Scancell Holdings plc (SCLP.L) Earnings Call Transcript & Summary

Good morning and good afternoon to all our listeners. Welcome to Scancell's results call for the 6 months ended 31st of October 2025. My name is Mary-Ann Chang, Investor Relations. And with us presenting today, we have our CEO, Phil L’Huillier; and our CFO, Sath Nirmalananthan. After the presentation, we'll conduct a Q&A session for which you may submit written questions at any point during the webcast. Before we start, a few housekeeping items. This call is being recorded. [Operator Instructions] Please note, today's discussion will include forward-looking statements, which are based on current expectations and assumptions. Actual results may differ materially, and we encourage you to review our filings for more information on risks and uncertainties. With that, I'll now turn the call over to our CEO, Phil L’Huillier, to get us started. Over to you, Phil.

Thank you, Mary-Ann. Hello, everybody. Thank you for joining this Scancell update. Both myself and Sath will present this update to you this afternoon. This is our disclaimer. Here's a summary slide of the highlights for the interim period that we're summarizing. iSCIB1+ as a novel DNA active immunotherapy has shown and is showing best-in-class potential. It has the potential to redefine the standard of care in first-line unresectable melanoma, a really terrible condition. This is a significant unmet need and a large market opportunity, blockbuster opportunity as pharma calls it. And we're now at the stage of being registrational ready to move this product forward into a Phase III registrational study. iSCIB1+ has demonstrated progression-free survival of 74% at 16 months. That's a 24% delta over historic studies and real-world data that exists from recent studies. And it has the potential to really double standard of care progression-free survival as the study continues to read out with no potentiating toxicities. We have a strong clinical data package, a translational package also. And these packages illustrate to us that we understand well how our drug is working, and we understand mechanistically what's going on. And we understand why we're seeing long durable responses because we're seeing development of memory T cell responses in our patients and those T cell responses correlate to clinical response. This product and the platform that iSCIB1+ comes from ImmunoBody is really now a differentiated therapy. The platform is validated in the clinic with the recent data and the endorsement from the FDA earlier in the week. It overcomes some of the predecessor challenges that existed with these types of technologies. And we have clinical monotherapy efficacy data as well, which highlights the potential to move into earlier settings in melanoma, what we call neoadjuvant adjuvant setting. We're putting in place the commercial building blocks in parallel with advancing forward the development of the Phase III program. And we have a strong patent protection through to 2041 for the product. So the commercial proposition is really very positive. It's a large market opportunity, and we have protection in that market for a long period of time. Those that follow us closely will have seen we announced this week clearance from the FDA for our Phase III study. That was a very positive interaction we had with the FDA, and I'm delighted that we've got that clearance. There's really nothing standing in our way to move this forward in partnership or alone into the clinic and on our time line and on our plan, as we'll show you, we see the possibility to take this to commercialization in the second half of 2029. We've had a strong focus over the last couple of quarters on the lead program, the ImmunoBody platform and iSCIB1+, but we shouldn't forget the additional assets that make up our pipeline. Modi-1 is in the clinic in 2 studies in head and neck and renal cancer. And we also have the GlyMab's portfolio of antibodies at the preclinical stage, and we continue to progress forward those 2 parts of our pipeline. We also continue and have had good active conversations over the last quarter, evaluating partnering and financing options. As I've said previously, we deploy a two-pronged strategy, build to go it alone whilst be opportunistic for partnering, and we continue to work both of those fronts as we move forward to find the path to take our lead program into the clinic. This slide shows you our pipeline. That's a little more extended than some of the earlier versions we've had. You can see on the top there, the 2 clinical platforms, the ImmunoBody platform with the SCIB product, but also the modified platform with the Modi-1 product. And as I just mentioned, iSCIB1+, we selected that during the year to go forward into development for quite a number of really important reasons. And it's that product we want to take forward into the Phase III later in 2026. As I touched on alongside that, Modi-1 continues in the clinic in the 2 indications, head and neck and renal, and that program is progressing positively. We, of course, have 2 partnered assets, as you can see on the slide, further down here with Genmab. Two antibodies heading towards the clinic under Genmab's development. And those -- both of those programs are on track and an important validation of what we're doing in the antibody space, but also they are potential upsides for us, as Sath will come to. And then in-house, we have 2 programs that we're talking publicly about in the antibody portfolio, GlyMab Therapeutics, one in small cell lung cancer, SC134 and SC27 that could be used in various cancers. We are moving forward those 2 products also. Let me come back to iSCIB1+. It has the potential to redefine the standard of care. This slide shows you the market opportunity and the market potential here. On the left, we lay out some of the indicators of the substantial unmet need that still exists in advanced melanoma. It is the fifth largest cancer. Unfortunately, there are a lot of patients die from this disease and a lot of patients that receive current therapies, but relapse or are resistant and need something else pretty quickly. 