35 slides from Actinium Pharmaceuticals, Inc. (delaware)'s technical presentation, May 20, 2024
Slide 1: Iomab-ACT Commercial CAR-T Trial KOL Webinar
Iomab-ACT Commercial CAR-T Trial KOL Webinar May 20, 2024 ATNM: NYSE AMERICAN
Slide 2: Disclaimer and Safe Harbor
Disclaimer and Safe Harbor The information presented herein contains express and implied forward-looking statements regarding the current intentions, expectations, estimates, opinions and beliefs of Actinium Pharmaceuticals, Inc. (“Actinium”) that are not historical facts. These forward-looking stat
Slide 3: Today’s Speakers & Agenda
Today’s Speakers & Agenda Sandesh Seth Dr. Madhuri Vusirikala Dr. Farrukh Awan Chairman & CEO VP, Clinical Development Professor, Internal Transplant & Cell Medicine, UTSW Therapy Opening Iomab-ACT: Next Iomab-ACT: Phase & Closing Remarks Generation Cell 1B/2 Commercial CAR- Therapy Conditioning T T
Slide 4: Opening Remarks
Opening Remarks February 18, 2022 ATNM: NYSE AMERICAN
Slide 5: Executive Summary
Executive Summary ▪ Actinium is pleased to invite Dr. Farrukh Awan, Professor of Internal Medicine - Division of Hematology Oncology at University of Texas Southwestern (UTSW), for today’s KOL webinar: ▪ Dr. Awan specializes in the treatment of patients with leukemia and lymphoma including CAR-T the
Slide 6: Innovation Focused R&D Yields Differentiated, High-Value Programs
Innovation Focused R&D Yields Differentiated, High-Value Programs Robust Experience Across Multiple Validated Broad Areas of Focus Leveraging Significant Cancer Targets & Isotopes Clinical Development Experience Hematology Targeted Conditioning CD45 CD33 Undisclosed Leukemia, Lymphoma AML, MDS Solid
Slide 7: Pipeline: Transformative Potential in AML, Cell & Gene and Solid Tumors
Pipeline: Transformative Potential in AML, Cell & Gene and Solid Tumors Program Indication Stage of Development Active R/R AML 55+ Iomab-B Positive Phase 3 Data Regulatory Filings BMT Targeted Conditioning AML/Hematology Actimab-A + Fit R/R AML 18+ Phase 1b complete CLAG-M Actimab-A + Unfit R/R AML
Slide 8: Actinium: Differentiated by Late-Stage, Hematology-Focused Programs
Actinium: Differentiated by Late-Stage, Hematology-Focused Programs 90% of the radiopharma industry pipeline focused 4 of the top 10 cancer drugs on solid tumors, ~65% concentrated on 4 targets are for hematology indications 2.2% 2.2% 4.3% 2.2% 2024 Expected Cancer 2.2% Heme 2.2% 11% 2023 Incidences
Slide 9: Iomab-ACT’s Strong Value Proposition for CAR-T Conditioning
Iomab-ACT’s Strong Value Proposition for CAR-T Conditioning Unprecedented opportunity to shift outcomes in cell and gene therapy conditioning and access existing patient in the multi-billion-dollar CAR-T markets with Iomab-ACT program Novel Radiotherapeutic Strong Scientific Rationale Applications I
Slide 10: Iomab-ACT: Next-Generation Cell Therapy Conditioning
Iomab-ACT: Next-Generation Cell Therapy Conditioning February 18, 2022 ATNM: NYSE AMERICAN
Slide 11: Dr. Madhuri Vusirikala, VP, Clinical Development BMT & Cell Therapy
Dr. Madhuri Vusirikala, VP, Clinical Development BMT & Cell Therapy • Joined Actinium in October 2022 as Vice President, Clinical Development, Transplant & Cellular Therapy • Over 20 years of clinical experience specializing in adult allogeneic bone marrow transplant • Most recently, Director of the
Slide 12: Multiple Applications with Actinium’s CD45 ARC Conditioning
Multiple Applications with Actinium’s CD45 ARC Conditioning CD45 ARC is the only clinical-stage targeted conditioning program with applications in bone marrow transplant, gene therapy, CAR-T, and other adoptive cell therapies Application Outcome Program Name (For Conditioning) Higher Dose BMT Myeloa
