A conversation with Celia Beline, CEO of Cilcare — hosted by Alan Vanderborght, CEO & Founder ofKYBORA
Alan 00:26
So what I thought we would do first is to maybe spend a little bit of time getting to know you better. So if you can kind of take us through your career in the Pharmaceutical industry where you work and things like that. And also, I think the audience might be interested to know, you know, where you came from, how you ended up in the industry and then how you moved from, you know, one company to the other and how you ended up as a CEO of Cilcare.
Celia 00:52
Thank you, Alan. I’m very happy to be with you. I will talk a little bit about me, but that’s not usual. So I, I was born in the Alps, so in a region called Old Zalt, which is in the South of the French Alps. So I’m a kind of mountain girl, but with a lot of diversities in my family. So my grandparents, they came from Normandy, the London, which is another area in the southwest of France, and also from Tunisia. So you see, I have a kind of patchwork of many different culture in my family. And, and I say that because I think it’s important to understand how I work and why I like so much diversity. And I’m not afraid of, you know, having people that have nothing to do come together for a common project because I think this is what I lived in my childhood.
I did my first study. So the small school, I don’t know how you call that some when I was a child in a very small village in Rome, which is in province in France, 400 inhabitants. So I’m really from the countryside more, more than from a city. And I actually always like to work. And I actually started to work when I was 12 in the field. And I also say that because it’s important in my, it has been very important in my career because I think it gives me a test of what an effort can bring you to. Because when you work in a field, you, you, you know, you see this big field that you have to work in the corn or, you know, picking up garlic or whatever.
So it’s, and it starts when you start. It’s a huge space and huge field that you need, you know, you feel that you will never with the work and you, you learn how one step after another, you can actually finally end up to conclude your work. And, and this has been very important also in my life because this is something I learned. So you, even if you feel that there is a mountain in front of you will never reach the heat. You can actually do it step by step. And then I studied, start to study mathematics and physics doing what we call this preparatory class is for high engineer school in France. So it’s a kind of, it would be if I translate into what it could be in the US, it could be preparation to MIT for instance.
And so it was intensive mathematics and physics. And finally I pivoted very early to the pharmaceutical faculty where I learned drug development because I missed a lot doing only mathematics and physics. I actually missed a lot the biology and that kind of classes that I had before. So I studied pharmacy. I did a master in environment and industrial strategy, which is also unusual at the time I did that was back in 1999. And so I’m an environmentalist. I used to say because I very early had the to learn the mindset about sustainable development people. Yeah, that that kind of yeah, mindset about what is important for the Earth and globally for people to live in a better world and in a sustainable way.
And so that’s also has been very important all along my carrier to have that background. I ended up my study with a master as well in drug development. So I’m a drug developer and my training, I studied everything that is from drug discovery to the market and even beyond. So that has been my, my, what I studied at the university and the last year I actually joined Sanofi as an intern. So that’s how I came to the Pharmaceutical industry because I was studying in Montpellier, which is in the South of France. And Sanofi had a very big R&D centre, which is the original R&D centre of Sanofi where everything started maybe 40 or 50 years ago now. So I joined Sanofi as an intern working at the time they were doing the merger with Synthélabo.
And at that time, I was working in the planification, but especially in the implementation of new tool and new organization for the planification of all the projects in R&D. So there was different levels at that time. So the operational level, the strategic level made it was a structure with about 300 people working for planification at Sanofi at that time. And they implemented also very new tools that enable to follow up everything from resource allocation to budget to to planning, of course. But it was a tool used and methods and process that were following how the tool which was opaques to at that time was working. So it, it was more than a tool.
It was also how the company was organised around the mindset of project management and this concept of matricial ways of working. So where you have people coordinating the projects and at the same time you have all the departments with the, but in each of the field that you need to address in a drug development also working together. So that was very interesting. I was finally hired after that and joined the Logistic International logistic department, which was a brand new department created in between the CMC in the pharma industry in chemistry, manufacturing and and controls, even the regulatory part of the CMC and the clinical development. And at that time, I was especially working on neurology, psychiatry, internal medicine and some oncology projects, especially the Regeneron one was already in my basket back in the year 2006.
We’re talking about that approximately and I ended up leading that group. So which was about 50 project manager all over the world. And that was at the time there was a merger with Aventis. So I had people in Bridgewater, in Grand Valley, in Budapest, in Frankfurt, in Paris, different area in Paris and in Montpellier in the South of France. I was 27 and so it was a big department for young 27 women. And so I am very thankful of the people that actually enabled me to get access to that position within Sanofi. And at that time I was actually intensively trained for management. So that’s also a part of my career that I’m very proud of because I I really learned a lot about how to motivate people, especially in the context of a merger where there are people that really do not want to work together.
