Zelluna ASA (ZLNA) Q2 2026 Earnings Call Transcript

Good morning everyone and welcome to Seluna's second quarter 2026 webcast presentation. We are delighted to give you an update on Seluna's progress and after the presentation there will be a Q&A session. You may post your question during the presentation and questions are most welcome. I will not take you through the disclaimer slide And I'm happy to hand the word over to Namir Hassam, CEO of Seluna. Please go ahead, Namir.

Good morning and welcome to our Q2 results. Thank you, Geyer, for the introduction. The agenda for today is that we will take you through our key events in Q2 2026, the TCRNK technology and pipeline, our lead and the first in human clinical trial, financial update, and a summary and outlook. If I can have the next slide, please. The second quarter and the period immediately following it have been defining for Zaluna. We set out on a number of ambitious targets and objectives, and I'm delighted that the team have been able to deliver against all of them. Most importantly, we have taken our lead into the clinic where we have dosed the first patient with Zema 4-1. We have generated the first clinical data on our platform. And I'm delighted to say, as we announced earlier in the week, that an expert committee has reviewed the safety data and has deemed that to be favorable and recommended continued enrollment onto the study as planned. This is a very exciting moment to have begun to generate data on our novel platform. In parallel, we have also activated the second clinical site, the Royal Marsden. We've strengthened our financial position, and we continue to build on our international profile, having been accepted to present at a number of international conferences including ESMO 2026 later this year. So a really defining moment for Zaluna and I'm incredibly proud of what the team have achieved. If I can have the next slide please. So as mentioned we generated the first clinical data on the platform over the period of Q2 and immediately following that period. And the initial safety observations have been favorable. The patient had received all three planned doses, that's on days one, four, and eight, and had been followed through a protocol-defined safety observation period. And what we have found for the first time, for the first experience with the platform, with our lead program, is that it was well tolerated with no dose limiting toxicities or serious adverse events. The initial safety observations, in essence, have been very encouraging. And this is the first evaluation of the platform and the committee, the safety committee, which is comprised of experts in the field, supported and recommended continued enrollment, which would mean the next two patients to be treated at the first dose level, dose level one. So this constitutes our first clinical data as we had guided previously that we are expecting initial clinical data to emerge around this time. And so this constitutes the first and very important clinical data. It's one patient nonetheless, but it's our initial safety signal and it looks to be favorable. i can have the next slide please and so if we take a look and continue to monitor the activities in the field we continue to monitor the patterns of transactions whereby we're seeing large companies really showing increasing appetite in platform technologies that are being developed around the off-the-shelf self-therapy arena. So most recently, in amongst the flurry of transactions that we have seen over the last year or two, the most recent one has been Colonia, just in the last few months, being acquired by Lilly. Colonia developing an in vivo CAR-T platform. And again, importantly, what's very important with these transactions, aside from demonstrating the appetite in off-the-shelf cell therapies, scalable cell therapies, is that the transactions are based on data generated on a few patients, relatively few patients. And the trigger for the transactions seems to be encouraging early safety and biological activity and some demonstration potentially of efficacy, which really can materially change the value of a platform. and of course we're moving now into this arena becoming a clinical stage company beginning to generate the first data on our own off-the-shelf cell therapy platform and so as we see here significant strategic investment continues across these types of next generation cell therapies and the appetite continues to be demonstrated for these types of platforms and Zaluna has entered the clinical data generation phase. We have begun to generate that data, the initial data being safety, and will continue to build on that data to allow the clinical picture to mature for the platform. I can have the next slide, please. And so as we think about the key milestones that we have gone through and the milestones ahead. In Q1, we selected a clinical CRO to partner for running the study Zima 101. We had our CTA approved by the UK authorities. And in parallel to that, we're developing our pipeline and had a collaboration announced that enables AI engineering, artificial intelligence engineering of our T cell receptor, as we had done with our lead program successfully. So adopting the same program of engineering, but for a different T cell receptor, a different target, one called KKLC1, which allows us to expand on the cancer indications that we can go after. Q2, as I mentioned, has been defining and the period immediately afterwards, where we had activated both our clinical sites, the Christie being our lead site where our first patient was treated, and the Royal Marsden. The first patient has been treated, we generated our initial clinical data on the platform, and enrollment continues as a consequence of the recommendation of our expert safety committee. And so we're expecting further clinical data to be emerging as we follow up on the patient and as we continue to enroll additional patients onto the study. In terms of our pipeline, we expect to generate a in vitro data package on our next program by towards the end of this year. And so as we're maturing and generating our clinical data, and as we have seen with the transactions and the nature of the transactions and the patterns of those transactions, we're really moving into a really exciting, potentially exciting phase with the program and with the company.

