What changed in this filing

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Item 1A. Risk Factors

2021-03-29 compared with 2020-03-17 · 690 added, 793 removed, 62 unchanged (96% of the section changed)

As discussed immediately prior to Item 1 of Part

I, “Business”

under “Cautionary Note Regarding Forward-Looking Statements,”

our actual results could differ

materially from those expressed in our forward-looking statements.

Factors that might cause or contribute to such differences include,

but are not limited to, those discussed below.

Additional risks and uncertainties not presently known to us, or that we currently

deem immaterial, may also impair our business operations.

If any of the following risks occur, our business, financial condition,

operating results, cash flows and the trading price of our common stock could be materially adversely affected.

Risks Relating to our Business

Our success is dependent on the successful

commercialization of ContraPest.

The EPA granted registration approval for ContraPest effective

August 2, 2016, and as of July 12, 2018, we have received registration for ContraPest in all 50 states and the District of Columbia.

However, we have not yet had meaningful sales of ContraPest, which is our only product to date that is available for commercialization

and the generation of revenue.

ContraPest and our other product candidates, if approved,

may not achieve adequate market acceptance necessary for commercial success.

Even following receipt of regulatory approval for ContraPest

or future regulatory approval of our other product candidates, such products may not gain market acceptance.

Market acceptance

of any of our product candidates for which we receive approval depends on a number of factors, including:

The potential and perceived advantages of product candidates

over alternative or complementary products;

The effectiveness of our sales and marketing efforts and those

of our collaborators;

The efficacy and safety of such product candidates as demonstrated

The uses, indications or limitations for which the product candidate

Product labeling or product insert requirements of the EPA or

other regulatory authorities;

The timing of market introduction of our products as well as

future competitive or alternative products;

Relative convenience and ease of use;

Unfavorable publicity relating to the product.

If we cannot successfully commercialize our products,

especially ContraPest, we will not become profitable.

If any of our approved product candidates fail to achieve sufficient

market acceptance, we will not be able to generate significant revenues or become profitable.

The commercial success of ContraPest

will depend on a number of factors, including the following:

The development of a viable commercial strategy and the successful

establishment of a commercial organization;

Our success in educating end users about the benefits, administration

and use of ContraPest;

The effectiveness of our own or our potential strategic partners’

discussed immediately prior to Item 1 of Part I, “Business”

under “Cautionary Note Regarding Forward-Looking

Statements,”

our actual results could differ materially from those expressed in our forward-looking statements.

that might cause or contribute to such differences include, but are not limited to, those discussed below.

Additional risks and

uncertainties not presently known to us, or that we currently deem immaterial, may also impair our business operations.

of the following risks occur, our business, financial condition, operating results, cash flows and the trading price of our common

stock could be materially adversely affected.

Relating to our Business

impacts of the coronavirus pandemic could adversely affect our business, and other similar crises could result in similar or other

outbreak of the novel coronavirus (COVID-19) pandemic has resulted in widespread travel and transportation restrictions and closures

of commercial spaces, industrial facilities and other spaces and businesses in and across the United States and the world, including

in the locations we operate or target sales.

As a result, our business has been impacted and we could face continued or more adverse

In addition, our results and financial condition may be adversely affected by federal or state legislation, or other

similar laws, regulations, orders or other governmental or regulatory actions or best practices, that would impose new restrictions

on our ability to operate our business or customers to operate their businesses.

For example, our sales and technical field forces

have been restricted from traveling or limited in travel, which adversely affects our ability to sell our products and complete

field studies.

While we have implemented cautionary procedures at our manufacturing facility, there may be disruptions to our

ability to manufacture due to current and additional workplace controls.

Our customers may be less inclined or unable to purchase

our products or continue product studies due to restrictions under which they may be operating.

Those restrictions have been and

are more severe in some jurisdictions, such as California.

If financial markets tighten, we may have more limited ability to raise

necessary financing.

The COVID-19 pandemic is also placing a significant budgetary burden on federal, state and local governments,

which may impede or delay their ability to purchase our products.

We source some of our critical raw materials from Asia, and

the coronavirus has caused supply chain disruptions, which could limit a timely supply of materials.

Each of these could have

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

Even if the coronavirus pandemic

passes, another crisis with similar effects could develop and harm our business, financial results and liquidity.

The degree to

which the COVID-19 pandemic may impact our results of operations and financial condition is unknown at this time and will depend

on future developments, including the ultimate severity and the duration of the pandemic, and further actions that may be taken

by governmental authorities or businesses or individuals on their own initiatives in response to the pandemic.

success is dependent on the successful commercialization of ContraPest.

EPA granted registration approval for ContraPest effective August 2, 2016, and as of July 12, 2018, we have received registration

for ContraPest in all 50 states and the District of Columbia.

However, we have not yet had significant sales of ContraPest, which

is our only product to date that is available for commercialization and the generation of revenue.

and our other product candidates, if approved, may not achieve adequate market acceptance necessary for commercial success.

following receipt of regulatory approval for ContraPest or future regulatory approval of our other product candidates, such products

may not gain market acceptance.

Market acceptance of any of our product candidates for which we receive approval depends on a

number of factors, including:

potential and perceived advantages of product candidates over alternative or complementary products;

effectiveness of our sales and marketing efforts and those of our collaborators;

efficacy and safety of such product candidates as demonstrated in trials;

uses, indications or limitations for which the product candidate is approved;

labeling or product insert requirements of the EPA or other regulatory authorities;

timing of market introduction of our products as well as future competitive or alternative products;

convenience and ease of use;

publicity relating to the product.

we cannot successfully commercialize our products, especially ContraPest, we will not become profitable.

any of our approved product candidates fail to achieve sufficient market acceptance, we will not be able to generate significant

revenues or become profitable.

The commercial success of ContraPest will depend on a number of factors, including the following:

execution of a viable commercial strategy and the successful establishment of a commercial organization;

success in educating end users about the benefits, administration and use of ContraPest;

effectiveness of our own or our potential strategic partners’

marketing, sales and distribution strategy and operations;

Establishment of commercially viable pricing;

Our ability to manufacture quantities of ContraPest using commercially

acceptable processes and at a scale sufficient to meet anticipated demand and enable us to reduce our cost of manufacturing;

A continued acceptable safety profile of ContraPest.

Many of these factors are beyond our control.

If we are unable

to successfully commercialize ContraPest, we may not be able to earn sufficient revenues or profits to continue our business.

We will require additional capital to fund

our operations.

Failure to obtain this necessary capital if needed may force us to delay, limit, or terminate our product development

efforts or other operations.

Commercialization of ContraPest and developing further product

candidates, including conducting experiments and field studies, obtaining and maintaining regulatory approval and commercializing

any products approved for sale, is a time-consuming, expensive and uncertain process that takes years to complete.

We expect our

expenses to continue and to increase in connection with our ongoing activities, particularly as we advance our commercialization

We may expand our operations, and as a result of many factors, some of which may be currently unknown to us, our expenses

may be higher than expected.

Securing additional financing may divert our management from their day-to-day activities, which may

adversely affect our ability to develop and commercialize our product candidates, including ContraPest.

In addition, we cannot

guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all.

If we are unable

to raise additional capital when required or on acceptable terms, we may be required to:

Significantly delay, scale back or discontinue the development

or commercialization of our product candidates, including ContraPest;

Seek strategic partners for the manufacturing, sales and distribution

of ContraPest or any of our other product candidates at an earlier stage than otherwise would be desirable or on terms that

are less favorable than might otherwise be available;

Relinquish, or license on unfavorable terms, our rights to technologies

or product candidates that we otherwise would seek to develop or commercialize ourselves.

The occurrence of any of the events described above would have

a material adverse effect on our business, operating results and prospects and on our ability to develop our product candidates.

ContraPest is the first product we have marketed, and

if we are unable to establish and maintain an effective sales force and marketing and distribution infrastructures, or enter into

and rely upon acceptable third party relationships, we may be unable to generate any revenue.

We are continuing to develop a functional infrastructure

for the sales, marketing, and distribution of our products and the cost of establishing and maintaining such an infrastructure

may exceed the cost-effectiveness of doing so.

In order to market ContraPest and any other products that may be approved by the

EPA and comparable foreign regulatory authorities, we must continue to build our sales, marketing, managerial and other non-technical

capabilities or make arrangements with third parties to perform these services for which we would incur substantial costs.

are unable to establish and maintain adequate sales, marketing, and distribution capabilities, whether independently or with third

parties, we may not be able to generate product revenue and become profitable.

Without an effective internal commercial organization

or the support of a third party to perform sales and marketing functions, we may be unable to compete successfully.

Our future success is also dependent regulatory

approval and commercialization of our other product candidates.

We cannot commercialize our product candidates in the

United States without first obtaining regulatory approval for each product and each use pattern from the EPA or, if applicable,

the Food and Drug Administration, or FDA, and from any related applicable state authorities.

Before obtaining regulatory approvals

for the commercial sale of any product candidate for a target indication, the law requires that applicants demonstrate through

laboratory and field studies and related data showing that the product candidate will perform its intended function without causing

unreasonable adverse effects on the environment.

The EPA or a comparable foreign regulatory authority may require more information,

including additional data to support approval that may delay or prevent approval.

Regulatory approval processes of the EPA and comparable

foreign regulatory authorities are lengthy, time-consuming and unpredictable, and if we are ultimately unable to obtain regulatory

approval for our product candidates, our business may fail.

Although we obtained EPA approval for ContraPest in less than

one year, the EPA review process for a product with one or more new active ingredients typically takes approximately two years

to complete and approval is never guaranteed.

Our other product candidates could fail to receive marketing approval from the EPA

or, with respect to ContraPest or our other product candidates, from a comparable foreign regulatory authority for many reasons,

Disagreement over the design or implementation of our trials;

Failure to demonstrate a product candidate is safe or works

according to our claims;

Failure to demonstrate a product candidate’s benefits

outweigh its risks;

Disagreement over our interpretation of data;

Disagreement over whether to accept efficacy results from trials;

The insufficiency of data collected from trials to obtain regulatory

Irreparable or critical compliance issues relating to our manufacturing

Changes in the approval policies or regulations that render

our data insufficient for approval.

