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Item 1A. Risk Factors

2025-03-31 compared with 2024-03-29 · 257 added, 766 removed, 338 unchanged (75% of the section changed)

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

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.

in our Common Stock involves a high degree of risk.

The following risk factors should be considered carefully in addition to the

other information contained in this Annual Report.

This 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.

Related to Our Business

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

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, and other related costs.

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

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, and other related costs.

The Company may not be able to continue as a

going concern.

During the year ended December 31, 2024, the Company

incurred a net loss of $9,798,083, and $1,591,426 of cash was used by the Company’s operating activities.

The Company estimates

that it may not have sufficient funds to operate its business for 12 months given its cash balance as of December 31, 2024 of approximately

$167,286 and revenues being generated by the Company’s operating business segments.

The ability of the Company to continue as a going concern is

dependent on the Company’s ability to fund future operations through additional financing from investors and/or lenders or through

the sale of its securities or through development of its operations.

Due to these and other factors, there is substantial doubt of the

Company’s ability to continue as a going concern.

limited operating experience could make our operations inefficient or ineffective.

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

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

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

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

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we may not be able to take advantage of market opportunities, execute our business strategies or respond to competitive pressures.

If we are unable to hire and retain qualified

personnel, we may not be able to implement our business plan.

As of March 28, 2024, we employed

56 full-time employees.

Attracting and retaining personnel will be critical to our success.

We may not be able to attract and retain the

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

of March 27, 2025, we employed 18 full-time employees.

Attracting and retaining

personnel will be critical to our success.

As a small company with an uncertain future, 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.

In 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.

Our CEO and certain other Company employees

devote substantial portions of their time to businesses other than the Company’s business.

Certain of our officers, directors

and employees devote substantial portions of their time to businesses of other companies.

Our 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 the manager of several non-affiliated investment partnerships, pursuant to which he devotes a significant portion of

The commitments of our officers, directors and employees to these other businesses may cause them to devote less time to the

Company than would otherwise be the case.

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.

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.

CEO and certain other Company employees devote substantial portions of their time to businesses other than the Company’s business.

of our officers, directors and employees devote substantial portions of their time to businesses of other companies.

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, as Managing Partner and Co-Founder of Atlas Resolution Partners LLC, an advisory

firm focused on resolving complex private capital fund issues, and as the manager of several non-affiliated investment partnerships,

pursuant to which he devotes a significant portion of his time.

The commitments of our officers, directors and employees to these

other businesses may cause them to devote less time to the Company than would otherwise be the case.

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

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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.

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not limited to:

in regulatory landscape reducing the demand for, and incentives relating to, our land reclamation, water treatment and related environmental

in regulatory landscape reducing the demand for, and incentives relating to, alternative energy developments, such as solar energy

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

or maintaining necessary regulatory permits, licenses or approvals;

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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 relationships with coal mining operators or other

landowners necessary to form strategic partnerships.

related to planning and commencing new operations, including inaccurate assessment of the demand for alternative energy

developments, such as solar projects, 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 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.

largest component of our equipment operating costs is made up of salaries and wages.

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.

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 operating costs is made up of salaries and wages.

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 revenues and 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 conflicts in Gaza and 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 or at prices that are financially feasible.

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 conflicts in Gaza and 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 operational.

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.

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 or at prices that are financially feasible.

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

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

Our competitors may be able to offer 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

Our competitors may be able to offer 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

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.

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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 our costs by requiring us to provide 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, our reputation, earnings and ability to obtain future business could be

materially adversely affected.

customers may seek performance guarantees as to our services.

Failure to meet specifications of our customers or our failure

to meet our performance guarantees may increase our costs by requiring us to provide 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, 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 the financial insolvency of other responsible parties could in

the future have a material adverse effect on our financial condition and 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 the 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.

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earthquakes, financial crises, economic depressions or other catastrophic events, which are either uninsurable or not economically

Any such losses could have a material adverse effect on the performance of our systems.

Any such losses could have a material adverse effect on the performance of our services and on our financial condition

and results of operations.

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

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coal mining industry.

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

The coal mining industry’s demand for our services 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

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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

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

and cash flows.

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portion of our revenues.

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

currently have one customer in West Virginia that accounts for 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

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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 with respect to our cannabinoid drug development business.

If sufficient capital is available, we may choose

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

our products.