They are all afraid of losing their position, especially when they are have a team to manage, cannot have two people managing the same team. So there was a lot to do with regards to team motivation, project coordination, of course, fixing the gap and and giving the vision of the department to to the different people. I was working with a lot of process, a lot of politics obviously in within a big pharmaceutical company, but that was I really enjoyed a lot doing that. After 10 years in this department, I actually moved to project direction also at a time where Chris Viehbacher joins Sanofi as a CEO and had this vision of implementing within Sanofi business unit from what they called at that time the entering development to the end of Phase 2A.
And so instead of having to work with therapeutic access, classical therapeutic access and having the strategy come from research, they decided to segmented through more big concepts. So there was an inflammatory business unit. Myself, I was in the healthy ageing unit, focusing on the ageing population and the ageing patient on a holistic way. And that was super disruptive back in 2010 because we were not only working on drug, but also on everything that was beyond the pill. So I, I still see, see some title of people in some Parma industry that are in this research beyond borders, you know, beyond the pill, blah, blah, blah. And so that’s exactly the same that was implemented at Sanofi at that time.
So I had not only project in drug, but also in nutrition, for instance, in digital, so many things to address the aging well. So that was the objective of the unit. And at that time inside the unit there was also sensory disorders. That was part of the focus of Sanofi. The ophthalmology was taken by Fovea. They at that time they, they wrote Fovea, which was a biotech company with drugs in ophthalmology. But hearing disorders, test disorders were also actually integrated within the unit. And I started to work then on hearing disorders at that time, so back in 2010. And at that time also I was part of different transversal groups to think about the vision of Sanofi 2020.
So it was in 2010. So working with especially Peter Guinter for instance, that has been the CEO of Merck afterwards. But at that time he was the head of the common Europe commercial operation at Sanofi. And we were trying to reinforce the links between R&D of course and the commercial operation. Try to have the the market access vision as early as we could within the unit. And also to integrate not only drugs and and look after business model where we could have not only drug, but also drug device repurposing of drugs, integration of course of digital platform, access to patients. All that kind of things were discussed within this vision. And I actually I had a project with also faster moving consumer good company.
So I cannot say the the the name, but it was really also very disruptive to try to have the pharma industry collaborate with the first consumer good company and trying to see what we could do in terms of prevention. So it was the early stage of how we can move from drug to a preventive approach, how we can detect it was already there a patient earlier when they had a problem with health. So that was the the type of things that we were doing in this unit like every pharma company after four years of this unit and all the other that were on all different topics, they decided to change their mind and they wanted to come back to the more classical business unit cardiovascular, diabetes, oncology.
So it means that they, yes, they totally broke the, the unit of healthy ageing. So at that time I was proposed to go to Paris and take the RNG of the DHC departments of consumer healthcare because I was working a lot with, with them also at that time. But I, yes, I was, that was not exactly what I wanted to do. I, I thought it was really a pity to actually give up with hearing loss because this was again back in 2010. There are very few companies interested in this field and we had a pretty good advance in the understanding of the different disease and the targets and what type of products we should develop in the year. And so with the other colleagues at the beginning we were five actually.
We looked at what we could do internally. There was no question of leaving company. The Sanofi at the time, everybody wanted to stay within the big Pharma. So we propose different business model different we worked on actually 5, we were followed by steering committee directly at the corporate level was the head of finance. They were the, so some people that are not not there anymore, but it was really at the very highest level just below this FIBARA. And we tried to push for having a unit that would have remained into into hearing. But finally they decided not to follow us. And so with two other colleagues, so at the time were only three, we decided to to leave Sanofi and to create our own company from 01 because we left company with €5000 one which to do a market study.
So and then you can think with what to do with 5000, I don’t know. That’s not a media market study for sure. So we left Sanofi. That was in June 2014 and the 3rd of July 2014 we created Cilcare so incorporated in the South of France, 3 women founder. So with my paddle when Sydney Pusher still at Cilcare with me and we started the race to raise money because we had nothing except a little bit of money that we put each of us, we created a company with exactly the same amount of shares for each of us. So it was divided into 3. We pitch our company to to lots of business Angel locally first, because we were not looking for a lot of money. We’re looking for 300K, so which is a small amount.
So we for that we had there’s a lot of solidarity in Montpellier between the play, different players. There’s a lot of people, I don’t know why, but it’s everybody has been very helpful from the financial side to also even the other companies that were there. So we we have been we made a collaboration with another company called Amgen and another women called Vanessa Villa was the CEO of this company and we shared labs and so we could actually access to labs. She was taking care of all the facility and and we have outsourced to her part of the work but and we hired our. Supplies. Yeah. So Cilcare was it means something, Yes, when we were at Sanofi, like in any pharma, you try to give a name to the project so that everybody can kind of appropriate the project.
And Cilcare was the name we gave, we looked at whether it was free or not of of use and and it was not. And SIL is for ourselves in French it’s called cellule ciliée. So SIL, is that really meaning the herself and care? It was because at the time we were watching, you know, looking for evaluating 5 different business models, we didn’t know what to do. There was many different options. And so care was enough, you know, large in large terms that we could use for any kind of business that we would want to do. And finally, it was nice to pronounce it in English or in any even in Japanese. Now we know it’s easy for them to pronounce Cilcare, so it’s OK.