Slide 13: Strong Rationale for Combining Radiotherapy with CAR-T Therapies
Strong Rationale for Combining Radiotherapy with CAR-T Therapies Radiotherapy can be leveraged to safely and effectively improve CAR-T patient outcomes Radiotherapy TCR Clonality Analysis 1 mo post- 2 mo post- Pre-treatment treatment treatment Radiation sensitizes tumor cells to Radiotherapy combine
Slide 14: Actinium’s Iomab-ACT as a Lymphodepleting Agent for CAR-T
Actinium’s Iomab-ACT as a Lymphodepleting Agent for CAR-T Iomab-ACT can potentially improve overall response to CAR-T cell therapy by promoting cell expansion, enhancing persistence and reducing side effects through targeted CD45 depletion Mechanism of Action: CD45+ Immune Cells Ablated: 1 Lymphocyt
Slide 15: Single Dose Iomab-ACT Lymphodepletion and Clearance for CAR-T
Single Dose Iomab-ACT Lymphodepletion and Clearance for CAR-T Favorable pharmacokinetics and effective lymphodepletion observed with Actinium’s targeted lymphodepleting technology which can be optimized for use with CAR-T Demonstrable safety and dose- SINGLE DOSE dependent lymphodepletion Myeloablat
Slide 16: A Pilot Clinical Study of Iomab-ACT Prior to CAR-T Therapy
A Pilot Clinical Study of Iomab-ACT Prior to CAR-T Therapy Iomab-ACT lymphodepletion results in a favorable safety profile for patients receiving CAR-T therapies Design Safety ✓ Favorable safety profile with no Gr 3.+ incidences of CRS and ICANS; only Gr 1. Disclosed Efficacy Results ✓ N=2 (50%) pat
Slide 17: Iomab-ACT has Clear Use as a CAR-T Conditioning Agent
Iomab-ACT has Clear Use as a CAR-T Conditioning Agent ✓Selective targeting of immune cells implicated in CRS and ICANS ✓Combat tumor microenvironment and reduce tumor burden ✓Favorable pharmacokinetics with flexibility to optimize lymphodepletion ✓Ease of administration with a single dose at an outp
Slide 18: Iomab-ACT: Phase 1B/2 Commercial CAR-T Trial
Iomab-ACT: Phase 1B/2 Commercial CAR-T Trial Farrukh Awan, MD – Professor of Internal Medicine – UTSW Medical Center
Slide 19: Farrukh Awan, MD
Farrukh Awan, MD Professor of Internal Medicine – UTSW Medical Center • Joined the UT Southwestern faculty in 2018 with over 20 years of clinical experience specializing in stem cell transplant, cellular therapies and evaluation of novel therapies for the treatment of patients with lymphoid malignan
Slide 20: Setting the Standard for Commercial CAR-T Therapy
Setting the Standard for Commercial CAR-T Therapy UT Southwestern Medical Center has been at the forefront in the delivery of CAR-Ts for its patients Hundreds of Commercial Experienced Use of CAR-T Procedures Conducted Commercial CAR-Ts • ~570-600 new lymphoma cases • Commercial CAR-T treatments ann
Slide 21: UT Southwestern – Innovative Leader in CAR-T Cell Therapy
UT Southwestern – Innovative Leader in CAR-T Cell Therapy Experience with various CAR-T products and clinical trials underscores commitment to changing outcomes for patients Multiple CAR-T Products Delivered to Patients Deep CAR-T Clinical Experience Non-exhaustive First CAR-T clinical trials init
Slide 22: CAR-T Cell Therapy – Groundbreaking Cancer Immunotherapies
CAR-T Cell Therapy – Groundbreaking Cancer Immunotherapies Landmark cellular therapies that have changed outcomes in various hematological malignancies Overview FDA-Approved CAR-T Products CD19 Targeted: First Approved: 2017 First Approved: 2017 Patient’s T-cells extracted, engineered to display Chi
Slide 23: Lymphodepletion Critical to Ensure Successful CAR-T Outcomes