5-year survival for late-stage melanoma is very, very low. Only 1/4 of the patients are still alive at 5 years. So a substantial unmet need. And I think we have a product here that will really make a dent in that unmet need. In the middle of the slide here, you can see the patient journey, but also the therapies that are being used or being evaluated as the patient progresses through the stages of melanoma. As you can probably see from this slide, we are down here in the blue box in the frontline advanced melanoma. That's where we're working at the moment. That's where the bulk of our data from the Phase II study comes from, and that's the focus of the Phase III. We know from our estimates of the market opportunity that, that market alone could be as much as $3 billion. On top of that, from our monotherapy data and from other work we've done, we know we also could go up to earlier disease, what we call the neoadjuvant or adjuvant therapy. And that's a real possibility to build out the value proposition in the future for the company. And that market opportunity is even more substantial in the range of $6 billion to $9 billion. So we're very much in blockbuster territory here. Over on the right hand of the slide, you can see the approved therapies. And below that, you can see the U.S. market and how the U.S. market is split for different types of therapies. The important takeaway from this slide -- this part of the slide is that 63% of patients in the U.S. receive still today the combination of ipilimumab and an anti-PD-1, most often nivolumab. And that's the combination of checkpoints that we are working with and that we'll add our iSCIB1+ onto in the Phase III. So even in the U.S., it is the dominant marketplace, let alone in the rest of the world. So a substantial market opportunity, and we have the potential to really create a new standard of care for advanced melanoma. This slide lays out the building blocks that we have put in place and we continue to build on to move forward towards a commercialization. We now have a product that we know is beneficial in the clinic and has an excellent safety profile. We have a protection, an IP protection out to 2041, a really long patent life here. The manufacturing is in place. It is a simple process off the shelf and it's scalable, and we have a long-term stability and the FDA have given us a good tick for our manufacturing process. We have in place a commercial agreement for a needle-free delivery device. This is our partnership with Pharmajet. That partnership includes development where we are at the moment, but also commercialization. We have had really good interaction with the regulators. The FDA clearance is, of course, the highlight this week of those, but we also have conversations going on with MHRA here in the U.K. and EMA in Europe. And then finally, we start to put our eyes on what does commercialization look like, how will we think about partnering and moving forward in a seamless way through registration and into commercialization. We have optionality there, and we start to really think about what that looks like. According to our study plan that we've laid out, we could be into commercialization in the second half of 2029. Just a reminder or an introduction for some of you, if you're new to us, of our iSCIB1+ product. It's a DNA ImmunoBody. It has a very novel mechanism of action. And you can see here that this is the product that's manufactured. It's a DNA molecule, a plasma DNA, we call it, delivered to patients with the needle-free device that I mentioned. It's in fact, a shot into each thigh and a shot into each arm, very quick, very convenient, pain-free for the patient. Scancell has developed 2 generations of this product over the last few years, a first gen that targets a restricted patient population and a second-gen product that targets a much broader patient population. And some of the learnings from the antibody work, as Lindy would say to you, have been applied to the second-generation product to improve its binding. So it's even better than the first-generation product. But importantly, it targets a much broader patient population. And our Phase II data told us which patients it works in. But also, we know it binds and it works better than the first-generation product. The product has epitopes to 2 proteins that come from melanoma from the production of melanin in the skin, epitopes to GP100 and TRP-2. Why are these relevant? Well, these were isolated from patients that have spontaneously recovered from melanoma. So that means the immune system sees them. But also from our translational work, our T cell work, we know that in most patients that they create an immune response to both of those proteins. And that's really important when you start to treat patients with this product because it makes it harder for the cancer to overcome the therapy and become resistant to the therapy because the T cells are working against both those products. So it's 2 shots rather than 1 to protect the patient, and that's really, really important. Our mechanism is a very novel one. The DNA molecule goes direct into muscle cells and is taken up, but it also alongside that, binds a receptor on immune cells, activated immune cells, dendritic cells, they call to stimulate a very potent T cell response. And