake foreign

exchange hedging transactions to cover a portion of our foreign currency exchange exposure, we currently do not hedge our exposure to

foreign currency exchange risks.

These transactions, however, may not adequately protect us from future currency fluctuations and, even

if they do protect us, may involve operational or financing costs we would not otherwise incur.

The COVID-19 pandemic,

or any other pandemic, epidemic or outbreak of an infectious disease, may materially and adversely affect our clinical trial operations,

our business and operations.

The spread of COVID-19 may

result in the inability of our suppliers to deliver supplies to us on a timely basis.

In addition, health professionals may reduce staffing

and reduce or postpone meetings with clients in response to the spread of an infectious disease.

Though we have not yet experienced such

events, if they would occur, they could result in a period of business disruption, and in reduced operations, any of which could materially

affect our business, financial condition and results of operations.

However, we experienced approximately

six months of delays in clinical trials due to slow-downs of recruitment for trials generally.

Although we do not expect any material

impact on our development timeline and our liquidity due to COVID-19, the ongoing development of the COVID-19 pandemic globally could

adversely impact our clinical trial operations in the United States, Israel and in Europe, including our ability to recruit and retain

patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19 if an outbreak

occurs in their geography or due to government or institutional quarantines or stay-at-home measures.

We continue to assess the effect

on our operations by monitoring the status of COVID-19.

We face uncertainties related

to Oravax’s oral COVID-19 vaccine.

We face uncertainties related

to Oravax’s oral COVID-19 vaccine, including uncertainties related to the risk that our continued development programs may not be

successful, commercially viable or receive approval from regulatory authorities.

Other companies may produce superior or competitive oral

or other products that make Oravax’s oral COVID-19 vaccine not commercially worthwhile.

Even if we succeed in developing the product,

the demand for any product we may develop may no longer exist, given the fluid nature of the COVID-19 pandemic, including possible decreased

demand for vaccines due to weaker strains, the need for different vaccines for new variants of the virus or an end of the pandemic that

may render Oravax’s vaccine obsolete.

Risks Related to our Common Stock

Future sales of our common

stock by our existing stockholders could adversely affect our stock price.

Supreme Court upheld the ACA when it dismissed a legal challenge to the ACA’s constitutionality.

Further attempts to repeal or

to repeal and replace the ACA may continue.

In addition, various other healthcare reform proposals have also emerged at the federal and

We cannot predict what healthcare initiatives, if any, will be implemented at the federal or state level, or the effect

any future legislation or regulation will have on us.

are exposed to fluctuations in currency exchange rates.

considerable amount of our expenses are generated in dollars or in dollar-linked currencies, but a significant portion of our expenses

such as some clinical trials and payroll costs are generated in other currencies such as NIS and Euro.

Most of the time, our non-dollar

assets are not totally offset by non-dollar liabilities.

Due to the foregoing and to the fact that our financial results are measured

in dollars, our results could be adversely affected as a result of a strengthening or weakening of the dollar compared to these other

During the years ended December 31, 2019, 2020 and 2021, the dollar depreciated in relation to the NIS, which raised the

dollar cost of our Israeli based operations and adversely affected our financial results, while during the year ended December 31, 2022

and 2023, the dollar increased in relation to the NIS, which reduced the dollar cost of our Israeli based operations costs.

our results could also be adversely affected if we are unable to guard against currency fluctuations in the future.

Although we may in

the future decide to undertake foreign exchange hedging transactions to cover a portion of our foreign currency exchange exposure, we

currently do not hedge our exposure to foreign currency exchange risks.

These transactions, however, may not adequately protect us from

future currency fluctuations and, even if they do protect us, may involve operational or financing costs we would not otherwise incur.

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

face uncertainties related to Oravax’s oral COVID-19 vaccine, including uncertainties related to the risk that our continued development

programs may not be successful, commercially viable or receive approval from regulatory authorities.

Other companies may produce superior

or competitive oral or other products that make Oravax’s oral COVID-19 vaccine not commercially worthwhile.

Even if we succeed

in developing the product, the demand for any product we may develop may no longer exist, given the fluid nature of the COVID-19 pandemic,

including possible decreased demand for vaccines due to weaker strains, the need for different vaccines for new variants of the virus

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

Related to the Note

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.

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.

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

Although the Note is secured by a first

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

be able to repay the 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.

may have difficulty realizing the full value of the Warrants.

