Can Sirona Rival Ozempic? A New Chapter in Obesity Treatment with Camilla Easter

[00:00:01] Susannah de Jager: Welcome to Oxford+. The podcast series for innovators and investors brought to you in partnership with Mishcon de Reya.

Our guest today is Camilla Easter, CEO of Oxford Medical Products. Camilla started her career as a vet before pivoting into the world of startups where she sought the opportunity to make a real impact on the world. After five years fast-paced work, culminating in a role as COO, Camilla took on the role at Oxford Medical Products in 2019. Now on the back of clinical trial results and an IDE approval to start a large scale trial in the US, that dream of impacting billions of lives is closer than ever. With their obesity fighting pills, Sirona being offered as an alternative to GLP-1 therapies such as Ozempic and Mounjaro. They are poised to deliver results to those who can't use existing therapies or who want to be weaned off them.

Camilla, thank you so much for joining today. I want to start off by getting a bit of context for Oxford Medical Products, what you're doing, what stage you're up to.

[00:01:03] Camilla Easter: Super, and thank you for having me. I guess a little bit of a background on Oxford Medical Products, OMP. We are a totally different solution for obesity, and for weight management more in general. When we look at this market I think it's useful to take a step back and understand the problem, and then I can tell you a little bit more about the solution.

Currently we have over 2 billion people worldwide living with overweight or obesity and when we look at places like the US and Europe, that's sort of 60, 70% of our population. At OMP, we took a step back and we said, well, when we have a disease that's affecting so many people, with so many different demographics and backgrounds, it's a very complex disease, we need multiple solutions. We could see these incretin hormone therapies coming through, and we said, let's do something different. Let's go back to basics and let's create a non-pharmacological treatment for obesity, which is what we've done.

[00:01:59] Susannah de Jager: Amazing. Why don't you explain a little bit about the actual technology you have designed, but also if you wouldn't mind,how you designed what you wanted to produce, because it's a little bit atypical for things coming out of Oxford.

[00:02:12] Camilla Easter: Absolutely, so when we looked at this problem, we said, well, what else works? You know, how else have people been treating obesity? And of course the obvious solution is diet and exercise, and we can go into the complexities around that and why that doesn't work on a society scale. But also bariatric surgery. Bariatric surgery works incredibly well on an individual basis. But when we look at the world's population, we cannot operate on 2 billion people. We don't have the resources. It's far too expensive, and to be honest, it's just too invasive as well. But at its most fundamental, essentially what bariatric surgery is doing is it's reducing the available volume in your stomach.

So we said there must be a less invasive way to do this, and so between our founding team, we have come up with our technology Sirona. So Sirona is a dual polymer hydrogel. Which means it has ability to absorb water very, very rapidly and expand multiple times its size. So essentially what this means is we've created a pill, you can just take it home, comes in a blister pack, looks like a paracetamol, and when you swallow it with a glass of water, it expands really rapidly in the stomach to about the size of a golf ball, and there it stays for several days before it breaks down and passes naturally.

What this means is by taking one or two of these pills a day, you reduce the available volume of your stomach. You reduce the amount of food that you will want to eat, and ultimately, of course, that leads to a calorie deficit and weight loss. But in a much more manageable way for the individual taking away those desires to eat and that urge and that hunger that we have when we're dieting.

In terms of how we got set up, it was very unusual, as you say. So, I personally had worked another university spinout several years ago. Chairman Nick Edwards, again, very involved with the ecosystem, and when we came up with this concept back in 2016, it was at a time when the university structure of spinouts was very different to what it is today, and I'd like to sort of say that, but the university we're taking quite a lot of the percentages of these spin outs of companies and just wasn't something that we wanted to do at this point. We'd come up with this idea completely outside of the university. All of our founders were outside of the university and so we said, well, let's not go and spin out of the university. Let's go and see who their best material scientists are cause of course they do have

phenomenal talent at the university. So, Dr Xue Min, who is our CSO, she was just finishing up her DPhil there in biomaterials and we took her out of the university. We employed her directly and she essentially did a postdoc, but within the company itself.

So by the end of, I think it was like two and a half years of iteration after iteration of different materials, she came up with what was to go on to become Sirona and that's when we really put the core team together, and got going from there.