If I can have the next slide, please.

And so as we normally do, let's take a moment to reflect on the nature of the platform and the moment that we're in at this stage, having gone through Q2. We believe we're building on four pillars. The first is that we think we have a game-changing platform. It's a novel cell therapy platform, highly differentiated. Now, despite that differentiation, each component we believe is validated, and therefore we think the path has been de-risked. We have moved into the clinic, which of course de-risks the regulatory pathway up until that point, and we're now at an exciting phase. We have a concept patent that protects, we think, the entire therapeutic fields, which could hold huge value if we begin to demonstrate favorable clinical data, the first of which has been safety, and as we continue to build that clinical picture to understand anti-tumor activity. So there could be huge value unlocked as a consequence of the concept patent. Of course, under that, or building from that concept patent, we have layers of protection, including individual products, as well as the manufacturing process. It's an exciting time as we've been building over the last years to get to this point, where we're expecting some potential near-term clinical value inflection points, as we just described with the clinical sites activated and the first clinical data emerging. and so all of this in the context of a field where early clinical data is particularly meaningful we have seen that with transactions we have seen that with the data that constitutes approvals so early clinical data can potentially be meaningful if we're able to demonstrate that the biology the pre-clinical biology that we have demonstrated and published is able to be translated into the clinic.

If I can have the next slide, please.

