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2015/11/18

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Actinium Pharmaceuticals, Inc. (ATNM) | Moving a Step Closer to Targeting Cancer

Actinium Pharmaceuticals, Inc. (ATNM)

Moving a Step Closer to Targeting Cancer

Rating:

BUY

Actinium Pharmaceuticals, Inc.
757 Third Avenue, 21st Floor
New York, NY 10017
Phone: (646) 459-4201
www.actiniumpharma.com

Published November 18, 2015

  • Submits Iomab™-B Investigational New Drug ("IND") application with U.S. Food and Drug Administration.
  • Prepares for initiation of Phase 3 Clinical Study in refractory and relapsed Acute Myeloid Leukemia ("AML") patients needing Bone Marrow Transplants ("BMT").

COMPANY OVERVIEW AND PRODUCTS:

Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM), ("the company") is a biopharmaceutical company that develops innovative targeted payload immunotherapeutics for the treatment of advanced cancers. The company develops cancer drugs, primarily using its Alpha Particle Immunotherapy Technology ("APIT") platform. This patented technology combines monoclonal antibodies (mAB) for targeting specific types of cells with alpha emitting radioisotopes, to precisely target and kill cancerous cells. The Company's products are based on patented technology co-developed with Memorial Sloan Kettering Cancer Center (MSKCC). �The company has developed drugs for treating leukemia, metastatic colorectal and prostate cancers, antiangiogenesis (prevention of blood supply to and growth of many solid cancers), and bone marrow ablation (a treatment for leukemias, lymphomas and multiple myeloma).

The company has two clinical stage products, Actimab™-A for acute myeloid leukemia ("AML"), which was co-developed with MSKCC, and Iomab™-B for bone marrow conditioning before a hematopoietic stem cell transplant (HSCT), which was developed by Fred Hutchinson Cancer Center. Over 300 patients have been treated in multiple Phase 1 and Phase 2 clinical trials for Actimab™-A and Iomab™-B. The company's product pipeline contains additional treatments focused on antiangiogenesis, metastatic colorectal cancer, and prostate cancer. The market potential for the company's cancer drugs is illustrated below.1

Market Potential for Lead Products
# 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
  1. Target market indicates 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.

RECENT DEVELOPMENTS:

On Tuesday, November 17, 2015, the company announced that it had successfully submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for Iomab-B™, a radioimmunotherapeutic that conditions Acute Myeloid Leukemia (AML) patients for a Hematopoietic Stem Cell Transplant ("HSCT"), commonly referred to as a Bone Marrow Transplant (BMT). �This announcement was ahead of the company's previous guidance for a year-end IND application filing. Pending the FDA's acceptance of the IND filing, the company will initiate a single, pivotal Phase 3 clinical study in refractory and relapsed AML patients over the age 55. The company anticipates this Phase 3 study starting in 2016, and has worked to eliminate previous manufacturing issues.

According the company's Executive Chairman, Sandesh Seth, "this much anticipated regulatory filing is an important one that marks the first step in Actinium's transition to a later development stage biopharmaceutical company. �As we prepare for the pivotal Phase 3 clinical trial for Iomab-B™ in 2016, we have added key members to our executive, regulatory and clinical operations teams, and will continue to add selectively. �This strengthening of the company will enable us to meet our goals of efficient execution of not only the Iomab-B™ program but also of the Actimab-A™ Phase 2 trial planned for early 2016, as well as other pre-clinical and clinical programs expected for next year."

Iomab-B™ will be used in preparing patients for hematopoietic stem cell transplantation (HSCT), which is the fastest growing hospital procedure in the U.S. ��The company established an agreement with the FDA that the path to a Biologics License Application ("BLA") submission could include a single, pivotal Phase 3 clinical study, if it is successful. �The population in this "two arm", randomized, controlled, multicenter trial will be refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55. �The trial size was set at 150 patients with 75 patients per arm. �The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year.

It is important to note that there are currently no effective treatments approved by the FDA for AML in this patient population, and there is no defined standard of care. �In 2015, the U.S. National Cancer Institute ("NCI") estimates that 20,800 cases of AML will be diagnosed in the United States.2 An estimated 10,500 individuals will be killed by AML in 2015.3

Iomab-B™ has completed several physician sponsored clinical trials examining its potential as a conditioning regimen prior to HSCT in various blood cancers, including the Phase 1/2 study in relapsed and/or refractory AML patients. �The results of these studies in over 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by:

  • Expanding the pool to ineligible patients who do not have any viable treatment options currently;
  • Enabling a shorter and safer preparatory interval for HSCT;
  • Reducing post-transplant complications;
  • Showing a clear survival benefit including curative potential.

Iomab-B™ is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. �BC8 has been developed by the Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. �This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia ("CML"), acute lymphoblastic leukemia ("ALL"), chronic lymphocytic leukemia ("CLL"), Hodgkin's disease ("HD"), Non-Hodgkin lymphomas ("NHL") and multiple myeloma ("MM"). �When labeled with radioactive isotopes, BC8 carries radioactivity directly to the site of cancerous growth and bone marrow while avoiding effects of radiation on most healthy tissues.

OUTLOOK:

While the company has not recorded any revenues from sales of any of its immunotherapeutics, the company has a relatively strong balance sheet.�As of September 30, 2015, the company had approximately $24,762,045 in cash, as compared to approximately $6,706,802 in cash on December 31, 2014. The company's total liabilities were approximately $2,155,294 for the period ended September 30, 2015, as compared to approximately $9,491,616 on December 31, 2014.

BOTTOM LINE:

As with an investment in many smaller biotechnology companies that are "pre-revenue", an investment in the shares of Actinium Pharmaceuticals, Inc. continues to be a "high risk, high reward" situation. The company will continue to report no revenue until its products receive FDA approval and are in the marketplace. Additionally, the company's share price is likely to remain highly volatile and will react to news releases, such as announcements of year end results for 2015, and results of the Phase 2 and Phase 3 studies that that are about to begin. Following this evening's announcement, I continue to believe that the rewards outweigh the foreseeable risks, and I reiterate my Buy recommendation. A more detailed report on the company will be released before the market open on Thursday, November 19, 2015.

SOURCES:

1 http://www.actiniumpharma.com/wp-content/uploads/ATNM-Corporate-Profile1.pdf

2 http://www.bionapcfa.com/2015/11/actinium-pharmaceuticals-platform.html?m=1

3 Ibid.

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