that's an important part of the way it works and why we see such positive responses. I touched on before that we have some monotherapy activity from an early study that the company did. And monotherapy activity is really important in the pharma discussions that we have, but also that's doing the study in that setting helps us think about that earlier setting of the neoadjuvant adjuvant disease setting. But for now, we're developing the product in combination with the checkpoints. And that's what we want to take forward into the clinic in Phase III. There's quite a lot on this slide, but we've created this slide to illustrate why our iSCIB1+ and our ImmunoBody platform is differentiated from other therapies that have come before, but also why we believe in it for melanoma. So firstly, there is compelling science. Lindy and the team really developed a very compelling product with a very novel mechanism that when you compare it to predecessor products, it's overcome many of the weaknesses that were there. And basically, by creating these very strong high avidity T cells and targeting the 2 proteins, GP100 and TRP-2, we have overcome many of the challenges that led to products not progressing forward in earlier decades. This is also a nonpersonalized approach. It's scalable. It's cost effective. It's easy to manufacture, fast to patients and straightforward to deliver the patients. We have very good clinical validation now. I showed you the PFS data at the beginning. But I think the other thing to take on board now is we have a much better understanding of how to use the immune system to attack a cancer. And the combination of our therapy with the checkpoints is really an important part of success of our product, but products like this going forward. And that's learning over the last decades of testing different immunotherapies on the immune system. We've got the FDA clearance to move forward. We've also identified from our Phase II studies, a biomarker that we can use to enrich for responders as we go into the Phase III. This derisks that development. And then I've touched on the commercial opportunity, a substantial first commercial opportunity and even more substantial one to follow on in the neoadjuvant adjuvant, the resectable disease setting, and we have very good regulatory support to move forward with the study and to seek commercial approval second half of 2029, if the data stacks up in a positive way. This is the PFS curve. This is the data that I just mentioned at the beginning, iSCIB1+ showing you a progression-free survival at 16 months of 74%. You can see here when we overlay it with earlier older studies, that in this case, at 11.5 months, ipi and nivo alone show a median PFS that means 50% at 11.5 months. So we've got this big delta of 24%. Now let me just try to put that into a context for you. In the study that led to this -- the combination of ipi/nivo being -- becoming a blockbuster, at the same stage, the ipi/nivo combination was only 6% better than nivo alone. We are at 24%. So this is why we get excited about what we've got in front of us. Look at the difference in that delta. Now I have to caution that the ipi/nivo nivo comparison is from a single controlled study. And what I've done here is to compare across 2 studies. There's a bit of license there, but if you look at that delta, we're very excited about what's happening. And then -- so that's the clinical parameter. Clinical success is based on that progression-free survival. The commercial success really comes down to we make a difference to the overall survival. And at the moment, with the SCIB1 product, because we went into the clinic earlier, we've started to get data there, and we've got a 16% improvement for SCIB1 compared to that red line that I showed you. So the commercial proposition is also starting to build positively. And just to give you a comparison, some of you might have seen that Moderna published some data, 5-year follow-up recently. In their data, the risk of death was reduced in that study, and that's what they publicized. When I do that same calculation based on our data, we're actually at a similar order of magnitude. So we're tracking very well with the Moderna data that is published. But of course, remember, we're off the shelf. We don't have the high-cost logistics and the other challenges with our product. So I'm excited about this data as it builds both, as I say, for PFS, that's about the clinical impact, but also overall survival, that's about the commercial impact potential going forward. This is the indicative plan for the registrational study. It's a simple 2-arm study, as we call it. The control arm is the standard of care now, the ipi and nivo, and we put a placebo into that. And then the treatment arm is the ipi/nivo with our product, iSCIB1+ added on to that. The study will have about 230 patients per arm. So a substantial study that will be carried out across the U.K., Europe, the U.S., Australia and maybe some other locations. So a substantial study for us. And we have an initial readout as we go through the study, and that will be a registrational readout. But we also want to follow the patients for a longer period of time to do a post in-market follow-up on the survival of the patients. Down the bottom here, we've got a number of factors that we stratify the patients coming into the study for. So that means we just balance each side of the study with patients of particular types so that it's a balanced study. This is the design that the FDA have seen and -- let me just comment on how do we think about risk mitigation in a study like this. There is still risk there. That's the nature of what we do. But we believe we can really mitigate and are mitigating risk