What changed in this filing

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Item 1A. Risk Factors

2025-04-01 compared with 2024-03-28 · 225 added, 254 removed, 276 unchanged (63% of the section changed)

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profitability

We have an accumulated deficit of $63,905,658

as of December 31, 2023.

We incurred a net loss of $4,506,044 for the year ended December 31, 2023, and a net loss of $26,744,440 for

the year ended December 31, 2022.

We have an accumulated deficit of $69,084,565 as

of December 31, 2024.

We incurred a net loss of $5,178,907 for the year ended December 31, 2024, and a net loss of $4,506,044 for the

year ended December 31, 2023.

We may never achieve profitability.

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In recent years, the generic pharmaceutical business

has experienced increased volatility in volumes due in large part to global supply chain issues and the COVID-19 pandemic.

global economy was continuing to recover from the impacts of the COVID-19 pandemic and also began experiencing additional macroeconomic

has experienced increased volatility in volumes due in large part to global supply chain issues following the COVID-19 pandemic.

2022, as the global economy has recovered from the impact of the COVID-19 pandemic, it has also been experiencing additional macroeconomic

pressures such as rising inflation and disruptions to the global supply chain, in part resulting from the ongoing conflict between Russia

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business include:

macroeconomic conditions are becoming increasingly less stable due to the war in Ukraine, and tensions in the Middle and Far East.

macroeconomics conditions pose a serious threat to supply chains around the world including those for the generic pharmaceutical business.

Nearly all of Nora Pharma’s generic drugs are manufactured outside Canada and the United States and could experience disruptions

which would adversely affect our main source of revenue.

chains discontinuities due to other issues, including unforeseen regulatory actions, economic sanctions, trade restrictions, labor disturbances

and approval delays, may impact our ability to timely meet customer demand in certain instances.

These adverse market forces would have

a direct impact on our ability to achieve our sales projections.

· A significant

portion of Nora Pharma’s revenues are derived from relatively few key customers, and any financial difficulties experienced by

a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on Nora Pharma’s

business, financial condition, and results of operations.

Pharma encounters difficulties in executing launches of new products, it may not be able to offset the increasing price erosion on existing

products resulting from pricing pressures and accelerated generics approvals for competitors.

Such unsuccessful launches can be caused

by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.

delays to execute launches of new generic products could have a material adverse effect on Nora Pharma’s business and its ability

to realize projected sales.

Current macroeconomic conditions are becoming increasingly less stable due to the war in Ukraine, and tensions in the Middle and Far East.

Destabilized macroeconomics conditions pose a serious threat to supply chains around the world including those for the generic pharmaceutical business.

Nearly all of Nora Pharma’s generic drugs are manufactured outside Canada and the United States and could experience disruptions which would adversely affect our main source of revenue.

Supply chains discontinuities due to other issues, including unforeseen regulatory actions, economic sanctions, trade restrictions, labor disturbances and approval delays, may impact our ability to timely meet customer demand in certain instances.

These adverse market forces would have a direct impact on our ability to achieve our sales projections.

A significant portion of Nora Pharma’s revenues are derived from relatively few key customers, and any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on Nora Pharma’s business, financial condition, and results of operations.

If Nora Pharma encounters difficulties in executing launches of new products, it may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and accelerated generics approvals for competitors.

Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.

Failure or delays to execute launches of new generic products could have a material adverse effect on Nora Pharma’s business and its ability to realize projected sales.

Sales of our generic products may be adversely

affected by the drug regulatory environment in Canada

Currently we sell our generic drugs only in Canada.

Our net sales may be affected by fluctuations in the buying patterns of our customers resulting from government lead pricing pressures

and other factors.

Our generic sales in Canada are done via retail pharmacies, pharmacy channels, distributors, and wholesalers.

pressures in Canada represent the highest risk due to ongoing and unresolved negotiations between the pharmaceutical industry and the

federal government.

