Oxford Biomedica plc ($OXB)

Earnings Call Transcript · June 2, 2026

LSE GB Health Care Biotechnology Analyst/Investor Day 169 min

Earnings Call Speaker Segments

Aurélie Charpentier

Executives
#1

Good afternoon, everyone, and welcome to OXB's Capital Markets event. I'm Aurélie Charpentier, Head of Marketing and Communications at OXB, and I'm delighted to be here with you today. For everyone joining us here, thank you for coming despite the chip strike. And to our webcast audience joining from around the world, thank you for being here. Today, you're going to hear from OXB's senior leadership team and industry-leading voices. Let me take you through the agenda. We'll have 6 presentations broken in 2 sessions with a 15-minute break in between. First, you'll hear from our Chief Executive Officer, Dr. Frank Mathias, who will provide an overview of where OXP is at today and our market positioning. Second, Professor Luk Vandenberghe from Harvard Medical School will join us online. He will provide an independent perspective on the current advances in cell and gene therapy and the opportunities ahead. Third, our Chief Innovation Officer, Dr. Kyriacos Mitrophanous, will show you how innovation can enable client delivery. You'll hear about next-generation platforms, AI, automation and new markets. And fourth, our Head of Process Development, Dr. Nick Clarkson, will demonstrate how process development excellence and the client-centric approach can deliver value. We'll then have our first Q&A session of 15 minutes with these 4 speakers, followed by a 15-minute break. After the break, you'll hear from our Chief Business Officer, Dr. Sebastien Ribault, who will take you through a deep dive into the cell and gene market opportunity, our business pipeline, our conversion rate and why clients choose OXB. Sebastien will then sit down with Arun Das for a fireside chat. Arun Das is the Chief Business Officer at Cabaletta Bio, one of our key clients. Sebastien and Arun will discuss our partnerships, why Cabaletta chose OXB and the value we deliver. And finally, our Chief Financial Officer, Dr. Lucy Crabtree, will cover our strong financials and attractive outlook. We'll move to our second Q&A session, 30 minutes with Frank Sebastien and Lucy. Frank will then return to summarize and close the session before our drinks reception. During the Q&A session, we'll be taking questions from the room. For our webcast audience, you can submit your questions throughout the day and we read as many as we can today for we will answer to individuals after the session if we couldn't get to the question. And with that, I will now hand over to Frank to open the session.

Frank Mathias

Executives
#2

Thank you so much, Aurélie, and hello, everyone. Nice to see you here despite the strike. It took me 2.5 hours this morning to come from the airport. But I'm on time and I'm happy about that. So it's a pleasure to welcome you all to our Capital Market event. And we really appreciate that you took the time to come to follow this session. So we have prepared a very nice agenda, as Aurélie just showed you, and we will share different perspectives on the company. So first, what are the market opportunities we have and we see ahead of us. Then we will discuss the progress we have made over the last few years in building a pure-play CDMO company. And then we will also try to show you why we are so confident in delivering long-term sustainable growth. But before we start and Aurélie has already mentioned it, I want also to express my gratitude to our guest to Luk Vandenberghe, who will join us virtually. He is from our innovation and Technology Excellence Board to kind of Advisory Board to the company. And of course, to Arun Das, you presented him already Aurélie, Chief Business Officer at Cabaletta. Thank you for taking the long journey to visit us also today Das -- Arun. Thank you so much. So let's start. And because some of you might not be -- yes, you all know this one. So please consider it. So perhaps some of you are not so familiar with what we do and what [indiscernible] space is about. We saw some potential short slide to make it evident what kind of world, crucial world to say we play, so just in one center cell and gene therapy is a medical approach that treats diseases by modifying replacing or introducing cells and genetic material to restore -- a normal functional hedge the burden to fight in this. That's what cell and gene therapy is about. And what you see is that this therapies are about fixing diseases at the biological source. So instead of just treating the symptom, you try to correct to replace or to add what's working not so well into the body. And this has a potential to cure. I will come back to that because I believe this is an important part to understand. So we play obviously here a central role, as you see by providing the viral vector, which you can consider to be a kind of vehicle to bring the code, the genetic material into the body. That's what we do in the middle. We just focus on the development and production of viral vectors. So let's have a short look at the market we are in currently. And I believe it's important to mention here that what we are seeing across the cell and gene therapy market is not just a short-term cycle. It's everything but not that. It's really a sustained expansion of therapeutic pipelines across all stage of development from preclinical programs up to commercialization. So the number of products is estimated of programs to say, it's estimated to grow, and you see that on the left-hand side here, 9% year-on-year over the next 5 years. So by doing that, they will fuel demand for high-quality manufacturing partners. What we see also in the middle is at the bottom of the middle is that currently 38 cell and gene therapy products are already approved globally. And what we see also is that we expect a high level of development of the revenues for the outsource is on the right-hand side just outsource potential market growth, which is supposed to grow whatever source you take of data, are very similar in what they say from 4 to 10 billion in the next 5 to 6 years. So this will be 18% growth on average every year. So what we see also it's a lot of dynamics in this market. cell and gene therapy M&A deals just in 2025 up to $12 billion in value shows that there is a lot of dynamic in this market. Now coming to what OXB is about and I think it's important to remember that our vision is to transform lives whose synergy can tell me how, by helping and by enabling our clients to deliver life changing therapies to patients. So this shield is fundamentally shifting the paradigm and [indiscernible] moving beyond the just same treatment towards treatment with potential towards where the disease at it's source end to cure. We or the company provides them the expertise, quality and manufacturing excellence needed to translate this scientific innovation, into a scalable commercial reality. So we have done that for more than 30 years, now we have been leading innovators in viral vector design, process optimization and large-scale manufacturing, I'm sure [indiscernible] few things about that, it's part of our long time history and today we focus on best-in-class capabilities, scalable platforms and start-of-the-art facilities. And our strategy is also very clear, we want to cell and gene therapies to be more filled as the trusted partner so an unmatched quality and innovation. So our focus is to build long-term partnerships with leading innovators. I want to mention you, Arun here with Cabaletta Bio because I believe it's a strong example of what a good partnership can bring for the benefit of the end the patients. So if we go to a little bit of history because I believe the history is important to understand us, you might know, everything started in Oxford in 1995. It was a spin out of the Oxford University. And over the years out from the origin at the end from the spinout, we went through a lot of progress. We achieved a lot of milestones in cell and gene therapy, and we have been consistently evolving alongside the industry itself. I believe that the most important transformation was somewhere between '20 and '22, when both of the company decided, we need to take a decision. Do we continue to do product development for our own or are we going for CDMO business, we decide to become a pureplay CDMO company and this brings us into the unique position in the field. So this says of course required strategic clarity and execution building of a 30 years of expertise, we have continue to strengthen our global CDMO network and manufacturing footprint, so strategic investment and targeted acquisition as you know in the U.S. and in Frank will come back to that. So by doing so we have broaden our technical capabilities across vector platforms we are today vector agnostic, we can do every kind of vector and we have builded an integrated international network and at the same time, and we'll see if we [indiscernible] on that we will able to deliver 33% gross in full year 2025, but as we look back to 2023 we more or less even doubled our revenues within 2 years, so I believe I can say today that OXB is stronger, more focused, more scalable, more globally integrated and never before and as such will extremely well positioned to continue to capture substantial market opportunities ahead of us. Just a few words on our global sites network as you might know, we have now facilities in U.K. in France and in U.S. and I wanted to show you how is this came together, so everything started that as I said before in Oxford in 1995, today Oxford will be our center of excellence for lengthy viral vector development and also production up to commercialization, we are also able to do other formats, but into center of excellence in U.K. Then through the acquisition we did in 2022 of the [indiscernible] CMC part we acquired a center of excellence and we acquired a site in U.S. which we now developed to center of excellence for AAV, I believe this was important because you cannot be considered as a global company if you don't have a footprint in U.S. At the same time and there is a little bit due to the Brexit, we also decided to make an acquisition from Acetum in France by acquiring 2 different sites, one in Lyon and one in Strasburg, and you see that the vector focus here is AAV and lentiviral vector. We can do both, but we can also do other oncolytic and MVAs in Strasburg. And finally, and I'm sure this was a game changer. We made this acquisition last year at the end of 2025 of a site, state-of-the-art site in Durham, North Carolina, which we acquired from Resilience. And I said it already, I'm sure this was a game changer because it has increased our awareness immediately in the market. We need to know that this is fully FDA approved commercial scale facility already with additional fill and finished capacity. So this allows us to really end-to-end offering in the United States now and the way we see both Bedfort will be the center of excellence for AAV, development up to E&P and 1/6 in those E&P status will be transferred to [indiscernible] production, it's a way we see. So we are now globally in the western part of the -- at least of the world and we are able with the high level of flexibility to serve all our clients, whatever the level of their clinical development is our -- it's needs for commercial or for development we are able to do it from all the different geographies. And as always behind everything, which is successful U.S. people, and I have to say that, yes, as you can see we have a highly experienced management team, we have highly experienced people around the different geographies and I have to say that I'm extremely proud to be working with such inspiring people around me and us, and you will hear from some of them later, from the team about what the experience are in financial market, via vector development, while vector manufacturing and the border CDMO space. And this brings me to my last slide, little bit as an introduction to the different presentation you will see, alongside the afternoon. I believe it's important to see that our performance, the ones which we consider to be outperforming, performance 4 different pillars, they are mentioned here. So first is our global scalable infrastructure, this is the foundation that enables us to support programs from early development up to commercialization or up to commercial supply. Second we have process development, excellence and we will show you a lot of data in this direction, when our ability to solve even very complex technical challenges. We have the third block is about our innovation led platform, which ensure that we continue to evolve and stay ahead of what the client needs, but also of what the science is doing. And fourth, our commercial momentum, which reflect the strength of our pipeline and of our order book, and I'm sure that Sebastien will tell us a lot about that. So these are the 4 blocks, the 4 areas we're really defining how we operate and where we focus as a business. And having said that, I would like now to introduce our first speaker today, guest speaker in this case. So I hope that Professor Luk Vandenberghe is online. He's Associate Professor at Harvard Medical School and an associate member of the Broad Institute of Harvard and MIT in Boston. Professor Vandenberghe is a leading expert in the evolution of cell and gene therapy and his lab work is focused on improving viral vector design and use. We are very happy to have him being part of our Scientific Advisory Board. He's joining us today in a live call to discuss with us cell and gene therapies, how they are maturating and to impact a growing number of patients and the role CDMOs have to play in fulfilling the potential of this modality. So Luk, the floor is yours. I would say, in this case, the screen is yours. Thank you so much.

