Good afternoon, and welcome to the Scancell Holdings plc investor update. Throughout this recorded update, investors will be in listen-only mode. Questions are encouraged, and they can be submitted at any time by the Q&A tab situated in the right corner of your screen. Just simply type in your questions and press Send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company can review all the questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you to CEO Phil L'Huillier. Good afternoon to you, sir.
Good afternoon. Thank you, and welcome everybody to this Scancell update webinar. I'm pleased to see so many people have joined this afternoon. We appreciate the interest and the ongoing support to the company. What we plan to do this afternoon, myself and my CFO, Sath, we'll give you a presentation, a general update, of the company, and then we will take Q&A. We see quite a number of questions have been submitted, which is fantastic. We'll go through as many of those as we can and answer following the presentation. Let me kick off. I really like to get my key takeaways out, upfront in this type of presentation. It's an exciting time for Scancell. Our products are showing real benefit to patients, which is first and foremost, the reason we do this and what is important to us.
These products, particularly the SCIB product as an example, has a huge market potential. We'll show you that more shortly. We're building real momentum. There are multiple value inflection points coming through 2025, and on top of that, there's substantial value creation potential in the medium term, and we'll show you that later in the presentation. Strategic partnering has been part of Scancell's history, but it is also an important part of our future to augment the pace of what we're doing, the capabilities that we need, to go forward, and also our reach. We are now evaluating options to build greater shareholder value in the GlyMab pipeline and portfolio and platform. Let me talk more about the lead product, the SCIB product, which addresses the unmet need in melanoma. SCIB, the SCIB product offers really some quite compelling features.
It has a unique mechanism, it's off-the-shelf as a product, a needle-free delivery, and we're seeing excellent safety profile. It's a non-personalized immunotherapy. It is easy to administer and quick to administer to patients, and we're seeing in the clinic really good safety and very strong efficacy from this therapeutic. I want to just expand on the market potential here, and I'm excited to show you this slide. We have near-term potential in the market from what we're doing now in the clinic, in the SCOPE trial, but there's also really significant potential future growth. On the left, you can see we've got the two products, the first gen SCIB1 and the second gen, as I call it, the iSCIB1 product. These are near-term opportunities in unresectable melanoma. This is the advanced stage melanoma, the metastatic patient population.
If you look over on the right-hand side, you can see potential future growth. I'm really excited about the possibilities here. Future growth to the resectable population, what we call the neoadjuvant, adjuvant therapies. Beyond that, there's even the possibility of moving this vaccine towards the preventative space, even earlier stage melanoma in the patients. It's a really exciting potential today, but also in the future for this product. Drilling down a little further on the advanced melanoma landscape. We've laid out both the patient journey, so to speak, through various stages of therapy, but also the therapeutic approaches and that are available to patients at different stages. You can see on the left, we've mentioned some of the key players alongside us that are working in this area.
You start off, of course, in melanoma with an early stage of melanoma disease, where surgery can be used to remove the melanoma. That's called the resectable melanoma population. With resectable patients, they can receive a neoadjuvant therapy and an adjuvant therapy. That's really just a therapy before the surgery. In many ways, it shrinks the tumor, the surgeon removes the tumor, and then they have adjuvant therapy afterwards. That is the checkpoint immunotherapies these days that are in the neoadjuvant, adjuvant space. You can see Moderna, and probably many people know of Moderna from COVID, but also from now cancer mRNA vaccines in the middle of the slide, treating the relapse population. Scancell is down the bottom of the slide in the unresectable melanoma stage 3 and 4 patients.
These are patients where the tumor cannot be resected because unfortunately it's become metastatic and spread throughout the body. This is the population that we are currently testing the SCIB product in the SCOPE study. On the right-hand side, you can see the approved therapies in this landscape, principally the checkpoints from Merck, BMS and others, and they are the standard of care in the U.K. and in a lot of other markets. On the slide, we've also showed the patient populations as they progress through therapy to give you an indication of the market sizes that we're working in as we go into first line, and then patients progress through second line and third line. We see large market opportunities for SCIB in advanced melanoma.
