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Item 1. Business

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Business Overview

Description of Our Business

Actinium Pharmaceuticals, Inc.

is a clinical-stage, biopharmaceutical company applying its proprietary platform technology and deep understanding of radiobiology to

the development of novel targeted radiotherapies for patients with unmet needs.

Our targeted radiotherapies combine the cell-killing ability

of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody, to deliver radiation in a precise manner

inside the body to specific, targeted cells, to potentially achieve greater efficacy with lower toxicity than with external beam radiation.

They also enable a broader usage of radiation than external beam radiation as they can be used in the treatment of both solid tumors and

blood cancers, which generally cannot be treated with external radiation given their diffuse nature.

Our clinical pipeline is focused

on targeting the antigens CD45 and CD33, both of which are expressed in multiple hematologic cancers, which are known to be highly sensitive

to radiation.

Our clinical programs are focused on two primary areas:

(1) targeted conditioning prior to a bone marrow transplant (“BMT”),

adoptive cell therapy (“ACT”) such as CAR-T or gene therapy with Iomab-B and (2) targeted radiotherapy combinations with Actimab-A

and other therapeutic agents.

Our product development strategy is actively informed by clinical data with Iomab-B and Actimab-A in approximately

600 patients, including our ongoing Pivotal Phase 3 SIERRA trial, which completed its targeted enrollment of 150 patients in the third

quarter of 2021, with the last patient receiving their BMT in the fourth quarter of 2021.

Our clinical pipeline has emanated from our

Antibody Warhead Enabling (“AWE”) technology platform, which is protected by over 170 issued and pending patents, trade secrets

and know-how that we are applying to the development of targeted radiotherapies for blood and solid tumor indications, independently and

with collaborators.

Ongoing collaborations include a research partnership with Astellas Pharma, Inc.

(“Astellas”) focused

on the development of theranostics, which enable the diagnosis and treatment, for solid tumor indications, a collaboration with EpicentRx,

Inc, focused on a novel CD47 immunotherapy targeted radiotherapy combination, leveraging EpicentRx’s RRx-01, that is being studied

in a Phase 3 trial in non-small cell lung cancer, with our clinical stage Actimab-A in AML models, and a collaboration with AVEO Oncology,

focused on developing a HER3 targeting ARC or Antibody Radiation Conjugate for solid tumors leveraging with their clinical stage antibody.

We are also utilizing our AWE technology platform to advance our research objectives focused on developing next-generation targeted radiotherapies

with our expanded research and development organization and research laboratories leveraging our drug development experience.

Targeted Conditioning

To the best of our knowledge, we are advancing the only multi-target, multi-indication, clinical-stage pipeline for targeted conditioning.

Our targeted conditioning agents are intended to potentially enable improved access and outcomes to cell-based therapies with curative

potential, including BMT, ACT, and gene therapy Conditioning in the context of BMT, ACT or gene therapy is the act of depleting certain

blood and immune-forming cells, including bone marrow stem cells and, in some cases, cancer cells prior to transplanting new cells into

Currently, conditioning is accomplished using a combination of cytotoxic chemotherapeutic agents and external radiation.

non-targeted conditioning regimens are highly toxic and may prevent a patient from receiving a potentially curative therapy and hinder

We believe our targeted conditioning agents have the potential to increase patient access and outcomes by way of their ability

to selectively deplete targeted cells while sparing normal healthy cells, resulting in potentially lower systemic and off-target toxicities.

We use our ARCs both at high isotope dose levels to achieve myeloablation, which fully depletes bone marrow stem cells and at lower isotope

dose levels to achieve lymphodepletion, which spares bone marrow stem cells from depletion.

In addition, dosing may be titrated downward

from myeloablative doses to achieve partial myeloablation, which may be appropriate for certain gene therapy programs.

CD45 Targeted Conditioning Program

Iomab-B (I-131 apamistamab),

our lead candidate and targeted conditioning agent is comprised of the anti-CD45 monoclonal antibody known as apamistamab (formerly BC8)

and the radioisotope Iodine-131 (“I-131”).

CD45 is an antigen expressed on leukemia, lymphoma and myeloma cancer cells, as

well as nucleated immune cells including bone marrow stem cells, but is not expressed outside of the hematopoietic, or blood forming,

This unique expression on blood cancer and immune cells enables simultaneous depletion of both cell types, making CD45 an optimal

antigen for targeted conditioning applications.

CD45 is a cell surface antigen with an average expression of 200,000 copies per cell,

however, it only internalizes at a rate of 10-15%.

We believe our ARC approach is the most effective method to target CD45 positive cells,

as the radioisotope payload linear energy transfer can readily ablate a targeted cell without requiring payload internalization like an

antibody drug conjugate or without relying on biological effector function processes like a naked antibody.

Furthermore, since CD45 expression

level varies from low to high antigen density as the immune cells become more terminally differentiated, we can selectively condition

depending on the therapeutic application, from full myeloablation to transient lymphodepletion, by adjusting the dose or intensity of

the I-131 isotope payload.

Full myeloablation can be achieved with high doses of I-131, as its energy pathlength and crossfire effect

can penetrate into bone marrow niches to target and deplete blood and immune system forming bone marrow stem cells.

Myeloablation is applicable

to autologous or allogeneic BMT and to autologous gene-edited or modified therapies that can reconstitute a patient’s blood and

immune systems.

Alternatively, low doses of I-131 can be transiently lymphodepleting and spare a patient’s bone marrow stem cells,

which we believe is ideal for ACT applications such as CAR-T.

We intend to develop our CD45 targeted conditioning program for BMT, ACT

and gene therapy applications for malignant and non-malignant diseases and believe that multiple radioisotopes beyond I-131 may be utilized

including alpha and beta emitters.

Iomab-B uses high doses of

I-131 to achieve myeloablative conditioning prior to a BMT, is currently being studied in the pivotal Phase 3 Study of Iomab-B in Elderly

Relapsed or Refractory AML (“SIERRA”), clinical trial for targeted conditioning prior to an allogeneic BMT for patients with

active, relapsed or refractory (“r/r”) Acute Myeloid Leukemia, (“AML”), who are age 55 or older.

Enrollment of

the planned 150 patients in the SIERRA trial was completed in the third quarter of 2021 with the last patient receiving their BMT in the

fourth quarter of 2021.

Patients with active, r/r AML are not normally considered eligible for BMT and the SIERRA trial is the only randomized

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

The SIERRA trial compares outcomes of patients randomized

to receive Iomab-B and a BMT (the “study arm”) to those patients randomized to receive physician’s choice of salvage

therapy (the “control arm”).

The control arm is also defined as conventional care, as no standard of care exists for this

patient population and includes over 20 agents that may be used as single agents or in combination including venetoclax, a targeted Bcl-2

inhibitor, Midostaurin and Sorafenib, targeted FLT3 inhibitors, hypomethylating agents and cytotoxic chemotherapies.

Patients who fail

to achieve a Complete Remission (“CR”) on the control arm are ineligible to proceed to a BMT, but the trial design permits

these patients to “cross over” to receive the study arm treatment if they meet the eligibility criteria.

The primary endpoint

of the SIERRA trial is durable Complete Remission (“dCR”) of 180 days and the secondary endpoint is Overall Survival (“OS”).

When the crossover patients receive Iomab-B and BMT, they have not achieved remission with their salvage therapy and are considered to

be failures for the primary endpoint of the study.

The SIERRA trial recruited patients at 24 sites in the United States and Canada, which

includes many of the leading BMT sites based on volume.

If approved, we expect our initial commercial launch would target the leading

50-100 BMT and medical centers that perform the vast majority of BMT’s in the United States.

In the European Union (“EU”),

we received favorable feedback from the European Medicines Agency (“EMA”) via their scientific advice program that the trial

design, primary endpoint and planned statistical analysis from the SIERRA trial are acceptable as the basis for a Marketing Authorization

Application, or MAA.

Additionally, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology

or safety studies.

Overall, transplant procedures in the EU are approximately fifty percent higher than in the United States with a similar

market dynamic, with a majority of BMT volume being conducted in a concentrated number of leading medical centers.

Currently we intend

to secure a partner for Iomab-B in the EU.

Data from full patient enrollment in the SIERRA trial (151 patients), was presented at the American Society of Hematology (“ASH”)

Annual Meeting in December 2021.

The data presented includes rates of BMT access and engraftment, 100-day non-relapse transplant-related

mortality (100-day TRM) and adverse events, which has been reported from interim analyses conducted at 25%, 50% 75% and 100% of patient

enrollment pursuant to the study protocol.

The data presented at ASH highlighted that 100% of patients (59/59) on the study arm that received

a therapeutic dose of Iomab-B received a BMT, with a median time to BMT of 30 days, and all patients achieved neutrophil and platelet

engraftment in a median time of 18 days despite a high median blast count of 29%.

On the control arm, only 17% of patients (13/76) achieved

remission after salvage therapy, and then received a BMT with a median time to BMT of 67 days and median blast count of 20%.

of patients failing to achieve a CR with conventional care (47/57), 30 patients were eligible to cross over to receive Iomab-B followed

by transplant.

These patients are considered as having failed the primary endpoint of the study.

All crossover patients who received the

therapeutic dose of Iomab-B (30/30) received a BMT, with a median time to BMT of 24 days and they achieved engraftment in a median time

of 19 days despite high median blast count of 22% at time of crossover.

It was also reported that 100-day TRM of the study or Iomab-B

arm was 10% (6/59) of patients that received a BMT compared to 15% of patients (2/13) who received a BMT after salvage therapy on the

The universal engraftment rate and low 100-day TRM rate of the Iomab-B arm resulted in 53 patients potentially evaluable

for the primary endpoint compared to 11 patients in the control arm, an approximate five times difference.

At each of the interim analyses

throughout the SIERRA trial, this approximate five times difference has been consistent in favor of the Iomab-B arm as a result of higher

rates of BMT engraftment and lower rates of 100-day TRM.

Data from the SIERRA trial has

also been accepted for presentation at the upcoming Transplantation & Cellular Therapy (“TCT”) Tandem Meetings of the

American Society for Transplantation and Cellular Therapy (“ASTCT”) and Center for International Bone & Marrow Transplant

Research (“CIBMTR”), which has been postponed from February to April 2022.

At TCT, we expect to present additional data from

the SIERRA trial to include patients who have matured for BMT engraftment and 100-day TRM analysis, for which data was not available at

time of the submission cutoff for ASH in December of 2021.

Top-line data for the primary endpoint of durable Complete Remission is expected

to be presented in the third quarter of 2022.

We believe topline data from SIERRA will support the submission of a Biologics License Application

(“BLA”) with the U.S.

Food and Drug Administration (“FDA”), which we expect to file in the first half of 2023.

Our Iomab-ACT program is intended

for targeted conditioning prior to ACT or gene therapy and uses the same I-131-apamistamab construct as Iomab-B at varying doses.

doses of one-eighth to one-sixth of the myeloablative dose, it is applicable for lymphodepletion prior to CAR-T or certain gene therapy

applications where stem cell myeloablation is not necessary.

At higher doses it is applicable for gene therapy applications where stem

cell myeloablation is necessary.

