What changed in this filing

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Item 1A. Risk Factors

2024-03-21 compared with 2023-03-22 · 181 added, 249 removed, 1433 unchanged (23% of the section changed)

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We have no products approved for commercial sale and have generated only limited revenue to date.

April 2022, we focused primarily on pre-clinical development efforts associated with our XCART technology.

With the licensing of the DNase

oncology platform from CLS in April 2022, our primary focus is now on advancing that technology via partnering opportunities or through

regulatory approval and commercialization.

We expect to continue to incur significant research and development and other expenses related

to our ongoing operations.

As a result, we have never been profitable and we may not achieve profitability in the foreseeable future,

Our ability to generate profits in the future will depend on a number of factors, including:

focus is now on advancing our DNase oncology platform via partnering opportunities or through regulatory approval and commercialization.

We expect to continue to incur significant research and development and other expenses related to our ongoing operations.

we have never been profitable and we may not achieve profitability in the foreseeable future, if at all.

Our ability to generate profits

in the future will depend on a number of factors, including:

Funding the costs relating to the research and development, regulatory approval, commercialization and sale and marketing of our drug candidates and technologies;

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$9.0 million.

We expect that we will require additional capital to commence and complete clinical trials, obtain regulatory approval

for, and to commercialize, our drug candidates, including our other preclinical drug candidates and our future drug candidates.

our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than

Additional funding may come through public or private equity or debt financings, third-party funding, marketing and distribution

arrangements or other collaborations, strategic alliances and licensing arrangements (or a combination of these approaches).

In any event,

we will require additional capital to pursue preclinical and clinical activities, pursue regulatory approval for, and to commercialize,

our longer term pipeline drug candidates.

Even if we believe we have sufficient funds for our current or future operating plans, we may

seek additional capital if market conditions are favorable or if we have specific strategic considerations.

We expect that we will require additional capital to commence and complete clinical trials, obtain regulatory approval for,

and to commercialize, our drug candidates, including our other preclinical drug candidates and our future drug candidates.

operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned.

Additional funding may come through public or private equity or debt financings, third-party funding, marketing and distribution arrangements

or other collaborations, strategic alliances and licensing arrangements (or a combination of these approaches).

In any event, we will

require additional capital to pursue preclinical and clinical activities, pursue regulatory approval for, and to commercialize, our longer

term pipeline drug candidates.

Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional

capital if market conditions are favorable or if we have specific strategic considerations.

Our ability to raise additional funds will depend

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Market volatility

resulting from the ongoing COVID-19 pandemic or other factors, such as geopolitical tension, including the recent Russian invasion of

Ukraine, and any resulting sanctions, export controls or other restrictive actions, could also adversely impact our ability to access

capital as and when needed.

Additional funds may not be available when we need them, on terms and at a cost that are acceptable to us,

resulting from economic, political or other factors, such as geopolitical tension, including the conflicts in the Ukraine and the Middle

East, and any resulting sanctions, export controls or other restrictive actions, could also adversely impact our ability to access capital

as and when needed.

Additional funds may not be available when we need them, on terms and at a cost that are acceptable to us, or at all.

Any additional fundraising efforts may divert

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and financial resources in developing our products, and we currently do not have any products that have gained marketing approval.

revenues to date consist primarily of collaboration and royalty revenue from a single partner and not from product sales.

to generate product revenues, which may not occur for several years, if ever, will depend on the successful development and eventual commercialization

revenues currently consist primarily of royalty revenue from a single partner and not from product sales.

Our ability to generate product

revenues, which may not occur for several more years, if ever, will depend on the successful development and eventual commercialization

of our drug candidates.

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As described above, any of these events could

prevent us from achieving or maintaining market acceptance of our pharmaceutical products and impair our ability to generate revenues.

prevent us from achieving or maintaining market acceptance and approval of our pharmaceutical products and impair our ability to generate

If we complete the necessary preclinical

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be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,

conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state

requirements in the United States and requirements of comparable foreign regulatory authorities.

reporting, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal

and state requirements in the United States and requirements of comparable foreign regulatory authorities.

