Marc Giroux, Kurve Therapeutics - Studio Interview | LSI Europe ‘22

Transcription

Nick Talamantes  0:00  

Marc, thank you so much for coming by and talking to us here at LSI Europe

Marc Giroux  0:05  

Is my pleasure, happy to be here.

Nick Talamantes  0:06  

Tell me a little bit about Kurve Therapeutics.

Marc Giroux  0:09  

Kurve Therapeutics is pioneering new neurodegenerative disease states that really are unmet entirely. There are a few things that will help relieve symptoms and maybe slow the progression for a short period of time. But the answer hasn't been found yet. And, you know, we have some affinity with it, I everybody really does, you know, I have a father who had Alzheimer's and all five of the sisters did. My younger brother Jim died of ALS. So we have, you know, but my story is similar to everybody else's, everybody knows somebody like that. But the idea that you can actually, you know, live for 10 years with Alzheimer's and be on your own to do it is not something anybody can do. And what we've been doing with the technology that we built in the platform, is to find a way to actually treat the underlying cause of why these things even happened. And the pathologies, interestingly enough, are very similar. They you know, what you get why the reasons why you get Parkinson's is very similar. The reason why you get Alzheimer's just depends on on who you are, what your body is, and what your your gene your gene history is. So there's just a lot of similarities, and we want to be able to do is get the right drugs into the brain to the right place. And the brain is just inaccessible. Until, you know, we came along, there's a lot of work being done on infusions, they seem to really struggle. We're 3,000% better than an infusion right now. So we have tremendous dose flexibility. And we just want to be the device of choice for you know, all of the things that big pharma wants to do. But we also want to do our own products, and our own projects where we have our own drug formulations in there. But there's too much to do. There's too many patients that are suffering right now. And we can't do it all. So we need partners to go and do the ones that we're not going to do, we simply cannot do. So that was probably a lot longer answer than you were looking for.

Nick Talamantes  2:12  

No, that's perfect. You know, what I do want to understand a bit better maybe is you have a drug delivery device? Explain the technology? How is it better than infusion? How is it crossing that blood brain barrier that a lot of current medicine has struggled to do?

Marc Giroux  2:29  

Oh, yeah, that's a really it's a really fascinating topic. That's good question, the crossing the blood brain barrier is done through the blood. And that's part of their problem is they're locked into the circulatory system, what we're doing is more neuronal pathways, so we get to the olfactory region of the of the nasal cavity where that it has direct access to the brain. So instead of being in the blood and trapped there, and you're hoping to have a mechanism that will take that drug into the brain, we're not enslaved to that, we're going around the neuron and into the brain. And so we're not actually in the blood or in the cell, initially. So what that does is gives us a lot of flexibility to put more drug in there. And at this point, we've just filed some new intellectual property, which allows us to then once the drug is in the brain to move it where it's needed. So we have a press release that will be coming out shortly about our success, treating glioblastoma, which is a brain tumor. And we shrunk the tumor by 50%, using stem cells, which people have said, you know, you'll never get a stem cell in the brain, nose to brain because it's too big. It's too big a molecule. It's just it's a huge cell. And I was like, Well, have you ever done anything into brain is No, we've never succeeded. So why do you think you get an opinion? And we did we got it in the brain. So you know, we have to stop saying these things can't be done, and start looking at ways to do it. But if the brain tumors in the frontal lobe, we can get that. And we did, right. But if it's in the back of the brain, what are we going to do, we're only putting it right here. So we've developed new technology, that's going to put it right there. But it's not going to absorb, it's not going to get in the blood, it's not going to get in the cell, and we're going to move it and then it will. So we can target in the brain where the the drug will be released. And it's really exciting. And we want to be able to really bring that bring that out because it opens the doors to so many more things. I have a sister in law, who passed from myotonic dystrophy not that this is a death, a death interview. But these are the these are just

Nick Talamantes  4:38  

you know, it's very personal.

