John Climaco - Chairman & CEO of CNS Pharmaceuticals | Curing Brain Cancer

Welcome to success story the most useful podcast in the world. I'm your host, Scott Larry The success story podcast is part of the HubSpot podcast network Which has other amazing podcasts like entrepreneurs on fire hosted by John Lee Doomass entrepreneurs on fire Stokes inspiration and share strategies to fire up your entrepreneurial journey and create the life You've always dreamed of check out some of the reason episodes eight tools of improv comedy that you can use in work and life How to turn your Instagram into a money-making machine how to build a seven figure side hustle without quitting your full-time day job and Overcoming the beast of depression as an entrepreneurial leader if these topics are interesting for you You definitely have to check it entrepreneurs on fire wherever you download your podcast today My guest is John Climico. He is the CEO of CNS pharmaceutical. He has 15 years Experience in leadership roles at various health care companies including EVP at permifix medical President and CEO of Axial biotech a DNA diagnostics company Throughout building his career throughout building all these companies. He's developed partnerships with Metronik Johnson and Johnson Smith and nephew currently he's building CNS farmer. They're a drug drug development company. They focus on developing novel treatments for Primary and metastatic cancers of the brain and nervous system. So they are trying to cure cancer They have a lead drug candidate that they are taking to market from the ground up going through all the clinical trials all the phases of regulatory approval this particular drug Baru Bison is Proposed for the treatment of GBM. It's an aggressive and incurable form of brain cancer Basically before this drug was around there was a good chance that if you got GBM There was no treatment option. You would be going You would be going to hospice and you would most likely pass. So he is creating a drug. He's taking a drug to market to Basically give people that have GBM a chance to live So he walks through his origin story Why he pivoted from rock climbing into law into building health care companies I always speak about the problem that he's solving at CNS pharma and the entire business strategy required to build A drug a drug development company being the entire business strategy required to take a drug to market including the regulatory The marketing the sales the pricing strategy. It's incredibly complex But he is an evangelist for for CNS pharma He's a he's an evangelist for the work to do the drugs that they put forward because it can actually save lives So he's going to walk through how he builds a drug development company and takes a drug to market From inception all the way through to something that in this particular case an oncologist can use for a patient So let's jump right into it. This is This is John Climico. He is the CEO of CNS pharmaceuticals Yeah, I had I had kind of an interesting path Circuitist path to get here, you know, I I didn't dream of being a pharmaceutical executive I turned to being a climbing guide and when I graduated from college, that's what I did For six years all over the world. I was a alpine climbing guide So I took clients, you know all over the world. South America, Himalayas, Alps, all over North America And and I loved it But you know, I found after a while that it was really hard on my body and And I wasn't getting quite the mental stimulation that I wanted so you know, I did what everybody did What many people my family did I went to law school. I practiced laws for about seven years and One of my clients came to me one day with an idea for a medical device that he had Wanted to license to metronic and you didn't know anything about licensing You didn't know anything about business and that's what I had done was emerging growth companies and securities law for about seven years So I called that that was the meeting that ended up eating my career because After a few years I was no longer practicing law I was running the company that we started we raised a whole bunch of venture capital We raised a bunch of money from Johnson and Johnson from metronic from Smith and nephew and we developed the first Molecular diagnostic test in the orthopedic industry. It was a test to predict Kids who were diagnosed with scoliosis whether they were ultimately need surgery or not and it was fascinating It was you know learning on the job. I mean I had done that kind of work for other people as an attorney But but I had never done it for myself and so sometimes I say you know if I'm any good at this job It's because I hit every pot hole that you can hit Made a remiss date that you can make Learned from those hopefully and and grew I went on from that after we sold that company I sat on a number of boards and you know all that school of hard knocks Experience was really helpful because I got tapped by a few hedge funds to help with some very difficult turnaround projects small public companies that were headed for zero and You know sometimes we were successful sometimes we weren't but you know that's the way it goes sometimes and And then after doing that for a few years a colleague that I had met at one of those turnarounds It become friends with the management team and which is unusual in those circumstances and and he Introduced me to Dr. Valdemar Pribe who's the founder of CNS Pharmaceuticals and And you know I had really come to appreciate Through all this experience the the kind of virtue of the simple Eleganics Solution to a problem and Dr. Pribe was tackling one of the biggest problems in oncology which was a real You know a carrot for me. I love challenges. That's why I became a climbing guide and I've been doing that for my whole life I just I love that kind of thing and And he was trying to solve the problem of glioblastoma, which is the most common and deadly form of primary brain cancer It's essentially a death sentence for people who get it, you know, it doesn't matter if you're Joe Biden's son or if you're Ted Kennedy Or if you're the head of MD Anderson Cancer Center if you get glioblastoma, you're probably going to die 60 years of try to treat this disease. We've hardly moved the needle at all and Dr. Pribe came up with what I thought was a just a brilliant Elegan solution when he created the