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BioStock Life Science Summit 2026

Nov 4, 2026

Summary

ZI-MA4-1, a MAGE-A4-targeting TCR-NK therapy, has entered dose escalation across four solid-tumor indications. The platform combines dual cancer recognition with scalable manufacturing, while early patient data could shape registration and strategic options.

Namir Hassan
CEO, Zelluna

Good morning, everyone. Thank you, Cecilia, for the kind introduction, and thank you to BioStock for the invitation and the opportunity to change gears somewhat and talk to you about a cell therapy that we have been developing over the last few years, in fact, since early 2020. It's an off-the-shelf cell therapy, and what we're aiming to do is to unlock scalable cell therapy for the treatment of solid cancers. I'll be focused on oncology and how we can try to really address solid cancers with our off-the-shelf platform. I've subtitled the talk "From Platform to Patients." We're at a very exciting time at the company. We've started to treat patients. We've announced that recently. We are listed on the Oslo Stock Exchange under the ticker Zelluna, and we also have our Q3 update tomorrow morning. What do we do at Zelluna?

We develop a differentiated technology. It's one that brings together T-cell receptors, which is nature's scaffold to detect diseased cells. It's a clinically validated scaffold. It's a targeting mechanism, if you will, and we bring that together with natural killer cells in what we call TCR-NK. Why natural killer cells? We know natural killer cells, through decades of clinical development, are safe in patients, and they can drive potent effects. Where they fall short is to really target solid tumors, and that's where the T-cell receptor comes in. So we bring these two complementary immune mechanisms together in our differentiated TCR-NK platform. We're a clinical-stage company. I can share the excitement of some of my co-speakers in entering the clinic for a startup.

It's been a treacherous time over the last few years, and kudos to anyone that is able to move forward and enter into the clinic and begin to understand the translation of science into patients, and we are at that stage. We have a lead molecule, a lead therapy called ZI-MA4-1. It targets a well-known cancer antigen, probably the most validated antigen for T-cell receptor targets. It's called MAGE-A4, and it's expressed across a whole range of solid cancers. We're targeting, in our clinical study, four solid cancers: lung cancer, head and neck cancer, sarcoma, and ovarian cancers. Recently, there has also been external evidence from a high-profile group in the U.S. at the MD Anderson, led by Katy Rezvani, demonstrating that the TCR-NK concept can work in patients. This is a group that's also developing TCR-NK therapies. It's a different target, and it's a different disease setting.

It's in multiple myeloma. But what they have shown is a complete durable response in a multiple myeloma patient that has had multiple prior lines of therapy, including the latest cell therapies for myeloma and bispecifics. What that shows for us is that the TCR-NK engine, the core concept, can drive really deep responses in late-stage cancer patients. Finally, we have a scalable manufacturing process. This is very important when it comes to cell therapies and is one of our areas that we are addressing. It's a challenge for current cell therapies. We have a scalable manufacturing process which delivers hundreds of vials from a single manufacturing run. We also have multiple layers of IP, including IP on the concept, so the approach of bringing together T-cell receptors with natural killer cells. It's a concept patent that's been approved across major commercial territories.

Aside from that, as is fairly common, we also have IP on individual products and the manufacturing process. We are very excited about the current stage of the company, a number of years in the making. We are starting to treat patients, and as mentioned, we have our Q3 update tomorrow morning, where we will give an update on our clinical progress. The next two slides are just setting some context on the value of small data sets in this arena of cell therapy, and I will address this from two angles. The first is what we have seen across the approvals in cell therapy. There have been nine approvals in cell therapy, most of which have been in liquid cancers, so seven in liquid cancers, a couple in solid tumors.

What we have seen, one of the common themes is that small patient data sets have actually driven many of these approvals, as you can see, between 44 and 97 patients. The reason for that is because these cell therapies, when they work, they are very robust, and small data sets can actually predict outcomes for larger later data sets. A recent example, actually a week ago, Iovance, who has an approved cell therapy in solid tumors, in melanoma, they announced that in another indication, in synovial sarcoma, they treated eight patients, 50% of them, so four patients responded, and they are now moving immediately into a registration study on the back of that small patient data set. Small patient data sets are incredibly meaningful when it comes to cell therapy.

