Amber Therapeutics: Landmark $100M Series A, and the Future of Neuromodulation for Mixed Urinary Incontinence | LSI Europe '24

Henry Peck 00:05
Thank you, everyone, for joining our next panel. Really exciting opportunity to sit down with this group. We're going to ask the investors on stage to introduce themselves in a moment, but just to level set, the panel's title is Amber Therapeutics, their landmark $100 million Series A, which we're going to dive into in the future of neuromodulation for mixed urinary incontinence. I want to ask the investors to introduce themselves, and first, for the audience to understand, one of the unique aspects of this panel is we have the opportunity to speak with investors in the company, from early investors at company inception to now later-stage investors coming in for this larger round, and those that represent strategic investors as well as more traditional financial investors. So first, we'll start at the end with Caroline. I'll ask you to introduce yourself with one sentence on your fund, your investment mandate, and what you focus on. And then we'll come around to Aidan.

Caroline Gaynor 00:48
Sure. So, Caroline Gaynor, partner with Lightstone Ventures. So it's a U.S. fund focused on biotech and med tech. Fund size is $375 million. We're typically Series A, but that said, we do invest also at the company creation stage and then later stage as well, and based out of the Dublin office, and try to keep an eye on what's happening in Europe, as well as getting rolled into the U.S. side too. So, I do both biotech and med tech.

Lillian Ann Chalmers 01:16
Hello, I'm Lillian Ann Chalmers. I'm an investor at OSC Enterprises. For the ease of this, I'll just call it OSC. We are an independent investment firm. We're kind of the new kids on the block, so this is a really nice opportunity to also introduce ourselves. We've been around for about nine years. We're based in Oxford in the UK, and our remit, Amanda, is really to find transformative IP at the University of Oxford, where we have a special relationship that allows us to see IP two to three years in advance, and we have a blanket NDA with all of the academics, and then we can invest and help build these companies. So we have about a billion U.S. dollars under management, and a team of 55 that covers everything from life sciences, health tech, med tech, which is where I operate, and then deep tech, which includes quantum, ag tech, software, and more. We do everything from last year. The smallest ticket that we did in my team, at least, was $250k for a very early-stage, kind of de-risking technology, and the largest was $30 million for our pro rata. So we follow our companies through to exit, and to date, we've had about eight exits, two listings, and we have over 80 portfolio companies. So there's quite a lot going on, and I'm really excited to be part of this.

Henry Peck 02:33
Thank you, Lillian. So...

Murielle Thinard McLane 02:34
Murielle Thinard McLane, I manage Intuitive Ventures. So if you're the new kid on the block, I guess I'm the toddler. We're four years old, managing $250 million in assets under management across two funds. Fund one is fully invested at this point, and now we're managing $150 million out of fund two, where we just started to deploy. Aidan was our first investment out of that fund. We typically invest in early-stage companies, but like Lillian, we can go from seed all the way to crossover and typically invest in the area of minimally invasive care. We're really thinking about the ecosystem and how we can help reimagine it. So we invest in med tech, diagnostics, and health tech from that perspective.

Henry Peck 03:27
Great, Aidan. When I ask you to introduce yourself, I want you to talk about Amber and introduce it. We're all familiar with Amber. We've seen the headline: $100 million raised, implantable neuromodulation, closed-loop targeting stress urinary incontinence. But I wanted to understand this is not just a story about creative financing in an awesome round. This is a story about timing and how timing plays into the unique architecture of this company, the syndicate, and where you're going. So I'd love to hear a little bit about your background and kind of the unique forces of timing here that played into you being able to put this together and Amber being able to be where it is.

