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Zelluna ASA’s third-quarter 2025 earnings call provided a detailed overview of the company’s financial performance, strategic initiatives, and future outlook. Despite a 3.95% drop in stock price, Zelluna showcased strong strategic positioning and innovative advancements in its TCR-NK platform. The company reported a negative EBIT of NOK 40 million for the quarter, with a year-to-date loss of NOK 101 million. However, a successful capital raise of NOK 58 million has extended its cash runway to Q1 2027.
Key Takeaways
- Zelluna’s stock price decreased by 3.95% following the earnings call.
- The company raised NOK 58 million, extending its cash runway to Q1 2027.
- Significant advancements in Zelluna’s TCR-NK platform and pipeline expansion.
- Negative EBIT of NOK 40 million in Q3 2025.
Company Performance
Zelluna’s performance in Q3 2025 was marked by strategic growth and financial challenges. The company reported a negative EBIT of NOK 40 million, reflecting increased expenses, including higher payroll costs and share option program costs. Despite these financial hurdles, Zelluna achieved a successful capital raise, which will support its operations until Q1 2027. The company’s focus on innovative cell therapy solutions positions it well within the competitive landscape of the biotech sector.
Financial Highlights
- Cash balance: NOK 47 million
- EBIT: -NOK 40 million in Q3 2025
- Year-to-date EBIT: -NOK 101 million
- Capital raise: NOK 58 million
- Cash runway extended to Q1 2027
Market Reaction
Zelluna’s stock price fell by 3.95% following the earnings call, with a decrease of 0.42 from the last close value of 10.62. This decline positions the stock closer to its 52-week low, indicating a cautious market sentiment. The drop may be attributed to the negative EBIT and overall financial performance despite the company’s strategic advancements.
Outlook & Guidance
Looking forward, Zelluna plans to submit a Clinical Trial Application in the second half of 2025, with initial patient data expected by mid-2026. The company’s strategic focus remains on advancing its TCR-NK lead program and exploring potential business development opportunities. The guidance for FY2025 and FY2026 projects negative EPS, highlighting the ongoing investment in research and development.
Executive Commentary
CEO Namir Hassan emphasized the company’s progress, stating, "We have been building the TCR-NK platform for a number of years and have optimized the manufacturing process." He also highlighted the potential of natural killer cells, noting, "Natural killer cells, by definition, are the most potent killers known." These insights reflect Zelluna’s commitment to innovation and its strategic positioning in the biotech field.
Risks and Challenges
- Financial losses and negative EBIT could impact investor confidence.
- Increased expenses from employee growth and share option programs.
- Potential challenges in achieving clinical milestones and securing regulatory approvals.
- Market competition and technological advancements in the cell therapy sector.
Q&A
During the earnings call, analysts inquired about Zelluna’s patient cohort strategy and potential business development opportunities. The company plans to focus on safety and initial efficacy with cohorts of three patients and remains open to strategic deals based on early-stage data. Zelluna’s proactive approach to business development aims to leverage its innovative platform and strategic partnerships.
Full transcript - Zelluna ASA (ZLNA) Q3 2025:
Namir Hassan, CEO, Zelluna: Good morning, everyone, and welcome to Zelluna’s third quarter business updates and financial results. My name is Namir Hassan, the CEO of Zelluna. Can I have the next slide, please? And the next one. Today we’ll be going through the key events in the third quarter 2025. We’ll cover the Zelluna TCR-NK technology and pipeline, provide the financial update, and summarize at the end. Can I have the next slide, please? Firstly, I’m delighted to share that we have successfully raised NOK 58 million, as was announced last night. This is an incredible achievement. We have strong support from existing shareholders, management, and board members. I think the raise demonstrates the confidence underpinning the science of the platform and the caliber of the team and the progress and the execution we have made to date. It is truly a pivotal moment.
