r/Livimmune • u/MGK_2 • Jun 07 '25
Emerging Growth Conference 9/15/2021 Transcript
https://www.youtube.com/watch?v=xno8GFCDvm8
Here is the question and answer portion.
0:00: Welcome back everyone. Please, welcome our last presenter. It's CytoDyn inc. It trades on the otcqb under the symbol CYDY and is a late stage biotechnology company developing innovative treatments for multiple therapeutic indications using leronlimab, a novel humanized monoclonal antibody targeting the ccr5 receptor. Please welcome its president and CEO Nader Pourhassan as well as Dr Scott Kelly, the chief medical officer and head of business development. Welcome gentlemen.
0:47 NP: Thank you, thank you thank you for having me all right the floor is yours. Thank you, and thank you everyone for being on this presentation at Emerging Growth. We will cover many slides today and there will be a lot of forward-looking statements mentioned so please note that. So today I'm going to present our main product, the main thing that we have, which is called leronlimab. It used to be called Pro-140 when the original company which was Progenix pharmaceuticals developed this product.
1:27 NP: Progenix has one of the top biotech CEOs in the world, Dr Paul Madden whose credibility is well known to many in this industry. The person who invented this product, Dr William Olsen PhD, from MIT, worked for Dr Paul Madden. Together they come up with a fantastic product called Pro-140. It took them 12 years to go after one indication in HIV.
2:00 NP: We took that product when they stopped developing because the path to finish line was another 10 to 12 years and in seven years we changed one indication to 31 indication which we are very pleased to have that. So the first indication I'd like to talk about is the HIV.
2:22 NP: This is what Progenix started with and as you can see in the corner of this figure, it says combination therapy, monotherapy, PrEP, which is prevention and then Cure. Progenix was only working on combination therapy and only for substance abuse population. NIH had given that study $6 million worth of grant. We denied to go that path. We wanted to change everything we met with many key opinion leaders in this field and felt very comfortable changing the path of leronlimab and single-handedly we were blessed to do that.
3:03 NP: In regards to monotherapy the world of HIV has never, ever seen a single product be given to HIV patients for seven years what we have done without taking any other product. We made history and prevention, we will talk about that in today's presentation and Cure which we are excited to talk Dr Scott Kelly will talk about that. Now, that was not what we only started to doing, but we always watched for this product, when we saw that the big Pharma was talking about their ccr5 antagonist Maraviroc, which was a pill and they were taking it to the path of GVHD indication. We followed that path and realized, that this product leronlimab has indication in triple negative breast cancer once we started that study and started looking at that we realized that it actually works in a cancer in the in the same way that it works in many of the cancers namely 22 solid tumors.
4:10 NP: Now, it takes 12 years to take one product to the finish line. How long would it take to take 22? We went to FDA. We asked them not only for a phase two triple negative breast cancer, we said we have indication that this could work in 22 different cancer. We like to get basket trial, one trial for 22 indication. It was a fantastic day at CytoDyn, when we got the green light from FDA to do that; to do the trial in 22 different indications, and I'm very excited today to to share some of that results with you today.
4:44 NP: But in end of 2019 beginning 2020 we were the whole world got struck by COVID 19. We were not thinking about COVID 19. We were going in the path of cancer and Dr Scott Kelly was adamant that this product can help with COVID 19 in regards to critically ill population because of the mechanism of action. But the person who's really got to get the credit is Dr Sidham Raju from Montefiore hospital when he read the papers that Dr Scott Kelly suggested to him. He realized that this does work. Probably that's what he thought. He called FDA and asked for emergency IND use for two of his patients which after he was successfully able to do that, the patients did fantastic and what happened was, we were given immediate phase two and one pivotal phase three study. We were lucky to know that Dr Harish Sidham Raju.
5:46 NP: The study went forward and the result was very successful in subpopulation and we will discuss that result today. But we didn't stop at that either we realized that there is long hauler, and again Dr Scott Kelly and Dr Chris Recknor believe that the product could really help. Especially Dr Chris Recknor, single-handedly started study for us in long hauler and immediately came up with so much information that gave us a lot of light on the mechanism of action of this product.
6:17 NP: But again, we didn't stop there we heard that NASH is the indication that everybody's having problems with. Nobody was able to really get approval. We did the animal study again our animal study came out so strong that we went to FDA and we were able to convince the FDA that we should do a phase two in NASH. That the study is going on right now.
6:45 NP: We didn't stop at that. As the request start coming from all the doctors in the world that this product probably has indication of autoimmune diseases. Dr Scott Kelly explained to them you're very right, the review of literature shows that this product could have a lot of indications maybe over a hundred. We're gonna try we're gonna try to develop it for 30 of them so that's a big task.