We believe our Iomab-ACT program

is highly differentiated when compared to Fludarabine and Cyclophosphamide (“Flu/Cy”) or other chemotherapy-based regimens

that are used as the standard of practice today for lymphodepletion prior to CAR-T.

CD45 is an antigen expressed on certain immune cell

types that are relevant to the mechanism of CAR-T therapies including lymphocytes, regulatory T-cells and macrophages that have been associated

with clinical responses that may limit the safety, efficacy and durability of response of these CAR-T therapies including cytokine release

syndrome (“CRS”) and neurotoxicity.

Some of these limitations may be attributable to the chemotherapy-based conditioning agents

that are being used prior to CAR-T therapies.

Preclinical data supporting the rational for our Iomab-ACT program was presented at multiple

medical conferences in 2019.

Unlike chemotherapy, Iomab-ACT is targeted in nature and, due to this CD45-directed targeting, we expect

we can improve CAR-T cell expansion, potentially resulting in responses that are more durable, but also resulting in reduced CAR-T related

Importantly, we expect the Iomab-ACT program construct to enable lymphodepletion through a single-dose, outpatient administration

versus Flu/Cy or other chemotherapy-based lymphodepletion regimens that can require multiple infusion cycles over several days.

of this potentially superior profile, the Iomab-ACT construct could result in improved access to CAR-T therapy and better outcomes.

We are studying Iomab-ACT in a

clinical collaboration with Memorial Sloan Kettering Cancer Center (“MSKCC”) for targeted conditioning prior to administration

of MSKCC’s 19-28z CD19 targeting CAR-T in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (“ALL”)

or diffuse large B-cell lymphoma (“DLBCL”).

We received grant funding from the National Institute of Health (“NIH”)

to fund this trial with MSKCC being a co-recipient on this grant.

This is a first of its kind study to use an ARC-based conditioning regimen

with CAR-T therapy.

The hypothesized rationale for this study is that Iomab-ACT will exert an anti-tumor effect on the chemotherapy-refractory

B-ALL cells that are sensitive to radiation resulting in reduced disease burden and simultaneously deplete CD45 expressing immune cells

implicated in CAR-T related toxicities, resulting in an optimal homeostatic environment for the CAR-T cells.

Results with MSKCC’s

19-28z CD-19 CAR-T in 53 patients with r/r B-ALL published in the New England Journal of Medicine reported complete remissions in 83%

(44/53) of patients, which compares favorably to standard chemotherapy regimens that have complete remission rates of 18% - 45% in this

patient population.

Median event-free survival (EFS) was 6.1 months and median overall survival (OS) was 12.9 months at a median follow

up period of 29 months (range 1 – 65 months).

There was a 26% (14/53) rate of Grade 3 or greater CRS and a 42% rate of Grade 3 or

4 neurotoxicity reported.

The study will evaluate the feasibility of using an ARC-based conditioning regimen with CAR-T therapy and will

evaluate safety measures including incidence of CRS and neurotoxicity and efficacy measures including responses and survival outcomes.

In March 2021, we announced that patient enrollment was initiated, and the first patient was administered Iomab-ACT followed by their

19-28z CAR-T therapy.

We expect proof of concept data from this study in the second half of 2022.

In addition, we are working

in collaboration with the University of California Davis to utilize Iomab-ACT conditioning with a novel anti-HIV autologous gene therapy.

We continue to identify additional gene therapies for which Iomab-ACT can be used for targeted conditioning with the goal of collaborating

with multiple academic or industry developers to establish Iomab-ACT as a non-chemotherapy universal targeted conditioning solution.

CD33 Program:

Combinations and Therapeutics

Our CD33 program is evaluating

the clinical utility of Actimab-A, comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225

CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome (“MDS”) as well

as approximately one-third of patients with multiple myeloma.

Ac-225 emits four alpha particles and can kill a cell with one alpha-particle

hit, making it one of the most powerful cell-killing agents with no know resistance mechanism to the double strand DNA breaks it can cause.

We source Ac-225 from the Department of Energy’s Oak Ridge National Laboratory.

Our CD33 development program

is driven by data obtained from nearly one hundred fifty treated patients, including results from a Phase 1/2 trial that studied Actimab-A

as a single agent at multiple dose levels in 58 patients with newly diagnosed AML, which was completed in 2018, as well as trials studying

Actimab-A in combination with other agents.

We believe that radiation delivered

internally via a targeting moiety can be synergistic when used in combination with chemotherapy, targeted agents and immunotherapy based

on mechanistic rationales supported by our own clinical data, preclinical research and scientific and clinical evidence in the literature.

We have prioritized our efforts and resources in favor of combination trials for our CD33 program development strategy rather than single

agent trials at this time as we believe Actimab-A can be a backbone therapy in AML when combined with other therapeutic modalities.

CD33 development program encompasses the following ongoing trials:

Actimab -A Combination Trials :

Actimab-A + CLAG-M

The combination of Actimab-A with CLAG-M has been

studied in a Phase 1 combination trial that was conducted in collaboration with the Medical College of Wisconsin (“MCW”) in

patients age 18 and above with r/r AML who are fit for intensive therapy.

Patient enrollment was completed in November 2021.

CLAG-M (cladribine,

cytarabine, filgrastim and mitoxantrone) is a salvage chemotherapy regimen that produced a 55% remission rate in patients with r/r AML

in a previous study conducted by MCW that compared outcomes of patients receiving either CLAG-M, MEC or CLAG salvage therapy regimens.

Data from the Phase 1 combination trial of Actimab-A + CLAG-M were presented at ASH in December 2021.

After completion of dose-escalation

in the Phase 1 trial, the recommended Phase 2 dose was determined to be 0.75 µCi/kg of Actimab-A.

3 patients were enrolled in the

0.75 µCi/kg dose cohort, which had a 100% remission rate comprised of 1 complete remission (“CR”) and 2 complete remissions

with incomplete platelet recovery (“CRp”), there were no dose limiting toxicities (“DLTs”) or 30-day mortality

Overall, a 67% (12/18) overall response rate (“ORR”) was reported across all dose cohorts (0.25 – 1.0 µCi/kg)

and remissions were achieved in every dose cohort including the 0.25 and 0.50 µCi/kg doses of Actimab-A, which have been shown to

be subtherapeutic as a single agent.

In addition, there was a 72% minimal residual disease (“MRD”) negativity rate, which

compares favorably to the 39% MRD negativity rate reported by MCW with CLAG-M alone.

This study enrolled patients who previously failed

Venetoclax, a targeted Bcl-2 inhibitor, and efficacy was similar in patients Venetoclax naïve and those that previously failed Venetoclax,

with a 60% response rate in previous Venetoclax failures.

We are working to develop a regulatory and development pathway for the Actimab-A

CLAG-M combination and will be evaluating potential registration enabling strategies.

In addition, we believe this Actimab-A + CLAG-M

combination study has provided proof of principle that the addition of Actimab-A to other AML therapies can lead to well-tolerated regimens

with improved responses, which supports our Actimab-A backbone therapy in AML strategy.

Actimab-A + Venetoclax

We are also conducting a Phase

1/2 Actimab-A combination trial with the Bcl-2 inhibitor Venetoclax in fit and unfit patients age 18 and above with relapsed or refractory

This multi-center trial is being led by UCLA Medical Center.

This combination is supported by mechanistic evidence in preclinical

studies using Venetoclax -resistant AML tumor cell lines.

In these models, we have demonstrated that Actimab-A can deplete Mcl-1 and Bcl-XL,

two proteins implicated in mediating resistance to Venetoclax, in addition to causing potentially lethal double-stranded DNA breaks in

these CD33 expressing cells.

Furthermore, in vivo studies in animal models of Venetoclax-resistant AML demonstrated robust tumor regression

and improved survival in cohorts receiving the Actimab-A Venetoclax combination compared to Venetoclax alone.

The rationale for this clinical

study is that the addition of Actimab-A will;

1) have a direct anti-tumor effect via double-stranded DNA breaks and 2) deplete Mcl-1 and

Bcl-XL making the AML cells more susceptible to Venetoclax.

Updated data from the Phase 1 dose escalation portion of this study was presented

at ASH in December 2021 from three dose cohorts of 0.50, 0.75 and 1.0 µCi/kg of Actimab-A in a total of 12 patients.

50% of patients

received Venetoclax therapy prior to enrollment on the Actimab-A combination trial.

And 67% of patients had poor risk cytogenetics, of

which, 3 had a TP53 mutation, which is associate with poorer response rates and survival outcomes.

Of the patients with a TP53 mutation,

67% achieved a remission including a patient that achieved a CR and at the time of data cutoff for ASH, the patient was in follow-up 230

days (~7.5 months).

The combination of Actimab-A with Venetoclax was reported to be well-tolerated with no 30-day mortality.

to date support advancing to the Phase 2 portion of the trial and we expect to provide an update on the development strategy, including

consideration of patients with a TP53 mutation, after the Phase 1 dose finding portion of the trial is complete and the recommended Phase

2 dose is determined.

In addition to these ongoing

trials, we actively seek and evaluate additional modalities and agents that can be the basis for Actimab-A therapeutic combinations such

as the CD47 immunotherapy magrolimab combinations we announced at the Society for Immunotherapy of Cancer in November 2021 to leverage

our clinical experience, supply chain and AWE technology platform.

CD47 Based ARC Combinations in Solid Tumors

and Blood Cancers

CD47 is a macrophage checkpoint

that is upregulated in multiple cancers including blood cancers such as AML and MDS as well as solid tumors.

CD47 acts as a “don’t

eat me” signal on cancer cells to suppress phagocytosis and evade detection and destruction by the immune system.

It has become

an immunotherapy target of significant interest with multiple biopharmaceutical companies actively developing CD47 targeting agents across

a wide range of oncology and hematology indications.

CD47 targeting agents have shown limited efficacy as single agent monotherapies in

AML/MDS or solid tumors, which has led to combinations such as with hypomethylating agents in AML/MDS.

We hypothesized that targeted radiotherapy

via ARCs could synergize with CD47 targeting agents via the direct cytotoxic and immunogenic effect of ARCs without overlapping toxicities.

To explore this synergy and the potential to improve patient outcomes and we have initiated a program in AML with our Actimab-A ARC, consistent

with our strategy to establish Actimab-A a backbone AML therapy, and in solid tumors with a HER-2 targeting ARC, which emanated from our

AWE technology platform.

To our knowledge, these are the first and only ARC-based targeted radiotherapy combinations with CD47 immunotherapy.

Data from these novel combinations were presented at the 36 th Annual Meeting of the Society for Immunotherapy for Cancer.

The most advanced CD47 development

programs are being studied in patients with AML and MDS.

Leveraging our clinical experience with Actimab-A in these indications we have

begun studying Actimab-A with the anti-CD47 antibody immunotherapy magrolimab, which is owned by Gilead Sciences, Inc., in preclinical

models of AML.

In preclinical models, it was shown that in multiple AML cell lines, the combination of Actimab-A with magrolimab led to

increased phagocytosis of AML cells compared to magrolimab alone.

Our studies also demonstrated that AML cell lines exposed to Actimab-A

had an upregulation of calreticulin, which is a pro-phagocytic or “eat me” signal, which we hypothesize makes Actimab-A potentially

synergistic with magrolimab and other anti-CD47 antibodies.

The Actimab-A and magrolimab combination showed a significant increase in

survival compared to Actimab-A alone in a disseminated AML animal tumor model.