We may be unable

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

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

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

designation or to maintain the benefits associated with orphan drug status, including market exclusivity, which may cause our revenue,

if any, to be reduced.

authorities in some jurisdictions, including the United States and European Union, may designate drugs for relatively small patient populations

as orphan drugs.

The FDA may grant Orphan Drug Designation to drugs intended to treat a rare disease or condition that affects fewer

than 200,000 individuals annually in the United States, or, if the disease or condition affects more than 200,000 individuals annually

in the United States, if there is no reasonable expectation that the cost of developing and making the drug would be recovered from sales

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

conditions affecting not more than five in 10,000 persons in the European Union.

Additionally, designation is granted for products intended

for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without

incentives, it is unlikely that sales of the drug in the European Union would be sufficient to justify the necessary investment in developing

the United States, Orphan Drug Designation entitles a party to financial incentives, such as opportunities for grant funding towards

clinical trial costs, tax credits for certain research and user fee waivers under certain circumstances.

In addition, if a product receives

the first FDA approval for the indication for which it has orphan designation, the product is entitled to seven years of market exclusivity,

which means the FDA may not approve any other application for the same drug for the same indication for a period of seven years, except

in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity.

Orphan drug exclusivity

does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease

or condition.

In the European Union, Orphan Drug Designation also entitles a party to financial incentives such as reduction of fees

or fee waivers and ten years of market exclusivity following drug approval.

This period may be reduced to six years if the Orphan Drug

Designation criteria are no longer met, including where it is shown that the product is sufficiently profitable so that market exclusivity

is no longer justified.

a result, even if our products receive orphan exclusivity, the FDA or European Medicines Agency (EMA) can still approve other drugs that

have a different active ingredient for use in treating the same indication.

Furthermore, the FDA can waive orphan exclusivity if we are

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

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

and years of clinical development effort.

currently have no pharmaceutical products on the market, and our product candidates are still in pre-clinical development.

The success of our cannabinoid drug development business

depends on the successful clinical development, regulatory approval and commercialization of our product candidates, and additional pre-clinical

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

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 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.

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

their clinical trials.

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

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

costs to us and could delay, prevent or limit our ability to generate revenue and continue our business.

date, we have not completed our pre-clinical animal studies or commenced any clinical trials.

Successful completion of such pre-clinical

animal studies and clinical trials is a prerequisite to submitting an NDA to the FDA or a marketing authorization application (MAA) to

Clinical trials are expensive, difficult to design and implement, can take many years to complete and their outcomes are uncertain.

A product candidate can unexpectedly fail at any stage of clinical development.

The historic failure rate for product candidates is high

due to scientific feasibility, safety, efficacy, changing standards of medical care and other variables.

The commencement and completion

of clinical trials can be delayed or prevented for a number of reasons, including, among others:

delays in reaching or failing to reach agreement on acceptable terms with prospective clinical trial sites, the terms of which can be

subject to extensive negotiation and may vary significantly among different clinical trial sites;

delays or inability in manufacturing or obtaining sufficient quantity or quality of a product candidate or other materials necessary

to conduct clinical trials due to regulatory and manufacturing constraints, including delays or an inability to hire appropriate staff

or consultants with requisite expertise in chemistry and manufacturing controls for pharmaceutical products;

difficulties obtaining Institutional Review Board (IRB), DEA or comparable foreign regulatory authority, or ethics committee approval

to conduct a clinical trial at a prospective site or sites;

challenges in recruiting and enrolling patients to participate in clinical trials, including the size and nature of the patient population,

the proximity of patients to clinical trial sites, eligibility criteria for the clinical trial, the nature of the clinical trial protocol,

the availability of approved effective treatments for the relevant indication and competition from other clinical trial programs for

similar indications;

severe or unexpected toxicities or drug-related side effects experienced by patients in our clinical trials or by individuals using drugs

similar to our product candidates;

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 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;

difficulties retaining patients who have enrolled in a clinical trial who may withdraw due to lack of efficacy, side effects, personal

issues or loss of interest;

ambiguous or negative interim results;

lack of adequate funding to continue the clinical trial.

addition, a clinical trial may be suspended or terminated by us, the FDA, IRBs, ethics committees, data safety monitoring boards or other

foreign regulatory authorities overseeing the clinical trial at issue or other regulatory authorities due to a number of factors, including,

among others:

failure to conduct the clinical trial in accordance with regulatory requirements or our clinical trial protocols;

inspection of the clinical trial operations, clinical trial sites, or drug manufacturing facilities by the FDA, the DEA, the EMA or other

foreign regulatory authorities that reveals deficiencies or violations that require us to undertake corrective action, including the

imposition of a clinical hold;

unforeseen safety issues, including any safety issues that could be identified in our ongoing toxicology studies;

adverse side effects or lack of effectiveness;

changes in government regulations or administrative actions.

intend to focus on prodrugs for certain indications, and may fail to capitalize on other product candidates or other indications that

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

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.

