Good morning and welcome to Zelluna's Second Quarter 2025 Business Updates and Financial Results. My name is Namir Hassan, the CEO of Zelluna, and I'm joined by Hans Eid, the CFO. Can I have the next slide, please? The next one. What we'll be covering with you today are the key events over the second quarter of 2025, a reminder on the TCR-NK technology and pipeline, a financial update, and summarize at the end. The next slide, please. The next. Perhaps two of the key messages that we would like to communicate from the second quarter are shown here. The first key message is, excitingly, we are on track for a clinical trial application filing for our lead program, ZI-MA4-1, scheduled for sometime in the second half of 2025, which means we are on track for generating that all-important human data in the first half of 2026.
This is a very exciting moment for the company on the cusp of generating patient data for our novel platform technology. It's exceptionally exciting when we think about the context. There has been growing appetite for early-stage, off-the-shelf cell therapies, and we have seen a flurry of deals of late. I'll come on to those, where small biotechs that have entered into the clinic with off-the-shelf cell therapies have really commanded high value. This, we believe, reinforces Zelluna's unique positioning and the current timing being on the cusp of generating that all-important patient data. Have the next slide, please. If we delve into more detail around the building blocks of our preparation to really drive our lead program, ZI-MA4-1, towards the clinic, on the preclinical front, we have successfully completed a full round of all key investigations in support of a clinical trial application.
On the manufacturing front, following April's announcement of successful manufacturing lockdown, we have initiated GMP production of a clinical batch that was initiated in July and forms a major step forward towards clinical trial preparation. On the regulatory front, we've broadened our regulatory engagement following positive FDA pre-IND feedback that we've communicated previously. We have recently submitted a scientific advice briefing package for the UK regulatory authorities that was submitted in July 2025. On the clinical front, we have had really strong support from leading clinical experts in the cell and gene therapy space. We continue to refine our trial design and our clinical strategy as we move to operational readiness ahead of a clinical trial application submission. All of this is in the strategic context of a cell therapy market where the trends are favoring early-stage, off-the-shelf platforms.
If we look at recent deals from AbbVie and AstraZeneca and the acquisitions of small early-stage biotechs, Capstan and EsoBiotec , both in the off-the-shelf cell therapy space, we really are witnessing the reinforcing of Zelluna's unique positioning, being a unique developer of an off-the-shelf cell therapy platform on the cusp of generating that all-important, potentially high-value clinical data on patients. Overall, on track for our lead program towards an IND or CTA scheduled for the second half of 2025, with data emerging on patients anticipated in the first half of 2026. Really great progress by the talented team. Can I have the next slide, please? We have seen a flurry of deals in the off-the-shelf cell therapy space in the last quarter. I communicated a couple of those deals.
In the interim, we have seen further deals. There has been a recent deal announced in June where AbbVie have acquired Capstan Therapeutics, Capstan, a small biotech that is developing an off-the-shelf cell therapy platform, a type of CAR T therapy. They only treated a single healthy volunteer at the time of the deal, and the total deal value is approximately $2.1 billion. Reinforcing the idea that early-stage, off-the-shelf cell therapy platforms with small patient data sets can really unlock enormous value. What has been our journey? If I can have the next slide, please. What has been our journey and what does potentially the horizon hold? As we've communicated previously, we have really developed the basic science, the preclinical data, and we announced in April the lockdown of manufacturing.
As we're looking towards the clinical preparations, we're aiming to generate that all-important clinical data for our world's first lead asset and, by extension, also generating data on the platform itself. As we've seen with the flurry of deals, small human data sets can really drive high value. The Capstan and AbbVie deal I just mentioned in March, we also had the Eso Biotec AstraZeneca deal where AstraZeneca bought out the small biotech company, Eso Biotec, again on the basis of data from a few patients, and the Roche acquisition of Poseida in November 2024, all indicating a trend towards increasing appetite for off-the-shelf cell therapies and for unlocking high value with small patient data sets. That's what we're aiming for in our move towards the clinic and dosing patients in the first half of 2026.
