Good morning and welcome to this webcast. My name is Jonas Einarsson, and I'm the Chairman of the Board of Ultimovacs. Yesterday we announced an agreement to combine Ultimovacs with Zelluna Immunotherapy, an intention to launch a fully committed private placement. To put this in context, during the last years, Ultimovacs has been running quite a lot of randomized clinical studies in different indications and different combinations to see what the UV1 product can do. However, and unfortunately, we have had three negative readouts where we didn't meet the endpoints. The company has been exploring new avenues to optimize shareholder value. Yesterday, as a result of this work, we announced a business combination with Zelluna. We think that's presenting an exceptional opportunity to leverage complementary strengths and unlock the full potential of both companies, positioning us for the future success.
Next slide, please, so I've just had to show you this disclaimer since we are a listed company, and on this slide, we're trying to show you why we think this is a business combination that will leverage the strengths of both companies. Zelluna has a proprietary novel cell therapy platform, and its lead asset is nearing the clinic. Ultimovacs, on the other hand, has an experienced team which have a very good track record of doing clinical trials, and that will help Zelluna and their technology get into the clinic and do successful trials. In Ultimovacs, we also have the MultiClick platform, which you will hear a little bit more about later in this presentation, and Zelluna has an established and very experienced team that can help us unlock the potential of the MultiClick platform.
And then again, we are a public listed company which will help also bringing the new technology from Zelluna and will help the combined company. So overall, we transform into a company positioned at the forefront of solid cancer treatment innovation. Now I would like to pass you over to Namir Hassan, who is the CEO of Zelluna. Namir has been over 20 years in biotech and pharma, with 15 years in biotechs developing TCR-based therapies in both operational and corporate roles. Namir was one of the early developers of Kimmtrak, the first ever T cell receptor therapy approved in the EU and the US for treatment of solid cancer. So we're very pleased to have you with us, Namir, and I'll leave it to you.
Thank you, Jonas, and thank you for the kind introduction. I share the excitement for this announcement of the combination of these two companies and the merits and the strengths of bringing the compatibility of the companies together. I just want to acknowledge the strong existing shareholder backing also for this combination and enabling us to really take the technology forward. If I can have the next slide, please, Hans. Thank you. I'd like to start with a story, and it's a story of a young girl called Emily Whitehead, who was seven years old and dying of a liquid cancer, leukemia. There were no other options for her, but she was the first pediatric patient to be treated with what's called a CAR T- cell therapy. That eliminated her disease. 12 years on, she remains cancer-free, effectively cured.
Since then, hundreds of patients have been treated with cell therapy. Thousands of patients have been treated, with hundreds of them effectively cured. Cell therapies have shown us that they have curative potential. There have been nine approvals in the space, mainly in liquid cancer. Though despite the successes, there have been some challenges, and they're shown on the slide. A couple of the main challenges have been to really penetrate and drive durable responses in solid tumors. The second has been to really scale the treatment in order to meet global demand. That's why over the last few years, the incredibly talented team at Zelluna have been building a platform to take the curative potential of cell therapies to solid tumors at a global scale. Next slide, please, Hans. What are the elements of the Zelluna approach?
They're shown on this slide here, and I would like to summarize them in four areas. The first is a game-changing platform, a platform that has the potential to transform treatment of solid tumors with the prospect of cures and being able to scale that to meet global demand. The second, very importantly, is that we have an unprecedented position in the space with an opportunity to landgrab an entire therapeutic field, and I'll come on to elaborate on that further a little later, but what that provides is immense value creation opportunity. The third is that, as Jonas had mentioned, we have a lead asset that's been developing that's nearing the clinic, a pathway that's been validated through interactions with the FDA through a pre-IND, which enables near-term catalyzation of value.