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

inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will

be substantially harmed.

are not permitted to market our product candidates in the United States or the European Union until we receive approval of an NDA from

the FDA or an MAA from the EMA, respectively, or in any foreign countries until we receive the requisite approval from such countries.

Prior to submitting an NDA to the FDA or an MAA to the EMA for approval of our product candidates we will need to complete our ongoing

pre-clinical studies, as well as Phase 1, Phase 2 and Phase 3 clinical trials.

We are still conducting pre-clinical studies and have

not yet commenced our clinical program or tested any product in humans.

Successfully initiating and completing our clinical program and

obtaining approval of an NDA or MAA is a complex, lengthy, expensive and uncertain process, and the FDA or EMA may delay, limit or deny

approval of our product candidates for many reasons, including, among others, because:

we may not be able to demonstrate that our product candidates are safe and effective in treating patients to the satisfaction of the

the results of our clinical trials may not meet the level of statistical or clinical significance required by the FDA or EMA for marketing

the FDA or EMA may disagree with the number, design, size, conduct or implementation of our clinical trials;

the FDA or EMA may require that we conduct additional clinical trials;

the FDA or EMA or other applicable foreign regulatory authorities may not approve the formulation, labeling or specifications of our

product candidates;

the contract research organizations, or CROs, and other contractors that we may retain to conduct our clinical trials may take actions

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’ clinical

and other benefits outweigh their safety risks;

the FDA or EMA may disagree with our interpretation of data from our pre-clinical studies and clinical trials;

the FDA or EMA may not accept data generated at our clinical trial sites or may disagree with us over whether to accept efficacy results

from clinical trial sites outside the United States where the standard of care is potentially different from that in the United States;

if and when our NDAs or MAAs are submitted to the FDA or EMA, as applicable, the regulatory agency may have difficulties scheduling the

necessary review meetings in a timely manner, may recommend against approval of our application or may recommend or require, as a condition

of approval, additional pre-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;

the FDA may require development of a Risk Evaluation and Mitigation Strategy (REMS), which would use risk minimization strategies beyond

the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks, as a condition of approval

or post-approval, and the EMA may grant only conditional approval or impose specific obligations as a condition for marketing authorization,

or may require us to conduct post-authorization safety studies;

the FDA, EMA, DEA or other applicable foreign regulatory agencies may not approve the manufacturing processes or facilities of third-party

manufacturers with which we contract;

the DEA or other applicable foreign regulatory agency may establish quotas that limit the quantities of controlled substances available

to our manufacturers;

the FDA or EMA may change their approval policies or adopt new regulations.

of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully

market our products.

if our products receive regulatory approval, they may still face future development and regulatory difficulties.

we seek and obtain regulatory approval for any of our products, such approval would be subject to extensive ongoing requirements by the

DEA, FDA, EMA and other foreign regulatory authorities related to the manufacture, quality control, further development, labeling, packaging,

storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping and reporting of safety and other post-market

The safety profile of any product will continue to be closely monitored by the FDA, EMA and other comparable foreign regulatory

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.

addition, manufacturers of therapeutic products and their facilities are subject to continual review and periodic inspections by the

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.

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 which may inhibit

our ability to commercialize our product candidates and may otherwise have a material adverse effect on our business, financial condition

and results of operations.

products will be subject to controlled substance laws and regulations;

failure to receive necessary approvals may delay the launch of

our products and failure to comply with these laws and regulations may adversely affect the results of our business operations.

products will contain controlled substances as defined in the federal Controlled Substances Act of 1970 (CSA).

Controlled substances

that are pharmaceutical products are subject to a high degree of regulation under the CSA, which establishes, among other things, certain

registration, manufacturing quotas, security, recordkeeping, reporting, import, export and other requirements administered by the DEA.

The DEA classifies controlled substances into five schedules:

Schedule I, II, III, IV or V substances.

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

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

Pharmaceutical products approved for

use in the United States may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest potential

for abuse or dependence and Schedule V substances the lowest relative risk of abuse among such substances.