These together with the fact that a significant portion of our revenues is derived from relatively few key customers,

any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a

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

Our revenues and profits from generic products

may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy

we sell our generic drugs only in Canada.

Our net sales may be affected by fluctuations in the buying patterns of our customers resulting

from government lead pricing pressures and other factors.

Our generic sales in Canada are done via retail pharmacies, pharmacy channels,

distributors, and wholesalers.

Pricing pressures in Canada represent the highest risk due to ongoing and unresolved negotiations between

the pharmaceutical industry and the federal government.

Any financial difficulties experienced by a single key customer, or any delay

in receiving payments from such a customer, could have a material adverse effect on our business, financial condition, and results of

from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy

Our generic drugs face intense competition.

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of their approvals.

Furthermore, brand pharmaceutical companies continue

to manage products in a challenging environment through marketing agreements with payers, pharmacy benefits managers and generic manufacturers.

For example, brand companies often sell or license their own generic versions of their products, either directly or through other generic

pharmaceutical companies (so-called “authorized generics”).

No significant regulatory approvals are required for

authorized generics, and brand companies do not face any other significant barriers to entry into such market.

Brand companies may seek

to delay introductions of generic equivalents through a variety of commercial and regulatory tactics.

These actions may increase the costs

and risks of our efforts to introduce generic products and may delay or prevent such introduction altogether.

We may experience delays in launching our

new generic products

If we cannot execute timely launches of new products,

we may not be able to offset the increasing price erosion on existing products resulting from pricing pressures and accelerated generics

approvals for competing products.

Such unsuccessful launches can be caused by many factors, including delays in regulatory approvals,

lack of operational or clinical readiness or patent litigation.

Failure or delays to execute launches of new generic products could have

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

We may not receive required regulatory approval

for any of our non-generic pharmaceutical product candidates

We have not received approval for any of our proprietary

(non-generic) drug development operations product candidates from the FDA.

Any compounds we discover or in-license will require extensive

and costly development, preclinical testing and clinical trials prior to seeking regulatory approval for commercial sales.

Our most advanced

product candidate, K1.1 mRNA and our potential Covid-19 treatment in development may never be approved for commercial sale.

made any filings to date with the FDA or other regulatory bodies in other jurisdictions.

The time required to attain product sales and

profitability is lengthy and highly uncertain.

If we fail to obtain required regulatory approvals for our pharmaceutical product candidates,

our business will be materially harmed.

As we have no approved non-generic pharmaceutical

products on the market, we do not expect to generate significant revenues from non-generic pharmaceutical product sales in the foreseeable

future, if at all

To date, we have no approved non-generic pharmaceutical products on the

market and have generated product revenues solely from our OTC supplements operations and generic pharmaceutical product sales.

funded our operations primarily from sales of our securities.

We have not received, and do not expect to receive for at least the next

three to four years, if at all, any revenues from the commercialization of our non-generic pharmaceutical product candidates.

revenues from sales of such pharmaceutical product candidates we must succeed, either alone or with third parties, in developing, obtaining

regulatory approval for manufacturing, marketing and distributing drugs with commercial potential.

We may never succeed in these activities,

and we may not generate sufficient revenues to continue our business operations or achieve profitability.

We will require additional funding to satisfy

our future capital needs, which may not be available

We will require significant additional funding in

large part due to our research and development expenses, future preclinical and clinical testing costs, and insufficient sales revenues

in the near future.

brand pharmaceutical companies continue to manage products in a challenging environment through marketing agreements with payers, pharmacy

benefits managers and generic manufacturers.

For example, brand companies often sell or license their own generic versions of their products,

either directly or through other generic pharmaceutical companies (so-called “authorized generics”).

No significant

regulatory approvals are required for authorized generics, and brand companies do not face any other significant barriers to entry into

Brand companies may seek to delay introduction of generic equivalents through a variety of commercial and regulatory tactics.