molecule that we work on called Barubeson and It's the first drug of its kind across the blood brain barrier and actually demonstrate response and improvement in the condition in human beings with with glioblastoma So, you know, I I love that kind of outside the box I hate you know that phrase, but just really that's what it was here You know, Dr. Pribe was looking at this problem that everyone else had looked at for one way He looked at it a totally different way and and seemed to hit Peter. So We started the company about four years ago. We took a public about two years ago and You know, we're executing a Pivotal trial here for this really exciting drug and it's It's awesome. I love it every day is a new challenge. You know, every day is a new Incredible problems Congratulations. That's that's super incredibly. That's incredibly impressive Thank you very very very interesting and this is so Before before this Particular drug that and I want to understand where the company is at right now And I want to understand like some thoughts that you have about how you even like build a company in this space that is again So so disruptive to everything else that's already existing but before before this company What was the was there a de facto treatment? Was there anything at all because you're literally like hearing cancer at this point Right, you know, yeah, that's it. It's a great question. So There are a couple of drugs. They're used. There's a drug called temozolamide It's an alkylating agent. That's how it works and it's basically It's the standard of care around the world But what's interesting about a temozolamide or sometimes it's called TMZ is that it's only effective in 60% of Excuse me 40% of patients. So 60% of patients have a genetic predisposition that renders the drug Infective for them their body will repair the damage that Temozolamide drug does to the cancer cells a faster than it can kill them So imagine that situation right the standard of care. It's approved. It's used here. It's used in Europe She used all over the world But only four out of ten people get any benefit from it at all and it's so It's so bad the standard of care today that you know I said it's used in Europe, but it's only used in Europe in those 40% of patients that you know have that genetic profile That will allow it to work the 60% of patients that don't those patients go from Radiation to hospice. There's no chemotherapy at all for those people and the first time I heard that it was it was I had to ask that was in Poland where we do a lot of work I was talking to one of the leading researchers there We were talking about their treatment protocols and I said so you know walk me through your protocol She said well, you know for them For the methylated patients. That's what this predisposition is called we give them surgical resection So we try to remove as much of the tumors possible then We treat them with radiation and then we treat them at all Temozolamide. I said okay That sounds like the US protocol. What about the un methylated patients? He said well We stop at radiation and then we send them to hospice and I just said Can you say that again? I want to make sure I heard yeah We stop at radiation and then we send them to hospice so 6 out of 10 patients. They have radiation They're almost all of those patients will re-occur and then they go to hospice to pass and you know It still sends a chill through me to to hear that today in 2021 that this you know It's it's a rare cancer, but it's not so rare and Most of those patients have no chance at all. They have no drugs that work for them And so, you know, we are we are trying to change that and I think we've got something that could change that Yeah, no, that's it's sad when you realize the the reality that's um Because I don't think anybody who you know Thank God that nobody in my immediate vicinity has gone through that But I don't think if if anybody in your family or your friends or your peer group haven't gone through that. I don't think they realize That this is essentially a death sentence I think that there's always some sort of a notion that there can be some sort of There can be some sort of treatment or cure or at least an attempt But yeah, that's true. So so so you're saying a 60% of people do not qualify Out the gate and then of those 60% of those 40% obviously you're not going to have 100% success rate. So the numbers are like The numbers are devastating in fact the 40% that that responded treatment with tennis all of my they were almost 100% of those will have a recurrence of the disease and that's the point that we're shooting out Which is the recurrent disease? So we're not going against tennis all of my tennis all of my you know works as a first-line therapeutic But there's nothing approved for secondary or refractory cases those are the ones that recur and since almost everyone will reoccur There's a large market opportunity, but more importantly there's a huge clinical opportunity and and really in this disease It's about extending life. We call it either progression free survival, which means you you know You haven't eliminated the tumor, but it's no longer growing or the holy grail is overall survival And that's the primary endpoint of our currently conducting Trial that we have going on in the United States and Europe basically to demonstrate As we believe that Barubuson will improve overall survival And that's really the the the mark that that the FDA and the EMA want to see Do people now with this drug of course? Yeah And now the way that you mentioned it's like a simple elegant solution that looks at the problem through a different lens And that's what's allowing it to be effective and Is this like the IP the proprietary The proprietary lens that this is being looked at through is this something that could transcend just this particular disease or this particular So there's a lot of different opportunities In metastatic disease going to that a little bit. Yeah, I will if people understand like exactly how it works Sure, so so let me back up and talk about the molecule itself. So it's called Barubuson and this is um Yeah, technically what it is is it's a synthetic Obencelated analog of a drug called doxarubuson doxarubuson is an anthracyclean Anthracycleans are a class of drugs that have been around for 60 years Their first line therapeutics for all kinds of