Schedule I and II drugs are

subject to the strictest controls under the CSA, including manufacturing and procurement quotas, security requirements and criteria for

In addition, dispensing of Schedule II drugs is further restricted.

For example, they may not be refilled without a new

prescription.

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” 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

I in order for it to be prescribed to patients in the United States.

If approved by the FDA, we expect the finished dosage forms of our

products to be listed by the DEA as a Schedule II, III, IV or V controlled substance.

Consequently, their manufacture, importation, exportation,

domestic distribution, storage, sale and legitimate use will be subject to a significant degree of regulation by the DEA.

The scheduling

process may take additional time after FDA approval, thereby significantly delaying the launch of our products.

Furthermore, if the FDA,

DEA or any foreign regulatory authority determines that our products may have potential for abuse, it may require us to generate more

clinical data than that which is currently anticipated, which could increase the cost and/or delay the launch of our products.

our products will contain compounds considered to be Schedule I substances, to conduct pre-clinical studies and clinical trials with

our products in the United States prior to approval, each of our research sites must submit a research protocol to the DEA and obtain

and maintain a DEA researcher registration that will allow those sites to procure necessary materials from suppliers, and to handle and

dispense our products.

If the DEA delays or denies the grant of a research registration to one or more research sites, the pre-clinical

studies or clinical trials could be significantly delayed, and we could lose and be required to replace clinical trial sites, resulting

in additional costs.

will also need to identify wholesale distributors with the appropriate DEA registrations and authority to distribute our products to

pharmacies and other healthcare providers, and these distributors would need to obtain Schedule II through V distribution registrations.

The failure to obtain, or delay in obtaining, or the loss of any of those registrations could result in increased costs to us.

products are Schedule II drugs, pharmacies would have to maintain enhanced security with alarms and monitoring systems and they must

adhere to recordkeeping and inventory requirements.

Furthermore, state and federal enforcement actions, regulatory requirements, and

legislation intended to reduce prescription drug abuse, such as the requirement that physicians consult a state prescription drug monitoring

program, may make physicians less willing to prescribe, and pharmacies to dispense, Schedule II products.

may manufacture the commercial supply of our products, or necessary raw materials, outside of the United States.

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 Register,

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

states have also established controlled substance laws and regulations.

Although state-controlled substance laws often mirror federal

law, states may schedule our product candidates in a different manner.

While some states automatically schedule a drug based on federal

action, other states schedule drugs through rulemaking or a legislative action.

State scheduling may delay commercial sale of any product

for which we obtain federal regulatory approval and adverse scheduling could have a material adverse effect on the commercial attractiveness

of such product.

We or our partners must also obtain separate state registrations, permits or licenses in order to be able to obtain,

handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements

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

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

from being marketed in those jurisdictions.

order to market and sell our products in jurisdictions other than the United States and the European Union, we must obtain separate marketing

approvals and comply with numerous and varying regulatory requirements.

The regulatory approval process outside the United States and

the European Union generally includes all of the risks associated with obtaining FDA and EMA approval, but can involve additional testing.

We may need to partner with third parties in order to obtain approvals outside the United States and the European Union.

in many countries worldwide, it is required that the product be approved for reimbursement before the product can be approved for sale

in that country.

We may not obtain approvals from regulatory authorities outside the United States and the European Union on a timely

basis, if at all.

Even if we were to receive approval in the United States or the European Union, approval by the FDA or the EMA does

not ensure approval by regulatory authorities in other countries or jurisdictions.

Similarly, approval by one regulatory authority outside

the United States and the European Union would not ensure approval by regulatory authorities in other countries or jurisdictions or by

the FDA or the EMA.

We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products

in any market.

If we are unable to obtain approval of our product candidates by regulatory authorities in other foreign jurisdictions,

the commercial prospects of those product candidates may be significantly diminished and our business prospects could decline.

legislation, including potentially unfavorable pricing regulations or other healthcare reform initiatives, may increase the difficulty

and cost for us to obtain marketing approval of and commercialize our product candidates.

the United States there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system

that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities or affect our

ability to profitably sell any product candidates for which we obtain marketing approval.

Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act, or the Affordable Care Act,

among other things, imposes a significant annual fee on companies that manufacture or import branded prescription drug products.

contains substantial provisions intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending,

enhance remedies against healthcare fraud and abuse, add new transparency requirements for the healthcare and health insurance industries,

impose new taxes and fees on pharmaceutical and medical device manufacturers, and impose additional health policy reforms, any of which

could negatively impact our business.

