Scancell Holdings plc (AIM:SCLP)
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May 6, 2026, 4:28 PM GMT
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Status update

Jun 25, 2025

Operator

Good morning and welcome to the Scancell Holdings PLC Clinical and Corporate Update. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged, and they can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Simply type in your questions and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company can review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I would like to submit the following poll. I would now like to hand you over to CEO, Phil L'Huillier. Good morning to you.

Phil L'Huillier
CEO, Scancell Holdings PLC

Good morning and welcome to everybody joining the Scancell update. I'm Phil L'Huillier , CEO of Scancell, and today I'm joined by our CMO, Nermeen, but also later our CFO, Sath will join for the Q&A. As an organization, we are building strong momentum across key areas of the business. Today, we want to give you an update on two of those key areas. The clinical program, the SCOPE study, an update on the design and where we are with the SCOPE study, but also a corporate update. Today we're announcing the formation of a wholly-owned subsidiary company of Scancell, GlyMab Therapeutics, which will house our antibody portfolio and enable us to unlock greater value in the portfolio by taking this step. We'll come back and talk to you about this later in the presentation.

Before I hand over to Nermeen, I just want to remind you of where we are with our key timelines. We continue to make strong momentum in our SCOPE study, but also in the ModiFY study. We told you that we would make key announcements of data in the middle of the year, and we are on track to do that. Today we're announcing that we will be sharing data later in July for the first cohorts of the SCOPE study, and we are on track to re-release data for cohort four towards the end of the year. The ModiFY study with Modi-1 in renal and head and neck cancer remains on track, and we'll be sharing data from those cohorts later in the year.

As I mentioned, with the antibody portfolio, we are today announcing the formation of a spin-out company, GlyMab Therapeutics. We are also making great progress on the lead asset, SC134, towards IND. We are making progress on our discussions with Genmab for future milestones from the existing partnered assets. Nermeen, I'd like to hand over to you now to talk us through the clinical update for the SCOPE study. Before we do that, you're new to these investor conversations, so could I ask you to just briefly introduce yourself. You bring deep late-stage clinical strategy and execution expertise to Scancell. Just a brief intro, and then I can hand over to you to go through the slides.

Nermeen Varawalla
CMO, Scancell Holdings PLC

Thank you very much, Phil, and good morning, everyone. It's a great pleasure to be on this call, and I'm very happy to have this opportunity. As you've heard, my name is Dr. Nermeen Varawalla, and I've had the privilege and pleasure of serving as Scancell's Chief Medical Officer for now 10 months, and these have been busy 10 months. What I bring to Scancell is my expertise in global clinical development. I have an MD and a DPhil PhD from the University of Oxford in molecular medicine, and over 20 years experience in drug development. I have worked both in the CRO sector as well as for Big Pharma and biotech across a number of therapeutic areas as well as treatment types. I worked in medical devices, biologicals, new chemical entities.

It is this experience in global clinical development, including taking studies all the way to registration, that I'm very pleased to apply at Scancell. We've made some great strengths and additions to the clinical operations, to our systems and processes, as well as developed our strategies for developing our very exciting portfolio of vaccines. It is some of this, these findings and our thoughts and plans that I look forward to sharing with you this afternoon. With that, let me move on to our first slide, and I'm hoping you can all see this slide very clearly. This presentation will really focus on SCIB1 and iSCIB1+. As you know, this is Scancell's ImmunoBody DNA plasmid vaccine, which has the potential to create a new standard of care for melanoma.

For those of you not very familiar with the disease, let me just remind you that there continues to be an unmet need. There are, give or take, 58,000 deaths per year from this disease. Although the checkpoint inhibitors, which are now approved therapies both for advanced as well as early-stage disease, although they have changed the landscape, 50% or so patients treated with these therapies are refractory or soon relapse, i.e., there continues to be a large group of patients that are not fully served by checkpoint inhibitors. As a result, the five-year survival rate from stage four melanoma is unfortunately less than 23%.