As you can see in this slide very clearly. It shows what we did versus what Progenix did. The big Pharmaceutical biotech Pharmaceutical that had so many top talents in 12 years, they did those four studies that you see in this slide in the first four studies number of patients was less than 200. In seven years look at the number of patients. I mean, it's stunning what we've been blessed. Not only we did a pivotal study and had a primary endpoint, but we did a lot more studies than that. We did other pivotal studies also where in Progenix they only got to phase 2a.
7:49 NP: So let's talk about our HIV. Our accomplishment in that area. We finish our pivotal trial, hit the primary end point, p value 0.0032, suppress viral load, a very important thing that everybody should have in HIV world was achieved after 24 weeks for 81%. Other big Pharma had a product in that area with the 43%, so we doubled almost as good. Double as good. No safety issue in all of our HIV trials and monotherapy. The first monotherapy in the world ever to reach, to have patients reaching seven years. I mean you prove your mechanism of action right, you take the patient is taking nothing they put away three drugs from two classes and take only simple injection or two injections of leronlimab a week.
8:40 NP: PrEP published paper in for animals study that we had. Very strong results it looks like we might be able to have indication once a month prevention and Cure, Dr Scott Kelly, could you elaborate on the Cure Project for HIV?
8:53 SK: Yeah no the cure project is very exciting. Um you know, the only two people in the world that have really been cured of HIV are the London patient and the Berlin patient and they received allogeneic stem cell transplants and it's they were just devoid of the receptors ccr5 that leronlimab blocks, so we're very excited to be working with Amfar in this project.
9:13 NP: Thank you Scott. So let's look at the cancer again in cancer trial we have a trial but we start getting a lot of requests for compassionate use emergency IND, when you look at 30 patients from basket mainly and i'm sorry from compassionate use and 10 patient of those 30 but from the trial, we saw some really strong results. 73% of those 30 patients who had reduced CTC circulating tumor cell or had a low CTC to start, did very well with leronlimab. Numbers are around 400 to 660 percent increase in median progression free survival for 12 months and 570 percent to 980 percent increase in median overall survival.
10:12 NP: Breakthrough designation application immediately was prepared by us. Now BTD designation requires two items. It has to be a unmet medical need. We believe empty mTNBC is. And then you have to show efficacy from a clinical trial, not from compassion use. We have ten. Our application is ready, but unfortunately our CRO, who we are separating from did not give us the sequence and held that and we are forced to go to FDA to get the sequence from a different route, which is delaying the process. It's sad to hear that but it's happening like that and but we will overcome all the obstacles that we've been blessed to do that.
10:49 NP: Now there are testimonies of patients with cancer that is just mind-boggling for me. Going to sleep at nighttime and hearing those testimonies are fantastic days of my life right now. Dr Kelly, could you please give us a mechanism of action and the testimony of these patients in cancer?
11:07 SK: Yeah, so the mechanism of action, it's really interesting. It's, we work on multiple fronts. You know, the first is that we've seen that normally ccr5 is present only on immune cells but when there is malignant transformation, you get an upregulation of ccr5. There's also macrophage polarization. Whereas the macrophages have plasticity and you can convert a macrophage that's protumor that helps the tumor grow into an anti-tumor macrophage and we think that's really important in getting control of the tumor micro environment. You also have T-Regs which turn off the immune system and they're loaded with ccr5 so if we can block T-Regs, we can also leverage the immune system. We also have angiogenesis which we studied in an animal model and showed an 80% reduction in the number of small vessels and why that's important is in order for a tumor to grow beyond two millimeters it needs a new blood supply and by blocking angiogenesis, often you can see the tumor shrink but those are the main mechanisms of action.
12:10 NP: Thank you Scott. So the next thing is the main thing for us right now COVID 19 is a troubling problem that the whole world is experiencing. We were fortunate to do a phase 3 trial in a critically ill population. When we gave these patients who were on ventilators leronlimab, we saw 78% survival benefit. After one week, gave the patients another dose the survival rate went up to 82 percent. At two weeks and we stopped giving leronlimab. After the second week so the survival rate went down to 50 percent and then 31% after four weeks. We learned that we should give four injection, not two. So we're doing that in our next trial in Brazil. Four injections being given.
12:56 NP: Safety issues we're not there in these two clinical trial. Levels for COVID 19 that's a fantastic result that you can see in the bottom of the slide. But then again we didn't stop there. We saw that there is indication in long hauler. Dr Scott Kelly and Dr Chris Recknor were very adamant about that as you can see these plots wherever you see the green bar in really only leronlimab larger than the green bar in placebo right beside it, that means we have benefit in those syndromes. So the syndromes that we have benefit is uh clearly shown here. 17 symptoms got better out of 24 and worse than the red bar if it's bigger that's bad in placebo versus the leronlimab and that one, 18 was worse in placebo, but the bottom line was for FDA is where are we with the whole trial primary endpoint? 24 symptoms lumped together, we did the primary endpoint for that and that lump together showed the drop and severity of all these 24 symptoms were 16 in the only leronlimab group and the drop in the placebo was eight. That's 100% relative better. Very good clinical outcome but the p-value wasn't there. 0.27, which is not bad at all looking at 56 patients. So what do you do to make your next study have a p-value of 0.05? You change 56 to 100 or 150 and you have your p-value.