And I think lastly, but also very importantly, what we have seen in the cell therapy space is a number of approvals for cell therapies on the basis of treating fewer than 100 patients. And so what that means is that with early phase clinical studies, one can then rapidly move to registration studies, and that really holds incredible value from very few patients. Next slide, please, Hans. Next again, thanks. So this is a slide which takes you through some of the key findings over the last 10 or 15 years that we have come across the cell therapy space. It's meant for read only, so I won't delve into the details and perhaps move to the next slide, please, Hans.
Just to pick up on the point of the approvals that we have seen on the basis of less than 100 patients, here is a couple of examples here with two companies that are operating in the cell therapy space. BMS have a licensed cell therapy which was registered on the basis of under 70 patients in a single-arm study for the treatment of mantle cell lymphoma. Novartis has a treatment, Kymriah, one of the earlier T- cell therapies, again registered on the basis of fewer than 70 patients in a single-arm study. What this shows is that the prospect of an accelerated path to approval has been demonstrated with cell therapies and precedented with a number of approvals going down the path with relatively few patients for registration. Next slide, please, Hans.
If we just take a step back and take an overall high-level look at the total tumor burden and where we have seen the successes of cell therapies to date. As we know, solid cancer constitutes the majority of the total tumor burden globally, 90%, with 10% of global tumor burden constituted with liquid cancer. Now, if I can have the next animation, please. Most of the successes that we have seen, largely in the last 10 to 12 years, have been with cell therapies that are treating liquid cancer. You can see those on the left-hand side, seven approvals in what are called CAR-based cell therapies. You can see that while we have had responses in liquid cancers, these therapies have failed to expand in a meaningful way to solid cancers.
The cost of goods of these therapies are particularly high, and there is a challenge to scale the therapy to meet the demand. Now, if I can have the next animation, please. Where we have seen cell therapies penetrating and giving responses in solid tumors are those that are TCR-based therapies. And for TCR-based cell therapies, we've seen two approvals in this space, a couple of those examples shown there. Though again, the challenges remain where virtually all patients relapse. So whilst we do see some compelling solid tumor shrinkages with these types of cell therapies, virtually all patients relapse. The cost of goods are also high, and there is a challenge in scaling to meet demand, particularly in the solid tumor space where there is an immense unmet medical need. And as you can see, the estimated tumor treatment market by 2028 is approximately predicted to be $383 billion.
And so there is an enormous opportunity in the solid tumor space to drive therapies that can provide curative potential and can meet the demand required. I can have the next slide, please, Hans. So I'd just like to spend a few slides on taking you through one of the major challenges of driving long-term responses in solid tumors. And that's down to principally the diversity of tumors. Tumors are not one thing. They're heterogeneous. They're diverse. They have multiple faces. And as you can see from this illustration and the multiple colors, designed to demonstrate the different faces of a tumor in any given patient. And so that presents a challenge for extremely precise therapies. And if I can have the next animation, please, Hans.
Whereby, where we have seen solid tumor responses with what are called T- cell receptor therapies, the therapies are able to attack portions of the tumor that they target, but other portions are able to escape and cause patients to relapse. And that's because the therapy is designed to precisely target a particular protein, which may not be shared across the entire tumor. And so while patients may show tumor shrinkages initially, parts of the tumor that are not recognized by the therapy begin to outgrow. And you can see that in the next slide with the animation.
And so what's needed in the field, and this is through development, clinical development over the last decade, a realization is that what's needed in the field is both a targeted therapy that's able to target the tumor and at the same time broadly detect cancers to be able to cope with the diversity presented in cancer. If you go on to the next slide, please. That's exactly what's offered with the platform cell therapy that's been developed at Zelluna. It's what's called a TCR- NK platform. It's designed to take the most validated clinical components and bring them together. And it's made up of two major components. The first, which I have already introduced, but I'll introduce it further now, is what's called the TCR, the T- cell receptor. That's what forms a guidance system for the cell.