[00:04:51] Susannah de Jager: Because you have a different equity shareholder base, because you're not a university spinout, how do you think this has impacted the shape of your investor base? Both positives and perhaps any negatives that you observe now with a bit of hindsight?

[00:05:04] Camilla Easter: When we got going, rather than having OSE on board in terms of that big fund behind you, which a lot of university spin outs will have. We did a much more, I guess, historically traditional route. So we went to high net worth individuals around the Oxford ecosystem and did our pre-seed like that.

So it was just funded by high net worth individuals who maybe had founded their own companies here, et cetera, and then of course, as we, became bigger and we had to raise more money, we just went to London, to Cambridge and the rest of Europe ultimately and put our seed together with some sort of sector agnostic that sort of seed VC funds.

And what that meant was it was a slightly different route. We didn't necessarily go down the pure biotech route that we may well have done, I think if we had been more closely sort of related to the university and to OSE at the time, and so it did give us this broader shareholder base and interestingly I think if you'd asked me that question 12 months ago, I would've said, I think that was quite a detriment to us. I think we needed that more sort of scientific, biotech base, but actually, today what we've seen with obesity as a disease and the way it is being treated it's a much more consumer approach.

So when you look at individuals, buying Mounjaro, sort of Zepbound or Wegovy, which are the two drugs from Lilly and Novo for obesity. 95% of people in the UK buying those drugs are buying them out of pocket. They're going on telemedicine and they're paying for them themselves. This is not being reimbursed through the NHS. This is not being reimbursed through any healthcare system really in Europe. Not across a scale that it ultimately needs to be, or in fact is being used. Now we have this different small sector agnostic shareholder base, which is really coming into its own as this becomes more of a consumer driven treatment option rather than your traditional pharma biotech.

[00:06:53] Susannah de Jager: You and I have spoken about funding in the current macroeconomic environment, which for anyone listening when we record this, we are right in the middle of the Trump tariffs. In fact, yesterday he announced for context the tariffs on the film industry.

So that will tell anyone listening where we are in the playbook, where in sort of early May. It's a nightmare for a company, any company, raising money. How are you seeing that your investor base is responding to that? What are concerns that you have and where are you at with that?

[00:07:23] Camilla Easter: So we finished our most recent trial, really towards the backend of last year. So we started gearing up for our Series A towards the backend of last year. and we were getting some lovely meetings in the diary. We were starting to make fantastic relationships, and interestingly as the tarrifs really truly hit, I think everyone took a sort of sharp breath in and I would say everything just slowed down. It wasn't so much that the whole landscape disappeared, but you know, meetings took longer to get in the diary. Everything just seems much slower at the moment, and that's true, you know, we are speaking both to VCs, but we're also speaking a lot to strategics at the moment and of course those strategics are being incredibly affected and they have to work out, you know, where do we manufacture? What's the influence of these tariffs on us? And so everything has really slowed down and we can see that across the board in terms of deals being done. We've got to, as a sector, really just ensure that we have runway to weather this period.

It will be fine. Things will pick up. But ultimately we have to survive this slower period.

So at OMP, we have been making sure that we can deliver on milestones that we can do within our current budget.

So for instance, and we just put in our IDE, so this is the approval that we need in order to conduct our big pivotal trials to get market approval for Sirona, and that's something we were able to run internally ourselves with the team that we have, and we flew through that process and I was also conscious of what's going on at the FDA said, right, we have to execute on this now before more changes at the FDA. We can already see the rapid changes. So I think just being adaptive where you can to the current climate is all you can do as a CEO.

[00:09:04] Susannah de Jager: Yeah, and it's an interesting one because I think for some companies that are so US focused in terms of their domestic market. It's going to be very unsettling, but you have a product that affects so many people or that would be beneficial to so many that hopefully you can pivot and refocus.

[00:09:21] Camilla Easter:

It's an extraordinary market that you are in. It does have this global application. How are you narrowing down where you are focusing and how do you see that puzzle? So as I said, we've approached this disease very, very differently. We've got Lilly and Novo dominating this field with their incretin hormone therapies, which are very effective. There's no question about it. But when we have a disease that is affecting more than 2 billion people, we need these multiple tools.

