Actinium Pharmaceuticals Inc.

Company Overview

Business Model: Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on pioneering targeted radiotherapies for oncology. The company employs a biology-driven approach to develop differentiated, first-in-class radiopharmaceutical therapeutics for patients with solid tumors and hematologic malignancies. Its mission is to transform cancer treatment by maximizing therapeutic efficacy and minimizing toxicity through a deep understanding of tumor biology, translational medicine, and radiochemistry expertise.

Market Position: The radiopharmaceutical therapeutics market has experienced significant growth and validation, with products like Pluvicto® achieving approximately $2 billion in sales in 2025 and forecasted peak sales of $5 billion. Actinium Pharmaceuticals, Inc. aims to broaden patient populations benefiting from targeted radiopharmaceuticals by developing novel programs against differentiated targets with multi-indication potential, contrasting with the industry's cluster around targets like PSMA, SSTR2, and FAP. The company highlights its competitive strengths in a biology-driven approach, differentiated first-in-class pan-tumor programs (ATNM-400 and Actimab-A MDSC are unique in their targets/indications to the company's knowledge), a de-risked late-stage hematology franchise, an end-to-end supply chain, vertically integrated capabilities, and a strong intellectual property portfolio. The radiopharmaceutical field has seen approximately $17 billion in M&A from 2013-2023 and $8 billion in strategic investments and licensing since 2024, indicating a demand for novel and differentiated assets.

Recent Strategic Developments:

• Pipeline Advancement: Rapidly advancing ATNM-400 into clinical development, leveraging pre-clinical validation across mCRPC, EGFR-mutant NSCLC, and breast cancer.
• Immunomodulatory Approach: Intends to conduct a Phase 1b basket trial for Actimab-A in combination with PD-1 inhibitors across four MDSC-rich solid tumor types (HNSCC, NSCLC, GBM, MSI-high colorectal cancer), with initial data expected in 2H:2026.
• Hematology Partnerships: Actively seeking strategic partnerships to advance Phase 2/3-ready hematology programs, Actimab-A and Iomab-B, which have substantial clinical validation and FDA alignment on trial designs.
• Manufacturing Infrastructure: Completing construction of an internal cGMP radiopharmaceutical manufacturing facility, expected to be operational in 2H:2026, to provide clinical supply capabilities for Ac-225 based radioconjugates.
• Workforce Optimization: Conducted workforce optimizations in Q2 2025 (14% reduction) and Q3 2024 (20% reduction, primarily clinical and CMC groups) to prioritize strategic pipeline.
• Executive Leadership Change: In February 2026, the Chief Financial Officer resigned, and Sandesh Seth, the current Chairman and Chief Executive Officer, was appointed Principal Financial Officer.
• Legal Proceedings: Facing a putative class action complaint and shareholder derivative complaints filed in March and May 2025, respectively, alleging material misrepresentations and omissions concerning the Iomab-B Phase 3 SIERRA trial.

Geographic Footprint: Actinium Pharmaceuticals, Inc. is incorporated in Delaware with its principal executive offices in New York, NY, and leased lab and manufacturing space in Bronx, NY. The company's patent portfolio provides market exclusivity in major territories including the United States, Europe, Canada, Japan, and key emerging markets. Iomab-B has been licensed to Immedica for commercialization in the EUMENA region (Europe, Middle East, and North Africa). Clinical trials have been executed at approximately 50 treatment centers, including leading comprehensive cancer centers.

Financial Performance

Revenue Analysis

Profitability Metrics:

• Gross Margin: N/A
• Operating Margin: -40274.4% (Note: Revenue is minimal, leading to a highly distorted percentage)
• Net Margin: -37652.2% (Note: Revenue is minimal, leading to a highly distorted percentage)

Investment in Growth:

• R&D Expenditure: $21.12 million (-29.7% YoY)
• Capital Expenditures: $0.10 million (+845.5% YoY)
• Strategic Investments: Contractual commitments of approximately $1.5 million for modular removable manufacturing space, with $1.4 million expected to be incurred in 2026.