Luk Vandenberghe

Attendees
#3

Thank you, Frank, for that introduction. And it's a great pleasure to be here at this event in OXB. I'm sorry, I can't be there in London with you. If we can switch over to the first slide. I was asked to provide an external perspective on the state-of-the-art in cell and gene therapy by OXB. And of course, that field of cell and gene therapy is the field that OXB is providing essential services in, as you've just heard. At the same time, beyond from this external perspective, I am, if you will, a prototype end user of the services that OXB provides. I often seek out manufacturing services from companies like OXB and the likes. In terms of the title here, maybe if you go back to the title slide, please, gene therapy is at an inflection point. And as is usual, during periods of transition, this leads to a lack of clarity in terms of where the future trajectory leads us. It's my goal here today to share with you where my compass points and provide you then also with some data points that informs that opinion. So on the next slide, I'll give you a brief introduction as to where I'm coming from. I'm an academic primarily with training in biochemical engineering and virology, and I live in the field of molecular medicine. Originally from Belgium, spent most of my career on the East Coast in the U.S., where I eventually became the Founding Director of a center called the [indiscernible] Gene Therapy Center at Mass General Brigham in Boston, where I'm also a faculty at Harvard. I'm an engineer by training. So most of our work really is around building technologies, designing these technologies. We study these technologies as well. But importantly, for this discussion, we try to translate these products, that last word there on the slide on the right. This process translation is building science out into drugs into the clinic. So on the next slide, I described to you where this journey has taken me over the past 20 years on the industry side. I just talked about kind of my academic path, but I've been fortunate to see several of these technologies and experimental drugs progress through development and in one case, even the marketplace. Sometimes this happens through partnerships, like is the case with this vector kind of in the middle there, AAV9 that was incorporated into a drug Zolgensma, which Novartis sells. And sometimes that path leads us to the creation of a new company right next to it on the right, Akos, a hearing gene therapy company, which is leading one of our technologies to the clinic and that I still remain involved with even after its acquisition by Lilly. So on that journey of each of these programs that are listed here, a critical step is solving for your manufacturing needs. And that is a critical component all the way from the laboratory down to eventual market authorization and beyond in terms of commercial supply. On the next slide, let us maybe try to get to the same page feel briefly here by providing you some of the key concepts in the field. And I'll try to keep it relatively clear. I don't think we need full depth to have a sufficient understanding here in terms of what gene therapy is. The goal of gene therapy is really no different than any other field of drug development. We develop drugs for diseases where there's a need to develop these drugs. But unlike other fields in drug development. We have an active compound in that drug that is not a small molecule. It's not a protein and the traditional drugs that you're familiar with, it is a gene or it is a gene-modified cell there in the middle on the left. Why is this compelling? Why do we need a different modality than the drugs that we have? Well, cell and gene therapy has the potential to address, as I think Frank also referred to the root cause of disease. It allows us to go after diseases that currently there are no treatments because they're technically hard to get to. And another aspect that I think speaks to the imagination, it has the potential to be durable, a onetime intervention with a lifelong benefit to the patients. There we say, and this is a word we use very carefully, in the best case scenario, a cure. So next slide, I will highlight to you why this hasn't been done before. Well, the challenge is threefold. It's called delivery, delivery, delivery. It's basically how do we get a gene safely and efficiently into the body to have that therapeutic effect that I just talked about. On the next slide, I'll share with you the kind of the solution that the field has come up with, and that's summarized here. The solution really is called a vector illustrated on the top right there. The vector is a vehicle that facilitates this delivery issue. It's a post fan, if you will, that shuttles in a gene to the cell. The blueprint of a vector looks like that's there on the top right. It's got an outer shell, which is the vector and it protects and it guides the internal therapeutic cargo illustrated there in orange in the middle, and that's the gene. This vector is either applied directly to the patient in a field called in vivo gene therapy. As you can see there with the arrow circling down to the right -- to the left. And on the right, there's an intermediate step called ex vivo gene therapy, where that vector is applied to cells outside of the body, and those cells are then delivered to the patient in this field called ex-vivo gene therapy. Now OXB holds the expertise and the capabilities of producing these vectors at a purity for use in humans and at a scale to support products through testing phases and eventually into commercial. The most common vectors in use are viral vectors, and these are inspired on naturally occurring viruses, but they were neutered to eliminate the noxious features of the virus. And 2 types you will hear throughout the presentation, you've already heard about AAV and lentiviral vectors are the most common ones, but OXB provides services in a variety of other ranges. So on the next slide, I'd like to give you just a little bit of the human element of how gene therapy, cell and gene therapy can impact lives and it's already doing so on a growing scale. I won't do it in terms of the numbers that Frank presented, but I'll do it in terms of these vignettes. Starting on the top right, this woman Emily Whitehead. You can look her up. It's one of the first patients treated with a CAR-T cell when she is very young and suffering from an otherwise fatal pediatric cancer. Now we have several CAR-T cell therapies, as you know, available globally, and they are making a market difference for these patients. Moving to the middle, spinal muscular atrophy, a fatal genetic disorder that leads to death often in the first few years of life. A single administration brings therapy to these patients. Now on the flanks and on the bottom here, 2 examples from sensory disorders, all the way on the bottom right, and we'll come back to that later in the presentation, hearing. Recently, there's been an approval just about a month ago from Regeneron in this field. We have been active in this field as well. On the left here, a particular story from just a few weeks ago, this is a drug that's now one of the first gene therapies ever to be approved, Luxturna. I had the privilege of teaming up with my old mentor, Gene Bennett, the woman who developed this drug and eventually brought it to a company to Roche and Novartis to commercialize it. Here, we were reunited with one of the first patients who delivered who got -- who received the drug in both of his eyes when he was 9 years old. I was a translator and helped during the surgeries. And now I met him when he was 26-year old at a celebration event for Gene and Al, husband and wife who developed this and really a remarkable story. This was not a cure. You can see the cane there that he's holding, but he gave testimony, Yannick, his name is, of how this changed his life to lead an independent productive life. He's a psychologist now. He went through a career path, found a partner and is now living independently and working in a professional context, something that would not have been possible without this drug that gave him back his science. As a small vignette, just 2 weeks after this event now a month ago, Gene and Al, together with the team of Luxturna received what's called the Oscars of Science. This is the breakthrough prize in sciences given out in California by Sergey Brins and the Zuckerberg a $3 million award. In any case, in the next slide, let's go back to the science here. And this is just a brief iteration of the 50-year-old history of the field. This is not a -- while this is an innovative and ambitious field, went through various stages since the '70s, foundations that were laid, first steps that were taken, some stumbles in the early 2000s. And now -- and this is going back to the title of the talk, pivoting from a stage of maturity. We have drugs that work. We have technologies that work to some extent, but we're really now transitioning into this industrialization phase. And that is one of the pieces of that inflection point that I described to my time. So let's go into the inflection point and what's behind it in the next slide. Indeed one where we now have all of these things that have happened, overall, quite good things, validation of the science behind this ambitious field, annual markets north of $1 billion of certain drugs, dramatic clinical outcomes, increasing investment and acquisitions in areas like CAR-T, neuromuscular and ophthalmology. But we also see clear signs of hesitation, commercial hesitation. And these have to do with safety events. These have to do with pricing. These have to do with market access. And these are legitimate, I would say. These are concerns that are legitimate. I'm not here to kind of gloss over those and tell you that these are over reactions. No, there is a real reason between -- behind this moderation. However, I would be remiss to not highlight the clear opportunity that's there as well and particularly that is sometimes overlooked in this window of time. The opportunity stems from the fact that the investments of an era of exuberance, and this is probably an era somewhere from the 2015 to a few years ago, where massive amount of investments have led to scientific and commercial hurdles that have been dramatically overcome and that now the field is really primed to have an expanded impact in terms of biopharma. So in the next slide, let me walk you through some data points behind this. The first generation of cell and gene therapies has identified several limitations in terms of delivery, the types of car we can deliver and how we bring those to patients. But as I mentioned, a lot of these areas have been significantly matured because of the technologies that have been invested in. So in the next slide, I'll give you a few short vignettes, and I'll briefly guide you through the scientific slide is actually some of our own data. And I understand not all of you are scientists. It's my full intent to make you a scientist by the end of this talk, so bear with me. But let me point you to actually the scientific slides, the histology on the right there. There, you see 2 columns, liver and muscle, and you see 3 generations affected. I'll briefly walk you through it. When there's more brown there, it means that the targeting was effective. When there's little brown, it means that it was not effective. I tell you now that muscle drugs that are emerging today and coming on the market have been based on this first-generation vector that we see there. Barely actually reaches the muscle, largely gets trapped in the liver. That investment that I talked about before has led to several parties developing a second-generation vector that at least gets you in the muscle significantly better. And then a third generation that shows that you can actually delete the liver where it doesn't even belong when you develop a muscle drug. So we are now -- we have an uncanny ability to target these innovative medicine. And what it does is it effectively overcomes some of the main issues. Two issues are that because of this limited capability of that first generation, we have to dose massive doses to the patients. That leads to high cost of goods and toxicity. And guess where that toxicity shows up in the liver. So you can imagine the impact that a third-generation vector could have for diseases like Duchenne muscular dystrophy. Next slide, just very briefly, a similar effort is ongoing in terms of the target, what goes on. So not the vector on the outside, that outer shell, but also what goes inside. Up until a few years ago, we could really only do this gene augmentation approach. But I'm sure you've heard of things like CRISPR and so forth. We now have abilities like gene editing, RNA-based approaches, sophisticated ways to control genetically where our target goes. And that is really because of a revolution in molecular medicine. In the next slide, I want to make the point that the opportunity goes beyond the science. Because of the appeal of gene therapy, the impact it has on patients, there's been large incentives to accelerate this modality. These incentives have come from drug makers, regulators and investors. And they have led to accelerated pathways for approval, potential for expansions earlier than many other modalities, a probability of success in terms of development, the risk that one takes early versus later in development is lower and it's increasingly dropping because of the experience we gain. And it's lower compared to other modalities. So that means faster approvals, earlier access because of these faster approvals to the need to commercialize and the preparation for commercial license. And this brings us back to OXB, CMC that needs this manufacturing piece needs an early attention. So in the next slide, 2 brief vignettes in terms of support, and then I'll round off. Here is that probability of success that I referred to. Compared to a small molecule on the right, there's these relatively modest but real increases of probability of success, particularly early in the pipeline. You can see, for example, a CAR-T cell has about double the likelihood of success all the way to approval compared to a small molecule. And that has -- we know why that is. That's because we use twezers rather than hammers in this modality. We know the biology of disease that we target better than often with a small molecule drug, and we're learning as we're going. So in the next slide, I'll come back to some of these regulatory pieces and the importance of manufacturing, that manufacturing or that CMC piece. Regulators used to go around in meetings and talk -- make statements like 50% of a gene therapy drug is CMC. And that's not the case for a small molecule. That is the case for a gene therapy because of the complexity of the drug compounds. And when you ask sponsors here in a survey organized by Jefferies and published last year, sponsors see as key execution risk, 2 areas that directly land back into a CDMO, product quality and CDMO. These are critical path in terms of quality and in terms of time line for any drug development, and I can testify to that from my own experience. Now the last slide in the next one, what is so important. So in the next slide, what is so important in terms of what a CDMO delivers. It's quite a lot. We're asking the CDMO to really optimize parameters in terms of speed, in terms of scale, in terms of robustness. But conversely, we also expect them to be flexible. And the only way to achieve that really is to do that with a deep level of specialization and a party like OXB has a track record of the level of focus in the cell and gene therapy space that now goes back, I think, more than a decade plus. So with that, I'll leave you here. And in the next slide, I'll ask for questions that I'm happy to address in the Q&A session a little bit later. But thank you for your attention.

Aurélie Charpentier

Executives
#4

Thank you, Professor Vandenberghe, for this valuable scientific and industry context. A key takeaway is the importance of manufacturing for the success of cell and gene therapies. Speed, scale, robustness, flexibility are key enablers for these therapies to reach the patients. And that's exactly where our next session is going to take us. I'll hand over now to our Chief Innovation Officer, Dr. Kyriacos Mitrophanous, who will explain how innovation can help us to address these challenges, how we can create competitive differentiation and enable the next wave of therapies.