Manufacturers and manufacturing facilities are

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the safety and efficacy of the drug candidate.

We will be required to report certain adverse reactions and production problems, if any,

to the FDA and comparable foreign regulatory authorities.

Any new legislation addressing drug safety or other issues related to regulatory

review and approval could result in delays in product development or commercialization or increased costs to assure compliance.

have to comply with requirements concerning advertising and promotion for our products.

Promotional communications with respect to prescription

drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s

approved label.

As such, we are not allowed to promote our products for indications or uses for which they do not have approval.

drug candidates are approved, we must submit new or supplemental applications and obtain approval for certain changes to the approved

products, product labeling or manufacturing process.

We could also be asked to conduct post-marketing clinical trials to verify the safety

and efficacy of our products in general or in specific patient subsets.

An unsuccessful post-marketing study or failure to complete such

a study could result in the withdrawal of marketing approval.

We will be required to report certain adverse reactions, serious adverse events and production

problems, if any, to the FDA and comparable foreign regulatory authorities.

Any new legislation addressing drug safety or other issues

related to regulatory review and approval could result in delays in product development or commercialization or increased costs to assure

We will have to comply with requirements concerning advertising and promotion for our products.

Promotional communications

with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information

in the product’s approved label.

As such, we are not allowed to promote our products for indications or uses for which they do not

have approval.

If our drug candidates are approved, we must submit new or supplemental applications and obtain approval for certain changes

to the approved products, product labeling or manufacturing process.

We could also be asked to conduct post-marketing clinical trials

to verify the safety and efficacy of our products in general or in specific patient subsets.

An unsuccessful post-marketing study or failure

to complete such a study could result in the withdrawal of marketing approval.

If a regulatory agency discovers previously unknown

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requirements, a regulatory agency or enforcement authority may, among other things:

Issue inspectional findings;

Issue untitled and warning letters;

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their conditions generally rely on third-party payors to reimburse all or part of the costs associated with their treatment.

coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid, and commercial payors are critical to

new product acceptance.

coverage and reimbursement from federal health care programs, such as Medicare and Medicaid, and commercial payors are critical to new

product acceptance.

Government authorities and third-party payors,

such as private health insurers and health maintenance organizations, decide which drugs and treatments they will cover and the amount

of reimbursement.

Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s

determination that use of a product is:

such as private health insurers and health maintenance organizations, as well as their pharmacy benefit managers decide which drugs and

treatments they will cover and the amount of reimbursement.

Coverage and reimbursement by a third-party payor may depend upon a number

of factors, including the third-party payor’s determination that use of a product is:

A covered benefit under its health plan;

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Additionally, third-party payors and their pharmacy benefit

managers may not cover, or provide adequate reimbursement for, long-term follow-up evaluations required following the use of our gene-modifying

Patients are unlikely to use our drug candidates unless coverage is provided and reimbursement is adequate to cover a significant

portion of the cost of our drug candidates.

There is significant uncertainty related to insurance coverage and reimbursement of newly-approved

It is difficult to predict at this time what third-party payors will decide with respect to the coverage and reimbursement for

our drug candidates.

managers may not cover, or provide adequate reimbursement for, long-term follow-up evaluations that may be required for our products.

Patients are unlikely to use our drug candidates unless coverage is provided and reimbursement is adequate to cover a significant portion

of the cost of our drug candidates and/or if patient out-of-pocket costs (such as co-pays or co-insurance) are prohibitively high.

is significant uncertainty related to insurance coverage and reimbursement of newly-approved products.

It is difficult to predict at this

time what third-party payors will decide with respect to the coverage and reimbursement for our drug candidates.

