ATNM US Equity☆

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

10-K

(Mark

One)

☒

Annual Report Pursuant To Section 13 or 15(d) Of The Securities Exchange Act Of 1934

For

the fiscal year endedDecember 31, 2024

or

☐

Transition Report Pursuant To Section 13 or 15(d) Of The Securities Exchange Act Of 1934

For

the transition period from _____ to _____

COMMISSION

FILE NUMBER: 001-36374

ACTINIUM

PHARMACEUTICALS, INC.

(Exact

name of registrant as specified in its charter)

100

Park Ave., 23rd Floor

New

York, NY10017

(Address

of principal executive offices) (Zip Code)

(646)677-3870

Registrant’s

telephone number, including area code

Securities

registered pursuant to Section 12(b) of the Act:

Title of each class Trading symbol Name of exchange on which registered

Common stock, par value $0.001 ATNM NYSE American

Securities

registered pursuant to Section 12(g) of the Act: None

Indicate

by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No

☒

Indicate

by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No

☒

Indicate

by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange

Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)

has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate

by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule

405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant

was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated

filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions

of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging

growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐

Non-accelerated filer ☒ Smaller reporting company ☒

Emerging growth company ☐

If

an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying

with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate

by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness

of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered

public accounting firm that prepared or issued its audit report. ☐

If

securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant

included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate

by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation

received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate

by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the act): Yes ☐ No ☒

The

aggregate market value of voting stock held by nonaffiliates of the registrant as of June 30, 2024, the last business day of the

registrant’s most recently completed second fiscal quarter, based on the closing price of the common stock on the NYSE American

on June 28, 2024 was $226,015,477.

As

of March 28, 2025, 31,195,891 shares of common stock, $0.001 par value per share, were outstanding.

Table of

Contents

Item 1. Business 1

Item 1A. Risk Factors 28

Item 1B. Unresolved Staff Comments 63

Item 1C. Cybersecurity 63

Item 2. Properties 64

Item 3. Legal Proceedings 64

Item 4. Mine Safety Disclosures 64

Item 6. Reserved 66

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 69

Item 8. Financial Statements and Supplementary Data F-1

Item 9A. Controls and Procedures 70

Item 9B. Other Information 70

Item 9C Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 70

Item 10. Directors, Executive Officers and Corporate Governance 71

Item 11. Executive Compensation 84

Item 12. Security Ownership of Certain Beneficial Owners and Management 88

Item 14. Principal Accountant Fees and Services 89

Item 15. Exhibits, Financial Statement Schedules 90

Signature Page 95

i

CAUTIONARY

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This

Annual Report on Form 10-K (this “Report”) contains forward-looking statements that involve risks and uncertainties, principally

in the sections entitled “Description of Business,” “Risk Factors,” and “Management’s Discussion

and Analysis of Financial Condition and Results of Operations.” All statements other than statements of historical fact contained

in this Report, including statements regarding future events, our future financial performance, business strategy and plans and objectives

of management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by terminology

including “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,”

“expects,” “intends,” “may,” “plans,” “potential,” “predicts,”

“should,” or “will” or the negative of these terms or other comparable terminology. Although we do not make forward-looking

statements unless we believe we have a reasonable basis for doing so, we cannot guarantee their accuracy. These statements are only predictions

and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Risk Factors” or

elsewhere in this Report, which may cause our or our industry’s actual results, levels of activity, performance or achievements

expressed or implied by these forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment.

New risks emerge from time to time and it is not possible for us to predict all risk factors, nor can we address the impact of all factors

on our business or the extent to which any factor, or combination of factors, may cause our actual results to differ materially from

those contained in any forward-looking statements. All forward-looking statements included in this document are based on information

available to us on the date hereof, and we assume no obligation to update any such forward-looking statements.

You

should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this Report. Before you

invest in our securities, you should be aware that the occurrence of the events described in the section entitled “Risk Factors”

and elsewhere in this Report could negatively affect our business, operating results, financial condition and stock price. Except as

required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after the date of this

Report to conform our statements to actual results or changed expectations.

ii

PART

I

ITEM

1. BUSINESS.

Description

of Our Business

Actinium Pharmaceuticals,

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

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

who have failed existing therapies. We are advancing a pipeline of differentiated clinical stage product candidates focused on validated

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

therapies that we believe have high unmet needs that are not addressed by currently available treatment options. Our goal is to create

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

research and development (“R&D”) and clinical development. We are deploying our technologies and capabilities, which we

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

and next-generation radiotherapies.

