Item 1A. Risk Factors
ITEM
1A. RISK FACTORS
Risks
Related to Our Business
If
we are unable to keep up with rapid technological changes, our products may become obsolete.
The
market for our products is characterized by significant and rapid change. Although we will continue to expand our product line capabilities
to remain competitive, research and discoveries by others may make our processes, products, or brands less attractive or even obsolete.
Competition
could adversely affect our business.
Our
industry in general is competitive. It is possible that future competitors could enter our market, thereby causing us to lose market
share and revenues. In addition, some of our current or future competitors may have significantly greater financial, technical, marketing,
and other resources than we do or may have more experience or advantages in the markets in which we will compete that will allow them
to offer lower prices or higher quality products. If we do not successfully compete with these competitors, we could fail to develop
market share and our future business prospects could be adversely affected.
If
we are unable to develop and maintain our brand and reputation for our product offerings, our business and prospects could be materially
harmed.
Our
business and prospects depend, in part, on developing and then maintaining and strengthening our brand and reputation in the markets
we serve. If problems with our products cause our customers to have a negative experience or failure or delay in the delivery of our
products to our customers, our brand and reputation could be diminished. If we fail to develop, promote and maintain our brand and reputation
successfully, our business and prospects could be materially harmed.
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We
are subject to government regulation, and unfavorable changes could substantially harm our business and results of operations.
We
are subject to general business regulations and laws as well as regulations and laws specifically governing our industries in the U.S.
and other countries in which we operate. Uncertainty surrounding existing and future laws and regulations may impede our services and
increase the cost of providing such services. These regulations and laws may cover taxation, tariffs, user pricing, distribution, consumer
protection and the characteristics and quality of services.
We
depend heavily on key personnel, and turnover of key senior management could harm our business.
Our
future business and results of operations depend in significant part upon the continued contributions of our senior management personnel.
If we lose their services or if they fail to perform in their current positions, or if we are not able to attract and retain skilled
personnel as needed, our business could suffer. Significant turnover in our senior management could significantly deplete our institutional
knowledge held by our existing senior management team. We depend on the skills and abilities of these key personnel in managing the product
acquisition, marketing and sales aspects of our business, any part of which could be harmed by turnover in the future. We may not have
written employment agreements with all of our senior management. We do not have any key person insurance.
Our
products may not meet health and safety standards or could become contaminated.
We
do not have control over all of the third parties involved in the manufacturing of our products and their compliance with government
health and safety standards. Even if our products meet these standards, they could otherwise become contaminated. A failure to meet these
standards or contamination could occur in our operations or those of our manufacturers, distributors or suppliers. This could result
in expensive production interruptions, recalls and liability claims. Moreover, negative publicity could be generated from false, unfounded
or nominal liability claims or limited recalls. Any of these failures or occurrences could negatively affect our business and financial
performance.
The
sale of our products involves product liability and related risks that could expose us to significant insurance and loss expenses.
We
face an inherent risk of exposure to product liability claims if the use of our products results in, or is believed to have resulted
in, illness or injury. Our products contain combinations of ingredients, and there is little long-term experience with the effect of
these combinations. In addition, interactions of these products with other products, prescription medicines and over-the-counter treatments
have not been fully explored or understood and may have unintended consequences.
Any
product liability claim may increase our costs and adversely affect our revenue and operating income. Moreover, liability claims arising
from a serious adverse event may increase our costs through higher insurance premiums and deductibles and may make it more difficult
to secure adequate insurance coverage in the future. In addition, our product liability insurance may fail to cover future product liability
claims, which, if adversely determined, could subject us to substantial monetary damages.
The
success of our business will depend upon our ability to create and expand our brand awareness.
The
markets we compete in, including the wellness drink market, sexual wellness and hair growth markets we intend to compete in, are highly
competitive, with many well-known brands leading the industry. Our ability to compete effectively and generate revenue will be based
upon our ability to create and expand awareness of our products distinct from those of our competitors. It is imperative that we are
able to convey to consumers the benefits of our products. However, advertising and packaging and labeling of such products will be limited
by various regulations. Our success will be dependent upon our ability to convey to consumers that our products are superior to those
of our competitors.