And finally, yeah, it was a nice name, smooth, you know, easy to pronounce. And so we kept it.
Alan 16:40
Amazing evolution from working in the field at 12 years old to launching your own company. It’s, it’s kind of an interesting pathway. So then, so you, you, you launched a company and then at the beginning you were more focused on acting as a, as a clinical research organization initially and doing some lab work for clients, more of a service before you started to think about your own product or did you have the idea of coming up with your own product right from the get go?
Celia 17:09
Right from the get go we knew we wanted to develop drugs and if we look at because I I kept the business plan that we wrote back in 2014 and there is this strategy of you know, starting with a platform so that and it’s not clinical, it was pre clinical. I come from clinical, but the piece that was missing for developing drugs, yeah, back in 2014 was this pre clinical piece. So there was nothing in between the academic lab and the clinical bed. And so this is one reason why we think that some companies unfortunately have not succeeded in clinic. It’s also because in preclinical stage they they couldn’t do what you would have done in another therapeutic area which is you know, looking for the dose of the treatment scheme, looking at the talks, really defining the right models or the right disease you want to target understanding mechanism of action, that kind of things were done at the academic club which is good.
And that’s more on the target identification purpose rather than the preclinical reproducible studies that you need at some point in time. So that was really the missing piece and, and so we decided to develop that platform 1st and that was the easiest way for us to do because we come from development, at least my and myself project direction. So really coordinating used to, to use process and and scale up from labs to, you know, it’s a bigger study, larger scale, that kind of things. So it, it was easier for us, Sylvia and my other associates more discovery and and by the way, today she’s responsible for preclinical innovation. So she’s really still interacting with the academic labs trying to find new models that we can use for accelerating drug development non animal methods.
That’s also her focus right now, how we can use iPSC organoids, It’s 3D-printing a tympanic membrane to actually accelerate also drugs with in vitro model rather than in vivo. So it was easy, but not easy, but easier for us to say, well, we start by developing the skills that are missing it. And so to answer your question, yes, we started this. We left Sanofi no salary. So the idea was to and and no legitimity to raise several €1,000,000 or dollars to in license drug and develop them and no tools to do that anyway. So even with a drug, if you don’t have the the platform to develop the drug, you don’t do anything. And nobody outside of what we had developed at Sanofi was really involved to provide us with the right model and the right skills that were needed in the lab.
So we actually developed that. So it was quickly called platform and with animal models PK in the in the ear sampling the perilymph, injecting directly in the cochlear intracochlear or or in, in the middle ear. So it’s all that kind of things had to be developed. The measure how you measure hearing. Loss with electrophysiology we call auditory brainstem response or DPOAE, which are Electro acoustic measure how you do for Histology of the cochlea. Cochlea is super fragile, so it’s very hard to work with cochlea, how you stay in the cochlea, what structure you look at. All that kind of things had to be developed. This is what we did, but we generated.
So we created the company in July 2014. We started in the lab in October, October 2014 with our first employee Philip still there. We installed everything, every equipment, calibrate everything. We raised a little bit of money, but we generated our first revenue in February 2015 and our first client. I, I think now I can say it, but it was my previous boss at Sanofi who actually who was in, in the US, in the Boston area, the CEO of a company in Alzheimer’s disease and wanted to look at what we could do in tinnitus, which was also very linked to neuroscience. And that was, you know, the 1st and then we signed the 2nd and then the third. And you start to have a very, very nice partnership with many companies in the US, in Europe and in Japan.
We signed very early as well with a big, big pharmaceutical company.
Alan 21:44
It’s that piece up there because that’s a unique skill set that you developed as an organization. As you said, nobody else had it, right? So you had something that was very unique, not only in terms of tools, but know how. And then you started to make money. Was there ever a temptation to say, OK, let’s go full in into this and we’re just gonna offer that service and forget about they’re not being drugs or, or were you always OK, we’re just doing this because in reality, we want to become a a pharmaceutical company or biotech.
Celia 22:14
No, so, so the what has always driven us is survive to stand by again. We started something that was it was horrible and there was no way for us not to get paid or you know, so we have that capacity. I think of anticipating things long in advance and that’s a good skill that we have within the company. And so to answer your question, yes, of course the platform and especially because we expanded the platform in the US in 2017. So from the almost the very beginning, we had two labs with capabilities both in the US and in and in France to address the world entirely. The problem was the market size. So the number of player in the India that was even in our business plan again from 2014, the first risk was the size of the market will pharma industry really engaging to hearing and what happened since the very beginning, but now it’s changing.
But since the very beginning is that there were big players there for two years, but their program maybe did not show up enough in terms of efficacy and so they stop and then you have another big player replacing the first big player and so far and so on. So every two years we had a full renewal of the players in the field of hearing instead of, you know, incrementally have a additional players. And the third thing is that our clients at that time, they were asking us to do GLP compliance study. So they asked us why don’t you do that? And in France, we didn’t have the capabilities to do that in the lab we have and we say, well, we go to the US and we do that in the US.
