What changed in this filing

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Item 1A. Risk Factors

2025-03-28 compared with 2024-04-01 · 378 added, 302 removed, 441 unchanged (61% of the section changed)

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protection and the characteristics and quality of services.

or probable governmental regulations relating to CBD products may harm or prevent our ability to sell our product offering.

majority of state governments in the United States have legalized the growing, production, and use of CBD.

However, cannabis remains

illegal under federal law.

In addition, in July 2017, the United States Drug Enforcement Agency issued a statement that certain CBD extractions

fall within the definition of marijuana and are therefore a Schedule I controlled substance under the Controlled Substances Act of 1970,

Thus, the cannabis industry, including companies which sell products containing CBD, faces very uncertain regulation by the

federal government.

While the federal government has for several years chosen to not intervene in the cannabis business conducted legally

within the states that have legislated such activities, there is, nonetheless, potential that the federal government may at any time

choose to begin enforcing its laws against the manufacture, possession, or use of cannabis-based products such as CBD.

Similarly, there

is the possibility that the federal government may enact legislation or rules that authorize the manufacturing, possession or use of

those products under specific guidelines.

Local, state and federal cannabis laws and regulations are broad in scope and subject to evolving

interpretations.

In the event the federal government was to tighten its regulation of the industry, we would likely suffer a material

adverse effect on our business, including substantial losses.

We have recently ceased the marketing and sale of CBD products.

These regulations

could negatively affect our ability to dispose of our CBD related assets.

depend heavily on key personnel, and turnover of key senior management could harm our business.

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and marketing new products or in enhancing existing products.

success of new product introductions depends on various factors, including, without limitation, the following:

sales and marketing efforts;

delivery of new products;

of raw materials;

allowance of the products;

acceptance of new products

success of new product introductions depends on various factors, including, without limitation,

the following:

Successful sales and marketing efforts;

Timely delivery of new products;

Availability of raw materials;

Pricing of raw materials;

Regulatory allowance of the products;

Customer acceptance of new products.

publicity associated with our products or ingredients, or those of similar companies, could adversely affect our sales and revenue.

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use, could have a material adverse effect on the market demand for our products, including reducing our sales and revenue.

do not have and may never have any products on the market that have been approved for the treatment of disease.

Our business is highly

dependent upon receiving approvals from various U.S.

and international governmental agencies and will be severely harmed if we are not

granted approval to manufacture and sell our product candidates.

order for us to commercialize a product for the treatment of any disease, we must obtain regulatory approvals of such treatment for that

Satisfying regulatory requirements is an expensive process that typically takes many years and involves compliance with requirements

covering research and development, testing, manufacturing, quality control, labeling, and promotion of drugs for human use.

necessary regulatory approvals, we must, among other requirements, complete clinical trials demonstrating that our products are safe

and effective for a particular indication.

There can be no assurance that our products will prove to be safe and effective, that our

clinical trials will demonstrate the necessary safety and effectiveness of our product candidates, or that we will succeed in obtaining

regulatory approval for any treatment we develop even if such safety and effectiveness are demonstrated.

delays or difficulties we encounter in our clinical trials may delay or preclude regulatory approval from the FDA or from international

regulatory organizations.

Any delay or preclusion of regulatory approval would be expected to delay or preclude the commercialization

of our products.

Examples of delays or difficulties that we may encounter in our clinical trials include without limitation the following:

trials may not yield sufficiently conclusive results for regulatory agencies to approve the use of our products;

products may fail to be more effective than current therapies, or to be effective at all;

may discover that our products have adverse side effects, which could cause our products to be delayed or precluded from receiving

regulatory approval or otherwise expose us to significant commercial and legal risks;

may take longer than expected to determine whether or not a treatment is effective;

involved in our clinical trials may suffer severe adverse side effects even up to death, whether as a result of treatment with our

products, the withholding of such treatment, or other reasons (whether within or outside of our control);

may fail to be able to enroll a sufficient number of patients in our clinical trials;

enrolled in our clinical trials may not have the characteristics necessary to obtain regulatory approval for a particular indication

or patient population;

may be unable to produce sufficient quantities of product to complete the clinical trials;

if we are successful in our clinical trials, any required governmental approvals may still not be obtained or, if obtained, may not

be maintained;

approval for commercialization is granted, it is possible the authorized use will be more limited than is necessary for commercial

success, or that approval may be conditioned on completion of further clinical trials or other activities, which will cause a substantial

increase in costs and which we might not succeed in performing or completing;

granted, approval may be withdrawn or limited if problems with our products emerge or are suggested by the data arising from their

use or if there is a change in law or regulation.

success we may achieve at a given stage of our clinical trials does not guarantee that we will achieve success at any subsequent stage,

including without limitation final FDA approval.

may encounter delays or rejections in the regulatory approval process because of additional government regulation resulting from future

legislation or administrative action, or from changes in the policies of the FDA or other regulatory bodies during the period of product

development, clinical trials, or regulatory review.

Failure to comply with applicable regulatory requirements may result in criminal

prosecution, civil penalties, recall or seizure of products, total or partial suspension of production, or an injunction preventing certain

activity, as well as other regulatory action against our product candidates or us.

We have no experience in successfully obtaining regulatory

approval for a product and thus may be poorly equipped to gauge, and may prove unable to manage, risks relating to obtaining such approval.

the U.S., our ability to market a product is contingent upon receiving clearances from appropriate non-U.S.

regulatory authorities.

regulatory approval typically includes all of the risks associated with FDA clearance discussed above as well as geopolitical uncertainties

and the additional uncertainties and potential prejudices faced by U.S.

pharmaceutical companies conducting business abroad.

cases, pricing restrictions and practices can make achieving even limited profitability very difficult.

have limited experience in completing regulatory filings and any delays in regulatory filings could materially affect our financial condition.

are currently initiating clinical trials of our product candidates.

