Good afternoon, ladies and gentlemen, and welcome to Scancell Holdings Interim Results. At this time, all participants are in 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 Dr. Phil L'Huillier, Chief Executive Officer, to open the presentation. Please go ahead.
Hello, everyone, and welcome to this update from Scancell presenting the interim results. We've titled this presentation Products, People and Progress because indeed these are all important ingredients for a successful biotech company and Scancell is strong in all of these. Could I have the next slide, please? This slide shows you a company snapshot and also our pipeline. We have two differentiated products in clinical development in markets with major unmet needs. We're seeing impressive efficacy data with long-term immune control of tumors emerging from our studies and importantly, adding our vaccines on top of standard of care is not adding any safety concerns. We have very good safety profiles with our products. The research and development of the company is supported by deep cancer immunology and translational medicine expertise, and to me, this is foundational to a company developing products in such complex diseases.
Scancell bolstered the leadership team in the latter half of 2024 with myself joining, bringing an industrial background, but also our CMO, Nermeen Varawalla, who brings really strong late-stage development expertise to the company. We have a number of important industry specialist investors, Redmile and Vulpes, but others joined us in the last round. We're execution-focused and have cash through to the second half of 2026. We'll talk you through the pipeline as we go through the presentation, so let's move to the next slide. This slide is a pictorial of numbers and data summarizing some of the key highlights and the current state of the company. We won't present this today in the interest of time, but leave it for you to review at your leisure. Next slide, thank you. Here's the leadership team as it stands now of Scancell.
I've introduced myself and Nermeen. Let me just pause and acknowledge the tremendous work Lindy Durrant has done for the company over many years, but also over the last few years, carrying both the CEO and CSO role. Lindy's now focused as the Chief Scientific Officer of the company, and I have to say, I think she's really enjoying the being able to get into the science and get into the data, and I see her smiling much more as she's focused in the area that she loves to work in. Next slide, thank you. Let's turn to our lead vaccine products. We're developing these in advanced melanoma. Next slide, thank you. These products come from our ImmunoBody platform, and there's a number of key features about our platform and about our products that differentiate them from others out there.
I bucket these into three broad areas. Firstly, the mechanism of action. It's a dual-acting vaccine product. That's about how it works. What we're seeing in the clinic from this dual mechanism of action is we're seeing both the vaccines being very effective, but also giving this long-term immune control over the tumors, and that's important for the patients. Our products are off-the-shelf, which differentiates us from others, but off-the-shelf also means it's one product for all the patients that can be treated and that's a relatively quicker development, a cheaper manufacturing and the products are available to patients more quickly. They are patient-convenient products delivered through a needle-free device. That device we access through a strategic partnership with PharmaJet.
In the clinic, as we'll show you, our products are demonstrating real effectiveness, but also as I mentioned, they are very safe. Finally, the platform is customizable. We are able to make other products. Let's now turn and look at the market opportunities. Next slide. Thank you. Here I want to just drill down to the broad melanoma market opportunity, and then on the next slide, show you the opportunities for our products. Now, we're focused in advanced melanoma, and some might say, because melanoma is a highly immunogenic tumor type, that checkpoint therapies have really addressed the need here. If you look at the second bullet point in the black box here, you'll see that 50% of patients that are treated by checkpoints do not respond or progress very quickly.
There is a significant need still for products that are more efficacious for more patients, but also that last longer for the patients. On the bottom of the slide, you can see three boxes where we went out to get some third-party KOL feedback through a third party to help us with product positioning. These KOLs agree with me in saying that there is a need for more efficacious products that will treat patients for longer, and that an off-the-shelf approach such as the Scancell vaccine is something that would be highly desirable in the clinic. Next slide. When we drill down to our market opportunity, we've got two products that we're currently developing in the melanoma setting.
On the left-hand side, you can see the first generation, the SCIB1 product, and that treats a HLA-restricted patient population, which is about 30% of the population we're treating. That is the unresectable melanoma population, the stage 3 and stage 4 patients. On the right-hand side of the slide is our second-gen product, which we call iSCIB1+. That vaccine has additional epitopes over the two that are in the SCIB1 product that mean we may be able to address a broader population of patients by virtue of the technology that's been implemented into that product. iSCIB1+ also has an added value add because it has a longer patent life as well.