And so we think it's always important to come back to what the problem is. What is the problem that we're aiming to address? Now we know solid tumors constitute the largest tumor burden, over 90% of total cancer burden is a result of solid tumors, a collection of different types of tumors, lung cancer, prostate cancer, pancreatic cancer, ovarian cancer, and so on and so forth. And one of the major challenges with solid tumors is that they're made up of different cancer cells. They are not all the same, and that's shown in this diagram here. And so what we have seen over the last decades where there has clearly been some progress is that while some patients may initially respond, the cancer more often than not returns. And that's because many, if not most, treatments target a single antigen, a single type of cancer characteristic that's presented within that tumor, which leaves the rest of the cancers to flourish. And so new therapies, we believe, need to be both targeted, they need to make it to the tumors, find their way to the tumors, so that you don't get the overall toxicity in a patient. But whilst being targeted, we also believe they need to be broad in the recognition of cancer. So they need to be able to recognize the different flavors of cancer. And that's what we have been building at Zaluna on the next slide. What you can see here is that we have been building on this idea, this targeted and broad therapeutic paradigm or model, where we have brought together two what we think are validated components. The first component is a GPS, a homing device, if you like. It's the T cell receptor. This is a scaffold that naturally exists. We engineer it to recognize cancers even better, but it's a scaffold that the immune system uses to recognize disease cells, including cancers, and it does that effectively. In fact, we have a validated, it's a validated approach we have approved therapies targeting solid cancers that use the t-cell receptor as a targeting agent to cell run kim track being those two so we have a validated gps the t-cell receptor aimed at targeting solid tumors and we bring that together with natural killer cells these are naturally occurring cells they're the most efficient killers in our body and it's also a validated cell type where we have seen in clinical development really favorable responses both in terms of safety profile and in terms of high degree of killing with natural killer cells. The challenge with natural killer cells is that they don't always find their way to solid tumors and that's why we bring it together with the T cell receptor the homing device. So together we think we're able to bring the targeting into solid tumors with the T cell receptor, and also the breadth of activity against the tumor with natural killer cells that are able to recognize different flavors of cancers. So it's targeted and broad. And that's what we think is really essential to be able to deal with and treat diverse solid tumors. So if I can have the next slide. It's also a scalable and off-the-shelf approach. So just to touch on manufacturing as we have communicated previously. What we have been able to do thanks to the CMC team is to be able to generate a process and develop a process where we can generate hundreds of vials from a single batch, freeze those down as we have done with our first batch and allow them to be used immediately at the point of need. And this is the paradigm that we're following and what that means is that we're really able to reduce the cost per dose and so what we're expecting as we have done with the first patient is to treat the patient with multiple doses and then potentially patients can be re-dosed again if necessary to drive even further responses or to increase durability of responses and that's all made feasible on account of a scalable platform that we have developed together with our partners. And so this is another advantage of the approach. It's a scalable off-the-shelf approach, reducing cost of goods, and also therefore making it more feasible when thinking about reimbursement down the line. If I can have the next slide, please. And so a snapshot of our pipeline, we're now a clinical stage company so the lead program moves into the clinic and we're generating our first data as mentioned we have behind that our KKLC1 program which is going through engineering and a path to understanding the outcome of the engineering process as driven by artificial intelligence and then behind that we have another target frame which we have a TCR against and the idea the strategy behind the pipeline really is to have a blend of targets that are either clinically validated, MAJ4 is a clinical validated target, I'll come on to that in a moment, or pre-clinically validated targets that are really attractive when it comes to the nature of cancers that we can potentially address. And you can see the array of cancers that we can address in the indications column, and they're all cancers with really high unmet medical need. And so the regulatory pathway that we have established with the LEAD program, we believe, is one that we can apply across all programs. The strategy we've applied there when it comes to preclinical and manufacturing strategy is one that we can adopt to the entire platform. and so we think overall that would de-risk continues to de-risk the concept and the development path really for all pipeline programs if I can have the next slide please okay so just focusing on our lead and the first in human study of course this is a very exciting program for the company so if I can have the next slide please to remind ourselves of the validity of the target. MAGE A4 is the target for our lead. It's expressed across multiple solid cancers, really representing a high unmet medical need with over 50,000 potentially treatable patients, according to our analysis, and also according to others that are targeting MAGE with other formats. And on that note, what we have seen with other clinical programs that are targeting MAGE A4, all of which have been T-cell programs, is that we have seen clinical responses demonstrated. And those have been demonstrated across multiple solid tumors. And so what that tells us is that by targeting MAGE A4, you certainly stand the chance to shrink tumors across multiple solid cancers. So in essence, it validates the target in its ability ability to be able to then shrink tumors across a range of cancer types. What we have also seen on account of some of that data is one approved MAJ4 therapy. It's a T-cell-based therapy that's targeting synovial sarcoma, which is one of the indications in our study, though it's limited by scalability and durability, and that's on account of using autologous T-cells. We're the only company that has a MAJ4 targeting TCRNK product with the advantages that we believe a natural killer cell brings over a T-cell in the ability to attack diverse tumors, but also in the nature of being off the shelf and scalable. And so we're building on the data that we have seen in clinical development with an off-the-shelf MAJ4 cell therapy. So if I can have the next slide. So we believe it's a very strong starting target to demonstrate the ability of the platform. And so what we do with the product is we're combining TCR recognition with natural NK cell biology. And I've talked through the merits of the platform, which is reproduced here. But just to say on this slide that the T cell receptor itself has also been artificially intelligently engineered, and that was a successful engineering process in order to enable high affinity, in essence, to be able to detect cancers more potently in a better way and stronger. And that's what the outcome of the engineering of the TCR had enabled and we're using the same engineering process with our pipeline program and that's an important point because it also is another differentiating element of our platform in engineering the T cell receptor. So if I can have the next slide please this is to give a snapshot of our two activated leading investigators and UK leading sites the Christie and the Roald Marsden. For our study the Christie is the lead site and Professor Thistle Thwaites is the lead investigator. Both sites are really world-renowned, recognized for early phase trials, recognized for their cell therapy experience and really a strong and long track record in this space and so both sites are activated and are now recruiting our first patient was recruited at the lead site at the Christie and now as we have cleared the first safety assessment both sites will be looking to recruit for the next two slots on that first dose level.

