Good morning, everyone, and welcome to our fourth quarter business update and financial results. My name is Namir Hassan, the CEO of Zelluna, and I'm delighted to be joined by Guy Christian, our CFO. Can I have the next slide, please? So today we'll be covering our key events. If we can have our agenda slide, please. Fantastic. Today, we'll be covering our key events in Q4 2025. We'll also cover the Zelluna TCR-NK platform and pipeline. We'll give a financial update and end with a summary and Q&A. Can I have the next slide, please? The next. Thank you. It's been a incredibly exciting and strong period for Zelluna over Q4.
We raised NOK 58 million to advance the ZIMA-401 into first-in-human clinical trials and progress the pipeline, allowing us with a cash runway into Q1 2027. We completed our first batch of ZIMA-401 to support patient treatment in the ZIMA-101 first-in-human study. We also published compelling preclinical data demonstrating the merits of TCR-NK and supporting the translation of ZIMA-401 into the clinic. All of that culminating into a submission to the U.K. MHRA of our clinical trial application, which is currently under review and in dialogue with the MHRA. We're advancing trial startup preparations with a couple of leading U.K. oncology centers, The Christie and The Royal Marsden. All of this really pointed to being on track for initial clinical data to emerge from mid-2026.
It's a big and exciting year for Zelluna. Can I have the next slide, please? So if we just take a moment to reflect on the context in which we're operating. We're of course a cell therapy company, an off-the-shelf cell therapy company. And when we look at cell therapies, we see that it's a validated—a clinically validated modality with nine approvals to date, several based on small human datasets, and you can see those in this slide here. Over the course of a number of years, a number of cell therapies have been approved for the treatment of various indications, and many of these are based on datasets that are fewer than 100 patients. And what this demonstrates is, A, the power of cell therapies, the validity of cell therapies, but also the power of small human datasets.
Can I have the next slide, please? Now, while we have seen this validation in cell therapies and really remarkable improvements in patient lives, what we're also witnessing currently is a major shift in the field and that's towards next-generation cell therapies that have particular features, and we believe that this really defines Zelluna's opportunity. The shift that we're seeing is from a move from complex so-called autologous cell therapies, where one batch is produced per patient, to scalable off-the-shelf solutions. And these scalable off-the-shelf solutions have certain features such as simplicity in manufacturing, scalability, and lower cost of goods. And so these have become strategic priorities in the move towards the next generation of cell therapies. And what symbolizes this is the flurry of deals and the strong deal momentum that we have seen in this space.
These are often based on early phase I human data. So what you can see on the right-hand side of this slide is some examples of the deals that we have seen in this space. And the features of the deals and the companies involved in these deals is that they land in this scalable, off-the-shelf solution to cell therapies. An example is Eesa Biotech and AstraZeneca, an acquisition for around $1 billion for a company, Eesa Biotech, that had generated data on very few patients, in fact, one patient, demonstrating the potential of this particular platform that they had been developing, which is a scalable off-the-shelf cell therapy solution.
In fact, on top of these, just recently, in the last few days, a company called Orna Therapeutics, again, another company developing a platform technology for off-the-shelf cell therapies, was acquired by Lilly for over $2 billion, and it's a preclinical-stage company. So what these deals show is that there is a really intentional move to try to harness the merits that we have seen of cell therapies, but a movement towards platforms that allow a simpler manufacturing, more accessible treatments, and scalable platforms. And this is exactly the shift that Zelluna is built to address.
The features of our platform capture scalability, accessibility, lower cost of goods, and on top of that, are aimed to treat solid tumors, which are the largest cancer burden globally, constituting over 90% of total cancer burden. So it's an opportune time, it's an opportune moment for Zelluna. Can I have the next slide, please? And so, what we have been able to do over the last years is develop the basic science, develop the preclinical data, lock down and develop the manufacturing process, and also file a CTA at the end of last year. And what we're firmly aiming for and focused on this year is to generate that all-important initial clinical data to understand the potential of the platform in solid cancer patients.
