What changed in this filing

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Item 1A. Risk Factors

2023-03-31 compared with 2021-05-19 · 683 added, 294 removed, 544 unchanged (64% of the section changed)

following risk factors should be considered carefully in addition to the other information contained in this Annual Report.

Annual Report contains forward-looking statements.

Our business, financial condition, results of operations and stock price could

be materially adversely affected by any of these risks.

Report contains forward-looking statements.

Our business, financial condition, results of operations and stock price could be materially

adversely affected by any of these risks.

Related to Our Business

have a history of operating losses and expect to continue to incur losses and we may never become profitable.

The Company’s

independent registered public accounting firm has issued a report questioning our ability to continue as a going concern.

the fiscal year ended March 31, 2021, the Company incurred a net loss of $880,851 and used $1,605,076 of cash in our operating activities.

We have incurred losses since inception, resulting in an accumulated deficit of $47,427,709 as of March 31, 2021.

have a history of operating losses and expect to continue to incur losses.

We may never become profitable.

The Company’s independent

registered public accounting firm has issued a report questioning our ability to continue as a going concern.

the year ended December 31, 2022, the Company incurred a net loss of $1,072,176 and used $603,778 of cash in our operating activities.

We have incurred losses since inception, resulting in an accumulated deficit of $50,212,854 as of December 31, 2022.

These factors raise

substantial doubt about the Company’s ability to continue as a going concern for the next twelve months from the date that the

financial statements are issued which are a part of this Annual Report on Form 10-K.

In addition, the Company’s independent registered

public accounting firm, in their report on the Company’s March 31, 2021 audited financial statements, raised substantial doubt

about the Company’s ability to continue as a going concern.

We expect to incur further losses as we continue to develop our

substantial doubt about the Company’s ability to continue as a going concern for the next twelve months from the date that the

financial statements which are a part of this Annual Report on Form 10-K are issued.

In addition, the Company’s independent registered

public accounting firm, in their report on the Company’s December 31, 2021 audited financial statements, raised substantial doubt

about the Company’s ability to continue as a going concern.

We expect to incur further losses as we continue to develop our business.

We have not yet received significant revenues from sales of products or services and have recurring losses from operations.

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Even if we succeed in obtaining

regulatory approval to market our products, we may still incur losses for the foreseeable future.

We also expect to experience negative

cash flow for the near future, as we plan to use all available resources to fund our operations and if we proceed with an expansion

of our corporate strategy as discussed elsewhere in this Annual Report, to make significant capital expenditures.

we would need to generate significant revenues if we are to achieve and maintain profitability.

We may not be able to generate these

revenues or achieve profitability.

Our failure to achieve or maintain profitability could negatively impact the value of our common stock

and you could lose some or all of your investment.

regulatory approval to market our glycosylated cannabinoid prodrugs, we may still incur losses for the foreseeable future.

We also expect

to experience negative cash flow for the near future, as we plan to use all available resources to fund our operations and if we proceed

with an expansion of our corporate strategy as discussed elsewhere in this Annual Report, to make significant capital expenditures.

a result, we would need to generate significant revenues if we are to achieve and maintain profitability.

We may not be able to generate

these revenues or achieve profitability.

Our failure to achieve or maintain profitability could negatively impact the value of our common

stock and you could lose some or all of your investment.

will need to raise substantial additional capital to operate our business.

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If we do issue equity or convertible debt securities to raise additional funds

our existing stockholders may experience substantial dilution, and the new equity or debt securities may have rights, preferences and

privileges senior to those of our existing stockholders.

If we incur additional debt, it would increase our leverage relative to our

earnings, if any, or to our equity capitalization, requiring us to pay additional interest expense.

Obtaining commercial loans,

assuming those loans would be available, would increase our liabilities and future cash commitments.

If we pursue capital through alternative

sources, such as collaborations or other similar arrangements, we may be forced to relinquish rights to our proprietary compounds, technology

or other intellectual property or marketing rights, which could result in our receipt of only a portion of any revenue that may be generated

from a partnered product or business.

or to fund, in whole or in part, acquisitions in furtherance of our business strategy, our existing stockholders may experience substantial

dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders.

If we incur additional debt, it would increase our leverage relative to our earnings, if any, or to our equity capitalization, requiring

us to pay additional interest expense.

Obtaining commercial loans, assuming those loans would be available, would increase our liabilities

and future cash commitments.

If we pursue capital through alternative sources, such as collaborations or other similar arrangements,

we may be forced to relinquish rights to our proprietary glycosylated cannabinoid compounds, technology or other intellectual property

or marketing rights, which could result in our receipt of only a portion of any revenue that may be generated from a partnered product

We also may raise funds by selling some or all of our assets.

Regardless of the manner in which

we seek to raise capital, we may incur substantial costs in those pursuits, including investment banking fees, legal fees, accounting

fees, printing and distribution expenses and other related costs.

the 12 months following March 31, 2021, we expect our total operating expenditures to be approximately $1,400,000.

However, our estimate

of total expenditures could increase if we encounter unanticipated difficulties.

In addition, our estimates of the amount of cash necessary

to fund our business may prove to be wrong and we could spend our available financial resources much faster than we currently expect.

Further, our operational expenses may increase substantially during our current fiscal year if we pursue an expansion of our current

operational goals and research and development activities.

If we cannot raise the money that we need in order to continue to develop

our business, we will be forced to delay, scale back or eliminate some or all of our proposed operations and/or forego other attractive

business opportunities that may arise.

If any of these were to occur, there is a substantial risk that our business would fail.

of additional funds may not be available on acceptable terms or at all.

In addition, weak economic and capital market conditions could

result in increased difficulties in raising capital for our operations.

We may not be able to raise money through the sale of our equity

securities or through borrowing funds on terms we find acceptable, or at all.

If we cannot raise the funds that we need, we will be unable

to continue our operations, and our stockholders could lose their entire investment in the Company.

currently face, and will continue to face, significant competition.

major competitors for the development of pharmaceutical products related to cannabinoids and inflammatory disorders include major pharmaceutical

companies, smaller companies, and academic research groups that are devoted to biological or pharmaceutical research either independently

or by providing contract research services.

A number of multinational pharmaceutical companies are developing products in similar therapeutic

areas, including, but not limited to, Biogen, Teva Neuroscience, Pfizer, Endo Pharmaceuticals, Genzyme, Novartis, Bayer Healthcare, and

additional companies such as GW Pharmaceuticals, Arena Pharmaceuticals, Corbus Pharmaceuticals, Trait Biosciences, and Zynerba Pharmaceuticals

are developing cannabinoid pharmaceuticals for treatment of various clinical indications and commercial applications.

Regardless of the manner in which we seek to raise capital,

we may incur substantial costs in those pursuits, including investment banking fees, legal fees, accounting fees, printing and distribution

expenses and other related costs.

the 12 months following December 31, 2022, we expect our total operating losses to be approximately $1,200,000 (not including any

capital expenditures).

However, our estimate of total operating losses could increase if we encounter unanticipated difficulties.

our estimates of the amount of cash necessary to fund our business may prove to be wrong and we could spend our available financial resources

much faster than we currently expect.

Further, our operational expenses may increase substantially during our current fiscal year if

we pursue an expansion of our current operational goals and research and development activities.

If we cannot raise the money that we

need in order to continue to develop our business, we will be forced to delay, scale back or eliminate some or all of our proposed operations

and/or forego other attractive business opportunities that may arise.

If any of these were to occur, there is a substantial risk that

our business would fail.

Sources of additional funds may not be available on acceptable terms or at all.

In addition, weak economic and

capital market conditions could result in increased difficulties in raising capital for our operations.

We may not be able to raise money

through the sale of our equity securities or through borrowing funds on terms we find acceptable, or at all.

If we cannot raise the funds

that we need, we will be unable to continue our operations, and our stockholders could lose their entire investment in the Company.

limited operating experience could make our operations inefficient or ineffective.

are an early-stage company with only a limited operating history upon which to base an evaluation of our current business and future

prospects and how we will respond to competitive, financial or technological challenges.

In order to conserve our cash resources, we

have significantly scaled back our product research and development efforts such that we are almost exclusively focused on pursuing the

orphan drug designation approval and exploring strategic alternatives.

