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

• 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

IMMUNOTHERAPY ATTRIBUTES

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.

 

KEY PRODUCT CANDIDATES

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

Begin Phase III trial: LDN and pediatric

Crohn’s disease

Begin Phase III Trial LDN and adult Crohn’s disease

Complete Phase III: LDN and pediatric Crohn’s

Complete Phase III: LDN and

adult Crohn’s

FDA Approval of

LDN for pediatric Crohn’s

FDA Approval of

LDN and adult

Crohn’s

2014 2014 2016 2016 2017 2017

PROJECTED MILESTONES: MULTIPLE SCLEROSIS (MS)

Begin Phase II trial: LDN and

SPMS

Complete Phase II: LDN

and SPMS

Begin Phase III: LDN and SPMS

Complete Phase III: LDN

and SPMS

FDA approval of LDN and

SPMS

2014 2015 2016 2018 2018

PROJECTED MILESTONES: CANCER

Begin Phase II LDN/MENK: Cancer

Complete Phase II:

LDN/MENK Cancer

Complete selection for

Phase III

Begin Phase III:

LDN/MENK in selected oncology indication

Complete Phase III:

LDN/MENK in selected oncology indication

FDA Approval of LDN/MENK in selected oncology indication

2014 2016 2016 2017 2019 2019

• 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

POTENTIAL CORPORATE MILESTONES

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

THANK YOU

6701 Democracy Blvd.Suite 300Bethesda, MD 20817

Website: http://www.tnibiotech.comPhone: (888) 613-8802Email: tnibiotech.info@tnibiotech.com