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Item 1. Business

2024-03-29 compared with 2023-03-31 · 1230 added, 892 removed, 153 unchanged (93% of the section changed)

1 unchanged sentence

Actinium Pharmaceuticals, Inc.

(“Actinium”) is a biopharmaceutical

company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high

unmet medical needs.

(“Actinium” or the “Company”)

develops targeted radiotherapies intended to meaningfully improve survival for patients with relapsed or refractory cancer who have failed

existing therapies.

Our vision is to build a specialty, hospital-focused, radiotherapeutics company that develops and markets medicines

for relapsed or refractory cancer patients who are treated primarily in large quaternary care hospitals and their catchment areas.

intend to leverage the clinical data of our lead product candidates, Iomab-B and Actimab-A, to improve outcomes in patients with relapsed

or refractory acute myeloid leukemia (“r/r AML”) by launching two radiotherapy drugs in 5 years that address the significant

need for better outcomes from treatment with therapeutics or from undergoing a bone marrow transplant (“BMT”).

We also intend during this time frame to further advance Iomab-B outside

of acute myeloid leukemia (“AML”) based on promising data as a disease control and conditioning agent for various other blood

Based on early promising clinical trial results, we are also working on a lower dose next generation conditioning program, Iomab-ACT,

for rapidly growing cell and gene therapies.

Our Clinical Pipeline

for patients who are treated primarily in large quaternary care hospitals and their catchment areas.

We are deploying our technology platform,

which we believe to be industry-leading, and intellectual property, with over 230 issued and pending patents worldwide, to develop ARCs,

or Antibody Radiation Conjugates, and next-generation radiotherapies against validated cancer targets.

Pipeline Highlights

We intend to leverage the

clinical data of our lead product candidates, Iomab-B and Actimab-A, to potentially improve outcomes in patients with relapsed or refractory

acute myeloid leukemia (“r/r AML”) by launching two radiotherapy drugs over the next several years to address the significant

unmet need for better outcomes from treatment with therapeutics or from undergoing a bone marrow transplant (“BMT”).

We also intend to further advance Iomab-B beyond acute myeloid leukemia

(“AML”), based on promising data as a disease control and conditioning agent for various other blood cancers.

Based on early

clinical trial results, we are also working on a next-generation conditioning program, Iomab-ACT, for rapidly growing cell and gene therapies.

Our Next Generation ARC Pipeline

AML is an aggressive, heterogeneous disease that is difficult to treat.

Most AML patients develop relapsed or refractory disease within one year and have an extremely poor prognosis and dismal survival.

a BMT is the only curative regimen available for AML patients, however, access is limited to AML patients who are fit enough to withstand

Over 50% of AML patients develop relapsed or refractory disease within one year of being afflicted and have an extremely poor prognosis

and dismal survival.

Currently, a BMT is regarded as being able to provide the best treatment outcome and is the only curative regimen

available for AML patients, however, access is limited to less than 20% of all AML patients, as patients must be fit enough to withstand

the challenges associated with this treatment.

The majority of AML patients are considered not transplantable in routine clinical practice

as they are not fit enough to withstand the rigors of the patient journey which includes:

therapy to attain a remission, conditioning

regimens to destroy diseased marrow, challenge of the transplant itself or post-transplant complications.

Our Iomab-B and Actimab-A product candidates fill the major unmet medical

needs in r/r AML in a complementary fashion as they are directed at different parts of the patient journey.

Iomab-B is a targeted bridging

therapy that provides both disease control and conditioning in one agent.

Results from a phase 3 trial has demonstrated unprecedented

access to a BMT and improved survival in unfit patients who are currently not considered transplantable in routine clinical practice.

Actimab-A is a targeted therapy for fit patients that has demonstrated an impressive extension in survival in a proof-of-concept study

and is poised for advanced development in collaboration with the NCI, or National Cancer Institute.

Together, they provide us the opportunity

to transform the treatment of AML, especially in the relapsed and refractory segment which represents over 50% of AML patients.

On October 31, 2022, we announced topline results from the pivotal

Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory AML or SIERRA trial, which demonstrated that Iomab-B met the primary endpoint

of durable Complete Remission (“dCR”) with a high degree of statistical significance (p<0.0001).

On February 18, 2023,

we announced full trial results, demonstrating unprecedented access, improved outcomes and better safety and tolerability with double

1-year and median overall survival (“OS”) compared to control arm patients receiving Iomab-B at the 2023 Tandem Meetings aka

the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (“ASTCT”)

and the Center for International Blood & Marrow Transplant Research (“CIBMTR”).

We believe these results provide the opportunity

to establish Iomab-B as a new standard of care, and if approved, we intend to commercialize the product in the United States (“U.S.”).

On April 12, 2022, we announced a commercialization

agreement for Iomab-B with Immedica AB (“Immedica”) for exclusive rights in Europe, the Middle East and North Africa (“EUMENA”).

Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales

milestones and mid-twenty percent royalties.

The market in the EU region is attractive due to the higher incidence of AML and number of

BMT procedures compared to the U.S.

with the same unmet patient need, and our partnership with Immedica positions us well to capitalize

on this opportunity.

Actimab-A is the industry-leading program, leveraging the potent alpha

radiation emitting isotope Actinium-225 (“Ac-225”) based on clinical development in approximately 150 patients treated over

6 clinical trials.

The potent linear energy transfer emitted by Ac-225 has no known resistance mechanism.

Actimab-A is being developed

in combination with other regimens to exploit mechanistic synergies and leverage the mutation-agnostic mechanism of action of Ac-225 with

the objective of establishing it as a backbone therapy in AML, an extremely heterogenous disease.

On December 10, 2022, we shared the Phase 1 results from the Actimab-A

CLAG-M combination trial at the American Society of Hematology (“ASH”) Annual Meeting & Exposition that showed high response

rates and minimal residual disease (“MRD”) negativity, translating to a meaningful survival benefit of 53%and 32%at one and

two years in patients who are typically expected to live two to four months.

At the same meeting, we shared Phase 1 data showing that

the combination of Actimab-A + venetoclax was well-tolerated with responses, including a Complete Remission (“CR”) and a partial

response in early dose escalation cohorts.

We believe the promise of these results paved the way for the NCI Cooperative Research and

Development Agreement (“CRADA”), announced on February 6, 2023, to develop Actimab-A for the treatment of patients with AML

and other hematologic malignancies.

Our differentiated R&D is further exemplified by our next-generation

Iomab-ACT conditioning program for rapidly growing cell and gene therapies, as well as our solid tumor and immunotherapy collaborations

with Astellas Pharma Inc.

(“Astellas”), AVEO Oncology/LG Chem (“LG Chem”) and EpicentRx, Inc.

(“EpicentRx”).

In addition, we have several other programs in solid tumors at the pre-clinical stage with investigational new drug (“IND”)

enabling studies ongoing and our extensive intellectual property (“IP”) portfolio includes over 200 issued patents and pending

patent applications worldwide.

We are actively working on launching an early access program (“EAP”)

for Iomab-B and intend to file a Biologics License Application (“BLA”) by year-end while preparing for a U.S.

commercial launch

and working with our partner Immedica to support the Marketing Authorization Application (“MAA”) and commercialization in

Late-stage Actimab-A development is expected to begin in the second half of 2023 under the NCI CRADA and is anticipated to have

a material balance sheet sparing impact over the next several years.

We expect to create significant value due to the combination of major

milestones and balance sheet strength with the approximately $100 million cash on hand at year-end 2022 projected to fund operations through

2025 as we continue to drive ahead with realizing our five-year plan.

as they are not fit enough to withstand the rigors of the patient journey, which includes therapy to attain a remission, conditioning

regimens to destroy diseased marrow, the challenge of the transplant itself or post-transplant complications.

Our Iomab-B and Actimab-A product candidates have the potential to

fill the major unmet medical needs in r/r AML in a complementary fashion as they are directed at different parts of the patient journey.

Iomab-B, an ARC that is comprised of the anti-CD45 apamistamab and the radioisotope iodine-131 (“I-131”), is being developed

as a targeted bridging therapy candidate that we believe could provide both disease control and conditioning in one agent.

the results from our Phase 3 Study of Iomab-B in Elderly Relapsed or Refractor AML “SIERRA trial” demonstrate the possibility

for unprecedented access to a BMT and improved survival in unfit patients who are currently not considered transplantable in routine clinical

We are developing Actimab-A, an ARC comprised of the anti-CD33 lintuzumab and the radioisotope actinium-225 (“Ac-225”),

as a targeted therapy candidate for fit patients.

Actimab-A has demonstrated an extension in survival in a proof-of-concept study and

is poised for advanced development and program expansion in collaboration with the National Cancer Institute (“NCI”).

we believe these two product candidates could provide us the opportunity to transform the treatment of AML, especially in the relapsed

and refractory segment which represents over 50% of AML patients.

Iomab-B was evaluated in

the randomized SIERRA trial and met the primary endpoint of durable Complete Remission (“dCR”) with a high degree of

statistical significance (p<0.0001).

In February 2023, we announced full SIERRA trial results, demonstrating unprecedented

transplant access and improved outcomes in patients with r/r AML, with double 1-year and median overall survival (“OS”)

compared to control-arm patients.

These data were presented at the 2023 Tandem Meetings aka the Transplantation & Cellular

Therapy (“TCT”) Meetings of the American Society for Transplantation and Cellular Therapy (“ASTCT”) and the

Center for International Blood & Marrow Transplant Research (“CIBMTR”).

We believe these results from the SIERRA

trial may provide the opportunity, if we are able to obtain U.S.

Food and Drug Administration (“FDA”) approval, to

establish Iomab-B as a potential new standard of care.

The results from the SIERRA trial have been and are expected to be

presented at the most prestigious and high-impact bone marrow transplant and hematology medical conferences, nuclear medicine conferences

and nursing congresses.

This wide exposure is helping broaden the awareness of Iomab-B among members of these relevant medical and scientific

communities as we and our partner Immedica Pharma AB (“Immedica”) prepare for potential commercialization in the US and European,

Middle East and North Africa (“EUMENA”) region subject to FDA and marketing authorization application (“MAA”)

approvals, respectively.

Including TCT, the SIERRA Phase 3 results have now been highlighted in oral presentations at several U.S.

European bone marrow transplant, hematology, nuclear medicine and nursing conferences attended by key Iomab-B stakeholders, including

bone marrow transplant physicians, hematologists and nuclear medicine physicians.

Iomab-B SIERRA trial d ata

presentations include:

Society for Blood and Marrow Transplantation (“EBMT”) Annual Meeting, 2023 and

Nursing Society (“ONS”) 48 th Annual Congress, April 2023

Hematology Association (“EHA”) 2023 Hybrid Congress, June 2023

for Nuclear Medicine and Molecule Imaging (“SNMMI”) Annual Meeting, June 2023

Association of Nuclear Medicine (“EANM”) 2023 Congress, September 2023

of Hematologic Oncology (“SOHO”) 2023 Annual Meeting, September 2023

Annual American Society of Hematology (“ASH”) Meeting & Exposition,

December 2023

and 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

We believe that the medical

and scientific communities present at these events took note of the positive SIERRA clinical trial results and their potential positive

impact in treating elderly r/r AML patients, the safety and tolerability of Iomab-B and the successful administration of Iomab-B infusions

at various BMT centers, which was done without increasing radiation exposure risks to treating nursing staff.

The SIERRA results were

awarded the Henry N.

Wagner, Jr., Abstract of the Year award at SNMMI, representing the top selection out of more than 1,500 abstracts

accepted for presentation, which we believe highlights the recognition by the nuclear medicine community.

Iomab-B SIERRA trial data

presented in an oral presentation at ASH in December 2023 detailed survival outcomes of patients with a TP53 mutation enrolled in the

SIERRA trial, highlighting improved survival in patients who received Iomab-B.

A total of 37 patients (24.2%) enrolled in the SIERRA trial

had a TP53 mutation with 17 patients randomized to the Iomab-B arm and 20 patients randomized to the control arm of the study.

OS for TP53 negative patients receiving Iomab-B was 6.37 months and 5.72 months for TP53 positive patients.

In the control arm (including

crossover patients), the median OS for TP53 positive patients was 2.96 months.

Iomab-B was shown to significantly improve outcomes in

TP53 positive patients (initial randomization and crossover patients) with a median OS of 5.49 months versus 1.66 months in patients that

did not receive Iomab-B (hazard ratio 0.23, p-value=0.0002).

These results for patients with a TP53 mutation were also accepted for oral

presentation at the EBMT 50 th Annual Meeting in Glasgow, UK to be held on April 14 through April 17, 2024.

Most recently, at

the 2024 Tandem Meetings held from February 21 through February 24, 2024, in San Antonio, Texas, five abstracts were accepted for two

oral presentations and three poster presentations.

Two posters detailed results and findings from the SIERRA trial of Iomab-B, including

outcomes in patients with a TP53 mutation and dosimetry details and another poster for a Phase 1 study demonstrating safety and lymphodepletion

from Iomab-ACT conditioning with CD19 CAR-T therapy.

In an oral presentation, data from the SIERRA trial highlighted the outcomes and

safety of Iomab-B in patients 65 years and older that were similar to what we presented for the overall SIERRA population, and the second

oral presentation highlighted unprecedented BMT engraftment in patients receiving a therapeutic dose of Iomab-B, and demonstration of

successful donor chimerism was presented.

The data presented from the SIERRA trial highlight the opportunity for Iomab-B to provide better

access and outcomes in these hard-to-treat sub-groups, including patients with a TP53 mutation and those 65 years of age and older.

We continue to advance our efforts

to file our Biologics License Application (“BLA”) for Iomab-B to the FDA and support Immedica, our EUMENA commercial partner,

with the MAA for Iomab-B with the European Medicines Agency (“EMA”).

We conducted a successful meeting with the FDA where

we received positive feedback regarding our Chemistry, Manufacturing and Controls (“CMC”) package for Iomab-B and have been

assigned a BLA number.

We have also submitted a meeting request with the FDA to continue to discuss the clinical and non-clinical sections

of our BLA package prior to submitting our BLA filing and expect to hold this meeting in the second quarter of 2024.

As part of the MAA

filing process, Immedica has conducted meetings to review the SIERRA trial clinical and CMC data with its rapporteur and co-rapporteur,

representatives of EU member states designated to lead the evaluation of an MAA application, and following those meetings Immedica is

proceeding with its MAA filing for Iomab-B.

Based on our current assumptions, we believe we may be able to receive regulatory approval

for Iomab-B in 2025.

We are committed to working to bring Iomab-B to patients globally, as there are a significant number of patients

with r/r AML globally.

Europe represents a large commercial market opportunity with approximately twice as many transplants performed

compared to the United States.

We also plan to seek approvals in Canada, Latin America and the Asia-Pacific region following U.S.

approval, either ourselves or in collaboration with potential future partners.

We are also working on a next-generation

conditioning program, Iomab-ACT, for the rapidly growing cell and gene therapy market.

We have a National Institutes of Health (“NIH”)-funded

ongoing proof-of-concept study with Memorial Sloan Kettering Cancer Center (“MSKCC”) using single agent Iomab-ACT as conditioning

in place of traditional fludarabine and cyclophosphamide (“Flu/Cy”) to achieve improved lymphodepletion prior to CD19 CAR-T

treatment in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (“ALL”) or diffuse large B-cell lymphoma

The consistent CD45 expression on select immune and hematopoietic cells leads to potent lymphodepletion and

reduced cytokine release syndrome (“CRS”) and immune effector cell–associated neurotoxicity syndrome (“ICANS”)

with a single dose administered in an outpatient setting.

The NIH grant was recently extended to fund the ongoing clinical trial with

In March 2024, we announced a new clinical trial that will study Iomab-ACT as targeted conditioning prior to patients receiving

an FDA approved commercial CAR-T therapy.

This trial will be conducted at the University of Texas Southwestern and will start recruiting

patients following FDA review and clearance of the study.

To our knowledge, this is the first time a targeted radiotherapy conditioning

regimen will be used prior to a commercial CAR-T therapy.

We have an industry-leading

clinical development program investigating Actimab-A, a CD33 targeting ARC conjugated to the potent alpha radiation emitting isotope Ac-225,

that has been studied in approximately 150 patients treated over six clinical trials.

The potent linear energy transfer emitted by Ac-225

has no known resistance mechanism.

Actimab-A is being developed in combination with other regimens, including chemotherapies and targeted

agents utilizing its potential mechanistic synergies.

We are attempting to leverage the mutation-agnostic ability of Ac-225 to establish

Actimab-A as a backbone therapy in AML, an extremely heterogenous and radiosensitive disease.

We believe our Actimab-A +

CLAG-M therapeutic combination trial results in r/r AML validate this approach.

Phase 1 results from the Actimab-A + CLAG-M combination

trial showed high response rates and minimal residual disease (“MRD”) negativity, translating to a survival benefit in patients

who are typically expected to live two to four months.

On September 6, 2023, updated data from the Actimab-A + CLAG-M combination trial

was presented at SOHO where 1-year OS for patients with prior venetoclax treatment was 46% and 48% in all patients receiving Actimab-A

+ CLAG-M treatment.

In patients who received a transplant, the median OS was 24 months or more.

In 2023, we announced the

NCI Cooperative Research and Development Agreement (“CRADA”) to develop Actimab-A for the treatment of patients with AML and

other hematologic malignancies.

The NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties

to study Actimab-A, and the CRADA will provide extensive support for and accelerate the development of Actimab-A alone or in combination

with chemotherapy, immunotherapy, targeted agents and other novel combinations.

The CRADA studies will be overseen by the NCI in collaboration

with Actinium’s clinical development team, where Actinium has the right to review and approve all protocols and has full rights

The NCI CRADA provides for Actinium to supply Actimab-A and for NCI to cover all clinical trial execution and development

The NCI CRADA is anticipated to have a material balance sheet sparing impact over the next several years.

We expect the NCI

to initiate further development of Actimab-A in combination with CLAG-M and other targeted agents to broaden the scope of its development

Our Phase 1 data showed the

combination of Actimab-A + venetoclax was well-tolerated with responses, including a CR and a partial response in early dose-escalation

Additionally, at SOHO, we presented the first-ever preclinical data demonstrating the potential synergy of Actimab-A with FLT3

(Fms-like tyrosine kinase 3) inhibitors gilteritinib and midostaurin.

FLT3 is one of the most commonly mutated genes in AML and is associated

with aggressive disease with poor outcomes.