Any of these factors, some of which are beyond our control,

could jeopardize our ability to obtain regulatory approval for and successfully market any of our product candidates.

setback in our pursuit of regulatory approval could have a material adverse effect on our business and prospects.

Even following receipt of any regulatory approval for

ContraPest and our other product candidates, we will continue to face extensive regulatory requirements and our products may face

future development and regulatory difficulties.

Even following receipt of any regulatory approval

for ContraPest or our product candidates, our products will be subject to ongoing requirements by the EPA and comparable state

and foreign regulatory authorities governing the manufacture, quality control, further development, labeling, packaging, storage,

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

PMPs to deploy ContraPest in quantity as an enhancement to, or replacement of their current strategy of use of rodenticides;

Establishment

of commercially viable pricing;

ability to manufacture quantities of ContraPest using commercially acceptable processes and at a scale sufficient to meet

anticipated demand and enable us to reduce our cost of manufacturing;

continued acceptable safety profile of ContraPest.

of these factors are beyond our control.

If we are unable to successfully commercialize ContraPest, we may not be able to earn

sufficient revenues or profits to continue our business.

will require additional capital to fund our operations.

Failure to obtain this necessary capital if needed may force us to delay,

limit, or terminate our product development efforts or other operations.

Commercialization

of ContraPest and developing further product candidates, including conducting experiments and field studies, obtaining and maintaining

regulatory approval and commercializing any products approved for sale, is a time-consuming, expensive and uncertain process that

takes years to complete.

We expect our expenses to continue and to increase in connection with our ongoing activities, particularly

as we advance our commercialization activities.

We may expand our operations, and as a result of many factors, some of which may

be currently unknown to us, our expenses may be higher than expected.

Securing additional financing may divert our management

from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates,

including ContraPest.

In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms

acceptable to us, if at all.

If we are unable to raise additional capital when required or on acceptable terms, we may be required

Significantly

delay, scale back or discontinue the development or commercialization of our product candidates, including ContraPest;

strategic partners for the manufacturing, sales and distribution of ContraPest or any of our other product candidates at an

earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;

or license on unfavorable terms, our rights to technologies or product candidates that we otherwise would seek to develop

or commercialize ourselves.

occurrence of any of the events described above would have a material adverse effect on our business, operating results and prospects

and on our ability to develop our product candidates.

is the first product we have marketed, and if we are unable to establish and maintain an effective sales force and marketing and

distribution infrastructures, or enter into and rely upon acceptable third-party relationships, we may be unable to generate any

continue to develop a functional infrastructure for the sales, marketing, and distribution of our products and the cost of establishing

and maintaining such an infrastructure may exceed the cost-effectiveness of doing so.

In order to market ContraPest and any other

products that may be approved by the EPA and comparable foreign regulatory authorities, we must continue to build our sales, marketing,

managerial and other non-technical capabilities or make arrangements with third parties to perform these services for which we

would incur substantial costs.

If we are unable to establish and maintain adequate sales, marketing, and distribution capabilities,

whether independently or with third parties, we may not be able to generate product revenue and become profitable.

effective internal commercial organization or the support of a third party to perform sales and marketing functions, we may be

unable to compete successfully.

Regulations Have on Our Business

approval processes of the EPA and comparable foreign regulatory authorities are lengthy, time-consuming and unpredictable, and

if we are ultimately unable to obtain regulatory approval for our product candidates, our business may fail.

EPA review process for a product with one or more new active ingredients typically takes approximately two years to complete and

approval is never guaranteed.

In addition, we continue to seek approvals to expand labels and use designations for ContraPest

to broaden its market and usability.

Our efforts could fail to receive marketing approval from the EPA or, with respect to ContraPest

or our product candidates, from a comparable foreign regulatory authority for many reasons, including:

over the design or implementation of our trials;

to demonstrate a product candidate is safe or works according to our claims;

to demonstrate a product candidate’s benefits outweigh its risks;

over our interpretation of data;

over whether to accept efficacy results from trials;

insufficiency of data collected from trials to obtain regulatory approval;

or critical compliance issues relating to our manufacturing process;

in the approval policies or regulations that render our data insufficient for approval.

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

market any of our product candidates.

Any such setback in our pursuit of regulatory approval could have a material adverse effect

on our business and prospects.

following receipt of any regulatory approval for ContraPest and our other product candidates, we will continue to face extensive

regulatory requirements and our products may face future development and regulatory difficulties.

following receipt of any regulatory approval for ContraPest or our product candidates, our products will be subject to ongoing

requirements by the EPA and comparable state and foreign regulatory authorities governing the manufacture, quality control, further

development, labeling, packaging, storage, distribution, safety surveillance, import, export, advertising, promotion, recordkeeping

and reporting of safety and other post-market information.

The safety profile of any product will continue to be closely

monitored by the EPA and comparable foreign regulatory authorities after approval.

In addition, we may be required, from time to

time, to provide further testing results and certifications to the EPA and state regulatory agencies for ContraPest.

or comparable foreign regulatory authorities become aware of new safety information after approval of ContraPest or any other product

candidate, or we are unable to adequately complete testing and certification requirements, a number of potentially significant

negative consequences could result, including:

We may be forced to suspend marketing of such product;

Regulatory authorities may withdraw their approvals of such

product after certain procedural requirements have been met;

Regulatory authorities may require additional warnings on the

label that could diminish the usage or otherwise limit the commercial success of such product;

The EPA or other regulatory bodies may issue safety alerts,

press releases or other communications containing warnings about such product;

The EPA may require the establishment or modification of restricted

use or a comparable foreign regulatory authority may require the establishment or modification of a similar strategy that

may, for instance, restrict distribution of our product and impose burdensome implementation requirements on us;

We may be required to change the way the product is administered

or conduct additional trials;

We could be sued and held liable for harm caused;

We may be subject to litigation or product liability claims;

Our reputation may suffer.

In addition, we may be required, from time

to time, to provide further testing results and certifications to the EPA and state regulatory agencies for ContraPest.

For instance, we have found it challenging to produce applicable

stability test results for certain of our active ingredients, due in part to the small quantities used in the final product, and

continue to work with the EPA to develop appropriate biological or chemical measurements of product stability.

our data continue to demonstrate the long-term efficacy of ContraPest, we believe that the testing is a matter we will resolve.

If the EPA or comparable foreign regulatory authorities

become aware of new information after approval of ContraPest or any other product candidate, or we are unable to adequately complete

required testing and certification requirements, a number of potentially significant negative consequences could result, including:

may be forced to suspend marketing of such product;

authorities may withdraw their approvals of such product after certain procedural requirements have been met;

authorities may require additional warnings on the label that could diminish the usage or otherwise limit the commercial success

of such product;

EPA or other regulatory bodies may issue safety alerts, press releases or other communications containing warnings about such

EPA may require the establishment or modification of restricted use or a comparable foreign regulatory authority may require

the establishment or modification of a similar strategy that may, for instance, restrict distribution of our product and impose

burdensome implementation requirements on us;

may be required to change the way the product is administered or conduct additional trials;

could be sued and held liable for harm caused;

may be subject to litigation or product liability claims;

reputation may suffer.

Any of these events could prevent us from achieving or maintaining

5 unchanged sentences

or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and/or be

subject to fines or enhanced government oversight and reporting obligations, which would adversely affect our business, prospects,

and ability to achieve or sustain profitability.

Even following receipt of any regulatory approval for

ContraPest and our other product candidates, we will continue to be subject to regulation of our manufacturing processes and advertising

As a manufacturer of pest control products, we are subject

to continual government oversight and periodic inspections by the EPA and other regulatory authorities.

If we or a regulatory

agency discover problems with a facility where our products are manufactured, a regulatory agency may impose restrictions on the

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

until certain procedural requirements have been met.

The occurrence of any such event or penalty could limit our ability to market

ContraPest or any other product candidates and generate revenue.

In addition, the EPA strictly regulates the advertising and

promotion of pest control products, and these pest control products may only be marketed or promoted for their EPA approved uses,

consistent with the product’s approved labeling.

Advertising and promotion of any product candidate that obtains approval

will be heavily scrutinized by the EPA, other applicable state regulatory agencies and the public.

Violations, including

promotion of our products for unapproved or off-label uses, are subject to enforcement actions, inquiries and investigations,

and civil, criminal and/or administrative sanctions imposed by the EPA.

Failure to obtain regulatory approval in foreign jurisdictions

would prevent ContraPest or any other product candidates from being marketed in those jurisdictions.

To market and sell our products globally, we must obtain separate

marketing approvals and comply with numerous and varying regulatory requirements.

The approval procedure varies among countries

and can involve additional testing.

The time required to obtain approval may differ substantially from that required to obtain

EPA approval.

Obtaining foreign regulatory approvals and maintaining compliance with foreign regulatory requirements could result

in significant delays, difficulties, and cost for us and could delay or prevent the introduction of our products in certain countries.

Approval by the EPA does not ensure approval by regulatory authorities in other countries or jurisdictions, but EPA approval may

influence decisions by the foreign regulatory authority.

If we are unable to obtain approval of ContraPest or for any of our other

product candidates by regulatory authorities in the world market, the commercial prospects of that product candidate may be significantly

diminished and our business prospects could decline.

We depend on key personnel to operate our business.

we are unable to retain, attract and integrate qualified personnel, our ability to develop and successfully grow our business could

We believe that our future success is highly dependent on the

contributions of our employees, as well as our ability to attract and retain highly skilled and experienced sales, research and

development, and other personnel in the U.S.

and internationally.

All of our employees are free to terminate their employment relationship

with us at any time and their knowledge of our business and industry would be difficult to replace.

If one or more of our executive

officers or employees terminates his or her employment or becomes disabled or experiences long-term illness, we may not be able

to replace their expertise, fully integrate new personnel or replicate the prior working relationships, and the loss of their services

might significantly delay or prevent the achievement of our research, development and business objectives.

Qualified individuals

with the breadth of skills and experience in our industry that we require are in high demand, and we may incur significant costs

to attract them.