It's a homing device, if you like, allowing the cell to target solid tumors. We have seen clinically with TCR-based therapies that those therapies are able to target solid tumors. So we are taking a known validated clinical guidance system, and we are then putting that into a cell type shown at the bottom left, the natural killer cell. By definition, it's the most efficient cell killer in the human body. And the benefit of the natural killer cell, as you might be able to see from the illustration with the sticks sticking out of the cell, is that it's able to recognize cancers in multiple ways, allowing that cell type to overcome the diversity of cancers. And so we bring together those two components in what we call TCR-NK, as shown on the right-hand side.
We believe it combines the proven targeting ability of T- cell receptors with the most potent killers, natural killer cells, and the ability to detect diverse cancers. The additional benefit of this type of therapy is that it can be generated upfront, frozen, stored, and used at the point of need, so-called off the shelf, and therefore able to potentially meet global demand. So if I can have the next slide, please. What the TCR- NK platform therefore offers is, in one therapeutic, the potential to address the challenges we're facing with deploying cell therapies in solid cancers, namely a targeting element, the TCR, that is proven to target solid tumors. Secondly, the ability to broadly detect cancers, which is necessary because cancers are diverse, and thereby, with broad detection, one can overcome potential escape of cancers.
Finally, and importantly, the ability to scale this treatment to meet global demand, given the massive global burden of solid tumor cancer. I can have the next slide, please. Does it work? Do we see the ability of TCR- NKs to recognize tumors that have multiple faces? I'd like to illustrate this with a couple of videos. On the left-hand side in the video, in both videos, we have a mix of cancer cells mimicking what you may expect in tumors, a mixture of cancer cells that have multiple faces. You can see the video running. On the left-hand side, we have a benchmark T- cell therapy that is precise and only targets the red cancer cells that are able to be recognized by that T- cell therapy.
And on the right-hand side, we have our lead asset, a TCR- NK, with the ability to detect and kill diverse tumors, so both the red and the green cancer cell types. And hopefully, what you can see over the course of this experiment is that with the TCR- NK cells, we eliminate the entire population, and it happens very fast. NK cells are extremely efficient killers. And on the left-hand side, with the benchmarked approved T- cell therapy, while you have elimination of the red cancer cells, the green cells remain intact and, in fact, outgrow over the course of the experiment, which is exactly what we see in patients. And so to summarize, the TCR- NK concept has also been proven to demonstrate the ability to kill diverse cancers rapidly and specifically. I can have the next slide, please.
So moving on to Zelluna's patent estate, this is illustrated in this diagram. And I think one of the most important messages from this slide is that we have an unprecedented position in the space. We have a granted patent for the concept, which is the approach that we're taking. In essence, the therapeutic field, we call it a TCR- NK concept patent, which captures any T- cell receptor in any natural killer cell. And I'll come on to talk about the potential implications of such a patent. Aside from that, we also have patents which are more common with this kind of therapy, composition of matter patent, for example, for TCR sequences. And we've also filed patents for a manufacturing process, all of which strengthens our position in the field. If I can have the next slide, please, to elaborate somewhat on the concept patent.
This is a slide showing the landscape of off-the-shelf cell therapies, the different operators in this space. Mostly, what you will see is that in the quadrants on the left-hand side, we have CAR- NK and CAR- T off-the-shelf cell therapies. These are therapies that are driven by CAR, which I mentioned earlier on, that largely are relevant for liquid cancers. Successes have mainly been shown in liquid cancers on account of being driven by a CAR. On the other hand, by being guided with a TCR, as we have with TCR- NKs, we're able to target solid tumors. What you can see in the top right quadrant is that we're virtually the only operators in this space. We have a barrier to entry with the TCR- NK concept patent. It provides the prospect of land-grabbing the entire therapeutic field.
If we were to take an analogy and we look at the other quadrants, you can see that many operators are operating in the other quadrants. And so the prospect here of land-grabbing an entire therapeutic field is analogous to the aggregate value of the operators in the other quadrants. And just to give one example of this, recently, there was a deal with Poseida, which has been acquired by Roche, with a deal value of approximately $1.5 billion. You can see Poseida highlighted in the bottom left. It's also an off-the-shelf cell therapy company with a pipeline mainly in liquid cancers. And so it demonstrates the value potential, and that's one company in that quadrant. And we have a real strong position for the entire therapeutic field in a space which can be applied to solid tumors.
