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Item 1A. Risk Factors

2022-08-12 compared with 2022-05-13 · 441 added, 428 removed, 1223 unchanged (42% of the section changed)

In analyzing our company,

you should consider carefully the following risk factors, together with all of the other information included in this Quarterly Report

on Form 10-Q.

Factors that could cause or contribute to differences in our actual results include those discussed in the following

subsection, as well as those discussed above in “Management’s Discussion and Analysis of Financial Condition and Results

of Operations” and in our Annual Report filed on Form 10-K for the year ended December 31, 2021.

Each of the following risk factors,

either alone or taken together, could adversely affect our business, operating results and financial condition, as well as adversely

affect the value of an investment in our company.

The risks and uncertainties described below are not the only ones we face.

risks not currently known to us or other factors not perceived by us to present significant risks to our business at this time also may

impair our business operations.

Summary of Risk Factors

We are providing the following

summary of the risk factors contained in this Annual Report on Form 10-K to enhance the readability and accessibility of our risk factor

We encourage you to carefully review the full risk factors contained in this Annual Report on Form 10-K in their entirety

for additional information regarding the material factors that make an investment in our securities speculative or risky.

and uncertainties include, but are not limited to, the following:

We are a clinical-stage company and have generated no revenue from

commercial sales to date;

We have incurred net losses in every year since our inception and anticipate

that we will continue to incur net losses in the future;

If we fail to obtain additional financing, we will be unable to continue

or complete our product development and you will likely lose your entire investment;

We are highly dependent on the success of Iomab-B and the SIERRA trial

and we may not be able to complete the necessary clinical development or our development efforts may not result in the data necessary

to receive regulatory approval;

Our business could be adversely affected by the effects of health epidemics,

including the global COVID-19 pandemic;

We have not demonstrated that any of our products are safe and effective

for any indication and will continue to expend substantial time and resources on clinical development before any of our current or

future product candidates will be eligible for FDA approval, if ever;

Our clinical trials may fail to demonstrate adequately the efficacy

and safety of our product candidates, which would prevent or delay regulatory approval and commercialization;

Preliminary, Interim, and “top-line” data from our clinical

trials that we announce or publish from time to time may change as more patient data become available and are subject to audit and

verification procedures that could result in material changes in the final data.;

Healthcare legislative reform measures intended

to increase pressure to reduce prices of pharmaceutical products paid for by Medicare or, otherwise, affect the federal regulation

healthcare system could have a material adverse effect our business, future revenue, if any, and results of operations;

We rely on third parties to conduct our clinical trials.

If these third

parties do not successfully carry out their contractual duties or meet expected deadlines or comply with regulatory requirements,

we may not be able to obtain regulatory approval for or commercialize our product candidates;

We currently depend on a single third-party manufacturer to produce

our pre-clinical and clinical trial drug supplies.

Any disruption in the operations of our current third-party manufacturer, or other

third-party manufacturers we may engage in the future, could adversely affect our business and results of operations;

Our product candidates may cause undesirable side effects or have other

properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential, or result

in significant negative consequences;

Our patent position is highly uncertain and involves complex legal

and factual questions.

The use of hazardous materials, including radioactive and biological

materials, in our research and development efforts imposes certain compliance costs on us and may subject us to liability for claims

arising from the use or misuse of these materials;

We are highly dependent on our key personnel, and the demand for talent

in the biotechnology industry is highly competitive;

if we are not successful in attracting and retaining highly qualified personnel,

we may not be able to successfully implement or execute our business strategy;

Certain provisions of our Certificate of Incorporation and Bylaws and

Delaware law make it more difficult for a third party to acquire us and make a takeover more difficult to complete, even if such

a transaction were in our stockholders’ interest;

Our ability to utilize our net operating loss carryforwards and certain

other tax attributes may be limited.

Risks Related to Our Business

We are a clinical-stage company and have

generated no revenue from commercial sales to date.

We are a clinical-stage biopharmaceutical

company with a limited operating history.

We have no products approved for commercial sale and have not generated any revenue from product

sales to date.

We will encounter risks and difficulties frequently experienced by early-stage companies in rapidly evolving fields.

we do not address these risks successfully, our business will suffer.

We have incurred net losses in every year

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

We are not profitable and

have incurred losses in each period since our inception.

As of March 31, 2022 and December 31, 2021, we had an accumulated deficit of

$260.9 million and $255.7 million, respectively.

We reported a net loss of $5.1 million and $5.3 million for the three months ended March

31, 2022 and 2021, respectively.

We expect to continue to operate at a net loss as we continue our research and development efforts, continue

to conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities.

There can be no assurance that the

products under development by us will be approved for sale in the United States or elsewhere.

Furthermore, there can be no assurance that

if such products are approved, they will be successfully commercialized, which would have an adverse effect on our business prospects,

financial condition and results of operation.

If we fail to obtain additional financing,

we will be unable to continue or complete our product development and you will likely lose your entire investment.

In August 2020, we entered

into the Capital on Demand™ Sales Agreement with JonesTrading, pursuant to which we may sell, from time to time, through or to

JonesTrading, up to an aggregate of $200 million of our common stock.

Shares of common stock are offered pursuant to our shelf registration

statement filed with the SEC on August 7, 2020.

For the year ended December 31, 2021, we sold 4.6 million shares of common stock, resulting

in net proceeds of $35.3 million.

As of the date of filing this report, we expect that our existing resources will be more than sufficient

to fund our planned operations for more than 12 months following the date of this report.

Our business or operations

may change in a manner that would consume available funds more rapidly than anticipated and substantial additional funding may be required

to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business or technologies or

otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a change in preferred

cancer treatment modalities.

However, we may not be able to secure funding when we need it or on favorable terms or indeed on any terms.

In addition, from time to time, we may not be able to secure enough capital in a timely enough manner which may cause the generation

of a going-concern opinion from our auditors which can and may impair our stock market valuation and also our ability to finance on favorable

terms or indeed on any terms.

To raise additional

capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable for our

common stock.

We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per share

that is equal to or greater than the price per share paid by investors, and investors purchasing shares or other securities in the future

could have rights superior to existing stockholders.

If we cannot raise adequate

funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development activities, clinical

studies or future operations.

We may also be required to obtain funds through arrangements with collaborators, which arrangements may

require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing, including rights

to future product candidates or certain major geographic markets.

analyzing our company, you should consider carefully the following risk factors, together with all of the other information included

in this Quarterly Report on Form 10-Q.