Kyriacos Mitrophanous

Executives
#5

Thanks Aurélie and thank you, Luke, for that very insightful presentation. So I'm Kyri Mitrophanous. I'm the Chief Innovation Officer at OXB. I've been working in cell and gene therapy for over 30 years, and I manage a team working in innovation in vector engineering, cell engineering, process development, AI and analytics. Over the next 15 minutes, I want to explain why innovation is not a nice to have for a cell and gene therapy CDMO. It is critical for our future success that we stay at the cutting edge of this growing and exciting field, as you've just heard. So why is innovation critical for CDMO? Well, the technology is still developing. Unlike biologics, cell and gene therapy processes have not yet been commoditized, making vector to the scale that we need and to the purity that we need, this is still an ongoing challenge. The regulators are continuing to raise the bar in terms of the purity and quality of the vectors that are generated and clients' needs are more sophisticated. In the past, they were expecting a CDMO to provide all the different technologies and processes. But increasingly, pharma companies have got internal capabilities in this area. So they are coming to CDMOs to obtain additional capabilities that they don't have internally. And finally, it's not -- developments in cell and gene therapy have not finished. We hear about in vivo CAR-T. We have heard from Luk on AAV targeted vectors, gene editing, all these different technologies are coming in. If we don't innovate in these areas, then we won't be able to be part of that -- those developments. So we look to see which areas we should innovate in. We talk to clients. We talk to industry leaders, and we identified these 5 key areas. The first one is tighter. So how much vector do we make in a batch, the yield. The more vector we can make, the better the cost of goods, the better the cost per dose for that particular product. The next one is speed. Clients want a batch made and released as quickly as possible, and they want that batch to be as affordable as possible. Then robustness. For every new trans gene that a client will bring, can our processes generate high-quality, high amounts of vector? Can our platform achieve that? And finally, quality, when we are making batches again and again, do we meet the specifications? Do we meet the tighter expectations and the impurity profile to allow those batches to be released and used in the clinic without interruption. And in terms of the 2 vector systems that, as Luk mentioned, we are focused on lenti and AAV in terms of titer and speed, we are best-in-class in terms of pricing, we are competitive in terms of robustness, top tier and in terms of the quality of the vector that we generate, again, best-in-class. Now the reason we have those achievements is because of the innovation we've done over the years. These are some of the technologies we've developed over time. I'm not going to go through the whole list. Just to name a few. So Tetravector, this is our fourth-generation lentiviral vector system. It has increased capacity. It gives higher titer, higher expression and has additional safety features. For AAV, we have our Innovate system. This uses a dual plasmid production, a simplified version to allow better ease for production. And it's married to a downstream purification process that allows us to have best-in-class AAV420. We're getting 90% from this particular technology that OXB has developed. So where do we see cell and gene therapy going in the future? Well, there are 4 main areas. We have AI and automation, how can we use digital tools to improve how we work and speed up our processes. Next, as we've heard from Luk, AAV targeted vectors. These vectors are targeted to specific cell types or tissues and away from organs that are sensitive such as the liver. This opens up new avenues, new therapeutic opportunities. Next, we have lentiviral vectors used in vivo for CAR-T therapy. So CAR-T therapy, autologous CAR-T therapy has been very successful, but it is cumbersome and complicated. The patient cells are patient's blood is taken, cells are purified, -- they're shipped to GMP facilities that are limited in their number. Those cells are turned into CAR-Ts with viral vector and then administered into patients that have been often lymphodepleted. This means that only a subset of patients can benefit from this. If we can instead switch to an in vivo lenti, so a vector that has been engineered to only bind to T cells after administration into a patient, then it becomes an off-the-shelf product and many more patients can benefit. And finally, we have new modalities such as nonviral vectors, LNPs that can mediate gene editing and transient expression. They can achieve things that viral vectors are -- they can achieve therapeutic benefit that viral vectors can't, for example, repeat dosing and delivery of larger payloads. So in terms of the -- our digital tools, we -- at OXB, we work in a number of different areas for bringing in digital tools. I'm going to describe some of these. So we have digitized lab analysis. So moving away from manual Excel workflows to automated analysis and real-time dashboards. We're also using predicted scale up performance. So using the data we've accumulated over many years to understand better what are the critical parameters for our processes. So can we predict when a client brings in a new gene, a new product, what kind of titer we will achieve and what level of impurities will be -- are likely to -- we see in that product. This will allow us to -- allows us to condense the development time that we do in the labs, and Nick will talk more about that in a minute. So I won't go through the rest, but these different digital tools allow us to achieve higher operational efficiency. It allows us to reduce the errors, the number of deviation, each deviation means additional work. So limiting those makes us more efficient and faster. We get a stronger understanding of processes and are able to make better, faster informed decisions. For our clients, it allows faster program delivery, lower development and manufacturing risk, greater transparency and stronger regulatory documentation. So as I mentioned, in vivo CAR-T is an exciting new area. From a manufacturing perspective, we see 3 main challenges. One is vector quantity. If more patients can be treated, can we make -- we're going to need to make a lot more vector. At the moment, only about, as I said, 20% of patients are benefiting from CAR-T therapy where it's available. Next, the vector quality. This -- for in vivo use, we want to minimize the impurity profile, so reduced host cell DNA, reduced plasmid DNA, reduced host cell proteins. One other important aspect is vector particles are made -- there's a mixture of active and inactive particles. Can we maximize the number of active particles so fewer particles can be administered into a patient to elicit the benefit, the efficacy from these therapies. The fewer the particles that are administered, the less it's likely that a patient will develop antiviral immune responses, which will be a key parameter for the rollout of these technologies. And finally, vector complexity. So these vector particles will have proteins on their surface for specific targeting that have proteins that allow immune modification, cloking and also T-cell activation. And at OXB, the technologies we've been developing over the last few years can address some of these needs. So we have a 400-liter large-scale perfused bioreactor. This gives us higher titer with reduced impurities. We have additives that improve the potency, make more vector particles and more active particles. And we have a lot of experience with the different envelopes that are likely to be used by clients for in vivo CAR-T. So what we've seen a surge in clinical trials and in product development for in vivo cell therapies. As of March this year, there are 112 in development. 74% of these are in CAR-T. 33% are using lentiviral vectors and 47% are using LNPs. LNPs are being used primarily for autoimmune disease and lentiviral vectors are for cancer. Interestingly, many of these are still in the preclinical or discovery stage, 55 and 34. This means that it's going to be a few years yet before these are commercially successful. So RXP is there to help be part of that. And finally, the nonviral space. So as a company, we have some experience in this. So this is a rapidly growing modality. Clients are not viral vector or nonviral anymore. They tend to be both, and they choose CDMOs based on the ability to deliver for both of these. The clinical data that we've seen for using these modalities has been compelling. And OXB capabilities, we have experience with viral vectors, viral-like particles, our GMP facilities, our processes, our capabilities in process development, analytical development are readily transferable to these nonviral systems. So it's an opportunity for us to enter new markets which helps protect our revenues. It derisks cannibalization and allows us to secure new partnerships. So in summary, I hope I've shown you that innovation for a cell and gene therapy CDMO is a must and that we've established innovation processes and governance that we're doing essentially the innovation that matters to clients. We have a culture of scientific excellence and our scientists are very skilled in terms of the biological processes underlying vector production and purification and are able to solve the problems that clients bring to us. We have an unrivaled track record in innovation. We've got a strong intellectual property position and deep technical expertise. And this creates a competitive moat across the company. So that nicely brings me to an end of my section. And now I'll hand over to Nick, who will tell us about how we help clients help patients.