Now, these are the market opportunities we're addressing today, but as you can see in the middle of the slide, there is also potential in the adjuvant and the neoadjuvant setting, which it's a larger market opportunity, and I'll come back to that shortly. Next slide, please. Here's the design of the SCOPE study. Many of you will have seen this before. As I mentioned, we're targeting unresectable stage 3 and stage 4 melanoma. These are front-line patients, and these are patients that are suitable to be treated with what standard of care currently in the United Kingdom, ipilimumab and nivolumab. There's four arms to the study. The SCIB arm, which is the vaccine being added on top of the double checkpoints, and that study has 43 patients in it.
We're testing SCIB1 also on top of standard of care pembrolizumab, and some patients that are not eligible for the double checkpoints receive the single checkpoint. We're running an arm with that therapy also. We have the new, the second gen product, iSCIB1+ intramuscular delivery with the double checkpoints. We've added a new arm to the study, the fourth arm, where we're now testing the iSCIB1+ product with a different delivery, an intradermal delivery, and that cohort is kicking off. We're measuring endpoints, the response rate, the duration of the response, progression-free survival, overall survival and safety. The benchmarks, as we'll come back to, are 50% response rate almost for the double checkpoints. We're looking to achieve around a 70% response rate.
On the bottom of the slide, you can see the dosing schedule. On the next slide, we show you a waterfall plot of the data, the response rate data from 25 patients at 25 weeks. We shared this data in October last year. What we see here for these patients is a 72% overall response rate at the six-month mark, with 20% of patients achieving a complete response. The overall response rate at 72% is a remarkable result. Standard of care, as I mentioned at the moment, is less than 50%, about 40% for the current setting. So this is a remarkable benefit to patients when we add our vaccine on top of the double checkpoints. Next slide. Here is an important measure for the patients, progression-free survival.
Again, we're seeing superiority over standard of care and long-term immune control of the tumors. What we've done here is overlay our curve, our data, the black line on top of the standard of care. Normally, when you see this sort of graph, you have two lines that are pretty close together, but you can see the divergence of these lines showing the remarkable benefit of our therapy on top of what is standard care. Next slide, please. Here's a study that actually the company conducted several years ago, and I wanted to include this study for two particular points. First of all, it highlights the potential of the vaccine as a monotherapy. This study was conducted in a number of patients that had melanoma but had their melanomas resected, and then after resection, went on for our vaccine.
What we see here is an 88% disease-free state at five years, which is a remarkable result. I brought this slide back into our data because this hints at the possibility of the vaccine working in the neoadjuvant-adjuvant setting, which will add market potential to our products. Next slide. Here's the comparison of our data in numbers versus the real-world outcomes for the double checkpoints. As I mentioned, disease control rate in the cohort one, 25 patients at 25 weeks, 84% versus 58%. The response rate. Overall response rate 72% versus 48%, and the complete response rate of 20%. Remarkable achievements above the benchmarks across the board for our therapy at this stage of the study. Next slide. Let me just summarize where we are and where we're going with the lead product.
The SCIB1 cohort is now fully recruited with the 43 patients, and we will expect to get 25-week response data around the middle of the year. Similarly, with the second-gen product, iSCIB1+, that's recruiting well, and we also anticipate having the 25-week response rate data around the middle of the year. I mentioned we've added an intradermal cohort for the iSCIB1+ product that's been added to the SCOPE study. We've added this because the industry is moving towards intradermal as a delivery. It could be more convenient for patients. It provides us with a direct comparison of the delivery route, and we will see results coming from this cohort later in the second half of 2025.
Our development team have achieved some remarkable results over the last half year, improving the manufacturing process of the iSCIB1+, and we now have a manufacturing process that we think is set for further development. Finally, we are of course planning the next stage of the randomized studies as we head on the path towards registration. A lot of the results coming in 2025 and also a lot of work underway to work towards the next stage of development as we head towards registration. Next slide. Let me turn to our second product, Modi-1, which is focused on head and neck and renal cancers. Like the first slide, the Moditope vaccine platform has a number of features that are similar. It is an off-the-shelf product in the same way as the SCIB products is off the shelf.
