What changed in this filing

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Item 1A. Risk Factors

2025-08-11 compared with 2024-08-13 · 145 added, 236 removed, 2153 unchanged (15% of the section changed)

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Disruptions in the global economy and supply chains may have a material adverse effect on our business, financial condition and results of operations and the financial condition of the third parties on which we rely, including Austrianova.

The recent and ongoing COVID-19 pandemic has affected and could continue to affect our operations, as well as the business or operations of third parties with whom we conduct business.

Our business could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which we rely have significant business operations.

If we are unable to successfully raise sufficient capital, our future clinical trials and product development could be limited, and our long-term viability may be threatened.

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We have generated significant operating losses since our inception.

Our net losses attributable to common stockholders for the

years ended April 30, 2024, and 2023 were approximately $17.2 million and $4.3 million, respectively.

As of April 30, 2024, we had an

accumulated deficit of approximately $115.6 million.

Substantially all our losses have resulted from expenses incurred relating to our

research and development programs and from general and administrative expenses and operating losses associated with our business.

Our net income attributable to common stockholders for the

year ended April 30, 2025 was approximately $23 million, mostly attributable to a gain on the related party investment of approximately

$21 million and fair value fluctuations of approximately $14 million, and for 2024 our net loss attributable to common stockholders was

approximately $17.2 million.

As of April 30, 2025, we had an accumulated deficit of approximately $85 million.

Substantially all our losses

have resulted from expenses incurred relating to our research and development programs and from general and administrative expenses and

operating losses associated with our business.

We expect to continue to incur significant expenses

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and to generate and prepare the requested information.

It is possible that the service providers that we will utilize for such work may

have considerable backlogs and/or are suffering from slowdowns as a result of COVID-19 and supply chain disruptions and may not be able

to perform such work for an extended period of time.

Even if we are able to fully respond to the FDA’s requests, the agency may

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facilities to produce our encapsulated live cell product candidates for cancer.

We rely on and expect

to continue to rely on Austrianova to manufacture supplies of our product candidates for preclinical studies and clinical trials, if allowed

to proceed, as well as for commercial manufacture of our product candidates, and these must be maintained for us to receive marketing

approval for our product candidates.

We rely on and expect to continue to rely on Austrianova

to manufacture supplies of our product candidates for preclinical studies and clinical trials, if allowed to proceed, as well as for commercial

manufacture of our product candidates, and these must be maintained for us to receive marketing approval for our product candidates.

Our encapsulated live cell product candidates

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Austrianova from time to time has experienced significant supply chain

disruptions, some of which may be related to COVID-19, and we believe it is experiencing liquidity issues.

Any further significant delay

in the supply of a product candidate or the raw material components thereof our clinical trials, if allowed to proceed, due to the need

to replace a third-party supplier of these raw materials could considerably delay completion of our clinical studies, product testing

and potential regulatory approval of our product candidates.

If we are unable to purchase these raw materials after regulatory approval

has been obtained for our product candidates, the commercial launch of our product candidates, if approved, would be delayed or there

would be a shortage in supply, which would impair our ability to generate revenues from the sale of our product candidates.

disruptions, and we believe it is experiencing liquidity issues.

Any further significant delay in the supply of a product candidate or

the raw material components thereof our clinical trials, if allowed to proceed, due to the need to replace a third-party supplier of these

raw materials could considerably delay completion of our clinical studies, product testing and potential regulatory approval of our product

If we are unable to purchase these raw materials after regulatory approval has been obtained for our product candidates, the

commercial launch of our product candidates, if approved, would be delayed or there would be a shortage in supply, which would impair

our ability to generate revenues from the sale of our product candidates.

Our current and anticipated future dependence

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to commercialize any products that receive marketing approval on a timely and competitive basis.

Disruptions in the global economy

and supply chains may have a material adverse effect on our business, financial condition and results of operations and the financial

condition of the third parties on which we rely, including Austrianova.