And so from the recent data from a study we've just done across actually three NHS hospitals, we were able to see that our products working incredibly well, but particularly in individuals who have a lower class of obesity. So we looked at people with a BMI of 30 to 40, and we found that people with a BMI of 30 to 35, which is class one obesity, responded incredibly well to the treatment. And then in sort of further discussions with the FDA, going through this IDE process, we have actually decided, in our pivotal trials, to look at everybody with overweight and class one and class two obesity and that's because of our risk benefit profile. So we saw phenomenal side effect profile we saw sort of very little, almost no vomiting and diarrhea and constipation, which means we could be very, very suitable for people living with overweight.

Whereas these GLP-1s are licensed for people with BMI of 30 and over, or 27 with comorbidity. So really trying to be sort of preemptive in our treatment approach there.

Secondly, the other area that we think we have huge potential in is in the weight maintenance space. So what do we do with these millions and millions of people taking GLP-1? They're working incredibly well to reduce their weight, but we also know that 70% of people stop taking these drugs within a year.

And further to that, we also know that 70% of the weight comes back on within 12 months. So we must find a way to keep that weight off long term. The weight is lost as fat and as muscle, and we don't really want to be losing muscle, particularly as we get older, and unfortunately when that weight starts to come back on, it is nearly all coming back on as fat. So these individuals end up in a worse metabolic state than they were before.

So we believe that Sirona could be an absolutely fantastic option long term. So you take your GLP-1 if that's appropriate for you at that stage. You lose that weight and then you transition onto Sirona for long-term weight maintenance. Because of our safety profile, because of our cogs, we're very, very well positioned for long-term weight management.

[00:11:45] Susannah de Jager: That makes so much sense and particularly. You know, another thing you haven't even touched upon, especially there, but we all know, is these things are expensive, and I was incredibly struck by what you said earlier in the conversation, that 95% of people are paying out of pocket. So that's a huge contributing factor as well, that they're just too expensive for people to fund themselves long term.

Also, when I was looking through your deck, which is just so excellent and full of slightly terrifying statistics, if I'm honest, about the unknown consequences of some of these drugs long term, like osteoporosis being another one in terms of stripping out,nutrients. But in that cohort you've identified there where the BMI is 25 to 30, the mortality rates from that overweight, but not being technically obese, are still exceptionally high.

[00:12:30] Camilla Easter: That's right. So there was this great paper published in the New England Journal, which essentially said, it's not just about disease happening when you become obese, actually this is a chronic disease and it's progressive, and so as soon as you start to carry excessive weight, an excessive weight for you will be very different from excessive weight to me, and we use BMI because it's a very useful tool on a large scale. But absolutely as soon as we start to carry extra adipose tissue, which is the cell that stores the fat in it, we start to have increased inflammation in our body. Chronic inflammation is a terrible thing for aging, for cancers, for osteoarthritis.

So many chronic disease can be found in that root cause of chronic inflammation. Any way that we can stop that in a safe manner is going to be advantageous for individuals and society as a whole.

[00:13:18] Susannah de Jager: Slightly off the main subject I appreciate here, but given that there is this trend. We've almost got these two extremes in society at the moment. You've got people dealing with obesity and overweight and then you've got people trying to live forever that we're reading about and fight aging.

Do you think as a professional in this field that we all will be taking something like this in 10 years time to try and lower inflammation?

[00:13:39] Camilla Easter: Ooh, that's a great question. So I think longevity's very complex when we look at that as a sort of sub-sector of biotech. I don't know the answer to everybody, but when we have this disease, obesity, and excessive weight that's affecting 70% of our population, arguably this should be being used on a society scale.

I did a talk a few weeks ago now and there was a pharma leader there on the panel and I was getting a lot of feedback from the audience that we shouldn't be treating obesity as a disease, we should be going diet and exercise. And it got animated, shall we say, and the pharma guy that was next to me whohis pharma company, doesn't have an obesity asset, just turned around and said, I think we should put GLP-1s in the water. That is the scale of this problem.

Now, I'm not saying that that's where we're at, but I could see he was being provocative. But I can see his point of where he's coming from. If we can reduce the burden of obesity and excessive weight on individuals and on society the health economics are just enormous and we can go into them, but they're just wild when you look at it.

