Actinium Pharmaceuticals Provides Business Update After Presentation at Trump Mar-A-Lago Club Announcing Novel Non-PSMA Prostate Cancer Radiotherapy ATNM-400 and Outlining Revitalized Clinical Pipeline with 2025 Corporate Objectives

Rhea-AI Summary

Actinium Pharmaceuticals (NYSE: ATNM) announced significant updates to its clinical pipeline, highlighting the introduction of ATNM-400, a novel non-PSMA targeting Actinium-225 radiotherapy for prostate cancer. Initial preclinical results will be presented at AACR on April 27, 2025.

The company is establishing radiopharmaceutical manufacturing infrastructure in 2025 and expects multiple clinical trial data readouts in H2 2025, including:

• Actimab-A frontline AML trial with NCI
• Solid tumor trials combining Actimab-A with KEYTRUDA and OPDIVO in HNSCC and NSCLC
• Iomab-ACT trials in commercial CAR-T and sickle cell disease

Actinium's pipeline now targets four multi-billion-dollar market opportunities. The company reports a strong balance sheet with cash runway extending into mid-2027.

Positive

• Strong cash position with runway extending into mid-2027
• Expansion into prostate cancer market with novel ATNM-400 therapy
• Multiple clinical trial data readouts expected in H2 2025
• Pipeline targeting four distinct blockbuster market opportunities

Negative

• Manufacturing infrastructure still needs to be established in 2025
• ATNM-400 still in preclinical stage with no human trial data
• Potential competition from established PSMA-targeting therapies in prostate cancer

Insights

Biotechnology Analyst

Actinium's business update reveals a substantially expanded radiopharmaceutical pipeline with four distinct blockbuster market opportunities. The unveiling of ATNM-400, a novel non-PSMA targeting Actinium-225 radiotherapy for prostate cancer, represents a strategic entry into a lucrative market currently dominated by Pluvicto. The differentiated targeting mechanism potentially addresses an important unmet need for patients who don't respond to PSMA-targeted treatments.

The company's clinical momentum is accelerating with multiple trials generating data in 2H 2025, including the Actimab-A frontline AML trial (via NCI CRADA), solid tumor trials combining Actimab-A with established PD-1 inhibitors (KEYTRUDA and OPDIVO), and Iomab-ACT for cell and gene therapy conditioning. The mutation-agnostic mechanism of Actimab-A is particularly noteworthy, as it could position the therapy as a backbone treatment across multiple indications.

Most significantly, Actinium is establishing manufacturing infrastructure this year to support expanded clinical development and leverage its proprietary Actinium-225 cyclotron manufacturing technology. This vertical integration addresses a critical industry bottleneck in radioisotope supply and positions the company advantageously for later-stage development.

While ATNM-400 is still preclinical with data coming at AACR, the Actimab-A combinations are in more advanced stages, with published results in Leukemia showing promising MRD negativity and improved survival in r/r AML when combined with CLAG-M.

Financial Analyst

Actinium's strategic expansion into four distinct blockbuster market opportunities significantly enhances its long-term commercial potential. The company's cash runway extending into mid-2027 provides substantial operational flexibility, allowing management to execute on multiple clinical programs simultaneously without immediate financing pressure.

The introduction of ATNM-400 for prostate cancer represents an entry into a high-value therapeutic area. The prostate cancer treatment market is substantial, with Novartis's Pluvicto generating $978 million in 2023 sales despite its limitations for non-PSMA expressing tumors. Actinium's differentiated approach could capture meaningful market share if successful.

The company's investment in radiopharmaceutical manufacturing infrastructure in 2025 represents an important strategic move that could yield long-term competitive advantages in controlling supply chain, quality, and costs. Their proprietary Actinium-225 cyclotron manufacturing technology could become a valuable asset, potentially enabling partnerships beyond their internal pipeline.

Multiple clinical data readouts in 2H 2025 provide several potential value inflection points that could drive share price appreciation. The diversity of Actinium's pipeline - spanning hematologic malignancies, solid tumors, and cell therapy conditioning - creates multiple shots on goal and reduces program-specific risk.

