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Item 1A. Risk Factors

2022-11-14 compared with 2022-08-12 · 293 added, 287 removed, 1377 unchanged (30% of the section changed)

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.

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.

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.

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 of

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 September 30, 2022, and December 31, 2021, we had an accumulated deficit

of $278.1 million and $255.7 million, respectively.

We reported a net loss of $22.3 million and $16.8 million for the nine months ended

September 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.

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.

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.

We may further have to license our technology to others.

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;

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;

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.

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.

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.

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

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.

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

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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).

The SIERRA trial may be unsuccessful

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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 effectiveness of COVID-19 vaccines and boosters 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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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.

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 COVID-19 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.

Certain 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 further divert the attention and efforts of the medical community to coping with COVID-19, and may

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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Additionally, COVID-19 may

result in delays in receiving approvals from domestic and foreign regulatory authorities, delays in necessary interactions with Institutional

Review Boards (“IRBs”), domestic and foreign regulators, ethics committees and other important agencies and contractors due

to limitations in employee resources or forced furlough of government employees.

result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s

or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors due to limitations

in employee resources or forced furlough of government employees.

We continue to monitor the

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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

variants of the virus, the possible imposition of 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.

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

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.

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

We are in the

early stages of evaluating other product candidates consisting of conjugates of Ac-225 with human or humanized antibodies for pre-clinical

and clinical development in other types of cancer.

The FDA may not approve these products for the indications that are necessary or desirable

for successful commercialization.

The FDA may fail to approve any BLA we submit for new product candidates or for new intended uses or

indications for approved products or future product candidates.

Failure to obtain FDA approval for our products in the proposed indications

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

The approval process in the

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

Assuming the Phase 3 trial meets

its endpoints and there are no unexpected issues or delays, 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.

have multiple Phase 1 and Phase 2 clinical trials ongoing and others that we have planned but not-yet commenced, for our other drug candidates

under our own sponsorship and multiple 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.

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.

The Phase 3 trial SIERRA trial has

met its primary endpoint assuming there are no unexpected issues or delays, including with secondary endpoints, 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.

And, we have multiple Phase 1 and Phase 2 clinical trials ongoing and others that we have

planned but not-yet commenced, for our other drug candidates under our own sponsorship and multiple 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.

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.

We may encounter substantial delays in our

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condition and results of operation.

The FDA or comparable foreign regulatory

authorities may disagree with our regulatory plans, and we may fail to obtain regulatory approval of 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

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 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 utilizing the lintuzumab

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

We are in the early stages of evaluating other product

candidates consisting of conjugates of Ac-225 with human or humanized antibodies for pre-clinical and clinical development in other types

The FDA may not approve these products for the indications that are necessary or desirable for successful commercialization.

The FDA may fail to approve any BLA we submit for new product candidates or for new intended uses or indications for approved products

or future product candidates.

Failure to obtain FDA approval for our products in the proposed indications would have a material adverse

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

Clinical trials necessary to support approval

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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

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

more comprehensive review of the data related to the particular study or trial.

For example, at the ASH annual meeting in December 2021

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 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 more comprehensive review of the data related

to the particular study or trial.

For example, in October 2022 we announced that Iomab-B met the primary endpoint of dCR in the SIERRA

trial with statistical significance (p<0.0001).

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.

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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we have licensed has expired or likely expired.

The key patents related to the

humanized antibody, lintuzumab, which we use in our CD33 program product candidates have expired.

The key patents related to

the humanized antibody, lintuzumab, which we use in our CD33 program product candidates have expired.

It is generally possible that others

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Our CD33 program is comprised

of several clinical trials including investigator-initiated trials in AML that are studying the same drug construct consisting of lintuzumab-Ac-225.

Negative results from any of these trials could negatively impact our ability to enroll or complete our other trials studying lintzumab-Ac-225.

Additionally, negative outcomes including safety concerns, may result in the FDA discontinuing other trials utilizing lintuzumab-Ac-225.

of several clinical trials including investigator-initiated trials in r/r AML that are studying the same drug construct consisting of

lintuzumab-Ac-225.

Negative results from any of these trials could negatively impact our ability to enroll or complete our other trials

studying lintzumab-Ac-225.

Additionally, negative outcomes including safety concerns, may result in the FDA discontinuing other trials

utilizing lintuzumab-Ac-225.

We may be unable to obtain a sufficient

supply of isotopes to support clinical development or at commercial scale.

Iodine-131 is a key component

of our Iomab-B drug candidate.

We currently source medical grade I-131 from three suppliers including two leading global manufacturers.

Currently, there is sufficient supply of I-131 to advance our ongoing SIERRA clinical trial, support additional trials we may undertake

utilizing I-131 and for commercialization of Iomab-B.

We continually evaluate I-131 manufacturers and suppliers and intend to have multiple

qualified suppliers prior to the commercial launch of Iomab-B.

While we consider I-131 to be commoditized and obtainable through several

suppliers, there can be no guarantee that we will be able to secure I-131 or obtain I-131 on terms that are acceptable to us.

Actinium-225 is a key component

of our CD33 ARC program, AWE platform and other drug candidates that we might consider for development with the Ac-225 payload.

are adequate quantities of Ac-225 available today to meet our current needs via our present supplier, the Department of Energy (“DOE”).

The current Ac-225 currently supplied to Actinium’s clinical trials from the DOE is derived from the natural decay of thorium-229

from so-called ‘thorium-cows’ and is able to produce sufficient quantities that are several multiples of the amount of Ac-225

we require to supply our clinical programs through to early commercialization phase.

The DOE is also producing Ac-225 from a recently

developed alternative route for Ac-225 production via a linear accelerator that is currently being evaluated by Actinium.