We intend to continue to study preclinically this combination

with the goal of advancing to human clinical trials.

In January 2022, we announced

a research collaboration with EpicentRx that will evaluate Actimab-A in combination with EpicentRx’s RRx-001in AML.

RRx-001, currently under investigation in a Phase 3 trial for Small Cell Lung Cancer and in other oncology and non-oncology indications,

is a versatile next generation small molecule immunotherapeutic that targets the CD47-SIRPα axis and the NLRP3 inflammasome to

alter the tumor microenvironment and optimize immune response.

This collaboration will explore the mechanistic synergy of RRx-001’s

CD47–SIRPα downregulation with Actinium’s targeted radiotherapy calreticulin upregulation to increase the immune detection

and destruction of cancer cells.

Preclinical experiments have begun exploring this combination in AML models.

We intend to leverage our

experience with CD47 targeting agents such as magrolimab in this collaboration.

Based on Actimab-A and RRx-001 both being clinical-stage

assets, we believe there is a potentially faster pathway to clinical trials with this novel combination, particularly if the preclinical

safety and efficacy profile are in line with what was observed with Actimab-A and magrolimab.

Antibody Warhead Enabling Technology Platform

Our proprietary AWE technology

platform is supported by intellectual property, know-how and trade secrets that cover the generation, development, methods of use and

manufacture of targeted radiotherapies and certain of their components.

Our AWE technology patent portfolio presently includes 39 patent

families comprised of 173 issued patents and pending patent applications, of which 8 are issued and 30 are pending in the United States,

and 135 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 2042.

Our technology enables the direct labeling,

or conjugation and labeling, of a biomolecular targeting agent to a radionuclide warhead and its development and use as a therapeutic

regimen for the treatment of diseases such as cancer.

Our AWE intellectual property covers various methods of use in multiple diseases,

including indication, dose and scheduling, radionuclide warhead, and therapeutic combinations.

We have particular 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 United States and 49 patents internationally related to the

manufacturing or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than currently utilized

In 2021 we have enhanced our

research and development capabilities around AWE by securing and staffing research facilities.

Our research laboratories are focused on

applying our AWE technology platform to the development of radiation conjugates and to execute on research collaborations.

efforts employ a multidisciplinary approach leveraging our team’s knowledge and experience in cancer cell biology, radiochemistry,

radiation sciences, immunology and oncology drug development.

We intend to focus on generating targeted radiotherapies using our existing

intellectual property, evaluating assets for in-licensing to complement our existing clinical pipeline and securing collaborations and

partnerships with biopharmaceutical companies.

By adding research and development capabilities to our clinical development and clinical

supply chain capabilities, we seek to enable the rapid translation of radiotherapies.

Our AWE technology platform

is being utilized in our ongoing research collaboration with Astellas to arm select targeting agents owned by Astellas with the alpha-emitting

radioisotope Ac-225 for the development of theranostics for solid tumor indications, which combine the ability of radioisotopes to be

used for both diagnostic and therapeutic purposes.

We also utilized AWE to create aHER2-targeting radiotherapy using

the antibody Trastuzumab with either Ac-225 or Lu-177 radioisotopes to study in combination with magrolimab for solid tumors.

monotherapies, such as magrolimab, have not shown meaningful responses in clinical studies in solid tumors.

We hypothesized that radiation

directed at HER2 expressing cells would upregulate cell surface calreticulin, a pro-phagocytic “eat me” signal, that when

combined with an anti-CD47 blockade therapy would enhance antitumor activity.

Data from this combination was presented at the Annual Meeting

of the Society for Immunotherapy for Cancer in November 2021.

In vitro studies showed that immunogenicity, determined by binding to HER2

expressing cells, remained intact after radiolabeling Trastuzumab with Ac-225 or Lu-177.

In multiple cells lines radiolabeled Trastuzumab

increased cell surface calreticulin and the combination with magrolimab increased phagocytosis.

The combination of the Ac-225 or Lu-117

Trastuzumab with magrolimab slowed tumor growth in animal models of solid tumors compared to either the radiolabeled Trastuzumab or magrolimab

as single agents.

We are continuing to evaluate this combination in additional tumor models, and we intend to continue to study this combination

with the goal of advancing to human clinical trials.

We are also collaborating

with AVEO Oncology (“AVEO”) to develop a targeted radiotherapy against ErbB3, also known as HER3, with the Ac-225 isotope

for solid tumor indications.

HER3 is overexpressed in several solid tumor indications with high unmet needs, including colorectal, gastric,

head and neck, breast, ovarian, melanoma, prostate and bladder cancers with HER3 agents under development demonstrating activity in preclinical

and clinical studies.

To our knowledge, this is the first HER3 targeting radiotherapy in development.

AVEO is developing high affinity

antibodies including HER3 targeting AV-203, which has demonstrated preclinical activity across a number of solid tumor indications and

was studied in a Phase 1 open-label trial in patients with advanced solid tumors where it was found to be safe and generally well tolerated.

In March 2022, we announced that data from studies of Ac-225 radiolabeled HER3 antibody have been accepted for presentation at the American

Association for Cancer Research (“AACR”) Annual Meeting.

Preliminary results contained in the AACR abstract showed potent

tumor cell cytotoxicity, complete anti-tumor response in a HER3 tumor xenograft models and significantly prolonged survival compared to

control groups (p<0.0001).

Additional data from these studies will be presented at AACR in April 2022.

We believe these preliminary

results support our collaboration with AVEO and given that AV-203 has clinical safety data, a potentially accelerated regulatory pathway

to clinical studies with an Ac-225 HER3 targeted radiotherapy.

Intellectual Property Portfolio and Regulatory Protections

(“Actinium”) is a biopharmaceutical

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

unmet medical needs.

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

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

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

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

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

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

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

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

for rapidly growing cell and gene therapies.

Our Clinical Pipeline

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

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

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

the challenges associated with this treatment.

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

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

therapy to attain a remission, conditioning

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

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

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

Iomab-B is a targeted bridging

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

Results from a phase 3 trial has demonstrated unprecedented

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

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

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

Together, they provide us the opportunity

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

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

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

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

On February 18, 2023,

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

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

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

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

We believe these results provide the opportunity

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

On April 12, 2022, we announced a commercialization

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

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

milestones and mid-twenty percent royalties.

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

BMT procedures compared to the U.S.

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

on this opportunity.

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

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

6 clinical trials.

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

Actimab-A is being developed

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

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

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

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

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

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

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

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

response in early dose escalation cohorts.

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

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

and other hematologic malignancies.

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

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

with Astellas Pharma Inc.

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

(“EpicentRx”).

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

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

patent applications worldwide.

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

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

commercial launch

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

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

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

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

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

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

Market Opportunity

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

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

We believe that Iomab-B and Actimab-A can

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

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

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

Over 50% of patients

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

Despite 10 new approved therapies

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

provide the opportunity for Actimab-A.

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

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

Using Actimab-A in combination

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

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

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

the only potentially curative option.

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

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

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

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

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

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

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

diseases outside of AML.

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

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

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

This data provides an opportunity to expand the market for

Iomab-B beyond AML via label expansion.

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

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

patients who could potentially benefit from transplant.

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

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

agents required to ablate the marrow prior to a BMT.

Beyond BMT, the opportunity exists for better conditioning in other

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

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

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

by 2030 based on the current pipeline.

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

11% over the next 5 plus years.

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

patients receive conditioning of some type prior to these treatments.

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

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

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

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

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

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

We believe our focus on relapsed and refractory disease

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

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

The cell killing power of linear energy transfer

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

can succeed over other approaches.

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

barriers are higher than with other types of medicines.

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

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

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

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

expected to survive two to four months.

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

Actimab-A, a therapeutic agent, and

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

Based on solid clinical

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

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

Iomab-B and Actimab-A have the potential

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

The operating model required to achieve our vision is attractive for

several reasons, including the concentrated point of care;

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

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

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

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

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

Our product pipeline is targeting a broader opportunity

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

for rapidly growing cell and gene therapies.

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

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

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

a commercial partner.

Our strategic priorities are to:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

leveraging the NCI CRADA and its balance sheet sparing opportunity.

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

and explore partnerships as a means to achieve commercialization.

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

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

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

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

specialty radiotherapeutics company focused on the top 100 large hospitals.

Our Product Pipeline

We have strategically focused our development

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

We are developing a portfolio of novel radiotherapeutics that has the

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

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

our targeted conditioning programs.

AML Focused Programs – Iomab-B

and Actimab-A

Our Iomab-B and Actimab-A product candidates are

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

Iomab-B – Targeted Radiotherapeutic

for Induction and Conditioning.

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

with poor survival prognosis

Opportunity to Change the Current Paradigm

for Accessing a BMT and Improving Outcomes

The current approach in preparing patients

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

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

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

As this approach

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

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

Iomab-B is a targeted therapy that provides both

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

routine practice today.

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

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

improved survival and curative outcomes.

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

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

patients in the relapsed or refractory setting.

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

with FIT patients.

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

between these trials are depicted in the graphic below.

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

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

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

in this setting.

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

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

Sequential conditioning is not novel

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

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

Augmented Reduced Intensity Regimen Does Not Improve Postallogeneic Transplant

Outcomes in Acute Myeloid Leukemia.

J Clin Oncol.

The SIERRA trial results therefore can change the paradigm in transplant

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

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

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

Schetelig et al.

Results from the Randomized

Phase III ASAP Trial.

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

The SIERRA trial was designed to demonstrate the

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

Unfortunately, approximately 30% of patients with

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

Getting these patients with primary r/r

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

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

Patients must be able to overcome several challenges related to curative

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

The current clinical practice is not

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

The National Comprehensive Cancer Network (“NCCN”)

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

The second challenge to access

is tolerance to current conditioning regimens.

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

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

Inadequate conditioning can lead

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

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

outcomes and a survival of a few weeks.

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

The conditioning

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

In the SIERRA

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

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

and targeted myeloablation.

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

related to improved outcomes through Iomab-B.

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

Tandem Meetings:

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

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

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

The design of the SIERRA trial is provided in

the figure below.

A Novel, Pivotal Phase 3 Study of

Iomab-B in r/r AML

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

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

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

In this study, Iomab-B

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

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

attempting to get patients to CR.

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

became available.

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

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

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

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

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

These patients would not be offered BMT in standard

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

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

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

The comparison of OS in subjects randomized to the control

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

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

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

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

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

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

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

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

The results presented

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

considered for the analysis.

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

the same as the per protocol analysis.

SIERRA Results:

Iomab-B Meets Primary Endpoint

with High Significance (p<0.0001)

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

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

Median OS had not been reached in these patients.

It is worth noting that two

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

Overall Survival for Patients who Achieved

6-month dCR with Iomab-B

OS was one of the secondary endpoints of the

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

arm and the control arm.

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

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

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

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

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

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

In order to isolate the true impact of Iomab-B

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

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

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

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

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

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

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

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

The 1-year OS for patients in

the crossover arm was 35.8%.

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

in survival outcomes possible with its use.

Kaplan-Meier Plot of Overall Survival ‒

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

Iomab-B produced a significant and clinically meaningful improvement

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

and ITT basis).

