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Item 2. Management’s Discussion and Analysis

2024-04-26 compared with 2023-11-02 · 852 added, 737 removed, 445 unchanged (78% of the section changed)

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FORWARD-LOOKING STATEMENT NOTICE

This Form 10-Q contains certain

forward-looking statements.

For this purpose, any statements contained in this Form 10-Q that are not statements of historical fact may

be deemed to be forward-looking statements.

This Quarterly Report on Form 10-Q contains certain forward-looking

For this purpose, any statements contained in this Quarterly Report on Form 10-Q that are not statements of historical fact

may be deemed to be forward-looking statements.

Without limiting the foregoing, words such as “may,” “will,”

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Description of Business

Actinium Pharmaceuticals,

(“Actinium”) develops targeted radiotherapies intended to meaningfully improve survival for patients with relapsed or

refractory cancer who have failed existing therapies.

Our vision is to build a specialty, hospital-focused, radiotherapeutics company

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

Actinium Pharmaceuticals, Inc.

(“Actinium” or the “Company”)

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

existing therapies.

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

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

We are deploying our technology platform,

which we believe to be industry-leading, and intellectual property, with over 235 issued and pending patents worldwide, to develop ARCs,

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

Pipeline Highlights

We intend to leverage the clinical data of our lead product candidates,

Iomab-B and Actimab-A, to potentially improve outcomes in patients with relapsed or refractory acute myeloid leukemia (“r/r AML”)

by launching two radiotherapy drugs over the next several years to address the significant need for better outcomes from treatment with

therapeutics or from undergoing a bone marrow transplant (“BMT”).

We intend to leverage the

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

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

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

We also intend to further

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for various other blood cancers.

Based on early 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.

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

and dismal survival.

Currently, a BMT is regarded as being able to provide the best treatment outcomes and 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.

Based on early clinical trial results, we are also working on a next-generation conditioning program,

Iomab-ACT, for rapidly growing cell and gene therapies.

Our Next Generation ARC Pipeline

AML is an aggressive, heterogeneous

disease that is difficult to treat.

Over 50% of AML patients develop relapsed or refractory disease within one year of being afflicted

and have an extremely poor prognosis and dismal survival.

Currently, a BMT is regarded as being able to provide the best treatment outcome

and is the only curative regimen available for AML patients, however, access is limited to less than 20% of all AML patients, as patients

must be fit enough to withstand the challenges associated with this treatment.

The majority of AML patients are considered not transplantable

in routine clinical practice as they are not fit enough to withstand the rigors of the patient journey, which includes therapy to attain

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

Our Iomab-B and Actimab-A

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at different parts of the patient journey.

Iomab-B is being developed as a targeted bridging therapy candidate that we believe could provide

both disease control and conditioning in one agent.

We believe results from our Phase 3 SIERRA trial demonstrate the possibility for unprecedented

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

We are developing Actimab-A as a targeted therapy candidate for fit patients.

Actimab-A has demonstrated an extension in survival in a

proof-of-concept study and is poised for advanced development in collaboration with the NCI, or National Cancer Institute (“NCI”).

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

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

Iomab-B, an ARC that is comprised of the anti-CD45 apamistamab and the radioisotope iodine-131

(“I-131”), is being developed as a targeted bridging therapy candidate that we believe could provide both disease control

and conditioning in one agent.

We believe the results from our Phase 3 Study of Iomab-B in Elderly Relapsed or Refractor AML “SIERRA

trial” demonstrate the possibility for unprecedented access to a BMT and improved survival in unfit patients who are currently not

considered transplantable in routine clinical practice.

We are developing Actimab-A, an ARC comprised of the anti-CD33 lintuzumab and

the radioisotope actinium-225 (“Ac-225”), as a targeted therapy candidate for fit patients.

Actimab-A has demonstrated an

extension in survival in a proof-of-concept study and is poised for advanced development and program expansion in collaboration with the

National Cancer Institute (“NCI”).

Together, we believe these two product candidates could provide us the opportunity to transform

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

Iomab-B was evaluated in the

pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractor AML, or “SIERRA trial” with Iomab-B meeting the primary

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

In February 2023,

we announced full SIERRA trial results, demonstrating unprecedented transplant access and improved outcomes in patients with r/r AML,

with double 1-year and median overall survival (“OS”) compared to control arm patients.

These data were presented at the 2023

Tandem Meetings aka the Transplantation & Cellular Therapy (“TCT”) Meetings of the American Society for Transplantation

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

We believe these results from the SIERRA trial may provide the opportunity, if we are able to obtain U.S.

Food and Drug Administration

(“FDA”) approval, to establish Iomab-B as a potentially new standard of care.

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

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

and nursing congresses.

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

communities as we prepare for potential commercialization subject to FDA approval.

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

significance (p<0.0001).

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

improved outcomes in patients with r/r AML, with double 1-year and median overall survival (“OS”) compared to control-arm

These data were presented at the 2023 Tandem Meetings aka the Transplantation & Cellular Therapy (“TCT”) Meetings

of the American Society for Transplantation and Cellular Therapy (“ASTCT”) and the Center for International Blood & Marrow

Transplant Research (“CIBMTR”).

We believe these results from the SIERRA trial may provide the opportunity, if we are able

to obtain U.S.

Food and Drug Administration (“FDA”) approval, to establish Iomab-B as a potential new standard of care.

The results from the SIERRA

trial have been and are expected to be presented at the most prestigious and high-impact bone marrow transplant and hematology medical

conferences, nuclear medicine conferences and nursing congresses.

This wide exposure is helping broaden the awareness of Iomab-B among

members of these relevant medical and scientific communities as we and our partner Immedica Pharma AB (“Immedica”) prepare

for potential commercialization in the US and European, Middle East and North Africa (“EUMENA”) region subject to FDA and

marketing authorization application (“MAA”) approvals, respectively.

Including TCT, the SIERRA Phase 3 results have now been

highlighted in oral presentations at seven international medical conferences in the U.S.

and EU attended by key Iomab-B stakeholders including

bone marrow transplant physicians, hematologists and nuclear medicine physicians.

Previous and expected Iomab-B SIERRA trial data presentations

● Oral Presentation:

European Society for Blood

and Marrow Transplantation (“EBMT”) 49 th Annual Meeting, April 2023

● Oncology Nursing Society (“ONS”)

48 th Annual Congress, April 2023

● Oral Presentation:

European Hematology Association

(“EHA”) 2023 Hybrid Congress, June 2023

● Oral Presentation:

Society for Nuclear Medicine

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

We believe that the medical

and scientific communities present at these events took note of the positive SIERRA clinical trial results, safety and tolerability of

Iomab-B and the successful administration of Iomab-B infusions at various BMT centers, which was done without increasing radiation exposure

risks to treating nursing staff.

highlighted in oral presentations at several U.S.

and European bone marrow transplant, hematology, nuclear medicine and nursing conferences

attended by key Iomab-B stakeholders, including bone marrow transplant physicians, hematologists and nuclear medicine physicians.

Iomab-B SIERRA trial data presentations

European Society for Blood and Marrow Transplantation (“EBMT”) Annual Meeting, 2023 and 2024

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

European Hematology Association (“EHA”) Hybrid Congress,

2023 and 2024

Society for Nuclear Medicine and Molecule Imaging (“SNMMI”)

Annual Meeting, 2023 and 2024

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

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

65 th Annual American Society of Hematology (“ASH”) Meeting & Exposition, December 2023

2023 and 2024 Tandem Meetings | Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR

We believe that the medical and scientific communities present at these

events took note of the positive SIERRA clinical trial results and their potential positive impact in treating elderly r/r AML patients,

the safety and tolerability of Iomab-B and the successful administration of Iomab-B infusions at various BMT centers, which was done without

increasing radiation exposure risks to treating nursing staff.

The SIERRA results were awarded the Henry N.

Wagner, Jr., Abstract of the Year award at SNMMI, representing

the top selection out of more than 1,500 abstracts accepted for presentation, which we believe highlights the recognition by the nuclear

medicine community.

Recent Iomab-B SIERRA trial data presentations

● Oral Presentation:

European Association of Nuclear

Medicine (“EANM”) 2023 Congress, September 10, 2023

● Society of Hematologic Oncology

(“SOHO”) 2023 Annual Meeting, September 6, 2023

Upcoming Iomab-B SIERRA trial data presentations

● Oral Presentation:

American Society of Hematology

Annual Meeting & Exposition, December 10, 2023

The data accepted for oral

presentation at ASH on December 10, 2023, will detail survival outcomes of patients with a TP53 mutation enrolled on the SIERRA trial,

highlighting improved survival in patients who received Iomab-B.

As disclosed in the ASH abstract published on November 2, 2023, a total

of 37 patients (24.2%) enrolled on the SIERRA trial had a TP53 mutation with 17 patients randomized to the Iomab-B arm and 20 patients

randomized to the control arm of the study.

Median Overall Survival for TP53 negative patients receiving Iomab-B was 6.37 months and 5.72

months for TP53 positive patients, demonstrating Iomab-B’s ability to overcome TP53 gene mutations.

The median overall survival

of TP53 positive patients on the control arm, including patients who crossed over and received Iomab-B, was 2.96 months.

When analyzing

all TP53 positive patients who received Iomab-B, either after initial randomization or crossover, median overall survival was 5.49 months

compared to 1.66 months in patients that did not receive Iomab-B, hazard ratio= 0.23 (p=0.0002).

We are working towards completing

and submitting our Biologics License Application (“BLA”) for Iomab-B to the FDA, and if approved, we intend to commercialize

Iomab-B in the U.S.

We have been meeting with the FDA regarding our BLA strategies, and have received positive feedback regarding the

Chemistry, Manufacturing and Controls (“CMC”) package for Iomab-B.