We only recently commenced operations in the development of pharmaceutical

products and have limited experience with these activities and the revenue and income potential of our business is unproven.

because of our limited operating history, we have limited insight into trends that may emerge and affect our business, and limited experience

responding to such trends.

We may make errors in predicting and reacting to relevant business trends and we will be subject to the risks,

uncertainties and difficulties frequently encountered by early-stage companies in evolving markets.

We may not be able to successfully

address any or all of these risks and uncertainties.

Failure to adequately do so could cause our business, results of operations and

financial condition to suffer or fail.

coronavirus pandemic is adversely affecting and will continue to adversely affect our business.

have only a limited operating history upon which to base an evaluation of our current business and future prospects and how we will respond

to competitive, financial or technological challenges.

In order to conserve our cash resources, we have significantly scaled back our

glycosylated cannabinoid product research and development efforts until additional capital is raised to advance our drug development program.

In addition, because of our limited operating history, we have limited insight into trends that may emerge

and affect our businesses, and limited experience responding to such trends.

We may make errors in predicting and reacting to relevant

business trends and we will be subject to the risks, uncertainties and difficulties frequently encountered by early-stage companies in

evolving markets.

We may not be able to successfully address any or all of these risks and uncertainties.

Failure to adequately do so

could cause our business, results of operations and financial condition to suffer or fail.

coronavirus pandemic is adversely affecting and will continue to adversely affect our current business.

inception, the Company has funded its operations primarily through equity and debt financings.

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The coronavirus pandemic

may also make it more difficult for us to pursue capital through alternative sources, such as collaborations or other similar arrangements,

since we expect that many potential strategic partners are either suffering financially or operationally as a result of the coronavirus

may also make it more difficult for us to pursue capital through alternative sources, such as pharmaceutical drug collaborations or other

similar arrangements, since potential strategic partners may be either suffering financially or operationally as a result of the coronavirus

pandemic or are focused on the development of treatment therapies or vaccines for the coronavirus.

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may not be able to manage our expansion of operations effectively.

we are able to attract additional capital, we may seek to expand our operations.

we are able to attract additional capital, we intend to expand our operations.

To manage this growth, we may need to expand our facilities,

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Our management will also be required

to develop relationships with customers, suppliers and other third parties.

Our current and planned operations, personnel, systems, and

internal procedures and controls may not be adequate to support our future growth.

to develop new relationships with customers, suppliers and other third parties.

Our current and planned operations, personnel, systems,

and internal procedures and controls may not be adequate to support our future growth.

If we are unable to manage our growth effectively,

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we are unable to hire and retain qualified personnel, we may not be able to implement our business plan.

of May 18, 2021, we employed three full-time employees, including one professional dedicated to research and development.

and retaining qualified scientific, management and other personnel will be critical to our success.

There is intense competition for

qualified personnel in our area of activities and we may not be able to attract and retain the qualified personnel necessary for the

development of our business.

In addition, we may have difficulty recruiting necessary personnel as a result of our limited operating

The loss of key personnel or the failure to recruit necessary additional personnel could impede the achievement of our business

may choose to hire part-time employees or use consultants.

As a result, certain of our employees, officers, directors and consultants

may from time to time serve as officers, directors and consultants of other companies.

These other companies may have interests in conflict

In addition, we expect to rely on independent organizations, advisors and consultants to provide certain services, including

product testing and development plan construction.

The services of these independent organizations, advisors and consultants may not

be available to us on a timely basis when needed or on acceptable terms, and if they are not available, we may not be able to find qualified

replacements.

If we are unable to retain the services of qualified personnel, independent organizations, advisors and consultants, we

may not be able to implement our business plan.

of March 30, 2023, we employed 40 full-time employees.

Attracting and retaining personnel will be critical to our success.

We may not be able to attract and retain the qualified

personnel necessary for the development of our business.

In addition, we may have difficulty recruiting necessary personnel as a result

of our limited operating history.

The loss of key personnel or the failure to recruit necessary additional personnel could impede the

achievement of our business objectives.

of our employees, officers, directors and consultants may from time to time serve as employees, officers, directors and consultants

of other companies.

In fact, our current CEO, Michael Cavanaugh, currently serves as Chief Investment Officer of Tower 1

Partnership, LLC, an investment firm focused on private and public investments in a variety of industries, and as manager of several

affiliated investment partnerships, pursuant to which he devotes a significant portion of his time.

The commitments of our

employees, officers, directors and consultants to these other companies may cause them to devote less time to the Company than would

otherwise be the case.

addition, we expect to rely on independent organizations, advisors and consultants to provide certain services.

The services of these

independent organizations, advisors and consultants may not be available to us on a timely basis when needed or on acceptable terms,

and if they are not available, we may not be able to find qualified replacements.

If we are unable to retain the services of qualified

personnel, independent organizations, advisors and consultants, we may not be able to implement our business plan.

incidents or attacks directed at us could result in information theft, data corruption, operational disruption and/or financial loss.

depend on digital technologies, including information systems, infrastructure and cloud applications and services, including those of

third parties with which we may deal.

Sophisticated and deliberate attacks on, or security breaches in, our systems or infrastructure,

or the systems or infrastructure of third parties or the cloud, could lead to corruption or misappropriation of our assets, proprietary

information and sensitive or confidential data.

As an early-stage company without significant investments in data security protection,

we may not be sufficiently protected against such occurrences.

We may not have sufficient resources to adequately protect against, or

to investigate and remediate any vulnerability to, cyber incidents.

It is possible that any of these occurrences, or a combination of

them, could have adverse consequences on our business and lead to financial loss.

Related to Our Environmental-Related Businesses

may have difficulty accomplishing our growth strategy within and outside of our current service areas.

ability to expand our business, both within our current service areas and into new areas, involves significant risks, including, but

not limited to:

in regulatory landscape reducing the demand for, and incentives relating

to, our land reclamation, water treatment and related environmental services;

or maintaining necessary regulatory permits, licenses or approvals;

in economic or population growth and development in our service areas, particularly in the coal mining industry and in those agricultural

and commercial businesses and real estate developments which benefit from our land reclamation and water treatment services;

related to planning and commencing new operations, including inaccurate

assessment of the demand for our land reclamation, water treatment and related environmental services and products and inability to begin

operations as scheduled;

potential inability to identify suitable acquisition opportunities or to form the relationships with coal mining operators or other

landowners necessary to form strategic partnerships.

costs, construction costs and costs of providing services may rise faster than revenue.

ability to increase the rates at which we provide our land reclamation,

water treatment and related environmental services may be limited by a variety of factors.

However, our costs are subject to market conditions

and other factors, and may increase significantly.

The second largest component of our equipment operating costs is made up of salaries

These costs are affected by the local supply and demand for qualified labor.

Other large components of our costs are general

insurance, workers compensation insurance, employee benefits and health insurance costs.

These costs may increase disproportionately to

our service rate increases and may have a material adverse effect on our financial condition and results of operations.

suppliers may fail to deliver materials and parts according to schedules, prices, quality and volumes that are acceptable to us, or we

may be unable to manage these materials and parts effectively.

equipment we use in our land reclamation and water treatment and reclamation business contains materials and parts purchased

globally from many suppliers which exposes us to potential component shortages or delays.

Unexpected changes in business conditions,

materials pricing, labor issues, wars such as the current conflict in Ukraine, trade policies, natural disasters, health epidemics

such as the global COVID-19 pandemic, trade and shipping disruptions, port congestions and other factors beyond our or our

suppliers’ control could also affect these suppliers’ ability to deliver components to us or to remain solvent and

Additionally, if our suppliers do not accurately forecast and effectively allocate production or if they are not

willing to allocate sufficient production to us, it may reduce our access to components and require us to search for new suppliers.

The unavailability of any component or supplier could result in delays in providing our services and products.

Our suppliers may not

be willing or able to sustainably meet our timelines or our cost, quality and volume needs, or to do so may cost us more, which may

require us to replace them with other sources.