We're seeing low toxicity, good safety in the clinic. In this case, the platform targets stress-induced post-translational modifications. In fact, this vaccine is two peptides that target citrullinated peptides that target the stress-induced post-translational modifications. Next slide. As I mentioned, we're focused on market opportunities in head and neck cancer and in renal cancer. These are significant unmet needs across a number of markets. Sadly, the five-year or the one-year prognosis for these diseases patients is poor. There's going to be anticipated significant growth in both markets. Large markets with significant unmet needs. Next slide. It's the design of the Modi-1 study. Two arms as I mentioned. The first arm is focused in head and neck, and that's being conducted where we add our vaccine on top of standard of care, which is anti-PD-1 pembrolizumab.
The second arm is the renal cohort, where we add our vaccine on top of the combination, the double checkpoint therapy, ipilimumab and nivolumab. Of course, our endpoints are response, duration, and progression-free survival. Just to note on the bottom of this slide, we mentioned this when we made an announcement recently about Modi-1, that we've had a patent granted over our product in the U.S. Next slide. On this slide, we've summarized the results so far for this study, and of course, it's early days. In the head and neck space, we have reached the first stage of this study and demonstrated non-futility. That was measured by needing to see a response in three of seven patients. Indeed, we have seen that response, which is an overall response rate of 43% for these patients.
That's a significant advantage over standard of care or historic controls, where it's 19% for pembrolizumab and 13% for nivolumab. We have already kicked off the second stage of the study, and we'll expect further readouts over 2025 for this arm, and also further readouts for the renal arm. Next slide. Now let me turn to the latter part of the pipeline, the GlyMab, a unique portfolio of antibody that target the sugars on tumor cells, the glycans. Again, here are some features of the platform. I think what's important to note here is targeting these glycans that are expressed on sugars is a way to target the tumor and not the normal tissue.
The challenge in targeting such molecules in the past has been that it's— it is difficult and challenging to get high affinity and high specificity of antibodies. This is one of the things that the Scancell platform and the team have cracked. We have generated a number of really high affinity and high specificity antibodies. Next slide. This slide shows you some of the pipeline from the GlyMab portfolio. The point I want to make on this slide is that Genmab exercised their option and took another license to one of our products, the SC2811 product, in December. We announced that at that time. What that says to me is that there is now really strong industry validation of what we're doing.
We're creating antibody products that are of interest to industry. Next slide. In-house, we're now focused on development of this antibody, SC134 as we call it, which targets Fucosyl-GM1, a glycolipid that's highly expressed on tumors, and indeed it's expressed on over 70% of small cell lung cancer tumors. There's very little normal distribution or normal expression. It's a clinically validated target. BMS are testing the naked antibody in the clinic as we speak. Our antibody is an IgG1 humanized antibody which has patent protection broadly, but recently additional patent protection granted in China. We're focused on developing what we call a bispecific antibody and are currently going through in vivo testing and doing developability analysis as we speak. A strong asset that we want to take forward from our portfolio. Now, let me pause there and hand over to Sath to talk you through the financials. Next slide.
Next slide, please. Thank you, Phil. I echo your sentiments about the strong development and organizational progress that we've made and lay the foundations for the year ahead. I'll briefly take you through the key highlights from our interim results. Starting with revenues. While we reported no revenues in the period, we were delighted to sign our second commercial deal with Genmab for a second GlyMab antibody in December 2024. True validation of our fantastic science and research. The total upfront was $6 million, which comprised of $1 million for an exclusive evaluation period, currently recognized as deferred revenue, and a further $5 million on the full license being exercised. We expect the full amount to be recognized as revenue in fiscal year 2025.
Total development milestones on this deal could be up to $630 million with low single-digit royalties on sales. As just mentioned, this is the second deal from our GlyMab portfolio. Development of the first antibody deal signed in October 2022 remains on track for future milestone payments. The operating loss for the period was $10.5 million versus $8.1 million in the prior period. The majority of our spend is focused on research and development and lead clinical trials. The year-on-year increase reflects our investment in manufacturing capabilities and processes. This includes improving scalability of production for late-stage studies and commercial use. We expect some of this investment will ease in future periods. Our loss for the year is $12.5 million versus $2.5 million in the prior period.