We have not, however, demonstrated the ability to obtain marketing

approvals, manufacture product candidates at a commercial scale, or conduct sales and marketing activities necessary for the successful

commercialization of a product.

Consequently, we have no historical basis as a company by which one can evaluate or predict reliably

our future success or viability.

Additionally,

while our team has experience at prior companies with regulatory filings, we have limited experience with regulatory filings with agencies

such as the FDA or the European Medicines Agency, or EMA, and will rely on third-party expertise for this.

Any delay in our regulatory

filings for our product candidates, and any adverse development or perceived adverse development with respect to the applicable regulatory

authority’s review of such filings, including, without limitation, the FDA’s issuance of a “refuse to file” letter

or a request for additional information, could materially affect our financial condition.

serious adverse or undesirable side effects are identified during the development of our product candidates, we may abandon or limit

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of these occurrences may harm our business, financial condition and prospects significantly.

we experience delays or difficulties in the enrollment of subjects to our clinical trials, our receipt of necessary regulatory approvals

could be delayed or prevented, which could materially affect our financial condition.

we experience delays or difficulties in the enrollment of subjects to our clinical trials, our ability to complete such trials will be

adversely affected

screening and enrolling patients to participate in clinical trials of our product candidates is critical to our success, and we may not

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result in slower enrollment than we anticipate.

addition, we may experience enrollment delays related to increased or unforeseen regulatory, legal and logistical requirements at certain

clinical trial sites.

These delays could be caused by reviews by regulatory authorities and contractual discussions with individual clinical

Any delays in enrolling and/or dosing patients in our planned clinical trials could result in increased costs, delays in

advancing our product candidates, delays in testing the effectiveness of our product candidates or in termination of the clinical trials

enrollment may be affected if our competitors have ongoing clinical trials with products for the same indications as our product candidates,

and patients who would otherwise be eligible for our clinical trials instead enroll in our competitors’ clinical trials.

addition, we may experience enrollment delays related to increased or unforeseen legal and logistical requirements at certain clinical

These delays could be caused by reviews by contractual discussions with individual clinical trial sites.

Any delays in enrolling

and/or dosing patients in our planned clinical trials could result in increased costs, delays in advancing our product candidates, delays

in testing the effectiveness of our product candidates or in termination of the clinical trials altogether.

enrollment may also be affected by other factors, including:

● coordination

with clinical research organizations to enroll and administer the clinical trials;

● coordination

and recruitment of collaborators and investigators at individual sites;

of the patient population and process for identifying patients;

of the participant population and process for identifying participants;

of the clinical trial protocol;

● eligibility

and exclusion criteria;

risks and benefits of the product candidates under study;

of competing commercially available therapies and other competing products’ clinical trials;

of year in which the trials are initiated or conducted;

of the diseases under investigation;

to obtain and maintain subject consents;

to enroll and treat patients in a timely manner;

to enroll participants in a timely manner;

that enrolled subjects will drop out before completion of the trials;

and availability of clinical trial sites for prospective patients;

and availability of clinical trial sites for prospective participants;

to monitor subjects adequately during and after treatment.

referral practices of physicians.

inability to enroll a sufficient number of patients for clinical trials would result in significant delays and could require us to abandon

one or more clinical trials altogether.

Enrollment delays in these clinical trials may result in increased development costs for our

product candidates, which could materially affect our financial condition.

we or our licensees, development collaborators, or suppliers are unable to manufacture our products in sufficient quantities or at defined

quality specifications or are unable to obtain regulatory approvals for the manufacturing facility, we may be unable to develop or meet

demand for our products and lose time to market and potential revenues.

of our clinical trials and commercialization of our product candidates require access to, or development of, facilities to manufacture

a sufficient supply of our product candidates.

We intend to utilize third parties to manufacture our products.

the future we may become unable, for various reasons, to rely on our sources for the manufacture of our product candidates, either for

clinical trials or, at some future date, for commercial distribution.

We may not be successful in identifying additional or replacement

third-party manufacturers, or in negotiating acceptable terms with any we do identify.

We may face competition for access to these manufacturers’

facilities and may be subject to manufacturing delays if the manufacturers give other clients higher priority than they give to us.

if we are able to identify an additional or replacement third-party manufacturer, the delays and costs associated with establishing and

maintaining a relationship with such manufacturer may have a material adverse effect on us.

we can begin to commercially manufacture any product candidate, we must obtain regulatory approval of the manufacturing facility and

Manufacturing of drugs for clinical and commercial purposes must comply with current Good Manufacturing Practices requirements,

commonly known as “cGMP.” The cGMP requirements govern quality control and documentation policies and procedures.

with cGMP and non-U.S.

regulatory requirements will require that we expend time, money, and effort in production, recordkeeping, and

quality control to ensure that the product meets applicable specifications and other requirements.

We, or our contracted manufacturing

facility, must also pass a pre-approval inspection prior to FDA approval.

Failure to pass a pre-approval inspection may significantly

delay or prevent FDA approval of our products.

If we fail to comply with these requirements, we would be subject to possible regulatory

action and may be limited in the jurisdictions in which we are permitted to sell our products and will lose time to market and potential

is uncertain whether product liability insurance will be adequate to address product liability claims, or that insurance against such

claims will be affordable or available on acceptable terms in the future.

research involves the testing of new drugs on human volunteers pursuant to a clinical trial protocol.

research involves the testing of products on human volunteers pursuant to a clinical trial protocol.

Such testing involves a risk of

liability for personal injury to or death of patients due to, among other causes, adverse side effects, improper administration of the

new drug, or improper volunteer behavior.

new product, or improper volunteer behavior.

Claims may arise from patients, clinical trial volunteers, consumers, physicians, hospitals,

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that has technical expertise and could support a distribution capability.