Business Segment Analysis

Actinium Pharmaceuticals, Inc. operates as a single operating and reportable segment. The following details pertain to its key product candidates.

ATNM-400 (Solid Tumor Program)

Financial Performance: Pre-clinical stage. Key Growth Drivers:

• First-in-class Ac-225 antibody radioconjugate targeting a novel, undisclosed, non-PSMA antigen.
• Demonstrated pre-clinical superiority to PSMA-targeted agents and ARPIs in mCRPC, and to EGFR inhibitors (osimertinib, datopotamab deruxtecan, amivantamab) in EGFR-mutant NSCLC models (3-5 fold greater tumor growth inhibition).
• Achieved 100% complete responses in combination with osimertinib in NSCLC models and complete tumor eradication with trastuzumab in HER2-resistant breast cancer models.
• Target expression observed in 60%-80%+ of mCRPC, NSCLC, and breast cancer patient tumors. Product Portfolio: Ac-225 antibody radioconjugate. Utilizes a theranostic strategy with Zr-89 as a companion imaging agent for patient selection and tumor visualization. Market Dynamics:
• Potential addressable population exceeding 100,000 patients across all lines of treatment in mCRPC and mHSPC.
• EGFR-mutant NSCLC represents approximately 30,000 U.S. patients annually, with potential for ~200,000 NSCLC patients regardless of oncogenic driver mutation.
• Breast cancer (HR-positive, HER2-resistant, TNBC) represents approximately 300,000 U.S. patients annually.

Actimab-A for MDSCs (Solid Tumor Program)

Financial Performance: Pre-clinical stage, with a Phase 1b basket trial planned. Key Growth Drivers:

• CD33-targeted Ac-225 radioconjugate designed to enhance checkpoint inhibitor efficacy by depleting immunosuppressive CD33+ MDSCs.
• Pre-clinical studies show selective homing to tumor-resident CD33+ MDSCs, cytotoxicity to patient-derived MDSCs ex vivo, and rescue of T-cell proliferation and anti-tumor immune responses.
• Addresses MDSC-mediated resistance to PD-1/PD-L1 checkpoint inhibitors. Product Portfolio: Lintuzumab-Ac-225. Market Dynamics:
• Phase 1b basket trial evaluating combination with PD-1 inhibitors (Keytruda® or Opdivo®) in HNSCC, NSCLC, GBM, and MSI-high colorectal cancer. Initial data expected 2H:2026.
• Potential to expand the >$40 billion PD-1/PD-L1 inhibitor market.

Actimab-A (Hematology Program)

Financial Performance: Phase 1b clinical trial completed, FDA alignment on Phase 2/3 trial design. Key Growth Drivers:

• Mutation-agnostic backbone therapy for AML and high-risk MDS.
• Phase 1b trial in R/R AML patients (including high-risk populations) demonstrated high rates of MRD-negative complete remissions and improved survival outcomes.
• 70% of eligible patients proceeded to bone marrow transplant, achieving a 24-month median overall survival.
• Well-tolerated safety profile consistent with CLAG-M chemotherapy. Product Portfolio: Lintuzumab-Ac-225. Market Dynamics:
• FDA alignment on Phase 2/3 trial design for combination with CLAG-M in first or second salvage R/R AML patients.
• Actively seeking a strategic partner to execute the trial.
• Supported by a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute.
• Potential market: estimated >$2 billion AML/MDS therapeutics market.