The disruptions to the global economy in recent

years have impeded global supply chains, resulting in longer lead times and also increased critical component costs and freight expenses.

Austrianova, a third-party supplier on whom we rely, from time to time has experienced significant supply chain disruptions, some of which

may be related to COVID-19, and we believe it may be experiencing liquidity issues.

Despite any actions we have undertaken to minimize

the impacts from disruptions to the global economy, there can be no assurances that unforeseen future events in the global supply chain,

inflationary pressures, and delays our third parties face will not have a material adverse effect on our business, financial condition

and results of operations.

The recent and ongoing COVID-19

pandemic could materially affect our operations, as well as the business or operations of third parties with whom we conduct business.

Our business could be adversely affected by the effects of other future health pandemics in regions where we or third parties on which

we rely have significant business operations.

We face the ongoing risk that the coronavirus

pandemic may slow our operations, our preclinical studies or the eventual enrollment of our planned clinical trial.

In order to prioritize

patient health and that of the investigators at clinical trial sites, we may need monitor enrollment of patients in our clinical study.

In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines

or travel restrictions impede patient movement or interrupt healthcare services.

These and other factors outside of our control could

delay our ability to conduct clinical trials or release clinical trial results.

In addition, the effects of the ongoing coronavirus pandemic

may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time

from key personnel, and negatively impact our key clinical trial vendors.

We cannot guarantee that COVID-19 or any other public health

crisis will not cause delays or impact on our business or proposed clinical trial.

If we are unable to successfully

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Until such time, if ever, as the FDA lifts its clinical hold on our IND related to our planned clinical trial in LAPC, our

Cell-in-a-Box ® encapsulation technology is validated in our planned clinical trial, and sufficient additional funding

is available, we have halted spending on behalf of our development program with respect to cannabinoids.

Cell-in-a-Box ® encapsulation technology is validated in our planned clinical trial, and sufficient additional funding is

available, we have halted spending on behalf of our development program with respect to cannabinoids.

Due to the significant resources required for

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delays or disruptions in our supply chain.

and (x) the adverse impacts caused by COVID-19.

We may be unable to adequately protect our

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data, damage our reputation, and subject us to significant financial and legal exposure.

We rely on information technology

systems that we or our third-party providers operate to process, transmit and store electronic information in our day-to-day operations.

In connection with our product discovery efforts, we may collect and use a variety of personal data, such as name, mailing address, email

addresses, phone number and clinical trial information.

A successful cyberattack could result in the theft or destruction of intellectual

property, data, or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our

We rely on information technology systems that

we or our third-party providers operate to process, transmit and store electronic information in our day-to-day operations.

In connection

with our product discovery efforts, we may collect and use a variety of personal data, such as name, mailing address, email addresses,

phone number and clinical trial information.

A successful cyberattack could result in the theft or destruction of intellectual property,

data, or other misappropriation of assets, or otherwise compromise our confidential or proprietary information and disrupt our operations.

Cyberattacks are increasing in their frequency, sophistication and intensity, and have become increasingly difficult to detect.

Cyberattacks could include wrongful conduct by hostile foreign governments, industrial espionage, wire fraud and other forms of cyber

fraud, the deployment of harmful malware, denial-of-service, social engineering fraud or other means to threaten data security, confidentiality,

integrity and availability.

A successful cyberattack could cause serious negative consequences for us, including, without limitation,

the disruption of operations, the misappropriation of confidential business information, including financial information, trade secrets,

financial loss and the disclosure of corporate strategic plans.

Although we devote resources to protect our information systems, we realize

that cyberattacks are a threat, and there can be no assurance that our efforts will prevent information security breaches that would result

in business, legal, financial or reputational harm to us, or would have a material adverse effect on our results of operations and financial

could include wrongful conduct by hostile foreign governments, industrial espionage, wire fraud and other forms of cyber fraud, the deployment

of harmful malware, denial-of-service, social engineering fraud or other means to threaten data security, confidentiality, integrity and

availability.