As I mentioned earlier, there are also other potentials going forward in earlier lines of therapy in melanoma. This slide lays out a little bit more detail about the products and about how the products work. As I mentioned, there's the first gen SCIB1 product, which is a DNA vaccine, and it encodes two epitopes, one from gp100 and one from TRP-2. These are proteins, play a key role in melanin production in the skin, so this is very much a melanoma-specific vaccine. On the right-hand side, we have the SCIB iSCIB1+ product, the second gen product, which contains additional epitopes to treat a broader patient population, but also has some immunological tweaks to make it more potent. It has an extended patent life associated with it also.
Here's some of the data that excited us from the preclinical work from studies in the laboratory, you could say. The key points here to note are, first of all, that we have seen that the second gen product, the iSCIB1+ product, is superior in animal models to the SCIB1 product. Perhaps more importantly for today's discussion and also for the Cancer Vaccine Launch Pad partnership that we announced last week, intradermal delivery in mouse models has generated better immune responses. This is one of the key reasons why in the SCOPE study we've undertaken the cohort 4, this is intradermal delivery, and why we've also entered into the partnership with the Cancer Vaccine Launch Pad. On the bottom of the slide, this slide shows you a survival curve from one of those laboratory studies.
What you can see is that the darker line here is the iSCIB1+ product, where the survival is much greater than the other products in this animal model. A good indication that we are in a strong situation, and that was part of the dataset that led us to go into the clinic with these two products. On this slide, we have conducted a monotherapy study in adjuvant advanced melanoma setting. This data is part of the basis for saying we could contemplate moving to the earlier lines of therapy, the adjuvant, neoadjuvant and potentially one day, a preventative situation. Because in this study with this patient population, all of the patients that were treated after the surgery and with our vaccine were all still alive at 39 months.
In fact, 88% of the patients had no recurrence of disease, and this is in the monotherapy setting. To a question that was asked on the platform, why do we, and how can we claim that we're developing immunotherapies for a cancer-free future? This is part of the dataset that sets that out. Perhaps I should also say in answer to that question now, this is an ambition and in sum that we have, a mission for the company. But these datasets and the data that shows at least a 20% complete response rate in the metastatic disease give us a suggestion and support the idea that we could move to a world where we really are preventing and treating metastatic and earlier stage melanoma. Let me talk in a little bit more depth about the SCOPE study.
It's the study that's being conducted now, and it's laid out here on this slide. I think an important thing to say on this slide is there's four cohorts or four arms to this study. We've been conducting this study over 2025, and in fact, cohort one started prior to 2025. What we will generate from this study is a set of data from approximately 140 patients across 16 sites in the U.K. I'll show you those in a moment. We are treating patients with our cancer vaccine on top of immunotherapy standard of care. In cohort one, that standard of care is nivolumab and ipilimumab in 43 patients. In cohort one, we deliver the vaccine through an intramuscular needle-free administration.
This is in patients with the target haplotype, the right immune system to respond to the treatment. This cohort is fully recruited. We've shared previously 25-week data for 25 patients, and we're now collecting longer-term follow-up on patients from this cohort. In the second cohort, we added our vaccine on top of a different checkpoint, pembrolizumab. Pembrolizumab is used and approved for some patients in metastatic melanoma, and we've collected a dataset for cohort two. We've paused this cohort for now because of a change in standard of care. It was an intramuscular delivery also. Cohort three, you'll see I mentioned later that we've now successfully fully enrolled cohort. This is the second-gen product, the iSCIB1+ product on top of the double checkpoints, the ipi/nivo, and it's being delivered by intramuscular administration.
In this case, you'll remember I mentioned before, we have broadened the potential patient population that can be treated in this second-gen product. Now we have a non-target and target haplotypes, as we call them in this study. 43 patients again. Then the fourth cohort, which is just opening and is part of the recently announced NHS Cancer Vaccine Launch Pad partnership. Cohort four, the second-generation product, iSCIB1+, with ipi/nivo 43 patients, and the delivery in this case is the intradermal administration. On top of that, we are also giving what we call an accelerated immunization. Dosing the 3 doses that we believe are important for the therapy, dosing them earlier and giving them in an accelerated fashion.
