8/8/2019 Crayon Talk

1/2

ImmuneRegen BioSciences (IRBS) Talking Points

ImmuneRegens Homspera is a first in class drug that uses a natural reparative pathway bysending out an injury signal throughout the body to stimulate built-in repair mechanisms to treatserious diseases in man.

It does this in several ways including providing more stem cells with the potential to, for example, heal tissues damaged by injury or diseases causing lethal lung scarring, increase lowlevels of disease-fighting white blood cells and enable the body to better fight influenza infectionand even cancer.

Additionally, because Homspera also stimulates the immune system directly, it makes vaccinesstronger and more effective.

ImmuneRegens Homspera is based on a natural protein, and based on studies to date, thecompany believes there will be no toxicity at therapeutic doses.

The unique regenerative properties created by Homspera make this novel an extremely promising drug to treat several serious human diseases for which there are no good treatments.

ImmuneRegens lead drug candidate, Homspera, really is a first in class compound.

Emerging from extensive preclinical development and poised to enter human testing within a year ,this protein uses a persons natural regenerative and self-defense (immune) powers to treat a number of diseases and conditions.

This regenerative system has been found in all animals and basically sends a signal that says an injuryhas occurred and the damage needs to be repaired.

That signal causes stem cells to come out of the bone marrow into the blood where they areactivated and stimulated to mature. The increase in blood cells boosts the immune system to betterfight infections (or cancer), repairs damaged tissue by removing damaged cells and helps healwounds that result from that injury .

Such a central repair system can be used to protect against a large number of diseases, and the areastargeted to be first are those with a large number of patients; diseases causing lung scaring, thecondition of low white blood cell count (common in patients being treated for cancer), certainvirus infections like influenza, and even cancer itself.

In addition to triggering stem cells, Homspera acts on cells of the immune system to directly

modulate their activity. This causes increased responses to vaccines, making them more effective .It is this effect that supports the ability of Homspera to slow cancer growth when used with a cancer vaccine. It may also be how Homspera works to decrease symptoms of infection by flu virus inanimals.

Homspera is modeled after a natural protein and generates a signal just like the natural system, so we believe the risk of toxicity is reduced. Indeed, we have seen no evidence of toxicity at drugconcentrations that are beneficial in our development work . It is the unique regenerative properties(there are no other drugs on the market that work similarly) of Homspera that support the use of the drugfor multiple human diseases that currently have no good treatments available.

8/8/2019 Crayon Talk

2/2

Comparative Companies/Technologies

Dendreon will likely market the first immunostimulatory anti-cancer treatment using activecellular immunotherapy (ACI), in which immune cells are taken from the cancer patient, activatedto produce a stronger immune response to the cancer cell, and re-injected into the patients blood,

providing the immune system with a boost in fighting off cancer cells. The expansion of Dendreons ACI clinical efforts from Provenge (sipuleucel-T) for prostate cancer to lapuleucel-Tto treat bladder, breast, ovarian and colon cancer suggests Homsperaa immune activation could

be of use in treating or immunizing against other cancers as well. We might be of value inmaking Dendreons injected immune cells more effective. Studies underway at the NationalCancer Institute, the Fred Hutchinson Cancer Research Center and Scancell (a UK companytesting a cancer vaccine) are all confirming Homsperas capability to stimulate the immunesystem, either in an injected vaccine or as ACI.

Neupogen (Filgrastim) and Neulasta (Pegfilgrastim) currently have a market of over $2 billion

worldwide for treating neutropenia (low levels of white blood cells), while Genzymes recentlyapproved Mozobil (plerixafor) for stem cell mobilization is expected to be additive to thesegrowth factors currently used for this purpose (and estimated at approximately $6500/patient withabout 100,000 bone marrow transplants/year, for a $0.65 billion potential). Planned studies andpotential licensing could expand Homsperas utility to both of these indications as well. Tamiflu (Roche)- Sales of Tamiflu were expected to increase 531% in 2009 due to the

pandemic influenza threat and governmental stockpiling around the world. With the U.S.Strategic National Stockpile acquiring approximately 50 million treatment courses of oseltamivir (Tamiflu) or zanamivir (Relenza), this represents a significant opportunity. With our datashowing efficacy in accepted animal models for seasonal, pandemic and avian influenza,even above that of Tamiflu (by virtue of Homspera working to enhance the host immunesystem), we can potentially be additive to these traditional anti-viral agents and stretch thecapabilities of the Strategic National Stockpile as well as provide a unique therapeutic totreat flu patients.

Ongoing studies support Homsperas ability to treat Idiopathic Pulmonary Fibrosis, which hassignificant unmet medical need as there are NO approved drugs on the US market at this time(Intermunes pirfenidone Esbriet was not approved by FDA after an Advisory Meeting clearly

showed it has disappointing efficacy data). ImmuneRegen has filed with FDA to get Orphan DrugStatus for this indication, which, if granted, means additional support from the FDA in movingdevelopment forward.

Also ongoing are studies with Neostem Inc., an adult stem cell company with proprietary VSEL(Very Small Embryonic Like stem cells) technology. Neostem has facilities around the countryand an ownership stake in a Chinese research and pharmaceutical company.