company presentation march 2014
DESCRIPTION
TRANSCRIPT
Actinium Pharmaceuticals, Inc.
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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
March 2014 Company Presentation
Ticker: ATNM
2
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”). Reliance on this presentation and its slides for the purpose of engaging in investment activity may expose an individual to a significant risk of losing all of the property or other assets invested. 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein. These slides and the presentation are exempt from the general restriction (in section 21 of the Act) on the communication of invitations or inducements to engage in investment activity on the grounds that it is made to: (a) persons who have professional experience in matters relating to investments who fall within Article 19(1) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (b) high net worth entities and other persons to whom it may otherwise lawfully be communicated, falling within Article 49(1) of the Order (all such persons together being referred to as “relevant persons”). Any person who is not a relevant person should not rely on this presentation or any of its contents and all persons (whether relevant persons or otherwise) are recommended to seek their own independent financial advice from a person authorized for the purposes of the Act before engaging in any investment activity involving the Company’s securities. Safe Harbor Statement This presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the private securities litigation reform act of 1995. Such forward-looking information and statements are based on the current estimates and projections of the Company or assumptions based on information currently available to the Company. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including changes from anticipated levels of revenues, future national or regional economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward-looking information contained in this presentation. Any forward-looking statements or information in this presentation speak only as at the date of this presentation.
3 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Company Description
A public biotechnology company using world class science to develop and commercialize antibody directed radioisotopes to target unmet medical needs in cancer.
4 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Highlights
ü Prior clinical data for both Iomab-B and Actimab-A favor successful trial results
ü Breakthrough therapy potential implies successful market penetration for both Iomab-B and Actimab-A
ü APIT platform poised to deliver multiple blockbuster cancer drugs
ü An expert team possessing the vision and desire to enhance shareholder value
ü Positioned to benefit from increased market recognition of targeted
payload therapies and an initial high-value, niche product model
5 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Core Team & Advisors Team Background
Kaushik J. Dave, PhD, MBA President and CEO,
♦ 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) ♦ BPharm from University of Bath (UK), PhD from University of Kansas, MBA from Wharton School at The University of
Pennsylvania;
Gerri Henwood Chief Development Officer
♦ President & Founder of Malvern Consulting Group and President & CEO of Recro Pharma ♦ Former Founder, President & CEO of Auxilium Pharmaceuticals, Inc (NASDAQ:AUXL) ♦ Former Founder & CEO of IBAH (formerly NASDAQ listed; acquired by Omnicare (NYSE)) ♦ Board of Directors of Alkermes, Inc. (NASDAQ:ALKS), Garnet BioTherapeutics, Inc., LZ Therapeutics, Inc., and MAP
Pharmaceuticals, Inc.(NASDAQ:MAPP)
Dragan Cicic, MD, MBA COO & CMO
♦ 9 years at Actinium Pharmaceuticals (ATNM), previously serving as Medical Director ♦ Formerly a strategic consultant at QED Technologies and an investment banker at SG Cowen Securities ♦ MBA, Wharton School at The University of Pennsylvania; MD, School of Medicine at The Belgrade University ♦ Nieman Fellow at Harvard University
Richard Steinhart BBA, MBA Director
♦ Industry Consultant ♦ Formerly Senior Vice President, Finance and Chief Financial Officer of MELA Sciences Inc. ♦ Formerly Managing Director of Forest Street Capital/SAE Ventures, a boutique investment banking, venture capital, and