These two components will be compared ultimately to the results from cohort three, where we gave on the normal administration, but also on the intramuscular administration. This study has just opened. Actually, just to let you know, now we anticipate the first patient is not far away from joining this study. I think something that's really important about the overall dataset from the SCOPE study is this study is exploratory. It helps us identify which of the two products we want to move forward towards registration, which patient population should be in that next phase of study, which are the patients that respond to the therapy, what's the right mode of administration, is it intramuscular or is it intradermal delivery, and what's the dosing schedule.
All of these pieces of data from the different cohorts builds to a picture that enables us to, in a more precise, data-driven way, design the next phase of development. This study is not about one dataset or one cohort, it's about the collective dataset from the 140 patients, testing the different aspects of the product, the patient population, the administration route, and the dosing schedule. On the right-hand slide of this side, you can see the 15 sites where we're conducting the study, where we have conducted the study for the initial cohorts. Then on the left, you can see the addition of the Cancer Vaccine Launch Pad. You can see that our existing sites, the large orange dots, but the Cancer Vaccine Launch Pad sites are the red dots.
You can see the potential here, I think by just looking at the number of red dots on there, the potential that the Cancer Vaccine Launch Pad provides to us to help us accelerate patients into the study, accelerate recruitment, but also provide our therapy that we see is working well in these patients, to patients that have a need for the therapy. We were really delighted, of course, with the announcement and the profile that has been raised with this announcement. Starting with, of course, Sir Keir Starmer mentioning the partnership, but then there was a lot of coverage, which was great for Scancell, great for the Cancer Vaccine Launch Pad and for our partnership. Perhaps first and foremost, what does this announcement do?
Because there was so much profile, we're now getting a deluge of potential patients and sites in the Cancer Vaccine Launch Pad partnership are now very keen to get involved in the study even more than were originally signed up. It's been really, really great for us to have this. This partnership and then the high profile associated with the announcement. Here's some new data that will be announced at AACR in the next couple of days. This data shows you the T-cell responses. To an immunotherapy, it's really important that a T-cell response is generated by be it a vaccine or a checkpoint therapy.
There's a lot of words and data on this slide, but I think the piece to really note most is at the bottom of the slide here, where we have listed out 16 T-cell responses. 70% of our patients are showing a good T-cell response. We're very, very pleased when we look at the response in the patients. There's a high level of T-cell response, but we're also seeing that pan out in clinical response also. This data will be shared at AACR in the next couple of days. To finish off my section on Scope, let me just remind you of the milestones and the value drivers that we set out earlier in the year. As I mentioned, we have completed recruitment for cohort 3. That was as set out and on time.
I'm pleased with that, and we're now, of course, monitoring patients for the data readouts associated with that cohort. We will, as we said earlier in the year, be sharing data on cohort one, a full dataset, in the middle of the year, and alongside that, we'll share the initial full dataset for cohort three. This data, importantly, will enable us to make decisions around which of the two products is the product that we would take forward into further development. Later in the year, as cohort four with the intradermal delivery recruits and starts to read out, we'll then be able to make decisions in cohort four on both the mode of administration and also that accelerated immunization strategy. As I said to you, the collective data set then feeds into the design detail of the next phase of development.
Let me summarize very briefly where we are on the Modi vaccine, and you'll remember, if you followed, we're testing Modi in both head and neck cancer and renal cell carcinoma. The Modi vaccine is a very different vaccine to the SCIB vaccine. It's first of all a peptide vaccine, but it targets the stress-induced post-translational modifications or citrullination in the cancer cell. The cancer cell is under stress, and this leads to a biochemical process in the cell known as autophagy, and we're able to target that process with peptides that create an immune response in the patient. As I mentioned, this is in the clinic in the ModiFY study, and we're testing in head and neck and renal or kidney cancer.
We've previously tested, as you can see at the top, safety and dose in 50 patients, and this study is now being conducted across 14 sites and will enroll over time around 120 patients. The study is, we're delivering our vaccine in combination with the standard of care checkpoint therapies, and we're looking to see an improvement in response, but also in the duration of response and in what we call progression-free survival in our patients. The head and neck cohort, you will recall, we passed the interim stage and announced that just a little while ago, and that study continues to recruit well, and we will likely read out a full cohort towards the end of the year. The renal cell carcinoma, the kidney study, we're very close to an interim readout on this study, likely to be around mid-year.
