Good afternoon, ladies and gentlemen, and welcome to Scancell Holdings PLC full year results. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session through the phone lines and instructions will follow at that time. I would like to remind all participants that this call is being recorded. I will now hand over to Mary-Ann Chang from Investor Relations to open the presentation. Please go ahead.
Good morning and good afternoon to all our listeners. It's my pleasure to welcome you to Scancell's results call for the year ended 30th of April, 2025. My name is Mary-Ann Chang, Investor Relations for Scancell. With us presenting today, we have Phil L'Huillier, our CEO, and Sath Nirmalananthan, our CFO. Following the presentation, we'll be taking questions directly from analysts as well as written questions from our audience, which you may submit at any point during the webcast. Next slide, please. Before we begin, I'd like to draw everyone's attention to this statement. Today's discussion will include forward-looking statements, which are based on current expectations and assumptions. Actual results may differ, so we encourage you to review our filings for more details. With that, I'll now turn the call over to our CEO to get us started. Phil?
Hello and welcome, everybody. Thank you for joining this business update and year-end results for Scancell. As Mary-Ann has just said to you, I'm joined to present today by our CFO, Sath. This slide gives you a snapshot of Scancell today, as a reminder for those that have listened in previous presentations, but also a summary for anybody new that's joined us. During the term, we formed a major partnership with the Cancer Vaccine Launch Pad, just one of our highlights from the year. You are right to ask me what is new, and there's a number of important things to mention. First and foremost, from our SCOPE study, we selected the iSCIB1+ product to move forward with in further development in advanced melanoma.
Just one snapshot of the data for iSCIB1+, we're seeing the progression-free survival, the PFS, at a level of 78% in our target population. If you compare this to historic doublet checkpoints or standard of care, that's around 46%. There's a whopping difference that we're seeing here. I mentioned the PFS to you and focus on this because now we are progressing forward into further development. As many of you will have seen, the FDA is very much focused on progression-free survival and overall survival in patients as we go into these later-stage developments. This is what really counts as the endpoints going forward. Another aspect that is new is we told you back in July that we were going to accelerate our planning for further development, and we've delivered on that.
We have submitted documentation to the FDA and other regulators and have scheduled review meetings with the regulators about our plans for randomized studies towards registration for iSCIB1+. I have to just give kudos to the Scancell team here. It's been a Herculean effort to get the documentation ready, prepared in a very quick and very efficient way such that it's been submitted. We told you last time that we were going to go to the FDA. Of course, we need to do that. But also we are in conversations with EMA and MHRA. That's about being able to consider randomized studies in multiple territories, but it's also about hedging our bets in an uncertain world that's out there. What's also new is we've been able to confirm we've got a commercial scale manufacturing process now for iSCIB1+.
It's a high-quality formulation and the long-term stability that we're seeing with this formulation is really quite amazing. I hope you can see from what I've summarized here is we now have a focus and an eye on the registrational development of this drug, but also one eye on the stage after that, the commercialization. We'll talk you through more on the SCOPE study and iSCIB1+ as we go through the presentation. Let me also remind you that we have other assets in the pipeline, Modi-1 and GlyMab assets. Modi-1 is in the ModiFY study, a phase II study being conducted across centers in the U.K., being tested in both head and neck cancer, and we shared some early data from that study showing a benefit over and above standard of care.
We also have a study running in renal cell carcinoma, and that study is recruiting well and looking good, and we anticipate sharing data from the renal cohort towards the end of the year. During the year, we also established GlyMab Therapeutics. This was a strategic initiative, giving us optionality about how we could develop that portfolio. To me, there's a little goldmine there that it was difficult as we were structured to apply significant resource to move that preclinical pipeline forward. By forming GlyMab Therapeutics, putting the pipeline, the platform, and the IP into that entity, we can potentially bring focused investment, but also focused management to move forward those assets. We did a financing late in 2024, raised GBP 12.1 million from new and also from some of our existing investors.
I want to acknowledge the support, ongoing support of our investors. That financing was in fact in my first two weeks, so it was a bit of a baptism by fire, but a successful financing for the company. That gives us a strong financial position for us to move forward, and Sath will talk you through that later. We have upside on that cash runway from our partnerships with Genmab, and there are, as I hope you can see, multiple near-term and longer-term value creation opportunities here. Let me remind you of our pipeline as it stands today, and I like to go back and just mention the monotherapy study that was conducted in the adjuvant setting in melanoma with SCIB1.