Moreover, increasing efforts by governmental and

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We expect to experience pricing pressures in connection with the sale of any of our drug candidates due to the trend toward

managed healthcare, the increasing influence of health maintenance organizations, cost containment initiatives and additional legislative

managed healthcare, value-based pricing, the increasing influence of health maintenance organizations, cost containment initiatives and

additional legislative changes.

We intend to seek approval to market our drug

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Furthermore, facilities used by these third party CROs, clinical investigators and clinical study sites may be negatively affected by

catastrophic events, such as pandemics, including the ongoing COVID-19 pandemic, terrorist attacks, wars or other armed conflicts, geopolitical

tensions, such as the ongoing conflict between Russia and Ukraine and related sanctions and other economic disruptions or concerns, natural

disasters, such as floods or fire, or such facilities could face manufacturing issues, such as contamination or regulatory concerns following

a regulatory inspection of such facility.

In such instances, we may need to locate an appropriate replacement third-party facility and

establish a contractual relationship, which may not be readily available or on acceptable terms, which would cause additional delay and

increased expense, including as a result of additional required FDA approvals, and may have a material adverse effect on our business.

catastrophic events, such as pandemics, terrorist attacks, wars or other armed conflicts, geopolitical tensions, such as the ongoing conflict

between Russia and Ukraine and related sanctions and other economic disruptions or concerns, natural disasters, such as floods or fire,

or such facilities could face manufacturing issues, such as contamination or regulatory concerns following a regulatory inspection of

such facility.

In such instances, we may need to locate an appropriate replacement third-party facility and establish a contractual relationship,

which may not be readily available or on acceptable terms, which would cause additional delay and increased expense, including as a result

of additional required FDA approvals, and may have a material adverse effect on our business.

We, our clinical investigators, and our CROs are

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partners to develop and manufacture our products for commercialization in the pharmaceutical marketplace, and we will be dependent on

collaborations with drug development and manufacturing collaborators.

collaborations with drug development and manufacturing capabilities.

If we are not able to maintain existing collaborative arrangements

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Risks Related to Our Business Operations

Adverse developments affecting the financial

services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional

counterparties, could adversely affect the Company’s current and projected business operations and its financial condition and results

of operations.

Actual events involving limited liquidity, defaults,

non-performance or other adverse developments that affect financial institutions, transactional counterparties or other companies in the

financial services industry or the financial services industry generally, or concerns or rumors about any events of these kinds or other

similar risks, have in the past and may in the future lead to market-wide liquidity problems.

For example, on March 10, 2023, Silicon

Valley Bank (“SVB”) was closed by the California Department of Financial Protection and Innovation, which appointed the Federal

Deposit Insurance Corporation (“FDIC”) as receiver.

Similarly, on March 12, 2023, Signature Bank and Silvergate Capital Corp.

were each swept into receivership.

Although a statement by the Department of the Treasury, the Federal Reserve and the FDIC indicated

that all depositors of SVB would have access to all of their money after only one business day of closure, including funds held in uninsured

deposit accounts, borrowers under credit agreements, letters of credit and certain other financial instruments with SVB, Signature Bank

or any other financial institution that is placed into receivership by the FDIC may be unable to access undrawn amounts thereunder.

have substantially all of our cash on deposit with SVB, most of which would be uninsured by the FDIC, and we regularly maintain cash balances

that are not insured or are in excess of the FDIC’s insurance limit.

As of March 13, 2023, we had full access to our funds.

to have access to our funds on deposit could have material adverse impacts on our liquidity and our current and/or projected business

operations and financial condition and results of operations.

Although we are not a borrower or party to any such instruments with SVB,

Signature or any other financial institution currently in receivership, if any of our customers, suppliers or other parties with whom

we conduct business are unable to access funds pursuant to such instruments or lending arrangements with such a financial institution,

such parties’ ability to pay their obligations to us or to enter into new commercial arrangements requiring additional payments

to us could be adversely affected.