We've got enough patients recruited for that readout, so we're waiting for the patients to go through therapy and for the data to read out in that cohort. Then alongside that, I touched on neoadjuvant adjuvant therapy earlier, and we're doing a little, I'll call it a look-see, with the Modi-1 product, in head and neck in a neoadjuvant study alongside the larger cohorts in head and neck and renal. We see partial responses in the head and neck population. We passed that initial assessment phase, and at that point, we were at a 43% overall response rate at 25 weeks in seven patients. This is well above standard of care, which is 19% for pembrolizumab and 13% for nivolumab.
The second half of this study will read out towards the end of the year in December 2025. We're in good shape with the MODI study. It's an exciting, interesting product, and we're continuing to generate data from both of the cohorts, the renal cohort and the head and neck cohort. Let me turn to the final part of the pipeline, GlyMab, unique antibodies targeting sugars on cancer cells. We have a portfolio of antibodies in Scancell, and you will recall two of these have been partnered previously with Genmab, one in 2022 and one in 2024. SC129, the top of this table, shows partnering with Genmab and also SC2811. They have been partnered with Genmab. They're progressing well through development.
We get development updates from Genmab and of course, there are financial upsides associated with those partnerships and licenses. On top of that, there's a number of products here that are in-house, and we're looking to move those forward to further develop them. I know on the Proactive webinar, I stated that I was determined to see a way for us to build greater value and move forward the antibody portfolio. Perhaps to address it from that conversation, but also from questions coming up today. The company previously has struggled to have sufficient resource to develop the antibody portfolio, and it's typical of a biotech company. Investors want the investment to go into the lead assets.
The lead assets drive the value of the company, and so the trickle-down, as I call it, to the earlier stage pipeline, preclinical assets, is always a challenge. I'm determined to find the ways that we can augment the value from this antibody portfolio. There's validated assets here. These are unique assets, and there's really good opportunities here. We are evaluating, as I said upfront, the ways that we could leverage greater value to move these assets forward and potentially move these assets forward into the clinic and increase value, increase shareholder value and potential shareholder return from these assets. The lead asset that's a key part of our focus is SC134. This targets a sugar on cancer cells, fucosyl-GM1.
It's a sugar that's highly expressed on the majority of small cell lung cancer tissues, and there's very little expression of this sugar in normal human tissue. It makes it a good target. Targeting these sugars is really quite a difficult process to generate a good antibody that targets them. It's part of the secret sauce, as I call it, or the capability of the antibody team within Scancell, that they've been able to generate what we call very highly specific antibodies to these sugars that bind to the tumor form of the sugar and not to the normal form of the sugar. SC134 is an example of this. This is what we call a validated product.
BMS have a product or an antibody in clinical development, which is showing up as being a positive product. There's validation for this product. We believe we've created a better antibody, so a best in class potential here. It's well-protected from a patent perspective, and we are now working on the development of this product and looking to be able to do developability assessments to take it into the next stage of manufacturing and ultimately into the clinic. Then there are a number of other antibodies behind SC134 that are earlier, but similarly have excellent properties that could be taken forward for further development. This slide just shows you a little bit about the opportunity here.
Sadly, there's a major unmet need in small cell lung cancer, and the prognosis for patients is really poor here. Five-year survival of around 18%. There's a real need for new therapies. This therapy will target small cell lung cancer, and there's a real need for better products that can be taken forward. A significant commercial opportunity, but also a major unmet need for patients. Let me pause there. I would like to hand over to Sath to talk you through the timelines and the outlook for us.
Thank you, Phil. I will take you through our near-term milestones, including our cash runway and other growth areas too. Building on our delivery in H1 2025, we have a data-rich second half of the year coming up. There are five key data milestones. We expect full cohort 1 data with SCIB1 and full cohort 3 data with iSCIB1+, the initial data, around mid-year this calendar year. Initial data on cohort 4 testing iSCIB1+ intradermally and with accelerated dosing by the end of the year. As you will recall, recruitment to this cohort has been augmented by our partnership with the NHS Cancer Vaccine Launch Pad. On Modi-1, we expect interim readout with renal cell carcinoma in combination with checkpoint inhibitors in Q3 2025, and we expect further data with Modi-1 in head and neck cancer towards the end of this year.