management consulting firm focused on healthcare and technology companies. ♦ B.B.A. and M.B.A., Pace University
Sergio Traversa, PharmD, MBA Director
♦ CEO of Relmada Therapeutics, Inc. ♦ 25+ years of management and investment experience in healthcare as a Portfolio Manager & Sr. Pharmaceutical Analyst (Mehta &
Isaly, ING Barings, Merlin BioMed & Rx Capital) and in industry (CNS at Eli Lilly, Pfizer) ♦ MBA, Finance at New York University, Laurea of Pharmacy at the University of Turin
David Nicholson, PhD Director
♦ Head of R&D, Bayer CropScience ♦ Formerly Sr. VP and Head Worldwide Licensing and Knowledge Management at Merck ♦ Formerly Head of R&D at Organon prior to acquisition by Schering-Plough ♦ Ph.D., University of Wales
Sandesh Seth, MS, MBA Chairman of the Board
♦ Head of Healthcare Investment Banking at Laidlaw & Company (UK) Ltd. ♦ 20+ years experience in investment banking (Cowen & Co.), equity research (Bear Stearns, Commonwealth Associates) and in
industry (Pfizer, Warner-Lambert, SmithKline) ♦ MBA, Finance at New York University; MS, Pharmaceutical Sciences at University of Oklahoma Health Center
6 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Clinical Advisory Board
Treatment Center Advisory Board Members Memorial Sloan Kettering Cancer Center
David Scheinberg, M.D., PhD Chairman of Experimental Therapeutics at MSKCC Vincent Astor Chair Scientific Co-Founder
Fred Hutchinson Cancer Center
Elihu H. Estey, M.D. Professor of Medicine Division of Hematology University of Washington School of Medicine WHO Treatment guidelines for AML
John Pagel, M.D., PhD Assistant Professor/Assistant Member Department of Medicine, Division of Oncology Lead Investigator for Iomab-B
MD Anderson Cancer Center Hagop Kantarjian, M.D. Professor of Leukemia Department Chair, Department of Leukemia Division of Cancer Medicine University of Texas Key Investigator for Actimab-A
Johns Hopkins Medicine Richard Wahl, M.D. Director, Division of Nuclear Medicine/PET Professor of Nuclear Medicine Professor of Radiology and Oncology Vice Chairman, Technology and New Business Development Department of Radiology “Father of PET Imaging”
Judith Karp, M.D. Professor of Oncology Director, Adult Leukemia Program, Division of Hematologic Malignancies The Sidney Kimmel Comprehensive Cancer Center
Columbia University Medical Center
Joseph G. Jurcic, M.D. Professor of Clinical Medicine Director of Hematologic Malignancies Hematology/Oncology Division CAB Chairman, Lead Investigator for Actimab-A trials
University of Pennsylvania Health System
Alexander Perl, M.D. Assistant Professor of Medicine Division of Hematology/Oncology
7 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Cancer Treatment Options
Treatment % 50% <10%
Pharmaceutical Revenue %
<3% ~30%
Always a pharmaceuticalStrong IP protectionMostly proprietary
Monoclonal Antibodies (mAbs)Radiation
External radiation majority treatmentInternal radiation has mostly no IPCommoditized
♦♦♦
♦♦♦
Antibody Approaches Targeting Cancer Cells
αβ
Common Payload Approaches α
Cancer cell
β
Range .06mm
Range 1 - 10mm
DNA
Opportunity
Market Capitalization as of 1/30/2014. Bloomberg.
Company Market Cap($mm)
Algeta (Acquired by Bayer) $2,900
GSK NMSpectrum Pharmaceuticals $540Immunomedics $409Novelos Therapeutics $20
Pfizer NMSeattle Genetics $5,519Immunogen $1,318Peregrine Pharmaceuticals $285
α - emitters
β - emitters
Toxins
8 This presentation does not constitute or form part of any offer for sale or subscription or solicitation of any offer to buy or subscribe for any securities in Actinium Pharmaceuticals, Inc. (“ATNM” or the “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
ATNM’s Proprietary Technology Platform
♦ Delivers radiation to cancer site via pharmaceutical carrier through an injection – Antibody provides precision, targeting cancer cells specifically while avoiding normal cells – α emitters provide killing power with a very short range for narrow targeting – β emitters kill by crossfire which is useful in select indications
* APIT is Actinium Pharmaceutical’s Alpha Particle Immunotherapy platform technology. It does not apply to Iomab-B. ** Certain β emitters, specifically iodine 131 in Iomab-B, do not require a linker.