A successful cyberattack could cause serious negative consequences for us, including, without limitation, the disruption

of operations, the misappropriation of confidential business information, including financial information, trade secrets, financial loss

and the disclosure of corporate strategic plans.

Although we devote resources to protect our information systems, we realize that cyberattacks

are a threat, and there can be no assurance that our efforts will prevent information security breaches that would result in business,

legal, financial or reputational harm to us, or would have a material adverse effect on our results of operations and financial condition.

Any failure to prevent or mitigate security breaches or improper access to, use of, or disclosure of our clinical data or patients’

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new studies and potentially disrupt our business.

In addition, the computer

systems of various third parties on which we rely, and other contractors, consultants and law and accounting firms, may sustain damage

from computer viruses, unauthorized access, data breaches, phishing attacks, cybercriminals, natural disasters (including hurricanes and

earthquakes), terrorism, war and telecommunication and electrical failures.

We rely on our third-party providers to implement effective

security measures and identify and correct for any such failures, deficiencies or breaches.

If we or our third-party providers fail to

maintain or protect our information technology systems and data integrity effectively or fail to anticipate, plan for or manage significant

disruptions to our information technology systems, we or our third-party providers could have difficulty preventing, detecting and controlling

such cyber-attacks and any such attacks could result in losses described above as well as disputes with physicians, patients and our partners,

regulatory sanctions or penalties, increases in operating expenses, expenses or lost revenues or other adverse consequences, any of which

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

by such third parties to prevent or mitigate security breaches or improper access to or disclosure of such information could have similarly

adverse consequences for us.

If we are unable to prevent or mitigate the impact of such security or data privacy breaches, we could be

exposed to litigation and governmental investigations, which could lead to a potential disruption to our business.

In addition, the computer systems of various third

parties on which we rely, and other contractors, consultants and law and accounting firms, may sustain damage from computer viruses, unauthorized

access, data breaches, phishing attacks, cybercriminals, natural disasters (including hurricanes and earthquakes), terrorism, war and

telecommunication and electrical failures.

We rely on our third-party providers to implement effective security measures and identify

and correct for any such failures, deficiencies or breaches.

If we or our third-party providers fail to maintain or protect our information

technology systems and data integrity effectively or fail to anticipate, plan for or manage significant disruptions to our information

technology systems, we or our third-party providers could have difficulty preventing, detecting and controlling such cyber-attacks and

any such attacks could result in losses described above as well as disputes with physicians, patients and our partners, regulatory sanctions

or penalties, increases in operating expenses, expenses or lost revenues or other adverse consequences, any of which could have a material

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

Any failure by such third parties

to prevent or mitigate security breaches or improper access to or disclosure of such information could have similarly adverse consequences

If we are unable to prevent or mitigate the impact of such security or data privacy breaches, we could be exposed to litigation

and governmental investigations, which could lead to a potential disruption to our business.

Risks Related to Regulatory Matters

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for their products by the regulatory agencies.

The review processes of regulatory

authorities are lengthy, time consuming, expensive and inherently unpredictable.

If we are unable to obtain approval for our drug candidates

from applicable regulatory authorities, we will not be able to market and sell those drug candidates in those countries or regions and

our business could be substantially harmed.

The review processes of regulatory authorities

are lengthy, time consuming, expensive and inherently unpredictable.

If we are unable to obtain approval for our drug candidates from

applicable regulatory authorities, we will not be able to market and sell those drug candidates in those countries or regions and our

business could be substantially harmed.

The research, testing, manufacturing, labeling,

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– Accelerated Approval Pathway.”

Prior to requesting accelerated approval, we will

seek feedback from the FDA and will otherwise evaluate our eligibility to use the accelerated approval pathway.

There can also be no assurance

that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA or a BLA, as applicable, for accelerated

approval or any other form of designation or program intended to expedite the product development, review or approval processes.

there can be no assurance that after subsequent feedback from the FDA that we will continue to pursue or apply for accelerated approval

or any other form of designation or expedited program, even if we initially decide to do so.