Scancell's therapies are well suited to change the treatment outcomes for this disease by both being applied in the advanced phase, that is for unresectable disease, along with checkpoint inhibitors, as well as we believe there is a potential for it to be used in the adjuvant/neoadjuvant space. Now, if I may, let me just set the scene by reminding you that ours is an off-the-shelf DNA vaccine, which is administered by needle-free injection using our PharmaJet device. I will share with you two key quotes from our panel of world-class key opinion leaders and advisors that substantiate what I've just said.

We recently held a very successful SCOPE Investigator meeting where we assembled our 16 U.K. investigators, that panel is led by Professor Heather Shaw. At this meeting, the consensus that emerged was that SCIB1 and iSCIB1+ appear to offer the potential to redefine disease outcomes in patients with advanced melanoma by significantly improving the response rate to the standard of care treatment with double checkpoint inhibitors, and very importantly, without the burden of treatment-associated toxicity and the important benefit of a durable recurrence-free response. Some of this early data I will share with you this afternoon.

The second quote that I'd like to share with you is from Professor Sapna Patel at the University of Colorado and Chair of the SWOG Melanoma Committee, who's one of the world's key opinion leaders in the area of early-stage treatments for melanoma. She says, "In view of the emerging SCIB1/iSCIB1+ efficacy and safety data, there's an exciting opportunity to evaluate its application in the neoadjuvant-adjuvant setting for the management of resected early-stage melanoma so as to further increase the number of patients who become cancer-free." Let me now share with you where we are with our SCOPE clinical development program.

This program is for SCIB1/iSCIB1+, which is being our treatment population are patients with advanced unresectable melanoma, where the therapy or vaccines are being given in combination with standard of care checkpoint inhibitors. It's a phase II open-label study which is being conducted at 16 U.K. clinical trial sites, enrolling over 140 patients. The purpose of this program, which is a, is to select the best product, the best and most appropriate patient population, their HLA type, the mode of administration, and dosing schedule for the most advantageous design of the follow-on phase IIb/III randomized controlled registration trial.

As I'll show you in a minute, we now have the evidence that we are able to elicit the efficacy and safety that we expect from our vaccines, and the question for us is how do we design the most effective therapy to take this to take the vaccine onwards to registration? You can see there the list of the inclusion/exclusion criteria. I'm not gonna dwell on it, except to say that we're excluding, as you would expect, patients with acral and mucosal melanoma, those who have active CNS metastasis, and those who had exposure to checkpoint inhibition in the previous six months. The way I'd like you to think about this program is the first step of it, is we've have.

We've trialed SCIB1, which is our first-generation vaccine, administered along with standard of care, ipi and nivo, in 43 patients, all of which have a restricted HLA haplotype, namely A2 positive and one of the other haplotypes that you see listed on the slide. Cohort 2 has a similar design, except here the standard of care is pembro. In this cohort, we've enrolled 10 patients. One of the reasons why this cohort is slightly smaller in size or smaller in size is because of the changing standard of care in the U.K. with respect to the choice of checkpoint inhibition for this group of patients. Cohort 3 or step 3 is when we have introduced our next-generation vaccine, iSCIB1+.

What's exciting about the design of iSCIB1+ is that by the addition of additional epitopes, we are exploring and evaluating the option to increase the patient population in terms of their HLA type, who might be eligible for the vaccine. Also, by the addition of an adjuvant, we believe that the immune response driven by iSCIB1+ will be superior to SCIB1. This is what we are evaluating in Cohort 3. We have enrolled 50 patients, and these include those with the target haplotype that I've described before, as well as patients with a wider haplotype. It is this analysis of this data that will allow us to widen the target population in which the vaccine could be used. In addition, the final cohort is step 4, our Cohort 4.

Here there are two additions we've made. One is where we are continuing with iSCIB1+, our next generation vaccine. We are continuing to enroll patients with a larger haplotype so that we can understand which group of patients with which haplotype would be eligible for the vaccine. Importantly, these are the two differentiators. One is we are administering the vaccine intradermally, and that's because on the basis of our preclinical data, there is a suggestion that the activation and the presentation of the vaccine to the antigen-presenting dendritic cells would be, could be superior with the intradermal route. It is this that we seek to evaluate. The other important change is we're introducing what we are calling an accelerated dosing schedule.