In addition to these clinical programs, as Phil has highlighted, we are focused on unlocking the true potential of the GlyMab, starting with SC134 for small cell lung cancer. As you can see, there are multiple near-term value inflection points and multiple assets, which in our view diversifies our development risk too. We are in a strong financial position. Our cash runway runs through to H1 2026, with further upside potential on this runway too. For example, further milestone payments on our out-licensed assets with Genmab could extend our runway further, and there is a certain level of discretionary nature about our cash too. As we consider the right approaches of development, we will consider out-licensing, partnering, and further financing, all with timely development of these assets and shareholder value in mind.
Stepping back from that near-term focus, we wanna start demonstrating the growth potential of these assets too. We believe these can be achieved in a variety of ways. With our lead assets, we are close to entering registrational studies in advanced melanoma. In addition, as previously highlighted, we have the potential to move into the earlier neoadjuvant, adjuvant setting, addressing a larger population and potentially even the preventative vaccine space, too. With Modi-1, based on the data, we have the opportunity to progress in renal cell carcinoma and head and neck, to the next stages of development. As we demonstrate efficacy of Modi-1, we have the opportunity to move into other solid tumors too. For the antibodies, we are focused on unlocking the right value in these assets, so we are considering the options for in-house development to realize their potential.
The GlyMab platform, which is now commercially validated, is producing attractive antibodies, and we expect future antibody generation too. In closing, we are focused on the near-term potential and the value creation opportunities in the future too. We believe we can achieve these with partners through out-licensing and through in-house development too. Lots to look forward to. With that, thank you for listening and your ongoing support. We will hand back to the operator who will take us through to the question and answer session.
That's great. Phil, Sath, thank you very much for your presentation. Ladies and gentlemen, please you can continue to submit your questions, which you can do so just by using the Q&A tab that's situated on the top right-hand corner of your screen. Just while the company takes a few moments to view the questions that have been submitted today, I'd like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via your investor dashboard. As you can see, we have received a number of questions both pre-submitted and throughout today's live presentation. Mandeep, at this point, if I can hand over to you to chair the Q&A, that'd be great, and I'll pick up from you at the end.
Thank you, and good afternoon. As mentioned, we have collated some of the pre-submitted questions and we'll address these in this session. First one for Sath. Can you please restate how your funding is going to play out over the next two years? And is there any chance shareholders will not be asked again to support a dilutive placing?
Thank you. I'd like to reiterate, I think Scancell is in a strong financial position, with upside opportunities in our cash runway too. Our cash runway extends beyond value inflection points on both the SCOPE and ModiFY study. We continuously explore, as a management team and as a board, what our options are for the next stages of development and how best to achieve that. One of the key considerations is shareholder value. I think there is a chance that it could be non-dilutive, but we are considering all options on the table, all with good development in mind for all our assets.
Thank you. The next one may be for you, Phil. I have heard it said that oncology companies in phase II trials have a 90% chance of failure. How does Scancell see its risks so far?
Thank you for the question. I think the first thing I'd say is clinical development, whether it's in pharma or in a biotech company, has risks associated with it. I often say as we go through development, we wring out the risk. An example of that is when you start clinical development in phase I, you really have both the safety risk and the efficacy risk. You don't know whether your drug at that stage is safe or is efficacious. We've already wring out those risks. We know we've got good safety, we know we've got good efficacy. On top of that, I would say that we have strong belief in the products that we're developing.
That in part comes from the very strong underlying science, the immunology and translational science in Scancell, but also as we go through the studies, we're also endeavoring to just understand how our products are working, which helps us then build on the products as we move forward.
Back to you, Sath. Why is the share price dropping with good news?
It's a tricky one to answer. I think there's probably a multitude of factors. Firstly, I'd say it doesn't always react badly because our recent news, the share price has trended upwards. We do analyze our shareholder register on a regular basis, and a lot of the volume on high volume days are traded by the retail investors. Combined with low liquidity on certain days, it introduces volatility to our share price.