Aidan Corde 04:01
Yeah, thanks. Hi. I'm Aidan Corde, as Henry said, the founder and CEO of Amber Therapeutics. I think there are two timing elements. I think there's the timing of our seed round and then obviously what led to the Series A. I think, however, an amazing idea for us in terms of the potential of the therapy that we're developing, the key part to us starting was actually having access to a really good piece of hardware that we could use off the bat. My background was more software and technology, not med tech. I made the crazy move to go from there to deal with a highly regulated medical device industry, but what I learned is that in software, the skill is that it's very cheap and very quick to test an idea to see if it has value. And I think one of the really difficult things about med tech is it can often be very long and very expensive to test an idea to see if it has value. And I think that's one of the main perceptions of why it's difficult to invest in as a sector. We got lucky thanks to my co-founder, Tim Denison, who was an ex-Medtronic guy, a brilliant engineer, because we had access to a device that he'd been using for the brain. It meant that we could, from founding the company, get to a first-in-human implant in 18 months on a couple of million dollars, or two and a half million dollars, of which half was actually non-dilutive funding. If you think about the investment story, that's like a software model where you're able to test and validate that we have a therapy that is what we think it is, very, very fast without raising a lot of money. What that does is, A, it gets you there fast; B, it builds a lot of trust with your investor base that you can execute on a timeline. Obviously, once you've proven something has a lot of value, then raising the big money, in our case, you know, $100 million to then take it to market, makes a lot more sense. Again, the paradox with a lot of the timing stories is that it can take you 10 years in med tech to get to that MVP point and cost a lot of money, and you can churn through a whole set of investors and all be quite tired at the end of it. We were lucky; I would put it down to, well, not luck, having access to Tim and this device. There are other ways to do that, but I think that was the timing of the first part of the story. The only other point I would make, which I kind of made yesterday, but with regard to the Series A, I think one of the—and I'd like the investors to maybe back me up on this—but I think one of the misconceptions of a very tough market is that in a tough market, it's actually very good for good companies with a good value proposition because the best funds all want in on the same deals. I think that it's actually in a very good market, and sometimes the best companies, there's so much noise that it gets a bit dispersed. I'm actually grateful for the toughness of the market because it brought, and we're missing any A and F Prime here, but I think it brought the absolute A1 set of U.S. investors all around the table with me, having this discussion of how we could all get involved. We might not have had that if it had been a really buoyant market back in the early days. Anyway, I've dominated the conversation.

Henry Peck 06:53
We're going to talk about that efficiency and some of the kind of conundrums in med tech, both on this panel and through some of the other sessions today. But Lillian, coming in early when you did, I want to ask you a little bit about what got you excited at the stage that you got excited about the company. Is it the market that they're pursuing? Some of these unique architecture points of the product and access they had? These timing forces? You hear Aidan's background coming outside the space. What's the founder-market fit look like at that stage? Just kind of unpack your process of thinking about the company at that stage and then maybe going downstream a little bit when you guys looked at the company, Caroline and Murielle, what got you excited, kind of, in the why now to come in on this round?

Lillian Ann Chalmers 07:30
So maybe I'll lay some background. In some ways, Aidan and I have a lot in common; we both came from not the med tech space. My background is a clinical geneticist, and my training was very scientific, so I'm a pain in diligence because, you know, when you're a geneticist, you kind of turn over every rock. I think one of the biggest things for me in diligencing and getting to know the opportunity with Amber—well, first of all, it was my first investment ever. I had just been at OSC for a couple of months at that point. I think Aidan as well; we had started at the same time. Aidan had started as an EIR, which is one of the models that we have for venture building at OSC, and I had started as an investor. I learned about things like ICs and IRRs, and I was just thinking, great, I have to produce one of these things and convince our investment committee about this new opportunity. The reason I was excited about it is, one, like, whenever, by background, as a clinical geneticist, you start with what is the clinical piece? What is the patient paradigm right now? What's missing? What's wrong with it? It was very quick, particularly, obviously, these being women's issues as well. It was very clear to me that the fit was there. We had to do just a tiny bit of diligence to understand that not only is this an underserved market, but the technology paradigm is basically lazy, to be honest. There’s tons of stigma that means we're only scratching the surface in terms of the population that we do know, and current treatment is just ridiculous. It's like, you know, you try one thing, it doesn't work. You try another, it doesn't work. Well, maybe she won't talk about it again. It was just a lot of that core problem statement that struck me. Obviously, huge market. Aidan and Tim had a very compelling vision on how they were going to bring things together. Tim was the leader in the brain space, and he's just like, you know, the plumbing area, the technology they're using down there is dumb. Let me show you how we can lift it. We just sat down, and it was incredibly compelling. It's funny; I look back at the investment memo that I wrote, and oh my god, it must have taken a lot of time to do that, but I think because, you know, a Class III implantable is not for the faint of heart, and I wanted to make sure my first investment memo was the best. In that, you know, every question that there was, and I retrospectively apologize to Aidan and the team, but we spent a lot of time on diligence, even for a small ticket at that time, because we wanted to make sure that we understood how to future-proof this. Yes, we have a system right now that enables us to go first in human right away. But that's someone else's system, and other people have systems, and what does it mean going to market, and what does it mean for the exit at the end? I think it was that type of questioning that we brainstormed initially, and that allowed us to develop quite an interesting strategy early on for such an early-stage company. So yeah, that was the exciting bit for me. This company, in some ways, is kind of also my baby because we started from such a young stage with it. So it's incredible to be sitting on a panel where we have, you know, proper blue-chip investors coming in and kind of supporting the journey onward.