Iomab-ACT (Hematology Program)

Financial Performance: Three active clinical trials (Phase 1/2 in commercial CAR-T, Phase 1 in experimental CAR-T, Phase 1 in Sickle Cell Disease BMT). Key Growth Drivers:

• CD45-targeted conditioning platform for cell and gene therapies (CAR-T, allogeneic hematopoietic stem cell transplant, gene therapy).
• Designed to provide targeted lymphodepletion and myeloablation while minimizing off-target toxicities of chemotherapy conditioning. Product Portfolio: CD45-targeted conditioning platform. Market Dynamics:
• Cell and gene therapy market: >30,000 patients annually receiving CAR-T or allogeneic transplant in the U.S. and Europe.
• Potential to improve patient access and outcomes for these therapies.

Iomab-B (Hematology Program)

Financial Performance: Phase 3 SIERRA trial completed. Key Growth Drivers:

• CD45-targeted radioimmunotherapy (apamistamab-I-131) for bone marrow transplant in R/R AML patients ineligible for conventional conditioning.
• SIERRA trial met primary endpoint of durable complete remission (dCR) with statistical significance (p<0.0001).
• Composition of matter patents extending to 2038.
• Established network of 24 clinical sites from the SIERRA trial.
• Pre-clinical and clinical data support potential development in five additional disease indications (ALL, MDS, CML, multiple myeloma, lymphoma). Product Portfolio: Apamistamab-I-131. Market Dynamics:
• FDA alignment on Phase 2/3 trial design for an expanded R/R AML patient population (age 18+ with active AML, blast counts >5% and <20%).
• Actively seeking a strategic partner for pivotal development and commercialization.
• Total addressable market: approximately 150,000 patients across six indications.
• Licensed to Immedica for the EUMENA region.
• Note: FDA requires an additional randomized head-to-head clinical trial to demonstrate an OS benefit and a dose optimization trial based on absorbed bone marrow dose for BLA filing.

Capital Allocation Strategy

Shareholder Returns:

• Share Repurchases: Not disclosed.
• Dividend Payments: Actinium Pharmaceuticals, Inc. has never declared or paid any cash dividends on its common stock. Future earnings, if any, are expected to finance business growth.
• Dividend Yield: N/A
• Future Capital Return Commitments: Not disclosed.

Balance Sheet Position:

• Cash and Equivalents: $47.998 million (as of December 31, 2025)
• Total Debt: $0.011 million (current finance lease liabilities as of December 31, 2025)
• Net Cash Position: $47.987 million (as of December 31, 2025)
• Credit Rating: Not disclosed.
• Debt Maturity Profile: $0.011 million in finance lease liabilities due in 2026.

Cash Flow Generation:

• Operating Cash Flow: -$24.580 million (2025)
• Free Cash Flow: -$24.684 million (2025)
• Cash Conversion Metrics: Not disclosed.

Operational Excellence

Production & Service Model: Actinium Pharmaceuticals, Inc. operates a clinical-stage biopharmaceutical model focused on research, discovery, and clinical development of targeted radiotherapies. The company has established and actively manages an end-to-end supply chain encompassing radioisotope sourcing, manufacturing targeting agents, producing final drug product candidates, and delivering them to the point of care. It has demonstrated the ability to execute complex radiopharmaceutical trials at approximately 50 treatment centers, including a Phase 3 trial for Iomab-B involving high doses of Iodine-131 and patient isolation, successfully completed without missed doses.

Supply Chain Architecture: Key Suppliers & Partners:

• Radioisotope Suppliers:
  • Iodine-131: Sourced from multiple suppliers, including two leading global manufacturers.
  • Actinium-225: Multiple cGMP suppliers for clinical trials, with the Department of Energy (DOE) historically being the primary supplier. DOE's capacity from thorium-229 decay and a linear accelerator is expected to meet current and early commercial needs. The contract with DOE is renewed yearly and was extended through the end of 2025.
• Contract Manufacturing Organizations (CMOs): Qualified multiple CMOs.
• Distribution Partners: Established network to approximately 50 leading hospitals.