We
must develop and introduce new products to succeed.
Our
industry is subject to rapid change. New products are constantly introduced to the market. Our ability to remain competitive depends
in part on our ability to enhance existing products, to develop and manufacture new products in a timely and cost-effective manner, to
accurately predict market transitions, and to effectively market our products. Our future financial results will depend to a great extent
on the successful introduction of several new products. We cannot be certain that we will be successful in selecting, developing, manufacturing
and marketing new products or in enhancing existing products.
● The
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; and
●
Customer acceptance of new products.
Adverse
publicity associated with our products or ingredients, or those of similar companies, could adversely affect our sales and revenue.
Adverse
publicity concerning any actual or purported failure by us to comply with applicable laws and regulations regarding any aspect of our
business could have an adverse effect on the public perception of us. This, in turn, could negatively affect our ability to obtain financing,
endorsers and attract distributors or retailers for our products, which would have a material adverse effect on our ability to generate
sales and revenue.
Our
distributors’ and customers’ perception of the safety and quality of our products or even similar products distributed by
others can be significantly influenced by national media attention, publicized scientific research or findings, product liability claims
and other publicity concerning our products or similar products distributed by others. Adverse publicity, whether or not accurate, that
associates consumption of our products or any similar products with illness or other adverse effects, will likely diminish the public’s
perception of our products. Claims that any products are ineffective, inappropriately labeled or have inaccurate instructions as to their
use, could have a material adverse effect on the market demand for our products, including reducing our sales and revenue.
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If
serious adverse or undesirable side effects are identified during the development of our product candidates, we may abandon or limit
our development or commercialization of such product candidates.
If
our product candidates are associated with undesirable side effects or have unexpected characteristics, we may need to abandon their
development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are
less prevalent, less severe or more acceptable from a risk-benefit perspective.
If
we elect or are forced to suspend or terminate any clinical trial with one of our product candidates, the commercial prospects of such
product candidate will be harmed, and our ability to generate revenue from such product candidate will be delayed or eliminated. Any
of these occurrences may harm our business, financial condition and prospects significantly.
If
we experience delays or difficulties in the enrollment of subjects to our clinical trials, our ability to complete such trials will be
adversely affected
Identifying,
screening and enrolling patients to participate in clinical trials of our product candidates is critical to our success, and we may not
be able to identify, recruit, enroll and dose a sufficient number of patients with the required or desired characteristics to complete
our clinical trials in a timely manner. The timing of our clinical trials depends on our ability to recruit patients to participate as
well as to subsequently dose these patients and complete required follow-up periods. In particular, because our planned clinical trials
may be focused on indications with relatively small patient populations, our ability to enroll eligible patients may be limited or may
result in slower enrollment than we anticipate.
In
addition, we may experience enrollment delays related to increased or unforeseen legal and logistical requirements at certain clinical
trial sites. 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.
Participant
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;
● size
of the participant population and process for identifying participants;
● design
of the clinical trial protocol;
● eligibility
and exclusion criteria;
● perceived
risks and benefits of the product candidates under study;
● time
of year in which the trials are initiated or conducted;
● ability
to obtain and maintain subject consents;
● ability
to enroll participants in a timely manner;
● risk
that enrolled subjects will drop out before completion of the trials;
● proximity
and availability of clinical trial sites for prospective participants;
● ability
to monitor subjects adequately during and after treatment.
It
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.
Clinical
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 product, or improper volunteer behavior. Claims may arise from patients, clinical trial volunteers, consumers, physicians, hospitals,
companies, institutions, researchers, or others using, selling, or buying our products, as well as from governmental bodies. In addition,
product liability and related risks are likely to increase over time, in particular upon the commercialization or marketing of any products
by us or parties with which we enter into development, marketing, or distribution collaborations. Although we are contracting for general
liability insurance in connection with our ongoing business, there can be no assurance that the amount and scope of such insurance coverage
will be appropriate and sufficient in the event any claims arise, that we will be able to secure additional coverage should we attempt
to do so, or that our insurers would not contest or refuse any attempt by us to collect on such insurance policies. Furthermore, there
can be no assurance that suitable product liability insurance (at the clinical stage and/or commercial stage) will continue to be available
on terms acceptable to us or at all, or that, if obtained, the insurance coverage will be appropriate and sufficient to cover any potential
claims or liabilities.
