Introduction

From the company website: NuLife Sciences (NULF)  is a biomedical company focused on medical research and technology that has the potential to address significant unmet medical needs in applications including transplantation/regenerative medicine/cell therapy/organ and tissue transplants. Through its wholly-owned subsidiary NuLife BioMed, it is currently working on advancing human organ transplant technology based upon a patent protected and unique proprietary method ("NuLife Technique") that could potentially eliminate the need for an organ or tissue match and the necessity for anti-rejection drugs.

We recently had the opportunity to interview NuLife's CEO, John Hollister.

What is NuLife Sciences all about?

NuLife Sciences is committed to developing and commercializing advances in medical science which have significant benefits for patients. Our first area of focus is in kidney transplant, utilizing the NuLife Technique, which harnesses the potential power of cytokines released from our proprietary process.

How did NuLife determine what services it would provide?

We reviewed a number of variables including the unmet need, potential impact (survival, cost, and QOL), regulatory pathway, competitive environment, and time to commercialization to determine which indication to pursue first.

Are your services patented?

Yes. And, we will be expanding our existing patent portfolio, as well as adding additional patents.

What is the total available market for your services?

If we limit the discussion to kidney transplants, there are roughly 18,000 transplant procedures each year. While we have not established a price for our process, we believe that there is an available market approaching $1B. This does not include any expansion in the number of transplants conducted per year.

Given this market, how much market share is reasonable for NuLife Medical to acquire?

If the NuLife Technique is able to accomplish what we hope, we believe it is reasonable to assume that 90% of kidney transplants will utilize the process within three years of marketing authorization.

What companies, if any, do you perceive as your market competitors? How has that shaped the way NuLife has targeted this space?

There are a number of very early stage approaches, mostly stem cell related, attempting to grow human replacement organs. There are others attempting to improve mechanical methods replicating the role of the kidney.  We are also aware of at least one other group exploring how to do something similar to our approach. We believe that our core proprietary technology is essential to being successful in this.  

Does NuLife have any partnerships or license agreements?

Not at this time but we are exploring the potential of these sorts of arrangements.

What are the clinical pathways for your services?

The development and commercialization pathway for the NuLife Technique will include the FDA, a series of studies, and working with the existing transplant system, overseen by the Organ Procurement Organization and their Centers around the country.

When can investors expect significant clinical and regulatory developments?

 Pre-clinical work is underway. We should have results from this work within a  couple of months. We hope to be moving into human work by late 2018.  In the meantime, we will likely be publishing the basic science to help explain the Technique.

What has NuLife accomplished in clinic? Why does NuLife think that such accomplishments warrant continued clinical development?

Prior to acquiring the technology, our Scientific Advisors conducted a series of exploratory surgeries to determine whether the Process was feasible and to tease out the surgery.They came away convinced that all the steps of the Technique can be done in the allotted time and excited about the potential.They were able to utilize their firsthand experience in designing the current study protocol. Having this experience under their belt is a big help in the next series of studies.

Is there any precedent for clinical development in this space? Is there anything that is helping NuLife shape clinical development of its products (e.g., expertise of management)?

Absolutely. Our Scientific Advisors are very experienced transplant surgeons, with outstanding reputations.  Dr. Arenas was formerly the Director of Transplant at UT Southwest and now heads the program at the Memorial Healthcare System in South Florida.  Additionally, Dr. Hranjec has extensive experience in cytokines.  From a management perspective, I have nearly 30 years of pharma and biotech development and commercialization experience and our President, Fred Luke, has nearly 40 years of start-up and SEC experience.

The United States Congress has taken significant steps to repeal and replace the Affordable Care Act. In what ways, if any, has NuLife prepared for significant regulatory changes?

Clearly, healthcare in the US is undergoing change. Much of this is focused on  access and reducing costs. We believe both efforts will present opportunities to  NuLife, as we believe our Process will provide an opportunity for more people to receive kidneys faster AND significant financial savings to the system.

Are there any aspects of NuLife that you think Wall Street is overlooking?

Wall Street is not yet aware of us. We are just beginning to share our story. [Ed. note: NULF current trades OTC at $0.59 per share.]

Could you elaborate on insider ownership?

It's at 71%.

Can you please summarize your financials?

We are pre-commercialization.

Are you involved in any significant litigation?

No.

Where do you see NuLife in 10 years?

In 10 years, NuLife will have commercialized a couple of potential uses of our proprietary technology.  Likely, we will have expanded our areas of focus through partnerships or joint ventures. We will also explore the potential benefits of uplisting, as well as the potential of acquisitions or being acquired. Lots can happen in ten years.

Culminating from our discussion, why should someone invest in NuLife and what is the earliest near-term catalyst that a potential investor can look forward to?

If our core technology proves successful, NuLife will revolutionize the world of transplant helping many people and saving our system huge amounts of money. Further, we are mitigating the inherent risks by looking to diversify our offering through partnerships, which have the potential of developing revenue streams earlier than the transplant pathway.  Healthcare investments always carry risk and some have immense potential to impact patients. NuLife is one of those.