APIT* Technology
Antibody (targeting agent)
Chelator (linker)
α / β** emitter (killing agent)
9 This presentation does not constitute or form part of any offer for sale or subscription or solicitation of any offer to buy or subscribe for any securities in Actinium Pharmaceuticals, Inc. (“ATNM” or the “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Clinically Relevant α Emitters
* Clinically relevant but commercially not feasible in ATNM’s opinion.
α emitterPlatform Potential
Half Life Stage IP OwnershipMarket Cap
($mm)
Actinium 225 Yes 10 days Phase I/II Actinium Pharmaceuticals
Bismuth 213 Yes 46 minutes Phase II Actinium Pharmaceuticals
Radium 223 No 11 days Marketed Algeta
Thorium 227 Yes 18 days Preclinical Algeta
Astatine 211 * Yes 7 hours Phase II Duke University NM
Lead 212 * Yes 11 hours Phase I Areva Med NM
Bismuth 212 * Yes 1 hour Preclinical NM NM
$141
$1,601
10 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
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 Preparation Methods Ac-225 labeling 2029 Pending
Drug Preparation Methods Bi-213 labeling 2017/2020 Issued
Isotope Production Methods Ac-225 cyclotron production 2023/2025 Pending/Allowed
mAb Composition and Production Production of leukemia antibody 2015 Issued
Methods of Treatment Protection of toxicity 2023 Pending
* DOTA is the name of the chelator (linker) that Actinium uses to attach the antibody to the α emitter.
11 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
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 at this time due to supply, logistics and cost reasons. Actimab-A is the second generation drug of Bismab-A. 3 Properties of actinium 225 are uniquely suited for Antiangiogenesis and ATNM is considering options for further development in that area. 4 Glioblastoma (GBM) and breast cancer models are founded on an antiangiogenesis approach. Antiangiogenesis therapies starve cancerous tumors by choking off blood supplies to them.
12 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
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 preparation for HSCT
Iomab-B regimen Conventional Care (high dose chemo followed by HSCT)
♦ Almost all patients eligible ♦ <10% eligible
♦ ~30% survive 1 year plus, ~20% survive 2 years plus
♦ <10% survive 1 year plus, <2% survive 2 years plus
♦ Up to $200K per patient ♦ Up to $330K per patient
Treatment Options for Older Refractory AML Patients*
Survival:
Cost:
Treatment:
Usage:
*Source: Oran B, and Weisdorf DJ. Survival for older patients with acute myeloid leukemia: a population-based study. Haematologica 2012;97(12):1916-1924. doi:10.3324/haematol.2012.066100 “Overall economic burden of total treatment costs in acute myeloid leukemia throughout the course of the disease”, Dalia Mahmoud, MBA, Barry S. Skikne, MD, Izabela Kucmin-Bemelmans, MSc, Cathelijne Alleman, MSc and Marja Hensen, MSc, 54th ASH Annual Meeting abstract.
13 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
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 both PI and PII trials, Iomab-B led to effective treatment in patients with no other options left
All relapsed/refractory AML patients over 50 Rel/ref AML patients over 50 w/ poor cytogenetics
30%
19%
10%
0%
10%
0%0%
5%
10%
15%
20%
25%
30%
35%
1 year 2 years
Per
cent
age
Surv
ival
Iomab-B HSCT (N=27)
Current HSCT (N=10)
Chemotherapy (N=61)
33%
16%
3%
0%
3%
0%0%
5%
10%
15%
20%
25%
30%
35%
1 year 2 years
Per
cent
age
Surv
ival
Iomab-B HSCT (N=18)
Current HSCT (N=19)
Chemotherapy (N=95)
N = Number of patients treated; Iomab-B results from FHCRC clinical trials; Current HSCT and Chemotherapy results from MD Anderson outcomes analysis.
14 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Iomab-B Development Plan
Currently no approved treatments for Iomab-B targeted patients
* Phase I and Phase II represent physician trials at Fred Hutchison Cancer Center. Phase III trials represent ATNM sponsorship.
