What changed in this filing

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Item 1A. Risk Factors

2026-03-30 compared with 2025-03-31 · 867 added, 713 removed, 1304 unchanged (55% of the section changed)

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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;

We have incurred net

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

If we fail to obtain additional

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your entire investment;

are highly dependent on the clinical, regulatory and commercial success of Iomab-B, Actimab-A, Iomab-ACT and other pipeline candidates

which we may never achieve;

We are highly dependent

on the clinical, regulatory and commercial success of ATNM-400, Actimab-A, Iomab-ACT, ATNM-400 and other pipeline candidates which

we may never achieve;

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;

We continuously evaluate

our business strategy and may modify our strategy as necessary to respond to developments in our business and other factors, and

any such modification, if not successful, could have a material adverse effect on our business, financial condition, and results

of operations;

any such modification such as a divestiture, spin-off, spin-out, merger or acquisition, if not successful, could have a material

adverse effect on our business, financial condition, and results of operations;

We may expand our business through the acquisition

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

ownership interests in our company;

Our business could be adversely

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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;

that any of our products are safe or 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

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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 the U.S.

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

in the healthcare industry and in healthcare spending could adversely affect our grant funded clinical programs, business, financial

condition and results of operations

“top-line” data from our clinical trials that we announce or publish from time to time may change as more 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 regulation of the U.S.

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

of operations;

Changes in the healthcare

industry and in healthcare spending could adversely affect our grant funded clinical programs, business, financial condition and

results of operations;

We may rely on third parties

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

Disruptions at the FDA

and other government agencies caused by leadership changes, changes to regulatory approach, layoffs, funding shortages or global

health concerns could negatively impact our business;

Our ability to advance clinical development of trials under our CRADA,

obtain regulatory interactions/approvals, or secure government-funded grants may be delayed or disrupted by federal government shutdowns

such as the shutdown that began October 1, 2025 and ended on November 12, 2025, as it curtailed operations of key agencies such as the

FDA and the National Institutes of Health (“NIH”);

Our patent position is

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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

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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 December 31, 2024 and December 31, 2023, we had

an accumulated deficit of $375.8 million and $337.6 million, respectively.

We reported a net loss of $38.2 million and $48.8 million

for the years ended December 31, 2024 and 2023, 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.

have incurred net losses 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 December 31, 2025 and December 31, 2024, we had an accumulated deficit

of $409.7 million and $375.8 million, respectively.

We reported a net loss of $33.9 million and $38.2 million for the years ended December

31, 2025 and 2024, respectively.

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

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

There can be no assurance that the

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

Furthermore, there can be no assurance that

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

financial condition and results of operation.

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

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financial condition and our continued viability will be materially adversely affected.

are highly dependent on the clinical, regulatory and commercial success of Actimab-A, Iomab-ACT and other pipeline candidates

which we may never achieve

are highly dependent on the clinical, regulatory and commercial success of ATNM-400, Actimab-A, Iomab-ACT, ATNM-400 and other pipeline

candidates which we may never achieve

of the drug candidates we are developing, or have developed, have received regulatory approval.

Based on the current status of our pipeline

candidates, it will likely take several years or additional clinical studies before we can seek approval for any drug candidate.

Our Actimab-A drug candidate

was studied in a Phase 2 clinical trial as a monotherapy and we are now studying it in combination with other therapies.

We have aligned

with the FDA on an operationally seamless Phase 2/3 trial that is intended to support a BLA filing.

There can be no assurance that the

Phase 2 portion of the trial will be successful and support advancing to the Phase 3 portion of the trial.

In addition, our Iomab-ACT

drug candidate has only been studied in a limited number of human subjects in a Phase 1 trial with a novel CAR-T therapy.

While the initial

results from this trial were encouraging, there can be no assurance that future results with Iomab-ACT from the commercial CAR-T trial

at UTSW or sickle cell conditioning trial at Columbia will be positive.

for Iomab-B in particular, as previously disclosed, we completed the pivotal Phase 3 SIERRA trial (Study of Iomab-B in Elderly Relapsed

candidates, it will likely take several years and additional clinical studies before we can seek approval for any drug candidate.

ATNM-400 is currently being studied preclinically and has not yet been

studied in human subjects.

There can be no assurances that we will advance ATNM-400 into clinical trials and even if we are successful

in doing so, our preclinical results to date may not translate in connection with human subjects.

Our Actimab-A drug candidate was studied

in a Phase 2 clinical trial as a monotherapy, and we are now studying it in combination with other therapies.

We believe we have aligned

with the FDA on a Phase 2/3 trial that is intended to support a BLA filing.

There can be no assurance that the Phase 2 portion of the

trial will be successful and support advancing to the Phase 3 portion of the trial.

In addition, our Iomab-ACT drug candidate has only

been studied in a limited number of human subjects in a Phase 1 trial with a novel CAR-T therapy.

While we believe the initial results

from this trial were encouraging, there can be no assurance that future results with Iomab-ACT from the commercial CAR-T trial at UTSW

or sickle cell conditioning trial at Columbia will be positive.

for Iomab-B in particular, as previously disclosed, we completed the Phase 3 SIERRA trial (Study of Iomab-B in Elderly Relapsed

or Refractory AML) and presented the trial results in February 2023, which were expected to support a BLA filing.

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the primary endpoint of dCR with statistical significance (p-value<0.0001) but did not meet the secondary endpoint in achieving a

statistically significant improvement in overall survival in the intent to treat population.

On August 5, 2024, we announced that the

FDA determined that the SIERRA trial alone is not adequate to support a BLA filing and is requiring an additional randomized head-to-head

clinical trial to demonstrate an overall survival benefit in an intent to treat population.

Further, the FDA is also requiring an additional

dose optimization trial to calculate the dose of Iomab-B based on absorbed dose by the bone marrow, rather than the maximum tolerable

dose of 24 Gy of radiation to the liver as was done in the SIERRA trial based on several interactions with the FDA prior to the start

of the SIERRA trial.

Based on this revised approach now required by the FDA, the safety and efficacy data generated from all Iomab-B

studies, including the SIERRA trial, are inadequate to seek regulatory approval for Iomab-B, as dosing based on maximum tolerable dose

of 24 Gy to the liver will lead to variable doses to the bone marrow (the target organ), result in underdosing or overdosing of patients

and translate to a global patient safety risk.

statistically significant improvement in OS in the intent to treat population.

On August 5, 2024, we announced that the FDA determined

that the SIERRA trial alone is not adequate to support a BLA filing and is requiring an additional randomized head-to-head clinical trial

to demonstrate an OS benefit in an intent to treat population.

Further, the FDA is also requiring an additional dose optimization trial

to calculate the dose of Iomab-B based on absorbed dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation

to the liver as was done in the SIERRA trial based on several interactions with the FDA prior to the start of the SIERRA trial.

on this revised approach now required by the FDA, the safety and efficacy data generated from all Iomab-B studies, including the SIERRA

trial, are inadequate to seek regulatory approval for Iomab-B, as dosing based on maximum tolerable dose of 24 Gy to the liver will lead

to variable doses to the bone marrow (the target organ), result in underdosing or overdosing of patients and translate to a global patient

We are seeking a strategic partner for the U.S.

in order to conduct the additional studies

required by the FDA;

however, we may not be successful in our efforts to find such a partner, or the trials and studies may not be successful.

Further, there are no assurances that we can satisfy all of the FDA’s requests, and there could be additional regulatory hurdles

that may result in either non-acceptance or non-approval of a future BLA filing.

commercial opportunity for Iomab-B may thus

never be realized.

As previously disclosed and noted above, Actinium has licensed to Immedica

the exclusive product rights for commercialization of Iomab-B in the EUMENA region.

We are evaluating the impact of the FDA’s 2024

determination of the SIERRA trial results in the context of global regulatory submissions for Iomab-B.

At this time, filings for regulatory

approval, obtaining regulatory approvals, and successful commercialization of Iomab-B in the EUMENA region and on a global basis are highly

uncertain and may never be realized.

in order to conduct the additional studies required by the FDA;

we may not be successful in our efforts to find such a partner, or the trials and studies may not be successful.

Further, there are no

assurances that we can satisfy all of the FDA’s requests, and there could be additional regulatory hurdles that may result in either

non-acceptance or non-approval of a future BLA filing.

commercial opportunity for Iomab-B may thus never be realized.

previously disclosed and noted above, Actinium has licensed to Immedica the exclusive product rights for commercialization of Iomab-B

in the EUMENA region.

We are evaluating the impact of the FDA’s 2024 determination of the SIERRA trial results in the context of

global regulatory submissions for Iomab-B.

At this time, filings for regulatory approval, obtaining regulatory approvals, and successful

commercialization of Iomab-B in the EUMENA region and on a global basis are highly uncertain and may never be realized.

We are highly dependent on our key personnel,

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

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.

In February 2026, Steve

O’Loughlin tendered his resignation as the Chief Financial Officer of our Company.

To fill this executive vacancy, our Board

appointed Sandesh Seth, the current Chairman and Chief Executive Officer of the Company, to serve as our principal financial

In the second quarter of 2025, we conducted a workforce optimization that reduced our headcount by approximately

fourteen percent and announced a strategic pipeline prioritization which led to further departures from the workforce in 2025.

In the third quarter of 2024, our overall headcount was reduced

by approximately twenty percent, with a majority of departures coming from our clinical and CMC groups.

We do not expect these

departures to have a material impact on our operations or ability to execute our operating plan and are actively seeking a strategic

partner for Actimab-A and Iomab-B in the U.S.

to advance the registrational Phase 2/3 trials required by the FDA.

An overall tightening and

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

employment market generally.

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 as a result of general macroeconomic factors of force majeure events, or due

to dynamics within our industry, could lead to increased costs, such as increased wage rates to attract and retain employees, and could

negatively affect our ability to efficiently conduct our clinical development, R&D, business development and potential regulatory

and commercial activities.

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

we may take to respond to a decrease in labor availability, have unintended negative effects, our business could be adversely affected.

An overall labor shortage, lack of skilled labor, increased turnover or labor inflation, general macroeconomic factors or as a result

of biotechnology industry dynamics could have a material adverse impact on our operations, results of operations, liquidity or cash flows.

Our future success also depends

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

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

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

submitting a BLA and building a commercial organization.

The market for talent in our industry is very competitive.

Many of the other

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

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

They also may provide more diverse opportunities

and better chances for career advancement.

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

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 affect our ability to operate, grow and manage our business.

at the FDA and other government agencies caused by government shutdowns, leadership changes, changes to regulatory approach, layoffs,

funding shortages or global health concerns could negatively impact our business

The ability of the FDA to review proposed clinical trials or approve

new products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory, and policy

changes, the FDA’s ability to hire and retain key personnel and accept the payment of user fees, and other events that may otherwise

affect the FDA’s ability to perform routine functions.

