Thanks very much. Good morning, good afternoon to everyone, and thanks very much for joining both Sophia and me for the UCB installment of our 2026 JP Morgan CEO call series. It is our great pleasure to have the CEO from UCB, Jean-Christophe Tellier, with us today. Before I hand over to Jean-Christophe for a few introductory remarks, I would like to remind you that this is primarily a call for your questions. Sophia and I will ask a few upfront. You can ask your questions either by raising your hand, dialing star nine, or alternatively, you can send an email to me, and that is to richard.vosser@jpmorgan.com, and we will ask your question for you. With that, welcome, JC. Great to have you with us, and I hand over to you for a few introductory remarks.
Thank you, Richard. It is always a pleasure to participate in your CEO call series, and thank you for your invitations to participate, and thanks all of you for your interest in the company. I am really looking forward to answering your questions and potentially continue to engage the dialogue with you. Thank you for the time for preliminary remarks. What I would like to share with you before answering the question is a very simple type of statement that rely on a couple of few components. First component is, for the last two years, I have been starting all of my presentation, I think, by mentioning that we are entering in the period of growth, and this period of growth will be during a decade course ahead of us.
I am very pleased to see that six months after six months and presentation after presentation, I can continue to confirm that we are pleased with the current execution of the plan. We are pleased with our ability to deliver the results, and we are entering into this period of growth. Our five growth drivers are performing accordingly to plan and expectation. That put us really in a very particular situation. When you look about the competition and the environment and the marketplace, I do not think there is a lot of companies who can claim that they will have and benefit from such a long period of growth ahead of us right now. That give us a benefit of two things. One, we have an ability to continue to invest in our pipeline.
You know that for UCB, the strategy of innovation always have been at the heart of what we are doing because we think that it is important that for a company our size in particular, we continue to invest in what can be translated into differentiated medicine. I think that we have seen during the last 10 years, good example of this strategy in motion with the ability to discover, to develop, and to launch differentiated medicine that create unique outcome for the patient, which is really the mission that we are in. Thanks to the growth that we are now engaging into, we can continue to invest not only into the success of the launch product, but in the preparation on the future with investments in the pipeline. The second component is we have a very good balance sheet that give us a strategic flexibility.
We have reduced our level of debt. We have already made four acquisitions this year, and we are in a situation where we can even do more. I think you agree with me that the acquisitions that we have done, and I just want to mention Neurona and Candid in both neurology and immunology, are ways to strengthen our two pillars that have been strictly important for UCB. That could give us, if things go well, of course, but that could give us potential additional growth beyond 2037, beyond the period by which BIMZELX will lose exclusivity.
We are not only in a good shape because we are in a growth period right now, we are reinforcing our ability to invest in our innovation, and we have also, through inorganic growth, strengthened our pipeline and portfolio to be even more secure potentially, or to have in our hands potential to continue to grow above and beyond the market growth after 2030 for the 2035, for the decade after. That is the third element that I would like you to keep in mind is this ability, thanks to the period we are in and thanks to the success that we have been able to deliver, to continue to strengthen.
Last but not least, this strategic flexibility will remain, and because of the period we are in and the stability we are in and the visibility that we have, we have also the potential not to be under the pressure of time and to start to think about how to at best continue to grow and to develop and to deliver value for our shareholders, for our patients, and for our employees, and this is to be consistent with our purpose. So this is maybe, Richard, a quick introduction that I wanted to share with you, and now I hand over back to you, Richard and Sophia, maybe for the question that you may have.
Thanks, Jean-Christophe. We definitely want to talk about the continuation of the innovation. But I think to start with, maybe we could talk about some of the growth that is going to fuel that investment, but also fuel the top line. I think most, BIMZELX, you mentioned, of course, is one of the key growth drivers we all know. So I wanted to ask to start with just about how BIMZELX is going. You took the decisions in the first half to invest in expanding access, which was announced with the results. So how is that going? How should we think about the unlocks in terms of volume and growth potential for BIMZELX in the U.S. across the different indications?