These actions may increase the costs and risks of our efforts to introduce generic products and may delay or prevent such introductions

We may experience delays in launching our new

generic products

we cannot execute timely launches of new products, we may not be able to offset the increasing price erosion on existing products resulting

from pricing pressures and accelerated generics approvals for competing products.

Such unsuccessful launches can be caused by many factors,

including delays in regulatory approvals, lack of operational or clinical readiness or patent litigation.

Failure or delays in executing

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

We may not receive required

regulatory approval for any of our non-generic pharmaceutical product candidates

have not received approval for any of our proprietary (non-generic) drug development operations product candidates from the FDA.

compounds we discover or in-license will require extensive and costly development, preclinical testing and clinical trials prior to seeking

regulatory approval for commercial sales.

Our most advanced product candidate, K1.1 mRNA and our potential Covid-19 treatment in development

may never be approved for commercial sale.

We have not made any filings to date with the FDA or other regulatory bodies in other jurisdictions.

The time required to attain product sales and profitability is expensive, lengthy and highly uncertain.

If we fail to obtain required

regulatory approvals for our pharmaceutical product candidates our business will be materially harmed.

As we have no approved non-generic

pharmaceutical products on the market, we do not expect to generate significant revenues from non-generic pharmaceutical product sales

in the foreseeable future, if at all

date, we have no approved non-generic pharmaceutical products on the market and have generated product revenues largely from our

generic pharmaceutical product sales.

We have funded our operations primarily from sales of our securities.

We have not received,

and do not expect to receive, for the foreseeable future, if at all, any revenues from the commercialization of our non-generic

pharmaceutical product candidates.

To obtain revenues from sales of such pharmaceutical product candidates we must succeed, either

alone or with third parties, in developing, obtaining regulatory approval for manufacturing, marketing and distributing drugs with

commercial potential.

We may never succeed in these activities, and we may not generate sufficient revenues to continue our business

operations or achieve profitability.

We will require additional

funding to satisfy our future capital needs, which may not be available

will require significant additional funding for our operations, including future preclinical and clinical testing costs, and insufficient

sales revenues in the near future.

We do not know whether additional financing will be available to us on favorable terms or at all.

raise additional funds, we may be required to reduce our capital expenditures, scale back product development programs, reduce our workforce

and license to others products or technologies that we may otherwise be able to commercialize.

We are currently unable to project when

or whether our operations will generate positive cash flow.

Any additional equity securities we issue or issuances

of debt we may enter into or undertake may have rights, preferences or privileges senior to those of existing holders of common stock.

To the extent that we raise additional funds through collaboration and licensing arrangements, we may be required to relinquish some rights

to our technologies or product candidates or grant licenses on terms that are not favorable to us.

The FDA may change its approval policies

or requirements, or apply interpretations to its policies or requirements, in a manner that could delay or prevent commercialization of

K1.1 mRNA or our potential Covid-19 treatment in development

Regulatory requirements may change in a manner

that requires us to conduct additional clinical trials, which may delay or prevent commercialization of our K1.1 mRNA and potential Covid-19

treatment in development.

We cannot provide any assurance that the FDA will not require us to repeat existing studies or conduct new or

unforeseen experiments in order to demonstrate the safety and efficacy of any product candidate before considering the approval of such

product candidates.

Our business would be materially harmed if

we fail to obtain FDA approval for our pharmaceutical product candidates

We anticipate that our ability to generate significant

product revenues from our drug development business will depend on the successful development and commercialization of K1.1 mRNA or our

potential Covid-19 treatment in development.

The FDA may not approve in a timely manner, or at all, any of our drug candidates.

are unable to submit a new drug application for our product candidates, we will be unable to commercialize such products and our business

will be materially harmed.

The FDA imposes substantial requirements on the introduction of pharmaceutical products through lengthy and

detailed laboratory and clinical testing procedures, sampling activities and other costly and time-consuming procedures.

of these requirements typically takes several years and may vary substantially based upon the type and complexity of the pharmaceutical

Our product candidates are novel compounds or new chemical entities, which may further increase the time required for satisfactory

testing procedures.