Competition in the biopharmaceutical industry for technically

Competition in the dietary supplement industry for technically

proficient marketing, sales, and distribution personnel is intense and attracting and retaining such personnel may significantly increase

There can be no assurance that we will be able to establish internal marketing, sales, or distribution capabilities or that

these capabilities will be sufficient to meet our needs.

commercial success of our non-OTC product candidates will depend on the acceptance of these products by physicians, payers, and patients.

non-OTC product candidate that we may develop may not gain market acceptance among physicians and patients.

Market acceptance of and

demand for any non-OTC product that we may develop will depend on many factors, including without limitation:

superiority of the effectiveness and safety in the treatment of the disease indication compared to alternative treatments;

prevalence and severity of adverse side effects;

advantages over alternative treatments;

effectiveness;

and ease of administration;

third-party coverage and/or reimbursement;

of sales, marketing and distribution support;

ability to provide acceptable evidence of safety and efficacy.

any non-OTC product candidate developed by us receives regulatory approval but does not achieve an adequate level of market acceptance

by physicians, payers, and patients, we may generate insufficient, little, or no product revenue and may not become profitable.

addition, pandemics, including the novel coronavirus, COVID-19, could decrease consumer spending and adversely affect demand for our

non-OTC products may not be accepted for reimbursement or properly reimbursed by third-party payers.

successful commercialization of any non-OTC products we might develop will depend substantially on whether the costs of our non-OTC products

and related treatments are reimbursed at acceptable levels by government authorities, private healthcare insurers, and other third-party

payers, such as health maintenance organizations.

Reimbursement rates may vary, depending upon the third-party payer, the type of insurance

plan, and other similar or dissimilar factors.

If our non-OTC products do not achieve adequate reimbursement, then the number of physician

prescriptions of our products may not be sufficient to make our non-OTC products profitable.

effectiveness research demonstrating benefits of a competitor’s non-OTC product could adversely affect the sales of our non-OTC

product candidates.

If third-party payers do not consider our products to be cost-effective compared to other available therapies, they

may not cover our products as a benefit under their plans or, if they do, the level of payment may not be sufficient to allow us to sell

our non-OTC products on a profitable basis.

third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our

investment in the product development of that non-OTC product.

In addition, in the U.S.

there is a growing emphasis on comparative effectiveness

research, both by private payers and by government agencies.

To the extent other drugs or therapies are found to be more effective than

our non-OTC products, payers may elect to cover such therapies in lieu of our products or reimburse our non-OTC products at a lower rate.

effects of economic and political pressure to lower pharmaceutical prices are a major threat to the economic viability of new research-based

pharmaceutical products, and any development along these lines could materially and adversely affect our prospects.

on managed care in the U.S.

has increased and we expect this will continue to increase the pressure on pharmaceutical pricing.

policies and third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained

for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented

in the future.

development along these lines could materially and adversely affect our prospects.

We are unable to predict what legislative or regulatory

changes relating to the healthcare industry, including without limitation any changes affecting governmental and/or private or third-party

coverage and reimbursement, may be enacted in the future, or what effect such legislative or regulatory changes would have on our business.

we obtain FDA approval for any of our product candidates, we will be subject to various federal and state fraud and abuse laws;

laws may impact, among other things, our proposed sales, marketing and education programs.

Fraud and abuse laws are expected to increase

in breadth and in detail, which will likely increase our operating costs and the complexity of our programs to insure compliance with

such enhanced laws.

we obtain FDA approval for any of our product candidates and begin commercializing those products in the U.S., our operations may be

directly, or indirectly through our customers, distributors, or other business partners, subject to various federal and state fraud and

abuse laws, including, without limitation, anti-kickback statutes and false claims statutes which may increase our operating costs.

laws may impact, among other things, our proposed sales, marketing and education programs.

our operations are found to be in violation of any of the federal and state fraud and abuse laws or any other governmental regulations

that apply to us, we may be subject to criminal actions and significant civil monetary penalties, which would adversely affect our ability

to operate our business and our results of operations.

our operations are found to be in violation of any of the federal and state fraud and abuse laws, including, without limitation, anti-kickback

statutes and false claims statutes or any other governmental regulations that apply to us, we may be subject to penalties, including

criminal and significant civil monetary penalties, damages, fines, imprisonment, exclusion from participation in government healthcare

programs, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business

and our results of operations.

To the extent that any of our product candidates are ultimately sold in a foreign country, we may be subject

to similar foreign laws and regulations, which may include, for instance, applicable post-marketing requirements, including safety surveillance,

anti-fraud and abuse laws, and implementation of corporate compliance programs and reporting of payments or transfers of value to healthcare

professionals.

face business disruption and related risks resulting from the recent pandemic of COVID-19, which could have, and has had, a material

adverse effect on our business plan.

supply chain and the development of our product candidates, including that of our subsidiaries, could be, and have been, disrupted and

materially adversely affected by the recent outbreak of COVID-19.

As a result of measures imposed by the governments in affected regions,

businesses and schools have been suspended due to quarantines intended to contain this outbreak.

We are still assessing our business

plans and the impact COVID-19 may have on our supply chain and ability to conduct our clinical trials, but there can be no assurance

that this analysis will enable us to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns

in business sentiment generally.

The extent to which the COVID-19 pandemic and global efforts to contain its spread will impact our operations

will depend on future developments, which are highly uncertain and cannot be predicted at this time, and include the duration, severity

and scope of the pandemic and the actions taken to contain or treat the COVID-19 pandemic.

can be no assurance that we will be able to establish internal marketing, sales, or distribution capabilities or that these capabilities

will be sufficient to meet our needs.

disasters and other events beyond our control could materially adversely affect us.

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to our customers and could decrease demand for our services.

The World Health Organization declared the COVID-19 outbreak a pandemic.

