 Today, I'm speaking with Dr. Colleen Delaney of Coeptus Therapeutic Holdings. And she's got a lot of very interesting things to tell us. And since this is a very technical field, all I'm going to say is that I am thrilled to hear anybody and I've read your company's material as far along in treating cancer as you are. And I'd like you to tell us in simple terms, because the audience here are ordinary people. What is it that your company is doing and hopes to accomplish? Yeah, first, thanks, Jack, for chatting with me. I could talk about this, I could go on and on talking about all the really cool things that we're doing. But let me try to, I'll try to make this very high level and then we can dig in deeper as you see fit. So effectively, I think most of us know who have had cancer or seen the side effects that cancer can cause with the chemotherapy regimens and the side effects and you know, many people don't survive. I'm a pediatric stem cell transplant physician, pediatric oncologist by training. So I have lived this for many, many years and my goal has always been to really develop therapies that I felt would be accessible to anyone who needed them. One of the really cool things we're now seeing in the field of oncology and treatment of oncology and other types of diseases, autoimmune diseases and infectious diseases is the use of cellular therapies. And when I say that, what I mean by that are living drugs. So we are taking healthy functioning cells and trying to replace diseased or non functioning cells within the human body. And this has proven to be incredibly effective. Many people, even if you're not in the field, will have heard of immunotherapy or CAR T's. So we know that those have been transformative. What we are trying to do is really turn that whole thing on its head. While CAR T's or immunotherapy have been transformative, they are not from my standpoint as a physician scientist, I would say that they are not uniformly accessible. They are very expensive to make and to deliver. And really our goal is to utilize a platform that I developed from my years back at the Fred Hutch Cancer Center where we can generate cells almost of any lineage that we want. We can make a white blood cell, we can make a red blood cell, we can do all of these different things. And we are creating the means to generate cells, immune cells, that we can give to anyone regardless of who they are or where they are. So what we are trying to do is say, okay, this is transformative, but I want to be able to make that therapy and be able to stockpile it effectively, like going to your bathroom cabinet and pulling out a jar of aspirin, right? We want physicians to have access to these therapies that are immediately available to their patient, regardless of any kind of tissue typing or where they are and make them easy to deliver. And we've really started to do just that. And how far are you from having a therapy and a treatment that anyone can go to see their local oncologist and they'll have heard about it and it'll be accessible. Now, I've had a personal background in clinical trials and things in the study of them, not in participating. And so I'd like to know the timing here because that's very important for investors who are of course interested in a return on their capital within their non-diseased lifetimes. So can you give me some idea of where you are in the development of a saleable product or a licensable product? Right, so something that makes it all the way to FDA approval is really what you're talking about. Now, some of that, and I'm not trying to get out of addressing that question, but some of that really does depend on the cancer you're treating. So for example, if you are treating a cancer or a patient who has a certain type of cancer where they have already tried everything else, and this is their last-ditch effort, right? Those trials are going to be smaller because that patient really has certain death versus maybe a therapy that can save their life, right? And that's what CAR-T has done. But those trials to reach actually FDA approval can be single-arm meaning, you know, because really who wants to get randomized when you're at that point, right? So some of these trials can be single-arm trials, low numbers, and you can get there fast. But let me back up a little. We are already at the stage where we know exactly how to make these sales, right? We have been doing this, my group has been doing this for 20-ish years now, right? If you go back to the beginning of when this platform was developed, we have developed a number of products along the way. And what coeptus is doing is really taking that immune effector cell platform. And when I mean that, I'm talking about natural killer cells or monocytes and macrophages that we can engineer. We already have two INDs that have been approved by the FDA. Now, that's not a drug approval. That's an approval to do your clinical trials. I just want to be clear about that. But what is very interesting and unique about this is, again, back to that idea of making this accessible, cost-effective, reliable. We are the only company that's doing pool donor manufacturing, right? So we have optimized ways of combining donors. So we have ultimate scalability. We already know how to make them in a very cost-effective way. We can freeze them, right? That's pretty important. You need to be able to freeze them if you want to deliver them globally, right? They need to be able to be sitting in the doctor's office. So we are currently in phase one trials with our natural killer cell product. And we are in the preclinical aspects of engineering these cells to make them even more universal and target more cancer. Are the raw materials for you the available readily? Or is there going to be a limit