In this regard, counterparties to SVB credit agreements and arrangements, and third parties such as

beneficiaries of letters of credit (among others), may experience direct impacts from the closure of SVB and uncertainty remains over

liquidity concerns in the broader financial services industry.

Similar impacts have occurred in the past, such as during the 2008-2010

financial crisis.

Inflation and rapid increases in interest rates

have led to a decline in the trading value of previously issued government securities with interest rates below current market interest

Although the U.S.

Department of Treasury, FDIC and Federal Reserve Board have announced a program to provide up to $25 billion

of loans to financial institutions secured by certain of such government securities held by financial institutions to mitigate the risk

of potential losses on the sale of such instruments, widespread demands for customer withdrawals or other liquidity needs of financial

institutions for immediate liquidity may exceed the capacity of such program.

Additionally, there is no guarantee that the U.S.

of Treasury, FDIC and Federal Reserve Board will provide access to uninsured funds in the future in the event of the closure of other

banks or financial institutions, or that they would do so in a timely fashion.

Although we assess our banking relationships as

we believe necessary or appropriate, our access to funding sources and other credit arrangements in amounts adequate to finance or capitalize

our current and projected future business operations could be significantly impaired by factors that affect the Company, or the financial

services industry or economy in general.

These factors could include, among others, events such as liquidity constraints or failures,

the ability to perform obligations under various types of financial, credit or liquidity agreements or arrangements, disruptions or instability

in the financial services industry or financial markets, or concerns or negative expectations about the prospects for companies in the

financial services industry.

These factors could involve financial institutions or financial services industry companies with which the

Company has financial or business relationships, but could also include factors involving financial markets or the financial services

industry generally.

The results of events or concerns that involve

one or more of these factors could include a variety of material and adverse impacts on our current and projected business operations

and our financial condition and results of operations.

These could include, but may not be limited to, delayed access to deposits or other

financial assets or the uninsured loss of deposits or other financial assets or the uninsured loss of deposits or other financial assets;

or the termination of cash management arrangements and/or delays in accessing or actual loss of funds subject to cash management arrangements.

Investor concerns regarding the U.S.

or international

financial systems could result in less favorable commercial financing terms, including higher interest rates or costs and tighter financial

and operating covenants, or systemic limitations on access to credit and liquidity sources, thereby making it more difficult for us to

acquire financing on acceptable terms or at all.

Any decline in available funding or access to our cash and liquidity resources could,

among other risks, adversely impact our ability to meet our operating expenses, financial obligations or fulfill our other obligations,

result in breaches of our financial and/or contractual obligations or result in violations of federal or state wage and hour laws.

of these impacts, or any other impacts resulting from the factors described above or other related or similar factors not described above,

could have material adverse impacts on our liquidity and our current and/or projected business operations and financial condition and

results of operations.

In addition, any further deterioration in the macroeconomic economy

or financial services industry could lead to losses or defaults by our customers or suppliers, which in turn, could have a material adverse

effect on our current and/or projected business operations and results of operations and financial condition.

For example, a customer

may fail to make payments when due, default under their agreements with us, become insolvent or declare bankruptcy, or a supplier may

determine that it will no longer deal with us as a customer.

In addition, a customer or supplier could be adversely affected by any of

the liquidity or other risks that are described above as factors that could result in material adverse impacts on the Company, including

but not limited to delayed access or loss of access to uninsured deposits or loss of the ability to draw on existing credit facilities

involving a troubled or failed financial institution.

Any customer or supplier bankruptcy or insolvency, or the failure of any customer

to make payments when due, or any breach or default by a customer or supplier, or the loss of any significant supplier relationships,

could result in material losses to the Company and may have a material adverse impact on our business.

Market conditions and changing circumstances,

some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to

timely pay collaborators and others.

Market conditions and changing circumstances,

some of which may be beyond our control, could impair our ability to access our existing cash, cash equivalents and investments and to

timely pay key vendors and others.