We may be sued or become a party to litigation,

which could require significant management time and attention and result in significant legal expenses and may result in an unfavorable

outcome which could have a material adverse effect on our business, financial condition, results of operations and cash flow

If we cannot raise additional funds, we may be required to reduce our capital expenditures, scale back product development programs,

reduce our workforce and license to others products or technologies that we may otherwise be able to commercialize.

We are currently

unable to project when or whether our operations will generate positive cash flow.

additional equity securities we issue or issuances of debt we may enter into or undertake may have rights, preferences or privileges

senior to those of existing holders of common stock.

To the extent that we raise additional funds through collaboration and licensing

arrangements, we may be required to relinquish some rights to our technologies or product candidates or grant licenses on terms that

are not favorable to us.

We may be sued or become

a party to litigation, which could require significant management time and attention and result in significant legal expenses and may

result in an unfavorable outcome which could have a material adverse effect on our business, financial condition, results of operations

and cash flow

We may be forced to incur costs and expenses in

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adverse effect on our business, results of operations and cash flows.

If we are unable to attract and retain qualified

scientific, technical, and key management personnel, or if our key executive, Dr.

Slilaty, discontinues his employment with us,

it may delay our research and development efforts

If we are unable to attract

and retain qualified scientific, technical, and key management personnel, or if our key executive, Dr.

Slilaty, discontinues

his employment with us, it may delay our research and development efforts

We rely on the services of Dr.

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delay or prevent the achievement of our business objectives.

Our business exposes us to potential product

liability risks and we may be unable to acquire and maintain sufficient insurance to provide adequate coverage against potential liabilities

Our business exposes us to

potential product liability risks and we may be unable to acquire and maintain sufficient insurance to provide adequate coverage against

potential liabilities

Our business exposes us to potential product liability

risks that are inherent in the testing, manufacturing and marketing of pharmaceutical products.

The use of our products

by our customers exposes us to the possibility of product liability claims and possible adverse publicity.

These risks will increase to

the extent our pharmaceutical product candidates receive regulatory approval and are commercialized.

We currently have product liability

insurance for our generic drugs and OTC products and we plan to obtain product liability insurance in connection with clinical trials

of our pharmaceutical product candidates in the near future.

However, our current and future product liability insurance may not provide

adequate protection against potential liabilities.

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

on drugs that had unanticipated side effects.

A successful product liability claim, or series of claims brought against us would decrease

our cash reserves and could cause our stock price to fall significantly.

We face regulation and risks related to hazardous

materials and environmental laws, violations of which may subject us to claims for damages or fines that could materially affect our business,

cash flows, financial condition and results of operations

The use of our products by our customers

exposes us to the possibility of product liability claims and possible adverse publicity.

These risks will increase to the extent our

pharmaceutical product candidates receive regulatory approval and are commercialized.

We currently have product liability insurance for

our generic drugs and OTC products and we plan to obtain product liability insurance in connection with clinical trials of our pharmaceutical

product candidates in the near future.

However, our current and future product liability insurance may not provide adequate protection

against potential liabilities.

On occasion, juries have awarded large judgments in class action lawsuits based on drugs that had

unanticipated side effects.

A successful product liability claim, or series of claims brought against us would decrease our cash reserves

and could cause our stock price to fall significantly.

We face regulation and risks

related to hazardous materials and environmental laws, violations of which may subject us to claims for damages or fines that could materially

affect our business, cash flow, financial condition and results of operations

Our research and development activities involve

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a pollution and remediation insurance policy.

Third party manufacturers may not be able

to manufacture our pharmaceutical product candidates, which would prevent us from commercializing our product candidates

Third party manufacturers

may not be able to manufacture our pharmaceutical product candidates, which would prevent us from commercializing our product candidates

If any of our pharmaceutical product candidates

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If we are able to reach an agreement with any collaborator or third-party manufacturer in the future, of which there can be

no assurance due to factors beyond our control, these collaborators and/or third-party manufacturers may not be able to increase their

no assurance, these collaborators and/or third-party manufacturers may not be able to increase their

manufacturing capacity for any of our product candidates in a timely or economic manner, or at all.

