Actinium Pharmaceuticals, Inc. (Delaware) · AMEX:ATNM
Actinium Pharmaceuticals, Inc. (Delaware) — Actinium Pharmaceuticals — Biotech Showcase 2014
25 slides from Actinium Pharmaceuticals, Inc. (Delaware)'s conference presentation, Jan 13, 2014
Slide 1: Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. January 13, 2014 Biotech Showcase Presentation Trading Symbol: ATNM
Slide 2: Disclaimer and Safe Harbor Statement
Disclaimer and Safe Harbor Statement Disclaimer The contents of this presentation and the information which you are given at the time of these slides and the presentation have not been approved by an authorized person within the meaning of the Financial Services and Markets Act 2000 (the “Act”). Rel
Slide 3: Company Description
Company Description A public biotechnology company using world class science to develop and commercialize antibody directed radioisotopes to target unmet medical needs in cancer. 3
Slide 4: Company Overview
Company Overview Prior clinical data for both Iomab-B and Actimab-A favor successful trial results Breakthrough therapy potential implies successful market penetration for both Iomab-B and Actimab-A APIT platform poised to deliver multiple blockbuster cancer drugs An expert team possessing t
Slide 5: Core Team & Advisors
Core Team & Advisors Team Background Kaushik J. Dave, PhD, MBA ♦ 25 years of Pharma and Biotech industry at both big Pharma and small startups. ♦ Formerly, EVP at Antares Pharma Inc., VP at Palatin Technologies Inc., and Big Pharma (Schering-Plough and Merck) President and CEO, ♦ BPharm from Univers
Slide 6: Clinical Advisory Board
Clinical Advisory Board Treatment Center Advisory Board Members Memorial Sloan Kettering David Scheinberg, M.D., PhD Chairman of Experimental Therapeutics at MSKCC Cancer Center Vincent Astor Chair Scientific Co-Founder Fred Hutchinson Elihu H. Estey, M.D. John Pagel, M.D., PhD Professor of Medicine
Slide 7: Antibody Approaches Targeting Cancer Cells
Antibody Approaches Targeting Cancer Cells Opportunity Cancer Treatment Options Radiation Monoclonal Antibodies (mAbs) Treatment % 50% ♦ External radiation majority treatment <10% ♦ Always a pharmaceutical ♦ Internal radiation has mostly no IP ♦ Strong IP protection Pharmaceutical <3% ♦ Commoditized
Slide 8: ATNM's Proprietary Technology Platform
ATNM’s Proprietary Technology Platform APIT Technology Antibody (targeting agent) Chelator (linker) α / β* emitter (killing agent) ♦ 68 Patents issued and pending, United States 17, International 51 ♦ Eligible for orphan drug exclusivity ♦ IP encompases core aspects of drug preparation, production,
Slide 9: ATNM's Product Pipeline
ATNM’s Product Pipeline Development Status Drug Indication R&D Preclin. Phase I Phase II Phase III Iomab-B BMT (Bone Marrow Transplant) 1 Bismab-A AML (Acute Myeloid Leukemia) Actimab-A (s.d.) AML s.d. – single dose f.d. – fractionated dose (2) Actimab-A (f.d.) AML L19-A2252 GBM, Breast Cancer3 Acti
Slide 10: Iomab-B Overview
Iomab-B Overview ♦ Breakthrough therapy for BMT conditioning especially for elderly, very sick patients with few curative treatment options – Initial indication is relapsed and refractory AML patients over 55 years old ♦ Compelling clinical data from proof of concept trial in elderly refractory and
Slide 11: Iomab-B Program Overview
Iomab-B Program Overview Extensive safety and efficacy across multiple indications Clinical Trials* N Key Findings Study AML, MDS, ALL 34 -7/34 patients with median DFS of 17 years. Protocol 557 -18/34 patients in remission at day 80 AML >1st remission 23 -15/23 in remission at day 28 Protocol 1297,
Slide 12: Study 1432 Overview
Study 1432 Overview ♦ Advanced AML/MDS over Age 50 ineligible for standard BMT ♦ Such patients represent the vast majority of the elderly AML population ♦ These patients had no alternative treatment strategy with curative intent ♦ Median survival of this patient population is six weeks to six months
Slide 13: Iomab-B Phase I/II Results