Facility Network:

• Manufacturing: Completing construction of an internal cGMP radiopharmaceutical manufacturing facility in New York, expected to be operational in 2H:2026. This facility is purpose-built for alpha-emitter handling and flexible manufacturing of Ac-225 based radioconjugates for clinical supply. The company also leases manufacturing space at Albert Einstein College of Medicine (lease expires December 31, 2030).
• Research & Development: Leases lab space at Albert Einstein College of Medicine (lease expires August 31, 2026).
• Distribution: Established distribution network to approximately 50 leading hospitals.

Operational Metrics: Not disclosed.

Market Access & Customer Relationships

Go-to-Market Strategy: Distribution Channels:

• Direct Sales: Actinium Pharmaceuticals, Inc. does not currently have commercial sales and marketing capabilities. If products are approved without a commercial partner, the company would need to build these capabilities.
• Channel Partners: Actively seeking strategic partnerships to advance its Phase 2/3-ready hematology programs (Actimab-A and Iomab-B). Iomab-B has been licensed to Immedica for commercialization in the EUMENA region. Customer Portfolio:
• Enterprise Customers: Collaborations include a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A development and a clinical collaboration with Memorial Sloan Kettering Cancer Center (MSK) for Iomab-ACT.
• Customer Concentration: Not disclosed. Geographic Revenue Distribution:
• United States: Primary focus for development and potential commercialization.
• EUMENA region: Iomab-B licensed to Immedica.
• Growth Markets: Patent protection extends to Canada, Japan, and key emerging markets, indicating potential for future international expansion.

Competitive Intelligence

Market Structure & Dynamics

Industry Characteristics: The radiopharmaceutical therapeutics field is experiencing significant growth, validation, and rapid technological change, characterized by intense competition. The market has seen substantial M&A activity (approximately $17 billion from 2013-2023) and strategic investments/licensing ($8 billion since 2024) for novel and differentiated assets. Most industry development pipelines are clustered around a few biological targets (PSMA, SSTR2, FAP).

Competitive Positioning Matrix:

Direct Competitors

Primary Competitors:

• Large Pharmaceutical Companies: Novartis, Eli Lilly, Bristol Myers Squibb, AstraZeneca, Bayer, and Johnson & Johnson have entered the radiopharmaceutical space, often focusing on PSMA- or SSTR2-targeted therapies.
• Clinical-Stage Radiopharmaceutical Companies: Includes Telix Pharmaceuticals, Perspective Therapeutics, Clarity Pharmaceuticals, Cellectar Biosciences, Bicycle Therapeutics, Molecular Partners, Ratio Therapeutics, Convergent Therapeutics, Aktis Oncology, Radiopharm Theranostics, and Plus Therapeutics. Actinium Pharmaceuticals, Inc. states that, to its knowledge, none of these directly compete with its product candidates in terms of biological targets.
• Antibody-Drug Conjugate Companies: In solid tumors, Actinium Pharmaceuticals, Inc. may compete with ADCs, but highlights radiopharmaceutical advantages such as the "crossfire" effect and non-invasive imaging for patient selection.
• Therapeutic Area Competitor Companies: Established pharmaceutical companies with marketed drugs in prostate cancer (Johnson & Johnson, Astellas/Pfizer, Bayer, Novartis, AstraZeneca/Merck), EGFR mutant NSCLC (AstraZeneca, Johnson & Johnson, Roche, Daiichi Sankyo), breast cancer (Roche, Pfizer, Lilly, Novartis, AstraZeneca/Daiichi Sankyo), and AML (AbbVie, Bristol Myers Squibb, Astellas, Servier).

Emerging Competitive Threats: The rapidly evolving landscape includes new entrants, disruptive technologies, and alternative solutions. Mergers, acquisitions, and collaborations by larger companies to access novel pipeline agents and manufacturing capabilities can quickly reshape the competitive landscape.

Competitive Response Strategy: Actinium Pharmaceuticals, Inc. differentiates itself through its focus on novel, first-in-class targets with pan-tumor potential, vertically integrated capabilities spanning isotope production through drug product manufacturing, late-stage hematology programs with clear regulatory pathways, and a comprehensive intellectual property position.