What I would add is our institutional investors mainly are keeping their holdings steady, and as we approach our value inflection points and data, I hope our share price reflects the true value of the company. Our consensus target price is 25p across all of our covering analysts, even before those value inflection points. I'm hoping with investors and attracting the right investors who hold us for our potential, we should see the share price moving in the right direction.
How will shareholders prosper from your NHS filing?
Perhaps the first thing to say here is, I see the Cancer Vaccine Launch Pad partnership as fantastic validation of Scancell's science, but also of the medicines that we're creating and the benefit to patients that they're achieving. As I've said previously, it's fantastic to see a British biotech company making its experimental medicines available to patients in the U.K. We're the first U.K. company, and this is the first DNA vaccine that has been available through the Cancer Vaccine Launch Pad to patients. Shareholders will benefit or prosper from this partnership because it accelerates access to patients for us. It'll accelerate our clinical development. You could say time is money in these situations, but it will also potentially give us access to greater patients in this study, but also in future studies.
Scancell is now developing antibodies in-house. What have you discovered recently that has led to a stronger focus on in-house development?
We've always been very strong believers in the GlyMab platform and in the GlyMab antibodies that have been generated. The partnerships with Genmab provide industry validation that these are valuable assets. The company has not been able to apply sufficient resources into develop in-house these assets in the past and has partnered for further development. Now, we're determined to bring resources in-house and through partnership to be able to develop these products further, create greater value for shareholders and then potentially partner these products further through development.
What are the clinical expectations for SCIB2 and Modi-2?
SCIB2 and Modi-2 are products, second products from the respective platforms. These products have been developed through a preclinical early stage and are effectively on the shelf, ready to go into manufacturing for further development. At this stage, we're applying our resource to the lead programs, iSCIB1+, SCIB1, and Modi-1. To me, and I go back to the days I was a buyer in a pharma company, when you look at the situation in a biotech company, you're looking at the platform and the products. The measure of a platform is how good are the lead products out of the platform. If the lead products are good, then you know the platform is a good prospect for generating more products.
That was a long-winded way of saying we need to really validate these lead products, Modi-1 and iSCIB1+, first and foremost, as we're doing in these studies. That then creates value, additional value for the platforms, and then those two products, SCIB2 and Modi-2, become potentially more valuable development opportunities for Scancell or partnering opportunities that we can partner with the pharmaceutical industry.
What guidance can you give on the number of NDAs signed in relation to SCIB1, iSCIB1+ trial data, and what are the partnering options for the registrational trial? As a follow-on question to that as well, is there a preference for the location of these trials, and what are the expectations for achieving fast-track registrations in the U.K. and/or U.S.A.?
Okay. A few parts to that question, and Mandy, keep me honest to make sure I answer all parts of this question. So the first part, can I give a number of NDAs that have been signed? I take that as a crafty way of asking me how we're going with our business development activities. The first thing I'd say is I'm too long in the tooth in BD to share anything that puts conversations with companies at risk. So that's not something that I would reveal. But what I can say is we are, of course, actively in conversation with pharma that are in the immunotherapy space, but also with major biotechs that also work in this space. Sharing what we're doing, sharing data updates, and exploring the possibilities of partnerships in various forms.
The second part of the question was around the preference for the location of these trials. The next phase of development is randomized studies, be it an adaptive IIb/III or a randomized IIb study. They're larger studies and to me, first and foremost, I'd say it's really important that we get into the U.S. with a portion of patients in the study. That's filing an IND with the FDA and executing some of the study in clinical centers in the U.S. Of course, we want to continue here in the U.K. if funding, infrastructure, and support is available, and then add additional regions, such as Europe, such as Australia. Melanoma unfortunately is a serious problem in Australia.
A number of countries outside the U.S. and the U.K. that we're likely to expand into for the future studies. Then the last part of that question was the Fast Track possibilities. Absolutely. Under the FDA processes, there's both an Accelerated Approval path, there's a Fast Track path, and a Breakthrough designation. We are exploring, as data emerges, all of those options that could help us accelerate our development. In fact, to this end, recently we've brought on board a very experienced regulatory person who has recent experience with working with the FDA on these sorts of processes, but also working with the European regulators. We're exploring the possibilities for faster regulatory paths. These paths are data-dependent, and it does depend on the data that comes out of the studies.