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overruns or other problems that could seriously harm our business.

If we are unable to establish sales and marketing

capabilities for our pharmaceutical product candidates or enter into agreements with third parties to sell and market any such products

we may develop, we may be unable to generate revenues from our non-generic pharmaceutical business

If we are unable to establish

sales and marketing capabilities for our pharmaceutical product candidates or enter into agreements with third parties to sell and market

any such products we may develop, we may be unable to generate revenues from our non-generic pharmaceutical business

We do not currently have product sales and marketing

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unforeseen costs associated with creating an independent sales and marketing organization.

Even if we successfully develop and obtain

approval for our proprietary drug product candidates, our business will not be profitable if such products do not achieve and maintain

market acceptance

Even if we successfully develop

and obtain approval for our proprietary drug product candidates, our business will not be profitable if such products do not achieve and

maintain market acceptance

Even if our proprietary drug product candidates

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capabilities by other parties that render our product obsolete.

Because the results of preclinical studies

for our preclinical product candidates are not necessarily predictive of future results, our pharmaceutical product candidates may not

have favorable results in later clinical trials or ultimately receive regulatory approval

Because the results of preclinical

studies for our preclinical product candidates are not necessarily predictive of future results, our pharmaceutical product candidates

may not have favorable results in later clinical trials or ultimately receive regulatory approval

Our proprietary drug product candidates have not

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revenues and may damage our reputation in the industry and in the investment community.

The future clinical testing of our proprietary

drug product candidates could be delayed, resulting in increased costs to us and a delay in our ability to generate revenues

Our proprietary drug product candidates will

require additional preclinical testing and extensive clinical trials prior to submission of a regulatory application for

commercial sales.

We do not know whether clinical trials will begin on time, if at all.

Delays in the commencement of clinical

testing could significantly increase our product development costs and delay product commercialization.

In addition, many of the

factors that may cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to denial of regulatory

approval of a product candidate.

Each of these results would adversely affect our ability to generate revenues.

The future clinical testing

of our proprietary drug product candidates could be delayed, resulting in increased costs to us and a delay in our ability to generate

Our proprietary drug product candidates will require

additional preclinical testing and extensive clinical trials prior to submission of a regulatory application for commercial sales.

do not know whether clinical trials will begin on time, if at all.

Delays in the commencement of clinical testing could significantly

increase our product development costs and delay product commercialization.

In addition, many of the factors that may cause, or lead to,

a delay in the commencement of clinical trials may also ultimately lead to denial of regulatory approval of a product candidate.

of these results would adversely affect our ability to generate revenues.

The commencement of clinical trials can be delayed

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trials for our product candidates could be delayed until sufficient numbers are achieved.

We face or will face significant competition

from other biotechnology, pharmaceutical and OTC supplements companies, and our operating results will suffer if we fail to compete effectively

We face or will face

significant competition from other biotechnology and pharmaceutical companies, and our operating results will

suffer if we fail to compete effectively

Most of our pharmaceutical company competitors,

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to compete successfully with our competitors' existing or future products.

We also face competition in our OTC supplements

The business of marketing OTC supplements is highly competitive.

This market segment includes numerous manufacturers, marketers,

and retailers that actively compete for the business of consumers both in the United States and abroad.

The market is highly sensitive

to the introduction of new products, which may rapidly capture a significant share of the market.

Sales of similar products by competitors

may materially and adversely affect our business, financial condition, and results of operations.

Because our proprietary drug product candidates

and our development and collaboration efforts depend on our intellectual property rights, adverse events affecting our intellectual property

rights will harm our ability to commercialize products

Because our proprietary drug

product candidates and our development and collaboration efforts depend on our intellectual property rights, adverse events affecting

our intellectual property rights will harm our ability to commercialize products

Our success will depend to a large degree on our

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that are reasonable under the circumstances, if the government determines that such action is necessary.