The other important point is that over the last couple of years, given the limitations we have seen in cell therapy, despite the successes, one of the main challenges has been to scale cell therapies to make them more accessible and available for late-stage cancer patients. There has been a flurry of deals, multi-billion dollar deals in some cases, to acquire platform technologies that promise scalable cell therapy solutions. Some of these are in vivo CAR-Ts, which promise scalable cell therapy solutions, or allogeneic T-cells, which again promise scalable cell therapy solutions. It is symbolic of the appetite of companies to try to identify scalable solutions for cell therapies that we know can work in the clinic. The majority of these deals are congregating around targets that are relevant for liquid cancers.

As we know at the bottom here, as shown in the illustration, liquid cancers constitute about 10% of global cancer burden, whereas the largest cancer burden lies in the aggregation of solid tumors, and that is exactly what our platform is designed to address. Small data sets can really drive high value. Just to cover in a bit more technical detail, our platform technology is made up of two components. Each individual component, we would say, is clinically validated. The first component is the T-cell receptor, and this is a targeting mechanism for solid tumors. There are two approvals to date that are driven by T-cell receptors. I had the privilege of leading the early development of one of those in my last organization, a molecule that is being used to treat uveal melanoma currently, very devastating disease.

On the other side is the NK cell, where we have seen decades of clinical development that have shown a favorable safety profile when using natural killer cells, and the ability to really scale these and generate billions of cells from manufacturing runs. The combination of the two, we believe, provides the potential and ability to really address two key areas that are limiting the treatment of solid tumors with cell therapies. The first is the scalability that I talked about, but the second, which I haven't mentioned yet, is the ability to address tumor escape. Most therapies that are currently addressing solid tumors are targeting via a single targeting mechanism. With the TCR-NK approach, you lean on two recognition mechanisms. The T-cell receptor, on one hand, recognizes particular patterns on cancer, and natural killer cells also recognize a variety of patterns on cancer.

The idea is to reduce the possibility of tumor escape. I'm rapidly running out of time, so maybe moving on to just a few words on our lead. Our lead targets MAGE-A4. A number of companies are going after MAGE-A4. They're all T-cell therapies. We have the only TCR-NK therapy that's aiming to target MAGE-A4. Just one data set perhaps, and then Cecilia, I'll hand over to you. We have, through our preclinical work, been comparing our TCR-NK to an approved TCR-T therapy that targets the same target, MAGE-A4. What these two videos that I'll play are designed to show is the ability of the TCR-NK to actually recognize a mixed population of cancers on account of the ability to detect through multiple recognition systems.

Whereas the TCR-T, on the right-hand side, or your left of this slide, is only able to recognize cancers that have the pattern for the T-cell receptor. So only one of those populations, which will be the green population. You can see that the cells are being eliminated, both populations with the TCR-NK, and only a single population. This is exactly what we see in patients. Whilst they may respond initially, they relapse on account of parts of the tumor that don't contain the antigen. We have a couple of very high-profile U.K. sites, maybe going back to the earlier talk about moving from the U.S. to the U.K. We set up in the U.K. due to the volatility of the FDA, and they are very engaged in recruiting patients.

We're excited because we're beginning to generate patient data now, and patient data can have incredibly high value, even from small patient groups in this setting. I will stop there and leave perhaps the most important slide, which is the team behind all of it. Thank you very much for the time.

Operator

Thank you. Do we have any questions from the room? I have a question here about the market strategy and what does that look like?

Namir Hassan
CEO, Zelluna

The indications that we have with MAGE-A4 are large indications, and of course, if we see responses in those, then we believe there could be a potential for really driving that forward through registration studies. We are a very small organization. We are 13 people in total. I usually say small, but with very high ambitions. I think if we are able to generate some responses even in the first few patients that we are treating, a handful of patients, we are moving through dose escalation right now, then I think that will really increase strategic options. We know pharma companies are watchfully waiting to see how the data emerges.

Operator

I saw one of the slides you had to click through there was about the pipeline.

Namir Hassan
CEO, Zelluna

Yes.

Operator

Would you just like to tell us, as a final question, a little bit about the pipeline?

Namir Hassan
CEO, Zelluna

Sure. We've really doubled down on our lead, given the importance of actually moving that into the clinic and beginning to demonstrate some clinical data. But behind that, we also have a couple of other programs. The furthest advance behind that is going through now some early preclinical testing, and we hope to have some more complete preclinical data on that in the coming months. Again, solid tumors, complementary indications to our lead.

Operator

Thank you so much.

Namir Hassan
CEO, Zelluna

Thank you very much.