cancers their breast cancer ovarian cancer testicular cancer lung cancer Kind of you name it doctors will reach for anthracycleans because they've been around for a long time They're extremely effective. They're very potent side of toxins So they're very poisonous drugs, but they're very effective at killing cancer and you know the side effect profile The toxicity profiles all very well understood. So when I heard that Dr. Prebe was using an anthracyclean for glioblastoma I was immediately excited because I love the idea of using something that's tried and true You know one of the things that I learned in my first Company when we were developing molecular diagnostics and it was really at the beginning of that is that It's much easier to develop new technology Particularly in the medical space than it is to get Physicians to adopt it and change the way they do business because you got to remember that every piece of technology You hand it to a physician a clinician and oncologist in this case the decision to use it comes down to that person Standing in a room with a very sick terminal ill patient in their family trying to decide is this drug Going to extend their life and they don't have a lot of life left So they don't have a lot of time to make wrong choices and anything you can do to make that decision Based on confidence and experience. I think you're going to have a more successful outcome for your drugs So in this case six decades of use with this class of drugs Gives oncologists tremendous confidence that they understand what this molecule does how it does it and how to use it So what's so special about this and why hasn't you know Why don't oncologists have been using? You know, it's recycling is against the bestoma for years The problem is the blood brain barrier and that's this specialized network of endothelial cells that surround your brain And they create the most privileged sanctuary in your body Which means it's basically impossible to get harmful substances across that barrier into your brain for obvious reasons Because your brain is the you know the central computer for the whole system So you don't want anything in there that could damage it the problem with that when you're treating brain cancer Whether it's primary or metastatic disease is that the blood brain barrier typically pumps out or blocks Harmful substances like chemotherapy agents faster than they can be pumped in so they can't get into the brain Or if they do you have to flood the body with such a high concentration That you make the patient sicker before you can actually treat the cancer So what a doctor what a doctor pre-paid you so doctor pre-paid took this molecule This uh this docks of rubies and molecule and he created an analog of it with a benzal group attached to the central glycone ring that's at the sort of the center of this molecule And what doing that doing that procedure did two things basically number one It changed the molecular weight of the compound and that helped across the blood brain barrier more efficiently But most importantly it created a molecule that's highly lipophilic that means it has an affinity to a fat rich environment And the brain is the fattiest environment in your body and so this molecule now has a natural affinity And it will pass the blood brain barrier very efficiently in high concentration So that's the first step in what I call this sort of elegant simple solution because For decades people have been chasing a new mechanism of action specific to glioblastoma Dr. Priebe said let's treat glioblastoma as if it functions like other tumors Let's just get something that we know works against other tumors into the place where it might work against GBM So that was the first step But the cool second step is that this is called a topoisomerase 2 inhibitors So remember I said temozole mine is an outlining agent. That's how it works This is a topoisomerase 2 inhibitors. So topoisomerase 2 is an enzyme That is produced in cells that assists in the cleaving of the double strand of DNA so that those strands can separate and then the cell can divide and replicate Now in the adult brain the only cells that are going to overexpress that enzyme that is cells that are rapidly dividing are of course tumor cells Which means that That barubus is going to not only pass the blood brain barrier and get into the brain But it's going to have selective uptake into tumor cells that are overexpressing the enzyme Against which it works. So it's a really elegant and simple I don't mean to downplay that you know the complexity of what it took to discover this and to build this molecule But when I look at it, I say okay Mechanism a action that's well understood been around for decades take that molecule change it in a way that allows it to pass through the blood Brain barrier and when it gets in there It's going to do what other anthrocytines do is going to disrupt that topoisomerase 2 enzyme process and destroy those cells by inhibiting their ability to replicate So that's that's how it works And it's it's a fascinating molecule. It was the subject of a really successful phase one study Where almost for 49% actually of patients who received the drug and had not been treated With another drug called a vastine which is sometime used Against scuba blastoma, but can have a detrimental effect on subsequent chemotherapy 49% had a response treatment effect response for this drug Several patients had their tumors shrink and one patient had his tumor completely disappear We call him a durable complete response because he's been around for 14 years after treatment with this drug Which is absolutely unheard of in global lastoma You know, I've met this guy had dinner with him a couple of times Fascinating guy and just you know sort of slams home the idea that this is a human being that simply would not be here Would not be with his family would not be productive and doing the cool things that he does Were it not for this molecule? So that's the kind of thing that drives us, you know every day So so where where is this drug at now in terms of Somebody actually being able to eventually use it because you've done clinical trial So help me understand that process too because I'm incredibly curious about The the business around taking a drug like this to market so that it can be widely accessible. Oh, it's complicated I have no doubt. I have