Confidentiality agreements with employees

and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately protect our

intellectual property

Confidentiality agreements

with employees and others may not adequately prevent disclosure of trade secrets and other proprietary information and may not adequately

protect our intellectual property

We rely on trade secrets to protect our technology,

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rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.

The implementation of our business plan may

result in a period of rapid growth that will impose a significant burden on our current administrative and operational resources

The implementation of our

business plan may result in a period of rapid growth that will impose a significant burden on our current administrative and operational

Our ability to effectively manage our growth will

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Our failure to successfully manage our growth will have a negative impact on our anticipated results of operations.

A significant or prolonged economic downturn

could have a material adverse effect on our results of operations

A significant or prolonged

economic downturn could have a material adverse effect on our results of operations

A significant or prolonged economic downturn may

adversely affect the disposable income of many consumers and may lower demand for some of our products.

Any decline in economic conditions could negatively impact our business.

Any decline in economic conditions

could negatively impact our business.

A significant decline in consumer demand, even if only due in part to general economic conditions

could have a material adverse effect on our revenues and profit margins.

The failure of our service providers and

suppliers to supply quality services and materials in sufficient quantities, at a favorable price, and in a timely fashion could adversely

affect the results of our operations

The failure of our service

providers and suppliers to supply quality services and materials in sufficient quantities, at a favorable price, and in a timely fashion

could adversely affect the results of our operations

Our outside manufacturers buy raw materials from

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with other sources could result in shortages of products we manufacture from such raw materials, with a resulting loss of sales and customers.

A shortage of raw materials or an unexpected

interruption of supply could also result in higher prices for those materials.

We have experienced increases in various raw material

costs, transportation costs and the cost of petroleum-based raw materials and packaging supplies used in our business.

cost pricing pressures on raw materials and other products occurred throughout fiscal 2023 as a result of limited supplies of

various ingredients, the effects of higher labor and transportation costs, and the impact of Covid-19.

We expect these upward

pressures to continue through fiscal 2024.

Although we may be able to raise our prices in response to significant increases in the

cost of raw materials, we may not be able to raise prices sufficiently or quickly enough to offset the negative effects such cost

increases could have on our results of operations or financial condition.

A shortage of raw materials or an unexpected interruption

of supply could also result in higher prices for those materials.

We have experienced increases in various raw material costs, transportation

costs and the cost of petroleum-based raw materials and packaging supplies used in our business.

Increasing cost pricing pressures on

raw materials and other products occurred throughout fiscal 2023 as a result of limited supplies of various ingredients, the effects of

higher labor and transportation costs, and the impact of Covid-19.

We expect these upward pressures to continue through fiscal 2024.

we may be able to raise our prices in response to significant increases in the cost of raw materials, we may not be able to raise prices

sufficiently or quickly enough to offset the negative effects such cost increases could have on our results of operations or financial

There can be no assurance suppliers will provide

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geopolitics, natural disasters, and other catastrophic events.

Our business is subject to the effects of

adverse publicity, which could negatively affect our sales and revenues

Our business is subject to

the effects of adverse publicity, which could negatively affect our sales and revenues

Our business can be affected by adverse publicity

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consumers or to have unanticipated and unwanted health consequences.

Our manufacturing and third-party fulfillment

activities are subject to certain risks

Our manufacturing and third-party

fulfillment activities are subject to certain risks

Our products are manufactured at third party manufacturing

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agencies, including the FDA and Health Canada may have a material adverse effect on our business, financial condition and results of operations.

Risks Related to Our Common Stock

There is significant volatility in the price and trading volume of our common

stock, and investors may find it difficult to buy and sell our shares

common stock has been listed on the Nasdaq Capital Market since February 15, 2022.

