Actinium Pharmaceuticals, Inc. (delaware) · AMEX:ATNM
Actinium Pharmaceuticals, Inc. (delaware) — Actinium Pharmaceuticals — Investor Presentation (February 2023)
42 slides from Actinium Pharmaceuticals, Inc. (delaware)'s investor presentation, Feb 21, 2023
Slide 1: Iomab-B SIERRA Trial Phase 3 Results
ATNM: NYSE AMERICAN February 18, 2022 Iomab - B SIERRA Trial Phase 3 Results
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 - lookin
Slide 3: Today's Speakers & Agenda
Sandesh Seth Chairman & CEO Dr. Madhuri Vusirikala VP, Clinical Development, BMT & Cellular Therapy Dr. Avinash Desai Chief Medical Officer Caroline Yarbrough Chief Commercial Officer Today’s Speakers & Agenda 3 Introduction and Closing Remarks Iomab - B Phase 3 SIERRA Results Significance of SIERRA
Slide 4: SIERRA Results Support Becoming a New Standard of Care
SIERRA Results Support Iomab - B Becoming a New Standard of Care 4 AML – Acute Myeloid Leukemia; BMT – Bone Marrow Transplant; R/R – Relapsed/Refractory; GVHD – Graft versus host disease Unprecedented BMT Access with Iomab - B Large Underserved R/R AML Patient Segment Improved Outcomes with Iomab -
Slide 5: Dr. Madhuri Vusirikala, VP, Clinical Development BMT & Cell Therapy
Dr. Madhuri Vusirikala, VP, Clinical Development BMT & Cell Therapy 5 • 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 t
Slide 6: SIERRA: Positive Efficacy, Safety, and Long-Term Outcomes in R/R AML
SIERRA: Positive Efficacy, Safety, and Long - Term Outcomes in R/R AML 6 Trial Endpoints and Metrics Results 6 - month durable Complete Remission (dCR) p <0.0001 Event - Free Survival (EFS) EFS Hazard Ratio of 0.22, p<0.0001 Overall Survival (OS) 100% Increase over control arm 2 - year survival in p
Slide 7: AML Fast Facts
AML Fast Facts 7 ≈ 21,000 AML patients annually 1 AML is an aggressive disease that can progress rapidly despite treatments 68 years Median age at diagnosis 1 Older patients have limited treatment options and poor outcomes Develop R/R disease 2 > 50 % of AML patients access BMT 3 < 20 % BMT is the o
Slide 8: Challenges to Achieving Cures in AML
Challenges to Achieving Cures in AML Patients must be able to overcome several challenges related to curative BMT Curative Potential Access Need to attain a complete remission (CR) Tolerate and survive effective BMT conditioning • Achieve BMT engraftment • Achieve post - BMT CR • Surmount BMT relate
Slide 9: Challenge 1: Need to Achieve a CR
Challenge 1: Need to Achieve a CR 9 1) Ferguson, et al. An operational definition of primary refractory acute myeloid leukemia allowing early identification of p ati ents who may benefit from allogeneic stem cell transplantation. Haematologica. 2016 Nov; 101(11): 1351 – 1358. 2) Gyurkocza et al. All
Slide 10: Challenge 2: Tolerate and Survive BMT Conditioning Regimens
Challenge 2: Tolerate and Survive BMT Conditioning Regimens 10 Reduced intensity chemotherapy (RIC) conditioning is “too cold” and is associated with in higher risk of disease relapse due to residual disease High intensity, myeloablative conditioning (MAC) is “too hot”, making it difficult to tolera
Slide 11: A Next Generation Approach to Improve BMT Access, Outcomes
Iomab - B: A Next Generation Approach to Improve BMT Access, Outcomes 11 • Iomab - B targets CD45, which has high expression only in AML immune and stem cells, thereby sparing organs and increases tolerability • Enables high amounts of radiation to be delivered to radiation sensitive AML and immune
Slide 12: SIERRA: A Novel, Pivotal Phase 3 Study in R/R AML
SIERRA: A Novel, Pivotal Phase 3 Study of Iomab - B in R/R AML 12 Primary Endpoint • Durable CR 1 Secondary Endpoints • EFS, OS Iomab - B Led Regimen Control Arm* BMT CR Other Modality No CR BMT Crossover Arm R 1:1 N=153 NCT 02665065 . CT – Chemotherapy 1) Durable defined as at least 6 months from t
Slide 13: First Randomized Trial with Goal to Transplant R/R AML Patients
First Randomized Trial with Goal to Transplant R/R AML Patients 13 1) Maiti et al. Outcomes of relapsed or refractory acute myeloid leukemia after front - line hypomethylating agent and venetoclax regimens . Haematologica . 2021 Mar 1; 106(3): 894 – 898. Late Breaking Abstract, TCT 2023, Efficacy an
Slide 14: Patients Are Heavily Pre-treated With Active Disease
Patients Are Heavily Pre - treated With Active Disease 14 1) Per NCCN Guidelines, Version 3, 2020. 2) Patients with <5% marrow blasts had circulating leukemic blasts Late Breaking Abstract, TCT 2023, Efficacy and Safety Results of the Sierra Trial: A Multicenter, Pivotal Phase 3 Study of Io mab - B