So that was around that time. And so in 2019 when we had less order, we say we actually have to think about the business model that will enable us also to raise money. And the service part, when you do 10% or 20% margin that I’m very ambitious, that’s the maximum you can do. And in the field that is deep science evolving, but you still need to improve and improve and improve and improve to reach the plate where you don’t have to improve too much anymore. We had to spend a lot of it in R&D and we, we knew we could not sustain that business model for long. So what we started to do was first to look at constructing. And so we started to work with pharma to look at their portfolio of assets and see whether there were, you know, interesting assets within their portfolio that could be developing hearing.
And then we proposed to that pharma actually to to take care of the preclinical part of the pre and until the talks because we had all those capacity and even to think about target product profile because again, I’m coming from clinical development and project direction, same for my care. So that was really our very strong skill was in this vision of how we can develop in clinical those assets. And so we started that and at the end when we ended up with shortest of asset, very interesting what happened and was with Sanofi especially, we say, well, it’s going to be difficult maybe to find from zero someone that will say I’m in license in those assets and I’m using them in, in hearing disorders, but Cilcare was the best place to do that.
So we started to negotiate and that was in 2020 a deal to get access if a license agreement with assets that we had identified very, very high potential for treating hearing disease. So that was 2020. Then as of COVID time, you know with decreased revenue of course, because in 2020 with 0 revenue in the US, fortunately in France, it was OK for, I mean France, we used to work also with other countries and it’s not French only activity. So in France was OK. But at that time, we had actually in license assets from Sanofi. So signed December 2020. And afterward what happened is that we could raise money sufficiently for developing those assets until the end of clinical proof of concept.
So we had four assets. What we are good at as well is to do head to head comparison, so optimize as much as we can the preclinical plan so that one asset is compared to the other. And you in terms of yes, so efficiency and the execution of this preclinical plan, we’ve been very good. And when we reached the preclinical proof of concept, identify 2 candidates that were really exceptional for on our eyes for addressing some hearing disease. We were supposed to out license those assets. But we said who else than us will actually have the clinical strategy that we think we should pursue with those assets, Nobody. So we raised money again at that time to actually be able to develop those assets further.
And but in between what we had to do and that we found we took some risk out we found ourselves is the those observational trials. You know that we are indeed for really understanding because our hypothesis again is that the assets that failed before also failed before they were the the tools to develop those assets in Clinique were missing. It was not enough sensitive the primary, secondary endpoint on the right one and the population of patients was not sufficiently focused and understood to be able to actually demonstrate an efficacy on those populations. So what we had to do and and this I come back to the pharma strategy because this is what we did at some of here as well is working on biomarkers and what we call phase zero trials.
Before you engage into efficacy study, what you do is that you kind of use study to first, yes, find the right endpoint that you want to implement in your efficacy studies, but also you use those study as a feasibility study. Will I recruit the patient? Yes, no. How, through which investigator, what should I put in place in the study so that I can do the measure the right way to all that kind of very operational things that I love were actually checked within also those observational trial which give us of course a very high probability of success for the Phase 2?
Alan 28:52
So it’s really interesting because it’s a continuation of what you did on the preclinical work where you have to create the environment that allow you to get the data that you were looking for. And now you’re in the clinical side of things and you have to you almost have to do that again because the industry was not there, right. So you’ve, you’ve been a pioneer in many ways in basically building that segment of the industry that’s, that’s remarkable. You’re focusing on cochlear synaptopathy. So can you talk a little bit about that? Because you know, when people think about hearing loss, they think about, you know, either people who are deaf from birth and then they’ve heard the word cochlear implant.
I think some people have heard that you can use gene therapy and there’s bringing back hearing, but you’re really targeting the typical hearing loss as people are aging and starting to start little by little losing their hearing, which will happen to all of us, right? So you were talking at the beginning the size of the market, which was more. Remember when you were talking about that? Now you’re talking about a very large market potentially, right? So tell us a little bit more about, you know, what cochlear synaptopathy is and why you’re targeting it. And then I know because you and I have worked in the past together, you also have a very interesting angle as how hearing loss is potentially the driver of very large disease states that the pharmaceutical companies are spending hundreds of 1,000,000 billions of dollars trying to address, right, the Alzheimer, those kinds of things, right.
So can you kind of talk to us a little bit about that?
Celia 30:39
Maybe I start with what we wanted to target and that was actually also advised us by some board member not really official working with us at that time. What matters in hearing loss, I mean, besides of course in hereditary hearing loss that for us was already addressed and for which we, we work with major player in this in therapy field. But as a platform company not it’s not IP for us. But what matters is this age- 489 00:31:11,480 –> 00:31:15,080 related hearing loss when people start losing their hearing age-related hearing loss. If you wait for having hearing loss confirmed with audiogram, you reach 65 years of age people and they lose about two decibel per year.
