Earnings call transcript: Zelluna Q2 2025 highlights cell therapy progress

Zelluna ASA (market cap: $3.63M) reported its Q2 2025 earnings, showcasing significant strides in its TCR NK cell therapy platform. Despite a challenging operating environment and an overall "WEAK" InvestingPro Financial Health score, the company maintains a stable cash position, projecting a financial runway through Q2 2026. Zelluna’s stock saw a modest rise of 1.85% following the earnings call, closing at $1.34, up from its previous close of $1.31, though trading well below its 52-week high of $2.19.

Key Takeaways

• Zelluna’s cash position stands at 76 million NOK, with a runway through Q2 2026.
• The company is advancing its ZEMA four one cell therapy platform, targeting multiple cancer types.
• Stock price increased by 1.85% after the earnings call.
• Zelluna plans to file for clinical trials in the second half of 2025.

Company Performance

Zelluna continues to focus on its innovative TCR NK cell therapy platform, ZEMA four one, targeting solid tumors such as lung, head/neck, ovarian, and synovial sarcoma. The company has completed preclinical investigations and is preparing for clinical trials. Zelluna remains one of the few companies in this niche, potentially unlocking significant value with early clinical data.

Financial Highlights

• Cash position: 76 million NOK (approximately $7 million USD)
• Operating profit (EBIT) for Q2: -38 million NOK
• Year-to-date EBIT: -68 million NOK
• Operating cash flow in Q2: -59 million NOK

Outlook & Guidance

Zelluna is targeting the submission of its clinical trial application in the second half of 2025, with the first human clinical data anticipated in 2026. The company is also expanding its pipeline to include multiple solid tumor targets and continues to develop its scalable, off-the-shelf cell therapy platform.

Executive Commentary

CEO Namir Hassan expressed optimism, stating, "We believe we’re at the cusp of a significant catalyst." He emphasized Zelluna’s unique position in the cell therapy space, noting, "We’re virtually the only company operating in this space." CFO Hans Eid highlighted the company’s financial stability, stating, "The current cash is expected to give a financial runway into the second quarter 2026."

Risks and Challenges

• Regulatory hurdles in clinical trial approvals could delay progress.
• High competition in the cell therapy market may impact market share.
• Financial sustainability depends on reducing cash burn rate.
• Market volatility could affect stock performance.

Zelluna’s strategic focus on innovation and its robust patent portfolio position it well in the burgeoning cell therapy market. As the company continues to refine its clinical trial design and strategy, it remains a key player to watch in the field of cancer treatment.

Full transcript - Zelluna ASA (ZLNA) Q2 2025:

Namir Hassan, CEO, Zaluna: Good morning, and welcome to Zaluna’s Second Quarter twenty twenty five Business Update and Financial Results. My name is Nami Hassan, the CEO of Zaluna, and I’m joined by Hans Eid, the CFO. Can I have the next slide, please? And the next one. So what we’ll be covering with you today are the key events over the 2025.

A reminder on the TCR NK technology and pipeline. We’ll provide a financial update, and summarize at the end. The next slide, please. And the next. So perhaps two of the key messages that we would like to communicate from, the second quarter, are shown here.

The first key message is, excitingly, we are on track for a clinical trial application filing for our lead program, ZEMA four one, scheduled for sometime in the 2025, which means we are on track for generating that all important human data in the 2026. This is a very exciting moment for the company on the cusp of generating patient data for our novel platform technology. And it’s exceptionally exciting when we think about the context. There’s been growing appetite for early stage off the shelf cell therapies, and we have seen a flurry of deals of late, I’ll come on to those, where small biotechs that have entered into the clinic with off the shelf cell therapies have really commanded high value. And and this, we believe, reinforces Zuluna’s unique positioning, and the current timing being on the cusp of generating that all important patient data.

