Josef Christensen Presents StemMedical at LSI Europe '23

Transcription

Josef Christensen  0:05  
Thanks for coming. So StemMedical is a cell therapy biotech based in Denmark with us, I hope I'll show you guys now a fairly versatile platform. So our secret sauce is a proprietary IP protected mesenchymal stem cell manufacturing platform capable of producing 12 to 16 billion mesenchymal stem cells per batch per patient, which I would venture is unprecedented in the field. We do currently, so at 10,000 euros per batch, which was also ventures industry leading, but we actually have a very defined roadmap to 3000 euros per batch, within the next three, four years. And that's just depending on scale. When you harvest at the 1516, we do so at stellar quality, meaning high viability and high vitality of the cells that has translated to ask getting a 48 hour transport validation, meaning that we can cover all of Europe and the Middle East. Now, where's that platform then applied in the real world? Well, we do so in in two branches. First one being in plastic surgery under the brand name stem form covering reconstructive surgery and cosmetic surgery. The second branch being arthritis of the knee under the brand name stem treat. I'll get back into the status of those applications in a in a second, but I just want to highlight the broad applicability of unsinkable stem cells in different indications. Some of them are listed here already. And indeed, We have already been approached by by both companies and hospitals, asking if we can produce mesenchymal stem cells for them, for skin burn victims and wound healing. So we're actively also thinking of doing sort of an scmo leg. But let's go into the first application, which is in plastic surgery where we have a natural filler on the market. And so as a plastic surgeon, a lot of what you do is replace lost volume. So this could be in you know, a female cancer patient that have had a breast removal and mastectomy, you could also be in a traffic accident accident victim that has damages to to the face, a lot of what a plastic surgeon will do is replace that lost tissue that lost volume. Typically, that's done by day, if it's if it's breast by an implant, if it's the face, it's using artificial fillers, such as wrestling. But increasingly, the field is moving away from those artificial fillers Case in point and again had some of the implants pulled from the UK market a couple of years ago due to cancer signals. And so what they're moving towards is natural fillers, fat being the biggest one of them. So basically transplanting fat from one part of the body to another part of the body. The issue with transplanting fat is that on average, only about 45% of fat grafts survive. And that's actually covering a wide range. So anywhere between 20 and 80% of such a graft will die. That means that as a as a plastic surgeon, you have zero predictability in your work the face that you just reconstructed, you don't know whether it'll look like that one month or three months from now. And so to compensate for that you bring in the patients, three, four, or five times over a two three year period to fill them up until you have the desired outcome that of course drives cost and that drives patient burdens. So the question is, can you increase that graft survival. And that's what we've figured out how to do in instant medical. So we basically found out that if you were to infuse a fat graft with missing a couple of stem cells, a very, very high number of unsinkable stem cells, you could significantly improve that survival. And of course, that survival translates to retained volume. And so what we saw in our clinical trials were that we was that we could take that, that retained volume of average 45% and bump it all the way up to 80%. This week, published in The Lancet, and in stem cells translational medicine. And interestingly, we have since then perfected our our process even more. So now in our commercial patients, we have about 99 to 100% survivability of the graft, which means that as a plastic surgeon, you now have full predictability in your work and you can pull into patients just once. I mentioned that we are launched, were launched in Denmark as a commercial pilot as a pilot, because in cell therapy, there's a lot to be figured out in terms of logistics, patient sequencing between hospitals and your manufacturing, as well as just hospital onboarding. It's a big deal. But we're figuring it out now. And so we're ready to ready to launch in other countries. And so this fall, we're launching in UK, this winter, we're launching in Norway. Next year, we'll be launching in several European countries as well. And we're actually in in fairly advanced conversations with partners in in Middle East and and Japan so it's not infeasible that in 24 We'll also seen Launch in UAE and in Japan. So basically, I hope that I've sort of demonstrated that at least on on on our plastic surgery arm, we have sort of a very good directory right now. The second application is often arthritis of the knee, we call that our therapeutic application. The reason why we chose to go into that application is that it has a very strong fit with our platform. I'll get back to that in a second. But secondly, it's a very, very large indication 10 to 13% of all individuals aged 16 or above will have arthritis in the knee. And there's currently nothing on the market that can hold or reverse progression. And we of course, hope to be able to demonstrate that in our clinical trials. But in terms of of match to our our platform, so what we do is missing humble stem cells and fat right. And interestingly, if you look on at both those components individually, this is not our data. This is from from academic groups. If you are to inject unsinkable stem cells into the knee, that alone has a clinically meaningful effect on the patients measured by what's called the Womack score, which is pain, stiffness and function of the knee. So the more cells you inject the buildup, and earlier the function. Also, if you inject just two adipose tissue fat into into a knee that also has clinically clinically meaningful effect, this time, on this case measured by what's called a CT score, which is WOMAC plus quality of life. So our ideas, of course, like if you combine those two things, it's probably not going to be worse. And that's indeed what we'll do in our phase one trial, we'll be the first ones to ever try the combination of those two. And not only will we be the first ones doing that, but because of our production platform where we can produce in so large numbers. compared to our competitors, we can go in with way higher numbers of mesenchymal stem cells. And so our best competitors are able to do 100 million, but in our Phase One will test 400 million 800 million all the way up to above 1 billion mesenchymal stem cells injected. So we are launching our phase one trial in 24, with a readout in 25. We'll be doing it in collaboration with the St. Louis as our CRO that's the same CRO that Novartis is using for that I'll start with why just trials will have 20 patients in 10 on an otologist arm and 10 on an allogenic arm. So we're quite excited about about that were 20 people in the in the company this is the senior management. It has a very good mix of people with a very strong scientific background, as well as medical background, but also industry professionals. I came in from from Novo Nordisk so did our CEO clouds and clouds actually is spearheaded the launch of sand pick which I think many of you guys know already. What are we doing here at LSI. So we're basically looking for investors we're doing a 15 to 18 million Series B round that we hope to close by end of this year. We have about seven and a half in right now with a cornerstone investor and we're looking for other investors to close the round 80% of the round will go to basically if funding the production scale up so capex and optics on manufacturing 10% of the rounds will go to funding the phase one trial and the remaining 10% will go to overhead and and marketing and sales. So I hope that I've given you guys appetite to to look closer at STEM medical and I'm I'm looking forward to to see as many of you guys today and tomorrow. Also today at 6pm. We'll be doing a fireside chat and cocktail chat at the P 41 bar at this hotel. So from six to eight please swing by at four one p four one bar and meet the Meet the team. Thank you very much.