In this schedule we will dose our patients, and indeed we started dosing our patients with 3 priming doses given in quick succession at weeks 0, 1, and 3. By doing this, we believe that we will be able to elicit a stronger priming response, which will then be followed up with a booster dose at week 7, also, importantly, address this group of patients who tend to have a delayed or missed second dose because of the side effects that they experience from their checkpoint inhibition that often requires administration of steroids. We are optimistic that by introducing this accelerated dosing, we will take care of both these requirements and therefore even further improve the response.

I'm pleased to say that step four, Cohort 4 is enrolling very well, and we've completed the preliminary safety check associated with sentinel dosing, and we are rapidly enrolling patients into this cohort. Just to remind you that with this, from all these patients, what we are seeking and looking to do is improve the reported overall response rate that is reported with double checkpoint inhibition. That's the primary endpoint. Also we want to get a steer on our secondary endpoints, which is the duration of response, PFS, overall safety, progression-free survival, overall survival, and safety and tolerability. Of course, it is these endpoints that will be critical for our registration study.

In order to accelerate the enrollment in Cohort 4, we've been thrilled and delighted to be able to set up a partnership with the Cancer Vaccine Launch Pad of our NHS. The benefit of this is that this allows patients in England and Wales who are eligible for our study to have their HLA typing and if eligible from peripheral clinical trial centers across the country, be then referred to one of our 16 clinical trial sites. We believe that this will further accelerate enrollment and therefore enable us to get the readouts that we need to progress to the phase IIb/III trial.

As many of you may be aware that our partnership with CVLP received a positive recognition throughout the national press, and we've been pleased with that as we now eagerly await to enroll patients that come through this partnership. Let me now share with you some preliminary data of patients from Cohort 1. These are patients who have received our first-generation vaccine, SCIB1. These are still HLA-restricted patients, and SCIB1 has been administered intramuscularly. Here you see in the first 25 patients, we are reporting at 25 weeks, their best response by RECIST 1.1 scanning. You see a very promising 72% overall response rate.

Alongside this, you also see, which is really important, the T cell responses in these patients. You can see that we have obtained data. We've demonstrated broad immunogenicity of SCIB1+, across a number of epitopes, and 70% of our patients have demonstrated a T cell response, and very importantly, the T cell response correlates with the clinical response. This gives us a very nice and important validation of the mechanism of action of the vaccine. Also in patients of Cohort 1 SCIB1 who've received SCIB1, we are pleased to report that the safety profile has been confirmed to be excellent. You can see that there are very few grade three and four toxicities. There's been nothing to suggest.

In this cohort that the addition of the vaccine in any way increases the toxicity that's associated with checkpoint inhibitors, and most of these side effects have been very easily managed. With that, I'm pleased to confirm that we are well on track for our development pathway for SCIB1 and iSCIB1+, and in due course, through the course of the year, I look forward to sharing with you data from the full Cohort 3 as well as the initial Cohort 4 data, which, as I've been describing, should place us very well to design the most effective registration study. Thank you for your attention, and with that, I will hand you back to Phil.

Phil L'Huillier
CEO, Scancell Holdings PLC

Thank you, Nermeen. Just to let everybody know, Nermeen is joining us for the questions at the end. So feel free to send in questions that you might have of Nermeen or of any of us. I want to turn to the corporate update now, and I want to focus on the announcement we made this morning to form GlyMab Therapeutics. What I'd like to do is to talk you through what it is. What is the rationale for doing it, and what's the initial execution plan? We're in the fortunate situation, you could say, of having a diversity and a breadth of assets, and that these assets are being progressed very well, particularly the clinical assets, but also the lead antibody asset, SC134.