Many of the other companies that we compete against for qualified personnel have greater financial and other resources,

different risk profiles and a more established history in the industry.

They also may provide more diverse opportunities and better

chances for career advancement.

Additionally, our facilities are located in Arizona, which may make attracting and retaining qualified

scientific and technical personnel from outside of Arizona difficult.

Our failure to attract or retain key personnel could impede

the achievement of our research, development and commercialization objectives.

We have internal manufacturing capabilities to meet our

current demand for ContraPest, however, we must develop additional manufacturing capability or rely upon third parties to manufacture

our products to meet future demand.

subject to different marketing requirements or fines or enhanced government oversight and reporting obligations, which would adversely

affect our business, prospects, and ability to achieve or sustain profitability.

future success is also dependent on regulatory approval and commercialization of our other product candidates.

are working on a semi-solid product as well as an alternative dispenser.

We cannot commercialize our product candidates in the

United States without first obtaining regulatory approval for each product and each use pattern from the EPA or, if applicable,

the Food and Drug Administration, or FDA, and from any related applicable state authorities.

Before obtaining regulatory approvals

for the commercial sale of any product candidate for a target indication, the law requires that applicants demonstrate through

laboratory and field studies and related data showing that the product candidate will perform its intended function without causing

unreasonable adverse effects on the environment.

The EPA or a comparable foreign regulatory authority may require more information,

including additional data to support approval that may delay or prevent approval.

following receipt of any regulatory approval for ContraPest and our other product candidates, we will continue to be subject to

regulation of our manufacturing processes and advertising practices.

a manufacturer of pest control products, we are subject to continual government oversight and periodic inspections by the EPA

and other regulatory authorities.

If we or a regulatory agency discover problems with a facility where our products are manufactured,

a regulatory agency may impose restrictions on the manufacturing facility, including requiring recall or withdrawal of the product

from the market or suspension of manufacturing until certain procedural requirements have been met.

The occurrence of any such

event or penalty could limit our ability to market ContraPest or any other product candidates and generate revenue.

addition, the EPA strictly regulates the advertising and promotion of pest control products, and these pest control products may

only be marketed or promoted for their EPA approved uses, consistent with the product’s approved labeling.

Advertising and

promotion of any product candidate that obtains approval in the U.S.

will be heavily scrutinized by the EPA, other applicable

state regulatory agencies and the public.

Violations, including promotion of our products for unapproved or off-label uses, are

subject to enforcement actions, inquiries and investigations, and civil, criminal and/or administrative sanctions imposed by the

to obtain regulatory approval in foreign jurisdictions would prevent ContraPest or any other product candidates from being marketed

in those jurisdictions.

market and sell our products globally, we must obtain separate marketing approvals and comply with numerous and varying regulatory

requirements.

The approval procedure varies among countries and can involve additional testing.

Obtaining foreign regulatory approvals

and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties, and cost for

us and could delay or prevent the introduction of our products in certain countries.

Approval by the EPA does not ensure approval

by regulatory authorities in other countries or jurisdictions, but EPA approval may influence decisions by the foreign regulatory

If we are unable to obtain approval of ContraPest or for any of our other product candidates by regulatory authorities

in the world market, the commercial prospects of that product candidate may be significantly diminished and our business prospects

could decline.

Related to our Operations and Supply Chain

depend on key personnel to operate our business.

If we are unable to retain, attract and integrate qualified personnel, our ability

to develop and successfully grow our business could be harmed.

believe that our success is highly dependent on our ability to attract and retain highly skilled and experienced sales, research

and development, and other personnel.

If one or more of our executive officers or key employees terminates employment or becomes

disabled or experiences long-term illness, we may not be able to replace their expertise, fully integrate new personnel or replicate

the prior working relationships, and the loss of their services might significantly delay or prevent the achievement of our research,

development and business objectives.

Qualified individuals with the breadth of skills and experience in our industry that we require

are in high demand, and we may incur significant costs to attract them.

Many of the other companies that we compete against for

qualified personnel have greater financial and other resources, different risk profiles and a more established history in the

They also may provide more diverse opportunities and better chances for career advancement.

Our failure to attract or

retain key personnel could impede the achievement of our research, development and commercialization objectives.

have internal manufacturing capabilities to meet our current and near term forecasted demand for ContraPest, however, we must develop

additional manufacturing capability or rely upon third parties to manufacture our products to meet future demand and our single location

manufacturing operations could be disrupted.

Our existing internal manufacturing platform is adequate for

meeting our current demand for ContraPest.

We may be required to spend significant time and resources to expand these manufacturing

facilities to fully meet future demand.

If we are unable to develop full-scale manufacturing capabilities, we may not be able

to meet demand of our products without relying on third party manufacturers, which could adversely affect our operations or financial

We will need to expand our operations and grow the size

of our organization, and we may experience difficulties in managing this growth.

As of December 31, 2019, we had 34 full-time and four part-time

As our development and commercialization plans and strategies develop, we will need additional managerial, operational,

sales, marketing, scientific, financial headcount and other resources.

Our management, personnel, and systems currently in place

may not be adequate to support this future growth.

Future growth would impose significant added responsibilities on members of

management, including:

Identifying, recruiting, maintaining, motivating and integrating

additional employees with the expertise and experience we will require;

Managing our internal development efforts effectively while

complying with our contractual obligations to licensors, licensees, contractors and other third parties;

Managing additional relationships with various strategic partners,

suppliers and other third parties;

● Managing our trials

effectively, which we anticipate being conducted at numerous field study sites;

● Improving our managerial,

development, operational, marketing, production and finance reporting systems and procedures;

● Expanding our facilities.

Our failure to accomplish any of these tasks could prevent

us from successfully growing our business.

Business or supply chain disruptions could seriously harm

our future revenues and financial condition and increase our costs and expenses, particularly because we have limited suppliers

and a critical ingredient is sourced from China.

Our operations could be subject to a variety of potential business

disruptions, including power shortages, telecommunications failures, water shortages, floods, fires, earthquakes, extreme weather

conditions, medical epidemics and other natural or manmade disasters or other interruptions, for which we are predominantly self-insured.

We do not carry insurance for all categories of risk that our business may encounter.

The occurrence of any of these business disruptions

could seriously harm our operations and financial condition and increase our costs and expenses.

Moreover, we rely on third parties

to supply various ingredients and other items which are critical for producing our product candidates.

We currently use one supplier for each of our two active ingredients,

triptolide and VCD.

Our ability to produce our product candidates would be disrupted if the operations of these suppliers are affected

by a manmade or natural disaster or other business interruption.

Because triptolide is sourced from China and other Asian countries,

we have a greater risk of supply interruption, including as a result of tariff and trade disputes, or disruptive events like the

outbreak of the Coronavirus.

The ultimate impact on our operations from any business interruption impacting us or any of our significant

suppliers is unknown, but our operations and financial condition would likely suffer adverse consequences.

Further, any significant

uninsured liability may require us to pay substantial amounts, which would adversely affect our business, results of operations,

financial condition and cash flows from future prospects.

We are dependent on triptolide, a key ingredient for ContraPest,

which has limited sources and must be in a very refined condition.

If we are unable to develop additional sources of or alternatives

to triptolide, a key ingredient for ContraPest, our long term ability to produce ContraPest at a cost effective price could be

If market demand for triptolide causes the price to increase beyond our ability to market at a competitive price or

causes the quality of the refined ingredient to be less than needed for our production, our ability to commercialize ContraPest

could be limited or delayed, which would adversely affect our business, results of operations and financial condition

We may be subject to legal proceedings in the ordinary

course of our business that could result in significant harm to our business, financial condition and operating results.

We could be subject to legal proceedings and claims from time

to time in the ordinary course of our business, including actions arising from tort, contract or other claims.

See “Legal

Proceedings”

elsewhere in this filing for more information.

Litigation is expensive, time consuming, and could divert management’s

attention away from running our business.

The outcome of litigation or other proceedings is subject to significant uncertainty,

and it is possible that an adverse resolution of one or more such proceedings could result in reputational harm and/or significant

monetary damages, injunctive relief or settlement costs that could adversely affect our results of operations or financial condition

as well as our ability to conduct our business as it is presently being conducted.

Insurance might not cover such claims, might

not provide sufficient payments to cover all the costs to resolve one or more such claims and might not be available on terms

acceptable to us.

In addition, regardless of merit or outcome, claims brought against us that are uninsured or underinsured could

result in unanticipated costs, which could harm our business, financial condition and operating results and reduce the trading

price of our stock.

Product liability lawsuits against us could cause us

to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related

to the use of ContraPest and any of our other products.

If we cannot successfully defend ourselves against claims from our product

users, we could incur substantial liabilities.

Regardless of merit or eventual outcome, liability claims may result in:

● Decreased demand for

any product that we may develop;

● Termination of field

studies or other research and development efforts;

● Injury to our reputation

and significant negative media attention;

● Significant costs to

defend the related litigation;

● Substantial monetary

awards to plaintiffs;

● Loss of revenue;

● Diversion of management

and scientific resources from our business operations;

● The inability to commercialize

our product candidates.

We may be unable to obtain commercially reasonable product

liability insurance for any products approved for marketing.

Large judgments have been awarded in class action lawsuits based

on products that had unanticipated side effects, including, without limitation, any potential adverse effects of our products

on humans or other species.

A successful product liability claim or series of claims brought against us, particularly if judgments

exceed our insurance coverage, could decrease our cash and adversely affect our business.

A variety of risks associated with marketing our product

candidates internationally could materially adversely affect our business.

We may seek regulatory approval of our product candidates outside

and, in that case, we expect that we will be subject to additional risks related to operating in foreign countries

if we obtain the necessary approvals, including:

● Differing regulatory

requirements in foreign countries;

● Unexpected changes in

tariffs, trade barriers, price and exchange controls and other regulatory requirements;

● Economic weakness, including

inflation or political instability in particular foreign economies and markets;

● Compliance with tax,

employment, immigration and labor laws for employees living or traveling internationally;

● Foreign taxes, including

withholding of payroll taxes;

● Foreign currency fluctuations,

which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another

● Difficulties staffing

and managing foreign operations;

● Workforce uncertainty

in countries where labor unrest is more common than in the United States;

● Potential liability

under the U.S.

meeting our current and near term forecasted demand for ContraPest.