Our Product Candidate Pipeline

We are advancing two clinical stage product candidates that are directed

against validated cancer targets. Actimab-A is our lead product candidate in development and is intended to address the significant unmet

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

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

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

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

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

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

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

prostate cancer directed against a novel radiotherapy target.

Actimab-A is being developed

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

ubiquitously in patients with AML, MDS and expressed in other myeloid malignancies. We are attempting to leverage the mutation-agnostic

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

as a single agent or in combinations with chemotherapy, targeted agents, cellular therapy and immunotherapy. Actimab-A has been studied

in over 150 patients. We plan to initiate a Phase 2/3 trial with Actimab-A in combination with the chemotherapy regimen CLAG-M in patients

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

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

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

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

with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML. We believe this trial is supported by our Actimab-A + Venetoclax

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

concepts for Actimab-A have been submitted under the CRADA and are being reviewed. We anticipate that additional clinical trials with

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

1

In March of 2025, we initiated

our Actimab-A solid tumor program that will combine Actimab-A with PD-1 checkpoint inhibitors. We initiated this program to evaluate if

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

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

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

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

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

ATNM-400 is our newest targeted

radiotherapy program that we are advancing for prostate cancer. Given the biology of the antigen targeted by ATNM-400 and the precise

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

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

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

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

radioisotope Lutetitium-177 (“Lu-177”) that is approved for patients with metastatic prostate cancer. ATNM-400 is differentiated

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

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

effects such as xerostomia.

In addition to ATNM-400, we

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

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

programs for solid tumor indications.

Iomab-ACT is our next-generation

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

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

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

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

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

regimens that are currently used. Iomab-ACT is currently being studied in three clinical trials. These trials include Iomab-ACT with a

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

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

We

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

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

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

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

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

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

resources and strategic priorities in focus. As previously disclosed and noted above, Actinium also has a License Agreement with Immedica,

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

East and North Africa (“EUMENA”) region.

Actinium’s Approach to Targeted Radiotherapy

Development

Radiation is a validated cancer

therapy that has been used to treat patients for over 100 years. It is used to treat over half of all patients diagnosed with cancer today.

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

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

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

2

With our targeted radiotherapy

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

targeting ability of biologic molecules with the cancer cell killing ability of radioisotopes. In doing so, we seek to improve efficacy

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

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

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

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

Actinium’s Targeted Radiotherapies

Alpha particles emitted by

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

of producing double strand DNA breaks. However, alpha-particles travel short distances of just several microns and as a consequence do

not exert radiation outside of the body. Alpha particles can be stopped by an ordinary sheet of paper. Therefore, alpha particle-based

therapies do not require special shielding or that patients remain isolated following treatment. Beta particle-based therapies have a

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

Comparison of Radioisotope Pathlength

We focus on producing drug candidates that match a specific targeting

agent with the appropriate isotope for a desired indication. We employ an isotope-agnostic approach to targeted radiotherapy development.

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

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

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

3

Our Strategy

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

via radiotherapeutics is unmatched by other technologies and that there are multiple indications where radiotherapeutics can succeed over

other approaches. However, radiotherapeutics must be delivered on a just-in-time basis, and commercial and supply chain barriers are higher

than with other types of medicines. Actinium’s strategy is to build a specialty radiotherapeutics company with the capabilities

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

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

Our strategic priorities are to:

Establish Actimab-A as a mutation agnostic,

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

Establish Actimab-A as a pan solid tumor therapy

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

cells;

Determine the potential of ATNM- as a viable

treatment for patients with prostate cancer;

Establish Iomab-ACT as a universal targeted

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

Leverage our R&D capabilities and clinical

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

Establish in-house manufacturing infrastructure

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

manufacturing technology.