Risk Assessment Framework

Strategic & Market Risks

Market Dynamics:

• Clinical-Stage Operations: Actinium Pharmaceuticals, Inc. is a clinical-stage company with no commercial product sales to date and has incurred net losses since inception, with an accumulated deficit of $409.7 million as of December 31, 2025.
• Pipeline Dependence: Highly dependent on the clinical, regulatory, and commercial success of its product candidates (ATNM-400, Actimab-A, Iomab-ACT, Iomab-B), none of which have received regulatory approval.
• Regulatory Disagreement: The FDA may disagree with regulatory plans, as seen with Iomab-B, which requires additional randomized head-to-head clinical trials to demonstrate an overall survival benefit and a dose optimization trial.
• Market Acceptance: Product candidates may not achieve market acceptance among physicians, patients, and the medical community, impacting commercial success.
• Competition: Faces intense competition from larger pharmaceutical and biotechnology companies with greater financial resources and established infrastructure.
• Healthcare Legislative Reform: Measures like the Inflation Reduction Act of 2022 and the One Big Beautiful Bill Act, along with other federal and state initiatives, could lead to drug price controls, reduced reimbursement, and increased operational costs.
• Healthcare Spending Changes: Reductions in government funding for cancer research (e.g., NIH, NCI, HHS) could limit grants and delay clinical programs.

Operational & Execution Risks

Supply Chain Vulnerabilities:

• Supplier Dependency: Relies on single third-party manufacturers for preclinical and clinical trial drug supplies, including monoclonal antibodies, linkers, and radioisotopes. Disruptions could delay development or regulatory approval.
• Isotope Supply: Dependence on third-party suppliers for Iodine-131 and Actinium-225. The Actinium-225 supply contract with the Department of Energy requires yearly renewal. Failure to secure sufficient quantities of isotopes would severely impact development and commercialization.
• Manufacturing Capabilities: Currently relies on third-party manufacturers. Plans to build an internal manufacturing facility, but lacks prior experience, posing risks of delays, cost overruns, or failure to achieve expected benefits.
• Third-Party Contractors: Dependence on contract research organizations, medical institutions, clinical investigators, and contract laboratories for clinical trials. Non-compliance or failure to meet deadlines by these third parties could delay or terminate trials.
• Hazardous Materials: Research, development, and manufacturing involve controlled use of hazardous, radioactive, and biological materials, posing risks of contamination, injury, liability, and compliance costs.

Financial & Regulatory Risks

Market & Financial Risks:

• Financing Risk: Anticipates continued net losses and requires substantial additional funding. Limited access to capital markets could force delays, scaling back R&D, or relinquishing product rights.
• Dilution: Future equity or debt financing could dilute existing stockholders' ownership interests.
• Stock Price Volatility: The common stock is subject to significant price volatility due to various factors, including clinical trial results, regulatory actions, and market perception.
• Litigation: Subject to legal proceedings, including a putative class action and shareholder derivative complaints, which are costly, time-consuming, and uncertain in outcome.
• NOL Limitations: Ability to utilize federal net operating loss carryforwards and other tax attributes may be limited by ownership changes under Sections 382 and 383 of the Internal Revenue Code. Regulatory & Compliance Risks:
• FDA Approval Uncertainty: The BLA approval process is costly, lengthy, and uncertain. The FDA may require additional data, trials, or deny approval.
• Ongoing Regulatory Obligations: Post-approval, products are subject to extensive and ongoing regulatory requirements, including surveillance, REMS, and compliance with cGMPs and GCPs.
• Orphan Drug Exclusivity: While Actimab-A and Iomab-B have orphan drug designation, this does not guarantee approval or market exclusivity, which can be lost or challenged.
• Healthcare Laws: Relationships with healthcare professionals and third-party payors are subject to federal and state fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA, Sunshine Act), with potential for significant penalties for non-compliance.
• Government Shutdowns: U.S. federal government shutdowns (e.g., Oct 1 - Nov 12, 2025) can disrupt operations of regulatory agencies like the FDA and NIH, delaying clinical development and regulatory interactions.
• BIOSECURE Act: New legislation restricting government procurement from "biotechnology companies of concern" could impact vendor relationships and government grants.