I raise this because monotherapy activity is an important part of our pharma conversations, and it's an important study that the company has done. We're now, of course, developing in combination with checkpoints in the advanced setting. Why did we move from the adjuvant setting to the advanced setting? Well, adjuvant studies are pretty long-term studies and not easy studies necessarily for a biotech company to do. The readouts in the advanced setting tend to come more quickly, so hence moving into that setting. I touched on Modi-1 in the ModiFY study in head and neck and two of several assets in the GlyMab therapeutic pipeline. Let me remind you about our platforms.
Two very novel platforms in the clinical part of Scancell, with some key features that are important to the overall success of the products and of the company. The first one is the Immunobody platform, a DNA-based immunotherapy. The second one is the Moditope platform, which is a peptide-based immunotherapy. Both have unique mechanisms of action and are very, very novel platforms. The lead out of the DNA Immunobody platform is iSCIB1+, and the lead out of the Moditope platform is Modi-1. As some of you that have been involved for a while will of course recall, there are other products out of these platforms, but we've got those on the shelf at the moment whilst we're developing our leads.
Some of the key features that are really important as we move forward to partner and to go into, commercialization with these products is the fact that they are off-the-shelf. That means they're straightforward in terms of cost, scale, et cetera. They are conveniently delivered to patients and accessible to patients. They're also, we're seeing from the clinic, excellent safety, and the products are very well-tolerated. That means they are, what I call, easily combinable with other therapies, which is the way cancer therapy is going. As I said to you, there's unique novel mechanisms. Another way of saying it is these are not me-toos. These are very, very novel products. Let me come back to iSCIB1+ and remind you first of all of the unmet need that's here in melanoma.
The checkpoints have made a big difference to patients in melanoma, but unfortunately, still 50% of patients really do not respond very well or don't respond for long. There's a big unmet need still there. We're working with iSCIB1+ in the unresectable melanoma, the late stage metastatic disease population. We have calculated that that's a market opportunity in the order of $3 billion. There are additional upsides to this, and this is shown in the middle of the slide here. The potential to take the product into the neoadjuvant and adjuvant setting. Patients that could get surgery, have their melanoma removed, and then have therapy after that. You can see that that's an even larger market opportunity, and that's where many of the pharmas have now focused their checkpoint therapies.
We want to also, at some point, explore the possibility of moving to this earlier disease setting. Large market opportunities here. I want to pause on this slide because I think in one slide, it summarizes nicely the drug, the features of the drug that we have, and the characteristics. First of all, what's the product? iSCIB1+, the second gen of the SCIB drugs. The first gen was SCIB1, and it was designed to work in patients with an HLA-A2 haplotype, so a profile HLA-A2 haplotype. Lindy Durrant and the team went back after seeing some activity with that drug and then designed iSCIB1+. The I is an immune modification, and the plus is additional HLA haplotypes for which it was predicted would stimulate T-cells in patients. Amazingly, it's doing what it says on the tin.
We're seeing that it's stimulating T-cells and bringing clinical benefit to patients in the clinic. This represents 80% of melanoma populations. Just a little bit of scientific detail, but here's the mechanistic understanding. To me, in pharma conversations, they want to see the data, but they also want to know how this drug works, what's the translational data coming out of these studies? That we know that well here. We know that this drug is dual acting, direct and indirect targeting of the CD64 receptor on activated dendritic cells. That's a unique mechanism. It was built with epitopes or peptides from two melanoma proteins, GP100 and TRP2. These play key roles in melanoma. The epitopes that were put into these two products were actually isolated from patients that had spontaneously recovered from melanoma, so we know the immune system sees them.
Here's the real crunch, the clinical data. We've demonstrated effective monotherapy activity in the adjuvant setting, and we've now demonstrated a strong, meaningful clinical benefit in the combination setting in metastatic disease. Just a few really important headlines of this data. We're seeing T-cell responses in 72% of patients to both TRP2 and GP100. Why do I emphasize that? Well, that means because we're seeing T-cells to both of those epitopes, that reduces the likelihood of immune escape. So it gives the prospect of a longer-term immune control. Again, I come back to the PFS. It's a whopping delta over the standard of care, and it's being well-tolerated into the clinic. A feature that could be really important going forward.