in the study design. First of all, we did a fairly substantial Phase II translational or exploratory study with 140 patients in it. It was designed to determine the parameters, the key parameters for the Phase III study, and it was successful. We've been able to identify those parameters. We use some of those parameters to give us a statistical model to design the Phase III study, but we've used a conservative delta on that design. So we feel comfortable about the delta that we're using for that design. We've also built in a piece that we call an adaptive design. So if we get through towards the end of the study and we see we, for example, might not quite have enough patients in there, then we've built in the ability to add some more patients to make sure we hit the end goal. And also then we've looked very hard at our patient characteristics. We often compare our data with that historic standard of care, as I was showing you earlier. Okay. So then you ask the question, how do our patient characteristics look compared to those patients from that study, CheckMate 067, but also alongside real-world studies that have been recently conducted. And we know our patient profiles are very similar. So in other words, we've not inadvertently or on purpose selected patients that are one type or another, and they are not directly comparable with those older studies. They are very, very comparable. And then as I've showed you previously, we've also looked at subgroups of patients where the benefit of particularly the checkpoints is less because of a particular condition of the patients. And we know when you add iSCIB1+ on top, that adds a benefit in all of those, I call them poor prognosis subgroups. So we've done a detailed analysis of our patient characteristics and feel really comfortable we're comparing like with like, and therefore, that helps us mitigate the risk going forward. In terms of market risk mitigation, it's worth recognizing that we have that study in metastatic disease, but we have the possibility of doing the neoadjuvant study also. And the neoadjuvant study is derisked because we've seen monotherapy activity in that setting previously. Of course, investor risk is also mitigated, I have to say, by the other components of our portfolio, the Modi program, but also the GlyMab's part of the portfolio. So I feel really comfortable that we have a design. It's been endorsed by the FDA, and we've really thought through how do we mitigate risk here to be successful in the outcome. Here's a summary of the regulatory conversations. Massive tick here on Monday or Friday, but Monday when we announced that we've got IND clearance. Getting IND clearance for a Phase III registrational study is a pretty rare beast, but it's an even rare beast as a U.K. biotech company. I'm really proud of what we did there. What it means in breakdown is the FDA have said, we accept your proposal for the dose and how you deliver the dose Scancell. We accept and we agree with the design of the study, the stats plan, the endpoints and all of those things. Your manufacturing process is satisfactory for this late stage of study. And then on other information and other studies, preclinical, nonclinical, other sorts of studies, they agreed that we had satisfied all of those criteria. They've granted us a safe to proceed and IND is open, and they've granted that with a surrogate primary endpoint. That's effectively granting us an accelerated approval in the one swipe of the pen. So it's a really big outcome for us and a really exciting time for us. As I touched on earlier, we progressed forward with the MHRA and EMA and other regulatory bodies because it will be a global study. Now with the IND under our belt, we are also moving forward with a breakthrough designation application and other regulatory applications and the CTA is near completion. CTA's clinical trial agreement, the next step down underneath the IND clearance that you need to move forward a study. So really strong progress on the regulatory front. This slide comes back -- this slide and the next slide are really where we start to think about what's the longer term look like, now with a validated ImmunoBody platform? We're able to start to think about what's beyond iSCIB1+ in advanced melanoma. So perhaps for the first time down the bottom of this slide, we've started to think about how else could we use this platform. And there are a lot of possibilities here. So this makes the market opportunity and the value potential of the company even more substantial going forward. I think we've probably shown SCIB2 before with the NY-ESO antigen. There are a number of others now we are in concept stage, I'll say, thinking about. I'm not going to disclose those antigens. We're in a world in the biotech industry where things get copied very quickly these days. And then if you look more broadly across the Scancell portfolio, my last slide, I think, but just to say to you, we have the iSCIB1+ program in melanoma, and there's multiple ways we can move that forward in multiple indications in the future this product could be taken into. But the ImmunoBody platform, iSCIB1+ -- iSCIBx has the potential to go into quite a number of other therapy areas. So a lot of potential in that platform. But on top of that, there's the Modi program, which is applicable to a broad range of solid tumors, and that has its own potential and is making good progress. And then, of course, there's the antibody portfolio where there are a number of products at various stages of preclinical development. So as a company, the potential currently is substantial, I think, but the future is even larger for us. Let me finish there and hand over to Sath to walk you through the financials.

