Good morning, everyone, and thank you for joining the 2026 H.C. Wainwright 28th Annual Global Investment Conference. My name is Dr. Jade Montgomery, an associate research analyst at H.C. Wainwright, and I'm happy today to introduce our presenter for this session, Dr. Phil L'Huillier, CEO of Scancell Holdings. Dr. L'Huillier? Thank you, Jade. Firstly, thank you to the H.C. Wainwright team for the opportunity to present Scancell to you today. I'm Phil L'Huillier, CEO of Scancell, and I'm joined by my colleague, David Schilansky, our interim CFO. We're excited to present Scancell to you today. We've specifically titled this presentation Ready for Prime Time, because what we've achieved over the last nearly a decade, developing the platforms that we have inside the company, we've made enormous progress and are really ready to accelerate development of those programs, the lead program to registration. This is our forward-looking state. Here's our forward-looking statement just for the record. Let me start with this slide here to show you the three pillars of our investment proposition. The first is really around the lead program known as iSCIB1+. It's an off-the-shelf, phase III-ready cancer vaccine. In a large phase II study, I'll show you some data shortly, we've seen compelling clinical evidence across a number of clinical endpoints. On this slide, I've focused on the PFS readout because that's the readout that we've been granted a chance for Accelerated Approval with the FDA. At 22 months in the study, we're seeing a 77% PFS for the iSCIB1+ added on top of Ipi/Nivo. If you compare that to the CheckMate 067 study, the registrational study for Ipi/Nivo, at the same time point, the PFS was 43%. So I sometimes say a whopping 34% delta there. A really significant overall PFS improvement. There's also a favorable safety profile with the product. It is a potential best-in-class opportunity in advanced melanoma with a defined regulatory path towards a global phase III registrational study that we're aiming to kick off later this year. Earlier in the development of this product, we ran a dose escalation phase I, a monotherapy study in resectable melanoma patients and saw some good evidence of responses in a small population. This is the basis on which we also think there's an expansion opportunity for the product into the perioperative or neoadjuvant/adjuvant setting. We deliver this device to patients with a needle-free intramuscular delivery. As I mentioned, it's an off-the-shelf product. It's convenient to deliver to the patients, and it's generating these really quite compelling clinical responses. The second pillar to our investment proposition is the pipeline coming along behind this lead program. iSCIB1+ comes out of the Immunobody platform, and this platform is now validated based on the lead in melanoma, but we are now also building out other products from this platform to go after hard-to-treat cancers and targets that are difficult to target, such as PDAC cancer, pancreatic non-small cell, and colorectal cancer. Other products in early stage being developed from this validated platform. We have a second product, a peptide vaccine, Moditope, in phase II in head and neck and renal, also progressing, and we will see some readouts from this study later this year. Then the same cancer immunology discovery expertise has been applied to develop a set of antibodies that target the sugars on tumor cells, the glycans, anti-tumor glycans. We have partnered two of these antibodies with Genmab, and they are taking it forward in development as ADCs, but we also have a small portfolio in-house that we develop as T-cell engagers. Then the third pillar to our strategy is we are well-financed now to move the lead program through the registrational study. In July, we announced a merger with Neuphoria Therapeutics, and that will give us, when we close this later in the year, a total of $95 million, which gives us runway through to early 2029 and beyond the interim readout for the phase III study. It also gives us a Nasdaq listing. We have some near-term catalysts from initiating the phase III, from further data readouts and maturity from the phase II that I have just talked about, but we will also add this neoadjuvant/adjuvant study that will give us additional news flow and data readouts while the phase III is running in the background. This slide summarizes the pipeline. I think I have talked through the other assets in the pipeline, but just to say, beyond the lead program going into phase III later this year, I see the other assets in the pipeline as potential collaboration opportunities, news flow, and potentially non-dilutive funding opportunities. Let me move to the lead program, iSCIB1+, in front-line advanced melanoma. The first thing that I should say here is I am delighted to now see immune priming plus checkpoint blockade is now a proven strategy in melanoma. You probably all saw the news from Merck and Moderna in the adjuvant setting, demonstrating that cancer vaccine plus checkpoint blockade met its primary endpoints in the phase III study. We are looking forward to see that data at ESMO in October. That demonstrates the concept of the cancer vaccine plus a checkpoint blockade in the resectable melanoma setting. We are in the unresectable advanced stage disease, and that is a substantial opportunity for this mechanism. There is about 10% of stage three patients and 85% of stage four patients that are at primary diagnosis are unresectable. Plus, of course, the market opportunity is expanded by patients that relapse on earlier therapies. The mechanism of iSCIB1+, our off-the-shelf product, drives a very similar T-cell response to the personalized neoantigen approaches. We deliver six epitopes in our product, and it generates a T-cell response across all six epitopes. These epitopes were identified from patients that had spontaneously recovered from melanoma. The mechanism delivered through cross-presentation overcomes