Transcript Slide 20

CORPORATE OVERVIEW
• TNIB is a late stage immunotherapy
company with short term sustainable
revenue delivering low cost,
effective, safe immuno therapies
treatments for HIV/AIDS, cancer and
autoimmune diseases revolving
around LDN and MENK in
underserved countries.
CORPORATE OVERVIEW
• TNI BioTech is focused on
developing and commercializing
therapeutics to treat cancer,
HIV/AIDS and autoimmune diseases
by combating these chronic and
often life-threatening diseases
through the activation and
rebalancing of the body’s
immune system.
CORPORATE HISTORY
• TNIB acquired numerous patents revolving
around two interrelated compounds that
both modulate and enhance the immune
system
• LDN (Low Dose Naltrexone) and
• MENK (Methionine Enkephalin)
• LDN and MENK in a combination or on their own are
proven immune-enhancing drugs with the ability to
to increase the T and NK cells in the body, activating
its own natural defenses
TARGET MARKETS
LDN and MENK provide intellectual property pipeline and
a platform to treat a number of indication but the
company has decided to focus of the following:
• Crohn’s disease: pediatric and adult
• Cancer, such as pancreatic and other solid tumors
• Infections, such as HIV/AIDS, malaria, drug-resistant
tuberculosis or salmonella
• Autoimmune diseases, such as multiple sclerosis (MS)
MARKET SIZE
• Crohn’s market estimated to range between $3.5
billion to $5 billion, with annual growth projected at
13% through 2020
• Multiple Sclerosis (MS) market estimated to range
between $11 billion to $20 billion, with annual growth
projected at 12% through 2017
• HIV/AIDS market valued at $13.5 billion in 2011,
increasing at a CAGR of 12.5% during 2004-2011;
projected to grow 7% during 2011-2018 to reach
$21.8 billion
IMMUNOTHERAPY ATTRIBUTES
• TNIB’s immunotherapy are used to to increase
production of the immune system by
increasing production of DC cells,
macrophages, CD4+T Cells (CD4), CD8+T cells,
NK cells, NKT cell and Gammadelta T cells and
inhibiting Treg cells
• Allow the body to recognize cells as foreign
invaders and thereby remove them
KEY PRODUCT CANDIDATES
IRT-101 is an active immunotherapy with MENK for patients with deficient
functioning of the immune system, which works by restoring immune functions
and by activating a patient's lymphocytes to attack cancer cells and also infectious
diseases, including HIV/AIDS.
IRT-102 is an adoptive form of immunotherapy, which involves isolation and
enrichment of a patient's own immune cells and exposing them to MENK in the
laboratory. After a few days of culture, the activated lymphocytes are infused back
into the patient to boost the ability of the immune system to control cancer cells or
infected cells...
IRT- 103 (LDN) is an active immunotherapy with low dose naltrexone (LDN), an
oral medication that works by activating a patient's immune system against
HIV/AIDS and cancer cells, or by rebalancing the immune system of patients with
autoimmune diseases, for example inflammatory bowel diseases such as Crohn’s
disease, or multiple sclerosis.
SCIENTIFIC TEAM
•
Dr. Ronald Herberman Previously, he served at the founding director of University of
Pittsburgh Cancer Institute (UPCI) and the UPMC Cancer Center, and Associate Vice
Chancellor for cancer research within the School of Medicine, Department of Health
Sciences and formerly of the National Cancer Institute in Washington D.C., the University of
Pittsburgh (Health and Sciences)
•
Dr. Angus Dalglish, was appointed to Foundation Chair of Oncology at St. George’s
University of London in 1991. His main interest as been the immunology of cancer and the
development of immunotherapies to treat, in particular, melanoma. i
•
Nicholas Plotnikoff, University of Illinois Medical Center in Chicago
•
Eugene Youkilis, Abbott Labs, Baxter International, Pfizer and Eli Lilly and Co.
•
Fengping Shan has a Ph.D. in Microbiology/Immunology. Dr. Shan is Professor of
Immunology and Vice Director of the Institute of Immunology, China Medical University,
and Shenyang, China.