no doubt it's complicated It's a long-long process. So basically the process starts with preclinical work which dr. Priebe did extensively Then you go to what's typically called a phase one study and that's basically to look at toxicity side effects and try to determine the maximum tolerated dose that a human can Can tolerate now you typically don't look for efficacy in in that phase You're really just looking for do people tolerate the drug as it's safe Well in this phase one we saw efficacy. I gave you some of the statistics there was really Remarkable we had incredible response rates So what we did with that data is that was the data on which we used To take the company public Along with our trial design and for the for the phase two slash three because that's really what we are We we decided based on the fact that we had efficacy data We took a little bit different approach. I said to the team look. I don't want to spend you know a ton of money on a phase two study That's really just designed to show that the drug has efficacy because we already know it has efficacy from the phase one So I would like to understand How do we get this drug approved? So we were fortunate to have a significant consultation with FDA and and we brought an original trial design to them That had one endpoint they came back and they told us that they strongly suggested that we change that endpoint to overall survival Because that was as they put it the only Approvable endpoint for drugs attacking GBM So we changed our study design that meant changing the statistical power the design the number of patients all sorts of things like that That took months and months and months Simultaneous to that we were manufacturing the drug as I said this is a cytotoxic so it's an extremely potent poison You don't want to touch this stuff. You don't want to breathe it. Certainly you definitely don't want to eat it unless you have cancer So there's only a few places in the world that can actually manufacture this material safely We were manufacturing both We had some components of the drug in Europe and some in the US last year The pandemic hit and the borders closed We suddenly found ourselves with you know two pieces to the puzzle and different jurisdictions So we had to quickly switch gears Start a batch in the US continue the batch in Europe we ended up with batches in both jurisdictions Which we have now which has actually been a great benefit um, and then we took all of that we brought it to the FDA In thousands and thousands of pages of application called an iMD Which stands for investigational new drug and you apply to the to the FDA basically based on all of your data that you have on the drug Plus all the information on the drug that you've manufactured and you're essentially asking permission to use this investigational new drug in human beings So they gave us that permission and we started the trial last year and We dozed our first patient in September of last year We have quite a few patients on on study right now and we have i think 40 centers open in the United States in Europe And we're kind of rapidly expanding across Europe and the United States More centers to make sure that it's you know available to as many patients as possible And they're enrolling in our clinical study which is a very strict protocol because you know you want at this stage One of the heartbreaking things about this is you want to get the drug into as many people as you possibly can Because we believe this is a life-saving medication However in order to produce the cleanest data possible for approval You really have to be very very strict in terms of the inclusion criteria for patients and the exclusion criteria So, you know, we unfortunately have to turn away a number of patients if they've either had too many prior therapies They have complicating conditions Etcetera etcetera, but when we get the right patients in place we enroll them with their clinician oncologist Wherever they may be in the country We have sites all over the place and and then we follow them through a very strict dosing regimen You know collecting all the data that we can along the way and eventually that data Will be compiled Analyze for statistical significance and if we see that the drug is having a positive treatment effect We will apply to the FDA For an NDA or a new drug application and then hopefully we'll have it on the market and and since and not in what a time frame Well the time frame so we've got a couple of big milestones basically so this year We're just building out the trial. That's really our main goal this year is to acquire as many patients as possible We expect our forecast now tells us that in the first half of next year We should reach what we call our interim analysis point and that's between 30 and 50% of patients on study for six months And we will not stop the trial at that point But what we will do is analyze everything that we have and we will determine Either the drug is having treatment effect and we'll proceed with the trial or that or it's not having treatment effect And we will consider either changing the protocol or our terminating the trial and then after that We will complete the trial We expect to complete enrollment probably in late next year or early the following year Compile the data and we might be looking at an NDA submission in late 2024 something like that I just want to take a second and thank the sponsor of today's episode hub spot So I was thinking about the shortest day of the year earlier Well, technically we have the same amount of time as every other day the lack of daylight makes it feel so much shorter Which is kind of the same feeling is working with disconnected tools or work day is the same length as always But before we know what we spent three hours manually fixing something that is quote unquote automated Thankfully hub spots all in one connected CRM platform serves as a single source of truth For managing customer relationships across marketing sales service and operations Meaning all of your team's data is truly connected with multiple hubs over a thousand integrations and an easy to use interface HubSpot helps you spend less time managing your software and more time connecting with your customers Plus with a quick and easy onboarding process your teams can get started quicker than even the shortest day of the year Learn how hubSpot