In addition, government funding of other government agencies that fund research

and development activities is subject to the political process, including executive and congressional priorities, the impacts of which

are inherently fluid and unpredictable.

Disruptions at the FDA and other agencies may slow the time necessary for new product candidates

to be reviewed and/or approved, which would adversely affect our business.

In the recent past, the U.S.

government shutdown on October

1, 2025 to November 12, 2025, which curtailed operations at key agencies such as the FDA and NIH.

Based on this shutdown, we expect trials

under our CRADA with the NCI to be delayed.

There can be no assurances that additional shutdowns will occur in the future or how long

such shutdowns may last.

For example, over the last several years, including for 35 days beginning on December 22, 2018, the U.S.

has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical

In addition, the current administration has enacted and continues to propose substantial reductions in force at various government

agencies including the FDA, which could significantly reduce the FDA’s capacity to perform its functions in a manner consistent

with its past practices and could delay reviews and negatively impact our business.

There has been significant turnover and changes in

senior leadership at the FDA and other government agencies including the Center for Biologics Evaluation and Research (“CBER”),

which is the division of the FDA that would oversee and review biologics-based targeted radiotherapies like those we currently develop

and plan to continue to develop.

We believe these changes could result in changes in the FDA’s perception of the approvability of

therapies, the perceived value of certain therapies or therapeutic modalities, which could create material challenges for our development

As of the date of this Report, there is significant uncertainty and risks associated with future FDA regulatory policies and

actions that could have a material negative impact on our business.

Any or all of these factors could cause us to amend, suspend or terminate

the development of certain of our preclinical or clinical programs, which could have material adverse impacts on our business, our product

candidates or our ability to continue operations.

may be unable to establish sales, marketing and commercial supply capabilities.

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to travel to sites to perform work for us, which may result in delays or hinder our ability to collect data from our clinical trials.

Additionally,

a future pandemic may 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.

Additionally, a future pandemic may result in delays in receiving approvals

from local and foreign regulatory authorities, delays in necessary interactions with IRB, local and foreign regulators, ethics committees

and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees.

business is subject to cybersecurity risks.

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

For instance, as for Iomab-B, despite the Phase SIERRA 3 trial meeting

the primary endpoint of durable Complete Remission (dCR) with statistical significance (p-value<0.0001), the FDA has determined that

demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing.

In addition, the FDA is also

requiring that an additional dose optimization trial demonstrating safety and efficacy be completed to calculate the dose of Iomab-B based

on absorbed dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA

trial based on several interactions we had with the FDA before starting the SIERRA trial.

The head-to-head Phase 3 trial will evaluate

allogeneic bone marrow transplant (BMT) using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation

(Flu/TBI) versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI.

This is different from

the SIERRA trial, which allowed physician’s choice of salvage therapies and heterogenous conditioning regimens in the control arm.

However, there are no assurances that the additional trials will be successful or that we can satisfy all of the FDA’s requests.

There could also be additional regulatory hurdles that may result in either non-acceptance or non-approval of a future BLA filing.

instance, as for Iomab-B, despite the Phase SIERRA 3 trial meeting the primary endpoint of durable Complete Remission (dCR) with statistical

significance (p-value<0.0001), the FDA has determined that demonstrating an OS benefit in a randomized head-to-head trial is required

for a BLA filing.

In addition, the FDA is also requiring that an additional dose optimization trial demonstrating safety and efficacy

be completed to calculate the dose of Iomab-B based on absorbed dose by the bone marrow, rather than the maximum tolerable dose of 24

Gy of radiation to the liver as was done in the SIERRA trial based on several interactions we had with the FDA before starting the SIERRA

The head-to-head Phase 3 trial will evaluate allogeneic bone marrow transplant (BMT) using Iomab-B plus a reduced intensity conditioning

regimen of fludarabine and total body irradiation (Flu/TBI) versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide

plus Flu/TBI.

This is different from the SIERRA trial, which allowed physician’s choice of salvage therapies and heterogenous conditioning

regimens in the control arm.

However, there are no assurances that the additional trials will be completed or successful or that we can

satisfy all of the FDA’s requests.

There could also be additional regulatory hurdles that may result in either non-acceptance or

non-approval of a future BLA filing.

As previously disclosed and noted above, Actinium has licensed to Immedica

the exclusive product rights for commercialization of Iomab-B in the EUMENA region.

We are evaluating the impact of the FDA’s 2024

determination of the SIERRA trials results referred to above in the context of global regulatory submission for Iomab-B.

At this time,

filings for regulatory approval, obtaining regulatory approvals, and successful commercialization of Iomab-B in the EUMENA region and

on a global basis are highly uncertain and may never be realized.

the exclusive product rights for commercialization of Iomab-B in the Europe, Middle East, and North Africa (EUMENA) region.

We are evaluating

the impact of the FDA’s 2024 determination of the SIERRA trials results referred to above in the context of global regulatory submission

At this time, filings for regulatory approval, obtaining regulatory approvals, and successful commercialization of Iomab-B

in the EUMENA region and on a global basis are highly uncertain and may never be realized.

are also evaluating Iomab-ACT, which uses a lower dose I-131 for conditioning prior to cellular therapies such as CAR-T and gene therapies.

We are currently studying Iomab-ACT in three clinical trials including two investigator sponsored studies.

Our Actimab-A (lintuzumab-Ac-225)

product candidate has also been studied in several Phase 1 and 2 trials under our sponsorship and investigator-initiated trials in patients

with r/r AML and we plan to continue to study Actimab-A in clinical trials.

Actimab-A is also being developed under a cooperative research

and development agreement (CRADA) with the National Cancer Institute (NCI) and we expect clinical trials to be initiated that will study

Actimab-A as a single agent or in combination with other therapies.

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.

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

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.

Actimab-A (lintuzumab-Ac-225) product candidate has also been studied in several Phase 1 and 2 trials under our sponsorship and investigator-initiated

trials in patients with r/r AML and we plan to continue to study Actimab-A in clinical trials.

Actimab-A is also being developed under

a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) and we expect clinical trials to be

initiated that will study Actimab-A as a single agent or in combination with other therapies.

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 such as ATNM-400.

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 IND, BLA or NDA 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.

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

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desirable for successful commercialization or profitability.

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

Disruptions at the FDA and other agencies may slow the time necessary

for new product candidates to be reviewed and/or approved, which would adversely affect our business and may cause us to amend our business

From October 1, 2025 until November 12, 2025, the U.S federal government was shutdown, which curtailed operations of key

agencies such as the FDA and the NIH.

Our ability to advance clinical development, obtain regulatory interactions/approvals, or secure

government-funded grants may be delayed or disrupted by the aformentioned federal government shutdown.

For example, the NCI with whom

we have a CRADA with for the development of Actimab-A was not operating during the shutdown.

As a result, trials active and planned under

our CRADA are expected to be delayed.

For example, over the last several years, including for 35 days beginning on December 22, 2018,

government has shut down several times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees

and stop critical activities.

In addition, the current administration has enacted and continues to propose substantial reductions in force

at various government agencies including the FDA, which could significantly reduce the FDA’s capacity to perform its functions in

a manner consistent with its past practices and could delay reviews and negatively impact our business.

There has been significant turnover

and changes in senior leadership at the FDA and other government agencies including the Center for Biologics Evaluation and Research (“CBER”),

which is the division of the FDA that would oversee and review biologics based targeted radiotherapies like those we currently develop

and plan to continue to develop.

We believe these changes could result in changes in the FDA’s perception of the approvability of

therapies, the perceived value of certain therapies or therapeutic modalities, which could create material challenges for our development

At this time, there is significant uncertainty and risks associated with future FDA regulatory policies and actions that could

have a material negative impact on our business.

Any or all of these factors could cause us to amend, suspend or terminate the development

of certain of our preclinical or clinical programs, which could have material adverse impacts on our business, our product candidates

or our ability to continue operations.

have not demonstrated that any of our products are safe or 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.

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for the foreseeable future, as there are numerous developmental steps that must be completed before we can prepare and submit a BLA.

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

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

the following:

the United States, the FDA regulates pharmaceutical and biological product candidates under the Federal Food, Drug, and Cosmetic Act

(“FDCA”) and the Public Health Service Act (“PHSA”), as well as their respective implementing regulations.

products and product candidates are also subject to other federal, state, and local statutes and regulations.

The process of obtaining

regulatory approvals and the subsequent compliance with appropriate federal, state, local, and foreign statutes and regulations requires

the expenditure of substantial time and financial resources.

The process required by the FDA before a drug or biological product may

be marketed in the United States generally involves the following:

completion of preclinical

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submission to the FDA of

an Investigational New Drug (“IND”), which must become effective before human clinical trials in the United States may

an Investigational New Drug (“IND”) application, which must become effective before human clinical trials in the United

States may begin;

performance of adequate

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The clinical trial sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data,

any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

Some preclinical testing may

continue even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises

concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin.

The FDA may also

impose clinical holds on a biological product candidate at any time before or during clinical trials due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and then only under terms authorized by the FDA.

Accordingly, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin or that, for those

that have already commenced under an active IND, that issues will not arise that suspend or terminate such trials.

Clinical trials

involve the administration of the biological product candidate to healthy volunteers or patients under the supervision of qualified investigators,

generally physicians not employed by or under the trial sponsor’s control.

Clinical trials are conducted under protocols detailing,

among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters

to be used to monitor subject safety, including stopping rules that assure a clinical trial will be stopped if certain adverse events

should occur.

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

Clinical trials must

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

all research subjects provide informed consent.

Further, each clinical trial must be reviewed and approved by an independent institutional

review board, or IRB, at or servicing each institution at which the clinical trial will be conducted.

An IRB is charged with protecting

the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical

trials are minimized and are reasonable in relation to anticipated benefits.

The IRB also approves the form and content of the informed

consent that must be signed by each clinical trial subject or his or her legal representative and must monitor the clinical trial until

Human clinical trials are typically conducted in three sequential phases that may overlap or be combined:

any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND application.

Some preclinical

testing may continue even after the IND application is submitted.

The IND application automatically becomes effective 30 days after receipt

by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the trial on a clinical hold

within that 30-day time period.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical

trial can begin.

The FDA may also impose clinical holds on a biological product candidate at any time before or during clinical trials

due to safety concerns or non-compliance.

If the FDA imposes a clinical hold, trials may not recommence without FDA authorization and

then only under terms authorized by the FDA.