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

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

of the issuance date.

For purposes of the Penny Warrants, the Management Sale Trigger Date is generally the first date that certain members

of Scilex management engage in certain sales or other similar transfers of shares of Scilex Common Stock or other of Scilex’s or

any of its subsidiaries’ securities, subject to certain exceptions as are customary for lock-up agreements executed by directors

and officers in connection with financings or similar transactions.

Subsequent Penny Warrants will vest and become exercisable on the date that is the later of (i) Subsequent Penny Warrant Vesting Date,

and (ii) the earliest of (A) March 14, 2025, (B) the date on which the Note has been repaid in full and (C) the Management Sale Trigger

Date, if any.

Each Subsequent Penny Warrant will expire on the date that is the fifth anniversary of the issuance date;

provided that,

if the 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.

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

10 unchanged sentences

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

Our issuance of warrants,

options and RSUs to investors, employees and consultants may have a negative effect on the trading prices of our common stock as well

as a dilutive effect.

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

3 unchanged sentences

We also had outstanding

RSUs exercisable for 265,302 shares of common stock at a total exercise price of $900.

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

Because we will not pay

cash dividends in the foreseeable future, investors may have to sell shares of our common stock in order to realize their investment.

We have not paid any cash

dividends on our common stock and do not intend to pay cash dividends in the foreseeable future.

We intend to retain future earnings,

if any, for reinvestment in the development and expansion of our business.

Any credit agreements which we may enter into with institutional

lenders or otherwise may restrict our ability to pay dividends.

Whether we pay cash dividends in the future will be at the discretion

of our Board and will be dependent upon our financial condition, results of operations, capital requirements and any other factors that

our Board decides is relevant.

Our failure to maintain

compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of our common stock.

Our common stock is currently

listed on The Nasdaq Capital Market.

In order to maintain this listing, we must satisfy minimum financial and other requirements.

Listing Rule 5550(a)(2) requires the minimum bid price of our common stock on the Nasdaq Capital Market to remain above $1.00.

bid price of our common stock closes below $1.00 per share for 30 consecutive business days, we would be in violation of Nasdaq Listing

Rule 5550(a)(2).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we would have 180 calendar days to regain compliance with the minimum

bid requirement to achieve compliance with the minimum bid price requirement.

While we intend to engage

in efforts to maintain compliance, and thus maintain our listing, there can be no assurance that we will continue to meet all applicable

Nasdaq Capital Market requirements in the future, especially in light of any strategic transaction we may choose to undertake.

common stock were removed from listing with the Nasdaq Capital Market, it may be subject to the so-called “penny stock” rules.

The SEC has adopted regulations that define a “penny stock” to be any equity security that has a market price per share of

less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange, which is the exception

on which we currently rely.

For any transaction involving a “penny stock,” unless exempt, the rules impose additional sales

practice requirements on broker-dealers, subject to certain exceptions.

If our common stock were delisted and determined to be a “penny

stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire

or dispose of our common stock on the secondary market.

If our common stock is delisted

and there is no longer an active trading market for our shares, it may, among other things:

● cause stockholders difficulty in selling our

shares without depressing the market price for the shares or selling our shares at all;

● substantially impair our ability to raise additional

● result in a loss of institutional investor interest

and fewer financing opportunities for us;

● result in costly litigation, significant liabilities

and diversion of our management’s time and attention and could have a material adverse effect on our financial condition, business

and results of operations.

A delisting would also reduce

the value of our equity compensation plans, which could negatively impact our ability to retain employees.

As the market price of

our common stock may fluctuate significantly, this may make it difficult for you to sell your shares of common stock when you want or

at prices you find attractive.

The price of our common stock

is currently listed on The Nasdaq Capital Market and on the Tel Aviv Stock Exchange and constantly changes.

In recent years, the stock

market in general has experienced extreme price and volume fluctuations.

We expect that the market price of our common stock will continue

to fluctuate.

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.

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

have not paid any cash dividends on our common stock and do not intend to pay cash dividends in the foreseeable future.

retain future earnings, if any, for reinvestment in the development and expansion of our business.

Any credit agreements which we may

enter into with institutional lenders or otherwise may restrict our ability to pay dividends.

Whether we pay cash dividends in the future

will be at the discretion of our Board and will be dependent upon our financial condition, results of operations, capital requirements

and any other factors that our Board decides is relevant.

failure to maintain compliance with the Nasdaq Capital Market’s continued listing requirements could result in the delisting of

our common stock.

common stock is currently listed on the Nasdaq Capital Market.