The NCI collaboration through a CRADA adds credibility and potentially accelerates development of Actimab-A, while partnerships with major cancer centers like Memorial Sloan Kettering enhance scientific validation. With four distinct market opportunities now established, Actinium has dramatically expanded its addressable market.

- ATNM-400 is a novel, non-PSMA targeting, first-in-class Actinium-225 radiotherapy for prostate cancer with initial preclinical results to be presented at the AACR Annual Meeting

- Actinium is establishing radiopharmaceutical manufacturing infrastructure in 2025 to support expanding clinical trials and to leverage its proprietary Actinium-225 cyclotron manufacturing technology

- Data from several clinical trials expected in 2H:2025 across myeloid malignancies, solid tumors and cell and gene therapy conditioning

- Actinium's targeted radiotherapy programs expanded to four multi-billion-dollar market opportunities

NEW YORK, March 27, 2025 /PRNewswire/ -- Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, today provided a business update detailing recent achievements and anticipated milestones from its revitalized and expanding clinical pipeline. The update featured the unveiling of ATNM-400, Actinium's new Actinium-225 (Ac-225) solid tumor program, which is a novel, non-PSMA targeting, first-in-class radiotherapy for prostate cancer. Initial preclinical data from ATNM-400 will be presented at AACR on April 27, 2025. In addition, Actinium highlighted its 2025 manufacturing infrastructure activity, including its Actinium-225 cyclotron manufacturing technology, to support its expanding clinical pipeline. Finally, Actinium highlighted several clinical trials that are expected to generate clinical data in the second half of 2025 including its Actimab-A frontline AML trial under its Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), data from trials in the Actimab-A solid tumor program which combines Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA^® and OPDIVO^® in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) and Iomab-ACT commercial CAR-T and sickle cell disease (SCD) trials.

This update follows Actinium's company presentation at Trump Mar-a-Lago Club on March 26th and an Actimab-A KOL investor call on March 25^th, which can be accessed for replay here.

Sandesh Seth, Actinium's Chairman and CEO, said, "We are resurgent and expect 2025 will be an impactful year for Actinium as we execute to demonstrate the inherent value of our truly innovative and first of their kind clinical programs that focus on patients with high unmet needs. We are thrilled to introduce ATNM-400 and we look forward to presenting our promising preclinical results at AACR in April. We believe a significant opportunity exists in prostate cancer for ATNM-400, particularly for patients progressing or not well served by the PSMA targeting radiotherapy Pluvicto given its novel target and the potent cell killing ability of the Ac-225 isotope payload. In conjunction with advancing our clinical programs, several of which are expected to generate clinical data this year, we are building out manufacturing infrastructure in 2025 to support these programs which are expected to enter advanced development in 2026. Our strong balance sheet with cash runway expected to last into mid-2027 allows us to focus on unlocking the value inherent in our pipeline which has four distinct blockbuster opportunities with Actimab-A in hematology and solid tumors, Iomab-ACT in cell and gene therapy conditioning and now ATNM-400 in prostate cancer."

Actinium's 2025 achievements to date including the following:

• Unveiled ATNM-400, a first-in-class, novel non-PSMA targeting Actinium-225 radiotherapy for prostate cancer with initial preclinical data to be presented at AACR on April 27, 2025
  
  
• Initiated Actimab-A frontline AML triplet trial under NCI CRADA that will study Actimab-A as a backbone in combination with Venetoclax and ASTX-727, an oral hypomethylating agent developed by Taiho oncology, Inc., an Otsuka Holdings company
  
  
• Results of Actimab-A + CLAG-M combination trial published in the peer-reviewed journal Leukemia highlighting high rates of MRD- and improved overall survival in patients with r/r AML
  
  
• Initiated Actimab-A solid tumor program to combine Actimab-A with PD-1 checkpoint inhibitors KEYTRUDA and OPDIVO in head-to-head trials in head and neck squamous cell carcinoma and non-small cell lung cancer
  
  
• Entered into sponsored research agreements with Memorial Sloan Kettering Cancer Center to further elucidate Actimab-A's mutation agnostic mechanism of action and potential as a backbone therapy in myeloid malignancies
  
  
• Executed a supply agreement with Exckert & Ziegler for Actinium-225 Radioisotope to support comprehensive development activities for both U.S. and international clinical trials
  
  
• Abstracts accepted for presentation at the American Association for Cancer Research Annual Meeting highlighting Actimab-A's mutation agnostic profile in AML

Actinium's pipeline revitalization has resulted in expanded market opportunities for its first-in-class targeted radiotherapies in myeloid malignancies, solid tumors and cell and gene therapy conditioning. Actinium seeks to address four distinct blockbuster opportunities with ATNM-400, Actimab-A and Iomab-ACT.

