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Item 1. Business

2025-03-31 compared with 2024-03-29 · 1111 added, 1334 removed, 49 unchanged (98% of the section changed)

Description of Our Business

Actinium Pharmaceuticals, Inc.

(“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 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.

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, 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 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

radiotherapeutics company focused on the top 100 cancer hospitals, using the power of our platform to deliver new treatment options for

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

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.

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 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.

our strategy will enable us to build a successful company with high operating efficiencies and is feasible to achieve without requiring

a commercial partner.

of Our Business

Actinium Pharmaceuticals,

(“Actinium”, the “Company”, or “we”) is a pioneer in the development of targeted radiotherapies

intended to meaningfully improve outcomes for patients with advanced cancers including relapsed or refractory (“r/r”) disease

who have failed existing therapies.

We are advancing a pipeline of differentiated clinical stage product candidates focused on validated

cancer targets.

Our current pipeline is focused on indications in myeloid malignancies, solid tumors and conditioning for cell and gene

therapies that we believe have high unmet needs that are not addressed by currently available treatment options.

Our goal is to create

a specialty radiopharmaceutical company with capabilities across radioisotope production, final drug product manufacturing, preclinical

research and development (“R&D”) and clinical development.

We are deploying our technologies and capabilities, which we

believe to be industry-leading, and intellectual property with approximately 230 issued and pending patents worldwide, to develop targeted

and next-generation radiotherapies.

Our Product Candidate Pipeline

We are advancing two clinical stage product candidates that are directed

against validated cancer targets.

Actimab-A is our lead product candidate in development and is intended to address the significant unmet

medical needs of patients with myeloid malignancies including acute myeloid leukemia (“AML”) and myelodysplastic syndromes

We are also evaluating Actimab-A’s potential to synergize with PD-1 immune checkpoint inhibitors (“ICIs”)

in solid tumor indications through the depletion of immune cells known as myeloid derived suppressor cells (“MDSCs”).

is a next-generation targeted conditioning agent we are developing with the intent to improve patient access to and outcomes with cellular

therapies such as CAR-T for various blood cancer indications and gene therapies for non-malignant hematologic disorders such as sickle

cell disease (“SCD”).

We are also developing ATNM-400, a novel preclinical, non-prostate specific-membrane antigen (“PSMA”)

targeting, first-in-class radiotherapy utilizing the Actinium-225 (“Ac-225”) radioisotope payload intended for patients with

prostate cancer directed against a novel radiotherapy target.

Actimab-A is being developed

as a targeted radiotherapeutic to leverage the Actinium-225 (“Ac-225") isotope payload directed against CD33, a target expressed

ubiquitously in patients with AML, MDS and expressed in other myeloid malignancies.

We are attempting to leverage the mutation-agnostic

ability of Ac-225 to establish Actimab-A as a backbone therapy in myeloid malignancies, which are extremely heterogenous and radiosensitive,

as a single agent or in combinations with chemotherapy, targeted agents, cellular therapy and immunotherapy.

Actimab-A has been studied

in over 150 patients.

We plan to initiate a Phase 2/3 trial with Actimab-A in combination with the chemotherapy regimen CLAG-M in patients

with r/r AML.

In addition to our internal development efforts, we entered into a Cooperative Research and Development Agreement (“CRADA”)

with the National Cancer Institute (“NCI”) in February 2023 for the development of Actimab-A for AML and other myeloid malignancies.

The first clinical trial to be conducted under our CRADA with NCI will evaluate the triplet combination comprised of Actimab-A, Venetoclax

and ASTX-727, a novel oral HMA developed by Taiho Oncology, an Otsuka Holdings company, in frontline AML patients.

Venetoclax in combination

with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML.

We believe this trial is supported by our Actimab-A + Venetoclax

combination trial that showed that combination was well-tolerated and showed supportive anti-leukemic activity.

Additional clinical trial

concepts for Actimab-A have been submitted under the CRADA and are being reviewed.

We anticipate that additional clinical trials with

Actimab-A will be initiated in 2025 including under the CRADA to leverage Actimab-A’s mutation agnostic mechanism.

In March of 2025, we initiated

our Actimab-A solid tumor program that will combine Actimab-A with PD-1 checkpoint inhibitors.

We initiated this program to evaluate if

Actimab-A can deplete CD33 expressing MDSCs and hence improve patient outcomes in combination with PD-1 ICIs such as KEYTRUDA ® and

The Actimab-A solid tumor program is comprised of several controlled, head-to-head clinical trials that will evaluate

the combination of Actimab-A with KEYTRUDA ® versus KEYTRUDA ® alone, and Actimab-A with OPDIVO ® versus

OPDIVO ® alone.

The initial tumors that are being targeted are Head and Neck Squamous Cell Carcinoma (“HNSCC”)

and Non-Small Cell Lung Cancer (“NSCLC”) with a separate trial for each indication.

ATNM-400 is our newest targeted

radiotherapy program that we are advancing for prostate cancer.

Given the biology of the antigen targeted by ATNM-400 and the precise

and potent cell-killing of Ac-225, we believe ATNM-400 has the potential to address unmet needs in prostate cancer.

We have generated

preclinical data with ATNM-400 showing selective tumor accumulation with minimal uptake in normal tissues.

Our experiments also showed

dose-dependent cytotoxicity.

We continue to study ATNM-400 with additional data expected from Pluvicto-resistant prostate cancer models.

Pluvicto (Lu-177-PSMA-617) is a prostate-specific membrane antigen (PSMA) directed targeted radiotherapy that uses the beta-particle emitting

radioisotope Lutetitium-177 (“Lu-177”) that is approved for patients with metastatic prostate cancer.

ATNM-400 is differentiated

from Pluvicto as it targets a different marker than PSMA that has been shown to be overexpressed in patients with prostate cancer and

uses the alpha-particle emitter Ac-225, which is more potent than Lu-177 but has a shorter path length, which could result in fewer off-target

effects such as xerostomia.

In addition to ATNM-400, we

have active R&D efforts leveraging our in-house preclinical development and translational research capabilities that are primarily

focused on supporting our ATNM-400 preclinical program, the Actimab-A and Iomab-ACT clinical programs and advancing several preclinical

programs for solid tumor indications.

Iomab-ACT is our next-generation

targeted conditioning agent directed against CD45, a target expressed widely across the hematopoietic system including normal nucleated

immune cells such as lymphocytes that is relevant to this program and uses the Iodine-131(“I-131") radioisotope payload.

are developing Iomab-ACT for cell and gene therapies for both malignant and non-malignant hematologic indications.

Iomab-ACT utilizes

non-myeloablative doses of I-131, to not fully deplete the patient’s bone marrow and immune system with the goal of improving patient

access and outcomes for potentially curative cell and gene therapies by replacing the need for the non-targeted, chemotherapy-based conditioning

regimens that are currently used.

Iomab-ACT is currently being studied in three clinical trials.

These trials include Iomab-ACT with a

commercial CAR-T therapy, Iomab-ACT prior to allogeneic BMT for patients with SCD, which could potentially inform a trial design with

gene therapy for SCD, and Iomab-ACT with a novel investigational CD19 CAR-T therapy.

previously advanced our targeted conditioning program Iomab-B through the Phase 3 Study of Iomab-B in Elderly Relapsed and Refractory

AML (“SIERRA”) trial, a 153 patient, randomized multi-center trial conducted in the United States.

comprised of the anti-CD45 monoclonal antibody apamistamab with myeloablative doses of I-131 intended to enable patient access to bone

marrow transplant (“BMT”), the only potentially curative treatment option for patients with r/r AML.