Lymphodepletion Critical to Ensure Successful CAR-T Outcomes CAR-T Typical Patient Journey Principles of Lymphodepletion Typical Agents Fludarabine (Flu) Cyclophosphamide (Cy) Bendamustine • Reduce endogenous lymphocytes to prepare a niche for engraftment of CAR-T infusions and to support their long
Slide 24: Standard Flu/Cy Lymphodepletion Chemotherapy is Not Ideal
Standard Flu/Cy Lymphodepletion Chemotherapy is Not Ideal Multiple critical unmet needs exist with the current lymphodepletion (e.g., flu/cy) practices Effectiveness • Flu/Cy is toxic, and not fully optimized for CAR-T programs • Fatal toxicities such as CRS and ICANS remain significant with current
Slide 25: Advantages of Iomab-ACT Lymphodepletion
Advantages of Iomab-ACT Lymphodepletion Iomab-ACT conditioning offers a potentially more targeted profile, enhanced outcomes, and improved convenience Administration Limitations of Flu/Cy • Multiple administrations needed Flu/Cy CAR-T Lymphodepletion ADMINISTRATION • Non-targeted chemotherapy engend
Slide 26: Strong Rationale for Conditioning with Commercial CAR-T
Strong Rationale for Conditioning with Commercial CAR-T Iomab-ACT experience to date is indicative that benefits of conditioning will translate into commercial CAR-T setting Next Stage (I-131-Apamistamab) Iomab-ACT CD45+ Clinical Trial with CD19 Clinical Trial with Preclinical Proof-of-Concept CAR-T
Slide 27: Study Design – Phase 1B/2 Commercial CAR-T study at UTSW
Study Design – Phase 1B/2 Commercial CAR-T study at UTSW In a single-arm study, patients will receive Iomab-ACT as a lymphodepletion regimen prior to commercial CAR-T infusion Conditioning CAR-T Therapy Monitoring and Assessment CD45+ Commercial CAR-T Short and Long-term Iomab-ACT Infusion Infusion
Slide 28: Multiple Goals to Shift Paradigm for Commercial CAR-T Conditioning
Multiple Goals to Shift Paradigm for Commercial CAR-T Conditioning Ensuring Safety Advancing Outcomes Reduce incidences of CRS and ICANS with Ensure long-term durability and persistence of commercially available CAR-Ts commercial CAR-T products Decrease incidences of post CAR-T cancer Mitiga
Slide 29: Iomab-ACT’s Value Proposition to the CAR-T Paradigm
Iomab-ACT’s Value Proposition to the CAR-T Paradigm Using a proven modality to achieve optimized lymphodepletion to increase efficacy, reduce toxicities and expand access of CAR-T Depletes lymphocytes and reduces tumor burden – Potentially lowers risk for CRS/Neurotoxicities Iomab-ACT – CAR-T cells
Slide 30: Closing Remarks
Closing Remarks February 18, 2022 ATNM: NYSE AMERICAN
Slide 31: Opportunity to Transform Existing Multi-Billion-Dollar Markets
Opportunity to Transform Existing Multi-Billion-Dollar Markets >$3.5B in annual CAR-T sales underscores blockbuster opportunity for Iomab-ACT conditioning $3.7B Worldwide Sales Annual CAR-T $500M $2.7B $472M $133M $364M $388M $371M $182M $1.7B $299M $523M $164M $87M $536M $176M $1.0B $734M $474M $58
Slide 32: Rapidly Expanding Market Highlights Potential Impact for Conditioning
Rapidly Expanding Market Highlights Potential Impact for Conditioning New CAR-T indications and gene therapy approvals expected to significantly increase addressable market and catalyze uptake of Iomab-ACT conditioning Cell and Gene Therapy Market1,3 Addressable Patient Population CGT Projections by
Slide 33: Upcoming Value-Creating Milestones for Iomab-ACT
Upcoming Value-Creating Milestones for Iomab-ACT Success of phase 1B/2 commercial CAR-T trial will inform pivotal study, paving a path for Iomab-ACT approval and launch 2024 2025 2026 Endpoints N = ~100-150 patients Randomized Pivotal Experimental Phase 3 (Planned) Primary: Modified EFS Control Seco
Slide 34: Q&A
Q&A Actinium Pharmaceuticals, Inc.
Slide 35: Thank you
Thank you February 18, 2022 Actinium Pharmaceuticals, Inc. ATNM: NYSE AMERICAN