If I can have the next slide, please.

And so maybe to remind ourselves of the expected mechanism in patients and then to go on to look at what we think success would look like from the initial phase of the clinical study. So the expected mechanism really is as defined by the platform and the hypothesis and the date scientific data that really supports the platform and that is that by adding the t-cell receptor an engineered t-cell receptor that recognizes major A4 on to natural killer cells that when we infuse the product into patients and they get the three injections on day one, four, and eight. We expect that the cells to then move and traffic towards the tumors within that patient. We're treating late-stage cancer patients, and so they will have multiple tumor sites. And so we expect the cells to traffic to those tumors. the T cell receptor targeting MAGE A4, which is a pattern on cancers across different indications, in this case demonstrating the cancer cells in red, presenting that pattern. And once in the tumor, then the natural killer cells are also able to recognize the different patterns on any of the other tumor types. And so the idea is we're targeting into the tumor via the T cell receptor. And then we're allowing natural killer cells, natural killing ability to then really kill the cancers in the surrounding area and really diminish the tumor. And so that's the hypothesis. And so in trying to understand if that hypothesis is reading out into patients, then I would say in the next slide, this is what we would be looking at to really understand the performance of the therapy. In the first instance, we'll be wanting to understand safety. Of course, safety is a key parameter. It's our main objective for the phase one study, and it's becoming, increasingly becoming a key differentiator in next generation cell therapies. With the initial autologous CAR-T therapies, this is where a single batch is generated for a single patient, and also with the emerging in vivo CAR-T approaches, what we have seen is association of severe toxicities, including cytokine release syndrome and neurotoxicity. Now, sometimes that has required extensive hospitalization and intensive monitoring. And so, of course, one can imagine this limits and has limited broader patient access to some of these therapies. And so safety is a really important feature. So it's really vital for us, and indeed it's our primary objective, to demonstrate that the platform can be delivered to patients in a safe way with reduced incidence of severe toxicities that would also allow repeat dosing and outpatient treatment, meaning patients can come in, get treated, and go home. And this would support broader access and improved patient experience. And so safety could certainly be an important differentiator, we believe, for the TCRNK platform. And now it's supported by encouraging initial observations. It's observations from a single patient so that's important to remember but nonetheless it's encouraging to see the favorable safety profile emerging for the lead and by extension for the platform. And so that's an important element to understand. Next slide shows some other elements that are also important to understand but before actually I come on to that, just to take us through the patient journey, just to spend a moment now that we have gone through that journey with a patient to give you a sense of what the patient really goes through in their journey. So from treatment to clinical data generation. Initially, the patient is prepared with what's called a lymphodepletion regimen for a few days. And then the patient then receives the treatment with Zima 4.1 doses on day one, four, and eight. We then have a safety observation period, which is a standard observation period, typically of about 28 days, and the safety committee made up of independent experts in the field that know cell therapy, understand cell therapy, understand the translational and clinical aspects of cell therapy. review the totality of the data and then make a judgment on whether to continue or not. And we're delighted to have announced earlier this week that the committee had recommended to continue enrollment. So we have a favorable initial safety observation from this patient, well-tolerated, no dose-limiting toxicities, and of course the first clinical data generated from the platform. Now, alongside that, this is very important. What we do is we have a number of and a suite of analyses that continues. And that's looking at tumor response by imaging and clinical assessments. It's also looking at tumor biology. So this is analyzing biopsies and looking to see what's happening in biopsies. If you remember, what we're expecting is that the NK cells traffic into tumors, so we're really keen to see the makeup of biopsies, if we can detect our natural killer cells in there and any other cell type. Cell kinetics, so the changes in the circulating cells over time, the changes in the trafficking of natural killer cells, for example, in the bloodstream over time, and also immune biology, any immunological changes in the blood, all of this builds a picture of what is happening with each individual patient. And so each treated patient really builds evidence across safety, biology, and clinical activity. And so now that we have treated the first patient, of course, we're activating these studies in order to build that clinical picture. So on the next slide, what we have here is how we would see it and how we would see success from the initial phase of the study. Now, the context of this is that we're treating really heavily pretreated patients. These patients would have had multiple lines of therapy and would have progressed as a consequence of those, and more often than not, will have no other options available to them. So they will have had advanced late-stage disease and would be a difficult-to-treat population in general. But the early indicators of success. Initially, as I mentioned, safety is very important to demonstrate. So we have now our initial favorable safety observations from the first patient, which is very encouraging. Next, of course, will be to understand proof of mechanism in patients. So that That is, to understand whether the TCRNKs are reaching and engaging tumors, and that will be through the analysis that I described in my last slide, and also to really understand any immunological responses in general in the patient's pre- and post-treatment. And then, of course, what we're aiming for are efficacy signals, so that signals demonstrating that the TCRNKs can shrink tumors and those will be ultimately determined through imaging and our expectation is that we would need to go up the doses in order to really identify the optimal dose to be able to unlock the strongest clinical responses. At the moment we have begun with the lowest dose level, it's a dose escalation, and so our expectation is that we may need to go to a higher dose level in order to really unlock the strongest clinical responses. But that clinical picture continues to build. I can have the next slide, please. So I'd like to hand over to Guy Christian, our CFO, to provide the financial update. Thanks, Guy.