What that may do is may land us, really in, what we call a potential, deal zone, where early clinical data, as demonstrated here in the, in the previous slide, has really catalyzed high value in a number of, companies, over the last year. Can I have the next slide, please? Thank you. Let's take a deeper look, and remind ourselves of the platform technology. We believe it's the right moment, for Zelluna. And we have, if you like, four pillars, that really drive, our momentum. The first is that we believe we have a game-changing platform, a novel, a truly differentiated platform technology. And while it's differentiated, we also believe, that it's a de-risked concept. The components, from which we build the platform, we believe are de-risked.
The components are clinically validated, and we bring these together in a novel way. We're also aiming to treat solid cancer patients, which is the largest global cancer burden, and the largest commercial market in cancer. Secondly, we believe we have a unprecedented position where we have protection of the entire therapeutic field. So the approach that we have has been captured and is protected with a concept patent that has been granted across key commercial territories. So what we say to describe this is a potential land grab opportunity. The third is that we are on course for a term clinical inflection point, and as we have seen, small human data sets can really catalyze enormous value.
And for that, we submitted a CTA at the end of last year, in December. We announced just yesterday that we selected a clinical CRO to support the clinical study, a global CRO called Medpace. They have incredibly deep experience in oncology and early-phase clinical studies in cell therapies, and really constitute an ideal partner for Zelluna in really executing swiftly on a clinical study, and we're very excited to be working with them. And we're on track for initial clinical data to emerge from mid-2026. And the last pillar here is to again reiterate that we have seen across the field that early clinical data, data from a few patients, in fact, really can drive high-value deals.
And approvals have been fast in this space with data from fewer than 100 patients. So if I can have the next slide, please. Just a reminder of the concept and the platform that we're developing is what we call a T-cell receptor natural killer cell platform, and we bring two components together. Both components are clinically validated. On the left-hand side you can see those two components. One of the components is called the T-cell receptor. It's a clinically validated targeting molecule, where we have seen approvals that are based on this targeting molecule. Two approvals, in fact, that are approved for solid tumors. So we know this targeting molecule itself is able to target solid tumors, so that's the first component.
What we do is we bring that together with a cell type called natural killer cells that occur naturally in the body. In fact, they're the most efficient killers in the human body. And the benefit of natural killer cells is that they can recognize cancers in different ways, and they also have been demonstrated over the last decades to be clinically safe. But the challenge with natural killer cells alone is that they can struggle to find their way to solid tumors. And so when we bring the targeting molecule, the T-cell receptor, together with natural killer cells, we enable them to really find solid tumors, and then they can unleash their power, and destroy cancers and recognize cancers in different ways. And so what this provides is a platform that is aimed at targeting solid tumors...
is, can be used off-the-shelf, is scalable, and can be immediately used to treat patients. So these would be, frozen vials. In fact, we've generated, our clinical batch, as we've announced, and those are frozen and ready to, be used in patients. So very much, really landing in the, in this shift that we're seeing, in cell therapies and, really, containing the patterns, that we're seeing, that the shift is moving towards scalability, lower cost of goods, and the potential to immediately treat patients. If I can have the next slide, please. I mentioned our, what we believe is, a really valuable, patent, that protects the, therapeutic field.
Just to maybe elaborate on that and perhaps provide an analogy around that, on the left-hand side, what we show here is that with this patent, potentially, any product that is developed that is under the TCR-NK concept, so you can see a number of products that are shown as an example, would be captured by this patent. And so it's really a patent that covers the approach. Now, layered on top of that, we also have product-specific patents that is more common, but the patent that covers the field is somewhat unprecedented. And the analogy and the comparator one can make is if we look at what are called CAR-T therapies, and CAR-T therapies have been the first wave of cell therapies.
