Jonathan Waldstreicher Presents Galvanize Therapeutics at LSI USA '24

Jonathan Waldstreicher  0:06  
My name is Jonathan    Waldstreicher and I'm the CEO and founder of Galvanize. We are a commercial stage biomedical platform company. With about 100 employees based on Redwood City, California. We've had an extensive experience to date. Thus far we've treated about 3000 patients across clinical trials and commercially, our commercial presence is installed at about 70 US hospitals to date with 1000s of procedures under our belts, we've got two product lines, one in interventional oncology, which is what I'm going to focus on mostly today, the other interventional pulmonology with very exciting first class product for chronic bronchitis, which will read out a US pivotal trial 270 patient randomized sham controlled in about the third quarter of this year. In the meanwhile, our focus in the short term is on revenue growth, and secondarily bringing new products the market with clinical indication expansion thereafter, we've got an amazing investor base with tiro Price who recently joined fidelity appletree partners, the firm that I come from an Intuitive Surgical and Gilmartin capital. So the current state of technology today for ablation is microwave cryo irreversible electroporation, and about 350 million of the 750 is radio anabolics, mostly from Boston Scientific. But the problem there is that patients have to be very late stage disease but only have one focus of disease focal therapy. The issue is that most of these patients have much more broad disease than just that focal therapy alone. So what's really needed in this market is something that is going to activate the biology of this and when we have an opportunity to tackle that we all of a sudden could bring lung metastases in a billion and a half market opportunity, late stage lung cancer and almost a billion early stage lung cancer, intermediate risk prostate cancer meaning watchful waiting and active surveillance, late stage breast cancer and sarcoma head and neck and bladder cancers. All of these are targets for a focal therapy that has a bigger biologic role. These are patients who would have never been treated with any one of those four therapies before you had these are three patients who we've treated. On the left side is a nurse, unfortunately, 61 years old with metastatic colorectal cancer on her eighth line of therapy. In the middle, a 37 year old guy with alveolar soft parts are coming out on the right side, a 14 year old girl with metastatic osteosarcoma, each of these patients wouldn't have been amenable to any other therapy at our very late stage, we've treated all of them and have had good outcomes in them. So our target here is for every biopsy that's done to give the physician an opportunity to potentially deliver our energy energy based therapy through it. What is that energy based therapy, it's based on pulsed electric field activation with very novel waveforms, where we're able to directly target the cells in a disruptive way. And in doing so we emit that electric field over the tissue on an individual cell basis. It's depolarizing, the cell membrane that causes sodium and chloride to flow into the cell water follows that and they burst via osmotic swelling, and eventually by apoptosis, this is a very gentle form of cell death. And when we do this delivered percutaneously, as you can see here, a physician in this case is sticking a needle into tumor that's in the liver. All he has to do is just the same way he delivers every biopsy is get that needle in there, he hooks up our electrode steps on the pedal, and over the course of a couple of minutes delivers that therapy. But most importantly, it doesn't only ablate those cells that are there. When we do so we're actually preserving many of those tumor antigens that are released thereafter into the bloodstream. And that's what activates the immune system. Focal ablation cannot do this. This is a gentleman, unfortunately, who had a squamous cell carcinoma of the sinus cavity that grew out eventually actually grew into his temporal lobe of his brain as well. He was treated twice with our therapy directly into that, from that percutaneously from the outside, and you could see the effective resolution thereafter. This is not just focal ablation. How does this work? So when we stick that needle into that lesion and deliver the energy, it releases all of these tumor antigens, those are picked up on what are called antigen presenting cells or dendritic cells, they travel up to the lymph nodes, where they activate T cells and B cells, those traffic back down to the tumor via the bloodstream. And that's what comes in and infiltrate cytotoxic li invades the tumor and starts to kill the tumor. If checkpoint inhibitors are on board, the effect is even better thereafter. This is incredibly specific. So think about the tumor vaccines that are coming through mostly in the form of micro RNA similar to the COVID vaccines