Zelluna ASA

Zelluna ASA

1.73
EUR
-0.02
(-1.43%)
-0.41EPS
50.30MMarket Cap
Nov 05Next Earn

Q4 FY2025 · Earnings Call TranscriptFebruary 12, 2026

Namir Hassan

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? 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 58 million NOK to advance the ZMA-041 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 ZMA-041 to support patient treatment in the ZMA-101 first-in-human study.

We also published compelling preclinical data demonstrating the merits of TCR-NK in supporting the translation of ZMA-041 into the clinic. All of that culminating into a submission to the UK 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 UK 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?

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.

When we look at cell therapies, we see that it's 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.

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, whilst 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. 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 a move from complex so-called autologous cell therapies where one batch is produced per patient to scalable off-the-shelf solutions. These scalable off-the-shelf solutions have certain features such as simplicity in manufacturing, scalability, and lower cost of goods.

These have become strategic priorities in the move towards the next generation of cell therapies. 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 1 human data. 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.

The features of the deals and the companies involved in these deals is that they land in the scalable off-the-shelf solution to cell therapies. An example is Gracell Biotech and AstraZeneca, an acquisition for round about $1 billion, for a company, Gracell 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. 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 simpler manufacturing, more accessible treatments, and scalable platforms.

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.

It's an opportune time. It's an opportune moment for Zelluna.

Can I have the next slide, please? 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.

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 land us really in what we call a potential deal zone, where early clinical data, as demonstrated here and in the previous slide, has really catalyzed high value in a number of companies over the last year.

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.

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 truly differentiated platform technology.

Whilst 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.

Their 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. The approach that we have has been captured and is protected with a concept patent that has been granted across key commercial territories.

What we use to describe this is a potential land-grab opportunity. The third is that we are on course for short-term clinical inflection points, and as we have seen, small human datasets can really catalyze enormous value.

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, in 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. We're on track for initial clinical data to emerge from mid-2026.

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. Approvals have been fast in this space with data from fewer than 100 patients.

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.

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. We know this targeting molecule itself is able to target solid tumors.

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. The benefit of natural killer cells is that they can recognize cancers in different ways, and they're also have been demonstrated over the last decades to be clinically safe.

The challenge with natural killer cells alone is that they can struggle to find their way to solid tumors. 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.

What this provides is a platform that is aimed at targeting solid tumors, can be used off the shelf, is scalable, and can be immediately used to treat patients. 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. Very much really landing 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.

I can have the next slide, please. I mentioned 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, you can see a number of products there shown as an example, would be captured by this patent.

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.

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 nine 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, our lead program and lead asset is called ZMA-041. 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.

This is something that others that are also going after this target have assessed, 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. 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.

If I can have the next slide, please. 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. 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 center 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.

We have recruited a couple of really globally known and renowned UK cell therapy sites, The Christie and the Royal Marsden, where The Christie would be the lead site with Professor Thistlethwaite as the lead investigator. We can have the next slide, please.

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, ZMA-041, which are shown in the dark blue bars, and when we compare to the benchmarks, this is the approved major TCR T-cells, and we go from left to right, when we expose these different therapeutics to cancers, 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 higher level than the benchmark, and we've shown that in different cancer cell types.

This is not a surprise, given the highly efficient killing potential of natural killer cells. 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, 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.

This is exactly what we see in patients when they're treated with this benchmark TCR-T. Whilst 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. 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.

I can have the next slide, please. Here we show our pipeline, our lead targeting MAGE-A4 and that, as is moving towards the clinic.

Behind that, we have another very exciting program where we target another validated cancer target called KK-LC-1. It's relevant across a number of different indications, as shown here: breast, gastric, lung, pancreatic, and cervix.

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 been worked on in the field, and it's called PRAME.

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. What we have been doing over the last years in really clearing the path to the clinic and de-risking various elements, including manufacturing and our preclinical pathway, is applicable across the entire platform.

The learnings and the pathway that we are treading with our lead, ZMA-041, 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? That covers our TCR-NK platform, our lead, and our momentum towards a first-in-human clinical study with ZMA-041.