Actimab-A was shown to have single-agent activity against FLT3 mutant AML cell lines, supporting

its mutation-agnostic mechanism, and enhanced the anti-leukemic activity of the FLT3 inhibition in vitro.

CD33-expressing myeloid derived

suppressor cells, (“MDSCs”), are present within the tumor microenvironment and exert immunosuppressive effects.

In April 2023,

we presented preclinical data at the Association for Cancer Research (“AACR”) Annual Meeting that depicted Actimab-A’s

role in the tumor microenvironment to overcome immunosuppression driven by MDSCs.

We believe that our findings show that Actimab-A has

the potential to selectively deplete MDSCs in lung, colorectal and other cancers.

Actimab-A also demonstrated statistically significant

depletion of human MDSCs compared to Mylotarg, a CD33-targeted antibody-drug conjugate (“ADC”) in colorectal cancer (p<0.01),

highlighting the potent cytotoxicity and potential therapeutic benefit of radiotherapy compared to naked antibodies or ADCs.

demonstrates the advantages of ARCs over ADCs by using the power of radiation, against which cells have no known resistance or repair

Radiation can cause double stranded breaks in DNA, which lead to cancer cell death.

At the Society of Immunotherapy of Cancer

(“SITC”) 38 th Annual Meeting on November 4, 2023, data was presented highlighting Actimab-A’s unique

ability to target and deplete MDSCs and restore T-cell proliferation and effector response.

SPECT/CT imaging confirmed uptake of Actimab-A

in a humanized non-small cell lung cancer model, indicating enrichment of CD33+ MDSCs in the tumor microenvironment.

We believe that the

data continues to support our objective to demonstrate the potential for Actimab-A to be a backbone therapy to broadly improve antitumor

activity of immunotherapies and other targeted therapeutic modalities.

To realize the broader development potential for Actimab-A, we are

exploring its role as a maintenance therapy for various indications through our research and development (“R&D”) efforts.

Despite advances in therapeutics, a major

concern remains, with relapse risk greater than 50% for adults with high-risk AML.

The goal of maintenance therapy is to improve overall

survival and eradicate MRD.

Having demonstrated 72% MRD negativity rate in r/r AML patients who received Actimab-A + CLAG-M and achieved

CR/CRi (Complete Remission with incomplete count recovery), we aim to develop a treatment strategy in the maintenance setting utilizing

Actimab-A alone or in various combinations.

Our ARC product

candidates are intended to combine the targeting ability of monoclonal antibodies (“mAb”) with the cell-killing ability

of radioisotopes.

Our ARC product candidates target antigens that are expressed on certain cancer cell types and are able to

destroy cellular DNA and kill these cells with the energy that they emit.

We are deploying our technology platform, which we believe to be industry-leading,

and intellectual property, with over 230 issued patents and pending patent applications worldwide, to develop ARCs and

next-generation targeted radiotherapies that we intend to be ideally suited for particular disease indications and patient populations.

working on several preclinical programs that include novel approaches to validated cancer targets, as well as novel targets that

show immense potential for radiotherapeutic approaches.

We have several ongoing programs in solid tumors at the pre-clinical stage

with investigational new drug (“IND”) enabling studies underway.

Our research collaborations with large pharmaceutical

and biotech companies such as Astellas Pharma Inc.

(“Astellas”), AVEO Oncology/LG Chem (“LG Chem”), and

EpicentRx, Inc.

(“EpicentRx”) established our work with immunotherapies and in solid tumors in 2023 and years prior.

Preclinical pharmacology studies with our targeted radiotherapeutics directed at validated cancer targets have shown strong

improvement in tumor growth inhibition in various preclinical tumor models, prompting our efforts in multiple solid tumor

At year-end 2023, we had approximately $76.7 million of cash on hand.

of March 27, 2024, our unaudited cash on hand of $84.3 million is expected to fund operations into the second half of 2026, which we believe

will provide a path for Actinium to potentially achieve regulatory approvals for Iomab-B in the U.S., EUMENA, and other regions, advance

Actimab-A through multiple trials in front-line and r/r AML settings to realize our vision.

In addition, we expect to continue to advance

Iomab-ACT for cell and gene therapy conditioning, advance key R&D solid tumor programs and realize the value of our Ac-225 manufacturing

technology and know-how.

Market Opportunity

The market opportunity for Iomab-B and Actimab-A, as depicted in the

diagram below, exists in AML and for cellular therapy conditioning in various blood cancers.

We believe that Iomab-B and Actimab-A can

fill the major unmet medical needs in r/r AML in a complementary fashion as they are utilized in different parts of the patient treatment

The incidence of AML is approximately 21,000 patients per year, with a prevalence of approximately 70,000 in the U.S., (approximately

27,500 new patients per year in Europe) and the disease has an outsized economic impact relative to its population size.

Over 50% of patients

diagnosed with AML will develop relapsed or refractory disease, with a median age of 68 years at diagnosis.

Despite 10 new approved therapies

since 2017, no significant advancements have been made toward a cure and there is a significant unmet need for better therapeutics, which

provide the opportunity for Actimab-A.

Actimab-A is a targeted radiotherapy for fit patients that has demonstrated an impressive improvement

in survival in a proof-of-concept study and is poised for advanced development in collaboration with the NCI.

Using Actimab-A in combination

with chemotherapy or a targeted therapy, we have the potential opportunity to treat both newly diagnosed or r/r AML patients, with the

potential addressable population comparable to the prevalence of patients with AML.

Today, less than 20% of AML patients are able to access a BMT, currently

the only potentially curative option.

These patients are usually younger, fit, and able to withstand the challenges associated with this

treatment, leaving the large majority of AML patients ineligible for transplant.

This provides an opportunity for Iomab-B, which has demonstrated

the ability to enable unfit patients to benefit from a BMT.

Thus Iomab-B can potentially expand the market from the approximately 400

r/r AML patients who are transplanted currently to approximately 8,000 unfit patients that could be eligible for transplant.

demonstrated the ability to improve BMT access with extended survival and potentially curative outcomes in several other hematological

diseases outside of AML.

Several clinical trials in over 300 patients with myelodysplastic syndromes (“MDS”), acute lymphocytic

leukemia (“ALL”), Hodgkin’s lymphoma (“HL”), Non-Hodgkin lymphoma (“NHL”) and multiple myeloma

(“MM”) have demonstrated the same value proposition as in AML.

This data provides an opportunity to expand the market for

Iomab-B beyond AML via label expansion.

In the U.S., there are approximately 185,000 patients diagnosed with blood cancers (e.g., leukemia,

lymphoma, and myeloma) that are treatable with BMT, of which, only approximately 20,000 are transplanted, leaving greater than 165,000

patients who could potentially benefit from transplant.

These patients do not receive a BMT today primarily because they are unfit with

active disease and are not considered eligible, as they cannot tolerate the rigors of therapy required to induce a remission and the conditioning

agents required to ablate the marrow prior to a BMT.

Beyond BMT, the opportunity exists for better conditioning in other

areas of cellular therapy such as CAR-T as well as gene therapies.

The pipeline of CAR-T and gene therapies has rapidly expanded, with

the addressable patient population expected to nearly double in the next one to five years and reach approximately 93,000 patients in

by 2030 based on the current pipeline.

The CAR-T market size in terms of dollars is estimated to grow at a CAGR of approximately

11% over the next 5 plus years.

The addressable market for Iomab-ACT is in line with the patient population for cellular therapy as all

patients receive conditioning of some type prior to these treatments.

We will continue to develop Iomab-ACT, our lower dose, next generation

conditioning program for rapidly growing cell and gene therapies based on early promising results, ultimately with the value proposition

of improving overall access and outcomes for patients who need cellular or gene therapies.

The market opportunity for

Iomab-B and Actimab-A, as depicted in the diagram below, exists for AML therapies and for cellular therapy conditioning in various blood

We believe that Iomab-B and Actimab-A can fill the major unmet medical needs in r/r AML in a complementary fashion as they are

utilized in different parts of the patient treatment journey.

Today, less than 20% of all AML patients and less than 5% of r/r AML patients

are able to access a BMT, currently the only potentially curative option.

Most patients receiving BMT are fit, in remission and able to

withstand the challenges associated with this treatment, leaving the large majority of AML patients ineligible for transplant.

This provides

an opportunity for Iomab-B, which has demonstrated the ability to enable unfit patients to benefit from a BMT.

The incidence of AML is

approximately 21,000 patients per year, with a prevalence of approximately 70,000 in the U.S., (approximately 27,500 new patients

per year in Europe) and the disease has an outsized economic impact relative to its population size.

In a retrospective analysis of

commercial payer data published in the Journal of Managed Care & Specialty Pharmacy, total mean episode costs for patients with

r/r AML were approximately $439 thousand, with hospitalization as the largest contributor to cost.

Over 50% of patients diagnosed

with AML will develop relapsed or refractory disease, with a median age of 68 years at diagnosis.

In the U.S., Iomab-B can

potentially expand the market from the approximately 400 r/r AML patients who are transplanted currently to approximately 8,000

unfit patients that could be eligible for transplant.

Despite 11 new approved therapies since 2017, no significant advancements have

been made toward a cure and there is an important unmet medical need for better therapeutics, which provides the opportunity for

Using Actimab-A in combination with chemotherapy or a targeted therapy, we have the potential opportunity to treat both

newly diagnosed or r/r AML patients, with the potential addressable population comparable to the prevalence of patients with

and the five largest countries in Western Europe (France, Germany,

Italy, Spain and the United Kingdom, which we refer to as “EU5”), we believe there is the potential market opportunity to

address more than 85 thousand r/r AML patients, as shown above.

Globally, the number of BMTs performed has doubled in the last 10 years,

with an estimated ~70 thousand allogeneic BMTs performed annually.

Europe represents 40% of BMTs, the largest share of any continent globally.

Similar to the U.S., we believe the EUMENA market opportunity for Iomab-B has favorable commercial dynamics where the majority of the

estimated7,200 BMTs performed in AML patients (approximately twice the number of BMTs performed in the U.S.) are concentrated in major

centers that treat the majority of patients in each country and region.

Iomab-B has also demonstrated the ability to improve BMT access with extended survival and potentially curative outcomes in several

other hematological diseases outside of AML.

Several clinical trials in over 300 patients with myelodysplastic syndromes (“MDS”),

acute lymphocytic leukemia (“ALL”), Hodgkin’s lymphoma (“HL”), Non-Hodgkin lymphoma (“NHL”)

and multiple myeloma (“MM”) have demonstrated the same value proposition as in AML.

This data provides a potential opportunity

to expand the market for Iomab-B beyond AML via label expansion.

In the U.S., there are approximately 185,000 patients diagnosed annually

with blood cancers (e.g., leukemia, lymphoma, and myeloma) that are treatable with BMT, of which, approximately 20,000 are transplanted,

leaving greater than 165,000 patients who could potentially benefit from transplant.

These patients do not receive a BMT today primarily

because they are unfit with active disease and are not considered eligible, as they cannot tolerate the rigors of therapy required to

induce a remission and the conditioning agents required to ablate the marrow prior to a BMT.

Beyond BMT, the opportunity exists for better conditioning in other areas

of cellular therapy, such as CAR-T as well as gene therapies.

The pipeline of CAR-T and gene therapies has rapidly expanded, with the

addressable patient population expected to nearly double and reach approximately 93,000 patients in the U.S.

by 2030 based on the current

pipeline of therapies.

The CAR-T market size in terms of revenue is estimated to grow at a CAGR of approximately 11% over the next 5 plus

Currently, there are six CAR T-cell therapies approved by the FDA that are used to treat patients with lymphomas, leukemia and

multiple myeloma, which collectively had total sales over $3.5 billion in 2023.

The addressable market for Iomab-ACT is in line with the

patient population for cellular therapy as all patients receive conditioning of some type prior to these treatments.

We will continue

to develop Iomab-ACT, our next-generation conditioning program for rapidly growing cell and gene therapies based on early promising results,

ultimately with the value proposition of improving overall access and outcomes for patients who need cellular or gene therapies.

an opportunity exists for Iomab-ACT to potentially generate significant revenue, if it can provide one or more clinical benefits related

to lower CRS, less neurotoxicity, longer duration of response or a higher overall success rate of cellular therapy due to benefits of

targeted conditioning.

Actinium’s strategy is to build a fully integrated, specialty

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patient populations living with high unmet medical needs in hematology and oncology.

We believe our focus on relapsed and refractory disease

in cancer indications with high unmet medical need, with limited or no competition, and where the primary delivery of care occurs in a

few large comprehensive cancer care centers, is the appropriate strategy for our company.

The cell killing power of linear energy transfer

delivered via radiotherapeutics is unmatched by other technologies and we believe relapsed, refractory disease is an area where radiotherapeutics

can succeed over other approaches.

However, radiotherapeutics must be delivered on a just-in-time basis, and commercial and supply chain

barriers are higher than with other types of medicines.

The validity of our approach is demonstrated by our product development strategy

as well as the commercial and operating model that we are building for our lead product candidates, Iomab-B and Actimab-A.

We intend to transform the treatment of AML with our Iomab-B and Actimab-A

product candidates, each of which has demonstrated impressive extension of survival in the most difficult-to-treat patients who are typically

expected to survive two to four months.

We believe our focus on relapsed or refractory disease

in cancer indications with high unmet medical need, with limited or no competition, and where the primary delivery of care occurs in large

comprehensive cancer care centers, is the appropriate strategy for our company.

We believe that the cell-killing power of linear energy

transfer delivered via radiotherapeutics is unmatched by other technologies and we believe relapsed/refractory disease is an area where

radiotherapeutics can succeed over other approaches.

However, radiotherapeutics must be delivered on a just-in-time basis, and commercial

and supply chain barriers are higher than with other types of medicines.

The validity of our approach is demonstrated by our product development

strategy as well as the commercial and operating model that we are building for our lead ARC product candidates, Iomab-B and Actimab-A.

We intend to transform the

treatment of AML with our Iomab-B and Actimab-A product candidates, each of which has demonstrated extension of survival in the most difficult-to-treat

patients who are typically expected to survive for two to four months.

The r/r AML segment comprises over 50% of all AML patients.

Actimab-A, a therapeutic agent, and

Iomab-B for induction and conditioning, can be used in a complementary fashion as depicted in the diagram below.

Based on solid clinical

evidence with these product candidates, we intend to develop and commercialize these two radiotherapy drugs, starting with Iomab-B in

2024 and Actimab-A in 2027, if approved, to improve survival in patients with r/r AML.

Iomab-B and Actimab-A have the potential

to significantly improve r/r AML outcomes in a complementary manner

The operating model required to achieve our vision is attractive for

several reasons, including the concentrated point of care;

the top 50 transplant centers account for approximately 75% of BMTs and the

top 100 hospitals treat over 50 percent of r/r AML patients.

a therapeutic agent, and Iomab-B for induction and conditioning, can be used in a complementary fashion as depicted in the diagram below.

Based on the clinical evidence with these product candidates, we intend to develop and commercialize these two radiotherapy drugs, starting

with Iomab-B and followed by Actimab-A, if approved, with the goal of improving survival in patients with r/r AML.

Iomab-B and Actimab-A have the potential to significantly improve

r/r AML outcomes in a complementary manner

We believe the operating model required to achieve our vision is attractive

for several reasons, including the concentrated point of care;

the top 50 transplant centers account for approximately 75% of BMTs and

the top 100 hospitals treat over 50% of r/r AML patients.

Further, there is significant overlap in the healthcare providers and ecosystem

required to diagnose, treat and care for r/r AML patients within these hospitals, which will enable us to deploy a relatively small commercial

organization and operate a supply chain without the need for large investments.

Our product pipeline is targeting a broader opportunity

in conditioning via label expansion of Iomab-B into BMT for other blood cancers and with Iomab-ACT, our next generation conditioning program

for rapidly growing cell and gene therapies.

Further, our solid tumor programs are initially directed at relapsed or refractory cancers,

required to diagnose, treat and care for r/r AML patients within these hospitals, which we believe will enable us to deploy a relatively

small commercial organization and operate an appropriately sized supply chain.

Our product pipeline is targeting

a broader opportunity in conditioning via label expansion of Iomab-B into BMT for other blood cancers and with Iomab-ACT, our next generation

conditioning program for rapidly growing cell and gene therapies.

Further, our solid tumor programs are initially directed at r/r cancers,

a stage of disease where treatment is again concentrated in large hospitals, which account for a significant portion of patients.

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Establish Iomab-B as the standard of care to improve BMT access and survival outcomes in r/r AML patients who are currently not considered transplantable in routine clinical practice:

We intend to file a BLA in the second half of 2023 based on the strong results from the Pivotal Phase 3 SIERRA trial and leverage our proven operating track record at key cancer centers to build a high impact organization that can effectively commercialize Iomab-B.

By virtue of the SIERRA trial, we have established operations at 24 leading BMT centers that represent about 30% of transplant volume in the U.S.

and have strong working partnership with Key Opinion Leaders and their teams.

The positive SIERRA results demonstrating unprecedented access to BMT and outcomes along with our commitment to operational excellence provides a strong foundation for our commercial team in the U.S.

We will also work with our partner Immedica to file the MAA for the EU and support Iomab-B’s potential approval and launch with our expertise, as well as supply drug product for commercialization.

With the SIERRA results demonstrating unprecedented access to BMT,

Iomab-B is being developed to address the high unmet need in conditioning for potentially curative BMT, where the majority of patients

are treated in a concentrated number of leading centers globally.

and EU5, we believe there is the potential market opportunity

to address more than 85 thousand r/r AML patients, as shown above.

Europe represents 40% of BMTs globally.

We intend to leverage our operating

track record at key cancer centers to build an organization that can effectively commercialize Iomab-B.

By virtue of the SIERRA trial,

we have established operations at 24 leading BMT centers in the U.S.

(22) and Canada (2) that represent about 30% of transplant volume

and have strong working partnerships with Key Opinion Leaders (“KOLs”) and their teams.

The SIERRA results demonstrating unprecedented

access to BMT and outcomes, along with our commitment to operational excellence provide a strong foundation for our commercial team in

Similar to the U.S.

market, we believe the EUMENA market opportunity for Iomab-B has favorable commercial dynamics where the

majority of BMTs performed in AML patients (twice the number performed in the U.S.) are concentrated in major centers that treat the majority

of patients in each country and region.

Advance Actimab-A in combinations as a backbone therapy for r/r AML:

We intend to progress late-stage development of Actimab-A to leverage its mutation-agnostic mechanism of action and exploit synergies by combining with other treatments to develop it as an AML backbone therapy.

