What changed in this filing

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Item 1A. Risk Factors

2023-08-14 compared with 2023-05-15 · 312 added, 344 removed, 1381 unchanged (32% 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 success of Iomab-B and the SIERRA trial and we may not be able to complete the necessary clinical development or our development efforts may not result in the data necessary to receive regulatory approval;

We are highly dependent on the regulatory and commercial success of

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

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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;

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

Any disruption in the operations of our current third-party manufacturers, 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;

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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 March 31, 2023 and December 31, 2022, we had an accumulated deficit of

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 $11.0 million and $5.1 million for the three months ended March

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

2023 and 2022, respectively.

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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 our control.

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

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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will be materially adversely affected.

We are highly dependent on the success of

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

result in the data necessary to receive regulatory approval.

We have completed patient

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 will compare outcomes of patients who receive Iomab-B and a BMT to those 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).

The SIERRA trial may be unsuccessful

and fail to demonstrate a safety and efficacy profile that is necessary to receive favorable regulatory approval.

Even if Iomab-B receives

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

We are highly dependent on the regulatory

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.

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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

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.

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

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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

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.

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.

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.

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 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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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.

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

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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.

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.

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.

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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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;

of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical

interpretation of data by the FDA or similar foreign regulatory authorities;

to achieve primary or secondary endpoints or other failure to demonstrate efficacy;

safety issues;

of adequate funding to continue the clinical trial.

inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;

varying interpretation of data by the FDA or similar foreign regulatory authorities;

failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy;

unforeseen safety issues;

lack of adequate funding to continue the clinical trial.

Modifications to our product candidates

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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.

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.

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.

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

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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, in February

2023 we announced that Iomab-B met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001).

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

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.

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 February 2023 we announced that Iomab-B

met the primary endpoint of dCR in the SIERRA trial with statistical significance (p<0.0001) producing a durable Complete Response

rate of 22% compared to a 0% durable Complete Response rate in the control arm.

We may 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

Our clinical trials may be open label studies and certain of our clinical development and or operations staff may review interim

or preliminary safety or efficacy data during routine data collection, cleaning and analysis from time to time.

Interim or preliminary

results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such

results once additional data have been received and fully evaluated.

Preliminary, interim or top-line data also remain subject to audit

and verification procedures that may result in the final data being materially different from the top-line, interim or preliminary data

we previously published.

As a result, top-line, interim and preliminary data should be viewed with caution until the final data are available.

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

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

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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 ongoing and planned clinical trials including investigator-initiated trials in AML 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 including future studies conducted under our CRADA with the NCI.

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

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We may experience difficulties in patient enrollment in our clinical trials for a variety of reasons, including:

size and nature of the patient population;

patient eligibility criteria defined in the protocol;

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

proximity of patients to trial sites;

design of the trial;

ability to recruit clinical trial investigators with the appropriate competencies and expertise;

clinical trials for similar or alternate therapeutic treatments;

● clinician’s

and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to

other available therapies;

ability to obtain and maintain patient consents;

risk that patients enrolled in clinical trials will not complete a clinical trial.

the size and nature of the patient population;

the patient eligibility criteria defined in the protocol;

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

the proximity of patients to trial sites;

the design of the trial;

our ability to recruit clinical trial investigators with the appropriate competencies and expertise;

competing clinical trials for similar or alternate therapeutic treatments;

clinician’s and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies;

our ability to obtain and maintain patient consents;

the risk that patients enrolled in clinical trials will not complete a clinical trial.

In addition, refractory patients,

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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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in, among other things:

● restrictions

on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product

warning letters or holds on clinical trials;

by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license

seizure or detention, or refusal to permit the import or export of our product candidates;

● 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.

restrictions on the marketing or manufacturing of our product candidates, withdrawal of the product from the market, or voluntary or mandatory product recalls;

fines, warning letters or holds on clinical trials;

refusal by the FDA to approve pending applications or supplements to approved applications filed by us or suspension or revocation of license approvals;

product seizure or detention, or refusal to permit the import or export of our product candidates;

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.

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.

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.

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.

Healthcare legislative reform measures intended

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healthcare laws and regulations that may affect our operations, directly or indirectly, include the following, among others:

federal Anti-Kickback Statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting, offering,

receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual

for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal

and state healthcare programs such as Medicare and Medicaid;

federal false claims laws, including civil whistleblower or qui tam actions under the federal False Claims Act, which impose criminal

and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the

federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation

to pay money to the federal government;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic

and Clinical Health Act of 2009, or HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to

defraud any healthcare benefit program or making false statements relating to healthcare matters and also imposes obligations, including

mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses,

and their respective business associates that create, receive, maintain or transmit individually identifiable health information for

or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission

of individually identifiable health information;

federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or

state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of

a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception

federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires certain

manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of value

provided to physicians and any ownership and investment interests held by physicians or their immediate family members.