The Company, as a continuation of our regulatory interactions

with the FDA, will request a meeting prior to completion of the CMC package to further discuss the clinical and non-clinical modules that

will determine the finalization and timing of our planned BLA filing.

As a result of the CMC meeting, as well as updated project timelines

necessitated by the now complete facility modifications at one of our third-party manufacturers, the Company is progressing with completion

of CMC activities and believes it is on track to complete the CMC modules and be in a position to submit a BLA filing in the first half

The Early Access Program for Iomab-B is also anticipated to start post completion of these activities.

We simultaneously plan

to bring Iomab-B to patients globally and are working with Immedica Pharma AB (“Immedica”), our European, Middle East and

North Africa (“EUMENA”) partner, for the marketing authorization application (“MAA”) of Iomab-B with the European

Medicines Agency (“EMA”).

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

performed in Europe compared to the U.S.

Actimab-A is being developed

under what we believe to be the current industry-leading clinical-study program utilizing the potent alpha radiation emitting isotope

Actinium-225 (“Ac-225”) with clinical data in approximately 150 patients treated over six clinical trials.

The potent linear

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

Actimab-A is being developed in combination with other regimens including

chemotherapies and targeted agents to exploit potential 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.

Wagner, Jr., Abstract of the

Year award at the 2023 SNMMI Annual Meeting, representing the top selection out of more than 1,500 abstracts accepted for presentation,

which we believe highlights the recognition by the nuclear medicine community.

Iomab-B SIERRA trial data

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

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

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

had a TP53 mutation with 17 patients randomized to the Iomab-B arm and 20 patients randomized to the control arm of the study with 10

of these patients crossing over to receive Iomab-B.

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

for TP53 positive patients.

In the control arm (including crossover patients), the median OS for TP53 positive patients was 2.96 months.

Iomab-B was shown to significantly improve outcomes in TP53 positive patients (initial randomization and crossover patients) with a median

OS of 5.49 months versus 1.66 months in patients that did not receive Iomab-B (hazard ratio 0.23, p-value=0.0002).

These results for patients

with a TP53 mutation were also presented in an oral presentation at the EBMT 50 th Annual Meeting in Glasgow, UK on April 17,

2024 and are expected to be presented in an oral presentation at EHA being held June 13 through June 16, 2024, in Madrid, Spain.

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

presentations and three poster presentations.

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

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

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

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

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

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

successful donor chimerism was presented.

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

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

We continue to advance our

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

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

We conducted a successful meeting with the FDA

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

been assigned a BLA number.

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

sections of our BLA package prior to submitting our BLA filing and we continue to expect to hold this meeting in the second quarter of

As part of the MAA filing process, Immedica has conducted meetings to review the SIERRA trial clinical and CMC data with its rapporteur

and co-rapporteur, representatives of EU member states designated to lead the evaluation of an MAA application, and following those meetings

Immedica is proceeding with its MAA filing for Iomab-B.

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

approval for Iomab-B in 2025.

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

patients with r/r AML globally.

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

compared to the United States.

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

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

We are also working on a next-generation conditioning program, Iomab-ACT,

for the rapidly growing cell and gene therapy market.

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

study with Memorial Sloan Kettering Cancer Center (“MSKCC”) using single agent Iomab-ACT as conditioning in place of traditional

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

with relapsed or refractory B-cell acute lymphoblastic leukemia (“ALL”) or diffuse large B-cell lymphoma (“DLBCL”).

consistent CD45 expression on select immune and hematopoietic cells leads to potent lymphodepletion and reduced cytokine release syndrome

(“CRS”) and immune effector cell–associated neurotoxicity syndrome (“ICANS”) with a single dose administered

in an outpatient setting.

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

In April 2024, we announced

an Investigational New Drug (“IND”) application for a new clinical trial that will study Iomab-ACT as targeted conditioning

prior to patients receiving an FDA approved commercial CAR-T therapy.

This trial will be conducted at the University of Texas Southwestern

and to our knowledge, is the first trial to evaluate a targeted radiotherapy conditioning regimen with a commercial CAR-T therapy.

We have an industry-leading

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

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

The potent linear energy transfer emitted by Ac-225

has no known resistance mechanism.

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

agents utilizing its potential mechanistic synergies.

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

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

We believe our Actimab-A +

CLAG-M therapeutic combination trial results in r/r AML, presented in an oral presentation at ASH in December 2022 validate this approach.

Phase 1 results from the Actimab-A + CLAG-M combination trial showed high response rates and minimal residual disease (“MRD”)

negativity, translating to a survival benefit of 53% and 32% at one and two years in patients who are typically expected to live two to

On September 6, 2023, updated survival data from the Actimab-A + CLAG-M combination trial was presented at SOHO with 30-month

median Overall Survival (“OS”) reported in patients with prior venetoclax treatment who proceeded to BMT and 24-month median

OS in all patients who proceeded to BMT following Actimab-A + CLAG-M treatment.

We have also presented 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 in February 2023, to develop Actimab-A for the treatment of patients with AML and

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

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

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

who are typically expected to live two to four months.

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

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

+ CLAG-M treatment.

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

In 2023, we announced the

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

other hematologic malignancies.

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

with FLT3 inhibitors gilteritinib and midostaurin at SOHO.

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

aggressive disease with poor outcomes.

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

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

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

The CRADA studies will be overseen by the NCI in collaboration

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

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

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

We expect the NCI

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

Our Phase 1 data showed the

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

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

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

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

with aggressive disease with poor outcomes.

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

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

We believe these results support

continued evaluation of the combination with the goal of advancing to clinical trials.

Based on this data update, Actinium expects to

initiate the late-stage development of Actimab-A, including a potential pivotal trial, in combination as a backbone therapy for r/r AML

under the CRADA with the NCI and the NCI expects to meet with the FDA in the first quarter of 2024 to finalize a pivotal trial design.

To explore the potential for

a broader development opportunity with our Actimab-A program, we are studying the potential use of Actimab-A in solid tumor indications

through our R&D efforts.

CD33-expressing myeloid derived suppressor cells (“MDSCs”) are present within the tumor microenvironment

and exert immunosuppressive effects.

In April 2023, we presented preclinical data at the Association for Cancer Research (“AACR”)

Annual Meeting that depicted Actimab-A’s role in the tumor microenvironment to overcome immunosuppression driven by MDSCs.

that our findings thus far show Actimab-A’s potential to selectively deplete MDSCs in lung and colorectal cancer.

Actimab-A also

demonstrated superior depletion of human MDSCs compared to Mylotarg, a CD33-targeted antibody-drug conjugate (“ADC”) in colorectal

cancer (p<0.01), highlighting the powerful cytotoxicity and potential therapeutic benefit of radiotherapy compared to naked antibodies

Additional preclinical data evaluating Actimab-A for the targeting of MDSCs has been accepted for presentation at the Society

of Immunotherapy of Cancer (“SITC”) 38 th Annual Meeting on November 4, 2023.

We believe that the data we have

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

antitumor activity of immunotherapies and other therapeutic modalities.

Our differentiated R&D

efforts are 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”).

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

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

Our platform has been

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

Preclinical pharmacology studies with our

targeted radiotherapeutics directed at validated cancer targets including HER3, HER2, CD33 and CD38, have shown strong improvement

in tumor growth inhibition in various preclinical tumor models as single agents or in combination with targeted agents and

immunotherapy such as checkpoint inhibitors including magrolimab, an anti-CD47 monoclonal antibody.

These results have prompted our

team to spearhead efforts in multiple solid tumor programs.

Our intellectual property

(“IP”) portfolio includes over 220 issued patents and pending patent applications worldwide.

With approximately $82.9 million

cash on hand as of September 30, 2023, we expect to fund operations through 2025 as we continue to drive ahead in executing our strategy

to realize our vision.

CD33-expressing myeloid derived suppressor cells, (“MDSCs”),

are present within the tumor microenvironment and exert immunosuppressive effects.

In April 2023, we presented preclinical data at the

Association for Cancer Research (“AACR”) Annual Meeting that depicted Actimab-A’s role in the tumor microenvironment

to overcome immunosuppression driven by MDSCs.

We believe that our findings show that Actimab-A has the potential to selectively deplete

MDSCs in lung, colorectal and other cancers.

Actimab-A also demonstrated statistically significant depletion of human MDSCs compared to

Mylotarg ® , a CD33-targeted antibody-drug conjugate (“ADC”) in colorectal cancer (p<0.01), highlighting the

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

Actimab-A demonstrates the

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

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

At the Society of Immunotherapy of Cancer (“SITC”)

38 th Annual Meeting on November 4, 2023, data was presented highlighting Actimab-A’s unique ability to target and

deplete MDSCs and restore T-cell proliferation and effector response.

SPECT/CT imaging confirmed uptake of Actimab-A in a humanized non-small

cell lung cancer model, indicating enrichment of CD33+ MDSCs in the tumor microenvironment.

We believe that the data continues to support

our objective to demonstrate the potential for Actimab-A to be a backbone therapy to broadly improve antitumor activity of immunotherapies

and other targeted therapeutic modalities.

To realize the broader development

potential for Actimab-A, we are exploring its role as a maintenance therapy for various indications through our research and development

(“R&D”) efforts.

Despite advances in therapeutics, a major concern remains, with relapse risk greater than 50% for adults

with high-risk AML.

The goal of maintenance therapy is to improve overall survival and eradicate MRD.

Having demonstrated 72% MRD negativity

rate in r/r AML patients who received Actimab-A + CLAG-M and achieved CR/CRi (Complete Remission with incomplete count recovery), we aim

to develop a treatment strategy in the maintenance setting utilizing Actimab-A alone or in various combinations.

