What changed in this filing

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Item 1A. Risk Factors

2023-11-02 compared with 2023-08-14 · 217 added, 234 removed, 1459 unchanged (24% of the section changed)

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

We are highly dependent on the regulatory and commercial success of

We are highly dependent on the regulatory and commercial success of Iomab-B

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

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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 June 30, 2023 and December 31, 2022, we had an accumulated deficit of $315.0

million and $288.8 million, respectively.

We reported a net loss of $26.2 million and $12.9 million for the six months ended June 30,

2023 and 2022, 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.

We are not profitable and

have incurred losses in each period since our inception.

As of September 30, 2023 and December 31, 2022, we had an accumulated deficit

of $328.3 million and $288.8 million, respectively.

We reported a net loss of $39.5 million and $22.4 million for the nine months ended

September 30, 2023 and 2022, 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,

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and even if we can raise additional funding, we may be required to do so on unfavorable terms.

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

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.

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 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

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and commercial success of Iomab-B

We have completed patient enrollment in the pivotal Phase 3 SIERRA

trial (Study of Iomab-B in Elderly Relapsed or Refractory AML), a 153-patient multi-center randomized trial that compared outcomes of

patients who receive Iomab-B and a BMT to those of patients receiving physician’s choice of salvage chemotherapy, defined as conventional

care, as no standard of care exists for this patient population.

We have announced that Iomab-B met the primary endpoint of dCR in the

SIERRA trial with statistical significance (p<0.0001) and we intend to submit a BLA with the FDA by the end of 2023.

Even if Iomab-B

receives favorable regulatory approval, we may not be successful in securing adequate reimbursement or establishing successful commercial

Any or all of these factors could have a material adverse impact on our business and ability to continue operations.

We have completed patient

enrollment in the pivotal Phase 3 SIERRA trial (Study of Iomab-B in Elderly Relapsed or Refractory AML), a 153-patient multi-center randomized

trial that compared outcomes of patients who receive Iomab-B and a BMT to those of patients receiving physician’s choice of salvage

chemotherapy, defined as conventional care, as no standard of care exists for this patient population.

We have announced that Iomab-B

met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001) and we intend to submit a BLA with the

Even if Iomab-B receives favorable regulatory approval, we may not be successful in securing adequate reimbursement or establishing

successful commercial operations.

Any or all of these factors could have a material adverse impact on our business and ability to continue

We may be unable to establish sales, marketing

and commercial supply capabilities.

We do not currently have, nor

have we ever had, commercial sales and marketing capabilities.

If any of our product candidates become approved, we would have to build

and establish these capabilities in order to commercialize our approved product candidates.

The process of establishing commercial capabilities

will be expensive and time consuming.

Even if we are successful in building sales and marketing capabilities, we may not be successful

in commercializing any of our product candidates.

Any delays in commercialization or failure to successfully commercialize any product

candidate may have material adverse impacts on our business and ability to continue operations.

We do not currently have,

nor have we ever had, commercial sales and marketing capabilities.

If any of our product candidates become approved, we would have to

build and establish these capabilities in order to commercialize our approved product candidates.

The process of establishing commercial

capabilities will be expensive and time consuming.

Even if we are successful in building sales and marketing capabilities, we may not

be successful in commercializing any of our product candidates.

Any delays in commercialization or failure to successfully commercialize

any product candidate may have material adverse impacts on our business and ability to continue operations.

Our business could be adversely affected

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it is difficult to predict the impact of a future pandemic on our business.

Many countries around the world

imposed quarantines and restrictions on travel and mass gatherings in response to the COVID-19 pandemic and could reinstitute such policies

in response to future infectious disease outbreaks.

In such a scenario, 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 hybrid working

for our office-based staff, while our research staff has been actively working in our laboratory throughout the pandemic and thus far

have not experienced a significant disruption or delay in our operations as it relates to the clinical development, preclinical development

of manufacturing of our drug candidates.

Although we are adhering to health and safety protocols, an outbreak of infectious disease at

our facilities could nonetheless cause shutdowns of facilities and a reduction in our workforce, which could cause a disruption or delay

in such operations.

New outbreaks may further divert the attention and efforts of the medical community to coping with such outbreaks

and may disrupt the marketplace in which we operate and may have a material adverse effect on our operations.