We expect that the Affordable Care Act, as well as other healthcare reform measures that have been

and may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that

we receive for any approved product, and could negatively impact our future revenues.

Any reduction in reimbursement from Medicare or

other government programs may result in a similar reduction in payments from private payors.

The implementation of cost containment measures

or other healthcare reforms may compromise our ability to generate revenue, attain profitability or commercialize our products.

if we are able to commercialize our products, the products may not receive coverage and adequate reimbursement from third-party payors,

which could harm our business.

availability of reimbursement by governmental and private payors is essential for most patients to be able to afford expensive treatments.

Sales of our products, if approved, will depend substantially on the extent to which the costs of these products will be paid by health

maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration

authorities, private health coverage insurers and other third-party payors.

If reimbursement is not available, or is available only to

limited levels, we may not be able to successfully commercialize our products.

Even if coverage is provided, the approved reimbursement

amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, or Medicare Modernization Act, established

the Medicare Part D program and provided authority for limiting the number of drugs that will be covered in any therapeutic class thereunder.

The Medicare Modernization Act, including its cost reduction initiatives, could decrease the coverage and reimbursement rate that we

receive for any of our approved products.

Furthermore, private payors often follow Medicare coverage policies and payment limitations

in setting their own reimbursement rates.

Therefore, any reduction in reimbursement that results from the Medicare Modernization Act

may result in a similar reduction in payments from private payors.

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

In the United States, the

principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services (CMS),

an agency within the U.S.

Department of Health and Human Services (HHS), as CMS decides whether and to what extent a new medicine will

be covered and reimbursed under Medicare.

Private payors tend to follow CMS to a substantial degree.

intended use of a drug product by a physician can also affect pricing.

For example, CMS could initiate a National Coverage Determination

administrative procedure, by which the agency determines which uses of a therapeutic product would and would not be reimbursable under

This determination process can be lengthy, thereby creating a long period during which the future reimbursement for a particular

product may be uncertain.

the United States, particularly in member states of the European Union, the pricing of prescription drugs is subject to governmental

In these countries, pricing negotiations or the successful completion of health technology assessment procedures with governmental

authorities can take considerable time after receipt of marketing approval for a product.

In addition, there can be considerable pressure

by governments and other stakeholders on prices and reimbursement levels, including as part of cost containment measures.

Certain countries

allow companies to fix their own prices for medicines, but monitor and control company profits.

Political, economic and regulatory developments

may further complicate pricing negotiations, and pricing negotiations may continue after reimbursement has been obtained.

Reference pricing

used by various European Union member states and parallel distribution, or arbitrage between low-priced and high-priced member states,

can further reduce prices.

In some countries, we or our collaborators may be required to conduct a clinical trial or other studies that

compare the cost-effectiveness of our product candidates to other available therapies in order to obtain or maintain reimbursement or

pricing approval.

Publication of discounts by third-party payors or authorities may lead to further pressure on the prices or reimbursement

levels within the country of publication and other countries.

If reimbursement of any product candidate approved for marketing is unavailable

or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business, financial condition, results of operations

or prospects could be adversely affected.

relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare

laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished

profits and future earnings.

providers, physicians and third-party payors play a primary role in the recommendation and prescription of any product candidates for

which we obtain marketing approval.

Our future arrangements with third-party payors and customers may expose us to broadly applicable

fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships

through which we market, sell and distribute our products for which we obtain marketing approval.

As a pharmaceutical company, even though

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

to our business.

laws and regulations exist in the countries within the European Economic Area (EEA).

Although such laws are partially based upon European

Union law, they may vary from country to country.

Healthcare specific, as well as general European Union and national laws, regulations

and industry codes constrain, for example, our interactions with government officials and healthcare practitioners, and the handling

of healthcare data.

Non-compliance with any of these laws or regulations could lead to criminal or civil liability.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve

substantial costs.

It is possible that governmental authorities will conclude that our business practices may not comply with current

or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations.

If our operations

are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant

civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government funded healthcare programs, such

as Medicare and Medicaid, and the curtailment or restructuring of our operations.

If any physicians or other healthcare providers or

entities with whom we expect to do business are found to not be in compliance with applicable laws, they may be subject to criminal,

civil or administrative sanctions, including exclusions from government funded healthcare programs.