some of the traditional limitations of the cancer vaccine approach, and it specifically drives towards the high avidity T-cell response that correlates very well with the clinical response. Interestingly, in comparison with the neoantigen approach, we are in fact seeing very parallel mechanisms but very different product opportunities. We generate high avidity CD8 T-cell responses, and we have also put in the product epitopes to deliver a CD4 helper T-cell response to have the opportunity to modify the tumor microenvironment. Here is a little bit more detail on the product. I will not spend too long on this, but just to say our product is delivered as a plasmid DNA molecule. It encodes for a modified antibody. We have modified the CDR regions of the antibody and inserted epitopes to two antigens, GP100 and TRP2, and the antibody scaffold delivers to the immune system these two antigens. We deliver it with a device, and I will show you that in a moment. It is taken up by both muscle cells and via binding to the CD64 receptor dendritic cells. Of course, then is internalized, the plasmid DNA is transcribed, translated, and presented on MHC class I and class II, giving us our CD8 killer T-cells, but also our CD4 helper T-cells. We deliver this product in combination with checkpoint blockade in the advanced disease setting with a high tumor burden. We believe that the T-cells need protection from exhaustion, and that is what the checkpoint therapies give. So it is very much a synergistic mechanism. This is the device that delivers the product, a quick jab in the shoulders and the two thighs, a device that we have in partnership with PharmaJet. The device has broad regulatory approval, and we have a development and commercialization agreement. Some of our phase II data from a large study in the U.K. that we conducted across 132 patients. A pretty typical inclusion criteria in this type of study, and there were four cohorts of patients in the study. The first two were a first-generation product restricted to HLA-A2 patients. The second two cohorts in the bottom of the slide there were the second-gen product that had application to a wider patient population, and this is the product that we are going to take forward into the phase III. The newer product, of course, also has a much longer patent life. Some trial population characteristics, a lot of data on this side. The take home message is our trial population is very similar to some of the historic other studies in melanoma, such as the CheckMate 067 study and some of the more recent phase III studies. So we can benchmark our data alongside some of these other studies. Here is a readout of the data. The dark blue and the green column are our data. The first column is from the whole cohort of patients across the study where we saw a response rate of 62% and a disease control rate of 81%. If you scan across the comparator studies there, you can see that we are a good delta over some recent studies, but also some historic studies for overall response and for disease control rate. The more important part, the PFS readout from the Kaplan-Meier curve here shows you a 77% progression-free survival at 22 months for iSCIB1+ on top of Ipi/Nivo. We have overlaid on this the CheckMate 067 curve for Ipi/Nivo from the registrational study, and you can see the divergence of the curves progressing over time. Really very positive response rate, disease control rate, and PFS from this data. We will have more mature PFS and some updates on the OS from this study in the first half of 2027. Some data showing you the T-cell responses, and really this is to say to you, we are seeing, with respect to T-cell responses, what we would expect for the product in the patients. A T-cell response to all six epitopes, to the two antigens from the patients, and a significant response in T-cells. The T-cell response correlates very positively with clinical response, particularly complete responses and partial responses. We are seeing the emergence over time, and after a number of vaccinations, a memory T-cell response emerging as we would expect for this type of product. The safety profile, iSCIB1+ is well-tolerated, and there is no increase in the checkpoint blockade-related toxicity. Three take-home messages here. One, only low-grade and transient AEs for SCIB or iSCIB1+. The standard array of AEs for Ipi/Nivo that have been reported over the last decade or so. Perhaps most importantly, we see no potentiation of those AEs for Ipi/Nivo by adding iSCIB1+ on top. A combination that is very well tolerated. Let me move forward and show you our plans for the phase III study. We have an Accelerated Approval opportunity granted by the FDA and clearance for the study from the FDA. It is a phase III double-blind and randomized study. Around 550 patients across 90 global sites. The same trial population in the phase III as we used in the phase II, and a two-arm study, 275 patients in each arm, placebo controlled control arm, and then 8 mg of iSCIB1+ delivered the same dose and the same dose schedule as was used in the phase II. We have the opportunity for an Accelerated Approval at an interim readout based on a primary PFS readout. The FDA have asked that we share overall survival data at a descriptive level at that point to be considered for Accelerated Approval. We follow up the study, of course, for the full PFS readout and more mature overall survival readout. This slide illustrates the thoughtful work we have done around looking how we can de-risk the study. First of all, in the phase II, we did a lot of work around dose and dose scheduling. We have really optimized the dose and dose scheduling in conjunction with the checkpoint therapies. We go into this phase III study in a defined population and have a selection marker to select for the patient population where we saw the most efficacy in the phase II, and that represents 80% of advanced melanoma patients. On the trial design, the stats, and the