At this time, we are

seeking a strategic partner for Iomab-B to conduct an additional clinical trial based on feedback from the U.S.

Food & Drug Administration

(“FDA”) and are committed to establishing the best development path forward for Iomab-B in the U.S., while keeping internal

resources and strategic priorities in focus.

As previously disclosed and noted above, Actinium also has a License Agreement with Immedica,

granting Immedica the exclusive product rights for commercialization of Iomab-B in certain countries in the European Economic Area, Middle

East and North Africa (“EUMENA”) region.

Actinium’s Approach to Targeted Radiotherapy

Radiation is a validated cancer

therapy that has been used to treat patients for over 100 years.

It is used to treat over half of all patients diagnosed with cancer today.

Radiation therapy utilizes rays of energy to kill cancer cells and is commonly used in combination with other cancer treatment modalities.

Radiation therapy is primarily administered from outside of the body and therefore passes through normal healthy tissue and organs that

result in side effects and toxicities, which can be acute and/or chronic.

With our targeted radiotherapy

approach, we seek to address the limitations of external radiotherapy and achieve cellular level precision by leveraging the cancer cell

targeting ability of biologic molecules with the cancer cell killing ability of radioisotopes.

In doing so, we seek to improve efficacy

outcomes, reduce toxicities and expand the use of radiation to cancer indications like blood cancers that cannot be addressed with externally

delivered radiation.

In addition, we are also testing the use of targeted radiotherapies in solid tumor cancers where there are unmet

medical needs.

Biological molecules have demonstrated high affinity for cancer cell identification and binding to biological markers on

the surface of cells known as antigens or ligands, which are the target receptors for our targeted radiotherapies.

Actinium’s Targeted Radiotherapies

Alpha particles emitted by

as the element Ac-225 are the heaviest and have the highest charge, resulting in high amounts of linear energy transfer, which is capable

of producing double strand DNA breaks.

However, alpha-particles travel short distances of just several microns and as a consequence do

not exert radiation outside of the body.

Alpha particles can be stopped by an ordinary sheet of paper.

Therefore, alpha particle-based

therapies do not require special shielding or that patients remain isolated following treatment.

Beta particle-based therapies have a

longer pathlength but have lower amounts of linear energy transfer and at certain dose levels may require isolation or special handling.

Comparison of Radioisotope Pathlength

We focus on producing drug candidates that match a specific targeting

agent with the appropriate isotope for a desired indication.

We employ an isotope-agnostic approach to targeted radiotherapy development.

Our development efforts are centered on validated targets that are known to have high expression on cancer cells compared to normal healthy

We are advancing our clinical product candidates targeting CD33 and CD45 and have completed preclinical studies against other blood

cancer targets such as CD38, as well as various validated solid tumors targets.

We believe that the cell-killing power of linear energy transfer delivered

via radiotherapeutics is unmatched by other technologies and that there are multiple indications 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.

Actinium’s strategy is to build a specialty radiotherapeutics company with the capabilities

to produce radioisotopes, manufacture radiotherapies, conduct preclinical research, clinical development and supply radiotherapies to

the point of care.

We believe our strategy will enable us to build a successful company with the potential for high operating efficiencies.

Our strategic priorities are to:

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:

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 (“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:

We intend to leverage data from several clinical trials that demonstrate the ability of Iomab-B to improve BMT access and outcomes in five additional hematologic indications.

These data in MDS, ALL, HL, NHL and MM provide the foundation to expand the label for Iomab-B and increase its market potential.

In AML, we would seek label expansion into haploidentical transplants, earlier lines of treatment and younger patients below the age of 55, the cutoff in the SIERRA trial.

As much as possible, we would seek to use investigator sponsored trials as the primary strategy for label expansion in order to maximize capital utilization.

Further expand our conditioning franchise by developing Iomab-ACT for cell and gene therapies:

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 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 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.

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 (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.

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.

Results from the Randomized

Phase III ASAP Trial.

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 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

The first access challenge is that the patient needs to be in complete remission prior to BMT.

The current clinical practice is not

to transplant patients with active AML as outcomes are poor due to high relapse rates.

The National Comprehensive Cancer Network (“NCCN”)

guidelines also recommend treatment to achieve remission prior to transplant in patients with relapsed AML.

The second challenge to access

is tolerance to current conditioning regimens.

For older patients, myeloablative regimens are not an option due to intense toxicity and

The third challenge is the ability to achieve post-BMT remission and successful engraftment.

Inadequate conditioning can lead

to graft failure, which is associated with very high mortality.

Patients who fail to achieve a CR post-transplant have extremely poor

outcomes and a survival of a few weeks.

The fourth challenge relates to BMT tolerability and post-BMT complications.

The conditioning

and immunosuppressive regimens given to these patients put them at high risk for infectious complications and toxicity.

In the SIERRA

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.

Patients enrolled had blast counts of 5% or greater in the marrow or circulating blasts suggestive of active AML.

In this study, Iomab-B

was compared to the control arm that allowed physician’s choice of over 20 available agents, including chemotherapies and/or targeted

therapies such as venetoclax (BCL-2 inhibitor), FLT3 inhibitors, IDH inhibitors and Mylotarg, reflecting current best-treatment practices

attempting to get patients to CR.

The control arm included recently approved AML therapies that were added to the SIERRA protocol as they

became available.

The crossover arm was designed in SIERRA for an equipoise that offered Iomab-B to patients failing to achieve a CR on

the control arm with an intent to rescue them by taking them to transplant.

Of note, SIERRA had highly restrictive optionality for post-transplant

Patients with active, r/r AML are not considered eligible for BMT with current approaches and the SIERRA trial was the only

randomized Phase 3 trial to offer BMT as a treatment option for this patient population.

These patients would not be offered BMT in standard

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

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

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

The comparison of OS in subjects randomized to the control

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 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:

Iomab-B Meets Primary Endpoint

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.

Overall Survival for Patients who Achieved

6-month dCR with Iomab-B

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 ‒

Iomab-B, Crossover, and Non-Crossover Control Arm

Iomab-B produced a significant and clinically meaningful improvement

in the secondary endpoint of EFS, with a 78% reduction in the probability of an event (Hazard Ratio=0.22, p<0.0001 for both per protocol

and ITT basis).

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 (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

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.

Grade ≥3 Treatment-Emergent Adverse Events

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.

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 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

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.

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 areas.

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

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

Establish Actimab-A as a mutation agnostic,

backbone therapy for myeloid malignancies including patients with AML and high-risk MDS;

Establish Actimab-A as a pan solid tumor therapy

in combination with PD-1 inhibitors including KEYTRUDA ® and OPDIVO ® by depleting myeloid derived suppressor

Determine the potential of ATNM- as a viable

treatment for patients with prostate cancer;

Establish Iomab-ACT as a universal targeted

conditioning agent for cell and gene therapies to improve patient access and outcomes;

Leverage our R&D capabilities and clinical

development experience to further advance pipeline assets for cancer indications with high unmet needs;

Establish in-house manufacturing infrastructure

to support our planned later-stage clinical development and secure partnerships to enable the deployment of our proprietary Ac-225 cyclotron

manufacturing technology.