This is somewhat of an unprecedented patent position and provides a prospect of immense value creation. I can have the next slide, please. I think we can move on to the next slide. We talked about a lead asset which is nearing the clinic. I'd like to spend a bit of time talking through the lead asset. It's an asset that we call ZI-MA4-1, which is a TCR-NK world's first that recognizes probably the most well-validated solid cancer target out there called MAGE-A4. MAGE-A4 is what's called a cancer testis antigen. It's a very clean target. It's really not expressed in normal tissues, but it's expressed across a wide range of solid cancers.
You can see in this slide here that the potential of a treatment that targets solid cancers is a vast array of potentially eligible patients, greater than 50,000 across multiple solid tumors, including many of the big tumors with unmet medical need. There's a substantial amount of evidence on the ability of MAGE-A4 targeting therapies to drive solid tumor responses, which adds further validation to targeting a clinically valid target as MAGE-A4. And we have recently, just in the summer this year, one market approval for a T- cell therapy that targets MAGE-A4. Now, it's what's called an autologous T cell therapy. And what that means is that the ability to scale that therapy is limited. And one of the major challenges of that therapy is the inability to address diverse tumors.
So with that therapy, we have seen patients respond, but the cancers relapse on account of this problem that I had talked through in a few slides earlier. And that's where we think TCR- NK can really provide the edge. I can have the next slide, please. So here's a breakdown of the potential patients that may be treatable with a TCR- NK therapy. As you can see, there are many patients across the common solid tumor types with high unmet medical need. And this has been a part of our analysis as we have developed our clinical strategy that I'll come on to talk about in a moment. If I can have the next slide, please. So over the course of this year, we have had interaction with the regulator, specifically the FDA, in a pre-IND interaction.
And what we have managed to do through that process, it was a positive pre-IND meeting where we were able to validate and ratify our strategies and growing data on three particular areas. That's the preclinical pathway, manufacturing track, and also our clinical strategy. And that was very important, not only for the assets, but also provides validation of the regulatory path for the entire platform. If I can have the next slide, please. And so where are we with the lead program? I've shown you some of the science in the videos to demonstrate the ability to outperform current therapies that are targeting MAGE-A4. And that's principally on the ability to recognize diverse cancers, as well as the ability to scale this kind of therapy to meet the huge demand. So that's the science.
On the regulatory path, I mentioned that we have been through a pre-IND with the FDA and managed to validate the path for the assets, which also spills over to validation for the platform, which is incredibly important for the organization, and lastly, the clinical strategy has developed very well, and we are prioritizing indications shown here, lung, head, and neck, and ovarian cancer, and that was in concert with a number of advisors.
I think we can have that on the next slide, who are deeply experts in the cell therapy or TCR or MAGE-A4 therapeutic space, have run clinical studies in that space across borders and also in dialogue with the City of Hope, which is a lead site in the U.S., again, deeply experienced with these types of agents or cell therapies in general, and really come to converge on the indications shown on the slide, non-small cell lung cancer, head and neck cancer, and ovarian cancer with some sarcoma patients to benchmark against the clinically approved therapy, which has been approved in sarcoma. If I can have the next slide, please. So our development pipeline behind MAGE-A4 is also made up of a blend of relatively novel targets and other highly clinically valid targets for T-cell receptors. I've talked about MAGE-A4, our lead.
Behind that, we have a target called KK-LC-1. It forms and comes under the same family of targets as MAGE-A4, what are called cancer-testis antigens. These are very clean targets expressed across multiple solid tumors and not expressed in normal tissues. And you can see the indications relevant for KK-LC-1, which are complementary to those relevant for MAGE-A4. And that's going through the research discovery preclinical stage. And then behind that, we have a program which targets PRAME, a target that is also highly clinically valid. There are a number of players that are targeting PRAME, and we have seen solid tumor responses in patients that have been treated with PRAME-targeting agents. And so, again, we would be anchoring on an extremely valid clinical target with PRAME. I can have the next slide, please.