can help your business grow better at hubSpot.com You're you're mentioning Something along the lines of because there isn't any precedent for this kind of drug But I cut you off my accident. So what was what was the what was the point on yes? So basically, you know the the um So the bar regular to the regulatory bar is always high. I mean, there's no question about it, right? It has to be safe and effective and you have to prove that Um, and we're doing that now But a disease like this that is almost uniformly fatal and on a secondary or refractory basis has no approved Treatment whatsoever anywhere in the world The the bar is about as low as it can get we don't have to prove necessarily that we're better than anything else Because there isn't anything else. We have to prove that it's safe and effective Meaning that it has positive treatment effect for the patients and it's safe for them So so we feel like we've chosen the right regulatory strategy here We definitely have a fantastic trial design. I think you know, it's been reviewed by some of the best Biostatisticians and neuron colleges in the country It's absolutely state of the art and I love what we're doing the patients love it as well You know, we've really designed a patient-centric trial with things like patient concierge to make sure that it's Especially during covid, you know patients that come in they want to participate in the trial You know, we have a service that you know, they'll pick them up in a safe transport from their home They'll bring them to the treatment center. They'll make sure everything is taken care of all the paperwork etc. If they have to travel to a center. They'll take care of all the travel arrangements for them We try to make it as smooth as possible because You know, the sad fact is I mean in the four years that I've Been working for CNS, you know almost all the patients that I've spoken with and I've spoken with a lot They've almost all passed away and and it's it's not an easy passing it's a tragedy for them and their family and the fact that they're willing to participate in this trial I think speaks to both the lack of treatment opportunities But it also speaks to the spirit in the community of realizing that They are part of something for which there is no solution right now and even Though they are at the end of their lives They're still trying by participating to not only save themselves, but to create data for the future that may save other people And so, you know, we try to make it as easy for them as possible And can you walk me through something that I thought was interesting when I when I was looking into the company and and and it got me thinking about the addressable market because Some of the points about the company on the website it speaks about a growing addressable market for for Cancer and for for this particular issue now why Why is this market growing why is there more of a need why are there more cases Appearing what why would this market be growing? It seems like the market from an outsider. It should it should be stagnant It should be something that yes, there's outside of just population growth outside of that. There shouldn't be more Rain tumors popping right so that's scary too Yeah, so I think what we were referring to there is the Is the metastatic market? Okay, and that's the market where you've got, you know, other tumors so you've got lung cancer that metastasizes to the brain And once that happens, you know, it's got this could be used for that's right You've got the same problem right now. You've got this cancer that might have been addressable in the lungs But it's not gonna be much more difficult to address it once it's behind the blood brain barriers So, you know, we've got, you know, lots of different cancers that metastasize to the brain Not a great suite of treatments for those and so this this drug has got tremendous potential for that as well as primary as a primary drug Amazing, so 2024 is is hopefully what you're aiming for now You mentioned that there's not a lot of there's not a lot of competition. There's no other drugs that do this So from from like a from a business perspective say you say you get the full approval that you need What are the steps to actually make this the de facto treatment? Is it like the second it's FDA FDA approved Every oncologist gets a notification and email like I don't know how this whole process works So what's the actual tactical strategy so that as many people know about this as possible? Sure, I know they don't just all automatically get an email so Right Good question So in this space, you know, first of all, it's a pretty tight community of neuron colleges around the world The treat this disease. It is a rare disease. There's only 15,000 cases of it a year in the United States But again, it's almost uniformly fatal. So, you know, I often say about this. This is a funny disease When I started working on this and talking to people, you know almost everybody that I That I Talked to had some GBM story right and sometimes they were really attenuated It was their you know best friends aunts husband died of GBM or something like that and I thought to myself why How does so many people know about this disease? There's only 15,000 cases in a country of 300 million people What what's the story and then one day it dawned on me that you know if that same attenuated person had breast cancer You know, she probably got better. You probably never heard about it But if they had GBM she died and you remember it Because everybody dies from this disease almost everyone dies from this disease. So In that context anything that moves the needle significantly Defuses through that community incredibly quickly now separate and distinct from that, you know, we're a drug developer We don't market drugs. I don't think it's our strong suit I'm not saying that that is the case forever perhaps that could be the case in some day in the future But we think that probably the way to commercialize this is to Partner with a company that already has a sales force that already has expertise in your own college sales and marketing and development and we bring this molecule to them and allow that engine to help us You know push it around the world So that patients have as fast and access as possible. We're not overly worried about that step at the moment simply because You know look while