This approach is validated by proof-of-concept data from our Actimab-A + CLAG-M combination trial in r/r AML, which included 57% of patients who had failed venetoclax and live two to four months on average.

The results demonstrated high response rates overall and in these venetoclax failed patients median overall survival was 59% at one year and thirty-two percent at two years.

Our collaboration with the NCI under the CRADA will provide broad support for late-stage development of Actimab-A + CLAG-M and also other clinical trials to broaden use while preserving our balance sheet.

Actimab-A, if approved, would enable us to launch a second product that is complementary to Iomab-B and fulfill our ambition of radically transforming the treatment outcomes of r/r AML and expand our commercial footprint into the remaining top 100 cancer care centers outside of the leading BMT hospitals.

We intend to progress late-stage development of Actimab-A to leverage its mutation-agnostic mechanism of action (“MOA”) and exploit synergies in combination with other treatments to develop it as an AML backbone therapy.

This approach is validated by proof-of-concept data from our Actimab-A + CLAG-M combination trial in r/r AML, which included 57% of patients who had failed venetoclax and are expected to live two to four months on average.

The results demonstrated high response rates overall and in these venetoclax failed patients’ median OS was 59% at one year and 32% at two years.

Our collaboration with the NCI under the CRADA could provide broad support for late-stage development of Actimab-A + CLAG-M and also other clinical trials to broaden use of Actimab-A.

Actimab-A, if approved, would enable us to launch a second product that is complementary to Iomab-B and fulfill our ambition of transforming the treatment outcomes of r/r AML and expand our commercial footprint into the remaining top 100 cancer care centers outside of the leading BMT hospitals.

Expand the Iomab-B label and revenue stream via life cycle management:

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We plan to develop Iomab-ACT to be used for either lymphodepletion or reduced intensity conditioning prior to CAR-T and gene therapies.

Similar to BMT, access and outcomes of patients who might benefit from these therapies is limited by sub-optimal chemotherapy-based conditioning agents.

Similar to BMT, access and outcomes of patients who might benefit from these therapies is currently limited by sub-optimal chemotherapy-based conditioning agents.

The number of patients potentially eligible for Iomab-ACT is growing with increased availability of commercial cell and gene therapy products, as well as the expanding number of indications.

We are studying Iomab-ACT in conditioning prior to CAR-T cellular therapy via a National Institutes of Health (“NIH”) funded clinical trial with Memorial Sloan Kettering Cancer Center (“MSKCC”).

We expect to present proof-of-concept data from this study in the second half of 2023 and announce further development of this program in the CAR-T space.

Leverage our R&D capabilities and technological prowess to advance our solid tumor programs and partnerships:

We intend to continue to direct our R&D effort to advance our solid tumor programs into the clinic and support life cycle management for Iomab-B and Actimab-A.

Our solid tumor programs and technological capabilities are validated by our partnerships with Astellas, LG Chem, and EpicentRx, which are focused on solid tumors and immunotherapies.

Our R&D prowess is demonstrated by our robust patent portfolio with over 200 issued and pending patent applications worldwide which include protection for Iomab-B into 2037.

Our IP portfolio also includes several patent families to manufacture Ac-225 in a cyclotron, and valuable know-how.

In keeping with our strategic vision over the next five years, we would

first focus our energies on ensuring an Iomab-B approval and successful launch into core BMT centers to ensure commercial success.

intend to expand the Iomab-B label and revenue stream in a capital efficient manner while progressing the development of Actimab-A by

leveraging the NCI CRADA and its balance sheet sparing opportunity.

We will progress the development of Iomab-ACT to proof-of-concept

and explore partnerships as a means to achieve commercialization.

Our solid tumor programs will progress toward the clinic as we continue

to build out our commercial footprint into the top 100 hospitals leaving us well-positioned to develop them in accordance with our vision.

With commercial dynamics aligning favorably for a successful Iomab-B launch and with late-stage development of Actimab-A in collaboration

with the NCI, we plan to deliver on our mission to transform the treatment of AML and patient outcomes, and create a highly differentiated,

specialty radiotherapeutics company focused on the top 100 large hospitals.

Our Product Pipeline

We have strategically focused our development

efforts in areas where there is a significant unmet medical need.

We are developing a portfolio of novel radiotherapeutics that has the

potential to positively impact the outcomes of people living with hard-to-treat diseases such as r/r AML via both a therapeutic and induction/conditioning

Outside of AML, our pipeline development offers the opportunity to enhance the value proposition of cell and gene therapies with

our targeted conditioning programs.

AML Focused Programs – Iomab-B

We are studying Iomab-ACT in conditioning prior to CAR-T cellular therapy via a NIH grant that was recently extended to the Phase 2 portion to fund the ongoing clinical trial with MSKCC.

In October 2023, we announced the extension of a NIH Small Business Technology Transfer grant to support the clinical collaboration with MSKCC.

In March 2024, we announced a new clinical trial that will study Iomab-ACT as targeted conditioning prior to patients receiving an FDA-approved commercial CAR-T therapy.

This trial is expected to be conducted at the University of Texas Southwestern and expected to start recruiting patients following FDA review and clearance of the study.

Leverage our R&D capabilities and technological

prowess to advance our solid tumor directed ARC programs and partnerships:

Our preclinical programs include novel approaches to validated cancer

targets, as well as novel targets that we believe to show immense potential for radiotherapeutic approaches.

We intend to continue to

direct our R&D effort to advance our solid tumor directed ARC programs into the clinic and support life cycle management for Iomab-B

and Actimab-A.

Our Iomab-B and Actimab-A product candidates are

focused on addressing the major unmet medical needs in r/r AML in a complementary manner and are directed at different parts of the patient

Iomab-B – Targeted Radiotherapeutic

for Induction and Conditioning.

A potential new standard of care enabling a curative BMT in currently non-transplantable r/r AML patients

with poor survival prognosis

Results from our preclinical pharmacology studies with our targeted ARCs have led to multiple solid tumor programs in the

preclinical stage with IND enabling studies underway.

We currently believe that Actinium’s ARCs are less likely than small molecules

to face pricing pressure and negotiation, given that small molecules are subject to price negotiations under the Inflation Reduction Act

(“IRA”) seven years after approval compared to eleven years for a biologic, with negotiated pricing taking effect two years

after selection.

While generic versions of certain radiopharmaceuticals utilizing peptides have been submitted to the FDA via the Abbreviated

New Drug Application (“ANDA”) pathway, ARCs fall under biologics and therefore only the biosimilar approach pertains to ARCs

filed under 351(k) BLA pathway.

The regulatory pathway for biosimilars is much more comprehensive than the pathway for generics, and it

has not been proven that biosimilars are interchangeable with the innovator’s ARCs.

Our R&D capabilities in developing ARCs and next-generation targeted

radiotherapies are reflected in our worldwide patent portfolio of over 230 issued and pending patents.

The subject matter covered in this

portfolio includes ARC compositions of matter, radiopharmaceutical formulations and manufacturing, methods of treatment and administration,

and novel bifunctional chelators (linkers), as well as several aspects of manufacturing Ac-225 using a cyclotron among other subject matter.

In keeping with our strategic vision over the next several years, we

plan to first focus on ensuring an Iomab-B approval and successful launch into core BMT centers in the U.S.

and working with our partner

Immedica to support its commercial success.

We intend to expand the Iomab-B label and its revenue stream while progressing the development

of Actimab-A by leveraging the NCI CRADA.

We will endeavor to progress the development of Iomab-ACT to proof-of-concept and explore potential

partnerships as a means to achieve commercialization.

Our solid tumor programs are expected to progress toward the clinic as we continue

to build out our commercial footprint into the top 100 hospitals, which we hope will position us to develop our ARCs in line with our

With commercial dynamics aligning favorably for a successful Iomab-B launch and with late-stage development of Actimab-A planned

in collaboration with the NCI, we plan to deliver on our mission to transform the treatment of AML and patient outcomes, and create a

highly differentiated, specialty radiotherapeutics company focused on the top 100 large hospitals.

Our ARC Pipeline

We have strategically focused

our development efforts in areas where there is a significant unmet medical need.

Our novel Antibody Radiation Conjugates or ARCs have

the potential to positively impact the outcomes of people living with hard-to-treat diseases such as r/r AML and we are developing both

therapeutic and induction/conditioning agents for this purpose.

Outside of AML, our ARC pipeline development offers the opportunity to

enhance the value proposition of cell and gene therapies with our clinical stage targeted conditioning programs.

AML Focused ARC Programs – Iomab-B

and Actimab-A

Our ARC product candidates,

Iomab-B and Actimab-A, are focused on addressing the major unmet medical needs in r/r AML in a complementary manner and are directed at

different parts of the patient journey.

Iomab-B – Targeted ARC for Induction

and Conditioning.

A potential new standard of care enabling a curative BMT in currently non-transplantable r/r AML patients with poor

survival prognosis

Opportunity to Change the Current Paradigm

for Accessing a BMT and Improving Outcomes

The current approach in preparing patients

for a BMT is to first induce a remission with therapeutic agents to reduce the disease burden and then suppress or destroy the

patient’s immune system, including the diseased bone marrow, with conditioning regimens prior to transplanting the healthy

donor hematopoietic stem cells, which are expected to restore normal bone marrow function following engraftment.

As this approach

requires patients to withstand multiple challenges from non-targeted therapies, which include chemotherapy agents and/or total body

irradiation that are highly toxic, BMT is typically limited to FIT patients.

Iomab-B is a targeted therapy that provides both

disease control and conditioning in one agent and is well-tolerated even by UNFIT patients who typically are not transplanted in

routine practice today.

The SIERRA trial was designed to demonstrate that UNFIT patients with active disease could be

administered Iomab-B and proceed directly to a BMT without the need for inducing a remission and that this approach could result in

improved survival and curative outcomes.

As seen by the positive results of the SIERRA trial detailed below, Iomab-B represents an

exciting new paradigm in the management of AML patients and establishes a potential new standard of care especially for UNFIT

patients in the relapsed or refractory setting.

A similar approach has also been tried in the Phase 3 ASAP trial but

with FIT patients.

However, to avoid confusion between the potential of the approaches used in the ASAP and SIERRA trials, important distinctions

between these trials are depicted in the graphic below.

The ASAP trial sought to demonstrate non-inferiority between two non-novel approaches

and found that outcomes similar to those of current practice could be achieved without first getting a patient into remission before taking

them to BMT by giving them sequential conditioning or treating them twice with non-targeted chemotherapy agents that are typically used

in this setting.

The current approach in preparing

patients for a BMT is to first induce a remission with therapeutic agents to reduce the disease burden and then suppress or destroy the

patient’s immune system, including the diseased bone marrow, with conditioning regimens prior to transplanting the healthy donor

hematopoietic stem cells, which are expected to restore normal bone marrow function following engraftment.

As this approach requires patients

to withstand multiple challenges from non-targeted therapies, which include chemotherapy agents and/or total body irradiation that are

highly toxic, BMT is typically limited to FIT patients.

Iomab-B is a targeted therapy that provides both disease control (induction) and

conditioning in one agent and is well-tolerated even by UNFIT patients who typically are not transplanted in routine practice today.

SIERRA trial was designed to demonstrate that UNFIT patients with active disease could be administered Iomab-B and proceed directly to

a BMT without the need for inducing a remission and that this approach could result in improved survival and curative outcomes.

by the positive results of the SIERRA trial detailed below, Iomab-B represents an exciting new potential paradigm in the management of

AML patients and establishes a potential new standard of care especially for UNFIT patients in the relapsed or refractory setting.

A trial conducted in Germany

from 2015 to 2022 explored outcomes in patients proceeding to BMT but enrolled r/r AML patients FIT to tolerate sequential conditioning,

an intensive, salvage chemotherapy-based regimen.

Scheitleg et al.

presented their findings at ASH in December 2022 titled , In Patients

with Relapsed/Refractory AML Sequential Conditioning and Immediate Allogeneic Stem Cell Transplantation (allo-HCT) Results in Similar

Overall and Leukemia-Free Survival Compared to Intensive Remission Induction Chemotherapy Followed By Allo-HCT:

Results from the Randomized

Phase III ASAP Trial or (the “ASAP trial”).

The ASAP trial sought to demonstrate non-inferiority between two non-novel

approaches and found that outcomes similar to those of current practice could be achieved without first getting a patient into remission

before taking them to BMT by giving them sequential conditioning or treating them twice with non-targeted chemotherapy agents that are

typically used in this setting.

The ASAP approach is limited to only FIT patients as the UNFIT patients

treated in SIERRA could not tolerate ASAP’s highly toxic sequential conditioning approach.

Sequential conditioning is not novel

as a similar trial to ASAP was conducted by the UK National Cancer Research Institute in 2019, which did not show any benefit from this

approach in high-risk AML and MDS patients (Craddock et al.

Augmented Reduced Intensity Regimen Does Not Improve Postallogeneic Transplant

Outcomes in Acute Myeloid Leukemia.

J Clin Oncol.

The SIERRA trial results therefore can change the paradigm in transplant

because non-transplantable patients in routine clinical practice can benefit from a transplant with Iomab-B and have superior outcomes.

While both approaches in these trials support increased access to BMT, only Iomab-B is applicable to the unfit patients who comprise approximately

80%of r/r AML patients and can potentially expand the market for transplant.

However, we believe the ASAP trial results

support the use of Iomab-B, which is intended to enable patients with active r/r AML to proceed directly to BMT, without first achieving

CR with salvage induction chemotherapy.

By doing so, we seek to reduce the amount and severity of toxicities, allowing patients to receive

their BMT in better physical condition, reducing the need for in-patient hospital admissions, providing a pharmacoeconomic benefit, increasing

access to potentially curative BMT and improve patient outcomes.

We believe the SIERRA trial results therefore can change the paradigm

in transplant because non-transplantable patients in routine clinical practice can benefit from a transplant with Iomab-B and could have

superior outcomes.

While both approaches in these trials support increased access to BMT, only Iomab-B is applicable to the UNFIT patients

who comprise approximately 80% of r/r AML patients and can potentially expand the market for transplant.

To avoid confusion between the

potential of the approaches used in the ASAP and SIERRA trials, important distinctions between these trials are depicted in the graphic

Schetelig et al.

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Pivotal Phase 3 SIERRA Trial for Iomab-B ( 131 Iodine-apamistamab)

The SIERRA trial was designed to demonstrate the

ability of Iomab-B to overcome challenges related to patient access to curative BMT.

Unfortunately, approximately 30% of patients with

AML have primary refractory disease while 50% relapse quickly after achieving initial remission.

Getting these patients with primary r/r

AML into remission is very challenging due to characteristics such as age, comorbidities, and disease features such as high-risk mutations

that contribute to lack of response to salvage therapies and limit treatment options.

The SIERRA trial was designed

to demonstrate the ability of Iomab-B to overcome challenges related to patient access to curative BMT.

Unfortunately, approximately 30%

of patients with AML have primary refractory disease while approximately 50% relapse quickly after achieving initial remission.

these patients with primary r/r AML into remission is very challenging due to characteristics such as age, comorbidities, and disease

features such as high-risk mutations that contribute to lack of response to salvage therapies and limit treatment options.

Patients must be able to overcome several challenges related to curative

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In the SIERRA

trial, Iomab-B addresses all four of these challenges.

Access to BMT is improved as CR is not needed pre-BMT given effective disease control

and targeted myeloablation.

With better post-BMT engraftment, CR and lower complications, the SIERRA trial also addressed the challenges

related to improved outcomes through Iomab-B.

The SIERRA results, presented in the late-breaker session at the 2023

Tandem Meetings:

Transplantation & Cellular Therapy Meetings of the ASTCT and the CIBMTR, support Iomab-B’s value proposition

of enabling both improved access and outcomes of a BMT, thereby providing a significant curative option for r/r patients, a segment that

represents approximately 50% of all AML patients and the majority not transplanted today.

The design of the SIERRA trial is provided in

the figure below.

A Novel, Pivotal Phase 3 Study of

Iomab-B in r/r AML

The pivotal Phase 3 SIERRA trial is a 153-patient, randomized, multi-center,

trial, Iomab-B addressed all four of these challenges.

Access to BMT is improved as CR is not needed pre-BMT, given effective disease

control and targeted myeloablation.

With better post-BMT engraftment, CR and lower complications, the SIERRA trial also addressed the

challenges related to improved outcomes through Iomab-B.

We believe the SIERRA results presented in the late-breaker session at

the 2023 Tandem Meetings, support Iomab-B’s value proposition of enabling both improved access and outcomes of a BMT, thereby providing

a curative option for r/r AML patients, a segment that represents approximately 50% of all AML patients and the majority not transplanted

The design of the SIERRA trial is provided in the figure below.

A Novel, Pivotal Phase 3 Study

of Iomab-B in r/r AML

The pivotal Phase 3 SIERRA trial was a 153-patient, randomized, multi-center,

controlled trial of Iomab-B in patients aged 55 and above with active r/r AML, who were heavily pre-treated and had high-risk characteristics.

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practice and therefore have dismal survival outcomes of two to three months.

The primary endpoint of the SIERRA trial was dCR of 180 days

The primary endpoint of the SIERRA trial was dCR of 6-months

and the secondary endpoints are OS and Event-Free Survival (“EFS”).

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arm who crossed over to receive Iomab-B versus all others in the control group was an exploratory efficacy endpoint.

As seen in the graphic below, the primary endpoint of 6-month dCR was

met with a high degree of statistical significance (p<0.0001).

75% of patients (44/59) receiving Iomab-B achieved an initial remission

30 days after their BMT compared to 6.3% of patients (4/64) in the control arm.

22% of the patients receiving Iomab-B maintained dCR lasting

180 days or more despite limited optionality for post-transplant maintenance, while none of the patients on the control arm achieved dCR.

The current standard practice is to administer post-transplant maintenance therapy to reduce chances of relapse.

The results presented

below are on a per protocol basis, which means that only data that was in strict adherence to the protocol without any deviations was

considered for the analysis.

It is important to note that the p-value of the primary endpoint in the intent-to-treat analysis was <0.0001,

the same as the per protocol analysis.

As seen in the graphic below,

the primary endpoint of 6-month dCR was met with a high degree of statistical significance (p<0.0001).

75% of patients (44/59) receiving

Iomab-B achieved an initial remission 30 days after their BMT compared to 6.3% of patients (4/64) in the control arm.

