Video Transcription
Jon-Paul Bogers 00:02
Thank you for the opportunity to present my life's work. So this story started in 2015 when, together with my co-founder engineer, we started thinking about solutions, or physical solutions, to treat patients with advanced cancer. My mother died 30 years ago from pancreatic cancer, and from my clinical practice, I knew that pancreatic cancer did not change that much over the last 30 years, or the treatment was approximately the same. So we thought, can we do something more? And it sounds a little bit arrogant, but we thought we could. So that's why we started in my lab at the University of Antwerp to try different methods of treatment modalities, using physical agents, not always believing—and sorry for the previous speaker—in chemical ways of treating cancer or combining it. I will definitely have to have a chat, actually, afterwards. So, and that's why we tried a number of things, and we ended up with heat, because heat was already known, even by Plato, but it was already known for years that heat could work and total body heating could work, and there were very good results in the literature that it did work. But the problem is that it was not safe, that patients had complications, that actually patients died in treatment sessions in Amsterdam, in Rotterdam, in the US, in a couple of sites, and that's why it stopped. So we said, "Okay, we have to change something," but we still think it's a very interesting treatment modality, and that's why we started ElmediX. So ElmediX is a company which will potentially transform pancreatic cancer. And well, I would love to leave out a potentially, but I have regulatory people, so we need to put that in—transform pancreatic cancer into a chronic disease. Pancreatic cancer has 500,000 new patients a year; almost all of them die within one or two years. But it's also a treatment platform, so it should be—or it could be—extended to more tumors. It could be extended to colon cancer, it could be extended to cervical cancer, it can be extended to melanoma. It can be extended even beyond oncological indications like serious depression. There is big data on that as well. So it's a huge market and almost never-ending market, and we have, at the moment, excellent clinical trial data, both on safety but also on first signs of efficacy. We have a very strong patent portfolio, with 37 patents in seven families. Most of the patents have been granted in most of the important areas in the world, and we have an experienced team. Well, you don't have to believe me, but the rest of the team is very experienced and good, and we have a very strong advisory board backing us to put us in pole position. And we are here to raise an A round of 15 to 25 million. So the team which we have teamed up is a multidisciplinary team of engineering, clinical research, medicine, medical people, regulatory, of course, finance, mathematical modeling, AI—we can do anything in the team. We are not that big yet, but we are very versatile. We are also backed by a very strong advisory board. So, an International Advisory Board, all the key opinion leaders from the US, from Europe, and from Southeast Asia are in our advisory board. And all the people who are actually writing the guidelines in the US, writing the guidelines in Europe, are members of our advisory board, and very active and enthusiastic. This is the device. And for someone who wants to see it afterwards, I have a film, a very small cartoon that shows how it works. But so it's a device which is—this is a prototype device which is now used for the first-in-human trial in the University Hospital in Antwerp, which we are at the end of. We improved it a little bit for the next version. We are opening up now for a Phase 2 pivotal trial in three Belgian hospitals. The University Hospital of Antwerp has already signed; one larger regional hospital is almost ready, and I have a meeting with Gasthuisberg, that's the largest university hospital of Leuven, on Monday. So I hope we can all get them in to do the next trial, which we would do 13 to 30 patients in a Fleming two-stage design to boost and to look at or confirm the efficacy data we have up till now. So what we have from the first-in-human data? We did 12 patients. We have very strong safety data. We didn't have any serious adverse events related to the procedure. We only have some fatigue after the treatment. We have patients—one patient surviving 18 months after treatment, 15 months after treatment, 11 months after treatment. The mean overall survival of these patients is six to seven months after treatment. So from the patients we have treated, most of the patients with pancreatic cancer have already extended way above the mean overall survival that would have been expected for these patients in this specific state. We are using blood-based markers like CA 19-9 to follow the treatment of the patient. We see that they drop down very rapidly, that they stay down for at least 100 days after treatment, and we see that the disease stabilizes at imaging. So we bring these patients from progressive disease to stable disease; they will keep them in stable disease for at least two to three months after the treatment. And for the rest, we don't have follow-up data yet, but that's something which we would like to get in the next trial. The science behind thermal therapy is very old. We still do a lot of preclinical work. I'm still a university professor. I still have PhD students. So I have three PhD students now working together with the University of Antwerp on the science behind this specific thermal treatment; we find new things. There is a lot of data already out there. It's a very multi-target way of working with enhancing the immune system, making cancer cells visible to the immune system, reducing the stroma, even direct cell killing effect, and synchronizing the S phase of tumor cells, which is very interesting from a theoretical point of view. The business model is based on the recurrent sale of a disposable sensor kit. So to make the treatment safe, we have developed proprietary sensors. These sensors are sold in a kit form. These kits are one-time use only, so they are disposable, so we can—that's the business model. The device can be sold, leased, even rented to the hospital, and this is the way how we think that a modern cancer treatment center will look like in the next coming years. So it looks a little bit like a dialysis center. So it's a number of beds where patients are being kept in a hypothermic state during a number of hours while under supervision of one or two medical doctors and one or two medical nurses. So that makes it also financially sustainable for the hospital. The investment proposal we would like to put on the table is we are looking for an A round to finance the next phase of the next trial. You see Use of Proceeds here. But of course, this is more for demonstration purposes. Well, for the exit, of course, there are multiple ways, but the two most important ones for all of us, I think, are the same: trade sale or IPO. So in conclusion, ElmediX is shifting to the next phase of clinical trial. We really want to put this method on the planet. We think it is a very underutilized way of treating patients, not only for cancer treatment, but even beyond cancer treatment; it's a very interesting and innovative, but still old, and underused way of treating patients. We have excellent first-in-human data. We have a platform technology that can be expanded to all kinds of other tumors. We have strong protection with a strong patent portfolio, sorry, patent portfolio. And we have a very strong team to make, together with you, we hope the next European unicorn. Do.