Our ARC product candidates are intended to combine the targeting ability

of monoclonal antibodies (“mAb”) with the cell-killing ability of radioisotopes.

Our ARC product candidates target antigens

that are expressed on certain cancer cell types and are able to destroy cellular DNA and kill these cells with the energy that they emit.

We are deploying our technology platform, which we believe to be industry-leading, and intellectual property, with over 235 issued patents

and pending patent applications worldwide, to develop ARCs and next-generation targeted radiotherapies that we intend to be ideally suited

for particular disease indications and patient populations.

We are working on several preclinical programs that include novel approaches

to validated cancer targets, as well as novel targets that show immense potential for radiotherapeutic approaches.

We have several ongoing

programs in solid tumors at the pre-clinical stage with investigational new drug (“IND”) enabling studies underway.

collaborations with large pharmaceutical and biotech companies such as Astellas Pharma Inc.

(“Astellas”), AVEO Oncology/LG

Chem (“LG Chem”), and EpicentRx, Inc.

(“EpicentRx”) established our work with immunotherapies and in solid tumors

in 2023 and years prior.

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

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

Market Opportunity

Actinium aims to be a leader in the development of ARCs for hematologic

malignancies or blood cancers with a late-stage, multi-asset pipeline focused on this potentially high-value market.

Hematologic malignancies

have an outsized share of oncology drug sales.

Across all expected cancer incidences in 2024, only 11% are expected to be in hematologic

indications with the other 89% being solid tumor indications.

However, drugs for hematologic cancer indications account for 31% of the

top fifty oncology drug sales and four of the top ten oncology drugs by revenue are for hematologic cancer indications.

Actinium, if we

are able to obtain eventual FDA approval, is uniquely positioned with two of only four targeted radiotherapies for hematologic malignancies,

as approximately 90% of the clinical stage radiopharmaceutical industry pipeline is focused on solid tumors, with approximately 65% of

these focused on four solid tumor targets.

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 journey.

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 11 new approved therapies since 2017, no significant advancements have been made toward a cure and there

is an important unmet medical need for better therapeutics, which 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

Today, less than 20% of all

AML patients and less than 5% of r/r AML patients are able to access a BMT, currently the only potentially curative option.

Most patients

receiving BMT are fit, in remission and able to withstand the challenges associated with this treatment, leaving the large majority of

AML patients ineligible for transplant.

This provides an opportunity for Iomab-B, which has demonstrated the ability to enable unfit patients

to benefit from a BMT.

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.

Iomab-B has also demonstrated the ability to improve

BMT access with extended survival and potentially curative outcomes in several other hematological diseases outside of AML.

Several clinical

trials in over 300 patients with myelodysplastic syndromes (“MDS”), acute lymphocytic leukemia (“ALL”), Hodgkin’s

lymphoma (“HL”), Non-Hodgkin lymphoma (“NHL”) and multiple myeloma (“MM”) have demonstrated the same

value proposition as in AML.

This data provides a potential opportunity to expand the market for Iomab-B beyond AML via label expansion.

In the U.S., there are approximately 185,000 patients diagnosed annually with blood cancers (e.g., leukemia, lymphoma, and myeloma) that

are treatable with BMT, of which, approximately 20,000 are transplanted, leaving greater than 165,000 patients who could potentially benefit

from transplant.

These patients do not receive a BMT today primarily because they are unfit with active disease and are not considered

eligible, as they cannot tolerate the rigors of therapy required to induce a remission and the conditioning agents required to ablate

the marrow prior to a BMT.

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

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

utilized in different parts of the patient treatment journey.

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

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

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

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

This provides

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

The incidence of AML is approximately

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

and the disease has an outsized economic impact relative to its population size.

In a retrospective analysis of commercial payer data

published in the Journal of Managed Care & Specialty Pharmacy, total mean episode costs for patients with r/r AML were approximately

$439 thousand, with hospitalization as the largest contributor to cost.

Over 50% of patients diagnosed with AML will develop relapsed

or refractory disease, with a median age of 68 years at diagnosis.

In the U.S., Iomab-B can potentially expand the market from the approximately

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

11 new approved therapies since 2017, no significant advancements have been made toward a cure and there is an important unmet medical

need for better therapeutics, which provides the opportunity for Actimab-A.

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.

and the five largest

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

there is the potential market opportunity to address more than 85 thousand r/r AML patients, as shown above.

Globally, the number of BMTs

performed has doubled in the last 10 years, with an estimated ~70 thousand allogeneic BMTs performed annually.

Europe represents 40% of

BMTs, the largest share of any continent globally.

Similar to the U.S., we believe the EUMENA market opportunity for Iomab-B has favorable

commercial dynamics where the majority of the estimated 7,200 BMTs performed in AML patients (approximately twice the number of BMTs performed

in the U.S.) are concentrated in major centers that treat the majority of patients in each country and region.

Iomab-B has also demonstrated

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

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

Hodgkin’s lymphoma (“HL”), Non-Hodgkin lymphoma (“NHL”) and multiple myeloma (“MM”) have demonstrated

the same value proposition as in AML.

This data provides a potential opportunity to expand the market for Iomab-B beyond AML via label

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

myeloma) that are treatable with BMT, of which, approximately 20,000 are transplanted, leaving greater than 165,000 patients who could

potentially benefit from transplant.

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

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

required to ablate the marrow prior to a BMT.

Beyond BMT, the opportunity

exists for better conditioning in other areas of cellular therapy, such as CAR-T as well as gene therapies.

The pipeline of CAR-T and gene

therapies has rapidly expanded, with the addressable patient population expected to nearly double in the next one to five years and reach

approximately 93,000 patients in the U.S.

by 2030 based on the current pipeline of cellular therapies.

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.

will continue to develop Iomab-ACT, our lower dose, next generation conditioning program for rapidly growing cell and gene therapies based

on early promising results, ultimately with the value proposition of improving overall access and outcomes for patients who need cellular

or gene therapies.

The pipeline of CAR-T and

gene therapies has rapidly expanded, with the addressable patient population expected to nearly double and reach approximately 93,000

patients in the U.S.

by 2030 based on the current pipeline of therapies.

The CAR-T market size in terms of revenue is estimated to grow

at a CAGR of approximately 11% over the next 5 plus years.

Currently, there are six CAR T-cell therapies approved by the FDA that are

used to treat patients with lymphomas, leukemia and multiple myeloma, which collectively had total sales over $3.5 billion in 2023.

addressable market for Iomab-ACT is in line with the patient population for cellular therapy as all patients receive conditioning of some

type prior to these treatments.

We will continue to develop Iomab-ACT, our next-generation conditioning program for rapidly growing cell

and gene therapies based on early promising results, ultimately with the value proposition of improving overall access and outcomes for

patients who need cellular or gene therapies.

We believe an opportunity exists for Iomab-ACT to potentially generate significant revenue,

if it can provide one or more clinical benefits related to lower CRS, less neurotoxicity, longer duration of response or a higher overall

success rate of cellular therapy due to benefits of targeted conditioning.

Actinium’s strategy

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the primary delivery of care occurs in large comprehensive cancer care centers, is the appropriate strategy for our company.

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.

that the cell-killing power of linear energy transfer delivered via radiotherapeutics is unmatched by other technologies and we believe

relapsed/refractory disease is an area where radiotherapeutics can succeed over other approaches.

However, radiotherapeutics must be delivered

on a just-in-time basis, and commercial and supply chain barriers are higher than with other types of medicines.

The validity of our approach

is demonstrated by our product development strategy as well as the commercial and operating model that we are building for our lead ARC

product candidates, Iomab-B and Actimab-A.

We intend to transform the

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r/r AML outcomes in a complementary manner

The operating model

We believe the operating model

required to achieve our vision is attractive for several reasons, including the concentrated point of care;

the top 50 transplant

centers account for approximately 75% of BMTs and the top 100 hospitals treat over 50% of r/r AML patients.

Further, there is

significant overlap in the healthcare providers and ecosystem required to diagnose, treat and care for r/r AML patients within these

hospitals, which we believe will enable us to deploy a relatively small commercial organization and operate an appropriately sized

supply chain.

the top 50 transplant centers

account for approximately 75% of BMTs and the top 100 hospitals treat over 50% of r/r AML patients.

Further, there is significant overlap

in the healthcare providers and ecosystem required to diagnose, treat and care for r/r AML patients within these hospitals, which we believe

will enable us to deploy a relatively small commercial organization and operate an appropriately sized supply chain.

Our product pipeline is targeting

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

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

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

a commercial partner.

Our strategic priorities are to:

a stage of disease where treatment is again concentrated in large hospital s,

which account for a significant portion of patients.

We believe our strategy will enable us to build a successful company with high operating

efficiencies and is feasible to achieve without requiring a commercial partner.

strategic priorities are to:

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

intend to file a BLA in the first half of 2024 based on the positive results from the Pivotal

Phase 3 SIERRA trial and successful regulatory interactions with the FDA.

We intend to leverage

our operating track record at key cancer centers to build an organization that can effectively

commercialize Iomab-B.

By virtue of the SIERRA trial, we have established operations at 24

leading BMT centers in the U.S (22) and Canada (2) that represent about 30% of transplant

volume and have strong working partnership with Key Opinion Leaders (“KOLs”)

and their teams.

The SIERRA results demonstrating unprecedented access to BMT and outcomes

along with our commitment to operational excellence provides a strong foundation for our

commercial team in the U.S.

We will also work with our partner Immedica to support 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 (“MOA”) and exploit synergies in combination with other treatments to develop it as an AML backbone therapy.