So it means that if you want to have a demonstration of a drug that would delay the progression of age-related hearing loss, you can’t unless you go back to the big cardiovascular study that was done before, meaning 30,000 patients in you know, 300 sites or I don’t, 3000 sites all over the world and waiting for two years before you can demonstrate, you know, a very, very small difference between the placebo arm and what you have would have treated. So that was not something people can pursue and there are some that tried with six months trial and they failed of course because this is really hard to demonstrate because the natural degenerations of hearing is again to disability which is very, very small.
So what we wanted to demonstrate, and we say how we can address that, we can address that by looking at the first sign of age-related hearing loss. And the first sign of age-related hearing loss is the difficulty of hearing in a noisy environment. When you start feeling that you don’t understand someone with speaking to you in a cocktail party or in a family meal, you know, that’s that kind of things. And this is not, there’s no hair cell death at that time. It’s a disconnection of the fibers that link the inner hair cells that is a self appearing to the auditory brain and a retractation of the fibers. There’s no deaths. They are there. They just retracted because of noise, age, inflammation, oxidation.
And we come back to the big mechanism of aging and finally plus the environment, of course, that can play a role. And so at that time, we’re talking about fibers and synapses disconnection that can actually like a lot of strategy that we had for the brain that can actually be regrowth again and reconnected again. And so we looked at what type of mechanism of action has been described and can actually be used for this synapses reconnection and fiber growth. And so we looked at assets and pharmacological targets that were described for that. So, and my sensor compounder that you know, the CL-001 for instance. But the strategy initially was how we can address the big, big things in hearing and in if you compared to the ophthalmology, it’s the AMD in English, so macular degeneration.
So that’s the same in the ear, we have the same issue. So how we can actually work on this that we work in the earlier stage of the disease. So that’s called cochlear synaptopathy, but this is hidden hearing also, there are many terms that we’re working out of the moment to really see what we will target at the end. The second thing we did. So because this is so cochlear synaptopathy, we’re talking about 15% of the world population affected and you, everybody is going to be affected by this anyway and especially the young people listening to music from 8:00 in the morning to midnight. So that’s an issue. Not having silence mean that you are actually super exciting your hearing and that’s not a good thing.
So, so that’s the general population. So now come back to how you target sub population of patients that will have that cochlear synaptopathy earlier and stronger and that you can recruit in the context of a clinical trial. And that will interest the pharma industry as well because these are population that they visit, they know they have products for. And so they they will be able to make the link between the necessity of addressing hearing loss because they can also have a strategy that is aligned with all their other big, you know, therapeutic area. And I call the cardiology, oncology, blah, blah. So we say we will start with diabetes because it’s known for years.
I mean, everybody knows that diabetes, they have 50% of hearing loss. So it’s supposed to be in the US The CDC has published a long time ago a recommendation for a yearly assessment and monitoring of the hearing function of those patients, which is not necessarily followed strictly, but that’s the recommendation. Is there a lot of publication? So we know they have a hearing loss, but again hearing loss is audiogram and somehow we’re starting the late 65 years old is is the age. But what was not known is that this population, they have a super high prevalence of cochlear synaptopathy. And this is what we have demonstrated in our diamond trial on 350 patients that this population of patient and here are more rather talking about 50 to 55, they have cochlear synaptopathy.
So they have a much higher prevalence of this disease that is characterized by their very low score in understanding words in a noisy environment. It’s called speech-in-noise deficit. And they are standard and, and test for for looking at this specifically. So we started with this population. We know diabetes patient, they follow the, they are of endocrinologue, diabetologue, you get that you can really access them, you make the link. So there’s a lot of work of course to do, but we have time and we are doing a lot on this to make the diabetologist and the endocrinologist aware of the the problem of having cochlear synaptopathy. The why it’s important to address hearing loss, of course.
And and you make the link with the ENT doctors or the audiologists in the US that can make actually this measure and yeah, and more angularity along along the lifespan. So that’s one population. We have the same approach for neurodegenerative disease with early Alzheimer’s disease and Parkinson’s disease. And of course we have other target population for other types of hearing disease that are ongoing as well, but not disclosed yet. So it has been our strategy also for making sure that in a clinical plan strategy, we could have the demonstration of the efficacy of a drug because we are targeting the right population that we know in a short period of time will benefit from our therapeutics and we’ll be able to demonstrate the effect of this drug in clear endpoint.
Alan 38:01
Very interesting. And so tell us a little bit more about your lead compounds. So CL-001 and you know where it is in terms of development, what is the next step? You know, what does the program looks like? When do you expect it to potentially be on the market and all of that?
Celia 38:15
So this drug, we are expecting to start 2 clinical trials, as you know. So there is one that is focusing on Type 2 diabetes and cochlear synaptopathy in Type 2 diabetes. So this is a European study, five countries, 20 centers. I’m not sure I can disclose much about the study design, but the objective is to demonstrate that our drug CL-001 is, is an efficacy with a single administration of our drug on speech-in-noise deficit in this patient population. The second study that is planned is in the US, so it’s with Mass. Eye and Ear and it’s a study that is specifically on re establishing speech-in-noise deficit in patients with tinnitus. Because what is very important to understand as well is that this cochlear synaptopathy or that synapsis disconnection has been published to be one of the main cause of the onset of tinnitus and hyperacusia, which are two.