Thank you, Phil. I'm pleased to give you the key highlights from the interim financial results for the 6 months ended 31st of October 2025 before updating you on some key upcoming milestones this year. Starting with revenues. Whilst there were no revenues in the period, as previously highlighted, there is potential for near-term milestones from our partnered assets with Genmab. Development of those antibodies remain in progress. And based on recent updates from the company late last year, we anticipate further milestones this year. As a reminder, there are up to $630 million in further milestone payments with low single-digit royalties and commercial sales on each antibody license with Genmab. Research and development expenses were $6.2 million in the period. Research and development costs predominantly reflect our in-house clinical, manufacturing and research costs, where the majority of the spend is discretionary in nature. The reduction in the expense from the prior period primarily reflects lower manufacturing costs. We made additional investment in iSCIB1+ manufacturing in the prior period to ensure readiness for future stages of development. We have a robust, scalable manufacturing process for iSCIB1+ with a high-quality formulation and long-term stability. It has allowed us to move seamlessly through regulatory approval for late-stage development, the recent IND clearance being a mark of the team's diligent preparation and execution on this front. Administrative expenses were GBP 2.7 million with continued focus on cost control. The increase primarily noncash share-based payments following the last set of leadership appointments and share issues. This leaves our operating loss at GBP 8.9 million. We record a profit on finance and other income of GBP 2.1 million and recorded tax credit of GBP 1.1 million, resulting in a net loss for the year of GBP 5.7 million. Our cash of GBP 8.6 million at the end of October 2025 was enhanced by the timing receipt of the R&D tax credit of GBP 3 million. This leaves our cash runway in line with previous guidance as the second half of 2026 beyond key development milestones and with runway for ongoing partnering and finance discussions. We do have upside on this runway, too, namely the development milestones for SC129 anticipated this calendar year. Furthermore, the discretional nature of our spend allows us to take decisions if needed. We have good investor support too and remain confident of our near-term runway as we evaluate the right way to develop all of our assets. Next slide, please. Here are the key milestones for Scancell. We've made really strong progress over the last 18 months with solid execution from the team behind the scenes and on time, too. For iSCIB1+, we have already delivered U.S. IND clearance and we'll pursue U.S. Fast Track status on the back of this. Fast Track status has multiple benefits, including regular interactions with the U.S. FDA, which will favorably impact time lines and costs. In parallel, we are pursuing regulatory clearances in the U.K. and Europe, and we have already received some positive feedback in discussions so far. We continue to build our capabilities to execute development in-house while we assess the right way to finance the next stages of development. And on that, the recent IND clearance represents an important development milestone. It strengthens our development plans and discussions. And off the back, we are actively evaluating our options to ensure the right way forward with timely development and shareholder value in mind. In addition to the lead asset, we expect to report data on Modi-1 in the first half of this year, following which we will assess the right development path for that asset. Further, Genmab milestones, as I previously highlighted, are expected in the next -- in this calendar year. And finally, GlyMab Therapeutics, we continue our partnering and strategic discussions with the preclinical portfolio of antibodies targeting these novel glycans. This includes the most progressed antibody, SC134 for small cell lung cancer with -- which has a novel co-dosing approach, which we're quite excited about. We're also focusing on further antibody discovery in this space, too. So lots of upcoming milestones, and we remain confident of our ability to develop these assets and realize their true potential. Thank you for listening. I will now turn over to the operator for questions.