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

In the SIERRA trial, an event is defined

as one of the following:

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

In the figure below comparing EFS with Iomab-B

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

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

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

Event-Free Survival with Iomab-B Versus Control

The table below shows relevant adverse events

in transplanted Iomab-B patients.

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

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

50.0%), mucositis (15.2% vs.

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

Grade ≥3 Treatment-Emergent Adverse Events

in Transplanted Patients Through Day 100 Post-HCT

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

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

Using an Iomab-B led regimen, an unprecedented

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

to transplant the patient.

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

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

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

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

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

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

Iomab-B – New Paradigm to Upend BMT

Access and Improve r/r AML Outcomes

Future Development and Life Cycle Management

The results of the Pivotal Phase 3 SIERRA trial

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

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

for patients with r/r AML.

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

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

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

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

With its promising profile,

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

● Physicians :

Our goal is to help physicians

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

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

Iomab-B potentially unlocks value

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

● Competition :

While there have been multiple

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

in conditioning to increase access to BMT.

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

to impair the commercial success of Iomab-B

● Concentrated Call Points :

The commercialization

for Iomab-B will benefit from a concentrated market.

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

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

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

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

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

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

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

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

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

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

foundation for our commercial team.

In April 2022, Actinium licensed the EUMENA commercial

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

Immedica has significant know-how and experience

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

and capabilities.

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

retain commercialization rights in the U.S.

and rest of the world.

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

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

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

new patients per year.

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

regulatory and sales milestones and mid-twenty percent royalties.

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

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

Background on Iomab-B

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

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

to malignant and hematopoietic cells prior to allogeneic BMT.

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

cells at high levels.

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

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

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

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

Developed at the

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

lymphomas, MDS, and MM.

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

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

been granted Orphan Drug Designation from the U.S.

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

Actimab-A – CD33 targeting radiotherapeutic

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

Our Actimab-A ( 225 Ac-lintuzumab

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

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

There is no known resistance mechanism

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

The scientific rational is to use

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

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

Actimab-A has demonstrated

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

Actimab-A + CLAG-M Phase 1 Study Results

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

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

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

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

67% of these patients had adverse cytogenetics,

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

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

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

These trial results were presented as an oral

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

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

high potential.

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

available therapies.

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

rate, and a 75% MRD negativity rate.

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

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

have dismal outcomes.

Actimab-A + CLAG-M – Impressive Response

and Survival Benefit in r/r AML

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

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

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

Oncotarget 2018 and Mushtaq et al.

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

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

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

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

When combined

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

prior targeted treatment.

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

with a median OS of less than 3 months.

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

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

Actimab-A + venetoclax Phase 1/2 Study Results

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

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

On December 10, 2022, data from

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

We have demonstrated preclinically that combinations

of Actimab-A and venetoclax have mechanistic synergies.

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

to venetoclax in AML.

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

cells or reduce tumor resistance to venetoclax.

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

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

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

as well as the dosing regimen of the combination.

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

Advanced Development and Planning for Actimab-A

On February 6, 2023, we announced that we entered

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

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

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

targeted agents and other novel combinations.

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

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

This broad collaboration

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

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

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

Background on Actimab-A

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

radioisotope Ac-225.

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

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

These cells have no known resistance

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

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

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

Our CD33 development program is driven by data obtained

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

with prolonged neutropenia.

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

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

were developed and patients were enrolled into these studies.

Conditioning Focused Programs

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

management for label enhancement and indication expansion.

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

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

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

We will leverage these data with strong

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

role in a variety of malignant and non-malignant hematological disorders, We will continue to develop the Iomab-B franchise to potentially

address a broader market opportunity to address the over 165,000 patients diagnosed with cancers (e.g., leukemia, lymphoma, and myeloma),

who could potentially benefit from transplant, but are unable to access one today.

Iomab-ACT is comprised of apamistamab, the same anti-CD45 antibody

as Iomab-B, but utilizes lower, nonmyeloablative levels of I-131 to achieve lymphodepletion for cellular therapies such as CAR-T or reduced

intensity conditioning for gene therapies.

We intend to continue to develop the Iomab-ACT program designed specifically for use prior

to CAR-T and gene therapies, ultimately with a value proposition of improving overall access and outcomes for patients who need cellular

or gene therapies.

Preclinical data showed a single, low-dose of

Iomab-ACT demonstrated lymphodepletion and as CD45 positive immune cells are implicated in major CAR-T side effects, i.e., cytokine release

syndrome ("CRS") and immune effector cell–associated neurotoxicity syndrome (“ICANS"), Iomab-ACT has the potential

to be developed as a conditioning agent for CAR-T therapies.

CRS and ICANS remain two most common toxicities of CAR-T therapies with severe

cases (>Grade 3) seen in >20% of patients and fatality rates between 0-10%.

Due to its effect on host monocytes/macrophages, we

believe conditioning with Iomab-ACT will potentially reduce the incidence of CRS and ICANS.

Unlike chemotherapy, Iomab-ACT is targeted in

nature, and we expect it to potentially promote improved CAR-T cell expansion, resulting in responses that are higher and more durable.

We believe our Iomab-ACT program is highly differentiated when compared to fludarabine and cyclophosphamide (“Flu/Cy”) or

other chemotherapy-based regimens that are used as standard practice today for lymphodepletion prior to cell therapy.

We are studying Iomab-ACT in collaboration with MSKCC, for conditioning

prior to CAR-T therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (“B-ALL”) or diffuse large

B-cell lymphoma (“DLBCL”).

This study funded by a NIH grant is the first-of-its-kind study to use a radiotherapeutic-based

conditioning regimen with CAR-T therapy.

We have completed treatment of an initial cohort of three patients and will expand to a second

This study was presented at the ASH Annual Meeting in December 2022 as a trial-in-progress.

We expect to present proof-of-concept

data from this study in 2023 and look forward to sharing more on our Iomab-ACT trial with MSKCC, along with future development plans in

the CAR-T space.

R&D and Preclinical Programs

Our R&D efforts yield differentiated, high-value

programs that demonstrate our experience across multiple validated cancer targets and isotopes and cover broad areas of focus leveraging

our clinical development experience across hematology, targeted conditioning, solid tumors, and next generation radiotherapies.

also inform the advancement of our Iomab-B, Actimab-A, and Iomab-ACT programs.

Our research collaborations with Astellas, LG Chem, formerly

AVEO Oncology, and EpicentRx establish our work with immunotherapies and in solid tumors.

We are working on several preclinical programs

which include novel approaches to established targets such as HER2 and HER3, as well as novel targets that show immense potential for

radiotherapeutic approaches.

Underpinning our development programs is our expanded patent portfolio of over 200 issued patents and pending

patent applications worldwide.

We have utilized our technology platform to develop our clinical portfolio

in hematology – Iomab-B and Actimab-A, in conditioning for transplant and as a therapeutic, respectively.

In addition, our robust

platform been used to develop a pipeline of novel radiotherapeutic assets to drive company growth.

Preclinical pharmacology studies with

our targeted radiotherapeutics such as HER3-ARC, HER2-ARC or CD33-ARC have shown dramatic improvement in tumor growth inhibition in various

preclinical tumor models as single agents or in combination with immunotherapy such as magrolimab, an anti-CD47 monoclonal antibody.

results have prompted the team to spearhead efforts in multiple solid tumor programs.

Actinium’s lead solid tumor program is a targeted radiotherapy

against HER3, a pan-cancer target that is overexpressed in several solid tumor indications with high unmet need.

In April 2022, we presented

the first HER3-targeted radiotherapeutic agent at the American Association for Cancer Research (“AACR”) Annual Meeting showing

potent tumor cell cytotoxicity, enhanced antitumor effects and significantly improved survival with an Ac-225 radiolabeled HER3 antibody

compared to a naked HER3 antibody in a preclinical non-small cell lung cancer (“NSCLC”) model.

We have also demonstrated the

direct impact of targeted radiotherapy in modulating immune signals such as calreticulin upregulation to enhance tumor cell killing.

we have leveraged the immunomodulatory effect(s) of targeted radiotherapy in combination with CD47 targeting agents such as magrolimab

for sustained tumor growth inhibition in mouse models of AML and NSCLC.

These results were presented at the Society for Immunotherapy

of Cancer (“SITC”) Annual Meeting held in 2021.

Our R&D team continues to expand on capabilities

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

presentations at key conferences and publications in journals of high impact.

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

key programs with a robust “fast-to-clinic” approach in niche indications and are backed by an extensive IP estate that comprises

over 200 patents and patent applications including the methods of Ac-225 production.

Our Platform Technology

Our proprietary technology platform is built on

the core competency to produce targeted radiotherapeutics, and coupled with our know-how and IP, establishes our company in the development

of isotope-agnostic, multi-targeted products that may address the treatment of hard-to-treat diseases.

In our clinical and preclinical

programs, we have utilized multiple isotopes including Ac-225, I-131 and Lutetium-177 directed at multiple targets in oncology and hematology

such as CD45, CD33, HER3, among others.

Our targeted radiotherapies combine the cell-killing ability of radiation via a radioisotope payload

with a targeting agent, such as a monoclonal antibody.

In addition to developing targeted radiotherapies, we also own patents

related to the manufacturing of Ac-225 in a cyclotron.

We have expertise in utilizing the alpha emitting isotope Ac-225 including clinical

experience in treating approximately 150 patients with our alpha-emitter-based therapies, “gold standard” linker technology

and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing or Ac-225 in a cyclotron, which we believe

has the potential to produce higher quantities of highly pure Ac-225 than current methods.

When appropriate, we are well-positioned to

leverage this technology to produce Ac-225.

Intellectual Property

We have developed or in-licensed

numerous patents and patent applications and possess substantial know-how and trade secrets related to the development and manufacture

of our products.

As of March 2022, our patent portfolio includes 39 patent families comprised of 174 issued patents and pending patent

applications, of which 8 are issued and 30 are pending in the United States, and 135 are issued or pending internationally.

Several non-provisional

patent applications are expected to be filed in 2022 based on provisional patent applications filed in 2021.

More than 90% of our patents

are Actinium-owned and the remainder are in-licensed from third parties.

These patents cover key areas of our business, including the

use of actinium-225 and other alpha- or beta-emitting isotopes attached to cancer targeting carriers like monoclonal antibodies in the

treatment of cancers and non-malignant medical disorders, methods for manufacturing key components of our product candidates including

actinium-225, an alpha particle emitting radioisotope and carrier antibodies, or Iodine-131, a beta particle emitting radioisotope, and

methods for manufacturing finished product candidates for use in cancer treatment.

We own two issued patents

in the United States and issued patents in Europe and Japan that relate to the composition of our Iomab-B product candidate.

patent terms of these patents expire in 2036 and 2037.

Four related patent applications are also currently pending in the U.S.

Our proprietary technology platform is supported

by IP, know-how and trade secrets that cover the generation, development, methods of use and manufacture of targeted radiotherapies and

their select components.

Our IP covers various methods of use in multiple diseases, including indication, dose and scheduling, radionuclide

warhead, and therapeutic combinations.

As of March 2023, we have expanded our patent

portfolio to over 200 issued patents and pending patent applications worldwide, which we believe constitutes a valuable business asset.

Our IP includes 45 patent families, including key patents that relate primarily to our radiotherapeutic candidates.