With this set of assets, we want to create the opportunity to grow the value, particularly of the preclinical assets, through the formation of GlyMab Therapeutics. On this slide, we've laid out what it is. First and foremost, at this stage, GlyMab Therapeutics Limited is a wholly owned subsidiary of Scancell, as we mentioned, to create greater value from this antibody portfolio and capability. What's here, most importantly, I think, is the assets, but also the platform and the expertise that's been developed by Lindy Durrant and her team. It's the ability to generate high affinity and high specificity IgG1 antibodies to these glycans, the specific sugars on tumor cells. Typically, it's very challenging to create such antibodies due to the complexity of the sugars, but also due to the low immunogenicity of these sugars on the tumor cells.

Lindy and her team have worked out how to do this on an ongoing or on a repeated basis, and that's the secret sauce that created the GlyMab platform, and that will become part of GlyMab Therapeutics. Equally, there are assets and the lead asset, as I mentioned, SC134, we're developing as a T-cell engager, bispecific. It's a best-in-class targeting small cell lung cancer. There's clinical validation for this target, so that places us well to move forward our program towards IND and into the clinic. As you of course know, the platform has validation from the two partnered assets that we have with Genmab. Finally, there's a strong both a product and platform patent position, and the patents related to these products and the platform will in time be transferred to GlyMab Therapeutics. That's what it is.

Let me share with you some of the rationale for doing this. Scancell is fortunate to have this breadth and diversity of assets, but also fortunate that the clinical assets, as well as the preclinical assets, are progressing very well. It's emerging that really we have two distinct business lines or businesses in one here, the clinical-stage immunotherapies and the preclinical antibody assets and platform. We're at a point of wanting to unlock much greater value in the antibody portfolio alongside progressing the value of the clinical assets. Where we are now, really, we are seeing that we have different modalities that need to be developed on different timelines with very different capital resources and requirements, some different skill sets that are needed to take forward early-stage antibody assets versus later-stage clinical assets.

We want to set ourselves up for partnering optionalities for these different components of our business. Additionally, why do it now is I think it's really critical that we need to be able to bring a sharper focus and specialized teams and aligned resources to these two different business units. That I describe as corporate clarity. What's the strategic benefits of doing this? It's of course, a dedicated focus on the antibody innovation, and that's supported with better operational clarity and expertise, and that really will drive greater value from these assets. The asset split, as I describe it, also makes sense that it gives us better partnering optionality to partner or co-develop the antibodies in GlyMab Therapeutics, or similarly, do the same with the vaccines in Scancell Holdings. It fits with our partnering strategy also.

I describe it as, for investors, potentially two shots on goal. We're creating, you know, two independent value creation paths here. What's the initial execution plan? The structure is, of course, as we've mentioned, GlyMab Therapeutics Limited is a wholly owned subsidiary in Scancell. In the near term, we will transfer the patents, the platforms, and the teams across to the subsidiary company. We are engaging in conversations, as you would anticipate, with pharma and biotech for potential partnering. But we're also at the same time having conversations with the strategic and institutional investors that may join us to fund the development of the lead assets and other assets. What's the plan we've built for GlyMab Therapeutics? It's to fund SC134 through to get clinical data.

It's to advance a second asset to IND, but also use the platform to create 2-3 new exciting assets that could potentially be taken forward in-house in GlyMab Therapeutics or be partnered. That's the plan that we put together for the funding. The timeline to generate data from SC134, one of the critical catalysts for potential partnering or other transactions, is around 24-36 months. That will be a key catalyst for us. This is an outline to you of what is GlyMab Therapeutics, what the strategy is, and how we've kicked off execution of that strategy. Let me finish off today just to remind you of our timelines. We will be sharing data on Cohorts 1 and 3 in July. Later in July, we set that out, that we would do that.