Factors that could cause or contribute to differences in our actual results include those

discussed in the following subsection, as well as those discussed above in “Management’s Discussion and Analysis of Financial

Condition and Results of Operations” and in our Annual Report filed on Form 10-K for the year ended December 31, 2021.

the following risk factors, either alone or taken together, could adversely affect our business, operating results and financial condition,

as well as adversely affect the value of an investment in our company.

The risks and uncertainties described below are not the only ones

Additional risks not currently known to us or other factors not perceived by us to present significant risks to our business

at this time also may impair our business operations.

of Risk Factors

are providing the following summary of the risk factors contained in this Annual Report on Form 10-K to enhance the readability and accessibility

of our risk factor disclosures.

We encourage you to carefully review the full risk factors contained in this Annual Report on Form 10-K

in their entirety for additional information regarding the material factors that make an investment in our securities speculative or

These risks and uncertainties include, but are not limited to, the following:

are a clinical-stage company and have generated no revenue from commercial sales to date;

have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future;

we fail to obtain additional financing, we will be unable to continue or complete our product development and you will likely lose

your entire investment;

are highly dependent on the success of Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development

or our development efforts may not result in the data necessary to receive regulatory approval;

business could be adversely affected by the effects of health epidemics, including the global COVID-19 pandemic;

have not demonstrated that any of our products are safe and effective for any indication and will continue to expend substantial

time and resources on clinical development before any of our current or future product candidates will be eligible for FDA approval,

clinical trials may fail to demonstrate adequately the efficacy and safety of our product candidates, which would prevent or delay

regulatory approval and commercialization;

Interim, and “top-line” data from our clinical trials that we announce or publish from time to time may change as more

patient data become available and are subject to audit and verification procedures that could result in material changes in the final

legislative reform measures intended to increase pressure to reduce prices of pharmaceutical

products paid for by Medicare or, otherwise, affect the federal regulation of the U.S.

system could have a material adverse effect our business, future revenue, if any, and results

of operations;

rely on third parties to conduct our clinical trials.

If these third parties do not successfully carry out their contractual duties

or meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize

our product candidates;

currently depend on a single third-party manufacturer to produce our pre-clinical and clinical trial drug supplies.

Any disruption

in the operations of our current third-party manufacturer, or other third-party manufacturers we may engage in the future, could

adversely affect our business and results of operations;

product candidates may cause undesirable side effects or have other properties that could halt their clinical development, prevent

their regulatory approval, limit their commercial potential, or result in significant negative consequences;

patent position is highly uncertain and involves complex legal and factual questions.

use of hazardous materials, including radioactive and biological materials, in our research and development efforts imposes certain

compliance costs on us and may subject us to liability for claims arising from the use or misuse of these materials;

are highly dependent on our key personnel, and the demand for talent in the biotechnology industry is highly competitive;

if we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement or

execute our business strategy;

provisions of our Certificate of Incorporation and Bylaws and Delaware law make it more difficult for a third party to acquire us

and make a takeover more difficult to complete, even if such a transaction were in our stockholders’ interest;

ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited.

Related to Our Business

are a clinical-stage company and have generated no revenue from commercial sales to date.

are a clinical-stage biopharmaceutical company with a limited operating history.

We have no products approved for commercial sale and

have not generated any revenue from product sales to date.

We will encounter risks and difficulties frequently experienced by early-stage

companies in rapidly evolving fields.

If we do not address these risks successfully, our business will suffer.

have incurred net losses in every year since our inception and anticipate that we will continue to incur net losses in the future.

are not profitable and have incurred losses in each period since our inception.

As of June 30, 2022, and December 31, 2021, we had an

accumulated deficit of $268.6 million and $255.7 million, respectively.

We reported a net loss of $12.9 million and $10.3 million for

the six months ended June 30, 2022, and 2021, respectively.

We expect to continue to operate at a net loss as we continue our research

and development efforts, continue to conduct clinical trials and develop manufacturing, sales, marketing and distribution capabilities.

There can be no assurance that the products under development by us will be approved for sale in the United States or elsewhere.

there can be no assurance that if such products are approved, they will be successfully commercialized, which would have an adverse effect

on our business prospects, financial condition and results of operation.

we fail to obtain additional financing, we will be unable to continue or complete our product development and you will likely lose your

entire investment.

August 2020, we entered into the Capital on Demand™ Sales Agreement with JonesTrading, pursuant to which we may sell, from time

to time, through or to JonesTrading, up to an aggregate of $200 million of our common stock.

Shares of common stock are offered pursuant

to our shelf registration statement filed with the SEC on August 7, 2020.

As of December 31, 2021, we had sold 6.7 million shares of

common stock, resulting in gross proceeds of $59.1 million and net proceeds of $57.0 million.

For the six months ended June 30, 2022,

we sold 2.7 million shares of common stock, resulting in gross proceeds of $17.2 million and net proceeds of $16.7 million.

June 28, 2022, we entered into an Amendment and Restated Capital on Demand™ Sales Agreement, or the A&R Sales Agreement, with

JonesTrading and B.

Riley Securities, Inc., or B.

Riley Securities.

The A&R Sales Agreement modifies the Original Capital on Demand™

Sales Agreement to include B.

Riley Securities as an additional sales agent thereunder.

of the date of filing this report, we expect that our existing resources will be more than sufficient to fund our planned operations

for more than 12 months following the date of this report.

business or operations may change in a manner that would consume available funds more rapidly than anticipated and substantial additional

funding may be required to maintain operations, fund expansion, develop new or enhanced products, acquire complementary products, business

or technologies or otherwise respond to competitive pressures and opportunities, such as a change in the regulatory environment or a

change in preferred cancer treatment modalities.

However, we may not be able to secure funding when we need it or on favorable terms

or indeed on any terms.

In addition, from time to time, we may not be able to secure enough capital in a timely enough manner which may

cause the generation of a going-concern opinion from our auditors which can and may impair our stock market valuation and also our ability

to finance on favorable terms or indeed on any terms.

raise additional capital, we may in the future offer additional shares of our common stock or other securities convertible into or exchangeable

for our common stock.

We cannot assure you that we will be able to sell shares or other securities in any other offering at a price per

share that is equal to or greater than the price per share paid by investors, and investors purchasing shares or other securities in

the future could have rights superior to existing stockholders.

we cannot raise adequate funds to satisfy our capital requirements, we will have to delay, scale back or eliminate our research and development

activities, clinical studies or future operations.

We may also be required to obtain funds through arrangements with collaborators, which

arrangements may require us to relinquish rights to certain technologies or products that we otherwise would not consider relinquishing,

including rights to future product candidates or certain major geographic markets.

We may further have to license our technology to others.

result in sharing revenues which we might otherwise have retained for ourselves.