Now that we know that the drug works on the patient profiles that it was designed to, we can actually reverse that and use that as a selection tool to select for patients into the phase III that we know will respond. This basically enhances the chances of success, and it's very, very rare that you have a selection marker for an IO therapy. Let me come back to some of the data. We shared this data with you on July 22nd, but it's worth going over it again. This is the combined data for the target population for both Cohort 1 and Cohort 3. Now, ask me the question, why do I combine this data? Well, I know from my pharma experience, they want to see good sizable datasets.
The only difference between the two cohorts here was one is SCIB1 and one is iSCIB1+. But they all are in the target population, all receiving our drugs on top of Ipi/Nivo and all having a very much the same demographics. I just remind you here that the PFS in this target population is 69% at 22 months versus the historic control population, which is shown here just as an illustration. This is not a randomized study. For CheckMate 067, the median PFS was 11.5 months, so that's 50% at 11.5 months. We are 69% at 22 months. That's a whopping delta.
As one of my board members said yesterday, "If you're a metastatic melanoma, you would really want to get this stuff, wouldn't you?" And another example that I was alerted to yesterday, anecdote, you could say for one patient, we had one patient that was on the study for a little over a year on the therapy. For whatever reason, the patient and the doctor decided to stop the therapy. Whereas when on therapy, there was good control of the tumor, a few weeks after going off therapy, they have progressed. A nice example of the power of this therapy. This patient had probably an extra year of life. Now, digging in a little bit more, we want to look at iSCIB1+ because that's the drug we're taking forward.
This is the PFS curve in the target population, and this is impressive compared to the non-target patients and also compared again to the standard of care. Here, 78% at 11 months versus 50% for this non-target population where the vaccine wasn't predicted to stimulate T-cells. This really is very superior, the target population to the non-target population and markedly better than the historic control. Let me come back to the SCOPE study and just remind you of this. Of course, Cohort 1, 2, and 3 are fully recruited, and we've got data coming in for those cohorts as we're showing you. Cohort 4, which is iSCIB1+ with accelerated dosing, and with intradermal delivery, is recruiting well, and we will have data coming out of that cohort later in the year.
Really on track with this overall study. Let me come back to overall response rate and disease control rate. This is the data we showed you in July. I want to remind you of the waterfall plot on the left, but perhaps more importantly, the spider plot on the right. A patient responds, you see the lines go down, and then they're pretty damn flat. This is impressive. You are right, the eagle-eyed amongst you, to ask me, "Why is the overall response rate now at 65%?" Let me show you that on this slide and explain that. We have now a full set of patient profiles, the patient demographics they are called.
What we've seen looking at that data is our patients are very similar to CheckMate 067, we want to be able to really compare more precisely to 067. When we first put this data out, we took out a couple of patients from the target population that had progressed or died before their first scan. Now, we realized that in CheckMate 067, that wasn't done. We've put these two patients in the target population back into the data so we can all strictly compare with CheckMate 067, we've got 20 patients showing a response out of 31, a 65% response rate. We are still waiting for a further seven patients to read out.
We screened patients as they came onto the study for the target HLA haplotypes, but we also took patients that were non-target. The target population represents 80% of patients, we did have some patients that were non-target, and that ended up to be 11 patients. What we're seeing here is a response rate of 27%. I showed you earlier the PFS curve there, where it's at about 50%. I do think that this non-target population could be a representation of what the double checkpoints do without iSCIB1+ generating a response in this patient population. Now I think we didn't add up all the numbers in this cohort well previously. Now we're doing that. There's 50 patients in this cohort, 38 target patients and 11 non-target patients.
1 patient got through screening with active brain mets. We've taken that patient out. Active brain mets were not included in CheckMate 067. This slide shows you the safety readout. Now, it's quite a bit of data here, but perhaps the message to take away is when we add iSCIB1+ or SCIB1 on top of the checkpoints, the drugs are very, very well tolerated. We're not seeing any major toxicities from adding these drugs on, which is great. We can combine them with these checkpoints or potentially in the future with other therapies. Let me summarize where we are with this program. We're seeing really good efficacy for iSCIB1+ in the wider population that represents 80% of melanoma patients.