Many countries around the

world imposed quarantines and restrictions on travel and mass gatherings in response to the COVID-19 pandemic and could reinstitute such

policies in response to future infectious disease outbreaks.

In such a scenario, 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.

New outbreaks may further divert the

attention and efforts of the medical community to coping with such outbreaks and may disrupt the marketplace in which we operate and

may have a material adverse effect on our operations.

Market disruption and volatility

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in employee resources or forced furlough of government employees.

We continue to monitor the

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

However, the ultimate impact from COVID-19 or any future pandemic

on our business operations and financial results during 2023 will depend on, among other things, the ultimate severity and scope of the

pandemic, including the new variants of the virus, and whether governmental and private travel restrictions and public concerns about

public gatherings are reinstated.

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

2022 and will have in 2023.

Our business is subject to cybersecurity

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

In June 2012, we acquired rights

to apamistamab, a clinical stage anti-CD45 monoclonal antibody with safety and efficacy data in more than 300 patients in need of a BMT.

Iomab-B is our product candidate that links I-131 to apamistamab that is being studied in the pivotal Phase 3 SIERRA trial.

Product candidates

utilizing apamistamab would require BLA approval before they can be marketed in the United States.

We are also evaluating Iomab-ACT, which

uses a lower dose I-131 for lymphodepletion prior to CAR-T or adoptive cell therapy.

We are currently evaluating clinical trials that

would use our construct for lymphodepletion.

Our CD33 Alpha program studying Actimab-A (lintuzumab-Ac-225) product candidate is also being

studied in several Phase 1 trials under our sponsorship and investigator-initiated trials in patients with r/r AML.

In June 2012, we acquired

rights to apamistamab, a clinical stage anti-CD45 monoclonal antibody with safety and efficacy data in more than 300 patients in need

Iomab-B is our product candidate that links I-131 to apamistamab that was studied in the pivotal Phase 3 SIERRA trial.

candidates utilizing apamistamab would require BLA approval before they can be marketed in the United States.

We are also evaluating Iomab-ACT,

which uses a lower dose I-131 for lymphodepletion prior to CAR-T or adoptive cell therapy.

We are currently evaluating clinical trials

that would use our construct for lymphodepletion.

Our CD33 Alpha program studying Actimab-A (lintuzumab-Ac-225) product candidate is also

being studied in several Phase 1 trials under our sponsorship and investigator-initiated trials in patients with r/r AML.

Product candidates

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

In the United States, the FDA

regulates pharmaceutical and biological product candidates under the FDCA and the Public Health Service Act (“PHSA”), as well

as their respective implementing 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.

The process required

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

In the United States, the FDA regulates pharmaceutical

and biological product candidates under the FDCA and the Public Health Service Act (“PHSA”), as well as their respective

implementing 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.

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;

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Each protocol and any amendments to the protocol must be submitted to the FDA as part of the IND.

Clinical trials must be

conducted and monitored in accordance with the FDA’s regulations composing the GCP requirements, including the requirement that

Clinical trials must

be conducted and monitored in accordance with the FDA’s regulations composing the GCP requirements, including the requirement that

all research subjects provide informed consent.

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requires substantial time and effort.

In December 2015, the FDA cleared

our IND filing for Iomab-B and we have completed patient enrollment of a randomized, controlled, pivotal Phase 3 clinical trial under

such IND to study Iomab-B in patients 55 years of age or older with relapsed or refractory AML.

The Phase 3 SIERRA trial met its primary

endpoint with high statistical significance with positive results for secondary endpoints and exploratory endpoints and it is expected

to form the basis for a BLA for Iomab-B for use in preparing and conditioning AML patients for a BMT.

Additionally, there are physician

IND trials at the FHCRC that have been conducted or are currently ongoing at FHCRC with Iomab-B (for other target indications) and the

apamistamab antibody (formerly known as BC8) we licensed.

We have other clinical trials ongoing and others that we have planned but not-yet

commenced, for our other drug candidate Actimab-A under our own sponsorship and investigator-initiated trials ongoing.

Except for Iomab-B

(for patients with AML), we expect that the clinical trials we need to conduct to be in a position to submit BLAs for our product candidates

currently in-development will take, at least, several years to complete.