Any of these actions may harm our business, financial

condition and results of operations.

The amount of funding we

will need depends on many factors, including the progress, timing and scope of our product development programs;

the progress, timing

and scope of our preclinical studies and clinical trials;

This could result in sharing revenues which we might otherwise have retained for ourselves.

Any of these actions may harm our business,

financial condition and results of operations.

amount of funding we will need depends on many factors, including the progress, timing and scope of our product development programs;

the progress, timing and scope of our preclinical studies and clinical trials;

the time and cost necessary to obtain regulatory approvals;

the time and cost

necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into and maintain collaborative,

licensing and other commercial relationships;

and our partners’ commitment of time and resources to the development and commercialization

of our products.

We have limited access to the capital markets

and even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.

We have limited access to

the capital markets to raise funds.

The capital markets have been unpredictable in the recent past for radioisotope and other oncology

companies and unprofitable companies such as ours.

In addition, it is generally difficult for development-stage companies to raise capital

under current market conditions.

The amount of capital that a company such as ours is able to raise often depends on variables that are

beyond our control.

the time and cost necessary to further develop manufacturing processes and arrange for contract manufacturing;

our ability to enter into

and maintain collaborative, licensing and other commercial relationships;

and our partners’ commitment of time and resources to

the development and commercialization of our products.

have limited access to the capital markets and even if we can raise additional funding, we may be required to do so on terms that are

dilutive to you.

have limited access to the capital markets to raise funds.

The capital markets have been unpredictable in the recent past for radioisotope

and other oncology companies and unprofitable companies such as ours.

In addition, it is generally difficult for development-stage companies

to raise capital under current market conditions.

The amount of capital that a company such as ours is able to raise often depends on

variables that are beyond our control.

As a result, we may not be able to secure financing on terms attractive to us, or at all.

If we are able to consummate

a financing arrangement, the amount raised may not be sufficient to meet our future needs.

If adequate funds are not available on acceptable

terms, or at all, our business, including our technology licenses, results of operations, financial condition and our continued viability

will be materially adversely affected.

We are highly dependent on the success

of Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development or our development efforts may

not result in the data necessary to receive regulatory approval.

are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs.

If adequate funds are

not available on acceptable terms, or at all, our business, including our technology licenses, results of operations, financial condition

and our continued viability will be materially adversely affected.

We are highly dependent on the success of

Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development or our development efforts may not

result in the data necessary to receive regulatory approval.

We have completed patient

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by the effects of health epidemics, including the global COVID-19 pandemic.

The global health crisis

caused by the novel coronavirus COVID-19 pandemic and its resurgences has and may continue to negatively impact global economic activity,

which, despite progress in vaccination efforts, remains uncertain and cannot be predicted with confidence.

In addition, the Omicron variant

of COVID-19, which appears to be the most transmissible variant to date, has spread globally.

The full impact of the Omicron variant,

or any subsequent variant, cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among

the population, the effectiveness of COVID-19 vaccines against the Omicron variant and the response by governmental bodies and regulators.

Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our business.

The global health crisis caused by the novel coronavirus COVID-19 pandemic

and its resurgences has and may continue to negatively impact global economic activity, which, despite progress in vaccination efforts,

remains uncertain and cannot be predicted with confidence.

In addition, the Omicron variants of COVID-19, including subvariants BA.4 and

BA.5, which appear to be the most transmissible variants to date, have spread globally.

The full impact of the Omicron variant, or any

subsequent variant, cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among the population,

the effectiveness of COVID-19 vaccines against the Omicron variant and the response by governmental bodies and regulators.

Given the ongoing

and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our business.

Many countries around the

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our ability to continue to operate our business may also be limited.

Such events may result in a period of business, supply and drug

product manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and

results of operations.

In response to COVID-19, we implemented remote working and thus far have not experienced a significant disruption

or delay in our operations as it relates to the clinical development of our drug candidates.

Such government-imposed precautionary measures

may have been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again

due to a resurgence in COVID-19 cases, including those involving new variants of the coronavirus, which may be more contagious and deadly

than prior strains.

Therefore, the COVID-19 pandemic may continue to affect our operation, may further divert the attention and efforts

of the medical community to coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect

on our operations.

Such events may result in a period of business, supply and drug product

manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and results

of operations.

In response to COVID-19, we implemented remote working and thus far have not experienced a significant disruption or delay

in our operations as it relates to the clinical development of our drug candidates.

Such government-imposed precautionary measures may

have been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again due to

a resurgence in COVID-19 cases, including those involving new variants of the coronavirus, which may be more contagious and deadly than

prior strains.

Therefore, the COVID-19 pandemic may continue to affect our operation, may further divert the attention and efforts of

the medical community to coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect on

our operations.

A continuation or worsening

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impacts of COVID-19 on the global economy and on our business operations.

However, the ultimate impact from COVID-19 on our business

operations and financial results during 2022 will depend on, among other things, the ultimate severity and scope of the pandemic, including

the new variants of the virus, the pace at which governmental and private travel restrictions and public concerns about public gatherings

will ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed

with which the economy recovers.

We are not able to fully quantify the impact that these factors will have on our financial results during

2022 and beyond.

However, the ultimate impact from COVID-19 on our business operations

and financial results during 2022 will depend on, among other things, the ultimate severity and scope of the pandemic, including the new

variants of the virus, the pace at which governmental and private travel restrictions and public concerns about public gatherings will

ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed with which

the economy recovers.

We are not able to fully quantify the impact that these factors will have on our financial results during 2022 and

Our business is subject to cybersecurity

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theft or misappropriation of funds;

loss, corruption, or misappropriation of intellectual property, or

other proprietary, confidential or personally identifiable information (including supplier, clinical data or employee data);

disruption or impairment of our and our business operations and safety

damage to our reputation with our potential partners, patients and

loss, corruption, or misappropriation of intellectual property, or other proprietary, confidential or personally identifiable information (including supplier, clinical data or employee data);

disruption or impairment of our and our business operations and safety procedures;

damage to our reputation with our potential partners, patients and the market;

exposure to litigation;

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procedures and controls to mitigate our exposure to such risk, cybersecurity attacks and other cyber events are evolving and unpredictable.

Moreover, we have no control over the information technology systems of third parties conducting our clinical trials, our suppliers,

and others with which our systems may connect and communicate.

As a result, the occurrence of a cyber incident could go unnoticed for

a period time.

Moreover, we have no control over the information technology systems of third parties conducting our clinical trials, our suppliers, and

others with which our systems may connect and communicate.

As a result, the occurrence of a cyber incident could go unnoticed for a period

We have cybersecurity insurance

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any particular losses we may experience as a result of such cyberattacks.