At a time which is a difficult time in biotech, to be able to raise in this time is pivotal, not only for the raise itself, but for what it means for the company. I’d like to take a moment to explain what it means. We have been building the TCR-NK platform for a number of years and have optimized the manufacturing process and our science that goes into the platform, leading up to a lead that is on the cusp of the clinic. With this raise, we’re able to now advance the lead into the clinic and really understand the potential of the platform in patients with late-stage cancer. This becomes very meaningful because it allows us to validate the platform in patients and really interrogate the potential.
The backdrop for this is that we know these types of therapies, so-called cell therapies, are able to really deliver efficacy in small patient numbers. What we also know is that there have been a number of transactions in the space on the back of data from very few patients. The symbol of this raise, the potential of this raise, what this raise enables is getting to that next phase and to understand the platform in patients. Truly a pivotal moment for the organization. The proceeds will be used to advance the lead into a phase 1 clinical trial and to really generate that all-important patient data. We expect data to emerge in mid-2026. We’ll also be using the proceeds to develop the pipeline. I’ll talk through some of that in the later slides and for general corporate purposes. We expect the cash to allow us to reach Q1 2027.
I’d like to just take a moment to acknowledge really all of the Zellunian team that have been part of this, past and present, to get us to this moment. Also acknowledge Anders Tove and the rest of the board for their continued commitment, and the investors who have really shown confidence and commitment to our vision and our science and have enabled us to get to this point. We’re on track to have a CTA submission second half of this year. As explained, with first patient data expected in mid-2026. With respect to the pipeline, in the last quarter, we have enriched the pipeline with the acquisition of a portfolio of characterized TCRs targeting KKLC1, which is a program that is in our pipeline. It’s a program which we’re excited about.
KKLC1 is expressed on a number of cancers, and I’ll come on to explain why we’re excited by that program. Can I have the next slide, please? If we take a moment to reflect on the progress made since our business combination announced in March. Since then, we have successfully integrated and become a publicly listed company following the merger of Ultimovacs ASA and Zelluna ASA. We’ve expanded the pipeline, as I briefly mentioned, with the acquisition of promising KKLC1 TCRs. We’ve locked down our manufacturing process for our lead assets, which also is applicable to the entire platform. This is a platform-applicable manufacturing process. We announced that locking down of that process back in April. We’ve completed the preclinical package on the lead program, and that allows us to advance closer towards a clinical trial application and submitted a manuscript summarizing that data, which has been submitted for publication.
We’ve initiated the production of a clinical batch of the lead program with analytics ongoing. If completed, that will then allow us to have a clinical batch of material to test in patients. We also explained at the last quarter update that we have engaged really top U.K. investigators with deep expertise in the space and have assigned Professor Thistlewaite as Chief Investigator for a potential study with Dr. Andrew Furness, who has been really deeply involved also in co-creating the clinical strategy together with us. We recently announced that we had positive MHRA feedback, which really de-risked the path to a clinical trial application and clinical entry into the U.K. That covered preclinical, manufacturing, the clinical strategy, and patient screening. We have really cleared the pathway towards a clinical trial application, which we’re working towards.
As of last night, we announced the all-important raise of NOK 58 million to enable us, to allow us, to give us the resources to move ahead and to really test the hypothesis in those first patients, which will be very important for the company, important for patients, we hope, and potentially a value inflection also for shareholders. We’re on track for a CTA submission by year-end with initial data expected in mid-2026 and the means now to get there. Can I have the next slide, please? Some reflections on the field that we’re operating in. It’s a cell therapy space. As we have explained in the last quarter, this is a space where we have seen several approvals on the basis of relatively few patients. It’s a space where we have seen strong efficacy in early patient data that’s been translated to an expansion and increased number of patients.
What that tells us is the value of data from relatively few patients is very high when it comes to patient impact and also when it comes to potential inflection. Can I have the next slide, please? A further demonstration to that is that in the last year alone, we have really seen five major deals in this space. I show here four of those. There are patterns across those deals which are consistent. The first of those is that these are deals with companies that are developing platforms that have tried to simplify cell therapies, so-called off-the-shelf cell therapies, either off-the-shelf CAR-T or what are called in vivo CAR-Ts. The common thread with these platforms is that they’re aimed to try to take the power of cell therapies but simplify the application of those cell therapies, reduce the cost of goods, allow them to be more accessible and scalable.