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

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

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

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

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

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

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

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

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

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

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

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

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

We are studying Iomab-ACT in conditioning prior to CAR-T cellular therapy via a National Institutes of Health (“NIH”) grant that was recently extended to the Phase 2 portion to fund the ongoing clinical trial with Memorial Sloan Kettering Cancer Center (“MSKCC”).

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

Leverage our R&D capabilities

and technological prowess to advance our solid tumor programs and partnerships:

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.

capability is demonstrated by our patent portfolio with over 220 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 includes valuable know-how.

In keeping with our strategic vision over the next five years, we plan to first focus on ensuring an Iomab-B approval and successful launch into core BMT centers to support commercial success.

We intend to expand the Iomab-B label and revenue stream while progressing the development of Actimab-A by leveraging the NCI CRADA.

We will progress the development of Iomab-ACT to proof-of-concept and explore potential 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 positioned to develop them in line 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

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

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

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

our R&D capabilities and technological prowess to advance our solid tumor directed ARC

programs and partnerships

keeping with our strategic vision over the next several years, we plan to first focus on ensuring an Iomab-B approval and successful

launch into core BMT centers in the U.S.

and working with our partner Immedica to support its commercial success.

expand the Iomab-B label and its revenue stream while progressing the development of Actimab-A by leveraging the NCI CRADA.

We will endeavor

to progress the development of Iomab-ACT to proof-of-concept and explore potential partnerships as a means to achieve commercialization.

Our solid tumor programs are expected to progress toward the clinic as we continue to build out our commercial footprint into the top

100 hospitals, which we hope will position us to develop our ARCs in line with our vision.

With commercial dynamics aligning favorably

for a successful Iomab-B launch and with late-stage development of Actimab-A planned in collaboration with the NCI, we plan to deliver

on our mission to transform the treatment of AML and patient outcomes, and create a highly differentiated, specialty radiotherapeutics

company focused on the top 100 large hospitals.

Our ARC Pipeline

We have strategically focused

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

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 agent.

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

Our novel Antibody Radiation Conjugates or ARCs have

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

therapeutic and induction/conditioning agents for this purpose.

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

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

AML Focused ARC Programs – Iomab-B

and Actimab-A

Our 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 journey.

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

Our ARC product candidates,

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

different parts of the patient journey.

Iomab-B – Targeted ARC for Induction

and Conditioning.

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

survival prognosis

Opportunity to Change the Current Paradigm

for Accessing a BMT and Improving Outcomes

The current approach in

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

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

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

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

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

Iomab-B is a targeted therapy that provides

both disease control (induction) and conditioning in one agent and is well-tolerated even by UNFIT patients who typically are not

transplanted in routine practice today.

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

UNFIT patients in the relapsed or refractory setting.

A similar approach has also

been tried in the Phase 3 ASAP trial but with FIT patients.

However, to avoid confusion between the potential of the approaches used in

the ASAP and SIERRA trials, important distinctions between these trials are depicted in the graphic below.

The ASAP trial sought to demonstrate

non-inferiority between two non-novel approaches and found that outcomes similar to those of current practice could be achieved without

first getting a patient into remission before taking them to BMT by giving them sequential conditioning or treating them twice with non-targeted

chemotherapy agents that are typically used in this setting.

The current approach in preparing

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

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

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

As this approach requires patients

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

highly toxic, BMT is typically limited to FIT patients.

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

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

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

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

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

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

A trial conducted in Germany

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

an intensive, salvage chemotherapy-based regimen.

Scheitleg et al.

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

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

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

Results from the Randomized

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

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

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

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

typically used in this setting.

The ASAP approach is limited

to only FIT patients as the UNFIT patients treated in SIERRA could not tolerate ASAP’s highly toxic sequential conditioning approach.

Sequential conditioning is not novel as a similar trial to ASAP was conducted by the UK National Cancer Research Institute in 2019, which

did not show any benefit from this approach in high-risk AML and MDS patients (Craddock et al.

Augmented Reduced Intensity Regimen Does

Not Improve Post allogeneic Transplant Outcomes in Acute Myeloid Leukemia.

J Clin Oncol.

The SIERRA trial results therefore

can change the paradigm in transplant because non-transplantable patients in routine clinical practice can benefit from a transplant with

Iomab-B and have superior outcomes.

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

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

However, we believe the ASAP trial results support the use of Iomab-B, which is intended to enable patients with active r/r AML to proceed

directly to BMT, without first achieving CR with salvage induction chemotherapy.

By doing so, we seek to reduce the amount and severity

of toxicities, allowing patients to receive their BMT in better physical condition, reducing the need for in-patient hospital admissions,

providing a pharmacoeconomic benefit, increasing access to potentially curative BMT and improve patient outcomes.

We believe the SIERRA

trial results therefore can change the paradigm in transplant because non-transplantable patients in routine clinical practice can benefit

from a transplant with Iomab-B and could have superior outcomes.

While both approaches in these trials support increased access to BMT,

only Iomab-B is applicable to the UNFIT patients who comprise approximately 80% of r/r AML patients and can potentially expand the market

for transplant.

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

between these trials are depicted in the graphic below.

Schetelig et al.

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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 AML patients, a segment that represents approximately 50% of all AML patients and the majority not transplanted today.

We believe the SIERRA results

presented in the late-breaker session at the 2023 Tandem Meetings, support Iomab-B’s value proposition of enabling both improved

access and outcomes of a BMT, thereby providing a curative option for r/r AML patients, a segment that represents approximately 50% of

all AML patients and the majority not transplanted today.

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

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Iomab-B in r/r AML

The pivotal Phase 3 SIERRA

trial was a 153-patient, randomized, multi-center, controlled trial of Iomab-B in patients aged 55 and above with active r/r AML, who

were heavily pre-treated and had high-risk characteristics.

Patients enrolled had blast counts of 5% or greater in the marrow or circulating

blasts suggestive of active AML.

In this study, Iomab-B was compared to the control arm that allowed physician’s choice of over

20 available agents, including chemotherapies and/or targeted therapies such as venetoclax (BCL-2 inhibitor), FLT3 inhibitors, IDH inhibitors

and Mylotarg, reflecting current best treatment practices attempting to get patients to CR.

The control arm included recently approved

AML therapies that were added to the SIERRA protocol as they became available.

The crossover arm was designed in SIERRA for an equipoise

that offered Iomab-B to patients failing to achieve a CR on the control arm with an intent to rescue them by taking them to transplant.

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

Patients with active, r/r AML are not considered eligible

for BMT with current approaches and the SIERRA trial was the only randomized Phase 3 trial to offer BMT as a treatment option for this

patient population.

These patients would not be offered BMT in standard practice and therefore have dismal survival outcomes of two to

three months.

The primary endpoint of the SIERRA trial was dCR of 6-months and the secondary endpoints are OS and Event-Free Survival

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.

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

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

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

In this study, Iomab-B

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

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

practices attempting to get patients to CR.

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

as they became available.

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

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

Of note, SIERRA had highly restrictive optionality

for post-transplant maintenance.

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

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

These patients would not be

offered BMT in standard practice and therefore have dismal survival outcomes of two to three months.

The primary endpoint of the SIERRA

trial was dCR of 6-months and the secondary endpoints are OS and Event-Free Survival (“EFS”).

The comparison of OS in subjects

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

As seen in the graphic below,

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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, or a patient relapse or death.

a patient not achieving CR/CRp (Complete Remission with partial hematologic

recovery) or crossing over, patient not receiving BMT, or a patient relapse or death.

In the figure below comparing

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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

arm mainly represents patients who did not achieve a remission with salvage therapy and either crossed over to Iomab-B or went on to best

supportive care.

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in less than half the time compared to conventional care.

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 benefit.

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

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

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

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

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

patients having a long-term survival benefit.

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

in routine clinical practice can be successfully transplanted, administering myeloablative radiation with reduced intensity conditioning

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

Iomab-B – New Paradigm to Upend BMT

Access and Improve r/r AML Outcomes

At the 2024 Tandem Meetings,

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

highlighting improved survival in patients who received Iomab-B.

A total of 37 patients (24.2%) enrolled on the SIERRA trial had a TP53

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

Median OS for TP53

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

In the control arm (including crossover

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

Iomab-B was shown to significantly improve outcomes in TP53 positive

patients (initial randomization and crossover patients) with a median OS of 5.49 months versus 1.66 months in patients that did not receive

Iomab-B (hazard ratio 0.23, p-value=0.0002).

These results for patients with a TP53 mutation were also highlighted in an oral presentation

at the EBMT 50 th Annual Meeting in Glasgow, UK on April 17, 2024.

In a second oral presentation, data from the SIERRA trial

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

The data presented from the SIERRA trial highlight the opportunity for Iomab-B to provide better access and outcomes in these

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

Future Development and Life Cycle Management

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standard of care for patients with r/r AML.

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

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

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

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

We plan to commercialize Iomab-B

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

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 practice.

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

Iomab-B potentially unlocks value through getting patients safely to effective, potentially

curative transplants, with improved outcomes and a manageable safety and tolerability profile.

● Competition :

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

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

Concentrated Call Points :

While there have been multiple new product approvals in AML over the last several years, they primarily focus on addressing genetic mutations,

with limited competition in conditioning to increase access to BMT.

We do not see direct or indirect visible competition for Iomab-B

in the 5-to-10-year horizon to impair the commercial success of Iomab-B.

● Concentrated

Call Points :

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

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

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

The favorable commercial dynamics

for Iomab-B in the U.S.

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

The top 50 centers perform 75% of BMTs and

tend to be concentrated in metropolitan areas.

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

organization.

We believe the favorable commercial

dynamics for Iomab-B in the U.S.

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

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

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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.

In April 2022, Actinium exclusively

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

is solely responsible for the commercialization of the product.