22% of the patients

receiving Iomab-B maintained dCR lasting 6-months or more despite limited optionality for post-transplant maintenance, while none of the

patients on the control arm achieved dCR.

The current standard practice is to administer post-transplant maintenance therapy to reduce

chances of relapse.

The results presented below are on a per protocol basis, which means that only data that was in strict adherence to

the protocol without any deviations was considered for the analysis.

It is important to note that the p-value of the primary endpoint

in the Intent-to-Treat (“ITT”) analysis was <0.0001, the same as the per protocol analysis.

SIERRA Results:

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with High Significance (p<0.0001)

As demonstrated in the OS graph below, patients who achieved 6-month

dCR had 92.3% 1-year survival and 59.9% 2-year survival.

Median OS had not been reached in these patients.

It is worth noting that two

years in CR is a significant milestone in this patient population, highly indicative of long-term survival and a possible curative outcome.

As demonstrated in the OS

graph below, patients who achieved 6-month dCR had 92.3% 1-year survival and 59.9% 2-year survival.

Median OS had not been reached in

these patients.

It is worth noting that two years in CR is a significant milestone in this patient population, highly indicative of long-term

survival and a possible curative outcome.

Overall Survival for Patients who Achieved

6-month dCR with Iomab-B

OS was one of the secondary endpoints of the

The Kaplan-Meier plot in the inset of the graph below shows Intent-to-Treat (“ITT”) OS results between the Iomab-B

arm and the control arm.

Due to the crossover design, ITT analysis of OS was confounded by the early crossover of patients (within 28

days) from the control arm to the Iomab-B arm (57.1%).

The effective rescue of these crossover patients by Iomab-B led to an outsized

contribution of the Iomab-B effect on control arm patients.

As a result, median OS in the Iomab-B arm was similar to that in the control

arm and this secondary endpoint was not met in the ITT analysis.

In order to isolate the true impact of Iomab-B

on OS, one of the exploratory efficacy endpoints was the comparison of OS in subjects randomized to the control arm who crossed over to

receive Iomab-B versus all others in the control arm, as well as the control arm patients who did not crossover versus the Iomab-B arm.

The Kaplan-Meier plot of OS in the graphic below shows that this exploratory analysis demonstrated the clear benefit of Iomab-B over the

The median OS for the Iomab-B group was 6.4 months which was double the 3.2 months for the non-crossover patients in the

Patients who crossed over from the control arm to receive Iomab-B had a median OS of 7.1 months demonstrating further the

ability of Iomab-B to treat patients who are non-treatable by conventional means.

A similar pattern favoring the Iomab-B group was seen across the pre-defined

subgroups, where 1-year OS for Iomab-B was 26.1% compared with 13.1% for the non-crossover control arm.

The 1-year OS for patients in

the crossover arm was 35.8%.

This clearly demonstrates the OS benefit of Iomab-B over the control arm and two to three-fold improvement

in survival outcomes possible with its use.

OS was one of the secondary

endpoints of the study.

The Kaplan-Meier plot in the inset of the graph below shows ITT OS results between the Iomab-B arm and the control

Due to the crossover design, ITT analysis of OS was confounded by the early crossover of patients (within 28 days) from the control

arm to the Iomab-B arm (57.1%).

The effective rescue of these crossover patients by Iomab-B led to an outsized contribution of the Iomab-B

effect on control arm patients.

As a result, median OS in the Iomab-B arm was similar to that in the control arm and this secondary endpoint

was not met in the ITT analysis.

In order to isolate the true

impact of Iomab-B on OS, one of the exploratory efficacy endpoints was the comparison of OS in subjects randomized to the control arm

who crossed over to receive Iomab-B versus all others in the control arm, as well as the control arm patients who did not crossover versus

the Iomab-B arm.

The Kaplan-Meier plot of OS in the graphic below shows that this exploratory analysis demonstrated the clear benefit

of Iomab-B over the control arm.

The median OS for the Iomab-B group was 6.4 months which was double the 3.2 months for the non-crossover

patients in the control arm.

Patients who crossed over from the control arm to receive Iomab-B had a median OS of 7.1 months demonstrating

further the ability of Iomab-B to treat patients who are non-treatable by conventional means.

A similar pattern favoring

the Iomab-B group was seen across the pre-defined subgroups, where 1-year OS for Iomab-B was 26.1% compared with 13.1% for the non-crossover

The 1-year OS for patients in the crossover arm was 35.8%.

This clearly demonstrates the OS benefit of Iomab-B over the control

arm and two to three-fold improvement in survival outcomes possible with its use.

Kaplan-Meier Plot of Overall Survival ‒

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and ITT basis).

EFS at 180 days for the Iomab-B arm was 28% compared to 0.2% for the control arm.

EFS at 6 months for the Iomab-B arm was 28% compared to 0.2% for the control arm.

In the SIERRA trial, an event is defined

as one of the following:

a patient not achieving CR/CRp or crossing over, patient not receiving BMT, a patient relapsing or death.

In the figure below comparing EFS with Iomab-B

versus the control arm, the initial vertical drop in the curve in the Iomab-B arm represents those patients who did not achieve a remission

after Iomab-B or those who did not proceed to transplant, while the initial vertical drop in the curve in the control arm mainly represents

patients who did not achieve a remission with salvage therapy and either crossed over to Iomab-B or went onto best supportive care.

a patient not achieving CR/CRp (Complete Remission with partial hematologic recovery) or crossing over, patient

not receiving BMT, or a patient relapse or death.

In the figure below

comparing EFS with Iomab-B versus the control arm, the initial vertical drop in the curve in the Iomab-B arm represents those

patients who did not achieve a remission after Iomab-B or those who did not proceed to transplant, while the initial vertical drop

in the curve in the control arm mainly represents patients who did not achieve a remission with salvage therapy and either crossed

over to Iomab-B or went on to best supportive care.

Event-Free Survival with Iomab-B Versus Control

The table below shows relevant adverse events

in transplanted Iomab-B patients.

In these patients, incidence of sepsis was four times lower in the Iomab-B arm than the control arm

In addition, rates of other treatment related adverse events were lower in favor of Iomab-B, including febrile neutropenia

50.0%), mucositis (15.2% vs.

The table below shows relevant adverse events in transplanted Iomab-B

In these patients, incidence of sepsis was four times lower in the Iomab-B arm than the control arm (6.1% vs.

rates of other treatment-related adverse events were lower in favor of Iomab-B, including febrile neutropenia (43.9% vs.

50.0%), mucositis

21.4%) and acute graft versus host disease (“GVHD”) (26.1% vs.

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in Transplanted Patients Through Day 100 Post-HCT

With current treatment practice, patients who have r/r AML with active

disease, utilizing current conditioning agents have poor outcomes and very low survival rates.

Using an Iomab-B led regimen, an unprecedented

number of patients were able to access transplant and were able to do so with active disease, eliminating need for achieving a CR in order

to transplant the patient.

Thus, patients are also able to access BMT faster with Iomab-B, in less than half the time compared to conventional

Iomab-B represents an exciting new paradigm with the potential to establish a new standard of care in r/r AML setting, making it

possible for most patients to get to a successful transplant with Iomab-B with a portion of these patients having a long-term survival

As shown below, with an Iomab-B led regimen, the majority of patients who are non-transplantable in routine clinical practice

can be successfully transplanted, administering myeloablative radiation with reduced intensity conditioning tolerability to ultimately

achieve transformative survival outcome, changing the treatment paradigm for r/r AML patients.

With current treatment practice,

patients who have r/r AML with active disease, utilizing current conditioning agents have poor outcomes and very low survival rates.

an Iomab-B led regimen, an unprecedented number of patients were able to access transplant and were able to do so with active disease,

eliminating the need for achieving a CR in order to transplant the patient.

Thus, patients are also able to access BMT faster with Iomab-B,

in less than half the time compared to conventional care.

Iomab-B represents a new paradigm with the potential to establish

a new standard of care in r/r AML setting, making it possible for most patients to get to a successful transplant with Iomab-B, with a

portion of these patients having a long-term survival benefit.

As shown below, with an Iomab-B led regimen, the majority of patients who

are non-transplantable in routine clinical practice can be successfully transplanted, administering myeloablative radiation with reduced

intensity conditioning tolerability to ultimately achieve transformative survival outcome, changing the treatment paradigm for r/r AML

Iomab-B – New Paradigm to Upend BMT

Access and Improve r/r AML Outcomes

At the 2024 Tandem Meetings,

Iomab-B SIERRA trial data in an oral presentation detailed survival outcomes of patients with a TP53 mutation enrolled in the SIERRA

trial, highlighting improved survival in patients who received Iomab-B.

A total of 37 patients (24.2%) enrolled on the SIERRA trial had

a TP53 mutation with 17 patients randomized to the Iomab-B arm and 20 patients randomized to the control arm of the study.

for TP53 negative patients receiving Iomab-B was 6.37 months and 5.72 months for TP53 positive patients.

In the control arm (including

crossover patients), the median OS for TP53 positive patients was 2.96 months.

Iomab-B was shown to significantly improve outcomes in

TP53 positive patients (initial randomization and crossover patients) with a median OS of 5.49 months versus 1.66 months in patients

that did not receive Iomab-B (hazard ratio 0.23, p-value=0.0002).

These results for patients with a TP53 mutation were also accepted

for oral presentation at the EBMT 50 th Annual Meeting in Glasgow, UK to be held on April 14 through April 17, 2024.

oral presentation, data from the SIERRA trial highlighted the outcomes and safety of Iomab-B in patients 65 years and older that were

similar to what we presented for the overall SIERRA population.

The data presented from the SIERRA trial highlight the opportunity for

Iomab-B to provide better access and outcomes in these hard-to-treat sub-groups, including patients with a TP53 mutation and those 65

years of age and older.

Future Development and Life Cycle Management

The results of the Pivotal Phase 3 SIERRA trial

validate the value proposition of Iomab-B, and we believe it could establish unprecedented access to transplant (currently the only curative

option) with better safety and tolerability and improved outcomes, all of which could potentially make Iomab-B the new standard of care

for patients with r/r AML.

We are actively working to launch an EAP and successfully file a BLA in the second half of 2023, and if approved,

we anticipate the commercial launch for Iomab-B in 2024.

We intend to commercialize Iomab-B in the U.S.

The results of the Pivotal

Phase 3 SIERRA trial validate the value proposition of Iomab-B, and we believe it could establish unprecedented access to transplant (currently

the only curative option) with better safety and tolerability and improved outcomes, all of which could potentially make Iomab-B the new

standard of care for patients with r/r AML.

We plan to commercialize

Iomab-B in the U.S.

The commercial opportunity is supported by favorable dynamics, summarized by the “Three Ps and Two Cs”:

With its promising profile,

Iomab-B provides the opportunity for unprecedented BMT access and better outcomes for patients, with favorable safety and tolerability

● Physicians :

Our goal is to help physicians

make BMT an option for a vast majority of r/r AML patients who currently are unable to access transplant without disruption to current

Patients are able to return to their referring physicians for post-BMT follow-up, long-term care

Iomab-B potentially unlocks value

through getting patients safely to effective, potentially curative transplants, with improved outcomes and a manageable safety and tolerability

With its promising profile, Iomab-B provides the opportunity for unprecedented BMT access and better outcomes for patients, with favorable safety and tolerability

Our goal is to help physicians make BMT an option for a vast majority of r/r AML patients who currently are unable to access transplant without disruption to current practice.

Patients are able to return to their referring physicians for post-BMT follow-up, and long-term care

Iomab-B potentially unlocks value through getting patients safely to effective, potentially curative transplants, with improved outcomes and a manageable safety and tolerability profile

Competition :

While there have been multiple

new product approvals in AML over the last several years, they primarily focus on addressing genetic mutations, with limited competition

in conditioning to increase access to BMT.

We do not see direct or indirect visible competition for Iomab-B in the 5-to-10-year horizon

to impair the commercial success of Iomab-B

While there have been multiple new product approvals in AML over the last several years, they primarily focus on addressing genetic mutations, with limited competition in conditioning to increase access to BMT.

We do not see direct or indirect visible competition for Iomab-B in the 5-to-10-year horizon to impair the commercial success of Iomab-B.

Concentrated Call Points :

The commercialization

for Iomab-B will benefit from a concentrated market.

The top 50 centers perform 75% of BMTs and tend to be concentrated in metropolitan

The commercialization for Iomab-B will benefit from a concentrated market.

The top 50 centers perform 75% of BMTs and tend to be concentrated in metropolitan areas.

These factors allow for commercialization delivered by a focused 35–50-person commercial organization.

The favorable commercial dynamics for Iomab-B in the U.S.

supported by the strong foundation of core competencies developed during the successful execution of the SIERRA trial at leading high-volume

We established and actively managed end-to-end supply chain, never missing a patient dose, and were able to treat 60% more

patients than expected due to the high number of crossover patients.

We focused on operational excellence at the point of care, working

in partnership with leading Key Opinion Leaders and their teams to successfully execute SIERRA at a wide array of centers.

we have broad reach across leading BMT centers that account for 30% of BMT volume, which speaks to the concentration of the BMT market.

The positive SIERRA results of unprecedented access and outcomes along with our commitment to operational excellence provide a strong

foundation for our commercial team.

In April 2022, Actinium licensed the EUMENA commercial

rights for Iomab-B to Immedica, an independent pharmaceutical company headquartered in Sweden.

Immedica has significant know-how and experience

in commercializing niche and specialty care products across Europe and the Middle East, with extensive regulatory and commercial expertise

and capabilities.

Actinium will continue to be responsible for certain clinical development activities and Iomab-B manufacturing and will

retain commercialization rights in the U.S.

We believe the favorable commercial

dynamics for Iomab-B in the U.S.

are further supported by the foundation of core competencies, developed during the successful execution

of the SIERRA trial at leading high-volume BMT centers.

We established and actively managed an end-to-end supply chain, never missing

a patient dose, and were able to treat 60% more patients than expected due to the high number of crossover patients.

We focused on operational

excellence at the point of care, working in partnership with leading KOLs and their teams to successfully execute SIERRA at a wide array

As a result, we have broad reach across leading BMT centers that account for 30% of BMT volume, which speaks to the concentration

of the BMT market.

The positive SIERRA results of unprecedented access and outcomes along with our commitment to operational excellence

provide a strong foundation for our commercial team.

In April 2022, Actinium exclusively

licensed the EUMENA commercial rights for Iomab-B to Immedica, an independent pharmaceutical company headquartered in Sweden.

is solely responsible for the commercialization of the product.

Immedica has significant know-how and experience in commercializing niche

and specialty care products across Europe and the Middle East, with extensive regulatory and commercial expertise and capabilities.

will continue to be responsible for certain clinical development activities and Iomab-B manufacturing and will retain commercialization

rights in the U.S.

and rest of the world.

Currently, there an estimated ~7,200 BMTs for AML in EUMENA, two times

that of the U.S., performed in a concentrated of number of centers.

The incidence rate of AML in Europe is 3.7 per 100,000, or ~27,500

new patients per year.

Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in

regulatory and sales milestones and mid-twenty percent royalties.

Iomab-B has been granted Orphan Drug Designation by the EMA and has

received positive Scientific Advice from EMA that the SIERRA trial can support a marketing authorization with filing expected in 2024.

Currently, there are an estimated ~7,200 BMTs for AML in EUMENA, two times that of the U.S.,

performed in a concentrated number of centers.

The incidence rate of AML in Europe is 3.7 per 100,000, or approximately 27,500 new patients

Iomab-B has been granted Orphan Drug Designation by the EMA and has received positive Scientific Advice from EMA prior to the

start of the SIERRA trial.

Immedica has had rapporteur and co-rapporteur meetings to discuss the SIERRA trial clinical and CMC data, and

based on these meetings is proceeding with its MAA filing for Iomab-B.

Background on Iomab-B

Iomab-B is a first in class targeted radiotherapy consisting of apamistamab,

an anti-CD45 mouse antibody conjugated to radioactive iodine 131 (“I-131”) designed to deliver targeted myeloablative radiation

to malignant and hematopoietic cells prior to allogeneic BMT.

CD45 is uniquely expressed on blood cancer, immune and bone marrow stem

cells at high levels.

Targeting CD45 enables delivery of high radiation doses directly to the bone marrow, with a median of 16 gray and

as high as 44.6 gray in the SIERRA trial, while minimizing radiation exposure to vital organs such as lungs, heart and gastrointestinal

Iomab-B is a first-in-class

ARC consisting of apamistamab, an anti-CD45 mouse antibody conjugated to radioactive I-131 designed to deliver targeted myeloablative

radiation to malignant and hematopoietic cells prior to allogeneic BMT.

CD45 is uniquely expressed on blood cancer, immune and bone marrow

stem cells at high levels.

Targeting CD45 enables delivery of high radiation doses directly to the bone marrow, with a median of 16 gray

and as high as 44.6 gray in the SIERRA trial, while minimizing radiation exposure to vital organs such as lungs, heart and gastrointestinal

tract, thereby producing myeloablative outcomes with an overall better safety profile and the tolerability of a reduced intensity regimen.

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Over 300 patients received Iomab-B through prior studies, demonstrating the potential for unprecedented access

to BMT, improved survival and tolerability, and we intend to leverage these data as we plan for label expansion of Iomab-B.

been granted Orphan Drug Designation from the U.S.

Food and Drug Administration (“FDA”) and has patent protection into 2037.

Actimab-A – CD33 targeting radiotherapeutic

to BMT, improved survival and tolerability, and we intend to use these data as we plan for label expansion of Iomab-B.

Iomab-B has been

granted Orphan Drug Designation from the FDA and has patent protection into 2037.

Actimab-A – CD33 targeting ARC –

mutation agnostic mechanism of action has potential as combination backbone therapy in highly radiosensitive, mutation rich AML

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satetraxetan) program is focused on developing combinations with other AML treatment regimens with mechanistic synergies to establish

Actimab-A as a backbone therapy, leveraging the mutation-agnostic mechanism of action of Actimab-A.

Actimab-A as a backbone therapy, using the mutation-agnostic mechanism of action of Actimab-A.

There is no known resistance mechanism

to targeted radiotherapies, making Actimab-A an attractive candidate for a variety of combinations.

The scientific rational is to use

CLAG-M, a powerful chemotherapy regimen routinely used to treat patients with r/r AML, and then use Actimab-A for its precision targeting

ability that produces double-strand-DNA breaks that lead to cancer cell death to clear out residual disease.