that many of us got. In that way. The COVID vaccine showed the body that antigen and the body was allowed to develop an immune response to it. What we're showing you on the left side here is that as compared to radiofrequency ablation, our pulsed electric field ablation either alone or in combination with that anti PD one immunotherapy allows us to create those antigen specific T cells. So released from that lesion there via our energy, and now the T cell activation against those exact antigens that were presented there. The mRNAs are going to cost three to $4 million per patient in a customized way. We're doing this in a disruptive way during a surgical procedure. On the right side, we've also generated data that demonstrates that we're not only activating the T cells, but we're also activating the B cell pathways here with anti tumor antibodies, which is the longer term provision of the immune system. Let me show you another case. 71 year old guy walking down the street in Times Square, when he gets short of breath goes to the hospital has a CT scan, he has a pulmonary embolus, which they treat, unfortunately, he's got about 20 lung tumors and a four and a half centimeter tumor in his heart. You can see it in the middle picture, Pan scan him and the primary tumors in his leg. They biopsy differentiated metastatic lipo sarcoma, he's got 20 Something lesions, this guy's gonna die in a couple of months. The physician offers him our therapy, he refuses chemo immunotherapy, they stick a needle into his leg up there on the left side, as you can see, and in doing so they they activate the tumor via a 15 minute treatment, he goes home. Three months later, they get a scan, and every single one of his lung and heart lesion is gone. We activated the immune system via the leg to give a systemic effect one time treatment 15 minutes, this guy is still living, no better data than real world commercial experience. And while you do not believe in this mechanism, these are the first 20 patients that they treated the most difficult, most progressive patients that they had on board. And this is a waterfall plot of what's called the resist criteria. This is the sum of diameter. So these were patients that were all progressing before. And what you see here is that 80% of the patients are either stable or responded which Dr. Bill Moore, the highest volume lung biopsy physician in the country said this absolutely should not have happened. All of these patients besides two are still alive today. In the future, actually in a couple of months here, we're going to launch our endoscopic needle. This is going to allow us to deliver the energy through the robots. There are about 450 intuitive ion robots that are placed today, as I mentioned, intuitive as an investor and it'll be compatible with the robots. On day one here, we have ongoing trials for an indication. But let me show you what one of these cases looks like. So this is a 62 year old guy who had a prior renal cell carcinoma in his kidney had infected me a couple of years before and quite unfortunately, he shows up with two new lung lesions with the yellow arrows that are there. left lower lobe is a centimeter lesion and the right lower lobe is a five millimeter lesion. CT scan CT screening is great. We're able to find these these days. But unfortunately, what do we do with this, this guy is gonna go on chemo immunotherapy. So the physician instead says, let me put you in the trial. We didn't even know what that was yet. It couldn't be lung cancer could have been a renal cell metastasis, so they have to go in and biopsy it, he gets an eye on procedure, they go and biopsy the left side in the room, they confirm that it's malignant in the room, they stick our needle in right there afterwards and activate it three times. Then they went over to the right side and treated that right side lesion as well. And in the meanwhile, the tumor board said, let's see the follow up on this. Let the patient settle down for a little bit after the procedure and then we'll start him on chemo immunotherapy. And they've never done so because if you look at the three months scan on the right side there, you can see that it's a fraction of the size as to what it was before. And actually this is metabolically inactive and dead. So here many firsts. The first is that we delivered it through ion the second is that we diagnosed and biopsied it in the same event. And the third is that it's the first time to do an endoscopic ablation bilaterally, and the fourth was that he went home the same day after he recovered from the procedure. So in going forwards here, we've really got three key strategies. The first is growing our revenue again 70 US hospitals and growing quite significantly many hospitals each quarter. Second is expanding the indications here working on the new clinical targets and the third is the new product such that we can deliver the energy through any needle that a physician sticks into a patient's tumor. Thank you