If
we are unable to establish relationships with licensees or collaborators to carry out sales, marketing, and distribution functions or
to create effective marketing, sales, and distribution capabilities, we will be unable to market our products successfully.
Our
business strategy may include out-licensing product candidates to or collaborating with larger firms with experience in marketing and
selling pharmaceutical products. There can be no assurance that we will successfully be able to establish marketing, sales, or distribution
relationships with any third-party, that such relationships, if established, will be successful, or that we will be successful in gaining
market acceptance for any products we might develop. To the extent that we enter into any marketing, sales, or distribution arrangements
with third parties, our product revenues per unit sold are expected to be lower than if we marketed, sold, and distributed our products
directly, and any revenues we receive will depend upon the efforts of such third parties.
If
we are unable to establish such third-party marketing and sales relationships, or choose not to do so, we would have to establish in-house
marketing and sales capabilities. To market any products directly, we would have to establish a marketing, sales, and distribution force
that has technical expertise and could support a distribution capability. 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
our costs.
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.
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Natural
disasters and other events beyond our control could materially adversely affect us.
Natural
disasters or other catastrophic events may cause damage or disruption to our operations, international commerce and the global economy,
and thus could have a strong negative effect on us. Our business operations are subject to interruption by natural disasters, fire, power
shortages, pandemics and other events beyond our control. Such events could make it difficult or impossible for us to deliver our services
to our customers and could decrease demand for our services.
We
have a limited operating history upon which investors can evaluate our future prospects.
We
have a limited operating history upon which an evaluation of its business plan or performance and prospects can be made. The business
and prospects of the Company must be considered in the light of the potential problems, delays, uncertainties and complications encountered
in connection with a newly established business and new industry. The risks include, but are not limited to, the possibility that we
will not be able to develop functional and scalable products and services, or that although functional and scalable, our products and
services will not be economical to market; that our competitors hold proprietary rights that preclude us from marketing such products;
that our competitors market a superior or equivalent product; that we are not able to upgrade and enhance our technologies and products
to accommodate new features and expanded service offerings; or the failure to receive necessary regulatory clearances for our products.
To successfully introduce and market our products at a profit, we must establish brand name recognition and competitive advantages for
our products. There are no assurances that we can successfully address these challenges. If it is unsuccessful, we and our business,
financial condition and operating results could be materially and adversely affected.
The
current and future expense levels are based largely on estimates of planned operations and future revenues rather than experience. It
is difficult to accurately forecast future revenues because our business is new and our market has not been developed. If our forecasts
prove incorrect, the business, operating results and financial condition of the Company may be materially and adversely affected. Moreover,
we may be unable to adjust our spending in a timely manner to compensate for any unanticipated reduction in revenues. As a result, any
significant reduction in revenues may immediately and adversely affect our business, financial condition and operating results.
Our
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.
The
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.
The
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.
Individual
U.S. 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. For example,
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;
● the
recall or discontinuance of products;
● additional
record-keeping requirements;
● expanded
documentation of the properties of certain or all products;
● expanded
or different labeling or advertising for products;
● expanded
adverse event tracking and reporting requirements; and
● additional
scientific substantiation to support product claims.
We
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.
We
are subject to government regulations of the processing, formulation, packaging, labeling and advertising of our wellness and dietary
supplement products.
Under
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. These
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.
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We
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. If the FDA,
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.
The
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.
While
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. Additional
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.
Our
failure to comply with applicable laws or regulations could result in substantial monetary penalties and could adversely affect our operating
results.
In
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
claims. 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.
Even
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.
In
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.
Congress
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.
From
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. Those
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.
For
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. Such a
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.
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Our
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.
We
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.
We
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.
While
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. Further,
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.
In
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.
Further,
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. Because we
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.
We
may not meet our product development and commercialization milestones.