We may be required to spend significant time and resources

to expand these manufacturing facilities to fully meet future demand.

If we are unable to develop full-scale manufacturing capabilities,

we may not be able to meet demand of our products without relying on third party manufacturers, which could adversely affect our

operations or financial condition.

In addition, if our manufacturing operations fail or becomes disrupted

for any reason, including because of labor, disasters, and equipment malfunctions, among others, our ability to timely produce ContraPest

may be adversely affected, which would harm our sales and reputation .

We only operate in single location, which means we do not

have back-up facilities to produce our products during a time when our manufacturing facility becomes unavailable.

will need to expand our operations and grow the size of our organization, and we may experience difficulties in managing this

of December 31, 2020, we had 29 full-time employees.

As our development and commercialization plans and strategies develop, we

will need additional managerial, operational, sales, marketing, scientific, financial headcount and other resources.

Our management,

personnel, and systems currently in place may not be adequate to support this future growth.

Future growth would impose significant

added responsibilities on members of management, including:

recruiting, maintaining, motivating and integrating additional employees with the expertise and experience we will require;

our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors

and other third parties;

additional relationships with various strategic partners, suppliers and other third parties;

our trials effectively, which we anticipate being conducted at numerous field study sites;

our managerial, development, operational, marketing, production and finance reporting systems and procedures;

our facilities.

failure to accomplish any of these tasks could prevent us from successfully growing our business.

or supply chain disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses,

particularly because we have limited suppliers and a critical ingredient is sourced from China.

operations could be subject to a variety of potential business disruptions, including power shortages, telecommunications failures,

water shortages, floods, fires, earthquakes, extreme weather conditions, medical epidemics and other natural or manmade disasters

or other interruptions, for which we are predominantly self-insured.

We do not carry insurance for all categories of risk that

our business may encounter.

The occurrence of any of these business disruptions could seriously harm our operations and financial

condition and increase our costs and expenses.

Moreover, we rely on third parties to supply various ingredients and other items

which are critical for producing our product candidates.

currently use one supplier for each of our two active ingredients, triptolide and VCD.

Our ability to produce our product candidates

would be disrupted if the operations of these suppliers are affected by a manmade or natural disaster or other business interruption.

Because triptolide is sourced from China and other Asian countries, we have a greater risk of supply interruption, including as

a result of tariff and trade disputes, or disruptive events like the outbreak of the Coronavirus.

The ultimate impact on our operations

from any business interruption impacting us or any of our significant suppliers is unknown, but our operations and financial condition

would likely suffer adverse consequences.

Further, any significant uninsured liability may require us to pay substantial amounts,

which would adversely affect our business, results of operations, financial condition and cash flows from future prospects.

are dependent on triptolide, a key ingredient for ContraPest, which has limited sources and must be in a very refined condition.

we are unable to develop additional sources of or alternatives to triptolide, a key ingredient for ContraPest, our long-term ability

to produce ContraPest at a cost effective price could be in jeopardy.

If market demand for triptolide causes the price to increase

beyond our ability to market at a competitive price or causes the quality of the refined ingredient to be less than needed for

our production, our ability to commercialize ContraPest could be limited or delayed, which would adversely affect our business,

results of operations and financial condition.

variety of risks associated with marketing our product candidates internationally could materially adversely affect our business.

may seek regulatory approval of our product candidates outside of the U.S.

and, in that case, we expect that we will be subject

to additional risks related to operating in foreign countries if we obtain the necessary approvals, including:

regulatory requirements in foreign countries;

changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;

weakness, including inflation or political instability in particular foreign economies and markets;

with tax, employment, immigration and labor laws for employees living or traveling internationally;

taxes, including withholding of payroll taxes;

currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident

to doing business in another country;

staffing and managing foreign operations;

uncertainty in countries where labor unrest is more common than in the United States;

liability under the U.S.

Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, or comparable foreign regulations;

● Challenges enforcing

our contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual

property rights to the same extent as the United States;

● Production shortages

resulting from any events affecting raw material supply or manufacturing capabilities internationally;

● Business interruptions

resulting from geopolitical actions, including war and terrorism.

These and other risks associated with our international operations

may materially adversely affect our ability to attain or maintain profitable operations.

If we fail to obtain or protect intellectual property

rights, our competitive position could be harmed.

We depend on our ability to protect our proprietary

We rely on trade secret, patent, copyright and trademark laws, and confidentiality, licensing, and other agreements

with employees and third parties, all of which offer only limited protection.

Our commercial success will depend in part on our

ability to obtain and maintain intellectual property protection in the United States and other countries with respect to our proprietary

technology and products.

Where we deem appropriate, we seek to protect our proprietary position by filing patent applications in

the United States and internationally related to our novel technologies and products that are important to our business.

our financial resources constrain us from seeking protection in every instance, so we may rationalize and selectively pursue expensive

patent protection.

Patent positions can be highly uncertain, involve complex legal and factual questions and be the subject of

As a result, the issuance, scope, validity, enforceability and commercial value of our patents, including those patent

rights licensed to us by third parties, are highly uncertain.

The steps we have taken to protect our proprietary

rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property

rights, both inside and outside the United States.

The rights already granted under any of our currently issued patents and those

that may be granted under future issued patents may not provide us with the proprietary protection or competitive advantages we

If we are unable to obtain and maintain protection for our technology and products, or if the scope of the protection

obtained is not sufficient, our competitors could develop and commercialize technology and products similar or superior to ours,

and our ability to successfully commercialize our technology and products may be adversely affected.

enforcing our contractual and intellectual property rights, especially in those foreign countries that do not respect and

protect intellectual property rights to the same extent as the United States;

shortages resulting from any events affecting raw material supply or manufacturing capabilities internationally;

interruptions resulting from geopolitical actions, including war and terrorism.

and other risks associated with our international operations may materially adversely affect our ability to attain or maintain

profitable operations.

Relating to Protections of our Intellectual Property and Legal Actions

we fail to obtain or protect intellectual property rights, our competitive position could be harmed.

depend on our ability to protect our proprietary technology.

We rely on trade secret, patent, copyright and trademark laws, and

confidentiality, licensing, and other agreements with employees and third parties, all of which offer only limited protection.

Our commercial success will depend in part on our ability to obtain and maintain intellectual property protection in the United

States and other countries with respect to our proprietary technology and products.

Where we deem appropriate, we seek to protect

our proprietary position by filing patent applications in the United States and internationally related to our novel technologies

and products that are important to our business.

However, our financial resources constrain us from seeking protection in every

instance, so we may rationalize and selectively pursue expensive patent protection.

Patent positions can be highly uncertain,

involve complex legal and factual questions and be the subject of litigation.

As a result, the issuance, scope, validity, enforceability

and commercial value of our patents, including those patent rights licensed to us by third parties, are highly uncertain.

steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information

or infringement of our intellectual property rights, both inside and outside the United States.

The rights already granted under

any of our currently issued patents and those that may be granted under future issued patents may not provide us with the proprietary

protection or competitive advantages we are seeking.

If we are unable to obtain and maintain protection for our technology and

products, or if the scope of the protection obtained is not sufficient, our competitors could develop and commercialize technology

and products similar or superior to ours, and our ability to successfully commercialize our technology and products may be adversely

respect to patent rights, we do not know whether any of our pending patent applications for any of our technologies or products

23 unchanged sentences

are illustrative:

may be able to make compounds that are the same as or similar to our future products

but that are not covered by the claims of the patents that we own or have exclusively

may be able to make compounds that are the same as or similar to our future products but that are not covered by the claims

of the patents that we own or have exclusively licensed;

might not have been the first to file patent applications covering certain of our inventions;

may independently develop similar or alternative technologies or duplicate any of our

technologies without infringing on our intellectual property rights;

patents that we own or have exclusively licensed may not provide us with any competitive

advantages, or may be held invalid or unenforceable, as a result of legal challenges

by our competitors;

may independently develop similar or alternative technologies or duplicate any of our technologies without infringing on our

intellectual property rights;

patents that we own or have exclusively licensed may not provide us with any competitive advantages, or may be held invalid

or unenforceable, as a result of legal challenges by our competitors;

competitors might conduct research and development activities in the U.S.

and other countries

that provide a safe harbor from patent infringement claims for certain research and development

activities, as well as in countries where we do not have patent rights and then use the

information learned from such activities to develop competitive products for sale in

our major commercial markets;

may not develop additional proprietary technologies that are patentable;

and other countries that provide a safe harbor from

patent infringement claims for certain research and development activities, as well as in countries where we do not have patent

rights and then use the information learned from such activities to develop competitive products for sale in our major commercial

may not develop additional proprietary technologies that are patentable or otherwise protectable;

may violate confidentiality and proprietary invention assignment agreements and we may not have the resources to enforce those

agreements or otherwise enforce our patent rights;

patents of others may have an adverse effect on our business.

14 unchanged sentences

and conditions, our business, operating results and financial condition could be materially adversely affected.

If our product candidates, methods, processes and other technologies

infringe the proprietary rights of other parties, we could incur substantial costs and we may have to:

● Obtain licenses, which

may not be available on commercially reasonable terms, if at all;

● Redesign our product

candidates or processes to avoid infringement;

● Stop using the subject

matter claimed in the patents held by others;

● Pay damages;

● Defend litigation or

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

financial and management resources.

We may need to license intellectual property from third

parties, and such licenses may not be available or may not be available on commercially reasonable terms.

A third party may hold intellectual property, including patent

rights that are important or necessary to the development of our product candidates.

It may be necessary for us to use the patented

or proprietary technology of a third party to manufacture or otherwise commercialize our own technology or products, in which

case we would be required to obtain a license from such third party.

Licensing such intellectual property may not be available

or may not be available on commercially reasonable terms, which could have a material adverse effect on our business and financial

We have not fully assessed our internal control over financial

If we experience material weaknesses in the future or otherwise fail to maintain an effective system of internal controls,

we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect

investor confidence in us and, as a result, the value of our Common Stock.