Market Opportunity for Our Targeted Radiotherapies

We believe our clinical programs

have the potential to address a significant number of patients with high unmet medical needs and therefore represent large potential market

opportunities.

To our knowledge, Actimab-A, Iomab-ACT and ATNM-400 are first in class targeted radiotherapies for myeloid malignancies,

targeted conditioning for cell & gene therapies and multiple solid tumors, respectively, with each discrete opportunity representing

a range of over 100,000 to several hundred thousand addressable patients.

Four Large & Distinct Potential Market

Opportunities

Actimab - A Myeloid Malignancies Program

We are focused on developing

our lead targeted radiotherapy Actimab-A for patients with AML and MDS, which are the most common myeloid malignancies in adults.

and certain MDS can progress rapidly, especially in patients with high-risk features such as certain genetic mutations.

To our knowledge,

Actimab-A is the only CD33 targeted radiotherapy in development for patients with myeloid malignancies.

Myeloid malignancies are a

group of cancers that affect blood-forming cells also referred to as hematopoietic cells in the bone marrow.

These cells are from the

myeloid lineage and include white blood cells, red blood cells and platelets.

Myeloid malignancies include AML, MDS, chronic myeloid leukemia

(“CML”) and myeloproliferative neoplasms (“MPNs”).

We believe Actimab-A can be used in multiple treatment settings across

the myeloid patient journey.

For patients with AML, we plan to develop Actimab-A for both fit and unfit patients in the frontline, relapsed

or refractory and maintenance settings either as a monotherapy or in combination with other treatments.

For patients with MDS, we plan

to develop Actimab-A for patients who have high-risk disease and in the maintenance setting.

In the United States and the

five largest countries in Western Europe (France, Germany, Italy, Spain and the United Kingdom, which we refer to as “EU5”) ,

we estimate the patient population across our target treatment settings in these diseases to be greater than 100,000 patients annually.

and EU5 AML & MDS Addressable Patient

AML is increasingly defined

by the presence of genetic mutations or cytogenetic abnormalities as well as prior therapy given the increased number of approved agents.

AML is a mutation rich disease that is genetically heterogeneous with identifiable mutations in over 95% of all patients.

The most common

mutations for which there are approved therapies include fms-like tyrosine kinase 3 (“FLT3”), isocitrate dehydrogenase 1 &

2 (“IDH1”) (“IDH2”), and nucleophosmin 1 (“NPM1”) & KMT2A rearrangements.

Various treatments are currently

approved or utilized for patients with AML and MDS including chemotherapies, targeted therapies, antibody drug conjugates (“ADCs”),

hypomethylating agents (“HMAs”) and BMT.

Since 2017, twelve therapies have been approved for patients with AML.

our development strategy, we have evaluated and expect to continue to evaluate Actimab-A in combination with these approved therapies

and other emerging treatment options or therapeutic modalities to leverage its mutation agnostic and potentially synergistic mechanism

Given the ubiquitous expression of CD33, we believe Actimab-A has the potential to be a backbone therapy for myeloid malignancies.

Fewer approved treatment options

exist for patients with MDS, particularly high-risk patients.

Treatments currently approved or utilized for high-risk patients include

chemotherapies, HMAs and IDH1 inhibitors.

We intend to evaluate the potential utility of Actimab-A in MDS either as single agent or in

combination with other therapies.

Given the complexity and aggressiveness

of AML and High-risk MDS, these patients are often referred to and treated in comprehensive treatment centers for in-patient treatment

as opposed to community, outpatient-based care.

As a result, we believe the majority of AML and High-risk MDS patients largely occurs

in a finite number of centers, which implies efficiencies from concentration of commercialization efforts.

Actimab-A Solid Tumor Program

We believe a large market

opportunity also exists for Actimab-A in solid tumor indications by depleting MDSCs to synergize with PD-1 checkpoint inhibitors and potentially

other immune checkpoint inhibitors.

Several solid tumor indications have shown to have high expression of MDSCs including non-small cell

lung cancer (“NSCLC”), melanoma, renal cell carcinoma (“RCC”), colorectal cancer (“CRC), triple negative

breast cancer (“TNBC”), head & neck squamous cell carcinoma (“HNSCC”), pancreatic cancer, glioblastoma (“GBM”)

prostate cancer and ovarian cancer.

Cumulatively, over 600,000 patients are diagnosed with these cancers annually.

PD-1 checkpoint inhibitors

are approved in a significant number of these indications and in 2024 generated sales totaling more than $45 billion.

We are planning to conduct our initial controlled, randomized clinical

trials in HNSCC and NSCLC in combination with the PD-1 checkpoint inhibitors KEYTRUDA ® and OPDIVO ® .

two indications represent a potential addressable patient opportunity of over 250,000 patients.

We expect to continue to evaluate additional

indications for potential future clinical trials assuming our initial efforts are successful.

ATNM-400 Prostate Cancer Program

Prostate cancer is the

most common cancer in men, with approximately 1 in 8 men diagnosed with prostate cancer during their lifetime.

According to the American

Cancer Society, an estimated 313,780 new cases of prostate cancer will be diagnosed in the United States in 2025.

The global incidence

of prostate cancer is approximately 1.5 million new cases annually.

Approximately 20% of prostate cancer cases are more aggressive forms

that progress to metastatic disease, which is associated with significantly worse survival outcomes.

Radiotherapy is commonly used to

treat prostate cancer, and in 2022, the PSMA-targeting radiotherapy Pluvicto was approved by the FDA and the European Medicines Agency

(“EMA”) for the treatment of patients with metastatic castration-resistant prostate cancer.

Pluvicto is marketed and sold

by Novartis and generated sales of $1.39 billion in 2024.

ATNM-400 is differentiated from Pluvicto as it targets a different marker than

PSMA that has been shown to be overexpressed in patients with prostate cancer and uses the alpha-particle emitter Ac-225, which is more

potent than Lu-177 but has a shorter path length, which could result in fewer off-target effects such as xerostomia.

Iomab-ACT Cell & Gene Therapy Conditioning

We are developing Iomab-ACT as a targeted conditioning agent to prepare

patients for cellular therapies such as CAR-T or BMT and gene therapies.

Our current clinical trials are focused on patients with blood

cancers and non-malignant blood disorders such as SCD.

The first CAR-T therapies was approved in 2017 and currently, there are 6 approved

CAR-T therapies for patients with lymphomas, leukemia and multiple myeloma, which generated sales of over $4.0 billion in 2024.

that there are approximately 125,000 patients diagnosed with blood cancers that can be potentially treated with CAR-T therapies, which

are currently approved for r/r patients.

SCD is a rare, debilitating and life-threatening blood disorder with significant unmet needs

that affects approximately 100,000 people in the U.S.

Patients with SCD have a mutation that causes red blood cells to develop a crescent

or “sickle” shape, which restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading

to severe pain and organ damage called vaso-occlusive events (“VOEs”) or vaso-occlusive crises (“VOCs”).

recurrence of these events or crises can lead to life-threatening disabilities and/or early death.

An allogeneic BMT is a potentially

curative treatment option for patients with sickle cell disease, particularly in pediatric and adolescent patients who have had complications

such as strokes, acute chest crises or recurring pain crises due to their disease.