While we believe that we will be able to secure additional or alternate sources for

most of our necessary components or products, there is no assurance that we will be able to do so quickly or at all.

financial results depend on successful project execution and may be adversely affected by cost overruns, failure to meet customer schedules

or other execution issues.

portion of our revenue is derived from projects that are technically complex and that may last over many months.

These projects are subject

to a number of significant risks, including project delays, cost overruns, changes in scope, unanticipated site conditions, design and

engineering issues, incorrect cost assumptions, increases in the cost of materials and labor, safety hazards, third party performance

issues, weather issues and changes in laws or permitting requirements.

If we are unable to manage these risks, we may incur higher costs,

liquidated damages and other liabilities to our customers, which may decrease our profitability and harm our reputation.

Our continued

growth will depend in part on executing a higher volume of large projects, which will require us to expand and retain our project management

and execution personnel and resources.

face competition in our industry, and we may be unable to attract customers and maintain a viable business.

can be no assurance that we will be able to successfully compete with our competitors.

Our competitors may prove more successful in offering

similar services which prove to be more popular with potential customers than our services.

Our ability to grow and achieve profitability

will depend on our ability to satisfy our customers and withstand increasing competition by providing superior environmental services

at reasonable cost.

There can be no assurance that we will be able to achieve or maintain a successful competitive position.

we become subject to environmental-related claims, we could incur significant cost and time to comply.

land reclamation and water treatment business activities create a risk of significant environmental liabilities and reputational

Under applicable environmental laws and regulations, we could be strictly, jointly and severally liable for releases of regulated

substances by us at the properties of others, including if such releases result in contamination of air or water or cause harm to individuals.

Our business activities also create a risk of contamination or injury to our employees, customers or third parties, from the use, treatment,

storage, transfer, handling and/or disposal of these materials.

the event that our business activities result in environmental liabilities, such as those described above, we could incur significant

costs or reputational damage in connection with the investigation and remediation of environmental contamination, and we could be liable

for any resulting damages including natural resource damages.

Such liabilities could exceed our available cash or any applicable insurance

coverage we may have.

Additionally, we are subject to, on an ongoing basis, federal, state and local laws and regulations governing the

use, storage, handling and disposal of these materials and specified waste products.

The cost of compliance with these laws and regulations

may become significant and could have a material adverse effect on our business, financial condition, results of operations or prospects.

we may incur costs to defend our position even if we are not liable for consequences arising out of environmental damage.

Our insurance

policies may not be sufficient to cover the costs of such claims.

to effectively treat emerging contaminants could result in material liabilities.

number of emerging contaminants might be found in water that we treat that may cause a number of illnesses.

In applications where treated

water enters the human body, illness and death may result if contaminants or pathogens are not eliminated during the treatment process.

The potential impact of a contamination of water treated using our products, services or solutions is difficult to predict and could

lead to an increased risk of exposure to product liability claims, increased scrutiny by federal and state regulatory agencies and negative

Further, an outbreak of disease in any one of the markets we serve could result in a widespread loss of customers across such

may incur liabilities to customers as a result of failure to meet performance guarantees, which could reduce our profitability.

customers may seek performance guarantees as to our equipment and services.

Failure to meet specifications of our customers or our failure

to meet our performance guarantees may increase costs by requiring additional resources and services, monetary reimbursement to a customer

or could otherwise result in liability to our customers.

To the extent that we incur substantial performance guarantee claims in any

period, our reputation, earnings and ability to obtain future business could be materially adversely affected.

in, and compliance with, current and future environmental and climate change laws and regulations could impact our land reclamation and

water treatment business, financial condition or results of operations.

business, operations, and product and service offerings are subject to and affected by many federal, state, local and foreign environmental

laws and regulations, including those enacted in response to climate change concerns.

Compliance with existing laws and regulations currently

requires, and compliance with future laws is expected to continue to require, increasing operating and capital expenditures in order

to conform to changing environmental standards and regulations, which could impact our business, financial condition and results of operations.

Furthermore, environmental laws and regulations may authorize substantial fines and criminal sanctions to address violations, and may

require the installation of costly pollution control equipment or operational changes to limit emissions or discharges.

We also incur,

and expect to continue to incur, costs to comply with current environmental laws and regulations.

At the same time, the demand for our

land reclamation and water treatment services also is driven by federal and state laws, regulations and programs which

create incentives for our services.

Developments such as the adoption of new environmental laws and regulations, stricter enforcement

of existing laws and regulations, violations by us of such laws and regulations, discovery of previously unknown or more extensive contamination,

litigation involving environmental impacts, our inability to recover costs associated with any such developments, or financial insolvency

of other responsible parties could in the future have a material adverse effect on our financial condition and results of operations.

insurance may not provide adequate coverage.

we maintain general and product liability, property and commercial insurance coverage, which we consider prudent, there can be no assurance

that such insurance will prove adequate in the event of actual casualty losses or broader calamities such as earthquakes, financial crises,

economic depressions or other catastrophic events, which are either uninsurable or not economically insurable.

Any such losses could

have a material adverse effect on the performance of our systems.

land reclamation and water treatment business is subject to various statutory and regulatory requirements, which may

increase in the future.

land reclamation and water treatment business is subject to various statutory and regulatory requirements.

to continue to hold licenses and permits required for our land reclamation and water treatment business is subject to

maintaining satisfactory compliance with such requirements.

We may incur significant costs to maintain compliance.

Our ability to obtain

modifications to our permits may be met with resistance, substantial statutory or regulatory requirements or may be too costly to achieve.

These requirements may cause us to postpone or cancel our plans.

Future statutory and regulatory requirements, including any legislation

focused on combating climate change, may require significant cost to comply or may require changes to our products or services.

environmental regulations to which we are subject may increase our costs and potential liabilities and limit our ability to operate.

land reclamation and water treatment business is subject to various federal, state, and local environmental requirements,

including those relating to emissions to air, discharged wastewater, storage, treatment, transport and disposal of regulated materials

and cleanup of coal mining and groundwater contamination.

Efforts to conduct our operations in compliance with all applicable laws and

regulations, including environmental rules and regulations, require programs to promote compliance, such as training employees and customers,

purchasing health and safety equipment and in some cases hiring outside consultants and lawyers.

Even with these programs, we face the

risk of being subject to government enforcement proceedings, which can result in fines or other sanctions and require expenditures for

remedial work on contaminated sites.

The landscape of environmental regulation to which we are subject can change.

Changes to environmental

regulation often present new business opportunities for us;

however, such changes may also result in increased operating and compliance

While we seek to monitor the landscape of environmental regulation, our ability to navigate is limited by our small size and resources,

and any changes to such regulations may result in a material effect on our operations, cash flows or financial condition.

also have the power to suspend or revoke permits or licenses needed for operation of our equipment and vehicles based on, among other

factors, our compliance record, and customers may decide not to do business with us because of concerns about our compliance record.

Suspension or revocation of permits or licenses would impact our land reclamation and water treatment business and

could have a material impact on our financial results.

Although we have never had any of our operating permits revoked, suspended or

non-renewed involuntarily, it is possible that such an event could occur in the future.

environmental laws and regulations impose liability and responsibility on present and former owners, operators or users of facilities

and sites for contamination at such facilities and sites without regard to causation or knowledge of contamination.

Investigations undertaken

in connection with these activities may lead to discoveries of contamination that must be remediated, and closures of facilities might

trigger compliance requirements that are not applicable to operating facilities.

the coal mining remediation market, demand for our services will be limited to a specific customer base and highly correlated to the

coal mining industry.

The coal mining industry’s demand for our services and products is affected by a number of factors including

the volatile nature of the coal mining industry’s business, increased use of alternative types of energy and technological developments

in the coal mining extraction process.

A significant reduction in the target market’s demand for coal mining would reduce the demand

for our services and products, which would have a material adverse effect upon our business, financial condition, results of operations

and cash flows.

require a variety of permits to operate our business.

If we are not successful in obtaining and/or maintaining those permits it will

adversely impact our operations.

land reclamation and water treatment business requires permits to operate.

Our inability to obtain permits in a timely

manner could result in substantial delays to our business.

The issuance of permits is dependent on the applicable government agencies

and is beyond our control and that of our customers.