Foreign Corrupt Practices Act and similar worldwide anti-bribery laws generally prohibit companies and their intermediaries

from making improper payments to non-U.S.

officials for the purpose of obtaining or retaining business.

Our internal control policies

and procedures may not protect us from reckless or negligent acts committed by our employees, future distributors, licensees or agents.

Violations of these laws, or allegations of such violations, could result in fines, penalties or prosecution and have a negative impact

on our business, results of operations and reputation.

products, if approved, may be unable to achieve broad market acceptance and, consequently, limit our ability to generate revenue from

new products.

when product development is successful and regulatory approval has been obtained, our ability to generate significant revenue depends

on the acceptance of our products by physicians and patients.

The market acceptance of any product depends on a number of factors, including

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

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

by regulatory authorities, competition, and marketing and distribution support.

Any factor preventing or limiting the market acceptance

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

we receive regulatory approvals, we may market our products in multiple jurisdictions where we have limited or no operating experience

and may be subject to increased business and economic risks that could affect our financial results.

we receive regulatory approvals, we may market our products in jurisdictions where we have limited or no experience in marketing, developing

and distributing our products.

Certain markets have substantial legal and regulatory complexities that we may not have experience navigating.

We are subject to a variety of risks inherent in doing business internationally, including risks related to the legal and regulatory

environment in non-U.S.

jurisdictions, including with respect to privacy and data security, trade control laws and unexpected changes

in laws, regulatory requirements and enforcement, as well as risks related to fluctuations in currency exchange rates and political,

social and economic instability in foreign countries.

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.

our products will contain controlled substances, their regulatory approval may generate public controversy.

Political and social pressures

and adverse publicity could lead to delays in approval of, and increased expenses for, our products.

These pressures could also limit

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.

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

our intellectual property rights would diminish.

We may be unable

to obtain patents or other protection for any technologies we develop, because such technologies are not coverable by patents or other

forms of registered intellectual property, because third parties file patents covering the same claims earlier than we do, or for other

If we are able to obtain issued patents, we cannot predict the degree and range of protection any patents will afford us against

competitors, including whether third parties will find ways to invalidate or otherwise circumvent our patents.

Others may obtain patents

claiming aspects similar to those covered by our patents and patent applications, which may limit the efficacy of the protections afforded

by any patents we may obtain.

success will also depend upon the skills, knowledge and experience of our personnel, our consultants and advisors as well as our licensors

and contractors.

To help protect any proprietary know-how we develop and any inventions for which patents may be unobtainable or difficult

to obtain, we expect to rely on trade secret protection and confidentiality agreements.

To this end, we expect to require our employees,

consultants, advisors and contractors to enter into agreements which prohibit the disclosure of confidential information and, where applicable,

require disclosure and assignment to us of the ideas, developments, discoveries and inventions important to our business.

These agreements

may not provide adequate protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized

use or disclosure or the lawful development by others of such information.

If any of our trade secrets, know-how or other proprietary

information is disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired and our

business and competitive position would suffer.

we infringe the rights of third parties we could be prevented from selling products and forced to pay damages or defend against litigation.

our products, methods, processes and other technologies infringe the proprietary rights of other parties, we could incur substantial

In that case, we could be required to:

licenses from such third parties, which may not be available on commercially reasonable terms, if at all;

our products or processes to avoid infringement, which may not be feasible;

using the subject matter claimed in the patents held by others;

litigation or administrative proceedings, which may be costly whether we win or lose, and which could result in a substantial diversion

of our valuable management resources.

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

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

we are able to develop and commercialize our proposed products, we could become subject to product liability claims.

If we are not

able to successfully defend against such claims, we may incur substantial liabilities or be required to limit commercialization of

our proposed products.

If we are unable to obtain sufficient product liability insurance at an acceptable cost to protect against

potential product liability claims this could prevent or inhibit the commercialization of products we develop, alone or with

collaborators.

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.

processing, formulation, manufacturing, packaging, labeling, advertising and distribution of our products is subject to regulation by

one or more federal agencies, and various agencies of the states and localities in which our products are manufactured and sold.

government regulatory agencies may attempt to regulate any of our products that fall within their jurisdiction.

Such regulatory agencies

may not accept the evidence of safety for any new ingredients that we may want to market, may determine that a particular product or

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

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

Such a determination would prevent us from marketing particular products or using certain statements of nutritional support on our products.