But the cost of these drugs is what's preventing healthcare systems like the NHS, implementing them quicker. Cause it would cripple us if we were to actually, as a society, treat everybody who was eligible for them at the moment. So we've had to come up with different ways of doing it.

[00:14:53] Susannah de Jager: I think that's fascinating cause it sounds very extreme and to people listening who perhaps aren't in this field, they would say, oh my God, you can't put things in the water. But it has been done. So fluoride being one example for teeth and then iodine is one because when they worked out that people in the Midwest of America were developing, what's it called? Goiter?

[00:15:10] Susannah de Jager: But it was effectively because they weren't getting any salt.

[00:15:13] Camilla Easter: And folic acid, of course, for women.

[00:15:14] Susannah de Jager: Indeed. So it's not actually unprecedented as much as it sounds quite extreme.

Okay. Camilla, you're going to have to forgive me, but when I've been reading all of this, and this is such a layperson question, but I keep thinking, and I would like to know because I'm sure others may think this when they hear the description. What would happen if I took four of your pills and I was overdosed?

[00:15:33] Camilla Easter: No, that is an absolutely fair question and what I get.

[00:15:36] Susannah de Jager: From stupid people all the time?

[00:15:37] Camilla Easter: No, this isn't a stupid question because we are treating a disease that is open to abuse, of course, and we need to make sure that we're responsible with that. Of course, it's possible for someone to try and take a whole packet or four of these at once. The short answer is you'll feel a little bit sick, but nothing bad will happen. So there is no systemic absorption of the hydrogel, what goes in ultimately comes out, and so you are not going to get some horrible liver toxicity or kidney toxicity if you were to take too many. It would be a stupid mistake. You would feel a bit nauseous. But ultimately you'd be absolutely fine long term.

[00:16:13] Susannah de Jager: And we hear a lot more about gut biome. Clearly this has an interplay with inflammatory markers that we see. It's not that well understood yet. Is it something that you are studying and looking at and do you have any idea how your product impacts factors like that yet?

[00:16:28] Camilla Easter: Yeah, absolutely. So we know that by reducing weight we can really improve certain biomarkers. So glycemic control is an obvious one. I think we all understand with type two diabetes, some liver enzymes as well. Some of our liver enzymes will start to go up as our weight goes up cause we will store excess fat in our liver and that's bad for our liver.

So within our most recent study, we were actually looking at individuals without type two diabetes and things within this study. But we did have a subset of individuals with pre-diabetes and we saw a shift change in their glycemic controls. So we looked at fasting glucose, we looked at HbA1c for instance, and they were trending down across all those individuals, which was a small portion of the study.

So we'll continue to study that on a much larger scale and in fact the study that we've just submitted to FDA to carry out includes 25% of our population having pre-diabetes because again, going back to who are we and where do we fit into this market? We are looking at sort of preventative obesity. What about preventative diabetes? Why should we hit full blown type two diabetes before we start to treat it? We can see it happening on the bloods, and so we very much want to look at that can we actually stop individuals at that pre-diabetic level and bring their glycemic control back under control.

[00:17:39] Susannah de Jager: And as we know, these things are always easier when they're not so far advanced.

[00:17:42] Camilla Easter: Absolutely.

[00:17:43] Susannah de Jager: Really, really interesting. Thank you, that's been such a wonderful understanding of what OMP is doing.

I'm going to take a kind of different pivot now, given that you are not a university spin out, it's even more of an active choice to have started and stayed and be scaling your manufacturing capabilities here in the region.

Can you talk a bit more about why you founded in Oxford, what the opportunities are here that you see?

[00:18:07] Camilla Easter: So although we're not a traditional spin out, obviously from the university, that doesn't detract from the fact that Oxford is an enormously amazing ecosystem. The talent that is around here. The capital that is also around here. Even outside of the university and the attached funds there. There are still fantastic other funds and high net worth individuals.

And so it still makes sense to be here and I think talent has to be one of the biggest drivers. So our CSO, we took her out of the university, employed her directly. But her training and her education is second to none having been at Oxford University.