Accordingly, we cannot be sure that submission of an IND application will result in the

FDA allowing clinical trials to begin or that, for those that have already commenced under an active IND application, that issues will

not arise that suspend or terminate such trials.

Clinical trials involve the administration of the biological product

candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or

under the trial sponsor’s control.

Clinical trials are conducted under protocols detailing, among other things, the objectives of

the clinical trial, dosing procedures, subject selection and exclusion criteria, and the parameters to be used to monitor subject safety,

including stopping rules that assure a clinical trial will be stopped if certain adverse events should occur.

Each protocol and any amendments

to the protocol must be submitted to the FDA as part of the IND application.

Clinical trials must be conducted and monitored in accordance

with the FDA’s regulations composing the GCP requirements, including the requirement that all research subjects provide informed

Further, each clinical trial must be reviewed and approved by an IRB, at or servicing each institution at which the clinical

trial will be conducted.

An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether

the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.

IRB also approves the form and content of the informed consent that must be signed by each clinical trial subject or his or her legal

representative and must monitor the clinical trial until completed.

Human clinical trials are typically conducted in three sequential

phases that may overlap or be combined:

The biological

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The clinical trial process is also

lengthy and requires substantial time and effort.

lengthy and requires substantial time, effort and expense.

expect that the clinical trials we need to conduct to be in a position to submit BLAs for our product candidates currently in-development

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participants are being exposed to unacceptable health risks;

Funding cuts to the NCI,

which could delay and/or pauses or termination of our ongoing and planned clinical trials under our CRADA;

the placement by the FDA

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factors related to toxicity, clinical efficacy, imbalances in safety and efficacy profiles or for other reasons.

Further, individuals

involved with our clinical trials may serve as consultants to us from time to time and receive stock options or cash compensation in

connection with such services.

individuals involved with our clinical trials may serve as consultants to us from time to time and receive stock options or cash compensation

in connection with such services.

If these relationships and any related compensation to the clinical investigator carrying out the study

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trials necessary to support approval of our product candidates are time-consuming and expensive.

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.

For instance, we worked with

the FDA to develop the SIERRA clinical trial to test the safety and efficacy of Iomab-B in patients with r/r AML who are aged 55 and above

prior to a BMT.

Even though the SIERRA trial met the primary endpoint of dCR with statistical significance (p-value<0.0001), the FDA

has determined that the analyses from the SIERRA trial do not support a BLA filing for Iomab-B.

The FDA now requires an additional head-to-head

Phase 3 clinical study.

We have further discussed the specifics of this additional clinical trial with the FDA.

Based on these discussions,

Actinium believes it has aligned with the FDA on the patient population for this additional clinical trial, which can include all adult

patients aged 18 and above with active AML with blasts counts greater than 5% and less than 20%.

This is a broader patient population

than the patients enrolled on the SIERRA trial, which only enrolled patients aged 55 and above.

Further, the FDA is also requiring that

an additional dose optimization trial demonstrating safety and efficacy be completed to calculate the dose of Iomab-B based on absorbed

dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver as was done in the SIERRA trial based

on several interactions we had with the FDA before starting the SIERRA trial.

We are seeking a strategic partner for Iomab-B in the U.S.

and completing clinical trials necessary to support FDA approval of a BLA for ATNM-400, Actimab-A, Iomab-ACT, Iomab-B, 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.

instance, we worked with the FDA to develop the SIERRA clinical trial to test the safety and efficacy of Iomab-B in patients with r/r

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

Even though the SIERRA trial met the primary endpoint of dCR with statistical significance

(p-value<0.0001), the FDA has determined that the analyses from the SIERRA trial do not support a BLA filing for Iomab-B.

now requires an additional head-to-head Phase 3 clinical study.

We have further discussed the specifics of this additional clinical trial

with the FDA.

Based on these discussions, Actinium believes it has aligned with the FDA on the patient population for this additional

clinical trial, which can include all adult patients aged 18 and above with active AML with blasts counts greater than 5% and less than

This is a broader patient population than the patients enrolled on the SIERRA trial, which only enrolled patients aged 55 and above.

Further, the FDA is also requiring that an additional dose optimization trial demonstrating safety and efficacy be completed to calculate

the dose of Iomab-B based on absorbed dose by the bone marrow, rather than the maximum tolerable dose of 24 Gy of radiation to the liver

as was done in the SIERRA trial based on several interactions we had with the FDA before starting the SIERRA trial.

We are seeking a

strategic partner for Iomab-B in the U.S.

to advance these additional trials.

Even if we are able to secure a partner, there are no assurances that the additional trials will be

successful or that we can satisfy all of the FDA’s requests.

There could also be additional regulatory hurdles that may result in

either non-acceptance or non-approval of a future BLA.

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.

Even if we are able to secure a partner, there are no assurances

that the additional trials will be successful or that we can satisfy all of the FDA’s requests.

There could also be additional

regulatory hurdles that may result in either non-acceptance or non-approval of a future BLA.

Interim, and “top-line” data from our preclinical studies and 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.

time to time, we may publicly disclose preliminary, interim, and top-line data from our clinical trials, which is based on a preliminary

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time to time, we may also disclose interim data from our preclinical studies and clinical trials.

Interim data from clinical trials that

we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues

and more patient data become available.

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

Further, disclosure of interim data by us or by our competitors could result in volatility in the price of our common stock.

Interim data from preclinical studies

are not necessarily predictive of future success in 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.

Further, disclosure

of interim data by us or by our competitors could result in volatility in the price of our common stock.

others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions, or analyses

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harm our business, operating results, prospects or financial condition.

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

approval and commercialization.

if our clinical trials are completed as planned, we cannot be certain that their results will support our product candidate claims or

that the FDA or foreign authorities will agree with our conclusions regarding them.

Success in pre-clinical studies and early clinical

trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the

results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate that our product candidates are

safe and effective for the proposed indicated uses.

If FDA concludes that the clinical trials for Actimab-A, Iomab-ACT, or any

other product candidate for which we might seek approval, have failed to demonstrate safety and effectiveness, we would not receive FDA

approval to market that product candidate in the United States for the indications sought.

In addition, such an outcome could cause us

to abandon the product candidate and might delay the development of others.

Any delay or termination of our clinical trials will delay

or preclude the filing of any submissions with the FDA and, ultimately, our ability to commercialize our product candidates and generate

It is also possible that patients enrolled in clinical trials will experience adverse side effects that are not currently part

of a product candidate’s profile.

intellectual property related to antibodies we have licensed has expired or likely expired.

if our preclinical studies or early clinical trials are favorable, later clinical trials may fail to demonstrate adequately the efficacy

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

if our preclinical studies are favorable and our clinical trials are completed as planned, we cannot be certain that their results will

support our product candidate claims or that the FDA or foreign authorities will agree with our conclusions regarding them.

pre-clinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that

the later trials will replicate the results of prior trials and pre-clinical studies.

The clinical trial process may fail to demonstrate

that our product candidates are safe and effective for the proposed indicated uses.

If the FDA concludes that any current or future clinical

trials for ATNM-400, Actimab-A, Iomab-ACT, Iomab-B or any other product candidate for which we might seek approval, have failed to demonstrate

safety and effectiveness, we would not receive FDA approval to market that product candidate in the United States for the indications

In addition, such an outcome could cause us to abandon the product candidate and might delay the development of others.

or termination of our clinical trials will delay or preclude the filing of any submissions with the FDA and, ultimately, our ability

to commercialize our product candidates and generate revenues.

It is also possible that patients enrolled in clinical trials will experience

adverse side effects that are not currently part of a product candidate’s profile.

intellectual property related to certain antibodies we have licensed has expired or likely expired.

key patents related to the humanized antibody lintuzumab, which we use in our Actimab-A product candidate, have expired.

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patents, 2 issued

Canadian patents, 1 issued European patent (validated as a national patent in several countries) and 1 issued Japanese patent that relate

to the composition of our Iomab-B product candidate.

Canadian patents, 2 issued European patent (each validated as a national patent in several countries) and 1 issued Japanese patent that

relate to the composition of our Iomab-B product candidate.

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

and internationally.

We have and may continue to file patents related to Iomab-B that can provide barriers to entry but there is no certainty that these patents

will be granted or such granting thereof will adequately prevent others from seeking to replicate and use the apamistamab antibody or

the construct.

Our patent portfolio includes pending applications related to radioimmunoconjugate composition, formulation administration,

and methods of use in treating solid or liquid cancers.

This subject matter includes composition, administration, and methods of treatment

for our product candidates Actimab-A and Iomab-B.

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

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

internationally.

We have and may continue to file patents related to Iomab-B that can provide barriers to entry but there is no certainty

that these patents will be granted or such granting thereof will adequately prevent others from seeking to replicate and use the apamistamab

antibody or the construct.

Our patent portfolio includes pending applications related to radioimmunoconjugate composition, formulation

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

This subject matter includes composition, administration, and

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

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

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

regulatory hurdles.

Further, if approved, Iomab-B would be entitled to 12 years of market exclusivity in the U.S.

and 10 years in Europe, during which time

no generic biologic or biosimilar referencing Iomab-B can be granted marketing approval.

Our Actimab-A program clinical trials are

testing the same drug construct.

Our Actimab-A program is

comprised of several clinical trials conducted under the CRADA with NCI, Actinium sponsored trials, investigator-initiated trials in

AML and other myeloid indications and solid tumors that will study the same drug construct consisting of lintuzumab-Ac-225.

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

and 10 years in Europe,

during which time no generic biologic or biosimilar product referencing Iomab-B can be granted marketing approval.

Actimab-A program clinical trials are testing the same drug construct.

Actimab-A program is comprised of several clinical trials conducted under the CRADA with NCI, Actinium sponsored trials, investigator-initiated

trials in AML and other myeloid indications and solid tumors that will study the same drug construct consisting of lintuzumab-Ac-225.

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

including future studies conducted under our CRADA with the NCI.

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other trials utilizing lintuzumab-Ac-225.

We are currently developing, and in the future may develop, product

candidates in combination with other therapies and that may expose us to additional risks.

We are currently developing, and may develop future

product candidates, for use in combination with one or more currently approved therapies.

For example, Actimab-A is expected to be tested

in combination with KEYTRUDA ® and OPDIVO ® for treating HNSCC and NSCLC.

If any of the approved therapies

we currently or may, in the future, use in combination with a current or future product candidate is found defective, removed from the

market, or otherwise becomes unavailable, our clinical trials may face significant delays, be suspended, or terminated.

Any such events

would likely have a material impact on our operations and the development of the affected product candidate(s) and may ultimately prevent

the approval of such product candidate or render continued development efforts too costly to proceed.