We also may be unable to disseminate third-party literature that supports our products if the third-party literature fails to satisfy

certain requirements.

addition, a government regulatory agency could require us to remove a particular product from the market.

Any product recall or removal

would result in additional costs to us, including lost revenues from any products that we are required to remove from the market, any

of which could be material.

Any such product recalls or removals could lead to liability, substantial costs and reduced growth prospects.

any of our products contain plants, herbs or other substances not recognized as safe by a government regulatory agency, we may not be

able to market or sell such products in that jurisdiction.

Any such prohibition could materially adversely affect our results of operations

and financial condition.

Further, if more stringent statutes are enacted, or if more stringent regulations are promulgated, we may not

be able to comply with such statutes or regulations without incurring substantial expense, or at all.

are not able to predict the nature of future laws, regulations, repeals or interpretations or to predict the effect additional governmental

regulation, if and when it occurs, would have on our business in the future.

Such developments could, however, require reformulation

of certain products to meet new standards, recalls or discontinuance of certain products not able to be reformulated, additional record-keeping

requirements, increased documentation of the properties of certain products, additional or different labeling, additional scientific

substantiation, or other new requirements.

Any such developments could involve substantial additional costs to us, which we may not be

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

Our ability to

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

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

If customers refuse

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

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.

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

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

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

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to acquire or develop.

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

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

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

strategy or if those businesses do not generate sufficient revenue, our business, financial condition and results of operations could

be materially adversely affected.

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 investment criteria utilized by the Company may differ from the investment criteria that any

particular shareholder considers relevant in evaluating a company’s sustainability or impact investing practices.

allocation and investment decisions, Company management will be dependent upon information and data obtained through voluntary or

third-party reporting, if available, that may be incomplete, inaccurate 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 impact investing practices.

Socially and environmentally-responsible norms differ

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 impact investing

practices that meet criteria established by the Company in an effort to improve such target’s impact investing 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 sustainability issues, and there can be no assurance that

the strategy or techniques employed will 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 investment criteria utilized by the Company may differ from the investment criteria that any particular shareholder

considers relevant in evaluating a company’s sustainability or impact investing practices.

In making allocation and investment

decisions, Company management will be dependent upon information and data obtained through voluntary or third-party reporting, if available,

that may be incomplete, inaccurate 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.

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 impact investing practices that meet criteria established by the Company in an effort

to improve such target’s impact investing 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 sustainability

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

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businesses we may seek to acquire or develop will require substantial capital investment.

Our 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 result in financing available 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 our M&A activities 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.

Our 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 result in financing available on favorable terms.

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 our M&A activities using recourse capital such as direct equity investments or the incurrence of additional

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.

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legislative changes could affect our financial results.

environmental assets we are considering purchasing are often subject to environmental regulations, and we expect such regulatory

conditions to influence the assumptions we will make regarding the future revenues and expenses associated with such proposed acquisitions.

If those regulatory conditions

change, our revenues may decrease and our expenses may increase, adversely affecting our financial results.

environmental assets we are considering purchasing are often subject to environmental regulations, and we expect such regulatory conditions

to influence the assumptions we will make regarding the future revenues and expenses associated with such proposed acquisitions.

regulatory conditions change, our revenues may decrease and our expenses may increase, adversely affecting our financial results.

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

impact investing strategy benefits from those 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 various states within the United

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.

Changes to such public policies or any reduction in or

elimination or expiration of such government incentives supporting or

deregulating the exploration, production and use of fossil fuels may create regulatory uncertainty in the renewable energy industry, which could have a material adverse effect on our business, financial condition, future results, and cash

impact investing strategy benefits from those 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 various 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.

Changes to such public policies or any reduction in or elimination or expiration of such government

incentives supporting or deregulating the exploration, production and use of fossil fuels may create regulatory uncertainty in the renewable

energy industry, which 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

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investing business including:

ability to compete with the large number of other companies pursuing similar business opportunities, many of which already have

established businesses in the geographic regions we are targeting and/or have greater financial, strategic, technological or other

resources than we have;

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

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

ability to compete with the large number of other companies pursuing similar business opportunities, many of which already have established

businesses in the geographic regions we are targeting and/or have greater financial, strategic, technological or other resources

than we have;

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

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

expansion, or to fund internal research and development;

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ability to recruit appropriate employees and address labor market challenges in those geographic regions in which we intend to operate.