there are I think there's about 243 different GBM trials going on in the United States right now So lots and lots of people are studying lots of elements of it Nothing has hit the mark and when something does hit the mark and and really move the needle for patients I think it will very rapidly become the standard of care because again This is not a disease and I you know, I don't mean to minimize or solve kinds of diseases that aren't fatal Terrible for people but this is a disease that the average life expectancy from diagnosis is 14 to 18 months So everyday counts If there's something new you're going to hear about it because if you don't you're you're going to die And so we think that the uptake will be very rapid particularly again because of the nature of this drug right one of the things again I said this earlier, but you know I learned earlier in my career that changing clinician behavior that sort of last half mile in the process of getting a new standard of care It's as hard as anything else. I mean we spent in in developing the molecular diagnostic that I worked on for 10 years we we spent five years studying hundreds of thousands of people creating a massive database doing Statistics for years on this and creating a data set that was so far beyond Any individual orthopedic surgeons anecdotal set or published papers. It was you know the biggest numbers anybody had ever seen in the space It still took us years to convince clinicians to change their clinical behavior on the basis of the result of our test And that was because what we were doing was utterly novel There was nothing like it in orthopedics nobody in orthopedics had ever considered using a you know a test This was just a you know a saliva test like we're all used to for COVID Just spit in the tube and it's going to tell you whether you're going to need surgery nobody had ever heard of such thing It's still in use. It's used very widely now, but it took a very very long time In this case because this is an anthracycling on colleges Every oncologist practicing the world today started in medical school understanding what anthracyclins are how they work How you don't use them how you do use them what their toxicity is et cetera. It says they're all familiar with those it's really You know what we call sort of old school Sledgehammer carpet bombing chemotherapy, you know anthracyclins go in and kill cells. That's what they're good at This is a targeted anthracycling in the in the organ system that it's in so we think that that kind of familiarity with the class of drugs is going to give people comfort that this is not some you know black box You know again not to derive immunotherapy, but you know immunotherapy is had almost no success in In GBM or brain cancer and it's also a bit of a black box and it's and it can be a challenge to trust it This is a this is a drug that comes from a well-known class that Uncologists are familiar with we just put it in a place that they've never been able to put it before and we think that's going to give Uncologists a lot of Confidence to use it with their patients right away And I would I would ask a follow-up in term another sort of a business question when you when you take this to market How do you balance and this is maybe a tough question, but I'm curious your mindset on how do you balance like the the pricing strategy the business objectives Versus the fact that this is a life-saving drug that people need to have access to How do you balance that pricing discussion is that pricing discussion leads to a lot of Like a lot of ethical questions, I guess because if somebody needs to survive, right? Right, they if if it's costing million. I don't know what this costs at all So I have no idea what this type of drug would cost But if it costs an exceptional amount then there's no option for them to not go with it Right, so it's a good question and it's a challenging question you know and faced by lots of companies and I think At the outset, I would say you know, we have not We have not priced this drug. We haven't you know really finished modeling those things and looking at it But I would say our goal overall is to make sure that First of all that you know as many patients as possible have access to this drug Because it is a life-saving drug. This is a deadly cancer. We certainly don't ever want to see anyone Turned away because they can't afford it Who would have almost by definition no other option you know that said we do have to balance the fact that this drug Has cost you know a tremendous amount of money of our shareholders to develop You know, we're a public company so we do have an obligation to our shareholders You know to have a return from them But I think that we will be able to balance those things effectively You know, there are strategies for that. There's strategies to assist patients You know with our help with a partner's help to assist patients that are you know Infinancial difficulty to make sure that they have access to the drug You know, certainly we plan to be aggressive in terms of our approach on reimbursement and so on And I think that you know for us again if we are fortunate to see this drug You know in an approvable position in a couple of years Well, I think we will be able to have some very You know a powerful discussions with CMS and with private payers in the sense that look um You know There really isn't another option for patients and this is terminal disease So you know we don't we you know we don't intend to hold anyone hostage for that Opportunity of course um, but at the same time you know we expect You know to have a fair return for the work that we've put into the risk that we've undertaken because it is It's highly risky to develop drugs like this. You know This is gbm is known as a you know as a graveyard for biotech companies because almost everything that's That's tried has failed And so it's a huge risk for our shareholders to take and I think it's fair to ask That the market except you know a fair return for us, but at the same time You know the number one but it's also you can you can lobby like you can lobby It's not lobby, but you can speak to insurance providers and and what and like that can be a discussion So that like you're championing that you're making them aware of what this is and absolutely Yeah, no question and you know and I mean I personally have a lot