Yes. Thank you very much for the question. First of all, I would like to remind all of you about the particular competitive situation that BIMZELX is in, because I feel that sometimes we take for granted, but we forgot exactly what does it mean. First and foremost, BIMZELX is a unique monoclonal antibody. We are able to target at the same time two very important inflammations mediator in dermatological disease, IL-17A and IL-17F. There is no other component today with this ability to do this at the same time. It is not a bispecific per se, because we have added one arm that targets the A and one arm that targets the F. It is the same monoclonal antibody. They are able to get the same type of affinity for both antibody, which is really quite unique.
These have been based on a better understanding and knowledge of human biology, where the F is present in opposition to animal model, which is very often used in preclinical study where there is no unimportance of the F. So it is based on a human biological evaluation that we understood the role of the F, and we get this scientific hypothesis that by targeting the two, we can translate that into a differentiated medicine for people suffering from these diseases. So that is one element. The second element is by doing so, and I always have shared that with you, I always have asked you to look at the result of BIMZELX from a data standpoint on three criteria. One, which is the speed onset of action. Two, which is the depth of the efficacy. And three, which is the durability of this action.
I think it is fair to say that on these three components, we are raising the bar of what a product can deliver for patient. The third component that I would like to highlight, and sometimes we have a tendency to forgot that we are the unique product that have been able, during the clinical development program, to study and demonstrate that the product is superior to the standard of care in psoriasis. Earlier this year, we have done the same superiority clinical trial versus SKYRIZI in psoriatic arthritis.
I just would like to come back on this framework just to make sure that this is clear, that when we talk about competition, when we talk about access, when we talk about how much and how well BIMZELX is doing, we are building on unique set of data and fact, which are not only unprecedented because nobody have done that before, but two, we have been able to demonstrate clinically the added value, the differentiation that we are able to deliver to the patient. This has been confirmed since the launch.
And before talking about access, I would like also to remind all of you that when you look at the launch curve in terms of prescription by all of the competitors in psoriasis, in this indication for the product in the class of IL-17 or IL-23, and you look at the performance of BIMZELX in terms of takeoff since launch, we are at the top of the package. So we have been able to demonstrate the fact that the product is superior to deliver clinical outcome for patient. And we have been able, as an organization, to demonstrate that we have been able to translate that into value, into prescriptions, into adoption. And by the way, some of you have done that, and Richard, I know you have done that also.
But when you ask European leaders, when you ask dermatologists or rheumatologists what is their experience with BIMZELX compared to others, what I have just shared with you, I am sure is also shared by them. So that should give you, as well as that have give us the confidence about the perspective and the performance of BIMZELX on the long term. Because if we are building on the evidence, which every physician should do, BIMZELX should be the product of choice. Now, of course, we are operating in a different type of environment. There are different hurdles, there are different resistance to the adoption, and we need to change the habit. So none of that, of course, is done obviously immediately, and the change management still needs to be done.
But fundamentally, the outcome to the patient since the day of launch have more than confirmed what we have observed during the clinical trial. I have not seen so far one physician, I have not seen so far one patient for who the BIMZELX have been a success, who have not shared with me how different the experience of a success was with BIMZELX compared to other treatment in the past. The speed, the depth, the percentage of patients having full clear skin, and the durability, because now we have studies in three and four and five years. We have all of this data available to show that we have everything in our hands to become a best-in disease in the different disease we are present because of the quality of the product.
So when you have such a great product and when you have an asset like that in your hands, and particularly in the U.S. where access is dependent on price and on negotiation with the three major PBMs, you need to make sure that you adjust and address the access to the maturity of the physician to prescribe. And at the same time, you want to ensure that the experience for the physician or the experience for the patient will be the best possible. What does it mean, the best possible? That mean reducing the burden of the administrative hurdle, the pain between the patient and the drug. Reducing and facilitating the prior authorization and the benefit investigation. Increasing the percentage of success. Increasing the facility by which, and the easiness for the patient and for the physicians to get to the product.
And this is kind of an art because you don't want at the beginning to give up too much of a price in order to get an access that you will not be able to benefit because the physician is not ready to prescribe you at an early stage. Physicians need to have the experience of the products to be reassured by the products. We have now almost 150,000 patients treated by BIMZELX. We have this experience, and little by little, the numbers of physicians who are very confident to treat patients with the drugs are more and more important. We are trying to get access earlier and earlier, which is what we have been able to achieve.