There can be no assurance that we and/or our customers will receive the permits

necessary to operate, which could substantially and adversely affect our operations and financial condition.

on the nature of our business we currently depend and are likely to continue to depend on a limited number of customers for a significant

portion of our revenues.

currently have three customers in West Virginia that account for substantially all of our land reclamation and water treatment business.

The failure to obtain additional customers or the loss of all or a portion of the revenues attributable to any current or future

customer as a result of competition, creditworthiness, inability to negotiate extensions or replacement of contracts or otherwise could

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

our customers do not enter into, extend or honor their contracts with us, our profitability could be adversely affected.

to receive payment for production depends on the continued solvency and creditworthiness of our customers and prospective customers.

If any of our customers’ creditworthiness suffers, we may bear an increased risk with respect to payment defaults.

refuse to make payments for which they have a contractual obligation, our revenues could be adversely affected.

Related to Our Cannabinoid Drug Development Business

we are unable to market and distribute our products effectively, we may be unable to generate significant revenue.

currently have no sales, marketing or distribution capabilities.

We intend to build these capabilities internally, as needed, and also

to pursue collaborative arrangements regarding the sales and marketing of our products, including steps necessary to commercialize our

pharmaceutical products.

However, we may be unable to establish or maintain any such collaborative arrangements, or if able to do so,

they may not provide us with the sales and marketing benefits we expect.

To the extent that we decide not to, or are unable to, enter

into successful collaborative arrangements with respect to the sales and marketing of our cannabinoid products, significant capital expenditures,

management resources and time will be required to establish and develop an in-house marketing and sales force with appropriate expertise.

We may be unable to establish or maintain relationships with third party collaborators or develop in-house sales and distribution capabilities.

To the extent that we depend on third parties for marketing and distribution, any revenues we receive will depend upon the efforts of

such third parties and there can be no assurance that such third parties will establish adequate sales and distribution capabilities

or be successful in gaining market acceptance of any approved product.

If we are not successful in commercializing any product approved

in the future, either on our own or through third parties, our business, financial condition and results of operations could be materially

adversely affected.

currently have no sales, marketing or distribution capabilities with respect to our cannabinoid drug development business.

decide to build sales, marketing or distribution capabilities internally or pursue collaborative arrangements for the sales and

marketing of our products, including steps necessary to commercialize our pharmaceutical products.

Any such collaborative

arrangements may not provide us with the sales and marketing benefits we expect.

To the extent that we decide not to, or are unable

to, enter into successful collaborative arrangements with respect to the sales and marketing of our cannabinoid products,

significant capital expenditures, management resources and time will be required to establish and develop an in-house marketing and

sales force with appropriate expertise.

We may be unable to establish or maintain relationships with third party collaborators or

develop in-house sales and distribution capabilities.

To the extent that we depend on third parties for marketing and distribution,

any revenues we receive will depend upon the efforts of such third parties and there can be no assurance that such third parties

will establish adequate sales and distribution capabilities or be successful in gaining market acceptance of any approved product.

If we are not successful in commercializing any product approved in the future, either on our own or through third parties, our

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

may seek orphan drug status for our products for the treatment of certain diseases or conditions, but we may be unable to obtain such

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in the United States.

In the European Union, the EMA’s Committee for Orphan Medicinal Products grants Orphan Drug Designation to

promote the development of products that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating

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unable to manufacture sufficient supply of our products or the EMA could reduce the term of exclusivity if our products are sufficiently

January 2018, we filed a request with the FDA’s Office of Orphan Products Development (OOPD) for an Orphan Drug Designation of

our VBX-100 prodrug for the treatment of pediatric ulcerative colitis, which was denied in March 2018.

However, in December 2019, we

received a letter from the OOPD informing us that the FDA has determined that the Company may be eligible for pediatric-subpopulation

designation because we submitted our original request for an Orphan Drug Designation before the guidance Clarification of Orphan Designation

of Drugs and Biologics for Pediatric Subpopulations of Common Diseases was finalized in July 2018.

In May 2020, we filed a response

letter with the OOPD addressing the other deficiencies noted in the Company’s original submission in January 2018.

In August 2020,

we received a letter from the OOPD informing us that it was unable to grant our request for an Orphan Drug Designation status because

our VBX-100 prodrug was administered before and after colitis was induced in our in vivo mouse studies, which resulted in the

need for more scientific data to support the efficacy of our VBX-100 prodrug in a treatment-only setting.

As a result, we were advised

to perform a second in vivo mouse study in which our VBX-100 prodrug would be administered only after colitis was induced in order

to provide a clear indication that the active drug was released only after ulcerative colitis was present.

In May 2021, we completed

the treatment-only in vivo mouse study and filed a supplemental response letter with the OOPD providing the requested in

vivo treatment-only mouse study results in support of our position that VBX-100 may be effective as a treatment for pediatric

ulcerative colitis.

we have sought orphan drug designation for our VBX-100 prodrug, exclusive marketing rights in the United States may be limited if we

seek approval for an indication broader than the orphan designated indication and may be lost if the FDA or EMA later determines that

the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product

to meet the needs of patients with the rare disease or condition.

In addition, we may never receive such designation, or there may be

a delay in receiving such designation that would impact our expected timeframe for clinical development.

we have received orphan drug designation for our VBX-100 prodrug for the treatment of pediatric ulcerative colitis, exclusive marketing

rights in the United States may be limited if we seek approval for an indication broader than the orphan designated indication and may

be lost if the FDA or EMA later determines that the request for designation was materially defective or if the manufacturer is unable

to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition.

are dependent on the success of our products, which are still in pre-clinical development and will require significant capital resources

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testing and substantial clinical development and regulatory approval efforts will be required before we are permitted to commence commercialization,

The clinical trials and manufacturing and marketing of product candidates will be subject to extensive and rigorous review and

Any clinical trials and manufacturing and marketing of product candidates will be subject to extensive and rigorous review and

regulation by numerous government authorities in the United States and other jurisdictions where we intend to test and, if approved,

market our product candidates.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we must demonstrate

through pre-clinical testing and clinical trials that the product candidate is safe and effective for use in each target indication,

and potentially in specific patient populations.

This process can take many years and may include post-marketing studies and surveillance,

which would require the expenditures of substantial resources beyond our current resources.

Of the large number of drugs in development

for approval in the United States and the European Union, only a small percentage successfully complete the FDA or EMA regulatory approval

processes, as applicable, and are commercialized.

Accordingly, even if we are able to obtain the requisite financing to continue to fund

our research, development and clinical programs, we are not certain that any of our product candidates will be successfully developed

or commercialized.

Before obtaining regulatory approvals for the commercial sale of any product candidate, we would need

to demonstrate through pre-clinical testing and clinical trials that the product candidate is safe and effective for use in each target

indication, and potentially in specific patient populations.

This process can take many years and may include post-marketing studies

and surveillance, which would require the expenditures of substantial resources beyond our current resources.

Of the large number of

drugs in development for approval in the United States and the European Union, only a small percentage successfully complete the FDA

or EMA regulatory approval processes, as applicable, and are commercialized.

Accordingly, even if we are able to obtain the requisite

financing to continue to fund our research, development and clinical programs, we are not certain that any of our product candidates

will be successfully developed or commercialized.

the results of pre-clinical testing are not necessarily predictive of future results, our products may not have favorable results in

our planned clinical trials.

positive results from our pre-clinical testing of our products may not necessarily be predictive of the results from our planned clinical

trials in humans.

Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials

after achieving positive results in pre-clinical development, and we cannot be certain that we will not face similar setbacks.

pre-clinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their

product candidates performed satisfactorily in pre-clinical studies and clinical trials nonetheless failed to obtain FDA or EMA approval.

If we fail to produce positive results in our clinical trials, the development timeline and regulatory approval and commercialization

prospects for our products and, correspondingly, our business and financial prospects, would be materially adversely affected.

their clinical trials.

positive results from our pre-clinical testing of our products may not necessarily be predictive of the results from clinical trials

Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical trials after

achieving positive results in pre-clinical development, and we cannot be certain that we will not face similar setbacks.

Moreover, pre-clinical

and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates

performed satisfactorily in pre-clinical studies and clinical trials nonetheless failed to obtain FDA or EMA approval.