If I can have the next slide, let's maybe spend a moment or two with a reminder on our platform technology. What is it that we're aiming to address? With our platform technology, what we call the TCR-NK technology, we're aiming to address one of the biggest burdens of humanity, which is the burden of solid tumors. We know that solid tumors, the likes of lung cancer, prostate cancer, pancreatic cancer, and so on, are the cause of over 9 million annual deaths. Over 83% of patients with late-stage cancer, unfortunately, will die from the disease. The context is that we have seen some progress with treatments that are really penetrating solid tumors, but the challenge has been that virtually all patients relapse, the tumors come back, and unfortunately, the patients end up dying when they have late-stage disease.
We have been developing over the years a differentiated platform that's really designed to address solid tumors and overcome cancer escape, which is one of the biggest problems in treating solid tumors. In parallel to that, we're aiming to do that in a way that allows us to make the therapy accessible and scalable. Two main things are to address solid cancer escape and also to allow the therapy to be accessible and scalable. If I can have the next slide, please. What we're developing is a type of cell therapy. I've mentioned off-the-shelf cell therapy. It's a type of cell therapy. Why cell therapies? We know cell therapies have cured cancer patients, and there are nine approvals currently with cell therapies. They're mainly in liquid cancer, but what that tells us is that cell therapy can really actually make a difference to patients.
Nine approvals is really a validation of the cell therapy approach. The challenges with cell therapies are two, currently, or two of the main ones are treating solid tumors. As I mentioned, cell therapies have struggled since cancers can escape treatment. That's the first. The second is actually enabling these cell therapies to be used at scale for global access. With the high effectiveness of these types of therapies, of course, there's a desire to deploy these at a global scale. At Zelluna, we've been building a platform called the TCR-NK platform, really designed to address both of these challenges. It's really designed to address solid tumors and overcome cancers from escaping to really allow long-term responses. At the same time, these therapies are also produced to be used at scale and accessible so they can be frozen down and used at the point of need.
You may remember in April, we announced a manufacturing lockdown, and from a single batch, we generated hundreds of doses. It's a really scalable concept that we have proven now with our manufacturing process. If I can have the next slide, please. What is Zelluna offering? We believe we have a game-changing platform, and it's a novel approach, the TCR-NK approach. Whilst it's novel, it's built from two validated components, and I'll come on to talk about what I mean there. Very importantly, I think this is somewhat unprecedented. We hold a very strong patent portfolio, layers of protection. One of the very exciting areas of protection is actually the protection of the therapeutic space, so the entire therapeutic approach, the approach of treating cancer with TCR-NK. Not just single products, but the actual approach. We've called this a landgrab opportunity, and I'll come on to talk about that.
We have other layers of IP that are in flow around products and manufacturing, but really the entire field on top of that. What's exciting is the moment that we're in right now, which is there's an expected near-term clinical inflection. We're reporting today that we're on track for our IND or CTA submission in the second half of 2025, with a view to generating that all-important clinical data emerging in the first half of 2026. We know strategically from a context perspective that there is growing appetite for off-the-shelf cell therapies that are novel, which we believe we have, especially when there is early human patient data, and that can really drive high value. We also know that these types of cell therapies can be fast to approval. Many of the nine approved therapies have been approved on the basis of less than 100 patients.
I think that demonstrates the potential fast-track approval for these types of therapies. If I can have the next slide, please. Just a moment to spend on the nature of the platform. We're developing, as I mentioned, a T-cell receptor natural killer cell platform. We can think about the product in two components. One component in the top left is what's called the T-cell receptor. This is, if you like, a guidance system. It's a targeting scaffold. It's a validated scaffold. It naturally occurs. We use engineered T-cell receptors, and they've been validated and shown to be able to effectively target solid cancers. We have a number of approvals which use T-cell receptors as targeting agents, and they're approved for solid cancers. We know that type of scaffold and guidance system can target solid cancers very effectively, with the clearest proof being approved therapies on the basis of T-cell receptors.