A material weakness is a deficiency, or combination of deficiencies,

in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our financial

statements will not be prevented or detected on a timely basis.

This Annual Report on Form 10-K for the year ended December 31,

2019 does not include an attestation report of the company’s registered public accounting firm due to a transition period

established by rules of the SEC for smaller reporting companies and emerging growth companies.

As a result, we have not yet fully

assessed our internal control over financial reporting and are unable to assure that the measures we have taken to date, together

with any measures we may take in the future, will be sufficient to remediate the control deficiencies that led to our material

weaknesses in our internal control over financial reporting, or to avoid potential future material weaknesses.

If we are unable to develop and maintain an effective system

of internal control over financial reporting, successfully remediate any existing or future material weaknesses in our internal

control over financial reporting, or identify any additional material weaknesses, the accuracy and timing of our financial reporting

may be adversely affected, we may be unable to maintain compliance with securities law requirements regarding timely filing of

periodic reports and Nasdaq listing requirements, investors may lose confidence in our financial reporting, and our stock price

may decline as a result.

Privacy breaches and other cyber security risks related

to our business could negatively affect our reputation, credibility and business.

We expect to begin making direct-to-consumer sales through our

new e-Commerce tool, which depends on information technology systems and networks.

We are also responsible for storing data relating

to our customers and employees and rely on third party vendors for the storage, processing and transmission of personal and Company

Consumers, lawmakers and consumer advocates alike are increasingly concerned over the security of personal information

transmitted over the Internet, consumer identity theft and privacy.

We do not control our third-party service providers and cannot

guarantee that they have implemented reasonable security measures to protect our employees’

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

substantial costs and we may have to:

licenses, which may not be available on commercially reasonable terms, if at all;

our product candidates or processes to avoid infringement;

using the subject matter claimed to be held by others;

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

diversion of our financial and management resources.

may need to license intellectual property from third parties, and such licenses may not be available or may not be available on

commercially reasonable terms.

third party may hold intellectual property, including patent rights that are important or necessary to the development of our

product candidates.

It may be necessary for us to use the patented or proprietary technology of a third party to manufacture or

otherwise commercialize our own technology or products, in which case we would be required to obtain a license from such third

Licensing such intellectual property may not be available or may not be available on commercially reasonable terms, which

could have a material adverse effect on our business and financial condition.

may be subject to legal proceedings in the ordinary course of our business that could result in significant harm to our business,

financial condition and operating results.

could be subject to legal proceedings and claims from time to time in the ordinary course of our business, including actions arising

from tort, contract or other claims.

See “Legal Proceedings”

elsewhere in this filing for more information.

is expensive, time consuming, and could divert management’s attention away from running our business.

The outcome of litigation

or other proceedings is subject to significant uncertainty, and it is possible that an adverse resolution of one or more such

proceedings could result in reputational harm and/or significant monetary damages, injunctive relief or settlement costs that

could adversely affect our results of operations or financial condition as well as our ability to conduct our business as it is

presently being conducted.

Insurance might not cover such claims, might not provide sufficient payments to cover all the costs

to resolve one or more such claims and might not be available on terms acceptable to us.

In addition, regardless of merit or outcome,

claims brought against us that are uninsured or underinsured could result in unanticipated costs, which could harm our business,

financial condition and operating results and reduce the trading price of our stock.

example, we have become aware that we were involved in a transaction in which an investor of the Company may have resold approximately

175,000 shares of our common stock pursuant to a registration statement that was not declared effective by the Securities and

Exchange Commission (SEC).

As a result, it is possible that the SEC brings an action against us, or we may ultimately be responsible

for an action for rescission by purchasers of the securities that were resold.

If the SEC were to bring such an enforcement action

against us, or if purchasers were to bring such an action for rescission, it may have a material adverse effect on our financial

liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that

we may develop.

face an inherent risk of product liability exposure related to the use of ContraPest and any of our other products.

successfully defend ourselves against claims from our product users, we could incur substantial liabilities.

Regardless of merit

or eventual outcome, liability claims may result in:

demand for any product that we may develop;

of field studies or other research and development efforts;

to our reputation and significant negative media attention;

costs to defend the related litigation;

monetary awards to plaintiffs;

of management and scientific resources from our business operations;

inability to commercialize our product candidates.

may be unable to obtain commercially reasonable product liability insurance for any products approved for marketing.

Large judgments

have been awarded in class action lawsuits based on products that had unanticipated side effects, including, without limitation,

any potential adverse effects of our products on humans or other species.

A successful product liability claim or series of claims

brought against us, particularly if judgments exceed our insurance coverage, could decrease our cash and adversely affect our

Related to our Reporting and Cybersecurity

have not fully assessed our internal control over financial reporting.

If we experience material weaknesses in the future or otherwise

fail to maintain an effective system of internal controls, we may not be able to accurately or timely report our financial condition

or results of operations, which may adversely affect investor confidence in us and, as a result, the value of our Common Stock.

material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there

is a reasonable possibility that a material misstatement of our financial statements will not be prevented or detected on a timely

Annual Report on Form 10-K for the year ended December 31, 2020 does not include an attestation report of the company’s

registered public accounting firm due to a transition period established by rules of the SEC for smaller reporting companies and

emerging growth companies.

As a result, we have not yet fully assessed our internal control over financial reporting and are unable

to assure that the measures we have taken to date, together with any measures we may take in the future, will be sufficient to

remediate the control deficiencies that led to our material weaknesses in our internal control over financial reporting, or to

avoid potential future material weaknesses.

we are unable to develop and maintain an effective system of internal control over financial reporting, successfully remediate

any existing or future material weaknesses in our internal control over financial reporting, or identify any additional material

weaknesses, the accuracy and timing of our financial reporting may be adversely affected, we may be unable to maintain compliance

with securities law requirements regarding timely filing of periodic reports and Nasdaq listing requirements, investors may lose

confidence in our financial reporting, and our stock price may decline as a result.

breaches and other cyber security risks related to our business could negatively affect our reputation, credibility and business.

expect to begin making direct-to-consumer sales through our new e-Commerce tool, which depends on information technology systems

and networks.

We are also responsible for storing data relating to our customers and employees and rely on third party vendors

for the storage, processing and transmission of personal and Company information.

Consumers, lawmakers and consumer advocates

alike are increasingly concerned over the security of personal information transmitted over the Internet, consumer identity theft

We do not control our third-party service providers and cannot guarantee that they have implemented reasonable security

measures to protect our employees’

and customers’

and privacy, or that no electronic or physical computer break-ins or security breaches will occur in the future.

Our systems and

technology are vulnerable from time-to-time to damage, disruption or interruption from, among other things, physical damage, natural

disasters, inadequate system capacity, system issues, security breaches, “hackers,”

email blocking lists, computer

viruses, power outages and other failures or disruptions outside of our control.

A significant breach of customer, employee or

Company data could damage our reputation and our relationship with customers, and could result in lost sales, sizable fines, significant

breach-notification costs and lawsuits, as well as adversely affect our results of operations.

We may also incur additional costs

in the future related to the implementation of additional security measures to protect against new or enhanced data security and

privacy threats, or to comply with state, federal and international laws that may be enacted to address those threats.

Risks Related to our Capital Stock

We have incurred significant operating losses every quarter

since our inception and anticipate that we will continue to incur significant operating losses in the future.

Investment in product development is highly speculative

because it entails substantial upfront capital expenditures and significant risk that any potential product candidate will fail

to become commercially viable or gain regulatory approval.

To date, we have financed our operations primarily through the sale

of equity securities and debt financings as well as research grants.

Until August 2, 2016, we did not have any products approved

by a regulatory authority for marketing or commercial sale, and we have generated minimal revenue from product sales to date.

We continue to incur significant sales, marketing, research, development, and other expenses related to our ongoing operations.

As a result, we are not profitable and have incurred losses in every reporting period since our inception.

For the years ended

December 31, 2019 and 2018, we reported net losses of $10.0 million and $12.2 million, respectively.

As of December 31, 2019,

we had an accumulated deficit since inception of $95.9 million.

Since inception, we have dedicated a majority

of our resources to the discovery and development and marketing of our proprietary product candidates.

We expect to continue to

incur significant expenses and operating losses for the foreseeable future.

The size of our losses will depend, in part, on the

rate of future expenditures and our ability to generate revenues.

In particular, we expect to incur substantial and increased expenses

● Attempt to achieve market

acceptance for our products;

● Continue to establish

an infrastructure for the sales, marketing and distribution of ContraPest and any other product candidates for which we may receive

regulatory approval;

● Scale up manufacturing

processes and quantities to prepare for the commercialization of ContraPest and any other product candidates for which we receive

regulatory approval;

● Continue the research

and development of ContraPest and our other product candidates, including engaging in any necessary field studies;

● Seek regulatory approvals

for ContraPest in various jurisdictions and for our other product candidates;

● Expand our research

and development activities and advance the discovery and development programs for other product candidates;

● Maintain, expand and

protect our intellectual property portfolio;

● Add operational, financial

and management information systems and personnel, including personnel to support our clinical development and commercialization

efforts and operations as a public company.

We may encounter unforeseen expenses, difficulties,

complications, delays, and other unknown factors that may adversely affect our financial condition.

Our prior losses and expected

future losses have had, and will continue to have, an adverse effect on our financial condition.

If ContraPest or any other product

candidate does not gain or maintain sufficient regulatory approval, or if approved, fails to achieve market acceptance, we may

never become profitable.

Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent

Our failure to become and remain profitable would decrease the value of our company and could impair our ability to raise

capital, expand our business, diversify our product offerings or continue our operations.

A decline in the value of our company

could cause you to lose all or part of your investment.

If we are unable to continue as a going concern, our

securities will have little or no value.

We have incurred operating losses since our inception, and

identity and privacy, or that no electronic or physical computer

break-ins or security breaches will occur in the future.

Our systems and technology are vulnerable from time-to-time to damage,

disruption or interruption from, among other things, physical damage, natural disasters, inadequate system capacity, system issues,

security breaches, “hackers,”

email blocking lists, computer viruses, power outages and other failures or disruptions

outside of our control.