So that summarizes the section on the novel proprietary off-the-shelf cell therapy platform, TCR- NK. And now I'd like to switch gear to MultiClick. Jonas introduced the MultiClick platform, an early-stage platform, and I'd like to give a little more detail on the platform. So the initial expansion plans for the pipeline at Ultimovacs had really led to the development of a novel conjugation technology, what's called MultiClick. And the benefits of the technology is that it potentially can serve multiple drug types across various diseases. It's a versatile platform that can be deployed across different diseases, including oncology. And there has been some work with this early-stage technology, a preclinical set of investigations to really evaluate prospective directions for the science and ways to potentially unlock value for the technology.
And in concert with industry players and in dialogue with potential partners down the line, it was established, and the potential merits and characteristics of what could potentially be appealing for a partnership was established. And really, that fell on three specific characteristics. So if we can move on to the next slide, please. And those characteristics for potential partner players would be a technology that enabled flexibility of coupling, on-target delivery, and favorable CMC. Really, three characteristics that people have been looking for this type of technology. So if I can move on to the next slide, please, just to illustrate the potential of this technology to meet those characteristics. MultiClick is a flexible core molecule. You can see that in this illustration. And it can be selectively coupled to several different modules. You can see in this illustration, three modules being coupled to the core molecule.
And so each of those modules, in essence, can drive a different effect. You can have targeting units or active entities. So it provides this flexibility of attachment to different modules with different effects. And so use cases, one can imagine, can be in different areas. And a few of those are shown here. One can potentially increase payload delivery for cell internalization, enhance tissue specificity, improve safety profiles. The options are varied, and the flexibility prospect is open. And so currently, the evaluation of the technology continues with a view to understand the potential pathways that can lead to the most efficient unlocking of any opportunities with this platform.
As Jonas had mentioned earlier, part of the industrial rationale for the combination of the companies is we have a team that have built a TCR- NK platform from the ground up, in essence, really unlocked value from a platform technology. Being able to deploy a team to understand the prospect and potential of MultiClick is another key feature. I can have the next slide, please. And the next to summarize. Thanks, Hans. In this union of these two companies, we believe it comes at really the right moment for both companies. It is a moment that really builds on the strengths and many years of building those strengths for both companies. The prospect of bringing these companies together and the investment highlights are shown on this slide.
We have a proprietary off-the-shelf cell therapy platform targeting solid tumors with curative potential and the prospect to meet the demand of the global tumor burden. We have compelling preclinical data that demonstrates the ability of the technology platform to outperform clinical benchmarks and the ability to address diverse tumors for high-value cancer markets. We have a robust set of IP, including, and importantly, an unprecedented TCR- NK concept patent that has the potential to land-grab the entire therapeutic space, creating immense value, and a well-established regulatory and clinical strategy validated through discussions with the FDA. Together, we have a strong execution track record of complex clinical studies across sites, across jurisdictions, and in the cancers of interest for the lead asset. We have a runway expected through to Q2 2026, which importantly captures a key milestone, which is the IND for the lead asset.
And only limited further funds would be needed to secure clinical data beyond that. Very importantly, a company is nothing without its people. We have management and board with broad experience from drug development and building shareholder value, which, in essence, positions us very strongly together to be leaders in the space. If I have the next slide, please. So what are the objectives of the combined company? And it's very important to state that at the outset. We aim to bring patient-to-patient transformative off-the-shelf cell therapies for the treatment of solid cancers. And our first priority would be to advance the world's first MAGE-A4 targeting TCR-NK into first-in-human studies to really serve those patients with little other options. And we'll be leveraging the established and experienced clinical execution team to be able to advance that as fast as possible. Secondly, we'll be developing the TCR-NK pipeline.