Timeline* Worldwide Market
Indication 2014 2015 2021 2022 Potential ($mm)
Acute Myeloid Leukemia Approval Sales Start $793
Myelodysplastic Syndrome Approval Sales Start $264
Acute Lymphoblastic Leukemia Approval Sales Start $264
Non-Hodgkin's Lymphoma and Hodgkins Disease
Approval Sales Start $1,455
Multiple Myeloma Approval Sales Start $1,322
Total $4,098
III
III
III
III
II
II
I
I
III
II
II
2018 20192013 2017 20202016
Source: GLOBOCAN, SEER , and the Company
15 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Actimab-A vs. Current Treatments
Treatment:
Usage: ♦ 64% of patients 60+ use this option due to lack of tolerable alternatives
♦ 36% of patients 60+ are eligible
♦ Potentially any AML patient due to limited side effects
Survival: ♦ Less than 2 months ♦ Less than 6 months ♦ Limited history; Bismab-A trials show median survival is 4x greater
Cost: ♦ $55K per patient ♦ $170K per patient ♦ $60K per patient
New Treatment Option
Supportive Care Actimab-AHigh Dose Chemotherapy
Current Treatment Options*
*Source: ARCH INTERN MED/Vol 162, July 22, 2002; Overall Economic Burden of Total Treatment Costs in Acute Myeloid Leukemia throughout the Course of the Disease, Dalia Mahmoud, MBA, Barry S. Skikne, MD, Izabela Kucmin-Bemelmans, MSc, Cathelijne Alleman, MSc and Marja Hensen, MSc, 54th ASH Annual Meeting.
16 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Target: ♦ AML ♦ AML
Effectiveness: ♦ Proof of concept in humans + 500x more potent than Bismab-A
Clinical Stage: ♦ Excellent results in Phase II ♦ Currently in a Phase I/II Trial
Supply Chain: ♦ Complex, high COGS + Simple, 10x lower COGS
Ease of Use: ♦ Complex on site preparation + Central manufacturing
♦ Does not require additional diagnostics ♦ Does not require additional diagnostics
Bismab-A Actimab-A
Actimab-A shows superior efficacy to Bismab-A in a comparable trial
* More than 5% of bone marrow blasts signifies persistent presence of leukemia cells.
Bismab-A Profile Actimab-A Advantages 1st Generation 2nd Generation APIT
Platform
Bismab-A experience implies successful Actimab-A trial results
Parameter Bismab-A Actimab-AElimination of peripheral blasts 27% 63%Bone Marrow blasts decrease by 50% or more 28% 50%Bone Marrow blasts 5% or less post treatment* 0% 20%
17 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
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 Cancer Center
♦ New protocol sets lower standard than MSKCC PI Trial – Treating newly diagnosed patients – Introducing cytoreduction (reduces the number of cancer cells) – New patient population is likely to respond better to treatment based on medically accepted criteria – No toxicity outside of blood cells at doses expected to be clinically effective
♦ Targeting end of Phase II trial in 2015, preliminary data by ASH 2014
♦ No new AML drugs have been approved; unmet medical needs remain, which should create interest from potential licensors, investors (Stemline, Marshall Edwards)
18 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Market Positioning for Iomab-B, Actimab-A
Treatment Response Treatments Diagnosis
AML Age >55
Complete Response
Relapsed & Refractory
AML HSCT
Death
High dose chemotherapy
Actimab-A Complete Response
Death
Reduced Intensity BM Conditioning
Reduced Intensity BM Conditioning
Iomab-B
♦ HSCT is a procedure that restores stem cells destroyed by high doses of chemotherapy and/or radiation therapy ♦ HSCT is widely used in
other forms of cancer outside of AML ♦ ATNM can leverage its
proprietary platform for additional HSCT indications
Negative Response
ATNM Pipeline Drugs Positive Response
Current Treatments
ATNM products target both treatment stages for AML patients over 55 years of age
19 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Market Potential of Product Pipeline
♦ The $1.3 billion Bone Marrow Transplant (BMT) market in the US is largely unaddressed by novel pharmaceutical drug companies
♦ BMT is the fastest growing hospital procedure in the US – ~20,000 of the ~60,000 BMTs in 2010 were
performed in the US ♦ Sustained growth in patients treated over 55 yrs old
– 8% in 2000 to 21% in 2005 and 27% in 2007
♦ Acute Myeloid Leukemia is the deadliest form of leukemia
– 55% of AML patients are over 65 years old – Disease is worse in older people – Insufficient treatment options are available in the
marketplace – Treatment kills as many patients as it helps due to
toxicity
HSCT (Iomab-B) AML (Actimab-A)
1. Target market includes USA, EU and Japan 2. Market Potential calculated based on assumption that Actinium products for solid cancer indications will be priced at $20,000 per treatment;
HSCT preparation product will be priced at $85,000 per treatment; AML product will be priced at $60,000 per treatment; and GBM product will be priced at $60,000 per treatment. Estimates based on independent third party research and adjusted for lower pricing in non-US markets.