Caroline Gaynor 10:32
From the Lightstone perspective, I guess a couple of things, and probably more than a couple. We've always had an interest in the OAB space, or incontinence, I should say more generally, and had taken many pitches over the years. I think internally, there was an acceptance of the potential nerve as the brain of what we're trying to do. We never came across anyone doing that. It always struck me that, you know, women with incontinence are forced to choose whether the OAB or SUI, which is more annoying. It's like they're both really annoying. We need to deal with both of them. The proposition of women having one quite invasive procedure and then having to do another suboptimal procedure to deal with the SUI component never resonated. So when we came across Amber, for me, it was pretty exciting to see that we could, for the first time, address both indications in one. So that was the thing that got me really excited. Then when we met with the team, Aidan talked about it, you know, just proving your concept real quick with off-the-shelf technology. Now, you can't do that in every indication; I understand, but here there was the possibility we could partner very closely with the foundry, and that's their whole ethos. There was a kindred spirit vibe on that pitch. I know my engineering team came off pretty excited. You know, these guys have actually pulled stuff off the shelf and done what we wish every startup would do: just prove there's a there there. That was there, and it also gave us confidence that this team thinks like we do and wants to achieve the same things we do. Then it came down to the usuals. You know, who else is around the table? Take the financing risk off the table. Do we have a nice clinical strategy? Everything started falling into place for us, and we got pretty excited. Again, I know we said it, but it really is a huge market, and it's massively under-penetrated. If you can bring that right product to the right patients, I think there's something special here. It's the right agile team, and I love the kind of tech mindset. It's a little bit like the foundry incubator vibe of, let's just keep motoring on because the expensive part is all to come. So let's just prove it's worth putting all that money into. So I guess that's what got us excited and around the table, absolutely.

Henry Peck 12:34
Murielle, I want to adapt the question a little bit using something that Caroline just said: that the expensive part is to come. Obviously, you're in this for a while, but as Aidan was talking about, this is a very unique opportunity to repurpose technology that Medtronic doesn't already own for this purpose and apply it to a space that's massively underserved. You represent the strategic side of the equation, and obviously Intuitive Ventures is a little bit different than some of the corporate balance sheet CVCs, but we were talking a few minutes ago, you know, after Duke's keynote about the efficiency problem in med tech and the new models that are needed. This company seems like it fits into this kind of new model, new paradigm. Talk about how this compares to a little bit of the problem we see in med tech more broadly, and how, as a strategic, where on the other end of the equation, strategics are buying things later. M&A has had some challenges. How does this differentiate from the pack, potentially in med tech, and align incentives better between investors and the company itself?

Murielle Thinard McLane 13:36
Yeah, so I would say the—

Henry Peck 13:38
Go ahead.