If banks and financial institutions with whom we have banking relationships enter receivership or become

insolvent in the future, we may be unable to access, and we may lose, some or all of our existing cash, cash equivalents and investments

to the extent those funds are not insured or otherwise protected by the FDIC.

In addition, in such circumstances we might not be able

to make timely payments to our collaborators or others.

The Company maintains its primary banking relationship with one large financial

institution and all cash on deposit is federally insured.

The Company has not experienced any losses on its accounts, and does not believe

it is exposed to any unusual credit risk beyond the normal credit risk currently associated with commercial banking relationships.

any delay in our ability to access our cash, cash equivalents and investments or to timely pay our collaborators and others could have

a material adverse effect on our operations and cause us to need to seek additional capital sooner than planned.

Our future success depends on our ability

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qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to

There is currently a shortage of skilled executives in our industry, which is likely to continue.

As a result, competition

for skilled personnel is intense and the turnover rate can be high.

We may not be able to attract and retain personnel on acceptable terms

given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar skill sets.

failure to succeed in preclinical or clinical studies may make it more challenging to recruit and retain qualified personnel.

The inability

to recruit or loss of the services of any executive, consultant or advisor may impede the progress of our research and development objectives.

Competition for skilled personnel is intense and the turnover rate can be high.

We may not be able to attract and retain

personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for individuals with similar

In addition, failure to succeed in preclinical or clinical studies may make it more challenging to recruit and retain qualified

The inability to recruit or loss of the services of any executive, consultant or advisor may impede the progress of our research

and development objectives.

We will need to expand our organization

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Risks Related to Our Common Stock

Our failure to meet the continued listing

requirements of The Nasdaq Capital Market could result in a de-listing of our common stock.

Failure to regain compliance with Nasdaq listing

rules could affect the market price of our Common Stock and liquidity and reduce our ability to raise capital.

Currently, our Common Stock trades on the Nasdaq

Capital Market.

On June 3, 2022, we received a written notification (the “Notice”) from the Listing Qualifications Department

of the NASDAQ Stock Market LLC (“Nasdaq”) notifying us that the closing bid price for our common stock had been below $1.00

for 30 consecutive business days and that we therefore were not in compliance with the minimum bid price requirement for continued inclusion

on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Requirement”).

The Notice has no immediate

effect on the listing of the Company’s common stock on the Nasdaq Capital Market.

Under the Nasdaq Listing Rules, we had a period

of 180 calendar days from the date of the Notice to regain compliance with the Bid Price Requirement.

Accordingly, we had until November

30, 2022 (the "Compliance Date"), to regain compliance with the Bid Price Requirement.

On December 1, 2022, we received a letter

from Nasdaq informing us that although the Company’s common stock had not regained compliance with the minimum $1.00 bid price per

share requirement, Nasdaq had determined that we were eligible for an additional 180 calendar day period, or until May 29, 2023, to regain

Nasdaq’s determination was based on the Company meeting the continued listing requirement for market value of publicly

held shares and all other applicable requirements for initial listing on the Nasdaq Capital Market with the exception of the bid price

requirement, and our written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse

stock split, if necessary.

If at any time before May 29, 2023, the closing

bid price of our common stock closes at or above $1.00 per share for a minimum of, subject to Nasdaq’s discretion, 10 consecutive

business days, Nasdaq will provide written notification that we have achieved compliance with the Bid Price Requirement.

We will continue to monitor the closing bid price

of our common stock and will consider our available options to resolve the deficiency and regain compliance with the Bid Price Requirement

within the allotted compliance period.

However, there can be no assurance that we will be able to regain compliance with the Bid Price

Requirement, or will otherwise be in compliance with other Nasdaq Listing Rules.

If we fail to regain compliance with the Nasdaq Listing

Rules, including the Bid Price Requirement, we could be delisted and our stock would be considered a penny stock under regulations of

the SEC, and would therefore be subject to rules that impose additional sales practice requirements on broker-dealers who sell our securities.

The additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from effecting transactions in

our common stock, which could severely limit the market liquidity of our common stock and stockholder’s ability to sell our securities

in the secondary market.

If our common stock were to be delisted from the NASDAQ Capital Market, the liquidity of our common stock

would be materially affected, which would decrease the attractiveness of our common stock to investors and result in a decline in the

market price of our common stock.

Also, it may be difficult for us to raise additional capital if we are not listed on a major exchange.

We may not continue to meet the continued

listing requirements of Nasdaq, which could result in a delisting of our common shares.

Our common shares are listed on the Nasdaq.

we are currently in compliance, we have in the past been, and may in the future be, unable to comply with certain listing standards that

we are required to meet to maintain the listing of our common shares on the Nasdaq.

For instance, on June 3, 2022, we received written

notification from the Listing Qualifications Department of Nasdaq notifying us that the closing bid price for our common stock had been

below $1.00 for 30 consecutive business days and that we, therefore, were not in compliance with the Nasdaq minimum bid price requirement.

After approval from the Company’s Board of Directors, on May 15, 2023, we effected a reduction, on a 1-for-10 basis, in our authorized

common stock, par value $0.001, along with a corresponding and proportional decrease in the number of shares issued and outstanding(the

“Reverse Stock Split”).

On May 30, 2023, we received a letter from Nasdaq notifying us that we had regained compliance with

the minimum bid price requirement as a result of the closing bid price of our common stock being at $1.00 per share or greater for the

10 consecutive business days from May 15, 2023 through May 26, 2023 and that this matter was closed.

The primary intent for the Reverse Stock Split

was that the anticipated increase in the price of our common shares immediately following and resulting from a reverse stock split due

to the reduction in the number of issued and outstanding common shares would help us meet the minimum bid price requirement.

be assured that the Reverse Stock Split will result in any sustained proportionate increase in the market price of our common shares,

which is dependent upon many factors, including the business and financial performance of the company, general market conditions, and

prospects for future success, which are unrelated to the number of shares of our common shares outstanding.

It is not uncommon for the

market price of a company’s common shares to decline in the period following a reverse stock split.

Thus, while we have regained

compliance with the continued listing requirements for Nasdaq, it cannot be assured that we will continue to do so.

If Nasdaq delists

our common shares from trading on its exchange for failure to meet the listing standards, an investor would likely find it significantly

more difficult to dispose of or obtain our shares, and our ability raise future capital through the sale of our shares could be severely

Delisting could also have other negative results, including the potential loss of confidence by employees, the loss of institutional

investor interest and fewer business development opportunities.

The Reverse Stock Split may decrease the

liquidity of our common shares.

The liquidity of our common stock may be adversely

affected by the reduced number of shares outstanding after the Reverse Stock Split.

In addition, the Reverse Stock Split may have increased

the number of shareholders who own odd lots (less than 100 shares) of our common shares, creating the potential for such shareholders

to experience an increase in the cost of selling their shares and greater difficulty effecting such sales.

The market price of our securities may be

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Our securities could be subject to wide fluctuations in price in response to a variety of factors, including the following:

Failure to realize the anticipated potential of the DNase or PolyXen technologies;

Adverse results, delays, or holds in pre-clinical or clinical studies;

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Trading volume of our securities.

Our preferred stock has rights, preferences

and privileges that are not held by, and are preferential to, the rights of our common stockholders, which could result in the interests

of the holders of our preferred stock differing from those of our common stockholders.

Our preferred stockholders have rights,

preferences and privileges that are not held by, and are preferential to, the rights of our common stockholders, which could result in

the interests of our preferred stockholders differing from those of our common stockholders.

The holders of our preferred stock have the right

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offerings in the future or prevent or delay a change of control.