By the way, since the beginning, we have been able to avoid to have exclusion in our main indication, PSO, PSA, and axSpA, with all of the three majors PBMs, which is quite unique when you compare to even the more and the more important product or companies. Now, where we are, we are now moving from double-step edit to first step to single-step edits to in one of the three major PBMs across indication of first line, which of course give us more facility to prescribe, make the life of the physician and the patient easier, will increase over time the volume, but the price reduction that you have is immediate.
But once again, what I would like you to keep in mind in the way to modernize objective is to be as protective enough to the price not to give up too much, and particularly with regard with the level of differentiations and quality of the product. At the same time, being at the place where we fit the best with the mindsets and the readiness of the prescribers to prescribe. We are now in this phase where we need to translate the quality of the product into an easiness to prescribe and an easiness for the patients to get the product that we had initially with our bridge program, which was really highly successful and now is translated into this access piece. I'm very confident that we have today into this phase, we are maneuvering into the access program very well.
We kind of managed to have the best possible balance between speed, between easiness, and between sales and revenue. We will continue to do that in the next coming years to little by little joining what will be the place of BIMZELX over time, which will be the first.
We should imagine going forward when we think about 2027 formulary discussions and going forward as you said, a gradual improvement in access and a gradual increase in rebates, reduction in price that is not matching that, but facilitating that. Is that how we should think about it?
You can think about it this way. If you keep in mind the fact that we have already accessed 80% of the marketplace. The majority in a sense, we have already done a lot in this progression, and we need now to continue to move. And you are right, this will continue to increase the volume and have a net price per patient that will balance, but the volume increase will compensate. And in the end, if you want to lead in the market, you need to create an experience which is the easy one. I have not seen a leader on the market being double-step or single-step edit. What we are doing is not exceptional. Everybody have done that before.
It is just the natural expansion when you are not the first one in the marketplace in order to reach the leadership position while protecting as much as possible the best possible price.
And maybe one more from me. That is the same in HS. HS obviously was launched slightly later, so maybe slightly less access, probably the same rebates these days. But that is something you are building and we should expect that just to follow behind in sync with a slight delay, effectively.
HS is different, as you mentioned, because the timing of the launch was a little bit delayed versus the rest of the indication. Everybody's talking about HS. I can remind you maybe that three, four years ago, nobody was talking about HS. It is funny how things are moving quickly. I just would like to remind everyone that HS is not just an additional arm towards the psoriatic type of disease in dermatology. It is a very specific disease. This disease have, compared to psoriasis, have three maybe elements that I would like us to keep in mind. First, it has been a disease, first of all, it is a disease which is not very well known. It is a very complex disease. The pathways and the physiopathology of the disease is more complex than psoriasis.
It is much likely that in the future, there will be different type of pathways that would be potentially active in psoriasis. The first, it is a very complex severe disease where the biology is not exactly comparable to what you have in psoriasis. I met once a dermatologist expert in HS, and he told me, look, each time I need to train physicians and dermatologists on HS, my first message is, please forget everything you know about psoriasis, because HS is completely different. That is also my message to you. Please be aware that HS is the beginning of the story. It is the beginning of the better knowledge of the disease. It is the beginning of this ability to provide the best treatment. The second message about HS, it is a more complex disease.
It is a more severe disease. It is not just about an ability to treat the skin. You get abscesses, you get tunnels, you get fistulas. Sometimes you need surgery that you never need for psoriasis. It is a disease that requires sometimes more dramatic treatment than just a treatment of biologics or a pill. The third element is because it is the beginning of the knowledge of the disease, and the reason why is it the beginning of the knowledge of the disease is because very often it is a catch-22 between treatment and understanding a diagnostic. If you do not have the right tool to treat the patient, well, guess what? The patient will not visit the physician because they are not pleased with the outcome. Of course, they are very frustrated because there is not a lot of solution for them.
It is not illogical that in this environment for years, patients with access have suffered from a lack of diagnostic, a delay of diagnostic, a lack of treatment, the severity of their stage. We are in this phase, thanks to BIMZELX in particular, that the patients and the physician get new tools in their toolbox where they can treat these patients. Little by little, the patients who are not treated, who are even not diagnosed, are coming back to the dermatologist, want to be back to the dermatologist, and have access to potential solution that will help them. Last but not least, I do feel that there will be a moment where not only the diagnostic will increase, we will be much better into bringing this patient to the dermatologist. At the same time, we will be able to treat the patients earlier.