Of course, that’s exactly the space that we are in. What we have seen in the deals themselves is that they have really been based on relatively few patients. You can see the deals demonstrated here with some of the key metrics of those deals, with recently Kite and Interius, Interius being acquired by Kite Gilead, and that has been on the back of very few patients. Similarly with Capstan and AbbVie, again, similarly with EtherBiotech and Poseidon. So relatively few patients. Data on those few patients has really triggered high-value deals. If we can move on to the next slide, please. If we were to consider that backdrop and the relevance for where we are today, again, this highlights the importance of the raise that we successfully closed last night.
What that does is that now enables us to get to that early patient data in 2026, which potentially, potentially based on what we have seen in the space, could be a real inflection for the company if we’re able to really impact patients the way we would like to and really demonstrate efficacy and benefit to patients in those first patients treated with data coming out in 2026. A really exciting phase for the company, one that we have been building over the last five years and very excited to get to the clinic. I have the next slide, please. In the next set of slides, it’s a reflection on where we are, where the company is, and a reflection on some of the data that gives us the motivation, and also a presentation of the pipeline. I can have the next slide, please. Right.
What we consider to be pillars for the organization are shown in this slide. We believe we have a game-changing platform, a novel cell therapy with a de-risked concept and path that’s aimed to treat solid cancer patients at scale. Secondly, we have what we believe is a unique and unprecedented patent position where we have a concept patent protecting the entire therapeutic field, which can potentially hold huge value if we demonstrate clinically that we’re able to benefit patients. We also have IP on products and manufacturing. We are at perhaps one of the most exciting moments where we have a lead program that’s looking very exciting. We have de-risked the path to the clinic, most recently with the MHRA feedback. We expect to have a CTA submission the second half of this year and clinical data in 2026, and now the resources and means to get there.
As I explained, this is all in the backdrop of small clinical data sets driving high value. I talk through the approvals that we’ve seen in the space and also the flurry of high-value deals just in the last year alone. We feel it’s the right moment. It’s an exciting moment, and we’re really motivated to press ahead. I have the next slide, please. Just a brief reminder of what we have been building. It’s a TCR-NK platform. It’s made from two components. One of those components is what’s called a T cell receptor, which, if you like, provides a guidance system. It’s a validated targeting mechanism. We have seen a couple of therapies that have been approved based on that targeting mechanism. We’re excited by it because it’s been clinically validated to target solid tumors. We have attached to that the natural killer cell.
Natural killer cells, by definition, are the most potent killers known. They exist in the human body. They can recognize cancers in various ways. They can be safely used in an off-the-shelf format. By bringing these two together, we’re able to target natural killer cells that are inherently very potent into solid cancers by virtue of the T cell receptor, which guides them to solid cancers. We have a strong underpinning of science that has been built over the last years, thanks to the efforts by the team. We’ve demonstrated that this format is able to do what we expect it to, which is target solid tumors and really deliver potent and safe effects. If I can have the next slide, please. I mentioned our unprecedented IP position, which includes a concept patent.
Just to try to visualize that, on the left-hand side, what we have is an illustration of the TCR-NK concept. With a concept patent which protects the approach, one can then imagine that numerous products that emerge from the platform will also be covered with the concept patent. To try to further visualize this, one can perhaps think about an analogy with CAR-T cell products. These are. Approved products based on T cells that are guided by what are called CARs, shown on the right-hand side. We have a number of approved therapies in that space. Of course, a concept patent for CAR-T does not exist. If it were, one can then imagine the aggregate value of the products generated in that space. That maybe forms an interesting analogy.