In addition, there are two approved gene therapies

for patients with sickle cell disease, Casgevy (Vertex Pharmaceuticals, Inc.

and CRISPR Therapeutics) and Lyfgenia (Bluebird Bio, Inc.).

Our Clinical Product Candidates

Mutation Agnostic Mechanism of Action

with Backbone Therapy Potential in Myeloid Malignancies including AML and high-risk MDS

Actimab-A (Ac-225-lintuzumab satetraxetan) is our lead radiotherapeutic

product candidate in development for patients with myeloid malignancies.

To our knowledge, Actimab-A is the only CD33 targeting radiotherapy

in clinical development.

We are focused on developing Actimab-A as both a monotherapy and in combination with other treatment regimens

to leverage both the potential mechanistic synergies of radiation and its mutation agnostic cell killing ability.

In addition to our internal

development efforts, we entered into a CRADA with the NCI in February 2023 for the development of Actimab-A for AML and other myeloid

malignancies.

We intend to establish Actimab-A as a backbone therapy leveraging the

broad expression of CD33 in myeloid malignancies such as AML and MDS, which, like most blood cancers, are highly sensitive to radiation.

AML is a highly heterogenous, mutation rich cancer with over 70 identified driver genetic mutations.

However, there are only approved

therapies for four mutations including FLT3, IDH1 & IDH2, and NPM1.

CD33 is expressed regardless of other mutations being present

The Ac-225 isotope payload that we utilize with Actimab-A emits potent alpha-particles with high linear energy that kill cells via double

strand DNA breaks for which there is no known resistance or repair mechanism.

Actimab-A’s Mechanistic

Synergy and Potential Combinations

Our development strategy is

to exploit these properties of Actimab-A to address the unmet needs of patients with myeloid malignancies across the treatment journey

including the frontline, relapsed/refractory and maintenance settings.

To accomplish this, we are leveraging our clinical development

experience, clinical data and preclinical work supporting Actimab-A’s mutation agnostic capabilities.

Actimab-A Clinical Development Experience

To our knowledge, Actimab-A

is one of the most studied alpha-particle based targeted radiotherapies in clinical development having been studied in over 150 patients

across multiple clinical trials.

Actimab-A has been studied at multiple dose levels, different administration schedules and as a single

agent or in combination with chemotherapy and targeted agents in patients with AML in the front line and relapsed or refractory settings

with promising results to date.

Actimab-A Monotherapy Phase 2 Trial

Following multiple Phase 1

clinical trials, Actimab-A was studied in a 40-patient multi-center Phase 2 trial as a single agent in patients newly diagnosed with AML

age 60 and above who were ineligible for intensive chemotherapy.

At the dose level of 2.0 μCi/kg, Actimab-A produced high overall response

rates (“ORR”) of 69% including Complete Remission (“CR”), Complete Remission with incomplete platelet recovery

(“CRp”) and Complete Remission with incomplete blood count recovery (“CRi”).

Prolonged myelosuppression was the

most common adverse event and was expected as it is a known class effect of CD33 targeting therapies and given the advanced age of the

patients enrolled.

The Actimab-A dose was adjusted to 1.5μCi/kg, which produced an ORR of 22%.

Potent anti-leukemic effect was observed

at both dose levels.

Of the patients treated with 1.5 μCi/kg of Actimab-A, the median age was 75 and over 50% of the patients had an

antecedent hematologic disorder including MDS, chronic myelomonocytic leukemia and myelofibrosis, which can compromise a patient’s

bone marrow function and ability to recover blood counts and proper function.

This trial was conducted prior to the approval of many of

the targeted therapies that are routinely used in the treatment of patients with AML today.

As a result of the prolonged myelosuppression

seen with doses of Ac-225 directed against CD33 expressing cells and the evolving AML treatment landscape, we adapted our development

strategy for Actimab-A to address the emerging unmet needs of patients in the era of precision medicines for AML.

Anti-Leukemic Activity

of Actimab-A Monotherapy

After completing the Phase

2 monotherapy trial, there was strong interest from trial investigators and other key opinion leaders to study Actimab-A in combination

with other treatment modalities to leverage its novel mutation agnostic radiotherapy mechanism.

We evaluated several clinical trial concepts

and elected to pursue combination trials with Actimab-A with the salvage chemotherapy CLAG-M in patients with r/r AML and with the Bcl-2

inhibitor Venetoclax based on the potential for these combinations to address large segments of the AML patient population with high unmet

Actimab-A + Venetoclax Phase 1/2 Combination

Venetoclax is an oral therapy

that works by attaching to and blocking the actions of the B-cell lymphoma-2 (“Bcl-2”) protein.

Bcl-2 is overexpressed in

several blood cancers and prevents cancer cells from undergoing normal programmed cell death or apoptosis, which can help the cancer cells

overexpressing Bcl-2 live longer or increase resistance to chemotherapy.

In November 2018, Venetoclax received accelerated approval from

the FDA in combination with the HMA azacitidine and decitabine or low-dose cytarabine for the treatment of newly diagnosed AML in patients

age 75 years or older or patients ineligible for intensive induction chemotherapy.

Venetoclax was granted regular approval by the FDA

in October 2020.

The Phase 1 portion of the

Actimab-A + Venetoclax trial enrolled 18 patients and was conducted at five clinical trial sites.

Four dose levels of Actimab-A were evaluated

with the primary objective of evaluating the safety of the combination.

Actimab-A + Venetoclax was well tolerated with an expected and

manageable adverse event profile with no early deaths observed.

Efficacy was also evaluated with reduction in bone marrow blasts up to

93% reported.

Actimab-A + CLAG-M Phase 1b/2 Combination

The Medical College of Wisconsin

(“MCW”) was an active clinical trial site in the Phase 2 Actimab-A Monotherapy trial.

MCW had previously conducted a study

evaluating salvage chemotherapies in patients with r/r AML including the regimens MEC, CLAG and CLAG-M.

The results demonstrated that

CLAG-M produced superior outcomes based on rates of response and overall survival resulting in CLAG-M being the preferred salvage regimen

for patients with r/r AML.

Based on MCWs experience with Actimab-A and CLAG-M, the team at MCW hypothesized that combining Actimab-A with

CLAG-M could improve patient outcomes compared to CLAG-M alone and lead to a clinical benefit by eliminating residual or resistant AML

blasts to produce higher rates of remissions and deep remissions including measurable residual disease (“MRD”) negativity.

MCW enrolled 26 adult patients

with high-risk r/r AML in the Phase 1b/2 trial of Actimab-A + CLAG-M with 23 patients evaluable for efficacy.

Patients in the efficacy

cohort had a median age of 62 and 91.3% of patients being intermediate risk (13%) or adverse risk (78.3%) according to the 2017 ELN cytogenetic

risk classification.

Additionally, 52.2% of patients had a TP53 mutation abnormality, 56.5% of patients had prior Venetoclax treatment

and 56.5% of patients had a prior allogeneic BMT with patients having a median of 2 lines of prior treatment (range:

evaluated four dose levels of Actimab-A in combination with CLAG-M ranging from 0.25 μCi/kg to 1.0 μCi/kg.

Patient Characteristics

The results from this trial

were published in the peer-reviewed journal Leukemia in February 2025.

In this publication, it was reported that Actimab-A + CLAG-M

had a tolerable safety profile with manageable toxicities and demonstrated promising efficacy supporting additional trials to further

evaluate the efficacy of the combination including survival outcomes.