Murielle Thinard McLane 13:39
I mean, kind of, I'll step back to part of why we invested is exactly because Aidan did this sort of step forward, leap forward in development. I met Aidan when he had done just a few experiments; he hadn't bought the company yet, and we were sort of saying, great, great way to actually get through the paradigm of the development. Now go, go, show me you can execute in acquisition and integration. To me, that was the biggest piece. We knew there was a massive need. We knew that he had it there, but show me you're the guy that can actually go execute around it, and you have the right team around you to do it. We talked for 12 months, I think through that process, a little longer. I'm going to get to the why the corporate. So what Aidan has done is what we want to see, frankly, more of: entrepreneurs that can execute faster. Yes, it's going to take a lot of cash. So then it's about the syndicate and who's around the table and do we have the same vision for the company, a big vision, and go execute around it, and not necessarily thinking about strategic as acquirers. I mean, this needs to be a standalone company, not just a tuck-in for somebody else. For us, it was really that vision, or for me, that vision that got us to be excited and come to the table. Now, going to corporate, yes, everybody wants a de-risked asset that's cheap. It's nothing new there, and that's what they do—coming later and paying less is certainly something that everybody wants to do. The market forces are the market forces. I would say that, yes, you'll see acquisitions that may happen later in some spaces because it's about getting traction in the marketplace and execution or sooner. But at the end of the day, what a strategic is looking at is not only the clinical data, but it's the team, and can they execute around it, and how cost-effective can they be at executing? Does that make sense, rather than developing internally? At the end of the day, we're all trying to optimize our capital deployment.

Henry Peck 15:56
Aidan, talk about acquiring and integrating the company. What Murielle was referencing, I'm not sure everyone knows that story of acquisition integration.

Aidan Corde 16:05
Yeah, I mean, it's a good one in the sense that we were, again, lucky, on the one hand, that we got to buy the company at the exact right moment. If we had to buy the company at the beginning, it would have been a very hard sell to investors to buy some old company that's made hardware for a long time to go and test an idea. I would say that Tim and I always thought that we would get a chance because we saw how the company was doing. We loved the device and the engineering team, so you just got to go forward and hope you get the right moment. The company began to struggle a bit, I would say, sort of early summer last year, and we kept pressing and pressing, and then, you know, in hindsight, we got to buy the company at the exact right time. We'd had our early-stage clinical results that had proved the value of the therapy. We were homeless at that point. So, you know, if we hadn't bought this company, I don't know what we'd have done. We certainly wouldn't have raised a big round. We'd have probably had to farm out our therapy idea to, you know, the dreaded strategic at that point. The great thing is we did the deal to buy the company just before things got really tough. When you buy a company, you never want to buy a company that is a fire sale because you've lost culture and people, and everyone is sort of gone. We managed to navigate by the team, taking the assets, even making the existing shareholders happy with the kind of the way the deal worked, even though it wasn't a kind of ministerial acquisition for us. Then you do have that secondary problem of now we were vertically integrated. We owned the therapy, we owned the hardware, we owned the manufacturing. We were really a genuine threat to go the whole way, and that was critical to the story. But again, timing-wise, we were super lucky at the beginning. We didn't own anything; we just had a therapy idea we could test fast, then we could buy it, then we could buy the company. As everyone knows, integration is hard because you inherit a culture, and we are a fast-moving, more tech-like culture. The fact that this company had been around for 20 years meant the people who were still there were very resilient, but often there's a cultural difference. There is a very critical period about making sure that you can navigate that correctly and kind of instill your culture and keep the right people. So I would say, really, as of just now, that integration process is, you know, we've consolidated, but it was our biggest opportunity, but a very difficult one to navigate.

Murielle Thinard McLane 18:16
If I could add, like, some of the magic there, and Aidan mentioned it a bit earlier, I think he made quite a lot of interesting early decisions that helped at least the case that I was building. Again, back to the dreaded IC, our Investment Committee, because basically they're like, hold on. You just seeded this company a year ago with a tech guy as a CEO, and there are four people in the company. We only have readouts on three patients, and you want to buy a whole new company and integrate it. There are about 30 people in that company. It was a fun IC moment, but I think some of the decisions that Aidan had taken early on, so he had de-risked our investment, and we always encourage that with non-dilutive funding. That was really interesting because he had applied to a public body to get the non-dilutive funding, which was almost equal to what we had provided. In some ways, we had seen experts in the field both validate and kind of go through their own line of diligence to make sure that that clinical piece and the market piece were validated externally from a needs perspective as well. He was kind of nimble and agile, and hadn't diluted himself. The founders were still driven. There were four of them working. I mean, at that time, Aidan, we were still all on Zoom; for the longest time, no one had met because this was still like post-COVID, where the UK was a bit mad. A lot of that work had started without anyone physically having met. Meanwhile, on Zoom, I'm making the case for our IC for, hey, let's do this. There was a moment of insanity where, like, actually, listen, we've read out positively. This is looking so good. There's an asset that's perfect. We did our technical diligence on the side. We spoke to all the top people, and they all said, by God, this device is exactly what this company would need. It gives you all the optionality, and it just kind of makes sense in an insane moment where also the markets were going down, and no one wanted to put money in early.