Very strong PFS coming out of the study versus CheckMate 067 versus SCIB1, and perhaps iSCIB1+ is slightly better on PFS, reflecting the AvidiMab modification. PFS, as I touched on earlier, is the critical endpoint now for registrational studies. I told you we are confident about our commercial scale manufacturing. A reminder, we have the PharmaJet partnership for the Stratis needle-free device for intramuscular delivery. That's what we're moving forward with in the further studies. Then I also told you about the biomarker or the selection tool that's available to us to use to select patients into the phase III study, and that will likely enhance success. I showed you some commercial figures. What's the opportunity? What's the size of this opportunity?
You can look at it in another way here, that ipilimumab was available for this advanced melanoma populations. BMS did the combination study adding nivo to ipi, and because of the delta out of that study, ipi/nivo has captured 65%-70% of the U.S. market for metastatic melanoma. The delta or the advantage SCIB1+ adds on top of ipi/nivo is not dissimilar. It's a way of sizing the commercial opportunity that's here with us. Let me quickly summarize the other assets in the pipeline, Modi and GlyMab Therapeutics, and in some ways a reminder. We are evaluating Modi-1 in the ModiFY study in head and neck and in renal cancer. We showed you data from head and neck earlier in the year showing a delta over standard of care, which is pembrolizumab.
That cohort continues, and I expect data readout later in the year. On top of that, we have the renal cell carcinoma cohort, which is Modi-1 on top of ipi/nivo going also. That cohort is recruiting well, and I anticipate having data readouts towards the end of the year from that cohort. I'm pleased how Modi-1 is going. We are seeing benefit in patients from Modi-1, and we continue to recruit and build that dataset. I told you earlier that we have formed GlyMab Therapeutics for this set of assets, the anti-glycan antibodies. There's a unique expertise in Scancell to generate these high-affinity IgG1 antibodies to the tumor-specific glycans on tumors. The lead is SC134 targeting fucosyl-GM1, and in some ways, this is a validated, t his is validated in the clinic from the work that BMS is doing.
We've done a lot of work recently developing this as a T-cell engager and are moving it forward towards the clinic. SC27 is the second product targeting Lewis Y, and that targets a broader set of cancers. We're developing that as an ADC, and also moving that towards the clinic. The team are also working on building other targets out of this platform. Of course, you'll remember we have industry validation here with the two licenses with Genmab. Let me pause now and hand over to Sath to talk to you about the financials and the outlook.
Thank you, Phil. Next slide, please. I'm pleased to update you all on the financial results for the year ending 30th of April, 2025, including some post-period highlights. Starting with revenue, we reported revenues of GBP 4.7 million in the period. This relates to the second commercial license agreement with Genmab for antibody SC2811. We received $6 million in total upfront payments, and there are up to $630 million in further milestone payments with low single-digit royalties on commercial sales. To reiterate, this is the second commercial license deal with development of the first outlicensed antibody, SC129, also to Genmab, on track for further milestone payments. Building on the success of these deals, we have established GlyMab Therapeutics.
This is a wholly-owned subsidiary of Scancell Holdings PLC, with the intention it will hold our in-house portfolio of antibodies with a transfer of trade planned. This move provides us with strategic optionality as we look to unlock the right value in these assets. Research and development expenses were GBP 14.7 million, slightly higher than prior year. As a reminder, our R&D costs predominantly reflect expenditure on our in-house clinical, manufacturing, and research costs. During the year, these were focused on SCOPE and ModiFY studies. We made an additional investment in the period to ensure readiness for the next stages of development. This includes the previously mentioned commercial-scale iSCIB1+ GMP manufacturing process, which has resulted in a high-quality formulation and long-term stability, leaving us well prepared for late-stage clinical development with iSCIB1+.
Administrative expenses was GBP 4.8 million, lower than prior period, with a focus on controlled expenditure despite continued investments in our organizational capabilities, including the recruitment of our CEO and CMO in the period. This leaves our operating loss at GBP 15 million, lower than prior year, primarily due to the revenue reported in the year. We record a small loss in finance and other income of GBP 0.3 million and recorded a tax credit of GBP 3 million, resulting in a loss for the year of GBP 12.3 million. During the period, we also announced the extension of the maturity dates of the convertible loan notes by two years. These maturity dates are now August 2027 and November 2027, and following a small partial redemption, the remaining loan notes total GBP 18.2 million.