The therapy also consists of a cell type called the natural killer cell. Natural killer cells occur naturally in the human body. They're probably the most efficient killers, highly efficient killers. We also know from clinical development that you can get really robust responses with natural killer cells. The challenge with natural killer cells is finding their way to solid tumors. That's where our approach comes in. We bring together the highly validated targeting scaffold, the T-cell receptor, and we put that into natural killer cells so that we can target solid tumors via the T-cell receptor, natural killer cells, so that they can then go on and do what they do well, which is kill with high efficiency. This TCR-NK platform, this blend where we bring together the T-cell receptor and natural killer cells, is a novel, differentiated approach. We're virtually the only company that is doing it.
We believe it combines a proven solid cancer targeting molecule, the T-cell receptor, with the most potent and safe cell type, natural killer cells, to form T-cell receptor natural killer cells. This is the platform we've been developing. We know it also can be used off the shelf, meaning that a single batch can be used to then treat many patients. This provides the convenience, it provides the scalability, and addresses one of the key challenges with current cell therapies that are not limited by scaling those types of therapies. If I can have the next slide, just spending a moment on an important point around the protection of the T-cell receptor natural killer platform, TCR-NK platform. We have a patent that we believe protects the approach, the TCR-NK approach.
Really just to try to put this into perspective, if we look across the landscape of different off-the-shelf approaches, so-called allogeneic approaches, you can see those split into these quadrants based on the cell type. You have other natural killer cells, but guided by a different targeting system, so-called CAR NK. Those are at the top. You see multiple companies operating in that space. We also have allogeneic off-the-shelf T-cells. That's the bottom left, again guided by a different scaffold, so CARs. You see multiple operators in that space. Then different types of cells, again off the shelf in the bottom right. What you'll notice is that there are multiple operators in these quadrants, whereas with the TCR-NK approach, not least of which due to our protection of the approach, we're virtually the only company operating in that space.
Therefore, one can imagine the potential aggregate value that could be unlocked by demonstrating the platform ability in patients could be huge, equivalent to perhaps aggregate value of these multiple operators that we see in these different quadrants. Maybe just to drive that message home further, we've seen the recent flurry of deals. You see in the bottom left the companies that are involved in those deals: Capstan , Eso Biotec, and Poseida, all acquired by large pharma on the basis of small human data sets. These are three companies operating in that quadrant where the deal values have been somewhere between $1 billion- $2 billion. The potential value that could be unlocked by demonstrating the TCR-NK approach in patients can be immense, we believe. Another way of thinking about it, perhaps, is shown on the next slide, where we have seen a number of T-cell therapies approved.
I mentioned nine therapies that have been approved in the cell therapy space. A number of those are CAR T-cell therapies, and you can see the products there and the companies that have been developing those. Maybe as an analogy, one can think about the protection of the TCR-NK space, which would be analogous, similar to the protection of the CAR T approach, which of course is not something that exists, but demonstrates the potential aggregate value. We know from these products that there's multi-billion revenue being generated with CAR T products. We believe we can potentially really unlock immense value through the protection of the TCR-NK therapeutic approach. If you like, multiple companies, multiple products in one. If I can have the next slide, please. Just a few comments on our lead program.
We're progressing well and on track and aiming for CTA/IND submission in the second half of this year. We have really further refined our clinical strategy together with expert clinicians in the field. We're looking at targeting lung, head and neck, ovarian, and synovial sarcoma, and collaborating with world-renowned clinical sites as we continue to develop our strategy. If I can have the next slide, please. What are the clinicians saying about the prospect and the potential? This is Professor Fiona Thistlethwaite, a really key expert in the cell and gene therapy space, a Medical Oncologist who has really conducted a number of clinical trials with cell and gene therapies, and we have a really strong dialogue with her. She says that she's genuinely excited to see the progress with ZI-MA 4-1 into the clinic.
She's optimistic that the dual killing mechanism of the NK cells and tumor antigen-directed T-cell receptor will provide us with the step change that we need in the solid tumor setting to provide the required level of tumor potency whilst avoiding tumor escape. This is a key point that our platform is really designed to address solid tumors and to address the issue of tumor escape. Professor Thistlethwaite is really excited about that prospect. If I can have the next slide, please. Here is our pipeline. We have a blend of assets in our pipeline beyond the lead ZI-MA 4-1, which you can see there, a couple of other programs in our pipeline, again targeting a blend of clinically validated or preclinically validated targets that would be relevant across a number of solid tumor indications, as you can see there.