We will select the product that we move forward, as Nermeen said to you, and we will be sharing data from Cohort 4 , the intradermal and accelerated dosing cohort, towards the end of the year, and we're on track to achieve those milestones as we laid out we would. Similarly, Modi-1 in the ModiFY study in the renal and head and neck is on track. We will share data for renal in Q3 and for head and neck later in 2025, probably in Q4. As I've outlined to you today, we've got a new strategic intent and strategy to unlock future value in the GlyMab portfolio, progressing SC134 to IND and into the clinic, establishing the new subsidiary to bring clarity, focus, and expertise to unlock greater value in the portfolio. There's potential further milestones from the partnered antibodies with Genmab.

We're in conversation, of course, with Genmab, and we know they are progressing the programs in a very positive way. We're pleased about the progression of those partnered programs also. Let me stop now, and I'd like to ask Sath to join, but also open up for questions.

Operator

That's great, Phil and Nermeen. Thank you very much indeed for your presentation. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the top right corner of your screen. While the company take a few moments to review those questions submitted today, I would 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. Phil, Sath, and Nermeen, as you can see, we have received a number of questions throughout today's presentation. Mandeep, if I may now hand back to you to chair the Q&A, read out the questions where appropriate to do so. I'll pick up from you at the end. Thank you.

Phil L'Huillier
CEO, Scancell Holdings PLC

Well, welcome, Mandeep, our Head of Business Development. You're going to run through the questions for us.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Absolutely, and thank you to all that have submitted so far. First question to you, Phil, and then maybe Sath, you can also follow up. You have been clear that you would like to develop SC134 further before you decide what to do. Where does the formation of a new legal entity lead to? If a company is spun out, how do existing shareholders share in the upside? Can non-institutional investors invest directly? Will the new company have its own staff? Because surely it needs different skills.

Phil L'Huillier
CEO, Scancell Holdings PLC

Okay. That's, I think that's four questions in one. You'll have to keep me honest that I answer all components of that, Mandeep. The first part was progressing the development of SC134. Yes, we are determined to do that, and we are doing that. The next stage of development of an antibody therapeutic becomes an expensive one, where we move towards manufacturing. Part of what we're doing to form GlyMab Therapeutics is also looking to bring on board the funding to be able to move forward the development of one-three-four and the other assets towards and in the clinic. Where does this entity or strategic intent take us?

It creates a vehicle for the assets, for the platform, and it will include the team members from the discovery team, the antibody team, as well as, of course, management and other staff in the entity, so become a fully fledged entity. We are seeking investment and partnership to support the development of the programs that I've mentioned. How do existing shareholders benefit from this? I describe this as a strategy to make the pie that we all share in much greater. If you sit down and do the numbers, then by making that pie greater, Scancell shareholders, but also potentially collaboration partners and any new investors that join us also will share in that pie in a very positive way. What did I miss? Sath, would you like to add?

Sath Nirmalananthan
CFO, Scancell Holdings PLC

Yes. There's just one element of the question, which was can non-institutional investors invest directly? At this stage, it is a wholly owned subsidiary of the Scancell group. The benefit is for the whole existing Scancell shareholders at the right time, and then when we finalize our options, 'cause this gives us strategic optionality. We'll consider the right structures to allow the right financing, the right type of financing to come in. We'll keep you all updated in due course. I do strongly believe that this gives us optionality to create value without diminishing our existing options. We're continuing our conversations, but we have the option now to get direct investment as well as have better partnering conversations to drive the development forward and unlock value in these assets that we believe will be beneficial to all existing shareholders too.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Thank you. Next one to you, Phil. Can we expect any deal or partnerships in the current year?

Phil L'Huillier
CEO, Scancell Holdings PLC

Can we expect any deals or partnerships within the current year? Well, the first thing to say is, of course, we are in conversation with pharma, large biotech, and others, across our portfolio. It wouldn't be right for me to lay out any timeline here, but we continue to have good conversations with potential partners on partnering, co-development, and investment into our programs.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Nermeen, a question for you now. Will Scancell proactively mitigate the effects of the current U.S. administration and perhaps focus on Europe for the iSCIB1+ registrational trial?