Hopefully, it will happen in HS, what 30 years ago when I started at med school, we have seen in rheumatoid arthritis. When I was a young rheumatologist, I still remember before the TNF-alpha time, where people have huge joint damage because we didn't have at that time, the right solution that can access and reduce the level of inflammation in their joint. Hopefully, we will play the same card with HS, and by being able to control the inflammation earlier in the HS patient, we'll be able to reduce the damage of the patient. My first message is HS is a disease which was not very well known, not very well treated, not very well diagnosed. We are in this phase that we are gaining maturity of the market. The market is expected to grow significantly in the next few years.
We think the patient will come back thanks to new solution, and by nature, we will get access to these. When you think about access, there is also a component which is increasing the numbers of patients coming in. But yes, you're right. HS was also for us, a bit delayed because the studies was done a little bit after, even if it done very quickly. We get now even three years of observations of patients in clinical trial. The durability that we have seen in our two phase III, which have been really, really strong in terms of efficacy. We can also have data now that show that the data that we have as in psoriasis have a very long durability.
We think that, little by little, as you said, we'll be able in HS also to move the PBMs towards an earlier usage of the product. But we think that we have also the patient with us to do so. It's not just a transaction or a negotiation, argumenting about price with the PBMs. I think there is also the power of the patients that are benefiting from BIMZELX and who make pressure also on their plan to say, look, why I don't have access to this drug? Because frankly, it's very good. So, gaining our dynamic market share, and during the first half of this year, we have gained dynamic market share. Gaining dynamic market share and becoming so, with a big volume and with a great feedback of the patient.
It's not like if you can substitute BIMZELX by a lot of different drugs and everything is okay. We are different. Keep that in mind. I feel very confident that over time, we will also in HS gain the ability to get access and not to be excluded in one PBMs and to get good access for the patients suffering from HS.
Thank you. To this point on how we are at the beginning of our understanding of the disease in HS and the scope for further innovation and market expansion, how are you thinking about some of the upcoming competitor readouts, specifically remibrutinib and leukocizumab? How do you think they are going to compare to BIMZELX from an efficacy and tolerability perspective? If they are successful, where do you see them fitting into the treatment paradigm? Do you see these additional entrants as potential drivers of HS market expansion?
First of all, there is a very generic law that when you add new mechanism and new compound in a market, the market is expanding. That is not necessarily linked to the quality of the product. It is linked to an increase on the offering. There is no doubt that having newcomers will help to inform the patients about the possibility of being treated and will bring more patients to the physicians to be treated. So I am very confident that newcomers will help to expand the marketplace and will help patients to go to the physicians. Now, towards what is the value of this competitor. I have a basic rule myself. I look at the data, and I not comment on something else than the data.
So far, I have not seen any data that can tell me that there is a promise of a product that can be superior to BIMZELX. Now, if someone wants to do a Phase III, what we have done ourselves, which is demonstrating that their value is superior to us, they are very welcome to do a superiority clinical trial. But I think that we and the patients deserve more than just extrapolation or just assumptions based on a very small of data on a very small numbers of patients to imagine that the result will be fantastic. I do not know that. I am waiting until I will see the data, and I will accept the results if a superiority clinical trial demonstrates superiority versus BIMZELX.
But so far, I have not seen any of this data, and I have not seen any plan towards demonstrating that a product can show superiority versus BIMZELX. I can tell you we have had the courage to do this. We have done that with four products, and in particularly the IL-23 in psoriatic arthritis. We had the courage because we think, and we continue to think that we have a very good product, that we have been able to demonstrate superiority versus standard of care. That is, to me, the trigger and the judge to demonstrate superiority. If you do not have that, do not talk about superiority, and let us see the data to see what this product really can bring.
Makes sense. We've just got a question in from an investor on access in psoriasis, and I think in general terms, they're asking around how to think of access in terms of the price and volume dynamics of it. Their question is, do we see price or the rebate level or price being active immediately you switch over onto a new access plan, and then you gain the volume over time coming through at that new price? Just the mechanics of it. This investor is asking. If there's any color you can shed, Jean-Christophe, that would be helpful.