The largest movement is the non-cash fluctuations following the substantial modification of our convertible loan notes in July 2024. As a reminder, in the period we extended the maturity dates of our convertible loan notes by two years, and we will accrue the interest until maturity, resulting in a net positive cash impact in the near term. Our cash and cash equivalents at the end of the period were $ 9.1 million. This was enhanced post-period by three things. One, the financing in December 2024, which raised gross proceeds of $ 11.3 million, attracting both existing and new life sciences investors. Two, the $5 million for the option exercised by Genmab, which has now been received. Three, the full year 2024 R&D tax credit of $ 2.7 million. Our expectation is that future R&D tax credits will be at similar levels.
This leaves us in a strong cash position through to the second half of 2026, beyond multiple clinical milestones. There are upside opportunities on this cash runway too, through further milestones on our out-licensed products or further licensing deals. We will continue to explore business development opportunities and strategic options to drive development of our products and in turn unlock shareholder value. In closing, we have set good foundations and from a strong cash position, look forward to the exciting clinical readouts this year. With that in mind, I hand back to Phil.
Thank you. Next slide. On this slide, we summarize the achievements of 2024 and lay out some of the key milestones for 2025. You can see that in 2024, we really made significant progress in a number of areas. Early readouts from the clinic for our lead product, which looks really positive and is potentially a game-changing therapy. We've raised additional funding at the close of the year of $ 11.3 million. That gives us strong runway through into the second half of 2026. We achieved another license with Genmab for a second GlyMab antibody, providing further validation of our platform that we're producing products of interest to industry. Finally, we strengthened the management team and the board with key hires. In 2025, we're pushing on to generate more data from the clinical studies.
Summarized up here, you can see we've already got through to the Simon's stage 1, the non-futility stage, and pushed on to initiate the second phase of the head and neck study. We will get results for 25 weeks for the SCIB1 product from the full 43 patients in the middle of the year, and similarly from the third cohort, our second generation product, 25 weeks in the middle of the year. Then the extra cohort, the intradermal cohort, will generate data in the second half of 2025. What we're aiming to do with these three readouts is identify the best product for the right patient population with the right delivery strategy. We'll also have readouts in both renal and head and neck for the Modi-1 product as we progress through 2025.
Importantly, in 2025, we'll also be proactive business development with pharma and biotech around our vaccines, but also continuing on the antibody products. Finally, we will continue planning what the next phase of development looks like for in randomized studies for our SCIB1 product as we head towards registration. Thank you. We're happy now to open up for questions.
Thank you. We will now begin the Q&A session. If you would like to ask a question on the phone lines, please signal by pressing star one on your telephone keypad to raise your hand and join the queue. A reminder to please unmute your device when called upon to ask your question. Again, that is star one to raise your hand and join the queue. We will pause just a moment for any phone questions. Your first question comes from the line of Julie Simmonds from Panmure Liberum. Please go ahead.
Hi. Can you hear me?
Yes, we can.
Perfect. Okay. Hi, Phil. I'm just wondering, in terms of the business development discussions that you're sort of continuing and ongoing, are they going to change now you're leading those versus what might have been done previously? I'm just sort of trying to get a feel for. You've obviously got a lot of experience in that area and how you see those progressing?
I think what changes with the business development discussions is data. To me, business development is data driven. What changes is that we now have good early data on the vaccine products. Business development in the past has been more focused on partnering the antibodies. That will continue, but on top of that, we'll add business development discussions on our vaccine products because of the data that's emerging.
Lovely. Thank you. Obviously so far on the antibody side of things, discussions have very much been with Genmab, who's, you know, you've already done two deals with. I just think, has the second one of those increased interest in that platform generally among others you might be talking to?
It's early days, but there are a number of other conversations going on around other antibodies in the pipeline.
Thank you.
Before we continue on to our next question, a reminder, if you would like to join the queue, to please press star one on your telephone keypad. Your next question comes from the line of Edward Sham from Singer Capital Markets. Your line is open.