Actinium outlined its 2025 business objectives for its revitalized and expanding clinical pipeline as follows:

Pipeline Expansion into Prostate Cancer with ATNM-400, a first-in-class, non-PSMA targeting Ac-225 radiotherapy

• Present abstract at AACR highlighting Actinium-225 targeted radiotherapy for novel radiotherapy cancer target

Establish In-house Radiopharmaceutical Manufacturing & Production

• Advance build-out of manufacturing facility
• Explore strategic partnerships leveraging proprietary Actinium-225 cyclotron manufacturing technology

Actimab-A as a mutation agnostic, backbone therapy for myeloid malignancies including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) across multiple treatment settings

• Initiate Phase 2/3 trial in combination with CLAG-M in relapsed or refractory AML and seek potential partners or collaborators
• Generate initial clinical data in frontline AML in first trial under CRADA with NCI
• Initiate additional clinical trials in myeloid malignancies

Actimab-A as a pan solid tumor therapy in combination with PD-1 inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs)

• Generate clinical proof of concept data in head and neck squamous cell carcinoma and non-small cell lung cancer
• Explore additional solid tumor indications for future trials

Iomab-ACT as a universal targeted conditioning agent to increase patients access to cell & gene therapies and improve patient outcomes

• Present initial data from commercial CAR-T trial at University of Texas Southwestern
• Generate clinical data in first non-malignant indication from sickle cell disease allogeneic stem cell transplant trial at Columbia University

About Actinium Pharmaceuticals, Inc.

Actinium is a pioneer in the development of targeted radiotherapies intended to meaningfully improve patient outcomes. Actinium is advancing its lead product candidate Actimab-A, a CD33 targeting therapeutic, as potential backbone therapy in acute myeloid leukemia (AML) and other myeloid malignancies leveraging the mutation agnostic alpha-emitter radioisotope payload Actinium-225 (Ac-225). Actimab-A has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA^® and OPDIVO^® by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Iomab-ACT, Actinium's next generation conditioning candidate, is being developed with the goal of improving patient access and outcomes for potentially curative cell and gene therapies. Iomab-B is an induction and conditioning agent prior to bone marrow transplant in patients with r/r AML, which Actinium is seeking a potential strategic partner for the U.S. ATNM-400 is Actinium's novel non-PSMA targeting Ac-225 radiotherapy for prostate cancer, which is supported by preclinical data and is being advanced to clinical trials. In addition, the company's R&D efforts are primarily focused on advancing several preclinical programs for solid tumor indications. Actinium holds 230 patents and patent applications including several patents related to the manufacture of the isotope Ac-225 in a cyclotron.

For more information, please visit: https://www.actiniumpharma.com/

Forward-Looking Statements

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Investors:
investorrelations@actiniumpharma.com 

 

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SOURCE Actinium Pharmaceuticals, Inc.

FAQ

When will ATNM-400's initial preclinical data for prostate cancer be presented?

ATNM-400's initial preclinical data will be presented at the AACR Annual Meeting on April 27, 2025.

What are the four major market opportunities in Actinium's (ATNM) pipeline?

ATNM's pipeline targets opportunities in: 1) ATNM-400 for prostate cancer, 2) Actimab-A for myeloid malignancies, 3) Actimab-A for solid tumors, and 4) Iomab-ACT for cell and gene therapy conditioning.

How long does Actinium Pharmaceuticals' (ATNM) cash runway extend?

The company reports having a cash runway expected to last into mid-2027.

What clinical trials is ATNM expecting data from in second half of 2025?

ATNM expects data from Actimab-A frontline AML trial, solid tumor trials with PD-1 inhibitors in HNSCC and NSCLC, and Iomab-ACT trials in CAR-T and sickle cell disease.