Nicholas Clarkson

Executives
#6

Thank you, Kyri. It's a great reminder of how important innovation is to our success and also the success of our clients. So I'm quite new to this. So for those who don't know me, I'm Nick Clarkson. I'm the Head of Process and Analytical Development at OXB. We kind of term it as development services. Now the group consists of about 100 scientists and process engineers, very client focused. We're often the very first team that a client once they're onboarded to OXB, they make contact with us, and we actually guide them from those very initial early stages all the way through to whatever outcome, usually commercial applications and licensing. So before I go through the presentation, because I'm new, I was going to tell you a little bit about my background. I've been at OXB for 12 years. I have worked in innovation. I've worked in analytics and most recently, I'm in process development. It sounds like a long time, but it's a great place to work, very inspirational, especially when you see the impact that you have on patient lives. Prior to that, I was working in immunology, analytics, and I spent many years in Oxford University studying immunology and T-cell biology. So it was a great grounding for the kind of work that you've been seeing today. So I was going to give you a little bit of background about process development and analytical development where it really sits. It kind of sits between innovation and manufacturing. So with that where the commercial journey starts really with the client. So we take clients on board. We can do feasibility studies. We can do all the preclinical development, and this can be anywhere from construct plasmid design, cell line development, even cell banking. And we follow the client through Phase I, Phase II, optimizing the process all the way up to Phase III and commercial. And the important Phase III and commercial, we actually perform analytical method validation and process characterization, which is part of the process validation. And this is something that we need to do before they apply for a BLA or MMA and get their licensing. So what really makes us unique? It's -- again, it's going back to 30 years of experience and the depth of knowledge that the team have. So combination of innovation and process development, we have amazing in-house expertise in virology and molecular biology. And I think this is probably unrivaled in many of the CDMOs. And this is really born from product development, transitioning into the pure-play CDMO. We've retained that knowledge so we can actually help our clients develop their vector and their product and offer advice on how to get the best results. We have great small-scale development for optimization, and this is really where we can try out our new technologies from innovation. So we can tailor it to how -- for a client need. So we can try different sort of enhancers or vector backbones, really just to optimize depending on what the target product profile is. We have qualified scale-down models. Now these are sort of smaller versions of what you would see in the manufacturing. So we can accurately determine how it's going to perform in a manufacturing setting, but without having to do the very large-scale runs, which are very costly and expensive. We leverage a lot of our data because we have a very robust and consistent platform across AAV and LV. So this is really a great benefit to our clients, and I'll explain a little bit later how this helps them out. But really key to this is the collaboration and how we work with the clients. It's central. We're almost an extension of an R&D team of our clients, and we can be very flexible and tailor our approach according to their needs. So an example of this really is not one size fits all when it comes to process development. We have different clients. They're very diverse. Some are very early phase small biotechs. So responding to that market need, we have a faster GMP offering, and this is sort of a fast-track route. It's leveraging a lot of our data that we know our platform, there's minimum development. We can go from a very small scale to like 250 mls. We can go straight up to a pilot to 50 and then into GMP, and we can do this in a relatively short time. And this is really leveraging our knowledge of the platform. It may not be the fully optimized for yield or tighter as we call it, but your quality is going to be good, and it's the quickest way that a small biotech will get it. And to them, quite often, time is everything. They want that first clinical batch very quickly. Kind of in the middle is like a derisked GMP, where we'll do the small-scale studies, and we may do an SDM where we can optimize some parameters. This is really trying to halfway house, getting improvements in yield before we really go into the sort of pilot and the manufacturing. And the last one is the full optimization. And this is really most popular with the well-established pharma and biotechs. We can do multiple rounds of development. So we'll do the small-scale development. We can move up into the scale-down model with 10 liter. We take that data and they may want to go back to the small scale and try different things. So it's kind of an iterative process. The benefit really of the full optimization for the big pharmas is they can take that data forward with them when they go to commercial. So they'll have a plan -- long-term plan of how they want to get to the commercial, and they can use that data later on in their process characterization. So this is just an example of the faster GMP offering, and it really gives you a sense of how we can cut down from our standard time lines. So for the LV, a standard time line can be 16 months. This is from a client initially making contact with us signing up until they get their first GMP batch. Leveraging that knowledge, leveraging our data, we can really take that down to 9 months. So it is very rapid indeed, and that's releasing the batch. For AAV, it's a little bit quicker. It's quicker because the processes are slightly different between AAV and LV, but we can really get that down to sort of 7 and 9 months, which is industry-leading really in that time. Some of it is skipping engineering batch, but the common theme about this, this is our experience coming through there. We know what are the critical parameters. We know what we can not take shortcuts, but we can accelerate and still give that same quality to the client. So going faster GMP is just one thing, but with our knowledge, we can actually deliver innovation quicker. So coming from Kyri's team, this is an example of innovation. So we work so closely together the teams that we know exactly what's coming out of the innovation department into the process development. Now this is an example of a change that we did to our downstream processing. So you probably all appreciate that yield is everything. And historically, in LV, it was quite low. We had a new downstream processing. It's an ion exchange resin. And this increased our yield about threefold. So you're getting 3x as much product at the end of your processing. Now it was in innovation, and we were challenged by a client, can we adopt this technology very quickly. They had a very important program. So we took it from innovation through process development into GMP in 6 months. This was an amazing feat for us. The actual results. These are real results. It was a threefold increase. It was improved quality of the vector. And what it really meant for OXP is that we gain the trust of that client, and we gain their business for a key client going forward. How do we do it so quickly though? This really comes back to the innovation and how we employ that in our development in our manufacturing. So we use statistical -- I can't pronounce it statistical approaches to determine how inputs affect our process. Now this is what we call design of experiments. It's kind of a very basic AI for people that don't know. AI really is just very advanced statistics. But the design of experiments, it uses statistics to accurately predict what's going to affect our process. So what this means we can study multiple parameters or inputs, we call it at once. So doing 1 or 2 is quite time consuming in a lab, we can do 10, we can do 100, and that's by utilizing the automation that Kyri was talking about earlier. So we can do multiple inputs simultaneously and really drill down and get a better understanding of how this technology is going to improve us. What it means for the clients, fewer experiments. We can do things quicker. We can leverage certain software and programs to sort of better predict what's going to happen. You get faster onboarding and progression to process characterization faster to GMP. But particularly important really is the robustness of these automated processes. When you're doing these kind of development works, if you're not robust, the development kind of means nothing, and we're very good and we're very robust at doing that. And what it means really for RXP is we can service more clients, and it really reinforces us in our market-leading position going forward. So we talked about faster GMP, and we talked about innovation. Another really important thing for us is our derisking that path to commercial. And I think this is one of our real strengths. Our in-depth knowledge and our experience really shows through when we're working with our clients. What I mean by commercialization is taking the product from the sort of development phase and validating that process so that they can go for a biologics license application or a medicines marketing authorization. We do this very well. We have -- the previous slide, you saw we've done about 10 of these process characterizations, which I think is probably more than any other CDMO in the market for viral vectors. We have standardized templates. We have the platform knowledge that we can leverage. We have the qualified scale-down models, and we have that extensive process characterization experience. What this means is that we can really accelerate this process and the clients have confidence in us, faster development times, lower development costs. And really, what it's setting OXB is we're kind of the go-to CDMO now for these late-stage commercial programs like the go-to CDMO because a lot of the other CDMOs do not have this experience. So it's kind of a sure bet if you go with OXB. And this is just an example of what we can do. So when you're going through a commercialization process or process validation, it's very time consuming. There's very long time lines. There's a very high experimental burden. It's very costly to the clients. So what we do at OXB, we take this leveraging historical process data where we can approach. And this is always in conjunction with the client. So we can focus on the parameters that we know to be genuine and really will impact our process. And we will exclude some of the well-characterized or well understood processes. This means we focused all of our energy on areas where the regulators are going to actually put more scrutiny. The impacts we get the accelerated commercialization time lines. Here, we've taken 6 months off of a program. That's half a year off of a commercial program, which is a big deal for a company trying to take their drug to market. It's reduced resource and reduced development costs. And it's just a more efficient way of working. But what we don't compromise on is quality. And I think this is, again, what's really setting us apart. We have that trust of the clients. They see our track record going forward, and they know we can deliver when we say we'll deliver. So just summing up, again, it's going back to this client-centric model. It all comes from our track record. This 30 years of experience is really incredible. There's the unrivaled technical excellence and deep knowledge of the vector platforms means we can do things that others can't in the field. We have that flexibility that you've seen. We can tailor our approach to the client. We can accelerate or we can go more in depth for the client. And that extensive commercialization experience really is key, I think, going into these later stages as more of the drugs are actually entering those phases, we're in a prime position to really capitalize on those. And it's shown through our repeat business. So client satisfaction is very high. So where we have clients with multiple assets in their portfolio, we tend to get those as well. So it's that repeat business, particularly going into the late phases. So I hope that gave you a little more insight into our process development and excellence, client centricity. And I'll hand back to Aurélie.

Aurélie Charpentier

Executives
#7

Thank you, Nick, for this clear and practical overview of process development. The message is clear. Process development is not just a step toward manufacturing. It's a critical lever for speed as well as cost and risk reduction. And it can become a competitive advantage when a platform approach like OXBs can cut time to GMP by 6 months.