The aggregate value potential of having a concept patent for TCR-NK could be huge and potentially unlocked once we take the platform into the clinic and understand the performance in patients. If I can have the next slide, please. Our lead program is one that targets an antigen called MAGE-A4, a target called MAGE-A4. This is perhaps the most well-validated target for the guidance system for the T cell receptor. Just some metrics and some information around the target MAGE-A4. What we can see on the left-hand side is that we believe, and others too who work on programs targeting MAGE-A4, that we could perhaps treat over 50,000 patients who may be eligible for a treatment with our lead program. What we have seen across the clinical development space over the years is that patients do respond to MAGE-A4 targeted therapies, and that gives us confidence in the target.
We have seen multiple responses that have shown shrinkages of tumors across different solid tumor indications. What we have also seen is that there is one market approval for a T cell-based therapy that targets MAGE-A4. Again, that gives us confidence in the target. We have benchmarked our preclinical data through the development of our lead against that approved T cell therapy. We believe we outperform that T cell therapy on a number of metrics. If I can have the next slide, please. Our lead program demonstrates that the science underpinning the program is very strong. We have data to show that we outperform a clinical benchmark. We kill diverse tumors, which is key, and I will come back to that for being able to potentially drive long-term responses. We have also cleared the regulatory path most recently with the feedback from the MHRA.
We have really developed a clinical strategy together with the investigators I mentioned earlier that targets lung, head and neck, ovarian cancer, and synovial sarcoma. We are really collaborating with world-leading clinical sites to initiate phase I in the U.K. I can have the next slide, please. We also announced back in April the locking down of a manufacturing process. Just to pause for a moment because this is an important feature of our off-the-shelf TCR-NK platform. That is that we are able to generate from a single batch hundreds of doses upfront through our proprietary manufacturing process. The idea would be to have those accessible, frozen, and used at the point of need. This is the strategy that we’re employing for our first in-human study. As I mentioned, we’ve initiated a clinical batch of material with the production complete and analytics ongoing.
If that is then fully successful, that will become the batch of material we use for our clinical study. This is an important feature of these types of therapies. We’ve seen a shift in the cell therapy space. That shift is really driven by an increased appetite for scalable cell therapies, ones where a production can allow many doses to be made and ones where doses can be frozen and easily accessible. These are the features that are offered with the TCR-NK platform. I can have the next slide, please. Just to touch on some data, one of the limitations currently of treating solid cancers with cell therapies is that solid cancers in every patient will be diverse. Targeting a single target against solid cancers becomes problematic because whilst one may see initial responses, cancers can escape because they may lose the target for that therapy.
This is where we believe the TCR-NK platform comes in, where natural killer cells naturally are able to recognize different features of the cancer. By targeting with a T cell receptor into the cancer, natural killer cells can then recognize the different features of cancer rather than only a single feature. We believe that helps to prevent cancer escape. We have some science that underpins that hypothesis and supports that hypothesis. When we’ve been looking at and interrogating the ability of the TCR-NK cells, in this case, the blue bars, to kill cancers experimentally compared to the benchmarked TCR-T cells, which, again, in this case, will be targeting the same target, MAGE-A4, we benchmark against this, which is a representation of the approved T cell therapy, and that’s shown in pink.
What we see on the left-hand side of the dotted line there is that against different cancer cell types, lung cancer cells or skin cancer cells, the TCR-NK, the dark blue bars, outperform the killing capacity of the TCR-T cells. We have higher levels of killing of those cancer cells compared to the pink bars, the benchmarked TCR-T. Importantly, also, on the right-hand side of the dotted line is that when we mimic the situation in patients where cancers within that patient, tumors within that patient, some of which may not be containing the target for the therapy, so MAGE-A4, what we see in that situation, in that context, is that the TCR-NK cells retain their killing capacity. You can see the dark blue bar there killing this variant of cancer cells where the target is not present.