A number of the 9 approvals are CAR-T therapies, and you can see some of those here. One can imagine if the CAR-T therapy approach had been protected in its entirety, the aggregate value that that would capture is many of these products, multiple billions of revenue, and so incredibly valuable. That provides perhaps a level of comparator to the prospect and the potential of protecting an entire field. If I can have the next slide, please. If we dive a little deeper into our lead program and lead asset is called ZIMA-401. It's a TCR-NK, our first TCR-NK that we've optimized over the last years, that targets a very well-known T-cell receptor target called MAGE-A4.
This is probably the most well-validated solid cancer target for a T-cell receptor. If we go from left to right, the potential of this, therapeutic, going after MAGE-A4, we believe, can potentially capture, and treat over 50,000 patients across a range of different indications. And this is something that others that are also going after this target, have assessed, so similar, levels of, patient reach. From the, evidence perspective, in terms of the target itself, when we look across, the clinical development space, we have also seen multiple, clinical, programs that target MAGE-A4, different approaches, but nonetheless target MAGE-A4, where we have seen, tumor shrinkages across different indications, demonstrating that when you target MAGE-A4, you're able to really drive responses in solid tumors.
That was important for us in choosing an appropriate target for our therapeutics. We anchor on a highly valid solid tumor target. Just to complete the picture, on the right-hand side, in terms of the competition, there is one market approval for a MAGE-A4 targeting T-cell therapeutic. It's what's called an autologous therapy. And so whilst it has shown strong responses in various solid tumors, it also has a limitation when it comes to scalability, and when it comes to affordability.
So there's limited potential for scaling this, as this type of therapy, if you like, forms the first wave of cell therapies, and doesn't move into the next wave of cell therapies, which is where we are, which is scalable, off-the-shelf cell therapy solutions. So if I can have the next slide, please. So if we, as we've been looking at our lead, some of the features here of where we are with our program, on the left-hand side, the science really looks very strong, and we've published on that at the end of last year. The preclinical data on our lead, which really demonstrates the merits of the platform, and also demonstrates how the TCR-NK and the lead outperforms the clinical benchmark.
So we see higher levels of killing of cancers, and we also see certain features where our lead is able to address the diversity of cancers that other targeting agents against MAGE-A4 are unable to do. At the centre there, from a regulatory path perspective, we submitted our CTA to the MHRA and have ongoing dialogue there. From a clinical perspective, we're going after lung, head and neck, ovarian, and sarcoma cancer indications. And we have recruited a couple of really globally known and renowned U.K. cell therapy sites, The Christie and The Royal Marsden, where The Christie will be the lead site with Professor Thistlethwaite as the lead investigator. I can have the next slide, please. So just a snapshot of some data, and more data can be seen in our publication.
What we're showing here is when we look at our lead product, ZIMA-401, which are shown in the dark blue bars, and when we compare to the benchmark, so this is the approved major CAR-T cells, and we go from, left to right. When we expose these different therapeutics to, cancer, so lung cancer cells, for example, on the left-hand side, what we can see is that the killing of those cancer cells with our product, is at a higher level than, the benchmark. And we've shown that in different, cancer cell types. And this is not a surprise, given the, highly efficient killing potential of, of natural killer cells.
But what's also very important to note is on the right-hand side of this slide, when we then expose our lead to cancer cells that don't contain the target for the T cell receptor, so these would be cancer cells that also exist in patients. We retain killing of those cancer cells with our lead product, but the benchmark TCR-T cells are no longer able to kill. And this is exactly what we see in patients, when they're treated with this benchmark TCR-T. So while we have seen tumor shrinkages, what we have also seen in virtually all patients is that the tumors come back.
What we're aiming to address is the problem of those tumors coming back, and our lead demonstrates the ability to actually address that, and be able to target the diversity of cancers. So not rely on a single target, but be able to really kill cancers with multiple features. And that's the real biological rationale and the merit of our lead program and of our concept. If I can have the next slide, please. So here we show our pipeline, our lead targeting MAGE-A4, and that, as you know, is moving towards the clinic. And behind that, we have another very exciting program, where we target another validated cancer target called KKLC-1. It's relevant across a number of different indications, as shown here: breast, gastric, lung, pancreatic, and cervix.