Even if a current or future product candidate were

to receive FDA approval to be commercialized in the U.S.

for use in combination with one or more existing therapies, we would continue

to be subject to the risk that the FDA or similar foreign regulatory authorities could revoke approval of the therapy used in combination

with our product candidate or that safety, efficacy, manufacturing or supply issues could arise with any such existing therapies.

could result in our own products being removed from the market or cause material delays in, or the suspension or discontinuation, of our

production and/or distribution of the applicable product, as our ability to market any such product will be limited to the extent specified

in the FDA’s approval, if granted.

are currently developing, and in the future may develop, product candidates in combination with other therapies and that may expose us

to additional risks.

are currently developing, and may develop future product candidates, for use in combination with one or more currently approved therapies.

For example, Actimab-A is expected to be tested in combination with KEYTRUDA ® and OPDIVO ® for treating

HNSCC and NSCLC.

If any of the approved therapies we currently or may, in the future, use in combination with a current or future product

candidate is found defective, removed from the market, or otherwise becomes unavailable, our clinical trials may face significant delays,

be suspended, or terminated.

Any such events would likely have a material impact on our operations and the development of the affected

product candidate(s) and may ultimately prevent the approval of such product candidate or render continued development efforts too costly

if a current or future product candidate were to receive FDA approval to be commercialized in the U.S.

for use in combination with one

or more existing therapies, we would continue to be subject to the risk that the FDA or similar foreign regulatory authorities could

revoke approval of the therapy used in combination with our product candidate or that safety, efficacy, manufacturing or supply issues

could arise with any such existing therapies.

This could result in our own products being removed from the market or cause material delays

in, or the suspension or discontinuation, of our production and/or distribution of the applicable product, as our ability to market any

such product will be limited to the extent specified in the FDA’s approval, if granted.

may be unable to obtain a sufficient supply of isotopes to support clinical development or at commercial scale.

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I-131 or obtain I-131 on terms that are acceptable to us.

Actinium-225 is a key component of our Actimab-A product candidate, technology

platform, preclinical R&D programs and other drug candidates that we might consider for development with the Ac-225 payload.

secured multiple suppliers that are expected to provide cGMP Ac-225 for our planned clinical trials.

There are adequate quantities of

Ac-225 available today to meet our current needs via our present supplier, the Department of Energy (“DOE”), who has been

our primary supplier of Ac-225 historically.

The Ac-225 currently supplied for our 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

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 at a scale

that would be able to satisfy commercial needs.

In addition, we are aware of at least ten 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-based drug candidate.

is a key component of our Actimab-A product candidate, technology platform, preclinical R&D programs including ATNM-400 and other

drug candidates that we might consider for development with the Ac-225 payload.

We have secured multiple suppliers that are expected

to provide cGMP Ac-225 for our planned clinical trials.

There are adequate quantities of Ac-225 available today to meet our current needs

via our present supplier, the Department of Energy (“DOE”), who has been our primary supplier of Ac-225 historically.

Ac-225 currently supplied for our 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 the 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 us.

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

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 at a scale that would be able to satisfy commercial needs.

we are aware of at least ten 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-based drug candidate.

contract for supply of this isotope from the DOE must be renewed yearly, and we renewed our contract to extend through the end of 2025.

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us from commercializing our product candidates on a timely basis.

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.

In addition, depending on the quantity and nature of the changes made, FDA could take the position that some

or all of the data generated by the clinical trial is not usable because the same protocol was not used throughout the trial.

require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying approval

of a product candidate.

If the FDA believes that its prior approval is required for a particular modification, it can delay or halt a

clinical trial while it evaluates additional information regarding the change.

can be no assurance that the data generated in our clinical trials will be acceptable to the FDA or that if future modifications during

the trial are necessary, that any such modifications will be acceptable to the 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.

In addition, depending on the quantity and nature of the changes made, the FDA could take the position

that some or all of the data generated by the clinical trial is not usable because the same protocol was not used throughout the trial.

This might require the enrollment of additional subjects, which could result in the extension of the clinical trial and the FDA delaying

approval of a product candidate.

If the FDA believes that its prior approval is required for a particular modification, it can delay

or halt a clinical trial while it evaluates additional information regarding the change.

delay or termination of our current or future clinical trials as a result of the risks summarized above, including delays in obtaining

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our business and prospects and could cause us to cease operations.

have obtained orphan drug designation from FDA for two of our current product candidates and intend to pursue such designation for other

candidates and indications in the future, but we may be unable to obtain such designations or to maintain the benefits associated with

any orphan drug designations we have received or may receive in the future.

We have received orphan drug

designation for Actimab-A and Iomab-B for treatment of AML in both the United States and the EU.

Under the Orphan Drug Act, the FDA may

grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a disease or condition that affects

fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals in the United States, there is no

reasonable expectation that the cost of developing and making available a drug or biologic for this type of disease or condition will

be recovered from sales in the United States for that drug or biologic.

Similarly, the EMA grants orphan drug designation to promote the

development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening or chronically debilitating

condition affecting not more than five in 10,000 persons in the EU.

Orphan drug designation neither shortens

the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage in the regulatory review

or approval process.

In the United States, orphan drug designation entitles a party to financial incentives, such as opportunities for

grant funding towards clinical trial costs, tax advantages, and application fee waivers.

In addition, if a product candidate receives

the first FDA approval for the indication for which it has orphan designation, such product is entitled, upon approval, to seven years

of orphan-drug exclusivity, during which the FDA may not approve any other application to market the same drug for the same indication,

unless a subsequently approved product is clinically superior to orphan drug or where the manufacturer is unable to assure sufficient

product quantity in the applicable patient population.

In the EU, orphan drug designation entitles a party to financial incentives such

as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product approval.

This period may

be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently

profitable not to justify maintenance of market exclusivity.

have obtained orphan drug designation from the FDA for two of our current product candidates and intend to pursue such designation for

other candidates and indications in the future, but we may be unable to obtain such designations or to maintain the benefits associated

with any orphan drug designations we have received or may receive in the future.

have received orphan drug designation for Actimab-A and Iomab-B for treatment of AML in both the United States and the EU.

Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or condition, which is a

disease or condition that affects fewer than 200,000 individuals in the United States, or if it affects more than 200,000 individuals

in the United States, there is no reasonable expectation that the cost of developing and making available a drug or biologic for this

type of disease or condition will be recovered from sales in the United States for that drug or biologic.

Similarly, the EMA grants orphan

drug designation to promote the development of products that are intended for the diagnosis, prevention, or treatment of a life-threatening

or chronically debilitating condition affecting not more than five in 10,000 persons in the EU.

drug designation neither shortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic

any advantage in the regulatory review or approval process.

In the United States, orphan drug designation entitles a party to financial

incentives, such as opportunities for grant funding towards clinical trial costs, tax advantages, and application fee waivers.

if a product candidate receives the first FDA approval for the indication for which it has orphan designation, such product is entitled,

upon approval, to seven years of orphan-drug exclusivity, during which the FDA may not approve any other application to market the same

drug for the same indication, unless a subsequently approved product is clinically superior to orphan drug or where the manufacturer

is unable to assure sufficient product quantity in the applicable patient population.

In the EU, orphan drug designation entitles a party

to financial incentives such as reduction of fees or fee waivers and ten years of market exclusivity following drug or biological product

This period may be reduced to six years if the orphan drug designation criteria are no longer met, including where it is shown

that the product is sufficiently profitable not to justify maintenance of market exclusivity.

if we obtain (or have obtained) orphan drug designation for certain product candidates, we may not be the first to obtain marketing approval

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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.

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

and results of operations.

affect the regulation of the U.S.

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

results of operations.

the United States, there have been a number of legislative and regulatory initiatives focused on containing the cost of healthcare.

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Affordable Care Act contains a number of provisions that could impact our business and operations, primarily, once we obtain FDA approval

to commercialize one of our product candidates in the United States, if ever, and may also affect our operations in ways we cannot currently

Affordable Care Act provisions that may affect our business include, among others, those governing enrollment in federal healthcare

programs, reimbursement changes, rules regarding prescription drug benefits under health insurance exchanges, expansion of the 340B program,

expansion of state Medicaid programs, fees and increased discount and rebate obligations, transparency and reporting requirements, and

fraud and abuse enforcement.

Such changes may impact existing government healthcare programs, industry competition, formulary composition,

and may result in the development of new programs, including Medicare payment for performance initiatives, health technology assessments,

and improvements to the physician quality reporting system and feedback program.

There have been significant

judicial, administrative, executive, and legislative initiatives to modify, limit, replace, or repeal the Affordable Care Act since its

For example, during his first term, former President Trump issued several Executive Orders and other directives designed to

delay the implementation of certain provisions of the Affordable Care Act or otherwise circumvent some of the requirements for health

insurance mandated by the Affordable Care Act.

Concurrently, Congress considered legislation that would repeal or replace all or part

of the Affordable Care Act.

to commercialize one of our product candidates in the United States, if ever.

The Affordable Care Act may also affect our operations

in ways we cannot currently predict.

Affordable Care Act provisions that may affect our business include, among others, those governing

enrollment in federal healthcare programs, reimbursement changes, rules regarding prescription drug benefits under health insurance exchanges,

expansion of the 340B program, expansion of state Medicaid programs, fees and increased discount and rebate obligations, transparency

and reporting requirements, and fraud and abuse enforcement.

Such changes may impact existing government healthcare programs, industry

competition, formulary composition, and may result in the development of new programs, including Medicare payment for performance initiatives,

health technology assessments, and improvements to the physician quality reporting system and feedback program.

have been significant judicial, administrative, executive, and legislative initiatives to modify, limit, replace, or repeal the Affordable

Care Act since its enactment.

For example, during his first term, President Trump issued several Executive Orders and other directives

designed to delay the implementation of certain provisions of the Affordable Care Act or otherwise circumvent some of the requirements

for health insurance mandated by the Affordable Care Act.

Concurrently, Congress considered legislation that would repeal or replace

all or part of the Affordable Care Act.

While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation

the Affordable Care Act have been passed.

of the Affordable Care Act have been passed.

For example, the Tax Cuts and Jobs Act of 2017 eliminated the Affordable Care Act provision

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products could have a material adverse impact on our business, results of operations and financial condition.

The Biden administration also

introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

For example, on January 28, 2021, former President

Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through

the Affordable Care Act marketplace, which began on February 15, 2021, and remained open through August 15, 2021.

The executive order

also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare,

including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements and policies that

create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the Affordable Care Act.

On the legislative

front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in relevant part, eliminates the statutory Medicaid

drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source drugs and innovator multiple source

drugs, which began on January 1, 2024.

