James Blackledge Presents Capella Imaging at LSI USA ‘23

Transcription

James Blackledge  0:00  

Good. Morning, thank you. I'm really grateful for the opportunity to talk to you about Capella Imaging and some of the things we're doing around fibrillin. So let's start with what is the problem we're trying to solve. We heard quite a bit about this earlier this morning. About 18% of deaths worldwide are attributed to heart disease, that number jumped to 20%. In the US, as a consequence, there are about 90,000 patients a year that are on the list for our transplant, and that number is growing every year. Conversely, there's about 2500 donor hearts available and that number has been stagnant for a long time. So there's a disconnect there. So left ventricular assist devices, or LVADs. have been used for quite some time. Now. These are essentially pumps that are used for bridge to transplant to essentially keep you alive until the donor heart becomes available. But as this figure shows, the numbers aren't in your favor, you're not going to get a donor heart. So more and more, they're being used for destination therapy, meaning you're gonna live with this. Now all these devices, the technology is getting better, the batteries are getting better, but they all suffer from a major complication of thrombus blood clots. And that can lead to one of the most serious side effects of stroke to counter that patients are treated with heavy anticoagulants, which leads to another problem, which is gastrointestinal bleeding. So about 30% of these patients are going to require hospitalization at least once a year to be treated for gastrointestinal bleeding. At present, there is no way to assess the level of clot buildup in these devices or to have an endpoint for assessing the effectiveness anticoagulation therapy. And this is where we think we can step in and fix an unmet need. So this is an image of Febris. And it's a cartoon we're gonna think I'm the only non device guy so far. It's basically a Tetra mer each of the arms is composed of a polyethylene glycol polymer terminated with two peptides, one which binds the radioactive technetium. The other which binds very specifically and avidly to February, what you see on the right, the rotating image is a SPECT scan of an LVAD pump that was removed from the human patient that came in for pump exchange. And this is important that it was removed from a patient. And the brightspot you see at the bottom is a large buildup of thrombus that this patient had, and he was at risk for a piece of that breaking away and causing a significant stroke. So some key concepts I want to stress here. The pumps are all taken from human patients. So this is our preclinical model, we take pumps out of patients that come in to the Washington University of Medical School for exchange, we implant them into 70 kilogram calves, which are a good model for humans in terms of mass and blood volume. And we acquire images from these guys. So this is as close as you can get to actual clinical data in a preclinical model. The second thing is as a nuclear imaging agent, the amounts of material we dose are exquisitely small, so there's very little risk of a toxicology concern. So these are the two areas where drugs typically fail transitioning from preclinical to clinical as either efficacy or toxicology and 50% is very highly de risked in both of these regards. So in terms of a market opportunity, you know, taking this 90,000 patients a year of looking at heart failure, if we assume 20% LVAD placement, and these are numbers from recent market reports. That market is growing in our estimation of 18% a year, but we fairly modest reimbursement $1,500 this as a new drug for an unmet need. So that's that's probably quite modest. We're looking at about $78 million annual revenue first year expecting that to grow to about 155 years down the road. However, this 90,000 patients, even though it's growing, still qualifies as an orphan drug. And I don't want to go through all the points on this slide. But there's some advantages to that. And what I think is the most valuable as the agency works with you to get into clinical trials and get first into human. Once you're in humans, it's fairly easy to pivot to follow on indications and we think there are other markets that we can be a significant player in this and those are pulmonary embolism and acute coronary syndrome. So these are unmet needs, but there needs that require better tools. And just a couple of figures of merit here. Like I said, these are much bigger markets. And the tools that are currently used are essentially designed to eliminate other potential sources of chest pain and what's left is potentially a pulmonary embolism. So our competitors in this space for the LVAD indication, there's nothing that says completely unmet need. We're aware of a another startup in the Boston area that was working on something similar a few years ago. They were using PET imaging were using SPECT and that's outside the, the realm of this talk, but we feel our SPECT imaging approaches are much better, much more universal in terms of availability of cameras and utility hospitals. For PE and ACS competition is the current standard of care. And as I said, there are tools that are used in terms of normal imaging, but they could be done better. So we did a series a Northstar medical radioisotopes invested a million dollars in us, and that was used to essentially drive all of our ind enabling activities we've contracted with a GMP manufacturing facility and worked out a scalable process to make the drug. We have done a GLP compliant TOC study and gotten clean results. We've done design of experiments to optimize the radio labeling, we're all ready to go. We just need to fund what we're doing. And that's why we're here. We're looking to do a $10 million Series B equity round which will drive us through beginning our phase one clinical trials simultaneously, we will be manufacturing GMP material to do a phase two clinical trial. Our key opinion leaders in this area have suggested that it's unlikely we will be able to exit at the end of phase two that we would not be required to do a phase three study. Again with a nuclear imaging agent. The numbers are a bit different. The requirements for forgetting the humans are a bit different. You only need a single species of talks. And that's because again this this mass that's those two so small Northstar medical radioisotopes has already expressed interest in this for acquisition but we're talking with other people as well a little bit of time on the team Capella, which is myself and three of the other founders here. We're very deep in drug development from, from discovery to commercial, both small and large pharma. Greg Lonza, is a cardiologist at the Washington Medical School. This product actually came out of his lab and was fully exclusively licensed to us from the Washington University Medical School. Our scientific and medical advisors really want to stress this, these guys are world class, Barry Siegel, has been working with the FDA on nuclear imaging for his entire career and is just a household name there. Sally Schwartz is author of a number of the guidance documents around experimental ind as a nuclear imaging, and Dr. Z Walden Ito are both very well regarded in their fields and are very active in supporting the development of this product. And all these people are behind it, believe in what we're doing, and are willing to talk to people about it. So we feel very fortunate to have them on our side. So with that in mind, if anybody's actually interested in a drug instead of a device, I hope to see you later. Thank you