So tinnitus, because this is the phantom sound that you have in the ear that makes you crazy and, and, and, and it’s really an unmet medical need and needs to be really addressed. And hyperacusia in the same way, it’s the hyper sensitivity to noise, meaning that you can’t bear a noise anymore. And, and so you, you have to also isolate yourself. Otherwise when you are in a room and you’re talking with people that’s talking too loud, you can’t, it’s painful. So it’s really something that is far also to to bear and it’s a it’s a huge prevalence as well. So this we are addressing the US, it’s a monocentric study and in the US we’re yeah, it’s it’s I’m not under entering into the detail either in terms of how long it can take to be on the market.
So we’re talking about phase 2A. So then if we managed to have them considered somehow as a [unclear ~40:09], we can like after have a phase 2B3 and then enter the market. So that’s the plan for a disease where there has been no. Drug yet on the market. So idea, yes, we’re talking about 2031 on the market for this type of drug in terms of mechanism of action. So maybe I can talk a bit. We have a local, so that’s another part of the strategy of Cilcare. We are working on local administration, so we target the cochlea by trans tympanic administration, which is a very standard procedure. So don’t be afraid. It’s a very small needle that go behind the tympanic membrane.
You inject a drug that is usually formulated into a gel form or an oil form so that it can goes on the round window niche, which is a little hole behind the tympanic membrane that the round window membrane that separate the middle ear from the inner ear. And so by diffusion, your drug goes into the cochlea. And the cochlea it’s like a piano. So you have high and low frequency and it’s what we call tonotopic, meaning that you need to go all along the cochlear that looks like a shell and you need to have a drug with a formulation that can stay for some time into the cochlea. In our case the CL-001 is the one, it’s a disease modifier. So it’s a single injection that enable the production of neurotrophin factor within the cochlea that makes the fibre regrowth again and the synapses reconnected.
So that’s the preclinical work that we’ve done to demonstrate this capacity of our drug to restore speech-in-noise deficit in technical settings. So this with a single injection, our drugs stay more 30 days into the inner ear fluid which is in contemporary cochlea and this is where it can do the work. And then of course, so she asked me, will this injection be repeated along the lifespan? Yes, probably because you again have oxidation, inflammation, noise exposure or if you have a diabetes or well, it will have the synapses disconnect and the fiber and, you know, retracted. So you set and you have to redo the injection.
Alan 42:31
That’s that’s super interesting. And you’re, you’re also going after very well defined markets, which is also, I think it’s as I’m listening to you talk, it’s a very deliberate approach to what you’re doing right. And it seems very calculated and things like that. You know where you’re going and moving in the right direction. Now you signed a big deal with Shionogi. Can you tell us a little bit about that and how it came about and and how that relationship is going and what it means to Cilcare?
Celia 43:04
Yeah, but it means a lot. Of course, we call it the three-step approach. So that’s the new way of presenting Cilcare strategy. So we started as I said to develop the tools. We talked about the technical platform, but what we have not talk talk about is the data science, the software that we developed as well and the the protocol that we can use now in clinic that is also very new. So we have data scientists internally and our own tools for demonstrating the efficacy of a drug. So that’s superpower of Cilcare using AI and then we did that proof of concept, we shouldn’t even call it like this and ended up with an option license. So I think it’s gives us some credibility on the market and the next step that we can talk up.
So what is the expansion of the pipe where we have our assets that we can bring up to the market. So that’s the big dream of Cilcare is becoming a pharma company. You know that in the hearings. So the second step, so this proof of concept with Shionogi. So I think that this would have never happened without all the pieces of the puzzle that Cilcare has developed since 2014. So the platform, the development platform, the preclinical development platform, our know how about, you know, developing drugs and and not only drugs and gene therapy, cell therapy in hearing is something that is super important and was super important fortunately. And then there is of course the pipeline and our leader set is a beautiful asset.
It’s again, this modifier. We have lots of human data. It was developed by, I didn’t say that by system include by Sanofi for Alzheimer’s and Parkinson, meaning that we have tons of data that also positive data on this compound. So on top of everything that we’ve done, our self enduring and the third thing that we do with Shionogi and that’s also public, it’s a joint research agreement where we are as I cannot disclose what is in it, but basically there are many things that we are doing together to help them in their strategy of really addressing hearing loss as a risk factor of many other chronic disease. So on that we were very much aligned also in the mindset.
So why addressing hearing loss for hearing loss of course, but also because, and you say that a little bit earlier because it’s recognized as the first risk factor, modifiable risk factor for dementia, which is huge. It means that you the same way in the past we address hypertension or we address all today obesity or or diabetes or cholesterol, high cholesterol as a risk factor of cardiovascular disease. They will now start to have risk factor of brain disease and that’s huge. How will we treat those horrible brain disease by addressing them earlier and addressing them earlier, meaning acting on the risk factor for those brain disease and hearing.