of experience with that You know the last product that I took from kind of cocktail napkin to patient use We did tons of that tons of medical review boards tons of discussions with medical directors explaining to them The you know the the cost benefit analysis of using you know a product like that and so on and I think you know We would probably be doing the same thing Uh, you know with where rubison and again another advantage for us from a business perspective of partnering with a bigger firm That does that type of work, you know in terms of marketing and sales of drugs like this is their experience in bringing the value proposition to payers Both public and private so that they understand, you know What we believe to be the case which is bruised and is not just going to you know be an incremental change You know for these patients, but it's going to be a significant life extending and life enhancing medication for them amazing I wanted to so uh last sort of last question that I want to ask you and then I want to do a couple rapid fire but 10 years from now 20 years from now What's What's the take a what's the mark that you want That you want to leave on the world that you want C and S to leave on the world What do you want people to look back and and associate with your company maybe with this particular uh This particular um disease or or issue or cancer or maybe a broader um a broader narrative or broader take away I'm just curious what you want your legacy to be Yeah, I mean for the company and for this drug in particular I would love to see people look back in 10 years and say this was the pivotal moment the focal moment in GBM This was when a new approach actually broke through demonstrated extension in progression free survival and most importantly overall survival for GBM patients with Importantly with a curative option, you know barubus and it's not going to cure everyone But if the chance is there and there's nothing else there Why would you not take that chance with this drug? I know I certainly would and I would recommend it to my to my loved ones as well So I think if if we could have a legacy, you know, it would be to be able to see those patients look those patients And their families in the eye in 10 years and say This drug is here because we brought it here Um, that would be more important than any money or any other return to me personally, you know That's what this is all that's what this is all about It's it's what the whole it's what it's about for the whole team. It's what it's about for Dr. Privy has been working on this drug for 20 years Um, there's nothing like the ability to say we changed that life, you know, for the better That's our that's our legacy and I think whether it's it's barubus and or the next drug that we work on it would be the same thing You know, we try to choose a target that's meaningful That's going to have an impact on people. This is super hard work. It's really risky work It requires a massive commitment from shareholders and for all of that effort, you know, it's it's like I don't know if I go back, you know, to my climbing days. It's like, you know, the stuff that got me off the couch You know, it was the stuff that was Beautiful and hard and aesthetic and unclimbed or rare or remote or things like that the kind of thing that on a bad day You know, when everything was going wrong. It was still going to motivate you to keep going and you know We have bad days, you know, you know, our stock has taken a beating this last year and some days you think Just anybody even pay attention to the good work we do and what keeps you going Is what it is that we're doing, you know, and why we're doing it because these are very sick people who have no other option and Boy, if I were in there shoes, I sure would want to know that somebody was fighting for me Yeah, no, that's amazing If people want to connect with you if people want to go find out about CNS Social website. Where should they go? Yeah, we're on Facebook. We're on Twitter. We're on Instagram. Our website is cns pharma.com So we're pretty easy to find if you search us in those ways You know, we're traded on the NASDAQ so wherever you get your financial information You can just put in our ticker, which is CNSP and You know, you'll find all all kinds of stuff about us all over the place Okay, amazing um a Couple rapid fire just to pull us some last like career entrepreneurial business insights from you the biggest challenge that you've overcome in your professional life What was that had you overcome it? Wow, that's a good question The biggest challenge, you know, I think um I think probably the one of the biggest challenges certainly was was financing my first company and It was just an incredible exercise in hearing no No and no and no and no and no and no I made all the rounds on sandhill road, you know And in New York and in Europe and I we had so many funds turn us down Nobody was interested in what we were doing at all Diagnostics was so not the flavor of the month like nobody cared and nobody cared about our power points and our interesting technology and our Pads and all that it was just nope. I had one fund. I'll never forget in San Francisco I walked into their office the fun manager walked in he opened up his notebook and sat down and he said So what are the genes that caused scoliosis and I said Well, that's actually what we're looking for in this project. He said so you don't have them yet And I said no not yet. It's land. There's no book. I have to walk out I'm much longer can I do this, you know, but it only takes one and the first one was Johnson and Johnson and You know pretty good first one. Yeah, it's a pretty good first one You know, but we kissed a lot of frogs. It was the overnight success that took two years, you know and You know, you just you just have to persevere you have to believe in what you're doing and you know That's I think I was sort of saying it before It's what I love about this company Everyone that is with us and we're a small tight almost a family team But we all just believe in what we're doing and it's not blind faith It's based on data that we all understand and our individual piece to the project But we believe and you know, that's what you've got to have because You hear a lot of notes you see your stock in the red a lot of days as a public company You get a lot of nasty emails