A significant breach of customer, employee or Company data could damage our reputation and our relationship

with customers, and could result in lost sales, sizable fines, significant breach-notification costs and lawsuits, as well as

adversely affect our results of operations.

We may also incur additional costs in the future related to the implementation of

additional security measures to protect against new or enhanced data security and privacy threats, or to comply with state, federal

and international laws that may be enacted to address those threats.

Related to our Capital Stock, Funding and Trading in our Stock

have incurred significant operating losses every quarter since our inception and anticipate that we will continue to incur significant

operating losses in the future.

in product development is highly speculative because it entails substantial upfront capital expenditures and significant risk

that any potential product candidate will fail to become commercially viable or gain regulatory approval.

To date, we have financed

our operations primarily through the sale of equity securities and debt financings as well as research grants.

We have generated

minimal revenue from product sales to date.

We continue to incur significant sales, marketing, research, development, and other

expenses related to our ongoing operations.

As a result, we are not profitable and have incurred losses in every reporting period

since our inception.

For the years ended December 31, 2020 and 2019, we reported net losses of $8.4 million and $10.0 million,

respectively.

As of December 31, 2020, we had an accumulated deficit since inception of $104.2 million.

inception, we have dedicated a majority of our resources to the discovery and development and marketing of our proprietary product

We expect to continue to incur significant expenses and operating losses for the foreseeable future.

Our financial statements

as of December 31, 2019 and 2018 have been prepared under the assumption that we will continue as a going concern.

Our independent

registered public accounting firm included in its opinion for the years ended December 31, 2019 and 2018 an explanatory paragraph

referring to our net loss from operations and net capital deficiency and expressing substantial doubt in our ability to continue

as a going concern without additional capital becoming available.

If we encounter continued issues or delays in the commercialization

of ContraPest, our prior losses and expected future losses could have an adverse effect on our financial condition and negatively

impact our ability to fund continued operations, obtain additional financing in the future and continue as a going concern.

are no assurances that such financing, if necessary, will be available to us at all or will be available in sufficient amounts

or on reasonable terms.

The size of our

losses will depend, in part, on the rate of future expenditures and our ability to generate revenues.

In particular, we expect

to incur substantial and increased expenses as we:

to achieve market acceptance for our products;

to establish an infrastructure for the sales, marketing and distribution of ContraPest and any other product candidates for

which we may receive regulatory approval;

up manufacturing processes and quantities to prepare for the commercialization of ContraPest and any other product candidates

for which we receive regulatory approval;

the research and development of ContraPest and our other product candidates, including engaging in any necessary field studies;

regulatory approvals for ContraPest in various jurisdictions and for our other product candidates;

our research and development activities and advance the discovery and development programs for other product candidates;

expand and protect our intellectual property portfolio;

operational, financial and management information systems and personnel, including personnel to support our clinical development

and commercialization efforts and operations as a public company.

may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our

financial condition.

Our prior losses and expected future losses have had, and will continue to have, an adverse effect on our

financial condition.

If ContraPest or any other product candidate does not gain or maintain sufficient regulatory approval, or

if approved, fails to achieve market acceptance, we may never become profitable.

Even if we achieve profitability in the future,

we may not be able to sustain profitability in subsequent periods.

Our failure to become and remain profitable would decrease

the value of our company and could impair our ability to raise capital, expand our business, diversify our product offerings or

continue our operations.

A decline in the value of our company could cause you to lose all or part of your investment.

we are unable to continue as a going concern, our securities will have little or no value.

have incurred operating losses since our inception, and we expect to continue to incur significant expenses and operating losses

for the foreseeable future.

Our financial statements as of December 31, 2020 and 2019 have been prepared under the assumption

that we will continue as a going concern.

Our independent registered public accounting firm included in its opinion for the years

ended December 31, 2020 and 2019 an explanatory paragraph referring to our net loss from operations and net capital deficiency

and expressing substantial doubt in our ability to continue as a going concern without additional capital becoming available.

If we encounter continued issues or delays in the commercialization of ContraPest or greater than anticipated expenses, our prior

losses and expected future losses could have an adverse effect on our financial condition and negatively impact our ability to

fund continued operations, obtain additional financing in the future and continue as a going concern.

There are no assurances

that such financing, if necessary, will be available to us at all or will be available in sufficient amounts or on reasonable

Our financial statements do not include any adjustments that may result from the outcome of this uncertainty.

If we are unable to generate additional funds in the future through financings, sales of our products, licensing fees, royalty

payments or from other sources or transactions, we will exhaust our resources and will be unable to continue operations.

cannot continue as a going concern, our stockholders would likely lose most or all of their investment in us.

Raising additional capital may cause dilution to our

existing stockholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.

Until such time, if ever, as we can generate sufficient product

revenues, we expect to finance our cash needs primarily through the sale of equity securities and debt financings, and possibly

through credit facilities and government and foundation grants.

We may also seek to raise capital through third party collaborations,

strategic alliances and similar arrangements.

We currently do not have any committed external source of funds.

Raising funds in

the future may present additional challenges and future financing may not be available in sufficient amounts or on terms acceptable

to us, if at all.

The terms of any financing arrangements we enter into may adversely affect the holdings or the rights of our

stockholders and the issuance of additional securities by us, or the possibility of such issuance, may cause the market price

of our shares to decline.

Certain of our outstanding warrants contain provisions that

impose limitations on our ability to participate in certain variable rate transactions, including at-the-market transactions,

which may limit our opportunities to obtain financing in sufficient amounts or on acceptable terms.

The sale of additional equity

or convertible debt securities would dilute all of our stockholders, and if such sales occur at a deemed issuance price that is

lower than the current exercise price of our outstanding warrants sold to investors in November 2017, the exercise price for those

warrants would adjust downward to the deemed issuance price pursuant to price adjustment protection contained within those warrants.

The incurrence of indebtedness through credit facilities would

result in increased fixed payment obligations and, potentially, the imposition of restrictive covenants.

Those covenants may include

limitations on our ability to incur additional debt, making capital expenditures or declaring dividends, and may impose limitations

on our ability to acquire, sell, or license intellectual property rights and other operating restrictions that could adversely

impact our ability to conduct our business.

If we raise additional funds through collaborations, strategic

alliances, or licensing arrangements or other marketing or distribution arrangements with third parties, we may have to relinquish

valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms

that may not be favorable to us.

If we are unable to expand our operations or otherwise capitalize on our business opportunities,

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

If we are unable to raise additional funds through equity or

debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization

efforts, or grant others rights to develop and market product candidates that we would otherwise prefer to develop and market

Our share price may be volatile, which could subject

us to securities class action litigation and your investment in our securities could decline in value.

Our stock could be subject to wide fluctuation in response

to many risk factors listed in this section, and others beyond our control, including:

● Market acceptance and

commercialization of our products;

● Our being able to timely

demonstrate achievement of milestones, including those related to revenue generation, cost control, cost effective source supply,

and regulatory approvals;

● Our ability to remain

listed on The Nasdaq Capital Market;

● Results and timing of

our submissions with the regulatory authorities;

● Failure or discontinuation

of any of our development programs;

● Regulatory developments

or enforcements in the United States and non-U.S.

unable to generate additional funds in the future through financings, sales of our products, licensing fees, royalty payments

or from other sources or transactions, we will exhaust our resources and will be unable to continue operations.

If we cannot continue

as a going concern, our stockholders would likely lose most or all of their investment in us.

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

to our technologies or product candidates.

such time, if ever, as we can generate sufficient product revenues, we expect to finance our cash needs primarily through the

sale of equity securities and debt financings, and possibly through credit facilities and government and foundation grants.

may also seek to raise capital through third party collaborations, strategic alliances and similar arrangements.

do not have any committed external source of funds.

funds in the future may present additional challenges and future financing may not be available in sufficient amounts or on terms

acceptable to us, if at all.

The terms of any financing arrangements we enter into may adversely affect the holdings or the rights

of our stockholders and the issuance of additional securities by us, or the possibility of such issuance, may cause the market

price of our shares to decline.

For example, during 2020, we completed equity financings that resulted in the issuance of shares

of Common Stock and warrants to purchase Common Stock, resulting in substantial dilution to the existing stockholders.

in the first quarter of 2021, we again issued shares of Common Stock and warrants to purchase Common Stock, resulting in additional

substantial dilution to the existing stockholders.

We generally have raised capital as the opportunity arises.

of our agreements with investors and our outstanding warrants contain provisions that impose limitations on our ability to participate

in certain variable rate transactions, including at-the-market transactions, which may limit our opportunities to obtain financing

in sufficient amounts or on acceptable terms.

The sale of additional equity or convertible debt securities would dilute all of

our stockholders, and if such sales occur at a deemed issuance price that is lower than the current exercise price of our outstanding

warrants sold to investors in November 2017, the exercise price for those warrants would adjust downward to the deemed issuance

price pursuant to price adjustment protection contained within those warrants.

Our various warrants contain other terms that may

affect our fundraising.

incurrence of indebtedness through credit facilities would result in increased fixed payment obligations and, potentially, the

imposition of restrictive covenants.

Those covenants may include limitations on our ability to incur additional debt, making capital

expenditures or declaring dividends, and may impose limitations on our ability to acquire, sell, or license intellectual property

rights and other operating restrictions that could adversely impact our ability to conduct our business.

we raise additional funds through collaborations, strategic alliances, or licensing arrangements or other marketing or distribution

arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research

programs or product candidates or grant licenses on terms that may not be favorable to us.