Thank you very much. Congratulations on another great set of results and what was an excellent 2024. Just a few questions from me. The first one really is on SCIB1, iSCIB1+. You guys obviously have some really compelling data coming out from your clinical trials. I just kinda wanna understand, in discussions you've had with potential partners, what kind of are the key sort of barriers to them kind of making that step, taking the next step with you guys and potentially partnering with you to continue development to the next stage in terms of the adaptive registrational trial? Say you don't get a partner, is there a chance that you guys can go at it alone and self-fund a potential phase II, phase III trial?
Thank you for the question. I'll take it in a number of ways and make a number of points. First of all, with the SCIB1 product, with the data that we've announced and we've just shared, in relation to partnering in a substantial way with pharma, I think it's fair to say that we've got an early, really intriguing data set, and that's the initial feedback that I've had from pharma. Pharma often asks for more data, and indeed, as we progress through the first half of 2025, we do add more data to that early intriguing data set, and there is interest coming from pharma to look at that data as we progress forward. The bar is pretty high, for pharma to be licensing or partnering on products in a general sense.
It's high in the immuno-oncology space and DNA vaccines or cancer vaccines on top of that adds an extra challenge. Our job is to generate the data, the compelling data, and then in a proactive way, present it to pharma and engage in conversation as the data progresses. I think we're in a strong place. The early data really shows a level of benefit that's well above the benchmarks, as I mentioned to you. That's the first positive aspect of having BD conversations with pharma. We'll progress conversations over the first half of the year as the data emerges.
That's very helpful. Thank you. Maybe just moving the focus to Modi-1, because I did notice in the presentation that you guys paid particular attention to head and neck cancer and renal cancer. I know that you guys are obviously exploring it in multiple solid tumors. I'm just wondering, is that the kind of the key focus for Modi-1 now?
Yeah. Ed, I can answer that. Yeah. I think these are the ongoing studies that we're doing in head and neck and renal cell carcinoma in combination with the checkpoint inhibitors. As you know from our basket slide that we presented a few years ago, we have tested in various other solid tumors as well, and it's shown safe tolerability and good stable disease in those patients as well. Right now, given our financial resources, we just wanna get to the end with renal cell carcinoma and head and neck as a priority. We'll assess where we are with our finances, et cetera, about other solid tumors as well. I think particularly renal cell carcinoma, because if the standard of care is double checkpoints, I think it really has some intriguing science behind that. We look forward to that reading out.
That's helpful, Sam. Thank you. Then just maybe just one last question for Phil, if you don't mind me asking. What attracted you to Scancell and really kind of what excites you the most over the next sort of 12 months - 18 months?
That's a good question, Ed. I'm data driven as an individual, and I saw emerging from Scancell really strong data and the potential to build enormous value within the company, within the pipeline. On top of that, there's a very strong team here, and it's tremendous the work that Lindy has done in the organization and the team over the last few years. The progress has been really positive. On top of that, Ed, there is of course a very committed set of investors. We have some new investors joining us at the end of last year, but a committed set of investors that have backed and supported the company for a number of years.
Drug development is a team sport, as I often say, and there's a strong team, including the investors and the board in Scancell. I think we're really set up well to execute and to achieve remarkable results with our products. Those were all of the features that drew me to Scancell.
Yeah. Perfect. Thank you.
That does conclude our phone questions. We do have a written submitted question. The question is, what happens if the data from SCOPE shows SCIB1 is more active or better in some way than iSCIB1+?
I guess you would say this is why we do these studies, is to get the answers, to get the data. We're doing a comparison of the first generation and the second generation products which have different features, so that we can really identify which is the right product to move forward in the right patient population, and with the right delivery strategy. To get those really clear answers from the studies that we're conducting now so that when we do move forward and embark on larger studies as we head towards registration, we really know we're in the right settings with the right product.
There are no further questions. I will now hand back over to the Scancell team for closing remarks.
Well, let me just say in finishing, look, as you can see, we have a lot to do in 2025. We're set up as a team to be able to execute, and we have the resources to execute our plan, and we will do that. I perhaps want to just finish and acknowledge the support of the new and existing investors, some of which joined us, in earlier years. We appreciate and value your support and your commitment to Scancell. Thank you.