Additionally, each share of Series A Preferred Stock and Series B Preferred

Stock are convertible into shares of our common stock, subject to an issuable maximum and subject to certain adjustments, which may cause

significant dilution to our common stockholders.

The preferential rights could result in divergent interests between the holders of shares

of preferred stock and holders of our common stock.

Additionally, each share of Series B Preferred Stock are convertible

into shares of our common stock, subject to an issuable maximum and subject to certain adjustments, which may cause significant dilution

to our common stockholders.

The preferential rights could result in divergent interests between the holders of shares of preferred stock

and holders of our common stock.

The issuance of future shares of common

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This risk is especially relevant for

us because pharmaceutical companies have experienced significant stock price volatility in recent years.

If we face such litigation, it

could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

us because we have experienced significant stock price volatility in recent years.

If we face such litigation, it could result in substantial

costs and a diversion of management’s attention and resources, which could harm our business.

An active, liquid and orderly market for

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Our common stock and purchase warrants trade on

An active trading market for our common stock or purchase warrants may never develop or be sustained.

If an active market for

our common stock or purchase warrants does not continue to develop or is not sustained, it may be difficult for investors to sell shares

or purchase warrants without depressing the market price, and investors may not be able to sell the shares or purchase warrants at all.

An inactive market may also impair our ability to raise capital by selling common stock or purchase warrants and may impair our ability

to acquire other businesses, applications or technologies using our common stock or purchase warrants as consideration, which, in turn,

could materially adversely affect our business.

the Nasdaq Capital Market.

An active, liquid trading market for our common stock or purchase warrants may never develop or be sustained.

If an active, liquid market for our common stock or purchase warrants does not continue to develop or is not sustained, it may be difficult

for investors to sell shares or purchase warrants without depressing the market price, and investors may not be able to sell the shares

or purchase warrants at all.

An inactive or illiquid market may also impair our ability to raise capital by selling common stock or purchase

warrants and may impair our ability to acquire other businesses, applications or technologies using our common stock or purchase warrants

as consideration, which, in turn, could materially adversely affect our business.

We have entered into several agreements

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not have been negotiated at arm’s length and may contain terms and conditions that are not in our best interest.

Actions of activist shareholders could cause

us to incur substantial costs, divert management's attention and resources, and have an adverse effect on our business.

We actively engage in discussions with our shareholders

regarding further strengthening our Company and creating long-term shareholder value.

Some shareholder activism, including potential proxy

contests, could result in substantial costs, such as legal fees and expenses, disrupt our operations, and divert management’s and

our Board of Directors’ attention and resources from our business and strategic plans.

Public shareholder activism can create perceived

uncertainties as to our future direction, strategy, or leadership and may result in the loss of potential business opportunities, harm

our ability to attract new employees, investors, collaborators and other partners, and cause our stock price to experience volatility.

These risks could adversely affect our financial performance.

We do not intend to pay dividends on our

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conflicts, terrorism or other geopolitical events, such as the Russian invasion of Ukraine, and related sanctions and other economic disruptions

For example, the global pandemic related to the

rapidly growing outbreak of a novel strain of coronavirus (COVID-19) has created, and may continue to create, significant volatility,

uncertainty and economic disruption, including significant volatility in the capital markets.

The extent to which the COVID-19 pandemic

affects our business, operations, financial results and the trading price of our common stock will depend on numerous evolving factors

that we may not be able to accurately predict.

If the global response to contain the COVID-19 pandemic escalates further or is unsuccessful,

or if governmental decisions to ease pandemic related restrictions are ineffective, premature or counterproductive, we could experience

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

Additionally, the global economy and financial

markets may also be adversely affected by the current or anticipated impact of military conflict, terrorism or other geopolitical events,

Sanctions imposed by the United States and other countries in response to such conflicts, may also adversely impact the financial markets

and the global economy, and the economic countermeasures by the affected countries or others could exacerbate market and economic instability.