No, yes, you're right. Price by nature, based on the contracting and the negotiation that happens on a yearly base, the price impact is immediate, while the volume growth is linked to the ability to facilitate the prescription. But frankly, there is still a certain time for price to be executed because of the complexity on the market. So it's not because the head in the U.S. decide to do something that all of the specialty pharmacy and all of in the different states in the U.S. in particularly are immediately putting that into motion. So that creates a little bit of time. On the other end, the gain in volume, for example, when you gain a first line, the gain of volume can come relatively quickly, because if you have a first line, then it's potentially becoming a reference and a preference.
It can go relatively quickly. It's not a modalization when you can say from A to B, suddenly you get a drop of a certain percentage and the volume go up two months later, and then you compensate. It's a little bit more complex than that from a modalizations. However, I guess my message is that there is absolutely a strong signal that BIMZELX will continue to get the preference in the indications we are in because of the quality that we bring for the patient, and so more and more physicians are choosing BIMZELX, and for more and more of patients, BIMZELX are really a treatment of reference. So, I'm very confident that, yes, from one month to the other, you can see sometimes in certain area, a certain plateau and then going up again.
Overall, it is what is needed in order to gain the leadership position, and so we will get there.
You have spoken to the breadth and the quality of the data we have for BIMZELX and the existing indications, and that is continuing to evolve with your ongoing trial in PPP or palmoplantar pustulosis. Maybe to that end, how is recruitment progressing? How are you thinking about the size of that opportunity relative to existing indications? Are you considering any further indication expansion for BIMZELX?
In terms of development, PPP is the next one that we have. It is a small disease in terms of numbers of patients. The epidemiology is, I think, something between 0.005% of the population to 0.12%, something like that. So it is a rare disease. However, currently there is no treatment available for the patients suffering from PPP. By nature, it is a disease which is very much damaging for the patient. If you think about it, imagine that by nature, your feet and your hands suffered from redness, from itching, from lesion that create very much difficulties even to walk or to hold something in our hands, right? So, I do feel that it is a very severe disease. It is a major burden on patients' lives because there is a huge discomfort. You cannot work. You are stuck at home. You have pain.
That is a very debilitating disease. We think that we can be very confident because of the type 1 and 3 inflammations connected to this disease, that potentially we will get a benefit from BIMZELX for this indication. So we are very positive. Remember that basically we get the big majority of the patient that we have tested in a multicenter study where we have had achieved a complete clearance of the hand and the feet based on the treatment. So, we are very confident that that will be very significant, even if a small number. It will be, once again, a significant illustration and example that BIMZELX is creating and building the best possible value for the patients. For the time being, the recruitment is doing on track.
We have initiated the phase III in November 2025, so last year. We will expect to report top-line data, I think, in 2028. We are on track with the recruitment. We have also in terms of development, as you know, a study in HS for adolescents. This is also a very important element because HS is a disease that start earlier and very often, this is kids at the moment of the adolescent that start to get into the disease. So it is important that patients may have a solution available as early as possible to be able to treat them. So, we have also that as a development.
And maybe thinking more generally about the pipeline and starting with galvokimig. For phase II-A, the efficacy on EASI 90 looked particularly strong compared to DUPIXENT. I think you showed on EASI 90 43% placebo-adjusted reached that rate, and this was only 26% for DUPIXENT. What do you see as the key underlying drivers of the better efficacy? Do you think this sort of relative differential in efficacy can be replicated in your phase II-B trial?
Yes, we think. Now, I need just to make sure that I do a caveat or an introduction umbrella into this conversation, right? I cannot say, ook, let's see the phase III data to see the real value that the product give. When you say that we are positioned well compared to DUPIXENT, well, look, it's a phase II-A. We had a small numbers of patient. You're right. On EASI 90, we have a good signal, and this is what we have said. We are pleased with the results. We think that we have a good signal. But we don't compare the signal to others because we want to compare things that are comparable. As you know one phase II for one asset compared to a phase III on another asset may not be exactly the level of comparison that scientifically you would like to do.
But yes, you're absolutely right. We think that we had a good signal. The signal was if you will, based on the hypothesis by which for these type of disease in particular, it will be very important. In which mainly we were targeting one target. I think particularly for atopic dermatitis, there is possible value by adding different synergistic anti-inflammatory action in order to reduce the level of inflammation. As you know, for these type of autoimmune disease, like for any type of autoimmune disease, much of the time, it is very important to get the lowest level of inflammation as early as possible. If I come back to BIMZELX, it's not just a question of percentage. It's not just a question of ability for the patients to increase the quality of life.