In order to maintain this listing, we must satisfy minimum financial and

other requirements.

Nasdaq Listing Rule 5550(a)(2) requires the minimum bid price of our common stock on the Nasdaq Capital Market to

remain above $1.00.

If the bid price of our common stock closes below $1.00 per share for 30 consecutive business days, we would be in

violation of Nasdaq Listing Rule 5550(a)(2).

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we would have 180 calendar days to

regain compliance with the minimum bid requirement.

we intend to engage in efforts to maintain compliance, and thus maintain our listing, there can be no assurance that we will continue

to meet all applicable Nasdaq Capital Market requirements in the future, especially in light of any strategic transaction we may choose

to undertake.

If our common stock were removed from listing with the Nasdaq Capital Market, it may be subject to the so-called “penny

stock” rules.

The SEC has adopted regulations that define a “penny stock” to be any equity security that has a market

price per share of less than $5.00, subject to certain exceptions, such as any securities listed on a national securities exchange, which

is the exception on which we currently rely.

For any transaction involving a “penny stock,” unless exempt, the rules impose

additional sales practice requirements on broker-dealers, subject to certain exceptions.

If our common stock were delisted and determined

to be a “penny stock,” a broker-dealer may find it more difficult to trade our common stock and an investor may find it more

difficult to acquire or dispose of our common stock on the secondary market.

our common stock is delisted and there is no longer an active trading market for our shares, it may, among other things:

cause stockholders

difficulty in selling our shares without depressing the market price for the shares or selling our shares at all;

substantially impair

our ability to raise additional funds;

result in a loss of institutional investor interest and fewer financing opportunities for us;

and/or result in costly litigation, significant liabilities and diversion of our management’s time and attention and could have

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

delisting would also reduce the value of our equity compensation plans, which could negatively impact our ability to retain employees.

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.

price of our common stock is currently listed on the Nasdaq Capital Market and on the Tel Aviv Stock Exchange and constantly changes.

In recent years, the stock market in general has experienced extreme price and volume fluctuations.

We expect that the market price of

our common stock will continue to fluctuate.

These fluctuations may result from a variety of factors, many of which are beyond our control.

For example, we experienced

a significant decline in the market price of our common stock after announcing the results of our ORA-D-013-1 Phase 3 trial in January

For example, we experienced a significant decline in the market price of our common stock after announcing the results of our ORA-D-013-1

Phase 3 trial in January 2023.

These factors include:

market acceptance of our new strategy, once determined and announced;

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

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

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

entering into or terminating strategic relationships;

changes in government regulation;

departure of key personnel;

disputes concerning patents or proprietary rights;

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 markets.

Future sales of common

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

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

Future sales of substantial

amounts of our common stock, including pursuant to any strategic opportunity, the 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.

Our stockholders may experience

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

To the extent that we raise

additional funds by issuing equity securities, including in connection with any strategic opportunity or pursuant to the 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.

Risks Related to Conducting Business in Israel

We are affected by the

political, economic and military risks of having operations in Israel.

We have operations in the

State of Israel, and we are directly affected by political, economic and security conditions in that country.

Since the establishment

of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors and a state of hostility,

varying in degree and intensity, has led to security and economic problems for Israel.

In addition, acts of terrorism, armed conflicts

or political instability in the region could negatively affect local business conditions and harm our results of operations.

predict the effect on the region of any diplomatic initiatives or political developments involving Israel or the Palestinians or other

countries and territories in the Middle East.

Recent political events, including political uprisings, social unrest and regime change,

in various countries in the Middle East and North Africa have weakened the stability of those countries and territories, which could result

in extremists coming to power.

In addition, Iran has threatened to attack Israel and is widely believed to be developing nuclear weapons.

Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza and Hezbollah in Lebanon.

This situation has escalated in the past and may potentially escalate in the future to violent events which may affect Israel and us.

Our business, prospects, financial condition and results of operations could be materially adversely affected if major hostilities involving

Israel should occur or if trade between Israel and its current trading partners is interrupted or curtailed.

All 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.

Some of our officers, directors and employees currently are or in the

future may be obligated to perform annual military reserve duty.

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

Because we received grants

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

We received royalty-bearing

grants from the Israel Innovation Authority of the Israeli Ministry of Economy & Industry, or IIA, for research and development programs

that meet specified criteria.

