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Actinium Pharmaceuticals, Inc. April 2014 Company Presentation Ticker: ATNM (NYSE MKT).

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Actinium Pharmaceuticals, Inc.


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actinium pharmaceuticals inc

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 “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.

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”). 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.

company description
Company Description

ACTINIUM is an oncology focused company with proprietary alpha and beta emitter (radiation) technology initially targeting early and late stage leukemia. We are one of only three companies in the world developing alpha emitters.

company overview
Company Overview
  • Overall investment of $100M to develop Alpha Emitter Technology to treat Leukemia
  • 68 Patents (owned and in-licensed from Memorial Sloan-Kettering Cancer Center and others)
  • Advisory Board Represents all Major Cancer Centers including Memorial Sloan-Kettering, Fred Hutchinson and MD Anderson
  • Iomab-B on the cusp of entering Phase III for Relapsed and Refractory Acute Myeloid Leukemia (AML) (Patients > 55)
company overview continued
Company Overview (continued)
  • Actimab-A in Phase I/II Trials for Newly Diagnosed AML
  • 1 of only 3 Companies in World with Alpha Technology
  • Fully Funded for next 12 months
  • World Class Board of Directors
  • Sloan-Kettering Largest Shareholder and also Merck a Shareholder
financial facts
Financial Facts

*Pro-forma from Jan 24th, 2014 Offering $3.3M Not Included

antibody approaches targeting cancer cells
Antibody Approaches Targeting Cancer Cells

α

β

Cancer Treatment Options

Range

1 - 10mm

Range

.06mm

DNA

Cancer cell

atnm s proprietary technology platform
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* Technology

Antibody (targeting agent)

Chelator (linker)

α / β** emitter (killing agent)

* 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.

clinically relevant emitters
Clinically Relevant  Emitters

* Clinically relevant but commercially not feasible in ATNM’s opinion.

robust intellectual property protection
Robust Intellectual Property Protection
  • 68 Patents issued and pending
    • United States 17
    • International 51
  • Eligible for orphan drug exclusivity

* DOTA is the name of the chelator (linker) that Actinium uses to attach the antibody to the α emitter.

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 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.

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 preparation for HSCT

Treatment Options for Older Refractory AML Patients*

Treatment:

Usage:

Survival:

Cost:

*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, IzabelaKucmin-Bemelmans, MSc, CathelijneAlleman, MSc and MarjaHensen, MSc, 54th ASH Annual Meeting abstract.

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 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

N = Number of patients treated;

Iomab-B results from FHCRC clinical trials;

Current HSCT and Chemotherapy results from MD Anderson outcomes analysis.

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
      • Statistical considerations
iomab b development plan
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.

Source: GLOBOCAN, SEER , and the Company

actimab a vs current treatments
Actimab-A vs. Current Treatments

*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, IzabelaKucmin-Bemelmans, MSc, CathelijneAlleman, MSc and MarjaHensen, MSc, 54th ASH Annual Meeting.

bismab a actimab a
Bismab-A Actimab-A

Bismab-A experience implies successful Actimab-A trial results

1st Generation

2nd Generation

APIT Platform

Bismab-A Profile

Actimab-A Advantages

  • 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.

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 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)
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

chemotherapy

Complete

Response

Reduced Intensity BM Conditioning

Relapsed & Refractory AML

AML

Age >55

Iomab-B

HSCT

  • 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

Actimab-A

Complete

Response

Reduced Intensity BM Conditioning

Current Treatments

Death

ATNM Pipeline Drugs

Positive Response

Negative Response

market potential of product pipeline
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

1. Target market includes USA, EU and Japan

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.

HSCT (Iomab-B)

AML (Actimab-A)

  • 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

Source: GLOBOCAN, SEER , and the Company

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)

Source: Medtrack, Company Reports.

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
    • Complete PIII Protocol
    • Start cGMP mAb mfg
    • Start drug mfg cGMPprocess
    • 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
  • Uplisting to NYSE MKT (Accomplished March 26, 2014)
  • Additional Analyst Coverage
  • Collaborations
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 vision and desire to enhance shareholder value
  • Positioned to benefit from increased market recognition of targeted payload therapies and an initial high-value, niche product model