And then of course just within that ecosystem we have quality and regulatory coming through. We have finance directors. All of that is because of this hub that has essentially been set up around the university and those spin outs, and so we can absolutely still benefit and utilize that infrastructure.

[00:18:56] Susannah de Jager: You've illuminated some of the really positive things there, but I know that when you were in Houston recently, you were commenting on how great the environment was. So if you were to say, but I'd love to see more of, what would those things be?

[00:19:09] Camilla Easter: Absolutely. So actually to be fair though, that was through a BioBridge, which was through Innovate UK so still part of that UK and EU ecosystem and so we spent about a month in the Texas Medical Center in Houston last year and what struck me was the connectivity of the entire place, and this is absolutely enormous. I can't remember how many hospitals, but it's the biggest site in the world for number of hospitals and number of doctors in one place. Every day, afternoon, evening, there would be an event on just connecting people, and you could call up any individual and say, I want to speak to so and so, and they would absolutely connect you.

The infrastructure and the sort of relationships around that were just so proactive. Everybody was just, let's get this job done, even if it's not directly to me, I will connect you to that right person because you are now part of our ecosystem and connecting you will help the ecosystem. And it was just, that can do, unbelievably positive mental attitude that I just loved. It was fantastic.

[00:20:06] Susannah de Jager: I mean, that sounds to me like Americans.

[00:20:08] Camilla Easter: And that is one of the things, you know when you get off the plane and it's like, welcome to Houston. You're like, why don't we have that in the UK? Like let's talk about how brilliant we are a little bit more. I think that's a very helpful thing to have.

[00:20:19] Susannah de Jager: So we've spoken more specifically about some of the mini hubs and clusters in Oxford, and you have subscribed towards one that's a coalescing of similar companies to you. Can you speak a little bit about where you are and that mini cluster within the broader Oxfordshire cluster?

[00:20:34] Camilla Easter: I have a vested interest cause I'm trying to grow this mini plastics, I think it's so fantastic. But essentially we had a base initially on the Oxford Science Park which served us very, very well when we were very small. But we had to grow very rapidly, which is a fantastic position to be in and we manufacture ourselves. So we went from needing a lab space that was maybe a hundred foot square to needing 4,000 foot square of space.

And of course, the cost of real estate, as you know, in places at Central Oxford or even around in those hubs is astronomical, and I have to then as CEO sit back and go, well, is that value for money? How is that creating more value in the company? Well, the truth is actually there's a balance to be had, isn't there?

And I said, well, putting that money into pure real estate is not creating value in the tech or in the people. So we started looking around and actually we looked over in Witney. So we found a fantastic place, the Wind rush Industrial Estate, they'd just built some empty industrial units there and the cost of the real estate was much cheaper, but we still had that infrastructure into Oxford.

But actually when I started looking further around, you know, we can see Abbott, from our windows, we've got, Owen Mumford, Lombard, so the infrastructure from a MedTech point of view was fantastic, and in fact, we've been able to recruit fantastic manufacturing techs, quality, regulatory, all from around this environment that exists, you know, 30 minutes west of Oxford and so I would encourage other founders who need much more space to think about putting that infrastructure in themselves and taking out industrial units. Particularly within, I would come and have a look around Witney within that area because we were able to put in class seven, class eight clean rooms. We're 13485 accredited and we've been able to put all of the infrastructure in ourselves for still a fraction of the cost that we would've lost just through rent. So I think it's just looking at that solution. There are other ways, to solve that problem.

[00:22:27] Susannah de Jager: You spoke earlier about an event you were at the other day and when you and I caught up, you went into even a bit more detail about how surprised you were by some of the views of what was quite an educated and healthcare focused audience that it was just healthcare, just healthy eating and exercise in spite of some very poor results from policies focused on that.

I'd love for the benefit of the listeners to go into that in a bit more detail because it is still such a stigma and it's really interesting how misplaced still some of our faith in those policies is.

[00:23:01] Camilla Easter: When I'm at an event like that and doing a talk or something, I tend to ask the room really upfront, put your hand up if you consider obesity to be a disease. And for me that's a really good marker of where the audience is at. So I spent a lot of time in the US last year and actually the beginning of this year, and you would see sort of plus 80, normally 90% of hands going up, and that could be across audiences.

