Actinium Pharmac - ATNM STOCK NEWS

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM), a leader in targeted radiotherapies, has announced its participation in the upcoming 37th Annual Roth Conference, scheduled for March 16th to 18th, 2025.

The company's management team will be available for one-on-one meetings with investors on March 17th and 18th. Interested investors can arrange meetings through their ROTH representative or by submitting a registration request at Roth2025Registration.

Actinium Pharmaceuticals (NYSE: ATNM) has initiated a groundbreaking clinical trial under its CRADA with the National Cancer Institute, testing a first-ever triplet combination therapy for newly diagnosed AML patients. The trial (NCT06802523) will evaluate Actimab-A in combination with Venetoclax and ASTX-727.

Actimab-A, a humanized anti-CD33 antibody with Actinium-225 payload, will be combined with Venetoclax (a Bcl-2 inhibitor) and ASTX-727 (an oral hypomethylating agent). The study aims to assess Complete Remission rates and safety parameters, with initial clinical data expected in 2H:2025.

Previous Phase 1 trials demonstrated Actimab-A's mutation agnostic properties and synergistic potential. The company aims to establish Actimab-A as a backbone therapy for AML treatment, targeting over 100,000 patients with AML and other myeloid malignancies in the U.S. and major international markets.

Actinium Pharmaceuticals (NYSE: ATNM) reported key developments and financial results for Q3 2024. The company aligned with FDA on Phase 2/3 trial for Actimab-A, and received FDA clearance for two Iomab-ACT INDs. The company reported cash and equivalents of $78.6 million, expected to fund operations into 2027. Q3 financial highlights include research and development expenses of $9.8 million, down from $11.6 million year-over-year, and a net loss of $11.6 million, improved from $13.3 million in Q3 2023. The company reduced headcount by 20% in Q3, expecting to save approximately $3.7 million in personnel expenses for 2025.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced the publication of Phase 3 SIERRA trial results for Iomab-B in the Journal of Clinical Oncology. The trial, involving 153 patients aged 55+ with relapsed/refractory Acute Myeloid Leukemia (r/r AML), compared Iomab-B with bone marrow transplant (BMT) to standard chemotherapy and BMT. Key findings include:

1. Primary endpoint of durable Complete Remission achieved (p<0.0001)
2. Significant improvement in Event-Free Survival (p<0.0001)
3. Overall survival endpoint not met due to high crossover rate
4. Improved outcomes for patients with TP53 mutation and those aged 65+

Despite positive results, the FDA requires an additional Phase 3 trial demonstrating overall survival benefit for BLA filing. Actinium plans to seek a strategic partner for Iomab-B's further development in the U.S.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced that the FDA has determined the Phase 3 SIERRA trial for Iomab-B is not adequate to support a Biologics License Application (BLA) filing, despite meeting its primary endpoint with statistical significance. The FDA requires an additional head-to-head randomized clinical trial demonstrating overall survival benefit to support a BLA filing.

Key points:

• Actinium will request a meeting with the FDA to discuss specifics of the additional trial
• The company will seek a strategic partner for Iomab-B in the U.S. after completing FDA interactions
• Actinium will focus development efforts on Actimab-A, Iomab-ACT, and preclinical programs

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) has expanded its patent coverage for Iomab-ACT, a targeted radiotherapy conditioning agent, with the issuance of U.S. Patent No. 11,912,780. This patent, extending to 2040, covers methods using Iomab-ACT for conditioning patients before gene-edited hematopoietic stem cell therapy for non-malignant disorders such as sickle cell disease, SCID, β-thalassemia, and Fanconi's anemia.

Iomab-ACT targets CD45, aiming to replace non-targeted chemotherapy in conditioning for cell and gene therapies. The company is conducting clinical trials with Memorial Sloan Kettering Cancer Center, the University of Texas Southwestern, and Columbia University to explore Iomab-ACT's potential in various applications, including CAR-T therapy and sickle cell disease treatment.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) announced FDA clearance for an IND application to study Iomab-ACT for targeted conditioning prior to bone marrow transplant (BMT) in sickle cell disease patients. The study, in collaboration with Columbia University, aims to evaluate Iomab-ACT's safety and potentially inform future gene therapy conditioning trials. Iomab-ACT, an Antibody Radiation Conjugate targeting CD45, could replace current non-targeted chemotherapy and total body irradiation conditioning methods, potentially reducing severe side effects and broadening access to curative cellular therapies. This initiative addresses the high unmet need among approximately 100,000 U.S. sickle cell patients annually. The study aligns with Actinium's strategy to expand Iomab-ACT's applications in transplant, cell therapy, and gene therapy conditioning, tapping into a growing market for CAR-T and gene therapies expected to reach 93,000 U.S. patients by 2030.

Actinium Pharmaceuticals (NYSE AMERICAN: ATNM) will present at the 3rd Annual Targeted Radiopharmaceuticals Summit US in San Diego from July 30 - August 1, 2024. The presentation, titled 'Overcoming Adverse Cytogenetics, TP53, Other Mutations & Treatment Resistant Disease in Relapsed/Refractory AML Using Antibody Radiation Conjugates,' will take place on July 31, 2024.

The presentation will highlight:

• Iomab-B, a CD45 I-131 ARC, enabling bone marrow transplant in otherwise ineligible patients
• Actimab-A, a CD33 Ac-225 ARC, demonstrating strong anti-leukemic activity
• Responses in heavily pretreated patients, including those with prior venetoclax treatment or TP53-mutated disease
• Preclinical data showing benefits of combining Actimab-A with targeted therapies like FLT3 inhibitors

Both Iomab-B and Actimab-A are the only clinical stage antibody radiation conjugates in development for acute myeloid leukemia patients.

Actinium Pharmaceuticals (NYSE: ATNM) has made significant strides in developing its blood cancer treatment pipeline, focusing on Antibody Radiation Conjugates (ARCs) and targeted radiotherapies. Recent highlights include the presentation of preclinical data combining Actimab-A with menin inhibitors at the European Hematology Association (EHA) Congress, and positive Phase 3 SIERRA trial results for Iomab-B in relapsed/refractory AML patients. The SIERRA trial showed a 92% 1-year survival and 69% 2-year survival for patients receiving Iomab-B led bone marrow transplants. Actinium also plans to extend Iomab-B for other blood cancers and introduce Iomab-ACT for enhanced cell and gene therapy outcomes. These advancements are important as biopharma companies work to address the rising incidence of blood cancers globally.