Actimab-A has demonstrated

clinically significant survival benefit in a proof-of-concept study and is poised for advanced development in collaboration with the NCI.

to targeted ARCs, making Actimab-A a candidate for a variety of combinations.

The scientific rationale is to use CLAG-M, a powerful chemotherapy

regimen routinely used to treat patients with r/r AML, and then use Actimab-A for its precision-targeting ability that produces double-strand-DNA

breaks that lead to cancer cell death to clear out residual disease.

Actimab-A has demonstrated clinically significant survival benefit

in a proof-of-concept study and is poised for advanced development in collaboration with the NCI.

We expect the NCI to initiate further

development of Actimab-A in combination with CLAG-M and other targeted agents to broaden the scope of its development in r/r AML.

Actimab-A + CLAG-M Phase 1 Study Results

In collaboration with the Medical College of Wisconsin, the Actimab-A

+ CLAG-M Phase 1 trial was conducted in r/r AML patients.

These patients had a median age of 63, failed two or more lines of therapy,

which includes 57% having received prior treatment with venetoclax, a BCL-2 inhibitor.

67% of these patients had adverse cytogenetics,

52% had a TP53 mutation, and 57% had a prior BMT.

Median OS is typically two to four months for this patient population, with a median

OS of less than 3 months for patients who relapsed following venetoclax and a median OS less than 2 months for those with a TP53 mutation.

These trial results were presented as an oral

presentation at the ASH Annual Meeting on December 10, 2022.

In this difficult-to-treat r/r AML population, the results demonstrate its

high potential.

We reported 1-year survival of 53% and 2-year survival of 32%, which are as much as double what can be expected with currently

available therapies.

The trial showed an Overall Response Rate (“ORR”) of 65% across all dose cohorts, 52% complete remission

rate, and a 75% MRD negativity rate.

As highlighted in the figure below, the results are highly encouraging and show that the high rates

of responses and MRD negativity are translating to a meaningful survival benefit in these difficult-to-treat patients, who would otherwise

have dismal outcomes.

Actimab-A + CLAG-M – Impressive Response

and Survival Benefit in r/r AML

In collaboration with the

Medical College of Wisconsin, the Actimab-A + CLAG-M Phase 1 trial was conducted in r/r AML patients fit for intensive therapy.

patients had a median age of 63, failed two or more lines of therapy, which includes 57% having received prior treatment with venetoclax,

a BCL-2 inhibitor.

67% of these patients had adverse cytogenetics, 52% had a TP53 mutation, and 57% had a prior BMT.

Median OS is typically

two to four months for this patient population, with a median OS of less than 3 months for patients who relapsed following venetoclax

and a median OS less than 2 months for those with a TP53 mutation.

In this difficult-to-treat

r/r AML population, the results demonstrate its potential.

We reported 1-year survival of 53% and 2-year survival of 32%, which are as

much as double what can be expected with currently available therapies.

The trial showed an Overall Response Rate (“ORR”)

of 65% across all dose cohorts, 52% complete remission rate, and a 75% MRD negativity rate.

As highlighted in the figure below, the results

are encouraging and show that the high rates of responses and MRD negativity are translating to a meaningful survival benefit in these

difficult-to-treat patients, who would otherwise have dismal outcomes.

Actimab-A + CLAG-M –Response and Survival

Benefit in r/r AML

Actimab-A + CLAG-M Compared to CLAG-M Alone

Efficacy of CLAG-M has been reported in older studies (Halpern

Efficacy of CLAG-M has been

reported in older studies (Halpern and Walter.

CLAG-M with dose-escalated mitoxantrone for adults with acute myeloid leukemia.

Oncotarget 2018 and Mushtaq et al.

of Salvage Chemotherapy Regimens in Relapsed/Refractory Acute Myeloid Leukemia.

ASH 2018) in patients with r/r AML, however, almost all

of these studies were conducted in the pre-targeted therapy era where no patients enrolled had prior venetoclax-based therapy, thus efficacy

data of CLAG-M in the current era, in patients exposed to prior venetoclax, or with other high-risk features, is limited.

When combined

with Actimab-A, the combination has demonstrated a clinically significant survival benefit in a proof-of-concept study irrespective of

prior targeted treatment.

Relapsed or refractory AML after failing venetoclax-based therapy is associated with dismal survival outcomes,

2018 and Mushtaq et al.

Comparison of Salvage Chemotherapy Regimens in Relapsed/Refractory Acute Myeloid Leukemia.

ASH 2018) in patients

with r/r AML, however, almost all of these studies were conducted in the pre-targeted therapy era, where no patients enrolled had prior

venetoclax-based therapy, thus efficacy data of CLAG-M in the current era, in patients exposed to prior venetoclax, or with other high-risk

features, is limited.

When combined with Actimab-A, the combination has demonstrated a clinically significant survival benefit in a proof-of-concept

study irrespective of prior targeted treatment.

R/R AML after failing venetoclax-based therapy is associated with dismal survival outcomes,

with a median OS of less than 3 months.

In comparison, the combination trial of Actimab-A + CLAG-M led to 1-year survival of 59% and 2-year

survival of 32% in patients who failed prior venetoclax-based therapy, which compares very favorably to the traditional outcomes in these

survival of 32% in patients who failed prior venetoclax-based therapy, which compares favorably to the traditional outcomes in these patients.

On September 6, 2023, updated data from the Actimab-A + CLAG-M combination trial was presented at SOHO where 1-year OS for patients with

prior venetoclax treatment was 46% and 48% in all patients receiving Actimab-A + CLAG-M treatment.

In patients who received a transplant,

the median OS was 24 months or more.

Actimab-A + venetoclax Phase 1/2 Study Results

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+ venetoclax in both fit and unfit patients 18 years and older with r/r AML led by UCLA Medical Center.

On December 10, 2022, data from

our Actimab-A + venetoclax combination trial was presented at the ASH Annual Meeting.

We have demonstrated preclinically that combinations

of Actimab-A and venetoclax have mechanistic synergies.

Overexpression of MCL-1, an anti-apoptotic protein, is associated with resistance

to venetoclax in AML.

Actimab-A kills tumors cells with DNA double-strand breaks and downregulates MCL-1, which can (re-)sensitize AML

cells or reduce tumor resistance to venetoclax.

The Actimab-A + venetoclax combination has been well-tolerated with responses, including

a CR and a partial response in early dose escalation cohorts.

In our ongoing clinical trial, we are exploring the optimal dose of Actimab-A,

as well as the dosing regimen of the combination.

We expect to present proof-of-concept of this study in the second half of 2023.

Advanced Development and Planning for Actimab-A

On February 6, 2023, we announced that we entered

into a CRADA with the NCI, part of the NIH, to develop Actimab-A for the treatment of patients with AML and other hematologic malignancies.

The NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A, and the CRADA

will provide extensive support for and accelerate the development of Actimab-A alone or in combination with chemotherapy, immunotherapy,

Data from our Actimab-A + venetoclax

combination trial was presented at the 2022 ASH Annual Meeting.

We have demonstrated preclinically that combinations of Actimab-A and

venetoclax have mechanistic synergies.

Overexpression of MCL-1, an anti-apoptotic protein, is associated with resistance to venetoclax

Actimab-A kills tumors cells with DNA double-strand breaks and downregulates MCL-1, which can (re-)sensitize AML cells or reduce

tumor resistance to venetoclax.

The Actimab-A + venetoclax combination has been well tolerated with responses, including a CR and a partial

response in early dose escalation cohorts.

Based on the acceptable safety of Actimab-A in combination with venetoclax, we are investigating

various approaches to further evaluate the safety and efficacy of Actimab-A in combination with venetoclax and HMA in newly diagnosed

AML patients.

Further Development for Actimab-A

In February 2023, we announced

that we entered into a CRADA with the NCI, part of the NIH, to develop Actimab-A for the treatment of patients with AML and other hematologic

malignancies.

The NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A,

and the CRADA is expected to provide support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy,

targeted agents and other novel combinations.

The CRADA studies will be overseen by the NCI in collaboration with Actinium’s clinical

development team, where Actinium has the right to review and approval all protocols and has full right to all data.

development team, where Actinium has the right to review and approve all protocols and has full rights to all data.

This broad collaboration

may accelerate our Actimab-A development efforts with access to NCI’s vast network of over 2,000 clinical trial sites and its Myelomatch

Later this year, we will provide updates on our progress as we move into late-stage development with Actimab-A + CLAG-M, as well

as other developments with our venetoclax combination trial as part of our backbone development strategy.

We expect the NCI to initiate further development of Actimab-A in combination with CLAG-M and other targeted agents to broaden

the scope of its development in r/r AML.

To realize the broader development potential for Actimab-A, we are also examining the role of

Actimab-A as a maintenance therapy for various indications through our R&D efforts.

We are exploring the broader opportunity with our Actimab-A program

and the potential use of Actimab-A in solid tumor indications through our R&D efforts.

CD33-expressing MDSCs are present within the

tumor microenvironment and exert immunosuppressive effects, and we believe that Actimab-A can play an important role in the tumor microenvironment

by depleting MDSCs in a targeted manner.

In April 2023, we presented data at the AACR Annual Meeting that we believe support the potential

role of Actimab-A to overcome immunosuppression by MDSCs in the tumor microenvironment.

We believe our preclinical findings show promise

with regard to Actimab-A’s ability to selectively deplete CD33-expressing MDSCs in both lung, colorectal, and other cancers, which

we intend to explore further via clinical development.

Actimab-A also demonstrated statistically significant depletion of human MDSCs

compared to Mylotarg, a CD33-targeted ADC in colorectal cancer (p<0.01), highlighting the powerful cytotoxicity and potential therapeutic

benefit of radiotherapy compared to naked antibodies or ADCs.

Actimab-A demonstrates the advantages of ARCs over ADCs by utilizing the

power of radiation, against which cells have no known resistance or repair mechanism.

Radiation can cause double stranded breaks in DNA

which lead to cancer cell death.

MDSCs are ubiquitous across multiple cancer indications and with the substantial number of immunotherapies

in development or currently in clinical use, we believe our data may support the potential for Actimab-A, if ultimately approved for commercialization

for such indication, to be a backbone therapy that could broadly improve antitumor activity of immunotherapies such as checkpoint inhibitors

and T and NK cell therapies and other therapeutic modalities in multiple solid tumor indications.

Additional preclinical data evaluating

Actimab-A for the targeting of MDSCs was presented at the SITC 38 th Annual Meeting on November 4, 2023, highlighting Actimab-A’s

ability to target and deplete MDSCs and restore T cell proliferation and effector response.

SPECT/CT imaging confirmed uptake of Actimab-A

in a humanized non-small cell lung cancer model, indicating enrichment of CD33+ MDSCs in the tumor microenvironment.

SPECT/CT imaging

confirmed uptake of Actimab-A in a humanized non-small cell lung cancer model, indicating enrichment of CD33+ MDSCs in the tumor microenvironment.

Background on Actimab-A

Actimab-A is an anti-CD33 antibody linked to the potent alpha-emitting

radioisotope Ac-225.

Actimab-A targets CD33, which is expressed in virtually all malignant cells in patients with AML regardless of cytogenetics

or mutations and enables potent alpha radiation to be directed against radiosensitive AML cells.

These cells have no known resistance

or repair mechanisms when hit with the alpha particles from the Ac-225 isotope payload that cause double stranded DNA breaks.

Actimab-A is the first radiotherapeutic for r/r AML and has the unique value proposition of broad applicability, a differentiated mechanism

of action, and targeted precision that is well-tolerated with minimal toxicity.

Our CD33 development program is driven by data obtained

from approximately 150 AML patients in 6 trials and demonstrated single agent activity with high response rates, but was also associated

with prolonged neutropenia.

Actimab-A, an ARC comprised of the anti-CD33 antibody linked to the

potent alpha-emitting radioisotope Ac-225.

Actimab-A targets CD33, which is expressed in virtually all malignant cells in patients with

AML regardless of cytogenetics or mutations and enables potent alpha radiation to be directed against radiosensitive AML cells.

cells have no known resistance or repair mechanisms when hit with the alpha particles from the Ac-225 isotope payload, which cause double

stranded DNA breaks.

We believe Actimab-A is the first radiotherapeutic for r/r AML and has the unique value proposition of broad applicability,

a differentiated mechanism of action, and targeted precision that is well-tolerated with minimal non-hematologic toxicity.

Our CD33 development

program is driven by data obtained from approximately 150 AML patients in six trials and demonstrated single agent activity with high

response rates.

A combination strategy was considered appropriate given the changing treatment landscape of AML;

on presumed mechanistic synergies, an investigator initiated trial of Actimab-A + CLAG-M and a company-sponsored Actimab-A + venetoclax

were developed and patients were enrolled into these studies.

hence, based on presumed

mechanistic synergies, an investigator-initiated trial of Actimab-A + CLAG-M and a company-sponsored Actimab-A + venetoclax were developed

and patients were enrolled into these studies.

Conditioning Focused Programs

We will further expand the Iomab-B franchise by focusing on lifecycle

management for label enhancement and indication expansion.

Iomab-B data in five additional hematologic indications (i.e., MDS, ALL, HL,

NHL, and MM) provide the foundation to explore indication expansion opportunities to increase the total addressable market for Iomab-B.

Across early trials at the FHCRC, Iomab-B demonstrated similar improved access to BMT and outcomes.

We will leverage these data with strong

results from the pivotal Phase 3 SIERRA trial to execute a comprehensive life cycle management strategy to further expand Iomab-B’s

role in a variety of malignant and non-malignant hematological disorders, We will continue to develop the Iomab-B franchise to potentially

address a broader market opportunity to address the over 165,000 patients diagnosed with cancers (e.g., leukemia, lymphoma, and myeloma),

who could potentially benefit from transplant, but are unable to access one today.

Iomab-ACT is comprised of apamistamab, the same anti-CD45 antibody

as Iomab-B, but utilizes lower, nonmyeloablative levels of I-131 to achieve lymphodepletion for cellular therapies such as CAR-T or reduced

intensity conditioning for gene therapies.

We intend to continue to develop the Iomab-ACT program designed specifically for use prior

to CAR-T and gene therapies, ultimately with a value proposition of improving overall access and outcomes for patients who need cellular

or gene therapies.

Preclinical data showed a single, low-dose of

Iomab-ACT demonstrated lymphodepletion and as CD45 positive immune cells are implicated in major CAR-T side effects, i.e., cytokine release

syndrome ("CRS") and immune effector cell–associated neurotoxicity syndrome (“ICANS"), Iomab-ACT has the potential

to be developed as a conditioning agent for CAR-T therapies.

CRS and ICANS remain two most common toxicities of CAR-T therapies with severe

cases (>Grade 3) seen in >20% of patients and fatality rates between 0-10%.

Due to its effect on host monocytes/macrophages, we

believe conditioning with Iomab-ACT will potentially reduce the incidence of CRS and ICANS.

Unlike chemotherapy, Iomab-ACT is targeted in

nature, and we expect it to potentially promote improved CAR-T cell expansion, resulting in responses that are higher and more durable.

We believe our Iomab-ACT program is highly differentiated when compared to fludarabine and cyclophosphamide (“Flu/Cy”) or

other chemotherapy-based regimens that are used as standard practice today for lymphodepletion prior to cell therapy.

We will further expand the

ARC pipeline with our Iomab-B franchise by focusing on lifecycle management for label enhancement and indication expansion.

in five additional hematologic indications (i.e., MDS, ALL, HL, NHL, and MM) provide the foundation to explore indication expansion opportunities

to increase the total addressable market for Iomab-B.

Across early trials at the FHCRC, Iomab-B demonstrated similar improved access to

BMT and outcomes.

We will leverage these data with strong results from the pivotal Phase 3 SIERRA trial to execute a comprehensive life

cycle management strategy to further expand Iomab-B’s role in a variety of malignant and non-malignant hematological disorders.

We will continue to develop the Iomab-B franchise to potentially address a broader market opportunity to address the over 165,000 patients

diagnosed with cancers (e.g., leukemia, lymphoma, and myeloma), who could potentially benefit from transplant, but are unable to access

Iomab-ACT is our next generation

ARC comprised of apamistamab, the same anti-CD45 antibody as Iomab-B, but utilizes lower, nonmyeloablative levels of I-131 to achieve

lymphodepletion for cellular therapies such as CAR-T or reduced intensity conditioning for gene therapies.

We intend to continue to develop

the Iomab-ACT program designed specifically for use prior to CAR-T and gene therapies, ultimately with a value proposition of improving

overall access and outcomes for patients who need cellular or gene therapies.

Preclinical data showed a

single, low-dose of Iomab-ACT demonstrated lymphodepletion and as CD45 positive immune cells are implicated in major CAR-T side effects,

i.e., CRS and ICANS, Iomab-ACT has the potential to be developed as a conditioning agent for CAR-T therapies.

CRS and ICANS remain two

most common toxicities of CAR-T therapies with severe cases (>Grade 3) seen in >20% of patients and fatality rates between 0-10%.

Due to its effect on host monocytes/macrophages, we believe conditioning with Iomab-ACT will potentially reduce the incidence of CRS and

Unlike chemotherapy, Iomab-ACT

is targeted in nature, and we expect it to potentially promote improved CAR-T cell expansion, resulting in responses that are higher and

more durable.

We believe our Iomab-ACT program is highly differentiated when compared to Flu/Cy or other chemotherapy-based regimens that

are used as standard practice today for lymphodepletion prior to cell therapy.

We are studying Iomab-ACT in collaboration with MSKCC, for conditioning

prior to CAR-T therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (“B-ALL”) or diffuse large

B-cell lymphoma (“DLBCL”).

This study funded by a NIH grant is the first-of-its-kind study to use a radiotherapeutic-based

conditioning regimen with CAR-T therapy.

We have completed treatment of an initial cohort of three patients and will expand to a second

This study was presented at the ASH Annual Meeting in December 2022 as a trial-in-progress.

We expect to present proof-of-concept

data from this study in 2023 and look forward to sharing more on our Iomab-ACT trial with MSKCC, along with future development plans in

the CAR-T space.

R&D and Preclinical Programs

Our R&D efforts yield differentiated, high-value

programs that demonstrate our experience across multiple validated cancer targets and isotopes and cover broad areas of focus leveraging

our clinical development experience across hematology, targeted conditioning, solid tumors, and next generation radiotherapies.

also inform the advancement of our Iomab-B, Actimab-A, and Iomab-ACT programs.