Any cyber incident could have a material adverse effect on

our business, financial condition and results of operations.

Any cyber incident could have a material adverse effect on our

business, financial condition and results of operations.

Risks Related to Regulation

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authorities may disagree with our regulatory plans and we may fail to obtain regulatory approval of our product candidates.

Our products are subject

to rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities.

Our products are subject to

rigorous regulation by the FDA and numerous other federal, state and foreign governmental authorities.

The process of seeking regulatory

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of a new antibody radiation-conjugate product only after a BLA for the product has received FDA approval.

The BLA process is costly,

lengthy and inherently uncertain.

Any BLA filed by us will have to be supported by extensive data, including, but not limited to, technical,

preclinical, clinical trial, chemistry, manufacturing and controls (“CMC”) and labeling data, to demonstrate to the FDA’s

satisfaction the safety and efficacy of the product for its intended use.

The lengthy approval process as well as the unpredictability

of future clinical trial results may result in our failing to obtain regulatory approval to market our product candidates, which would

significantly harm our business, results of operations and prospects.

In addition, even if we were to obtain approval, regulatory authorities

may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend

to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve

a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization

of that product candidate.

The BLA process is costly, lengthy

and inherently uncertain.

Any BLA filed by us will have to be supported by extensive data, including, but not limited to, technical, preclinical,

clinical trial, chemistry, manufacturing and controls (“CMC”) and labeling data, to demonstrate to the FDA’s satisfaction

the safety and efficacy of the product for its intended use.

The lengthy approval process as well as the unpredictability of future clinical

trial results may result in our failing to obtain regulatory approval to market our product candidates, which would significantly harm

our business, results of operations and prospects.

In addition, even if we were to obtain approval, regulatory authorities may approve

any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for

our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate

with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate.

Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

The approval process in the

United States and in other countries could result in unexpected and significant costs for us and consume management’s time and

other resources.

The FDA and other foreign regulatory agencies could ask us to supplement our submissions, collect non-clinical data,

conduct additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications.

even if we obtain approval to market our products in the United States or in other countries, the approval could be revoked, or other

restrictions imposed if post-market data demonstrates safety issues or lack of effectiveness.

We cannot predict with certainty how, or

when, the FDA or other regulatory authorities will act.

If we are unable to obtain the necessary regulatory approvals, our financial

condition and cash flow may be materially adversely affected, and our ability to grow domestically and internationally may be limited.

Additionally, even if we obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited

indications that we request.

The Company’s products may not be approved for the specific indications that are most necessary or

desirable for successful commercialization or profitability.

United States and in other countries could result in unexpected and significant costs for us and consume management’s time and other

The FDA and other foreign regulatory agencies could ask us to supplement our submissions, collect non-clinical data, conduct

additional clinical trials or engage in other time-consuming actions, or it could simply deny our applications.

In addition, even if we

obtain approval to market our products in the United States or in other countries, the approval could be revoked, or other restrictions

imposed if post-market data demonstrates safety issues or lack of effectiveness.

We cannot predict with certainty how, or when, the FDA

or other regulatory authorities will act.

If we are unable to obtain the necessary regulatory approvals, our financial condition and cash

flow may be materially adversely affected, and our ability to grow domestically and internationally may be limited.

Additionally, even

if we obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications that we

The Company’s products may not be approved for the specific indications that are most necessary or desirable for successful

commercialization or profitability.

We have not demonstrated that any of our

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subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, as applicable.

We are currently not permitted to market any of our current or future product candidates in the United States until we receive FDA approval

are currently not permitted to market any of our current or future product candidates in the United States until we receive FDA approval

(of each) via the BLA process.

To date, we have two product candidates in clinical development and have not-yet submitted a BLA for any

of our candidates and, for many such candidates, do not expect to be in a position to do so for the foreseeable future, as there are

numerous developmental steps that must be completed before we can prepare and submit a BLA.

of our candidates and, for many such candidates, do not expect to be in a position to do so for the foreseeable future, as there are numerous

developmental steps that must be completed before we can prepare and submit a BLA.

In the United States, the

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as well as their respective implementing regulations.

Such products and product candidates are also subject to other federal, state,

and local statutes and regulations.

Such products and product candidates are also subject to other federal, state, and

local statutes and regulations.

The process of obtaining regulatory approvals and the subsequent compliance with appropriate federal,

state, local, and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

required by the FDA before a drug or biological product may be marketed in the United States generally involves the following:

completion of preclinical laboratory tests and animal studies in accordance

with FDA’s good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals

or other applicable regulations;

submission to the FDA of an Investigational New Drug (“IND”),

which must become effective before human clinical trials in the United States may begin;

performance of adequate and well-controlled human clinical trials in

accordance with FDA’s IND regulations, GCPs, and any additional requirements for the protection of human research subjects

and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

The process required

by the FDA before a drug or biological product may be marketed in the United States generally involves the following:

completion of preclinical laboratory tests and animal studies in accordance with FDA’s good laboratory practices (“GLPs”) and applicable requirements for the humane use of laboratory animals or other applicable regulations;

submission to the FDA of an Investigational New Drug (“IND”), which must become effective before human clinical trials in the United States may begin;

performance of adequate and well-controlled human clinical trials in accordance with FDA’s IND regulations, GCPs, and any additional requirements for the protection of human research subjects and their health information, to establish the safety and efficacy of the proposed biological product for its intended use;

submission to the FDA of a BLA for marketing approval that meets applicable requirements to ensure the continued safety, purity, and potency of the product that is the subject of the BLA based on results of preclinical testing and clinical trials;

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clinical trials or may not be able to conduct our trials on the timelines we expect.

We cannot predict

whether we will encounter problems with any of our ongoing or planned clinical trials that will cause us or regulatory authorities

to delay, suspend, or discontinue clinical trials or to delay the collection or analysis of data from ongoing clinical trials.

of the following could delay or disrupt the clinical development of our product candidates and potentially cause our product

candidates to fail to receive regulatory approval:

We cannot predict whether

we will encounter problems with any of our ongoing or planned clinical trials that will cause us or regulatory authorities to delay, suspend,

or discontinue clinical trials or to delay the collection or analysis of data from ongoing clinical trials.

Any of the following could

delay or disrupt the clinical development of our product candidates and potentially cause our product candidates to fail to receive regulatory

conditions imposed on us by the FDA or comparable foreign authorities regarding the scope or design of our clinical trials;

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the placement by the FDA or a foreign regulatory authority of a clinical hold on a trial;

delays in obtaining regulatory agency authorization for the conduct of

our clinical trials;

delays by us or third parties in the collection or analysis

of data from our clinical trials;

delays in obtaining regulatory agency authorization for the conduct of our clinical trials;

delays by us or third parties in the collection or analysis of data from our clinical trials;

delays due to COVID-19 or a similar global health pandemic.