Immedica has significant know-how and experience in commercializing niche

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

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

rights in the U.S.

and rest of the world.

Currently, there an estimated ~7,200 BMTs for

AML in EUMENA, two times that of the U.S., performed in a concentrated number of centers.

The incidence rate of AML in Europe is 3.7 per

100,000, or ~27,500 new patients per year.

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

$417 million USD in regulatory and sales milestones and mid-twenty percent royalties.

Iomab-B has been granted Orphan Drug Designation

by the EMA and has received positive Scientific Advice from EMA that the SIERRA trial can support a marketing authorization with filing

expected in 2024.

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

performed in a concentrated number of centers.

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

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

start of the SIERRA trial.

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

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

Background on Iomab-B

Iomab-B is a first-in-class

targeted radiotherapy consisting of apamistamab, an anti-CD45 mouse antibody conjugated to radioactive iodine 131 (“I-131”)

designed to deliver targeted myeloablative radiation to malignant and hematopoietic cells prior to allogeneic BMT.

CD45 is uniquely expressed

on blood cancer, immune and bone marrow stem cells at high levels.

Targeting CD45 enables delivery of high radiation doses directly to

the bone marrow, with a median of 16 gray and as high as 44.6 gray in the SIERRA trial, while minimizing radiation exposure to vital organs

such as lungs, heart and gastrointestinal 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.

Iomab-B has been granted Orphan Drug Designation from the FDA and has patent protection into 2037.

Actimab-A – CD33 targeting radiotherapeutic

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

radiation to malignant and hematopoietic cells prior to allogeneic BMT.

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

stem cells at high levels.

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

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

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

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

Developed at the

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

lymphomas, MDS, and MM.

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

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

Iomab-B has been

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

Actimab-A – CD33 targeting ARC –

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

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

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

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

There is no known resistance mechanism

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

The scientific rationale is to use

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

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

Actimab-A has demonstrated

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

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

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

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

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

Actimab-A has demonstrated clinically significant survival benefit

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

We expect the NCI to initiate further

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

Actimab-A + CLAG-M Phase 1 Study Results

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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 2022 ASH Annual Meeting.

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

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.

In this difficult-to-treat

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

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

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

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

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

As highlighted in the figure below, the results

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

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

Actimab-A + CLAG-M –Response and Survival

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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

On September 6, 2023, updated survival data from the Actimab-A + CLAG-M combination trial was presented at SOHO with 30-month

median Overall Survival (“OS”) reported in patients with prior venetoclax treatment who proceeded to BMT and 24-month median

OS in all patients who proceeded to BMT following Actimab-A + CLAG-M treatment.

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

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

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

In patients who received a transplant,

the median OS was 24 months or more.

Actimab-A + venetoclax Phase 1/2 Study Results

10 unchanged sentences

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.

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

we are investigating various approaches to further evaluate the safety and efficacy of Actimab-A in combination with venetoclax and HMA

in newly diagnosed AML patients.

Further Development for Actimab-A

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

and the CRADA is expected to provide 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.

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 program.

By year-end we expect to provide updates on our progress as we move into late-stage development with Actimab-A

+ CLAG-M, as well as other developments with our venetoclax combination trial as part of our backbone development strategy.

We are exploring the broader

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

CD33-expressing

MDSCs are present within the tumor microenvironment and exert immunosuppressive effects, and we believe that Actimab-A can play an important

role in the tumor microenvironment by depleting MDSCs in a targeted manner.

In April 2023, we presented data at the AACR Annual Meeting

that we believe support the potential role of Actimab-A to overcome immunosuppression by MDSCs in the tumor microenvironment.

our preclinical findings show promise with regard to Actimab-A’s ability to selectively deplete CD33-expressing MDSCs in both lung

and colorectal cancer, which we intend to explore further via clinical development.

Actimab-A also demonstrated superior depletion of

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

therapeutic benefit of radiotherapy compared to naked antibodies or ADCs.

MDSCs are ubiquitous across multiple cancer indications and

with the substantial number of immunotherapies in development or currently in clinical use, we believe our data may support the potential

for Actimab-A, if ultimately approved for commercialization for such indication, to be a backbone therapy that could broadly improve antitumor

activity of immunotherapies such as checkpoint inhibitors and T and NK cell therapies and other therapeutic modalities in multiple solid

tumor indications.

Additional preclinical data evaluating Actimab-A for the targeting of MDSCs has been accepted for presentation at the

Society of Immunotherapy of Cancer (“SITC”) 38 th Annual Meeting on November 4, 2023.

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

targeted agents and other novel combinations.

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

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

This broad collaboration

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

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

the scope of its development in r/r AML.

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

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

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

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

CD33-expressing MDSCs are present within the

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

by depleting MDSCs in a targeted manner.

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

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

We believe our preclinical findings show promise

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

we intend to explore further via clinical development.

Actimab-A also demonstrated statistically significant depletion of human MDSCs

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

potential therapeutic benefit of radiotherapy compared to naked antibodies or ADCs.

Actimab-A demonstrates the advantages of ARCs over

ADCs by utilizing the power of radiation, against which cells have no known resistance or repair mechanism.

Radiation can cause double

stranded breaks in DNA which lead to cancer cell death.

MDSCs are ubiquitous across multiple cancer indications and with the substantial

number of immunotherapies in development or currently in clinical use, we believe our data may support the potential for Actimab-A, if

ultimately approved for commercialization for such indication, to be a backbone therapy that could broadly improve antitumor activity

of immunotherapies such as checkpoint inhibitors and T and NK cell therapies and other therapeutic modalities in multiple solid tumor

Additional preclinical data evaluating Actimab-A for the targeting of MDSCs was presented at the SITC 38 th Annual

Meeting on November 4, 2023, highlighting Actimab-A’s ability to target and deplete MDSCs and restore T cell proliferation and effector

SPECT/CT imaging confirmed uptake of Actimab-A in a humanized non-small cell lung cancer model, indicating enrichment of CD33+

MDSCs in the tumor microenvironment.

SPECT/CT imaging confirmed uptake of Actimab-A in a humanized non-small cell lung cancer model, indicating

enrichment of CD33+ MDSCs in the tumor microenvironment.

Background on Actimab-A

Actimab-A is an anti-CD33

antibody linked to the potent alpha-emitting radioisotope Ac-225.

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

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

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.

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

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

CD33 development program is driven by data obtained from approximately 150 AML patients in six trials and demonstrated single agent activity

with high response rates, but was also associated with prolonged neutropenia.

A combination strategy was considered appropriate given

the changing treatment landscape of AML;

hence, based on presumed mechanistic synergies, an investigator-initiated trial of Actimab-A

+ CLAG-M and a company-sponsored Actimab-A + venetoclax were developed and patients were enrolled into these studies.

Actimab-A, an ARC comprised

of the anti-CD33 antibody linked to the potent alpha-emitting radioisotope Ac-225.

Actimab-A targets CD33, which is expressed in virtually

all malignant cells in patients with AML regardless of cytogenetics or mutations and enables potent alpha radiation to be directed against

radiosensitive AML cells.

These cells have no known resistance or repair mechanisms when hit with the alpha particles from the Ac-225

isotope payload, which cause double stranded DNA breaks.

We believe Actimab-A is the first radiotherapeutic for r/r AML and has the unique

value proposition of broad applicability, a differentiated mechanism of action, and targeted precision that is well-tolerated with minimal

non-hematologic toxicity.

Our CD33 development program is driven by data obtained from approximately 150 AML patients in six trials and

demonstrated single agent activity with high response rates.

A combination strategy was considered appropriate given the changing treatment

landscape of AML;

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

Actimab-A + venetoclax were developed and patients were enrolled into these studies.

Conditioning Focused Programs

We will further expand the

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.

ARC pipeline with our Iomab-B franchise by focusing on lifecycle management for label enhancement and indication expansion.

in five additional hematologic indications (i.e., MDS, ALL, HL, NHL, and MM) provide the foundation to explore indication expansion opportunities

to increase the total addressable market for Iomab-B.

Across early trials at the FHCRC, Iomab-B demonstrated similar improved access to

BMT and outcomes.

We will leverage these data with strong results from the pivotal Phase 3 SIERRA trial to execute a comprehensive life

cycle management strategy to further expand Iomab-B’s role in a variety of malignant and non-malignant hematological disorders.

We will continue to develop the Iomab-B franchise to potentially address a broader market opportunity to address the over 165,000 patients

diagnosed with cancers (e.g., leukemia, lymphoma, and myeloma), who could potentially benefit from transplant, but are unable to access

Iomab-ACT is our next generation

ARC comprised of apamistamab, the same anti-CD45 antibody as Iomab-B, but utilizes lower, nonmyeloablative levels of I-131 to achieve

lymphodepletion for cellular therapies such as CAR-T or reduced intensity conditioning for gene therapies.

We intend to continue to develop

the Iomab-ACT program designed specifically for use prior to CAR-T and gene therapies, ultimately with a value proposition of improving

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

Preclinical data showed a

single, low-dose of Iomab-ACT demonstrated lymphodepletion and as CD45 positive immune cells are implicated in major CAR-T side effects,

i.e., 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.

i.e., CRS and ICANS, Iomab-ACT has the potential to be developed as a conditioning agent for CAR-T therapies.

CRS and ICANS remain two

most common toxicities of CAR-T therapies with severe cases (>Grade 3) seen in >20% of patients and fatality rates between 0-10%.

Due to its effect on host monocytes/macrophages, we believe conditioning with Iomab-ACT will potentially reduce the incidence of CRS and

Unlike chemotherapy, Iomab-ACT

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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 believe our Iomab-ACT program is highly differentiated when compared to Flu/Cy or other chemotherapy-based regimens that

are used as standard practice today for lymphodepletion prior to cell therapy.