2022, applicable manufacturers also will be required to report such information regarding payments and other transfers of value to physician

assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and

certified nurse midwives during the previous year;

state laws and regulations, including (among others) state anti-kickback and false claims laws, which may apply to our business practices,

including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services

reimbursed by any third-party payor, including private insurers;

state laws that require pharmaceutical companies to comply with the

pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the United States

federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information and that require tracking

gifts and other remuneration and items of value provided to healthcare professionals and entities;

state and local laws that require

the registration of pharmaceutical sales representatives;

and state laws governing the privacy and security of health information in

certain circumstances, many of which differ from each other in significant ways and often are not preempted by federal law, thus complicating

compliance efforts.

the federal Anti-Kickback Statute, which prohibits persons and entities from, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid;

the federal false claims laws, including civil whistleblower or qui tam actions under the federal False Claims Act, which impose criminal and civil penalties against individuals or entities for, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, which imposes criminal and civil liability for, among other things, executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters and also imposes obligations, including mandatory contractual terms, on covered entities, including certain healthcare providers, health plans, and healthcare clearinghouses, and their respective business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of the covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the federal Civil Monetary Penalties Law, which prohibits, among other things, the offering or transfer of remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies;

the federal Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually information related to certain payments or other transfers of value provided to physicians and any ownership and investment interests held by physicians or their immediate family members.

Beginning in 2022, applicable manufacturers also will be required to report such information regarding payments and other transfers of value to physician assistants, nurse practitioners, clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists and certified nurse midwives during the previous year;

analogous state laws and regulations, including (among others) state anti-kickback and false claims laws, which may apply to our business practices, including, but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers;

state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the United States federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources;

state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information and that require tracking gifts and other remuneration and items of value provided to healthcare professionals and entities;

state and local laws that require the registration of pharmaceutical sales representatives;

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

Efforts to comply with applicable

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market acceptance.

Iomab-B, Actimab-A product

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

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

and reliability of the product;

Iomab-B, Actimab-A and future

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

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

of the product;

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

the availability, relative

cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments using the product are approved

for reimbursement by public and private insurers;

the availability, relative cost and perceived

advantages and disadvantages of alternative technologies;

the degree to which treatments using the product are approved for reimbursement

by public and private insurers;

the strength of our marketing and distribution infrastructure;

and the level of education

and awareness among physicians and hospitals concerning the product.

and the level of education and awareness

among physicians and hospitals concerning the product.

We believe that oncologists

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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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in a number of potentially significant negative consequences, including:

authorities may withdraw their approval of the product;

authorities may require the addition of labeling statements, such as warnings or contraindications;

may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

may elect, or we may be required, to recall or withdraw product from the market;

could be sued and held liable for harm caused to patients;

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.

regulatory authorities may withdraw their approval of the product;

regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

we may be required to change the way the product is administered, conduct additional clinical trials or change the labeling of the product;

we may elect, or we may be required, to recall or withdraw product from the market;

we could be sued and held liable for harm caused to patients;

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.

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.

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.

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.

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.

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

Specific to the

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

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

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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.

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 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 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

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

or anticipated variations in our operating results;

● announcements

of developments by us or our competitors;

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

actions regarding our products;

● announcements

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

of new accounting standards affecting our industry;

or departures of key personnel;

● introduction

of new products by us or our competitors;

of our common stock or other securities in the open market;

or unfavorable reports from securities or industry analysts;

events or factors, many of which are beyond our control.

actual or anticipated variations in our operating results;

announcements of developments by us or our competitors;

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

regulatory actions regarding our products;

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

adoption of new accounting standards affecting our industry;

additions or departures of key personnel;

introduction of new products by us or our competitors;

sales of our common stock or other securities in the open market;

inaccurate or unfavorable reports from securities or industry analysts;

other events or factors, many of which are beyond our control.

The stock market is subject

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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

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stock will appreciate in value.

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.

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.

Provisions of our certificate

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Among other things, the certificate of incorporation and bylaws:

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;

the board of directors into three classes;

that stockholders seeking to present proposals before a meeting of stockholders or to nominate candidates for election as directors at

a meeting of stockholders must provide notice in writing in a timely manner, and meet specific requirements as to the form and content

of a stockholder’s notice;

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

provide that all vacancies, including newly-created directorships, may, except as otherwise required by law, be filled by the affirmative vote of a majority of directors then in office, even if less than a quorum;

divide the board of directors into three classes;

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

In addition, we are governed

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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