Dan Deardorf Presents Glycologix at LSI USA '23

Transcription

Dan Deardorf  0:05  

Good afternoon, and thank you all for your interest in Glycologix. I want to start with a question this afternoon. How many of you went to the restroom? Number one in the last 10 to 20 minutes? You don't need to show hands. I know I did, because I knew I was coming up here. But what I can tell you is if you suffered from interstitial cystitis or IC, you would have made sure you went to the restroom right before you walked in here, for fear that you might have to get up again, and leave this presentation and miss what's gonna happen here right now. I can also tell you, if you had IC, you would have already scoped out where the closest restroom is, in case you urgently needed to run there to urinate. And I can also tell you, if you're sitting here with IC, you would there's a good chance you'd be sitting here with significant pelvic discomfort and pain. This is the plight of patients that have interstitial cystitis. And I have to tell you, that the state of treatments for these patients today is quite poor. And we intend to change that. As mentioned, I'm Dan, CEO of Glycologix. We're developing novel biopolymer soft tissue coatings. Starting with interstitial cystitis or IC. We think we've got a unique opportunity in glyco logics. And that's because we have therapeutic market potential across multiple indications with device characteristics. That's why we're here. Our lead indication ICBPs that I mentioned is a large condition. There's only two approved treatments in the US now the last one in 1996. Both of those are largely ineffective for treating these, these patients with low response rates and low levels of evidence to support them. RGLX 100 is an elegantly simple solution that addresses the underlying cause of IC. And that will fit into current clinical practice with a targeted set of specialty physicians got a Class III regulatory pathway, relatively low cost trials, the first of which is a pilot study that will be starting in June of this year. So let's take a step back. What are we doing? We're developing locally delivered proteoglycan mimics for the protection and potential self repair of soft tissue proteoglycans complex polymers throughout our body, they do important things but they can break down. Our platform mimics those proteoglycans with high affinity to the tissue, enabling the protection and potential self repair of the tissue. We can tailor our materials to different to different tissue types and therefore to multiple conditions. For right now we're acutely focused on IC bps. What does ICBPS already alluded to it. It's characterized by often debilitating pelvic pain, increased urinary frequency and urgency and burning on urination, to a very large condition predominantly impacting women. And the economic impact is very large, in large part due to these folks on being unable to hold down a job and otherwise contribute to society as they would like to. I want to give you a sense of just how impactful this is. I'm going to read a couple blurbs for some quotes that say I'm holding on tight for dear life. I don't know how long I can take living this way. I am having a difficult time trying to live any type of life. Real quotes, real patients that give you a sense of just how debilitating this condition is, sadly driving some of these patients to commit suicide. What is the underlying cause of ICBPS is the end of the day. It's a loss of an impermeable layer that you have on the inside of your bladder. It's called the glycosaminoglycan or gag layer. You can see there on the right that's a normal layer urothelium line with these proteoglycans. These tightly bind water essentially create a mucous membrane on the inside of your bladder. When that breaks down, you get potassium noxious urinary solutes diffuse into the tissue, the adjacent tissue and cause the symptoms that I that I mentioned. Our approach is to take a proteoglycan mimic a biopolymer that has high affinity to this urothelium that's been broken down and risk temporarily restored that impermeable layer. We believe this has the opportunity to become a standard of care. Because as I mentioned, current limits current options are limited. They have limited efficacy, and they have low levels of evidence to support them. There's two basic categories. There's bladder instruments that are done in an in office catheterization. The only one available in the US is DMSO 50. And in cocktails that are made by clinicians that have all had marginal efficacy. XUS there's things called gag replacement therapies which are intended to read to read Plenish that layer on the inside of the bladder. Unfortunately, these do not have a long residence time and therefore also have marginal efficacy. The other product available approved in the US is an oral called Almeron concept here is, as this material goes through the bladder and is excreted, that it would again stick and replenish that that layer. The problem here, products only 5% bioavailable. And, as you can, perhaps see they're highlighted. When the FDA reviewed this, their ultimate Determined Determination was based on the data, the product was not approvable. But the content, the context behind it is they did determine it was safe, it did help a small subset of patients. And by the way, it's 1996. And the product got approved. And despite all of that this product achieve peak revenues of over a quarter billion dollars. So we believe with something that truly works. There's a huge opportunity here. What are we doing? We're taking these proto glycans, remember, those were the things in the picture on the urothelial layer, you cannot isolate these and you cannot synthesize these. So what we do is we take the gag polymer off in their in our case, conjoin sulfate, we do our magic to crosslink it and we come up with something that's an engineer proteoglycan mimic the advantages of that restores your three allele impermeability, because it closely mimics a number of characteristics and properties of natural protein glycans, that leads to a more prolonged resistance on the bladder. The other element is our materials are highly soluble for the tissue coding in this circumstance, or perhaps for other indications that could be injectable. And usually when you have a highly crosslinked biopolymer like this, they're not viscous. And so this is actually a key element of our intellectual property as well. Our development plan, we're going to take our SBIR funding and our seed funding to get us to and through a pilot clinical trial in Australia starting in June. 40 patients will have date out q1 q2 of next year. On the back of that will raise a Series A and or partner to do a single global pivotal trial and loop through regulatory submissions and approval. We made tremendous progress to date. Our preclinical efficacy data is extremely strong in the gold standard models for IC, but competed completed our entire preclinical safety package. We've scaled manufacturing to clinical clinical scale. We just recently approved ethics approval for us our Australian trial there. And we've already recruited and qualified all of our trial sites there. So tremendous progress, and poised to go into that trial in June of this year. Turning to the management team, I've been in this industry longer than I care to admit and hopefully don't look as long as like it's been as long as it has. But I spent a lot of my time in flexion, therapeutics, and even longer time at Genzyme and the management development program. They're working on local therapies, biopolymers, pain conditions, all things relevant here. Rich is my right hand and brilliant medicinal chemist, he has been a number of places, academic small and large. Rich is my right hand, man. We are lean and mean. There's rich, there's me. And there's Harry in the lab. The rest of everything else we do is outsourced and virtual. We have two co founders, George has started over 15 companies with many successful exits both IPO and m&a. And Thomas, our scientific co founder who has many successful bio polymer products to his name, on the ICBPS side, we work with Bob Hurst, who is a world renowned bladder epithelial biologist and the PI on our NIH grant and grant of Sant who is a world renowned urologist and importantly, created the leading outcome measurement for IC clinical trials. Grantham helped us recruit a world class Scientific Advisory Board that advise us on many things, most notably clinical trial design. I mentioned that we can tailor our materials to different to different substances, different tissue types. So you can see here are some of the places that we could we could extend our, our material into different indications. If any of these are of interest to you, please see me we will pursue these as we can with the appropriate partners as well. So with that, I will flash again what the elements of what we think make this a unique opportunity here at Glygologix. And I will thank you for your time. And of course, welcome any questions and discussions afterwards. Thank you