The extent of the impact of COVID-19 on our operational and financial performance will depend on certain developments, including the

duration and spread of the outbreak, the impact on our customers and employees, all of which are uncertain and cannot be predicted.

this point, the overall extent to which COVID-19 may impact our financial condition or results of operations is uncertain.

have a limited operating history upon which investors can evaluate our future prospects.

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significant reduction in revenues may immediately and adversely affect our business, financial condition and operating results.

products and manufacturing activities are subject to extensive government regulation, and failure to comply with these laws and regulations,

as they currently exist or as modified in the future, may increase our costs, limit or eliminate our ability to sell certain products,

subject us or our suppliers to the risk of enforcement action, or otherwise adversely affect our business, results of operations and

financial condition.

manufacture, packaging, labeling, advertising, promotion, distribution, import, export and sale of our products are subject to regulation

by numerous national and local governmental agencies in the United States and other countries, including but not limited to the U.S.

Food and Drug Administration (FDA) and the Federal Trade Commission (FTC).

Failure to comply with FDA regulatory requirements may result

in, among other things, injunctions, product withdrawals, recalls, product seizures, fines, and criminal prosecutions.

Any action of

this type by the FDA could materially adversely affect our ability to market our products successfully.

manufacture of nutritional or dietary supplements and related products in the United States requires compliance with dietary supplement

current Good Manufacturing Practice (GMP) regulations, which are based on the food-model GMP regulations, with additional requirements

that are specific to dietary supplements.

We believe the manufacturing processes for the Safety Shot Dietary Supplement substantially

complies with the applicable dietary supplement GMP requirements.

Nevertheless, any FDA action determining that such processes do not

comply with dietary supplement GMPs could materially adversely affect our ability to manufacture and market the Sure Shot Dietary Supplement

in the United States.

In addition, the Dietary Supplement & Nonprescription Drug Consumer Protection Act requires dietary supplement

manufacturers and distributors to notify the FDA when they receive reports of serious adverse events associated with their products that

occur within the United States.

states also regulate nutritional supplements.

A state may seek to interpret claims or products presumptively valid under federal

law as illegal under that state’s regulations, or otherwise seek to create restrictions to access under state law.

during the 204 legislative session, several states are considering bills that would restrict the sale of muscle building and/or weight

management supplements to people over the age of 18.

Government agencies, as well as legislative bodies, can change existing regulations,

or impose new ones, or could take aggressive measures, causing or contributing to a variety of negative consequences, including:

● requirements

for the reformulation of products to meet new standards;

recall or discontinuance of products;

record-keeping requirements;

documentation of the properties of certain or all products;

or different labeling or advertising for products;

adverse event tracking and reporting requirements;

scientific substantiation to support product claims.

cannot predict the nature of any future laws, regulations, interpretations, or applications, nor can we determine what effect additional

governmental regulations or administrative orders, when and if promulgated, could have on our business, financial condition, or results

of operations.

are subject to government regulations of the processing, formulation, packaging, labeling and advertising of our wellness and dietary

supplement products.

the Federal Food, Drug, and Cosmetic Act (the FD&C Act), companies that manufacture and distribute functional foods and dietary supplements,

such as our Safety Shot Dietary Supplement, are limited in the claims that they are permitted to make about nutritional support on the

product label without FDA approval.

Any failure by us to adhere to the labeling requirements could lead to the FDA requiring that our

products be repackaged and relabeled, which would have a material adverse effect on our business.

In addition, companies are responsible

for the accuracy and truthfulness of, and must have adequate scientific substantiation for, any nutritional or functional claims.

claims must be truthful and not misleading.

Promotional claims about foods and dietary supplements also must not include statements that

the product can diagnose, mitigate, treat, cure or prevent a specific disease or class of disease.

believe we are able to market our Sure Shot Dietary Supplement product in reliance on the self-affirmed Generally Recognized As Safe

(GRAS) status of our formulation’s current ingredients.

No governmental agency or other third party has made a determination as

to whether or not the Sure Shot Dietary Supplement has achieved GRAS status.

We make this determination based on independent scientific

opinions that the individual ingredients and formulation as a whole are not harmful under their intended conditions of use.

another regulatory authority or other third party denied our self-affirmed GRAS status for the Sure Shot Dietary Supplement, we could

face significant penalties or be required to undergo the regulatory approval process in order to market our product, and our business,

financial condition and results of operations will be adversely affected.

We cannot guarantee that in such a situation the Sure Shot

Dietary Supplement would be approved.

processing, formulation, packaging, labeling and advertising of our products may also be subject to regulation by the FTC, the Environmental

Protection Agency (EPA), and various agencies of the states and localities in which the products are sold.

Any changes in the current

regulatory environment could impose requirements that would limit our ability to market our supplement products and make bringing new

products to market more expensive.

In addition, the adoption of new regulations or changes in the interpretation of existing regulations

may result in significant compliance costs or discontinuation of product sales and may adversely affect our business, financial condition

and results of operations.

we have positioned the Sure Shot Dietary Supplement as a dietary supplement, it is possible that the FDA or a state regulatory agency

could classify our product as a drug.

If the Sure Shot Dietary Supplement is determined to be a drug, we would not be able to market

it further without making significant changes to the product and labeling or going through the drug approval process, which would limit

our ability to effectively market the product and would adversely affect our financial condition and results of operations.

clinical trials may be necessary in order to support any new drug approval for the Sure Shot Dietary Supplement, and clinical trials

designed to support drug approval may be time consuming, expensive, and uncertain.

If required, such additional studies may take years

to complete, and we may never generate the necessary data or results required to obtain marketing authorization of Safety Shot Dietary

Supplement as an over-the-counter drug product.

Accordingly, there can be no assurances that any such drug approval, if required, could

be obtained for the Sure Shot Dietary Supplement.