Our cash of GBP 16.9 million at year-end was boosted in the period by a financing in late 2024, raising proceeds of GBP 11.3 million, with participation from new and existing life sciences investors. We anticipate this will be enhanced by the FY 2025 tax credit, which will be at similar levels as in the past. This leaves our cash runway in line with previous guidance of half to 2026 beyond key developmental milestones and with a good runway for our ongoing partner discussions. We have upside opportunities on this runway too, namely the development of the first outlicensed antibody, SC127, which is anticipated within the next 12 months. Furthermore, I highlight the discretionary nature of our spend, which allows us to take decisions if required. Next slide, please. Here are the key milestones for Scancell.
As Phil has mentioned, we are making good progress across our programs with significant milestones already achieved from our clinical programs. In Q4, we expect further cohort three data with iSCIB1+ and early cohort four data. We expect this additional data to inform our development plans rather than prolong them, which is why we are accelerating both regulatory and business development conversations. Regulatory discussions, as Phil has highlighted, are already scheduled with feedback anticipated this year, and we believe we have the right data set to generate partnering interest. Based on regulatory feedback and business partnering discussions, we will evaluate the right next step forward, including assessing out licensing, partnering, and further financing, but all with timely development and shareholder value in mind. Outside of iSCIB1+, Modi-1 continues in the ModiFY study following early validation in head and neck cancer in early 2025.
Highly anticipated clinical data from Modi-1 is anticipated in Q4 in renal cell carcinoma in combination with the checkpoint inhibitors. With the establishment of GlyMab Therapeutics, we highlight SC134 and SC27 as key assets we are looking to progress under GlyMab Therapeutics. Next slide, please. Finally, I'd like to end on why Scancell, why now? Firstly, we have compelling science that is now clinically and commercially validated. We have over 100 patient data in the SCOPE study with iSCIB1+ and SCIB1. This is supplemented by Modi-1, showing early clinical validations in the settings we're evaluating that. The licenses with Genmab provides commercial validation of the GlyMab platform also. We are well-prepared for late-stage development.
We have good data, we have manufacturing in place, we have a strategic license with PharmaJet covering development and commercialization, and building the team with broad experience, ensuring we have the components for late-stage development. We believe all of our assets have substantial markets where there are unmet needs. iSCIB1+ has a clear development pathway to commercialization as well as growth areas in early disease settings. Modi-1 has the potential in multiple tumor types with the highly anticipated renal cell carcinoma data informing efficacy in the combination setting. GlyMab Therapeutics covers a preclinical portfolio of antibodies, which as previously highlighted, has potential to be developed as T-cell redirecting antibodies or ADCs. We have a phase III-ready asset with a clear pathway to market and other assets in Modi-1 and GlyMab Therapeutics, providing our shareholders value-creating opportunities in the near to medium term.
Thank you for listening. I'll now turn over to the operator for questions.
Thank you. We will now begin the question and answer session. As a reminder, participants can also submit questions by clicking the Ask a Question button on the webcast page. Please submit this and the company will get back to you in due course. If you would like to ask a question on the phone lines, please signal by pressing star one on your telephone keypad. We will pause for a moment to assemble the queue. Thank you. Once again, if you would like to ask a question, please press star one on your telephone keypad. Your first question comes from the line of Julie Simmonds with Panmure Liberum. Please go ahead.
Good afternoon. Congratulations on the progress over the last 12 months. Most impressive. A couple of questions. Firstly with the sort of selection of the patients for the registration trial, I mean, it seems to make a lot of sense to recruit those who are most likely to respond. Is the HLA typing done as a standard test, or would that be something that would be done specifically for use of iSCIB1+?
Thank you for the question, Julie. It is a standard or widely available test, and we would use that test to screen our patients. It's actually perfect in the sense that we don't have to develop a biomarker ourselves in parallel with the therapeutic. This is a test that's widely available. You know, there are examples of companies that use this type of testing. The KIMMTRAK product from Immunocore is an A2 specific product, and so they are testing patients for A2 positivity before they go onto therapy, as an example.
Brilliant. That sounds very good news. On the manufacturing side of things, good to hear that process has gone to plan. Is there any sort of lead-in period that's required in terms of the manufacture for doing a clinical trial? Is that going to cause any delay in process once you've obviously got it signed off and everything to get the active product necessary?