If we fail to

produce positive results in our clinical trials, the development timeline and regulatory approval and commercialization prospects for

our products and, correspondingly, our business and financial prospects, would be materially adversely affected.

or delays in the completion of our pre-clinical studies or the commencement and completion of our clinical trials could result in increased

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DEA or comparable foreign regulatory authority-related recordkeeping, reporting or security violations at a clinical trial site, leading

the DEA, state authorities or comparable foreign regulatory authorities to suspend or revoke the site’s controlled substance license

and causing a delay or termination of planned or ongoing clinical trials;

the DEA, state authorities or comparable foreign regulatory authorities to suspend or revoke the controlled substance license

at the site and causing a delay or termination of planned or ongoing clinical trials;

regulatory concerns with cannabinoid products generally and the potential for abuse of those products;

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may be more profitable or for which there is a greater likelihood of success.

we have limited financial and managerial resources, we are focusing on research programs relating to our proprietary products for certain

indications, which concentrates the risk of product failure in the event the products prove to be unsafe, ineffective or inadequate for

clinical development or commercialization.

As a result, we may forego or delay pursuit of opportunities with other product candidates

or for other indications that could later prove to have greater commercial potential.

Our resource allocation decisions may cause us

to fail to capitalize on viable commercial products or profitable market opportunities.

Our spending on proprietary research and development

programs relating to our products may not yield any commercially viable products.

If we do not accurately evaluate the commercial potential

or target market for our products, we may relinquish valuable rights to our products through collaboration, licensing or other royalty

arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to

our products.

we have limited financial and managerial resources, we have reduced the scope of our research program and have limited that research

to our proprietary products for certain indications, which concentrates the risk of product failure in the event the products prove to

be unsafe, ineffective or inadequate for clinical development or commercialization.

As a result, we may forego or delay pursuit of opportunities

with other product candidates or for other indications that could later prove to have greater commercial potential.

Our resource allocation

decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities.

Our spending on proprietary

research and development programs relating to our products may not yield any commercially viable products.

If we do not accurately evaluate

the commercial potential or target market for our products, we may relinquish valuable rights to our products through collaboration,

licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and

commercialization rights to our products.

regulatory approval processes of the FDA, the EMA and other comparable foreign regulatory authorities are lengthy, time-consuming and

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outside of our control that materially adversely impact our clinical trials;

the FDA or EMA may find the data from pre-clinical studies and clinical trials insufficient to demonstrate that our products’

the FDA or EMA may find the data from pre-clinical studies and clinical trials insufficient to demonstrate that our products’ clinical

and other benefits outweigh their safety risks;

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of any of our product candidates, these regulatory authorities may require labeling changes or establishment of a REMS, impose significant

restrictions on a product’s indicated uses or marketing, impose ongoing requirements for potentially costly post-approval studies

or post-market surveillance, or impose a recall.

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FDA, the EMA and other comparable foreign regulatory authorities for compliance with current good manufacturing practices (cGMP) regulations.

Our current facilities and staff have never undergone such an inspection, and we currently rely upon outside consultants and

advisors to provide guidance on chemistry and manufacturing controls for pharmaceutical products.

Further, manufacturers of controlled

substances must obtain and maintain necessary DEA and state registrations and registrations with applicable foreign regulatory authorities,

and must establish and maintain processes to ensure compliance with DEA and state requirements and requirements of applicable foreign

regulatory authorities governing, among other things, the storage, handling, security, recordkeeping and reporting for controlled substances.

If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or

frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product,

the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements,

a regulatory agency may, among other things:

Our current facilities and staff have never undergone such an inspection, and we currently rely upon outside consultants and advisors

to provide guidance on chemistry and manufacturing controls for pharmaceutical products.

Further, manufacturers of controlled substances

must obtain and maintain necessary DEA and state registrations and registrations with applicable foreign regulatory authorities and must

establish and maintain processes to ensure compliance with DEA and state requirements and requirements of applicable foreign regulatory

authorities governing, among other things, the storage, handling, security, recordkeeping and reporting for controlled substances.

we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency,

or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing

facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we, our product

candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory

agency may, among other things:

issue untitled letters or warning letters;

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Schedule I substances by definition

have a high potential for abuse, have no currently “accepted medical use”

in the United States, lack accepted safety for

have a high potential for abuse, have no currently “accepted medical use” in the United States, lack accepted safety for

use under medical supervision, and may not be prescribed, marketed or sold in the United States.

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cannabis is a Schedule I controlled substance, products approved for medical use in the United States that contain cannabis or cannabis

extracts must be placed in Schedules II - V, since approval by the FDA satisfies the “accepted medical use”

extracts must be placed in Schedules II – V, since approval by the FDA satisfies the “accepted medical use” requirement.

If and when our products receive FDA approval, the DEA will make a scheduling determination and place them in a schedule other than Schedule

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If our products are

each approved by the FDA and classified as a Schedule II or III substance, an importer can import that product for commercial

purposes if it obtains from the DEA an importer registration and files an application with the DEA for an import permit for each importation.

The DEA provides annual assessments/estimates to the International Narcotics Control Board which guides the DEA in the amounts of

controlled substances that the DEA authorizes to be imported.

The failure to identify an importer or obtain the necessary import authority,

including specific quantities, could affect the availability of our products and have a material adverse effect on our business, results

of operations and financial condition.

In addition, an application for a Schedule II importer registration must be published in the Federal

each approved by the FDA and classified as a Schedule II or III substance, an importer can import that product for commercial purposes

if it obtains from the DEA an importer registration and files an application with the DEA for an import permit for each importation.

The DEA provides annual assessments/estimates to the International Narcotics Control Board which guides the DEA in the amounts of controlled

substances that the DEA authorizes to be imported.

The failure to identify an importer or obtain the necessary import authority, including

specific quantities, could affect the availability of our products and have a material adverse effect on our business, results of operations

and financial condition.

In addition, an application for a Schedule II importer registration must be published in the Federal Register,

and there is a waiting period for third-party comments to be submitted.

states have also established controlled substance laws and regulations.

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could lead to enforcement actions and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.

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

shipment, import and export of our products and raw materials may require import and export licenses.

In the United States, the FDA and

Customs and Border Protection, and in other countries, similar regulatory authorities, regulate the import and export of pharmaceutical

products that contain controlled substances.

Specifically, the import and export process requires the issuance of import and export licenses

by the relevant controlled substance authority in both the importing and exporting country.

We may not be granted, or if granted, maintain,

such licenses from the authorities in certain countries.

Even if we obtain the relevant licenses, shipments of our products and materials

may be held up in transit, which could cause significant delays and may lead to product batches being stored outside required temperature

Inappropriate storage may damage the product shipment resulting in delays in clinical trials or, upon commercialization, a partial

or total loss of revenue from one or more shipments of our products.

A delay in a clinical trial or, upon commercialization, a partial

or total loss of revenue from one or more shipments of our products could have a material adverse effect on our business, results of

operations and financial condition.

currently face, and will continue to face, significant competition in our pharmaceutical business.

major competitors for the development of pharmaceutical products related to cannabinoids and inflammatory disorders include major pharmaceutical

companies, smaller companies, and academic research groups that are devoted to biological or pharmaceutical research either independently

or by providing contract research services.

A number of multinational pharmaceutical companies are developing products in similar therapeutic

areas, including, but not limited to, Biogen, Teva Neuroscience, Pfizer, Endo Pharmaceuticals, Genzyme, Novartis, Bayer Healthcare, and

additional companies such as Jazz Pharmaceuticals, Corbus Pharmaceuticals, Trait Biosciences, and Zynerba Pharmaceuticals

are developing cannabinoid pharmaceuticals for treatment of various clinical indications and commercial applications.

to obtain regulatory approval in jurisdictions outside the United States and the European Union would prevent our product candidates

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we do not and will not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-party payors, certain

federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’

rights are and will be applicable

federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable

to our business.

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to the electronic transmission of PHI and imposes notification obligations in the event of a breach of the privacy or security of PHI.