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to audit and verification procedures that could result in material changes in the final data.

From time to time, we

may publicly disclose preliminary, interim, and top-line data from our clinical trials, which is based on a preliminary analysis of then-available

From time to time, we may

publicly disclose preliminary, interim, and top-line data from our clinical trials, which is based on a preliminary analysis of then-available

data, and the results and related findings and conclusions are subject to change as more patient data become available or following a

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For example, at the ASH annual meeting in December 2021

we presented safety and feasibility data available at the time of data submission from 100% patient enrollment from the SIERRA trial.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had

the opportunity to fully and carefully evaluate all data.

Our clinical trials may be open label studies and certain of our clinical development

and or operations staff may review interim or preliminary safety or efficacy data during routine data collection, cleaning and analysis

from time to time.

Interim or preliminary results that we report may differ from future results of the same studies, or different conclusions

or considerations may qualify such results once additional data have been received and fully evaluated.

Preliminary, interim or top-line

data also remain subject to audit and verification procedures that may result in the final data being materially different from the top-line,

interim or preliminary data we previously published.

As a result, top-line, interim and preliminary data should be viewed with caution

until the final data are available.

and TCT annual meeting in April 2022, we presented safety and feasibility data available at the time of data submission from 100% patient

enrollment from the SIERRA trial.

We also make assumptions, estimations, calculations and conclusions as part of our analyses of data,

and we may not have received or had the opportunity to fully and carefully evaluate all data.

Our clinical trials may be open label studies

and certain of our clinical development and or operations staff may review interim or preliminary safety or efficacy data during routine

data collection, cleaning and analysis from time to time.

Interim or preliminary results that we report may differ from future results

of the same studies, or different conclusions or considerations may qualify such results once additional data have been received and fully

Preliminary, interim or top-line data also remain subject to audit and verification procedures that may result in the final

data being materially different from the top-line, interim or preliminary data we previously published.

As a result, top-line, interim

and preliminary data should be viewed with caution until the final data are available.

From time to time, we may

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alpha particle drug products comprising Ac-225.

Our final drug construct consists of the lintuzumab antibody labeled with the isotope

We have licensed issued patents that relate to the linker technology we use to conjugate the isotope to the antibody.

we own issued and pending patents related to methods for drug conjugation and isotope labeling and for methods of isotope production.

In addition, we possess trade secrets and know how related to the manufacturing and use of isotopes.

Any competing product based on the

lintuzumab antibody is likely to require several years of development before achieving our product candidate’s current status and

may be subject to significant regulatory hurdles but such development by others is nevertheless a possibility that could negatively impact

our business in the future.

Our final drug construct, Actimab-A, consists of the lintuzumab antibody labeled with

the isotope Ac-225.

We currently own issued and pending patents relating to methods of manufacturing Actimab-A, methods of treatment using

Actimab-A and production of the Ac-225 isotope.

In addition, we possess trade secrets and know how related to the manufacturing and use

Any competing product based on the lintuzumab antibody is likely to require several years of development before achieving

our product candidate’s current status and may be subject to significant regulatory hurdles but such development by others is nevertheless

a possibility that could negatively impact our business in the future.

We own 4 issued U.S.

patents, 1 issued European patent (validated as a national patent in several countries)

and 1 issued Japanese patent that relate to the composition of our Iomab-B product candidate.

Several patent applications relating to

Iomab-B are also pending in the U.S.

patents, 1 issued European patent (validated

as a national patent in several countries) and 1 issued Japanese patent that relate to the composition of our Iomab-B product candidate.

Several patent applications relating to Iomab-B are also pending in the U.S.

and internationally.

We have and may continue to file patents related to Iomab-B that can provide

barriers to entry but there is no certainty that these patents will be granted or such granting thereof will adequately prevent others

from seeking to replicate and use the apamistamab antibody or the construct.

We have pending patents related to radioimmunoconjugate composition,

formulation administration, and methods of use in solid or liquid cancers.

This matter includes composition, administration, and methods

of treatment for our products Actimab-A and Iomab-B.

Any competing product based on the antibody used in Iomab-B is likely to require

several years of development before achieving our product candidate’s current status and may be subject to significant regulatory

hurdles but such development by others is nevertheless a possibility that could negatively impact our business in the future.

We have and may continue to file patents

related to Iomab-B that can provide barriers to entry but there is no certainty that these patents will be granted or such granting thereof

will adequately prevent others from seeking to replicate and use the apamistamab antibody or the construct.

We have pending patents related

to radioimmunoconjugate composition, formulation administration, and methods of use in solid or liquid cancers.

This subject matter includes

composition, administration, and methods of treatment for our product candidates Actimab-A and Iomab-B.

Any competing product based on

the antibody used in Iomab-B is likely to require several years of development before achieving our product candidate’s current

status and may be subject to significant regulatory hurdles but such development by others is nevertheless a possibility that could negatively

impact our business in the future.

Our CD33 program clinical trials are testing

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Our contract for supply of

this isotope from the DOE must be renewed yearly, we recently renewed our contract to extend through the end of 2022.

While we expect

this contract will continue to be renewed at the end of its term as it has since 2009, there can be no assurance that the DOE will renew

the contract or change its policies that allow for the sale of isotope to us.

Failure to acquire sufficient quantities of medical grade

Ac-225 would make it impossible to effectively complete clinical trials and to commercialize any Ac-225 based drug candidates that we

may develop and would materially harm our business.

Ac-225 from the DOE must be renewed annually and our current contract extends through the end of 2022.

While we expect this contract will

continue to be renewed at the end of its term as it has since 2009, there can be no assurance that the DOE will renew the contract or

change its policies that allow for the sale of isotope to us.

Failure to acquire sufficient quantities of medical grade Ac-225 would make

it impossible to effectively complete clinical trials and to commercialize any Ac-225 based drug candidates that we may develop and would

materially harm our business.

Our ability to conduct clinical

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and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating compliance efforts.

Efforts to comply with

applicable healthcare laws and regulations will involve substantial costs.

Interpretations of standards of compliance under these laws

and regulations are rapidly changing and subject to varying interpretations and it is possible that governmental authorities will conclude

that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse

or other healthcare laws and regulations.

If our operations are found to be in violation of any of these laws or any other laws that may

apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government

funded healthcare programs, such as Medicare and Medicaid, reputational harm, imprisonment, additional reporting obligations and oversight

(if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws),

and the curtailment or restructuring of our operations, any of which could diminish our future profits or earnings.