Can have the next slide, please? So if we delve into, more detail around the building blocks of our preparation to really drive our lead program ZEMA four one towards the clinic. On the preclinical front, we have successfully completed a full round of all key investigations in support of a clinical trial application. On the manufacturing front, following April’s announcement of successful manufacturing lockdown, we have initiated GMP production of a clinical batch that was initiated in July, and forms a major step forward, towards clinical trial preparation. On the regulatory front, we broadened our regulatory engagement following, positive FDA pre IND feedback that we communicated previously.

We have recently submitted a scientific advice briefing backpackage for The UK regulatory authorities that was submitted in July 2025. And on the clinical front, we have had really strong support from leading clinical experts in the cell and gene therapy space. And we continue to refine our trial design, our clinical strategy as we move to operational readiness ahead of a clinical trial application submission. And again, all of this in the strategic context of a cell therapy market where the trends are favoring early stage off the shelf platforms. If we look at, recent deals from, AbbVie and AstraZeneca and the acquisitions of small early stage biotechs, Capstan and EZobiatek, both in the off the shelf cell therapy space, we really, are witnessing the reinforcing of Xeluna’s unique positioning, being a unique, developer of an off the shelf cell therapy platform on the cusp of generating that all important potentially high value clinical data on patients.

So overall, on track, for our lead program towards a IND or CTA scheduled for the 2025, with data emerging on patients anticipated in the 2026. So really great progress by, the talented team. Can I have the next slide, please? So we’ve seen a flurry of, deals in the off the shelf cell therapy space in the last quarter. I communicated a couple of those deals.

In the interim, we have seen further deals. There’s been a recent deal announced in June where AbbVie have acquired Capstan Therapeutics. Capstan, small biotech, that is developing an off the shelf cell therapy platform, a type of CAR T therapy. They only treated a single healthy volunteer at the time of the deal, and the total deal value is approximately 2,100,000,000.0. So, again, reinforcing the idea that off the early stage, off the shelf cell therapy platforms with small patient datasets can really unlock, enormous value.

So what has been our journey? If I can have the next slide, please. What has been our journey, and what is does the potentially the horizon hold? Well, as we’ve communicated previously, we have really developed the basic science, the preclinical data, and we announced in April the lockdown of manufacturing. And as we’re looking towards, the clinical preparations, we’re aiming to generate that all important clinical data for our world’s first lead asset and, by extension, also generating data on the platform itself.

And as we’ve seen with the flurry of deals, small human datasets can really drive high value. The the Capstan and AbbVie deal I just mentioned, in March, we also had the ESA Biotech, AstraZeneca deal where AstraZeneca bought out the small biotech company ESA Biotech, again, on the basis of, data from a few patients, and Roche, the Roche acquisition of Poseidah in November 2024, all indicating a trend towards increasing appetite for off the shelf cell therapies and for unlocking high value with small patient datasets. And that’s what we’re aiming for in in our move towards the clinic, and dosing patients in the 2026. So I can if I can have the next slide. Let’s maybe spend a moment or two, with a reminder on our platform technology.

So what is it, that we’re aiming to address? With our platform technology, what we call the TCR NK technology, we’re aiming to address one of the biggest burdens of humanity, which is, the burden of solid tumors. We know that solid tumors, the likes of lung cancer, prostate cancer, pancreatic cancer, and so on, are the cause of over nine million annual deaths. Over eighty three percent of patients with late stage cancer, unfortunately, will die from the disease. Now the context is that we have seen, some progress with treatments that are really penetrating solid tumors, but the challenge has been that virtually all patients relapse.

The chew the tumors come back, and, unfortunately, the patients end up dying, when they have late stage disease. And so we have been developing over the years a differentiated platform that’s really designed to address solid tumors and overcome cancer escape, which is one of the biggest problems in treating solid tumors. And, in parallel to that, we’re aiming to do that, in a way that allows us to make the therapy accessible and scalable. So two main things is to address solid cancer escape and also to, allow the therapy to be accessible, and scalable. So if I can have the next slide, please.

And what we’re developing is a type of cell therapy. I’ve mentioned off the shelf cell therapy. So it’s a type of cell therapy. And why cell therapies? Well, we know cell therapies have cured cancer patients, and there are nine approvals in currently, with cell therapies.