Then when I was back in the UK again, if you are at biotech events, you will get 80 to 90% of hands. But this was a more politically focused event that we were at, and maybe it was only 50% of hands that went up when I asked this question. And actually I think that's, a bit of a reflection on me and being in a bubble of the biotech. So I had to take a step back and go, okay, I've been in a bubble here more recently, we've got to look at that perhaps society isn't where we are all at. And so we started getting into a little bit more detail, and it was around this well, why can't we eat less and move more, which is what we were all taught at schools sort of 20 years ago.

Our obesity rates have tripled since the nineties, and so it just doesn't work. And so that's one of the things that got me so excited when we founded OMP, was that we were doing something different. We were taking a problem that kept on being, you know, hit with the same stick and we kept expecting a different solution. So for instance, just to put this in perspective for your listeners, John Major was the first prime minister to put in policy around diet and exercise and obesity targets. He actually put targets in for reducing the obesity levels in 1992.

Since 1992, we've had 689 policies on diet, exercise, and education, and as I just said, our obesity rates have tripled. And whilst on an individual level, of course, it is possible to diet, exercise. It just doesn't work on a society scale. In fact, if you look at the literature, it fails 90% over 90% of the time that weight will come back on, and quite often, you know, a little bit more each time you go on a diet, you put it on a little bit more, a little bit more weight.

And so given the implications of carrying excessive weight, you know, cancer, cardiovascular disease, type two diabetes, osteoarthritis, infertility. We have got to look at this as a disease and we have to treat it as a disease. We're treating all of its essentially comorbidities as a disease. Why don't we actually treat the underlying excessive weight?

We  have a lot of work to do. There is still a lot of stigma. Lily and Novo have done an absolutely fantastic job on that and are driving that forward. And when we look at the US I would say they are much more, they're much further ahead in their way of understanding and their thinking, and you can see that by some of the sort of high profile individuals that are taking these drugs and saying, look this has transformed my life. I'm suddenly in control of what I can eat. I can move more. I feel healthier. Everybody deserves that. Absolutely everybody, not just the people that can afford it.

[00:25:55] Susannah de Jager: I couldn't agree more.

I've got a question for you. Is there an understanding of why we put on more weight after Dieting.

[00:26:02] Camilla Easter: So there is, I'd have to dig the paper out, but essentially there was a very interesting study done quite a long time ago. They took individuals living with obesity and they asked them to go on a starvation diet for 12 weeks. So essentially they wanted them to reduce their weight by 10% within that 12 week period.

At the beginning, before they went from the diet, they took all of their gut hormones, which look at hunger and satiety really broadly speaking and fullness. And then they got to go on this diet and then the individuals who'd managed to lose 10% of their weight, they took those gut hormones again.

And as you would a hundred percent expect the individuals who had lost all of that weight were starving. If you looked at their biomarkers for hunger, they were elevated, very elevated. And then they said, okay, well that makes sense. You've just been on a starvation diet. Your body's telling you to go out and seek food.

What about now if you say, just go about your life, just go back and eat what you were eating before, no diet and come back in a year's time. So 52 weeks time. And they retook those biomarkers again and they were still elevated from the very original baseline bloods that they did. And the theory behind this is essentially, we for hundreds of thousands, millions of years, have needed to survive through famine and more famine than feast, let's face it. And so we became very, very good at saying, well, if we've just had a famine, let's put on a little bit more weight to prepare us for the next famine that's going to come and those people would survive. They would reproduce. They would survive longer, they'd have more children, et cetera, and they'd obviously pass on those genes.

We've potentially preselected ourselves in order to do that cause it was only maybe a hundred years ago, 150 years ago, that food really started to become abundant, and really in the last 50 years, very abundant that we see now with the sort of fast food and ultraprocessed food.

So we now live in an obesogenic environment. Whereas we didn't before. And so I think it's very easy for people to say, well, we never used to be overweight. How can it possibly be the genetics? We didn't have the environment you need both. We had the propensity there but not the environment, and now we have the environment as well. And so we have to treat this very holistically and that includes treating this medically.

[00:28:10] Susannah de Jager: That's absolutely fascinating. Thank you for explaining that because I think that's really not well understood.