And, in July 2021, the Biden administration released an executive order entitled, “Promoting

Competition in the American Economy,” with multiple provisions aimed at prescription drugs.

In response, on September 9, 2021, HHS

released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets

out a variety of potential legislative policies that Congress could pursue as well as potential administrative actions HHS can take to

advance these principles.

More recently, on August 16,

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

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

Specifically,

the IRA 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 announced on August 29, 2023, and the first year

of maximum price applicability to begin in 2026.

The IRA 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 creates significant changes

to the Medicare Part D benefit design by capping Part D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.

Additional legislative and regulatory changes could be made to governmental health programs that could significantly impact pharmaceutical

companies and the success of our product candidates.

At the state level, legislatures have increasingly passed legislation and implemented

regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts,

restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage

importation from other countries and bulk purchasing.

Changes in the healthcare

industry and in healthcare spending could adversely affect our grant funded clinical programs, business, financial condition and results

of operations.

Our business and research

efforts rely, in part, on funding and support from U.S.

government agencies such as the National Institutes of Health (“NIH”),

National Cancer Institute (“NCI”) and the Department of Health and Human Services (“HHS”).

Government funding

for these programs is subject to annual budgetary decisions, which can be unpredictable and influenced by shifting political and economic

Reductions in government support for cancer research or other healthcare initiatives could limit grants, contracts, or other

financial resources that we or our research collaborators depend on, potentially delaying our clinical programs and increasing our reliance

on alternative funding sources.

For instance, we have a CRADA with the NCI for the development of Actimab-A.

While we have been informed

that the funding for our CRADA is not expected to be impacted, there can be no assurances that this will remain the case and any reduction

or elimination of funding can have a material adverse impact on our business.

Moreover, with the change

in presidential administration that recently occurred in the United States, government spending programs have become even more difficult

to predict and may be subject to greater risk.

Considerable uncertainty exists regarding how future budget and program decisions will

unfold, including the spending priorities of the new U.S.

presidential administration and Congress and what challenges budget reductions

may present for our industry generally or for our company.

In particular, President Trump recently attempted to place a widespread freeze

on most federal grants and loans.

Any freeze on government support for our products, programs, or studies could significantly impair our

research and development activities, business, and operations.

Disruptions at

the FDA, the SEC and other government agencies or comparable regulatory authorities caused by funding shortages or global health concerns,

in addition to substantial uncertainty regarding the new Administration’s initiatives and how these might impact the FDA, its implementation

of laws, regulations, policies and guidance, and its personnel, could hinder government agencies’ ability to hire and retain key

leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner,

or otherwise prevent those agencies from performing normal business functions on which our business operations rely, including timely

reviews, which could negatively impact our business.

The ability of the FDA

or comparable foreign regulatory authorities to review and approve new products can be affected by a variety of factors, including government

budget and funding levels, ability to hire and retain key personnel and accept the payment of user fees, and statutory, regulatory, and

policy changes that may otherwise affect the FDA’s or comparable foreign regulatory authorities’ ability to perform routine

In addition, government funding of the SEC and other government agencies or comparable foreign regulatory authorities on which

our operations may rely, including those that fund research and development activities, is subject to the political process, which is

inherently fluid and unpredictable.

Disruptions at the FDA

and other agencies, including substantial leadership, personnel, and policy changes, may also slow the time necessary for new drugs to

be reviewed and/or approved by necessary government agencies, which would harm our business.

Changes in FDA staffing could result in delays

in the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance, or implement

or enforce regulatory requirements in a timely fashion or at all.

Similar consequences would also result in the event of another significant

shutdown of the federal government.

Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

For example, on

January 28, 2021, former President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining

health insurance coverage through the Affordable Care Act marketplace, which began on February 15, 2021, and remained open through August

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules

that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include

work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or

the Affordable Care Act.

On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which,

in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price,

for single source drugs and innovator multiple source drugs, which began on January 1, 2024.

And, in July 2021, the Biden administration

released an executive order entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at

prescription drugs.

In response, on September 9, 2021, the Department of Health and Human Services (“HHS”) released a “Comprehensive

Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative

policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

August 16, 2022, former President Biden signed into law the Inflation Reduction Act of 2022 (the “IRA”),

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

Specifically, the IRA authorizes and directs the HHS to set drug price caps for certain high-cost Medicare Part B and Part D qualified

drugs, with the initial list of drugs announced on August 29, 2023, and the first year of maximum price applicability beginning in 2026.

The IRA further authorizes the HHS to penalize pharmaceutical manufacturers that increase the price of certain Medicare Part B and Part

D drugs faster than the rate of inflation.

The IRA creates significant changes to the Medicare Part D benefit design by capping Part

D beneficiaries’ annual out-of-pocket spending at $2,000 beginning in 2025.

Further, on July 4, 2025, President Trump signed the

One Big Beautiful Bill Act into law which, among other things, is expected to reduce funding to federal healthcare programs, imposes

additional requirements to be eligible for healthcare, and clarifies exclusions for orphan drugs under IRA’s Drug Price Negotiation

The current Trump

Administration is also pursuing policies intended to, among other things, reduce regulations and expenditures across government

(including at the HHS, FDA, NIH, CMS, and other related agencies), lower prescription drug prices, and enhance drug price

transparency.

These actions, such as those directed by executive orders, may propose policy changes that create additional

uncertainty for our business.

For example, on April 15, 2025, the Trump Administration released an executive order entitled,

“Lower Drug Prices by Once Again Putting Americans First,” which among other things, included multiple directives to

various agencies aimed at lowering prescription drug prices.

Further, in May 2025, the Trump Administration released two executive

orders aimed to promote domestic production of critical medicines and to establish a most-favored-nation (“MFN”) drug

pricing policy that would tie U.S.

drug prices to the prices paid for drugs in other countries.

Other recent actions and proposals

include, for example, (1) reducing federal agencies workforces;

(2) directing program cuts;

(3) rescinding a Biden administration

executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug

spending and eliminating the Biden administration’s executive order that directed HHS to establishing an AI task force and

developing a strategic plan;

(4) directing certain federal agencies to enforce existing law regarding hospital and price plan price

transparency and by standardizing prices across hospitals and health plans;

(5) as part of the Make America Healthy Again (MAHA)

Commission’s recent Strategy Report, working across government agencies to increase enforcement on direct-to-consumer

pharmaceutical advertising;

(6) announcing a new payment initiative called the GENErating cost Reductions fOr U.S.

Medicaid Model

(“GENEROUS Model”) where drug manufacturers may voluntarily offer supplemental rebates to participating state Medicaid

(7) directing HHS and other agencies to lower prescription drug costs for Medicare through a variety of initiatives,

including by improving upon the Medicare Drug Price Negotiation Program and proposing two rules to incorporate MFN pricing into

federal reimbursement for drugs including the Global Benchmark for Efficient Drug Pricing Model (“GLOBE Model”) for

Medicare Part B and Guarding U.S.

Medicare Against Rising Drug Costs (“GUARD Model”) for Medicare Part D;

(8) launching

the TrumpRx direct-to-consumer platform designed to have drug manufacturers offer consumers prescription drug MFN pricing equal to

or lower than those paid in other developed nations;

and (9) calling on Congress to enact the “The Great Healthcare

Plan” to, among other things, codify and expand MFN pricing, lower government subsidies to private insurance companies,

increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions

on pharmacy benefit managers.

These actions and policies may significantly reduce drug prices, potentially impacting

manufacturers’ drug pricing strategies and profitability, while increasing operational costs and compliance risks.

the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and

biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and

marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk

and future legislative and regulatory changes aimed to further reform healthcare or reduce healthcare costs may limit coverage of or

lower reimbursement for healthcare products and treatments.

Any reduction in coverage or reimbursement from Medicare, Medicaid, or other

government programs may result in similar actions taken by private payors such as reductions in payments.

The implementation of cost

containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize

our product candidates.

in the healthcare industry and in healthcare spending could adversely affect our grant funded clinical programs, business, financial

condition and results of operations.

business and research efforts rely, in part, on funding and support from U.S.

government agencies such as the NIH, NCI and HHS.

funding for these programs is subject to annual budgetary decisions, which can be unpredictable and influenced by shifting political

and economic priorities.

Reductions in government support for cancer research or other healthcare initiatives could limit grants, contracts,

or other financial resources that we or our research collaborators depend on, potentially delaying our clinical programs and increasing

our reliance on alternative funding sources.

From October 1, 2025 until November 12, 2025, the U.S federal government was shutdown, which

curtailed operations of key agencies such as the FDA and the NIH.

The NCI, with whom we have a CRADA with for the development of Actimab-A,

was not operating during the shutdown.

As a result, our ability to advance clinical development, obtain regulatory interactions/approvals,

or secure government-funded grants may be delayed or disrupted by the federal government shutdown.

For example, active and planned trials

under our CRADA are expected to be delayed.

Additionally, in December

2025, the National Defense Authorization Act for Fiscal Year 2026 (“NDAA”) was enacted, which included legislation commonly

referred to as the “BIOSECURE Act.” The BIOSECURE Act restricts government agencies from procuring certain biotechnology equipment

or services from, or entering into contracts with, entities that use biotechnology equipment or services from designated “biotechnology

companies of concern,” (“BCCs”) and from expending certain federal loan or grant funds for such equipment or services.

BCCs include those that are identified on the Department of Defense’s annual List of Chinese Military Companies, also known as the

1260H List, and the government also has the ability to designate entities as BCCs through a separate designation process.

While the BIOSECURE

Act has not yet been fully implemented through final regulations, there remains a continued policy interest in limiting U.S.

relationships with biotechnology providers with relationships with foreign adversaries.

If any of our current or future

vendors, or their affiliates, are designated as a BCC or placed on other U.S.

restricted party lists, such designation could impact and

potentially restrict our ability to purchase equipment or services from such vendors and could adversely affect our existing government-funded

grants and our ability to secure future grants.

These disruptions could also have adverse effects on the development of our product candidates

and our business operations.

with the change in presidential administration that recently occurred in the United States, government spending programs have become

even more difficult to predict and may be subject to greater risk.

Considerable uncertainty exists regarding how future budget and

program decisions will unfold, including the spending priorities of the new U.S.

presidential administration and Congress and what

challenges budget reductions may present for our industry generally or for our company.

For example, President Trump recently

attempted to place a widespread freeze on most federal grants and loans.

Any freeze, reduction, recission, change in eligibility or

compliance requirements, or other actions affecting government support for our products, programs, or studies could significantly

impair our research and development activities, business, and operations.

at the FDA, the SEC and other government agencies or comparable regulatory authorities caused by government shutdowns, funding shortages

or global health concerns, in addition to substantial uncertainty regarding the new Administration’s initiatives and how these

might impact the FDA, its implementation of laws, regulations, policies and guidance, and its personnel, could hinder government agencies’

ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or

commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which our business

operations rely, including timely reviews, which could negatively impact our business.