Aurélie Charpentier

Executives
#8

We'll move on now to our Q&A session, slightly shorter than initially planned, but don't worry, there will be another session. We'll start by questions from the room. If you have a question, please raise your hand, wait for the microphone, state your name and organization and also a speaker. I invite to the seat Nick, and Frank. And we also have Luc, who is also available for questions.

Charles Weston

Analysts
#9

This is Charles Weston from RBC. Two, please. First of all, Nick, you mentioned the process development time lines and the process characterization time lines, you described as best-in-class. Are those -- I guess, how confident are you that they are best-in-class? Are they key characteristics that win new business, perhaps also to Sebastian in terms of how commercial that offer is? And the second question, Kyri, you mentioned LNPs quite a bit as another modality alongside viral vectors. Again, I'm not sure who the right person to answer this is, but would it be an important development for OSB to be able to offer those sorts of technologies alongside viral vectors?

Nicholas Clarkson

Executives
#10

Right. Well, I'll start. We are best-in-class when it comes to the commercialization. We've done 10 of these process characterizations. Not all of them have gone to commercial yet. Some are in progress, some are other things happened. We've never had negative feedback from a regulator or a client on our approach to this process characterization and that whole approach. So I really do think we are best-in-class, and we do get the repeat business from clients that have gone through the process with us and they're putting more assets our way. I don't know if Sebastian wants to add.

Sebastien Ribault

Executives
#11

Yes. So, it works. Yes. Thank you. So talking about the timing, how critical is that to win business was your question. The experience in process characterization tells you what you must do and what you can skip because we have the data coming to the platform. You know that because you've done it not just once, but 3, 4 times, you've discussed with EMA, MH or FDA, and they tell you that's fine. That can come from the platform, you can skip that step and this set of data you generate. For the reason that Nick just mentioned, we've done that 10 times. One of the Phase III programs on which we were approached 2 years ago, the question was how fast can you do that? And the standard time line is usually between 18 and 24 months, and they said, if you can do it in 12 months, we work with you. We don't even question other CMOs, we go with you directly. We started the onboarding 12 months after we had delivered the GMP batch. We had used the platform data for the discussions with FDA, went very well. It's part of the 10 now. Soon it's going to be history and waiting for the final approval, and we'll tick the box of another commercial product with OXB very soon. So it's critical to the point where people can come to you and say, you've done it before, can you even be faster? The answer is yes, because of automation, because of new tools coming from innovation and again, because we've done it before on time in full. So it's indeed critical to the business.

Nicholas Clarkson

Executives
#12

And perhaps let me add on this question about best-in-class. I like your answer, but that's the answer which we get also from our clients. So it's not coming out of the blue. It's really what clients are telling us -- and this is coming back to the 30 years of experience that we bring on the table. And because we just focus on viral vectors, we just do that. We are probably able to deliver the best service possible.

Kyriacos Mitrophanous

Executives
#13

And with regards to your -- does that answer your first question? Yes. With regard to your LNP question, so we are now getting clients who have both modalities and they're asking us, you've done a great job on the viral vectors. Can you help us with the our LNP need? And we're seeing in terms of the new products coming through a mixture. So sometimes you're seeing a combination of LNPs and lenti, AAV and lenti, viral-like particles. So being able to be in both viral and nonviral should allow us to help these products that are a combination as well as viral vector pure or LNP.

Frank Mathias

Executives
#14

So he's our Chief of Innovation. So he's ahead of us, yes. But I want to mention for now, we do viral vector. It's fair to say, Kyri, that we look at non-viral, but probably not in the next 6 to 12 months for sure. But perhaps Sebastian, you can address the point in your presentation later on where we are with non-viral.

Miles Dixon

Analysts
#15

It's Miles Dixon from Peel Hunt. If I can just return to the -- Kiri, it was the grid that you presented on the metrics, the quality, the yields, the pricing. On pricing, you said competitive. Is that competitive adjusted for the quality and the yield and the tighter? Or is it just competitive on an absolute basis?

Kyriacos Mitrophanous

Executives
#16

I'll refer that to Sebastien.

Sebastien Ribault

Executives
#17

Thank you, Kyri. It's -- so when we're talking about competitive, Kyri's example was about what we would consider the final product. In the end, the cost per dose, which is the cost per patient must be competitive. I'm not just in charge of the business activities. I'm a scientist myself. So comparing data to data, I would say, if we look at the cost per dose strictly, we're very competitive. If I look at the prices of the services we offer, we are indeed competitive. But the prices of the services we offer include the process development activities, the manufacturing of clinical scale, the manufacturing of commercial scale. The cost per dose is only commercial manufacturing, where we enjoy some benefits of the development through the robustness of the process. Process development is -- we have a lot of uncertainties that we face. I mean sometimes you have to change. So you understand what the budget should look like, but you will see variations. On commercial manufacturing, you don't see variation. You run a batch and then another batch and a third batch and a fourth and so on. So we know it's robust, and we know that we can deliver cost per dose that some of our clients in the recent years, I'm going to talk about the past 2 years have considered aggressive, and we've reached the target that they fixed. And that's why I can say very competitive if we look at the cost per dose. Cost, price is a different story.

Unknown Analyst

Analysts
#18

It's David at Berenberg. I just wondered just sort of broad brush comments about whether you've seen any changes to your competitive position recently. So have the key qualities that clients have valued changed over the last several years. So whether we'd be talking speed versus process development versus regulatory assistance versus house QC versus geography. I'm just wondering how you've seen that evolve, please?

Frank Mathias

Executives
#19

You want to...

Nicholas Clarkson

Executives
#20

I can take it.

Frank Mathias

Executives
#21

Yes, sure.

Nicholas Clarkson

Executives
#22

So we've seen an improvement in all 3. So one of the biggest things clients used to ask was yield several years ago. We're very competitive on the yield. You saw from the slide, we've improved it over threefold now with our new process. And the other point was speed. Now we've cracked the yield, the speed is really becoming critical. And I think every program who wants to take a long time to get the drug to market. So the pressures are there really for speed going forward, and that's why we're really leveraging the data and constantly improving what we can do going forward. So I think that's how we're staying ahead of the curve really against our competitors. And I think we hope to remain there going forward.

Aurélie Charpentier

Executives
#23

We'll take one more question. Don't worry if there will be time for a second Q&A.

Kane Slutzkin

Analysts
#24

Kane Slutzkin, Deutsche. With therapies potentially moving sort of into earlier lines of treatment and patient populations expanding, how should we sort of think about sort of vector demand growth? Is it sort of broadly linear to patient growth? Or how should we think about that?

Frank Mathias

Executives
#25

Very good question, Sebastien. You are the nearest to the client, but it's an interesting question.

Sebastien Ribault

Executives
#26

It's a difficult question, actually. I would love to have Arun's point of view on how the dynamic is evolving. But seen from my window, it's not linear at all. Because I would say, first, we are not working in a global environment from a regulatory standpoint. If you file with FDA, you file for U.S.A. If you file with EMA, you file for Europe, excluding U.K. So you have to file with MHI to be in U.K. And we're working on drugs, commercial, approved in the U.S., where our clients are looking at some countries in Middle East, some countries in Asia, some countries in Europe, not even all of Europe, which means that you're going to see the progression by step. It's approved in one country. And let's say that because it's one of these countries where at the very same time, they grow their biologics and cell and gene therapy markets. It's going to be adopted very quickly as a second line of treatment, for example, when cell and gene therapy is not as a standard a second line of treatment in the rest of the world. Most of the time, it's a third or fourth line of treatment. So for me, it's not linear. It's really a stepwise approach. If it was truly global, if we had alignment between the countries and the regulatory bodies, that could be, but we're not there yet. We'll discuss that question later.

Aurélie Charpentier

Executives
#27

We're taking one question from the room. So how do you balance the inherent bespoke nature of each client program you mentioned to maximize safety and other metrics with the need for a more commoditized offering that drives a lower cost of goods and hence, higher margins?