We
have established milestones, based upon our expectations regarding our technologies at that time, which we use to assess our progress
toward developing our products. These milestones relate to technology and design improvements as well as dates for achieving development
goals. If our products exhibit technical defects or are unable to meet cost or performance goals, our commercialization schedule could
be delayed, and potential purchasers of our initial commercial products may decline to purchase such products or may opt to pursue alternative
products.
We
may also experience shortages of equipment due to manufacturing difficulties. Multiple suppliers provide the components used in manufacturing
our products. Our manufacturing operations could be disrupted by fire, earthquake or other natural disaster, a labor-related disruption,
failure in supply or other logistical channels, electrical outages or other reasons. If there were a disruption to manufacturing facilities,
we would be unable to manufacture until we have restored and re-qualified our manufacturing capability or developed alternative manufacturing
facilities.
Our
operations in international markets involve inherent risks that we may not be able to control.
Our
business plan includes the marketing and sale of our proposed products in international markets. Accordingly, our results could be materially
and adversely affected by a variety of uncontrollable and changing factors relating to international business operations, including:
● Macroeconomic
conditions adversely affecting geographies where we intend to do business;
● Foreign
currency exchange rates;
● Political
or social unrest or economic instability in a specific country or region;
● Higher
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;
● Difficulties
associated with enforcing agreements and intellectual property rights through foreign legal
systems;
● Trade
protection measures and other regulatory requirements, which affect our ability to import
or export our products from or to various countries;
● Adverse
tax consequences;
● Unexpected
changes in legal and regulatory requirements;
● Military
conflict, terrorist activities, natural disasters and medical epidemics; and
● Our
ability to recruit and retain channel partners in foreign jurisdictions.
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Compliance
with new and existing laws and governmental regulations could increase our costs significantly and adversely affect our results of operations.
The
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
human use). 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
prospects.
Additional
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. In
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.
Significant
political, trade, regulatory developments, and other circumstances beyond our control, could have a material adverse effect on our financial
condition or results of operations.
Significant
political, trade, or regulatory developments in the jurisdictions in which we sell our products, such as those stemming from the change
in U.S. federal administration, are difficult to predict and may have a material adverse effect on us. Similarly, changes in U.S. federal
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. and other
countries in the international community. In response to tariffs, other countries have implemented retaliatory tariffs on U.S. goods.
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. and China
trade policies, could have a material adverse effect on our financial condition or results of operations.
Regulatory
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.
As
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.
In
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.
While
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.
Our
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.
As
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.
Risks
Related to our Financial Position and Capital Needs
Our
accountant has indicated doubt about our ability to continue as a going concern.
As
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.
In
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
$8,887,837. 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.
The
Company also holds 2,623,342 shares of SRM Entertainment, Inc. (Nasdaq: 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.
At
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.
Raising
additional capital may cause dilution to our existing stockholders, restrict our operations or require us to relinquish rights to our
technologies or other assets.
We
may seek additional capital through a combination of private and public equity offerings, debt financings, strategic partnerships and
alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities,
existing ownership interests will be diluted and the terms of such financings may include liquidation or other preferences that adversely
affect the rights of existing stockholders. Debt financings may be coupled with an equity component, such as warrants to purchase shares,
which could also result in dilution of our existing stockholders’ ownership. The incurrence of indebtedness would result in increased
fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur additional
debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could adversely
impact our ability to conduct our business and may result in liens being placed on our assets and intellectual property. If we were to
default on such indebtedness, we could lose such assets and intellectual property.
Our
potential for rapid growth and our entry into new markets make it difficult for us to evaluate our current and future business prospects,
and we may be unable to effectively manage any growth associated with these new markets, which may increase the risk of your investment
and could harm our business, financial condition, results of operations and cash flow .
Our
proliferation into new markets may place a significant strain on our resources and increase demands on our executive management, personnel
and systems, and our operational, administrative and financial resources may be inadequate. We may also not be able to effectively manage
any expanded operations or achieve planned growth on a timely or profitable basis, particularly if the number of customers using our
technology significantly increases or their demands and needs change as our business expands. If we are unable to manage expanded operations
effectively, we may experience operating inefficiencies, the quality of our products and services could deteriorate, and our business
and results of operations could be materially adversely affected.