At the same time, we do not see any killing with the TCR T cells, which is what we would expect, no killing, because the target MAGE-A4 is not present on those cancer cells. One can then imagine that situation in patients where the patient’s tumor will then outgrow, and the TCR T cell therapy will not be able to act against those tumors, whereas the TCR-NK retains its ability to do that. This is the central hypothesis, the ability of TCR-NK cells to really act on diverse tumors and hopefully deliver tumor shrinkages that can last and help to avoid tumor escape because of their ability to recognize different features on cancers, not just a single feature. If I can have the next slide, please. Here is a representation of our pipeline. We have the MAGE-A4 lead program expected to move into clinical in 2026.
Behind that, we have KKLC1, an exciting target expressed across multiple cancers. I will come on to mention that in a moment. Behind that, we have PRAME, another well-validated target, clinically validated target, which is also an exciting program in the pipeline. I can have the next slide, please. I want to spend a moment on KKLC1. KKLC1 is a preclinically validated target. It is, again, a very exciting target. It is what is called a cancer-testis antigen, meaning that it is expressed across multiple cancers. On the right-hand side, we can see a table of a preliminary assessment of potential eligible patients across different cancers: stomach cancer, breast cancer, cervical, and so on. The expression of this target is complementary to MAGE-A4, and we believe allows us to increase the breadth of reach into cancer patients with a program targeting KKLC1.
Recently, we were fortunate to acquire over 20 T cell receptors from really deeply expert biotech in the TCR space. They come with characterization, and that helps to enrich our pipeline of TCRs against KKLC1 and expands our opportunity to identify a suitable candidate for advancement into TCR-NK and ultimately advancement into some preclinical work. This really forms a de-risking of the program. As a consequence, the preclinical package has now, in terms of the timing of that, moved to Q3 2026 from Q1 in order to allow the real comprehensive assessment of these recently acquired T cell receptors and to allow us to really identify the most optimal to move into a TCR-NK format and form the desired candidate for preclinical testing. Very exciting program and very pleased with this acquisition. I can have the next slide, please.
Just a moment to mention that we continue to look at the multi-click technology to explore the potential merits and value. We continue to wrap up the UV1 program, as explained here. With that said, our focus is on really developing and advancing the TCR-NK lead program and developing the TCR-NK platform. If I can have the next slide, please. Hans, I’ll pass on to you. Yes, thanks, Namir. Good morning. We will now give a financial update. Moving on to the next slide, it’s a pleasure then to inform, as Namir also introduced in the beginning of the presentation, that we last night completed a successful capital raise raising NOK 58 million. We saw very strong support from existing shareholders who jointly provided pre-commitments of more than NOK 50 million.
The total gross profit is NOK 58 million from NOK 55 million from the prior placement, and then an additional NOK 3 million in a retail offering through primary bid. The subscription price was NOK 10 per share, and a so-called repair issue will be considered by the board. With the proceeds from the share issue, the company is expected to be funded into Q1 2027. Moving on to the next slide, looking more specifically at the Q3 key financials. At the end of the third quarter, we had a cash balance of NOK 47 million. This cash is expected to give a financial runway into the second quarter of 2026. Now, with the proceeds from the share issue, as I just said, the company is expected then to be funded into Q1 2027.
Looking at the operating profit, the EBIT, Q3, we had an EBIT of minus NOK 40 million, and year to date, minus NOK 101 million. The profit before tax is more or less at the same level as the operating profit. Also worth mentioning is that in July this year, we introduced a new share option program for all employees and two board members. This new option program replaced the two old programs and the old EURIMAX program. As of today, the options issued or granted, they represent roughly 8% of the total number of outstanding shares. Moving on to the next slide, looking at the P&L. We saw that payroll and payroll-related expenses were higher in 2025 compared to the previous year, mainly due to more employees as well as some restructuring costs as a result of the business combination between our previously ULTIMAX and Zelluna Immunotherapy.
