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‘The vaccines are going to bail us out of this:’ INmune Bio CEO on treatment demand amid pandemic

Yahoo Finance’s Alexis Christoforous and Dr. Raymond J. Tesi, INmune Bio CEO, discuss the company's treatment for COVID-19 patients and vaccine outlook.

Video Transcript

ALEXIS CHRISTOFOROUS: The biotech firm in INmune Bio has a unique approach to coronavirus, treating it as a disease of the immune system, rather than a neurological respiratory disease. Their new treatment, Quellor, is now in clinical trials, and INmune CEO Dr. RJ Tesi joins us now. Good to have you on the show, Doctor. This is exciting news for your company and also for all of us suffering with this virus. Tell us about the clinical trial right now, and how is it going?

RAYMOND TESI: Yeah, thanks for having me, Alexis. And you're right, we've-- the clinical trial is open, and we are focused on the patients that get to the hospital. That is, 20% of patients who get to the hospital-- or who get COVID-19-- end up requiring hospitalization. And those patients are a little different.

What people don't understand is by the time you get to the hospital, your immune system is actually winning the battle. I mean, your-- the virus-- amount of virus in your body is going down. So in fact, it's not an antiviral therapy you need. It's a therapy that-- to treat what's making you sick, and that's the immune system.

The immune system, in its quest to get rid of the virus, has gotten completely out of control. You get this-- what we call a hyper-inflammatory state. It's like, you know, inflammation on, you know-- on, you know, steroids. And it's what's killing us-- or killing patients or hurting patients.

So what you need to do is control that inflammation in a way that doesn't compromise the ability of the body to get rid of the virus. And that's what we do with Quellor. We go after what-- one of the cytokines of the cytokine storm. Cytokine storm is that overwrought immune state.

We chop the cytokine storm off at the knees, and that should allow the patient to calm down, the immune system to calm down. And hopefully, they'll be ready to go home in days, and that's what we're doing in this clinical trial. We're testing our drug against what the standard of care is, and we're pretty excited. And so far, so good.

ALEXIS CHRISTOFOROUS: Where is the trial taking place? I would imagine you have a few going up simultaneously. And how large a pool are you looking at?

RAYMOND TESI: Yeah, so thank you. So the trial will ultimately enroll 366 patients. And I want to give a strong-- strong support to the FDA here. The FDA has really gone out of the way to help companies like ours with promising therapies against this pandemic get their drug quickly into the field. And they helped us design this study. Their fingerprints are all over it.

So it's a 366 trial where half of the patients get Quellor and half don't. So that's a big trial, at least for a small company like ours. And we are-- right now, we're focused in, you know, the South-- Tennessee, Arkansas, Mississippi, Florida-- and we're reaching into the upper Midwest. I mean, we're basically going where the patients are.

Now, unfortunately, you know, it's not like you can hear about, oh, there's a lot of admissions in Salt Lake City tonight. Let's have a trial open there by, you know, three days from now. It takes some time. But you know, because of the-- as you mentioned, because of the way the pandemic has rolled out, you can just about open a site anywhere in the country, and there's patients that need help.

ALEXIS CHRISTOFOROUS: Sadly, you are right. What about a timeline? I know that can be difficult. You're still in clinical trials. But when might you seek FDA approval, and when might we actually realistically see this hit market?

RAYMOND TESI: Well, yeah, once again, a shout out to the FDA-- I mean, the FDA has been very open minded. They never promise anything. But you know, they've used this technique called emergency use authorization to help drugs get to the market very quickly. You saw that with things like, you know, hydroxychloroquine, with, you know, convalescent plasma, with Dexamethasone, with the Gilead, Lily, and Regeneron drugs. Now, sometimes they give it and then take it away as the data changes, and that's OK.

So we expect to fall under that kind of emergency use authorization. So the faster we can get enrolled, the faster we have data to present to the FDA. And we know that they're going to give us a solid listen-to.

You know, I think-- you know, fingers crossed, and I-- maybe I shouldn't say this-- but ultimately, the vaccines are going to bail us out of this whole thing. And you know, we've had a lot of good news on the vaccine front. But you know, there's going to be a while before everybody gets vaccinated. There's going to be some people that don't take vaccines, which are always going to need drugs for treating the disease in the hospital. So you know, we believe there's a big need and will continue to be a big need for a while.

ALEXIS CHRISTOFOROUS: I want to talk about this treatment briefly and as it relates to your bottom line. If it were to hit market, is this something insurance would cover? Would it be given to patients for free and the government would be paying for it? Because I'm just curious. I'm sure investors are, too--



RAYMOND TESI: Yeah, we don't do free. I mean, we're a small company, unfortunately. I admire the companies that have done that. But you know, admittedly, they've gotten tremendous support from, like, you know, Operation Warp Speed. So you know, free, it's a relative free.

No, we would expect this to be available through insurance companies. You know, I was a clinician for a very long time, and I understand the payer situation. And you know, one thing that's great about American health care is that if you walk in the door of a hospital or clinic and you're sick, they take care of you and then they figure out how to pay for it. You know, there's a lot of unfunded care.

The bottom line, we're not concerned about patients, at least in the US, not having access to the drug. That'll happen. But ultimately, it will be a drug covered by insurance.

I can tell you, if you look at our business plan from three or four years ago, you know, COVID-19 wasn't on the radar screen. So if we are successful in getting this drug through the clinical trial onto the market, we're going to be a couple of years ahead of where we thought we were going to be. But we'll be doing a good thing because we'll be making a difference in patients that have COVID-19, which they need help. There's really no good drugs out there yet.

ALEXIS CHRISTOFOROUS: Aside from-- I'm looking ahead and staying optimistic and post-this-pandemic, what could a Quellor be used for? What's the use case?

RAYMOND TESI: Ah, so-- right, so you're asking what we can use beyond COVID-19. Well, so--


RAYMOND TESI: --because this treats a cytokine-- and it's called soluble TNF. Soluble TNF is involved in a whole bunch of different inflammatory diseases, chronic inflammatory diseases that, you know, they're the who's-who of problems. For instance, we have an ongoing phase I trial in Alzheimer's disease. Neuroinflammation causes Alzheimer's disease. We have a-- about to open a phase II trial in treatment-resistant depression, another disease that causes-- that's caused by neuroinflammation. We have an interest in NASH and cancer. This drug really can treat a lot of different things.

Right now, we're very focused on CNS, Alzheimer's and treatment-resistant depression. And this-- you know, this COVID thing, like I said, wasn't part of the master plan. But in March, you know, we kind of-- the board, we-- and I looked at it and said, you know, this is a problem, and we may have something that'll help. Let's throw our hat in the ring. And so we've been working hard to get where we are today.

ALEXIS CHRISTOFOROUS: All right, Dr. RJ Tesi, CEO of INmune Bio, good luck with the clinical trials. Thank you.

RAYMOND TESI: Thank you, Alexis. It was a pleasure.