The ability of the FDA or comparable foreign regulatory authorities

to review and approve new products can be affected by a variety of factors, including government shutdowns, which recently occurred from

October 1, 2025 until November 12, 2025, budget and funding levels, ability to hire and retain key personnel and accept the payment of

user fees, and statutory, regulatory, and policy changes that may otherwise affect the FDA’s or comparable foreign regulatory authorities’

ability to perform routine functions.

In addition, government funding of the SEC and other government agencies or comparable foreign regulatory

authorities on which our operations may rely, including those that fund research and development activities, is subject to the political

process, which is inherently fluid and unpredictable.

Future government shutdowns could impact our ability to access the public markets

and obtain necessary capital in order to properly capitalize and continue to fund our operations.

at the FDA and other agencies, including substantial leadership, personnel, and policy changes, may also slow the time necessary for

new drugs to be reviewed and/or approved by necessary government agencies, which would harm our business.

Changes in FDA staffing could

result in delays in the FDA’s responsiveness or in its ability to review submissions or applications, issue regulations or guidance,

or implement or enforce regulatory requirements in a timely fashion or at all.

Similar consequences would also result in the event of

another significant shutdown of the federal government.

For example, over the last several years, the U.S.

government has shut down several times and certain

regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

If a prolonged government

shutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities from conducting their regular

inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to timely review and process

our regulatory submissions, which could materially adversely affect our business, financial condition, results of operations and prospects.

Such changes could significantly impact the ability of the FDA to timely review and take action on our regulatory submissions, which could

have a material adverse effect on our business.

Further, in our operations as a public company, future government shutdowns or substantial

leadership, personnel, and policy changes could impact our ability to access the public markets and obtain necessary capital in order

to properly capitalize and continue our operations.

If the FDA is constrained in its ability to engage in oversight and implementation

activities in the normal course, our business may be negatively impacted.

With the change in the

Presidential Administration in 2025, there is substantial uncertainty as to whether and how the new administration will seek to modify

or revise the requirements and policies of the FDA and other regulatory agencies with jurisdiction over our product candidates.

This uncertainty

could present new challenges and/or opportunities as we navigate development of our product candidates.

Some of these efforts have manifested

to date in the form of personnel measures that could impact the FDA’s ability to hire and/or retain key personnel, which could result

in delays or limitations on our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite

regulatory approvals in the future.

Moreover, the new Administration has proposed action to freeze or reduce the budget of the National

Institutes of Health, or NIH, as related to its funding for medical research, which could decrease the ability of facilities that rely

on NIH funding to enroll and conduct clinical trials or increase the costs to us of conducting clinical trials.

There remains general

uncertainty regarding future activities.

The new Administration could issue or promulgate executive orders, regulations, policies

or guidance that adversely affect us or create a more challenging or costly environment to pursue the development of new therapeutic products.

Alternatively, state governments may attempt to address or react to changes at the federal level with changes to their own regulatory

frameworks in a manner that is adverse to our operations.

If we become negatively impacted by future governmental orders, regulations,

policies or guidance as a result of the new Administration, there could be a material adverse effect on us and our business.

government has shut down several

times and certain regulatory agencies, such as the FDA, have had to furlough critical FDA employees and stop critical activities.

a prolonged government shutdown occurs, or if geopolitical or global health concerns prevent the FDA or other regulatory authorities

from conducting their regular inspections, reviews, or other regulatory activities, it could significantly impact the ability of the

FDA to timely review and process our regulatory submissions, which could materially adversely affect our business, financial condition,

results of operations and prospects.

Such changes could significantly impact the ability of the FDA to timely review and take action

on our regulatory submissions, which could have a material adverse effect on our business.

Further, in our operations as a public company,

future government shutdowns or substantial leadership, personnel, and policy changes could impact our ability to access the public markets

and obtain necessary capital in order to properly capitalize and continue our operations.

If the FDA is constrained in its ability to

engage in oversight and implementation activities in the normal course, our business may be negatively impacted.

With the change in the U.S.

Presidential Administration in 2025, there

is substantial uncertainty as to whether and how the new administration will seek to modify or revise the requirements and policies of

the FDA and other regulatory agencies with jurisdiction over our product candidates.

This uncertainty could present new challenges and/or

opportunities as we navigate development of our product candidates.

Some of these efforts have manifested to date in the form of personnel

measures that could impact the FDA’s ability to hire and/or retain key personnel, which could result in delays or limitations on

our ability to obtain guidance from the FDA on our product candidates in development and obtain the requisite regulatory approvals in

Moreover, the new Administration has proposed action to freeze or reduce the budget of the NIH, as related to its funding

for medical research, which could decrease the ability of facilities that rely on NIH funding to enroll and conduct clinical trials or

increase the costs to us of conducting clinical trials.

There remains general uncertainty regarding future activities.

The new Administration could

issue or promulgate executive orders, regulations, policies or guidance that adversely affect us or create a more challenging or costly

environment to pursue the development of new therapeutic products.

Alternatively, state governments may attempt to address or react to

changes at the federal level with changes to their own regulatory frameworks in a manner that is adverse to our operations.

negatively impacted by future governmental orders, regulations, policies or guidance as a result of the new Administration, there could

be a material adverse effect on us and our business.

relationships with customers, health care professionals and third-party payors may be subject to applicable healthcare laws, which could

14 unchanged sentences

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 false claims laws, including civil whistleblower or qui

tam actions under the FCA, 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;

HIPAA, as amended by 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

79 unchanged sentences

to commercialize our approved products and our overall financial condition.

and some jurisdictions outside the U.S., there have been a number of legislative and regulatory changes and proposed changes

regarding the healthcare system that could impact our business.

Generally, there has been increasing legislative and enforcement interest

with respect to drug pricing, including specialty drug pricing practices, in light of the rising cost of prescription drugs

and biologics.

Specifically, there have been U.S.

Congressional inquiries and federal and state legislative activity designed to, among

other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce

the price of drugs under Medicare, and reform government program reimbursement methodologies for drugs and biologics.

In addition, the

concept of most-favored nation pricing has been raised that would seek to establish drug prices in the U.S.

to the lowest level paid

by comparable countries.

Such policy action could cause us to amend, suspend or terminate the development of any or all of our product

candidates if a viable commercial market did not exist, which could have a material adverse impact on our business and ability to operate.

future legislation were to impose direct governmental price controls and access restrictions, it could have a significant adverse impact

on our business and financial results.

Managed care organizations, as well as Medicaid and other government authorities, continue to

seek price discounts.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control

pharmaceutical and biologic product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain

product access and marketing cost disclosure and transparency measures, and, in some cases, to encourage importation from other countries

and bulk purchasing.

Due to the volatility in the current economic and market dynamics, we are unable to predict the impact of any unforeseen

or unknown legislative, regulatory, payor or policy actions, which may include cost containment and healthcare reform measures.

policy actions could have a material adverse impact on our business and ability to operate.

Related to Third Parties

37 unchanged sentences

targeted radiotherapy product candidates.

Our ARC product candidates are regulated by the FDA as biologic products, and we intend

to seek approval for these products pursuant to the BLA pathway.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA,

created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products.

The abbreviated regulatory pathway

establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar

as “interchangeable” based on its similarity to an existing brand product.

Under the BPCIA, an application for a biosimilar

product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA and in Europe a biosimilar

product cannot be approved until 10 years after the original branded product was approved.

The law is complex and as a result, its ultimate

impact, implementation, and meaning are subject to uncertainty.

Even if a biosimilar gets approved for one of the antibodies that we

use, the final constructs of our drug candidates consist of an antibody, radioisotope and in some cases a linker and we are not aware

of any regulations that would require us to provide the final constructs or components to third parties or potential competitors.

based on the current regulations, we do not believe that the final drug product of our candidates can be subject to competition from

a biosimilar as outlined in BPCIA for at least 12 years in the U.S.

Our ARC product candidates are regulated by the FDA as biologic products, and we intend to

seek approval for these products pursuant to the BLA pathway.

The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created

an abbreviated pathway for the approval of biosimilar and interchangeable biologic products.

The abbreviated regulatory pathway establishes

legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable”

based on its similarity to an existing brand product.

Under the BPCIA, an application for a biosimilar product cannot be approved by

the FDA until 12 years after the original branded product was approved under a BLA and in Europe a biosimilar product cannot be approved

until 10 years after the original branded product was approved.

The law is complex and as a result, its ultimate impact, implementation,

and meaning are subject to uncertainty.

Even if a biosimilar gets approved for one of the antibodies that we use, the final constructs

of our drug candidates consist of an antibody, radioisotope and in some cases a linker and we are not aware of any regulations that would

require us to provide the final constructs or components to third parties or potential competitors.

Therefore, based on the current regulations,

we do not believe that the final drug product of our candidates can be subject to competition from a biosimilar as outlined in BPCIA

for at least 12 years in the U.S.

and 10 years in the EU.

We are aware that generic versions of certain

radiopharmaceuticals utilizing peptides have been submitted to the FDA via the Abbreviated New Drug Application (“ANDA”)

pathway, however, those products are not covered under the BPCIA and therefore that generic pathway is not applicable to Iomab-B or Actimab-A.

We expect this would also apply to other biologic drug candidates we may seek to develop in the future based on the current provisions

of the BPCIA.

Additionally, the Inflation Reduction Act (“IRA”) that was enacted in August 2022, states that reimbursement

by the Centers for Medicare& Medicaid Services (“CMS”) for high-expenditure single-source biologic drugs, which we expect

Iomab-B and Actimab-A to be, can only be negotiated after at least 11 years following approval compared to 7 years for non-biologic drugs

with negotiated prices taking effect two years after selection.

Therefore, we currently believe that our ARCs are less likely than small

molecules to face pricing pressure and negotiation from IRA.

Further, a drug or biological product that has an orphan drug designation,

which Iomab-B and Actimab-A both have, for only one rare disease or condition will be excluded from the IRA’s price negotiations

requirements until such time the biological products has designations for more than one rare disease or condition, or if is approved

for an indication that is not within that single designated rare disease or condition, unless such additional designation or such disqualifying

approvals are withdrawn by the time CMS evaluates the drug for selection for negotiation.

In August 2023, 10 initial drugs were identified

with negotiated prices expected to take effect starting in 2026.

In 2027 and 2028, it is expected that CMS will establish negotiated

prices for 15 additional drugs in each respective year.