In addition to adhering to the requirements of HIPAA, entities considered “covered entities”

under HIPAA (such as health

In addition to adhering to the requirements of HIPAA, entities considered “covered entities” under HIPAA (such as health

plans, healthcare clearinghouses, and certain healthcare providers) are required to obtain assurances in the form of a written contract

from certain business associates to which they transmit PHI (or who create, receive, transmit or maintain PHI on the covered entity’s

behalf) to ensure that the privacy and security of such information is maintained in accordance with HIPAA requirements.

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and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers.

state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the

relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to

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the indication statement and warnings approved by regulatory authorities in the product label, continued demonstration of efficacy and

safety in commercial use, physicians’

willingness to prescribe the product, reimbursement from third-party payors such as government

safety in commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party payors such as government

healthcare systems and insurance companies, the price of the product, the nature of any post-approval risk management plans mandated

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social and economic instability in foreign countries.

If we are unable to manage our international operations successfully, our financial

results could be adversely affected.

addition, controlled substance legislation may differ in other jurisdictions and could restrict our ability to market our products internationally.

Most countries are parties to the Single Convention on Narcotic Drugs 1961, which governs international trade and domestic control of

narcotic substances, including cannabis extracts.

Countries may interpret and implement their treaty obligations in a way that

creates a legal obstacle to us obtaining marketing approval for our products in those countries.

These countries may not be willing or

able to amend or otherwise modify their laws and regulations to permit our products to be marketed, or the approval of such amendments

to the laws and regulations may take a prolonged period of time.

We would be unable to market our products in countries with such obstacles

in the near future or perhaps at all without modification to laws and regulations.

In addition, controlled substance legislation may differ in other jurisdictions

and could restrict our ability to market our products internationally.

If we are unable to manage our international operations successfully,

our financial results could be adversely affected.

products will contain controlled substances, the use of which may generate public controversy.

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or restrict the introduction and marketing of our products.

Adverse publicity from cannabis misuse or adverse side effects from

cannabis or other cannabinoid products may adversely affect the commercial success or market penetration achievable by our products.

The nature of our business attracts a high level of public and media interest, and in the event of any resultant adverse publicity, our

reputation may be harmed.

Adverse publicity from cannabis misuse or adverse side effects from cannabis

or other cannabinoid products may adversely affect the commercial success or market penetration achievable by our products.

of our business attracts a high level of public and media interest, and in the event of any resultant adverse publicity, our reputation

may be harmed.

we fail to protect or enforce our intellectual property rights or secure rights to the intellectual property of others, the value of

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of these outcomes could divert management attention and other resources and could significantly harm our operations and financial condition.

use hazardous materials in our business.

Any claims relating to improper handling, storage or disposal of these materials could be time

consuming and costly.

research and development efforts and our manufacturing processes may involve the controlled storage, use and disposal of certain hazardous

materials and waste products.

We and our suppliers and other collaborators are subject to federal, state and local regulations governing

the use, manufacture, storage, handling and disposal of materials and waste products.

Even if we and these suppliers and collaborators

comply with the standards prescribed by law and regulation, the risk of accidental contamination or injury from hazardous materials cannot

be eliminated.

We may not be able to obtain and maintain insurance on acceptable terms, or at all, to cover costs associated with any

such accidental contamination.

In the event of such an accident, we could be held liable for any damages that result, and any liability

could exceed the limits or fall outside the coverage of any insurance we may obtain and exceed our financial resources.

significant costs to comply with current or future environmental laws and regulations.

may incur substantial liabilities and may be required to limit commercialization of our products in response to product liability lawsuits.

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liability, claims could prevent or inhibit the commercialization of products we develop, alone or with collaborators.

if our agreements with any future collaborators entitle us to indemnification against losses, such indemnification may not

be available or adequate should any claim arise.

Even if our agreements

with any future collaborators entitle us to indemnification against losses, such indemnification may not be available or adequate should

any claim arise.

regulation of our products could increase our costs, prevent us from offering certain products or cause us to recall products.

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product ingredient presents an unacceptable health risk, may determine that a particular statement of nutritional support that we want

to use is an unacceptable drug claim or an unauthorized version of a food “health claim,”

may determine that a particular

to use is an unacceptable drug claim or an unauthorized version of a food “health claim,” may determine that a particular

product is an unapproved new drug, or may determine that particular claims are not adequately supported by available scientific evidence.

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able to fund, and could have a material adverse effect on our business operations and financial condition.

use hazardous materials in our drug development business and may use such materials in our environmental businesses in the future.

claims relating to improper handling, storage or disposal of these materials could be time consuming and costly.

cannabinoid research and development efforts and manufacturing processes may involve the controlled storage, use and disposal of certain

hazardous materials and waste products.

The same may be true for our environmental businesses.

We and our suppliers and other collaborators

are subject to federal, state and local regulations governing the use, manufacture, storage, handling and disposal of materials and waste

Even if we and these suppliers and collaborators comply with the standards prescribed by law and regulation, the risk of accidental

contamination or injury from hazardous materials cannot be eliminated.

We may not be able to obtain and maintain insurance on acceptable

terms, or at all, to cover costs associated with any such accidental contamination.

In the event of such an accident, we could be held

liable for any damages that result, and any liability could exceed the limits or fall outside the coverage of any insurance we may obtain

and exceed our financial resources.

We may incur significant costs to comply with current or future environmental laws and regulations.

Related to our Impact Investing Strategy

we are unable to identify and acquire businesses or assets in furtherance of our impact investing strategy, we may be unable to generate

significant revenue.

We intend to acquire additional businesses and assets that will generate revenue related to our impact investing strategy

and there can no assurance that we will be able to do so, or to do so on terms that are acceptable to us, or in a manner that will provide

us with the revenue we expect.

consideration of sustainability and environmental criteria as the pre-eminent part of our business and investment strategy will limit

the types and number of business opportunities available to the Company and may result in the Company engaging in industry sectors that

underperform the market as a whole, or forgoing opportunities to invest available capital in businesses that might otherwise be advantageous

If we are not successful in acquiring or developing desirable businesses or assets which fit within our business strategy or

if those assets do not generate sufficient revenue, our business, financial condition and results of operations could be materially adversely

impact investing strategy is new, untested and may not be successful.

impact investing strategy is qualitative and subjective by nature, and there is no guarantee that the factors we utilize in making capital

and other resource allocation decisions or any judgment exercised by our management or Board will reflect the opinions of any particular

shareholder, and the criteria utilized by the Company may differ from the criteria that any particular shareholder considers relevant

in evaluating a company’s sustainability or ESG practices.

In making allocation and investment decisions, Company management will

be dependent upon information and data obtained through voluntary or third-party reporting that may be incomplete, inaccurate or unavailable,

or present conflicting information and data with respect to a particular opportunity, which in each case could cause the Company to incorrectly

assess a potential target’s business practices with respect to its sustainability and ESG practices.

Socially and environmentally-responsible

norms differ by region.

In implementing its impact investing strategy, management will seek to exclude businesses deemed to be fundamentally

misaligned with the Company’s sustainability principles.

In addition, as a result of the Company’s engagement activities,

the Company may make an investment in activities or companies that do not currently engage in sustainability or ESG practices that meet

criteria established by the Company in an effort to improve such target’s ESG practices.

Successful application of the Company’s

impact investing strategy and management’s engagement efforts will depend on management’s skill in properly identifying and

analyzing material ESG issues, and there can be no assurance that the strategy or techniques employed will be successful.

have limited experience operating an impact investing strategy and may be subject to

increased business and economic risks that could affect our financial results.

have limited experience operating a business with an impact investing strategy.

If we are unable to manage our ESG-related operations successfully, our financial results could be adversely

may be unable to obtain the financing we need to pursue our impact investing strategy and any future financing we receive may be less

favorable to us than our current financing arrangements, either of which may adversely affect our ability to expand our operations.

and sustainability-related projects and businesses we may seek to acquire or develop will require substantial capital investment.

access to capital on acceptable or favorable terms to us is necessary for the success of our impact investing strategy, particularly

in enhancing our portfolio through M&A activities.

Our attempts to obtain the necessary future financing may not be successful or

on favorable terms.