Slide 15: Patient Disposition
Control Arm Per Protocol Analysis* N=64 Patient Disposition * Patients were excluded from the Per Protocol Analysis Set due to: 1) major protocol deviations that impacted interpretation of the primary endpoint; 2) missed disease assessments; and 3) failure to complete primary therapy Late Breaking A
Slide 16: Unprecedented Access to BMT in Half the Time
Challenge 1 & 2 Addressed: Unprecedented Access to BMT in Half the Time 16 *From randomization. 1) Iomab - B Arm (N=76); 10 patients did not receive a therapeutic dose of Iomab - B; per protocol analysis; 2) Control Arm (N=77); 1 patient did not receive treatment on the control arm; per protocol ana
Slide 17: Unprecedented BMT Access & Engraftment and High Post-BMT CR
Challenge 3 Addressed: Unprecedented BMT Access & Engraftment and High Post - BMT CR 17 1) Per protocol analysis: 59 of 76 patients in Iomab - B arm and 64 of 77 patients in control arm; 2) 6 patients on Iomab - B arm no t evaluable for primary endpoint; 3) 3 patients on control arm not evaluable fo
Slide 18: Excellent Safety of Targeted Radiotherapy
Challenge 4 Addressed: Excellent Safety of Targeted Radiotherapy 18 Adverse Event* (%) Iomab - B Arm N=66 Control Arm N=14 Sepsis 1 6.1% 28.6% Febrile Neutropenia 43.9% 50.0% Mucositis 2 15.2% 21.4% Acute GVHD (Gr II - IV) 3 26.1% 35.7% * Relevant adverse events in transplanted Iomab - B patients. 1
Slide 19: SIERRA Results: Overcomes Key BMT Challenges
SIERRA Results: Iomab - B Overcomes Key BMT Challenges 19 1) 100% access in patients receiving a therapeutic dose of Iomab - B; 2) Per protocol analysis: 22% maintained durable CR lasting 180 days or more in the Iomab - B arm and none had a durable remission in the control arm Late Breaking Abstract
Slide 20: Long-Term Survival in Patients Achieving the Primary Endpoint
Long - Term Survival in Patients Achieving the Primary Endpoint 20 Time OS Rate 6 months 100% 12 months 92.3% 18 months 71.9% 24 months 59.9% Median OS not reached; 2 - year survival highly indicative of long - term outcomes including potential cure • Long - term survival achieved even though Iomab
Slide 21: Reduced the Probability of an Event by 78%
Iomab - B Reduced the Probability of an Event by 78% 21 Iomab - B HR = 0.22 (p<0.0001) Event defined as: • Not achieving CR/CRp • Crossover • Not receiving BMT • Relapse or death EFS HR of 0.22 (p< 0.0001) compared to control arm clearly supports the use of Iomab - B in this high - risk population L
Slide 22: Demonstrates Clear Survival Benefit
Iomab - B Demonstrates Clear Survival Benefit 22 Crossover confounds OS statistics Late Breaking Abstract, TCT 2023, Efficacy and Safety Results of the Sierra Trial: A Multicenter, Pivotal Phase 3 Study of Iomab - B Prior to Allogeneic HCT Versus Conventional Care in Older Patients with Active, R/R
Slide 23: Crossover Results Support Value Proposition
Crossover Results Support Iomab - B Value Proposition 23 82% of control arm patients did not achieve a remission and could not proceed to BMT 82 % No viable treatment options for control arm failures best supportive care or hospice 2/3 of control arm failures crossed over and were rescued with Iomab
Slide 24: Represents a New Paradigm
Iomab - B Represents a New Paradigm 24 Clear separation in access and outcomes favor Iomab - B utilization Patient with Active Disease New Paradigm Current Practice Iomab - B Led Regimen Unprecedented BMT Access and Engraftment Time to BMT Currently Available Treatment Achieve CR Conditioning BMT Di
Slide 25: Dr. Avinash Desai, Chief Medical Officer
Dr. Avinash Desai, Chief Medical Officer 25 • Joined Actinium in November 2020 and promoted to Chief Medical Officer in 2021 • 27 years of biopharmaceutical experience in clinical development and medical affairs • Joined Actinium from GSK where he was Vice President, Head of U.S. Medical Affairs - O
Slide 26: Represents a Practice Expanding Opportunity
Iomab - B Represents a Practice Expanding Opportunity 26 Improved Safety & Tolerability Improved Outcomes Patient can return to referring physician Day 100 post - BMT for long - term care Unprecedented Access Iomab - B offers the promise of transplant outcomes in the patient population for those can
Slide 27: Strongest P-Value Compared to Approved AML Drugs
Iomab - B Had Strongest P - Value for Primary Endpoint Compared to Approved AML Drugs 1 Iomab - B Produced Large Increase in OS Relative to AML Drugs 3 Iomab - B Results Stand Out in Most Difficult AML Patient Segment 27 1) Includes approved therapies with comparator arms with a reported p - value f