If the FDA or a state regulatory agency ultimately determines the Sure Shot Dietary

Supplement is a drug rather than a dietary supplement, the agency could claim that the product is misbranded and require that we recall,

repackage and relabel the product and impose civil and/or criminal penalties.

Any of these situations could adversely affect our business

and operations, and any public actions taken by the FDA or other regulatory agency against us could lead to consumer complaints, civil

lawsuits, retail customers terminating any supply agreements we may have with them, and significant reputational harms to the company.

failure to comply with applicable laws or regulations could result in substantial monetary penalties and could adversely affect our operating

recent years, the marketing and labeling of functional foods and beverages and dietary supplements has brought increased risk that consumers

will bring class action lawsuits and that the FTC and/or state attorneys general will bring legal action concerning the truth and accuracy

of the marketing and labeling of such products, seek removal of such products from the marketplace, and/or impose fines and penalties.

Our Sure Shot Dietary Supplement product is marketed with express and implied statements relating to the ingredients or health and wellness

related attributes, which may increase the potential risk of regulatory scrutiny over such claims.

The lack of specific regulations or

guidance on common supplement terms and statements used in product labeling has contributed to legal challenges against many supplement

companies, and plaintiffs have commenced legal actions against several nutritional supplement companies, asserting false, misleading

and deceptive advertising and labeling claims.

In addition, the FTC has instituted numerous enforcement actions against dietary supplement

companies for failure to have adequate substantiation for claims made in advertising or for the use of false or misleading advertising

Our failure to comply with applicable regulations could result insubstantial monetary penalties, which would likely have a material

adverse effect on our financial condition or results of operations.

when unmerited, class action lawsuits, action by the FTC or state attorneys general enforcement actions can be expensive to defend against

and may adversely affect our reputation with existing and potential customers and consumers and our corporate and brand image, which

would likely have a material and adverse effect on our business, financial condition or results of operations.

The number of private

consumer class actions relating to false or deceptive advertising against nutritional supplement companies has increased in recent years.

addition, the FDA has aggressively enforced its regulations with respect to different types of product claims that may or may not be

made for food or dietary supplement products.

These events could interrupt the marketing and sales of our Sure Shot Dietary Supplement

product, severely damage our brand reputation and public image, increase our legal expenses, result in product recalls or litigation,

and impede our ability to deliver our products in sufficient quantities or quality, which would likely result in a material adverse effect

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

and/or regulatory agencies may impose additional laws or regulations or change current laws or regulations, and state attorneys general

may increase enforcement of existing or new laws, and compliance with new or changed governmental regulations, or any state attorney

proceeding, could increase our costs significantly and materially and adversely affect our business, financial condition and results

of operations.

time to time, Congress, the FDA, the FTC, or other federal, state, local or foreign legislative and regulatory authorities may impose

additional laws or regulations that apply to us, repeal laws or regulations that we consider favorable to us or impose more stringent

interpretations of current laws or regulations.

We are not able to predict the nature of such future laws, regulations, repeals or interpretations

or to predict the effect that additional governmental regulation, when and if it occurs, would have on our business in the future.

developments could 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, adverse event reporting or other new requirements.

example, in recent years, the FDA has issued warning letters to several dietary supplement companies alleging improper and unapproved

drug claims regarding their products marketed for use as hangover cures or to prevent hangovers.

If the FDA determines that we have disseminated

inappropriate and unapproved drug claims for our Safety Shot Dietary Supplement, which we are positioning as a dietary supplement, we

could receive a warning or untitled letter, be required to modify our product claims or take other actions to satisfy the FDA.

public warning or untitled letter from the FDA could harm our reputation and could lead to potential customer or consumer complaints

or even civil lawsuits and other financial damages.

While we would intend to vigorously defend our company and the Safety Shot product

line in such a situation, any developments of this nature could increase our costs significantly and would likely have a material adverse

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

reliance on third parties to manufacture and supply our products, including the Sure Shot Dietary Supplement, may harm our business,

financial condition and operating results.

contract with third-party suppliers and manufacturers for the production of our products, including the Sure Shot Dietary Supplement.

These third-party suppliers and manufacturers produce and, in most cases, pack our products according to formulations and specifications

that have been developed by or in conjunction with our in-house product development team.

Products manufactured by third-party suppliers

at their facilities must also pass through quality control and assurance procedures to ensure they are manufactured in conformance with

our specifications.

We cannot assure you that our third-party contract manufacturers will continue to reliably supply products to us

at the levels of quality, or the quantities, we require, and in compliance with our specifications or applicable laws, including under

the FDA’s dietary supplement GMP regulations and the FD&C Act’s food safety provisions.

Should our contract manufacturers

experience quality issues or supply us with non-conforming products, we may need to terminate relationships or secure alternative suppliers.

Identifying and obtaining acceptable replacement manufacturing sources, on a timely basis or at all, for FDA-regulated functional beverages

and dietary supplement products is challenging.

Additionally, any future need to transfer our third-party manufacturing business to another

contract manufacturer could be expensive, time-consuming, result in delays in our production or shipping, reduce our net sales, damage

our relationship with customers and damage our reputation in the marketplace.

rely on third parties to conduct clinical trials and most nonclinical studies of our products, including the Sure Shot Dietary Supplement.

If these third parties do not perform as contractually required, fail to satisfy regulatory or legal requirements or miss expected deadlines,

our product development and commercialization efforts could be delayed with material and adverse effects on our business, financial condition,

results of operations and prospects.

we recently completed a clinical trial for the Safety Shot Dietary Supplement and may sponsor clinical trials in the future for the Sure

Shot Dietary Supplement or other products, we do not independently conduct clinical trials or the majority of nonclinical studies involving

our products or product candidates.

Accordingly, while we perform certain functions internally, we currently rely on third-party contract

research organizations (CROs), such as the Center for Applied Health Sciences, as well as laboratories, clinical investigators, clinical

data management organizations, and consultants, to help us design, conduct, supervise and monitor research involving our products and

human participants.