Frank Mathias

Executives
#28

Sebastien, this one is for you.

Aurélie Charpentier

Executives
#29

There's a second part. Do you want it now. If process intensification sustainably improves yields, how much of economic benefit is retained by OXB versus passed on to the client to improve that competitiveness you have discussed?

Sebastien Ribault

Executives
#30

Where should I start? I'm actually going to take it as one question. There are solutions today to go extremely fast to a first batch. Does it mean that all our clients are going to accept that solution? The answer is no. So when we talk about the cost of developing and the cost of manufacturing, you need to look at these costs through the lens of each client objective. Some clients from the very beginning say, I want a cost per dose that is the lowest possible. And Nick will tell you that if we -- and Kyri actually will tell you, if you want to go to the lowest, you need to develop a stable cell line, which is part of the efficiencies that we discussed in the second part of the question. It's going to take more time, though. Is it going to take more budget? If you take the overall process development budget, not really. But it's going to take another 6 months to 1 year, depending on the difficulty of creating the cell line. But the cost per dose in the end is probably going to be divided by 3 to even 10, if you decide finally process intensification to run not at 200 liter, which is more or less the standard in gene therapy today, but you decide to run at 1,000 liter, which we can do as well. So if you combine from the very beginning in your strategy, the cell line development and the final scale-up, we will pass all these benefits to the client, and I will come back on the why in a minute. We intensify the process. We run at a larger scale. It's not increasing significantly the cost of process development and early-stage manufacturing and the benefits are huge in the end. Why do we want to pass these benefits to the client? Because -- and Nick said it in one of his presentation, the client was very happy with what we delivered. Now we have recurrent business with this client, exactly for this reason. If the client is happy with us, we'll get #2, #3, #4. And when the fourth line of treatment will become third line and then second line, all that volume will be with us, which means that if passing the efficiencies to the client is seen by many analysts as we're losing value for OXB. No, no, no. midterm, there's a huge value for OXB, and we want to capitalize on that value.

Aurélie Charpentier

Executives
#31

Thank you, Sebastien. Thank you to everyone who asked a question, and thank you to our speakers. We'll now take 10 minutes break. See you back there at 3:30 sharp. So we are not late. Thank you. [Break]