We're really building our pipeline with a blend of clinically validated or preclinically validated targets that would be relevant across solid tumors of high unmet medical need. If I can have the next slide, please. This is a status on MultiClick and UV1. I won't spend time on this. This is as we have communicated in the last quarter, and there's been no change to that status. If I can hand over to Hans to provide the financial update.
Thank you, Namir, and good morning. Moving on to the next slide. Before we go into the financial numbers, I would like to give a quick reminder of a key accounting principle. Zelluna ASA, formerly Ultimovacs , acquired formerly Zelluna Immunotherapy in a transaction that was closed in March this year. From an accounting perspective, however, it's a subsidiary of Zelluna Immunotherapy that is regarded as the acquirer for accounting purposes.
Further, prior to March 2025, the financial information represents Zelluna Immunotherapy only, whereas from and including March this year, the financial information includes the full Zelluna Group. It's important to keep this in mind when comparing numbers. Going to the next slides with the key financials. By the end of the second quarter, we had a cash position of NOK 76 million, or roughly $7 million . The current cash is expected to give a financial runway into the second quarter of 2026, which will ensure that we capture the key IND or CTA catalyst for the TCR-NK technology. This expected runway also reflects that the cash burn rate is expected to come down significantly from the somewhat high Q2 2025 level.
Looking at the operating profit or the EBIT in the second quarter of this year, it was NOK - 38 million, and year- to- date, NOK 68 million as a negative result. Profit before tax was NOK - 38 million in the second quarter and NOK -66 million year- to- date 2025. If we move to the next slide and have a look at the P&L, again, when comparing the numbers for the second quarter 2025 and also year- to- date 2025 with the previous year, it's important to note that again from March 2025, the numbers include the full group, whereas the previous year's numbers only include the numbers of the subsidiary Zelluna Immunotherapy. This applies to all the main cost categories where we see higher numbers this year than the previous year.
In addition, the R&D costs were impacted by higher costs related to the CMC development, as well as milestone payments for the clinical trials in Zelluna ASA. Further, looking at the other operating expenses, these were impacted by significant transaction costs related to the business combination. Moving on to the next slide. The operating cash flow in the second quarter was approximately NOK 59 million negative , differing from the EBIT or operating profit of roughly NOK -38 million. This difference is due to changes in the working capital. As mentioned, the operating cash flow is forecasted to come down significantly after the second quarter of this year. That is driven mainly by the finishing of many R&D activities and also the capturing of the effect of workforce reduction in relation to the business combination. With that, I would like to give the word back to Namir. Thanks.
Thank you, Hans. To summarize, and if I can have the next slide, please. Thanks to really the incredible efforts across the team, what we have communicated today is that we are on track for a CTA/IND filing for our exciting world's first lead ZI-MA 4-1 planned for the second half of this year, aiming to generate that all-important clinical data emerging first half of next year. What we show here are the developments since the last quarter. We initiated GMP manufacturing for the clinical batch. We submitted a package to the UK regulatory authorities, really all in preparation for clinical initiation. What we're looking to do in the horizon, as mentioned, importantly, is to generate that clinical data next year.
As we have seen with the growing appetite in the field, we're operating now really in a space where there is increasing momentum in appetite for off-the-shelf cell therapies, particularly where there is early patient data. We believe we're at the cusp, really, of a significant catalyst in the short term, potentially. If I move on to the next slide, thank you for your attention and welcome any questions.
Okay, Namir, we have one question related to the clinical development. Where do you think you will run your first clinical trial? Is the U.S. or Europe most attractive?
That's a very good question, and there are a number of considerations, as you can imagine, to really determine that. What we have wanted to do is to really assess the path for both territories. We communicated the positive IND feedback previously, and now we're seeking U.K. feedback. We have sites that we have interacted and engaged with deeply across both territories. In due course, once we have really committed, we will announce the territory that we anticipate moving into. I think we're in a very good position now with sites excited, clinicians excited, and we want to ensure that we cover and really seek guidance across both territories that will feed into that final decision.
Okay, thank you, Namir. It seems that was the only question today.
Thank you very much. I'm really excited by what we have next and grateful for the attention today.