Based on the results of the study, it was determined that 0.75 μCi/kg

is the recommended Phase 2 dose (“RP2D”).

In addition to a safety analysis, the results of 5 patients treated in a pharmacokinetic

expansion cohort at the RP2D were reported.

Treatment-emergent adverse events (“TEAE”) were primarily hematologic and all

grade 3/4 TEAEs were hematologic.

No patients discontinued treatment due to TEAEs and no early deaths were attributed to the Actimab-A

The pharmacokinetic analysis evaluated radioactivity in whole blood and results showed that Actimab-A cleared rapidly with no

detectable radioactivity after a median of 24.5 hours.

Importantly, no significant kidney or liver toxicity has been reported to date

and no incidences of veno-occlusive disease (“VOD”) reported.

The efficacy analysis of this

trial evaluated rates of CR, composite Complete Remission (“CRc”) which includes CR and Complete Remission with Incomplete

Count Recovery (“CRi”) and ORR which include CR, CRi and Morphologic Leukemia-Free State (“MLFS”), as well as

MRD negativity and survival outcomes.

As listed in the table below, CR, CRc and ORR rates were reported for all patients as well as patients

treated at the RP2D, by number of lines or prior therapy and high-risk patients including those with a TP53 mutation and prior Venetoclax

Rates of CR, CRc and

ORR with Actimab-A + CLAG-M

In patients achieving a CRc,

MRD negativity was assessed including in patients in various high-risk subgroups.

Across all patients, the MRD negativity rate was 75%

and was 100% in patients with prior Venetoclax treatment.

In the ELN adverse risk patients and those with a TP53 mutation, MRD negativity

was 86% and 83%, respectively.

We believe these high rates of MRD negativity support the rationale for conducting this study, which was

to determine if Actimab-A could deplete residual or resistant AML blasts to produce deep remissions.

MRD Negativity Rates

in Evaluable Patients Achieving CRc

Long-term survival outcomes

in the evaluable patients receiving Actimab-A + CLAG-M were also reported from this study from a 2-year follow-up.

In the patients eligible

for a BMT, 60% of patients successfully received a BMT and had a median Overall Survival (“OS”) of 24 months.

with one or two lines of prior salvage therapy, the median OS was 18.4 months.

The median OS in patients with a TP53 mutation or prior

Venetoclax treatment was 9.6 months and 7.3 months, respectively.

These survival outcomes compare favorably to outcomes reported in the

In patients with prior Venetoclax treatment who then received intensive chemotherapy such as CLAG-M, OS has been reported

to be 2.4 - 4.6 months.

Overall Survival Outcomes

with Actimab-A + CLAG-M

Based on the positive findings

from this trial, we plan to evaluate Actimab-A + CLAG-M will be evaluated in a pivotal Phase 2/3 trial in patients with r/r AML.

Actimab-A + CLAG-M Pivotal Phase 2/3 Trial

We have aligned with the FDA

on an operationally seamless, randomized pivotal Phase 2/3 trial to compare Actimab-A + CLAG-M to CLAG-M alone in patients with r/r AML.

Based on our interactions with the FDA, this trial will first complete a Phase 2 portion where the Actimab-A dose will be optimized in

combination with CLAG-M.

We expect the Phase 2 portion of this trial to be initiated in 2025.

Once the optimized Actimab-A dose is determined,

we expect the trial will seamlessly advance to the Phase 3 portion of the study, which is expected to reduce time and resources required

compared to separate Phase 2 and Phase 3 studies.

Actimab-A + CLAG-M Pivotal Phase 2/3 Trial

The primary endpoint of the

Phase 3 trial will be Overall Survival.

Event-Free Survival (“EFS”) and other efficacy measures as well as safety also being

We are actively seeking potential strategic partners or collaborators to advance this trial.

Actimab-A NCI CRADA Trials

In 2023, we entered into a

CRADA with NCI 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 we have the right to review and approve all protocols and have full rights to all data.

The NCI CRADA provides for us to supply

Actimab-A and for NCI to cover all clinical trial execution and development expenses, which we believe will be a cost-efficient approach

as opposed to a Company sponsored trial and will therefore spare our balance sheet.

The NCI Cancer Therapy Evaluation Program (“CTEP”),

which sponsors approximately two thirds of all combination cancer studies, will accept Letters of Intent (“LOIs”) or concepts

for Phase 1, 2 or 3 studies of Actimab-A in AML and other hematological malignancies.

In October 2024, the NCI announced

that its myeloMATCH program was officially open to patient enrollment across the U.S.

MyeloMATCH is a portfolio of clinical

trials to test precision medicine treatments for adults with AML or MDS being designed and led by four leading cancer research organizations

including the Alliance for Clinical Trials in Oncology, Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, and SWOG Cancer

Research Network in collaboration with the NCI National Clinical Trials Network (“NCTN”).

Collectively, the myeloMATCH program

expects to open trials at hundreds of cancer care sites across the U.S.

and Canada with the goal of enrolling 5,000 or more patients over

the next several years.

Under our CRADA with the NCI, Actimab-A is part of the myeloMATCH program and may be included in future clinical

Actimab-A, Venetoclax & ASTX-727 –

Frontline AML Triplet Phase 1b Combination Trial

In March 2025, we announced

the initiation of the first clinical trial to be conducted under our CRADA by NCI.

The trial will evaluate the triplet combination comprised

of Actimab-A, Venetoclax and ASTX-727, a novel oral HMA developed by Taiho Oncology, an Otsuka Holdings company, in frontline AML patients.

Venetoclax in combination with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML.

We believe this trial is supported by

our Actimab-A + Venetoclax combination trial that showed that combination was well-tolerated and showed supportive anti-leukemic activity.

The frontline AML triplet trial is expected to enroll up to 48 patients who are newly diagnosed with AML that are age 75 and above and

not eligible for intensive chemotherapy.

The trial will evaluate various dose levels of Actimab-A along with dosing regimens.

initial clinical data to be generated from this trial in second half of 2025.

Triplet Combination Trial Design with Venetoclax,

HMA & Actimab-A Backbone

Additional clinical trial concepts for Actimab-A

have been submitted under the CRADA and are being reviewed.

We anticipate that additional clinical trials with Actimab-A will be initiated

in 2025 including under the CRADA to leverage Actimab-A’s mutation agnostic mechanism.

Broad Development Strategy for Actimab-A

Data Supporting Actimab-A’s Mutation Agnostic Profile

To leverage Actimab-A’s

mutation agnostic capabilities and support its broad development, we have conducted preclinical experiments studying Actimab-A in combination

with targeted agents including Bcl-2 inhibitors, FLT-3 inhibitors, IDH inhibitors and menin inhibitors for NPM1 and KMT2A AML, chemotherapies

such as CLAG-M and in cell lines expressing TP53 mutations.

The table below outlines the expression rates of these targets in patients

Actimab-A Combination Data with Menin Inhibitors

In June 2024, we presented

the first-ever preclinical data demonstrating the combination of Actimab-A with leading menin inhibitors resulted in anti-tumor control

and potent leukemia cell killing in AML models at the 2024 European Hematology Association (“EHA”) Congress.

We studied Actimab-A

in combination with the leading menin inhibitors, revumenib (Syndax Pharmaceuticals, Inc.) and ziftomenib (Kura Oncology, Inc.), which

are being developed for patients with KMT2A rearrangements and NPM1 mutations, which are present in approximately 10% and 30% of AML patients,

respectively.

Actimab-A as a single agent showed potent in vitro AML cell killing activity in both MV-4-11 and MOLM-13 KMT2A mutant cell

lines, compared to the non-radio conjugated CD33 antibody lintuzumab (p<0.0001) and the combination of Actimab-A with leading menin

inhibitors triggered an acute increase in AML necrosis and cell death in vivo relative to single agent therapy within 72 hours of dosing.

Actimab-A enhanced AML cell death when combined with both revumenib and ziftomenib at all dose levels in difficult to treat KMT2A mutant

Anti-tumor effect was significantly potentiated and prolonged when combining Actimab-A with a leading menin inhibitor compared to

monotherapies in xenograft leukemia models in vivo (p<0.0024 Actimab-A + menin).

Enhanced Tumor Control

with Actimab-A + Menin Inhibitor Revumenib

Actimab-A Combination Data with FLT3 Inhibitors

We have also evaluated Actimab-A

in combination with FLT3 inhibitors such as gilteritinib (Astellas Pharma, Inc.) and midostaurin (Novartis Pharmaceuticals, Inc.).

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.

We will continue to evaluate the potential of Actimab-A in combination with FLT3 inhibitors.

Synergistic Anti-Leukemic

Effect with FLT3 Inhibitors

We expect to present additional data supporting

Actimab-A’s mutation agnostic capabilities and backbone potential at future scientific and medical conferences.

In addition, we

will continue to explore potential clinical trials under our CRADA with NCI, investigator-initiated trials or under our sponsorship.

Actimab-A Solid Tumor Program:

Potential Pan Solid Tumor Therapy

in Combination with PD-1 Checkpoint Inhibitors Including KEYTRUDA ® and OPDIVO ® by Depleting Myeloid Derived

Suppressor Cells

Given the significant number

of patients treated with PD-1 ICIs, there is extensive data in the medical literature on outcomes in these patients.

PD-1 ICIs have significantly

improved patient outcomes across several solid tumor indications, however, not all patients have robust or durable responses.

therapeutic modalities have been studied in combination with PD-1 ICIs in attempt to improve patient outcomes, but few combinations have

produced a sufficient enough clinical benefit to have been approved.

To our knowledge, our Actimab-A solid tumor program is the only CD33

targeted radiotherapy being evaluated in combination with PD-1 ICIs.

The rationale for studying Actimab-A in combination with either KEYTRUDA ® or

OPDIVO ® is based on the premise that depleting MDSCs with Actimab-A will improve the efficacy of these drugs.

MDSCs are immune-suppressive cells that help tumors

evade immune detection and promote disease progression.

They are overexpressed in the tumor microenvironment in several different solid

tumors and associated with poor outcomes.

They work by multiple mechanisms but most relevant to PD-1 inhibitors which work by keeping

T-cells active is that MDSCs prevent T-cells from recognizing and attacking cancer cells.

MDSCs Immunosuppressive Effects

Studies have shown that MDSCs are overexpressed

in patients with cancers.

For instance, a study by Bronte et al., in patients with NSCLC receiving ICIs evaluated the role of immune cells

on patient outcomes.

In this study, MDSCs were the only immune cell subtype to show a statistically significant association with tumor

The median level of MDSCs was determined to be 1.9% with patients above that level being classified as “High-MDSC”

and patients below that level being classified as “Low-MDSC”.

In this study, only Low-MDSC patients had a clinical response

with no responses observed in High-MDSC patients and over 80% of High-MDSC patients having progressive disease.

In addition, Low-MDSC

patients had a statistically significantly improvement in progression-free survival (“PFS”) of 8.39 months compared to 1.94

months in High-MDSC patients and OS of 15.15 months compared to 3.03 months in High-MDSC patients.

There is considerable preclinical scientific evidence

in the literature that depleting MDSCs could be a viable strategy in improving the outcomes of PD-1 directed immunotherapy, however, there

have been no viable clinical approaches that have been tried successfully to our knowledge.

MDSCs are known to express the CD33

antigen which is the target of Actimab-A.

Actinium has also generated published and unpublished preclinical data showing that Actimab-A

can selectively deplete MDSCs in solid tumors.

Actimab-A Depletes MDSCs

in In Vivo Preclinical Models

We believe there is strong

scientific rationale supporting the potential for Actimab-A to deplete CD33 expressing MDSCs and hence improve patient outcomes with PD-1

ICIs such as KEYTRUDA ® and OPDIVO ® .

Our Actimab-A solid tumor program is expected to be comprised of

several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with KEYTRUDA ® versus

KEYTRUDA ® alone, and Actimab-A with OPDIVO ® versus OPDIVO ® alone.

tumors that are being targeted are HSNCC and NSCLC with a separate trial for each indication.

The patient population for

these trials will be adults with PD-L1 expression and locally advanced metastatic HNSCC or NSCLC randomized to either Actimab-A alone

or Actimab-A with a specific checkpoint inhibitor.

The objective of each trial would be to evaluate the safety and tolerability as well

as following endpoints including ORR, PFS and OS.

Further, the following biomarker data would be collected including the pattern of depletion

of CD33+ MDSCs and T-cell activity in peripheral blood.

We expect to present initial proof of concept clinical data from the first of

these trials in the second half of 2025 as well as provide an update on the outlook for the rest of the trials for the Actimab-A solid

tumor program.

ATNM-400 Program:

Potential Novel, First-in-Class Ac-225 Prostate

Cancer Radiotherapy

In March 2025, we announced

ATNM-400, a novel, first-in-class Ac-225-based radiotherapy intended for patients with prostate cancer.

We have generated preclinical

data with ATNM-400, which has been accepted for presentation at the American Association for Cancer Research (“AACR”) Annual

Meeting being held April 25 – 30, 2025.

The abstract accepted for presentation highlighted the following:

● ATNM-400 selectively binds to prostate cancer cells, undergoes

rapid internalization, and induces dose-dependent cytotoxicity;

● in prostate cancer xenograft mouse models, ATNM-400 accumulated

in tumors for up to 144 hours, while showing minimal uptake in normal tissues;

● small animal SPECT/CT imaging with Indium-111-labeled antibody

confirmed selective tumor accumulation and clearance from healthy tissues;

● a single dose of ATNM-400 achieved 68.5% tumor growth inhibition

at 20 µCi/kg and 99.8% at 40 µCi/kg, with all doses being well tolerated.

We continue to study ATNM-400

and expect additional data from Pluvicto-resistant prostate cancer models to be presented at AACR.

Iomab-ACT Program:

Potential Universal Targeted Conditioning Agent

for Cell & Gene Therapies to Improve Patient Access and Outcomes

The opportunity exists for

better conditioning regimens in the area of cellular therapies beyond the non-targeted chemotherapy-based regimens that are used currently.

We are working on a next generation targeted conditioning program, Iomab-ACT, for the rapidly growing cell and gene therapy market, as

well as BMT conditioning for non-malignant hematologic indications such as SCD.

We are studying Iomab-ACT

in collaboration with Memorial Sloan Kettering Cancer Center (“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 study of its kind to use an ARC, with CAR-T therapy.

