Actinium Pharmaceuticals, Inc. (delaware) · AMEX:ATNM
Actinium Pharmaceuticals, Inc. (delaware) — Actinium Pharmaceuticals — Technical Presentation (February 2023)
42 slides from Actinium Pharmaceuticals, Inc. (delaware)'s technical presentation, Feb 18, 2023
Slide 1: Iomab-B SIERRA Trial Phase 3 Results
Iomab-B SIERRA Trial Phase 3 Results February 18, 2023 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. Avinash Desai Caroline Yarbrough Chairman & CEO VP, Clinical Development, Chief Medical Officer Chief Commercial Officer BMT & Cellular Therapy Introduction and Iomab-B Phase 3 Significance Iomab-B Market Closing Remarks SIERRA Result
Slide 4: SIERRA Results Support Iomab-B Becoming a New Standard of Care
SIERRA Results Support Iomab-B Becoming a New Standard of Care Strong SIERRA Unprecedented Improved Large Favorable Results BMT Access with Outcomes Underserved R/R Commercial Iomab-B with Iomab-B AML Patient Dynamics and BMT Segment Met primary Patients got to Improved sepsis, Addressed by Patients
Slide 5: 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 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 Trial Endpoints and Metrics Results Primary 6-month durable Complete Remission (dCR) p<0.0001 Event-Free Survival (EFS) EFS Hazard Ratio of 0.22, p<0.0001 Secondary Overall Survival (OS) 100% Increase over control arm Long-term 60%
Slide 7: AML Fast Facts
AML Fast Facts AML is an aggressive disease that can progress rapidly despite treatments ≈21,000 10 drugs BMT is the only potential curative AML patients approved for treatment annually1 AML patients >50% <20% for R/R AML, since 2017 but only younger or fit patients can access it Older patients have
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 Challenge #1 Need to attain a complete remission (CR) Access Challenge #2 Tolerate and survive effective BMT conditioning • Achieve BMT engraftment Challenge #3 • Achieve post-BMT CR • S
Slide 9: Challenge 1: Need to Achieve a CR
Challenge 1: Need to Achieve a CR Current paradigm – existing therapies produce limited CRs of all AML Induction Therapy never >50% patients ~30% achieve develop R/R a CR1 Chemotherapies disease AML (i.e., 7+3, CLAG-M) Diagnosis • Mutations may drive treatment resistance Venetoclax + HMA of initial
Slide 10: Challenge 2: Tolerate and Survive BMT Conditioning Regimens
Challenge 2: Tolerate and Survive BMT Conditioning Regimens BMT conditioning requires the patient to be subjected to and survive another round of non-targeted chemotherapy (± radiation) RIC MAC Less Less More Mortality Relapse More Relapse Mortality Reduced intensity chemotherapy (RIC) conditioning
Slide 11: Iomab-B: A Next Generation Approach to Improve BMT Access, Outcomes
Iomab-B: A Next Generation Approach to Improve BMT Access, Outcomes Iomab-B 400+ 12 6 diseases Improved survival patients clinical trials (AML, MDS, MM, and curative ALL, NHL/HL) outcomes Leukemia • Iomab-B targets CD45, which has high expression Cells only in AML immune and stem cells, thereby spar
Slide 12: SIERRA: A Novel, Pivotal Phase 3 Study of Iomab-B in R/R AML
SIERRA: A Novel, Pivotal Phase 3 Study of Iomab-B in R/R AML Iomab-B Led BMT Regimen Active, Relapsed Crossover Arm or Refractory AML R 1:1 N=153 Primary Endpoint Age 55+, >5% • Durable CR1 bone marrow blasts No CR Secondary Endpoints • EFS, OS Control Arm* BMT CR Other Modality 3 Novel Iomab-B Cont
Slide 13: First Randomized Trial with Goal to Transplant R/R AML Patients
First Randomized Trial with Goal to Transplant R/R AML Patients Patients enrolled in SIERRA have poor expected survival SIERRA Designed to Evaluate if Iomab-B + BMT Can SIERRA Trial: Iomab-B Arm Patient Characteristics Improve the Outcomes of Active R/R AML Patients R/R after Frontline Therapy1 Medi
Slide 14: Patients Are Heavily Pre-treated With Active Disease
Patients Are Heavily Pre-treated With Active Disease Baseline patient and disease characteristics were balanced between study arms Iomab-B (n=76) Control Arm (n=77) Crossover (n=44) Median Age 64 (55-77) 66 (55-76) 64 (55-76) Favorable: 5 (6.6) Favorable: 2 (2.6) Favorable: 1 (2.3) Cytogenetics and
Slide 15: Patient Disposition