# Cancer Indication Cases/Yr. in
target market1
Target Population
Worldwide Market
Potential ($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 Prostate Cancer (metastatic) 591,000 298,455 $5,959
5th Metastatic Colorectal Cancer 536,000 241,200 $4,824
Source: GLOBOCAN, SEER , and the Company
20 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Platform Building Strategy
♦ Create mAb combos that use antibodies with proven safety and cancer binding capabilities
♦ Focus on unmet needs in the market where no other treatments are available
♦ Three mAbs currently under consideration – Antiangiogenesis – Prostate cancer – Colorectal cancer
APIT platform can produce targeted Actimabs and “Biobetters”
♦ Improve upon marketed biotech drugs with proven safety and efficacy
♦ mAb combos increase efficiency – Algeta–Genzyme program
– Attaches Algeta’s α emitter to Genzyme’s mAb
– Areva Med – Roche program – Attaches Areva’s α emitter to Herceptin
mAb Expansion Strategy Develop “Biobetters”
+ mAb
= Actimab™ Attacks various
cancer cells Ac-225
mAb Expansion
+ Approved mAb
= “Biobetter”
Ac-225 Attacks various cancer cells
“Biobetters”
Additional Products
Actimab™-B Second generation product for bone marrow conditioning prior to HSCT
Platform Drug Candidate Antiangiogenesis 2nd
1st
21 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Recent Phase I/Phase II Cancer Licensing Deals
Company Phase at Signing
Deal Size
Upfront Fee Date Deal Description
Algeta Phase II $800 $61 9/3/2009 Algeta signs $800 million deal with Bayer for Alpharadin in prostate cancer bone metastases
Areva Med Phase I NA NA 7/27/2012 Areva Med signs agreement with Roche for an alpha radio-immunotherapy platform (Lead-212) in malignant cancer
Endocyte Phase II $1,000 $120 4/16/2012 Endocyte signs agreement with Merck for Vintafolide (EC145)
Genmab Phase I/II $1,100 $55 8/30/2012 Genmab signs agreement with Johnson & Johnson for Daratumumab in multiple myeloma
Innate Pharma Phase I $465 $35 7/6/2011 Innate Pharma signs agreement with Bristol-Myers Squibb for AML antibody IPH2102
Medivation Phase II $765 $110 10/27/2009 Medivation signs agreement with Astellas Pharma for MDV3100
Threshold Pharmaceuticals Phase II $592 $25 2/3/2012 Threshold Pharmaceuticals signs agreement with Merck KGaA for TH-302 in AML and other indications
Topotarget Phase II $350 $30 2/2/2010 TopoTarget signs agreement with Spectrum Pharmaceuticals for Belinostat
All Figures in USD ($mm)
Rich deals available for novel technologies with proof of concept
Source: Medtrack, Company Reports.