As a result, we have less control over the timing, quality and other aspects of our clinical trials than we would

have had we conducted them on our own.

There is a limited number of third-party service providers that specialize in the wellness space

or have the expertise required to achieve our business objectives.

If any of our relationships with these third-party CROs terminate,

we may not be able to enter into arrangements with alternative CROs or investigators or to do so on commercially reasonable terms.

these laboratories, investigators, CROs and consultants are not our employees and we have limited control over the amount of time and

resources that they dedicate to our product development programs.

These third parties may have contractual relationships with other entities,

some of which may be our competitors, which may draw time and resources from our programs.

The third parties with which we contract might

not be diligent, careful or timely in conducting our nonclinical studies or clinical trials.

If we cannot contract with acceptable third

parties on commercially reasonable terms, or at all, or if these third parties do not carry out their contractual duties, satisfy the

legal and regulatory requirements for the conduct of nonclinical studies or clinical trials or meet expected deadlines for any reason,

our product development efforts could be delayed and otherwise adversely affected.

all events, we are responsible for ensuring that each of our nonclinical studies and clinical trials is conducted in accordance with

the general investigational plan and protocols for the relevant study or trial.

For example, the FDA requires certain nonclinical studies

to be conducted in accordance with good laboratory practices and clinical trials to be conducted in accordance with good clinical practices,

including practices and requirements for designing, conducting, recording and reporting the results of nonclinical studies and clinical

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

trial participants are protected.

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

Any adverse development or delay in our nonclinical studies or clinical trials could have a material and adverse effect on our business,

financial condition, results of operations and prospects.

should the FDA determine that the Sure Shot Dietary Supplement is a drug rather than a dietary supplement and require us to secure new

drug approval or another form of marketing authorization for the Sure Shot Dietary Supplement, there can be no assurance that the nonclinical

and clinical data we have generated to date would be sufficient to meet applicable regulatory standards for demonstrating substantial

evidence of effectiveness.

“Substantial evidence” represents the evidentiary threshold in the FD&C Act for the efficacy

of new drugs, and it requires at least one adequate and well-controlled clinical investigation to establish effectiveness.

have positioned the Sure Shot Dietary Supplement as a dietary supplement, our recently completed clinical trial may not meet FDA’s

expectations for a well-controlled clinical investigation adequate to support a potential drug approval.

may not meet our product development and commercialization milestones.

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be delayed, and potential purchasers of our initial commercial products may decline to purchase such products or may opt to pursue alternative

may also experience shortages equipment due to manufacturing difficulties.

may also experience shortages of equipment due to manufacturing difficulties.

Multiple suppliers provide the components used in manufacturing

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costs of doing business in foreign countries;

● Infringement

claims on foreign patents, copyrights or trademark rights;

● Difficulties

in staffing and managing operations across disparate geographic areas;

associated with enforcing agreements and intellectual property rights through foreign legal systems;

protection measures and other regulatory requirements, which affect our ability to import or export our products from or to various

● Difficulties

associated with enforcing agreements and intellectual property rights through foreign legal

protection measures and other regulatory requirements, which affect our ability to import

or export our products from or to various countries;

tax consequences;

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ability to recruit and retain channel partners in foreign jurisdictions.

Related to SRM Spin-Off

may be unable to achieve some or all of the expected benefits of the Spin-Off, and the Spin-Off may adversely affect our business.

we believe that separating SRM into a stand-alone, publicly traded company (the “Spin-off”) provided financial, operational

and other benefits to us and our stockholders, we cannot provide assurance that we will achieve the full strategic and financial benefits

expected from the Spin-Off.

The Spin-off resulted in us being a smaller, less diversified company, making us more vulnerable to changing

market and economic conditions.

Our business is now more concentrated in health and wellness products, and we have greater exposure to

legal, regulatory, political and other risks relating to the health and wellness industry.

In addition, as a smaller company, our ability

to absorb costs may be negatively impacted, and we may be unable to obtain financing, insurance, goods or services at prices or on terms

that are as favorable as those obtained by us prior to the Spin-off.

Any of these factors could have a material adverse effect on our

business, financial condition, results of operations, cash flows, business prospects and the trading price of our common stock.

ability to meet our capital needs may be harmed by the lo ss of revenue from SRM.

Spin-off resulted in the Company’s equity interest in SRM being reduced to approximately 45% and the Company is no longer able

to consolidate the operations of SRM and the Company in its financial statements.

This will result in a significant reduction of the

Company’s revenues as approximately 98% of the Company’s revenues in the year ended December 31, 2022 were derived from the

SRM business.

The loss of revenue from SRM could harm our ability to meet our capital needs.

After the spin-off, we expect to obtain

any additional funds needed in excess of the amounts generated by our operating activities through the capital markets or bank financing,

and not from revenue derived by SRM.

Further, we cannot guarantee you that we will be able to obtain capital market financing or credit

on favorable terms, or at all, in the future.

We cannot assure you that our ability to meet our capital needs will not be harmed by the

loss of revenue from SRM.

with new and existing laws and governmental regulations could increase our costs significantly and adversely affect our results of operations.

processing, formulation, safety, manufacturing, packaging, labeling, advertising and distribution of our products are subject to federal

laws and regulation by one or more federal agencies, including the FDA, the FTC, the CPSC, the USDA, and the EPA.

These activities are

also regulated by various state, local and international laws and agencies of the states and localities in which our products are sold.

Government regulations may prevent or delay the introduction, or require the reformulation, of our products, which could result in lost

revenues and increased costs to us.

For instance, the FDA regulates, among other things, the composition, safety, manufacture, labeling

and marketing of dietary ingredients and dietary supplements (including vitamins, minerals, herbs, and other dietary ingredients for

Dietary supplements and dietary ingredients that do not comply with FDA’s regulations and/or the DSHEA will be deemed

adulterated or misbranded.

Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing

products that are adulterated or misbranded, and the FDA may take enforcement action against any adulterated or misbranded dietary supplement

on the market.

The FDA has broad enforcement powers.

If we violate applicable regulatory requirements, the FDA may bring enforcement

actions against us, which could have a material adverse effect on our business, prospects, financial condition, and results of operations.

The FDA may not accept the evidence of safety for any new dietary ingredient that we may wish to market, may determine that a particular

dietary supplement or ingredient presents an unacceptable health risk based on the required submission of serious adverse events or other

information, and may determine that a particular claim(such as reducing Blood Alcohol Content) or statement of nutritional value that

we use to support the marketing of a dietary supplement is an impermissible drug claim or is not substantiated.

Any of these actions

could prevent us from marketing particular dietary supplement products or making certain claims or statements with respect to those products.

The FDA could also require us to remove a particular product from the market.

Any future 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 product recalls or removals could also lead to an increased risk of litigation and liability, substantial costs, and reduced growth

or more stringent laws and regulations of dietary supplements and other products have been considered from time to time.

These developments

could require reformulation of some products to meet new standards, recalls or discontinuance of some products not able to be reformulated,

additional record-keeping requirements, increased documentation of the properties of some products, additional or different labeling,

additional scientific substantiation, or other new requirements.

Any of these developments could increase our costs significantly.

addition, regulators’ evolving interpretation of existing laws could have similar effects.

International

trade disputes, including U.S.

trade tariffs and retaliatory tariffs, could adversely impact our business.

International

trade disputes, including threatened or implemented tariffs by the United States and threatened or implemented tariffs by foreign countries

in retaliation, could adversely impact our business.

Many of our tenants sell imported goods and tariffs or other trade restrictions

could increase costs for these tenants.

To the extent our tenants are unable to pass these costs on to their customers, our tenants could

be adversely impacted.

In addition, international trade disputes, including those related to tariffs, could result in inflationary

pressures that directly impact our costs, such as costs for steel, lumber and other materials applicable to our redevelopment projects.

Trade disputes could also adversely impact global supply chains which could further increase costs for us and our tenants or delay delivery

of key inventories and supplies.

political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial

condition or results of operations.

political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change

federal administration, are difficult to predict and may have a material adverse effect on us.

Similarly, changes in U.S.

policy that affect the geopolitical landscape could give rise to circumstances outside our control that could have negative impacts on

our business operations.

For example, during the prior Trump administration, increased tariffs were implemented on goods imported

into the U.S., particularly from China, Canada, and Mexico.

On February 1, 2025, the U.S.

imposed a 25% tariff on imports from Canada

and Mexico, which were subsequently suspended for a period of one month, and a 10% additional tariff on imports from China.

Historically,

tariffs have led to increased trade and political tensions, between not only the U.S.

and China, but also between the U.S.

countries in the international community.

In response to tariffs, other countries have implemented retaliatory tariffs on U.S.

Political tensions as a result of trade policies could reduce trade volume, investment, technological exchange, and other economic activities

between major international economies, resulting in a material adverse effect on global economic conditions and the stability of global

financial markets.

Any changes in political, trade, regulatory, and economic conditions, including, but not limited to, U.S.

trade policies, could have a material adverse effect on our financial condition or results of operations.

changes or actions may alter the nature of an investment in us or restrict the use of cryptocurrencies in a manner that adversely affects

our business, prospects, or operations.

cryptocurrencies have grown in both popularity and market size, governments around the world have reacted differently to cryptocurrencies;

certain governments have deemed them illegal, and others have allowed their use and trade without restriction, while some jurisdictions,

such as the United States, subject the mining, ownership and exchange of cryptocurrencies to extensive, and in some cases overlapping,

unclear and evolving regulatory requirements.

January 2025, U.S.

President Donald Trump issued an executive order forming a presidential working group to establish a clear regulatory

framework for digital assets, and leaders in both houses of the U.S.

Congress have announced a bicameral working group with the objective

of passing legislation to provide regulatory clarity for the industry.

Committees in both houses of the U.S.

Congress have held hearings

to ensure fair access to financial services, including for companies operating in the digital asset space.

Additionally, President Trump and

members of the U.S.

Congress announced that they are studying the possibility of creating a national strategic digital asset reserve

to include Bitcoin, and at least twelve states have introduced legislation to create strategic Bitcoin reserves.

these ongoing regulatory developments appear to be positive, and we anticipate greater regulatory certainty in the future, given the

difficulty of predicting the outcomes of ongoing and future regulatory actions and legislative developments, it is possible that future

developments could have a material adverse effect on our business, prospects, or operations.

business, operations, financial position and timelines, could be materially adversely affected by the continuing military action in Ukraine

and the war between Israel and Hamas.

a result of the military action commenced in February 2022 by the Russian Federation and Belarus in Ukraine and the war between Israel

and Hamas commenced in October 2023, and related economic sanctions imposed or that may in the future be imposed by certain governments,

our financial position and operations may be materially and adversely affected.

As our ability to continue to operate will be dependent

on raising debt and equity finance, any adverse impact to those markets as a result of these conflicts, including due to increased market

volatility, decreased availability in third-party financing and/or a deterioration in the terms on which it is available (if at all),

could negatively impact our business, results of operations, cash flows, financial condition, and/or prospects.

The extent of any potential

impact is not yet determinable, however.

Related to our Financial Position and Capital Needs

accountant has indicated doubt about our ability to continue as a going concern.

of December 31, 2023 and 2022, the Company had $3,833,349 and $1,931,068 in cash, accumulated deficit of $65,480,715 and $50,597,674

and cash flow used in operations of $10,515,314 and $6,395,942, respectively.

