Actinium Pharmaceuticals, Inc. (delaware) · AMEX:ATNM
Actinium Pharmaceuticals, Inc. (delaware) — Actinium Pharmaceuticals — Investor Presentation (April 2014)
26 slides from Actinium Pharmaceuticals, Inc. (delaware)'s investor presentation, April 2014
Slide 1: Actinium Pharmaceuticals, Inc. Company Presentation April 2014
Actinium Pharmaceuticals, Inc. April 2014 Company Presentation Ticker: ATNM (NYSE MKT) This presentation does not constitute or form part of any offer for sale or subscription or solicitation of any offer to buy or subscribe for any securities in Actinium Pharmaceuticals, Inc. (“ATNM” or the “Compan
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. This presentation does not constitute or form part of any offer for sale or subscription or solicitation of any offer to
Slide 4: Highlights
Highlights 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 the vis
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) ♦ Delivers radiation to cancer site via pharmaceutical carrier through an injection – Antibody provides precision, targeting cancer cells specifically while avoiding n
Slide 9: Clinically Relevant Emitters
Clinically Relevant Emitters Platform Market Cap α emitter Half Life Stage IP Ownership Potential ($mm) Actinium 225 Yes 10 days Phase I/II Actinium Pharmaceuticals $294 Bismuth 213 Yes 46 minutes Phase II Actinium Pharmaceuticals Radium 223 No 11 days Marketed Algeta $2,900 Thorium 227 Yes 18 day
Slide 10: Robust Intellectual Property Protection
Robust Intellectual Property Protection ♦ 68 Patents issued and pending – United States 17 – International 51 ♦ Eligible for orphan drug exclusivity Area Claim Expiration Status Platform Technology Metastases larger than 1mm 2020 Allowed Platform Technology DOTA* labeling 2021 Issued Drug Preparatio
Slide 11: ATNM's Product Pipeline
ATNM’s Product Pipeline s.d. – single dose f.d. – fractionated dose (2) 1 HSCT stands for Hematopoietic Stem Cell Transplantation, a procedure in which cells capable of reconstituting normal bone marrow function are transplanted to a patient. 2 ATNM has decided to discontinue development of Bismab-A
Slide 12: Iomab-B: Next Step – Phase III Trial
Iomab-B: Next Step – Phase III Trial ♦ Experience with 250+ patients in 5 Phase I and II clinical trials ♦ In-licensed from Fred Hutchinson Cancer Center, 7 ongoing physician trials with BC8 mAb ♦ Indication is to condition bone marrow in relapsed and refractory AML patients over 55 years old in pre
Slide 13: Iomab-B Phase I/II Results
Iomab-B Phase I/II Results ♦ Only potential cure for blood cancers is HSCT, but vast majority of patients over 50 are ineligible – Iomab-B has demonstrated ability to successfully prepare these patients for HSCT ♦ Clinical trials completed in 250+ patients with various incurable blood cancers – In b
Slide 14: Iomab-B FDA Meeting Results
Iomab-B FDA Meeting Results ♦ A successful End of Phase II meeting was held with the FDA and agreements were reached on the following – Path to approval – Number of studies – Phase III trial design to support a BLA submission – Patient population – Study size (n) – Primary and secondary endpoints –
Slide 15: Iomab-B Development Plan
Iomab-B Development Plan Currently no approved treatments for Iomab-B targeted patients imply blockbuster potential Timeline* Worldwide Market Indication 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 Potential ($mm) Approval Acute Myeloid Leukemia III Sales Start $793 Myelodysplastic Syndrome II
Slide 16: Actimab-A vs. Current Treatments
Actimab-A vs. Current Treatments Current Treatment Options* New Treatment Option Treatment: Supportive Care High Dose Chemotherapy Actimab-A Usage: ♦ 64% of patients 60+ use this ♦ 36% of patients 60+ are ♦ Potentially any AML patient option due to lack of tolerable eligible due to limited side effe
Slide 17: Bismab-A and Actimab-A
Bismab-A Actimab-A Bismab-A experience implies successful Actimab-A trial results 1st Generation APIT 2nd Generation Bismab-A Profile Platform Actimab-A Advantages Target: ♦ AML ♦ AML Effectiveness: ♦ Proof of concept in humans + 500x more potent than Bismab-A Clinical Stage: ♦ Excellent results in
Slide 18: Actimab-A Clinical Trial Update
Actimab-A Clinical Trial Update ♦ Started the new multicenter Phase I/II clinical trial ♦ Expanded the number of participating clinical centers: – Memorial Sloan Kettering Cancer Center, Johns Hopkins Medicine, Fred Hutchinson Cancer Center, University of Pennsylvania Health Center, MD Anderson Canc
Slide 19: Market Positioning for Iomab-B, Actimab-A
Market Positioning for Iomab-B, Actimab-A ATNM products target both treatment stages for AML patients over 55 years of age Diagnosis Treatment Response Treatments Death High dose Complete Reduced Intensity chemotherapy Response BM Conditioning AML Relapsed & Refractory Iomab-B HSCT Age >55 AML ♦ HSC
Slide 20: Market Potential of Product Pipeline
Market Potential of Product Pipeline # Cancer Indication Cases/Yr. in Target Worldwide Market target market 1 Population Potential ($mm)2 1st HSCT (Bone Marrow) 48,000 48,000 $4,100 2nd Acute Myeloid Leukemia (AML) 41,600 24,000 $920 3rd Glioblastoma Multiforme (GBM) 26,500 26,500 $1,100 4th Prostat
Slide 21: Platform Building Strategy
Platform Building Strategy mAb Expansion Strategy Develop “Biobetters” ♦ Create mAb combos that use antibodies with ♦ Improve upon marketed biotech drugs with proven proven safety and cancer binding capabilities safety and efficacy ♦ Focus on unmet needs in the market where no ♦ mAb combos increase
Slide 22: Recent Phase I/Phase II Cancer Licensing Deals
Recent Phase I/Phase II Cancer Licensing Deals Rich deals available for novel technologies with proof of concept All Figures in USD ($mm) Phase at Deal Upfront Company Signing Size Fee Date Deal Description Algeta Phase II $800 $61 9/3/2009 Algeta signs $800 million deal with Bayer for Alpharadin in
Slide 23: Company Milestones
Company Milestones Drug 2014 2015 2016 2017 Iomab-B Complete PIII protocol ♦ Complete PIII ♦ Close PIII database ♦ Drug approval in Ref/Rel AML ♦ Complete cGMP mAb ♦ recruitment ♦ BLA filing ♦ First sales revenue 55+ ♦ mfg Outlicense ex US ♦ Complete Drug mfg ♦ cGMP Submit PIII IND Start PIII Ioma
Slide 24: Near-term Value Drivers
Near-term Value Drivers Multiple development milestones in next 12-18 months as ATNM’s products advance to a stage of development ♦ Iomab-B Uplisting to NYSE MKT Complete PIII Protocol (Accomplished March 26, 2014) Start cGMP mAb mfg Start drug mfg cGMP process ♦ Additional Analyst Coverage
Slide 25: Market Valuations
Market Valuations ATNM is compellingly valued relative to comparable oncology companies and also recent biotech IPO’s Comparable Oncology Companies 2013 Biotech IPO’s Market Cap* ($MM) Market Cap at IPO ($MM) $500 $500 $450 $450 $400 $400 $395 $350 $382 $350 $355 $300 $300 $366 $250 $294 $250 $294 $
Slide 26: Highlights
Highlights 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 the vis
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