Achieving clear skin faster, deeper, completely, longer mean that you basically have controlled fully the inflammation for this patient for a very long period of time. Having done that, what is very important is that maybe not only the patient will suffer less from the symptom of the disease, but the disease itself may have a different evolution and may have a different expression because you have reached a very strong control of the inflammation sooner and longer. That's the same hypothesis that we have with galvokimig atopic dermatitis, for example. We do feel that targeting IL-13 and IL-17A and F at the same time creates an ability for the product to have a better control of the inflammation in this patient.
If we can reduce the level of the inflammation, that can translate for the patient from a clinical standpoint into a higher percentage of patients reaching EASI 90, for example, which have not been yet reached today. Not only these patients will have a better quality of life, not only will they have less pain and itching, and they will feel better. But on top of that, we can also argue that potentially by the control of the inflammation, we will have a better control, not just for the symptom, but also for the disease.
Yesterday, you announced the completion of enrollment for the phase II-B GALVO trial. We have seen from a number of novel agents in atopic derm the importance of baseline characteristics for recruited patients, including the proportion of naive and refractory patients. How have you thought about balancing naive and refractory recruitment in your phase II-B trial to determine the best positioning for the product ahead of the phase III?
First of all, you are absolutely right, in the sense that it is a very competitive environment. We are very pleased with what we have achieved. We are pleased that in an environment which is so competitive, we have been able, and the protocol and the product itself have been able to be sufficiently convincing and sufficiently attractive so that we have been able to recruit quickly and faster than expected the patient for this trial. Trial targets patients suffering from moderate to severe atopic dermatitis, which is the target that we want to achieve. We do not disclose today the level of numbers of bio-naive versus maybe secondary or tertiary. We will see what we will have. But it is important that for these patients with this level of severity, we will be able to provide a good outcome.
As you know, I have shared that with you on BIMZELX, whatever the quality that you bring on the marketplace, when you arrive with a new product, and particularly when it is a new mechanism of action, in this case, it will be a new bispecific today. The IL-13 by itself, IL-17 by themselves, the anti-interleukin are well known individually. But from a bispecific standpoint, it will be a new class, a new mechanism, a new experience. So physicians will rarely jump on that and immediately treat new patients completely bio-naive with this. First of all, there is an access question, but also above and beyond the access, there is a question of trust and confidence and creating and building a logical experience of the physician for this drug.
Whatever the quality of the clinical trials are, whatever the quality of the communication are, whatever the quality of the presentation in scientific congress, people like to make their own experience and to start. The reputation of the physician is at stake. It is rare that the physician starts immediately with new patient. They will start probably like they have done with BIMZELX, to start the patient that have some kinds of difficulties to take the control. The percentage of bio-naive, classically in this type of disease in particular, have a tendency to increase little by little. To be frank, we have been very positively surprised by the level of fast adoption of percentage of bio-naive in our bridge program and currently in the psoriatic environment and in BIMZELX where we had very quickly a certain percentage of bio-naive. But it is classic that it grows slowly.
Our target will not be a bio-naive first.
Thank you. We have actually had one investor question related to GALVO as well, which is just if you could provide us any insight into the PK profile of the Sub-Q and then your confidence in the translation of the IV in the Sub-Q from the phase II-A to the phase II-B.
Yes. It is a good question, and thank you for asking the questions. You remember that for currently it is an infusion, and we will move from an infusion to a Sub-Q. But basically, we are very confident about the ability to translate infusion into Sub-Q. It is something that we have a very good experience in, right? It is not the first time that we are translating an infusion for a monoclonal antibody into an ability to be and to get a subcutaneous formulation. So we are very confident that we will be able to translate. The question will be the dosage, and that is what we are trying to evaluate the exposure. That is also the reason why we are looking into multiple dose, and we are looking about the duration of the trial.
So we want to make sure that we will be able to evaluate that. But we are very positive on the ability to translate what we have achieved in infusions towards a subcutaneous administration.