We did not recognize any grants in the year ended December 31, 2022, the four month period ended December

31,2021 and the year ended August 31, 2021.

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.

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.

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.

Related to Conducting Business in Israel

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

have operations in the State of Israel, and we are directly affected by political, economic and security conditions in that country.

Since the establishment of the State of Israel in 1948, a number of armed conflicts have taken place between Israel and its Arab neighbors

and a state of hostility, varying in degree and intensity, has led to security and economic problems for Israel.

In addition, acts of

terrorism, armed conflicts or political instability in the region could negatively affect local business conditions and harm our results

of operations.

We cannot predict the effect on the region of any diplomatic initiatives or political developments involving Israel or

the Palestinians or other countries and territories in the Middle East.

Recent political events, including political uprisings, social

unrest and regime change, in various countries in the Middle East and North Africa have weakened the stability of those countries and

territories, which could result in extremists coming to power.

In addition, Iran has threatened to attack Israel and is widely believed

to be developing nuclear weapons.

Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas

in Gaza and Hezbollah in Lebanon.

This situation has escalated in the past and may potentially escalate in the future to violent events

which may affect Israel and us.

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

Israel has been in an ongoing state of war with Hamas since that time.

Following the attack by Hamas, Hezbollah 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 paid.

It may be difficult to

enforce a U.S.

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

may be difficult to enforce a U.S.

judgment against us or our officers and directors and to assert U.S.

securities laws claims in Israel.

Almost all of our directors

and officers are nationals and/or residents of countries other than the United States.

As a result, service of process upon us, our Israeli

subsidiary and our directors and officers, may be difficult to obtain within the United States.

Furthermore, because the majority of our

assets and investments, and most of our directors and officers are located outside the United States, it may be difficult for investors

to enforce within the United States any judgments obtained against us or any such officers or directors.

Additionally, it may be difficult

to assert U.S.

all of our directors and officers are nationals and/or residents of countries other than the United States.

As a result, service of process

upon us, our Israeli subsidiary and our directors and officers, may be difficult to obtain within the United States.

Furthermore, because

the majority of our assets and investments, and most of our directors and officers are located outside the United States, it may be difficult

for investors to enforce within the United States any judgments obtained against us or any such officers or directors.

Additionally,

it may be difficult to assert U.S.

securities law claims in original actions instituted in Israel.

Israeli courts may refuse to hear a claim based on a violation

Israeli courts may refuse to hear

a claim based on a violation of U.S.

securities laws because Israel is not the most appropriate forum in which to bring such a claim.

In addition, even if an Israeli

court agrees to hear a claim, it may determine that Israeli law and not U.S.

law is applicable to such claim.

law is found to

be applicable, the content of applicable U.S.

law must be proved as a fact, which can be a time-consuming and costly process.

matters of procedure will also be governed by Israeli law.

Subject to specified time

limitations and legal procedures, under the rules of private international law currently prevailing in Israel, Israeli courts may enforce

In addition, even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S.

law is applicable to such

law is found to be applicable, the content of applicable U.S.

law must be proved as a fact, which can be a time-consuming

and costly process.

Certain matters of procedure will also be governed by Israeli law.

to specified time limitations and legal procedures, under the rules of private international law currently prevailing in Israel, Israeli

courts may enforce a U.S.

judgment in a civil matter, including a judgment based upon the civil liability provisions of the U.S.

securities laws, as well

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

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

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

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

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

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

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

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

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.

If any of these conditions are not met,

Israeli courts will likely not enforce the applicable U.S.

General Risk Factors

Changes to tax laws could

have a negative effect on us or our stockholders.

At any time, the U.S.

or state income tax laws, or the administrative interpretations of those laws, may be amended.

Federal and state tax laws are constantly

under review by persons involved in the legislative process, the U.S.

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.

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

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

any time, the U.S.

federal or state income tax laws, or the administrative interpretations of those laws, may be amended.

state tax laws are constantly under review by persons involved in the legislative process, the U.S.

Internal Revenue Service, the U.S.

Department of the Treasury and

state taxing authorities.

Changes to the tax laws, regulations and administrative interpretations, which may have retroactive application,

could adversely affect us.

Our stockholders are encouraged to consult with their tax advisors about the potential effects that changes

in law may have on them and their ownership of our securities.

Department of the Treasury and state taxing authorities.