Moreover, failure can occur at any stage of the trials, and we

could encounter problems that cause us to abandon or repeat clinical trials.

Also, the results of early preclinical and clinical testing

may not be predictive of the results of subsequent clinical trials.

A number of companies in the biopharmaceutical industry have suffered

significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding promising results

in earlier studies.

In December 2015, the FDA

cleared our IND filing for Iomab-B and we have completed patient enrollment of a randomized, controlled, pivotal Phase 3 clinical trial

under such IND to study Iomab-B in patients 55 years of age or older with relapsed or refractory AML.

The Phase 3 SIERRA trial met its

primary endpoint with high statistical significance with positive results for secondary endpoints and exploratory endpoints and it is

expected to form the basis for a BLA for Iomab-B for use in preparing and conditioning AML patients for a BMT.

Additionally, there are

physician IND trials at the FHCRC that have been conducted or are currently ongoing at FHCRC with Iomab-B (for other target indications)

and the apamistamab antibody (formerly known as BC8) we licensed.

We have other clinical trials ongoing and others that we have planned

but not-yet commenced, for our other drug candidate Actimab-A under our own sponsorship and investigator-initiated trials ongoing.

for Iomab-B (for patients with AML), we expect that the clinical trials we need to conduct to be in a position to submit BLAs for our

product candidates currently in-development will take, at least, several years to complete.

Moreover, failure can occur at any stage of

the trials, and we could encounter problems that cause us to abandon or repeat clinical trials.

Also, the results of early preclinical

and clinical testing may not be predictive of the results of subsequent clinical trials.

A number of companies in the biopharmaceutical

industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse safety profiles, notwithstanding

promising results in earlier studies.

And, preclinical and clinical data are often susceptible to multiple interpretations and analyses.

Many companies

that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have, nonetheless, failed

to obtain marketing approval of their products.

Success in preclinical testing and early clinical trials does not ensure that later clinical

trials, which involve many more subjects, and the results of later clinical trials may not replicate the results of prior clinical trials

and preclinical testing.

Any failure or substantial delay in our product development plans may have a material adverse effect on our business.

Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have, nonetheless,

failed to obtain marketing approval of their products.

Success in preclinical testing and early clinical trials does not ensure that later

clinical trials, which involve many more subjects, and the results of later clinical trials may not replicate the results of prior clinical

trials and preclinical testing.

Any failure or substantial delay in our product development plans may have a material adverse effect on

our business.

We may encounter substantial delays in our

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,

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 analysis of data from ongoing clinical trials.

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of our product candidates are time-consuming and expensive.

Initiating and completing clinical

trials necessary to support FDA approval of a BLA for Iomab-B, Actimab-A, and other product candidates, is a time-consuming and expensive

process, and the outcome is inherently uncertain.

Moreover, the results of early clinical trials are not necessarily predictive of future

results, and any product candidate we advance into clinical trials may not have favorable results in later clinical trials.

with the FDA to develop the SIERRA clinical trial to test the safety and efficacy of Iomab-B in patients with relapsed or refractory AML

who are age 55 and above prior to a BMT.

Initiating and completing

clinical trials necessary to support FDA approval of a BLA for Iomab-B, Actimab-A, and other product candidates, is a time-consuming and

expensive process, and the outcome is inherently uncertain.

Moreover, the results of early clinical trials are not necessarily predictive

of future results, and any product candidate we advance into clinical trials may not have favorable results in later clinical trials.

We worked with the FDA to develop the SIERRA clinical trial to test the safety and efficacy of Iomab-B in patients with relapsed or refractory

AML who are age 55 and above prior to a BMT.

This trial is designed to support a BLA filing for marketing approval by the FDA.

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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 also

disclose interim data from our preclinical studies and clinical trials.

Interim data from clinical trials that we may complete are subject

to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become

From time to time, we may

also disclose interim data from our preclinical studies and clinical trials.

Interim data from clinical trials that we may complete are

subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data

become available.

Adverse differences between interim data and final data could significantly harm our business prospects.

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candidates on a timely basis.

There can be no assurance that

the data generated in our clinical trials will be acceptable to FDA or that if future modifications during the trial are necessary, that

any such modifications will be acceptable to FDA.