It’s easy to measure. It’s something and easier and easier I may say, because there’s a lot of player in how to do that remotely and how to monitor including the Apple and all those big, all those big companies, tech companies are actually also working on monitoring engineering auditory data and that help us find it, develop those drugs and make understand that we can detect earlier and treat earlier. So on this we were very much aligned. And then as I told you in my career, I always worked on integration. So I came then I had to deal with my department on the integration of advances. Then when we expanded in the US, we did it through a joint venture.
So we are partnering. We’ve been partnering for now nine years with CBSET, which is a the biomedical Research Center in Lexington, MA where we integrated our auditory lab, you know, French culture, American culture. So we are super good in integration. And so when we did that, it’s human skills and and management skills. When we did that, we should know did that deal, it was clear for us and especially with all those 3 layers of joint research agreement, the option license and the enter inequity in Cilcare, we had to do something also integrated. So it means that we are working hand to hand. So we’re Cilcare small biotech and in front of us we have a pharma, big pharma company.
So we have to use the skills, the mindset, the power, the capabilities of this big pharma as well to together make the field accelerate and that’s what we do. So we’re working with, you know, joint student committee, we have sub teams in CMC night here in prickly calling, in many everything clinical development, of course, in translational research, we have a director of translational research working on this all together. So every regulatory pathway, so everything is worked out together and aligned. And so I think that makes the partnership very interesting on both sides because even if, let’s say we have to divorce at so one point in time, they would have learned a lot from us, but we would have learned a lot as well from them in terms of, you know, structuring the company with a pharma mindset.
Alan 48:24
Now, interesting and that point that you’re making about, you know, the correlation between hearing loss and some of these more major diseases is something that you’re starting to hear more and more. I mean, they’re doing this large longitudinal studies that are showing this, right, this I think people are starting to become aware of hearing losses drives not only isolation, but also potentially a faster onset of these really bad diseases. And so it’s interesting because I think that that that will drive a greater diagnosis, you know, which is one of the things that is missing today. If you were mentioning the the diabetic patient, you know, not a lot of physician today as the diabetic patient, how, how well is their hearing, right?
They might look at their feet to look for ulcers and other things, but asking how well they hear in a loud environment is probably not the first question that comes in. And so there’s all that education that needs to come through. And I think that’s super interesting and you guys are well positioned to take advantage of these changes moving forward. I wanted to ask you as a CEO, one of the things that is interesting is that there were three of you as a partner, but you ended up being the CEO. And then the question is, I guess is what are the characteristic of who you are that makes you successful? Or what are the things that you know you think are essential to you being a successful CEO, you know, and especially a woman CEO right in this industry?
And what are the key skill set that you would say are important in being successful?
Celia 50:01
I will. I will say first the authenticity. I think that’s something that is missing sometimes because you feel and and I am struggling many times with you know, coach or trying to make me put clothes that are not mine. No, but I think it’s simple. Finally, I I I, I struggled with this a lot, but I think I was right not to change myself. You, you progress. That’s of course you listen. Of course you you get skilled on other things perfect, but that does not mean that you have to change your value, you know, and again, behave differently than what you really are. So that’s for this you need to have a lot of convict confidence. So working on confidence is important, especially for women.
You come back to the women part. We are always doubting of, you know, the legitimity of being where we are. We see the amount of problems that will have to face when developing a company, but this does not mean that you should not, you know, be frank and and authentics in everything that you do. So that’s one thing. The second thing with regards to my associate is no jealousy. It’s important. I think also, and that’s again an advice for women CEO because jealousy is something we it’s hard for us to give up with this. I don’t know how to say it’s, you know, the instinctively you I don’t know you, you to work, yes, you need to work on that and you know, and maybe it’s the age that helps as well of being.
You don’t have to prove anything. You know, you’re what you are and you can succeed all together. Your success is not the failure of the other. You know, it’s not dependent on the failure of the others. And, and, and this is really a mindset I think we should push very much in our industry because if, when, when you’re talking about 15% of the population. So I think there is a room for much more than just one or two players, you know, so it’s even in how we collaborate and, and why we also support other companies. It’s very important. So collaborations serve the also recommendation no jealousy authenticity and you need to preserve yourself as well because it’s a long way.
I always say it’s easy to do something in six months. You know, give everything you have in six months. But in the case of building a company, we’re not talking about six months. I hate all those, you know, turnovers you, but I so before you here for three years, OK, first year you do an audit, second years you change everything and third years you think already where you’re going to go next. So what value are you really bringing within a company? Nothing because you’re you after you. We say the deluge, the storm, that’s OK. So, so I think it’s important. Then I come back to the very beginning of my interview where I was talking about sustainability that there was part of my study back in 1999.