•
Dr. Henry Lenz is a graduate of The Massachusetts College of Pharmacy and the University
of Florida. He was head of research at Key Pharmaceuticals and currently owns Skips
Pharmacy in Boca Raton, Florida. Skips Pharmacy is the leading outlet for the supply of LDN
IMPLEMENTATION OF GROWTH STRATEGY
•
Acquiring patents and therapies: TNIB owns two
interrelated drug therapies (LDN and MENK) that modulate
and enhance the immune system and over 20 patents
•
Acquiring Clinical data: TNIB owns clinical data, intellectual
properties, and technologies, and is continuing efforts to
collect information related to these therapies
•
Pursue near term commercialization of existing
immunotherapies that target cancer and HIV/AIDS in
emerging markets, including Africa, China, Caribbean, and
South America
•
Creating an intellectual community: TNIB has assembled a
team of leading doctors and scientists in the fields of
immunology, oncology, and research to work together using
these therapies to treat diseases
PARTNERS
• GB Oncology and Imagining Group
• Skip’s Pharmacy
• Government of Malawi
• Republic of Equatorial Guinea
• G-Extechnologies/St. Maris Pharma (Nigeria)
• Hubei Qianjiang Pharmaceutical Company
PROJECTED MILESTONES: CROHN’S DISEASE
Complete
Phase III:
LDN and
pediatric
Crohn’s
Begin Phase III trial:
LDN and pediatric
Crohn’s disease
2014
2014
Begin Phase
III Trial LDN
and adult
Crohn’s
disease
2016
FDA
Approval of
LDN for
pediatric
Crohn’s
2016
Complete
Phase III:
LDN and
adult
Crohn’s
2017
2017
FDA
Approval of
LDN and
adult
Crohn’s
PROJECTED MILESTONES: MULTIPLE SCLEROSIS (MS)
Begin Phase II
trial: LDN and
SPMS
2014
FDA approval
of LDN and
SPMS
Begin Phase III:
LDN and SPMS
2015
Complete
Phase II: LDN
and SPMS
2016
2018
Complete
Phase III: LDN
and SPMS
2018
PROJECTED MILESTONES: CANCER
Complete
selection for
Phase III
Begin Phase II
LDN/MENK: Cancer
2014
Complete
Phase III:
LDN/MENK
in selected
oncology
indication
2016
Complete
Phase II:
LDN/MENK
Cancer
2016
2017
Begin Phase
III:
LDN/MENK
in selected
oncology
indication
2019
2019
FDA
Approval of
LDN/MENK
in selected
oncology
indication
POTENTIAL CORPORATE MILESTONES
•
Develop safe and affordable immunotherapy treatments
available for commercialization in countries where an urgent
need exists for safe and effective treatments for autoimmune
diseases, HIV/AIDS and cancer
•
Help establish facilities to distribute its products in many
countries in Africa, Caribbean and South America
•
Potential contribution from Phase III study of low dose
naltrexone (LDN) for use in Crohn’s disease, scheduled to
begin in 2014
•
Revenues from provision of LDN to African Nations for
treatment of cancer and HIV/AIDS
•
Future FDA or other regulatory approvals
RECENT NEWS
• On January 8, 2012, TNIB announced the signing of
a licensing agreement for the exclusive patent
rights, IND, and clinical data for the treatment of
the pediatric Crohn’s, Crohn’s Disease,
inflammatory bowel, and ulcerative colitis using
naltrexone in low dose
• As part of the agreement, TNIB obtained the right
to apply to the FDA for the transfer of the orphan
drug status, the investigational new drug
applications (INDs), and the right to acquire the
relevant clinical data set.
CONCLUSION
• TNIB seeks to harness the power of the immune
system to improve global health and remove a
significant portion of suffering caused by diseases
such as HIV/AIDS, cancer, multiple sclerosis (MS),
and Crohn’s disease
• Execution of TNIB’s strategy will continue through
acquiring intellectual property, trials, technologies
and patents, and partnering with leading
scientists, researchers, and corporations
STOCK OVERVIEW
• Company Name:
TNI BioTech, Inc.
• Ticker:
OTC: TNIB
• Share Price:
$6.95
• Market Cap:
$316 mm
• Average Volume:
41,000
• Formed:
July 2012
6701 Democracy Blvd.
Suite 300
Bethesda, MD 20817
Website: http://www.tnibiotech.com
Phone: (888) 613-8802
Email: [email protected]
THANK YOU