Furthermore, if we decide to apply for accelerated

approval or under another expedited regulatory designation (such as the Breakthrough Therapy designation or Fast Track designation), there

can be no assurance that such submission or application will be accepted or that any expedited development, review or approval will be

granted on a timely basis or at all.

The FDA could also require us to conduct further studies prior to considering or grantingour application

or granting approval of any type and may require us to have a confirmatory trial to verify the clinical benefit of the product underway

and partially or fully enrolled before granting approval.

We might not be able to fulfill the FDA’s requirements in a timely manner,

which would cause delays, or approval might not be granted because our submission is deemed incomplete by the FDA.

Prior to requesting accelerated approval, we

will seek feedback from the FDA and will otherwise evaluate our eligibility to use the accelerated approval pathway.

There can also

be no assurance that after our evaluation of the feedback and other factors we will decide to pursue or submit an NDA or a BLA, as

applicable, for accelerated approval or any other form of designation or program intended to expedite the product development,

review or approval processes.

Similarly, there can be no assurance that after subsequent feedback from the FDA that we will continue

to pursue or apply for accelerated approval or any other form of designation or expedited program, even if we initially decide to do

Furthermore, if we decide to apply for accelerated approval or under another expedited regulatory designation (such as the

Breakthrough Therapy designation or Fast Track designation), there can be no assurance that such submission or application will be

accepted or that any expedited development, review or approval will be granted on a timely basis or at all.

The FDA could also

require us to conduct further studies prior to considering or granting our application or granting approval of any type and may

require us to have a confirmatory trial to verify the clinical benefit of the product underway and partially or fully enrolled

before granting approval.

We might not be able to fulfill the FDA’s requirements in a timely manner, which would cause delays,

or approval might not be granted because our submission is deemed incomplete by the FDA.

Even if we receive accelerated approval from the

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to and regulate the transport and use of such materials.

In addition, the development, manufacture, and sale of biologics is subject

to regulations that are often more complex and extensive than the regulations applicable to other pharmaceutical products.

In addition, the development, manufacture, and sale of biologics is subject to

regulations that are often more complex and extensive than the regulations applicable to other pharmaceutical products.

Manufacturing

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to market could be delayed.

Our reliance on these third parties for R&D

activities will reduce our control over these activities but will not relieve us of our responsibilities.

For example, we design our clinical

trials and will remain responsible for ensuring that each is conducted in accordance with the general investigational plan and protocol

for the trial.

Moreover, regulatory agencies require us to comply with GCP for conducting, recording and reporting the results of clinical

trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial

participants are protected.

Our reliance on third parties that we do not control does not relieve us of these responsibilities and requirements.

Regulatory agencies enforce GCP requirements through periodic inspections of trial sponsors, clinical investigators and trial sites.

we or any of our contractors fail to comply with applicable GCP regulations, the clinical data generated in the applicable trial may be

deemed unreliable and regulatory agencies may require us to perform additional clinical trials before approving a drug candidate for marketing,

which we may not have sufficient cash or other resources to support and which would delay our ability to generate revenue from future

sales of such drug candidate.We also are required to register ongoing clinical trials and post the results of completed clinical trials

on a government-sponsored database of regulatory agencies within specified timeframes.

Failure to do so can result in fines, adverse publicity

and civil and criminal sanctions.

Our reliance on these third parties for

R&D activities will reduce our control over these activities but will not relieve us of our responsibilities.

For example, we

design our clinical trials and will remain responsible for ensuring that each is conducted in accordance with the general

investigational plan and protocol for the trial.

Moreover, regulatory agencies require us to comply with GCP for conducting,

recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that

the rights, integrity and confidentiality of trial participants are protected.

Our reliance on third parties that we do not control

does not relieve us of these responsibilities and requirements.