Marc Giroux  4:40  

It's a you know, it's the story of how neurodegenerative diseases work and what you know what misery it causes, but her problem is center mass in the brain. So what we would have to do is move it to the side and then drag it through halfway and then drop it and we feel that we could do that now. The way it's done now is they drill a hole Linear skull and they stick something in there and they run the drug directly directly through your brain. So you got a hole in your skull that you're going to have drugs delivered to, for foreseeable future. We're far less invasive than that. And, you know, if you, if you're gonna get a choice, you know, you're the patient. Well, you can use this machine for a minute. Or we could drill a hole in your skull. Which one are you going to choose?

Nick Talamantes  5:24  

That's a really tough choice there. You know, the personal element of neurodegenerative diseases, as you said, a lot of us have family members who have lived with it, who have even passed from it unfortunately. It's great, there's a great unmet need clearly talking about the market opportunity, though, to help these people. What does it look like? How many people can be helped with your technology?

Marc Giroux  5:51  

Yeah, that's a tough number to come up with. Because if you look at all the things we're doing, you know, we're working with the army on PTSD. So how many is that working with the army on traumatic brain injury, how many is that, and then there's Parkinson's, Alzheimer's, the market opportunity is big, because none of these things have any therapies at all. And one of the reasons why we love the Reg A+ plus that we're doing here is because we get to talk to and in receive investment from those family members, the people that have a stake in this in this therapy, so we're able to form a community of people who can get involved, you know, we're a venture capitalists will give you 10 million, and that's great. But somebody could get involved with us for $600. And, you know, $285 billion in lost productivity every year, from caregivers in Alzheimer's alone. So if you could have these Alzheimer's patients who didn't need full time care, they could age in place, which is what we're hoping to provide, then, though, that those productivity dollars are back into the economy. And there's just those caregivers who are giving up all of this product productivity and the money that they could be earning if they weren't doing this. Or could become involved in our community. And they say, Well, alright, let's put $1,000 into this. And we'll get, we'll be a part of the solution to what my my grandmother had to go through what my wife went through, you know, there's always a family member, everybody knows someone. So you know, what we really want to do is wrap our arms around, everybody, bring them all in, and then we can, you know, march forward together to, to provide some real solutions,

Nick Talamantes  7:31  

Regulation A+ or a Reg A+, it's a pretty innovative financing model for our industry. You're kind of a pioneer, really one of the few companies that I'm aware of that's actually pursuing it. When did you guys start your Reg A+? How's it going? And what are you going to do with those funds?

Marc Giroux  7:51  

Well, the we're off to a little bit of a rocky start. But Scott's put together a really, really good team and everybody that's involved in it has been tremendous, you know, reality of markets is good that the broker dealer, Assurance Dimensions did a fantastic job, as you know, KoreConnect as a really good technology. But you know, Kurve was sort of built on a grassroots investor level, you know, where we were trying to get the company off the ground had just had a serious bubble burst, and all the investors are walking around with their hands in their pockets, right. So we had to figure out another way to get it off off the ground. And we did, right, we raised a lot of money through grassroots investment. And regulation A+  is just that writ large. And we want to communicate and actually be a part of, you know, getting everybody involved in it. And we are happy to be pioneers in finding out you know how viable this is because we find it very exciting. There's a lot of we still want private equity, we still want venture capital, because what we want to do is going to cost a boatload of money. But what we can do with Regulation A plus is is round everybody into it. And we're we're happy to do that. And we're hoping that's what actually happens. The key to it, though, and what we've learned over the last last six months is investor acquisition team is crucial, right? So we're focusing a lot on those ad buys and, and working with that team and capital raise agencies who we're using right now we're very confident they're going to do a good job. But you know, everybody else is going to be necessary only if the IA pice succeeds, right? We have to have no money to take it unless they get people to invest now. So that's that's what we're that's what we're here to do. And we've had nine meetings with venture capital and private equity here and we are really pushing through the Reg A+ so there's everybody gets to be involved in the way this is set up. So Reg A+ doesn't prohibit you from doing anything else. But it allows you to get other investment in that is less diluted.

Nick Talamantes  9:55  

Your technology is being looked at for numerous neurodegenerative conditions. sends it sounds like, what is regulation a fundraising going to help you do in the near term?