Patient Disposition 153 Patients Randomized Iomab-B Control Arm N=76 N=77 • 4 pts did not receive 1 pt did not receive chemo dosimetric dose • 6 pts did not proceed to therapeutic dose with HCT No CR Achieved CR N=62 N=14 66 patients received Crossover to Iomab-B therapeutic dose N=44 4 pts did not
Slide 16: Challenge 1 & 2 Addressed: Unprecedented Access to BMT in Half the Time
Challenge 1 & 2 Addressed: Unprecedented Access to BMT in Half the Time Unprecedented Access to BMT Access to BMT in Less Than Half the Time BMT Access Time to BMT Iomab-B Arm 100%1* Iomab-B Arm 29 days3* Control Arm 17%2 Control Arm 66.5 days* 0 20 40 60 80 100 0 20 40 60 80 Percent Days • Targeted
Slide 17: Challenge 3 Addressed: Unprecedented BMT Access & Engraftment and High Post-BMT CR
Challenge 3 Addressed: Unprecedented BMT Access & Engraftment and High Post-BMT CR BMT Access & Post-BMT Engraftment CR Rate 6x Higher 12x Higher Per Protocol BMT Access Patients in Analysis1 & Engraftment CR Post-BMT 100% 75% Iomab-B Arm2 N=59 N=59 N=44 N=64 17% 6.3% Control Arm3 N=11 N=4 1) Per pr
Slide 18: Challenge 4 Addressed: Excellent Safety of Targeted Radiotherapy
Challenge 4 Addressed: Excellent Safety of Targeted Radiotherapy Iomab-B side effects are meaningfully lower, implying less complexity (and cost) post-transplant Adverse Event* Iomab-B Arm Control Arm (%) N=66 N=14 Sepsis1 6.1% 28.6% Febrile Neutropenia 43.9% 50.0% Mucositis2 15.2% 21.4% Acute GVHD
Slide 19: SIERRA Results: Iomab-B Overcomes Key BMT Challenges
SIERRA Results: Iomab-B Overcomes Key BMT Challenges Primary endpoint met with high significance: High rates of post-BMT remissions resulted in significantly higher durable remissions with Iomab-B Evaluable Per BMT Access Patients in Primary Endpoint Protocol & Engraftment CR Post-BMT 6-month dCR2 I
Slide 20: Long-Term Survival in Patients Achieving the Primary Endpoint
Long-Term Survival in Patients Achieving the Primary Endpoint Median OS not reached; 2-year survival highly indicative of long-term outcomes including potential cure • Long-term survival achieved even though Iomab-B patient protocols had highly Time OS Rate restrictive optionality for maintenance 6
Slide 21: Iomab-B Reduced the Probability of an Event by 78%
Iomab-B Reduced the Probability of an Event by 78% Event defined as: • Not achieving CR/CRp • Crossover • Not receiving BMT • Relapse or death Iomab-B HR = 0.22 (p<0.0001) EFS HR of 0.22 (p<0.0001) compared to control arm clearly supports the use of Iomab-B in this high-risk population Late Breaking
Slide 22: Iomab-B Demonstrates Clear Survival Benefit
Iomab-B Demonstrates Clear Survival Benefit Iomab-B doubled 1-year overall survival rates and median overall survival 35.8% 1-Year OS of Iomab-B treated patients in study 26.1% and crossover arms 13.1% Crossover confounds OS statistics Late Breaking Abstract, TCT 2023, Efficacy and Safety Results of
Slide 23: Crossover Results Support Iomab-B Value Proposition
Crossover Results Support Iomab-B Value Proposition Iomab-B treatment yielded access and improved outcomes for crossover patients despite their failing an additional line of therapy 82% 2/3 82% of control No viable 2/3 of control 100% BMT & Crossover arm patients treatment options arm failures engra
Slide 24: Iomab-B Represents a New Paradigm
Iomab-B Represents a New Paradigm Clear separation in access and outcomes favor Iomab-B utilization New Paradigm Unprecedented BMT Survival Benefit Iomab-B Access and Led Regimen Engraftment Time to BMT Patient with Active Disease Current Practice Currently Available Achieve CR Conditioning Dismal T
Slide 25: Dr. Avinash Desai, Chief Medical Officer
Dr. Avinash Desai, Chief Medical Officer • 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 - Onco
Slide 26: Iomab-B Represents a Practice Expanding Opportunity
Iomab-B Represents a Practice Expanding Opportunity Iomab-B offers the promise of transplant outcomes in the patient population for those cannot access a transplant today Unprecedented Improved Improved Safety Access Outcomes & Tolerability These results open the entire universe of R/R patients for
Slide 27: Iomab-B Results Stand Out in Most Difficult AML Patient Segment
Iomab-B Results Stand Out in Most Difficult AML Patient Segment Iomab-B Had Strongest P-Value for Primary Iomab-B Produced Large Increase Endpoint Compared to Approved AML Drugs1 in OS Relative to AML Drugs3 200% 182% Drug P-Value2 180% % Increase in OS Iomab-B <0.0001 160% 140% Daurismo 0.0002 120%
