Sandy Zinke Presents Lumeda at LSI USA '23

Transcription

Sandy Zinke  0:05  

Good morning. I'm Sandy Zinke CEO of the Lumeda, very happy to have a chance to talk with you this morning about what we're doing and appreciate the the opportunity. So, we are bringing a photodynamic therapy which some of you may have heard of, into the adoptability category for our dynamic therapies used today in small part for esophageal and bronchial cancer treatment. But we've developed the first AI driven dosimetry system for activation of the of the photosensitizer drug used in photodynamic therapy. In addition, our technology is under evaluation already in two clinical studies. We'll talk more about that. And our goal initially is to improve quality of life and extend survival for late stage lung cancer patients of which as you can imagine, there are many, and we're also combining our treatment. Importantly, with immunotherapy. Our platform we think can be applied to other cancers as well, ovarian, and pancreatic specifically. And finally, we are mapping out a path that gets us to stage two efficacy, phase two efficacy and also we're positioning the company for strategic acquisition. We don't plan to commercialize ourselves. Our team is made up of serial entrepreneurs who built and sold companies and also medical experts in oncology, thoracic surgery, drug development, we have a really strong internal and external team. As you see here, we've raised about $8 million to date through a seed round of 1,000,000 4.3 series, a round and half of a convertible round which you plan to finish by the end of May. We have a couple of venture investors and also an exciting investment from a subsidiary of a Japanese company called SBI. holdings. photodynamic GmbH, is a company that makes a drug that we want to activate. And they both invested in us and are collaborating in a clinical study with us. So what is photodynamic therapy? It's a drug infused systemically through IV or through oral taking it orally, it accumulates in cancer cells, and dissipates in healthy cells then is activated by light, in our case, intraoperatively actually on the tissue, and then causes tumor cell death, which we'll talk more about. We're collaborating with the Roswell Park Cancer Center where we've licensed two patents. They have really a world renowned PTT Research Center, and a lot of services that we've been able to leverage and have helped us a great deal through through some cross functional efforts. We've built on those patents, and the two weeks the two we've licensed or we have global exclusive perpetual licenses, we follow the number of additional disclosures focused on the instrument that we have the hardware software, the minimally invasive, and the light applicator, and also some combination therapy, some outcomes that we think will be allowable as well. So what does our system look like and what's the innovation the upper right you can see, it's a it's a silicone flap that has light detecting and light emitting fibers. And what those allow us to do is to put directly on the tissue and monitor light that is put out and light that is received by the tissue. You can see an early system of ours here. And this shows a little bit about how deep we can go which is about five millimeters. But the key thing to our system, the word dosimetry the dosing of the light, and the really precise control allows a different level of adoption and objectivity for photodynamic therapy. Our plan eventually is to combine our solution with from our partner a compound called glial and also five als naturally occurring in the body. It brings a lot of reduced side effects postprocedure one of the things about PDT is there's a photo sensitivity period, post procedure where you have to be covered in direct sunlight. This takes that down from 30 to 60 days to two days. And we think that this also gives us a really selective drug to be combined with immune checkpoint inhibitors a little bit more about glial and it is one of the most selectively collecting drugs. It's an it when you take it, it becomes a photosensitizer when it interacts with cancer cells in the mitochondria of the cell. And it is not only highly selective, but as I mentioned reduces for photo sensitivity. So immunotherapy, it's a word we all probably have heard. It's truly revolutionary. One of the challenges is that it is not always taken up in the body because there is not a priming of the immune system. So our goal is to be not the first there are many efforts out there but we're trying to combine our therapy with immunotherapy to make that therapy more successful. Right now with lung cancer patients only about 20% of late stage patients get the extended life and quality of life benefit from extended survival from immunotherapy. We're trying to take that number to be much higher, and we think we have an opportunity to do that really well. A couple of quotes here important. I can say whatever I want, but a thoracic oncologist at Dana Farber said it really well. The challenge is to find ways to really increase the benefit to to more lung cancer patients is not the benefit per patient is getting more patients to benefit. If we can just add it instead of 20%. One and five, get it to two or three and five. It's a significant improvement. And Merck is also saying we're looking for the right combinations to make immunotherapy successful. They haven't been satisfied with what's come out there probably 1000 studies around the world going on, they haven't been satisfied that the right combination has been hit. They're rethinking things and looking at therapies that can be a mono therapy as well as a mechanism of action to help immunotherapy succeed. This just shows on the right that there are a lot of therapies being looked at. And what we do is something that chemo and radiation do already. They cause what's what's called immune immunogenic cell death. That just means the cell the body is being Prime, the immune system is being primed to be receptive. And one of the challenges is that you deal with toxicities off target side effects when you use chemo and radiation. We think we can bring a better mousetrap a better way to do those same things and not have to repeat the procedure as often. This just shows it in a little different form. But if you go down to where the second last row, which is, how many patients are responsive to immune checkpoint inhibitor immunotherapy, you can see the 20% one in five number that's about 10,000 out of 50,000 patients in the US alone, this is 2021 data, our job our objective is to double that. And we have indications both preclinical and clinically that we can do that. The benefit to patients is clear, extended survival and also extended quality of life. These are sick patients, but they can't have that. And the benefit to industry is also clear, you can expand the revenue obviously to a company that makes an immune checkpoint inhibitor just by adding one patient you can get a 60% increase in revenue over the two years of treatment instead of stopping treatment if they're refractory. So we think PTT is also curative. Obviously the focus, whether it's the moonshot project or anything else, the focus is upstream on screening. Stage one stage two early cancers, there's good evidence that PDT can be effective in those cases as well and with reduced side effects. So we think it has curative potential. We're focused on proving it out initially, because we think the immune checkpoint inhibitor immunotherapy is so significant. We think there's a platform here, we know we can we can use the same applicator and look ovarian, possibly other cancers as well. This cancer has a particularly bad situation because it is it has a high recurrence rate. You can see some of the numbers here. And we think we can combine with some of the standard of care procedures to because of the selectivity of the drug because of the precision of our dosimetry or like dosimetry system. We think we can deal with later stage patients and bring some benefits that are not so much related to immunotherapy as they are to to making all of the cancer disappear rather than just some of it. So this just emphasizes some of the treatment some of the platform potential. Besides lung and ovarian we think colorectal is possible that para biliary and pancreatic cancer is once we miniaturize the system, that is the applicator. The the platform technology aspect also is on the top if we can get to robotic and endoscopic applicators, which we think we can ever see and treat potential. And the right side shows the therapeutic part of photodynamic therapy. There's also photodynamic diagnostic, which is, which is potential as well. Lastly, we're in clinical studies, as I mentioned, we hope that by q4 of this year, we'll have biomarker data showing T cell activation. In phase two, we hope that we'll see efficacy data in two or three years. We have a number of strategic partners interested and we're talking with them because of some of the things I've mentioned, we're raising a convertible round right now. I'm happy to talk to anybody about that. And finally, just in closing, we have I think a team and the technology that can do great things. I really appreciate the time today. Thank you