Initial preclinical

and modelling results have indicated that the linear accelerator sourced Ac-225 does not impact labelling efficiency and expected distribution.

In accordance with representations made by the DOE, the capacity of Ac-225 from this route is expected to be sufficient to supply all

of Actinium’s pipeline and commercial Ac-225 needs and support new program expansion by not just Actinium but also other companies

that are developing Ac-225 based products.

Additional routes of Ac-225 production are being pursued by the DOE including the generation

of new thorium cows and production via a cyclotron.

The cyclotron production method for Ac-225 production leverages Actinium’s proprietary

technology and know-how and presents an additional path towards production of high-quality Ac-225 that would be able to satisfy commercial

In addition, we are aware of at least six other government and non-government entities globally including the U.S., Canada, Russia,

Belgium, France and Japan that have, or expect to have ability to supply Ac-225 or equipment for its production within the timeframes

Iodine-131 is a key component of our Iomab-B drug candidate.

source medical grade I-131 from three suppliers including two leading global manufacturers.

Currently, there is sufficient supply of I-131

to support additional trials we may undertake utilizing I-131 and for commercialization of Iomab-B.

We continually evaluate I-131 manufacturers

and suppliers and intend to have multiple qualified suppliers prior to the commercial launch of Iomab-B.

While we consider I-131 to be

commoditized and obtainable through several suppliers, there can be no guarantee that we will be able to secure I-131 or obtain I-131

on terms that are acceptable to us.

Actinium-225 is a key

component of our CD33 Alpha program, AWE platform and other drug candidates that we might consider for development with the Ac-225

There are adequate quantities of Ac-225 available today to meet our current needs via our present supplier, the Department

of Energy (“DOE”).

The Ac-225 currently supplied to Actinium’s clinical trials from the DOE is derived from the

natural decay of thorium-229 from so-called ‘thorium-cows’ and is able to produce sufficient quantities that are several

multiples of the amount of Ac-225 we require to supply our clinical programs through to early commercialization phase.

also producing Ac-225 from a recently developed alternative route for Ac-225 production via a linear accelerator that is currently

being evaluated by Actinium.

Initial preclinical and modelling results have indicated that the linear accelerator sourced Ac-225

does not impact labelling efficiency and expected distribution.

In accordance with representations made by the DOE, the capacity of

Ac-225 from this route is expected to be sufficient to supply all of Actinium’s pipeline and commercial Ac-225 needs and

support new program expansion by not just Actinium but also other companies that are developing Ac-225 based products.

routes of Ac-225 production are being pursued by the DOE including the generation of new thorium cows and production via a

The cyclotron production method for Ac-225 production leverages Actinium’s proprietary technology and know-how and

presents an additional path towards production of high-quality Ac-225 that would be able to satisfy commercial needs.

we are aware of at least six other government and non-government entities globally including the U.S., Canada, Russia, Belgium,

France and Japan that have, or expect to have ability to supply Ac-225 or equipment for its production within the timeframes

relevant to the potential first commercial approval of our Ac-225 ARC.

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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.

Failure to acquire sufficient quantities of medical grade Ac-225 at a cost

effective price 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

trials to advance our ARC drug candidates is dependent on our ability to obtain the radioisotopes I-131, Ac-225 and other isotopes we

may choose to utilize in the future.

trials to advance our drug candidates is dependent on our ability to obtain the radioisotopes I-131, Ac-225 and other isotopes we may

choose to utilize in the future.

Currently, we are dependent on third party manufacturers and suppliers for our isotopes.

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the patient eligibility criteria defined in the protocol;

the size of the study population required for analysis of the trial’s primary endpoints;

the size of the study

population required for analysis of the trial’s primary and secondary endpoints;

the proximity of patients to trial sites;

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and the potential success of our vaccine candidates.

Most recently, on August 16,

2022, President Biden signed into law the Inflation Reduction Act of 2022 (the “IRA Act”), which, among

other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

Specifically,

the IRA Act authorizes and directs the Department of Health and Human Services (the “DHHS”) to set drug price caps for certain

high-cost Medicare Part B and Part D qualified drugs, with the initial list of drugs to be selected by September 1, 2023, and the first

year of maximum price applicability to begin in 2026.

The IRA Act further authorizes the DHHS to penalize pharmaceutical manufacturers

that increase the price of certain Medicare Part B and Part D drugs faster than the rate of inflation.

Finally, the IRA Act creates significant

changes to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning

We cannot be sure whether additional or related legislation or rulemaking will be issued or enacted, or what impact, if any,

such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

Our relationships with customers, health

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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.

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.

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 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.

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.

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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 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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It is particularly difficult

to recruit and hire new employees during the COVID-19 pandemic as conducting interviews remotely makes it more difficult to ensure we

are recruiting and hiring high-quality employees, and the uncertainty created by the COVID-19 pandemic makes it less likely potential

candidates will be willing to leave a stable job to explore a new opportunity.

There can be no assurance that such professionals will

be available in the market, or that we will be able to retain existing professionals or meet or continue to meet their compensation requirements.

Furthermore, the cost base in relation to such compensation, which may include equity compensation, may increase significantly, which

could have a material adverse effect on us.

to recruit and hire new employees during the COVID-19 pandemic as the uncertainty created by the COVID-19 pandemic makes it less likely

potential candidates will be willing to leave a stable job to explore a new opportunity.

There can be no assurance that such professionals

will be available in the market, or that we will be able to retain existing professionals or meet or continue to meet their compensation

requirements.

Furthermore, the cost base in relation to such compensation, which may include equity compensation, may increase significantly,

which could have a material adverse effect on us.

Failure to establish and maintain an effective management team and workforce could adversely

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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;

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;

divide the board of directors into three classes;

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1A. Risk Factors