They’re mainly in liquid cancer, but what that tells us is that cell therapy can really actually make a difference to patients. Nine approvals is really a validation of the cell therapy approach. But the challenges with, cell therapies are are two currently, or two of the main ones are, treating solid tumors. As I mentioned, cell therapies have struggled since cancers can escape treatment, so that’s the first. And then the second is actually, enabling these cell therapies to be used at scale for global access.

With the high effectiveness of these types of therapies, of course, there’s a desire to deploy these, at a global scale. And so, at ZILUNA, we’ve been building a platform called the TCR NK platform really designed to address both of these challenges. So really designed to address solid tumors and overcome cancers from escaping to really allow long term responses. And at the same time, these therapies, are also produced to be used at scale and accessible so they can be frozen down and used at the point of need. You may remember in April, we announced a manufacturing lockdown, and from a single batch, we generated hundreds of doses.

And so it’s a really scalable concept that we have proven now with our manufacturing process. If I can have the next slide, please. So, what are Xeluna offering? We believe we have a game changing platform, and it’s a novel approach, the TCR NK approach. And whilst it’s novel, it’s built from two, validated components, and I’ll come on to talk about what I mean there.

And very importantly, I think this is somewhat unprecedented. We hold a very strong, patent portfolio, layers of protection. And one of the, very exciting areas of protection is actually the protection of the therapeutic space. So the entire therapeutic approach, the approach of treating cancer with TCR NK. So not just single products, but the actual approach.

We’ve called this a land grab opportunity, and I’ll come on to talk about that. We have other layers of IP that are in flow around products and manufacturing, but really the entire field on top of that. What’s exciting is the moment that we’re in right now, which is there’s an expected near term clinical inflection. So we’re reporting today that we’re on track for our IND or CTA submission in the second half of, 2025 with a view to generating that all important clinical data emerging in the 2026. And, again, we know strategically from a context perspective that there is growing appetite for off the shelf cell therapies that are novel, which we believe we have, especially when there is early human patient data, and that can really drive high value.

What we also know is that these types of cell therapies, can be fast to approval, and so many of the nine approved therapies have been approved on the basis of less than a 100 patients. And I think that demonstrates, the potential, fast track approval for these types of therapies. If I can have the next slide, please. And so, just a moment to spend on the nature We’re developing, as I, mentioned, a T cell receptor natural killer cell platform.

And we can think about, the product, in two components. One component in the top left there is, what’s called the T cell receptor. This is, if you like, a guidance system. It’s a targeting scaffold. It’s a validated scaffold.

It naturally occurs. We use engineered T cell receptors, and they’ve been validated and shown to be able to effectively target solid cancers. We have a number of approvals, which use T cell receptors as targeting agents, and they’re approved for solid cancers. So we know that type of scaffold and guidance system can target solid cancers very effectively, with the clearest proof being approved therapies on the basis of T cell receptors. On the other hand, the therapy is also consists of a cell type called the natural killer cell.

Natural killer cells, occur, naturally in the human body. They’re probably the most efficient killers, highly efficient killers. We also know from clinical development that you can get really robust responses with natural killer cells. The challenge, though, with natural killer cells is finding their way to solid tumors, and that’s where our, approach comes in. We bring together the highly validated targeting scaffold, the T cell receptor, and we put that into natural killer cells so that we can target two solid tumors via the T cell receptor, natural killer cells, so that they can then go on and do what they do well, which is, kill with high efficiency.

And this TCR NK platform, this blend where we bring together the T cell receptor and natural killer cells is a novel differentiated approach. We’re virtually the only company, that are doing it, and we believe it it combines a proven solid cancer targeting molecule, the T cell receptor, with the most potent and safe cell type natural killer cells to form T cell receptor natural killer cells. And this is a platform we’ve been developing. We know it also can be used off the shelf, meaning that a single batch can be used to then treat many patients. And so this provides the convenience, it provides the scalability, and addresses one of the key challenges with current cell therapies that are not that are limited by scaling those types of therapies.