Certain modifications to a clinical trial protocol made during the course of the clinical

trial have to be submitted to the FDA.

There can be no assurance

that the data generated in our clinical trials will be acceptable to FDA or that if future modifications during the trial are necessary,

that any such modifications will be acceptable to FDA.

Certain modifications to a clinical trial protocol made during the course of the

clinical trial have to be submitted to the FDA.

This could result in the delay or halt of a clinical trial while the modification is evaluated.

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injunctions or the imposition of civil or criminal penalties.

The FDA’s and other regulatory

authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory

approval of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise from future

legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes in existing

requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any

marketing approval that we may have obtained, and we may not achieve or sustain profitability.

The FDA’s and other

regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay

regulatory approval of our product candidates.

We cannot predict the likelihood, nature or extent of government regulation that may arise

from future legislation or administrative action, either in the United States or abroad.

If we are slow or unable to adapt to changes

in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we

may lose any marketing approval that we may have obtained, and we may not achieve or sustain profitability.

Coverage and reimbursement may be limited

or unavailable in certain market segments for our product candidates which could limit our sales of our product candidates, if approved.

The commercial success of our

product candidates in both domestic and international markets will be substantially dependent on whether third-party coverage and reimbursement

is available for patients that use our products.

However, the availability of insurance coverage and reimbursement for newly approved

cancer therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products are approved

by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or part of the product cost

by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations and other third-party payors are increasingly

attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as a result, they may

not cover or provide adequate payment for these products.

Submission of applications for reimbursement approval generally does not occur

prior to the filing of a BLA for that product and may not be granted until many months after BLA approval.

In order to obtain coverage

and reimbursement for these products, we or our commercialization partners may have to agree to a net sales price lower than the net sales

price we might charge in other sales channels.

The continuing efforts of government and third-party payors to contain or reduce the costs

of healthcare may limit our revenue.

Initial dependence on the commercial success of our products may make our revenues particularly susceptible

to any cost containment or reduction efforts.

The commercial success of

our product candidates in both domestic and international markets will be substantially dependent on whether third-party coverage and

reimbursement is available for patients that use our products.

However, the availability of insurance coverage and reimbursement for newly

approved cancer therapies is uncertain, and therefore, third-party coverage may be particularly difficult to obtain even if our products

are approved by the FDA as safe and efficacious.

Patients using existing approved therapies are generally reimbursed all or part of the

product cost by Medicare or other third-party payors.

Medicare, Medicaid, health maintenance organizations and other third-party payors

are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement of new drugs, and, as

a result, they may not cover or provide adequate payment for these products.

Submission of applications for reimbursement approval generally

does not occur prior to the filing of a BLA for that product and may not be granted until many months after BLA approval.

obtain coverage and reimbursement for these products, we or our commercialization partners may have to agree to a net sales price lower

than the net sales price we might charge in other sales channels.

The continuing efforts of government and third-party payors to contain

or reduce the costs of healthcare may limit our revenue.

Initial dependence on the commercial success of our products may make our revenues

particularly susceptible to any cost containment or reduction efforts.

Healthcare legislative reform measures intended

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purchase a manufacturing facility, we may not realize the expected benefits of these efforts.

We depend on vendors with specialized

operations, equipment and know-how to manufacture the respective components of our drug candidates.

We depend on vendors with

specialized operations, equipment and know-how to manufacture the respective components of our drug candidates.

We have entered into manufacturing

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our reputation may suffer.

Any of these events could substantially

increase the costs and expenses of developing, commercializing and marketing any such product candidates or could harm or prevent sales

of any approved products.

Any of these events could

substantially increase the costs and expenses of developing, commercializing and marketing any such product candidates or could harm or

prevent sales of any approved products.

Risks Related to Our Intellectual Property

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Litigation may also absorb significant management time.

Unpatented trade secrets, improvements,

confidential know-how and continuing technological innovation are important to our scientific and commercial success.

Although we attempt

to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of confidentiality

agreements with our partners, collaborators, employees and consultants and other appropriate means, these measures may not effectively

prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access to, the same

or similar information.

In addition, we cannot guarantee that we have executed these agreements with each party that may have or have

had access to our trade secrets.