[Operator Instructions] We'll take our first question from Julie Simmonds with Panmure Liberum.

Congratulations on all the good progress over the last few months. Initially, I was just wondering about -- you're talking about the sort of stratification of the patients in the iSCIB1+ Phase III. I was just wondering whether you have any idea whether you're expecting to see any geographical variation in that when you start bringing geography into the patient recruitment?

Julie, I'll take that one. Thank you for that question. We've looked very, very closely at the HLA types across geographical locations. So understand those details, which, as you know, our product works on that basis. And in the territories that I mentioned that we will go into in the Phase III study, I think we understand the patients from that perspective and don't anticipate major differences.

Excellent. That should simplify that. And then I was thinking you're currently applying for breakthrough designation for iSCIB1+ as well. From a sort of practical perspective, at what point do you think that might be likely to be received? And what difference does it make for you whilst the trial is ongoing?

It's a relatively fast process. It's kind of probably a 2- or 3-month process. So we should have an outcome on that fairly quickly. I'm a hostage to fortune now, but it's a relatively quick process. And what it means, as Sath mentioned, is that we'll be able to have more regular and ongoing dialogue with the FDA. And that's important as we go forward. You will have seen it over the last 18 months, the changing regulatory landscape out there with the FDA, but also elsewhere. So being able to have an active dialogue is important in this process as we move through this study. And I have to say the conversations to date that we've had over the last quarter with the FDA have been really collaborative and really positive. So I'm very pleased where we are with our interaction. But these other designations will help us have further interaction as we move through the Phase III study.

Excellent. And then just on the GlyMab program, you talked about a co-dosing approach for your sort of lead one there. Can you tell us a little bit more about that?

Yes. We have shared a little bit of data. I think I shared a little bit of data to tantalize everybody at the AGM on that, and we've now filed a patent over that approach. But Lindy and the team have identified an approach that uses a co-formulation of a code antibody and a T cell engager in combination and that has shown much greater efficacy. And also in at least our laboratory studies shows reduced toxicity. So what we could have in our hands here is a generally applicable approach to improve both the efficacy of this type of product, but also reduce the toxicity. And you'll know, Julie, that CRS toxicity is a feature of T cell engagers. So we're excited about this product and this new development and potentially have a best-in-class in small cell lung cancer on the back of this co-dosing approach.

Our next question comes from the line of Edward Sham with Singer Capital Markets.

Congratulations on another great update. So I think my -- I've got 2 questions really. So congratulations on the IND clearance. And I'm just thinking whether that will change the quality of conversations you're having with potential partners for the Phase III?

Yes. Good question. Yes, absolutely. I think it's an important catalyst for both the conversations we're having with pharma and mid-caps, the strategics, but also with investors. And in both cases, it illustrates, I think, not only the quality of the product, but the quality of the data. And as Sath touched on, the quality of the team that executed this, we're executing with pace and with precision. So it makes a difference to all of those conversations, and it is, I think, a key catalyst for the next stage.

That's really helpful. And then just my next question, just really on as you wait for the funding for the Phase III, what preparation activities can you continue to progress? So for example, the CTA?

Yes, absolutely. I'll take that one, Ed. Absolutely. We've got a decent runway, and we've got things planned that allows us to move as quickly as possible into Phase III development. The team are working diligently just to make sure that we're prepared and well planned as possible, subject to financing, of course, but we are making good steps so that we can start the study and build capabilities this year and start the study this year.

As there are no further questions on the conference line, we will now address the written questions submitted via the webcast page. I will hand over to Mary-Ann Chang, Investor Relations to read this out.

Thank you. So we have a follow-up for you, Sath. This is from Frank Gregory at Trinity Delta. I have read and heard about your plans to explore partnering arrangement, but I guess this is directed to Sath as he used to be an analyst in former life. Why are you not thinking of going it alone more proactively? The scope data is very solid, and you can identify the patients likely to respond. We reckon the study around 500 patients. So the risks are containable and the funding doable. The arithmetic is quite compelling, go it alone until the interim data in and retained with so much more of the value. So Sath, those are his words. Over to you.

Thank you, Frank. Thanks. It is an option, as Phil has highlighted, that we will actively consider. We are pursuing a dual track process. But Frank is right. The market potential, as we've highlighted, this has blockbuster potential. And so when we do the financial modeling and when we think about the value that this has, we have that go alone strategy firmly in our sight too, and it provides a nice proxy for conversations that we have on the partnering side. But it is something that we are actively evaluating. And the market potential and the sums that we have in mind for further development would make it compelling if we did decide to go alone as well.