So it really provides a further breadth of indications that we can go after with our TCR-NK platform. Behind that, we have some exploratory work with another target, again, relevant for solid tumors, one that is also being worked on in the field, and it's called PRAME. So we believe we have a real exciting blend of highly valid targets and also slightly more novel targets that can then potentially really cover a broad patient reach and a wide range of solid cancer indications. And what we have been doing over the last years in really clearing the path to the clinic and de-risking various elements, including in our preclinical pathway, is applicable across the entire platform.
So the learnings and the pathway that we are treading with our lead, ZIMA-401, can then be applied to the entire platform. We can deploy the manufacturing process, we can deploy the same preclinical pathway. And so really, we have been able to de-risk not only the lead, but also the entire platform and other TCR-NK programs that follow. Can I have the next slide, please? Okay, so that covers our TCR-NK platform, our lead, and our momentum towards a first-in-human clinical study with ZIMA-401. Just to complete this section, a couple of updates on a couple of other areas.
On the MultiClick technology, as we had guided previously, we have been looking at the MultiClick, and we completed a strategic review looking at intellectual property considerations, as well as commercial potential and strategic fit. And based on this review and taking into account our real focus on the TCR-NK platform and the momentum and the successes we have had and the progress we have made, and the real desire to be disciplined and focused with efficient allocation of resources, the conclusion from this review is that the company will not pursue further development of the MultiClick technology at this time. And for the UV1 programme, as you well know, so a therapeutic vaccine being evaluated in five Phase II...
Randomized controlled trials. four of those Phase II trials have shown disappointing results, and as we've guided, we've been in the process of wrapping up the program. The remaining trial is one called DOVACC and has completed enrollment, and top-line results are expected during the first half of 2026. This is all in the context of four Phase II trials with disappointing results. So if I can have the next slide, please. That's that section, and I would like to hand the word to Guy Christian, our CFO, to take us through the finance. Thanks, Guy.
Thanks, Namir. I'm delighted to provide a financial update on Zelluna's progress. In addition to the strong operational progress Zelluna made in the fourth quarter, the company also strengthened its capital position by successfully closing a new equity raise in November. We were very pleased with the strong support we experienced from existing shareholders and board members, and also strong participation from the management team. With the net proceeds from the share issue, the company is expected to be fully funded into first quarter 2027. I'd like to give an update. The company's cash position totaled NOK 78 million by the end of the fourth quarter, and as indicated, cash runway into the beginning of 2027. Before interest and taxes in the fourth quarter was NOK -35 million, and for the full year, it was NOK -144 million.
The profit before tax in the fourth quarter was -NOK 35 million, and for the full year, -NOK 141 million. Profit and loss side, on this slide, you see a comparison between the fourth quarter 2025 and 2024, and similar for the full year 2025 versus the full year 2024. Note that the full year 2025 only includes the Zelluna immunotherapy business, while in the 2025, from March onwards, the financials include the business combination for with Ultimovacs. The development has been as planned and as expected, with higher payroll and payroll-related expenses related to a higher number of employees in 2025 compared to 2024. Similarly, we had higher expenses in 2025, mainly related to manufacturing activities leading up to the completion of the first GMP batch for our lead program.
Also, other operating expenses were higher, especially related to the business combination. In the year, we also had an impairment of goodwill related to the combination of NOK 3.2 million, and there was some impairment in the fourth quarter related to an analyzed TCR in the pipeline of Zelluna, rated, totaling of NOK 2.3 million. So in the fourth quarter, we had a net increase in the cash position of NOK 31 million and the up by seven -- and for the full year, we had an increase in NOK 51 million. The total number of issued shares at the end of the quarter was 26.3 million. This slide, you see a comparison quarter-by-quarter over 2024 and 2025. This is for information purposes only.