Market Opportunity for Our Targeted Radiotherapies

We believe our clinical programs

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

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

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

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

Four Large & Distinct Potential Market

Opportunities

4

Actimab-A Myeloid Malignancies Program

We are focused on developing

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

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

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

Myeloid malignancies are a

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

myeloid lineage and include white blood cells, red blood cells and platelets. Myeloid malignancies include AML, MDS, chronic myeloid leukemia

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

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

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

or refractory and maintenance settings either as a monotherapy or in combination with other treatments. For patients with MDS, we plan

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

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

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

U.S. and EU5 AML & MDS Addressable Patient

Population

AML is increasingly defined

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

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

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

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

Various treatments are currently

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

hypomethylating agents (“HMAs”) and BMT. Since 2017, twelve therapies have been approved for patients with AML. As part of

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

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

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

5

Fewer approved treatment options

exist for patients with MDS, particularly high-risk patients. Treatments currently approved or utilized for high-risk patients include

chemotherapies, HMAs and IDH1 inhibitors. We intend to evaluate the potential utility of Actimab-A in MDS either as single agent or in

combination with other therapies.

Given the complexity and aggressiveness

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

as opposed to community, outpatient-based care. As a result, we believe the majority of AML and High-risk MDS patients largely occurs

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

Actimab-A Solid Tumor Program

We believe a large market

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

other immune checkpoint inhibitors. Several solid tumor indications have shown to have high expression of MDSCs including non-small cell

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

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

prostate cancer and ovarian cancer. Cumulatively, over 600,000 patients are diagnosed with these cancers annually. PD-1 checkpoint inhibitors

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

We are planning to conduct our initial controlled, randomized clinical

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

two indications represent a potential addressable patient opportunity of over 250,000 patients. We expect to continue to evaluate additional

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

ATNM-400 Prostate Cancer Program

Prostate cancer is the

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

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

of prostate cancer is approximately 1.5 million new cases annually. Approximately 20% of prostate cancer cases are more aggressive forms

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

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

(“EMA”) for the treatment of patients with metastatic castration-resistant prostate cancer. Pluvicto is marketed and sold

by Novartis and generated sales of $1.39 billion in 2024. ATNM-400 is differentiated from Pluvicto as it targets a different marker than

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

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

Iomab-ACT Cell & Gene Therapy Conditioning

Program

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

patients for cellular therapies such as CAR-T or BMT and gene therapies. Our current clinical trials are focused on patients with blood

cancers and non-malignant blood disorders such as SCD. The first CAR-T therapies was approved in 2017 and currently, there are 6 approved

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

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

are currently approved for r/r patients. SCD is a rare, debilitating and life-threatening blood disorder with significant unmet needs

that affects approximately 100,000 people in the U.S. Patients with SCD have a mutation that causes red blood cells to develop a crescent

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

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

recurrence of these events or crises can lead to life-threatening disabilities and/or early death. An allogeneic BMT is a potentially

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

such as strokes, acute chest crises or recurring pain crises due to their disease. In addition, there are two approved gene therapies

for patients with sickle cell disease, Casgevy (Vertex Pharmaceuticals, Inc. and CRISPR Therapeutics) and Lyfgenia (Bluebird Bio, Inc.).

6

Our Clinical Product Candidates

Actimab-A: Mutation Agnostic Mechanism of Action

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

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

product candidate in development for patients with myeloid malignancies. To our knowledge, Actimab-A is the only CD33 targeting radiotherapy

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

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

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

malignancies.

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

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

AML is a highly heterogenous, mutation rich cancer with over 70 identified driver genetic mutations. However, there are only approved

therapies for four mutations including FLT3, IDH1 & IDH2, and NPM1. CD33 is expressed regardless of other mutations being present

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

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

Actimab-A’s Mechanistic

Synergy and Potential Combinations

Our development strategy is

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

including the frontline, relapsed/refractory and maintenance settings. To accomplish this, we are leveraging our clinical development

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

Actimab-A Clinical Development Experience

To our knowledge, Actimab-A

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

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

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

with promising results to date.

7

Actimab-A Monotherapy Phase 2 Trial

Following multiple Phase 1

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

age 60 and above who were ineligible for intensive chemotherapy. At the dose level of 2.0 μCi/kg, Actimab-A produced high overall response

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

(“CRp”) and Complete Remission with incomplete blood count recovery (“CRi”). Prolonged myelosuppression was the

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

patients enrolled. The Actimab-A dose was adjusted to 1.5μCi/kg, which produced an ORR of 22%. Potent anti-leukemic effect was observed

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

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

bone marrow function and ability to recover blood counts and proper function. This trial was conducted prior to the approval of many of

the targeted therapies that are routinely used in the treatment of patients with AML today. As a result of the prolonged myelosuppression

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

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

Anti-Leukemic Activity

of Actimab-A Monotherapy

After completing the Phase

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

with other treatment modalities to leverage its novel mutation agnostic radiotherapy mechanism. We evaluated several clinical trial concepts

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

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

needs.