Geopolitical & External Risks

Geopolitical Exposure:

• Global Conflicts: Ongoing geopolitical conflicts and related sanctions/countermeasures could adversely impact global economic conditions and market volatility.
• Trade Relations: Uncertainty regarding tariff policies and potential countermeasures could increase costs and disrupt the global supply chain.
• International Operations: Future international expansion would expose the company to risks such as unexpected changes in regulatory requirements, export restrictions, tariffs, and difficulties in protecting intellectual property rights.

Innovation & Technology Leadership

Research & Development Focus: Core Technology Areas:

• Targeted Radiotherapies: Pioneering the development of targeted radiotherapies, employing a biology-driven approach to identify novel targets implicated in tumor biology, disease progression, and treatment resistance.
• Radioconjugate Design: Expertise in radiochemistry for designing novel radioconjugates.
• Ac-225 Production: Developed proprietary cyclotron-based technology for commercial-scale production of high-purity Actinium-225, which avoids long-lived radioactive contaminants. The company is seeking a partnership for this technology.
• Theranostic Strategy: Utilizes Zr-89 as a companion imaging agent for ATNM-400 to enable patient selection and tumor visualization. Innovation Pipeline: Committed to expanding its pipeline through internal discovery efforts and potential strategic acquisitions of complementary assets or technologies, with rigorous criteria for program advancement.

Intellectual Property Portfolio: Actinium Pharmaceuticals, Inc. has built a robust intellectual property portfolio comprising approximately 250 issued patents and pending patent applications across multiple jurisdictions.

• Patent Strategy: Includes composition of matter patents (e.g., Iomab-B patents extending to 2038), method of use patents, manufacturing and process patents (protecting Ac-225 production technology), and platform technology patents.
• Licensing Programs: Iomab-B is licensed to Immedica for the EUMENA region.
• IP Litigation: The company may become involved in patent litigation or administrative proceedings (e.g., post-grant review, inter partes review) to defend its patent rights.
• Trade Secrets: Relies on unpatented trade secrets, improvements, confidential know-how, and confidentiality agreements to protect proprietary information.

Technology Partnerships:

• Strategic Alliances: Has a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A development.
• Research Collaborations: Collaborating with Memorial Sloan Kettering Cancer Center (MSK) on a clinical trial for Iomab-ACT.
• Isotope Production Partnerships: Exploring partnerships to manufacture Actinium-225 using its patented cyclotron production technology.

Leadership & Governance

Executive Leadership Team

Leadership Continuity: The company experienced the resignation of its Chief Financial Officer, Steve O’Loughlin, in February 2026, with CEO Sandesh Seth assuming the Principal Financial Officer role. Workforce optimizations in 2025 and 2024 led to reductions in headcount, particularly in clinical and CMC groups. The company's future success is dependent on its ability to attract and retain highly qualified personnel in a competitive market.

Board Composition: The Board of Directors consists of six members, with five independent directors: June S. Almenoff, Jeffrey W. Chell, David Nicholson (Lead Independent Director), Ajit S. Shetty, and Richard I. Steinhart. Directors serve staggered terms across three classes. The Board's expertise spans drug development, clinical development, commercial strategy, business development, patient donor programs, bone marrow transplants, pharmaceutical R&D, supply chain operations, and financial management. The Board has an Audit Committee (chaired by Richard I. Steinhart, who is an "audit committee financial expert"), a Compensation Committee (chaired by David Nicholson), and a Nominating and Corporate Governance Committee (chaired by Ajit S. Shetty).