Our research collaborations with Astellas, LG Chem, formerly

AVEO Oncology, and EpicentRx establish our work with immunotherapies and in solid tumors.

We are working on several preclinical programs

which include novel approaches to established targets such as HER2 and HER3, as well as novel targets that show immense potential for

radiotherapeutic approaches.

Underpinning our development programs is our expanded patent portfolio of over 200 issued patents and pending

patent applications worldwide.

We have utilized our technology platform to develop our clinical portfolio

in hematology – Iomab-B and Actimab-A, in conditioning for transplant and as a therapeutic, respectively.

In addition, our robust

platform been used to develop a pipeline of novel radiotherapeutic assets to drive company growth.

Preclinical pharmacology studies with

our targeted radiotherapeutics such as HER3-ARC, HER2-ARC or CD33-ARC have shown dramatic improvement in tumor growth inhibition in various

preclinical tumor models as single agents or in combination with immunotherapy such as magrolimab, an anti-CD47 monoclonal antibody.

results have prompted the team to spearhead efforts in multiple solid tumor programs.

Actinium’s lead solid tumor program is a targeted radiotherapy

against HER3, a pan-cancer target that is overexpressed in several solid tumor indications with high unmet need.

In April 2022, we presented

the first HER3-targeted radiotherapeutic agent at the American Association for Cancer Research (“AACR”) Annual Meeting showing

potent tumor cell cytotoxicity, enhanced antitumor effects and significantly improved survival with an Ac-225 radiolabeled HER3 antibody

compared to a naked HER3 antibody in a preclinical non-small cell lung cancer (“NSCLC”) model.

We have also demonstrated the

direct impact of targeted radiotherapy in modulating immune signals such as calreticulin upregulation to enhance tumor cell killing.

we have leveraged the immunomodulatory effect(s) of targeted radiotherapy in combination with CD47 targeting agents such as magrolimab

for sustained tumor growth inhibition in mouse models of AML and NSCLC.

These results were presented at the Society for Immunotherapy

of Cancer (“SITC”) Annual Meeting held in 2021.

Our R&D team continues to expand on capabilities

and technologies across therapeutic modalities, linker technologies and in vivo cancer models, and build significant visibility through

presentations at key conferences and publications in journals of high impact.

Our R&D efforts are centered on the advancement of our

key programs with a robust “fast-to-clinic” approach in niche indications and are backed by an extensive IP estate that comprises

over 200 patents and patent applications including the methods of Ac-225 production.

prior to CAR-T therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (“B-ALL”) or DLBCL.

study funded by a NIH grant is the first study of its kind to use an ARC, or radiotherapeutic-based conditioning regimen, with CAR-T therapy.

In October 2023, we announced the extension of a NIH Small Business Technology Transfer grant to support the clinical collaboration with

Most recently, at the 2024 Tandem Meetings, we presented results from the ongoing phase 1 trial.

No patients (0/4) developed ICANS

of any grade, a major safety measure of the study, as ICANS is observed in 25% or more of patients with r/r B-ALL and DLBCL treated with

various CAR T-cell products and negligible incidence of CRS.

Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes

and monocytes.

Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been observed to date.

In March 2024, we announced a clinical trial to study Iomab-ACT with an

FDA approved commercial CAR T-cell therapy, which will be led by investigators at the University of Texas Southwestern.

To our knowledge

this will be the first trial to study a targeted radiotherapy conditioning agent with a commercial CAR-T therapy.

UT Southwestern expects

to start recruiting patients following FDA review and clearance of the study.

Currently, there are six CAR-T therapies approved to treat

patients with leukemias, lymphomas and multiple myeloma that had combined annual sales of over $3.5 billion in 2023.

Given the robust

clinical data that exists with commercial CAR-T therapies, we believe this trial may demonstrate Iomab-ACT’s potential to improve

outcomes over current chemotherapy conditioning regiments we are seeking to replace.

We believe an opportunity exists for Iomab-ACT to

potentially generate significant revenue, if it can provide one or more clinical benefits related to lower CRS, less neurotoxicity, longer

duration of response or a higher overall success rate of cellular therapy due to benefits of targeted conditioning.

R&D and Preclinical ARC Programs

Our R&D capabilities have the potential to yield differentiated,

high-value ARC programs that demonstrate our experience across multiple validated cancer targets and isotopes and cover broad areas of

focus leveraging our clinical development experience across hematology, targeted conditioning, solid tumors, and next generation radiotherapies.

We develop ARC product candidates that target antigens that are expressed on certain cancer cell types and are able to destroy cellular

DNA and kill these cells with the energy that they emit.

The efficacy of ARCs does not require internalization and stable linkers minimize

off-target toxicity of the payload.

Our R&D programs inform

the advancement of our Iomab-B, Actimab-A, and Iomab-ACT clinical programs.

We have utilized our technology platform to develop our clinical

portfolio in hematology – Iomab-B and Actimab-A, in conditioning for transplant and as a therapeutic, respectively.

Our differentiated

R&D efforts are further exemplified by our next-generation Iomab-ACT conditioning program for rapidly growing cell and gene therapies.

Our platform has been used to develop a pipeline of novel radiotherapeutic assets to drive company growth.

We are working on several preclinical

programs which include novel approaches to validated cancer targets, as well as novel targets that we believe to show immense potential

for radiotherapeutic approaches.

Preclinical pharmacology studies with our targeted radiotherapeutics, such as HER2, CD33 and CD38, have

shown strong improvement in tumor growth inhibition in various preclinical tumor models.

These results have prompted our R&D team

to spearhead efforts in multiple solid tumor programs in the preclinical stage with IND enabling studies underway.

Leveraging Actinium’s

platform and expertise in developing ARCs, we are exploring how nanobodies, single chain variable fragment (“scFv”), and other

related modalities can be combined with novel linkers and radioisotopes to enhance delivery to solid tumors.

We currently believe that Actinium’s ARCs are less likely than small

molecules to face pricing pressure and negotiation from IRA, given that small molecules are at risk for pricing negotiations seven years

after approval compared to eleven years for biologics with negotiated prices taking effect two years after selection.

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

In addition, regulatory barriers for a generic ARC are much higher than for small molecule radioligands such as those under

development or approved, namely, Pluvicto ® , Lutathera ® , and Xofigo ® .

While generic versions

of certain radiopharmaceuticals utilizing peptides, which are considered small molecules, have been submitted to the FDA via the ANDA

pathway, ARCs fall under biologics.

For this reason, only the biosimilar approach pertains to ARCs filed under 351(k) BLA pathway.

regulatory pathway for biosimilar is much more comprehensive than the pathway for generics, and it has not been proven that biosimilars

are interchangeable with the innovator’s ARCs.

In addition, we are not aware of any regulations that would require us to provide

Iomab-B or Actimab-A, including their respective mAbs, apamistamab and lintuzumab, to any third party or potential competitor.

We seek to expand our capabilities

and technologies across therapeutic modalities, linker technologies and in vivo cancer models, and build visibility through presentations

at key conferences and publications in journals of high impact.

Our R&D efforts are centered on the advancement of our key ARC programs

with a robust “fast-to-clinic” approach.

Underpinning our development programs is our expanded patent portfolio of over 230

issued patents and pending patent applications worldwide.

Our Platform Technology

Our proprietary technology platform is built on

the core competency to produce targeted radiotherapeutics, and coupled with our know-how and IP, establishes our company in the development

of isotope-agnostic, multi-targeted products that may address the treatment of hard-to-treat diseases.

In our clinical and preclinical

programs, we have utilized multiple isotopes including Ac-225, I-131 and Lutetium-177 directed at multiple targets in oncology and hematology

such as CD45, CD33, HER3, among others.

Our targeted radiotherapies combine the cell-killing ability of radiation via a radioisotope payload

with a targeting agent, such as a monoclonal antibody.

In addition to developing targeted radiotherapies, we also own patents

related to the manufacturing of Ac-225 in a cyclotron.

We have expertise in utilizing the alpha emitting isotope Ac-225 including clinical

experience in treating approximately 150 patients with our alpha-emitter-based therapies, “gold standard” linker technology

and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing or Ac-225 in a cyclotron, which we believe

has the potential to produce higher quantities of highly pure Ac-225 than current methods.

When appropriate, we are well-positioned to

leverage this technology to produce Ac-225.

Our proprietary technology

platform is built on the core competency to produce targeted radiotherapeutics, and coupled with our know-how and IP, establishes our

company in the development of isotope-agnostic, multi-targeted product candidates that have the potential to address the treatment of

hard-to-treat diseases.

In our clinical and preclinical programs, we have utilized multiple isotopes including Ac-225, I-131 and Lu-177

directed at multiple targets in oncology and hematology such as CD45, CD33, CD38, HER2, among others.

Our targeted radiotherapies combine

the cell-killing ability of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody.

With our in-depth, long-term experience in clinical development of

Ac-225 based radiopharmaceuticals, we have developed an end-to-end technology solution for producing Ac-225 that has demonstrated radiochemical

and radionuclidic purity identical to current gold standard methods.

This patented technology has been used to produce Ac-225 in a cyclotron

that is essentially identical to that derived from a Th-229 generator and has the potential to be a lower-cost, commercially scalable

higher-yielding approach.

Using the cyclotron-produced Ac-225 technology allows for large commercial scale production with estimated cost

of goods sold including capital expenditures and operational costs for a single cyclotron facility of between $650 and $1,000 per mCi,

which is between 10 to 20 times less expensive than the price of currently available Ac-225 material.

Our extensive know-how related

to this production technology is supported by five issued patents in the U.S.

and 49 patents internationally and covers:

solution including processing and recycling of Radium-226 starting material

of up to 100 mCi of Ac-225 per production cycle

● Utilization of a medium energy cyclotron

cost 10 to 20 times lower than currently available material

● Radiochemical

● Radioisotopic

purity 99.8% with no long-lived contaminants and <0.001% Ac-227

With our Ac-2225 based Actimab-A program and the rapidly increasing

number of Ac-225 based programs in development, we believe that we are well positioned to leverage this technology to produce Ac-225 to

address the growing clinical demand.

Manufacturing and Supply Chain

Actinium has established significant

manufacturing and supply chain expertise due to the unique manufacturing and distribution requirements of radiotherapeutics.

short half-life of radioisotopes, the finished drug product is shipped “hot” and must be administered within days.

has established core competencies in the process of manufacturing radiotherapeutics, coordinating with the hospital’s care team,

and delivering “just-in-time” doses.

We have delivered over 500 doses for 18 clinical trials at 45 large cancer hospitals

and have never missed a dose.

Isotope supply is critical

for the manufacturing of radiotherapeutics, and we have engaged several sources for the procurement of alpha (e.g., Ac-225) and beta (e.g.,

I-131 and Lu-177) emitters.

We also have multiple isotope supply agreements and qualified vendors in place to supply isotopes for commercial

For Iomab-B, we have established an actively managed end-to-end supply

chain that encompasses isotope sourcing through drug administration at the point of care.

Our end-to-end supply chain did not miss a patient

dose in our international, 24-site SIERRA Phase 3 clinical trial including 40 additional patients that crossed over from the control arm

to receive Iomab-B.

We believe we have a thorough understanding and working knowledge of the intricacies required to manufacture and distribute

radiotherapies.

Through our clinical experience with Iomab-B and Actimab-A, we have developed a wealth of proprietary knowledge to enable

coordination between Actinium and all key stakeholders including, but not limited to hematologists/oncologists, infusion center and in

patient rooms, nuclear medicine and radiology, hot labs and radio-pharmacies, and radiation safety committees, among others.

We have scaled

up and have commercially viable manufacturing operations in place to support U.S.

and international commercial sales.

Actinium has commercial agreements

with Contract Development and Manufacturing Organizations (“CDMOs”) with significant experience in mAb and final radio-labeled

drug products.

The CDMO we have selected to manufacture the finished drug product to support our commercial activity has been previously

inspected by the FDA and EMA.

Our finished drug product CDMO is centrally located in the U.S.

and has significant experience in the international

supply of radiotherapies.

We have scaled deliberately for manufacturing flexibility and are currently qualifying additional CDMOs

to ensure readily available drug product upon FDA approval and the ability to ramp up rapidly to meet commercial demand.

Intellectual Property

Our proprietary technology platform is supported

by IP, know-how and trade secrets that cover the generation, development, methods of use and manufacture of targeted radiotherapies and

their select components.

Our IP covers various methods of use in multiple diseases, including indication, dose and scheduling, radionuclide

warhead, and therapeutic combinations.

As of March 2023, we have expanded our patent

portfolio to over 200 issued patents and pending patent applications worldwide, which we believe constitutes a valuable business asset.

Our proprietary technology

platform is supported by IP, know-how and trade secrets that cover the generation, development, methods of use and manufacture of targeted

radiotherapies and their select components.

Our IP covers various methods of use in multiple diseases, including indication, dose and

scheduling, radionuclide warhead, and therapeutic combinations.

As of March 2024, our patent

portfolio is comprised of over 230 issued patents and pending patent applications worldwide, which we believe constitutes a valuable business

Our IP includes 47 patent families, including key patents that relate primarily to our radiotherapeutic candidates.

Our patent portfolio

includes 12 issued patents and 39 pending patent applications in the U.S., and 151 that are issued or pending internationally.

The effective

lives of the issued patents in our portfolio, or patents that may issue from the pending applications in our portfolio, ranges from expirations

between 2024 and 2043.

For our Iomab-B product candidate, we have four

issued patents in the U.S.

portfolio includes 15 issued patents and 52 pending patent applications in the U.S., and 166 that are issued or pending internationally.

The effective lives of the issued patents in our portfolio, or patents that may issue from the pending applications in our portfolio,

ranges from expirations between 2024 and 2043.

For our Iomab-B product candidate,

we have four issued patents in the U.S.

and issued patents in Canada, Europe and Japan that relate to the composition.

The basic patent terms of these

patents expire in 2036 and 2037.

The basic patent

terms of these patents expire in 2036 and 2037.

Related patent applications are also currently pending in the U.S.

and internationally.

we own both U.S.

and international pending patent applications that relate to the use of Iomab-B or Iomab-ACT in the treatment of cancers

and non-malignant conditions.

Our patents also cover key areas of our business

such as manufacturing key components of our product candidate, Actimab-A, including Ac-225 in a cyclotron.

We have expertise in utilizing

the alpha emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with our alpha-emitter-based therapies,

“gold standard” linker technology and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing

or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than currently utilized methods.

patents will expire in the years 2024 through 2027.

In addition, we own both U.S.

and international pending patent applications that relate to the use of Iomab-B or Iomab-ACT in the treatment

of cancers and non-malignant conditions.

Our patents also cover key

areas of our business such as manufacturing key components of our product candidate, Actimab-A, including Ac-225 in a cyclotron.

expertise in utilizing the alpha emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with our

alpha-emitter-based therapies, “gold standard” linker technology and 5 issued patents in the U.S.

and 49 patents internationally

related to the manufacturing of Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than

currently utilized methods.

In addition, we also own U.S.

and international patents and pending patent applications

that relate to the manufacturing of Actimab-A and its use in the treatment of cancers.

and international patents and pending patent applications that relate to the

manufacturing of Actimab-A and its use in the treatment of cancers.

Strategic Collaborations and Licensing Agreements

Fred Hutchinson Cancer Research Center

On June 15, 2012, the Company entered into a license

and sponsored research agreement with FHCRC to build upon previous and ongoing clinical trials with Iomab-B.

Developed at the FHCRC, a

pioneer in the field of BMT, Iomab-B has been studied in over 400 patients and is supported by data in six disease indications including

leukemias, lymphomas and multiple myeloma.

The Company has been granted exclusive rights to the antibody and related master cell

bank developed by FHCRC.

A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed

Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.

In April 2022, Actinium licensed the EUMENA commercial

Actinium has established strategic

partnerships to enable our vision of developing novel targeted radiotherapies in blood cancers and solid tumors.

As exemplified by our

partnerships, we work with renowned academic and research institutions such as FHCRC, the NCI, NIH and MSKCC.

Our collaborations with

large pharmaceutical and biotech companies such as Astellas, LG Chem, and EpicentRx have established our work with immunotherapies and

in solid tumors in 2023 and years prior.

We have collaborations that support the advancement of our ARC pipeline

clinical assets, including Iomab-B, Iomab-ACT and Actimab-A.

In June 2012, the Company entered into a license and sponsored research agreement

with FHCRC to build upon previous and ongoing clinical trials with Iomab-B.

Developed at FHCRC, a pioneer in the field of BMT, Iomab-B

has been studied in over 400 patients and is supported by data in six disease indications including leukemias, lymphomas and multiple

The Company has been granted exclusive rights to the antibody and related master cell bank developed by FHCRC.

payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed antibody.

Upon commercial sale of

the drug, royalty payments of 2% of net sales will be due to FHCRC.

In April 2022, Actinium exclusively licensed the EUMENA commercial

rights for Iomab-B to Immedica, an independent pharmaceutical company headquartered in Sweden.

Immedica has significant know-how and experience

in commercializing niche and specialty care products across Europe and the Middle East, with extensive expertise and capabilities across

sales and marketing, market access, regulatory and medical affairs, drug safety and quality assurance, among others.

Actinium received

an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty

percent royalties.

The market potential is extremely compelling in the EU with approximately 50% larger with 15,000 patients with r/r

AML and double the number of BMTs performed than in the US.

Iomab-B has been granted Orphan Drug Designation by the EMA and has received

positive Scientific Advice from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA.

National Cancer Institute

In February 2023, we announced that Actinium entered

into a CRADA with the NCI, part of the NIH, to develop Actimab-A in for the treatment of patients with AML and other hematologic malignancies.

Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to

study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing

additional support as needed.

The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy,

immunotherapy, targeted agents and other novel combinations.

The CRADA studies will be overseen by NCI in collaboration with Actinium's

clinical development team.

Astellas, LG Chem, and EpicentRx

We are leveraging our clinical experience, robust

IP and radiotherapy know-how through research collaborations.

Our collaborations with Astellas, LG Chem and EpicentRx establish our work

with immunotherapies and in solid tumors.

Through our research collaborations, such as with Astellas, we are advancing into solid tumors

With Astellas, we are utilizing a diagnostic agent developed in parallel with a therapeutic agent that shares the same target

to identify patients who would benefit from the treatment.

Our platform is being utilized in our ongoing

research collaboration with Astellas to arm select targeting agents owned by Astellas with the alpha-emitting radioisotope Ac-225 for

the development of theranostics for solid tumor indications, which combine the ability of radioisotopes to be used for both diagnostic

and therapeutic purposes.