In addition, we had costs in the third quarter related to the share option program amounting to NOK 5.6 million. This is also higher than in the last year. This is a NOK 5.6 million non-cash cost item. Looking at the costs, these were somewhat higher in Q3 and also year to date. This is mainly due to higher costs related to purchase of materials for manufacturing purposes. The other operating expenses were approximately at the same level in the third quarter this year and also year to date as the previous year. In the third quarter, we also had an impairment of goodwill. Following the business combination that was completed in March, we have been following up on the purchase price allocation, and we saw during the third quarter that. A recognition of goodwill. Then, based on an impairment test, also considering the share price development of the company.
The goodwill was fully written off through the income statement during the third quarter. That amounts to NOK 3.2 million, which is also a non-cash cost. The next slide shows a more detailed breakdown on a quarterly basis of the P&L. That is more for information purposes. I would like to move to the next slide showing the operating cash flow. The operating profit was, as I mentioned, around minus NOK 40 million. The operating cash flow was significantly lower, around minus NOK 29 million. The reason for the difference between the operating profit and the cash flow is then mainly the impairment of the goodwill of roughly NOK 3 million and also the share option expenses close to NOK 6 million, which have no cash effect. We see that, in line with previous guiding, the operating cash flow has come significantly down now in Q3.
With that, I would like to give the word back to Namir for a summary. Thank you very much, Hans. I can have the next slide, please. Here we summarize the key milestones and value inflection that we are expecting to come up and that we have gone through in the last quarter. I am incredibly proud of what the team have been able to achieve to operate with efficiency and to enable us to make the progress that we have made in the last months. We have discussed and communicated the positive MHRA feedback, which has been critical to clear the path to the clinic. We have communicated the initiation of production of a GMP potential clinical batch of material that is going through final analytics, and we are on course for a CTA submission this half.
We are really on the cusp of potentially moving into the clinic and generating that all-important clinical data. It is a really exciting time for the company, one that we have been working towards for the last number of years. We are excited by the science, and we are excited by understanding the potential of the platform in patients. I can have the next slide, please. I think that concludes the update, and we will be happy to take any questions. Thank you very much. Thank you, Namir. We have received a couple of questions, so I can start with the first one. Regarding the estimated readout in mid-2026, could you please provide an estimate of how many patients investors can expect will be included in that readout? That is a great question. Our clinical strategy defines the patient process and how we will be looking to enroll patients.
In essence, we will have cohorts of patients, cohorts of three, which is a standard strategy for this type of therapy. Each cohort of three will be treated with a particular dose. The plan is to initiate the study in the first half of next year. On that basis, we expect to begin to get readouts on the first patients around mid-2026. This will be the first cohort of patients. Depending on when the first will be recruited, it will be the first cohort of patients, so one to two patients initially as we establish safety and look for that initial efficacy. Those are the kinds of numbers that we would expect around that timeframe. Thank you, Namir. We have one other question. You have referenced several recent deals in the field, which, as we know, typically take considerable time to come together.
Given that, do you think it’s realistic to speculate about a potential deal based on the data expected in mid-2026? Yeah, I think what’s important in looking at what is happening in this space is to really understand the deal sentiment and the changing dynamics. I think the flurry of deals we have seen clearly demonstrates a shift in cell therapy with increased appetite for platforms that simplify cell therapies, that allow cell therapies to be more accessible and scalable. I think that’s the first thing. The next thing is that these deals almost exclusively have been on the back of data from relatively few patients. Now, of course, deals can take time and relationships can take time to build. At Zelluna, we’re in constant active mode when it comes to seeking out potential business development opportunities.
I think the backdrop of those deals symbolizes the potential power of data from relatively few patients. Now, can we be certain that we can apply that same formula to the TCR-NK platform? One can never be certain, but what it does show is that there is the potential if the therapy demonstrates activity in patients, it has the features to potentially also follow this kind of pattern that we’re seeing in the space. Our clinical strategy and our dosing strategy will hopefully enable us to understand the potential in the first patients. We will be going into patients with what we believe is therapeutic doses, so we’re really trying to maximize the opportunity to understand the potential of the therapy in those first patients. In the backdrop of these deals, we think that’s a very exciting and strong position to be in. Thank you, Namir.
We have no further questions today.
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