So very early, at the very beginning where it was was speaking about ecology and environment and it is so sustainability is very important in the company you want to the wrong way.
Alan 53:39
No, I know you can. As you were talking, I was thinking about you working in a farm and in the field and that is kind of teaching you the importance of, you know, as you said, one step at a time and you’re going to see the result. But also it takes a long time and it’s OK, right? I always say, you know, I have some, some mattress for myself about, you know, one of them is about knowing that I can achieve my objectives because I’m disciplined and consistent. And then the second one is about bringing my the best, the best myself every day on what I do. But the third one, which I think is really important, is to be grateful for the progress I’m making every day.
And the idea there is to give yourself a break. You don’t need to be perfect first and things like that, but you need to know that every day you’re becoming a little bit better, and you should be grateful for that, right? And so I think people put too much pressure on themselves to be perfect immediately instead of taking the time and also enjoy the journey, right? Because at the end of the day, that’s what matters, right? Just I guess as we’re, we’re going to wrap up here. Just a quick question for you related to the kind of advice that you would give to another young Celia starting the starting work in the industry. What would you what would you say to to her?
Celia 55:05
Well, first to, to you say trust in herself or yes, be confident. I had a conversation yesterday with someone that is thinking about becoming a CEO and and does not really know. And, and I say, if you want to, you do it. That’s it. You know, it’s really if there’s nothing that prevents you for being first line, because that’s that’s also often when someone wants to be a CEO and is, you know, thinking well, well, I have the shoulder, but nobody has actually. So it’s, it’s nobody, it’s there’s no recipe for this. And if the first thing is willing to do it and if you want to do it, you do it. And and that’s it. And remaining the second because I’ve all, I mean, when you are in the industry and I don’t want to generalize, but when you’re women, you’re all very often second because you don’t care about being first line.
And so you’re doing the back office, you know, of people that are taking the fight and, and you feel it’s your role to be there to support, you know, and the one is taking the fight and you’re not taking them, but you support and you’re doing all the back office work. You, you’re like in a bicycle and you run and you run and you run. That’s OK. But there’s no reason why you don’t take the fight yourself. It’s something that everybody can do. So I would recommend not to be afraid of being first line. You feel good at some point, you feel at the beginning you feel you will not make it. But when you do it and you battling yourself, it’s a good feeling.
Finally, yeah.
Alan 56:46
Yeah, no, I agree. As an entrepreneur myself, you of course you have a lot of stresses, but I would not give it up for anything else. I mean, I think that the the joy of building an enterprise that goes beyond yourself is critical. You know, I don’t know if you’ve read the book from Jim Collins called BE 2. 0. It stands for Beyond Entrepreneurship 2. 0. It’s about building a resilient organization. And one of the things that he talks about is you have to try to make sure that every everybody in your leadership team are level 5 leaders. And and what characterizes level 5 leader is 2 things. One is the humility to understand that you’re building something that will at last you.
So it’s not about you, it’s about Cilcare, we’re building Cilcare and things like that, right? And so you have to make sure, because you wanted to outlast you, you have to make sure that it’s, it’s not dependent on you. It’s, it’s so good by itself that it’s going to continue to grow. And then the second piece is the professional will to make that happen, right? And so those two concept is really nice. And so for, for me as an entrepreneur, the, the things that I’ve enjoyed the most in building KYBORA is actually building the team and the people and the young people will come in and helping them, you know, with their career and actually using the organization to make their dream come true, right?
So I often tell the young people, tell me what you want to do and I will make sure that KYBORA makes it happen for you, right? And so, and you get tremendous amount of joy among with, you know, meeting people like you. And so that’s always really, really fun. One last question for you. So when you were a little girl, what did you want to be? Do you remember you had dreams of aspiration, of wanting to be something?
Celia 58:31
But I said then you’re a singer, certainly a singer singing all the time. So yeah, I guess. But I realized that it’s harder. That’s one part of my story. When I decided to create Cilcare. We were so the three-year old person and and we had no labs. And so Sydney was saying, I’m not, I’m only following if I found labs, which she did not finally. But for me, I say, well, I quit anyway. And backup option is to do jazz lessons and become a singer. So that was my backup option. But that was not really a backup option because I think it’s much harder to, you know. Yeah, yeah.
Alan 59:12
Yeah, and I, I, I see your LinkedIn post and things like that that you do still very much enjoy singing. So that’s good that you’re have the chance to do that. And with the Japanese, they love singing, so that’s like. Yeah,
Celia 59:27
I enjoy town, I can tell you.
Alan 59:33
Wonderful. Well, listen, thank you so much for your time. I think this was great. I’m very pleased to have had the chance to do this interview with you and I’m impressed with what you know you and your colleagues have done. It’s it’s really remarkable. And in a short amount of time as well, right. I mean, when you think about it, you haven’t been at it for that long and you are in many ways, as I say, you’re a pioneer in that space and so. They will write books about you guys.
Celia 1:00:05
I hope they will write books about. Thank you so much. Thank you. Very much.