Regulatory agencies enforce GCP requirements through periodic

inspections of trial sponsors, clinical investigators and trial sites.

If we or any of our contractors fail to comply with

applicable GCP regulations, the clinical data generated in the applicable trial may be deemed unreliable and regulatory agencies may

require us to perform additional clinical trials before approving a drug candidate for marketing, which we may not have sufficient

cash or other resources to support and which would delay our ability to generate revenue from future sales of such drug candidate.

We also are required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored

database of regulatory agencies within specified timeframes.

Failure to do so can result in fines, adverse publicity and civil and

criminal sanctions.

Furthermore, these third parties may also have

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For instance, Austrianova

from time to time has experienced significant supply chain delays, some of which may be related to COVID-19, and we believe it may be

experiencing liquidity issues.

from time to time has experienced significant supply chain delays and we believe it may be experiencing liquidity issues.

We rely on numerous consultants for a substantial

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“Controls and Procedures,”

the senior management has identified a material weakness in our internal controls over financial reporting and cannot assure you that

the senior management has identified material weaknesses in our internal controls over financial reporting and cannot assure you that

additional material weaknesses will not be identified in the future.

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decreased ability to issue additional shares of our common stock or obtain additional financing in the future.

A large number of shares may be issued and

subsequently sold upon the exercise of existing options and warrants and upon the conversion of the Company’s Series B convertible

preferred stock (the “Series B Preferred Shares”).

As of August 8, 2024, there were 925,164 shares

of common stock issuable under outstanding options, 18,570,847 shares of common stock issuable upon exercise of outstanding warrants at

various exercise prices and 3,765,105 shares of common stock reserved for issuance upon conversion of the Preferred Shares.

To the extent

that holders of existing options or warrants sell the shares of common stock issued upon the exercise of warrants, the market price of

our common stock may decrease due to the additional selling pressure in the market.

The risk of dilution from issuances of shares of common

stock underlying existing options and warrants may cause shareholders to sell their common stock, which could further decline in the market

The requirement

that we redeem the Series B Preferred Shares in cash could adversely affect our business plan, liquidity, financial condition, and results

of operations.

If not converted, we are required to redeem some

or all of the outstanding shares of Series B Preferred Shares for cash under certain circumstances.

These obligations could have important

consequences on our business.

In particular, they could:

limit our flexibility in planning for, or reacting to, changes in our businesses and the industries in which we operate;

increase our vulnerability to general adverse economic and industry conditions;

place us at a competitive disadvantage compared to our competitors.

No assurances can be given that we will be successful

in making the required payments to the holders of the Series B Preferred Shares or that we will be able to comply with the financial or

other covenants contained in the Certificate of Designations.

If we are unable to make the required cash payments or otherwise comply

with the Certificate of Designations:

dividends will accrue on the Series B Preferred Shares at 15% per annum;

the holders of the Series B Preferred Shares could foreclose against our assets;

we could be forced into bankruptcy or liquidation.

The terms of the

Series B Preferred Shares could limit our growth and our ability to finance our operations, fund our capital needs, respond to changing

conditions and engage in other business activities that may be in our best interests.

The Certificate of Designations contains a number

of affirmative and negative covenants regarding matters such as the payment of dividends, maintenance of our properties and assets, transactions

with affiliates, and our ability to issue other indebtedness.

Our ability to comply with these covenants may

be adversely affected by events beyond our control, and we cannot assure you that we can maintain compliance with these covenants.

financial covenants could limit our ability to make needed expenditures or otherwise conduct necessary or desirable business activities.

We may obtain additional

capital through the issuance of preferred stock, which may limit your rights as a holder of our common stock.

We may obtain additional capital through

the issuance of preferred stock, which may limit your rights as a holder of our common stock.

Without any stockholder vote or action, our Board

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Government regulation of drug pricing.

The price of our

common stock is volatile, which substantially increases the risk that our investors may not be able to sell their shares at or above the

price that the investors have paid for their shares.