I will then go to this cash flow slide, the quarterly operating cash flow, and as expected and planned, the costs and the resulting cash flow is improved in fourth quarter compared to the third quarter. The difference between the operating cash flow and the earnings before interest and taxes in the fourth quarter is related to the impairment, sorry, for the non-cash cost related to the TCR we writing off and also a share option expense of NOK 3 million with no cash effect. Then thanks for that, and I will hand over to back to Namir for a summary.
Thanks a lot, Guy. So then just to summarize, can I have the next slide, please? So again, we've had a very exciting period. We have managed to accomplish what we had aimed for, and over the progress that we have made there, culminating in the completion of our first clinical batch, compelling preclinical data published, and the CTA submitted to the U.K. MHRA, all as planned, and as guided. And so looking ahead then in 2026, we announced our selection of a clinical partner, Medpace. Very excited to be working for them.
And in the horizon, what we're looking for is ultimately the clinical data, and in the meantime, awaiting and continuing a dialogue with the MHRA, with the prospect of a CTA approval in the first half of this year, and then generating that all-important clinical data. A very exciting and important year for Zelluna, with potential first data on an exciting platform with a first-in-class MAGE-A4 targeting TCR. Behind that, we have our second program targeting KKLC-1. Again, another very exciting program that we're aiming to generate in vitro data package for this year. So with that, that completes our update.
Thank you for listening and for your attention, and I will then hand to Gard for any questions that we may have.
Thanks, Namir. We have one question. We have several question, I would say. We have. The first question is, when do you expect to get approval for the CTA?
That's a very good question, and of course, it's something that is very important. So you may recall that we had submitted our CTA on the seventeenth of December, and credit to the team, a really important and a really substantial feat. And typically, for an advanced cell therapy like ours, with the U.K. MHRA, for approval, timelines for that are typically and commonly 60-90 days. So we are in dialogue with the MHRA, and we expect within that that we may see an approval if all goes well.
Thanks, Namir. Another question is, can you elaborate on the hospital's experience with cell therapies and their interest in participating in the clinical trial?
That's a very important question. Of course, the clinical sites and the clinical investigators are key for any clinical study and for the progress of any clinical study. We carefully have selected two of the world-leading sites in cell therapy, The Christie and The Royal Marsden, and both clinicians at both sites are hugely excited by testing for the first time this TCR-NK product. Professor Thistlethwaite has worked heavily on cell therapies. Both sites have worked heavily on cell therapies, and really sees the merit of the approach and the potential to really make a difference in solid tumors with an off-the-shelf type cell therapy. And she'll be our lead physician. And Dr. Andrew Furness is also incredibly excited, very deep experience in cell therapy.
So together, we really think we have a powerhouse of centers to really drive recruitment, and also really champion our platform and our technology, given the excitement they have around the science and the potential.
Thanks. A third question: Can you elaborate on the deals in the fields and the-
Yes. So as I mentioned, there have been a flurry of deals in the space. And if you look at the features of the companies involved in the deals, there are common features. The first is that these deals that are all with companies that are developing platform technologies, and platform technologies that are enabling products to be produced, that are off-the-shelf cell therapy solutions. And so these are off-the-shelf cell therapy platform technologies, where manufacturing is simplified, where there is an increase in the scalability, the prospect of scaling these treatments. So what they have been able to do is some of them have gone into the clinic, others not.
Some are preclinical, and they've generated data sets on a few patients to demonstrate that the science actually works in patients, even with one, two, or three patients, and that has driven the deals that we have seen, largely acquisitions, from anywhere between $500 million to upwards of $2 billion. So it really marks a shift in the field, and that is to take the potential we've seen in cell therapies, but move towards off-the-shelf, scalable solutions. That's exactly what is offered with Zelluna, and we're excited to see how that translates into patients.
Nice. There are no further questions, Namir, so it's just to wrap up, I guess.
Well, thanks for the questions, and thank you all again for the attention. I hope you have seen that it has really been a strong period, one of execution and delivery. I'd like to thank the team for their incredible efforts, resilience, focus, and discipline, and we're excited to continue and advance the progress, and we will keep the market updated as we go along. Thank you very much. Thank you.