from shareholders aren't happy with you And you just got to have the confidence that what you're doing is the right thing to do Yeah, no, let's say it's that I think that's what has you have to have that attitude When you're building something that's never been done before because if not You you can't you can't keep the energy you can't keep the mode like you can't keep that motivation up if you don't have it You know and it's not always other You know, you know, it's it's not always gonna work I mean sometimes the ideas that you have are just gonna fall fall flat But you know, I mean, you know, what was that great, you know quote from you know Thomas Edison He was like oh his first like 1200 light bulb tries failed and he was like oh, yeah Well, I found 1200 ways that didn't work You know, it's like that's yeah, what are you gonna do? You just got to keep going that you believe in what you're doing Yeah Yeah If you had to choose a person that's been impactful on you there's probably been many but pick one who was that person and what did they teach you? Hmm You know um, I would say probably I know this a little bit of a cliche answer, but Probably the most impactful person in my life and my career was my dad, you know, he He built You know, he he was not an entirely self-made guy, but probably as close as you could get He was an attorney as well built his law firm from nothing up to you know Big multi-city practice clients all over the country and everything and you know, I watched Some of the same things that I've talked about here and learned from him just watching you know that that perseverance that belief that you know You know, you know, even if he was the you know the David to some huge firm gliat He knew what he was doing. He had confidence in himself. He kept going You know, he survived through the mean and rough times by continuing that belief and persevering and and constantly just bootstrapping himself You know and looking around and and taking measure of what he had achieved even when it didn't feel like it was much There were always things there to be grateful for and happy for you know and and things like that It's that keeps me you know, we have bad days in the company. We have a lot of good days. We celebrate those But when we have bad days, you know You know particularly for what we do as a company, you know, I can look around and I know that So many of the patients that I've talked to over the years That have passed or still struggling with the disease would give anything to have one of my bad days Because they don't have any more days left and so It gives me a deep sense of gratitude and purpose to keep going With what we're doing because we know that the goal We think the goals in reach the goals in reach for barubisan It's our job to bring it there. We owe it to these patients. We owe it to our shareholders and we owe it to ourselves and And so you know, I sort of draw on on his degree of positive thinking and perseverance and endurance and And we keep going you know my my motto that's on my on the bottom of my email signatures is Through endurance we conquer that was earn a shackles and email if you happen to know that story But maybe one of the greatest survival stories in history and And so you know, we press on every single day even though you know Lots of people would say the odds are against us here We think we have a great solution that's going to move the needle in this It's going to take a lot more work, but this is the team to do it And you know, we couldn't be more stoked about what we're doing and what we're going to do for these patients That gets us out of bed every day keeps us going all day and keeps us telling the story because You know, we think we can change Neuron College with this drug and that's a pretty rewarding thing to be shooting for Um a book podcast source that you would recommend people go check out that you've learned from what was it and And what did you learn from it? Yeah, so I um, you know, it's an older business book. I mean, I read a ton But the first one that popped in mind was uh was the old book good to great. I love that book Talked me this super, you know guiding principle and they're like focus on what you can do better than anybody else in the world and stick to that I think this is the best team to develop a Neuron College chemotherapy drug in the world and And we've proven that I would challenge anybody to find another company with so few people and as limited resources We've had to push a drug this complicated as far as we have as fast as we have And that is because we are just 100% laser focused on one thing that we know we can do better than anybody else And that's advanced a drug like this through the clinic in into widespread use amazing I think uh, you know, I actually mentioned You know, I actually mentioned Shackleton a minute ago and the book it's called endurance. It's one of my favorite books ever if you haven't read it I would highly recommend it probably the greatest survival story ever But also the greatest story of just maintaining a positive forward looking attitude to through The longest odds on earth, you know It's it just when you read that You begin to think to yourself nothing that I'm likely to go through in life Could ever possibly begin to compare to what these people went through You know and survived and came out the other side It puts it in perspective right it puts everything in perspective. That's it. That's what it's all about You know, that's what it's all about having a little bit of perspective I mean we're so lucky to be here doing this. I mean, you know This is a dream job running a public company doing something like this. That's as good for people as it could be with people that I really love You know, I can't ask for I can't ask for more than that If you could tell your 20-year-old self one thing what would it be? Keep going Keep going You know keep going as the trick good keep going my 20-year-old self was you know Guiding and having fun, but not totally sure where the future was going to go and worried about that I would probably just tell him keep going just keep going. You know, it'll sort itself out And the last question what does success mean to you? Oh Yeah success, you know, I mean Success to me means um You know Achieving the goals that are meaningful to you, you know Not necessarily to other people