Nermeen Varawalla
CMO, Scancell Holdings PLC

In a word, yes, absolutely. Let me just share that our strategy and plans for the phase IIb/III study is to include clinical trial sites both in the U.S. and in Europe, and look for registration under both jurisdictions, U.S. FDA and EMA. It's fair to say, and many of you must be aware of this, that the situation with respect to FDA, both in terms of their timelines as well as their willingness to be supportive and encouraging of therapeutic cancer vaccines is evolving. We remain very close to that. Rest assured, we will take the right steps to mitigate any risks related to the FDA regulatory environment.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Agreements with Genmab.

Operator

Sorry, Mandeep could you just repeat the question there?

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Why have we not heard anything about either of the licensing agreements with Genmab?

Phil L'Huillier
CEO, Scancell Holdings PLC

We are in dialogue with Genmab about their development of these products under the license agreements. We know, as I just mentioned from regular reports we receive, that development is on track, and they are progressing these assets. We anticipate, as they progress these assets under the licenses, that further fees will come to Scancell. Of course, we will notify investors and the market when those eventualities come. What I can say is we're pleased with the progress Genmab is making with two products under the two licenses.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Sath, one for you. Presumably, we will now have funding to take SC134 into a phase I/II study. Would we consider a Nasdaq listing?

Sath Nirmalananthan
CFO, Scancell Holdings PLC

I reiterate, I think we're in a strong, healthy financial position. As previously stated, we have cash runway to the second half of 2026, well beyond the value-creating milestones of the SCOPE study, the ModiFY study, and now the initial stages of GlyMab Therapeutics creation as well. Very, very happy with our financial position. There are upside opportunities to that too. As Phil has just highlighted, we've got partnered licenses with Genmab already, and we anticipate further milestones which are currently not built into our runway. As a company, as a clinical-stage company, we continuously assess our options, all the options on the table to ensure that we can develop our assets in the most efficient and capital-effective manner possible.

One of those does include thinking about how we can potentially go onto the Nasdaq, if that's the right thing to do. I'll just finish on this. I think on the back of the imminent data will allow us to have stronger conversations on the partnering side, as well as assessing the right level or right strategic option that we wanna take forward. We will pick the right strategic step going forward, with shareholder value in mind.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Thank you. Phil, this one's for you regarding iSCIB1+. Have you decided to progress iSCIB1+ already? I thought you were waiting for results of Cohort 1 and 3.

Phil L'Huillier
CEO, Scancell Holdings PLC

We wait for the data from Cohort 1, 2, and 3 to make the decision, as we said earlier in the year, make the decision mid-year, which I've announced today, would be later in July, on which of the two products, SCIB1 or iSCIB1+, we will take forward into that further development that Nermeen outlined. We're close to being able to make that decision, but we still have data that's coming through from these cohorts. We will be announcing the data and that decision later in July.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Also, as a follow-on to that, will the data from SCOPE Cohort 2 also be available in July? Presumably, it has value from a safety perspective, even with the change in standard of care.

Phil L'Huillier
CEO, Scancell Holdings PLC

Yes. I anticipate that we will share the top-level results from Cohort 2 . As Nermeen said, because of the change in standard of care, the cohort is smaller than the other cohorts, but it's indeed correct. There is safety, there is efficacy data, and of course, it's in combination with pembrolizumab. That's interesting alongside the data from the other cohorts, which are in combination with the double checkpoints, ipilimumab and nivolumab.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Great. Sath, this question for you. What initial valuation are you ascribing to GlyMab Therapeutics?

Sath Nirmalananthan
CFO, Scancell Holdings PLC

I'm not gonna talk in precise terms about the valuation. I do strongly believe in the potential for GlyMab Therapeutics. The reason I'm not giving a direct valuation is it's commercially sensitive. What I would say is that the creation of GlyMab Therapeutics allows us to position or move from licensing deals, which could be similar in nature or similar-sized deals to the ones we've already done, to developing clinical stage data, which we believe will be significantly higher in terms of valuation, for those assets as well. We strongly believe in the potential for the antibodies, and that's what we're trying to do by the creation of GlyMab Therapeutics.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

Sure. Thank you. Another one regarding the share price. "The share price has been disappointing and seems to suggest your story and success isn't being believed. Is this of concern, and what are you doing to realize value other than the new company spinout?