I showed the pipeline behind MAGE. Thirdly, we'll be seeking to unlock the MultiClick technology potential. And finally, as Jonas had commented on the UV1 program, we'll be wrapping up the UV1 program. I can have the next slide, please. So what are we to expect in terms of key milestones? How far have we come? What have we achieved since 2023? In 2023, we reached an important milestone where we transferred the manufacturing process for the TCR-NK platform and lead asset to a large-scale manufacturer. In 2024, one of the key milestones, as I had mentioned, is the interaction with the regulators, specifically the FDA, and validating our preclinical manufacturing and clinical strategies, forming a validation not only for the lead asset, but also for the platform as a whole.
We also generated key preclinical data that enabled us to continue with the program and in-licensed a TCR for PRAME, which forms a part of our pipeline. Next year will be an important year and we aim to submit an IND in the second half of next year after completing the preclinical data sets and GMP manufacturing and also, over the course of next year, around the second half of next year, we'll continue to evaluate MultiClick technology. This, with the initial investment that comes with the combination. Now, looking further with further limited funds, we then expect to be able to generate clinical data on the world's first MAGE-A4 TCR-NK around the first half of 2026 and then over the course of the year, also generate in vitro data packages for the pipeline programs behind the lead. I can have the next slide, please.
Going back to the importance and the core nature of people in organizations, what we have proposed is a board composition as shown on this slide. Now, we're really lucky to have a really deeply experienced board with a breadth of expertise across the field and also specifically in the therapeutic space that we operate in, including pioneers in this space. The broad expertise extends to operational experience, corporate business development, M&A, investments, a real swathe of experience in biotech and in pharma. As I mentioned, including specialist expertise in the field with a founder of two of the leading TCR companies in the space, Bent Jakobsen. I'd like to mention Anders Tuv, who is proposed as the Chairman of the Board.
Anders has really been one of the key architects for the combination, a real driving force and project leader, a seasoned entrepreneur with a breadth of experience across the field, operation, corporate licensing, investments, and so really well positioned to chair the board of directors. I can have the next slide, please. And so with that, I will hand over to Hans to take us through the combination mechanics.
Thank you, Namir. The business combination of Ultimovacs and Zelluna is structured as an acquisition of Zelluna. So Ultimovacs , as the acquiring entity, will place a bid or has placed a bid on all the shares in Zelluna. And DNB Markets has assisted as a financial advisor in this transaction.
The implied valuation and the exchange ratio that has been agreed in this transaction implies a 90% ownership share to the current Ultimovacs shareholders and an 81% ownership share to the current Zelluna shareholders. More than 99% of the current Zelluna shareholders have given their pre-acceptance of the offer. And as Namir referred to, in addition to this business combination taking place as an acquisition, there is a private placement fully committed at a size of approximately 51.7 million NOK. And that is priced at 2.6 NOK per share. All the pre-commitments that are given come from existing shareholders in Ultimovacs and/or Zelluna. So we have experienced strong support from the current shareholders. And the funding provides an expected runway through the second quarter of 2026. And that enables the combined company to capture this key IND catalyst that Namir just referred to.
There is contemplated a repair issue after the closing of this transaction for those shareholders who have not been given an opportunity to invest in the private placement. This will be at the board's discretion as per market standard. Looking ahead, what does the process look like? The next step is a call for an extraordinary general meeting in Ultimovacs. The call will go out tomorrow, and the EGM will be held on the 9th of January 2025. And the closing of the business combination is expected late February 2025. Okay, with that, we have been through the presentation, and we are open for questions from the audience. So you may place those through the web. We have not received any incoming questions so far. So I think we have been very clear today, Namir. So hopefully the message has come across in a very good way.
So I leave the word back to you, Jonas, to close up this webcast.
Thank you, Hans. So thank you all for following us. And thank you, Namir and Hans, for a very good presentation. And as Hans said, hopefully we have come across with this message that we really think this is a very good combination both for both companies and for all the shareholders. So thank you for listening.