Our patent portfolio

includes 12 issued patents and 39 pending patent applications in the U.S., and 151 that are issued or pending internationally.

The effective

lives of the issued patents in our portfolio, or patents that may issue from the pending applications in our portfolio, ranges from expirations

between 2024 and 2043.

For our Iomab-B product candidate, we have four

issued patents in the U.S.

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 conditions.

We also own five issued patents in the United States and 49 patents outside the United States

that relate to the manufacturing of actinium-225, the radionuclide used in our Actimab-A product candidate, in a cyclotron.

we own both U.S.

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

and non-malignant conditions.

Our patents also cover key areas of our business

such as manufacturing key components of our product candidate, Actimab-A, including Ac-225 in a cyclotron.

We have expertise in utilizing

the alpha emitting isotope Ac-225 including clinical experience in treating approximately 150 patients with our alpha-emitter-based therapies,

“gold standard” linker technology and five issued patents in the U.S.

and 49 patents internationally related to the manufacturing

or Ac-225 in a cyclotron, which we believe has the potential to produce higher quantities of Ac-225 than currently utilized methods.

patents will expire in the years 2024 through 2027.

2 unchanged sentences

that relate to the manufacturing of Actimab-A and its use in the treatment of cancers.

Regulatory Protections

The indications for which we

are developing our product candidates for are orphan drug designations, which are disease indications that affect fewer than 200,000 patients

in the United States and less than 5 in 10,000 patients in the EU.

We have received orphan drug designation for Iomab-B and Actimab-A

for patients with AML in both the United States and the EU.

As a result, if our products are to be approved, they may receive 7 years

and 10 years of market exclusivity in the United States and EU, respectively.

In addition, our product candidates are biologics combined

with radioisotopes.

We believe that the nature of radioisotopes having half-lives combined with the complexities of biologic drugs would

make it difficult for a manufacturer to demonstrate bioequivalence to our product candidates.

The Hatch-Waxman Act requires that a manufacturer

of generic drugs, for which a biologic drug is called a biosimilar, demonstrate bioequivalence to the innovator.

However, we are not aware

of any existing or pending regulations or legislation that pertains to generic radiopharmaceutical products such as our antibody radiation-conjugate

product candidates

The biopharmaceutical industry

in which we operate, specifically, the field of oncology drug development is rapidly evolving and highly competitive.

Radiopharmaceuticals

for the treatment of cancer has received considerable interest from major and specialty pharmaceutical companies, biotechnology companies,

academic research institutions and other public and private entities, particularly in recent years.

For the targeted radiotherapies

we are developing, we face competition from biopharmaceuticals companies who are developing alpha particle-based therapies utilizing Actinium-225,

Radium-223 and Thorium-227.

Companies developing targeted alpha therapies include Bayer AG, who owns Xofigo, the only approved alpha therapy,

that is used in the treatment of metastatic prostate cancer, Novartis AG, Telix Pharmaceuticals Limited, Point Biopharma, Inc., Fusion

Pharmaceuticals, Inc., RayzeBio, Inc., Aktis Oncology, Curie Therapeutics, RadioMedix, Inc.

and Orano Med.

Significant attention and resources

is being applied to Ac-225 based therapies given its high linear energy and short path length.

Fusion Pharmaceuticals is studying FPI-1434,

targeting IFG-1R with Ac-225 in a Phase 1 trial in solid tumors and has recently initiated a Phase 1 study to test FGFR3 targeting agent

in development.

Point Biopharma is studying PNT2002, a PSMA targeting agent for metastatic prostate cancer in a Phase 1 trial, PNT2004,

a preclinical agent targeting solid tumors expressing FAP, and PNT2001, a preclinical agent also targeting PSMA in prostate cancer, which

all utilize Ac-225.

Novartis is also developing a PSMA targeting agent utilizing Ac-225 for prostate cancer.

RayzeBio, Aktis Oncology

and Curie Therapeutics are all pursuing Ac-225 based therapies but have not yet disclosed cancer targets or indications.

To our knowledge, our Actimab-A

product candidate is the only clinical stage Ac-225 based therapy in active development for hematologic indications.

There are also several companies

developing beta particle-based therapies such as Bayer, Novartis, Lantheus Holdings, Inc.

and Q BioMed, Inc., who all own approved products.

Beta particles used for oncology therapeutics includes Iodine-131, Lutetium-177, Strontium-89 and Yttrium-90.

Companies developing beta

particle-based therapies includes Cellectar Biosciences, Inc., Clovis Oncology, Inc., Y-mAbs Therapeutics, Inc., Ipsen S.A., and Novartis.

In the field of conditioning,

pharmaceuticals currently used for myeloablation prior to a bone marrow transplant, lymphodepletion prior to CAR-T and other adoptive

cell therapies and conditioning for gene therapy are largely generic, non-targeted chemotherapeutic agents like fludarabine or busulfan

and/or total body irradiation.

In targeted conditioning,

we face competition from companies developing agents targeting CD117 (Jasper Therapeutics and Magenta Therapeutics), CD45 (Magenta Therapeutics)

and CD66 (Telix Pharmaceuticals).

CD117 is expressed in normal CNS, GI, reproductive, kidney and skin tissue, which could result in on-target

toxicity to these organs.

CD117 is not expressed on mature circulating immune cells and thus cannot be targeted for lymphodepletion for

adoptive cell therapy.

Jasper Therapeutics, Inc, is developing JSP191, an anti-CD117 unconjugated monoclonal antibody that is being studied

in a Phase 1b trial in combination with fludarabine and total body irradiation in patients with MDS and AML.

Magenta has initiated a Phase

1/2 trial for its MGTA-117 CD117 ADC and will conduct this first in human dose finding study in patients with r/r AML MDS with excess

blasts and is exploring MGTA-117 for gene therapy conditioning in preclinical studies.

Magenta is also developing its CD45 ADC, which

is has not yet been studied in humans and is being evaluated in IND enabling studies.

Forty Seven, Inc.(acquired

by Gilead) announced a conditioning regimen comprised of its anti-CD47 monoclonal antibody Magrolimab with its preclinical stage FSI-174

anti-CD117 monoclonal antibody in a preclinical collaboration with bluebird bio, Inc.

for conditioning prior to gene therapy.

Molecular Templates announced

a collaboration with Vertex focused on targeted conditioning using its Engineered Toxin Bodies (ETBs) with two targets that were not disclosed.

In October 2021, Vertex terminated the research collaboration with Molecular Templates.

Molecular Templates has a preclinical stage CD45

ETB in development.

Telix Pharmaceuticals is developing

TLX66, a CD66 targeting antibody radio conjugated with Yttrium-90, for BMT conditioning in patients with Systemic Amyloid Light-Chain

Amyloidosis (SALA).

TLX66 is also being studied in a Phase 2 investigator sponsored trial in the U.K in patients with childhood leukemia.

Allogene Therapeutics is developing

an anti-CD52 monoclonal antibody for use as a lymphodepletion agent in conjunction with CAR-T therapies.

CD52 is not expressed on stem

cells and therefore cannot be used for myeloablation for a bone marrow transplant.

To our knowledge, we are the

only company with an anti-CD45 radio conjugate in clinical development and the only company with a targeted conditioning agent that has

completed enrollment of a pivotal Phase 3 trial.

Our Actimab-A product candidate

faces competition from several major pharmaceutical companies and biotechnology companies who are also developing multiple types of therapies

including chemotherapy, targeted agents, ADCs, monoclonal antibodies, bispecific antibodies, immunotherapies and cellular therapies for

patients with AML.

The standard of care for patients with AML has long been “7+3”, which is 7 days of treatment with cytarabine

with an anthracycline on the first 3 days for patients who can tolerate intensive therapy and hypomethylating agents, azacitidine or decitabine,

for patients who are “unfit” and cannot tolerate intensive therapy.

Since 2017, 9 agents have been approved for patients with

These approved agents include Vyxeos (liposomal cytarabine and daunorubicin) owned by Jazz Pharmaceuticals, venetoclax, a Bcl-2 inhibitor

owned by Abbvie, FLT3 inhibitors midostaurin (owned by Novartis) and gilteritinib (owned by Astellas), Daurismo, a hedgehog pathway inhibitor

owned by Pfizer, IDH inhibitors Tibsovo (IDH1) and Idhifa (IDH2) owned by Servier, Onureg (oral azacitidine) owned by Bristol Myers Squibb

and Mylotarg, a CD33 targeting ADC owned by Pfizer.

These agents are approved in

various AML patient segments including secondary or treatment related AML (Vyxeos), patients over the age of 75 or patients unfit for

intensive therapy (venetoclax and Daurismo) and patients with a specific cytogenetic mutation such as FLT3 or IDH1/2.

Despite these 9

approved agents, outcomes for patients with r/r AML remain dismal and it remains an area of high medical need that could accommodate many

new products with favorable safety and efficiency profiles.

We are pursuing CD33 because

it is expressed in virtually all patients with AML.

AML is known to be highly sensitive to radiation, which lends itself to our targeted

radiotherapy approach.

Also, AML has high cytogenetic and mutational heterogeneity, which targeted radiotherapy is agnostic to.

therapies are commonly used in hematologic indications, but we believe we are the only clinical stage Ac-225 based product candidate that

is being explored in hematologic indications in combination with other modalities, including with the salvage chemotherapy regimen CLAG-M

in fit patients with relapsed or refractory AML as well as in combination with the Bcl-2 inhibitor venetoclax in fit and unfit patients

with relapsed or refractory AML.

In addition to developing

targeted radiotherapies, we also own patents related to the manufacturing of Ac-225 in a cyclotron.

Medical grade Ac-225 is largely supplied

Department of Energy (“DOE”) derived from the natural decay of thorium-229 from so-called “thorium-cows”.

Additional routes of Ac-225 production are being pursued by the DOE including the generation of new thorium cows and production via a

cyclotron to increase supply.

The DOE’s cyclotron production method for Ac-225 production leverages Actinium’s proprietary

technology and know-how and presents an additional path towards production of high-quality Ac-225.

Previously, we utilized our cyclotron

production IP to create highly pure Ac-225.

We are aware of at least six other government and non-government entities globally that have

or expect to have ability to supply Ac-225 using various methods including ITM, Niowave, Terrapower, NorthStar Medical Radioisotopes,

IONETIX Corporation, TRIUMF and Canadian Nuclear Laboratories that could be competitors should we elect to manufacture Ac-225 in the future.

We believe our cyclotron method has the potential to produce robust amounts of highly pure Ac-225, which could address potential future

Ac-225 supply constraints should multiple Ac-225 products gain regulatory approval.

Strategic Collaborations and Licensing Agreements

Fred Hutchinson Cancer Research Center

On June 15, 2012, the Company entered into a license

and sponsored research agreement with FHCRC to build upon previous and ongoing clinical trials with Iomab-B.

Developed at the FHCRC, a

pioneer in the field of BMT, Iomab-B has been studied in over 400 patients and is supported by data in six disease indications including

leukemias, lymphomas and multiple myeloma.

The Company has been granted exclusive rights to the antibody and related master cell

bank developed by FHCRC.

A milestone payment of $1 million will be due to FHCRC upon FDA approval of the first drug utilizing the licensed

Upon commercial sale of the drug, royalty payments of 2% of net sales will be due to FHCRC.