Aidan Corde 20:07
I mean, I am very grateful to OSC for that particular moment. There are not many funds that effectively lent me the money as a convertible loan, so I didn't have to price around at a very bad market, at a time where that was just them putting their neck out to support me in this acquisition that honestly has made the whole difference, not just at the fundraise, but giving us what we have today. There are many examples where you get given a, you know, $10 million loan to buy a company to do an integration ahead of a big fundraise with no visibility on that fundraise being successful. In hindsight, it all makes total sense. If we hadn't bought the company, it would have taken 10 years of work to get to this point, you know, so it was worth it. But I'm just saying it's a very nice investor story, which you don't have that many of, where someone actually puts their neck out, you know, in a market that's high risk.

Henry Peck 20:49
Yeah, it's a testament to the value that the strong investor or founder partnerships can add. I am curious, you know, now having a strategic on the cap table, obviously, is an evolution. You bring in Lightstone as well. As you mentioned, partners like Tiffany from NEA and Kevin from F Prime that are not here on this panel today but will be with us in Dana Point, I'm curious, what has it been like having a strategic on the cap table? Caroline, I know you've worked with strategics on cap tables in other companies. What's it like working with strategics on cap tables and companies at this stage?

Caroline Gaynor 21:19
Look, coming from—

Henry Peck 21:21
I mean, and I'll plug Murielle here.

Caroline Gaynor 21:24
I mean, I come from pharma, so I was a nasty strategic at some point. I think what it brings is that product focus. They know the market. They know what it takes to actually get there at the end. It's great because Aidan gets this, but so often what we miss on teams is having that right understanding that this is a product. These are the marketing messages I need to deliver at the end. Now we work backwards and figure out the perfect trials, and having a strategic is great because they live that every day. That's how they think. That's the mindset. So at this stage of the company, I think it's helpful because they can always help back up that story and give you sort of where you're going at the end of the day.

Murielle Thinard McLane 22:03
But an extra point on that, which is, I think we get, with Intuitive, the benefits of a strategic without the drawback. They're not a strategic like a buyer strategic in terms of they're not in the urinary incontinence space like a Medtronic or now Boston, but they think like a strategic because that's where they come from. I can just say, even from the due diligence process, there was a very different flavor of questions being asked and the kind of the way that the due diligence process ran with Murielle compared to the other strategics. Things like reimbursement and the pay environment is one example I can think of, and that was one thing from our company. We got immediate feedback, being like, they're asking really interesting questions. They're coming from a different perspective, and that's where it's valuable.

Henry Peck 22:46
Yeah. Murielle, how is it different for you when you're on a board like this and working with a company that is kind of outside Intuitive's core focus areas versus when you're on maybe a robotics company or an adjunctive digital play to something that offers direct value to one of Intuitive's core business units?

Murielle Thinard McLane 23:02
They're not the only one. About half of my portfolio is actually outside of the core of what we do or not having collaboration necessarily with Intuitive. I would say that for all of those companies, what's common for us is having a grand vision and being transformative in a space and having the right syndicate to help execute. To Aidan's point, we really think about what is it going to be like when we're in market? How are we going to be successful commercially? Therefore, what does it mean in the development process? We try to be very diligent about bringing that back, being in our core, not our core, frankly, is very, very important. I came from biotech as well earlier in my career, and I remember very much having to deal with portfolios where something was developed. They throw it over the fence from R&D to commercial, and they're like, go sell this here. We're trying to come a little earlier and be able to really look at product-market fit. That's something that, I must say, Aidan and indeed the board here are extremely receptive to, and I really love working with folks that really think about this in a different way.