Slide 28: SIERRA Results Provide Compelling Foundation for Commercialization
SIERRA Results Provide Compelling Foundation for Commercialization 120% 100% 100% % Increase in Median Overall Survival1 80% 66% 61% 60% 53% 40% 20% 0% Newly Diagnosed Newly Diagnosed Relapsed/Refractory Active t-AML Age 18+ Relapsed/Refractory Age 55+ Decreasing Survival Probability Based on Diseas
Slide 29: Clear Pathway to Establishing Iomab-B as Standard of Care
Clear Pathway to Establishing Iomab-B as Standard of Care Significant Upcoming Iomab-B Milestones Iomab-B Established as Standard of Care Life Cycle Planning Initiatives 29
Slide 30: SIERRA Sets Foundation to Leverage Robust Iomab-B Data
SIERRA Sets Foundation to Leverage Robust Iomab-B Data Life cycle management and indication expansion opportunity supported by significant body of data with Iomab-B • Extensive data and consistent results from more than 400 patients including Fred Hutchinson Cancer Center studies demonstrate high BM
Slide 31: Strong Foundation From Positive Results and Operational Excellence
Strong Foundation From Positive Results and Operational Excellence SIERRA experience at leading high-volume BMT positions Iomab-B favorably for commercialization Core Competencies Developed During Iomab-B Experience at 24 Leading BMT Centers Execution of the SIERRA Trial that Account for 30% of BMT
Slide 32: Caroline Yarbrough, Chief Commercial Officer
Caroline Yarbrough, Chief Commercial Officer • 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 Myelogenou
Slide 33: Iomab-B Has a Paradigm Changing Profile
Iomab-B Has a Paradigm Changing Profile Iomab-B Checks All Boxes Practice Expanding Potential that Will Allow to Become New Standard of Care BMT Physicians to Transplant More Patients • Changes the paradigm by enabling R/R patients to go Unprecedented Access to BMT to BMT without physicians having t
Slide 34: Highly Favorable Dynamics Support Iomab-B Commercial Prospects
Highly Favorable Dynamics Support Iomab-B Commercial Prospects 3P’s, 2C’s: Key variables impacting commercial success align favorably toward Iomab-B • Unprecedented access to potentially curative BMT in AML with favorable safety Patients and tolerability • Increased opportunity to treat patients tha
Slide 35: Iomab-B Compares Favorably to High Value Hematology Therapies
Iomab-B Compares Favorably to High Value Hematology Therapies Therapies that provide a meaningful clinical benefit to R/R patients with limited treatment options have seen strong commercial adoption * * Iomab-B Indication R/R ALL R/R DLBCL R/R AML EFS HR NA 0.40 0.22 OS Improvement 93% NA 100% (7.7
Slide 36: Closing Remarks
Closing Remarks Actinium Pharmaceuticals, Inc.
Slide 37: Key Iomab-B and SIERRA Takeaways
Key Iomab-B and SIERRA Takeaways Addresses Improved Improved Clear Unmet Outcomes Access Need Makes BMT Possible for Patients Unprecedented BMT Increased 1-year and Median OS, with Active Disease Access & Engraftment Long-term Survival Highly Favorable Operational Commercial Excellence Dynamics in U
Slide 38: Iomab-B Compares Favorably Versus Other Radiotherapy Assets
Iomab-B Compares Favorably Versus Other Radiotherapy Assets Radiotherapies have commanded premiums based on scarcity of late-stage programs Iomab-B Active, R/R AML Indication GEP-NETs mCRPC mCRPC age 55+ Developer Approved in EU, Stage of Development at Acquisition/Current Stage Phase 3 Approved Pha
Slide 39: Actimab-A Development Bolstered By Recent NCI CRADA
Actimab-A Development Bolstered By Recent NCI CRADA 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 • CRADA provides access to 2,000 clinical trial sites in • Survival benefit in CLAG-M
Slide 40: Actinium's Opportunity to Transform Treatment Outcomes in AML
Actinium’s Opportunity to Transform Treatment Outcomes in AML Iomab-B and Actimab-A together afford Actinium the unique opportunity to significantly modify the dismal status quo in AML in a complementary manner Fit Unfit Companies Ability to Deliver Therapeutic on this Opportunity Actimab-A Mutation
Slide 41: Q&A
Q&A Actinium Pharmaceuticals, Inc.
Slide 42: Thank you
Thank you February 18, 2022 Actinium Pharmaceuticals, Inc. ATNM: NYSE AMERICAN
Actinium Pharmaceuticals — Technical Presentation (February 2023) on 6ix