The price and daily trading volume of our common stock

have been very volatile and may continue to be so, and any significant trading volume in our common stock may not be maintained.

factors may have an adverse impact on the trading and price of our common stock.

If we are unable to continue to meet the

listing requirements of Nasdaq, our common stock will be delisted

Our common stock currently trades on Nasdaq, where it is subject to various

listing requirements.

On March 24, 2023, we received a notification letter from Nasdaq’s Listing Qualifications Department notifying

us that, because the closing bid price of our common stock listed on Nasdaq was below $1.00 for 30 consecutive trading days, we no longer

meet the minimum bid price requirement for continued listing under Nasdaq Marketplace Rule 5550(a)(2), requiring a minimum bid price of

$1.00 per share (the “Minimum Bid Price Requirement”).

On September 21, 2023, we received another notification letter from

Nasdaq advising that Nasdaq’s staff has determined that we are eligible for an extension of an additional 180 calendar day period,

or until March 18, 2024, to cure the bid price deficiency.

On February 28, 2024, we received a notification letter from Nasdaq advising

that Nasdaq’s staff had determined that as of February 27, 2024, our common stock had a closing bid price of $0.10 or less for ten

consecutive trading days and accordingly, we were subject to the provisions contemplated under Listing Rule 5810(c)(3)(A)(iii).

Nasdaq determined that our securities would be removed from listing and registration on The Nasdaq Stock Market, subject to the procedures

set forth in the Nasdaq Listing Rule 5800 Series which provide for the opportunity to appeal such determination.

On February 28, 2024,

we applied for such appeal, and a hearing has been scheduled for April 25, 2024.

Accordingly, the delisting action referenced in the Nasdaq

staff’s determination letter has been stayed, pending a final written decision by the Nasdaq Hearings Panel.

In December 2023, we

had obtained shareholder approval for and intend to complete a reverse stock split to regain compliance with the Minimum Bid Price Requirement.

If we are unable to achieve and maintain compliance with such listing standards or other Nasdaq listing requirements in the future, we

could be subject to suspension and delisting proceedings.

Risks Related to Our Common

There is significant volatility

in the price and trading volume of our common stock, and investors may find it difficult to buy and sell our shares

Our common stock has been listed on the Nasdaq

Capital Market since February 15, 2022.

The price and daily trading volume of our common stock have been very volatile and may continue

to be so, and any significant trading volume in our common stock may not be maintained.

These factors may have an adverse impact on the

trading and price of our common stock.

If we are unable to continue

to meet the listing requirements of Nasdaq, our common stock will be delisted

stock currently trades on Nasdaq, where it is subject to various listing requirements.

February 28, 2024, we received a notification letter from Nasdaq advising that Nasdaq’s staff had determined that as of February

27, 2024, our common stock had a closing bid price of $0.10 or less for ten consecutive trading days and accordingly, we were subject

to the provisions contemplated under Listing Rule 5810(c)(3)(A)(iii).

Accordingly, Nasdaq determined to remove our securities from listing

and registration on Nasdaq, subject to the procedures set forth in the Nasdaq Listing Rule 5800 Series which provides us with the opportunity

to appeal this determination.

June 7, 2024, we received a notification letter from Nasdaq, that based on further review of our public filings with the Securities and

Exchange Commission and supporting materials submitted to Nasdaq, its staff determined to delist our securities pursuant to its discretionary

authority under Listing Rule 5101.

Specifically, as set forth in the letter, Nasdaq’s staff determined that the “alternative

cashless exercise” provision of the Series A Warrants the Company issued on February 15, 2024, raised public interest and investor

protection concerns because the issuance of Series A Warrants resulted in substantial dilution for the stockholders of the Company to

date and could cause potential future dilution.

Accordingly, as set forth in the letter, this matter served as an additional basis for

delisting the Company’s securities from The Nasdaq Stock Market.

letter served as a formal notification that the Nasdaq Hearings Panel (the “Panel”) would consider this matter in their decision

regarding our continued listing on The Nasdaq Capital Market.

