Video Transcript (met her en der wat fouten, maar op papier, dus na te lezen).
ADAM SHAPIRO: Let's bring you some good news. And our fingers are crossed because the CEO and president of CytoDyn, Nadar Pourhassan, is joining us to talk about what could be a potential breakthrough medication to treat people who are having respiratory difficulty with COVID-19. Thank you for being here.
You have an HIV drug that is doing what? Because we know you're in clinical trials for COVID patients. Nadar? I think you have to unmute yourself. If you're on the phone, hit star. Six
NADAR POURHASSAN: OK, can you hear me now?
ADAM SHAPIRO: Yes.
NADAR POURHASSAN: Perfect. OK, sorry about that. So, our product, leronlimab, which was referred to as PRO14 in past publications, has done very nicely in the clinical trials for HIV combination therapy. So the mechanism of action is that it binds to CCR5.
Now, people with COVID-19 die because of cytokine storm, which all have CCR5, same receptor that we bind to to stop HIV. We have done over 840 patients with zero serious adverse events attributed to the drug. So, being a product that has hardly any toxicity or side effects, that was a very big start for us with the FDA, when we said that our scientists believe we can stop cytokine storm, which that's the reason people die, because of ARDS, acute respiratory distress syndrome.
So when the doctor from New York believed in this product and they gave it to some patients, immediately, he wanted to give to two extra patients after the first two-- the first four, two of them extirpated. One of the patients was alert immediately and extirpated himself, got out of the ventilator, got out of ICU. Then he wanted to give to more patients. Immediately, he gave to four more patients and then two more patients. So now we have 10 patients that are taking this.
Now, the result of severe patient population for COVID-19 from China, one of the studies showed 31 dead out of 32, 97%. So now we've got 10 patients. These are anecdotal results. We communicated with the FDA. The FDA was very good to us, to immediately give us a phase two randomized trial for mild and moderate case of coronavirus.
But now we just announced this morning that we are starting a phase 2b-3, which we believe it could be the final study for a severe population of COVID-19 patients.
Now, this could be very, very interesting by coming Thursday or Friday because we will now get the results of the patients from day zero and day three. Already, the results that we got from the first four patients-- all four patients are immune-- have an immunological benefit, which was a very strong result for us. Our doctor, Dr. Bruce Patterson, former Stanford professor, Stanford University professor, is very, very happy with the results.
JULIE HYMAN: Nadar, this is Julie Hyman. Thank you for joining us. So, we have seen the stock in your company just skyrocket because there has been, of course, a lot of desire on the part of investors to look for solutions to this issue. The stock's up today. It's had an incredible run this year thus far.
But talk me through the financials of this. A company like Gilead, for example, which is a much bigger scale, looking at some similar treatment. What's your ability to manufacture and monetize this product if, indeed, it gets through the clinical testing phases?
NADAR POURHASSAN: So, not because our HIV success, but because of all cancer patients success-- as Fox News reported a few days ago, the oncologist on the Fox News said that I am a triple negative breast cancer oncologist. This product has some very interesting results in oncology. My own mother-in-law has breast cancer and is taking this product right now. And she's alive because of it, in my opinion.
Having said that, a year ago, we went to Samsung Biologics in South Korea. And we said, we need a tremendous amount of volume of this product to be produced. Samsung looked at our data room and said, wow, you guys really could get approved. The FDA had said that they didn't give us orphan drug designation because they thought we were going to sell to more than 200,000 patients.
So Samsung deferred the payment for this little company that we are and allowed the production to go forward, thank God. Now we will be able to get a tremendous amount of manufacturing product as needed starting April or May. We do have about 40,000 vials that we could make available. 30,000 is available now, 10,000 is being available shortly.
And we are talking to our manufacturing in the United States, which is in Seattle, AGC. They are working to do a six-run, immediate run. We really believe that the 10 patients that we just injected, anecdotal results that will be coming out very soon for all of them, the first four was spectacular. And we are planning to manufacture as much as we can.
And we just closed on $15 million at $4.50 conversion rate when our stock is at $2.80. So people in the finance community are believing that they need to get behind us. And we're getting quite a bit of offers of funding from different sources for our company.
ANJALEE KHEMLANI: That's wonderful news. But-- this is Anjalee here. Looking at what Gilead has had to go through on their own HIV drug, with having to rescind that orphan status because of all the criticism about taking advantage of the situation financially, they might be able to sustain that type of manufacturing and production, and sort of, in some degrees, donating their drug out there.
Are you able to sustain that? Or what are your plans to avoid high costs of this product?
NADAR POURHASSAN: So the cost of the product is pretty low for us. This is the humanized monoclonal antibody. Gilead's drug was antiviral drug. And given compassionate use, they had the problems that they had.
We gave two 10 patients. That's all. And we saw the results that we've seen so far, anecdotally. If we give this 75 patients-- that same doctor in New York called us yesterday saying that this protocol, randomized trial, I would enroll in one week. They need this data. They need patients to be able to stay out of ventilator and be able to get off of ICU.
If we can enter all the patients with 75, that's two-week trial. That's 75 times 250 doses. We have 40,000 ones. So we're going to finish that trial, randomized trial. We're not doing compassionate use. The compassionate use was for only the 10 patients.
ADAM SHAPIRO: Nadar, I just want to reiterate some of what you've said. First, is it a one-time inoculation or use of the drug per patient? And two, in a best case scenario, when is the quickest you could have approval to start using this drug for people who have COVID-19-- again, best case scenario, quickest?
NADAR POURHASSAN: The last thing I want to do is guess what the FDA would do. But they have been great to give us a phase 2b-3 just as of today for a final approval, I believe. So hopefully, we could see approved in six weeks or so if the results keep coming as fantastic as it is. That's my best guess.
ADAM SHAPIRO: And it's a one-time shot you need? Or is it recurring?
NADAR POURHASSAN: Two weeks. One week would be one shot. And then another shot after that. Then two weeks, we see the efficacy within 14 days. We see efficacy, we are on to immediately go to FDA and talk about approval.
ADAM SHAPIRO: All right, Nadar Pourhassan is the CEO of CytoDyn. We wish you the best. The whole country is counting on you-- more than just the country. And we wish you, again, the best with this.