The price of our common stock is volatile,

which substantially increases the risk that our investors may not be able to sell their shares at or above the price that the investors

have paid for their shares.

Because of the price volatility in our shares,

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governing our Preferred Shares presently restricts our ability to pay dividends.

We are a “smaller reporting

company” under the Commission’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable

to smaller reporting companies.

We are a “smaller reporting company”

under the Commission’s disclosure rules and have elected to comply with the reduced disclosure requirements applicable to smaller

reporting companies.

We are a “smaller reporting company” under the Commission’s

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We own securities of other public companies, including

the Notes, the MYMD Preferred Shares, the Femasys Warrants and the MyMD Warrants.

Management’s Discussion and

Analysis of Financial Condition and Results of Operations – Femasys Transaction” and “– MyMD Transaction”

the Notes, the TNF Preferred Shares, the Femasys common stock, the Femasys Warrants and the TNF Warrants.

Discussion and Analysis of Financial Condition and Results of Operations – Femasys Transaction” and “– TNF Transaction”

for more information regarding these securities.

Defined terms used in this risk factor are defined in such section.

The Notes are convertible at a conversion price

of $1.18 per share.

To the extent we convert the Notes when the market price of the Femasys Shares is lower than the conversion price,

we may realize a loss equal to the difference between the conversion price and the market price.

Femasys may require us to convert our

Notes into Femasys Shares if the closing price of the Femasys Shares exceeds $2.36 per share for 10 consecutive trading days and the daily

dollar trading volume of the Femasys Shares exceeds one million dollars ($1,000,000) per day during the same period and certain equity

conditions described in the Notes are satisfied.

The Femasys Notes are convertible at a conversion

price of $1.18 per share.

To the extent we convert the Notes when the market price of the Femasys Shares is lower than the conversion

price, we may realize a loss equal to the difference between the conversion price and the market price.

Femasys may require us to convert

our Notes into Femasys Shares if the closing price of the Femasys Shares exceeds $2.36 per share for 10 consecutive trading days and the

daily dollar trading volume of the Femasys Shares exceeds one million dollars ($1,000,000) per day during the same period and certain

equity conditions described in the Notes are satisfied.

If we are forced to mandatorily convert the Notes, we may realize additional loss.

The MyMD Preferred Shares are convertible at a

The TNF Preferred Shares are convertible at a

conversion price of $0.1832 per share.

To the extent we convert the MyMD Preferred Shares when the market price of the MyMD Common Shares

To the extent we convert the TNF Preferred Shares when the market price of the TNF Common Shares

is lower than the conversion price, we may realize a loss equal to the difference between the conversion price and the market price.

The Series A Warrants are exercisable at an exercise

price of $1.18 per share, and the Series B Warrants are exercisable at an exercise price of $1.475.

The Femasys Series A Warrants are exercisable

at an exercise price of $1.18 per share.

The Femasys Series B Warrants expired on November 21, 2024.

There can be no assurance that the

Femasys Warrants will be in the money when exercisable, and as such they may expire worthless.

The MyMD Warrants are exercisable at an exercise

The TNF Warrants are exercisable at an exercise

price of $0.1832 per share.

There can be no assurance that the MyMD Warrants will be in the money when exercisable, and as such they may

There can be no assurance that the TNF Warrants will be in the money when exercisable, and as such they may

expire worthless.

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compliance requirements and our activities may be restricted, which may make it difficult for us to continue operating our business.

Section 3(a)(1)(A) of the 1940 Act defines an

“investment company” as any issuer that is or holds itself out as being, engaged primarily, or proposes to engage primarily,

in the business of investing, reinvesting or trading in securities.

Section 3(a)(1)(C) of the 1940 Act defines “investment company”

to mean any issuer that is engaged or proposes to engage in the business of investing, reinvesting, owning, holding, or trading in securities,

Section 3(a)(1)(A) of the 1940 Act defines an “investment

company” as any issuer that is or holds itself out as being, engaged primarily, or proposes to engage primarily, in the business

of investing, reinvesting or trading in securities.