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Changes
in tax laws and unanticipated tax liabilities could adversely affect our effective income tax rate and ability to achieve profitability.
Our
effective income tax rate in the future could be adversely affected by a number of factors including changes in the mix of earnings in
countries with differing statutory tax rates, changes in the valuation of deferred tax assets and liabilities and changes in tax laws.
We regularly assess all of these matters to determine the adequacy of our tax provision which is subject to discretion. If our assessments
are incorrect, it could have an adverse effect on our business and financial condition. There can be no assurance that income tax laws
and administrative policies with respect to the income tax consequences generally applicable to us or to our subsidiaries will not be
changed in a manner which adversely affects our shareholders.
Risks
Related to our Intellectual Property
We
may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights.
A
third party may sue us or one of our strategic collaborators for infringing its intellectual property rights. Likewise, we may need to
resort to litigation to enforce licensed rights or to determine the scope and validity of third-party intellectual property rights.
The
cost to us of any litigation or other proceeding relating to intellectual property rights, even if resolved in our favor, could be substantial,
and the litigation would divert our efforts. Some of our competitors may be able to sustain the costs of complex patent litigation more
effectively than we can because they have substantially greater resources. If we do not prevail in this type of litigation, we or our
strategic collaborators may be required to pay monetary damages; stop commercial activities relating to the affected products or services;
obtain a license in order to continue manufacturing or marketing the affected products or services; or attempt to compete in the market
with a substantially similar product.
Uncertainties
resulting from the initiation and continuation of any litigation could limit our ability to continue some of our operations. In addition,
a court may require that we pay expenses or damages, and litigation could disrupt our commercial activities.
Any
inability to protect our intellectual property rights could reduce the value of our products and brands, which could adversely affect
our financial condition, results of operations and business.
Our
business is partly dependent upon our trademarks, trade secrets, copyrights and other intellectual property rights. Effective intellectual
property rights protection, however, may not be available under the laws of every country in which we and our sub-licensees may operate.
There is a risk of certain valuable trade secrets, beyond what is described publicly in patents, being exposed to potential infringers.
Regardless of our technology being protected by patents or otherwise, there is a risk that other companies may employ the technology
without authorization and without recompensing us.
The
efforts we have taken to protect our proprietary rights may not be sufficient or effective. Any significant impairment of our intellectual
property rights could harm our business or our ability to compete. In addition, protecting our intellectual property rights is costly
and time consuming. There is a risk that we may have insufficient resources to counter adequately such infringements through negotiation
or the use of legal remedies. It may not be practicable or cost effective for us to fully protect our intellectual property rights in
some countries or jurisdictions. If we are unable to successfully identify and stop unauthorized use of our intellectual property, we
could lose potential revenue and experience increased operational and enforcement costs, which could adversely affect our financial condition,
results of operations and business.
The
intellectual property behind our products may include unpublished know-how as well as existing and pending intellectual property protection.
All intellectual property protection eventually expires, and unpublished know-how is dependent on key individuals .
The
commercialization of our licensed products is partially dependent upon know-how and trade secrets held by certain individuals working
with and for us. Because the expertise runs deep in these few individuals, if something were to happen to any or all of them, the ability
to properly manufacture our products without compromising quality and performance could be diminished greatly.
Knowledge
published in the form of any future intellectual property has finite protection, as all patents and trademarks have a limited life and
an expiration date. While continuous efforts will be made to apply for patents and trademarks if appropriate, there is no guarantee that
additional patents or trademarks will be granted. The expiration of patents and trademarks relating to our products may hinder our ability
to sub-license or sell our products for a long period of time without the development of a more complex licensing strategy.
If
we are not able to adequately protect our intellectual property, then we may not be able to compete effectively, and we may not be profitable.
