Company Summary: Actinium Pharmaceuticals, Inc.

Business Overview

• Nature of Business:
  • Pioneer in targeted radiotherapies aimed at improving outcomes for patients with advanced cancers, particularly relapsed or refractory (r/r) cancers who have exhausted other treatments.
  • Focused on developing a pipeline of differentiated clinical-stage radiopharmaceutical candidates targeting validated cancer markers.
  • Aims to become a specialty radiopharmaceutical company with capabilities in radioisotope production, drug manufacturing, preclinical research, and clinical development.

Core Technologies & Capabilities

• Industry-leading technologies in radioisotope production, biologic drug conjugation, and in-house manufacturing.
• Portfolio of approximately 230 issued and pending patents worldwide.

Product Candidates & Pipeline

Key Product Candidates:

• Actimab-A:

  • Lead product targeting CD33 for myeloid malignancies, including AML and MDS.
  • Studied in over 150 patients.
  • Development includes a Phase 2/3 trial in combination with chemotherapy (CLAG-M).
  • Under a CRADA with NCI to develop treatments combining Actimab-A with Venetoclax and ASTX-727 in frontline AML.
  • Initiated a solid tumor program combining Actimab-A with PD-1 checkpoint inhibitors (KEYTRUDA®, OPDIVO®), targeting head & neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC).

• Iomab-ACT:

  • Next-generation targeted conditioning agent for cell and gene therapies.
  • Targets CD45 using I-131 radioisotope.
  • Developing for conditioning prior to CAR-T and BMT, including treatments for sickle cell disease (SCD) and other hematologic indications.
  • Ongoing clinical trials, including collaboration with Memorial Sloan Kettering and a planned IND study for SCD with Columbia University.

• ATNM-400:

  • Preclinical, novel radiotherapy for prostate cancer.
  • Uses Actinium-225 (Ac-225) targeting a different marker than PSMA (the target of Pluvicto).
  • Demonstrated promising preclinical results with selective tumor accumulation and dose-dependent cytotoxicity.

• Iomab-B:

  • Previously studied in a Phase 3 SIERRA trial in elderly r/r AML patients.
  • Demonstrated significant improvement in durable complete remission (dCR) and event-free survival (EFS), but did not meet the FDA requirement for overall survival (OS) benefit.
  • FDA requested a new head-to-head trial; efforts are ongoing to seek a strategic U.S. partner.

Market & Medical Need

• Focused on indications with high unmet needs:
  • Myeloid malignancies (AML, MDS): over 100,000 patients annually in the US and EU5.
  • Solid tumors such as HNSCC and NSCLC: over 600,000 patients annually worldwide.
  • Prostate cancer: approximately 1.5 million new cases annually globally.
  • Cell & gene therapy conditioning: market growing with multiple approved CAR-T therapies and gene therapies.
  • SCD: affects roughly 100,000 people in the U.S.

Business Strategy

• Establish Actimab-A as a mutation-agnostic backbone therapy for myeloid cancers.
• Deploy Actimab-A to synergize with PD-1 inhibitors in solid tumors.
• Develop ATNM-400 targeting prostate cancer.
• Position Iomab-ACT as a universal conditioning agent for cellular therapies.
• Build in-house manufacturing capability, including proprietary Ac-225 cyclotron technology, to lower production costs and support clinical and commercial supply.
• Aim to secure partnerships for late-stage trials and commercialization, especially for Iomab-B, which faces regulatory hurdles.

Employees

• As of March 28, 2025: 37 full-time employees
  • 22 engaged in R&D and clinical development.
  • Highly skilled personnel, including Ph.D. and M.D. holders.

Revenue & Income

• No revenue from product sales to date.
• Consistent net losses since inception:
  • December 31, 2024: Net loss of $38.2 million
  • December 31, 2023: Net loss of $48.8 million
• Accumulated deficit:
  • As of December 31, 2024: $375.8 million
  • As of December 31, 2023: $337.6 million
• Business operations are primarily funded through equity sales, grants, and collaborations. No commercialized products yet.