adaptive design, we have been conservative in our delta and in our stats proposal for the study, and then have a, what I call a what if factor. We do not quite hit what we expect, then we have an adaptive feature in the study that we can add additional patients at the interim readout and run the readout, the mature readout, for longer to maximize the probability of hitting statistical significance. Then finally, we have done a lot of work around subpopulations in advanced melanoma where immune therapies are less efficacious, and we have used that analysis to answer two questions. Firstly, how does iSCIB1+ impact in these less efficacious populations? We see a benefit across all of those populations. These are things like BRAF status, PDL1 low, prior checkpoint therapy, those types of factors. Then secondly, we have used this data to work out which factors to stratify in the phase III. So detailed planning for our phase III study, then we have the defined regulatory path. The IND was cleared in Q1 2026. We have been granted Fast Track designation. We have just had our CTA cleared in the U.K. at the MHRA, and we have submitted in Europe. So really on track for our regulatory path. We anticipate first patient in towards the end of the year, then it is an 18-24 month recruitment time, so we anticipate late 2028, early 2029, being in a position for the first interim readout from the study. As I mentioned to you at the beginning, we will have cash on closing of the merger through beyond this interim readout. Let me quickly turn and show you the earlier data from the phase I study and the rationale for planning a neoadjuvant adjuvant study. A lot of detail here, but this was a monotherapy study with the first-generation product in the resectable melanoma patients. We had a set of patients that had resection and had some tumor at baseline. We saw some responses in those patients, and we had 20 patients that received two doses that had full resection. These patients are on this slide, and it is perhaps the Kaplan-Meier curve that is the one to look at. Recurrence-free survival at the 39-month cutoff was 75% as a monotherapy with SCIB1. That compares very favorably with current standard of care, surgery plus pembro, which is about 63%. So we have the evidence here to move this forward and are proposing to kick off a randomized perioperative study in the resectable setting. This would be an open label phase II study comparing iSCIB1+ compared to pembro plus iSCIB1+ and pembro alone. This is given as a neoadjuvant therapy for 13 weeks. Patients will receive surgery, and we will look at a path response at that point, and then the same three therapies are continued in the adjuvant setting. We plan to kick this study off in the first half of 2027, and as it is open label, we will see some readouts from the neoadjuvant stage, later 2027, early 2028, while the phase III study is running in the background. The commercial opportunity is clear, I think, as I talked to you earlier, in the advanced melanoma setting, immunotherapies do work. But about half the patients either do not respond or relapse very quickly. Five-year survival is around 23%, so there is a significant opportunity for a therapy that gives robust responses and long-lasting responses, and that is what we have built iSCIB1+ to do. This product is an off-the-shelf one product for all patients. We need no starting material. We have the product stored in the freezer, ready for the patients. There is an optimized mechanism and treatment window, and it is easy to administer with the device I showed you through our partnership with PharmaJet. There are no constraints to scale here. So a very different proposition as an off-the-shelf product. We are also seeing with our product a very similar immune response. Here is the commercial opportunity. Firstly, in the U.S., in the cutaneous melanoma, there are about 112,000 patients diagnosed each year with melanoma. If I drop down to the advanced setting, you can see in the blue boxes there, it is about 8,000 patients are unresectable at first diagnosis, and then there is an additional 10,000 that come through from relapse after surgery or relapse after therapy. Our part of that population is about 14,000 patients in the U.S. If I look more broadly globally, there are another 12,000 patients. So in the advanced setting, there is a large market opportunity that is undiminished going forward. iSCIB1+ has the growth potential in a number of other smaller melanoma indications, uveal, acral, and mucosal melanoma, and the two antigens are also expressed in glioblastoma. So a real blockbuster potential here for this product. This is the team that is executing within Scancell. You have just met myself and David. The founder is Professor Lindy Durrant, founder and developer of the platforms, and we have got a strong team that is delivering on execution. This team will take over leadership of the combined company once we complete the merger with Neuphoria Therapeutics. We have delivered on what we have set out to the market in 2025 and early 2026, and we have mapped out here some key milestones and development plans to give us the opportunity of news flow, non-diluting funding, and also key clinical readouts for the neoadjuvant/adjuvant study and the phase III readout late 2028, early 2029. We have the capital, once we close the merger, to be able to get to that interim readout for the phase III and a little beyond. So we have got a product that is delivering deep and durable responses, and we are taking that into phase III. It is an off-the-shelf product, mechanistically delivering strong immune responses and showing strong clinical benefit. We have got a defined path with the regulators globally for that product to run the phase III study, and then it provides a significant commercial opportunity in the advanced setting, in potentially the earlier resectable setting, and in other melanoma and disease conditions. Thank you.
Loading workspace