If any of the physicians

or other providers or entities with whom we expect to do business are found to be not in compliance with applicable laws, they may be

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

Efforts to comply with applicable

healthcare laws and regulations will involve substantial costs.

Interpretations of standards of compliance under these laws and regulations

are rapidly changing and subject to varying interpretations and it is possible that governmental authorities will conclude that our business

practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare

laws and regulations.

If our operations are found to be in violation of any of these laws or any other laws that may apply to us, we may

be subject to significant civil, criminal and administrative penalties, damages, fines, exclusion from government funded healthcare programs,

such as Medicare and Medicaid, reputational harm, imprisonment, additional reporting obligations and oversight (if we become subject to

a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws), and the curtailment or restructuring

of our operations, any of which could diminish our future profits or earnings.

If any of the physicians or other providers or entities

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

sanctions, including exclusions from government funded healthcare programs.

Third-party payors may not adequately reimburse

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and prospects would be adversely affected.

The antibodies we use in our antibody radiation-conjugate

The antibodies we use in our targeted radiotherapy

product candidates may be subject to generic competition.

We are not aware of any existing

or pending regulations or legislation that pertains to generic radiopharmaceutical products such as our antibody radiation-conjugate product

or pending regulations or legislation that pertains to generic radiopharmaceutical products such as antibody radiation-conjugate product

Our product candidates are regulated by the FDA as biologic products and we intend to seek approval for these products pursuant

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market acceptance.

Iomab-B, CD33 ARC program

candidates and future product candidates that we may develop may never gain market acceptance among physicians, patients and the medical

The degree of market acceptance of any of our products will depend on a number of factors, including the actual and perceived

effectiveness and reliability of the product;

Iomab-B, CD33 program candidates

and future product candidates that we may develop may never gain market acceptance among physicians, patients and the medical community.

The degree of market acceptance of any of our products will depend on a number of factors, including the actual and perceived effectiveness

and reliability of the product;

the results of any long-term clinical trials relating to use of the product;

the availability,

relative cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments using the product

are approved for reimbursement by public and private insurers;

the availability, relative

cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments using the product are approved

for reimbursement by public and private insurers;

the strength of our marketing and distribution infrastructure;

level of education and awareness among physicians and hospitals concerning the product.

and the level of education

and awareness among physicians and hospitals concerning the product.

We believe that oncologists

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or continue to use, and hospitals may not purchase or continue to purchase, them.

Failure of Iomab-B, CD33 ARC

program candidates or any of our other product candidates to significantly penetrate current or new markets would negatively impact our

business financial condition and results of operations.

Failure of Iomab-B, CD33 program

candidates or any of our other product candidates to significantly penetrate current or new markets would negatively impact our business

financial condition and results of operations.

We may be subject to claims that our third-party

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or attempts by either party to terminate the agreement.

If in the future we are unable to establish

or global sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates,

we may not be successful in commercializing our product candidates if they are approved and we may not be able to generate any revenue.

We currently do not have a

marketing or sales team for the marketing, sales and distribution of any of our product candidates that may receive regulatory approval.

In order to commercialize any product candidates after approval, we must build on a territory-by-territory basis marketing, sales, distribution,

managerial and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful

If our product candidates receive regulatory approval, we may decide to establish an internal sales or marketing team with

technical expertise and supporting distribution capabilities to commercialize our product candidates, which will be expensive and time-consuming

and will require significant attention of our executive officers to manage.

Any failure or delay in the development of our internal sales,

marketing and distribution capabilities would adversely impact the commercialization of any of our product candidates that we obtain approval

With respect to the commercialization of all or certain of our product

candidates, we may choose to collaborate, either globally or on a territory-by-territory basis, with third parties that have direct sales

forces and established distribution systems, either to augment our own sales force and distribution systems or in lieu of our own sales

force and distribution systems.

In particular, we have and expect to continue to partner with third parties to commercialize Iomab-B outside

the United States.

In April 2022, we entered into a licensing agreement with Immedica, in which Immedica acquired the product rights

for commercialization of Iomab-B for certain territories outside the U.S.

If we are unable to enter into or maintain such arrangements

when needed on acceptable terms, or at all, we may not be able to successfully commercialize any of our product candidates that receive

regulatory approval or any such commercialization may experience delays or limitations.

If we are not successful in commercializing our

product candidates, either on our own or through collaborations with one or more third parties, our future product revenue will suffer

and we may incur significant additional losses.

We face significant competition from other

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that our processes and potential products may give rise to claims that they infringe the patents or trade secrets of others.

persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of

the affected product or process.

If any of these actions are successful, in addition to any potential liability for damages, we could

be required to obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the

affected process.

persons could bring legal actions against us claiming damages and seeking to enjoin clinical testing, manufacturing and marketing of the

affected product or process.

If any of these actions are successful, in addition to any potential liability for damages, we could be required

to obtain a license in order to continue to conduct clinical tests, manufacture or market the affected product or use the affected process.

Required licenses may not be available on acceptable terms, if at all, and the results of litigation are uncertain.

If we become involved in litigation or other proceedings, it could consume a substantial portion of our financial resources and the efforts

of our personnel.

If we become involved

in litigation or other proceedings, it could consume a substantial portion of our financial resources and the efforts of our personnel.

In addition to infringement

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Patent and Trademark

Office (or similar proceedings before corresponding tribunals in other jurisdictions) that challenge our patent rights or the patent

rights of our licensors.

The costs and efforts of defending our patents or enforcing our proprietary rights in post-issuance administrative

proceedings can be substantial and the outcome can be uncertain.

An adverse determination in these proceedings could weaken or invalidate

the patent claims that cover our technology, which adverse determination could harm our business significantly and dissuade companies

from collaborating with us or permit third parties to directly compete with the same technology.

Our ability to protect and enforce our

patents does not guarantee that we will secure the right to commercialize our patents.

Office (or similar proceedings before corresponding tribunals in other jurisdictions) that challenge our patent rights or the patent rights

of our licensors.

The costs and efforts of defending our patents or enforcing our proprietary rights in post-issuance administrative proceedings

can be substantial and the outcome can be uncertain.

An adverse determination in these proceedings could weaken or invalidate the patent

claims that cover our technology, which adverse determination could harm our business significantly and dissuade companies from collaborating

with us or permit third parties to directly compete with the same technology.

Our ability to protect and enforce our patents

does not guarantee that we will secure the right to commercialize our patents.

A patent is a limited monopoly

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protect our trade secrets.

If these agreements are breached by our employees or other parties, our trade secrets may become known to

our competitors.