It's really exciting to hear about what OMP is doing, and I think it makes so much sense that even in a marketplace where these things coming to market that are really impactful. There's space for alternatives and so much more, particularly something like Sirona that is so much less invasive with fewer side effects.

I'd love to know from your perspective, in an ideal world, what are the next steps? How much would you be looking to raise next to go into your next stage of approvals, and what sort of timeframes are we talking about until you could potentially be on a shelf in our local pharmacy?

[00:28:48] Camilla Easter: So as I just said, we just received our IDE approval, which is fantastic. Full approval to go into our pivotal trials. So this is a, 350, 400 person trial for long-term weight loss management. So we are currently fundraising in order to conduct those clinical trials.

[00:29:03] Susannah de Jager: And what's the cost of that?

[00:29:05] Camilla Easter: So we are looking at around about $12 to $14 million to conduct those trials and then overheads, et cetera around the company, and then also we're very keen to do a proof of concept weight maintenance. I think this is a ticking time bomb that we're sitting on here.

We have about 20 million people in the US at the moment taking a GLP-1. We know that 70% of we've already said will stop taking those. We do desperately need a long-term weight maintenance solution and given our side effect profile and given our cost of goods, we are just beautifully positioned to be the solution for that problem.

So I really desperately want to get a proof of concept study up and running as quickly as possible. In fact, we were speaking to some fantastic UK based clinicians, so we're just putting our team together for that now and I would love to conduct that here across the NHS. I think we are such a good ecosystem to be doing those sort of phase two, early phase trials.

So we'd be looking to raise, that would be about a $7 million raise. So really we are looking to raise somewhere between $30 and $40 million for that raise, although, we can pick and choose which parts that we do. So when I'm speaking to investors, like anything, some parts resonate really well, and a lot of people are very excited about that weight maintenance piece that we're talking about because it just fits really nicely into that sort of weight loss journey that entire lifecycle.

So currently we are raising for that at the moment across Europe and the US predominantly. Although actually as we spoke a little bit earlier, we're starting to look in the Middle East because obesity is a problem that affects people across the world, including in the Middle East.

So as we said, we're just getting going with this. It has been a bit slow, as you can imagine, through this period. But actually I do think it's starting to pick up. So not only are we speaking to your more traditional BioTech investors, we're also starting to get a lot of interest from more sort of wellness consumer base investors who can see this gap in the market. Who can see that we're coming at this with a very, very different treatment option and solution for individuals. And our regulatorystrategy is very different, so we don't have to have those trials that the pharma companies have to have. We are regulated as a class two device in the US and we just have that one trial left to do, which is that sort of 350 person trial.

So ideally, we'll have that closed out by the end of the year. Get into our first patient this year. As I said, we're all ready to go really on that front, which means that'll be around about an 18 month trial. It's a nine month treatment plus recruitment. So we would look to be on the market by 2028, early 2028, we'd be looking to be on the market.

[00:31:35] Susannah de Jager: So you're talking there about the FDA approval side of things, but you also mentioned the wellness industry. Are the route to market different lengths? How quickly might you be able to, if you weren't being prescribed, get onto the shelves?

[00:31:51] Camilla Easter: Yeah, absolutely. So, in the US we do have this strategy in place that we really have to go through with the FDA. Europe is a slightly different environment with the regulated notified bodies here and actually our competitors have managed to get their CE marks with about the same amount of data we already have from the clinical trials we've already done here in the UK.

So we will be submitting all of our preclinical and clinical data in order to get that CE mark and we'll be looking to submit that this year. So actually in Europe we may well be able to hit the market sort of back into 26, early 27.

[00:32:21] Susannah de Jager: That's super exciting.

I wish you all the best with it. I'm really excited to see how it develops, and thank you for coming

[00:32:27] Camilla Easter: Thank you very much. It's been great.

[00:32:29] Susannah de Jager: Thanks for listening to this episode of Oxford+, presented by me, Susannah de Jager. If you want to stay up to date with all things Oxford+, please visit our website, oxfordplus.co.uk and sign up for our newsletter so you never miss an update. Oxford+ was made in partnership with Mishcon de Reya and is produced and edited by Story Ninety-Four.