So if I can have the next slide, just spending a moment on an important point around, the protection of receptor natural killer platform, TCR NK platform. We have a a granted patent that, we believe protects the approach, the TCR NK approach. And really just to try to put this into perspective, if we look across the landscape of different off the shelf approaches, so called allogeneic approaches, you can see those split into these quadrants based on the cell type. So you have other natural killer cells, but guided by a different targeting system so called CAR NK. Those are at the top.

You see multiple companies operating in that space. You also have, allergenic off the shelf T cells, so that’s the bottom left, again, guided by a different scaffold, so CARs, and you see multiple operators in that space and then different type of cells, again, off the shelf in the bottom right. But what you’ll notice is that there are multiple operators in these quadrants. Whereas with the TCR and K approach, not least of which due to our, protection of the approach, we’re virtually the only company operating in that space. And, therefore, one can imagine the potential aggregate value that could be unlocked by demonstrating, the platform, ability in patients could be huge, equivalent to perhaps aggregate value of these multiple operators that we see in these different quadrants.

Maybe just to drive that message home further, we’ve seen the recent flurry of deals. You see in the bottom left the companies that are involved in those deals, Kapstan, Eto Biotech, and Posada, all acquired by large pharma on the basis of small human datasets, and these are three companies operating in that quadrant where the deal values have been somewhere between 1 to $2,000,000,000. So the potential value that could be unlocked by demonstrating the TCR NK approach in patients can be immense, we believe. Another way of thinking about it perhaps is shown on the next slide where, we have seen a number of T cell therapies approved. I mentioned, nine therapies that have been approved in the cell therapy space.

A number of those are CAR T cell therapies, and you can see the products there and the companies that have been developing those. And maybe as an analogy, one can think about the protection of the TCR NK space, which would be analogous similar to the protection of the CAR T approach, which, of course, is not something that exists but demonstrates the potential aggregate value. We know from these products that there’s multibillion revenue being generated, with CAR T products, and so, we believe, we can potentially really unlock immense value through, the protection of the TCR NK therapeutic approach, if you like multiple companies, multiple products in in one. So if I can have the next slide, please. So, just a few comments on our lead program.

We’re progressing well and, on track and aiming for CTA IND submission in the second half of this year. We have really further refined our clinical strategy together with expert clinicians in the field. We’re looking at targeting lung, head, and neck ovarian and synovial sarcoma, and collaborating with world renowned clinical sites as we continue to develop, our strategy. So if I can have the the next slide, please. You know, what are the clinicians saying about the prospect and the potential?

This is, professor, Fiona Thistleway, a really, key, expert in the cell and gene therapy space, a medical oncologist, who has really, conducted a number of clinical trials with cell and gene therapies, and we have really strong dialogue with her. And she says that she’s genuinely excited to see the progress with ZEMO four one into the clinic. She’s optimistic that the dual killing mechanism of the NK cells and tumor antigen directed T cell receptor will provide us with the step change that we need in the solid tumor setting to provide the required level of tumor potency whilst avoiding tumor escape. This is a key point that our platform is really designed to address solid tumors and to address the issue of tumor escape. And professor Thistowitt is is really excited about that prospect.

So if I can have the next slide, please. Here is our pipeline. We have a blend of, assets in our pipeline beyond the the lead ZEMA four one, which you can see there, a couple of other programs in our pipeline, again, targeting a blend of clinically validated or preclinically validated targets that would be relevant across a number of solid tumor indications as you can see there. So we’re really building our pipeline with a blend of clinically validated or preclinically validated targets that would be relevant across solid tumors of high unmet medical need. If I can have the next slide, please.

So this is a status on MultiClick and UV one. I won’t spend time on this. This is, as, we have communicated in the last quarter, and there’s been no change to that status. If I can hand over to Hans to provide the financial update.