22 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Company Milestones
Drug 2014 2015 2016 2017
Iomab-Bin Ref/Rel AML 55+
♦♦♦♦♦
Complete PIII protocolComplete cGMP mAb mfgComplete Drug mfg cGMPSubmit PIII IND Start PIII
♦♦
Complete PIII recruitmentOutlicense ex US
♦♦
Close PIII databaseBLA filing
♦♦
Drug approvalFirst sales revenue
Iomab-Bin MDS
♦ Complete PIII protocol ♦ Start PIII
Actimab-A in Newly diagnosed AML 60+
♦♦
♦
Complete PI TrialComplete manufacturing improvementsStart and complete PII trialOutlicense worldwide
♦ Start PIII ♦♦♦
Complete PIIIPIII end milestoneBLA filing
♦♦♦♦
FDA approvalMilestone paymentFirst Royalty RevenueFirst sales
Third Program ♦ Start preclinical development
♦ Start PI physician trial ♦ ♦
Complete PI trialStart PI/II trial
♦♦♦
Complete PI/II trialStart PIII trialOutlicense worldwide
23 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Near-term Value Drivers
♦ Iomab-B – Complete PIII Protocol – Start cGMP mAb mfg – Start drug mfg cGMP process – Complete cGMP mAb mfg – Complete Drug mfg cGMP – Submit PIII IND – Start PIII
♦ Actimab-A – Complete PI trial – Complete mfg. improvements – Start and complete PII trial
♦ Third Program – Start preclinical development – Complete preclinical development – File IND
Multiple development milestones in next 12-18 months as ATNM’s products advance to a stage of development
♦ Uplisting to NASDAQ / NYSE MKT
♦ Additional Analyst Coverage
♦ Collaborations
24 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Market Valuations
2013 Biotech IPO’s Comparable Oncology Companies
Market Cap* ($MM) Market Cap at IPO ($MM)
* Market Cap = Common Stock Outstanding * Share Price Source: SEC Filings. Capital IQ. Date as of 10/10/2013
Actinium Financials
ATNM is compellingly valued relative to comparable oncology companies and also recent biotech IPO’s
$141 $157
$444
$0
$50
$100
$150
$200
$250
$300
$350
$400
$450
$500
Actinium Phase II or earlier (Median)
Phase III or later (Median)
♦ Listed on OTCBB: ATNM ♦ Stock Price as of 10/10/2013: $5.50 ♦ Market Cap as of 10/10/2013: $140.7 mm ♦ Shares Outstanding: 25.7 mm ♦ Cash Position as of 6/30/2013: $5.7mm
$141
$199
$355 $366 $395
$0
$50
$100
$150
$200
$250
$300
$350
$400
$450
$500
Actinium Phase II or earlier (Median)
Phase III or later (Median)
25 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Highlights
ü Prior clinical data for both Iomab-B and Actimab-A favor successful trial results
ü Breakthrough therapy potential implies successful market penetration for both Iomab-B and Actimab-A
ü APIT platform poised to deliver multiple blockbuster cancer drugs
ü An expert team possessing the vision and desire to enhance shareholder value
ü Positioned to benefit from increased market recognition of targeted
payload therapies and an initial high-value, niche product model
26 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 “Company”) nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. No reliance may be placed for any purpose whatsoever on the information contained in these slides or presentation and/or opinions therein.