Section 3(a)(1)(C) of the 1940 Act defines “investment company” to mean

any issuer that is engaged or proposes to engage in the business of investing, reinvesting, owning, holding, or trading in securities,

and owns or proposes to acquire investment securities having a value exceeding 40% of the value of such issuer’s total assets.

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Our purchases of securities

of other companies, including pursuant to the Femasys Transaction and the MyMD Transaction (each as defined below), could give rise to

of other companies, including pursuant to the Femasys Transaction and the TNF Transaction (each as defined below), could give rise to

a determination that we are or were an investment company subject to registration under the 1940 Act.

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restrictions on the nature of our investments;

· restrictions on the issuance of securities, each of which may make it difficult for us to conduct our

business and raise working capital.

restrictions on the issuance of securities, each of which may make it difficult for us to conduct our business and raise working capital.

In addition, we may have imposed upon us burdensome

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adoption of a specific form of corporate structure different from our current operating structure;

· reporting, record keeping, voting, proxy and disclosure requirements and other rules and regulations that

we are currently not subject to.

reporting, record keeping, voting, proxy and disclosure requirements and other rules and regulations that we are currently not subject to.

Compliance with these additional regulatory burdens would require additional

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Managing Growth and Macroeconomic Conditions

We have experienced

significant management changes which could increase our control risks and have a material adverse effect on our ability to do business

and our results of operations.

We have recently experienced

a number of changes in our management, including changes in our Chief Executive Officer and Board.

The magnitude of these changes and

the short time interval in which they have occurred add to the risks of control failures, including a failure in the effective operation

of our internal control over financial reporting or our disclosure controls and procedures.

Control failures could result in material

adverse effects on our financial condition and results of operations.

It may take time for the new management team to become sufficiently

familiar with our business and each other to effectively develop and implement our business strategies.

The turnover of key management

positions could further harm our financial performance and results of operations.

Management attention may be diverted from regular business

concerns by reorganizations.

We have experienced significant management

changes which could increase our control risks and have a material adverse effect on our ability to do business and our results of operations.

We have recently experienced a number of changes

in our management, including changes in our Chief Executive Officer and Board.

The magnitude of these changes and the short time interval

in which they have occurred add to the risks of control failures, including a failure in the effective operation of our internal control

over financial reporting or our disclosure controls and procedures.

Control failures could result in material adverse effects on our financial

condition and results of operations.

It may take time for the new management team to become sufficiently familiar with our business and

each other to effectively develop and implement our business strategies.

The turnover of key management positions could further harm our

financial performance and results of operations.

Management attention may be diverted from regular business concerns by reorganizations.

We have a limited number of employees and

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Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

Unfavorable global economic conditions could

adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected

by general conditions in the global economy and in the global financial markets.

The recent global financial crisis related to COVID-19

caused extreme volatility and disruptions in the capital and credit markets.

Also, geopolitical tensions and the conflicts between Russia

and Ukraine and between Israel and Palestine continue to escalate, and numerous jurisdictions have imposed harsh sanctions on certain

industry sectors and parties in Russia, as well as enhanced export controls on certain products and industries.

These and any additional

sanctions and export controls, as well as any counter responses by the governments of Russia or other jurisdictions, could adversely affect,

directly or indirectly, the global supply chain, with negative implications on the availability and prices of raw materials, energy prices,

and our customers, as well as the global financial markets and financial services industry.

A severe or prolonged economic downturn, such

as the recent global financial crisis, could result in a variety of risks to our business, including our ability to raise additional capital

when needed on acceptable terms, if at all.

A weak or declining economy could also strain our suppliers, possibly resulting in supply

Any of the foregoing could adversely impact our business.

Our business and operations would suffer

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

What changed 10-K

Item 1A. Risk Factors