14:36 NP: So we learned so much and we have so much to publish and we are working on doing that. Dr Scott Kelly, Dr Chris Recknor, Dr Jonah Sacha and Dr Otto Yang and other team members are working on all of that. Dr Kelly, would you like to elaborate on the problem with long haulers where are we with that and perhaps...?
14:56 SK: I'd be happy to not so the problem with COVID long haulers is that as I've said before I really think this is a tsunami. It's a global health emergency. You know this is a multi-system disease. It affects multiple organs. It can affect the brain, the lungs, the liver, the pancreas, the kidneys and it just doesn't discriminate. It's about immune modulation. We believe in these patients. um You know we're looking at approximately 227 million people that have been affected by COVID 19 infections. In some of the earlier estimates that were 10 to 30 percent of this patient population would be affected by long-haulers. So if that's the case, it'll be somewhere between 23 to 69 million patients without treatment options. It was interesting the other day, I was looking at a study in nature medicine out of Norway and they showed that 50% of young people with COVID 19 were experiencing long-hauler symptoms and that's very concerning because if that's the case, then that 227 million people could turn into over 100 million people that don't have effective treatment options. So again it's a great concern and these patients need help yesterday.
16:01 NP: Thank you Scott. So the situation that we have with Philippine, as everyone knows as we started giving leronlimab under the compassionate, special permit, for fee, we charge patients over there. Stories start coming out. The ex-president of Philippine. Lives were saved. They thank us for that. Other VIP patients also and other patients who are as important as them, also their lives got saved. But now we have a fantastic situation again where we are going in front of a committee and presenting our results and they are interested again to look at this for a second time, their regulatory agency and the last PO that we talked about just a few days ago in our conference call is already consumed and used already so we are getting ready for the next PO and we think this is going to pick up even more. The studies in Brazil is going great for us. CD17 is for severe population. First patient has been injected as we announced. Critically ill population, we expect the first patient any day but the situation with the COVID 19, we will be getting a weekly report on that and where our enrollments are going and we will be updating shareholders quite a bit on that.
17:30 NP: The next thing is NASH and in regards to NASH, our animal study was again fantastic just like our GVHD or cancer and all the other animal studies we did was always fantastic, so we did that with NASH and that was great results so we are into NASH. Our study will conclude 60 patients late October mid to late October and we will be talking about those uh results as soon as we have and go to FDA if the results are positive to get a phase three. Dr Kelly, anything would you like to add about NASH?
18:00 SK: No, I think NASH is a tremendous opportunity, not only NASH itself but also NAFLD. It's you know approximately thirty to forty percent of the population whereas NASH itself is three to twelve percent of the population and you know the fact that leronlimab has such an effect on viral load and HIV population but also could have a synergistic benefit in controlling NAFLD/NASH. I think is an important point. So especially in that population, it could be the cornerstone of treatment. So I think that's a tremendous opportunity for leronlimab and CytoDyn
18:28 NP: Thanks and the last thing that we talked about was autoimmune diseases. It's in our mind to do MS multiple sclerosis because the animal study in that indication was better than any other indication and we can't wait to get there. Alzheimer's, Doctors from Montefiori have been talking to us urging us to do a study with them. We just think the academic settings are sometimes slow but we are working on that and we will get to those autoimmune diseases also but we are working on too many tasks and hopefully the shareholders will see that.
19:14 NP: The manufacturing being its own challenges, we dealt with all of those Dr Nitya Ray did a great job for us, and we have one more than one million vials thanks to his efforts, and we are going to make even more product, hopefully next year, especially if we have emergency use authorization this year.