Iomab-B Phase I/II Results Compelling clinical results enable pivotal Phase III trial ♦ Non-relapse mortality (NRM): – Day 100: 10% ♦ Complete response rate: 100% – Overall: 20% (NRM = 46% in comparable patients with myeloablative conditioning) ♦ Engraftment by day 28: 100% ♦ Transplant related mort
Slide 14: Iomab-B FDA Meeting Results
Iomab-B FDA Meeting Results ♦ A successful End of Phase II meeting was held with the FDA and agreements were reached on the following – Path to approval – Number of studies – Phase III trial design to support a BLA submission – Patient population – Study size (n) – Primary and secondary endpoints –
Slide 15: Key Opinion Leaders (KOL) Interest
Key Opinion Leaders (KOL) Interest Iomab-B’s curative potential has attracted the enthusiasm of leading transplanters ♦ Dr. Richard Champlin – MD Anderson Cancer Center ♦ Dr. Sergio Giralt – Sloan Kettering Cancer Research Center ♦ Dr. Hillard Lazarus – Case Western ♦ Dr. John Pagel – Fred Hutchinso
Slide 16: Bone Marrow Transplant Centers
Bone Marrow Transplant Centers Highly concentrated with top ten centers performing forty percent of allogeneic transplants Transplant Center Procedure Distribution* University of Texas-MD Anderson Cancer 9% Center Dana Farber / Brigham & Women's Cancer Institute 7% Fred Hutchinson Cancer Research Ce
Slide 17: Iomab-B Development Plan
Iomab-B Development Plan Currently no approved treatments for Iomab-B targeted patients imply blockbuster potential Timeline* Worldwide Market Indication 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Potential ($mm) Acute Myeloid Leukemia III Approval Sales Start $793 Myelodysplastic Syndrome II
Slide 18: Iomab-B A New Treatment Paradigm
Iomab-B A New Treatment Paradigm Provides treatment alternative to patients with no options Significantly expands patient population eligible for BMT Provides faster, safer way of performing bone marrow transplant Minimizes transplant related mortality Significantly increases curative outc
Slide 19: Bismab-A Actimab-A
Bismab-A Actimab-A Bismab-A experience implies successful Actimab-A trial results as an induction therapy in elderly AML 1st Generation 2nd Generation Bismab-A Profile Actimab-A Advantages Effectiveness: ♦ Proof of concept in humans + 500x more potent than Bismab-A Supply Chain: ♦ Complex, high COGS
Slide 20: Actimab-A Clinical Trial Update
Actimab-A Clinical Trial Update ♦ Started the new multicenter Phase I/II clinical trial ♦ Expanded the number of participating clinical centers: – Memorial Sloan Kettering Cancer Center, Johns Hopkins Medicine, Fred Hutchinson Cancer Center, University of Pennsylvania Health Center, MD Anderson Canc
Slide 21: Market Positioning for Iomab-B, Actimab-A
Market Positioning for Iomab-B, Actimab-A ATNM products target both treatment stages for AML patients over 55 years of age Diagnosis Treatment Response Treatments Death High dose Complete Reduced Intensity chemotherapy Response BM Conditioning AML Relapsed & Refractory Iomab-B BMT Age >55 AML Comple
Slide 22: Market Potential of Product Pipeline
Market Potential of Product Pipeline # Cancer Indication Cases/Yr. in Target Worldwide Market Target Market1 Population Potential ($mm)2 1st Bone Marrow Transplant (BMT) 48,000 48,000 $4,100 2nd Acute Myeloid Leukemia (AML) 41,600 24,000 $920 3rd Glioblastoma Multiforme (GBM) 26,500 26,500 $1,100 4t
Slide 23: Near-term Value Drivers
Near-term Value Drivers Multiple milestones in next 12-18 months ♦ Iomab-B ♦ Uplisting to NASDAQ / NYSE MKT – Complete Phase III Protocol – Start cGMP mAb mfg ♦ Additional Analyst Coverage – Start drug mfg cGMP process – Complete cGMP mAb mfg ♦ Collaborations – Complete Drug mfg cGMP – Submit Phase
Slide 24: Company Overview
Company Overview Prior clinical data for both Iomab-B and Actimab-A favor successful trial results Breakthrough therapy potential implies successful market penetration for both Iomab-B and Actimab-A APIT platform poised to deliver multiple blockbuster cancer drugs An expert team possessing t
Slide 25: Actinium Pharmaceuticals, Inc.
Actinium Pharmaceuticals, Inc. January 13, 2014 Biotech Showcase Presentation Trading Symbol: ATNM