Perfect. Thanks, Jean-Christophe. We wanted to make sure that we spent some time on some of your newly acquired acquisition products. Neurona, we were going to start with. It looks super interesting from the early data, and yet it takes a little bit of time to start phase III trials. So maybe you could just give us a little bit of background to set the scene, but also what takes the time, what do you need to see before starting phase III trials? Maybe even ahead of those trials or as an interim analysis on those trials, can you get an accelerated path to market given the unmet need in patients, and the efficacy data you've got? Just how are you thinking about the potential here and the product?
Well, thank you for the question, and Richard, thank you for your comment about the strategic fit and the interest with regard with these acquisitions. Because as you, we are very excited and we are very positive about both of them actually, because both of them are really a very nice complement to what we currently have. Let's start with Neurona. So the patients suffering from mesial temporal lobe epilepsy are very severe patients, and you can have it unilaterally or bilaterally. And basically, these patients today doesn't have any treatment. They can have as many as 30, 40, 50 seizures a month or even more than that today. So it's really a very debilitating disease where it's really dramatic for the patient itself, of course, himself or herself, and also for the family.
Very often these are potentially, they could be kids, and the parents, mothers or fathers need sometimes to leave their job to take care. So it's really a huge burden that this unfortunate disease creates. Our aim with this acquisition is, of course, as I said, to provide unique and differentiated outcome for these patients and an alternative solutions to surgery. And as you said, what we have seen in the data, in the individual data, has been quite compelling, and that has triggered the interest. As you know, we are following Neurona for a while, and through our venture fund that we have created eight years ago with the objective to get equity and have access to certain new platforms and technology that we didn't have internally at UCB, but we thought could be of an interest for UCB in the future.
We have been in touch with Neurona since almost the beginning, and we have participated in the evolution of the company. We knew it quite well. It is, for us, the first initiation and experience in cell therapy and for regenerative therapy. For these patients suffering from central neurological disease, we do feel that cell therapy could be something of an interest. We have also some equity in some other companies in cell therapy in neurology. The results are quite appealing. It is also very much a great and very elegant solution to avoid the surgery, which are not only a bigger trauma, but it quite archaic if you think about it, right?
Remove a part of the brain in order to reduce the numbers of seizure, even if the best accuracy and if you want to be very precise, it looks quite the last possible treatment if you have nothing else. Cell therapy for these type of patients are really a very interesting potential solutions moving forward. There is no time between phase II and phase III. It is a very new therapeutic area, a new modality, engaging with the design of the protocol of the study with the FDA for these type of patients. So required some discussions and some agreement, but we are very confident that we will be able to start the phase III, as we mentioned earlier, beginning of next year. That progress really well, and we are on track with what we had in plan.
Maybe one follow-up before we ask about the other acquisition. Just accelerated approval given the unmet need. Can you do anything around that? You mentioned discussions with the regulator, so it may be too early, but just thoughts about that.
I think everybody could understand. All of that is a balance between what you bring and the security that you can propose and convince the regulators. We are in this phase. It is new. There is no other cell therapy for these type of patients, of course. So it is normal that it takes a little bit of time to kind of secure what will be the best way to evaluate the drug, to ask something to the patient that could be acceptable. Because don't forget, you will have also to compare the patients to no treatment or placebo kind of control group. So it is also something that it is not easy.
You are right in the sense that if we are able to confirm and to quantify and to get into a more bigger cohort, the signal that we have seen so far, that will be a big value for this patient. An ability for the environment, the regulatory, the payers, and the society to recognize the uniqueness of what we are bringing is, of course, something that we have in mind.
I am actually going to just ask one other one. Just on here, I mean, it is early data that was seen in the phase II. Durability of efficacy, we have seen with other cell therapies, quite long durability. I mean, mainly it has been in cancer and stuff. Should we envisage a long durability here, and is there a possibility of redosing?
I am not an expert in cell therapy. I would say it is probably a question mark. An easy answer to your difficult question will be time will tell. There is no reason for the duration of the benefit that we have observed not to stay. That is the principle of a cell therapy. You inject cells, the cells mature, and the cells protect and change the behaviors of the other cells that they are supposed to modulate or to regulate. So there is no real reason why you will have a duration that will not be relatively long. We do not have long exposure. So for what we have seen, we have this durability. How long it will go, we will have to observe the patients over a long period of time.