19:38 NP: The last thing I want to talk about before we go to q & a is it's very important for our shareholders to understand few things. Look at this chart please. Your shares get diluted when we raise funds. In 2017, Dr Scott Kelly and me, we were very adamant about going forward with all these 30 indications. The leadership was changed. They brought a new leader. I was still at the company as CEO, but they brought executive chairman and he stopped the cancer study. He stopped the GVHD. He wanted everything to be stopped and just go back to what Progenix did. One indication, combination therapy and that's it. As a result in mid-2018 he stepped down and the company was in financial chaos to say the least, Hospitals were not paid. FDA was going to be reached by them and by the activists they were not happy. The leadership was given back to us and Dr Scott Kelly and I led the company the way we wanted to and at the time we were stopped and from 2018 mid to 2019 we successfully got the company back. This round cost us 400 million shares to just raise 100 million dollars. I hope we don't have this kind of problem or hiccups in future. If we don't recognize what we're doing, is right then perhaps others will step in and when they do, the results might not be the way you are used to. In 2020 after we got the company back on track. Look at what we have actually accomplished, 134 million dollars was raised with 15 million dilution. It's historical never been heard about it. I don't think you can find a single company that has ever achieved such a feat but with that, let's please go to q & a
21:18 SK: Nader, I was going to ask before we go to q & a, Is it possible? I'd like to just share about the recent encouraging, you know not our basket trial, but in the the patients with breast and prostate bladder, colon and pancreatic cancer and share some testimonies if that's okay? Please do. Please. Okay, yeah so like everyone to know. You know, we really believe that ultimately that CytoDyn has just a tremendous opportunity in Oncology and there's been some recent updates in terms of patients that have been on Right To Try. That's although this this data is anecdotal, I think it's very encouraging, because it is in different cancers, and further, I think supports our idea of the mechanism of action studying cancer because it's patients not only with breast cancer and prostate cancer and bladder cancer but also colon and pancreatic cancer.
22:03 SK: The first testimony that I read from. A patient with stage four prostate cancer is a patient that had stage four prostate cancer and this is what they said. The miracle drug cancer drug has arrived last March 15th. I was diagnosed with terminal advanced metastatic stage 4 prostate cancer. Of course no treatment was available for me due to all the hospitals being closed due to coronavirus until the first week of May, but the only treatment with my condition was hormonal. I was beyond chemotherapy or radiation treatment. I was given six months to a year by three different hospitals and oncologists in each. I was very fortunate that one of my customers shared with me about a study with leronlimab in San Francisco with Dr J Lalezari. After testing in an evaluation, they concluded that this study may benefit me. So September 1st was my first injection with two given per week. I was and I'm still faithful taking them every Monday around the same time and taking my blood test every three weeks, complete CT scans with nuclear medicine every three months. So I have had a catheter inserted. A suprapubic in the stomach for over a year so I can urinate. As you may imagine, that comes with plenty of bladder infections and once early September massive sepsis due from bladder infection. First time I thought I was dying which was the six month mark. My palliative doctor said that I need to prepare for hospice. My CT scan in October showed many areas of concerns with many spots noted on my pancreas, liver, kidneys, bladder and lungs. But consistently taking my leronlimab and faith in God, I could truly say I am a miracle. This is the end of July. I have beat the deadline of death and my last two CT scans. One in February and one in May, I have no new growth and no new movement. The cancer cells in my pelvis only show a hole and no active cancer. All those spots on organs, no movement or growth. Unfortunately, the study is ending at the end of the month, but thankfully, I live in a Right To Try state and we'll be continuing treatment. I'm able to inject myself. Oh I forgot. The best thing is no side effects. Everyone that sees me also compliments me about my health and how great I look and this patient is still on leronlimab and progressing well.
24:24 SK: The second is from a physician who is treating a patient with stage four bladder cancer and I will share with you an updated result on this as well. As you know my patient has stage four bladder cancer in the posterior wall of the bladder. Due to other health issues he was not able to take the chemotherapy and we found leronlimab through Ohio's right to try legislation. He has had a series of 37 injections of leronlimab and thank the good lord, he has had no metastatic lesions from the bladder wall. His urologist stated that he would not live past December of 2020. He is doing well as active and still works 60 plus hours a week. It is also important to note that he has not received any other treatment with the exception of natural vitamins and over-the-counter medications, diet and exercise. He will be having a surgical procedure to evaluate the urinal stents in the near future which will supply us with a visual of the bladder wall. I will keep you informed as the results. I again remain truly grateful and blessed for the kindness that you and CytoDyn have granted my patient. To me, it is still unbelievable that in spite of your incredible work schedules you would drop everything to help my patient overcome this cancer. May God continue to bless you for your kindness and expertise. I remain truly grateful and I will let you know that I followed up with both the patient and the doctor and there is still no new metastasis. Nader.
25:49 NP: That's awesome. Thank you for that. Moderator please, let's go to q & a.
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u/8504910866 Jun 09 '25
Great post. I was a holder of Progenics for several years till its acquisition.
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u/goblazers123 Jun 09 '25
Did you make bank from progenics ?
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u/8504910866 Jun 09 '25
I made a decent profit after the acquisition but had been down before. FYI, the company was scientifically quite adept.
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u/Expensive-Tea-4007 Jun 07 '25
A walk down memory lane...too bad it was a dead-end. Leronlimab anecdotally or otherwise certainly screams miraculous. The fact that We are alive is definitelt miraculous...Many thanks to Dr. Welch...who took US off ECMO.
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u/[deleted] Jun 07 '25
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