What changed in this filing

/stocks — the workspaceLOADING

Item 1A. Risk Factors

2023-03-06 compared with 2021-11-24 · 591 added, 334 removed, 338 unchanged (73% of the section changed)

RISK FACTORS.

An investment in our

4 unchanged sentences

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

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

of the statements in “Item 1A.

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.

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:

● 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 completion of our

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 the regulatory approval process for each of our product candidates during their respective developmental periods.

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.

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.

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 development 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

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

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

1 unchanged sentence

To date, we have financed

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

order to continue our 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 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 will not be able to fully develop and commercialize our technology.

Our future capital requirements

will depend upon many factors, including:

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;

1 unchanged sentence

competing technological and market developments;

Our ability to establish additional collaborative relationships, and

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 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.

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 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

2 unchanged sentences

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

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.

As of August 31, 2021, August 31, 2020 and August 31,

2019, we had working capital of $88,658,000, $35,975,000 and $28,016,000, respectively, and stockholders’ equity of $116,517,000,

$32,879,000 and $19,393,000, respectively.

During fiscal 2021 and the fiscal years ended August 31, 2020, or fiscal 2020, and 2019, we

generated revenues of $2,703,000, $2,710,000 and $2,703,000, respectively.

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

August 31, 2021, fiscal 2021, fiscal 2020 and fiscal 2019, we incurred net losses of $114,852,000, $22,238,000, $11,511,000 and $14,355,000,

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.

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.”

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

11 unchanged sentences

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

Patent litigation is becoming

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

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.

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.

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

4 unchanged sentences

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 87 patents issued by the United States, Australian, Canadian,

Chinese, Israeli, Japanese, New Zealand, South African, Russian, European, Hong Kong, Swiss, German, Spanish, French, United Kingdom,

Italian, Indian, Austrian, Belgian, Irish, Swedish, Denmark, Luxembourg, Monaco, Norway and Netherlands patent offices for our technologies

covering oral administration of insulin and other proteins, or for our technologies covering oral administration of exenatide, or for

methods and compositions for treating diabetes.

Further, 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 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.

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.

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

5 unchanged sentences

or commercialization.

Business—Description of Business—Patents and Licenses.”

At present, our success

depends primarily on the successful commercialization of our oral insulin capsule.

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 oral insulin capsule is crucial for our success.

At present, our principal product is the oral insulin capsule.

Our oral insulin

capsule is in a clinical development stage and faces a variety of risks and uncertainties.

Principally, these risks include the following:

Future clinical trial results may show that the oral insulin capsule is not well tolerated by recipients at its effective doses or is not efficacious as compared to placebo,

Future clinical trial results may be inconsistent with previous preliminary testing results and data from our earlier studies may be inconsistent with clinical data,

Even if our oral insulin capsule is shown to be safe and effective for its intended purposes, we may face significant or unforeseen difficulties in obtaining or manufacturing sufficient quantities or at reasonable prices,

Our ability to complete the development and commercialization of the oral insulin capsule for our intended use is significantly dependent upon our ability to obtain and maintain experienced and committed partners to assist us with obtaining clinical and regulatory approvals for, and the manufacturing, marketing and distribution of, the oral insulin capsule on a worldwide basis,

Even if our oral insulin capsule is successfully developed, commercially produced and receives all necessary regulatory approvals, there is no guarantee that there will be market acceptance of our product, and

Our competitors may develop therapeutics or other treatments which are superior or less costly than our own with the result that our products, even if they are successfully developed, manufactured and approved, may not generate significant revenues.

If we are unsuccessful in

dealing with any of these risks, or if we are unable to successfully commercialize our oral insulin capsule for some other reason, it

would likely seriously harm our business.

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:

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

2 unchanged sentences

FDA and foreign regulatory requirements.

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

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.

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

5 unchanged sentences

fashion, if at all.

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.

Finally, the COVID-19

pandemic has impacted clinical trials broadly.

We may experience 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.

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 1.

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

5 unchanged sentences

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

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.

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.

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 studies will be favorable.

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 have completed

certain non-FDA clinical trials and pre-clinical trials for our products.

In addition, we have completed a Phase IIb clinical trial in

patients with T2D under an IND with the FDA and we have completed Phase IIa clinical trials of ORMD-0801 in patients with T1D, under an

IND with the FDA.

However, success in pre-clinical testing and early clinical trials does not ensure that later clinical trials will be

Even within a clinical trial there might be discrepancies from statistically significant data, as occurred at two of the sites

in the initial cohort of our Phase IIb trial, which we excluded while we investigate such discrepancies.

For example, a number of companies

in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials.

We cannot predict with

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

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.

3 unchanged sentences

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

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.

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—Government Regulation.”

We are dependent upon third

party suppliers of our raw materials.

party suppliers of our raw materials and for other services.

We are dependent on outside

vendors for our entire supply of the oral insulin and GLP-1 capsules and do not currently have any long-term agreements in place for the

supply of oral insulin or GLP-1 capsules.

While we believe that there are numerous sources of supply available, if the third party suppliers

were to cease production, including as a result of the COVID-19 pandemic, 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.

Our future revenues from

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.

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

(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;

(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;

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.

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.

Our future revenues from HTIT

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.

Our future revenues from HTIT are also dependent upon the ability of third parties to scale-up one of our oral

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.

13 unchanged sentences

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 fiscal years ended August 31, 2021 and 2020.