Sath Nirmalananthan
CFO, Scancell Holdings PLC

This is something that we continuously talk about as well. I think there are structural elements in the markets right now that is probably impacting the value creation or reflecting the value that we are creating. At least in my nearly two years at the company, we've delivered new data, signed new deals. I strongly believe we are only increasing the intrinsic value of the company. The share price is unfortunately a reflection of external environmental factors, too. Nonetheless, we are continuing to communicate with investors, continuing to engage with the right type of investors so that we can find the right valuation for the company, and I'm confident that as we continue to deliver on the data and people realize the value of the science that our share price will reflect our true value.

Mandeep Sehmi
Head of Business Development, Scancell Holdings PLC

The last one I would say either to me or Phil: "Regarding iSCIB1+ and SCIB1, if things work out well, can you see these products receiving orphan status and getting to the market any quicker than the current timeline, seeing that so far no negatives and the faster to market people who need it can get it quicker and cured?

Phil L'Huillier
CEO, Scancell Holdings PLC

Nermeen, would you like to comment on the orphan status component?

Nermeen Varawalla
CMO, Scancell Holdings PLC

Yes, of course. It's a great question, and thank you for that. We have an application for Orphan Drug Designation with both EMA and FDA. However, as we are increasing the patient population in which our products will be used, our ability to meet that tight definition could become questionable, which frankly is, from our perspective and, more importantly, from the patient's perspective, a very nice problem to have. The most important point you make, which I'd like to address firmly, is that we are doing everything possible to progress these therapies as we're beginning to see signs of efficacy so that they're available to our clinicians and patients at the earliest possible.

The best and most effective way of doing that is embarking on a well-designed phase II/IIb/III registration study and getting our products approved using that route.

Operator

That's great. Phil, Sath, Nermeen, thank you for addressing all those questions from investors today. Of course, the company can review all questions submitted today and will publish those responses on Investor Meet Company platform. Phil, before redirecting investors to provide you with their feedback, which is particularly important to the company, could I please ask you for a few closing comments?

Phil L'Huillier
CEO, Scancell Holdings PLC

Yes. Firstly, let me say thank you to everybody for listening, and thank you for the questions. We'll continue to answer questions after this webinar also. Let me say to you, I'm excited about the breadth and depth of the portfolio that we have at Scancell, and also by the progress and the momentum that we've built in the clinical studies, but also in the pre-clinical studies and particularly SC134. The announcement today of GlyMab Therapeutics is there to unlock significant potential value in the antibody portfolio by putting focus and clarity and talent and investment into the antibody portfolio to move the assets forward. For the SCOPE study, I want you to take away from Nermeen's presentation today that the SCOPE study is not about Cohort 1 or Cohort 4. It's about the whole program.

We're in a position where we are very close to making decisions about which product to move forward. Based on that, we've started, of course, the planning of the next phase of development. It's not about all of our Cohort 4. No, we're not sitting on our hands waiting for Cohort 4 to read out. We are planning the next phase of development. As Nermeen said to you, Cohort 4 helps us define some of the parameters for the next phase of development. The mode of administration and the dosing regimen will come out of Cohort 4. We're in a position to be able to continue our planning for the next phase of development based on what we're seeing from the earlier cohorts.

We look forward to sharing with you data from the earlier cohorts from the SCOPE study later in July and from the Modi studies as we progress through the rest of 2025. It's an exciting period for Scancell. Thank you for listening.

Operator

That's great. Phil, Nermeen, Sath, Mandeep, thank you once again for updating investors today. Could I please ask investors now to close this session, as you will now be automatically redirected to provide your feedback in order that the board can better understand your views and expectations. This will only take a few moments to complete and I'm sure will be greatly valued by the company. On behalf of the management team of Scancell Holdings PLC, I'd like to thank you for attending today's presentation, and good morning to you all.

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