At the 2024 Tandem Meetings | Transplantation

& Cellular Therapy Meetings of ASTCT and CIBMTR, we presented results from the ongoing Phase 1 trial.

No patients (0/4) developed

Immune Effector Cell-Associated Neurotoxicity Syndrome (“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 cytokine

release syndrome (“CRS”) as outlined in the table below.

Minimal CRS and ICANS

in Iomab-ACT Pilot Trial

Additionally, 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.

These results prompted us to explore additional clinical trials with Iomab-ACT.

In May 2024, we announced

FDA acceptance of an IND for a new Phase 1b/2 clinical trial that will study Iomab-ACT as targeted conditioning prior to patients receiving

an FDA approved commercial CAR-T therapy.

This is an investigator sponsored trial conducted at the University of Texas Southwestern (“UTSW”).

To our knowledge, this will be the first trial to study a targeted radiotherapy conditioning agent with a commercial CAR-T therapy.

the robust clinical data that exists with commercial CAR-T therapies, we believe this trial may demonstrate the potential for Iomab-ACT

to improve outcomes over current chemotherapy conditioning regimens, which we are seeking to replace and provide patients better access

This trial will enroll up to 30 patients and we expect to commence patient enrollment of this study in the first half of 2025

and generate proof of concept clinical data by year end 2025.

The primary objectives are safety, tolerability and efficacy.

objectives will evaluate incidences of CRS and ICANS as well as the persistence and expansion of CAR-T cells, which has been associated

with improved efficacy and patient outcomes.

If successful, we believe this Phase 1b/2 trial could support a pivotal trial, which could

be initiated as early as 2026.

In July 2024, we announced

a program for Iomab-ACT focused on providing patients with sickle cell disease broader access to cellular therapies including bone marrow

transplant and gene therapies.

We also announced in July 2024 the FDA clearance of an IND for an investigator led clinical trial to study

Iomab-ACT as targeted conditioning prior to a BMT for patients with SCD in collaboration with Columbia University.

Sickle cell disease

is a rare, debilitating and life-threatening blood disorder with significant unmet need that affects approximately 100,000 people in the

Patients with sickle cell disease have a mutation that causes red blood cells to develop a crescent or “sickle” shape,

which restrict the flow in blood vessels and limit oxygen delivery to the body’s tissues, leading to severe pain and organ damage

called vaso-occlusive events (“VOEs”) or vaso-occlusive crises (“VOCs”).

The recurrence of these events or crises

can lead to life-threatening disabilities and/or early death.

A BMT is a potentially curative treatment option for patients with sickle

cell disease, particularly in pediatric patients who have had complications such as strokes, acute chest crises or recurring pain crises

due to their disease.

We expect patient enrollment for the Phase 1 trial to commence in the first half of 2025 and enroll up to 15 patients

with initial safety and efficacy results from the initial cohort of patients receiving Iomab-ACT prior to a BMT for their SCD in the second

half of 2025.If safety is demonstrated, the trial is expected to inform a clinical trial to evaluate Iomab-ACT as a targeted conditioning

agent prior to gene therapy for which there are two approved agents for patients with sickle cell disease, Casgevy (Vertex Pharmaceuticals,

Inc.) and Lyfgenia (Bluebird Bio, Inc.).

Iomab-ACT Clinical Trials

and Objectives

We plan to continue

to develop Iomab-ACT based on early promising results, ultimately with the value proposition of improving overall access and outcomes

for patients who need cellular or gene therapies.

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.

February 2023, Actinium announced that the SIERRA trial met the primary endpoint with statistical significance, as 22% of patients (13/76)

on the Iomab-B arm achieved dCR compared to 0% of patients (0/77) on the control arm resulting in a p-value of <0.0001.

trial met the secondary endpoint of Event-Free Survival (“EFS”) with a 78% reduction in the probability of an event (Hazard

Ratio=0.22, p<0.0001 for both per protocol and ITT basis).

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

In the SIERRA trial, an event was defined as one of the following:

a patient not achieving CR/CRp or crossing over, patient not

receiving BMT, a patient relapsing or death.

The SIERRA trial did not, however, meet the secondary endpoint in achieving a statistically

significant improvement in OS in the intent to treat (“ITT”) population.

August 5, 2024, Actinium announced that it concluded both its clinical and Chemistry, Manufacturing and Controls (“CMC”) interactions

with the FDA regarding the BLA pathway for Iomab-B based on the SIERRA trial results.

As previously disclosed, we had received positive

feedback from the FDA regarding our CMC package for Iomab-B and were also assigned a BLA number.

However, in the third quarter of 2024,

the FDA provided definitive feedback that the SIERRA trial alone is not adequate to support a BLA filing for Iomab-B, despite (a) the

SIERRA trial meeting the primary endpoint of dCR with statistical significance (p-value<0.0001) and other positive secondary endpoints

including Event Free Survival (“EFS”) and safety, and (b) our presentation of several additional analyses from the SIERRA

study, including long-term follow-up demonstrating a trend towards improved overall survival and evidence of survival benefit in patients

with high-risk TP53 mutations, to support Iomab-B’s impact on overall survival.

The FDA indicated that demonstrating an overall

survival benefit in a randomized head-to-head trial is necessary and has advised us to conduct a study to evaluate allogeneic BMT using

Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation (“Flu/TBI”) versus allogeneic

BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI.

This proposed additional study differs from the SIERRA

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

Additionally,

the proposed new study will not allow patients to cross over from the control arm, which was allowed in the SIERRA trial and confounded

the overall survival analysis in the ITT patient population, as nearly 60% of patients crossed over from the control arm.

continued interactions with the FDA in the third quarter of 2024 to further discuss the specifics of the additional head-to-head clinical

trial required by the FDA, including the patient population, which the FDA had suggested could include all adult AML patients.

fourth quarter of 2024, Actinium conducted a further meeting with the FDA.

Based on this meeting, Actinium believes it has aligned with

the FDA on the patient population for a head-to-head Phase 3 clinical trial to further evaluate allogeneic BMT using Iomab-B plus a reduced

intensity conditioning regimen of Flu/TBI versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus

Flu/TBI in all adult patients aged 18 and above with active AML with blasts counts greater than 5% and less than 20%.

This is a broader

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

Further, the FDA now

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

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

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

We are actively seeking a strategic partner

for Iomab-B in the U.S.

to advance the head-to-head clinical trial or other clinical development activity for Iomab-B.

On April 7, 2022, we entered

into a License Agreement with Immedica Pharma AB (“Immedica”), pursuant to which Immedica licensed the exclusive product rights

for commercialization of Iomab-B in certain countries in the EUMENA region.

Upon signing, we were entitled to an upfront, non-refundable

payment of $35.0 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement, we are eligible to receive

certain regulatory and commercial milestone payments and royalties on net sales of the product in certain countries that may result from

the License Agreement.

Immedica is responsible for regulatory submissions in the EUMENA region, and we continue to retain commercialization

rights in the U.S.

and rest of the world.

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

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.

I-131 is a beta- and gamma-emitting radioisotope that works on the cell surface and does not need to be internalized.

Developed at the

Fred Hutchinson Cancer Research Center (“FHCRC”), Iomab-B has been studied in multiple disease indications including leukemias,

lymphomas, MDS, and MM.

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 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

Our Actimab-A ( 225 Ac-lintuzumab

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

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

There is no known resistance mechanism

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 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 and Walter.

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

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 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

We are conducting a Phase 1/2 multi-center trial combining Actimab-A

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

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 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

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, 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;

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

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 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.

R&D and Platform Technology

Our R&D capabilities have

the potential to yield differentiated, high-value targeted radiotherapy 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 have internal R&D capabilities with our research laboratory capable

of executing in vitro and in vivo experiments and translational research.

We are working on several preclinical programs which include

novel approaches to validated cancer targets, as well as novel targets that we believe 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.

We currently believe that our targeted radiotherapies,

which utilize biologic molecules, 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 our Actimab-A

and Iomab-B programs both have, for only one rare disease or condition will be excluded from the IRA's price negotiations requirements

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

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

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

In addition, regulatory barriers for generic large molecule

biologic based targeted radiotherapies are much higher than for small molecule radioligands such as those under development or approved,

namely, Pluvicto ® , Lutathera ® , and Xofigo ® .

Generic versions of certain radiopharmaceuticals

utilizing peptides, which are considered small molecules, have been submitted to the FDA via the ANDA pathway.

To our knowledge, only

the biosimilar approach pertains to large molecule biologic-based radiotherapies filed under 351(k) BLA pathway.

The regulatory pathway

for a biosimilar is much more comprehensive than the pathway for generics, and it has not been proven that biosimilars are interchangeable

with the innovator’s large molecule biologic targeted radiotherapy.

In addition, we are not aware of any regulations that would

require us to provide Actimab-A or Iomab-ACT, including their respective mAbs, lintuzumab and apamistamab, to any third party or potential

Despite the above, we are aware that one or more of the policies or regulations that afford our pipeline candidates

market protections may change in the future and that one or more of pour product candidates may be disadvantaged by such change.

We seek to expand our capabilities

1 unchanged sentence

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

Our R&D efforts are centered on the advancement of key programs with

a robust “fast-to-clinic” approach.

Underpinning our development programs is our expanded patent portfolio of approximately

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 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.

Our Proprietary Ac-225 Cyclotron Manufacturing

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.

Importantly, the Ac-225 material produced by

our proprietary method contains no long-lived contaminants and less than 0.001% Actinium-227 (“Ac-227”).

Using the cyclotron-produced

Ac-225 technology may allow for large commercial scale production with estimated cost of goods sold including capital expenditures and

operational costs for a single cyclotron facility to be several times less expensive than the price of currently available Ac-225 material.

Demonstrated Radiochemical Equivalence

Actinium’s cyclotron-produced

Ac-225 from a Th-229 generator

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

End-to-end solution including processing and recycling of Radium-226 starting material

Production 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.

Expected cost 10 to 20 times lower than currently available material

Radiochemical purity > 99%

Radioisotopic purity 99.8% with no long-lived contaminants and <0.001% Ac-227

With our Ac-2225 based Actimab-A

and ATNM-400 programs 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 and potential commercial 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.

manufacturing and supply chain expertise having delivered over 500 doses for 18 clinical trials at 45 large cancer hospitals and have

never missed a dose.

We believe this experience

provides us with insights that are highly relevant to the unique manufacturing and distribution requirements of radiotherapeutics.

to the short half-life of radioisotopes, our finished drug products are shipped “hot” and must be administered within days.

Actinium has established core competencies in the process of manufacturing radiotherapeutics, coordinating with the hospital’s care

team, and delivering “just-in-time” doses.

We plan to establish our own

manufacturing capabilities and intend to commence the build-out of a facility in the second quarter of 2025.

We believe that having in-house

manufacturing will provide enhanced control, flexibility and scalability to serve our current and planned clinical trials and R&D

efforts as well as potential future activity.

Isotope supply is critical

1 unchanged sentence

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.

We also have multiple isotope supply agreements and qualified vendors in place to supply isotopes for our

active and planned clinical trials.

In March 2025, we announced that we entered into Ac-225 supply agreement with Eckert & Ziegler,

a leading specialist in isotope-related components for nuclear medicine and radiation therapy, to support our comprehensive development

including U.S.

and international clinical trials.

Actinium has commercial agreements

1 unchanged sentence

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.

Our finished drug product CDMOs are located in the U.S.

and have 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.

We have established an actively managed end-to-end

supply chain that encompasses isotope sourcing through drug administration at the point of care to execute our clinical trials.

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.

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.

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 2025, our patent

portfolio is comprised of over 230 issued patents and pending patent applications worldwide, which we believe constitutes a valuable business

portfolio is comprised of approximately 230 issued patents and pending patent applications worldwide, which we believe constitutes a valuable

business asset.

Our IP includes 47 patent families, including key patents that relate primarily to our radiotherapeutic candidates.

portfolio includes 15 issued patents and 52 pending patent applications in the U.S., and 166 that are issued or pending internationally.

patent 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.

For our Iomab-B product candidate, we have four issued patents

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.

1 unchanged sentence

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.

Strategic Collaborations and Licensing Agreements

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 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.

and international pending patent applications that relate to the use of Iomab-B or Iomab-ACT in the treatment of cancers and non-malignant

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 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.

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.

The biopharmaceutical industry

is extremely competitive and rapidly evolving, particularly in the field of oncology and hematology drug development.

is extremely competitive and rapidly evolving, particularly in the fields of oncology, hematology and cell and gene therapy.

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.

focus on three broad areas relevant to our pipeline candidates – hematology/oncology agents, 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 pipeline.

Additionally, our competition may have more resources than we do and more experience

in drug development.

In myeloid malignancies, specifically

AML, there are a significant number of programs in preclinical and clinical development.

In addition, there are 12 approved products including

small molecules and targeted therapies.

However, to our knowledge, our Actimab-A program is the only Ac-225 based targeted radiotherapy

in clinical development for AML and myeloid malignancies.

In addition, Actimab-A is potentially synergistic with a majority of the approved

AML therapies.

AML 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

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 diseases.

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.

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.

This process generally involves the following:

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

(acquisition by AbbVie announced in November 2023) and had a collaboration

with Molecular Templates, Inc.

(ceased operations in 2024) 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.

Several companies are focused

on developing radiotherapies for solid tumors, with a majority of radiotherapy programs focused on PSMA or prostate-specific membrane

antigen in prostate cancer, neuroendocrine tumors or fibroblast activation protein (“FAP”).

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 (acquired by Novartis AG in May 2024) ), 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.

(acquired by Bristol Myers

Squibb in February 2024), Q BioMed, Inc., Scintomics, Telix, and Y-mAbs Therapeutics, Inc.

None of these or other companies that we are aware of appears to be pursuing a development program directed against

our biological target.

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.

Review Process and Product Approval

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;

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.

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.

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

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

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

As in the U.S., we are subject to post-approval regulatory

requirements.

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.

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

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.

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

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.

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 requirements.

Regulatory Considerations

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.

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.

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 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.

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.

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.

12 unchanged sentences

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.

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.

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.

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.

Human Capital

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.

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 100 Park Avenue, New York, NY 10017, and our

telephone number is (646) 677-3870.

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.

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.

of March 28, 2025, we had 37 full-time employees, 22 of whom have Ph.D.

degrees and 22 of whom are engaged in research and development

and clinical development activities.

We believe 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 continue to engage external consultants on an as-needed basis to temporarily

supplement existing staff.

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.

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