We are studying Iomab-ACT

in collaboration with MSKCC, for conditioning prior to CAR-T therapy for patients with relapsed or refractory B-cell acute lymphoblastic

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

This study funded by a NIH grant is the first-of-its-kind

study to use a radiotherapeutic-based conditioning regimen with CAR-T therapy.

We have completed treatment of an initial cohort of three

patients and have begun treating patients in expand to a second cohort that is being funded by our recently extended NIH grant.

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

We expect to present an update on our Iomab-ACT program,

along with future development plans in the CAR-T space by year end.

R&D and Preclinical Programs

leukemia (“B-ALL”) or DLBCL.

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

conditioning regimen, with CAR-T therapy.

In October 2023, we announced the extension of a NIH Small Business Technology Transfer grant

to support the clinical collaboration with MSKCC.

Most recently, at the 2024 Tandem Meetings, we presented results from the ongoing phase

No patients (0/4) developed ICANS of any grade, a major safety measure of the study, as ICANS is observed in 25% or more of patients

with r/r B-ALL and DLBCL treated with various CAR T-cell products and negligible incidence of CRS.

Iomab-ACT demonstrated transient depletion

of peripheral blood lymphocytes and monocytes.

Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been

observed to date.

In April 2024, we announced an Investigational New Drug (“IND”)

application for a new clinical trial that will study Iomab-ACT as targeted conditioning prior to patients receiving an FDA approved commercial

CAR-T therapy.

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

Currently, there are six CAR-T therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that had combined

annual sales of over $3.5 billion in 2023.

Given the robust clinical data that exists with commercial CAR-T therapies, we believe this

trial may demonstrate Iomab-ACT’s potential to improve outcomes over current chemotherapy conditioning regiments we are seeking

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

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

due to benefits of targeted conditioning.

R&D and Preclinical ARC Programs

Our R&D capabilities have

the potential to yield differentiated, high-value 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

the potential to yield differentiated, high-value ARC programs that demonstrate our experience across multiple validated cancer targets

and isotopes and cover broad areas of focus leveraging our clinical development experience across hematology, targeted conditioning, solid

tumors, and next generation radiotherapies.

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

We have utilized our technology platform to develop our clinical portfolio in hematology – Iomab-B and Actimab-A, in conditioning

for transplant and as a therapeutic, respectively.

Our research collaborations with Astellas, LG Chem, and EpicentRx have established

our work with immunotherapies and in solid tumors.

We are working on several preclinical programs which include novel approaches to validated

cancer targets such as HER2 and HER3, as well as novel targets that show immense potential for radiotherapeutic approaches.

our development programs is our expanded patent portfolio of over 220 issued patents and pending patent applications worldwide.

Our platform has been used

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

Preclinical pharmacology studies with our targeted radiotherapeutics,

such as HER3, HER2, CD33 and CD38, have shown strong 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.

These results have prompted the team

to spearhead efforts in multiple solid tumor programs.

We continue to expand on capabilities

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

at key conferences and publications in journals of high impact.

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

with a robust “fast-to-clinic” approach in niche indications.

Underpinning our development programs is our expanded patent

portfolio of over 220 issued patents and pending patent applications worldwide.

We develop ARC product candidates that target antigens that are expressed on certain cancer

cell types and are able to destroy cellular DNA and kill these cells with the energy that they emit.

The efficacy of ARCs does not require

internalization and stable linkers minimize off-target toxicity of the payload.

Our R&D programs inform

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

We have utilized our technology platform to develop our clinical

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

Our differentiated

R&D efforts are further exemplified by our next-generation Iomab-ACT conditioning program for rapidly growing cell and gene therapies.

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

We are working on several preclinical

programs which include novel approaches to validated cancer targets, as well as novel targets that we believe to show immense potential

for radiotherapeutic approaches.

Preclinical pharmacology studies with our targeted radiotherapeutics, such as HER2, CD33 and CD38, have

shown strong improvement in tumor growth inhibition in various preclinical tumor models.

These results have prompted our R&D team

to spearhead efforts in multiple solid tumor programs in the preclinical stage with IND enabling studies underway.

Leveraging Actinium’s

platform and expertise in developing ARCs, we are exploring how nanobodies, single chain variable fragment (“scFv”), and other

related modalities can be combined with novel linkers and radioisotopes to enhance delivery to solid tumors.

We currently believe that

Actinium’s ARCs are less likely than small molecules to face pricing pressure and negotiation from IRA, given that small molecules

are at risk for pricing negotiations seven years after approval compared to eleven years for biologics with negotiated prices taking effect

two years after selection.

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

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

biological products has designations for more than one rare disease or condition, or if is approved for an indication that is not within

that single designated rare disease or condition, unless such additional designation or such disqualifying approvals are withdrawn by

the time CMS evaluates the drug for selection for negotiation.

In addition, regulatory barriers for a generic ARC are much higher than

for small molecule radioligands such as those under development or approved, namely, Pluvicto ® , Lutathera ® ,

and Xofigo ® .

While generic versions of certain radiopharmaceuticals utilizing peptides, which are considered small molecules,

have been submitted to the FDA via the ANDA pathway, ARCs fall under biologics.

For this reason, only the biosimilar approach pertains

to ARCs filed under 351(k) BLA pathway.

The regulatory pathway for biosimilar is much more comprehensive than the pathway for generics,

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

In addition, we are not aware of any

regulations that would require us to provide Iomab-B or Actimab-A, including their respective mAbs, apamistamab and lintuzumab, to any

third party or potential competitor.

We seek to expand our capabilities and technologies across therapeutic

modalities, linker technologies and in vivo cancer models, and build visibility through presentations at key conferences and publications

in journals of high impact.

Our R&D efforts are centered on the advancement of our key ARC programs with a robust “fast-to-clinic”

Underpinning our development programs is our expanded patent portfolio of over 235 issued patents and pending patent applications

Our Platform Technology

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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.

clinical and preclinical programs, we have utilized multiple isotopes including Ac-225, I-131 and Lu-177 directed at multiple targets

in oncology and hematology such as CD45, CD33, CD38, HER2, among others.

Our targeted radiotherapies combine the cell-killing ability

of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody.

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.

Manufacturing

company in the development of isotope-agnostic, multi-targeted product candidates that have the potential to address the treatment of

hard-to-treat diseases.

In our clinical and preclinical programs, we have utilized multiple isotopes including Ac-225, I-131 and Lu-177

directed at multiple targets in oncology and hematology such as CD45, CD33, CD38, HER2, among others.

Our targeted radiotherapies combine

the cell-killing ability of radiation via a radioisotope payload with a targeting agent, such as a monoclonal antibody.

With our in-depth, long-term

experience in clinical development of Ac-225 based radiopharmaceuticals, we have developed an end-to-end technology solution for producing

Ac-225 that has demonstrated radiochemical and radionuclidic purity identical to current gold standard methods.

This patented technology

has been used to produce Ac-225 in a cyclotron that is essentially identical to that derived from a Th-229 generator and has the potential

to be a lower-cost, commercially scalable higher-yielding approach.

Using the cyclotron-produced Ac-225 technology allows for large commercial

scale production with estimated cost of goods sold including capital expenditures and operational costs for a single cyclotron facility

of between $650 and $1,000 per mCi, which is between 10 to 20 times less expensive than the price of currently available Ac-225 material.

Our extensive know-how related

to this production technology is supported by five issued patents in the U.S.

and 49 patents internationally and covers:

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

Production of up to 100 mCi of Ac-225 per production cycle

Utilization of a medium energy cyclotron

Expected cost 10 to 20 times lower than currently available material

Radiochemical purity > 99%

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

With our Ac-2225 based Actimab-A

program and the rapidly increasing number of Ac-225 based programs in development, we believe that we are well positioned to leverage

this technology to produce Ac-225 to address the growing clinical demand.

Manufacturing and Supply Chain

Actinium has established significant

manufacturing and supply chain expertise due to the unique manufacturing and distribution requirements of radiotherapeutics.

short half-life of radioisotopes, the finished drug product is shipped “hot” and must be administered within days.

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

and delivering “just-in-time” doses.

We have delivered over 500 doses for 18 clinical trials at 45 large cancer hospitals

and have never missed a dose.

Isotope supply is critical

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

I-131 and Lu-177) emitters.

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

For Iomab-B, we have established

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that crossed over from the control arm to receive Iomab-B.

We have scaled up and have commercially viable manufacturing operations in

place to support U.S.

and international commercial sales.

We believe we have a thorough understanding and working knowledge of the intricacies

required to manufacture and distribute radiotherapies.

Through our clinical experience with Iomab-B and Actimab-A, we have developed a

wealth of proprietary knowledge to enable coordination between Actinium and all key stakeholders including, but not limited to hematologists/oncologists,

infusion center and in patient rooms, nuclear medicine and radiology, hot labs and radio-pharmacies, and radiation safety committees,

among others.

We have scaled up and have commercially viable manufacturing operations in place to support U.S.

and international commercial

Actinium has commercial agreements

with Contract Development and Manufacturing Organizations (“CDMOs”) with significant experience in monoclonal antibodies (“mAbs”)

and final radio-labeled drug products.

The CDMO we have selected to manufacture the finished drug product to support our commercial activity

has been previously inspected by the FDA and EMA.

We have scaled deliberately for manufacturing flexibility to ensure readily available

drug product upon FDA approval and the ability to ramp up rapidly to meet commercial demand.

We have multiple isotope supply

agreements and qualified vendors in place to supply isotopes for commercial production.

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

drug products.

The CDMO we have selected to manufacture the finished drug product to support our commercial activity has been previously

inspected by the FDA and EMA.