September 9, 2024, we received a letter from Nasdaq confirming that we had regained compliance with the bid price requirement in

Listing Rule 5550(a)(2) (the “Bid Price Rule”), as required by the Panel’s decision dated June 28, 2024.

letter further stated that the Company will be subject to a Mandatory Panel Monitor for a period of one year.

If, within that one-year

monitoring period, the Nasdaq Listing Qualifications staff (“Nasdaq Staff”) finds the Company again out of compliance with

the Bid Price Rule, the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency

and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will

the Company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3).

Instead, the Nasdaq Staff will issue a Delist

Determination Letter and the Company will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings

Panel if the initial Panel is unavailable.

The Company will have the opportunity to respond/present to the Hearings Panel as provided

by Listing Rule 5815(d)(4)(C).

The Company’s securities may be delisted from Nasdaq at that time.

may be unable to maintain compliance with Nasdaq listing requirements.

If we are unable to maintain compliance with Nasdaq listing requirements,

we could be subject to suspension and delisting proceedings.

A delisting of our common stock and our inability to list on another national

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of investors willing to hold or acquire our common stock, which could negatively impact our ability to raise equity financing;

(iii) limiting

our ability to use certain registration statements to offer and sell freely tradeable securities, thereby limiting our ability to access

the public capital markets;

limiting our ability to use certain registration statements to offer and sell freely tradeable securities, thereby limiting our ability

to access the public capital markets;

and (iv) impairing our ability to provide equity incentives to our employees.

We do not intend to pay dividends on our

common stock for the foreseeable future

We do not intend to pay dividends

on our common stock for the foreseeable future

We have paid no dividends on our common stock to

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Stock and as of the date of this Report, 130,000 of such shares are outstanding and held by our Chief Executive Officer.

Our board of directors

could authorize the creation of additional series of preferred stock that would grant to holders of preferred stock the right to our assets

upon liquidation, or the right to receive dividend payments before dividends are distributed to the holders of common stock.

subject to the rules of any securities exchange on which our stock is then listed, our board of directors could authorize the creation

of additional series of preferred stock that has greater voting power than our common stock or that is convertible into our common stock,

which could decrease the relative voting power of our common stock or result in dilution to our existing stockholders.

Additional stock

offerings in the future or the issuance of stock upon exercise of outstanding warrants may dilute then-existing shareholders’

percentage ownership in our Company

Given our plans and expectations that we will

need additional capital and personnel, we anticipate that we will need to issue additional shares of common stock or securities

convertible or exercisable for shares of common stock, including convertible preferred stock, convertible notes, stock options or

In addition, as of December 31, 2023, we have 23,395,046 common shares issuable upon exercise of outstanding warrants with

a weighted average exercise price of $1.94.

The issuance of additional securities in the future will dilute the percentage ownership

of our then current stockholders.

directors could authorize the creation of additional series of preferred stock that would grant to holders of preferred stock the right

to our assets upon liquidation, or the right to receive dividend payments before dividends are distributed to the holders of common stock.

In addition, subject to the rules of any securities exchange on which our stock is then listed, our board of directors could authorize

the creation of additional series of preferred stock that has greater voting power than our common stock or that is convertible into our

common stock, which could decrease the relative voting power of our common stock or result in dilution to our existing stockholders.

Additional stock offerings

in the future or the issuance of stock upon exercise of outstanding warrants may dilute then-existing shareholders’ percentage ownership

in our Company

our plans and expectations that we will need additional capital and personnel, we anticipate that we will need to issue additional shares

of common stock or securities convertible or exercisable for shares of common stock, including convertible preferred stock, convertible

notes, stock options or warrants.

In addition, as of the date of filing of this report, we had 12,226,549 Series B Warrants issued and

outstanding, each exercisable to purchase one share of our common stock at an exercise price of $2.79 per warrant..

The issuance of additional

securities in the future will dilute the percentage ownership of our current stockholders.

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