Our ability to arrange for financing on a substantially non-recourse or limited recourse basis, and the costs of

such financing, are dependent on numerous factors, including general economic conditions, conditions in the global capital and credit

markets, investor confidence, the success of our business, the credit quality of the businesses being financed, and the continued existence

of tax laws which are conducive to raising capital for these types of activities.

If we are not able to obtain financing on a substantially

non-recourse or limited recourse basis, we may have to finance them using recourse capital such as direct equity investments or the incurrence

of additional debt by us.

Also, in the absence of favorable financing options, we may decide not to develop or acquire facilities or

businesses from third parties.

Any of these alternatives could have a material adverse effect on our growth prospects.

may also need additional financing to implement our impact investing strategic plan.

For example, our cash flow from operations and existing

liquidity facilities may not be adequate to finance any acquisitions we may want to pursue or new technologies we may want to develop

Financing for acquisitions or technology development activities may not be available on terms we find acceptable.

legislative changes could affect our financial results.

of the types of environmental assets we are considering purchasing are subject to environmental regulations and we expect such regulatory

conditions to influence the assumptions we will make regarding future revenues and expenses.

If those regulatory conditions change, our

revenues may be decreased and our expenses could increase, adversely affecting our financial results.

reduction or elimination of government incentives could adversely affect our business, financial condition, future results and cash flows.

planned impact investing strategy may benefit in the future from public policies and government incentives that support renewable energy

and enhance the economic feasibility of sustainability-based projects in regions where we operate.

Such policies and incentives include

tax credits, accelerated depreciation tax benefits, renewable portfolio standards, carbon trading mechanisms, rebates, and may include

similar or other incentives to end users, distributors, or other participants in the energy or mining industry.

Some of these measures

have been implemented at the federal level, while others have been implemented by different states within the United States.

The availability

and continuation of these public policies and government incentives are likely to have a significant effect on the economics and viability

of our environmental businesses.

Any changes to such public policies, or any reduction in or elimination or expiration of such government

incentives could affect us in different ways.

For example, policies supporting or deregulating the exploration, production and use of

fossil fuels may create regulatory uncertainty in the renewable energy industry.

Any of the foregoing outcomes could have a material

adverse effect on our business, financial condition, future results, and cash flows.

may decide not to implement, or may not be successful in implementing, one or more elements of our multi-year strategic plan, and the

plan as implemented may not achieve its goal of enhancing shareholder value through the long-term growth of our Company

are implementing a multi-year strategic plan to develop an impact investing business engaged in a number of complimentary ESG businesses in the United

States which will permit us to explore synergistic growth opportunities utilizing our core competencies.

are uncertainties and risks associated with our strategic plan, including with respect to implementation and outcome.

We may decide to

change, or to not implement, one or more elements of the plan over time or we may not be successful in implementing one or more elements

of the plan, in each case for a number of reasons.

For example, we may face significant challenges and risks expanding into an impact investing business

ability to compete with the large number of other companies pursuing similar business opportunities in the ESG field, many of which

already have established businesses in these areas and/or have greater financial, strategic, technological or other resources than

ability to obtain financing on terms we consider acceptable, or at all, which we may need, for example, to develop new projects,

to obtain any technology, personnel, intellectual property, or to acquire one or more existing businesses as a platform for our expansion,

or to fund internal research and development;

ability to provide services or products that keep pace with rapidly changing technology, customer preferences, equipment costs,

increasing raw materials and transportation costs, market conditions and other factors that currently are unknown to us that

will impact these markets;

ability to manage the risks and uncertainties associated with our operating the facilities and projects in this line of business,

including the variability of revenues and profitability of such projects;

ability to devote the amount of management time and other resources required to implement this plan;

ability to recruit appropriate employees and labor market challenges.

from the risks associated with implementing the plan, the plan itself will expose us to other risks and uncertainties once implemented.

Expanding our customer base may expose us to customers with different credit profiles than our current customers.

Expanding our geographic

base will subject us to risks associated with doing business in new foreign countries in which we will have to learn the business and

political environment.

In addition, expanding into new technologies will expose us to new risks and uncertainties that are unknown to

us now in addition to the risks and uncertainties that may be similar to those we now face.

The success of the plan, once implemented,

will depend, among other things, on our ability to manage these risks effectively.

trading price of our common stock could decline if securities, industry analysts or our investors disagree with our strategic plan or

the way we implement it.

Accordingly, there is no assurance that the plan will enhance shareholder value through long-term growth of

the Company to the extent currently anticipated by our management or at all.

may engage in a business combination with one target business that has relationships with entities that may be affiliated with our sponsor,

executive officers, directors or initial shareholder which may raise potential conflicts of interest.

carrying our impact investing strategy, we may decide to acquire a business affiliated with our executive officers, directors or our

largest shareholder.

We would pursue a transaction with an affiliated entity if we determined that such affiliated entity met our criteria

and guidelines for a business combination and such transaction was approved by a majority of our independent and disinterested directors.

We may not obtain an opinion from an independent investment banking firm or another independent entity regarding the fairness to the

Company from a financial point of view of a business combination with a business affiliated with our executive officers, directors or

largest shareholder.

In the event of a transaction with an affiliated entity, potential conflicts of interest may exist and, as a result,

the terms of the transaction may not be as advantageous to our public shareholders as they would be absent any conflicts of interest.

may not be able to successfully conclude the transactions, integrate companies, which we may acquire in the future, which could materially

and adversely affect our business, financial condition, future results and cash flow.

impact investing strategy is to develop our ESG business primarily through acquisitions.

Integrating acquisitions is often costly,

and we may not be able to successfully integrate our acquired businesses with our existing operations without substantial costs,

delays or other adverse operational or financial consequences.

Completion of M&A transactions may be subject to fulfilling

conditions and receiving regulatory approval.

Integrating our acquired companies involves a number of risks that could materially

and adversely affect our business, including:

of the acquired companies to achieve the results we expect;

to retain key personnel of the acquired companies;

associated with unanticipated events or liabilities;

difficulty of establishing and maintaining uniform standards, controls, procedures and policies, including accounting controls and

any of our acquired companies suffers customer dissatisfaction or performance problems, this could adversely affect the reputation of

our group of companies and could materially and adversely affect our business, financial condition, future results and cash flow.

Concentration

of customers, specific projects and regions may expose us to heightened financial exposure.

ESG businesses may be heavily dependent on a single or limited number of customers.

The financial performance of our ESG businesses depends

on the ability of each customer to perform its obligations, possibly under a long-term agreement between the parties.

Our financial results

could be materially and adversely affected if any of our customers fail to fulfill its contractual obligations and we are unable

to find other customers in the marketplace to purchase at the same level of profitability.

We cannot assure that such performance failures

by our customers will not occur, or that if they do occur, such failures will not adversely affect the cash flows or profitability of

our businesses.

Moreover, there can be no assurance that we will be able to enter into replacement agreements on favorable terms or at

we have identified general criteria and guidelines that we believe are important in evaluating prospective target ESG businesses, we

may enter into business combinations that do not have attributes entirely consistent with our general criteria and guidelines.

we have identified general criteria and guidelines for evaluating prospective target ESG businesses, it is possible that we may not acquire

or enter into transactions with a target business which will not have all of these positive attributes.

If shareholder approval of the

transaction is required by applicable law or other requirements, or we decide to obtain shareholder approval for business or other reasons,

it may be more difficult for us to attain shareholder approval of those business combinations if the target business does not meet our

general criteria and guidelines.

may make future acquisitions or form partnerships and joint ventures that may involve numerous risks that could impact our financial

condition, results of operations and cash flows.

impact investing strategy may include expanding our scope of products and services organically or through selective acquisitions, investments

or creating partnerships and joint ventures.

We may selectively acquire other businesses, product or service lines, assets or technologies

that are complementary to our business.

We may be unable to find or consummate future acquisitions at acceptable prices and terms, or

we may be unable to integrate existing or future acquisitions effectively and efficiently and may need to divest those acquisitions.

We expect to continually evaluate potential acquisition opportunities in the ordinary course of business.