I am thinking about one of your other acquisitions this year, Candid Therapeutics and your T-cell engager cizutamig. Could you remind us what phase I efficacy data you have seen so far? How the efficacy relative to other mechanisms in MG, such as FcRn compares, such that you are confident to progress into phase II with this asset?
T-cell engager first, right? I think it is probably important to spend a little bit of time to remind why T-cell engager are a logical, natural possible evolution for UCB. As you know, we have been really mastering, I think, these notions of antibody engineering and the ability to translate an innovative scientific hypothesis into an antibody that can deliver to the patient the best possible solution. We have demonstrated that with the pepinemab in the phase II. We are confirming that in the phase 3. We have created the anti-sclerostin EVENITY where nobody before have been able to design an antibody against sclerostin as a target. We have been first, and we are still the only one with an antibody that target at the same time IL-17A and F.
I think that if you think about UCB as an innovative engine in immunoinflammation, you have to think about that first from, of course, the ability to translate patients' biology into a scientific hypothesis. Then you need to also understand how strong UCB is in our ability to translate a scientific hypothesis into an antibody able to deliver what the hypothesis was. For the T-cell engager, in the case of cizutamig, this notion of BCMA/CD3 at first and foremost, it is a bispecific. How to engineer the bispecific and how to make sure that the bispecific is really the one that will engage the target in a certain way and being able to deliver what needs to be delivered to the patient. I think this is something that we think that we have a very strong legitimacy to be able to bring and to deliver.
The second component is the strategic fit with the evolution of our research and discovery in immunoinflammation, right? We started with being experts in monoclonal antibody, with or without an Fc, and CIMZIA is a good example of that. By the way, CIMZIA just have had the orphan drug designation for an indication in antiphospholipid syndrome, which is a very rare syndrome in rheumatology where CIMZIA will be the unique anti-TNF with this indication, which is really a very great achievement that shows that differentiations continue over time, even with certain asset. The T-cell engager are the ability for us conceptually to move in immunoinflammation from symptom control to inflammation control and so potentially disease modification towards immune reset. This is what we are talking about with these categories of molecule.
You have to think about that in a much different way than the classical monoclonal antibody. We are not just targeting a target. We are not just targeting a mediation of inflammation, an IL-17 something. We are targeting with a bispecific two cell, and we are changing, modifying, impacting the ability for the immune system, and particularly the B cell and T cell, the ability to connect to each other and to change the message. By changing the message, there is a potential ability to create a new environment from an immunological standpoint and change the disease, the perception, the evolution, and the damage created by the disease. By being T-cell engager, we are able to interact at a cell level to change the way the immune system react and behave.
And that's the reason why, for this asset, we are not just thinking about one disease or one patient's population. We are really talking about an ability to interfere with the immune system to create a reset, that potentially have an interest in many indication. That's what we have today. We have in phase I, having certain patients in China, in Europe, in U.S., in different type of indication, when we have seen signals that give us the confidence that we may have an ability, in particular with cizutamig, to potentially address a lot of unmet medical need. The art will be now to detect, by understanding of the human biology, to detect where this BCMA/CD3 can create a fast, quick, significant impact that can give us access to a better understanding of the disease, right?
And better understanding of where we can develop the disease and where we can develop data that can demonstrate that we have the best. MG is one of them, but there are many others, and this is particularly what we are doing today. But from a conceptual standpoint, we felt that the T-cell engager was, once again, more elegant than if you think about CAR T in immuno inflammation. I think CAR T is very much appropriated for severe oncology, much more difficult to adapt and translate into immuno inflammation. I think the T-cell engager are really a natural evolution of what have been UCB expertise so far to be able to translate that for many patients in a different way.
Jean-Christophe, I know Sophia and I would like to carry on, because we're just scratching the surface there and there's plenty more assets, and there's plenty more to dig into the cizutamig. Never going to be able to say these things. But because your time's more important than ours. It's been a great discussion. Thank you very much. Thank you very much. Thank you everyone else for listening as well. We wish everyone a great day. Thanks, Jean-Christophe, from Sophia and I.
Thank you, Sophia. Thank you, Richard. And thank you everyone for your attention, your confidence and your trust. As you said, there is many more at UCB, so looking forward to the continuation of the journey together.
Thanks