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

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

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

3 unchanged sentences

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

Although Phase III clinical

trials for our oral insulin candidate, ORMD-0801 will start without a partner, if we engage such a partner, we anticipate such partner

or partners would be responsible for, or substantially support, late stage clinical trials, and sales and marketing of our oral insulin

capsule and other products.

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 studies, label expansions and other

regulatory requirements concerning future clinical development in the United States and elsewhere.

While our strategy is to partner with

an appropriate party for our expected Phase III clinical trials, no assurance can be given that any third party would be interested in

partnering with us.

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.

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

14 unchanged sentences

and institutions.

In addition, certain of our products may be subject to competition from products developed using other technologies.

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.

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

1 unchanged sentence

We expect the expansion of

our business 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.

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,”

Business—Description of Business—Strategy” and “—Employees.”

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.

Business—Description of Business—Employees.”

We depend upon our senior

18 unchanged sentences

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:

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

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

Our joint venture investors may have economic or other business interests or goals that are inconsistent with our business interests or goals and that could affect our ability to fully benefit from the assets owned by the joint venture;

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

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

Our 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;

● Disagreements with our joint venture investors could result in litigation

or arbitration that could be expensive and distracting to management and could delay important decisions.

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

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.

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;

● 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,

31 unchanged sentences

aspects of the ACA.

Various litigation to invalidate parts of the ACA are pending in court and, despite an upcoming change in presidential

administration, 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 us.

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

1 unchanged sentence

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 studies

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.

3 unchanged sentences

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

During the fiscal

years ended August 31, 2016, 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 fiscal year ended August 31, 2018 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.

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 business and operations.

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

5 unchanged sentences

affect our business, financial condition and results of operations.

Although, as of the date of this Annual Report on Form 10-K, we do

not expect any material impact on our long-term activity, the extent to which COVID-19 impacts our business will depend on future developments,

which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and

the actions to contain COVID-19 or treat its impact, among others.

We are actively monitoring the pandemic and we are taking any necessary

measures to respond to the situation in cooperation with the various stakeholders.

The outbreak of COVID-19

may materially and adversely affect our clinical trial operations and our financial results.

The outbreak of COVID-19 originated

in Wuhan, China, in December 2019 and has since spread to multiple countries, including the United States, Israel and several European

countries where we expected to initiate clinical trials.

The extent to which COVID-19 may impact our clinical trial operations will depend

on future developments, which are still uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the severity

of COVID-19, or the effectiveness of actions to contain and treat for COVID-19.

The continued spread of COVID-19 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.

Moreover, COVID-19 may also

affect employees of third-party contract research organizations located in affected geographies that we rely upon to carry out such enrollments

Any negative impact COVID-19 has to patient enrollment or treatment could cause costly delays to clinical trial activities,

which could adversely affect our ability to obtain regulatory approval for and to commercialize our product candidates, increase our operating

expenses, and have a material adverse effect on our financial results.

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

3 unchanged sentences

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

These sales also might make it more difficult for us to sell equity securities in the future at a time and at a price that

we deem appropriate.

As of November 24, 2021, we had outstanding 38,086,020 shares of common stock, a large majority of which are freely

Giving effect to the exercise in full of all of our outstanding warrants, options and restricted stock units, or RSUs, including

those currently unexercisable or unvested, we would have outstanding 41,151,814 shares of common stock.

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

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

Any strategic decision we make as a result of our strategic

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

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

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

As of March 6, 2023, we had outstanding 39,783,813 shares of common stock,

a large majority of which are freely tradable.

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

stock units, or RSUs, including those currently unexercisable or unvested, we would have outstanding 43,386,638 shares of common stock.

Our issuance of warrants,

3 unchanged sentences

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

As of November 24, 2021, we had outstanding

As of March 6, 2023, we had outstanding

warrants and options exercisable for 1,548,256 shares of common stock at a weighted average exercise price of $4.71.

15 unchanged sentences

our Board decides is relevant.

Because certain of our

stockholders control a significant number of shares of our common stock, they may have effective control over actions requiring stockholder

As of November 24, 2021, our

directors, executive officers and principal affiliated stockholders beneficially own approximately 7.0%

of our outstanding shares of common stock, excluding shares issuable upon the exercise of options, warrants and RSUs.

As a result, these

stockholders, should they act together, may have the ability to control the outcome of matters submitted to our stockholders for approval,

including the election of directors and any merger, consolidation or sale of all or substantially all of our assets.

In addition, these

stockholders, should they act together, may have the ability to control our management and affairs.

Accordingly, this concentration of

ownership might harm the market price of our common stock by:

Delaying, deferring or preventing a change in corporate control,

Impeding a merger, consolidation, takeover or other business combination involving us, or

Discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us.

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.

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

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

31 unchanged sentences

that meet specified criteria.

We did not recognize any grants in fiscals 2021, 2020 and 2019.

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.

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.

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

50 unchanged sentences

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

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 Nasdaq 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.

These factors include:

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,

The impact of the recent outbreak of COVID-19 on our business or on the economy generally,

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, and

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 our New 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 pursuant to our New Equity Distribution Agreement (as defined below), our stockholders

may experience significant dilution.

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

the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable to

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.

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.

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

nonpublic information generally and in connection with a cyber-security breach.

However, a breakdown in existing controls and procedures

around our cyber-security environment may prevent us from detecting, reporting or responding to cyber incidents in a timely manner and

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

Our management will have

4 unchanged sentences

Our management will have significant flexibility in applying

the net proceeds of any such offering.

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.

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

23 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors