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Item 1. Business

2026-03-30 compared with 2025-03-31 · 1041 added, 1143 removed, 17 unchanged (99% of the section changed)

Description of Our Business

We are a clinical-stage biopharmaceutical company pioneering the development

of targeted radiotherapies to address significant unmet medical needs in oncology.

We are focused on employing a biology-driven approach

to develop differentiated, first-in-class radiopharmaceutical therapeutics for patients with solid tumors and hematologic malignancies.

Our mission is to transform cancer treatment by delivering innovative radioconjugates that maximize therapeutic efficacy while minimizing

toxicity to healthy tissue by combining our deep understanding of tumor biology and translational medicine with our expertise in radiochemistry.

Since our inception, we

have focused on developing innovative and differentiated radiotherapies.

Our pipeline of both early and later stage development

programs is a testimony to our approach in three areas with:

(1) two novel solid tumor product candidates, ATNM-400 and Actimab-A,

with pan-tumor potential, (2) Actimab-A, which is also being developed as a therapeutic backbone for acute myeloid leukemia (AML)

and myelodysplastic syndrome (MDS) in partnership with the National Cancer Institute (NCI), and (3) two targeted conditioning

agents, Iomab-B for bone marrow transplant and Iomab-ACT for cell & gene therapies.

Our solid tumor asset, ATNM-400, targets a

novel, antigen which does not target PSMA, with demonstrated pre-clinical activity across metastatic castration-resistant prostate

cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer.

Actimab-A, targets myeloid derived suppressor cells

(MDSC’s) and is being studied in multiple solid tumors in combination with immune checkpoint inhibitors where MDSC’s are

known to act as an efficacy deterrent for these agents.

Our hematology franchise includes:

Actimab-A, a CD33-targeted therapy;

well as, Iomab-B and Iomab-ACT which are CD45-targeting conditioning agents.

Both Actimab-A and Iomab-B are Phase 2/3 ready assets and are

supported by extensive validation in over 15 clinical trials in which more than 500 patients were treated.

radiopharmaceutical therapeutics market has experienced significant growth and validation in recent years.

The FDA approval s of

Pluvicto ® (177Lu-PSMA-617) for prostate cancer and Lutathera ® (177Lu-DOTATATE) for gastroenteropancreatic

neuroendocrine tumors (GEP-NETs) ha ve demonstrated the transformative potential of targeted radiotherapy.

Pluvicto ® is the first radiopharmaceutical to achieve blockbuster status and generated approximately

$2 billion in sales in 2025 and is forecast by its sponsor Novartis to reach peak sales of $5 billion.

Lutathera® is also

forecasted to attain blockbuster status by Novartis.

Many companies have entered the space, perhaps attracted by the success

of the aforementioned products and also the acquisitions of several companies in recent years.

However, most companies have focused on

just a handful of targets.

Consequently, we believe the radiopharmaceutical field remains in its early stages despite the number of companies

now developing radiotherapies.

This is apparent as a majority of the radiotherapy industry development pipeline is clustered around a

handful of biological targets with most companies focused on prostate-specific membrane antigen (PSMA), somatostatin receptor type 2 (SSTR2)

antagonists/agonists and variations on the theme (NSTR2, NSTR3, etc), and fibroblast activation protein (FAP).

Each of these targets features

multiple programs using different targeting moieties including but not limited to peptides, small molecules, antibodies as well as various

isotope payloads including beta emitters like Lutetium-177 and alpha emitters such as Actinium-225 and Lead-212.

In contrast, we see a significant opportunity to broaden the patient populations benefiting from targeted radiopharmaceuticals by coupling

our understanding of tumor biology and translational medicine with our expertise in radiochemistry to develop novel programs against differentiated

targets with multi-indication potential.

From 2013 to 2023, there was approximately $17 billion in high-value mergers and acquisitions

focused on radiopharmaceutical assets, capabilities and infrastructure.

Six major pharmaceutical companies have a established radiotherapy

presence via acquisitions, resulting in approximately 300,000 square feet of radiopharmaceutical manufacturing infrastructure which is

largely underutilized as there are just three approved radiopharmaceutical therapeutics.

Since 2024, there has been $8 billion in strategic

investments and licensing transactions specifically targeting assets that offer novelty and differentiation in the radiotherapy space.

We believe this activity demonstrates both the validation of radiotherapies as a viable treatment modality and the larger companies urgent

need for truly differentiated assets to fill their pipelines.

Our Competitive Strengths

We believe we are well-positioned to capitalize on the radiopharmaceutical

opportunity based on the following competitive strengths:

Biology-Driven Approach to Radiopharmaceutical Development

biology first approach to identify targets that are implicated in underlying tumor biology, disease

progression and/or treatment resistance.

In doing so, we believe our targeted radiotherapies are

differentiated from the rest of the radiopharmaceutical industry pipeline and have first-in-class potential.

The recent acquisitions and

licensing transactions in the radiopharmaceutical field have been driven by novel assets and platforms beyond targets such as PSMA, SSTR

To our knowledge, ATNM-400 and Actimab-A MDSC are the only radiopharmaceuticals in development pursuing their respective targets

and indications.

Similarly, Actimab-A , Iomab-B and Iomab-ACT, are the only CD33 and CD45 targeting

radiotherapies in clinical development to our knowledge.

We will continue to identify and evaluate novel radiopharmaceutical assets leveraging

our biology-driven methodology.

Differentiated, First-in-Class Pan-Tumor Programs Addressing Large

Solid Tumor Indications

Our pipeline features multiple

first-in-class programs targeting novel antigens not currently addressed by existing radiopharmaceutical platforms.

ATNM-400 represents

a differentiated approach in prostate cancer by targeting a non-PSMA antigen, potentially addressing patients who do not respond to or

progress after PSMA-targeted therapy such as Pluvicto®, as well as enabling earlier line combinations with androgen receptor pathway

inhibitors (ARPIs).

With demonstrated pre-clinical efficacy across prostate cancer, NSCLC, and breast cancer, ATNM-400 has pan-tumor potential

addressing a combined patient population exceeding 800,000 in the United States.

Our pre-clinical data demonstrate that ATNM-400 outperformed

leading approved therapies by 3-5 fold in EGFR-mutant NSCLC models as a monotherapy in terms of tumor growth inhibition, produced cures

in combination with Tagrisso®, and achieved complete tumor regression in combination with Herceptin® in HER2-resistant breast

cancer models.

Actimab-A represents another differentiation

opportunity through its mechanism of depleting CD33+ MDSCs , potentially unlocking synergy with PD-1

checkpoint inhibitors such as Keytruda® and Opdivo® in MDSC-rich solid tumors.

This approach

addresses a well-documented mechanism of PD-1 resistance, with clinical data demonstrating that high MDSC levels correlate with poor outcomes

on PD-1 therapy.

This positions Actimab-A to potentially expand the $40+ billion PD-1 inhibitor market.

De-Risked Late-Stage Hematology Franchise with Near-Term Partnership

Our hematology programs are supported by extensive clinical validation

and represent potential near-term value creation opportunities.

Iomab-B has been evaluated in over 500 patients across multiple clinical

trials and has received FDA alignment on a Phase 2/3 trial design in an expanded relapsed/refractory (R/R) AML patient population.

program benefits from composition of matter patents extending into 2037, an existing network of 24 clinical sites with continued interest

from the Study of Iomab-B in Elderly Relapsed Refractory AML (SIERRA) trial, and potential market expansion across six disease indications

representing approximately 150,000 addressable patients who can benefit from improved bone marrow transplant conditioning.

Actimab-A has demonstrated what we believe to be compelling clinical

data in combination with CLAG-M chemotherapy, achieving high rates of measurable residual disease (MRD) negativity and improved survival

outcomes in high-risk R/R AML patients.

In Phase 1b clinical trials, patients treated with Actimab-A plus CLAG-M achieved a 24-month median

overall survival among the 70% who proceeded to bone marrow transplant, comparing favorably to the less than 2-4 month overall survival

typically observed in TP53-positive or prior venetoclax-treated patient populations.

We have received FDA alignment on Phase 2/3 trial

design for Actimab-A in combination with CLAG-M for R/R AML patients and are actively seeking strategic partnerships to advance these

The targeted conditioning franchise,

including Iomab-B for bone marrow transplant and Iomab-ACT for cell and gene therapies, addresses the fundamental challenge of establishing

donor cell engraftment while reducing toxicities associated with traditional chemotherapy based myeloablative

conditioning regimens.

Iomab-ACT has the potential to serve as a universal conditioning agent, improving patient access and outcomes for

CAR-T and other cell therapies, with three active clinical trials currently underway.

End-to-End Supply Chain and Demonstrated

Ability to Execute Complex Clinical Trials

Our clinical assets have been studied in over 500 patients to date

and we have executed multiple Phase 1 – 3 clinical trials across our Actimab-A, Iomab-ACT and Iomab-ACT programs.

In doing so, we

have established and actively managed an end-to-end supply chain that encompasses sourcing of radioisotopes, manufacturing targeting agents,

production of final drug product candidates and their delivery to the point of care.

We believe our demonstrated ability to execute radiopharmaceutical

trials at approximately 50 treatment centers including leading comprehensive cancer centers can be leveraged for our ongoing and planned

clinical development efforts.

We executed a phase 3 trial of Iomab-B which utilized extremely high doses of Iodine-131 (I-131) which required

specialized handling.

Additional operational parameters included the need for patient isolation in a transplant setting which added to

the complexity of the trial yet the company successfully executed the trial without missing a single dose.

We are exploring improved methods for efficiently generating quality clinical data by working with centers of excellence both in and outside

the United States.

We believe these capabilities

have strategic value to enable the successful and timely clinical execution of our own planned trials for product candidates we may in-license,

partner or acquire.

Vertically Integrated Capabilities and Infrastructure

We are in the process of establishing comprehensive end-to-end capabilities across the radiopharmaceutical value chain.

We have invested

in establishing an operational radiopharmaceutical manufacturing facility expected to be commissioned in 2H:2026, which will provide clinical

supply capabilities by year-end.

This facility, combined with our established distribution network to approximately 50 leading hospitals

and multiple redundant isotope supply agreements, positions us to serve patient demand at scale.

Our proprietary cyclotron-based Ac-225

production technology for which we are seeking a partnership, can help us secure reliable isotope supply at commercial scale via an internal

back-up source.

We believe our manufacturing process achieves radiochemical purity equivalent to the gold-standard thorium decay method

without generating long-lived radioactive contaminants.

We have demonstrated leading-edge pre-clinical radiochemistry and translational

biology capabilities that enable rapid advancement from target selection through clinical development.

This vertical integration provides

us with significant strategic flexibility and insulates us from supply chain disruptions that have historically challenged radiopharmaceutical

Strong Intellectual Property Position

We have built an intellectual

property portfolio comprising approximately 250 issued patents and pending patent applications, including critical composition of matter

patents, method of use patents, and proprietary Ac-225 production technology.

Our intellectual property estate provides extensive protection

for our product candidates and platform technologies across major global markets, with issued and pending patent coverage over key programs.

We believe our IP position creates substantial barriers to entry and positions our assets as attractive opportunities for strategic partnerships

and out-licensing.

Our goal is to establish Actinium as

a leading, fully integrated targeted radiotherapy company delivering transformative medicines to cancer patients.

Key elements of our strategy include:

Rapidly Advance ATNM-400 Through Clinical Development Across Multiple

We are focused on rapidly advancing

ATNM-400 into clinical development, leveraging the pre-clinical validation we have established across multiple solid tumor indications.

In mCRPC, the pre-clinical dataset demonstrating mechanistic synergy with ARPI’s such as enzalutamide, superiority to both single-agent

enzalutamide and 177Lu-PSMA-617, and strong combination activity supports the therapeutic potential in this indication.

Based on this

data, we believe ATNM-400, a non-PSMA targeting radioconjugate, demonstrates the potential to benefit patients who progress on or are

ineligible for PSMA-targeted therapy and potentially enable earlier-line combination approaches with ARPIs.

ATNM-400 also demonstrates clinical development

potential in EGFR-mutant NSCLC, where our pre-clinical data demonstrated 3-5 fold superiority compared

to approved EGFR inhibitors including osimertinib (Tagrisso ®), datopotamab deruxtecan (Dato-DXd),

and amivantamab, as well as 100% complete responses in combination with osimertinib.

We have established mechanistic rationale for this

combination through demonstrated upregulation of the ATNM-400 target following osimertinib treatment.

Furthermore, in pre-clinical

studies, both ATNM-400 monotherapy and ATNM-400 in combination with osimertinib is superior to an osimertinib combination with chemotherapy.

This positions ATNM-400 for potential development across first-, second-, and third-line EGFR-mutant NSCLC

treatment settings.

In breast cancer, we have demonstrated

efficacy across HR-positive, triple-negative breast cancer (TNBC), and HER2-resistant models, with complete tumor eradication observed

for ATNM-400 in combination with trastuzumab (Herceptin®) in trastuzumab-resistant models.

The ATNM-400 target shows increased expression

in trastuzumab-resistant tumors, providing mechanistic support for clinical development in this setting.

We believe ATNM-400 represents

a differentiated approach that can avoid the off-target toxicities such as interstitial lung disease observed with HER2 and TROP-2 antibody-drug

conjugates such as Ehertu® and Datroway®, respectively.

Establish Actimab-A MDSC in Combination with Checkpoint Inhibitors

We currently intend to conduct a basket trial evaluating Actimab-A

in combination with PD-1 inhibitors (Keytruda® or Opdivo®) across four MDSC-rich solid tumor types:

head and neck squamous cell

carcinoma (HNSCC), NSCLC, glioblastoma (GBM), and high microsatellite instability (MSI-high) colorectal cancer.

This trial, expected to

report initial data in 2H:2026, is supported by pre-clinical evidence demonstrating that Actimab-A selectively homes to and depletes tumor-resident

CD33+ MDSCs, which are primed for depletion and correlate with poor outcomes on PD-1 therapy.

Our pre-clinical data show that Actimab-A

treatment is cytotoxic to patient-derived MDSCs ex vivo and enhances T-cell responses.

The trial design includes comprehensive

biomarker assessments to evaluate MDSC depletion patterns in both tumor microenvironment and peripheral blood, as well as T-cell activity

We will compare clinical outcomes including objective response rate (ORR), progression-free survival (PFS), and overall survival

(OS) against real-world data comparators.

Success in this trial could position Actimab-A as a foundational combination partner for checkpoint

inhibitors across multiple solid tumor indications.

In addition, we are evaluating the potential for further clinical evaluation of Actimab-A

in patients with GBM and NSCLC with other PD-1 inhibitors.

GBM has a unique microenvironment in which ~40% of the glioma mass is comprised of tumor associated myeloid (TAM’s) cells which

play an important role in immunosuppression and inhibition of anti-tumor responses.

Selective eradication of these TAM’s which express

CD33 within the GBM tumor microenvironment with Actimab-A has the potential to enhance anti-tumor T-cell immunity thereby increasing the

effectiveness of immunotherapies for the treatment of GBM.

Execute Strategic Partnerships for Late-Stage Hematology Programs

We are actively seeking strategic partnerships to advance our Phase

2/3-ready hematology programs, Actimab-A and Iomab-B.

These programs benefit from substantial clinical validation, clear regulatory pathways

following FDA alignment, and concentrated commercial markets focused on approximately 100 quaternary care centers in the United States

The complementary nature of these programs—spanning AML/MDS therapeutics and targeted conditioning for bone marrow transplant

and cell/gene therapies—creates strong commercial synergies and represents blockbuster market opportunities.

Our partnership strategy prioritizes collaborations that can provide

the resources and infrastructure necessary to execute global pivotal trials while preserving meaningful economics for Actinium.

leveraging our existing relationship with the National Cancer Institute (NCI), which has established a Cooperative Research and Development

Agreement (CRADA) supporting Actimab-A development, to advance clinical programs in a cost-effective manner while retaining commercial

Build Fully Integrated cGMP Manufacturing and End-to-End Supply Chain

We are completing construction

of our internal cGMP radiopharmaceutical manufacturing facility, which is being designed to manufacture Ac-225 based radioconjugates and

provide drug product manufacturing to support clinical trials.

This facility, expected to be operational in 2H:2026, will complement our

established network of hospital administration sites and isotope suppliers.

Our hybrid internal-external manufacturing strategy is designed

to provide supply reliability, cost efficiency, and geographic flexibility to serve global patient populations at commercial scale.

addition, we will opportunistically seek partnerships to manufacture Ac-225 utilizing our patented cyclotron production technology.

Continue Platform Innovation and Pipeline Expansion

We are committed to continued innovation

in radiopharmaceutical discovery and development.

Our proven track record of generating highly differentiated programs positions us to

expand our pipeline through both internal discovery efforts and potential strategic acquisitions of complementary assets or technologies.

We maintain rigorous criteria for program advancement, requiring demonstration of clear differentiation, compelling pre-clinical

validation, and significant market opportunities before committing substantial resources to clinical development.

Solid Tumor Programs

First-in-Class Pan-Tumor Radiotherapy

ATNM-400 is our lead solid tumor program,

representing a first-in-class Ac-225 antibody radioconjugate targeting a novel, undisclosed, non-PSMA targeting antigen with expression

across multiple solid tumor types.

The ATNM-400 target is implicated

in disease biology during tumor progression and is also overexpressed when tumors become resistant

to many approved therapies in multiple solid tumors.

Our pre-clinical translational

data demonstrated that ATNM-400 is superior to:

● PSMA-targeted agents or ARPI’s in the mCRPC

setting of prostate cancer

● EGFR inhibitors (osimertinib), TROP-2 ADC (Dato-Dxd), and EGFR-cMET

bispecific (amivantamab) in EGFR-mutant NSCLC, and to

● HER2-therapy (trastuzumab) in HER2-resistant

breast cancer and endocrine therapy (tamoxifen) in tamoxifen-resistant breast cancer.

These data show that ATNM-400 works well as monotherapy but is even

better in combination in resistant settings where the target is overexpressed as part of the resistance mechanism.

Evidence of target

expression has been observed ranging from 60%-80%+ in mCRPC, NSCLC, and breast cancer patient tumors, representing a significant addressable

population of over a hundred thousand patients in the United States based on our existing datasets.

This number may expand as we continue

our work to demonstrate the potential of ATNM-400 in various additional disease and treatment settings.

Our pre-clinical development program has generated robust efficacy

and mechanism-of-action data across multiple indication-specific animal models:

Prostate Cancer:

ATNM-400 demonstrated

specific tumor uptake and decreased tumor cell proliferation in pre-clinical models, with significantly

greater efficacy than both 177Lu-PSMA-617 (the active agent in Pluvicto ®) and next-generation

225Ac-PSMA-617 in PSMA-low 22Rv1 prostate cancer xenograft models that are resistant to ARPI therapy.

Importantly, ATNM-400 also demonstrated superior efficacy to enzalutamide

and 177Lu-PSMA-617 in ARPI-resistant prostate cancer models, with strong and durable combination activity when combined with enzalutamide.

This combination activity is mechanistically supported by our observation that enzalutamide resistance increases ATNM-400 target expression

in both prostate cancer models and mCRPC patient samples.

data support ATNM-400 development in post-Pluvicto® and post-ARPI patient populations.

Between 45,000 to 55,000 patients will progress

on ARPI in the mCRPC and metastatic hormone sensitive prostate cancer (mHSPC) settings annually.

With a potential of Pluvicto®

approval in mHSPC based on the Phase 3 PSMAddition study, the number of eligible patients nearly doubles from 44,000 patients in the

mCRPC population to 86,500 patients in both mHSPC and mCRPC.

Given that the response rates for Pluvicto® in the VISION and PSMAfore

population are approximately 30% and 50%, respectively, a significant proportion of patients remain with few options following treatment.

Additionally, Pluvicto® refractory patients will receive as few as 2 cycles if no response is observed.

The mechanistic synergy with

ARPIs also supports potential expansion to earlier treatment lines in combination with standard-of-care hormonal therapies, representing

an addressable population exceeding 100,000 patients across all lines of treatment in the mCRPC and mHSPC settings.

EGFR-Mutant NSCLC:

ATNM-400 demonstrated 3-5 fold greater tumor growth

inhibition compared to approved EGFR-targeted therapies including osimertinib (first-line), datopotamab deruxtecan (second-line), and

amivantamab (third-line) in NCI-H1975 human lung cancer models harboring L858R and T790M EGFR mutations.

In combination with osimertinib, ATNM-400 achieved 100% complete responses

with durable efficacy extending throughout the study period.

We have established mechanistic support for ATNM-400 combinations with

EGFR inhibitors, demonstrating that osimertinib treatment increases ATNM-400 target expression both in vitro and in vivo.

This mechanistic

synergy, combined with clinical data showing improved outcomes when osimertinib is combined with external beam radiotherapy, supports

ATNM-400 development across multiple EGFR-mutant NSCLC treatment settings.

NSCLC represents approximately 30 ,000 U.S.

patients annually, with current treatment dominated by

AstraZeneca’s Tagrisso ® (osimertinib) and Johnson & Johnson’s Rybrevant ®

(amivantamab) combinations.

ATNM-400 offers a novel EGFR inhibitor plus radiotherapy combination approach

with potential differentiation across first-, second-, and third-line settings.

Additionally, given tumor cell apoptosis driven by the

irreversible double-stranded DNA damage from actinium-225, ATNM-400 could potentially provide benefit for the approximately 200,000 NSCLC

patients diagnosed annually regardless of oncogenic driver mutation.

Breast Cancer:

ATNM-400 demonstrated

robust anti-tumor activity and tumor regression as monotherapy and in combination with trastuzumab in pre-clinical breast

cancer models, including trastuzumab-resistant BT474-Clone5 model, HR+ breast cancer MCF-7 model and triple-negative breast cancer

(TNBC) and triple-negative MDA-MB-468 model .

In the trastuzumab-resistant

setting, we observed increased expression of both the survival pathway marker p-AKT and the ATNM-400 target, with ATNM-400 treatment inducing

DNA double-strand breaks as measured by p-H2AX staining.

ATNM-400 achieved 66% tumor growth inhibition as monotherapy and 103% tumor growth

inhibition (representing tumor regression) in trastuzumab-resistant models.

The ATNM-400 target is overexpressed in breast cancer, including tumors

resistant to endocrine therapies such as tamoxifen and HER2-targeted therapies, as well as in TNBC.

We believe that this broad expression pattern supports multi-lineage

development in breast cancer.

Current second-line therapies in HER2-positive disease, including trastuzumab deruxtecan and sacituzumab

govitecan, are limited by off-target toxicities including interstitial lung disease.

ATNM-400 represents a novel therapeutic approach

designed to avoid these toxicity concerns while providing efficacy across HR-positive, HER2-resistant, and TNBC patient populations representing

approximately 300,000 U.S.

patients annually.

We have developed a theranostic strategy utilizing Zr-89 as a companion

imaging agent to enable patient selection and tumor visualization.

This approach allows for non-invasive assessment of target expression

and drug biodistribution prior to therapeutic administration, potentially enhancing the therapeutic index by selecting patients most likely

Success in our clinical program could position ATNM-400 as a differentiated

pan-tumor targeted radiotherapy across multiple large solid tumor indications, potentially addressing the several hundred thousand U.S.

patients with mCRPC, EGFR-mutant NSCLC, and all sub-types of breast cancer, while also establishing a first-in-class radioconjugate with broad combination potential and

attractive partnership and commercial potential in the rapidly growing radiopharmaceutical market.

Actimab-A for MDSC’s:

Novel Immunomodulatory Approach in Solid

Actimab-A (lintuzumab-Ac-225) is a CD33-targeted Ac-225 radioconjugate

that we are developing to enhance checkpoint inhibitor efficacy by depleting immunosuppressive CD33+ MDSCs in the tumor microenvironment.

MDSCs are a heterogeneous population of immature myeloid cells that

accumulate in solid tumors and suppress anti-tumor T-cell responses, representing a well-validated mechanism of resistance to PD-1/PD-L1

checkpoint inhibitors.

Clinical studies have demonstrated that patients with high circulating MDSC levels have significantly reduced progression-free

and overall survival on PD-1 therapy compared to patients with low MDSC levels.

Low MDSC’s Associated with Statistically Significant

Improvement in PFS and OS

1) Bronte et al.

High Levels of Circulating Monocytic Myeloid-Derived

Suppressive-Like Cells Are Associated With the Primary Resistance to Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer:

An Exploratory Analysis https://pmc.ncbi.nlm.nih.gov/articles/PMC9043492/.

Frontiers in Immunology.

2022 Apr 13;13:866561

Our pre-clinical studies

have demonstrated that Actimab-A:

(1) selectively homes to tumor-resident CD33+ MDSCs in vivo;

(2) is cytotoxic to patient-derived MDSCs

and (3) rescues T-cell proliferation and anti-tumor immune responses ex vivo following MDSC depletion.

These data provide mechanistic

support for combining Actimab-A with PD-1 inhibitors to overcome MDSC-mediated resistance.

We intend to conduct a Phase 1b basket

trial evaluating Actimab-A in combination with pembrolizumab (Keytruda ®) or nivolumab (Opdivo ®)

in patients with R/R locally advanced or metastatic HNSCC, NSCLC, GBM, and MSI-high colorectal cancer.

tumor types were selected based on high MDSC infiltration and limited response rates to PD-1 monotherapy.

The trial design incorporates

comprehensive correlative biomarker assessments to evaluate MDSC depletion in both tumor microenvironment and peripheral blood, as well

as T-cell activity restoration.

Patients enrolled in the trial

must have MDSC-rich tumor types, be checkpoint inhibitor-naïve, be at least 18 years of age, and demonstrate PD-1/PD-L1 expression.

Primary endpoints include safety and tolerability of the combination, with secondary endpoints including ORR, PFS, and OS.

Biomarker endpoints

will evaluate the pattern of CD33+ MDSC depletion and T-cell activity in both tumor tissue and peripheral blood samples.

Clinical outcomes

will be compared against real-world data from similar patient populations treated with PD-1 monotherapy.

We expect to report initial data

from this trial in 2H:2026.

In addition, we are also evaluating clinical opportunities with other immune checkpoint inhibitors in GBM

We believe that success in this trial could position Actimab-A for

development across multiple solid tumor indications in combination with checkpoint inhibitors, potentially expanding the utility of the

$40+ billion PD-1/PD-L1 inhibitor market by addressing MDSC-mediated resistance.

Hematology Programs

Backbone Therapy for AML and MDS

In hematologic malignancies, we are developing

Actimab-A as a mutation-agnostic backbone therapy for AML and high-risk MDS.

CD33 is expressed on leukemic blasts in the majority of AML

patients and represents an established therapeutic target validated by the approval of gemtuzumab ozogamicin (Mylotarg ®).

antibody-drug conjugates like Mylotarg ® have limitations including hepatotoxicity and limited

efficacy in certain patient populations.

Actimab-A, delivering the highly potent alpha-emitter Ac-225 to CD33+ cells, represents a differentiated

approach designed to provide superior efficacy while maintaining a favorable safety profile.

Actimab-A in combination with

CLAG-M for R/R AML:

We have completed a Phase 1b clinical trial evaluating Actimab-A in combination with CLAG-M chemotherapy in R/R AML

patients , results of which were published in a peer-reviewed journal Leukemia in February 2025.

trial enrolled high-risk patients including those with TP53 mutations, prior venetoclax treatment failure, and patients who had

prior allogeneic transplant.

Results demonstrated high rates of MRD-negative complete remissions and improved

survival outcomes compared to historical controls.

Among patients treated with Actimab-A

plus CLAG-M, 70% of those deemed eligible for transplant proceeded to bone marrow transplant, and

this population achieved a 24-month median overall survival.

These results compare highly favorably to published data showing less than

2-4 month median overall survival in TP53-mutated or prior venetoclax-treated R/R AML patient populations.

The combination was well-tolerated

with a safety profile consistent with CLAG-M chemotherapy alone and no dose-limiting toxicities observed.

Based on these results, we have received FDA alignment on a Phase 2/3

trial design to evaluate Actimab-A plus CLAG-M in first or second salvage R/R AML patients.

We are currently actively seeking a strategic partner to execute this

The trial design allows for enrollment of a broad R/R AML population while enriching for patients most likely to benefit based

on Phase 1b results.

Actimab-A Development Programs:

Beyond R/R AML, we are developing Actimab-A in conjunction with the NCI across multiple AML and MDS treatment settings and exploring its

potential in additional areas:

● Frontline AML Triplet Combination:

Evaluating Actimab-A as a backbone therapy in combination with standard induction regimen of venetoclax and a hypomethylating

agent in newly diagnosed AML patients.

This mutation-agnostic approach could provide benefit across the

broad frontline AML population.

● Combination with Targeted Therapies:

Developing Actimab-A

combinations with FLT3 inhibitors, IDH1/2 inhibitors, and menin inhibitors in genomically-defined AML patient subsets.

These combinations

leverage Actimab-A’s mutation-agnostic mechanism while potentially enhancing efficacy through complementary mechanisms of action.

● High-Risk MDS Monotherapy:

Evaluating Actimab-A as monotherapy

in high-risk MDS patients who have failed hypomethylating agent therapy, representing a patient population with very limited treatment

options and poor outcomes.

● Maintenance

The potential exists for Actimab-A as maintenance therapy following achievement of remission to prevent relapse in AML and MDS

The programs are supported

by our Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute, which enables cost-effective clinical

development while retaining commercial rights to Actinium.

We believe that success in our hematology program could establish Actimab-A

as a mutation-agnostic backbone therapy for R/R AML and high-risk MDS, addressing a combined patient population with limited treatment

options, while generating important data to support regulatory approval and to enable a strategic partnership to commercialize Actimab-A

across the estimated $2+ billion AML/MDS therapeutics market.

Universal Conditioning for Cell and Gene Therapies

Iomab-ACT is our CD45-targeted conditioning platform being developed

as a universal conditioning agent to improve access and outcomes for cell and gene therapies, including CAR-T, allogeneic hematopoietic

stem cell transplant, and gene therapy.

The cell and gene therapy field has been limited by the need for lymphodepleting chemotherapy

conditioning, which is associated with significant toxicities and can limit the patient populations eligible for these potentially curative

Iomab-ACT is designed to provide targeted

lymphodepletion and myeloablation when necessary while avoiding the off-target toxicities associated

with chemotherapy conditioning.

By delivering targeted radiation specifically to CD45+ hematopoietic cells, Iomab-ACT aims to create an

optimal environment for therapeutic cell engraftment while minimizing treatment-related morbidity and mortality.

We currently have three active clinical trials evaluating Iomab-ACT:

● Phase 1/2 Trial in Commercial CAR-T:

Evaluating Iomab-ACT as conditioning

prior to commercial CAR-T therapy in patients with relapsed/refractory non-Hodgkins lymphoma.

This trial will assess the safety, tolerability,

and efficacy of Iomab-ACT conditioning.

The primary endpoint is engraftment and key secondary endpoints are incidence of Cytokine Release

Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) which are two potentially fatal adverse events associated

with CAR-T cell therapy.

● Phase 1 Trial in experimental CAR-T:

Evaluating Iomab-ACT

as conditioning prior to CD19 CAR-T cell therapy in patients with relapsed refractory B-cell malignancies (non-Hodgkins lymphoma, acute

lymphomablastic leukemia/lymphoma).

● Phase 1 Trial in Sickle Cell Disease BMT:

Evaluating Iomab-ACT

as conditioning for allogeneic bone marrow transplant in patients with sickle cell disease.

This trial addresses a critical unmet need

for safer conditioning regimens in non-malignant hematologic diseases.

The cell and gene therapy market represents a rapidly growing opportunity,

with over 30,000 patients annually receiving CAR-T or allogeneic transplant in the United States and Europe.

Success in these trials could

position Iomab-ACT as a universal conditioning platform applicable across multiple cell and gene therapy modalities, potentially expanding

patient access to these curative therapies while improving safety and tolerability.

Targeted Conditioning for Bone Marrow Transplant in R/R

Iomab-B (apamistamab-I-131) is a CD45-targeted radioimmunotherapy designed

to enable bone marrow transplant in R/R AML patients who are ineligible for conventional myeloablative conditioning due to age, comorbidities,

or prior treatment-related toxicities.

CD45 is expressed on all hematopoietic cells, enabling Iomab-B to deliver targeted radiation to

bone marrow while sparing non-hematopoietic organs from radiation exposure.

Conventional stem cell transplant

conditioning regimens utilize high-dose chemotherapy with or without total body irradiation to ablate the patient’s hematopoietic system

and create space for donor cell engraftment.

These regimens are associated with significant toxicities including mucositis, hepatotoxicity,

pulmonary toxicity, and treatment-related mortality.

Many elderly patients and those with comorbidities are deemed ineligible for these

intensive conditioning regimens, limiting access to potentially curative transplant therapy.

Iomab-B has been evaluated in over 500

patients across multiple clinical trials, including the Phase 3 SIERRA trial in R/R AML patients.

The SIERRA trial demonstrated that Iomab-B

enabled successful donor cell engraftment in elderly R/R AML patients who would otherwise be ineligible for conventional conditioning.

The study met the primary endpoint of durable complete remission

While the study did not meet the secondary endpoint of OS due to the cross over of two-thirds of the patients from the control

arm to Iomab-B arm , it provided important insights into optimal patient selection and trial design for future

We have received FDA alignment on a Phase

2/3 trial design in an expanded R/R AML patient population that includes all patients age 18 and older with R/R AML .

expanded population reflects learnings from SIERRA regarding optimal patient selection.

The trial design allows us to leverage both the

Phase 2 results and the SIERRA database to support regulatory submissions.

Iomab-B benefits from composition of matter patents extending to 2038,

a well-established network of 24 clinical sites from the SIERRA trial that maintains strong interest in the program, and potential for

market expansion beyond R/R AML.

Pre-clinical and clinical data support potential development in five additional disease indications including

acute lymphoblastic leukemia, myelodysplastic syndromes, chronic myeloid leukemia, multiple myeloma, and lymphoma, representing a total

addressable market of approximately 150,000 patients who could benefit from improved bone marrow transplant conditioning.

We are actively seeking a strategic partner to advance Iomab-B through

pivotal development and commercialization.

We believe Actimab-A,

Iomab-B and Iomab-ACT collectively have the potential to be successful commercial products based on the high unmet needs of their addressable

patient segments.

In total, we believe this opportunity exceeds 400,000 patients in the U.S.

Our Platform and Capabilities

Radiochemistry and Translational Science Capabilities

We have assembled a team with expertise in radiopharmaceutical discovery

and development, spanning target selection, radioconjugate design, pre-clinical evaluation, and clinical development.

Our capabilities

● Target Selection and Validation:

Comprehensive target assessment including expression profiling in tumor versus normal, binding and internalization

kinetics, and competitive landscape analysis to identify optimal targets for radiopharmaceutical development.

● Radioconjugate Design and Optimization:

Medicinal chemistry

expertise in chelator selection, linker design, and conjugation chemistry to optimize tumor uptake, retention, and biodistribution while

minimizing normal organ exposure.

● Pre-clinical Pharmacology:

vitro and in vivo models to assess binding affinity, internalization, tumor penetration, radiation dosimetry, and anti-tumor efficacy

across diverse tumor types.

● Translational Biomarkers:

Development of imaging companion

diagnostics, circulating biomarkers, and tissue-based assessments to enable patient selection and monitor treatment response.

These capabilities enable us to efficiently

advance programs from target selection through clinical development while maintaining high quality standards and generating comprehensive

translational data packages to guide clinical development and support

regulatory submissions and partnership discussions.

Ac-225 Production and Radiopharmaceutical Manufacturing

We have developed proprietary

cyclotron-based technology for commercial-scale production of Ac-225, one of the most critical bottlenecks in radiopharmaceutical development.

Our production method generates high-purity Ac-225 with radiochemical purity equivalent to the gold-standard thorium-229 decay method,

while avoiding the generation of long-lived radioactive contaminants such as Ac-227.

This production technology is protected by patents

and if operationalized may represent a significant competitive and cost advantage.

We are currently completing

construction of a radiopharmaceutical manufacturing facility designed to manufacture Ac-225-based final drug products for clinical supply.

The facility, expected to be operational in 2H:2026, incorporates purpose-built infrastructure for alpha-emitter handling and a flexible

manufacturing suite capable of supporting multiple trials.

We have also established an end-to-end supply chain spanning isotope

production through patient administration.

We maintain supply agreements with multiple redundant isotope suppliers, relationships with

multiple contract manufacturing organizations, and a distribution network to approximately 50 leading cancer centers amassed via the execution

of several Phase 1 – 3 clinical trials.

This supply chain infrastructure provides geographic coverage across major metropolitan

areas, minimizes risk of supply disruption, and positions us to reliably serve patient demand at clinical scale.

The radiopharmaceutical therapeutics field has experienced significant

growth in recent years, with numerous companies and academic institutions developing targeted radiotherapy programs.

We face competition

from several categories of organizations:

Large Pharmaceutical Companies:

major pharmaceutical companies have entered the radiopharmaceutical space through acquisitions or internal development, including Novartis

(through acquisition of Advanced Accelerator Applications and Endocyte ), Eli Lilly (through acquisition

of Point Biopharma), Bristol Myers Squibb (through acquisition of RayzeBio), AstraZeneca (through acquisition of Fusion Pharmaceuticals ),

Bayer (through acquisition of Algeta Pharmaceuticals , Noria Therapeutics, and PSMA Therapeutics),

and Johnson & Johnson.

These companies possess significantly greater financial resources, established

commercial infrastructure, and broader development pipelines than we do.

However, many of these companies are focused on PSMA-targeted

therapies for prostate cancer or SSTR2-targeted therapies for neuroendocrine tumors and have stated a need for novel differentiated assets

to expand their radiopharmaceutical portfolios.

Clinical-Stage Radiopharmaceutical Companies:

We compete with several clinical-stage companies developing novel radiopharmaceutical approaches .

A representative list of these

competitors include Telix Pharmaceuticals, Perspective Therapeutics, Clarity Pharmaceuticals, Cellectar Biosciences, Bicycle Therapeutics,

Molecular Partners, Ratio Therapeutics, Convergent Therapeutics, Aktis Oncology, Radiopharm Theranostics, and Plus Therapeutics.

is not a comprehensive list and none of these or any other radiotherapeutics company currently compete

are directly with Actinium’s product candidates in terms of biological targets.

Antibody-Drug Conjugate Companies :

Particularly solid tumors, we may compete with companies developing antibody-drug conjugates (ADCs) that

deliver cytotoxic chemotherapy payloads to tumor cells.

However, we believe radiopharmaceuticals offer potential advantages compared to

ADCs including the “crossfire” or “bystander” effect wherein alpha particles can kill neighboring tumor cells that

do not express the target antigen, potentially overcoming tumor heterogeneity.

Additionally, radiopharmaceuticals enable non-invasive

imaging to assess target expression and drug biodistribution, potentially improving patient selection.

Therapeutic Area Competitor Companies:

Several large pharmaceutical

companies are legacy areas in the therapeutic areas that our pipeline agents are being developed.

In prostate cancer, several marketed

drugs are available from Johnson & Johnson, Astellas/Pfizer, Bayer, Novartis, and AstraZeneca/Merck.

AstraZeneca, Johnson & Johnson,

Roche, and Daiichi Sankyo have approved agents in EGFR mutant NSCLC.

As for breast cancer, Roche, Pfizer, Lilly, Novartis, and AstraZeneca/Daiichi

Sankyo have therapeutics available.

AbbVie, Bristol Myers Squibb, Astellas, and Servier are primary companies with AML marketed agents.

In addition, these companies have active pipelines exploring a multitude of mechanisms of action to maintain or grow their positions in

these indications.

We believe our competitive position is differentiated by:

(1) our focus

on novel, first-in-class targets with pan-tumor potential rather than following validated targets already being pursued by multiple competitors;

(2) our vertically integrated capabilities that we intend to span isotope production through drug product manufacturing;

(3) our late-stage

hematology programs with clear regulatory pathways;

and (4) our comprehensive intellectual property position protecting our products and

platform technologies.

However, we face significant competitive

Our competitors may develop therapies that are more effective, safer, more convenient, or more cost-effective than our product

Competitors may also obtain regulatory approval before we do, establish superior market positions, or render our technologies

In the evolving landscape of targeted radiotherapies, mergers and acquisitions and collaborations can quickly reshape

the competitive landscape.

Large radiopharmaceutical companies are increasingly partnering with and acquiring small biotechnology companies

in the field to access novel pipeline agents and manufacturing capabilities for radiopharmaceutical production and development.

deals and partnerships, through increased access to capital, regulatory expertise, and global infrastructure, can expedite clinical development

timelines and hasten drug commercialization.

The radiopharmaceutical field is characterized by rapid technological

change and intense competition, and we cannot guarantee that we will be able to maintain our competitive position.

Government Regulation

United States Regulation

In the United States,

pharmaceutical products are subject to extensive regulation by the FDA.

The Federal Food, Drug, and Cosmetic Act (FDCA), and other

federal and state statutes and regulations, govern, among other things, the research, development, testing, manufacture, storage,

recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and

import and export of pharmaceutical products.

Failure to comply with applicable U.S.

requirements may subject a company to a variety

of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (NDAs) or biologics license

applications (BLAs), warning or untitled letters, product recalls, product seizures, total or partial suspension of production or

distribution, injunctions, fines, civil penalties, and criminal prosecution.

Pharmaceutical product development for a new product or certain changes

to an approved product in the United States typically involves completion of preclinical laboratory tests, animal studies and formulation

studies, all performed in accordance with the FDA’s Good Laboratory Practice (GLP) regulations, submission to the FDA of an IND which

must become effective before clinical trials may begin, adequate and well-controlled clinical trials to establish the safety and effectiveness

of the drug or biologic for each indication for which FDA approval is sought, and submission to the FDA of an NDA or BLA.

FDA review is conducted the via NDA pathway for product candidates regulated as drugs and via the BLA pathway for product candidates

regulated as biologics.

Both pathways require an IND for investigation.

Our lead product candidates are regulated as biologics.

Preclinical tests include laboratory evaluation of product chemistry,

formulation and toxicity, as well as animal trials to assess the characteristics and potential safety and efficacy of the product.

conduct of the preclinical tests must comply with federal regulations and requirements including GLPs.

The results of preclinical testing

are submitted to the FDA as part of an IND along with other information including information about product chemistry, manufacturing and

controls and a proposed clinical trial protocol.

Long-term preclinical tests, such as animal tests of reproductive toxicity and carcinogenicity,

may continue after the IND is submitted.

A 30-day waiting period after the submission of each IND is required

prior to the commencement of clinical testing in humans.

If the FDA has neither commented on nor questioned the IND within this 30-day

period, the clinical trial proposed in the IND may begin.

If the FDA raises concerns or questions about the conduct of the trial, such

as whether human research subjects will be exposed to an unreasonable health risk, the IND sponsor and the FDA must resolve any outstanding

concerns before clinical trials can proceed.

Clinical trials involve the administration of the investigational drug

to human subjects under the supervision of qualified investigators in accordance with Good Clinical Practice (GCP) requirements, which

include the requirement that all research subjects provide their informed consent in writing before their participation in any clinical

Clinical trials are conducted under protocols detailing, among other things, the objectives of the trial, the parameters to be

used in monitoring safety and the effectiveness criteria to be evaluated.

A protocol for each clinical trial and any subsequent protocol

amendments must be submitted to the FDA as part of the IND.

The FDA may order the temporary, or permanent, discontinuation of a

clinical trial at any time, or impose other sanctions, if it believes that the clinical trial either is not being conducted in accordance

with FDA requirements or presents an unacceptable risk to the clinical trial patients.

The study protocol and informed consent information

for patients in clinical trials must also be submitted to an institutional review board (IRB) for approval at each site at which the clinical

trial will be conducted.

An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure

to comply with the IRB’s requirements, or may impose other conditions.

Clinical trials to

support NDAs and BLAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

Phase 1, the drug is initially introduced into healthy human subjects or patients with the target disease or condition and tested

for safety, dosage tolerance, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its

effectiveness and to determine optimal dosage.

Phase 2 usually involves trials in a limited patient population to identify possible

adverse effects and safety risks, to determine the efficacy of the product for specific targeted diseases and to determine dosage

tolerance and optimal dosage.

Phase 3 trials are undertaken to further evaluate dosage, to provide substantial evidence of clinical

efficacy and to further test for safety in an expanded patient population at geographically dispersed clinical trial sites.

After completion of the required

clinical testing, an NDA or BLA is prepared and submitted to the FDA.

FDA approval of the NDA is required before marketing of the product

may begin in the United States.

The NDA/BLA must include the results of all preclinical, clinical and other testing and a compilation

of data relating to the product’s pharmacology, chemistry, manufacture and controls.

The cost of preparing and submitting an NDA/BLA is

The FDA has 60 days from its receipt of an NDA/BLA to determine whether

the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently complete to permit substantive

Once the submission is accepted for filing, the FDA begins an in-depth review.

The FDA has agreed to certain performance goals

in the review of NDAs and BLAs.

Most such applications for standard review drug products are reviewed within 10 months of submission;

most applications for priority review drugs are reviewed within six months of submission.

Priority review can be applied to drugs that

the FDA determines offer major advances in treatment, or provide a treatment where no adequate therapy exists.

The review process for

both standard and priority review may be extended by FDA for three additional months to consider certain late-submitted information, or

information intended to clarify information already provided in the submission.

The FDA may also refer

applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an advisory

committee—typically a panel that includes clinicians and other experts—for review, evaluation and a recommendation as to

whether the application should be approved.

The FDA is not bound by the recommendation of an advisory committee, but it generally

follows such recommendations.

Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the

product is manufactured.

Radiopharmaceuticals face

additional regulatory considerations beyond conventional pharmaceuticals.

Due to their radioactive nature, radiopharmaceuticals are also

regulated by the Nuclear Regulatory Commission (NRC) or Agreement States under the Atomic Energy Act.

We must obtain appropriate licenses

for possession, use, and distribution of radioactive materials.

These licenses impose requirements for radiation safety programs, personnel

training and monitoring, facility design and monitoring, waste disposal, and security.

We must also comply with regulations governing

the transportation of radioactive materials, including such regulation by the US Department of Transportation.

The FDA has issued guidance documents specific to radiopharmaceuticals

that address topics including dosimetry assessments, clinical trial design, and manufacturing controls.

Radiopharmaceutical development

programs typically require microdosing studies using imaging isotopes to assess biodistribution and dosimetry prior to therapeutic dose

administration.

Manufacturing of radiopharmaceuticals must account for short half-lives necessitating distributed manufacturing networks,

specialized quality control testing, and just-in-time production and distribution systems.

International Regulation

In addition to regulations in the United States, we are subject to

regulations in the foreign countries in which we conduct clinical trials or seek to market our products.

Whether or not we obtain FDA

approval for a product, we must obtain approval by the comparable regulatory authorities of foreign countries or economic areas, such

as the European Union, before we may commence clinical trials or market products in those countries or areas.

The approval process and

requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from place to place,

and the time may be longer or shorter than that required for FDA approval.

The European Union has centralized procedures for approving pharmaceuticals

that allow companies to submit a single marketing authorization application (MAA) to the European Medicines Agency (EMA).

Upon EMA approval,

this centralized procedure results in a single marketing authorization that is valid across the European Economic Area.

The EMA has specific

guidelines for radiopharmaceuticals addressing dosimetry, manufacturing, and clinical development considerations similar to FDA guidance.

In many foreign countries, radiopharmaceuticals face additional complexities

related to reimbursement structures, nuclear medicine facility requirements, and isotope supply chains that differ significantly from

Intellectual Property

We strive to protect and enhance the proprietary technologies that

we believe are important to our business, including seeking, maintaining and defending patent rights, whether developed internally or

licensed from third parties.

Our policy is to seek to protect our proprietary position by, among other methods, filing U.S.

patent applications related to our proprietary technology, inventions and improvements that are important for the development and implementation

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 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.

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

and technologies across therapeutic modalities, linker technologies and in vivo cancer models, and build visibility through presentations

at key conferences and publications in journals of high impact.

Our R&D efforts are centered on the advancement of 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 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:

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

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.

We also rely on trade secrets, know-how, continuing technological innovation and in-licensing opportunities to develop,

strengthen and maintain our proprietary position.

Our intellectual property portfolio comprises approximately 250 patents

and patent applications across multiple jurisdictions.

Our patent estate includes:

● Composition of Matter Patents:

Covering our key product candidates

including Iomab-B, Iomab-ACT, and ATNM-400,

● Method of Use Patents:

Covering specific therapeutic applications,

combination therapies, and treatment protocols for our product candidates Actimab-A.

Iomab-B, Iomab-ACT, and ATNM-400, as well as preclinical

pipeline candidates

● Manufacturing and Process Patents:

Protecting our cyclotron-based

Ac-225 production technology, radiopharmaceutical manufacturing processes, and formulation technologies.

● Platform Technology Patents:

Protecting core technologies

applicable across multiple programs including chelator chemistry, targeting approaches, and bioconjugation methods.

Our patents provide market exclusivity in major territories including

the United States, Europe, Canada, Japan, and key emerging markets.

We actively monitor and enforce our intellectual property rights and

investigate potential infringement of our proprietary technologies.

In addition to patents, we maintain proprietary know-how and trade

secrets relating to our radiopharmaceutical development platform, manufacturing processes, and clinical development strategies.

to protect this information through confidentiality agreements with employees, consultants, advisors, and collaborative partners.

We also rely on regulatory exclusivity to protect our products from

In the United States, biologics such as our antibody radioconjugates may be eligible for 12 years of market exclusivity under

the Biologics Price Competition and Innovation Act.

Additionally, therapies receiving orphan drug designation may be eligible for seven

years of market exclusivity in the United States, and similar exclusivity periods apply in other territories.

Manufacturing and Supply Chain

Actinium has established significant

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

for the manufacturing of radiotherapeutics, and we have engaged several sources for the procurement of alpha (e.g., Ac-225) and beta (e.g.,

I-131 and Lu-177) emitters.

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

with Contract Development and Manufacturing Organizations (“CDMOs”) with significant experience in mAb and final radio-labeled

drug products.

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.

As of March 2025, our patent

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.

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

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.

Related patent applications are also currently pending in the U.S.

and internationally.

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

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 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 – 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.

(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;

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.

Our manufacturing strategy combines internal capabilities with external

partnerships to create a flexible, redundant, and cost-effective supply chain capable of supporting both clinical development and commercial

This hybrid approach provides us with strategic flexibility, supply reliability, and the ability to scale production to meet patient

Internal Manufacturing Capabilities

We are completing construction of a state-of-the-art cGMP radiopharmaceutical

manufacturing facility located in New York, expected to be operational in 2H:2026.

This facility has been purpose-built for alpha-emitter

handling and radiopharmaceutical production with the following capabilities:

● Therapeutic Drug Product Manufacturing:

production suites

for radioconjugate synthesis, formulation, fill-finish, and quality control testing, designed to support multiple simultaneous programs.

● Quality Control and Analytics:

Comprehensive analytical capabilities

including radiochemical purity testing, stability assessment, sterility testing, and release testing in accordance with regulatory requirements.

● Radiation Safety Infrastructure:

Shielded manufacturing suites

and a comprehensive radiation safety program to protect personnel and environment.

The facility has been designed for clinical stage supply of radiolabeled

therapeutic drug product production .

External Manufacturing Partnerships

We have established partnerships with multiple contract manufacturing

organizations providing geographic redundancy and production flexibility:

● Isotope Supply:

We maintain supply agreements with multiple

domestic and international suppliers of Ac-225 and other radioisotopes, providing priority access and redundancy to ensure reliable supply.

Our suppliers include established radioisotope producers with proven track records of regulatory compliance and supply reliability.

● Contract Manufacturing:

We have qualified multiple contract

manufacturers capable of producing our drug products under cGMP conditions.

These partnerships provide backup capacity, geographic diversity,

and specialized capabilities complementing our internal manufacturing.

● Distribution Partners:

We have established relationships with

specialized radiopharmaceutical logistics providers capable of cold-chain distribution, real-time tracking, and just-in-time delivery

to clinical sites and commercial administration centers.

Supply Chain Management

Our supply chain team has established systems and processes to coordinate

the complex logistics of radiopharmaceutical production and distribution:

● Demand Forecasting:

Predictive models incorporating clinical

trial enrollment, commercial demand projections, and inventory optimization to ensure adequate supply while minimizing waste.

● Production Scheduling:

Coordinated scheduling across isotope

production, drug product manufacturing, quality testing, and distribution to optimize efficiency and minimize decay losses.

● Real-Time Tracking:

Systems to monitor location, temperature,

and radiation levels throughout the supply chain from production through patient administration.

● Regulatory Compliance:

Procedures ensuring compliance with

FDA, NRC, Department of Transportation, and international regulations governing radioactive material handling, transportation, and administration.

Our manufacturing and supply chain capabilities position us to serve

patient populations at clinical and commercial scale while maintaining the flexibility to respond to changing demand and expand into new

geographic markets.

Human Capital

of March 25, 2026, we had 25 full-time employees, 12 of whom have Ph.D.

degrees and 21

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.

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.

address is www.actiniumpharma.com.

The information contained on our website or that can be accessed through our website is not incorporated

by reference into this Report and should not be considered a 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.

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.

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:

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 Biologics License Application (“BLA”)

for a new biologic, after completion of all pivotal clinical trials;

a determination by the FDA within 60 days of its receipt of a BLA to file the application for review;

satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities to assess compliance with applicable current Good Manufacturing Practice (“cGMP”) regulations;

potential FDA audit of the clinical trial sites that generated the data in support of the BLA;

FDA review and approval of a BLA for a new biologic, prior to any commercial marketing or sale of the product in the U.S.

Clinical trials generally are conducted

in three sequential phases, although they may overlap or be combined.

Phase 1 studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness

Phase 2 studies are conducted to preliminarily or further evaluate the effectiveness of the investigational product for a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal dosage, and to identify possible adverse side effects and safety risks associated with the product

Phase 3 clinical trials generally involve a large number of patients at multiple sites designed to provide the data required to demonstrate the effectiveness of the product for its intended use, safety and to establish the benefit-risk relationship of the product and provide an adequate basis for product labeling

The results of the preclinical

and clinical testing, along with information regarding the manufacturing of the product and proposed product labeling, are evaluated and,

if determined appropriate, submitted to the FDA through a BLA.

Once the BLA submission has been accepted for filing, the FDA’s standard

goal is to review applications within ten months of the filing date or, if the application relates to a drug that treats a serious condition

and would provide a significant improvement in safety or effectiveness qualifying for Priority Review, six months from the filing date.

The review process is often significantly extended by FDA requests for additional information or clarification.

The FDA offers certain programs,

such as Breakthrough Designation (“BTD”) and Fast Track designation, designed to expedite the development and review of applications

for products intended for the treatment of a serious or life-threatening disease or condition.

For BTD, preliminary clinical evidence

of the product indicates that it may demonstrate substantial improvement over existing therapies on one or more clinically significant

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 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 required.

The DSCSA requirements, development of standards, and the system for product tracing were 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

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.

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.

In the U.S., Orphan Drug designation entitles a party to

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

Drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.

The first BLA

applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA Orphan Drug designation is

entitled to a seven-year exclusive marketing period in the U.S.

for that product, for that indication.

During the seven-year exclusivity period, FDA may not approve any other applications to market the same drug for the same orphan indication,

except in limited circumstances, such as a showing of clinical superiority to the product with orphan exclusivity or where the manufacturer

of the approved product cannot assure sufficient quantities.

As a result, there can be no assurance that our competitors will not receive

approval of drugs or biologics that have a different active ingredient for treatment of the diseases for which our products and product

candidates are targeted.

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

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.

Anti-Kickback Statute (“AKS), 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 AKS.

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 AKS 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 AKS and FCA

may not have adopted exceptions and safe harbors available at the federal level and therefore, may implicate a broader range of activities.

The Health Insurance

Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for knowingly and willfully executing,

or attempting to execute, a scheme to defraud or obtain, by any means of false or fraudulent pretenses, representations or promises, any

money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors,

and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially

false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.

federal physician payment transparency requirements, sometimes referred to as the “Physician Payments Sunshine Act,” created

federal physician payment transparency requirements, sometimes referred to as the “Sunshine Act,” created

under the ACA, and its implementing regulations, which requires applicable manufacturers of covered drugs, devices, biologics and medical

9 unchanged sentences

the Sunshine Act also have the potential to draw scrutiny on payments to and relationships with physicians and teaching hospitals, which

may have implications under the Anti-Kickback Statute and other healthcare laws.

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.

may have implications under the AKS and other healthcare laws.

We may also be subject to

data privacy and security regulation by both the federal government and the state governments in which we conduct our business.

as amended by the Health Information Technology and Clinical Health Act of 2009 (“HITECH”) and their respective implementing

regulations, imposes, among other things, obligations, including mandatory contractual terms with respect to safeguarding the privacy,

security and transmission of individually identifiable health information held by certain healthcare providers, health plans and healthcare

clearinghouses, known as covered entities, and business associates.

The HHS Office of Civil Rights (“OCR”) has increased its

focus on compliance and continues to train state attorneys general for enforcement purposes.

Even where HIPAA does not apply, according

Federal Trade Commission (“FTC”), failing to take appropriate steps to keep consumers’ personal information

secure constitutes unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act

(“FTCA”), 15 U.S.

Medical data is considered sensitive data that merits stronger safeguards.

There are numerous other laws and legislative and regulatory initiatives at the federal and state levels addressing privacy and security

concerns, and some state privacy laws apply in broader circumstances than HIPAA.

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.

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.

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.

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