In April 2022, Actinium licensed the EUMENA commercial

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

Immedica has significant know-how and experience

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

sales and marketing, market access, regulatory and medical affairs, drug safety and quality assurance, among others.

Actinium received

an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty

percent royalties.

The market potential is extremely compelling in the EU with approximately 50% larger with 15,000 patients with r/r

AML and double the number of BMTs performed than in the US.

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

positive Scientific Advice from the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA.

National Cancer Institute

In February 2023, we announced that Actinium entered

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

Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to

study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing

additional support as needed.

The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy,

immunotherapy, targeted agents and other novel combinations.

The CRADA studies will be overseen by NCI in collaboration with Actinium's

clinical development team.

Astellas, LG Chem, and EpicentRx

We are leveraging our clinical experience, robust

IP and radiotherapy know-how through research collaborations.

Our collaborations with Astellas, LG Chem and EpicentRx establish our work

with immunotherapies and in solid tumors.

Through our research collaborations, such as with Astellas, we are advancing into solid tumors

With Astellas, we are utilizing a diagnostic agent developed in parallel with a therapeutic agent that shares the same target

to identify patients who would benefit from the treatment.

Our platform is being utilized in our ongoing

research collaboration with Astellas to arm select targeting agents owned by Astellas with the alpha-emitting radioisotope Ac-225 for

the development of theranostics for solid tumor indications, which combine the ability of radioisotopes to be used for both diagnostic

and therapeutic purposes.

We are also exploring novel targeted radiotherapies

in solid tumors and blood cancers such as HER3 expressing solid tumors in collaboration with LG Chem and combinations with immunotherapies

such as CD47 immune checkpoint inhibitors with EpicentRx.

The biopharmaceutical industry is extremely competitive

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

Our competition is likely to come from larger

pharmaceutical companies, biotechnology companies, academia, and other public and private entities that focus on three broad areas relevant

to our pipeline candidates – AML drugs, conditioning agents and radiopharmaceuticals.

In addition, in markets where we are going

after a target, companies with research programs and capabilities in our disease area focus may also be competing with our programs and

In AML, the pipeline is crowded with 100+ programs, however, there

are a few Phase 3 assets with limited potential that do not represent an imminent, competitive threat to Iomab-B or Actimab-A.

the Phase 2 development programs in AML show the promise of producing high rates or duration of remission, and most patients that relapse

tend to have poor survival outcomes.

The Phase 2 assets primarily consist of agents targeting specific AML mutations, immunotherapies,

or cell cycle modulators.

Early clinical and preclinical stage assets consist of more cell therapy and immune cell engagers, and the potential

success of these modalities in AML remain uncertain.

Our strategy is to develop Actimab-A in combination with other products, and the

agents in the development pipeline have the potential for synergies in combination with Actimab-A.

In conditioning, agents currently used for

myeloablation prior to a BMT, lymphodepletion prior to CAR-T and other adoptive cell therapies and reduced intensity conditioning

for gene therapy are largely generic, non-targeted chemotherapeutic agents.

Recently, Jasper Therapeutics and Magenta Therapeutics

ceased development of their antibody and antibody-drug conjugate or ADC conditioning programs for BMT.

Certain companies such as Vertex

Pharmaceuticals (“Vertex”), Gilead Sciences (“Gilead”) and Allogene Therapeutics (“Allogene")

have or continue to explore non-chemotherapy conditioning with ADCs and antibodies for their in-house, proprietary cellular therapy

For example, Vertex has in-licensed ImmunoGen Inc.’s ADC technology, and had a collaboration with Molecular

Templates, Inc.

to develop targeted conditioning agents, which was subsequently terminated.

Allogene is using its own proprietary

anti-CD52 monoclonal antibody for use as a lymphodepletion agent in conjunction with CAR-T therapies.

Telix Pharmaceuticals has

announced plans for a conditioning program based on a CD66 radiotherapeutic approach in systemic amyloid light-chain amyloidosis

(“SALA”) via an early stage investigator sponsored trial.

Without exception, all these companies have either preclinical

or early-stage programs that are solely focused on their proprietary programs.

We believe that we are the only company with a phase

3 completed targeted conditioning asset that has demonstrated clinical benefit with the opportunity to be paradigm-changing.

Several companies are focused on developing radiotherapies, including,

but not limited to:

Abdera Therapeutics, Aktis Oncology, Bayer AG, Convergent Therapeutics, CuraSight, Fusion Pharmaceuticals, Inc., Lantheus

Holdings, Inc., Mariana Oncology (previously, Curie Therapeutics), Monopar Therapeutics, Novartis AG, Point Biopharma, Inc., RadioMedix,

Inc., Radiopharm Theranostics, Radionetics Oncology, RayzeBio, Inc., Q BioMed, Inc., Telix, and Y-mAbs Therapeutics, Inc.

Government Regulation

Governmental authorities in

the United States and other countries extensively regulate, among other things, the research, development, testing, manufacture, labeling,

promotion, advertising, distribution and marketing of radioimmunotherapy pharmaceutical products such as those being developed by us.

In the United States, the FDA regulates such products under the Federal Food, Drug and Cosmetic Act (“FDCA”) and implements

Failure to comply with applicable FDA requirements, both before and after approval, may subject us to administrative and

judicial sanctions, such as a delay in approving or refusal by the FDA to approve pending applications, warning letters, product recalls,

product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.

Food and Drug Administration Regulation

Our research, development

and clinical programs, as well as our manufacturing and marketing operations, are subject to extensive regulation in the United States

and other countries.

Most notably, products that may in the future be sold in the United States are subject to regulation by the FDA.

Certain of our product candidates in the United States will require FDA approval of a BLA prior to marketing.

Foreign countries may require

similar or more onerous approvals to manufacture or market these products.

FDA Approval Process for Biologics License

Prior to testing a biological

product on humans, the product must clear the preclinical testing stage.

The goal of preclinical testing is to perform laboratory evaluations

of the product’s chemistry and formulation as well as evaluate the product’s potential for adverse events by performing in

vitro and animal studies.

This information is packaged together and submitted to the FDA as part of an investigational new drug (“IND”)

application, which must be approved by the FDA before administering the product to human subjects in clinical trials.

From there, the product moves

to the clinical stage, where it is administered to healthy volunteers or patients.

The data gathered from the preclinical testing and

clinical trials is used to support the BLA submission.

The FDA must approve the BLA prior to commercial marketing of a biological product.

The BLA must include information about product development, laboratory and animal studies, human trials, manufacturing information, the

composition of the product, and proposed labeling.

The approval process requires significant time and financial resources and does not

guarantee that FDA will accept the BLA filing or ultimately approve the BLA.

The Prescription Drug User

Fee Act, as amended (“PDUFA”), requires each BLA to be accompanied by a substantial user fee.

The amount of the user fee changes

on an annual basis.

In addition to the BLA user fee, PDUFA also imposes an annual program fee for biological products.

The FDA will waive

or reduce the fee under limited circumstances, such as for first applications filed by small businesses.

Within 60 days following submission

of the BLA, the FDA reviews the BLA submission for completion to determine if it will accept it for filing.

The FDA may refuse to file

the BLA if it deems the submission incomplete or not properly reviewable at the time of submission.

For the BLA review process to proceed,

the BLA must be resubmitted with the necessary additional information.

After the BLA is accepted for filing, the FDA commences its substantive

review of the BLA.

The FDA reviews the BLA to determine, among other things, whether the proposed product is safe, potent, and/or effective

for its intended use, has an acceptable purity profile, and whether the product’s manufacturing is consistent with current Good

Manufacturing Processes (“cGMPs”) to ensure that the product meets the appropriate standards for identity, safety, strength,

Regulatory Compliance

Our research and development activities are all

subject to stringent regulation, primarily by the FDA in the U.S.

under the Federal Food, Drug, and Cosmetic Act (the “FDCA”)

and its implementing regulations, and the Public Health Service Act (“PHSA”) and its implementing regulations, and by comparable

authorities under similar laws and regulations in other countries.

This includes research and development, testing, and oversight of suppliers

and contract manufacturers involved in the production of our product candidates we are developing, as well as the design, manufacturing,

safety, efficacy, handling, labeling, storage, record-keeping, advertising, promotion and marketing.

If, for any reason, we do not comply

with applicable requirements, such noncompliance can result in adverse consequences, including delays in approval of, or even the refusal

to approve, product licenses or other applications, the suspension or termination of clinical investigations, the revocation of approvals

previously granted, as well as fines, criminal prosecution, recall or seizure of products, injunctions against shipping products and suspension

of production and/or refusals of government contracts.

FDA Review Process and Product Approval

Our product candidates are regulated as biologics

and must be approved by the FDA before they may be marketed in the U.S.

This process generally involves the following:

● 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.

Clinical trials generally are conducted in three

sequential phases, although they may overlap or be combined.

● Phase 1 studies are designed to evaluate the safety, dosage tolerance, metabolism and pharmacologic actions

of the investigational product in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on

effectiveness

● Phase 2 studies are conducted to preliminarily or further evaluate the effectiveness of the investigational

product for a particular indication(s) in patients with the disease or condition under study, to determine dosage tolerance and optimal

dosage, and to identify possible adverse side effects and safety risks associated with the product

● Phase 3 clinical trials generally involve a large number of patients at multiple sites designed to provide

the data required to demonstrate the effectiveness of the product for its intended use, safety and to establish the benefit-risk relationship

of the product and provide an adequate basis for product labeling

The results of the preclinical and clinical testing,

along with information regarding the manufacturing of the product and proposed product labeling, are evaluated and, if determined appropriate,

submitted to the FDA through a BLA.

Once the BLA submission has been accepted for filing, the FDA’s standard goal is to review applications

within ten months of the filing date or, if the application relates to a drug that treats a serious condition and would provide a significant

improvement in safety or effectiveness qualifying for Priority Review, six months from the filing date.

The review process is often significantly

extended by FDA requests for additional information or clarification.

The FDA offers certain programs, such as Breakthrough Designation (“BTD”)

and Fast Track designation, designed to expedite the development and review of applications for products intended for the treatment of

a serious or life-threatening disease or condition.

For BTD, preliminary clinical evidence of the product indicates that it may demonstrate

substantial improvement over existing therapies on one or more clinically significant endpoints.

The FDA may initiate review of sections

of a BLA before the application is complete, and the product may be eligible for accelerated approval.

However, receipt of BTD or Fast

Track designation does not ensure that a product will be developed or approved on an expedited basis, or at all.

The FDA reviews the BLA to determine, among other

things, whether the proposed product is safe, pure and potent, which includes determining whether it is effective for its intended use,

and whether the product is being manufactured in accordance with cGMP, to assure and preserve the product’s identity, strength,

quality, potency and purity.

The FDA may involve an advisory

committee for novel biological products that present complex questions of safety or efficacy.

The advisory committee typically consists

of a panel that includes clinicians and other subject matter experts that assist with the reviewing and evaluating the product.

the advisory committee provides a recommendation for whether the product should be approved and under what conditions, the FDA is not

bound to follow the recommendations.

However, the advisory committee’s recommendations are usually given significant consideration.

The FDA may also consider

requiring a risk evaluation and mitigation strategy (“REMS”) if it determines that one is necessary to ensure that the biological

product is used safely.