If we are unable to expand our operations

or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially

adversely affected.

we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce

or terminate our product development or commercialization efforts, or grant others rights to develop and market product candidates

that we would otherwise prefer to develop and market ourselves.

share price may be volatile, which could subject us to securities class action litigation and your investment in our securities

could decline in value.

stock could be subject to wide fluctuation in response to many risk factors listed in this section, and others beyond our control,

acceptance and commercialization of our products;

being able to timely demonstrate achievement of milestones, including those related to revenue generation, cost control, cost

effective source supply, and regulatory approvals;

ability to remain listed on The Nasdaq Capital Market;

and timing of our submissions with the regulatory authorities;

or discontinuation of any of our development programs;

developments or enforcements in the United States and non-U.S.

countries with respect to our products or our competitors’

● Failure to achieve pricing

acceptable to the market;

● Regulatory actions with

respect to our products or our competitors’

● Actual or anticipated

fluctuations in our financial condition and operating results or our continuing to sustain operating losses;

● Competition from existing

products or new products that may emerge;

● Announcements by us

or our competitors of significant acquisitions, strategic arrangements, joint ventures, collaborations or capital commitments;

● Issuance of new or updated

research or reports by securities analysts;

● Announcement or expectation

of additional financing efforts, particularly if our cash available for operations significantly decreases or if the financing

efforts result in a price adjustment to certain outstanding warrants;

● Fluctuations in the

valuation of companies perceived by investors to be comparable to us;

● Share price and volume

fluctuations attributable to inconsistent trading volume levels of our shares;

● Disputes or other developments

related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

● Entry by us into any

material litigation or other proceedings;

● Sales of our Common

Stock by us, our insiders, or our other stockholders;

● Exercise of outstanding

● Market conditions for

equity securities;

● General economic and

market conditions unrelated to our performance.

Furthermore, the capital markets can experience extreme price

and volume fluctuations that may affect the market prices of equity securities of many companies.

These broad market and industry

fluctuations, as well as general economic, political, and market conditions such as recessions, interest rate changes, or international

currency fluctuations, may negatively impact the market price of shares of our Common Stock.

In addition, such fluctuations could

subject us to securities class action litigation, which could result in substantial costs and divert our management’s attention

from other business concerns, which could seriously harm our business.

You may not realize any return on your investment in us

and may lose some or all of your investment.

Future sales, or the possibility of future

sales, of a substantial number of our common shares could adversely affect the price of the shares and dilute stockholders.

Future sales of a substantial number of shares of our

Common Stock, or the perception that such sales will occur, could cause a decline in the market price of our Common Stock.

is particularly true if we sell our stock at a discount.

As of February 5, 2020, we had 143,501 shares of our Common Stock subject

to outstanding warrants that contain anti-dilution adjustments that provide for an adjustment to the exercise price for certain

dilutive issuances of securities.

If we offer or issue additional securities at a deemed price lower than the current exercise

price of these outstanding warrants, these warrants will adjust pursuant to the price adjustment protection contained within these

For example, our January 2020 registered direct offering resulted in an additional downward adjustment of the exercise

price of these warrants from $19.00 per share to $7.126 per share.

Any future issuance of Common Stock or securities convertible

or exercisable into our Common Stock could cause a further downward adjustment of the exercise price of these warrants to the deemed

issuance price if the issuance price is less than the exercise price of the warrants at the time of the new issuance.

Also, in the future, we may issue additional shares

of our Common Stock or other equity or debt securities convertible into Common Stock in connection with a financing, acquisition,

litigation settlement, employee arrangements, or otherwise.

Any such issuance could result in substantial dilution to our existing

stockholders and could cause our common share price to decline.

As of December 31, 2019, our directors and officers

collectively beneficially hold 77,826 shares of Common Stock.

If these stockholders sell substantial amounts of common shares in

the public market, or if the market perceives that such sales may occur, the market price of our common shares and our ability

to raise capital through an issue of equity securities in the future could be adversely affected.

An active market in the shares may not continue to develop

in which investors can resell our Common Stock.

We cannot predict the extent to which an active market for

our Common Stock will continue to develop or be sustained, or how the development of such a market might affect the market price

for our Common Stock.

Market conditions in effect at the time you acquire our stock may not be indicative of the price at which

our Common Stock will trade in the future.

Investors may not be able to sell their Common Stock at or above the price they acquired

If securities or industry analysts, or other sources

of information, do not publish research, or publish inaccurate or unfavorable research or other information about our business,

our stock price and trading volume could decline.

The trading market for our Common Stock may depend on the research, reports

and other information that securities or industry analysts, or other third-party sources of information, publish about us

or our business.

We do not have any control over these analysts or other third-party sources of information.

From time to time inaccurate

or unfavorable research or other information about our business, financial condition, results of operations and stock ownership

may be published.

We cannot assure that analysts will cover us or provide favorable coverage.

If one or more of the analysts

who cover us downgrade our stock or change their opinion of our stock, our share price could decline.

If one or more of these

analysts cease coverage of us or fail to regularly publish reports on us, we could lose visibility in the financial markets, which

could cause our stock price or trading volume to decline.

If incorrect or misleading information is disseminated publicly by third

parties about us, our stock price could decline.

We may not be able to comply with all applicable listing

requirements or standards of The Nasdaq Capital Market and Nasdaq could delist our Common Stock.

Our Common Stock is listed on The Nasdaq Capital Market.

order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards.

On November 12,

2019, we received an initial deficiency letter from the listing qualifications staff of The Nasdaq Stock Market (“Nasdaq”)

providing notification that the bid price for our Common Stock had closed below $1.00 per share for the previous 30 consecutive

business days and that as a result our Common Stock no longer met the minimum bid price requirement for listing on The Nasdaq

Capital Market.

We were provided with an initial compliance period of 180 calendar days, or until May 11, 2020, to regain

to achieve pricing acceptable to the market;

actions with respect to our products or our competitors’

or anticipated fluctuations in our financial condition and operating results or our continuing to sustain operating losses;

from existing products or new products that may emerge;

Announcements

by us or our competitors of significant acquisitions, strategic arrangements, joint ventures, collaborations or capital commitments;

of new or updated research or reports by securities analysts;

or expectation of additional financing efforts, particularly if our cash available for operations significantly decreases

or if the financing efforts result in a price adjustment to certain outstanding warrants;

in the valuation of companies perceived by investors to be comparable to us;

price and volume fluctuations attributable to inconsistent trading volume levels of our shares;

or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent

protection for our technologies;

by us into any material litigation or other proceedings;

of our Common Stock by us, our insiders, or our other stockholders;

of outstanding warrants;

conditions for equity securities;

economic and market conditions unrelated to our performance.

the capital markets can experience extreme price and volume fluctuations that may affect the market prices of equity securities

of many companies.

These broad market and industry fluctuations, as well as general economic, political, and market conditions

such as recessions, interest rate changes, or international currency fluctuations, may negatively impact the market price of shares

of our Common Stock.

In addition, such fluctuations could subject us to securities class action litigation, which could result

in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our

You may not realize any return on your investment in us and may lose some or all of your investment.

sales, or the possibility of future sales, of a substantial number of our common shares could adversely affect the price of the

shares and dilute stockholders.

Future sales of a substantial number of shares of our Common

Stock, or the perception that such sales will occur, could cause a decline in the market price of our Common Stock.

This is particularly

true if we sell our stock at a discount.

As of March 29, 2021, we had 143,501 shares of our Common Stock subject to outstanding

warrants that contain anti-dilution adjustments that provide for an adjustment to the exercise price for certain dilutive issuances

of securities.

If we offer or issue additional securities at a deemed price lower than the current exercise price of these outstanding

warrants, these warrants will adjust pursuant to the price adjustment protection contained within these warrants.

our January 2020 registered direct offering resulted in an additional downward adjustment of the exercise price of these warrants

from $19.00 per share to $7.126 per share and our inducement offering in October 2020 resulted in an additional downward adjustment

of the exercise price of these warrants from $7.126 per share to $1.3659 per share.

Any future issuance of Common Stock or securities

convertible or exercisable into our Common Stock could cause a further downward adjustment of the exercise price of these warrants

to the deemed issuance price if the issuance price is less than the exercise price of the warrants at the time of the new issuance.

in the future, we may issue additional shares of our Common Stock or other equity or debt securities convertible into Common Stock

in connection with a financing, acquisition, litigation settlement, employee arrangements, or otherwise.

Any such issuance could

result in substantial dilution to our existing stockholders and could cause our common share price to decline.

active market in the shares may not continue to develop in which investors can resell our Common Stock.

cannot predict the extent to which an active market for our Common Stock will continue to develop or be sustained, or how the

development of such a market might affect the market price for our Common Stock.

Market conditions in effect at the time you acquire

our stock may not be indicative of the price at which our Common Stock will trade in the future.

Investors may not be able to

sell their Common Stock at or above the price they acquired it.

securities or industry analysts, or other sources of information, do not publish research, or publish inaccurate or unfavorable

research or other information about our business, our stock price and trading volume could decline.

trading market for our Common Stock may depend on the research, reports and other information that securities or industry

analysts, or other third-party sources of information, publish about us or our business.

We do not have any control over these

analysts or other third-party sources of information.

From time to time inaccurate or unfavorable research or other information

about our business, financial condition, results of operations and stock ownership may be published.

We cannot assure that

analysts will cover us or provide favorable coverage.

If one or more of the analysts who cover us downgrade our stock or change

their opinion of our stock, our share price could decline.

If one or more of these analysts cease coverage of us or fail to regularly

publish reports on us, we could lose visibility in the financial markets, which could cause our stock price or trading volume

If incorrect or misleading information is disseminated publicly by third parties about us, our stock price could decline.

may not be able to comply with all applicable listing requirements or standards of The Nasdaq Capital Market and Nasdaq could

delist our Common Stock.

Common Stock is listed on The Nasdaq Capital Market.

In order to maintain that listing, we must satisfy minimum financial and

other continued listing requirements and standards.

On November 12, 2019, we received an initial deficiency letter from the

listing qualifications staff of The Nasdaq Stock Market (“Nasdaq”) providing notification that the bid price for our

Common Stock had closed below $1.00 per share for the previous 30 consecutive business days and that as a result our Common Stock

no longer met the minimum bid price requirement for listing on The Nasdaq Capital Market.

We were provided with an initial compliance

period of 180 calendar days, or until May 11, 2020, to regain compliance with the minimum bid price requirement.

We implemented

a 1-for-20 reverse stock split on February 4, 2020.

On February 20, 2020 we received notification from Nasdaq that we had regained

compliance with the minimum bid price requirement.

We implemented a 1-for-20 reverse stock split on February 4, 2020.