Okay. So it's related to that, a similar question on financing, but from a different angle. So if we could just continue Sath. With your cash runway to H2 2026, could you please provide more commentary on options being explored, in particular, how you think about dilution risk?

Sure. I think it's definitely something very topical. But as I want to give a strong confidence on our runway. We feel very confident with the assets and the milestones and the pipeline that we have. And we have optionality. We've got multiple assets and multiple ways to raise funds as well. We are in active conversations on the partnering side. And one of those is thinking about how to drive shareholder value, too. So when we think about the individual assets and how we can drive value and drive development of iSCIB1+ forward, we continuously evaluate what it means for shareholder value too. So that is something that we will take into consideration when we pick a path forward.

It's perhaps worth adding there, Sath. If you read between the lines with Frank's question, when he does the numbers on the potential upside of going it alone, it's less about, I think, dilution risk and more about retain value and grow value by going it alone.

That's very true as well. I think the long-term potential, even if we did go alone, will definitely drive shareholder value. This is a blockbuster market, and we've got multiple assets. So a very good point, the long-term potential, whichever way we go, there's huge value to be gained here.

So going back to the data, Phil, there's a question about the chart that you showed. Forgive me if I missed it. Could you please explain why the PFS chart on Slide 10 is flat for iSCIB1+ versus standard of care? If you could just give a little bit more explanation there, please.

Well, that's a nice question. Thank you. It's flat because no patients are relapsing. So it's flat because all of the patients that are still on therapy are still getting a benefit from the therapy. So it just adds to our duration of response that these patients are on therapy, responding and remaining on therapy. It's very positive, unusual, too, but very positive for us.

Yes. And then related to that, another shareholder has asked looking out, could the results improve from here? So can you give a sort of an indication of should that -- where could that line be going? I think is the question.

Could the results improve even further? Yes, if you look at that PFS curve we were just talking about and it's flat, and you can see that as it's flat and the other red line is going down and down and down. So if our curve continues to stay flat or near flat, then the delta continues to grow. So it could become even more a greater delta.

Yes. Right. So the delta is the key to watch. Very good. Okay. We have another question on the Phase III trial. I understand the registration trial is to read out second half of 2029. Will there be any or even many updates during the trial? Or do we have to wait until the end, Michael Hart?

That's a very good question. By the nature of the design as a double-blinded study, as we call it, it means there are not data updates as you go through the study, like has been possible with, say, the Phase II study, where we do get data updates and we can share those. We won't even as a company, see results going through the Phase III study. It's double blinded. So that means we and the patients and the clinicians don't see the results as it progresses. And that's an important feature of the study because that feeds into the statistical power you have to analyze the results at the end. So it is a study that we take on board and then we execute that study. Where there will be readouts as we progress through that is things like our recruitment rate, our recruitment success because that then impacts on the time line. So I think that's the sort of milestones we will monitor is our recruitment, our execution of the study. I should also say there will be news flow also coming out of the company over this period of time from other components of the pipeline. If we start a neoadjuvant study, there will be news related to that study. That won't be a double-blinded closed study. So there will still be a lot of news coming from the company, but that Phase III registrational study is blinded for statistical reasons and for patient reasons.

Good. Question on SCIB1+ -- sorry, SCIB1 was granted FDA orphan drug status in the U.S. Does that automatically transfer to iSCIB1+? Or would you have to apply again for iSCIB1+? And if so, will it still meet qualification criteria given the expanded patient population?

That's a good question about orphan drug status. I'm not totally sure about the process of changing over from one product to the other. I think it possibly is a new application. But perhaps what's more important here is an orphan drug designation relates to a defined and small patient population. So whereas SCIB1 could get it because it just treated the A2 patients, about 30% of melanoma patients. Because iSCIB1+ works in 80% of the patient population, I think it's probably too big to get orphan drug designation. It's a good problem to have. We've got a large commercial opportunity now, which we may not get orphan drug designation for. But what's more important now is accelerated approval and breakthrough to move us forward to registration.

Good. Looking at the rest of the portfolio, there's a question if you can give more of an update on the rest of the portfolio. You've given some update, but any more detail you can add for either of the 2, Modi-1 or GlyMab? And in particular with GlyMab, there's a question on the progress in setting up the subsidiary status.