Changes to the tax laws, regulations and administrative interpretations, which

may have retroactive application, could adversely affect us.

Our stockholders are encouraged to consult with their tax advisors about

the potential effects that changes in law may have on them and their ownership of our securities.

business and operations would suffer in the event of computer system failures, cyber-attacks or deficiencies in our cyber-security.

1 unchanged sentence

damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks or

cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside our

organization.

cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside

our organization.

The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer

hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted attacks

and intrusions from around the world have increased.

If such an event were to occur and cause interruptions in our operations, it could

result in a material disruption of our product development programs.

For example, the loss of clinical trial data from completed or ongoing

or planned clinical trials could result in delays in our clinical trial efforts and significantly increase our costs to recover or reproduce

To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate

disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage to our reputation,

and the further development of our product candidates could be delayed.

hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted

attacks and intrusions from around the world have increased.

If such an event were to occur and cause interruptions in our operations,

it could result in a material disruption of our product development programs.

For example, the loss of clinical trial data from completed

or ongoing or planned clinical trials could result in delays in our clinical trial efforts and significantly increase our costs to recover

or reproduce the data.

To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications,

or inappropriate disclosure of confidential or proprietary information, we could incur material legal claims and liability, and damage

to our reputation, and the further development of our product candidates could be delayed.

also maintain compliance programs to address the potential applicability of restrictions against trading while in possession of material,

3 unchanged sentences

could have a material adverse effect on our financial position and value of our stock.

management will have significant flexibility in using the net proceeds of any offering of securities.

intend generally to use the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and

product development activities, and for general corporate purposes, including general working capital purposes.

Our management will have

significant flexibility in using the net proceeds of any offering of securities.

We intend generally to use

the net proceeds from any offerings of our securities for expenses related to our clinical trials, research and product development activities,

and for general corporate purposes, including general working capital purposes.

Our management will have significant flexibility in applying

the net proceeds of any such offering and we will necessarily be using our capital when we decide on new strategic initiatives.

amounts and timing of expenditures will vary significantly depending on a number of factors, including the amount of cash used in our

operations and our research and development efforts.

Management’s failure to use these funds effectively would have an adverse effect

on the value of our common stock and could make it more difficult and costly to raise funds in the future.

Delaware law could discourage

a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you, and thereby adversely

affect existing stockholders.

The Delaware General Corporation

Law contains provisions that may have the effect of making more difficult or delaying attempts by others to obtain control of the Company,

even when these attempts may be in the best interests of stockholders.

Delaware law imposes conditions on certain business combination

transactions with “interested stockholders.” These provisions and others that could be adopted in the future could deter unsolicited

takeovers or delay or prevent changes in our control or management, including transactions in which stockholders might otherwise receive

a premium for their shares of common stock over then current market prices.

These provisions may also limit the ability of stockholders

to approve transactions that they may deem to be in their best interests.

UNRESOLVED STAFF COMMENTS.

Not applicable.

We believe that our existing

facilities are suitable and adequate to meet our current business requirements.

In the event that we should require additional or alternative

facilities, we believe that such facilities can be obtained on short notice at competitive rates.

LEGAL PROCEEDINGS.

From time to time we may become

subject to litigation incidental to our business.

We are not currently a party to any material legal proceedings.

MINE SAFETY DISCLOSURES.

Not applicable.

significant flexibility in applying the net proceeds of any such offering and we will necessarily be using our capital when we decide

on new strategic initiatives.

The actual amounts and timing of expenditures will vary significantly depending on a number of factors,

including the amount of cash used in our operations and our research and development efforts.

Management’s failure to use these

funds effectively would have an adverse effect on the value of our common stock and could make it more difficult and costly to raise

funds in the future.

law could discourage a change in control, or an acquisition of us by a third party, even if the acquisition would be favorable to you,

and thereby adversely affect existing stockholders.

Delaware General Corporation Law contains provisions that may have the effect of making more difficult or delaying attempts by others

to obtain control of the Company, even when these attempts may be in the best interests of stockholders.

Delaware law imposes conditions

on certain business combination transactions with “interested stockholders.” These provisions and others that could be adopted

in the future could deter unsolicited takeovers or delay or prevent changes in our control or management, including transactions in which

stockholders might otherwise receive a premium for their shares of common stock over then current market prices.

These provisions may

also limit the ability of stockholders to approve transactions that they may deem to be in their best interests.

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