The Company has incurred and expects to continue to incur

significant costs in pursuit of its expansion and development plans.

These conditions raise doubt about the Company’s ability to

continue as a going concern and accordingly our auditors have included a going concern opinion in our annual report.

connection with certain public and private offerings (the “Financing”), the Company offered warrants as part of the Financing

During the year ended December 31, 2023, the Warrant Holders exercised a total of 10,266,845 warrants for shares of common

stock for a total exercise price of $8,887,837.

At December 12, 2023, the Company has 15,758,126 warrants outstanding at an average exercise

price of $1.45.

The Company expects, although there can be no assurance, that a majority of the outstanding warrants will be exercised

in the near future.

addition to the unexercised warrants, the Company also holds 1,200,821 shares of Chijet Motor Company, Inc.

CJET) valued at

$0.45 per share (as of March 27, 2024).

These shares are considered trading shares and are held as marketable securities on the balance

The Company also holds 3,650,048 shares of SRM Entertainment, Inc.

SRM) valued at $1.41 per share (as of March 27, 2024)

and are held as investment in affiliate and are accounted for using the Equity Method.

These shares are not covered by an effective

registration statement but may be sold subject to Rule 144.

December 31, 2023, the Company had $3,833,349 in cash and the Company recognizes that it may need to raise additional capital in order

to continue to execute its business plan in the future.

There is no assurance that the Warrant Holders will exercise their warrants or

additional financing will be available if needed or that the Company will be able to obtain financing on terms acceptable to it or whether

the Company will become profitable and generate positive operating cash flow.

If the Company is unable to obtain revenue producing contracts

or financing or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may be forced

to substantially curtail its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements

that may dilute the interests of existing stockholders.

of December 31, 2024, and 2023, the Company had $348,816 and $3,833,349 in cash, accumulated deficit of

$115,090,347 and $65,480,715 and cash flow used in operations of $18,089,748 and

$10,715,314, respectively.

The Company has incurred and expects to continue to incur significant costs in pursuit of its expansion

and development plans.

These conditions raise doubt about the Company’s ability to continue as a going concern and accordingly

our auditors have included a going concern opinion in our annual report.

connection with certain public and private offerings (the “Financing”), the Company offered warrants as part of the

Financing packages.

During the year ended December 31, 2024, the Warrant Holders exercised a total of 2,996,127 warrants for shares

of common stock for a total exercise price of $3,962,714 and during the year ended December 31,

2023, the Warrant Holders exercised a total of 10,266,845 warrants for shares of common stock for a total exercise price of

At December 31, 2024, the Company has 18,803,334

warrants outstanding at an average exercise price of $2.09.

The Company expects,

although there can be no assurance, that a majority of the outstanding warrants will be exercised in the near future.

Company also holds 2,623,342 shares of SRM Entertainment, Inc.

SRM) valued at $0.63 per share (as of December 31, 2024) and

these shares are considered trading shares and are held as marketable securities on the balance sheet.

These shares are not covered by

an effective registration statement but may be sold subject to Rule 144.

December 31, 2024, the Company had $348,816 in cash and the Company recognizes that it may need to raise additional capital in order to continue

to execute its business plan in the future.

There is no assurance that the Warrant Holders will exercise their warrants or additional

financing will be available if needed or that the Company will be able to obtain financing on terms acceptable to it or whether the Company

will become profitable and generate positive operating cash flow.

If the Company is unable to obtain revenue producing contracts or financing

or if the revenue or financing it does obtain is insufficient to cover any operating losses it may incur, it may be forced to substantially

curtail its operations or seek other business opportunities through strategic alliances, acquisitions or other arrangements that may

dilute the interests of existing stockholders.

additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our

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investors will find our common stock less attractive if we rely on these exemptions.

If some investors find our common stock less attractive

If some investors find our common stockless attractive

as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

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our results of operations, financial condition or business.

a public company, we are subject to the reporting requirements of the Securities Exchange Act of 1934 (as amended, the “Exchange

Act”) and the requirements of the Sarbanes-Oxley Act.

These requirements may place a strain on our systems and resources.

Act requires that we file annual, quarterly and current reports with respect to our business and financial condition.

As a public company, we are subject to the reporting requirements of the

Securities Exchange Act of 1934 (as amended, the “Exchange Act”) and the requirements of the Sarbanes-Oxley Act.

These requirements

may place a strain on our systems and resources.

Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition.

The Sarbanes-Oxley

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to cover these costs of being a public company in the future, our failure to comply with reporting requirements and other provisions

of securities laws could negatively affect our stock price and adversely affect our potential results of operations, cash flow and financial

of securities laws could negatively affect our stock price and adversely affect our potential results of operations, cashflow and financial

condition after we commence operations.

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to effect certain corporate actions.

December 31, 2023, our officers and directors are the beneficial owners of approximately 20% our issued and outstanding voting securities.

March 25, 2025, our officers and directors are the beneficial owners of approximately 14.7% our issued and outstanding voting securities.

As a result, they possess significant influence over our elections and votes.

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the purchaser’s prior written agreement to the transaction;

the purchaser with risk disclosure documents which identify certain risks associated with investing in “penny stocks”

and which describe the market for these “penny stocks” as well as a purchaser’s legal remedies;

a signed and dated acknowledgment from the purchaser demonstrating that the purchaser has actually received the required risk disclosure

document before a transaction in a “penny stock” can be completed.

the purchaser with risk disclosure documents which identify certain risks associated with

investing in “penny stocks” and which describe the market for these “penny

stocks” as well as a purchaser’s legal remedies;

a signed and dated acknowledgment from the purchaser demonstrating that the purchaser has

actually received the required risk disclosure document before a transaction in a “penny

stock” can be completed.

our common stock is not currently subject to these rules, it were to become subject to such rules, broker-dealers may find it difficult

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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