Henry Peck 24:23
When you think about the arc of the company, obviously, we're hearing a lot about what Aidan's done well and what Aidan and the team have done right, both in terms of timing with the development and efficiency, but I want to ask you and your investors a little bit to tell on you what has Amber maybe gotten wrong or not done as well. I think we see the headline, we assume that it's been nothing but success and smooth sailing up to this point, and it's going to continue to be that way. Aidan, maybe I'll start with you: a mistake or a learning hiccup in the road, and then to the investors as well, kind of piggybacking on that, or a similar example of where there was a learning or a rough patch that you were able to work through together.

Aidan Corde 25:01
I would say, I'll think of it. I'm going to try and take a mistake. But the hardest thing, so underneath the glossy surface, is actually keeping the momentum. It's been a rapid first, you know, period, as I said, from going from inception to this fundraise. It's very, very hard to keep that momentum. We have so much work between now and the next real value creation moment, which is, you know, FDA approval. Now we have to internally build value all the time and keep the team incentivized, keep trying to work at the same pace, but it is hard and slow. I think, for me, the hardest thing underneath the gloss and the fundraise is how can we take this startup, you know, almost tech mentality, keep the pace of the team without burning everyone out, and keep the value creation story at least internally as we move towards the next big milestone. In terms of mistakes, I think the hardest thing, as I said, was actually acquisition and the integration, but it's absolutely necessary. It's just keeping, you know, everything with a good company comes down to people. How you keep the right people engaged. My three co-founders are now more full-time at the company, but at the time it was remote. They were all working with their universities, and just, you know, it was quite a fragmented environment, and it's very hard to drive culture and momentum. I think those were the hairy moments. I think now we're building a new facility, and we've got some capital. We're in one place. We can navigate those. But I think the hardest thing for me is the maintenance of momentum.

Henry Peck 26:23
I want to press you a little bit before I go to the investors. Obviously a very different scale, but I was working at Oris Health when J integrated us. Obviously, there's been some news around that play out, but fully remote during COVID, they buy us, and six months later, they buy Verb, put all the companies together, move the office from Redwood City to Santa Clara. We're all on Zoom, and they say, play nice. I think there are a lot of things they would probably want to do over in that process. For people acquiring a team of 30 new technology, is there anything you would do differently that you look back on? You had success with it; obviously, you came out the other side, but anything you would do differently?

Aidan Corde 27:56
I think you hit the nail on the head. I think enforcing more in-person, Scrum-like work. I kind of accepted that we're a remote culture, and we had also the trouble of being in four different locations and doing a trial in Belgium. Seeing now the amount you can get through when you put everyone in a room so you're not leaving until we get to this next juncture. I sort of wish I'd done a little bit more of that. It was hard, but it was doable if I had created more like we need to do, you know, close out this phase gate of a submission process. The way we're going to do it is I'm going to get a hotel room and get everyone in the company to come spend three days until we leave. I think we could have been a little bit more efficient and not had some of those slightly corrosive interactions where people are stewing over a week offline, and you don't find out about it. We still move fast, but looking back in hindsight, there's just nothing beats getting everyone in a room and hammering it out. I think I would have tried to do that.

Henry Peck 28:50
He still seems too perfect. Can you give me something from the early day one?