Thanks, Lamia. and in addition to the substantial operation progress that the company has made over the quarter I'm happy to say that also on the financial side we have made significant progress and happy to give you a finance update first the key financials the cash position at the end of the quarter was knock 86 million and we our cash one way we expected that to take us into the third quarter of 2027 the operating profit that is the loss in the first in the second quarter was knock 20 million and year to date for the first half it was 40 million knock these figures and also you can also find them similar in the profit before tax, 20 and 40 million for the second quarter and the first half respectively. It's also great to see the strong support we received from existing shareholders and also complemented by new shareholders in the private placement and the retail offering we successfully completed in June. We've raised gross proceeds of 58 million through the essence of 3.1 million shares at the price of NOC 18.50 per share. We're also very pleased to see support from the Research Council of Norway. We were granted NOC 16 million under the IPN scheme following our application this spring. This scheme supports research-driven innovation projects in Norwegian industry and it will support our ongoing phase one clinical study over to the accounts here you can see the quarterly accounts for the second quarter compared to the second quarter last year and also the year-to-date figures compared to last year's figures i will not go through the details but i will focus on the key points there which is that the payroll expenses that is excluding share-based compensation and adjustment for government grants will lower in the second quarter this year compared to the second quarter last year, and it also goes for the first half. This is due to a lower number of people in the company, as you also can see at the bottom of the table. The key costs are, of course, related to our R&D program, and the main contributor to the costs in this year is the preparation for the startup of the clinical trial, whilst in 2025 it was mostly related to the CMC activities. Other operating expenses, you can see also there's a substantial decrease in these costs, and this reflects business combination costs that were incurred in 2025. On this slide, you will see key financials on a quarter-by-quarter basis, this is for information purposes and i don't plan to go through this slide on this slide you can see the cash flow we have incurred on a quarterly basis these are negative figures and you can see that from the second quarter last year we have been able to reduce the cash outflow that is related to a lover organization and also focusing entirely on the tcrnk program ending up to then 20 million knock in negative cash outflow uh in the negative operating cash flow in the second quarter this year with those words i'm happy to hand the word over to you again me for a summer and outlook section.

Thanks a lot, Guy. So if I can have the next slide just to summarize. So as we have been through, we have what we believe is a platform that has components with validated biology. Cell therapy itself is a clinically validated modality with nine approvals. The platform that we have combines two what we believe are validated components, the T-cell receptor, which recognizes and targets solid tumors. We've seen therapies approved in solid tumors that use T-cell receptors, including one for the target that is relevant to our lead, MAJ4. And NK cells have demonstrated strong safety and potency in clinical studies, and we're now building our own clinical data, the first of which demonstrates safety for that first patient on our TCR NK platform. We've also, in the field, seen major deals driven by early clinical data, often with small patient data sets, and that has continued with some further deals over the last months. And there's really a signal there with increasing industry focus on scalable, off-the-shelf approaches. And this is exactly what we have been building over the last years. And we're at an exciting time with Zaluna. We're now first in human clinical development with the first clinical data emerging, which has been initially safety, which has been favorable for the first patient. and further clinical data expected to emerge through continued patient follow-up and enrollment for the study. So in essence, we have a platform built on clinically validated biology with exciting clinical data now beginning to emerge. So I'd like to then move on to the next slide and bring the presentation to a close and invite any questions from the audience.