Our
existing proprietary rights may not afford remedies and protections necessary to prevent infringement, reformulation, theft, misappropriation
and other improper use of our products by competitors. We own the formulations contained in our products and we consider these product
formulations to be our critical proprietary property, which must be protected from competitors. Although trade secret, trademark, copyright
and patent laws generally provide a certain level of protection, and we attempt to protect ourselves through contracts with manufacturers
of our products, we may not be successful in enforcing our rights. In addition, enforcement of our proprietary rights may require lengthy
and expensive litigation. We have attempted to protect some of the trade names and trademarks used for our products by registering them
with the U.S. Patent and Trademark Office, but we must rely on common law trademark rights to protect our unregistered trademarks. Common
law trademark rights do not provide the same remedies as are granted to federally registered trademarks, and the rights of a common law
trademark are limited to the geographic area in which the trademark is actually used. Our inability to protect our intellectual property
could have a material adverse impact on our ability to compete and could make it difficult for us to achieve a profit.
Risks
Related to Our Securities and Other Risks
We
are an “emerging growth company” and we cannot be certain if the reduced disclosure requirements applicable to emerging growth
companies will make our common stock less attractive to investors.
We
are an “emerging growth company” as defined in the JOBS Act, and we intend to take advantage of certain exemptions from various
reporting requirements that are applicable to other public companies that are not “emerging growth companies” including,
but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and
reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict whether
investors will find our common stock less attractive if we rely on these exemptions. 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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The
requirements of being a public company may strain our resources and distract our management, which could make it difficult to manage
our business, particularly after we are no longer an “emerging growth company.”
We
are required to comply with various regulatory and reporting requirements, including those required by the SEC. Complying with these
reporting and other regulatory requirements is time-consuming and results in increased costs to us and could have a negative effect on
our results of operations, financial condition or business. 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.
The
Exchange Act requires that we file annual, quarterly and current reports with respect to our business and financial condition. The Sarbanes-Oxley
Act requires that we maintain effective disclosure controls and procedures and internal controls over financial reporting. To maintain
and improve the effectiveness of our disclosure controls and procedures, we will need to commit significant resources, hire additional
staff and provide additional management oversight. We will be implementing additional procedures and processes for the purpose of addressing
the standards and requirements applicable to public companies. Sustaining our growth also will require us to commit additional management,
operational and financial resources to identify new professionals to join our firm and to maintain appropriate operational and financial
systems to adequately support expansion. These activities may divert management’s attention from other business concerns, which
could have a material adverse effect on our results of operations, financial condition or business.
As
an “emerging growth company” as defined in the JOBS Act, we intend to take advantage of certain temporary exemptions from
various reporting requirements including, but not limited to, not being required to comply with the auditor attestation requirements
of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports
and proxy statements. We may also delay adoption of new or revised accounting pronouncements applicable to public companies until such
pronouncements are made applicable to private companies, as permitted by the JOBS Act.
We
have broad discretion in the use of the net proceeds from any offerings and may not use them effectively.
Our
management will have broad discretion in the application of the net proceeds from any offerings and may spend or invest these proceeds
in a way with which our stockholders disagree. The failure by our management to apply these funds effectively could harm our business
and financial condition. Pending their use, we may invest the net proceeds from any offering in a manner that does not produce income
or that loses value.
Our
management has limited experience in managing the day-to-day operations of a public company and, as a result, we may incur additional
expenses associated with the management of our Company.
We
only became a public company in October 2020. The management team is responsible for the operations and reporting of the Company. The
requirements of operating as a public company are many and sometimes difficult to navigate. This may require us to obtain outside assistance
from legal, accounting, investor relations, or other professionals that could be more costly than planned. If we lack cash resources
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, cashflow and financial
condition after we commence operations.
Compliance
with changing corporate governance regulations and public disclosures may result in additional risks and exposures.
Changing
laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002 and
new regulations from the SEC, have created uncertainty for public companies such as ours. These laws, regulations, and standards are
subject to varying interpretations in many cases, and as a result, their application in practice may evolve over time as new guidance
is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs
necessitated by ongoing revisions to disclosure and governance practices. As a result, our efforts to comply with evolving laws, regulations,
and standards have resulted in, and are likely to continue to result in, increased expense and significant management time and attention.
Certain
of our stockholders hold a significant percentage of our outstanding voting securities, which could reduce the ability of minority stockholders
to effect certain corporate actions.