Just to complete this section, a couple of updates on a couple of other areas. On the Multi-Click technology, as we had guided previously, we have been looking at the Multi-Click, and we completed a strategic review looking at intellectual property considerations, as well as commercial potential and strategic fit.

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 Multi-Click technology at this time. For the UV1 program, as you will know, it's a therapeutic vaccine being evaluated in five Phase 2 randomized controlled trials.

Four of those Phase 2 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 DOVAC and has completed enrollment, and topline results are expected during the first half of 2026.

This is all in the context of four Phase 2 trials with disappointing results. If I can have the next slide, please.

That concludes that section, and I would like to hand the word to Guy Christian, our CFO, to take us through the financials. Thanks, Geir.

Guy Christian

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, it has 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 would like to give an update the company's cash position totaled 78 million NOK by the end of the fourth quarter, and as indicated, cash runway into the beginning of 2027.

Earnings before interest and taxes in the fourth quarter was -35 million NOK, and for the full year, it was NOK -144 million. The profit before tax in the fourth quarter was -35 million NOK, and for the full year, -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, whilst in the 2025 from March onwards, the financials include the business combination 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. Similar, 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 3.2 million, and also some impairment in the fourth quarter related to an in-licensed TCR in the pipeline of Zelluna, totaling NOK 2.3 million.

In the fourth quarter, we had a net increase in the cash position of 31 million, ending up at 78 million, and for the full year, we had an increase in 51 million NOK. The total number of issued shares at the end of the quarter was 26.3 million.

On this slide, you see a comparison quarter by quarter of 2024 and 2025. This is for information purposes only.

I will then go to this cash flow slide, quarterly operating cash flow. 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 non-cash cost related to the TCR writing off, and also a share option expense of 2 million with no cash effect. Then thanks for that, and I will hand back to Namir for a summary.

Namir Hassan

Thanks a lot, Geir. Then just to summarize, can I have the next slide, please?

Again, we've had a very exciting period. We have managed to accomplish what we had aimed for.

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 UK MHRA, all as planned and as guided. Looking ahead and in 2026, we announced our selection of a clinical partner, Medpace, very excited to be working for them.

In the horizon, what we're looking for is ultimately, the clinical data. 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, 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 KK-LC-1, again, another very exciting program that we're aiming to generate in vitro data package for this year.

With that, that completes our update. Thank you for listening and for your attention, and I will then hand to Geir for any questions that we may have.

Guy Christian

Thanks, Namir. We have one question.

We have several questions, I would say. The first question is: when do you expect to get approval for the CTA?

Namir Hassan

That's a very good question, and of course, it's something that is very important. You may recall that we had submitted our CTA on the 17th of December, a credit to the team, a really important and a really substantial feat.

Typically for an advanced cell therapy like ours with the UK MHRA for approval, timelines for that are typically and commonly 60 to 90 days. We are in dialogue with the MHRA, and we expect within that that we may see an approval if all goes well.

Guy Christian

Thanks, Namir. Another question is: can you elaborate on the hospitals' experience with cell therapies and their interest in participating in the clinical trial?

Namir Hassan

Yes, 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. 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.

Dr. Andrew Furness is also an incredibly excited, very deep experience in cell therapy.

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.

Guy Christian

Thanks. A third question: can you elaborate on the deals in the field and the

Namir Hassan

As I mentioned, there've been a flurry of deals in the space. If you look at the features of the companies involved in the deals, there are common features.

The first is that these are 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. 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, and so what they have been able to do, some of them have gone into the clinic, others not, some are preclinical, and they've generated datasets on few patients to demonstrate that the science actually works in patients, even with one, two, or three patients.

That has driven the deals that we have seen, largely acquisitions from anywhere between half a billion to upwards of $2 billion. 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.

Guy Christian

Nice. There are no further questions, Namir, it's just to wrap up, I guess.

Namir Hassan

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. We're excited to continue and advance the progress, and we will keep the market updated as we go along.

Thank you very much.