Sebastien Ribault

Executives
#32

Welcome back. My name is Sebastien Ribault. I joined the company 3.5 years ago as Chief Business Officer, spent pretty much 15% of my career on the technical side. Starting as a gene therapy scientist before what Luk presented, first casualty in gene therapy in 1999 that pretty much killed the efforts in gene therapy during 10 years. Good to see that the field is back in the last 15 years of my career on the business side, including activities with a fairly large services business, where I was heading a business unit in charge of cell and gene therapy and biologics. I'm going to drive you today through our pipeline, how we grew our client base and tell you a bit about how we convert our proposals into a real contract and how that is translated into the day-to-day activity at OXB. It's going to be the first part of my section, and then I will tell you not only why the clients -- how the clients choose a CDMO, why they choose OXB, why they stay with OXB, but my opinion may be interesting, but it will be much more relevant to have Arun's opinion through the fireside chat that will follow immediately my presentation. Frank presented the space in which we play, viral vectors. And we often associate viral vectors and cell and gene therapy, which is wrong. Cell therapy is one area where sometimes you are not using vectors, which actually you will see here on that slide as cell therapy. We use a vector when we modify the cells. You can also use nonviral vectors to modify the cells. They are flagged here as only one segment, the RNAi gene therapy. So we play in a field that is relatively complex when we say CGT. We actually play in gene therapy, including the gene-modified cell therapy. And if you look at that field, I often read, including actually this morning, comments saying the field is depressed. The field is growing, but it's much slower than what it was in the past. Well, I would actually disagree. We still see the field growing 35% year-on-year, as you see it there. And we play in 3 segments: the gene-modified cell therapy, the gene therapy and the oncolytic virus space where we play. As you see, that's the majority of this business. And here, it's not just the viral vector numbers that we're looking at, just to be clear, it's the entire field of cell and gene therapy, but fast-growing market very, very clearly. Now if you look at the viral vector space only, there's often a question how much are you afraid of companies investing in their own capacity for manufacturing? We are not. And you see here the trend. 2025, we estimate -- well, the market studies estimate that 75% of the activities are outsourced. If we go to 5 years from now, we estimate that up to 80% of the activities will be fully outsourced. Why? We talked about it just before, cost of goods. If you want to make sure that you have a cost per dose and cost of goods that are low, you need to use the facility at their max capacity. If you run program only and you make 10 batches per year, there is no way you use a facility at its capacity. You need to be manufacturing hundreds of batches per year. And even regulatory agencies like FDA have recommended that the biotech and pharma of this world work with CDMOs to make sure that the capacity is used and that the costs are going down. So it's a very complex field as we know, reason why my colleagues emphasize the 30 years of experience of the company. You are successful in manufacturing only if you've developed the right process. It takes a few years to have this experience. If we go now, into the field in a bit more details similar to the comment on the field is depressed, I here many times, what about funding. How is the funding situation. Are you afraid that this programs won't progress? Well factually speaking comparison between Q1 '25 and Q1 '26 although the number of programs in gene therapy here is stable. 2100 programs, what has changed though is that the pre-clinical stage where you want feasibility studies, you check if your [indiscernible] combined to the vector have the effects that you expect. This segment is indeed going down from 1400 to let's say a 1300 here. But the other segments, Phase I, Phase II, Phase III and pre-registrations are the ones that are going, which means that the field is gaining in maturity. And that's the reason why we've seen in the first years of gene therapy, very few programs being adopted. And now we see 5 to 10 programs being adopted every year, which has a big impact for CDMOs. It means that the routine manufacturing is needed. It means that the process characterization capabilities and capacity that Nick mentioned earlier, where we make sure that the program is robust, that is needed, which means that we are running more Phase I, more Phase II and more Phase III batches. And for a CDMO, that's exactly where our business should be. We should be developing programs where the feasibility has shown that we have valid candidates. We should be manufacturing the batches and making sure that these products become commercial and are going to be accessible to patients. Gene therapy is about 50% of the entire field. And if I look at the past 3 years, it's been pretty stable. There's often that question, are you afraid of a complete replacement of the viral space by the nonviral space? Well, actually, RNA is here, and it's been pretty stable as well. So they coexist, but we don't see one replacing the other. That's why we believe that viral vectors have many years in front of them. Although as Kyri mentioned earlier, we're looking into the nonviral space to be ready to invest when the time will come. Moving from the market to the Oxford Biomedica pipeline now. 3 years ago, we were a lentivirus vector company, and the pipeline was 90% lenti. We had a few AAV programs couple of [indiscernible] virus opportunities as well, if you look at the pipeline as it is now, on the left side here. You see that for the very first time in 2026, we have these on more easy opportunities then lenti. Result of the OXB strategy where we acquired experienced expertise and a platform in the AAV space, when the company acquired the site we are in [ Braintree ] at Massachusetts, we developed our customer base in AAV and that's why today we see on power AAV, lenti. We have also made sure that we were diversifying the pipeline in terms of clinical phase or commercial phase where we work and you see that we have almost 20% of our activities in terms of distribution of opportunities in the commercial space, and 11% in phase III, meaning that about 1/3 of the opportunities on which we work today are revenues with recurrent manufacturing, Phase III preparation of the commercial introduction and commercial manufacturing as well. We still keep about 1/3 of the activities in the preclinical space because we want to make sure that we support our existing clients. We have new programs that they want to develop and also our emerging biotechs or small biotechs who come to us saying we have a candidate, we would like to run the feasibility with you because we know that when they run the feasibility with us, they test our platform, they see the benefit in timing, in automation and so on and they stay with us for the other phases on which I want to elaborate Phase I and Phase II. The biggest change we've seen in the past is the distribution between the geographies, back to 2022, we are 90% of the activity Oxford UK, the rest was in Bedford, Massachusetts with the acquisition [indiscernible] you see that today 20% of opportunities are in France between the two sides here or directly on our site in [indiscernible] and you see that's the U.S. also have a very significant presence now, I remember the time when we were discussing 90% of opportunities in Oxford 10% outside of Oxford. Today is a very different picture 70% outside of Oxford, 30% in Oxford. One of my colleague recently asked a good question, which was doesn't mean that we have less opportunities for Oxford that the absolute value for the power plant for Oxford went down, absolutely not, because at the same time we were growing the pipeline value and the pipeline value has more than doubled in the past 3 years. So in absolute value we still handled the same volume of opportunities for UK and we filled the other sides with new opportunities. If I look at the distribution over just one year of the pipeline dynamics it's very interesting to see that in Q2, 2025 we had 13% of the opportunities for the France sites, we still had 67% for UK and the rest was U.S. that for exclusively at that time. If I move now 12 months later Q2, 2026, 19% in France, so obviously increased versus about a year ago, 46% in value here, not number of opportunities that we had on the previous slide. 