Aidan Corde 28:56
Just out of interest, because sometimes we end up like the lights are shining, and we talk to everyone. I don't quite know who's here, just to kind of work out what flavor the dirt should look like. I try to work everything in the crowd. How many investors are in the crowd? If I can never even see—oh, wow. So there's everyone else. How many CEOs in the crowd? Oh, fantastic. Okay, great. And then I guess the rest are strategics, the dreaded strategics, or whoever else. Okay, this is helpful because I think sometimes we end up talking and not necessarily catering, but actually the two things that I was going to mention actually apply to the majority of the crowd. We find quite a lot, especially with companies that have academic roots and academic founders, that for all the right reasons, the company initially is in preservation mode and is very dilution-sensitive. They really think hard about, well, do I need this? Et cetera, et cetera. I think Aidan drove a really tough negotiation game. That's a Christmas I'll never get back. Thank you, Aidan, but that was a time where I'm like, Aidan, I'm pretty sure you need double that money. This is at the outset. He's like, No, I'm going to get diluted, and I don't need that money, and this is the valuation that I want. I was like, well, you're kind of 10 times over where I think the valuation should be, but we reached a good point. But gosh, that was hard. I think that discipline that he had on iteration, being agile, but kind of dilution-sensitive, I think from a—I completely get it. I would do the same if I was in his shoes. In some ways, I think you're a different DNA, but that requires tenacity because basically, then you guys all ran raw, right? I don't know how everyone didn't burn out because I think you should have raised the initial round. It should have been twice what we put in. This is even before the acquisition. Just to give the man and your team some room to live, really. I think you worked incredibly hard, exactly. But the interesting bit is flipped now, right? I think that spirit and you've learned the team has learned through it. The spirit is different now because $100 million raised is exactly the emphasis of that. This is saying we need to get somewhere. We're probably going to make mistakes. We don't want to waste time going out to market again because going out to market is an incredible opportunity because we get these beautiful souls, but also incredibly tough, right? Like you're Aidan; you were working 150% doing diligence, and then there was the company to run. So seven months, yeah. I think it went from a place where you didn't raise enough capital to begin with, and you ran extra hard. Now I talk to all of my founders about exactly that: think about just give yourself 30-40% more because you're going to need it in med tech. But now I think we've done exactly the opposite with this story, whereby we're just thinking hard about let's just make sure we have that buffer. Like, think carefully.

Aidan Corde 30:46
It sounds like a lot, but it would still be the cheapest, you know, raise to get to FDA approval if we could. I always like to caveat my team with that as well. I mean, even Axonics took more capital than that, I think, to get to their FDA approval. So it's not that much.

Caroline Gaynor 31:00
I want to ask you, you know, coming in now, when you think about, we're looking a little retrospective on some of the past challenges. In the next 18 months, what do you think are going to be the biggest challenges? What are you thinking about now as the risks you need to retire, the things you're, you know, oh boy, I know we're going to have to work through this, or I know this is coming, and I'm getting prepared for it.

Caroline Gaynor 31:19
I mean, look, that's half the reason behind the $100 million, right? People always ask that. I think as early-stage investors, you see you don't get value necessarily for all this hard piece to come. You get value for when you've actually proven it. That was a bit of the reason; all the hard bits are to come. We have a proof of concept. This is essentially a double indication that no one's gone after before. There'll be all that complexity around how you run that trial. How are the endpoints look? How are we going to get there? How many pre-pivotal studies do we need to do? That's all how you know what we're working through now. On top of that, you know, as we mentioned, Aidan coming into this startup from a startup $200 million raise, there's a lot of team that has to be built out. You're trying to manage getting that plan forward right because you get one shot at it. As he rightly said, $100 million is actually pretty cheap to get to FDA approval if we do it right, but it's a lot. I would say there's a ton of complexity ahead. We're at the very early stages, but I think the board works really well together to make sure we're trying to at least risk mitigate where we can and come out the other end of this with the best possible data set. But yeah, work in progress, I would say. It's all ahead of us.

Henry Peck 32:33
One more thing, one more question, kind of before we go into the wrap-up here. I love it, and Murielle's perspective on it. If you ask investors, a lot of times what they're looking for, they're looking for outstanding founders that are running super capital-efficient companies in giant markets with no competition and super easy to find, right? If I had wheels, I'd be a wagon. But a question for you, Aidan: how do you think about competition? Is it validating of the space you're pursuing? Is it a headwind that you're going to have to deal with? Is it something that has played into your conversations with investors previously, as either an impetus or a motivator? How do you think about the competition in the market?

Aidan Corde 33:10
I think about competition honestly as the best thing because it drives interest. Having people interested in the space and developing products, if you're Axonics getting sold for $3.7 billion to a company like Boston, all that drives interest and attention to your space, which ultimately makes it more valuable. Obviously, what I don't want is, when I say direct competition, someone copying our therapy or trying to do exactly what we're doing and having more money and going. But we don't have that right now. I think the more energy and innovation that is being applied to the space brings attention and light, and improves the value and ultimately will serve the market better. That's all positive, provided our product is always better. You know, you know. So there are two elements of competition, but on the whole, it's very positive.