Marc Giroux  10:06  

Well, we've done phase one, phase two and phase two B with Alzheimer's, using insulin, we're gonna reformulate that because it's not conducive to nasal drug delivery is meant to be a sub q injection, right. But we're one clinical trial from actually launching into the commercial marketplace. And so that we're looking to raise enough money through the Reg A+ to run that last clinical trial. And that's a, you know, 18 month study. So you get the prep that study and then the application for approval. But we have one of the one of the exciting things about some of the work that we're doing is it all ties together, right, so we're working with mild cognitive impairment, that's what Alzheimer's people have. But there's a lot of flavors of mild cognitive impairment. So you have mild cognitive impairment, because you have multiple sclerosis, and you will get it because you have diabetes, or HIV. And we have a project running with a university in southern part of United States that is targeting aging African Americans who seem to develop it earlier. So we wanted to be able to help that community out. So we send them a bunch of devices, but the whole thing is, is the same drug, same dose, same device, in all of these MCI studies. So there's an opportunity to, you know, do one study, and now we have access to all of these sub groups, and we should be able to help all of them as well. But if you have HIV and your your HIV is being controlled with the drugs they did for that, but your cognitive decline is still happening, your quality of life is still terrible. And you know, everybody with Parkinson's and ALS, and all that have a lousy quality of life, we have to be able to do have the opportunity to try and restore that.  And as a as a side note, another another part of our personal journey here is when my father had it, we were working with Johns Hopkins on a couple of studies, which have been published in peer reviewed. And so I was introduced to the neurologist there, and I got my father to see him. And she says, Yes, you have mild cognitive impairment, multimers, we're going to put you on this drug, and you can use your son's machine. And nine months later, he went back in for a follow up. And he said, If you walked in here today, for the first time, I would not diagnose you as MCI. So that's the symptoms that he had had completely resolved. And now we don't know how long that would have lasted because he ended up having a heart attack. And he also passed. But, you know, the great thing was we he stayed alive for six years with after his MCI diagnosis with no symptoms. And that's, that's, that's how he aged in place. And that's how he did not have to decline and not recognize his children and his grandchildren. Be able to, you know, be fully engaged in his entire life until until the end. So and I think that's what everybody wants, right? You want to be able to stay involved with all of your people recognize who they are, and, and have a better quality of life. And we, we want to be the ones who do, who provide that. We'd also like to make some money,

Nick Talamantes  13:18  

To be able to help someone so close to with your own technology is a truly powerful story to hear about. You know, I want to switch topics to commercialization, where are you guys looking to launch first?

Marc Giroux  13:34  

You mean, globally, geographically?

Nick Talamantes  13:36  

Geographically

Marc Giroux  13:37  

Going to be the United States. So I mean, we're here we're gonna manufacture in the United States, we have a really good high volume manufacturing. VP, may be VP of manufacturing, he's internationally known consultant, we're gonna set up high volume in the United States, we should have cost parity, if everything goes right with Southeast Asia. So we don't have to outsource to cheap labor, we can do it here. And we can do it in the US. And but the great thing that we're seeing, because we want to be a global company, is we want to set up manufacturing cells, you know, several parts of the US, but then we want to put one in the Middle East and in Ireland and somewhere and sea, you know, where is it best to manufacture for the groups that we're, we're treating? Right? So, you know, Southeast Asia is open to us as well. There's, you know, this whole many people there, we could set up a manufacturing facility and do China, Singapore, Australia, somewhere over there that is better for serving that those geographic areas. But since the manufacturing that, Herman Plank is his name, very, very good guy is, you know, is cloneable and scalable so that when we set it up in Seattle, we're going to then be able to take that same model and set it up in North Carolina, or or Arizona somewhere, right? And then we can branch that out, eventually will become completely vertically integrated in our manufacturing where we're making our own box boxes and printing are robots. That's just more jobs we can create, right? So, and we get control over quality. What we do is really sophisticated, when you look at the device, you know, it doesn't look like this is this is going to be doing something that everybody needs, right? But you know, and it's a razor razor blade model, and this is empty, you just chuck it in, you put a new one on, I mean, it's so easy to do, you know, people who are dexterously impaired can still do it. So a Parkinson's patient with tremors can change a cartridge. But it what it does is something very sophisticated. And it's the only one in the world that can do it. So while everybody else is trying to reach the area, that nasal cavity that will get into the brain, nobody actually can. So we, you know, for Alzheimer's, this is a device someone's going to use for 30 seconds in the morning and 30 seconds in the evening. It's one minute a day and your cognitive decline can can be severely slowed in, you know, we had one study with three out of four patients actually regain cognitive abilities they lost. Our target was to arrest the disease, at diagnosis. They were testing better coming out. And we worked with a really, really great principal investigator out of Harvard, to do cognition in diabetics. And the serendipity of that was the control group were normals, so people without diabetes over 50, they all tested better coming out then going in. So it's just age related memory loss, you know, the same thing we all have to put up with, you know, who's the lead singer of the Rolling Stones trying to tip of my tongue? Why did I walk in this room? You know, that now we can, everybody could benefit from that. Who wouldn't want to be sharper?