Actimab-A + Venetoclax Phase 1/2 Combination

Trial

Venetoclax is an oral therapy

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

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

overexpressing Bcl-2 live longer or increase resistance to chemotherapy. In November 2018, Venetoclax received accelerated approval from

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

age 75 years or older or patients ineligible for intensive induction chemotherapy. Venetoclax was granted regular approval by the FDA

in October 2020.

The Phase 1 portion of the

Actimab-A + Venetoclax trial enrolled 18 patients and was conducted at five clinical trial sites. Four dose levels of Actimab-A were evaluated

with the primary objective of evaluating the safety of the combination. Actimab-A + Venetoclax was well tolerated with an expected and

manageable adverse event profile with no early deaths observed. Efficacy was also evaluated with reduction in bone marrow blasts up to

93% reported.

8

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

Trial

The Medical College of Wisconsin

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

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

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

for patients with r/r AML. Based on MCWs experience with Actimab-A and CLAG-M, the team at MCW hypothesized that combining Actimab-A with

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

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

MCW enrolled 26 adult patients

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

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

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

and 56.5% of patients had a prior allogeneic BMT with patients having a median of 2 lines of prior treatment (range: 1-5). This trial

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

Patient Characteristics

The results from this trial

were published in the peer-reviewed journal Leukemia in February 2025. In this publication, it was reported that Actimab-A + CLAG-M

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

evaluate the efficacy of the combination including survival outcomes. Based on the results of the study, it was determined that 0.75 μCi/kg

is the recommended Phase 2 dose (“RP2D”). In addition to a safety analysis, the results of 5 patients treated in a pharmacokinetic

expansion cohort at the RP2D were reported. Treatment-emergent adverse events (“TEAE”) were primarily hematologic and all

grade 3/4 TEAEs were hematologic. No patients discontinued treatment due to TEAEs and no early deaths were attributed to the Actimab-A

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

detectable radioactivity after a median of 24.5 hours. Importantly, no significant kidney or liver toxicity has been reported to date

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

The efficacy analysis of this

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

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

MRD negativity and survival outcomes. As listed in the table below, CR, CRc and ORR rates were reported for all patients as well as patients

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

treatment.

Rates of CR, CRc and

ORR with Actimab-A + CLAG-M

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In patients achieving a CRc,

MRD negativity was assessed including in patients in various high-risk subgroups. Across all patients, the MRD negativity rate was 75%

and was 100% in patients with prior Venetoclax treatment. In the ELN adverse risk patients and those with a TP53 mutation, MRD negativity

was 86% and 83%, respectively. We believe these high rates of MRD negativity support the rationale for conducting this study, which was

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

MRD Negativity Rates

in Evaluable Patients Achieving CRc

Long-term survival outcomes

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

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

with one or two lines of prior salvage therapy, the median OS was 18.4 months. The median OS in patients with a TP53 mutation or prior

Venetoclax treatment was 9.6 months and 7.3 months, respectively. These survival outcomes compare favorably to outcomes reported in the

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

to be 2.4 - 4.6 months.

Overall Survival Outcomes

with Actimab-A + CLAG-M

Based on the positive findings

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

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

We have aligned with the FDA

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

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

combination with CLAG-M. We expect the Phase 2 portion of this trial to be initiated in 2025. Once the optimized Actimab-A dose is determined,

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

compared to separate Phase 2 and Phase 3 studies.

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

Design

The primary endpoint of the

Phase 3 trial will be Overall Survival. Event-Free Survival (“EFS”) and other efficacy measures as well as safety also being

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

Actimab-A NCI CRADA Trials

In 2023, we entered into a

CRADA with NCI to develop Actimab-A for the treatment of patients with AML and other hematologic malignancies. The NCI will serve as the

regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A, and the CRADA will provide extensive

support for and accelerate the development of Actimab-A alone or in combination with chemotherapy, immunotherapy, targeted agents and

other novel combinations. The CRADA studies will be overseen by the NCI in collaboration with Actinium’s clinical development team,

where we have the right to review and approve all protocols and have full rights to all data. The NCI CRADA provides for us to supply

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

as opposed to a Company sponsored trial and will therefore spare our balance sheet. The NCI Cancer Therapy Evaluation Program (“CTEP”),

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

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

In October 2024, the NCI announced

that its myeloMATCH program was officially open to patient enrollment across the U.S. and Canda. MyeloMATCH is a portfolio of clinical

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

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

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

expects to open trials at hundreds of cancer care sites across the U.S. and Canada with the goal of enrolling 5,000 or more patients over

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

trials.

