Benjamin Esque, Corstasis Therapeutics - New Nasal Diuretic | LSI USA ‘24

Benjamin Esque  0:04  
My name is Ben Eskew. I'm the co founder of Corstasis therapeutics. At Corstasis. We believe Home is where the heart is. And we're developing solutions to help treat to provide additional options for physicians to treat patients in the outpatient setting. So a little bit about myself, my background is largely in development and commercialization of cardiovascular products. Randy just mentioned cipher. I was the last person on Earth to sell cipher stents. And I've been doing this for over 20 years. So we have deep connections in the world of, of cardiology, interventional cardiology, and heart failure. And actually this company started as, as a solution to a problem many of our cardiologists were facing, kind of during my journeys with a previous company, a little bit about our technology. So we've developed a novel formulation that leverages existing products. So the whole intent of this program has been to be hyper capital efficient and time efficient. So just the some of you may be familiar with what happened with nasal Naloxone, otherwise known as nasal Narcan. It's now an OTC product, and several other products that are being developed such as nasal epinephrine. We're leveraging the same device delivery system that they're leveraging. But we've developed a novel formulation and have several US patents which I'll get into in a little bit. That TAS confirmed our 505 b two pathway. We have global patent coverage through 2040. There's a significant total addressable market. We have some additional pipeline opportunities, and we are pivotal trial stage, pivotal trial stage company with expected approval in 2025. For our lead product candidate is an intranasal diuretic. It's on this delivery system. I know it's a little hard to see, but very simple, easy to use delivery system for patients. And the whole intent of this therapy is to to provide an alternate route of administration. The nose bypasses the gut. And so why, why is there a problem oftentimes, patients are taking patients with congestive heart failure liver or kidney disease or taking an oral diuretic medication. Some of you may know that the brand name lasix is the most commonly used drug in the class. It's the 14th most prescribed drug on planet Earth. It's a gigantic problem. And so many of these patients taking that oral diuretic medication experienced some level of resistance and the typical algorithm is double, triple quadruple the dose of that oral medication. Depending on which cardiologist you ask them which day that works 40 to 70% of the time, when it doesn't work, those patients are admitted to the hospital for an IV version of the exact same drug. So some some quick facts for you. 80% of patients admitted to the hospital for worsening heart failure, the sole intervention is 65% of the time is is IV diuretic, and 80% of the time they're released from the hospital without any relief of their symptoms. The current national average is somewhere around 25% of those patients are readmitted to the hospital within 30 days, and 50% are readmitted within six months. So it presents a very expensive, very morbid treatment paradigm for our patients and a real opportunity to to provide value to our healthcare system improve outcomes for patients. So our therapy intends to deliver IV similar therapy in the outpatient setting. And so we hope to deliver a better solutions loop for for patients suffering from fluid overload by alleviating symptoms. So where would this be used to be used at the time of oral diuretic intensification as an adjunctive measure to help those patients avoid a hospitalization in the first place. So in the physician's office patients, often the present, many physicians would tell you that 20 30% of their practice is managing diuretics in heart failure, and keeping these patients out of the hospital. The second setting would be in the ER Urgent care setting. So many of our investors are actually IDI physicians. And when they heard about this, they said I could use this in a variety of ways. instead of admitting patients to the hospital simply for an IV version of this diuretic, I would send them home. And then the third where we think the lowest hanging fruit lies is patients being discharged from the hospital kind of as a pill in the pocket type of prescription to avoid a readmission to the hospital, which every hospital in America is hyper focused on because if your eye hospital is performing above the national average in terms of heart failure related readmissions, you face up to a 6% hit on all of your Medicare reimbursement. So our proposed price per cost of therapeutic episode, let's call it five days worth of therapy is about a 10th of the cost of a heart failure admission a very uncomplicated admission. So you know, our initial meetings with payers have been very positive. They're very excited about this. And they think that you know, this could could get me going you can do the simple math if if the product only works. Two out of 10 times it's it pays for itself and then some. So very large market here. We think this is very conservative estimate of a fraction of the of the current patients. We think it's at least $2 billion And this is only in the realm of CHF doesn't include the liver, kidney, and nephrotic syndrome patients. So, as I mentioned, we are a clinical stage company. This is data from our first study. And essentially I know there's a lot of grass a lot of text on the page. In the interest of time here, I'll summarize it very quickly, we had a faster time to max absorption than the oral by 50% Faster, which is exactly what we'd want it to see through the nose, delivering IV similar therapy, it was safe and worked. What these drugs do is they simply make a patient P. As you can see in the graph here at the irrespective of our nasal dose we had equal or better your diuresis versus the oral and intravenous dose forms, add zero to eight and zero to 24 hours. We're in our pivotal trial. Today, we're in cohort five of six. So basically 50 of our 64 patients are in house today, patients are being dosed as we speak. This is a quick overview of the design as a simple PK PD study in healthy volunteers. We expect to complete the pivotal trial by 416 2024. And I expect to file a new drug application sometime in either late q2 or late q3. As I mentioned, we are not just a single product company, we've also developed our own subcutaneous, very small format version of the product and we think our nasal applicator or nasal product has a serious benefit in the world of veterinary veterinary heart failure, and small dogs suffering from fluid overload. global patent coverage through 2040. These are issued sets of intellectual property for the methods and composition of edema refractory to oral diuretics, we've protected the actual composition of matter and the use of the product through the nose. We've filed in all commercially relevant geographies around the world. We believe we have the patent longevity of a new chemical entity, but the regulatory velocity and efficiency of of the 505 b two, which allows you to demonstrate relative bioequivalence. So a little bit about our milestones to date. We have commercial scale, GMP manufacturing in place today at a world class, commercial scale manufacturer are the same folks who manufacture Narcan and other drugs for the world. That product comes off of 12 months stability and two months from today. So as you can see here, we're in q4 there and are sorry, we're in q1 of this year, and I expect to complete that pivotal trial and have a pre NDA meeting in the next in the next couple of months here, which puts us on track to to follow our NDA as discussed. So once again, the goal is to prevent admissions and readmissions here. We've asked physicians if simply showing them nasal would be enough to sell Hey, we have a nasal version as diuretic with the same indication as the already approved medication. 98% plus of the physicians we polled in the 66 physicians surveyed said they would use the product kind of a no brainer if it was covered. So how would we sell this right? I'm a commercial person. This is where I really get excited and you know, everything we've done to this data stuff that I'm not good at, but I believe there are multiple opportunities for us. So you know, if you threatened me with a good time of putting together a small StrikeForce of high level medical device, ultra connected individuals, I'd love to do that. If we can find the appropriate partner, we could do that as well. There's a lot of pharma companies that needs something that would increase their access and increase their their their revenue capabilities, particularly some of the public companies that are already in space. What can we do with a small Salesforce so if we just focused on simply the post discharge population? This is 1010. Geographic metros, this is data from a top performing center. Here in Orange County are a group of centers in Orange County, they had 1900 37 patients discharged. Imagine if we just got that that those patients as as a pill in the pocket type of prescription we could do roughly $100 million in sales with a very small sales team. But obviously I would focus on the highest GDP areas and deploy, deploy deploy sales teams through our existing network of, of cardiology focused representation. So couple market comps for you. See Pharmaceuticals is the active player in the space there. They're funded by over $450 million of venture money from the who's who in the venture world. They're public today. They're having a little slow start because their specialty model but they're off to a great start. Soon to come to market is NASDAQ ARS pharmaceuticals with nasal epinephrine, and then I will skip the valuation stuff but we could see yourself doing an AI conducting an IPO here in late in late 2024. Thank you for our for your time.