If these agreements are breached by our employees or other parties, our trade secrets may become known to our

We rely on trade secrets that

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Risks Related to Our Operations

We expect to expand our development and

regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and, as a result, we may encounter difficulties

in managing our growth, which could disrupt our operations.

We expect to experience significant growth in

the number of our employees and the scope of our operations, particularly in the areas of product candidate development, regulatory affairs

and, if any of our product candidates receives marketing approval, sales, marketing and distribution.

We currently do not have a marketing or sales

team for the marketing, sales and distribution of any of our product candidates that are potentially able to obtain regulatory approval.

In order to commercialize any product candidates, we must build on a territory-by-territory basis marketing, sales, distribution, managerial

and other non-technical capabilities or make arrangements with third parties to perform these services, and we may not be successful in

If our product candidates receive regulatory approval, we intend to establish an internal sales or marketing team with technical

expertise and supporting distribution capabilities to commercialize our product candidates, which will be expensive and time consuming

and will require significant attention of our executive officers to manage.

We will also have to compete with other pharmaceutical and

biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

Any failure or delay in the development of our

internal sales, marketing and distribution capabilities would adversely impact the commercialization of any of our product candidates

that we obtain approval to market.

To manage our anticipated future growth, we must continue to implement

and improve our managerial, operational and financial systems, expand our facilities and continue to recruit and train additional qualified

Due to our limited financial resources and the limited experience of our management team in managing a public company with

such anticipated growth, we may not be able to effectively manage the expansion of our operations or recruit and train additional qualified

The expansion of our operations may lead to significant costs and may divert our management and business development resources.

Any inability to manage growth could delay the execution of our business plans or disrupt our operations.

The use of hazardous materials, including

radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject

us to liability for claims arising from the use or misuse of these materials.

radioactive and biological materials, in our research and development efforts imposes certain compliance costs on us and may subject us

to liability for claims arising from the use or misuse of these materials.

Our research, development

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We cannot completely eliminate the

risk of contamination or injury from these materials and we could be held liable for any damages that result, which could exceed our

financial resources.

risk of contamination or injury from these materials and we could be held liable for any damages that result, which could exceed our financial

We currently maintain insurance coverage for injuries resulting from the hazardous materials we use;

however, future

claims may exceed the amount of our coverage.

however, future claims

may exceed the amount of our coverage.

Also, we do not have insurance coverage for pollution cleanup and removal.

Currently the

costs of complying with such federal, state, local and foreign environmental regulations are not significant, and consist primarily of

waste disposal expenses.

However, they could become expensive, and current or future environmental laws or regulations may impair our

research, development, production and commercialization efforts.

Currently the costs

of complying with such federal, state, local and foreign environmental regulations are not significant, and consist primarily of waste

disposal expenses.

However, they could become expensive, and current or future environmental laws or regulations may impair our research,

development, production and commercialization efforts.

We may undertake international operations,

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tariffs and other trade barriers;

difficulties in protecting, acquiring, enforcing and

litigating intellectual property rights;

difficulties in protecting, acquiring, enforcing and litigating

intellectual property rights;

fluctuations in currency exchange rates;

and potentially adverse tax consequences.

If we were to experience

any of the difficulties listed above, or any other difficulties, any international development activities and our overall financial condition

If we were to experience any

of the difficulties listed above, or any other difficulties, any international development activities and our overall financial condition

may suffer and cause us to reduce or discontinue our international development and registration efforts.

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to manage our business.

If any member of our current senior management terminates his employment with us and we are unable to find a

suitable replacement quickly, the departure could have a material adverse effect on our business.

An overall tightening and increasingly

competitive labor market has been observed in the U.S.

If any member of our current senior management terminates his employment with us and we are unable to find a suitable

replacement quickly, the departure could have a material adverse effect on our business.

An overall tightening and increasingly competitive

labor market has been observed in the U.S.

employment market generally, especially in response to the COVID-19 pandemic.

Specific to the biotechnology industry in which we operate, there is significant demand and competition for highly specialized talent

that we require.

We have experienced high turnover rates, with approximately one third of our employee base turning over or being replaced

A sustained labor shortage or increased turnover rates within our employee base, caused by the COVID-19 pandemic, as a result

of general macroeconomic factors, or due to dynamics within our industry, could lead to increased costs, such as increased wage rates

to attract and retain employees, and could negatively affect our ability to efficiently conduct our clinical development, R&D, business

development and potential regulatory and commercial activities.

If we are unable to hire and retain employees capable of performing at

a high-level, or if mitigation measures we may take to respond to a decrease in labor availability, have unintended negative effects,

our business could be adversely affected.

An overall labor shortage, lack of skilled labor, increased turnover or labor inflation, caused

by the COVID-19 pandemic, general macroeconomic factors or as a result of biotechnology industry dynamics could have a material adverse

impact on our operations, results of operations, liquidity or cash flows.

Specific to the

biotechnology industry in which we operate, there is significant demand and competition for highly specialized talent that we require.

A sustained labor shortage or increased turnover rates within our employee base, caused by the COVID-19 pandemic, as a result of general

macroeconomic factors, or due to dynamics within our industry, could lead to increased costs, such as increased wage rates to attract

and retain employees, and could negatively affect our ability to efficiently conduct our clinical development, R&D, business development

and potential regulatory and commercial activities.

If we are unable to hire and retain employees capable of performing at a high-level,

or if mitigation measures we may take to respond to a decrease in labor availability, have unintended negative effects, our business could

be adversely affected.

An overall labor shortage, lack of skilled labor, increased turnover or labor inflation, caused by the COVID-19

pandemic, general macroeconomic factors or as a result of biotechnology industry dynamics could have a material adverse impact on our

operations, results of operations, liquidity or cash flows.

Our future success also depends

on our ability to identify, attract, hire or engage, retain and motivate other well-qualified managerial, technical, clinical and regulatory

This activity is likely to create additional demands on the time and attention of our senior management personnel as they

identify, hire, and train external and internal candidates to fill the sizable number of positions required to execute our business plans

including submit a BLA and build a commercial organization.

This activity is likely to create additional demands on the time and attention of our senior management personnel as they identify,

hire, and train external and internal candidates to fill the sizable number of positions required to execute our business plans including

submit a BLA and build a commercial organization.

The market for talent in our industry is very competitive.

Many of the other

biopharmaceutical companies we compete against for qualified personnel have greater financial and other resources, more favorable risk

profiles and a longer operating history in the biopharmaceutical industry than we do.

They also may provide more diverse opportunities

and better chances for career advancement.