on how much you can produce? No. And this is, thank you for asking that because this is the other, well, what I see as a beauty of our approach. So we start from what I would say is the healthiest source of starting material, of cellular material, and that is umbilical cord blood. So many of the listeners may have either had a child recently or about to have a child or, you know, know someone and you'll hear about private banks. That's not what I'm talking about. What I'm talking about are the public banks. So there are a number of banks across the United States that already have this system all in place. They are FDA licensed. So these are actually drugs, right, in the eyes of the FDA. And what's great about that is our starting material is the only source of regulated starting material. So unlike if I wanted to go to you, Jack, and say, hey, I want to harvest you just to make a whole bunch of starting NK cells, right? I want to take your blood and then make a whole lot of natural killer cells, right? I have to test you for all sorts of viruses and all the things you've been exposed to in your life. And many of those things right there are viruses that I would not say are clinically relevant, but we've all been exposed to them. And some with cancer, it might be a problem. Cord blood is really considered to be naive for all of those things, right? So it's a clean source of starting material. It's sitting frozen, already donor eligible in a cord blood bank. Our cord blood banking partners are continuously collecting and it's an endless supply, really. Right. It's a cost effective, highly regulated, already in drug in the eyes of the FDA source of starting material. And it's a very proliferative source of starting material. You've told me now, okay, that you are in a situation in extremis where a patient has, there's nothing left. They can request a trial of your material, okay? But tell me, if everything goes well, when will this be available across the board, at least in civilized countries? Go to your doctor and ask for a dose, right? Everyone would know about it. So I think the time to FDA approval for unmodified therapies, right? So one of the things we're talking about doing is expanding access to viral indications, right? That therapy's already been in the patient, right? So this is really around a phase two, phase three. And I would say that the earliest we would be to FDA approval would be somewhere around three years, right? If we get these studies done, get the resources in, get these studies done. It could be as early as three years and it could stretch out to about five years, right? Well, let me ask you a follow up question. How confident are you that these products will be approved and will be on the market in three to five years? Whatever the time frame is, because it's very common in academic research to have things not go as planned, okay? And in this case, you've formed a company, you've got a company, okay? That company is going to have constraints of time and finance and it's got to start generating revenue within a time frame, okay? How confident are you that these products will be able to be brought to the market in five years? Yeah, and say five years. I mean, I wouldn't be talking with you if I weren't confident about that. So I think really, I'm extremely confident. I think what this platform has that many other folks and many other people who are just starting out in this field don't have, is we have about 15 years of predecessor clinical trials, not with NK cells, but that product that's been put in over 300 patients, that's basically our starting material to make our immune effector cells. So this is one of the reasons why I have so much confidence, because I think the hurdles that are many people are facing today are things like, oh, I've got this great new target, but I can't make my cells reliably. We already have all of that done. So our CMC, we call it our manufacturing abilities, is already tried and true and developed and been seen by the FDA. That's the biggest hurdle. Let me add one more thing. Manufacturing of pharmaceuticals, which I'm familiar, is extremely regulated. And the expense of such a facility is not the equipment, it's being certified and maintaining that certification. Now, I believe that your CEO has this background in manufacturing, background in pharma. Is that correct? Yes. Okay, so that's a big plus. Yeah. I just wanted to say something. I'm very interested in this, and I'm going to follow it, because I read your website. I was very impressed by your advisory board, okay? And I have a question. I see that you're dealing with the Karolinska Institute in Sweden. Are they just advisors, or have they done R&D on this topic? They've absolutely done R&D, because some of that, so really what my platform has brought into co-optists, with me joining co-optists, that has been that self-factory piece of it, that reliable way to make cells that I can give to anyone. The Karolinska Institute has really defined some of the things you see on our website around how we will better make those cells really potent killers, and effectively get them to do their job better than what a naked cell would do. And then we also are working with the University of Pittsburgh, but now we can bring all of those things in-house, and we have full capability here to do all of our own R&D with scientists, our process development, and bring all that to the clinic. Thank you Dr. Delaney, and quite frankly, I'm very much looking forward to following you, because it's not just about investment, it's actually about life and death, and I find this very interesting. Thank you again. Yeah, thank you for talking with me, and thanks to everyone who's listening, and I hope you all follow along. We have a lot to do.