We do not believe there is a high likelihood that Iomab-B or Actimab-A would

be identified by CMS for negotiated pricing under IRA but there is potential that IRA and other additional state and federal healthcare

reform measures will be adopted in the future and the implementation of cost-containment measures or other healthcare reforms may prevent

us from being able to generate revenue, attain profitability or successfully commercialize our product candidates.

We are aware that generic versions of certain radiopharmaceuticals utilizing

peptides have been submitted to the FDA via the Abbreviated New Drug Application (“ANDA”) pathway, however, those products

are not covered under the BPCIA and therefore that generic pathway is not applicable to Iomab-B or Actimab-A.

We expect this would also

apply to other biologic drug candidates we may seek to develop in the future based on the current provisions of the BPCIA.

Additionally,

the Inflation Reduction Act (“IRA”) that was enacted in August 2022, states that reimbursement by the Centers for Medicare&

Medicaid Services (“CMS”) for high-expenditure single-source biologic drugs, which we expect Iomab-B and Actimab-A to be,

can only be negotiated after at least 11 years following approval compared to 7 years for non-biologic drugs with negotiated prices taking

effect two years after selection.

Therefore, we currently believe that our antibody radiation conjugates (“ARCs”) are less likely than small molecules to face pricing

pressure and negotiation from IRA.

Further, a drug or biological product that has an orphan drug designation, which Iomab-B and Actimab-A

both have, for only one rare disease or condition will be excluded from the IRA’s price negotiations requirements until such

time the biological products has designations for more than one rare disease or condition, or if is approved for an indication that is

not within that single designated rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn

by the time CMS evaluates the drug for selection for negotiation.

In August 2023, 10 initial drugs were identified with negotiated prices

that went into effect January 1, 2026.

In 2027 and 2028, it is expected that CMS will establish negotiated prices for 15 additional

drugs in each respective year.

We do not believe there is a high likelihood that Iomab-B or Actimab-A would be identified by CMS for

negotiated pricing under IRA but there is potential that IRA and other additional state and federal healthcare reform measures will be

adopted in the future and the implementation of cost-containment measures or other healthcare reforms may prevent us from being able

to generate revenue, attain profitability or successfully commercialize our product candidates.

product candidates may never achieve market acceptance.

Actimab-A, Iomab-ACT and Iomab-B

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-ACT, ATNM-400, Iomab-B and future product candidates that we may develop may never gain market acceptance among physicians, patients

and the medical community.

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

and perceived effectiveness and reliability of the product;

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

the availability, relative

cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments using the product are approved

for reimbursement by public and private insurers;

the availability, relative cost and perceived advantages and disadvantages of alternative technologies;

the degree to which treatments

using the product are approved for reimbursement by public and private insurers;

the strength of our marketing and distribution infrastructure;

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.

believe that oncologists and other physicians will not widely adopt a product candidate unless they determine, based on experience, clinical

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

Failure of Actimab-A or Iomab-ACT

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

condition and results of operations.

of Actimab-A, Iomab-ACT, ATNM-400, Iomab-B or any of our other product candidates to significantly penetrate current or new markets would

negatively impact our business financial condition and results of operations.

may be subject to claims that our third-party service providers, consultants or current or former employees have wrongfully used or disclosed

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compliance with these regulations and standards.

We currently plan to build out a manufacturing facility in the future

to operate for the purposes of manufacturing our own products.

We have never built, owned or operated a manufacturing facility.

can be no assurances that we will be able to successfully accomplish this and in doing so we may experience delays, cost overruns, or

other problems that could seriously hurt our business.

Even if we successfully build out our planned manufacturing facility, we may not

realize the expected benefits of these efforts.

currently plan to build out a manufacturing facility in the future to operate for the purposes of manufacturing our own products.

have never built, owned or operated a manufacturing facility.

There can be no assurances that we will be able to successfully accomplish

this and in doing so we may experience delays, cost overruns, or other problems that could seriously hurt our business.

Even if we successfully

build out our planned manufacturing facility, we may not realize the expected benefits of these efforts.

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

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of our clinical trials and pre-clinical work that may have a negative impact on our business.

Furthermore, these third-party contractors,

whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shutdowns, employee strikes, or any other unforeseeable

acts that may delay or limit production.

Our inability to adequately establish, supervise and conduct (either ourselves or through third

parties) all aspects of the formulation and manufacturing processes, and the inability of third-party manufacturers to consistently supply

quality product when required would have a material adverse effect on our ability to develop or commercialize our products.

We have faced

delays and risks associated with reliance on key third party manufacturers in the past and may be faced with such delays and risks in

Any future manufacturing interruptions or related supply issues could have an adverse effect on our company, including delays

in clinical trials.

these third-party contractors, whether foreign or domestic, may experience regulatory compliance difficulty, mechanical shutdowns, employee

strikes, or any other unforeseeable acts that may delay or limit production.

Our inability to adequately establish, supervise and conduct

(either ourselves or through third parties) all aspects of the formulation and manufacturing processes, and the inability of third-party

manufacturers to consistently supply quality product when required would have a material adverse effect on our ability to develop or

commercialize our products.

We have faced delays and risks associated with reliance on key third party manufacturers in the past and

may be faced with such delays and risks in the future.

Any future manufacturing interruptions or related supply issues could have an

adverse effect on our company, including delays in clinical trials.

we are successful in obtaining marketing approval from the FDA and/or other regulatory agencies for any of our product candidates, we

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obligations, payments for services, development obligations or the ownership of intellectual property developed during our collaboration.

We may seek to amend, modify or terminate agreements with partners, suppliers or service providers related to Iomab-B, Actimab-A or Iomab-ACT

but there can be no assurance that we can do so successfully or negotiate terms that are favorable to us.

Failure of which can increase

the risk of or result in litigation or alternative dispute resolution options taken against us.

Further, we may exercise our decision-making

authority under certain circumstances pertaining to global patient safety related to our products, which our partners may disagree with

and may result in potential conflicts and public disclosure of our rationale and position.

If any conflicts arise with any of our partners,

such partner may act in a manner that is adverse to our best interests.

Any such disagreement could result in one or more of the following,

each of which could delay or prevent the development or commercialization of our product candidates, and in turn prevent us from generating

unwillingness on the part of a partner to pay us milestone payments or royalties we believe are due under a collaboration;

uncertainty regarding ownership of intellectual property rights arising from our collaborative activities, which could prevent us from

entering into additional collaborations;

unwillingness by the partner to cooperate in the development or manufacture of the product,

including providing us with product data or materials;

unwillingness on the part of a partner to keep us informed regarding the progress

of its development and commercialization activities or to permit public disclosure of the results of those activities;

initiating litigation

or alternative dispute resolution options by either party to resolve the dispute;

or attempts by either party to terminate the agreement.

or alternative dispute resolution options can be lengthy and expensive, require significant time and attention from our management and

are highly uncertain.

There can be no assurance that if we pursue, or a partner pursues litigation or alternative dispute resolution

options, that we will prevail.

Monetary and equitable damages awarded against us could have a material adverse effect on our business.

We may seek to amend, modify or terminate agreements with partners, suppliers or service providers related to ATNM-400, Actimab-A, Iomab-ACT

or Iomab-B, but there can be no assurance that we can do so successfully or negotiate terms that are favorable to us.

Failure of which

can increase the risk of or result in litigation or alternative dispute resolution options taken against us.

Further, we may exercise

our decision-making authority under certain circumstances pertaining to global patient safety related to our products, which our partners

may disagree with and may result in potential conflicts and public disclosure of our rationale and position.

If any conflicts arise with

any of our partners, such partner may act in a manner that is adverse to our best interests.

Any such disagreement could result in one

or more of the following, each of which could delay or prevent the development or commercialization of our product candidates, and in

turn prevent us from generating revenues:

unwillingness on the part of a partner to pay us milestone payments or royalties we believe

are due under a collaboration;

uncertainty regarding ownership of intellectual property rights arising from our collaborative activities,

which could prevent us from entering into additional collaborations;

unwillingness by the partner to cooperate in the development or

manufacture of the product, including providing us with product data or materials;

unwillingness on the part of a partner to keep us

informed regarding the progress of its development and commercialization activities or to permit public disclosure of the results of

those activities;

initiating litigation or alternative dispute resolution options by either party to resolve the dispute;

by either party to terminate the agreement.

Litigation or alternative dispute resolution options can be lengthy and expensive, require

significant time and attention from our management and are highly uncertain.

There can be no assurance that if we pursue, or a partner

pursues litigation or alternative dispute resolution options, that we will prevail.

Monetary and equitable damages awarded against us

could have a material adverse effect on our business.

in the future we are unable to establish U.S.

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The ownership of our proprietary rights could also be challenged.

a result, our owned and licensed patents may not be valid, and we may not be able to obtain and enforce patents and to maintain trade

a result, our owned and licensed patents may be held invalid, and we may not be able to obtain and enforce patents and to maintain trade

secret protection for the full commercial extent of our technology.

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Litigation may also absorb significant management

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,

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

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.

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In addition, we may have to expend resources to protect our interests from possible infringement by others.

For instance,

we learned that a former employee, Qing Liang, Ph.D., who was employed by Actinium in the position of Vice President, Head of Radiation

Sciences, violated the non-compete provision of her employment agreement by working for a direct competitor.

Additionally, while working

for the direct competitor, Dr.

Liang continued to provide consulting services to Actinium.

We also learned that Dr.

Liang was providing

consulting services to another company, which was in violation of certain provisions of her post-employment consulting agreement with

Liang, who had access to materials containing proprietary information and trade secrets, pursuant to actions taken by Actinium,

is no longer employed by the direct competitor.

With the assistance of outside counsel and a forensic investigator, we identified that

Liang downloaded confidential information prior to her employment at Actinium ending.

To aid in arbitration proceedings, we petitioned

and were granted a Stipulated Preliminary Injunction by the Supreme Court of the State of New York, New York County (Index No.

on June 28, 2022 that ordered that Dr.

Liang is enjoined from destroying or deleting any Actinium documents or information, is enjoined

from using, transmitting or transferring any Actinium Information other than to her counsel or Actinium’s counsel, ordered to return

Actinium information within 5 days of Stipulated Preliminary Injunction, ordered to disclose to Actinium under oath, all persons and

devices she transferred or disclosed Actinium Information, and ordered to allow a qualified forensic examiner selected by Actinium to

remove and permanently delete all Actinium Information from any electronic devices, systems, email accounts, or other electronic or physical

storage sites belonging to Dr.

On April 25, 2023, a Final Award and Permanent Injunction was granted by the Supreme Court of the

State of New York, New York County (Case No.

01-22-0003-2375) that ordered that Dr.