That's a good question, Julie. No, we don't anticipate any delays. We're in fact factoring in, and it's factored into our runway that Sath just summarized, further manufacturing to have material ready to start the phase III study on the timeline that we've laid out.
I'd just add, Julie, that that's the investment that we made in the last period to make sure we were ready and could have a seamless transition into a late-stage study and not have good data and not be able to continue because we needed a better manufacturing process. We will be yielding the benefits of that earlier investment because we've got a good process now that should be late-stage ready.
Lovely. Thanks so much.
Thank you.
Your next question comes from the line of Edward Sham with Singer Capital Markets. Please go ahead.
Hi there. Congratulations on your results. I think it's clear to see that you guys are on a journey to becoming a late stage biotech. I've got a few questions. If I just start with the first one. You say you're having accelerated discussions with the FDA, EMA and MHRA. I just wanna kind of understand, how aligned are those agencies in terms of trial design, endpoints, and data expectations?
Yeah, that's a good question. It's early days. You know, we haven't had the conversations yet. We are wanting to have the scientific exchange in the phase II conversations all in parallel. So in fact, we could get to the point of having a single protocol for the study going forward. But sometimes, in my experience, you do find that there are some differences between agencies, so you do end up with slight differences in the protocols that are there. We've developed a, I think, a really robust study design. You know, recent activity from the FDA, and I'll mention one in relation to Replimune that didn't get their BLA, which surprised us all.
We're taking into account what we're seeing and hearing with the FDA and other agencies, and have made sure we've got a robust design that I am very, very hopeful will satisfy all of the agencies that we're talking to.
That's really helpful. Thank you. Then maybe just on the timeline you've indicated. You've shifted to initiate randomized studies in 2026. Is it safe to assume that you're confident in either a partnership or financing before that trial starts or the randomized study starts?
I'd say so. Ed, yes, we are confident. We have the bulk of the data. We are in active conversations, and I think we've got the runway to get through the initial steps on regulatory as well. I'd highlight we do have upside opportunities, as you know. I think that gives us a good runway to make sure we're ready. Obviously we need to find a partner and/or financing, but we're confident that we have the ingredients to move in a timely fashion.
Perhaps it's worth adding, Ed, that we have accelerated the regulatory conversations for, of course, that timeline for us, but also perhaps more importantly, for the partnering and investor conversations. They're asking us the question. What does the FDA or EMA think of this study? We have accelerated those conversations to coincide with our investor and partnering conversations also.
Great. That's really encouraging. Just my last one is just on the Genmab licensing deals. You've mentioned that you're now on track for near-term milestone payments. Is that a positive surprise? Is that something that's moved faster than expected, or is that simply the timing you've always expected?
I think we got a recent update, which is increasing our confidence that this is continuing on its development pathway. I think that is something incremental. I think we would obviously like development to move as quickly as possible, but we remain confident that these are gonna happen. To remind you, I didn't put that in my runway guidance. It is upside, but based on recent interaction, I think we're growing in confidence that this will happen.
Really helpful. Thank you.
Once again, if you would like to ask a question on the conference slides, please press Star followed by the number one on your telephone keypad. It seems there are no further questions on the conference line. We will now address the recent questions submitted via the webcast page. I will hand over to Mary-Ann Chang, Investor Relations, to read these out.
Thank you. A question for Phil, and it's again about the upcoming discussion with regulators. Is there a realistic accelerated or fast-track route for iSCIB1+? A second part of this, how is it differentiated from Moderna and BioNTech's cancer vaccine program?
Thank you, Mary-Ann. Taking the first question, the answer as I see it is yes, absolutely. There is a real possibility of breakthrough or accelerated development here. We have to go through the conversation with the FDA, submit our IND and be able to have a conversation, first of all about breakthrough, but then accelerated approval. If you look at the data that I was sharing with you, then I think we are a very good prospect.
Thank you.
Mary-Ann, sorry, there was a second part to the question.
Yeah. That was on the differentiation between iSCIB1+ and Moderna and BioNTech's programs.
Yes. A couple of components to mention here. We are working in different settings of melanoma. We're in advanced metastatic melanoma, unresectable melanoma. BioNTech and Moderna are working in the resectable, the earlier stage disease setting. We're talking about different markets, different patient populations. The other thing that I think is worth adding back to our platform, that both of those are using personalized therapies with all the associated cost and timeline to collect the material, sequence, develop algorithms, and then develop material to go back into the patients. That's a logistical, hurdle to overcome, but also very high cost of therapy. We are off-the-shelf, so I see us being more widely available to health systems once we get through to approval. Very different modalities also.