If the FDA requires a REMS, the BLA sponsor must develop and submit a proposed REMS for the BLA review process

to move forward.

The manufacturer of the biological

product is also subject to FDA inspection prior to the approval of the BLA.

The purpose of the inspection is to determine whether the

manufacturer adequately complies with the applicable cGMP requirements to ensure that the biological product is manufactured safely and

within the required specifications.

Additionally, the FDA may choose to inspect one or more clinical sites to assess compliance with IND

trial requirements and good clinical practices (“GCPs”).

Compliance with cGMP and GCP requirements involves significant expenditures

of time, money, and effort for BLA sponsors due to associated training, recordkeeping, production, and quality control needs.

If the FDA decides not to

approve the BLA in the form submitted, it will issue what is called a complete response letter that outlines the specific deficiencies

it would like to see addressed.

The deficiencies identified can be minor (e.g., labeling changes) or major (e.g., the need for additional

clinical trials).

The complete response letter may also include recommended actions the applicant may take to move closer towards securing

At this point, applicants may choose to resubmit the BLA to address FDA’s concerns or withdraw the application.

In addition, under the Pediatric

Research Equity Act, a BLA or supplement to a BLA must contain data to assess the safety and effectiveness of the product 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 FDA may grant deferrals for submission of data or full or partial waivers.

The FDA may refer an application to an advisory committee for review, evaluation and recommendation as to

whether the application should be approved, and applications for new molecular entities and original BLAs are generally discussed at advisory

committee meetings unless the FDA determines that this type of consultation is not needed under the circumstances.

After the FDA evaluates the BLA and conducts inspections of manufacturing

facilities, it may issue an approval letter or a complete response letter (“CRL”).

An approval letter authorizes commercial

marketing of the biologic with specific prescribing information for specific indications.

A CRL indicates that the review cycle of the

application is complete, but the FDA cannot grant approval.

A CRL may require additional inspections, and/or other significant, expensive

and time-consuming requirements related to clinical trials, preclinical studies or manufacturing.

The FDA could approve the BLA with a

Risk Evaluation and Mitigation Strategy (“REMS”) to mitigate risks, which could include medication guides, physician communication

plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

The FDA also may condition approval on, among other things, changes to proposed labeling, development of adequate controls and specifications,

or a commitment to conduct one or more post-market studies or clinical trials.

Such post-market testing may include Phase 4 clinical trials

and surveillance to further assess and monitor the product’s safety and effectiveness after commercialization.

Post-Approval Requirements

If the BLA is approved, the

FDA may include additional conditions as part of its approval, such as limiting the approval by designating specific diseases for which

the product may be used.

Additionally, conditions may include requiring the labeling to include specific contraindications, warnings,

or precautions, requiring post marketing clinical trials (sometimes referred to as Phase 4 clinical trials), and implementation of surveillance

program to monitor the approved product once commercialized.

Products approved by the FDA

under a BLA are subject to ongoing regulatory requirements, including, among other things, record-keeping requirements, adverse event

reporting requirements, responsibility for reporting updated safety and efficacy information to FDA, sampling and distribution requirements,

complying with advertising and promotion requirements, and complying with cGMPs.

Quality control and manufacturing

procedures must continue to comply with cGMP requirements even after the BLA is approved.

The cGMP regulations include, but are not limited

to, requirements to ensure quality control, maintain appropriate manufacturing records and documentation, and the obligation to investigate

and address deviations from cGMPs, when identified.

Manufacturers are also required to register their establishments with the FDA and

certain state agencies.

The establishments are also subject to unannounced inspections by regulators.

The advertising and promotion

of drug and biologic products are also subject to specific laws and regulations.

These authorities provide standards for direct-to-consumer

advertising, restrictions on promoting products for uses or to patient populations that are not described in the product’s approved

uses, known as “off-label” use, limitations on industry-sponsored scientific and educational activities, and requirements

for promotional activities involving the internet.

Regulatory Enforcement

Failure to comply with applicable

regulatory requirements can result in enforcement action by the FDA, the Nuclear Regulatory Commission or other regulatory authorities,

which may result in sanctions, including but not limited to, untitled letters, warning letters, fines, injunctions, consent decrees and

civil penalties;

customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;

operating restrictions

or partial suspension or total shutdown of production;

refusing or delaying our requests for BLA premarket approval of new products or

modified products;

withdrawing BLA approvals that have already been granted;

and refusal to grant export.

Additional Healthcare Laws

In addition to FDA regulations,

several other types of state and federal laws may restrict our business activities, including certain healthcare laws.

These laws include,

without limitation, anti-kickback laws, false claims laws, data privacy and security laws, as well as transparency laws regarding payments

or other items of value provided to healthcare providers.

The federal Anti-Kickback

Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce or in

return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item, good, facility or service

reimbursable under Medicare, Medicaid or other federal healthcare programs.

The term “remuneration” has been broadly interpreted

to include anything of value.

This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on the one

hand and prescribers, purchasers and formulary managers on the other hand.

Although there are a number of statutory exceptions and regulatory

safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exceptions and safe harbors are

drawn narrowly and arrangements must meet every element to qualify for an exception or safe harbor.

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 arrangement will be evaluated on a case-by-case basis based on the facts and circumstances involved.

Courts have interpreted the statute’s intent requirement to mean that if any one purpose of an arrangement involving remuneration

is to induce referrals of federal healthcare program business, the federal Anti-Kickback Statute has been violated.

Additionally, the

intent standard under the federal Anti-Kickback Statute was amended by the Patient Protection and Affordable Care Act of 2010, as amended

by the Health Care and Education Reconciliation Act of 2010, collectively the “Affordable Care Act,” to a stricter standard

such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have

committed a violation.

In addition, the Affordable Care Act codified case law that a violation of the federal Anti-Kickback Statute constitutes

a false or fraudulent claim for purposes of the federal False Claims Act.

Federal false claims laws,

including the federal False Claims Act, and civil monetary penalties laws, prohibit any person or entity from, among other things, knowingly

presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made,

a false statement to have a false claim paid.

Whistleblower or qui tam provisions under the False Claims Act permit whistleblowers to

sue in the name of the federal government for False Claims Act violations, and to share in the recovery from any award.

Pharmaceutical

and other healthcare companies have been prosecuted under these laws for, among other things, allegedly inflating drug prices they report

to pricing services, which in turn were used by the government to set Medicare and Medicaid reimbursement rates, and for allegedly providing

free product to customers with the expectation that the customers would bill federal programs for the product.

In addition, certain marketing

practices, including off-label promotion, may also violate false claims laws.

The federal Health Insurance

Portability and Accountability Act of 1996, or HIPAA, created additional federal civil and criminal statutes that prohibit among other

actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private

third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal

investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up 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.

Like the federal Anti-Kickback Statute, the Affordable Care Act amended the intent standard for certain healthcare fraud under HIPAA such

that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed

In addition, if we engage

in certain activities, we may be subject to data privacy and security regulation under HIPAA, as amended by the Health Information Technology

for Economic and Clinical Health Act, or HITECH.

HIPAA imposes certain requirements on covered entities, which include certain healthcare

providers, health plans and healthcare clearinghouses, and their business associates and covered subcontractors that receive or obtain

protected health information in connection with providing a service on behalf of a covered entity that involves the use or disclosure

of individually identifiable health information.

Additionally, the federal

Physician Payments Sunshine Act, created under the Affordable Care Act, and its implementing regulations, require certain manufacturers

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

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

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

Beginning in 2022, applicable

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

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

midwives during the previous year.

The majority of states also

have statutes or regulations similar to the aforementioned federal healthcare laws, including fraud and abuse laws, some of which are

broader in scope and apply to items and services reimbursed under Medicaid and other state programs, or, in some states, apply regardless

of the payor.

Many states also have some form of health information privacy or data security laws that could apply.

Further, some state

laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant

compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related to

payments or other transfers of value provided to physicians and other healthcare providers and entities, marketing expenditures, or drug

Certain state and local laws also require the registration of pharmaceutical sales representatives.

If our operations are found

to be in violation of any of the healthcare regulatory laws described above or any other laws that apply to us, we may be subject to potentially

significant criminal, civil and administrative penalties, damages, fines, disgorgement, imprisonment, additional reporting obligations

and oversight (if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with

these laws), exclusion from participation in government healthcare programs, as well as contractual damages, reputational harm, administrative

burdens, diminished profits and future earnings, and the curtailment or restructuring of our operations, any of which could adversely

affect our ability to operate our business and our results of operations.

As of March 25, 2022, we have

32 full-time employees including 20 with M.D., Ph.D.

or other advanced degrees.

We believe that our future

success largely depends upon our continued ability to attract and retain highly skilled employees.

We provide our employees with competitive

salaries and bonuses, opportunity for equity ownership, development programs that enable continued learning and growth, and an employment

package that promotes wellness across all aspects of their lives, including healthcare, retirement planning, and paid time off.

these employees are covered by a collective bargaining agreement, and we believe our relationship with our employees is good.

engage consultants on an as-needed basis to supplement existing staff.

Recent Developments

Impact of COVID–19 Pandemic

The global health crisis

caused by the novel coronavirus COVID-19 pandemic and its resurgences has and may continue to negatively impact global economic activity,

which, despite progress in vaccination efforts, remains uncertain and cannot be predicted with confidence.

In addition, the Omicron variant

of COVID-19, which appears to be the most transmissible variant to date, has spread globally.

The full impact of the Omicron variant,

or any subsequent variant, cannot be predicted at this time, and could depend on numerous factors, including vaccination rates among

the population, the effectiveness of COVID-19 vaccines against the Omicron variant and the response by governmental bodies and regulators.

Given the ongoing and dynamic nature of the circumstances, it is difficult to predict the impact of the COVID-19 pandemic on our business.

Many countries around the

world have continued to impose quarantines and restrictions on travel and mass gatherings to slow the spread of the virus.

our ability to continue to operate our business may also be limited.

Such events may result in a period of business, supply and drug

product manufacturing disruption, and in reduced operations, any of which could materially affect our business, financial condition and

results of operations.

In response to COVID-19, we implemented remote working and thus far have not experienced a significant disruption

or delay in our operations as it relates to the clinical development of our drug candidates.

Such government-imposed precautionary measures

may have been relaxed in certain countries or states, but there is no assurance that more strict measures will be put in place again

due to a resurgence in COVID-19 cases, including those involving new variants of the coronavirus, which may be more contagious and deadly

than prior strains.

Therefore, the COVID-19 pandemic may continue to affect our operation, may further divert the attention and efforts

of the medical community to coping with COVID-19 and disrupt the marketplace in which we operate and may have a material adverse effect

on our operations.

A continuation or worsening

of the levels of market disruption and volatility seen in the recent past could have an adverse effect on our ability to access capital,

which could in the future negatively affect our liquidity.

In addition, a recession or market correction resulting from the spread of

COVID-19 could materially affect our business and the value of our common stock.

We believe our earlier stage

CD33 clinical trials will continue to recruit and enroll patients given the acute nature of relapsed or refractory AML.

The continuation

of the pandemic could adversely affect our planned clinical trial operations, including our ability to conduct the trials on the expected

timelines and recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened

exposure to COVID-19 if their geography is impacted by the pandemic.