Liang is permanently enjoined from using, possessing,

transmitting or transferring any Actinium property, documents of business information.

may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of their

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of operation.

Related to Our Operations

are highly dependent on our key personnel, and if we are not successful in attracting and retaining highly qualified personnel, we may

not be able to successfully implement our business strategy.

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.

the third quarter of 2024, our overall headcount was reduced by approximately twenty percent, with a majority of departures coming from

our clinical and CMC groups.

As a result of these departures, we expect our personnel expenses to be reduced by approximately $3.7 million

in 2025, which may be offset by additional hires or consultants.

We do not expect these departures to have a material impact on our operations

or ability to execute our operating plan and are actively seeking a strategic partner for Iomab-B in the U.S.

to advance the additional

studies and trials required by the FDA.

overall tightening and increasingly competitive labor market has been observed in the U.S.

employment market generally.

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 as a result of general macroeconomic factors of force

majeure events, or due to dynamics within our industry, could lead to increased costs, such as increased wage rates to attract and

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

and potential regulatory and commercial activities.

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

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

could be adversely affected.

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

factors or as a result of biotechnology industry dynamics could have a material adverse impact on our operations, results of operations,

liquidity or cash flows.

future success also depends on our ability to identify, attract, hire, or engage, retain, and motivate other well-qualified managerial,

technical, clinical and regulatory personnel.

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

management personnel as they identify, hire, and train external and internal candidates to fill the sizable number of positions required

to execute our business plans, including submitting a BLA and building a commercial organization.

The market for talent in our industry

is very competitive.

Many of the other biopharmaceutical companies we compete against for qualified personnel have greater financial

and other resources, more favorable risk profiles and a longer operating history in the biopharmaceutical industry than we do.

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

Some of these opportunities may be more appealing to

high-quality candidates than what we have to offer.

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 affect our ability

to operate, grow and manage our business.

Risks Related to Our Operations

our growth as we expand operations may strain our resources.

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We are subject to federal, state, local and foreign environmental laws and regulations

governing, among other matters, the handling, storage, use and disposal of these materials and some waste products.

We cannot completely

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

exceed our financial resources.

governing, among other matters, the handling, transportation, storage, use and disposal of these materials and some waste products.

radiopharmaceutical operations depend on NRC/Agreement State licenses, hazardous-materials shipping permissions, and third-party radioactive

waste services;

loss or disruption of any of these could halt clinical supply or commercialization.

We cannot completely eliminate the

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

financial resources.

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

however, future claims may exceed the amount of our coverage.

however, future

claims may exceed the amount of our coverage.

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

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

primarily of waste disposal expenses.

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

impair our research, development, production and commercialization efforts.

Currently the

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

waste disposal expenses.

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

research, development, production and commercialization efforts.

may undertake international operations, which will subject us to risks inherent with operations outside of the United States.

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of any of our product candidates that we obtain approval to market.

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

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

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

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

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

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

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.

continuously evaluate our business strategy and may modify our strategy as necessary to respond to developments in our business and other

factors, and any such modification, if not successful, could have a material adverse effect on our business, financial condition, and

results of operations.

factors, and any such modification such as a divestiture, spin-off, spin-out, merger or acquisition, if not successful, could have a

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

continuously evaluate our business strategy and modify our plans as necessary to achieve our objectives in response to changing circumstances.

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and development efforts.

Any sale of common stock by us in a future offering could result in dilution to our existing stockholders as

a direct result of our issuance of additional shares of our capital stock.

In addition, our business strategy may include expansion through

internal growth or by establishing strategic relationships with targeted customers and vendors.

In order to do so, or to finance the

cost of our other activities, we may issue additional equity securities that could dilute our stockholders’ stock ownership.

may also assume additional debt and incur impairment losses related to goodwill and other tangible assets if we acquire another company

and this could negatively impact our earnings and results of operations.

sale of common stock by us in a future offering could result in dilution to our existing stockholders as a direct result of our issuance

of additional shares of our capital stock.

In addition, our business strategy may include expansion through internal growth or by establishing

strategic relationships with targeted customers and vendors.

In order to do so, or to finance the cost of our other activities, we may

issue additional equity securities that could dilute our stockholders’ stock ownership.

We may also assume additional debt and

incur impairment losses related to goodwill and other tangible assets if we acquire another company and this could negatively impact

our earnings and results of operations.

common stock is subject to price volatility which could lead to losses by stockholders and potential costly security litigation.

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many of which are beyond our control.

stock market is subject to significant price and volume fluctuations.

In the past, following periods of volatility in the market price

of a company’s securities, securities class action litigation has often been initiated against such a company.

Litigation initiated

against us, whether or not successful, could result in substantial costs and diversion of our management’s attention and our resources,

which could harm our business and financial condition.

The stock market is subject to significant price and volume fluctuations.

In the past, following periods of volatility in the market price of a company’s securities, securities class action litigation has

often been initiated against such a company.

Litigation initiated against us, such as the matters further described under “Legal

Proceedings”, whether or not successful, could result in substantial costs and diversion of our management’s attention and

our resources, which could harm our business and financial condition.

do not intend to pay dividends on our common stock, so any returns will be determined by the value of our common stock.

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delaying, deferring or preventing a change in our control.

We face risks associated with litigation

We are subject to certain legal proceedings, as further described under

“Legal Proceedings.” In addition, from time to time, we may become involved in various claims, disputes and legal or regulatory

proceedings that arise in the ordinary course of business and relate to contractual and other obligations.

Due to the uncertainties of

litigation, we can give no assurance that we will prevail on any claims made against us in any such lawsuit.

Also, we can give no assurance

that any other lawsuits or claims brought in the future will not have an adverse effect on our financial condition, liquidity, or operating

Adverse outcomes in some or all of these claims may result in significant monetary damages that could adversely affect our ability

to conduct our business.

face risks associated with litigation and claims.

are subject to certain legal proceedings, as further described under “Legal Proceedings.” In addition, from time to time,

we may become involved in various claims, disputes and legal or regulatory proceedings that arise in the ordinary course of business

and relate to contractual and other obligations.

Due to the uncertainties of litigation, we can give no assurance that we will prevail

on any claims made against us in any such lawsuit.

Also, we can give no assurance that any other lawsuits or claims brought in the future

will not have an adverse effect on our financial condition, liquidity, or operating results.

Adverse outcomes in some or all of these

claims may result in significant monetary damages that could adversely affect our ability to conduct our business.

with the reporting requirements of federal securities laws can be expensive.

are subject to the information and reporting requirements of the Exchange Act and other federal securities laws, and the compliance obligations

of the Sarbanes-Oxley Act.

The costs of preparing and filing annual and quarterly reports and other information with the Securities and

Exchange Commission and furnishing audited reports to stockholders are substantial.

In addition, we will incur substantial expenses in

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

We are subject to the information and reporting requirements of the

Securities Exchange Act (the “Exchange Act”) and other federal securities laws, and the compliance obligations of the Sarbanes-Oxley

The costs of preparing and filing annual and quarterly reports and other information with the SEC and furnishing audited reports

to stockholders are substantial.

In addition, we will incur substantial expenses in connection with the preparation of registration statements

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

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

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could cause the price of our common stock and trading volume to decline.

amended and restated bylaws, as amended, designate the U.S.

federal district courts as the exclusive forum for

the resolution of any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.

amended and restated bylaws, as amended, provide that, unless we consent in writing to the selection of an alternative forum,

the federal district courts of the United States of America will be the exclusive forum for resolving any complaint asserting a cause

of action arising under the Securities Act of 1933, as amended.

In addition, our amended and restated bylaws, as amended, state that

any person purchasing or otherwise acquiring any interest in our security shall be deemed to have notice of and to have consented to

such provision.

Such choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds

favorable for disputes with us or our directors, officers or other employees, which may discourage such lawsuits, if successful, might

benefit our stockholders.

Stockholders who do bring a claim in the federal district courts of the United States of America could face

additional litigation costs in pursuing any such claim.

Tariff policies and potential countermeasures

could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations.

President Trump has increased,

and has indicated his willingness to continue to increase, the use of tariffs by the U.S.

Bylaws designate the U.S.

federal district courts as the exclusive forum for the resolution of any complaint

asserting a cause of action arising under the Securities Act of 1933, as amended.

Our Bylaws provide that,

unless we consent in writing to the selection of an alternative forum, the federal district courts of the United States of America will

be the exclusive forum for resolving any complaint asserting a cause of action arising under the Securities Act of 1933, as amended.

In addition, our Bylaws state that any person purchasing or otherwise acquiring any interest in our security shall be deemed to have

notice of and to have consented to such provision.

Such choice of forum provision may limit a stockholder’s ability to bring a

claim in a judicial forum that it finds favorable for disputes with us or our directors, officers or other employees, which may discourage

such lawsuits, if successful, might benefit our stockholders.

Stockholders who do bring a claim in the federal district courts of the

United States of America could face additional litigation costs in pursuing any such claim.

The uncertainty of tariff policies and potential

countermeasures could increase our costs and disrupt our global supply chain, which could negatively impact the results of our operations.

President Trump has increased, and has indicated his willingness to

continue to increase, the use of tariffs by the U.S.

to accomplish certain U.S.

policy goals.

tariffs and any countermeasures could increase the cost of raw materials and components necessary for our operations, disrupt our global

supply chain and create additional operational challenges.

Further, it is possible that government policy changes and related uncertainty

about policy changes could increase market volatility.

Because of these dynamics, we cannot predict the impact of any future changes to

the U.S.’s or other countries’ trading relationships or the impact of new laws or regulations adopted by the U.S.

countries on our business.

Such changes in tariffs and trade regulations could have a material adverse effect on our financial condition,

results of operations and cash flows.

In February 2026, the U.S.

Supreme Court

ruled that tariffs imposed under the International Emergency Economic Powers Act (IEEPA) are unauthorized.

In response, the presidential

administration announced its intention to invoke other laws to collect tariffs and announced new tariffs on imports from all countries

under Section 122 of the Trade Act of 1974, in addition to any existing non-IEEPA tariffs.

The administration could additionally take

action to invoke other laws to collect tariffs also.

Such tariffs and any countermeasures could increase the cost of raw materials and

components necessary for our operations, disrupt our global supply chain and create additional operational challenges.

Further, it is

possible that government policy changes and related uncertainty about policy changes could increase market volatility.

Because of these

dynamics, we cannot predict the impact of any future changes to the U.S.’s or other countries’ trading relationships or the

impact of new laws or regulations adopted by the U.S.

or other countries on our business.

Such changes in tariffs and trade regulations

could have a material adverse effect on our financial condition, results of operations and cash flows.

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

What changed 10-K

Item 1A. Risk Factors