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Actimab-A, Venetoclax & ASTX-727 –

Frontline AML Triplet Phase 1b Combination Trial

In March 2025, we announced

the initiation of the first clinical trial to be conducted under our CRADA by NCI. The trial will evaluate the triplet combination comprised

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

Venetoclax in combination with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML. We believe this trial is supported by

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

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

not eligible for intensive chemotherapy. The trial will evaluate various dose levels of Actimab-A along with dosing regimens. We expect

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

Triplet Combination Trial Design with Venetoclax,

HMA & Actimab-A Backbone

Additional clinical trial concepts for Actimab-A

have been submitted under the CRADA and are being reviewed. We anticipate that additional clinical trials with Actimab-A will be initiated

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

Broad Development Strategy for Actimab-A

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Data Supporting Actimab-A’s Mutation Agnostic Profile

To leverage Actimab-A’s

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

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

such as CLAG-M and in cell lines expressing TP53 mutations. The table below outlines the expression rates of these targets in patients

with AML.

Actimab-A Combination Data with Menin Inhibitors

In June 2024, we presented

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

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

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

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

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

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

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

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

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

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

Enhanced Tumor Control

with Actimab-A + Menin Inhibitor Revumenib

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Actimab-A Combination Data with FLT3 Inhibitors

We have also evaluated Actimab-A

in combination with FLT3 inhibitors such as gilteritinib (Astellas Pharma, Inc.) and midostaurin (Novartis Pharmaceuticals, Inc.). 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 will continue to evaluate the potential of Actimab-A in combination with FLT3 inhibitors.

Synergistic Anti-Leukemic

Effect with FLT3 Inhibitors

We expect to present additional data supporting

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

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

Actimab-A Solid Tumor Program: Potential Pan Solid Tumor Therapy

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

Suppressor Cells

Given the significant number

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

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

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

produced a sufficient enough clinical benefit to have been approved. To our knowledge, our Actimab-A solid tumor program is the only CD33

targeted radiotherapy being evaluated in combination with PD-1 ICIs. The rationale for studying Actimab-A in combination with either KEYTRUDA® or

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

MDSCs are immune-suppressive cells that help tumors

evade immune detection and promote disease progression. They are overexpressed in the tumor microenvironment in several different solid

tumors and associated with poor outcomes. They work by multiple mechanisms but most relevant to PD-1 inhibitors which work by keeping

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

MDSCs Immunosuppressive Effects

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Studies have shown that MDSCs are overexpressed

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

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

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

and patients below that level being classified as “Low-MDSC”. In this study, only Low-MDSC patients had a clinical response

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

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

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

There is considerable preclinical scientific evidence

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

have been no viable clinical approaches that have been tried successfully to our knowledge. MDSCs are known to express the CD33

antigen which is the target of Actimab-A. Actinium has also generated published and unpublished preclinical data showing that Actimab-A

can selectively deplete MDSCs in solid tumors.

Actimab-A Depletes MDSCs

in In Vivo Preclinical Models

We believe there is strong

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

ICIs such as KEYTRUDA® and OPDIVO®. Our Actimab-A solid tumor program is expected to be comprised of

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

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

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

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The patient population for

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

or Actimab-A with a specific checkpoint inhibitor. The objective of each trial would be to evaluate the safety and tolerability as well

as following endpoints including ORR, PFS and OS. Further, the following biomarker data would be collected including the pattern of depletion

of CD33+ MDSCs and T-cell activity in peripheral blood. We expect to present initial proof of concept clinical data from the first of

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

tumor program.

ATNM-400 Program: Potential Novel, First-in-Class Ac-225 Prostate

Cancer Radiotherapy

In March 2025, we announced

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

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

Meeting being held April 25 – 30, 2025. The abstract accepted for presentation highlighted the following:

We continue to study ATNM-400