Slide 28: SIERRA Results Provide Foundation for Commercialization
Decreasing Survival Probability Based on Disease Status SIERRA Results Provide Compelling Foundation for Commercialization 28 1) Company research and calculations, FDA approval labels market reports, publications 53% 61% 66% 100% 0% 20% 40% 60% 80% 100% 120% Newly Diagnosed Newly Diagnosed t-AML Rel
Slide 29: Clear Pathway to Establishing as Standard of Care
Clear Pathway to Establishing Iomab - B as Standard of Care 29 Iomab - B Established as Standard of Care Life Cycle Planning Initiatives Significant Upcoming Iomab - B Milestones
Slide 30: SIERRA Sets Foundation to Leverage Robust Data
SIERRA Sets Foundation to Leverage Robust Iomab - B Data • Extensive data and consistent results from more than 400 patients including Fred Hutchinson Cancer Center studies demonstrate high BMT access and engraftment and improved outcomes in patients with MDS, younger AML, ALL, HL/NHL and MM • These
Slide 31: Core Competencies Developed During Execution of the SIERRA Trial
Core Competencies Developed During Execution of the SIERRA Trial Iomab - B Experience at 24 Leading BMT Centers that Account for 30% of BMT Volume Strong Foundation From Positive Results and Operational Excellence 31 Robust Supply Chain Operational Excellence at the Point of Care Strong KOL Relation
Slide 32: Caroline Yarbrough, Chief Commercial Officer
Caroline Yarbrough, Chief Commercial Officer 32 • Joined Actinium in October 2022 with 25 years of BioPharma commercial experience • Most recently, Portfolio General Manager, US Oncology at Novartis, a $1+ Billion product portfolio • Strong hematology experience from leading Novartis Chronic Myeloge
Slide 33: Has a Paradigm Changing Profile
Iomab - B Has a Paradigm Changing Profile Iomab - B Checks All Boxes to Become New Standard of Care Practice Expanding Potential that Will Allow BMT Physicians to Transplant More Patients Unprecedented Access to BMT Excellent Safety and Tolerability Meaningful Survival Benefit • Changes the paradigm
Slide 34: Highly Favorable Dynamics Support Commercial Prospects
Highly Favorable Dynamics Support Iomab - B Commercial Prospects Patients • Unprecedented access to potentially curative BMT in AML with favorable safety and tolerability Physicians • Increased opportunity to treat patients that previously had no other treatment options without disruption to current
Slide 35: Compares Favorably to High Value Hematology Therapies
Indication R/R ALL R/R DLBCL R/R AML EFS HR NA 0.40 0.22 OS Improvement 93% (7.7 vs 4.0 months) NA 100% (6.4 vs 3.2 months) Modality Bi - specific CAR - T Targeted radio Iomab - B Compares Favorably to High Value Hematology Therapies 35 Iomab - B Therapies that provide a meaningful clinical benefit
Slide 36: Closing Remarks
Closing Remarks Actinium Pharmaceuticals, Inc.
Slide 37: Key SIERRA Takeaways
Key Iomab - B and SIERRA Takeaways 37 Addresses Clear Unmet Need Makes BMT Possible for Patients with Active Disease Improved Access Unprecedented BMT Access & Engraftment Improved Outcomes Increased 1 - year and Median OS, Long - term Survival Highly Favorable Commercial Dynamics in US, Europe 3P’s
Slide 38: Compares Favorably Versus Other Radiotherapy Assets
Iomab - B Compares Favorably Versus Other Radiotherapy Assets 38 1 ) Advanced Accelerator Applications ADR Prospectus dated 11 / 17 / 2014 ; 2 ) Novartis R&D Day 2018 ; 3 ) Bayer Investor Handout May 2019 and Actinium Estimates ; 4 ) Actinium Estimates ; 5 ) FDA incidence rate 2018 ; 6 ) Novartis Q
Slide 39: Actimab-A Development Bolstered By Recent NCI CRADA
Actimab - A Development Bolstered By Recent NCI CRADA 39 NCI sponsored Actimab - A development to include Phase 1, 2 and 3 trials featuring with the potential to develop Actimab - A as a backbone of AML combination therapy Balance sheet sparing with full rights to data – Actinium supplies Actimab -
Slide 40: Actinium's Opportunity to Transform Treatment Outcomes in AML
Actinium’s Opportunity to Transform Treatment Outcomes in AML • Addressable patient population >50% R/R with dismal outcomes • Patient population largely treated in top 100 quaternary care centers • Favorable commercial dynamics for a successful Iomab - B launch with a lean commercial organization •
Slide 41: Q&A
Q&A Actinium Pharmaceuticals, Inc.
Slide 42: Thank you
ATNM: NYSE AMERICAN February 18, 2022 Thank you Actinium Pharmaceuticals, Inc.
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