Hans Eid, CFO, Zaluna: Thank you, Namir, and good morning. Moving on to the next slide. Before we go into the financial numbers, I would like to give a quick reminder of, a key accounting principle. Seluna ASA, formerly Ultimovax, acquired formerly Seluna Immunotherapy in a transaction that was closed in March. From an accounting perspective, however, it’s a subsidiary of immunotherapy that is regarded as the acquirer for accounting purposes.

Further, prior to March 2025, the financial information, represents Siluna immunotherapy, only, whereas from and including March, the financial information includes the full Siluna group. It’s important to keep this in mind when comparing numbers. Going to the next slides with the key financials. By the end of the second quarter, we had a cash position of 76,000,000 or roughly USD 7,000,000. The current cash is expected to give a financial runway into the second quarter twenty twenty six, which will ensure that we capture the key R and D or CTA catalyst for TCR Mk technology.

This expected runway also reflects that the cash burn rate is expected to come down significantly from the somewhat high Q2 twenty twenty five level. Looking at the operating profit or the EBIT in the second quarter of this year, it was minus NOK 38,000,000. And year to date NOK 68,000,000 as a negative result. Profit before tax was minus NOK 38,000,000 in the second quarter and minus NOK 66,000,000 year to date 2025. If we move to the next slide and have a look at the P and L.

Again, when comparing the numbers for the second quarter twenty twenty five and also year to date 2025 with the previous year, it’s important to note that again, from March 2025, the numbers include the full group, whereas previous year’s numbers only include the numbers of the subsidiary cellular immunotherapy. So, this applies to all the main cost categories where we see higher numbers this year than the previous year. In addition, the R and D costs were impacted by higher costs related to the CMC development as well as milestone payments for the clinical trials in Seluna ASA. Further, looking at the other operating expenses, these were impacted by significant transaction costs related to the business combination. Moving on to the next slide.

The operating cash flow in the second quarter was approximately NOK 59,000,000 negative, differing from the EBIT or operating profit of roughly minus NOK 38,000,000. And this difference is due to changes in the working capital. So as mentioned, the operating cash flow is forecasted to come down significantly after the second quarter of this year, and that is driven mainly by the finishing of many R and D activities and also the capturing of the effect of workforce reduction in relation to the business combination. With that, I would like to give the word back to Namir. Thanks.

Namir Hassan, CEO, Zaluna: Thank you, Hans. So to summarize, and if I can have the next slide, please. Thanks to really the incredible, efforts across the team. What we have communicated today is that we are on track for a CTA IND filing for our exciting world’s first lead ZEMA four one, planned for, the second half of this year, aiming to generate that all important clinical data emerging first half of next year. So what we show here are the developments since the last quarter.

We initiated GMP manufacturing for the clinical batch. We submitted a package to The UK regulatory authorities, really all in preparation, for clinical initiation. And what we’re looking to do in the horizon, as mentioned, importantly, is to generate that clinical data, next year. And as we have seen with the growing appetite in the field, we’re operating now really in a space where there is increasing momentum in appetite for off the shelf cell therapies, particularly where there is early patient data. And so we believe we’re at the cusp really of a significant catalyst in the short term potentially.

So if I move on to the next slide and just thank you for your attention and welcome any questions.

Hans Eid, CFO, Zaluna: Okay, Namir. We have one question related to the clinical development. Where do you think you will run your first clinical trial? Is The US or Europe most attractive?

Namir Hassan, CEO, Zaluna: That’s a very good question, and there are a number of considerations as you can imagine to really determine that. What we have wanted to do is to really assess the path for both territories. And so we communicated the positive IND feedback previously, and now we’re seeking UK feedback. We have sites that we have interacted and engaged with deeply across both territories. And in due course, we’ll announce where once we have really committed, we will announce the territory that we anticipate moving into.

I think we’re in a very good position now with sites excited, clinicians excited, and we want to ensure that we cover and really seek guidance across both territories that will feed into that final decision.

Hans Eid, CFO, Zaluna: Okay. Thank you, Namir. It seems that that was the only question today.

Namir Hassan, CEO, Zaluna: Well, then thank you very much, and really excited by, what we have next, and grateful for the attention today.

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