Yes, we have received a few questions, and some of them are related to the clinical trial and the data that investors are looking for going forward. So this question, Namir, is related to when should investors expect to see the first efficacy data and also including the number of patients they can expect to see and the data we intend to disclose.

Thanks, Gaia. Great question. Of course, a very important one, important for the market and important for us. we're paying very close attention to the clinical picture that's emerging. Maybe I should start by saying that this is a, remember, this is a dose escalation study. So we've started with our lowest dose and then we'll move on to higher doses once we treat a cohort of three patients. And so the clinical picture is expected to build with each patient. patient. Our current plan in terms of a presentation of updated data is to be able to present those at international conferences. We have been accepted to present at a few international conferences later this year. We mentioned ESMO 2026 being one of those, and that forms a really appropriate forum to present data on the clinical side, both safety and potentially efficacy up until that point. And so I wouldn't be expected, I think, to really speculate on a specific time point for efficacy data to emerge, but we're certainly planning to present the latest data at the conferences later this year. Now, in the interim, of course, as we've done with the committee recommendation, the safety committee recommendation to enroll additional patients and announce that to the market. In the interim, if there are clinical data that emerge that warrant disclosure, of course, that's something that we will assess internally and act on. But the clinical picture will continue to emerge. We have a number of assessments that are planned for the first patient and of course for all patients that will be enrolled onto the study. In terms of the pacing of patient recruitment, now that we have unlocked the cohort, we're aiming to treat the next two patients. Next, with the two UK sites active, we expect to be able to do that over the coming weeks and months. And the next safety review by the safety committee will be when both of those additional patients, in other words, when three patients have been treated on that dose level, completing that dose level. And that's when the next safety review will take place in order to then allow enrollment onto the second dose level. So over the coming months, we should expect the first dose level certainly to be recruited against.

Thank you, Namir. There is also another question related to the phase one study. When do you estimate the entire phase one study to be completed?

Yeah, so at the moment, the phase one really is split into two large categories. The first is to understand what the optimal dose might be, and that's the dose escalation part. And then the next part is the dose expansion part. I think what's important is really to get through the dose escalation phase and really identify the optimal dose to treat with our lead program. And so we're expecting to get through that dose escalation phase certainly within the first half of next year to be able to then zone and hone in on an optimal dose. And that's our current plan.

Thanks, Namir. We also have a question related to the longer term strategy. the question can we can you elaborate on the longer term strategy for the SEMA 101 or the lead product should the upcoming data be favorable including potential next steps for the program it's a very good question and I think the focus for us right now is really to diligently generate clinical data and what we have seen is that if the clinical data demonstrates the science translating into the clinic.

We have seen strategically that unlocks a number of options, and those options could be varied, and we're open to the opportunities. The options, as we have seen, could be as wide as a real M&A. It could be partnerships. The options really become unlocked when you focus and deliver on clinical data. And I'm really proud to say that the team have been able to deliver so far on all of our ambitious objectives. And that's our focus.

Once that is, and as that is achieved, we will potentially see further strategic options opening up and opportunities opening up that can take a number of different flavors. us thanks um i think this is then we have a last question here could you provide any guidance uh unexpected operating expenses for the full year 2026 i'm happy to answer that if you would you like yeah thanks yes um as you all have seen that we have guided that the cash position is expected to take us into the third quarter of next year and over and above that we don't give any guidance I'm sorry to say that. Unless there is any further questions, I think we can close this second quarter webcast presentation. Many thanks to all of you for joining.

Brilliant. Thanks, everyone.