Our finished drug product CDMO is centrally located in the U.S.

and has significant experience in the international

supply of radiotherapies.

We have scaled deliberately for manufacturing flexibility and are currently qualifying additional CDMOs

to ensure readily available drug product upon FDA approval and the ability to ramp up rapidly to meet commercial demand.

Intellectual Property

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scheduling, radionuclide warhead, and therapeutic combinations.

As of November 2023, our patent

portfolio is comprised of over 220 issued patents and pending patent applications worldwide, which we believe constitutes a valuable business

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

portfolio includes 13 issued patents and 47 pending patent applications in the U.S., and 162 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.

As of April 2024, our patent portfolio is comprised of over 235 issued

patents and pending patent applications worldwide, which we believe constitutes a valuable business asset.

Our IP includes 47 patent families,

including key patents that relate primarily to our radiotherapeutic candidates.

Our patent portfolio includes 16 issued patents and 53

pending patent applications in the U.S., and 170 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 2044.

For our Iomab-B product candidate,

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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.

alpha-emitter-based therapies, “gold standard” linker technology and 5 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

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

currently utilized methods.

These patents expire in the years 2024 through 2027.

In addition, we also own U.S.

and international patents

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

and international patents and pending patent applications that relate to the

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

Results of Operations –

Three Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022

Three Months Ended March 31, 2024 Compared to Three Months Ended March 31, 2023

The following table sets forth,

for the periods indicated, data derived from our statements of operations:

For the Three

September 30,

Three Months Ended

(in thousands)

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We recorded no commercial

revenue for the three months ended September 30, 2023 and September 30, 2022.

revenue for the three months ended March 31, 2024 and March 31, 2023.

Other revenue

We determined that certain

collaborations with a third-party were within the scope of Topic ASC 606, Revenue Recognition from Contracts with Customers, or

The collaboration agreement were made up of multiple modules related to various research activities.

While the third party had

the option to terminate the agreement at the conclusion of any module, we identified a single performance obligation to provide research

services within each module for which we received monetary consideration.

The consideration is recognized to revenue over each module

and revenue of $45 thousand was recognized during the three months ended September 30, 2022.

There was no corresponding revenue recognized

from a collaboration during the three months ended September 30, 2023.

On April 7, 2022, we entered

into a license and supply agreement with Immedica Pharma AB, or Immedica, pursuant to which Immedica licensed the exclusive product rights

for commercialization of Iomab-B in the European Economic Area, Middle East and North Africa (EUMENA) including Algeria, Andorra, Bahrain,

Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi Arabia,

Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen.

Upon signing, we were entitled

to an upfront payment of $35 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement, we are eligible

to receive regulatory and commercial milestone payments and are entitled to receive royalties in the mid-20 percent range on net sales

of the product in certain countries that may result from the License Agreement.

We will continue to be responsible for certain clinical

development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S.

and rest of the world.

The National Institutes of

Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan

Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeting Antibody Radio-Conjugate, for targeted conditioning to achieve

lymphodepletion prior to administration of a CD19-targeted CAR T-cell therapy developed at MSK.

There was no other revenue recognized

from a grant from a government-sponsored entity for the three months ended March 31, 2024 and 2023, respectively.

On April 7, 2022, we

entered into a license and supply agreement with Immedica Pharma AB, or Immedica, pursuant to which Immedica licensed the exclusive product

rights for commercialization of Iomab-B in the European Economic Area, Middle East and North Africa (EUMENA) including Algeria, Andorra,

Bahrain, Cyprus, Egypt, Iran, Iraq, Israel, Jordan, Kuwait, Lebanon, Libya, Monaco, Morocco, Oman, Palestine, Qatar, San Marino, Saudi

Arabia, Switzerland, Syria, Tunisia, Turkey, the United Arab Emirates, the United Kingdom, the Vatican City and Yemen.

Upon signing, we

were entitled to an upfront payment of $35 million from Immedica, which was received in May 2022.

Under the terms of the License Agreement,

we are eligible to receive regulatory and commercial milestone payments and are entitled to receive royalties in the mid-20 percent range

on net sales of the product in certain countries that may result from the License Agreement.

We will continue to be responsible for certain

clinical development activities and the manufacturing of Iomab-B and will retain commercialization rights in the U.S.

and rest of the

Our contract liabilities are

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advanced payments from licensees.

There was no Other revenue deferred-current liability at September 30, 2023 and December 31, 2022.

license revenue deferred was $35.0 million at September 30, 2023 and December 31, 2022, resulting from the receipt from Immedica;

deferred revenue will be recognized upon European Union regulatory approval of Iomab-B.

Research and Development Expense, net of reimbursements

Research and development expenses

of $11.6 million for the three months ended September 30, 2023 increased $4.8 million from $6.8 million for the three months ended September

Higher research and development expenses were primarily due to increased CMC activity related to the planned BLA-enabling work

Once complete, CMC expenses are expected to decrease in 2024 as we expect to use final drug product material produced to

support the BLA filing and to supply initial Iomab-B commercialization.

In addition, increased compensation of $1.1 million resulted due

to higher headcount necessary to support BLA-enabling CMC activity.

General and administrative expense

General and administrative

expenses of $2.7 million for the three months ended September 30, 2023 decreased by $0.4 million from $3.1 million for the three months

ended September 30, 2022.

Lower professional and consulting fees of $0.5 million, lower legal fees of $0.1 million and lower non-cash

equity compensation of $0.1 million were partially offset by increased compensation of $0.3 million as a result of higher headcount.

Other income is comprised

of net interest income in both reporting periods.

The amount for the three months ended September 30, 2023 of $1.1 million increased from

$0.3 million for the three months ended September 30, 2022 due to a higher average interest rate.

Net loss of $13.3 million

for the three months ended September 30, 2023 increased by $3.8 million from $9.5 million for the three months ended September 30, 2022

primarily due to higher research and development expenses, partially offset by lower general and administrative expenses and higher other

Results of Operations –

Nine months Ended September 30, 2023 Compared to Nine months Ended September 30, 2022

The following table sets forth,

for the periods indicated, data derived from our statements of operations:

September 30,

(in thousands)

Other revenue

Total revenue

Operating expenses:

Research and development, net of reimbursements

General and administrative

Total operating expenses

Other income:

Interest income – net

Total other income

We recorded no commercial

revenue for the nine months ended September 30, 2023 and September 30, 2022.

Other revenue

We determined that certain

collaborations with a third-party were within the scope of ASC 606.

The collaboration agreement is made up of multiple modules related

to various research activities.

While the third party has the option to terminate the agreement at the conclusion of any module, we identified

a single performance obligation to provide research services within each module for which we receive monetary consideration.

Other revenue

of $0.9 million was recognized during the nine months ended September 30, 2022.

There was no corresponding revenue recognized from a collaboration

during the nine months ended September 30, 2023.

The National Institutes of

Health awarded us a Small Business Technology Transfer cost reimbursable grant to support a clinical collaboration with Memorial Sloan

Kettering Cancer Center, or MSK, to study Iomab-ACT, our CD45-targeted conditioning program to achieve lymphodepletion prior to administration

of a CD19-targeted CAR T-cell therapy developed at MSK.

We recognized other revenue from this grant for the nine months ended September

30, 2022 of $0.1 million.

There was no other revenue recognized for the nine months ended September 30, 2023.

There was no Other revenue deferred-current liability at March 31, 2024 and December 31, 2023.

license revenue deferred was $35.0 million at March 31, 2024 and December 31, 2023, resulting from the receipt from Immedica;

this deferred

revenue will be recognized upon European Union regulatory approval of Iomab-B.

Research and Development Expense, net of reimbursements

Research and development expenses

of $30.6 million for the nine months ended September 30, 2023 increased $14.8 million from $15.8 million for the nine months ended September

Higher research and development expenses were primarily due to increased CMC activity related to the planned BLA-enabling work

for Iomab-B, which once complete, we expect to decrease in 2024 as we expect to use final drug product material produced to support the

BLA filing and to supply initial Iomab-B commercialization.

In addition, increased compensation of $3.2 million resulted due to higher

headcount primarily to support BLA-enabling CMC activity.

of $6.6 million for the three months ended March 31, 2024 decreased $1.2 million from $7.8 million for the three months ended March 31,

CMC expenses declined $1.3 million and clinical expenses declined $0.6 million due to lower CMC activity related to the planned

BLA and MAA-enabling work for Iomab-B, as well as lower clinical trial activity.

These declines were partially offset by increased preclinical

expenses of $0.4 million, compensation expense of $0.2 million due to higher headcount, and non-cash stock compensation expense of $0.1

General and administrative expense

General and administrative

expenses of $11.0 million for the nine months ended September 30, 2023 increased by $3.0 million from $8.0 million for the nine months

ended September 30, 2022.

Higher expenses were primarily due to increased compensation of $1.1 million due to higher headcount, higher

non-cash equity compensation of $0.8 million, and higher professional and consulting fees, including recruiting fees.

expenses of $3.0 million for the three months ended March 31, 2024 decreased by $0.7 million from $3.7 million for the three months ended

March 31, 2023.

Lower expenses were primarily the result of lower consulting fees and legal fees of $1.0 million, partially offset by

higher non-cash stock compensation expense of $0.3 million.

Other income is comprised

of net interest income in both reporting periods.

The amount for the nine months ended September 30, 2023 of $2.1 million increased from

$0.4 million for the nine months ended September 30, 2022 due to a higher average interest rate.

Net loss of $39.5 million

for the nine months ended September 30, 2023 increased by $17.1 million from $22.4 million for the nine months ended September 30, 2022

primarily due to higher research and development expenses and general and administrative expenses.