20, 2020 we received notification from Nasdaq that we had regained compliance with the minimum bid price requirement.

we can provide no assurance that we will be able to maintain compliance with the minimum bid price requirement.

In the event that we are unable to maintain compliance with

the applicable Nasdaq listing requirements or standards of The Nasdaq Capital Market, our Common Stock could be delisted from

The Nasdaq Capital Market, which could have a material adverse effect on our financial condition and which could cause the value

of our Common Stock to decline.

If our Common Stock is not eligible for listing or quotation on another market or exchange, trading

of our Common Stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted

securities such as the Pink Sheets or the OTC Bulletin Board.

In such event, it could become more difficult to dispose of, or

obtain accurate price quotations for, our Common Stock, and there would likely be a reduction in our coverage by security analysts

and the news media, which could cause the price of our Common Stock to decline further.

In addition, it may be difficult for us

to raise additional capital if we are not listed on a national securities exchange.

Our reverse stock split may not result in a proportional

increase in the per share price of our Common Stock.

We effected a 1-for-20 reverse stock split of our Common Stock

on February 4, 2020, with the primary intent of increasing the price of our Common Stock in order to regain compliance with the

Nasdaq bid price requirement.

The effect of the reverse stock split on the market price for our Common Stock cannot be accurately

In particular, we cannot assure you that the proportionate increase in the prices of our Common Stock immediately after

the reverse stock split will be maintained for a substantial period of time.

It is not uncommon for the market price of a company’s

common stock to decline in the period following a reverse stock split.

If the market price of our Common Stock declines following

the reverse stock split, the percentage decline may be greater than would occur in the absence of a reverse stock split.

price of our Common Stock may also be affected by other factors which may be unrelated to the reverse stock split or the number

of shares outstanding.

The reverse stock split may decrease the liquidity of

the shares of our Common Stock.

The liquidity of the shares of our Common Stock may be affected

adversely by the reverse stock split given the reduced number of shares that are outstanding following the reverse stock split.

In addition, the reverse stock split increased the number of stockholders who own odd lots (less than 100 shares) of our Common

Stock, creating the potential for such stockholders to experience an increase in the cost of selling their shares and greater

difficulty effecting such sales.

Our corporate documents, Delaware law and certain warrants

contain provisions that could discourage, delay or prevent a change in control of our company.

Provisions in our amended and restated certificate

of incorporation and our amended and restated bylaws may discourage, delay or prevent a merger or acquisition involving us that

However, we can provide no assurance that we will be able to maintain compliance

with the minimum bid price requirement.

the event that we are unable to maintain compliance with the applicable Nasdaq listing requirements or standards of The Nasdaq

Capital Market, our Common Stock could be delisted from The Nasdaq Capital Market, which could have a material adverse effect

on our financial condition and which could cause the value of our Common Stock to decline.

If our Common Stock is not eligible

for listing or quotation on another market or exchange, trading of our Common Stock could be conducted in the over-the-counter

market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board.

In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our Common Stock, and there

would likely be a reduction in our coverage by security analysts and the news media, which could cause the price of our Common

Stock to decline further.

In addition, it may be difficult for us to raise additional capital if we are not listed on a national

securities exchange.

corporate documents, Delaware law and certain warrants contain provisions that could discourage, delay or prevent a change in

control of our company.

in our certificate of incorporation and our bylaws may discourage, delay or prevent a merger or acquisition involving us that

our stockholders may consider favorable.

For example, our amended and restated certificate of incorporation currently provides

for a staggered board of directors, whereby directors serve for three-year terms, with approximately one-third of the directors

coming up for reelection each year.

Having a staggered board will make it more difficult for a third party to obtain control of

our board of directors through a proxy contest, which may be a necessary step in an acquisition of us that is not favored by our

board of directors.

Additionally, most of our warrants provide a Black Scholes value-based payment to the warrant holders in connection

with certain transactions that may discourage, delay or prevent a merger or acquisition.

We are also subject to the anti-takeover provisions of Section 203

of the Delaware General Corporation Law.

Under these provisions, if anyone becomes an “interested stockholder,”

may not enter into a “business combination”

with that person for three years without special approval, which could

discourage a third party from making a takeover offer and could delay or prevent a change of control.

For purposes of Section 203,

“interested stockholder”

means, generally, someone owning 15% or more of our outstanding voting stock or an affiliate

of ours that owned 15% or more of our outstanding voting stock during the past three years, subject to certain exceptions as described

in Section 203.

We are subject to anti-corruption and anti-money

laundering laws with respect to our operations and noncompliance with such laws can subject us to criminal and/or civil liability

and harm our business.

We are subject to the FCPA, which is the U.S.

bribery statute contained in 18 U.S.C.

§201, the U.S.

Travel Act, the USA PATRIOT Act and other anti-bribery and anti-money

laundering laws in countries in which we conduct our business.

Anti-corruption laws are interpreted broadly and prohibit companies

and their employees and third-party intermediaries from authorizing, offering or providing, directly or indirectly, improper payments

or benefits to recipients in the public or private sector.

As we commercialize our product candidates and commence international

sales and business, we may engage with collaborators and third-party intermediaries to sell our products internationally and to

obtain necessary permits, licenses and other regulatory approvals.

We or our third-party intermediaries may have direct or indirect

interactions with officials and employees of government agencies or state-owned or affiliated entities.

We may be found liable

for the corrupt or other illegal activities of these third-party intermediaries, our employees, representatives, contractors, partners

and agents, even if we do not explicitly authorize such activities.

Noncompliance with anti-corruption and anti-money laundering

laws could subject us to whistleblower complaints, investigations, sanctions, settlements, prosecution, other enforcement actions,

disgorgement of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension and/or debarment

from contracting with certain persons, the loss of export privileges, reputational harm, adverse media coverage and other collateral

consequences.

Responding to any action will likely result in a materially significant diversion of management’s attention

and resources and significant defense costs and other professional fees.

We are an “emerging growth company”

term is used in the JOBS Act, and we intend to take advantage of reduced disclosure and governance requirements applicable to

emerging growth companies, which could result in our Common Stock being less attractive to investors and adversely affect the

market price of our Common Stock or make it more difficult to raise capital as and when we need it.

We are an “emerging growth company”

is used 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, reduced disclosure obligations regarding executive

compensation in our periodic reports and proxy statements, exemptions from the requirements of holding a nonbinding advisory vote

on executive compensation and stockholder approval of any golden parachute payments not previously approved, and exemptions from

any rules that the Public Company Accounting Oversight Board may adopt requiring mandatory audit firm rotation or a supplement

to the auditor’s report on the financial statements.

We currently intend to take advantage of some of the reduced regulatory

and reporting requirements that will be available to us under the JOBS Act, so long as we qualify as an “emerging growth

For example, our certificate of incorporation currently provides for a staggered board

of directors, whereby directors serve for three-year terms, with approximately one-third of the directors coming up for reelection

Having a staggered board will make it more difficult for a third party to obtain control of our board of directors

through a proxy contest, which may be a necessary step in an acquisition of us that is not favored by our board of directors.

Additionally, most of our warrants provide a Black Scholes value-based payment to the warrant holders in connection with certain

transactions that may discourage, delay or prevent a merger or acquisition.

are also subject to the anti-takeover provisions of Section 203 of the Delaware General Corporation Law.

Under these provisions,

if anyone becomes an “interested stockholder,”

we may not enter into a “business combination”

person for three years without special approval, which could discourage a third party from making a takeover offer and could delay

or prevent a change of control.

For purposes of Section 203, “interested stockholder”

means, generally, someone

owning 15% or more of our outstanding voting stock or an affiliate of ours that owned 15% or more of our outstanding voting stock

during the past three years, subject to certain exceptions as described in Section 203.

are an “emerging growth company”

as that term is used in the JOBS Act, and we intend to take advantage of reduced

disclosure and governance requirements applicable to emerging growth companies, which could result in our Common Stock being less

attractive to investors and adversely affect the market price of our Common Stock or make it more difficult to raise capital as

and when we need it.

are an “emerging growth company”

as that term is used 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, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, exemptions

from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute

payments not previously approved, and exemptions from any rules that the Public Company Accounting Oversight Board may adopt requiring

mandatory audit firm rotation or a supplement to the auditor’s report on the financial statements.

We currently intend to

take advantage of some of the reduced regulatory and reporting requirements that will be available to us under the JOBS Act, so

long as we qualify as an “emerging growth company.”

For example, so long as we qualify as an “emerging growth

company,”

For example, so long as we qualify as an “emerging growth company,”

we may elect not to provide you

with certain information, including certain financial information and certain information regarding compensation of our executive

officers, that we would have otherwise been required to provide in filings we make with the SEC, which may make it more difficult

for investors and securities analysts to evaluate us.

Because of the exemptions from various reporting requirements

provided to us as an “emerging growth company,”

we may be less attractive to investors and it may be difficult for

us to raise additional capital as and when we need it.

We may take advantage of these reporting exemptions until we are no longer

an emerging growth company.

If some investors find our Common Stock less attractive as a result, there may be a less active trading

market for our Common Stock and our stock price may be more volatile.

Investors may be unable to compare our business with other

companies in our industry if they believe that our financial accounting is not as transparent as other companies in our industry.

If we are unable to raise additional capital as and when we need it, our business, results of operations, financial condition

and cash flows, and future prospects may be materially and adversely affected.

Unresolved Staff Comments.

Not applicable.

we may elect not to provide you with certain information, including certain financial information and certain

information regarding compensation of our executive officers, that we would have otherwise been required to provide in filings

we make with the SEC, which may make it more difficult for investors and securities analysts to evaluate us.

of the exemptions from various reporting requirements provided to us as an “emerging growth company,”

we may be less

attractive to investors and it may be difficult for us to raise additional capital as and when we need it.

We may take advantage

of these reporting exemptions until we are no longer an emerging growth company.

If some investors find our Common Stock less

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

Investors may be unable to compare our business with other companies in our industry if they believe that our financial accounting

is not as transparent as other companies in our industry.

If we are unable to raise additional capital as and when we need it,

our business, results of operations, financial condition and cash flows, and future prospects may be materially and adversely

Staff Comments.

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