Human Capital Strategy

Workforce Composition: As of March 25, 2026, Actinium Pharmaceuticals, Inc. had 25 full-time employees. Of these, 12 hold Ph.D. or M.D. degrees, and 21 are engaged in research and development and clinical development activities.

Talent Management: Acquisition & Retention: The company aims to attract and retain skilled and experienced personnel in a competitive hiring market. Its compensation program is designed to align employee interests with stockholder value creation, motivate achievement of objectives, and encourage retention through a combination of base salary, performance cash bonuses, and long-term equity incentive awards (primarily stock options). Diversity & Development: The Board considers overall composition and diversity, including areas of expertise, business experience, and appropriate perspectives on environmental, social, and governance matters, when evaluating director nominees.

Regulatory Environment & Compliance

Regulatory Framework: Actinium Pharmaceuticals, Inc.'s product candidates are regulated as biologics by the FDA under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, requiring approval via the BLA pathway. Due to their radioactive nature, radiopharmaceuticals are also subject to extensive regulation by the Nuclear Regulatory Commission (NRC) or Agreement States under the Atomic Energy Act, including licensing for radioactive materials, radiation safety, waste disposal, and security. The company must also comply with U.S. Department of Transportation regulations for radioactive materials transport. International operations are subject to comparable regulatory authorities, such as the European Medicines Agency (EMA), which has specific guidelines for radiopharmaceuticals.

Legal Proceedings:

• Securities Class Action: On March 27, 2025, a putative class action complaint was filed against the company and certain executives, alleging material misrepresentations and omissions concerning the Iomab-B Phase 3 SIERRA trial. Defendants have moved to dismiss the amended complaint.
• Shareholder Derivative Actions: Two substantially identical shareholder derivative complaints were filed in May 2025, consolidated, and stayed pending resolution of the motion to dismiss in the securities class action.
• Shareholder Demand: A shareholder demand for books and records related to the securities litigation was served on June 17, 2025, and rejected by the company.
• Actinium Pharmaceuticals, Inc. and other defendants intend to vigorously defend against these claims.

Tax Strategy & Considerations

Tax Profile: Actinium Pharmaceuticals, Inc. reported a loss before income taxes of $33.289 million in the United States and $0.598 million internationally for the year ended December 31, 2025. The company has recorded a full valuation allowance of $116.077 million against its net deferred tax assets as of December 31, 2025, indicating that it is not more likely than not that these assets will be realized.

• Net Operating Losses (NOLs): As of December 31, 2025, the company had federal NOL carryforwards of $218.9 million and foreign NOL carryforwards of $0.048 million. Federal NOLs generated prior to 2018 ($104.8 million) begin to expire in 2026, with $3.6 million expiring that year. NOLs from 2018 onwards ($114.6 million) have an indefinite life but are limited to 80% of taxable income. State NOLs of $204.6 million begin to expire in 2035.
• Tax Credits: The company holds federal research and development tax credits of $8.1 million (expiring from 2033) and orphan drug credits of $16.7 million (expiring from 2037).
• Tax Reform Impact: The One Big Beautiful Bill Act, enacted in July 2025, did not have a material impact on the company's financial position or results. Actinium Pharmaceuticals, Inc. believes its antibody radiation conjugates (ARCs) are less likely to face pricing pressure and negotiation from the Inflation Reduction Act of 2022 due to the 11-year protection for biologics and orphan drug exclusion.
• Uncertain Tax Positions: No uncertain tax positions were identified as of December 31, 2025, and no interest or penalties related to income taxes were accrued.

Insurance & Risk Transfer

Risk Management Framework:

• Insurance Coverage: Actinium Pharmaceuticals, Inc. maintains cybersecurity insurance coverage to mitigate financial exposure to cybersecurity incidents. It also holds a general liability insurance policy that covers liabilities of its directors and officers.
• Risk Transfer Mechanisms: The company does not have insurance coverage for pollution cleanup and removal, which is a risk given its use of hazardous materials.