Some of these opportunities may be more appealing to high-quality candidates than what we

have to offer.

Many of the other biopharmaceutical

companies we compete against for qualified personnel have greater financial and other resources, more favorable risk profiles and a longer

operating history in the biopharmaceutical industry than we do.

They also may provide more diverse opportunities and better chances for

career advancement.

Some of these opportunities may be more appealing to high-quality candidates than what we have to offer.

It is particularly difficult

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as potential commercial operations, which will place a significant strain on our financial, managerial and operational resources.

order to achieve and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities.

to achieve and manage growth effectively, we must continue to improve and expand our operational and financial management capabilities.

Moreover, we will need to increase staffing and to train, motivate and manage our employees.

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our business, financial condition or results of operations.

We may expand our business through the

acquisition of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current

stockholders’ ownership interests in our company.

We may expand our business through the acquisition

of rights to new product candidates that could disrupt our business, harm our financial condition and may also dilute current stockholders’

ownership interests in our company.

Our business strategy includes

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risks of entering markets in which we have limited or no direct experience;

and the potential loss of our key employees or

key employees of the acquired companies.

and the potential loss of our key employees or key

employees of the acquired companies.

We can make no assurances

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with some of these acquisitions.

We cannot assure that we will be able to make the combination of our business with that of acquired

products, businesses or companies work or be successful.

Furthermore, the development or expansion of our business or any acquired products,

business or companies may require a substantial capital investment by us.

We may not have these necessary funds, or they might not be

available to us on acceptable terms or at all.

We may also seek to raise funds by selling shares of our preferred or common stock, which

could dilute each current stockholder’s ownership interest in the Company.

We cannot assure that we will be able to make the combination of our business with that of acquired products,

businesses or companies work or be successful.

Furthermore, the development or expansion of our business or any acquired products, business

or companies may require a substantial capital investment by us.

We may not have these necessary funds, or they might not be available

to us on acceptable terms or at all.

We may also seek to raise funds by selling shares of our preferred or common stock, which could dilute

each current stockholder’s ownership interest in the Company.

Risks Related to Ownership of Our Common

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through the sales of stock and warrants in order to expand our level of operations to continue our research and development efforts.

Any sale of common stock

by us in a future offering could result in dilution to our existing stockholders as a direct result of our issuance of additional shares

Any sale of common stock by

us in a future offering could result in dilution to our existing stockholders as a direct result of our issuance of additional shares

of our capital stock.

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securities that could dilute our stockholders’ stock ownership.

We may also assume additional debt and incur impairment losses

related to goodwill and other tangible assets if we acquire another company and this could negatively impact our earnings and results

of operations.

We may also assume additional debt and incur impairment losses related

to goodwill and other tangible assets if we acquire another company and this could negatively impact our earnings and results of operations.

Our common stock is subject to price volatility

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common stock.

The trading price of our

common stock may be highly volatile and could fluctuate in response to factors such as:

The trading price of our common

stock may be highly volatile and could fluctuate in response to factors such as:

actual or anticipated variations in our operating results;

announcements of developments by us or our competitors;

the timing of IND and/or BLA approval, the completion and/or results

of our clinical trials;

the timing of IND and/or BLA approval, the completion and/or results of our clinical trials;

regulatory actions regarding our products;

announcements by us or our competitors of significant acquisitions,

strategic partnerships, joint ventures or capital commitments;

announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;

adoption of new accounting standards affecting our industry;

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class action litigation has often been initiated against such a company.

Litigation initiated against us, whether or not successful,

could result in substantial costs and diversion of our management’s attention and our resources, which could harm our business

and financial condition.

Litigation initiated against us, whether or not successful, could

result in substantial costs and diversion of our management’s attention and our resources, which could harm our business and financial

We do not intend to pay dividends on our

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Provisions of our certificate

of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in our control or change in

our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that

our stockholders might otherwise deem to be in their best interests.

Therefore, these provisions could adversely affect the price of

of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our

management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our

stockholders might otherwise deem to be in their best interests.

Therefore, these provisions could adversely affect the price of our stock.

Among other things, the certificate of incorporation and bylaws:

provide that the authorized number of directors

may be changed by resolution of the board of directors;

provide that all vacancies, including newly-created

directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office,

even if less than a quorum;

provide that the authorized number of directors may be changed by resolution of the board of directors;

that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative

vote of a majority of directors then in office, even if less than a quorum;

divide the board of directors into three classes;

provide that stockholders seeking to present proposals

before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice

in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice;

provide that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content of a stockholder’s notice.

In addition, we are governed

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with Section 404 at December 31, 2021 and 2020 and while our testing did not reveal any material weaknesses in our internal controls,

any material weaknesses in our internal controls in the future would be required us to remediate in a timely manner so as to be able

to comply with the requirements of Section 404 each year.

If we are not able to comply with the requirements of Section 404 in a timely

manner each year, we could be subject to sanctions or investigations by the SEC, NYSE American or other regulatory authorities which

would require additional financial and management resources and could adversely affect the market price of our common stock.

if we cannot provide reliable financial reports or prevent fraud, our business and results of operations could be harmed, and investors

could lose confidence in our reported financial information.

any material weaknesses in our internal controls in the future would be required us to remediate in a timely manner so as to be able to

comply with the requirements of Section 404 each year.

If we are not able to comply with the requirements of Section 404 in a timely manner

each year, we could be subject to sanctions or investigations by the SEC, NYSE American or other regulatory authorities which would require

additional financial and management resources and could adversely affect the market price of our common stock.

Furthermore, if we cannot

provide reliable financial reports or prevent fraud, our business and results of operations could be harmed, and investors could lose

confidence in our reported financial information.

If securities or industry analysts do not

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securities and industry analysts currently cover us.

If one or more of the analysts downgrade our common stock or publish inaccurate

or unfavorable research about our business, the price of our common stock would likely decline.

If one or more of these analysts cease

coverage of us or fail to publish reports on us regularly, demand for our common stock could decrease, which could cause the price of

our common stock and trading volume to decline.

If one or more of the analysts downgrade our common stock or publish inaccurate or

unfavorable research about our business, the price of our common stock would likely decline.

If one or more of these analysts cease coverage

of us or fail to publish reports on us regularly, demand for our common stock could decrease, which could cause the price of our common

stock and trading volume to decline.

Our amended and restated bylaws, as

3 unchanged sentences

Our amended and restated bylaws,

as amended, provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of

the United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities

as amended, provide that, unless we consent in writing to the selection of an alternative forum, the federal district courts of the

United States of America will be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities

Act of 1933, as amended.

10 unchanged sentences

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-Q

Item 1A. Risk Factors