At
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. As a result, their ownership and control may have the effect
of facilitating and expediting a future change in control, merger, consolidation, takeover or other business combination, or encouraging
a potential acquirer to make a tender offer. Their ownership and control may also have the effect of delaying, impeding, or preventing
a future change in control, merger, consolidation, takeover or other business combination, or discouraging a potential acquirer from
making a tender offer.
If
securities or industry analysts publish inaccurate or unfavorable research about our business, our stock price could decline.
The
trading market for our common stock will depend in part on the research and reports that securities or industry analysts publish about
us or our business. Once our common stock is quoted, if one or more of the analysts who cover us downgrade our common stock or publish
inaccurate or unfavorable research about our business, our common stock price would likely decline.
We
do not intend to pay dividends for the foreseeable future.
We
currently intend to retain any future earnings to finance the operation and expansion of our business, and we do not expect to declare
or pay any dividends on our common stock in the foreseeable future.
Our
Second Amended and Restated Certificate of Incorporation contains an exclusive forum provision for certain claims, which could limit
our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees .
Our
Second Amended and Restated Certificate of Incorporation provides that, unless we consent in writing to the selection of an alternative
forum, New York shall be the sole and exclusive forum for (a) any derivative action or proceeding brought on behalf of the Company, (b)
any action asserting a claim for breach of a fiduciary duty owed by any director, officer, employee, or agent of the Company to the Company
or the Company’s shareholders or (c) any action asserting a claim governed by the internal affairs doctrine, in each case subject
to said court having personal jurisdiction over the indispensable parties named as defendants therein. This provision may limit a shareholder’s
ability to bring a claim in a judicial forum that it finds favorable for disputes with the company and its directors, officers, or other
employees and may discourage lawsuits with respect to such claims. This provision does not apply to actions arising under the Exchange
Act or Securities Act.
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Our
issuance of additional common stock or preferred stock may cause our common stock price to decline, which may negatively impact your
investment.
Issuances
of a substantial number of additional shares of our common or preferred stock, or the perception that such issuances could occur, may
cause prevailing market prices for our common stock to decline. In addition, our board of directors is authorized to issue additional
series of shares of preferred stock without any action on the part of our stockholders. Our board of directors also has the power, without
stockholder approval, to set the terms of any such series of shares of preferred stock that may be issued, including voting rights, conversion
rights, dividend rights, preferences over our common stock with respect to dividends or if we liquidate, dissolve or wind up our business
and other terms. If we issue cumulative preferred stock in the future that has preference over our common stock with respect to the payment
of dividends or upon our liquidation, dissolution or winding up, or if we issue preferred stock with voting rights that dilute the voting
power of our common stock, the market price of our common stock could decrease.
Anti-takeover
provisions in the Company’s charter and bylaws may prevent or frustrate attempts by stockholders to change the board of directors
or current management and could make a third-party acquisition of the Company difficult.
The
Company’s certificate of incorporation and bylaws contain provisions that may discourage, delay or prevent a merger, acquisition
or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive
a premium for their shares. Furthermore, the Board of Directors has the ability to increase the size of the Board and fill newly created
vacancies without stockholder approval. These provisions could limit the price that investors might be willing to pay in the future for
shares of the Company’s common stock.
Our
common stock may become subject to the SEC’s penny stock rules and accordingly, broker-dealers may experience difficulty in completing
customer transactions and trading activity in our securities may be adversely affected.
The
SEC has adopted regulations, which generally define “penny stock” to be an equity security that has a market price of less
than $5.00 per share, subject to specific exemptions. The market price of our common stock is less than $5.00 per share and therefore
would be a “penny stock” according to SEC rules, unless we are listed on a national securities exchange. Under these rules,
broker-dealers who recommend such securities to persons other than institutional accredited investors must:
● Make
a special written suitability determination for the purchaser;
● Receive
the purchaser’s prior written agreement to the transaction;
● Provide
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; and
● Obtain
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.
Although
our common stock is not currently subject to these rules, it were to become subject to such rules, broker-dealers may find it difficult
to effectuate customer transactions and trading activity in our securities may be adversely affected. As a result, the market price of
our securities may be depressed, and you may find it more difficult to sell your securities.