Yes, yes. Okay. Let me, first of all, take Modi-1 there from the modified platform. As we touched on through the presentation, it's in -- Modi-1 is in a Phase II program in the U.K. in head and neck and renal cell carcinoma kidney cancer. That study progresses well. We are progressing towards full recruitment, in fact, in that study. So recruitment has progressed nicely. We continue to follow up and monitor the patients. We're now looking for a PFS readout, which will happen over this quarter, this half year. And then that could well be a driver subject to that data to a potential licensing opportunity and non-diluting financing for the company. That's certainly how Sath and I think about the opportunity. So we're excited about the program and about the progress of the product, but we don't have sufficiently mature data yet to talk about it either here or quite yet to talk about it with pharma companies about working with us to take it forward. The second part of the portfolio and the second part of the question was around GlyMab Therapeutics. We have gone through the process of setting up the subsidiary entity, and we've done a lot of work around conversations with pharma, strategics as well as investors to join us in the journey to make a wholly owned subsidiary and then bring investment on to progress that portfolio forward. The -- we've had a lot of conversations, and we continue to have further conversations there, and it's something that we continue to progress to move both the portfolio forward, but also move forward the concept of creating the GlyMab Therapeutics entity and then putting in place the management and investment to move forward the portfolio.

All right. We have one more question that just came in. In today's RNS, you mentioned partnering the broader ImmunoBody platform. Could you explain a little more about this, please?

Yes. You will have seen as we went through the slides that what we've got in our hands now is a validated platform that really is very effective to treat late-stage cancers. And I wouldn't call it quite plug and play, but in fact, we are exploring at a concept stage, how else do we move this platform forward and what else can we apply it to. And there is possibility, I think, now because of the validation from the iSCIB1+ and the scope study to contemplate other products being developed with this platform. And those even at an early stage may tickle the fancy of pharma companies to come on board and collaborate with us in disease areas where they are focused.

Very good. Going back to -- Miles Dixon has come back. He asked about the Kaplan-Meier curve. And he's asking on this, just how unusual is it to have a completely flat curve for 10-plus weeks in these patients? What is the end number?

How unusual is it to have a completely flat curve? That's a hard one for me to answer. You do -- I have seen in many other studies, curves like we see here where there's a rapid decline initially because of comorbidities of patients at the early stage and then the curves typically flatten out, maybe not absolutely flat, but flatten out as they progress over time. So it's not unusual. In the context of a long-term study here, we need to be -- remember that what we're talking about here is we have 16 months data. So it's a short snapshot of data that we're looking at, at the moment relative to long-term benefit for patients over 3, 4, 5 years. But I am really delighted to see that once a patient goes on to therapy and responds, that response is very, very durable.

Very good. Good. We have one final question asking about liquidity. And given the conservative nature, the question says of U.K. fund managers, have you looked at a stock rotation on the U.S. market to broaden the shareholder base?

Yes, we have. It is something that we've evaluated and I'd be quietly confident of our capabilities to be able to dual list, and it's something that we will continue to consider with development and access to capital in the U.S. and liquidity in mind. So I think the potential of a NASDAQ listing for pretty much all biotech is there for everyone to see. And it's something that we have actively considered and we have the capabilities to deliver. And if the time is right, we will definitely look to pursue that at the right stage in terms of a dual listing. But we're evaluating all our options at this stage, and we'll keep investors updated as we make decisions.

Very good. There are no further questions. So I'll hand back to Phil L’Huillier for closing remarks.

Good. Thank you, Mary-Ann. Today, my closing remark goes to acknowledge the team that put together the IND application. You'll remember those that follow us that during midyear or at the end of the summer, we said we're pivoting, going forward with the intramuscular approach, and we needed to get on with regulatory submission and planning for a study. A team put together 104 documents and submitted this to the FDA just before Christmas. They took a breath and waited over the Christmas, New Year period and into January to see how many questions would come back from the FDA on our 104 documents. There were, in fact, no questions back from the FDA. The FDA read all of that material and endorsed what we proposed as our study, back the data, back the manufacturing. It was a Herculean effort. I'm really proud of the team that did this, and it's now moved Scancell to a pretty special place for any company, let alone a U.K. biotech company. So my last word goes to the team in Scancell and our advisers that have got us the IND in pretty damn quick time. Thank you, everyone, for listening.