Nick Talamantes  13:37  

I could do some. I need some right now. Let's talk, you're you're an LSI alum. You're at Dana Point earlier this year, you're here in Europe? How? How is the conference experience treating you from earlier this year to now?

Marc Giroux  17:08  

Yeah, the the the Dana Point meeting was our first exploration into how the Reg A+ community works and operates and all that we learned a lot there. Scott puts on a top notch show, and it was it was a real eye opener for us. So we learned a lot there. With that experience, we're able to better find to what we're presenting here. And, you know, we're we got an overwhelming response in meeting acceptances. So we've been very busy. And the the meetings have all been, you know, they've been very candid. We love that. You know, you're too early or too late. That's okay. Yeah. If we're too early, then eventually we're going to be right in your wheelhouse. So let's, let's meet and chat about it now. Yeah. You know, we're a phase three ready company, so we're rarely too late. But if that particular investor only only invest in high volume manufacturing for medtech, then we're too early. But if we're if it's a, if it's a, you know, private equity group that does startups, where we're too late, where we're too far along, and, you know, their $10 million isn't going solve our problem. So we need to, we need to engage with as many people as possible. And this has been exactly that, we get to talk to the people that we want to talk to. And now we know where to go from here. And we're learning more about reaching out to the main street investor as well.

Nick Talamantes  18:32  

Mark, tell me about strategic partnerships. Who are you willing to work with?

Marc Giroux  18:36  

Yeah, great question. And we're willing to work with I mean, there's really not a group out there that is outside of our, our umbrella, right? We can we can, we can keep people dry in a lot of ways. So there's generic pharma, specialty pharma, midsize pharma, and then there's big pharma. But they're all doing things that you know, our technology platform is good for. So we want to partner with them. And there's too much to do for us to do at all. And we want to be able to engage with all of them. And so when you when you slide across the private equity and venture capital and hedge funds, those are great and we want to play with them and we can with the Reg A+ plus is also a group we want to play with. So when when you're talking about strategic partners, if you're doing pharmaceuticals, we want to be on your radar, right? We want you to make that make that phone call. If you're thinking about doing infusions we're begging you please just stop you know, we were 3,000% better

Nick Talamantes  19:31  

Try something new.

Marc Giroux  19:32  

Yeah, let's it historically in this is something the business world has recognized for a long time. paradigm shifts come from outside the industry. And that's where we are we weren't in the medical device industry. We were developing technologies that were going to help chronic sinusitis because that's what I suffer from. It's the only reason that exists now, but I didn't have chronic sinusitis. We wouldn't have built it. So you know, We want to be all things to all people but we cast a pretty wide net

Nick Talamantes  20:05  

Well Marc thank you so much for stopping by It was a pleasure getting to hear about what you guys are working on right now

Marc Giroux  20:09  

Thank you so much Nick. It's great to be here

Nick Talamantes  20:11  

Yeah.