Murielle Thinard McLane 33:50
When you think about competition, how do you think about it when you look to invest in companies?

Murielle Thinard McLane 33:54
Competition is healthy. I mean, to Aidan's point, it's really hard to be a market maker, so it's a lot easier when the market actually understands the problem and that there is an inferior solution to what you're coming in after. That was one of the big attractions here. Aidan is looking at SUI and OAB at the same time, so he's looking at a market that obviously others have developed. There's a really good understanding of the problem while coming at it with a very superior solution, frankly, and that was really what attracted us. It's really, really important. We haven't invested yet in an area where it's like, hey, there's this new market that nobody's gone after before. Being the first in any market is really hard, so we look at it as it's healthy to have competition, and we want to come at that market with a very novel solution.

Henry Peck 34:51
Fantastic. We'll start to wrap up here, and I'll start with Caroline. We'll work our way down with some closing thoughts. The question I'll pose for closing thoughts: when we all reconvene in March in Dana Point in the U.S., we'll, of course, have Aidan, and we'll have a regroup of where Amber is. It's already booked; you're done; you're there. But we'll also hopefully have some of our other friends, like Tiffany from NEA and Kevin from F Prime, to speak to the investor side as well. Where will we be then with Amber? What will have changed, and what will be the things that you know that we're discussing around the future of the company?

Caroline Gaynor 35:26
Yeah, well, I would hope at that stage we've possibly pinned down what worked clinically or what direction we'll pursue and how we're almost there. From that perspective, the road forward would be a ton clearer, and team additions will be made and booked up, and we'll be hopefully in a great position to start executing that speed like he's been proven so good at doing to date. So all Z, I hope.

Lillian Ann Chalmers 35:50
I think Caroline covered most of it, really. I mean, to me, it's been really interesting to see kind of the hurrah and hurray about the raise, and now seeing Aidan's face sprinted on buses all over town, or it feels like it. Everywhere you go, there's something about it. I mean, that's great that you guys have been celebrating, but really, the real work starts or continues now. I'm excited to just, let's remove the facade of $100 million financing and kind of join the rest of the conversation, which is there's people hard at work doing really difficult stuff, and we are excited to share progress, just like everyone else in this room is. I'm excited to get to that point, and hopefully what will be in Dana Point is you'll have someone else that you've printed the face of on a bus, and someone else is celebrating. No more magazine articles for a while. Thank God. No, those are really like LA, by the way, but no, genuinely, I think, you know, celebrations aside, and welcome to everyone on the board, and that's great. But I think the board's attitude, at least, is let's get to work, and Aidan's first call when I had a call and we knew that everything was closed was a congratulations; the work continues and starts. That's exactly the attitude on execution that allows us to back home. So that's what needs to happen.

Murielle Thinard McLane 36:59
Execution and scaling. I mean, it's really, really important right now. Well, no, it's, but it's, that's why you raise $100 million, right? It's in order to be able to get the team to go and execute and get to start looking at, okay, what's the clinical and regulatory strategy? How do we execute on it? Even having started to do some of that hard work. So I concur; the hard work has just started. Not that there was some hard work before, but we're doing it at scale this time.

Aidan Corde 37:28
For me, I don't want to put a timer on it because we know, as from the last panel, the idea of doing everything on time and budget—you don't want to have to swear by that. It's like it's being recorded. But for me, you know, I'm paranoid about getting to the next clinical validation point. Until we have the next set of implants based on all the modifications we don't, we kind of don't know where we stand. Since our first in human, we have a mountain of work to get there, and we won't have started a trial, but hopefully we're pretty close to the European feasibility by the March panel, and it's all invisible work. Until we have completed that and get to the clinical validation point, we don't know where we stand, so I'm paranoid about getting to that point. Maybe for LSI the year after, then it's the interesting part.

Henry Peck 38:11
Love it. Well, great. Thank you all so much for joining me. Thank you, everyone, for speaking with us today, and enjoy the rest of the day.