Furthermore, if the employees and consultants who are parties to these agreements breach or violate the

terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade secrets through

such breaches or violations.

Unpatented trade secrets,

improvements, confidential know-how and continuing technological innovation are important to our scientific and commercial success.

we attempt to and will continue to attempt to protect our proprietary information through reliance on trade secret laws and the use of

confidentiality agreements with our partners, collaborators, employees and consultants and other appropriate means, these measures may

not effectively prevent disclosure of our proprietary information, and, in any event, others may develop independently, or obtain access

to, the same or similar information.

In addition, we cannot guarantee that we have executed these agreements with each party that may

have or have had access to our trade secrets.

Furthermore, if the employees and consultants who are parties to these agreements breach

or violate the terms of these agreements, we may not have adequate remedies for any such breach or violation, and we could lose our trade

secrets through such breaches or violations.

Certain of our patent rights

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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 personnel.

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 personnel.

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.

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 personnel.

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 personnel.

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

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

Our research, development and

manufacturing activities involve the controlled use of hazardous materials, including chemicals, radioactive and biological materials,

Our research, development

and manufacturing activities involve the controlled use of hazardous materials, including chemicals, radioactive and biological materials,

such as radioactive isotopes.

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business strategy.

Our future operations and successes

depend in large part upon the continued service of key members of our senior management team whom we are highly dependent upon to manage

our business.

If any member of our current senior management terminates his or her 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.

Our future operations and

successes depend in large part upon the continued service of key members of our senior management team whom we are highly dependent upon

to manage our business.

If any member of our current senior management terminates his or her 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.

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

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may strain our resources.

We expect to need to grow rapidly

in order to support additional, larger, and potentially international, pivotal clinical trials of our product candidates as well as potential

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

In order to achieve

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

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

All of these activities will increase our expenses

and may require us to raise additional capital sooner than expected.

Failure to manage growth effectively could materially harm our business,

financial condition or results of operations.

We expect to need to grow

rapidly in order to support additional, larger, and potentially international, pivotal clinical trials of our product candidates as well

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

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.

All of these activities will increase our

expenses and may require us to raise additional capital sooner than expected.

Failure to manage growth effectively could materially harm

our business, financial condition or results of operations.

We may expand our business through the acquisition

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employees of the acquired companies.

We can make no assurances that

any acquisition will result in short-term or long-term benefits to us.

We may incorrectly judge the value or worth of an acquired product,

company or business.

In addition, our future success would depend in part on our ability to manage the rapid growth associated 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 can make no assurances

that any acquisition will result in short-term or long-term benefits to us.

We may incorrectly judge the value or worth of an acquired

product, company or business.

In addition, our future success would depend in part on our ability to manage the rapid growth associated

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.

Risks Related to Ownership of Our Common Stock

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lead to losses by stockholders and potential costly security litigation.

The trading volume of our common

stock has been and may continue to be extremely limited and sporadic.

We expect the market price of our common stock to fluctuate substantially

due to a variety of factors, including market perception of our ability to achieve our planned growth, quarterly operating results of

other companies in the same industry, trading volume in our common stock, changes in general conditions in the economy and the financial

markets or other developments affecting our competitors or us.

This volatility has had a significant effect on the market price of securities

issued by many companies for reasons unrelated to their operating performance and could have the same effect on our common stock.

The trading volume of our

common stock has been and may continue to be extremely limited and sporadic.

We expect the market price of our common stock to fluctuate

substantially due to a variety of factors, including market perception of our ability to achieve our planned growth, quarterly operating

results of other companies in the same industry, trading volume in our common stock, changes in general conditions in the economy and

the financial markets or other developments affecting our competitors or us.

This volatility has had a significant effect on the market

price of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our

common stock.

The trading price of our common

20 unchanged sentences

common stock, so any returns will be determined by the value of our common stock.

We have never declared or paid

any cash dividends on our common stock.

We have never declared or

paid any cash dividends on our common stock.

For the foreseeable future, it is expected that earnings, if any, generated from our operations

35 unchanged sentences

In addition, we will incur substantial expenses in connection with the

preparation of registration statements and related documents with respect any offerings of our common stock.

preparation of registration statements and related documents with respect to any offerings of our common stock.

Our ability to utilize our net operating

63 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