Acquisitions involve numerous

risks, including among others:

evaluation of the synergies and/or long-term benefits of an acquired business;

difficulties, including challenges and costs associated with implementing systems, processes and controls to comply with the requirements

of a publicly-traded company;

management’s attention;

arising from acquisition activity;

increased debt leverage;

issuance of dilutive equity securities;

markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions;

unanticipated

costs and exposure to undisclosed or unforeseen liabilities or operating challenges;

goodwill or other intangible asset impairments;

loss of key employees and customers of the acquired businesses, product or service lines, assets or technologies;

ability to properly establish and maintain effective internal controls over an acquired company;

demands on our operational and IT systems.

success of acquisitions of businesses, new technologies and products, or arrangements with third parties is not always predictable and

we may not be successful in realizing our objectives as anticipated.

Furthermore, any future credit facility we may have may contain

certain covenants that limit, or that may have the effect of limiting, among other things, the payment of dividends, acquisitions, capital

expenditures, the sale of assets and the incurrence of additional indebtedness.

could be exposed to significant liability for violations of hazardous substances laws because of the use or presence of such substances

at our facilities or properties.

ESG business operations will be subject to numerous federal, regional, state and local statutory and regulatory standards relating to

the generation, handling, transportation, use, storage, treatment and disposal of hazardous substances.

If any hazardous substances are

found to have been released into the environment at or by one of our facilities or on one of our properties in concentrations that exceed

regulatory limits, we could become liable for the investigation and removal of those substances, regardless of their source and time

If we fail to comply with these laws, ordinances or regulations (or any change thereto), we could be subject to civil or

criminal liability, the imposition of liens or fines, and cessation of operations, large expenditures to bring our operations into compliance

or other sanctions.

Furthermore, under certain federal and states laws in the United States, we can be held liable for the cleanup of

releases of hazardous substances at any of our current or former facilities or at any other locations where we arranged for disposal

of those substances, even if we did not cause the release at that location or if the release complied with applicable law at the time

Liability under these laws can be joint and several.

The cost of any remediation activities in connection with a spill or

other release of such substances could be significant and could expose us to significant liability.

operations could be adversely impacted by climate change.

Environmental Services operations may be susceptible to losses and interruptions caused by extreme weather conditions such as droughts, hurricanes, floods,

wildfires, and water or other natural resource shortages, occurrences of which may increase in frequency and severity as a result of

climate change.

Climate change may also produce general changes in weather or other environmental conditions, including temperature or

precipitation levels.

To the extent weather conditions continue to be impacted by climate change, our Environmental Services operations and facilities may

be adversely impacted in a manner that we could not predict which may in turn adversely impact our results of operations.

the potential physical effects of climate change, such as increased frequency and severity of storms, floods, and other climatic events,

could disrupt our operations and cause us to incur significant costs to prepare for or respond to these effects.

we are deemed to be an investment company under the Investment Company Act, we may be required to institute burdensome compliance requirements

and our activities may be restricted, which may make it difficult for us to carry out our impact investing strategy.

we are deemed to be an investment company under the Investment Company Act, our activities may be restricted, including:

(i) restrictions

on the nature of our investments;

and (ii) restrictions on the issuance of securities, each of which may make it difficult for us to

carry out our planned impact investing strategy.

addition, we may have imposed upon us burdensome requirements, including:

(X) registration as an investment company with the SEC;

adoption of a specific form of corporate structure;

and (Z) reporting, record keeping, voting, proxy and disclosure requirements and

other rules and regulations that we are currently not subject to.

we were deemed to be subject to the Investment Company Act, compliance with these additional regulatory burdens would require additional

expenses for which we have not allotted funds and may hinder our ability to carry out our impact investing strategy.

order not to be regulated as an investment company under the Investment Company Act, unless we can qualify for an exclusion, we must

ensure that we are engaged primarily in a business other than investing, reinvesting or trading of securities and that our activities

do not include investing, reinvesting, owning, holding or trading “investment securities” constituting more than 40% of our

assets (exclusive of U.S.

government securities and cash items) on an unconsolidated basis.

Our business will include identifying and

completing business combination and thereafter to operate the post-transaction business or assets for the long term.

We do not plan to

buy businesses or assets with a view to resale or profit from their resale.

We do not plan to buy unrelated businesses or assets or to

be a passive investor.

do not believe that our principal activities will subject us to the Investment Company Act.

Related to our Common Stock

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stock may never develop, in which case it could be difficult for stockholders to sell their common stock.

The market price of

our common stock could continue to fluctuate substantially.

of our stock is restricted by the SEC’s “penny stock”

regulations and certain FINRA rules, which may limit a stockholder’s

The market price of our common

stock could continue to fluctuate substantially.

of our stock is restricted by the SEC’s “penny stock” regulations and certain FINRA rules, which may limit a stockholder’s

ability to buy and sell our common stock.

securities are covered by certain “penny stock”

rules, which impose additional sales practice requirements on broker-dealers

securities are covered by certain “penny stock” rules, which impose additional sales practice requirements on broker-dealers

who sell low-priced securities to persons other than established customers and accredited investors.

For transactions covered by these

rules, a broker-dealer must make a special suitability determination for the purchaser and have received the purchaser’s written

consent to the transaction prior to sale, among other things.

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low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the

customer’s financial status, tax status, investment objectives and other information.

Under interpretations of these rules, FINRA

believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers.

requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit an investor’s

ability to buy and sell our common stock and could have an adverse effect on the market for our shares.

we issue and sell additional shares of our common stock in the future, our existing stockholders will be diluted and our stock price

articles of incorporation authorize the issuance of up to 1,000,000,000 shares of common stock, of which, as of May 18, 2021,

50,840,147 shares were outstanding and 13,204,504 shares were reserved for issuance under our stock incentive plan or other

outstanding options or warrants.

As a result, we have a large number of shares of common stock that are authorized for issuance and are

not outstanding or otherwise reserved, and could be issued at the discretion of our Board of Directors.

We expect to seek additional

financing in the future in order to fund our operations, and if we issue additional shares of common stock or securities convertible

into common stock, our existing stockholders will be diluted.

Our Board of Directors may also choose to issue shares of our common stock

or securities convertible into or exercisable for our common stock to acquire assets or companies, for compensation to employees, officers,

directors, consultants and advisors, to fund capital expenditures and to enter into strategic partnerships.

Additionally, shares of common

stock could be issued for anti-takeover purposes or to delay or prevent changes in control or management of the Company.

Directors may determine to issue shares of our common stock on terms that our stockholders do not believe enhance stockholder value,

or that may ultimately have an adverse effect on our business or the trading price of our common stock.

Further, the issuance of any

such shares may cause further dilution to the ownership interest of our current stockholders, reduce the book value per share of our

common stock and may contribute to a reduction in the market price for our common stock.

articles of incorporation authorize the issuance of up to 1,000,000,000 shares of common stock, of which, as of March 30, 2023, 78,116,814

shares were outstanding and 37,905,879 shares were reserved for issuance under our stock incentive plan and other outstanding options

As a result, we have a large number of shares of common stock that are authorized for issuance that are not outstanding or

otherwise reserved, and could be issued at the discretion of our Board of Directors.

We expect to seek additional financing in the future

in order to fund our operations, and if we issue additional shares of common stock or securities convertible into common stock, our existing

stockholders will be diluted.

Our Board of Directors may also choose to issue shares of our common stock or securities convertible into

or exercisable for our common stock to acquire assets or companies, for compensation to employees, officers, directors, consultants and

advisors, to fund capital expenditures and to enter into strategic partnerships.

Additionally, shares of common stock could be issued

for anti-takeover purposes or to delay or prevent changes in control or management of the Company.

Our Board of Directors may determine

to issue shares of our common stock on terms that our stockholders do not believe enhance stockholder value, or that may ultimately have

an adverse effect on our business or the trading price of our common stock.

Further, the issuance of any such shares may cause further

dilution to the ownership interest of our current stockholders, reduce the book value per share of our common stock and may contribute

to a reduction in the market price for our common stock.

principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters

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of our executive officers, directors and stockholders own a significant percentage of our outstanding capital stock.

As of May 18,

2021, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially

owned approximately 40.4% of our outstanding shares of common stock.

As of March 30,

2023, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned

approximately 55.6% of our outstanding shares of common stock.

Accordingly, our directors, executive officers and certain stockholders

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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