In late February 2022, Russia initiated significant military action against Ukraine.

In response, the United States and certain other

countries imposed significant sanctions and trade actions against Russia and could impose further sanctions, trade restrictions, and other

retaliatory actions if the conflict continues or worsens.

It is not possible to predict the broader consequences of the conflict, including

related geo-political tensions, and the measures and retaliatory actions that will be taken by the United States and other countries in

respect thereof, as well as any countermeasures or retaliatory actions Russia may take in response, are likely to cause regional instability

and geo-political shifts and could materially adversely affect global trade, currency exchange rates, regional economies, and the global

While it is difficult to anticipate the impact of any of the foregoing on our Company in particular, the conflict and actions

taken in response to the conflict could increase our costs, disrupt our supply chain, impair our ability to raise or access additional

capital when needed on acceptable terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

such as the wars in Ukraine and the Middle East.

Sanctions imposed by the United States and other countries in response to such conflicts,

may also adversely impact the financial markets and the global economy, and the economic countermeasures by the affected countries or

others could exacerbate market and economic instability.

For example, in response to the Russian invasion of Ukraine, the United States

and certain other countries imposed significant sanctions and trade actions against Russia and could impose further sanctions, trade restrictions,

and other retaliatory actions as the conflict continues or if it worsens.

It is not possible to predict the broader consequences of such

conflict or any others, such as the war in the Middle East, including related geo-political tensions, and the measures and retaliatory

actions that will be taken by the United States and other countries in respect thereof, as well as any countermeasures or retaliatory

actions Russia or any other country may take in response, are likely to cause regional instability and geo-political shifts and could

materially adversely affect global trade, currency exchange rates, regional economies, and the global economy.

While it is difficult to

anticipate the impact of any of the foregoing on our Company in particular, the conflict and actions taken in response to the conflict

could increase our costs, disrupt our supply chain, impair our ability to raise or access additional capital when needed on acceptable

terms, if at all, or otherwise adversely affect our business, financial condition, and results of operations.

There can be no assurance that further deterioration

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The use of our NOL carryforwards may have limitations

resulting from certain future ownership changes or other factors under the Code and other taxing authorities.

The TCJA changed both the

federal deferred tax value of the NOL carryforwards and the rules of utilization of federal NOL carryforwards.

resulting from certain future ownership changes or other factors under the Code and other taxing authorities, including foreign tax regimes.

The TCJA changed both the federal deferred tax value of the NOL carryforwards and the rules of utilization of federal NOL carryforwards.

If our NOL carryforwards are limited, and we have

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In addition, regardless of merit or eventual outcome, product

liability claims may result in:

liability claims may result in, among other negative effects:

Impairment of our business reputation;

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our results of operations.

Varying interpretations of existing standards

and rules have occurred with frequency and may cause us to have to restate previously reported result of operations.

Varying interpretations of existing accounting

standards and rules have occurred with frequency and may cause us to have to restate previously reported result of operations.

Varying interpretations of existing standards

14 unchanged sentences

Failure in our information technology systems

including by cybersecurity attacks or other data security incidents, could significantly disrupt our operations.

or those of our third-party service providers, including by cybersecurity attacks or other data security incidents, could significantly

disrupt our operations.

Our operations depend, in part, on the continued

performance of our information technology systems.

Our information technology systems are potentially vulnerable to physical or electronic

break-ins, computer viruses and similar disruptions.

Failure of our information technology systems could adversely affect our business,

profitability and financial condition.

performance of our information technology systems, which are cloud-based and maintained by third-party service providers.

Our information

technology systems are potentially vulnerable to physical or electronic break-ins, computer viruses and similar disruptions.

our information technology systems could adversely affect our business, profitability and financial condition.

A successful cybersecurity attack or other data

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for our common stock and our stock price may be more volatile and may decline.

ITEM 1B – UNRESOLVED STAFF COMMENTS

Not Applicable.

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