We are also exploring novel targeted radiotherapies

in solid tumors and blood cancers such as HER3 expressing solid tumors in collaboration with LG Chem and combinations with immunotherapies

such as CD47 immune checkpoint inhibitors with EpicentRx.

The biopharmaceutical industry is extremely competitive

and rapidly evolving, particularly in the field of oncology and hematology drug development.

Our competition is likely to come from larger

pharmaceutical companies, biotechnology companies, academia, and other public and private entities that focus on three broad areas relevant

to our pipeline candidates – AML drugs, conditioning agents and radiopharmaceuticals.

In addition, in markets where we are going

after a target, companies with research programs and capabilities in our disease area focus may also be competing with our programs and

In AML, the pipeline is crowded with 100+ programs, however, there

are a few Phase 3 assets with limited potential that do not represent an imminent, competitive threat to Iomab-B or Actimab-A.

the Phase 2 development programs in AML show the promise of producing high rates or duration of remission, and most patients that relapse

tend to have poor survival outcomes.

The Phase 2 assets primarily consist of agents targeting specific AML mutations, immunotherapies,

or cell cycle modulators.

Early clinical and preclinical stage assets consist of more cell therapy and immune cell engagers, and the potential

success of these modalities in AML remain uncertain.

Our strategy is to develop Actimab-A in combination with other products, and the

agents in the development pipeline have the potential for synergies in combination with Actimab-A.

In conditioning, agents currently used for

myeloablation prior to a BMT, lymphodepletion prior to CAR-T and other adoptive cell therapies and reduced intensity conditioning

for gene therapy are largely generic, non-targeted chemotherapeutic agents.

Recently, Jasper Therapeutics and Magenta Therapeutics

ceased development of their antibody and antibody-drug conjugate or ADC conditioning programs for BMT.

Certain companies such as Vertex

Pharmaceuticals (“Vertex”), Gilead Sciences (“Gilead”) and Allogene Therapeutics (“Allogene")

have or continue to explore non-chemotherapy conditioning with ADCs and antibodies for their in-house, proprietary cellular therapy

For example, Vertex has in-licensed ImmunoGen Inc.’s ADC technology, and had a collaboration with Molecular

Templates, Inc.

to develop targeted conditioning agents, which was subsequently terminated.

Allogene is using its own proprietary

anti-CD52 monoclonal antibody for use as a lymphodepletion agent in conjunction with CAR-T therapies.

Telix Pharmaceuticals has

announced plans for a conditioning program based on a CD66 radiotherapeutic approach in systemic amyloid light-chain amyloidosis

(“SALA”) via an early stage investigator sponsored trial.

Without exception, all these companies have either preclinical

or early-stage programs that are solely focused on their proprietary programs.

We believe that we are the only company with a phase

3 completed targeted conditioning asset that has demonstrated clinical benefit with the opportunity to be paradigm-changing.

Several companies are focused on developing radiotherapies, including,

but not limited to:

Abdera Therapeutics, Aktis Oncology, Bayer AG, Convergent Therapeutics, CuraSight, Fusion Pharmaceuticals, Inc., Lantheus

Holdings, Inc., Mariana Oncology (previously, Curie Therapeutics), Monopar Therapeutics, Novartis AG, Point Biopharma, Inc., RadioMedix,

Inc., Radiopharm Theranostics, Radionetics Oncology, RayzeBio, Inc., Q BioMed, Inc., Telix, and Y-mAbs Therapeutics, Inc.

Immedica is solely responsible for commercialization

of the product.

Immedica has significant know-how and experience in commercializing niche and specialty care products across Europe and

the Middle East, with extensive expertise and capabilities across sales and marketing, market access, regulatory and medical affairs,

drug safety and quality assurance, among others.

Actinium received an upfront payment of $35 million USD with the potential for an additional

$417 million USD in regulatory and sales milestones and mid-twenty percent royalties.

The market potential is extremely compelling in

the EU, where the potential market is approximately 50% larger than in the U.S.

with 15,000 patients with r/r AML and double the number

of BMTs performed than in the U.S.

Iomab-B has been granted Orphan Drug Designation by the EMA and has received positive Scientific Advice

from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA.

In October 2020, we announced

a Small Business Technology Transfer grant from the NIH to support a clinical collaboration with MSKCC to study Iomab-ACT for targeted

conditioning prior to CAR-T cellular therapy.

In October 2023, we announced the extension of the grant to support the ongoing clinical

collaboration with MSKCC.

In February 2023, we announced that Actinium entered into a CRADA with

the NCI, part of the NIH, to develop Actimab-A in for the treatment of patients with AML and other hematologic malignancies.

provides for the NCI to serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A and

for Actinium to be responsible for supplying Actimab-A to participating clinical sites and providing additional support as needed.

CRADA is expected to provide broad support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy,

targeted agents and other novel combinations.

The CRADA studies are overseen by NCI in collaboration with Actinium's clinical development

We intend to continue to pursue

selective partnerships with research institutions and biopharmaceutical companies to advance our technology in the solid tumor arena and

continue our progress from the foundation established by our research partnerships through our R&D and preclinical ARC programs.

The biopharmaceutical industry

is extremely competitive and rapidly evolving, particularly in the field of oncology and hematology drug development.

Our competition

is likely to come from larger pharmaceutical companies, biotechnology companies, academia, and other public and private entities that

focus on three broad areas relevant to our pipeline candidates – AML drugs, conditioning agents and radiopharmaceuticals.

in markets where we are going after a target, companies with research programs and capabilities in our disease area focus may also be

competing with our programs and pipeline.

In AML, the pipeline is crowded

with 100+ programs, however, this includes only a few Phase 3 assets with limited potential that do not represent an imminent, competitive

threat to Iomab-B or Actimab-A.

None of the Phase 2 development programs in AML show the promise of producing high rates or duration of

remission, and most patients that relapse tend to have poor survival outcomes.

The Phase 2 assets primarily consist of agents targeting

specific AML mutations, immunotherapies, or cell cycle modulators, which largely address finite segments of the population and do not

have the broad potential for utilization like Actimab-A.

Early clinical and preclinical stage assets consist of more cell therapy and

immune cell engagers, and the potential success of these modalities in AML remain uncertain.

Our strategy is to develop Actimab-A in combination

with other products, and agents in the development pipeline have the potential for synergies in combination with Actimab-A.

In conditioning, agents

currently used for myeloablation prior to a BMT, lymphodepletion prior to CAR-T and other adoptive cell therapies and reduced

intensity conditioning for gene therapy are largely generic, non-targeted chemotherapeutic agents.

Jasper Therapeutics and Magenta

Therapeutics ceased development of their antibody and antibody-drug conjugate or ADC conditioning programs for BMT in malignant

Certain companies such as Vertex Pharmaceuticals (“Vertex”), Gilead Sciences (“Gilead”) and

Allogene Therapeutics (“Allogene") have or continue to explore non-chemotherapy conditioning with ADCs and antibodies for

their in-house, proprietary cellular therapy programs.

For example, Vertex in-licensed ADC technology from ImmunoGen Inc.

(acquisition by AbbVie announced in November 2023) and had a collaboration with Molecular Templates, Inc.

to develop targeted

conditioning agents, which was subsequently terminated.

Allogene is using its own proprietary anti-CD52 monoclonal antibody for use

as a lymphodepletion agent in conjunction with CAR-T therapies.

Telix Pharmaceuticals has announced plans for a conditioning program

based on a CD66 radiotherapeutic approach in systemic amyloid light-chain amyloidosis (“SALA”) via an early-stage

investigator-sponsored trial.

Molecular Partners is developing a switch-DARPin targeting cKIT×CD16a×CD47 as a

conditioning regiment in AML, but this asset is in early preclinical studies.

Without exception, all these companies have either

preclinical or early-stage programs that are, for the most part, solely focused on their proprietary programs.

We believe that we

are the only company with a targeted conditioning asset that has completed a Phase 3 trial demonstrating a clinical benefit with the

opportunity to be paradigm-changing.

Several companies are focused on developing radiotherapies, although

most are focused on areas such as PSMA or prostate-specific membrane antigen in prostate cancer, neuroendocrine tumors or fibroblast activation protein

(“FAP”) whereas Actinium is the only mature hematology-focused company.

None of these companies compete directly with our

targets or programs.

Companies with radiotherapeutics in development include, but not limited to:

Abdera Therapeutics, Aktis Oncology,

Alpha-9 Theranostics, Ariceum Therapeutics, ARTbio, Bayer AG, Clarity Pharmaceuticals, Cellectar Biosciences, Convergent Therapeutics,

CuraSight, Curium Pharma, Full-Life Technologies, Fusion Pharmaceuticals, Inc., Johnson & Johnson, Lantheus Holdings, Inc., Mariana

Oncology (previously, Curie Therapeutics), Molecular Partners, Monopar Therapeutics, Novartis AG, Orano Med, Perspective Therapeutics,

Point Biopharma, Inc.

(acquired by Lilly in December 2023), RadioMedix, Inc., Radiopharm Theranostics, Radionetics Oncology, Ratio Therapeutics,

RayzeBio, Inc.

(acquisition by Bristol Myers Squibb announced in December 2023), Q BioMed, Inc., Scintomics, Telix, and Y-mAbs Therapeutics,

Government Regulation

Regulatory Compliance

Our research and development activities are all

subject to stringent regulation, primarily by the FDA in the U.S.

under the Federal Food, Drug, and Cosmetic Act (the “FDCA”)

and its implementing regulations, and the Public Health Service Act (“PHSA”) and its implementing regulations, and by comparable

authorities under similar laws and regulations in other countries.

This includes research and development, testing, and oversight of suppliers

and contract manufacturers involved in the production of our product candidates we are developing, as well as the design, manufacturing,

safety, efficacy, handling, labeling, storage, record-keeping, advertising, promotion and marketing.

If, for any reason, we do not comply

with applicable requirements, such noncompliance can result in adverse consequences, including delays in approval of, or even the refusal

to approve, product licenses or other applications, the suspension or termination of clinical investigations, the revocation of approvals

previously granted, as well as fines, criminal prosecution, recall or seizure of products, injunctions against shipping products and suspension

of production and/or refusals of government contracts.

Our research and development activities are all subject to stringent

regulation, primarily by the FDA in the U.S.

under the Federal Food, Drug, and Cosmetic Act (the “FDCA”) and its implementing

regulations, and the Public Health Service Act (“PHSA”) and its implementing regulations, and by comparable authorities under

similar laws and regulations in other countries.

This includes research and development, testing, and oversight of suppliers and contract

manufacturers involved in the production of our product candidates we are developing, as well as the design, manufacturing, safety, efficacy,

handling, labeling, storage, record-keeping, advertising, promotion and marketing.

If, for any reason, we do not comply with applicable

requirements, such noncompliance can result in adverse consequences, including delays in approval of, or even the refusal to approve product

licenses or other applications, the suspension or termination of clinical investigations, the revocation of approvals previously granted,

as well as fines, criminal prosecution, recall or seizure of products, injunctions against shipping products and suspension of production

and/or refusals of government contracts.

FDA Review Process and Product Approval

Our product candidates are regulated as biologics

and must be approved by the FDA before they may be marketed in the U.S.

Our product candidates are

regulated as biologics and must be approved by the FDA before they may be marketed in the U.S.

This process generally involves the following:

● completion of preclinical studies in accordance with the

FDA’s current Good Laboratory Practices (“GLP”) requirements;

● submission to the FDA of an IND, which must become effective

before human clinical trials may begin and must be updated annually;

● approval by an independent Institutional Review Board (“IRB”) ethics committee at each clinical

site before the trial is initiated;

● performance of adequate and well-controlled clinical trials to establish the safety, purity and potency

of the proposed biologic, and its safety and efficacy for each indication, in accordance with good clinical practice (“GCP”);

● submission to the FDA of a BLA for a new biologic, after completion of all pivotal clinical trials;

● a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

● satisfactory completion of an FDA pre-approval inspection of the manufacturing

facilities to assess compliance with applicable current Good Manufacturing Practice (“cGMP”) regulations;

● potential FDA audit of the clinical trial sites that generated the data in support of the BLA;

● FDA review and approval of a BLA for a new biologic, prior to any commercial marketing or sale of the

product in the U.S.

of preclinical studies in accordance with the FDA’s current Good Laboratory Practices (“GLP”) requirements;

to the FDA of an IND, which must become effective before human clinical trials may begin and must be updated annually;

by an independent Institutional Review Board (“IRB”) ethics committee at each clinical site before the trial is initiated;

● performance

of adequate and well-controlled clinical trials to establish the safety, purity and potency of the proposed biologic, and its safety

and efficacy for each indication, in accordance with good clinical practice (“GCP”);

to the FDA of a BLA for a new biologic, after completion of all pivotal clinical trials;

determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

● satisfactory

completion of an FDA pre-approval inspection of the manufacturing facilities to assess compliance with applicable current Good Manufacturing

Practice (“cGMP”) regulations;

FDA audit of the clinical trial sites that generated the data in support of the BLA;

review and approval of a BLA for a new biologic, prior to any commercial marketing or sale of the product in the U.S.

Clinical trials generally are conducted in three

sequential phases, although they may overlap or be combined.

● Phase 1 studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions

of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on

effectiveness

● Phase 2 studies are conducted to preliminarily or further evaluate the effectiveness of the investigational

product for a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal

dosage, and to identify possible adverse side effects and safety risks associated with the product

● Phase 3 clinical trials generally involve a large number of patients at multiple sites designed to provide

the data required to demonstrate the effectiveness of the product for its intended use, safety and to establish the benefit-risk relationship

of the product and provide an adequate basis for product labeling

The results of the preclinical and clinical testing,

along with information regarding the manufacturing of the product and proposed product labeling, are evaluated and, if determined appropriate,

submitted to the FDA through a BLA.

Once the BLA submission has been accepted for filing, the FDA’s standard goal is to review applications

within ten months of the filing date or, if the application relates to a drug that treats a serious condition and would provide a significant

improvement in safety or effectiveness qualifying for Priority Review, six months from the filing date.

The review process is often significantly

extended by FDA requests for additional information or clarification.

The FDA offers certain programs, such as Breakthrough Designation (“BTD”)

and Fast Track designation, designed to expedite the development and review of applications for products intended for the treatment of

a serious or life-threatening disease or condition.

For BTD, preliminary clinical evidence of the product indicates that it may demonstrate

substantial improvement over existing therapies on one or more clinically significant endpoints.

The FDA may initiate review of sections

of a BLA before the application is complete, and the product may be eligible for accelerated approval.

However, receipt of BTD or Fast

Track designation does not ensure that a product will be developed or approved on an expedited basis, or at all.

The FDA reviews the BLA to determine, among other

things, whether the proposed product is safe, pure and potent, which includes determining whether it is effective for its intended use,

and whether the product is being manufactured in accordance with cGMP, to assure and preserve the product’s identity, strength,

quality, potency and purity.

The FDA may refer an application to an advisory committee for review, evaluation and recommendation as to

whether the application should be approved, and applications for new molecular entities and original BLAs are generally discussed at advisory

committee meetings unless the FDA determines that this type of consultation is not needed under the circumstances.

After the FDA evaluates the BLA and conducts inspections of manufacturing

facilities, it may issue an approval letter or a complete response letter (“CRL”).

An approval letter authorizes commercial

marketing of the biologic with specific prescribing information for specific indications.

A CRL indicates that the review cycle of the

application is complete, but the FDA cannot grant approval.

A CRL may require additional inspections, and/or other significant, expensive

and time-consuming requirements related to clinical trials, preclinical studies or manufacturing.

The FDA could approve the BLA with a

Risk Evaluation and Mitigation Strategy (“REMS”) to mitigate risks, which could include medication guides, physician communication

plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications,

or a commitment to conduct one or more post-market studies or clinical trials.

Such post-market testing may include Phase 4 clinical trials

and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization.

1 studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product

in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness

2 studies are conducted to preliminarily or further evaluate the effectiveness of the investigational product for a particular indication(s)

in patients with the disease or condition under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse

side effects and safety risks associated with the product

3 clinical trials generally involve a large number of patients at multiple sites designed to provide the data required to demonstrate

the effectiveness of the product for its intended use, safety and to establish the benefit-risk relationship of the product and provide

an adequate basis for product labeling

The results of the preclinical

and clinical testing, along with information regarding the manufacturing of the product and proposed product labeling, are evaluated and,

if determined appropriate, submitted to the FDA through a BLA.

Once the BLA submission has been accepted for filing, the FDA’s standard

goal is to review applications within ten months of the filing date or, if the application relates to a drug that treats a serious condition

and would provide a significant improvement in safety or effectiveness qualifying for Priority Review, six months from the filing date.

The review process is often significantly extended by FDA requests for additional information or clarification.

The FDA offers certain programs,

such as Breakthrough Designation (“BTD”) and Fast Track designation, designed to expedite the development and review of applications

for products intended for the treatment of a serious or life-threatening disease or condition.

For BTD, preliminary clinical evidence

of the product indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically significant

The FDA may initiate review of sections of a BLA before the application is complete, and the product may be eligible for accelerated

However, receipt of BTD or Fast Track designation does not ensure that a product will be developed or approved on an expedited

basis, or at all.

The FDA reviews the BLA to

determine, among other things, whether the proposed product is safe, pure and potent, which includes determining whether it is effective

for its intended use, and whether the product is being manufactured in accordance with cGMP, to assure and preserve the product’s

identity, strength, quality, potency and purity.

The FDA may refer an application to an advisory committee for review, evaluation and

recommendation as to whether the application should be approved, and applications for new molecular entities and original BLAs are generally

discussed at advisory committee meetings unless the FDA determines that this type of consultation is not needed under the circumstances.

After the FDA evaluates the

BLA and conducts inspections of manufacturing facilities, it may issue an approval letter or a complete response letter (“CRL”).

An approval letter authorizes commercial marketing of the biologic with specific prescribing information for specific indications.

indicates that the review cycle of the application is complete, but the FDA cannot grant approval.

A CRL may require additional inspections,

and/or other significant, expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing.

The FDA could approve the BLA with a Risk Evaluation and Mitigation Strategy (“REMS”) to mitigate risks, which could include

medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries

and other risk minimization tools.

The FDA also may condition approval on, among other things, changes to proposed labeling, development

of adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical trials.