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

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 regions where we will have to learn the

local 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.

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 transactions with businesses or entities affiliated with our executive officers, directors or major shareholders which may raise potential conflicts of interest.

carrying our impact investing strategy, we may decide to enter into a transaction or acquire a business affiliated with our

executive officers, directors or one or more of our major shareholders.

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 or other transaction, 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 such a business combination or transaction.

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 or integrate the companies which we may acquire in the future, which

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

carry out our impact investing strategy primarily through acquisitions.

Integrating acquisitions is often costly, and we may be

unable to successfully integrate our acquired businesses with our existing operations without substantial costs, delays or other

adverse operational or financial consequences.

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

and adversely affect our business, including:

Expanding our geographic

base will subject us to risks associated with doing business in new regions where we will have to learn the local business and political

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.

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 transactions with businesses or entities affiliated with our executive officers, directors or major shareholders which

may raise potential conflicts of interest.

carrying our impact investing strategy, we may decide to enter into a transaction or acquire a business affiliated with our executive

officers, directors or one or more of our major shareholders.

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 or other transaction, 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 such a business combination

or transaction.

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 or integrate the companies which we may acquire in the future, which could

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

intend to carry out our impact investing strategy primarily through acquisitions.

Integrating acquisitions is often costly, and we may

be unable to successfully integrate our acquired businesses with our existing operations without substantial costs, delays or other adverse

operational or financial consequences.

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;

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

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

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

Concentration

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The financial performance

of those businesses depends on the ability of each customer to perform its respective 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 be assured 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 all.

we have identified general criteria and guidelines that we believe are important in evaluating prospective target 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 businesses that fall within our impact investing strategy, it is possible that

we may acquire or enter into transactions with a target business which will not meet all of these criteria.

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.

of those businesses depends on the ability of each customer to perform its respective 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.

assured 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 all.

we have identified general criteria and guidelines that we believe are important in evaluating prospective target 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 businesses that fall within our impact investing

strategy, it is possible that we may acquire or enter into transactions with a target business which will not meet all of these criteria.

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

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

or creating partnerships and joint ventures.

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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 entered into in

connection with such acquisitions may contain certain financial and operational 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.

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 entered into in connection

with such acquisitions may contain certain financial and operational 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.

impact investing 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.

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 of release.

If we fail to comply with these laws, ordinances or regulations (or any change

thereto), we could be subject to, among other things, civil or criminal liability, the imposition of liens or fines, the cessation

of operations, or substantial expenditures necessary to bring our operations into compliance.

Furthermore, under

certain federal and states laws, 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 it occurred.

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.

impact investing 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 of release.

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

among other things, civil or criminal liability, the imposition of liens or fines, the cessation of operations, or substantial expenditures

necessary to bring our operations into compliance.

Furthermore, under certain federal and states laws, 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 it occurred.

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.

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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 subject to, among other things,

restrictions on the nature of our investments and the issuance of securities, each of which may make it difficult for us to carry

out our planned impact investing strategy.

we are deemed to be an investment company under the Investment Company Act, our activities may be subject to, among other things, restrictions

on the nature of our investments and the issuance of securities, each of which may make it difficult for us to carry out our planned

impact investing strategy.

In addition, we may be subject to additional requirements including:

registration as an investment company with the SEC;

(i) registration as an investment company

with the SEC;

(ii) adoption of a specific form of corporate structure;

and (iii) reporting,

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

Compliance with these additional regulatory burdens would require additional expenses for which we have not allotted funds and may

hinder our ability to carry out our impact investing strategy.

and (iii) reporting, record keeping, voting, proxy and disclosure

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

Compliance with these additional regulatory burdens

would require additional 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.

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

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.

We do not believe that our principal activities will subject us to

registration under the Investment Company Act.

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.

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

Related to our Common Stock

1 unchanged sentence

unrelated to our operations.

common stock is quoted on the OTC and trading on the OTC is frequently highly volatile, with low trading volume.

common stock is quoted on the OTCQB and trading on the OTCQB is frequently highly volatile, with low trading volume.

We have experienced

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articles of incorporation authorize the issuance of up to 1,000,000,000 shares of common stock, of which, as of March 28, 2025, 108,616,078

2024, 101,023,485 shares were outstanding and 18,855,879 shares were reserved for issuance under our stock incentive plan and other outstanding

options or warrants.

shares were outstanding and 15,494,210 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

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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