Great. Okay. Thank you. One for Sath. How much of the planned iSCIB1+ registration trial is already funded, and what's the expected financing gap?
Sure. Within our runway, the guidance I previously guided to, we have all of the regulatory spend planned, and a little bit more in manufacturing to make sure we are ready to initiate the study. The actual study, our funding the study, we will evaluate our options following the active conversations we're having with partners right now. Based on those conversations, based on their feedback, as well as the confirmation from the regulators that we've got the right study design, we will come back and update you on what that right financing will be. We're confident we've got the runway to do it. We don't have it funded yet, but we have the data and the conversations ongoing. We hope to update you in due course, not too long, about how that next stage of development will take place.
That's great, thank you. Somewhat related to that, and Phil, you may not be able to fully answer this, but I'll go ahead with the question. Will you partner iSCIB1+ before 2026 randomized studies? You mentioned previously you were revisiting discussions. How are these discussions progressing? Or are you preparing to go it alone?
Thank you for the question. I see my job always as taking a two-prong strategy. The first being, be opportunistic about the possibility of partnering and with this data set and our push on regulatory conversations, we're very confident that we will have serious conversations about partnering and partnering in the broadest sense, and also possibilities around investment further. But alongside that, the second part of the strategy is to make sure we have the resource in terms of the expertise and the people and the drug, but also the finance to go it alone, because we don't necessarily control the timing on partnering activity. I always want us to be taking this two-pronged approach.
Good. A question again, Phil. Can you indicate how long the iSCIB1+ trial will take, and when might it start?
Is this in reference to a randomized study?
I think it must be, yes.
Yes. Yeah. So as it's designed, we anticipate starting in mid 2026. We've designed it to have an interim PFS readout 17 months into that study, if recruitment goes according to the design. At 27 months, we'll have our readout of PFS and an early readout on OS.
Very good. Okay, question for Sath. When is the next Genmab payment due?
Yeah. It's on IND submission and phase I initiation. That's on the first antibody. The same milestones exist on the second antibody too. As I said, in my answer to Ed, we've got a recent update and things are looking good, increasing our confidence, and I anticipate them within the next 12 months. Obviously the timing is reliant on Genmab.
Great. Okay, thank you. Follow on for you. What was the logic of the CLN redemption and size?
Yes. Firstly, I'd say Redmile are a very supportive investor. They continue to hold their equity stake. Given our runway and our confidence in our runway, there was a small partial redemption.
Yep. Thank you. Okay. Comment on the Modi-1 renal study. There was a question, has the study been delayed a quarter? Why?
No. I don't think it has. It's certainly recruiting well, and we're collecting data from patients, as we speak for that. I think we've signaled the second half of the year, and now we can be a little bit more precise on the timing of that. There's been no delay in recruitment or readout of data from that cohort.
Yeah.
Good. Okay, finally, we have one question for Sath. On the share price, the questioner is asking if there was a seller and if you can give any idea about whether or not that any exit that may have been happening has now been completed.
I'll answer this as best I can. Firstly, I'd say I think we're all disappointed in our share price performance. I don't think it reflects our intrinsic value and the value that we are building in the company. As a reminder, all three of our covering analysts have increased their target price in recent weeks. We strongly believe we are building value. I deduce based on my feedback and my interactions that this is related to low volumes and, you know, certain compliance nature of selling from large institutional investors who have been very historical supporters, but for various reasons need to sell out. Nothing related to our data and the progress that we're making.
We continue to work through some volume, but I'm confident that once that clears, that we will continue on the path to reflecting the right share price, as well. I'm confident about the future and we're working very hard to make sure that the share price reflects our intrinsic value.
Great. Thanks, Sath. There are no further questions, so I'll hand back to Phil for closing remarks.
Good. Thank you. We're excited. As my CMO says, we've got an active drug in our hands here. We need to get this to patients as quickly as we can. The next quarter or so, we're knocking on many doors to find partners and investors to help us move forward into the clinic, for further development to get this drug to patients, and we'll develop the rest of our pipeline. We continue to build our plans to execute the randomized studies towards registration, whether it's in partnership or going it alone. Thank you for listening, everyone.