Market Valuations – Oncology Companies
*Onyx Pharmaceuticals is acquired by Amgen for $10.4 Billion Source: Capital IQ. Data as of 10/10/2013
Actinium Financials
♦ Listed on OTCBB: ATNM ♦ Stock Price as of 10/10/2013: $5.50 ♦ Market Cap as of 10/10/2013: $140.7 mm ♦ Shares Outstanding: 25.7 mm ♦ Cash Position as of 6/30/2013: $5.7mm
Company Name TickerStock Price
($)Market Cap
($mm)LTM Revenue
($mm)
Early Stage (Primary Drug Phase II or earlier)Ambit Biosciences AMBI 16.44 293.9 25.4 Array BioPharma ARRY 5.70 667.7 69.6 Bio-Path Holdings BPTH 2.25 169.6 - Cleveland BioLabs CBLI 1.60 72.0 5.4 Coronado Biosciences CNDO 6.67 226.4 - CytRx Corporation CYTR 2.24 68.6 0.3 EntreMed Inc. ENMD 1.78 48.1 0.7 Enzon Pharmaceuticals ENZN 1.68 73.8 39.0 Galectin Therapeutics GALT 11.19 188.9 - Genspera GNSZ 1.47 40.1 - Geron Corporation GERN 3.03 389.8 2.2 ImmunoCellular Therapeutics IMUC 2.55 139.2 - Infinity Pharmaceuticals INFI 14.66 703.4 0.0 MEI Pharma MEIP 9.16 156.8 - Merrimack Pharmaceuticals MACK 3.53 360.8 58.6 Novelos Therapeutics NVLT 0.37 21.2 - Ohr Pharmaceutical OHRP 7.90 155.8 - OXiGENE OXGN 2.73 7.4 0.0 Peregrine Pharmaceuticals PPHM 1.42 222.2 22.1 Provectus Pharmaceuticals PVCT 0.90 115.8 - Puma Biotechnology PBYI 41.92 1,202.2 - Senesco Technologies SNT 0.61 19.4 3.8 Stemline Therapeutics STML 38.57 483.6 - TG Therapeutics TGTX 4.32 143.8 0.1 XOMA Corporation XOMA 4.68 432.5 31.2 Median 156.8
Company Name TickerStock Price
($)Market Cap
($mm)LTM Revenue
($mm)
Late Stage (Primary Drug Phase III or later)Algeta ASA ALGETA 36.55 1,601.2 166.4 Ariad Pharmaceuticals ARIA 5.41 1,001.4 20.6 ArQule ARQL 2.29 143.6 26.2 Astex Pharmaceuticals ASTX 8.50 806.9 80.0 AVEO Pharmaceuticals AVEO 2.10 109.6 17.2 BioCryst Pharmaceuticals BCRX 6.57 356.3 14.2 Celldex Therapeutics CLDX 28.35 2,296.0 9.3 CEL-SCI CVM 0.84 26.1 0.3 Celsion CLSN 1.20 73.5 0.3 Clovis Oncology CLVS 52.59 1,586.7 - Curis CRIS 4.02 328.3 8.5 Cyclacel Pharmaceuticals CYCC 3.70 65.5 0.5 Dendreon DNDN 2.68 422.6 304.4 Endocyte ECYT 13.78 496.8 57.9 Exelixis EXEL 5.28 972.1 42.7 GTX Inc. GTXI 1.56 98.6 - Immunogen IMGN 16.08 1,369.6 35.5 Immunomedics IMMU 5.56 461.1 5.0 Incyte Corporation INCY 37.23 5,698.5 346.7 Isis Pharmaceuticals ISIS 33.39 3,850.1 112.9 Medivation MDVN 51.61 3,881.7 218.3 OncoGenex Pharmaceuticals OGXI 8.69 127.6 27.8 Oncothyreon ONTY 1.89 119.9 - Onyx Pharmaceuticals ONXX NA 10,400.0 515.9 Pharmacyclics PCYC 123.14 9,007.6 218.2 Progenics Pharmaceuticals PGNX 4.15 252.4 13.9 Seattle Genetics SGEN 40.70 4,959.1 244.6 Spectrum Pharmaceuticals SPPI 8.55 541.3 211.0 Sunesis Pharmaceuticals SNSS 4.79 247.6 6.2 Synta Pharmaceuticals SNTA 6.43 444.0 - Threshold Pharmaceuticals THLD 4.65 270.1 9.9 Vical Incorporated VICL 1.29 111.9 7.5 ZIOPHARM Oncology ZIOP 4.33 359.8 0.8 Median 444.0