Further, the continuation and/or resurgence of the COVID-19 pandemic

could result in delays in our clinical trials due to prioritization of hospital resources toward the pandemic, restrictions in travel,

potential unwillingness of patients to enroll in trials at this time, or the inability of patients to comply with clinical trial protocols

if quarantines or travel restrictions impede patient movement or interrupt healthcare services.

In addition, we rely on independent clinical

investigators, contract research organizations and other third-party service providers to assist us in managing, monitoring and otherwise

carrying out our preclinical studies and clinical trials, and the pandemic may affect their ability to devote sufficient time and resources

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

clinical trials.

Additionally, COVID-19 may

result in delays in receiving approvals from local and foreign regulatory authorities, delays in necessary interactions with IRB’s

or Institutional Review Boards, local and foreign regulators, ethics committees and other important agencies and contractors due to limitations

in employee resources or forced furlough of government employees.

To date, COVID-19 has not

had a financial impact on our company.

We continue to monitor the impacts of COVID-19 on the global economy and on our business operations.

Although we expect that vaccinations for COVID-19 will continue to improve conditions, the ultimate impact from COVID-19 on our business

operations and financial results during 2022 will depend on, among other things, the ultimate severity and scope of the pandemic, including

the new variants of the virus, the pace at which governmental and private travel restrictions and public concerns about public gatherings

will ease, the rate at which historically large increases in unemployment rates will decrease, if at all, and whether, and the speed with

which the economy recovers.

We are not able to fully quantify the impact that these factors will have on our financial results during

2022 and beyond.

Any products manufactured or distributed by us

or on our behalf pursuant to FDA approvals are subject to continuing regulation by the FDA and certain state agencies, including requirements

for record-keeping, reporting of adverse experiences with the biologic, submitting biological product deviation reports to notify the

FDA of unanticipated changes in distributed products, establishment registration, compliance with cGMP standards, and certain state licensing

requirements.

Additionally, any significant change in the approved

product or in how it is manufactured, including changes in formulation or the site of manufacture, generally require prior FDA approval.

The packaging and labeling of all products developed by us are also subject to FDA approval and ongoing regulation.

Noncompliance with

any regulatory requirements can result in, among other things, issuance of warning letters, civil and criminal penalties, seizures, and

injunctive action.

Accordingly, manufacturers must continue to maintain compliance with cGMP and other aspects of regulatory compliance.

The commercial distribution of prescription drugs is subject to the Drug Supply Chain Security Act (“DSCSA”), which regulates

the distribution of the products at the federal level and sets certain standards for federal or state registration and compliance of entities

in the supply chain.

The DSCSA preempts certain previously enacted

state laws and the pedigree requirements of the Prescription Drug Marketing Act (“PDMA”).

Trading partners within the drug supply

chain must now ensure certain product tracing requirements are met, and are required to exchange transaction information, transaction

history, and transaction statements.

Product identifier information (an aspect of the product tracing scheme) is also now required.

DSCSA requirements, development of standards, and the system for product tracing have been and will continue to be phased in over a period

of years through 2023.

In addition to new legislation, FDA regulations, guidance documents, and policies are often revised or reinterpreted

by the agency in ways that may significantly affect our business and our product candidates.

Orphan Drug Act

We have received Orphan Drug designation for Iomab-B

and Actimab-A for patients with AML.

Under the Orphan Drug Act, FDA may grant Orphan Drug designation to drugs intended to treat a rare

disease or condition, which is generally defined as a disease or condition that affects fewer than 200,000 individuals in the U.S.

Drug designation must be requested before submitting a BLA.

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

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

Orphan Drug designation does

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

The first BLA applicant to receive

FDA approval for a particular active ingredient to treat a particular disease with FDA Orphan Drug designation is entitled to a seven-year

exclusive marketing period in the U.S.

for that product, for that indication.

During the seven-year exclusivity period, FDA may not approve

any other applications to market the same drug for the same orphan indication, except in limited circumstances, such as a showing of clinical

superiority to the product with orphan exclusivity or where the manufacturer of the approved product cannot assure sufficient quantities.

As a result, there can be no assurance that our competitors will not receive approval of drugs or biologics that have a different active

ingredient for treatment of the diseases for which our products and product candidates are targeted.

Pediatric Information

Under the Pediatric Research Equity Act (“PREA”),

certain BLAs must contain data to assess the safety and efficacy of the drug or biologic for the claimed indications in all relevant pediatric

subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.

The Food and Drug Administration Safety and Innovation Act (“FDASIA”), amended the FDCA to require that a sponsor who is planning

to submit a marketing application for a drug that includes a new active ingredient, new indication, new dosage form, new dosing regimen

or new route of administration submit an initial Pediatric Study Plan (“PSP”) within 60 days of an end of Phase 2 meeting

or, if there is no such meeting, as early as practicable before the initiation of the Phase 3 or Phase 2/3 study.

The initial PSP must

include an outline of the pediatric study or studies that the sponsor plans to conduct or a justification for not including such detailed

information, and any request for a deferral of pediatric assessments or a full or partial waiver.

The FDA may grant deferrals for submission

of pediatric data or full or partial waivers.

A sponsor can submit amendments to an initial PSP if changes to the pediatric plan need

to be considered based on preclinical data collected, early phase clinical trials as well as other clinical development programs.

Foreign Regulation

In addition to regulations in the U.S., we are

subject to foreign regulations governing clinical trials and commercial sales and distribution of our product candidates, and products

being marketed outside of the U.S.

We must obtain approval by the comparable regulatory authorities of foreign countries before we can

commence clinical trials or marketing of our products in those countries.

The approval process varies from country to country, and the

time may be longer or shorter than required by the FDA for BLA licensure.

The requirements governing the conduct of clinical trials, product

licensing, pricing and reimbursement vary greatly from country to country.

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

requirements.

Other Regulatory Considerations

We are also subject to regulation under the Occupational

Safety and Health Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, The Clean Air Act, and other current

and potential future federal, state, or local regulations.

Our research and development activities involve the controlled use of hazardous

materials, chemicals, biological materials and various radioactive compounds.

We believe that our procedures comply with the standards

prescribed by state and federal regulations;

however, the risk of injury or accidental contamination cannot be completely eliminated.

We may also be subject to healthcare regulation and enforcement by the federal government and the states and foreign governments where

we may market our products and product candidates, if approved.

These laws and regulations include, without limitation, state and federal

anti-kickback, fraud and abuse, false claims, data privacy and security, aggregate spend reporting, and product price advertising.

The federal Anti-Kickback Statute, which prohibits,

among other things, persons and entities including pharmaceutical manufacturers from knowingly and willfully soliciting, receiving, offering

or paying remuneration, directly or indirectly, overtly or covertly, in case or in kind, to induce or reward, or in return for, or either

the referral of an individual for, or the purchase, lease or order or recommendation of an item or service reimbursable, in whole or in

part, under a federal healthcare program, such as the Medicare and Medicaid programs.

The failure to meet all of the requirements of a

particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its

facts and circumstances.

In addition, Patient Protection and Affordable

Care Act of 2010, as amended (“ACA”) codified cash law that a claim including items or services resulting from a violation of

the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act (“FCA”).

The FCA prohibits individuals or entities from, among other things, knowingly presenting or causing the presentation of a claims payment

to, or approval by, the federal government that are false, fictitious or fraudulent, or knowingly making, using or causing to be made

or used, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money

to the federal government.

Our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting

of prices used to calculate Medicaid rebate information and other information affecting federal, state and third-party reimbursement for

our products, and the sale and marketing of our products, are subject to scrutiny under the FCA.

State statutes and regulations equivalent

or substantially similar to the federal laws may extend to items and services reimbursed by commercial insurers and/or by patients directly.

State law equivalents to the Anti-Kickback Statute and False Claims Act may not have adopted exceptions and safe harbors available at

the federal level and therefore, may implicate a broader range of activities.

The federal Health Insurance Portability and Accountability

Act of 1996 (“HIPAA”) imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute,

a scheme to defraud or obtain, by any means of false or fraudulent pretenses, representations or promises, any money or property owned

by, or under the control or custody of, any healthcare benefit program, including private third-party payors, and knowingly and willfully

falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent

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

The federal physician payment transparency

requirements, sometimes referred to as the “Physician Payments Sunshine Act,” created under the ACA, and its implementing

regulations, which requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available

under Medicare, Medicaid or the State Children’s Health Insurance Program (with certain exceptions) to annually report to the Department

of Health and Human Services (“HHS”), information related to certain payments or other transfers of value made or distributed

to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and

teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

legislation, the Sunshine Act will extend to payments and transfers of value to physician assistants, nurse practitioners, and other mid-level

healthcare providers.

The Centers for Medicare and Medicaid Services (“CMS”) has the potential to impose penalties for violations

of the Sunshine Act, depending on the circumstances, and payments reported under the Sunshine Act also have the potential to draw scrutiny

on payments to and relationships with physicians and teaching hospitals, which may have implications under the Anti-Kickback Statute and

other healthcare laws.

We may also be subject to data privacy and security

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

HIPAA, as amended by the Health

Information Technology and Clinical Health Act of 2009 (“HITECH”) and their respective implementing regulations, imposes, among

other things, obligations, including mandatory contractual terms with respect to safeguarding the privacy, security and transmission of

individually identifiable health information held by certain healthcare providers, health plans and healthcare clearinghouses, known as

covered entities, and business associates.

The HHS Office of Civil Rights (“OCR”) has increased its focus on compliance and

continues to train state attorneys general for enforcement purposes.

Even where HIPAA does not apply, according to the U.S.

Federal Trade

Commission (“FTC”), failing to take appropriate steps to keep consumers’ personal information secure constitutes unfair acts

or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act (“FTCA”), 15 U.S.

Medical data is considered sensitive data that merits stronger safeguards.

There are numerous other laws and legislative

and regulatory initiatives at the federal and state levels addressing privacy and security concerns, and some state privacy laws apply

in broader circumstances than HIPAA.

We are subject to the U.S.

Foreign Corrupt Practices

Act (“FCPA”), which prohibits corporations and individuals from engaging in certain activities to obtain or retain business

or to influence a person working in an official capacity.

Our present and future business has been and will continue to be subject to

various other laws and regulations.

Human Capital

As of March 31, 2023, we had 49 full-time employees,

17 of whom have Ph.D.

degrees and 22 of whom are engaged in research and development and clinical development activities.

that we have been successful to date in attracting skilled and experienced personnel despite the competitive hiring marketing in the industry.

Our employees are not covered by a collective bargaining agreement, and we believe that our relationship with our employees is excellent.

We continue to engage external consultants on an as-needed basis to temporarily supplement existing staff.

Corporate Information

We were incorporated under the laws of the State

of Delaware in 2013.

Our principal executive offices are located at 275 Madison Avenue, New York, NY 10016, and our telephone number is

(646) 677-3870.

Our website address is www.actiniumpharma.com.

The information contained on our website or that can be accessed through

our website is not considered part of this report.

We make available free of charge through our website

our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any such amendments to those reports

as soon as reasonably practicable after we electronically file such material with or furnish such material to the Securities and Exchange

Commission (“SEC”).

The SEC maintains a website at http://www.sec.gov that contains reports, proxy and information statements

and other information regarding companies that file electronically with the SEC.

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