Such post-market

testing may include Phase 4 clinical trials and surveillance to further assess and monitor the product’s safety and effectiveness

after commercialization.

Post-Approval Requirements

Any products manufactured or distributed by us

or on our behalf pursuant to FDA approvals are subject to continuing regulation by the FDA and certain state agencies, including requirements

for record-keeping, reporting of adverse experiences with the biologic, submitting biological product deviation reports to notify the

FDA of unanticipated changes in distributed products, establishment registration, compliance with cGMP standards, and certain state licensing

requirements.

Additionally, any significant change in the approved

product or in how it is manufactured, including changes in formulation or the site of manufacture, generally require prior FDA approval.

Any products manufactured

or distributed by us or on our behalf pursuant to FDA approvals are subject to continuing regulation by the FDA and certain state agencies,

including requirements for record-keeping, reporting of adverse experiences with the biologic, submitting biological product deviation

reports to notify the FDA of unanticipated changes in distributed products, establishment registration, compliance with cGMP standards,

and certain state licensing requirements.

Additionally, any significant

change in the approved product or in how it is manufactured, including changes in formulation or the site of manufacture, generally require

prior FDA approval.

The packaging and labeling of all products developed by us are also subject to FDA approval and ongoing regulation.

Noncompliance with

any regulatory requirements can result in, among other things, issuance of warning letters, civil and criminal penalties, seizures, and

injunctive action.

Accordingly, manufacturers must continue to maintain compliance with cGMP and other aspects of regulatory compliance.

The commercial distribution of prescription drugs is subject to the Drug Supply Chain Security Act (“DSCSA”), which regulates

the distribution of the products at the federal level and sets certain standards for federal or state registration and compliance of entities

in the supply chain.

The DSCSA preempts certain previously enacted

state laws and the pedigree requirements of the Prescription Drug Marketing Act (“PDMA”).

Trading partners within the drug supply

chain must now ensure certain product tracing requirements are met, and are required to exchange transaction information, transaction

history, and transaction statements.

Product identifier information (an aspect of the product tracing scheme) is also now required.

DSCSA requirements, development of standards, and the system for product tracing have been and will continue to be phased in over a period

of years through 2023.

In addition to new legislation, FDA regulations, guidance documents, and policies are often revised or reinterpreted

by the agency in ways that may significantly affect our business and our product candidates.

Noncompliance with any regulatory requirements can result in, among other things, issuance of warning letters, civil and criminal penalties,

seizures, and injunctive action.

Accordingly, manufacturers must continue to maintain compliance with cGMP and other aspects of regulatory

The commercial distribution of prescription drugs is subject to the Drug Supply Chain Security Act (“DSCSA”),

which regulates the distribution of the products at the federal level and sets certain standards for federal or state registration and

compliance of entities in the supply chain.

The DSCSA preempts certain

previously enacted state laws and the pedigree requirements of the Prescription Drug Marketing Act (“PDMA”).

Trading partners

within the drug supply chain must now ensure certain product tracing requirements are met, and are required to exchange transaction information,

transaction history, and transaction statements.

Product identifier information (an aspect of the product tracing scheme) is also now

The DSCSA requirements, development of standards, and the system for product tracing have been and will continue to be phased

in over a period of years through 2023.

In addition to new legislation, FDA regulations, guidance documents, and policies are often revised

or reinterpreted by the agency in ways that may significantly affect our business and our product candidates.

Orphan Drug Act

We have received Orphan Drug designation for Iomab-B

and Actimab-A for patients with AML.

Under the Orphan Drug Act, FDA may grant Orphan Drug designation to drugs intended to treat a rare

disease or condition, which is generally defined as a disease or condition that affects fewer than 200,000 individuals in the U.S.

Drug designation must be requested before submitting a BLA.

In the U.S., Orphan Drug designation entitles a party to financial incentives

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

Orphan Drug designation does

not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The first BLA applicant to receive

FDA approval for a particular active ingredient to treat a particular disease with FDA Orphan Drug designation is entitled to a seven-year

exclusive marketing period in the U.S.

We have received Orphan Drug

designation for Iomab-B and Actimab-A for patients with AML.

Under the Orphan Drug Act, FDA may grant Orphan Drug designation to drugs

intended to treat a rare disease or condition, which is generally defined as a disease or condition that affects fewer than 200,000 individuals

Orphan Drug designation must be requested before submitting a BLA.

In the U.S., Orphan Drug designation entitles a party to

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

Drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The first BLA

applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA Orphan Drug designation is

entitled to a seven-year exclusive marketing period in the U.S.

for that product, for that indication.

During the seven-year exclusivity period, FDA may not approve

any other applications to market the same drug for the same orphan indication, except in limited circumstances, such as a showing of clinical

superiority to the product with orphan exclusivity or where the manufacturer of the approved product cannot assure sufficient quantities.

As a result, there can be no assurance that our competitors will not receive approval of drugs or biologics that have a different active

ingredient for treatment of the diseases for which our products and product candidates are targeted.

During the seven-year exclusivity

period, FDA may not approve any other applications to market the same drug for the same orphan indication, except in limited circumstances,

such as a showing of clinical superiority to the product with orphan exclusivity or where the manufacturer of the approved product cannot

assure sufficient quantities.

As a result, there can be no assurance that our competitors will not receive approval of drugs or biologics

that have a different active ingredient for treatment of the diseases for which our products and product candidates are targeted.

Pediatric Information

Under the Pediatric Research Equity Act (“PREA”),

certain BLAs must contain data to assess the safety and efficacy of the drug or biologic for the claimed indications in all relevant pediatric

subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

The Food and Drug Administration Safety and Innovation Act (“FDASIA”), amended the FDCA to require that a sponsor who is planning

to submit a marketing application for a drug that includes a new active ingredient, new indication, new dosage form, new dosing regimen

or new route of administration submit an initial Pediatric Study Plan (“PSP”) within 60 days of an end of Phase 2 meeting

or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study.

The initial PSP must

include an outline of the pediatric study or studies that the sponsor plans to conduct or a justification for not including such detailed

information, and any request for a deferral of pediatric assessments or a full or partial waiver.

The FDA may grant deferrals for submission

of pediatric data or full or partial waivers.

A sponsor can submit amendments to an initial PSP if changes to the pediatric plan need

to be considered based on preclinical data collected, early phase clinical trials as well as other clinical development programs.

Under the Pediatric Research

Equity Act (“PREA”), certain BLAs must contain data to assess the safety and efficacy of the drug or biologic for the claimed

indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which

the product is safe and effective.

The Food and Drug Administration Safety and Innovation Act (“FDASIA”), amended the FDCA

to require that a sponsor who is planning to submit a marketing application for a drug that includes a new active ingredient, new indication,

new dosage form, new dosing regimen or new route of administration submit an initial Pediatric Study Plan (“PSP”) within 60

days of an end of Phase 2 meeting or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase

The initial PSP must include an outline of the pediatric study or studies that the sponsor plans to conduct or a justification

for not including such detailed information, and any request for a deferral of pediatric assessments or a full or partial waiver.

FDA may grant deferrals for submission of pediatric data or full or partial waivers.

A sponsor can submit amendments to an initial PSP

if changes to the pediatric plan need to be considered based on preclinical data collected, early phase clinical trials as well as other

clinical development programs.

Foreign Regulation

In addition to regulations in the U.S., we are

subject to foreign regulations governing clinical trials and commercial sales and distribution of our product candidates, and products

being marketed outside of the U.S.

We must obtain approval by the comparable regulatory authorities of foreign countries before we can

commence clinical trials or marketing of our products in those countries.

The approval process varies from country to country, and the

time may be longer or shorter than required by the FDA for BLA licensure.

The requirements governing the conduct of clinical trials, product

licensing, pricing and reimbursement vary greatly from country to country.

In addition to regulations

in the U.S., we are subject to foreign regulations governing clinical trials and commercial sales and distribution of our product candidates,

and products being marketed outside of the U.S.

We must obtain approval by the comparable regulatory authorities of foreign countries

before we can commence clinical trials or marketing of our products in those countries.

The approval process varies from country to country,

and the time may be longer or shorter than required by the FDA for BLA licensure.

The requirements governing the conduct of clinical trials,

product licensing, pricing and reimbursement vary greatly from country to country.

As in the U.S., we are subject to post-approval regulatory

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Other Regulatory Considerations

We are also subject to regulation under the Occupational

Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, The Clean Air Act, and other current

and potential future federal, state, or local regulations.

Our research and development activities involve the controlled use of hazardous

materials, chemicals, biological materials and various radioactive compounds.

We believe that our procedures comply with the standards

prescribed by state and federal regulations;

however, the risk of injury or accidental contamination cannot be completely eliminated.

We may also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments where

we may market our products and product candidates, if approved.

These laws and regulations include, without limitation, state and federal

anti-kickback, fraud and abuse, false claims, data privacy and security, aggregate spend reporting, and product price advertising.

The federal Anti-Kickback Statute, which prohibits,

among other things, persons and entities including pharmaceutical manufacturers from knowingly and willfully soliciting, receiving, offering

or paying remuneration, directly or indirectly, overtly or covertly, in case or in kind, to induce or reward, or in return for, or either

the referral of an individual for, or the purchase, lease or order or recommendation of an item or service reimbursable, in whole or in

part, under a federal healthcare program, such as the Medicare and Medicaid programs.

The failure to meet all of the requirements of a

particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its

facts and circumstances.

In addition, Patient Protection and Affordable

Care Act of 2010, as amended (“ACA”) codified cash law that a claim including items or services resulting from a violation of

the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (“FCA”).

The FCA prohibits individuals or entities from, among other things, knowingly presenting or causing the presentation of a claims payment

to, or approval by, the federal government that are false, fictitious or fraudulent, or knowingly making, using or causing to be made

or used, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money

to the federal government.

Our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting

of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement for

our products, and the sale and marketing of our products, are subject to scrutiny under the FCA.

State statutes and regulations equivalent

or substantially similar to the federal laws may extend to items and services reimbursed by commercial insurers and/or by patients directly.

State law equivalents to the Anti-Kickback Statute and False Claims Act may not have adopted exceptions and safe harbors available at

the federal level and therefore, may implicate a broader range of activities.

The federal Health Insurance Portability and Accountability

Act of 1996 (“HIPAA”) imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute,

a scheme to defraud or obtain, by any means of false or fraudulent pretenses, representations or promises, any money or property owned

by, or under the control or custody of, any healthcare benefit program, including private third-party payors, and knowingly and willfully

falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent

statement in connection with the delivery of or payment for healthcare benefits, items or services.

The federal physician payment transparency

requirements, sometimes referred to as the “Physician Payments Sunshine Act,” created under the ACA, and its implementing

regulations, which requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available

under Medicare, Medicaid or the State Children’s Health Insurance Program (with certain exceptions) to annually report to the Department

of Health and Human Services (“HHS”), information related to certain payments or other transfers of value made or distributed

to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and

teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

legislation, the Sunshine Act will extend to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level

healthcare providers.

The Centers for Medicare and Medicaid Services (“CMS”) has the potential to impose penalties for violations

of the Sunshine Act, depending on the circumstances, and payments reported under the Sunshine Act also have the potential to draw scrutiny

on payments to and relationships with physicians and teaching hospitals, which may have implications under the Anti-Kickback Statute and

other healthcare laws.

We may also be subject to data privacy and security

regulation by both the federal government and the state governments in which we conduct our business.

HIPAA, as amended by the Health

Information Technology and Clinical Health Act of 2009 (“HITECH”) and their respective implementing regulations, imposes, among

other things, obligations, including mandatory contractual terms with respect to safeguarding the privacy, security and transmission of

individually identifiable health information held by certain healthcare providers, health plans and healthcare clearinghouses, known as

covered entities, and business associates.

The HHS Office of Civil Rights (“OCR”) has increased its focus on compliance and

continues to train state attorneys general for enforcement purposes.

Even where HIPAA does not apply, according to the U.S.

Federal Trade

Commission (“FTC”), failing to take appropriate steps to keep consumers’ personal information secure constitutes unfair acts

or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act (“FTCA”), 15 U.S.

We are also subject to regulation

under the Occupational Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, The Clean

Air Act, and other current and potential future federal, state, or local regulations.

Our research and development activities involve

the controlled use of hazardous materials, chemicals, biological materials and various radioactive compounds.

We believe that our procedures

comply with the standards prescribed by state and federal regulations;

however, the risk of injury or accidental contamination cannot

be completely eliminated.

We may also be subject to healthcare regulation and enforcement by the federal government and the states and

foreign governments where we may market our products and product candidates, if approved.

These laws and regulations include, without

limitation, state and federal anti-kickback, fraud and abuse, false claims, data privacy and security, aggregate spend reporting, and

product price advertising.

The federal Anti-Kickback

Statute, which prohibits, among other things, persons and entities including pharmaceutical manufacturers from knowingly and willfully

soliciting, receiving, offering or paying remuneration, directly or indirectly, overtly or covertly, in case or in kind, to induce or

reward, or in return for, or either the referral of an individual for, or the purchase, lease or order or recommendation of an item or

service reimbursable, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs.

to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per

se illegal under the federal Anti-Kickback Statute.

Instead, the legality of the arrangement will be evaluated on a case-by-case basis

based on a cumulative review of all of its facts and circumstances.

In addition, Patient Protection and Affordable Care Act of 2010, as amended

(“ACA”) codified as law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute

constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (“FCA”).

The FCA prohibits individuals

or entities from, among other things, knowingly presenting or causing the presentation of a claims for payment to, or approval by, the

federal government that are false, fictitious or fraudulent, or knowingly making, using or causing to be made or used, a false record

or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.

Our activities relating to the reporting of wholesaler or estimated retail prices for products we may commercialize in the future, the

reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement

for products we may commercialize in the future, and the sale and marketing of products we may commercialize in the future, will be subject

to scrutiny under the FCA.

State statutes and regulations equivalent or substantially similar to the federal laws may extend to items

and services reimbursed by commercial insurers and/or by patients directly.

State law equivalents to the Anti-Kickback Statute and False

Claims Act may not have adopted exceptions and safe harbors available at the federal level and therefore, may implicate a broader range

of activities.

The federal Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for knowingly and willfully executing,

or attempting to execute, a scheme to defraud or obtain, by any means of false or fraudulent pretenses, representations or promises, any

money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors,

and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially

false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act,” created

under the ACA, and its implementing regulations, which requires applicable manufacturers of covered drugs, devices, biologics and medical

supplies for which payment is available under Medicare, Medicaid or the State Children’s Health Insurance Program (with certain

exceptions) to annually report to the Department of Health and Human Services (“HHS”), information related to certain payments

or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of,

or designated on behalf of, the physicians and teaching hospitals, as well as ownership and investment interests held by physicians and

their immediate family members.

Under recent legislation, the Sunshine Act will extend to payments and transfers of value to physician

assistants, nurse practitioners, and other mid-level healthcare providers.

The Centers for Medicare and Medicaid Services (“CMS”)

has the potential to impose penalties for violations of the Sunshine Act, depending on the circumstances, and payments reported under

the Sunshine Act also have the potential to draw scrutiny on payments to and relationships with physicians and teaching hospitals, which

may have implications under the Anti-Kickback Statute and other healthcare laws.

We may also be subject to

data privacy and security regulation by both the federal government and the state governments in which we conduct our business.

as amended by the Health Information Technology and Clinical Health Act of 2009 (“HITECH”) and their respective implementing

regulations, imposes, among other things, obligations, including mandatory contractual terms with respect to safeguarding the privacy,

security and transmission of individually identifiable health information held by certain healthcare providers, health plans and healthcare

clearinghouses, known as covered entities, and business associates.

The HHS Office of Civil Rights (“OCR”) has increased its

focus on compliance and continues to train state attorneys general for enforcement purposes.

Even where HIPAA does not apply, according

Federal Trade Commission (“FTC”), failing to take appropriate steps to keep consumers’ personal information

secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act

(“FTCA”), 15 U.S.

Medical data is considered sensitive data that merits stronger safeguards.

There are numerous other laws and legislative

and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some state privacy laws apply

in broader circumstances than HIPAA.

There are numerous

other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some

state privacy laws apply in broader circumstances than HIPAA.

We are subject to the U.S.

Foreign Corrupt Practices

Act (“FCPA”), which prohibits corporations and individuals from engaging in certain activities to obtain or retain business

or to influence a person working in an official capacity.

Our present and future business has been and will continue to be subject to

various other laws and regulations.

Foreign Corrupt Practices Act (“FCPA”), which prohibits corporations and individuals from engaging in certain activities to

obtain or retain business or to influence a person working in an official capacity.

Our present and future business has been and will

continue to be subject to various other laws and regulations.

Human Capital

As of March 31, 2023, we had 49 full-time employees,

17 of whom have Ph.D.

As of March 27, 2024, we had 49 full-time employees, 22 of whom have

degrees and 22 of whom are engaged in research and development and clinical development activities.

that we have been successful to date in attracting skilled and experienced personnel despite the competitive hiring marketing in the industry.

Our employees are not covered by a collective bargaining agreement, and we believe that our relationship with our employees is excellent.

We believe that we have

been successful to date in attracting skilled and experienced personnel despite the competitive hiring marketing in the industry.

employees are not covered by a collective bargaining agreement, and we believe that our relationship with our employees is excellent.

We continue to engage external consultants on an as-needed basis to temporarily supplement existing staff.

Corporate Information

We were incorporated under the laws of the State

of Delaware in 2013.

Our principal executive offices are located at 275 Madison Avenue, New York, NY 10016, and our telephone number is

(646) 677-3870.

We were incorporated under

the laws of the State of Delaware in 2013.

Our principal executive offices are located at 100 Park Avenue, New York, NY 10017, and our

telephone number is (646) 677-3870.

Our website address is www.actiniumpharma.com.

The information contained on our website or that can be accessed through

our website is not considered part of this report.

We make available free of charge through our website

our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any such amendments to those reports

as soon as reasonably practicable after we electronically file such material with or furnish such material to the Securities and Exchange

Commission (“SEC”).

The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements

and other information regarding companies that file electronically with the SEC.

The information contained on our website or that can

be accessed through our website is not considered part of this report.

We make available free of

charge through our website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any such

amendments to those reports as soon as reasonably practicable after we electronically file such material with or furnish such material

to the Securities and Exchange Commission (“SEC”).

The SEC maintains a website at http://www.sec.gov that contains reports,

proxy and information statements and other information regarding companies that file electronically with the SEC.

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 1. Business