The amount for the three months ended March 31, 2024 of $0.9 million increased from

$0.5 million for the three months ended March 31, 2023 primarily due to higher average interest rates.

Net loss of $8.7 million for

the three months ended March 31, 2024 decreased by $2.3 million from $11.0 million for the three months ended March 31, 2023 primarily

due to lower research and development expenses, lower general and administrative expenses and a higher level of other income.

Liquidity and Capital Resources

The following table sets forth

selected cash flow information for the periods indicated:

For the Nine months Ended

September 30,

Historically, we have financed

our operations primarily through sales of shares of our stock.

The following table sets forth selected cash flow information for the periods

Three Months Ended

(in thousands)

Cash (used in)/provided by operating activities

Cash used in operating activities

Cash used in investing activities

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Net cash used in operating

activities for the nine months ended September 30, 2023 of $39.8 million increased by $56.2 million from the prior-year period of $16.4

million provided by operating activities, as a result of the higher net loss of $17.1 million and the receipt of the $35.0 million up-front

payment from Immedica included in the prior-year period.

activities for the three months ended March 31, 2024 of $7.4 million decreased by $7.7 million from $15.1 million in the prior-year period,

primarily as a result of a lower net loss of $2.3 million, and compared to the prior-year period, an increase in accounts payable and

accrued expenses of $2.3 million and a reduction in prepaid expenses of $2.3 million.

Net cash used in investing

activities was $0.1 million and $0.4 million for the nine months ended September 30, 2023 and 2022, respectively, due to the purchase

of equipment.

activities was $11 thousand and $76 thousand for the three months ended March 31, 2024 and 2023, respectively, due to the purchase of

Net cash provided by financing

activities for the nine months ended September 30, 2023 of $13.7 million and for the nine months ended September 30, 2022 of $18.2 million

was primarily from the sale of shares of our common stock.

In August 2020 we entered

into the Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we

may sell, from time to time, through or to JonesTrading, up to an aggregate of $200 million of our common stock.

On June 28, 2022, we

entered into an Amended and Restated Capital on Demand™ Sales Agreement, or the Amended Sales Agreement, with JonesTrading and B.

activities for the three months ended March 31, 2024 was $14.8 million, primarily from the sale of common stock.

Net cash provided by

financing activities for the three months ended March 31, 2023 was $0.8 million, primarily from the sale of common stock.

In August 2020, we entered into the Capital on Demand™ Sales

Agreement with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we are able to sell, from time to time, through

or to JonesTrading, up to an aggregate of $200 million of our common stock.

On June 28, 2022, we entered into an Amendment and Restated

Capital on Demand™ Sales Agreement, or the Amended Sales Agreement, with JonesTrading and B.

Riley Securities, Inc.

The Amended Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B.

as an additional sales agent thereunder.

Shares of common stock are offered pursuant to our shelf registration statement on Form S-3 filed

with the SEC on August 7, 2020.

For the nine months ended September 30, 2023, we sold 1.7 million shares of common stock, resulting in

gross proceeds of $13.8 million and net proceeds of $13.4 million.

For the nine months ended September 30, 2022, we sold 3.0 million shares

of common stock, resulting in gross proceeds of $18.9 million and net proceeds of $18.3 million.

Sales Agreement modifies the original Capital on Demand™ Sales Agreement to include B.

Riley as an additional sales agent thereunder.

Shares of common stock are offered pursuant to a shelf registration statement on Form S-3 (File No.

333-273911), which was declared effective

February 5, 2024, including a base prospectus covering the offering, issuance and sale of up to $500 million of common stock, preferred

stock, warrants, units and/or subscription rights;

and a sales agreement prospectus covering the offering, issuance and sale of up to

a maximum aggregate offering price of $200 million of common stock that may be issued and sold under the Amended Sales Agreement.

the three months ended March 31, 2024, we sold 1.8 million shares of common stock, resulting in gross proceeds of $15.0 million and net

proceeds of $14.7 million.

For the three months ended March 31, 2023, we sold 0.1 million shares of common stock, resulting in gross proceeds

and net proceeds of $0.8 million.

As of the date of filing this

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Grant Revenue

We had a grant from a government-sponsored

We have a grant from a government-sponsored

entity for research and development related activities that provided for payments for reimbursed costs, which included overhead and general

and administrative costs as well as an administrative fee.

We recognized revenue from the grant as we performed services under this arrangement.

We recognize revenue from the grant as we performed services under this arrangement.

Associated expenses were recognized when incurred as research and development expense.

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We account for forfeitures of stock options as they occur.

Accounting Standards Recently Adopted

In November 2021, the FASB

issued ASU 2021-10, Government Assistance (Topic 832), Disclosures by Business Entities about Government Assistance , which provides

guidance on disclosure requirements to entities other than not-for-profit entities about transaction with a government that are accounted

for by applying a grant or contribution accounting model by analogy.

ASU 2021-10 requires an entity to make annual disclosures related

to (1) the nature of the transactions and the related accounting policy used to account for the government transactions, (2) quantification

and disclosure of amounts related to the government transactions included in balance sheet and income statement financial statement line

items, and (3) significant terms and conditions of the government transactions, including commitments and contingencies.

The amendments

of ASU 2021-10 are effective January 1, 2022, including interim periods.

We adopted this standard effective January 1, 2022 and the standard

did not have a material impact on our financial statements.

Recently Issued Accounting Pronouncements

In December 2023, FASB issued

ASU 2023-09, Income Taxes (Topic 740):

Improvements to Income Tax Disclosures , to enhance the transparency and decision usefulness

of income tax disclosures.

The amendments in ASU 2023-09 provide improvements primarily related to the rate reconciliation and income

taxes paid information included in income tax disclosures.

We would be required to disclose additional information regarding reconciling

items equal to or greater than five percent of the amount computed by multiplying pretax income (loss) by the applicable statutory tax

Similarly, we would be required to disclose income taxes paid (net of refunds received) equal to or greater than five percent of

total income taxes paid (net of refunds received).

The amendments in ASU 2023-09 are

effective January 1, 2025, including interim periods.

Early adoption is permitted for annual financial statements that have not yet been

issued or made available for issuance.

We will evaluate the impact of ASU 2023-09 on our financial statements.

In November 2023, FASB

issued ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures , which provides

improvements to reportable segment disclosure requirements, primarily through enhanced disclosures around segment expenses.

2023-07 requires us to disclose significant segment expenses that are regularly provided to the chief operating decision maker, or

CODM, and included within each reported measure of segment profit or loss.

ASU 2023-07 also requires that we disclose an amount for

other segment items by reportable segment, a description of their composition and provide all annual disclosures about a reportable

segment’s profit or loss and assets pursuant to Topic 280 during interim periods.

We must also disclose the CODM’s title

and position, as well as certain information around the measures used by the CODM and an explanation of how the CODM uses the

reported measures in assessing segment performance and deciding how to allocate resources.

For public entities with a single

reportable segment, the entity must provide all the disclosures required pursuant to ASU 2023-07 and all existing segment

disclosures under Topic 280.

The amendments of ASU 2023-07 are effective for us for annual

periods beginning January 1, 2024, and effective for interim periods beginning January 1, 2025.

Early adoption is permitted for

annual financial statements that have not yet been issued or made available for issuance.

We will evaluate the impact of ASU

2023-07 on our financial statements.

In October 2021, FASB issued

ASU 2021-08, Business Combinations (Topic 805), Account for Contract Assets and Contract Liabilities from Contracts with Customers,

which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance ASC

To achieve this, an acquirer may assess how the acquiree applied ASC 606 to determine what to record for the acquired revenue contracts.

Generally, this should result in an acquirer recognizing and measuring the acquired contract assets and contract liabilities consistent

with how they were recognized and measured in the acquiree’s financial statements.

The amendments of ASU 2021-08 are effective January

1, 2023, including interim periods.

We will evaluate the impact of ASU 2021-08 on any future business combinations that we may enter in

In May 2021, the Financial

Accounting Standards Board, or FASB, issued ASU 2021-04, Earnings Per Share (topic 260), Debt — Modifications and Extinguishments

(Subtopic 470-50), Compensation – Stock Compensation (Topic 718) and Derivatives and Hedging – Contracts in an Entity’s

Own Equity (Subtopic 815-40) – Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified

Written Call Options , which provides guidance of a modification or an exchange of a freestanding equity-classified written call option

that remains equity classified after modification or exchange as (1) an adjustment to equity and, if so, the related earnings per share

(EPS) effects, if any, or (2) an expense and, if so, the manner and pattern of recognition.

The amendments in this ASU are effective January

1, 2022, including interim periods.

We adopted this standard effective January 1, 2022 and the standard did not have a material effect

on our financial statements.

which provides guidance on accounting for contract assets and contract liabilities acquired in a business combination in accordance

with ASC 606.

To achieve this, an acquirer may assess how the acquiree applied ASC 606 to determine what to record for the acquired revenue

Generally, this should result in an acquirer recognizing and measuring the acquired contract assets and contract liabilities

consistent with how they were recognized and measured in the acquiree’s financial statements.

The amendments of ASU 2021-08 are

effective January 1, 2023, including interim periods.

We will evaluate the impact of ASU 2021-08 on any future business combinations we

may enter in the future.

Subsequent Events

Since March 31, 2024, we sold 0.4 million shares of common stock

under our A&R Sales Agreement, resulting in net proceeds of $3.4 million.

On April 23, 2024, outstanding warrants to purchase up to 1.4 million

shares of our common stock with an exercise price of $15.00 per share, expired according to their terms.

Following the expiration of such

warrants, we have less than thirteen thousand warrants outstanding.

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-Q

Item 2. Management’s Discussion and Analysis