For Modi-2, if you were able to release strong preclinical data to justify it going into the trial, you will also be releasing preclinical data on SC134. Will you also be releasing preclinical data on SC134 to justify taking it to trial?
We will publish data and in fact, some data may have already been published. I'd have to go back and check for SC-134. We will share preclinical data through conference presentations and discussions at conferences. There are aspects of the program, the features of the antibody and some of the data that we would also keep confidential because I don't want to enable a competitor to be able to replicate what we're doing. It's a combination of things, publishing through scientific journals, presenting at conferences, sharing with investors through announcements. I have to say there is some information that I would ask the team to keep confidential because it's too enabling to competitors.
I'm going to jump to some of the questions that I've prepared during the session. Given the turbulence, this one's from Mike M. "Given the turbulent background in the U.S. at the moment, especially with regards to planned or ongoing headcount reductions at the FDA, are you currently able to engage with regulators in the normal way you'd expect whilst advancing your lead program?
Yes, that's a very good question. It's a turbulent time for potential financing, potential partnership, but also with the regulators in the U.S. I, of course, keep my ear very close to the ground across the industry. At this stage, I'm not hearing from people that are engaging with the FDA now of major problems getting INDs and other processes through. So far, it's looking reasonably positive. Other commentators that I've talked with have indicated that perhaps we will see a little bit of streamlining out of the processes that are happening here. I haven't heard from my sources anything at this stage that really worries me in relation to us going forward with the FDA. Of course, it is a turbulent time.
The other aspect of this that I would say is we, as a company, have to look at how we mitigate any potential risk with the FDA in the U.S. by exploring those other geographies that I talked about earlier. Do we go into Europe earlier and quicker, the U.K., Australia, Switzerland? Make sure we are also progressing in those geographies through those regulators, which could help us mitigate potential risk if it's there with the FDA.
One from another listener: "Does iSCIB1+ have Orphan Drug Designation?
We're looking at getting Orphan Drug status. That's also an option available to us with the regulator. That's something that we're evaluating.
One from John G: "Why do we focus on the hard end of the success, namely stage three and four? Wouldn't our results look better if we approached early stages of melanoma?
That's a very good question. There's an element of truth in that, of course, earlier stages are easier to treat. Earlier stages are also treated with surgery, the resectable population. There's a lot of competition in the earlier stages. To some extent, the way one develops a medicine like this is you're driven by regulators saying that you need to take the late-stage last line patients, where the unmet need is the highest, test your medicine there, and if it's proved safe and efficacious, move to the earlier stages of development. It's a little bit driven by the regulatory strategy as well.
This could possibly be the last one for Sath. "Are there other institutional investors looking to get on board? Do they need a placing to get a suitable chunk of shares?
I do expect, I think we are generating a bit of interest, particularly among institutional investors, both in the U.K. and Europe, as well as the U.S. We're in regular contact and regular dialogue. I think there's different ways that they can get access to our shares. Buying in the open market is one, or waiting for other opportunities or block buying is another way. We're in constant conversations. We're generating some interest. We are exploring ways about how we can get those investors on board at the right time, but with shareholder value in mind and our existing shareholders in mind, too. Generating good interest, and we'll keep an eye on how we can get them in.
Thank you. I think that now concludes the Q&A session. We will endeavor to answer all the questions that have been submitted so far, and I will now hand back to Phil to summarize.
Thank you. Just a couple of concluding remarks. Let me say, first of all, again, echo the comments. Thank you for joining. Thank you for your ongoing support. It's an exciting time for Scancell. Built on, I have to say, acknowledge the work that Lindy and the team have done over many years, building on strong science, exciting products, and we're now seeing the fruits of all of that effort in the clinic. We've built an enormous momentum. We'll create multiple value inflection points through this year. I hope from today you see that we see a much greater upside in the future from these products as well. Thank you for listening, and as Mandeep said, we'll endeavor to answer other questions that we haven't following this webinar.
That's great. Phil, Sath, Mandeep, thank you very much for updating investors today. Could I please ask investors now to close this session, as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. On behalf of the management team of Scancell Holdings PLC, we'd like to thank you for attending today's presentation, and good afternoon to you.