46% of the value of the pipeline is in Oxford and the rest, very significant number, about 30% is for the U.S. site. Why such a dynamic? For one reason, the acquisition of a commercial ready FDA-approved site in the U.S., which was needed, which was requested by our clients and which had a numerous impact. We have firstly this which in 2 days, keep those meeting, of a phase III project in Durham, North Carolina the process characterization will be done in Bedford Massachusetts the phase III batches, the process qualification of the manufacturing process will be done in Durham, the same client without the acquisition of Durham, we could not have executed in the U.S. So the acquisition of the U.S. sites completely changed the pipeline dynamic by sites. And if we look only at the first months of the year here. We build that site about 3 weeks ago, the number has changed now. But we have signed at that time 10 new clients, 4 coming from U.S. 5 from New York and 1 from Asia. Actually we have 1 team in Asia today working with the client on the initiation of the program. Let's go back 3 years ago, I would have said 7 to 8 new clients in the U.S. 2 to 3 in New York that was the situation, with the 1 we started we really recognized as the global organization today, attracting some clients in Asia, we didn't even know that OXB was a severe one that time. Attracting clients who understand that we run these 10 process characterization and validation and as we can do the same for them. And that's why we acquire clients at Phase III now, that has been placebo only, because of the expansion of the organization including the new vectors, including the new sites and including some recurrence revenue that you see here in the existing business, when one of our existing clients tells us, I would like a proposal for a potential new project 84% of these proposal give a contract. That explains why we are very comfortable with our customer base, because usually when they tell us, we have a new program what do you think in more than 8 chasis out of design with us. If we are at the negotiation stage, meaning it's not just a proposal on one-day that's the time line that's the budget, it's a real negotiation we signed 97% of these contract with the existing clients. Moving to people who have not worked with us before, if we issue a proposal again 2 slides, 1 time line, 1 budget. We sign 1 program out of 3, at proposal's day. If we drafted the contact and we are not negotiating the terms, yet. If we drafted the contract meaning we have a scope of work, we're signing 2 out of 3, 72% exactly, but we sign 87% when we're at the negotiation stage. I've worked for 3 different services business, that's the first time I see conversion right that high, that goes with the customer satisfaction that we enjoy, which on a scale between 1 and 10 is systematically above 8, if I take the average of the responses we have from our clients to whom we ask twice a year to feel the question here. How did that change the situation actually we see it here, the number of pipeline is called development and early stage meaning called phase I, phase II activities has been pretty stable between April '24, May '26. And I'm going to focus actually on the difference between March and May '26 after. But number of early stage program pretty stable, between 40 and 45 roughly. The biggest change that we've seen in the last 2 years is the increase in late stage program, we doubled the number of late stage program from 3 to 6. We added one more commercial programs and looking just the dynamic in the last year from 4 to 6 from 2 to 3 and in the last 3 months compared to [indiscernible] late-stage. People come to us because they understand we are a CDMO, who can manufacture in 2 different geographies commercial products. So we can ensure dual sourcing, do we face tariffs, no because we can't manufacture in an U.S. Can we give you access to tax incentive in the op, yes because we can manufacturing in the Op. And so the Asian customers have been pretty happy with us making the manufacturing either in U.S. and New York. I'm going to finish very quickly on that one. The pipeline is also divided between the different client segments where you see emerging biotech, established biotech. We would consider Cabaletta Bio as being an established biotech. And finally, you have the big pharmas here. It is as it should be. We want to support early-stage activity. We are not a CMO or a CDMO. And we want to continue innovating and developing for people who need support at early stage. That's why the emerging biotech segment will stay high. I'm going to move now to the second section on which I will be quick because I believe that the discussion with Arun will be better than just going through the slides. But why do we see clients selecting OXB -- and first, how do people select CDMO. The selection criteria are more or less always the same. And as personally not seen any valuation in the past 5 years. [indiscernible] is #1. How many times did you do it on time in full. How many times did you respond to the regulatory agencies. Successfully could you take a program at early stage and push it to late stage. Do you have the technical expertise and experience, which is slightly different from that regard. Do you have the slots, can you make it. Can you start, can you be fast enough. Can enumerate complex programs, it is very complex. You need to design a vector, we are not working with just one vector, but multiples, LT, AAV, adeno, [indiscernible]. The list is quite long. We have this vector know-how. We have the manufacturing capability and capacity. We have the experience to support end-to-end. We can work hybrid capsules, where you need to create a new capsule. We can work on the stable cell lines as we discuss. So that's very, very early in the development process, and we can bring these programs to the commercial stage. Last but not least, for me, that's one of the most important points here. We don't want to be seen as an organization that is only dealing with clients transactional relationship is the way I would call it. We're really the development and the manufacturing arm of the companies who come and work with us. If you speak with our people running a project, they don't talk about the client project, they talk about their project. And we are also very impacted when we see that clinical data are not that good because many of our people, if not the vast majority, are motivated by giving access to new treatments to patients. So that's why we believe that each relationship can be a strategic partnership. And I like the question, aren't you afraid to be exposed to emerging biotech funding issues and so on. But some of these emerging biotechs are called today Gilead, Sanofi, Novartis, BMS and so on, but they started as a very small company as well. So we are working today with the future BMS, Novartis and so on. We -- why did they come to us. They come to us derisk the past 2 [indiscernible]. And I won't go through all the points, because these points have already been detailed by Nick in his presentation, we develop for GMP in the future. We want to show that the process harvest, they already [indiscernible] and we are going to deliver a consistent result. Then comes the quality and regulatory part. The documentation is ready we can manufacturing according to ICH, to the International Quality Standards, we're ready for any regulatory inspection, which means that we provide regular support to the client for the filing, and we are ready to be inspected by the agencies before inflation of the program on the market. Not only we want to our client, but we want to retain them and I'm just said, since I joined the company, we've not lost one client who said I'm to leaving and going to another CDMO, why are the clients staying with us? We try to extract from different customer survey the main arguments that we heard coming from our clients. The first one, successful tech transfer, we a feasibility some where else, can you take that in your lab and make sure that you optimize so that we have better process industry for early stage activity. Same comment for people coming to us saying we were working with a CDMO, that's made the phase I, they don't have the experience for Phase III and commercial can you do it, we did it successfully. I took about the 12 months process guide, early. I'm not going to come back on that. But we have a very structured transfer and support. If we ask people what do you like most with our scientist responsiveness, so where is #1, you guys propose options. You provide solution. We come with a problem, you are extremely responsive and you try to find a way to unblock the situation. Once we've defined the process, we deliver in a reliable way. It's consistent, it's on-time execution, OTIF, as we call it, on time in full. And last point, which gives me the opportunity to ask Arun to join me on stage, long-term trust. We want to be seen as partners. It goes beyond just delivering the development or just delivering one batch. We want to be seen as the commercial partner for the future of the program and of the treatments we're going to put on the market. Arun, if you don't mind joining me.

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