Good morning, and welcome to the Sareum Holdings Final Results Investor Presentation. Throughout this recorded presentation, investors will be in listen-only mode. Questions are encouraged and can be submitted at any time by the Q&A tab situated in the right-hand corner of your screen. Just simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company will review all questions submitted today and publish responses where it is appropriate to do so. Before we begin, I'd like to note the following poll, and I'd now like to hand you over to Dr. Stephen Parker, Non-Executive Chairman. Good morning, sir.
Good morning, everyone, and thank you for joining the Sareum Holdings presentation for the full year ending 30th of June, 2023. I'm Stephen Parker, Chairman of the company, but I'm joined today by Dr. Tim Mitchell, Sareum CEO, and Dr. John Reader, our Chief Scientific Officer. Without more ado, I'll hand you over to Tim to begin.
Thank you, Stephen, and good morning, everybody. First, I just need to draw your attention to the usual disclaimer for the results statements. This discussion may contain forward-looking statements, with respect to clinical plans, strategy, financial performance, that may cause our actual results, performance, or plans to differ from those expressed on the call. Before we get into the detail of the discussion, I'll just take a moment to introduce Sareum for the benefit of those of you who are new to the company, and a recap for those of you who know us quite well. Sareum is a clinical-stage biotechnology company, and we're developing next-generation kinase inhibitors for autoimmune diseases and cancer. We have a deep expertise in kinase inhibition and the JAK cell signaling family in particular, and this is a growing area of commercial focus with good scientific validation.
Our particular focus amongst this JAK family is the TYK2/JAK1 kinase inhibitors. Our lead program, SDC-1801, is a novel dual TYK2/JAK1 kinase inhibitor, which is currently in a phase I clinical trial. This is in healthy volunteers, and in the first instance, we're intending to target psoriasis, which will be the clinical focus for the phase I-B stage of the trial. Our strategy, as it's always been, is to develop our research programs to the late preclinical or early clinical stages before licensing or partnering to pharmaceutical majors. We're expecting to report key clinical milestones for SDC-1801 in particular throughout 2023 and 2024. I'll summarize the key developments we've achieved over the year here then.
So for SDC-1801 and the TYK2/JAK1 programs, as I've already noted, the lead program is now in phase I-A, and that study is being undertaken in Australia. The objective of the study is to evaluate the safety and pharmacokinetics of an oral formulation of SDC-1801. This study was initiated in May, with first subjects being dosed in June, and it's progressing very well at a specialist clinical unit in Melbourne, Australia. And in September, as you may have seen, after this period end, we started dosing in the multiple ascending dose phase of the clinical trial.
So this moved to the so-called MAD phase, followed approval by the Safety Review Committee after the planned review of the preliminary data from the first three cohorts in the single ascending dose part of the first bit of the study. John will take you through more details of this later in the presentation. In addition to the progress in the clinic for 1801, in June, Sareum was granted the first patent specifically for SDC-1801, and it just happened to be in China. And patent applications progressing through the offices in the US, Europe, and other major territories. Alongside SDC-1801, Sareum has a second TYK2 JAK kinase inhibitor.
This is SDC-1802, which we believe holds significant potential in both, in, in cancer and cancer immunotherapy. For this, translational studies continue, we still need to define the, the optimal cancer application before we, before we move on to the necessary toxicology and manufacturing, work for preparation for clinical trials for that compound. Alongside the TYK2/JAK1 portfolio, we continue to be optimistic about the potential for our Chk1 inhibitor, SRA737, which has demonstrated good clinical and preclinical efficacy. As you may have seen, Sierra Oncology, which is now a subsidiary of GSK, has returned the clinical study reports and other associated documents and data related to SRA737, to our co-development partner, CPF, the Cancer Research Technology Pioneer Fund.
CPF are taking the lead in evaluating, the opportunities and next steps for SRA737. We're really waiting for further developments from them, and we'll report those as soon as we're able. To summarize the financial results, we reported a loss for the 12 months to June of GBP 3.2 million. That's an increase over the last year, but it reflects the higher research and development costs involved with late preclinical development and preparation for these clinical studies. Cash at the end of the period was GBP 1 million, and after the period end, we announced a funding facility worth up to GBP 5 million with a group called RiverFort, of which GBP 2 million has so far been received to date.
After the period end, we also received an R&D tax incentive from the Australian government, and that was worth GBP 400,000, approximately. The slide here just shows the pipeline in a visual form. As you can see, SDC-1801 has now moved into clinical phase I. We have SRA737 completed two phase I/II clinical trials. But our primary focus here is on advancing SDC-1801 through its phase I trials. Before we move on to the technical part of the presentation, I'll just spend a bit of time on the TYK2/JAK1 landscape and set out why we're so excited about this approach.
So this is a space that's had increasing scientific and commercial momentum in recent years, as more and more evidence grows around the role that JAK signaling can have in managing autoimmune diseases, in particular. So TYK2 and JAK1 are involved in signaling pathways that are deregulated in many autoimmune diseases, including psoriasis and also lupus, psoriatic arthritis, inflammatory bowel diseases, and many others. We've seen greater recognition by large pharma and other developers of the potential that the TYK2 class, in particular, has to offer patients with autoimmune diseases. And the approval last year of the Bristol Myers Squibb TYK2 inhibitor, Sotyktu, by the FDA, in the U.S., and then this year by the European regulators, was important to us because it was the first specific TYK2 inhibitor to gain approval.
And we believe that this approval validates and significantly de-risks our approach. BMS are forecasting peak sales of $4 billion of this for Sotyktu, so there's a good understanding of the commercial potential of the TYK2 class out there. More aligned with our business model, we're very interested to see, from December last year, the acquisition of Nimbus Therapeutics' phase II stage TYK2 inhibitor by the Japanese pharmaceutical company Takeda, and this was for a $4 billion cash payment up front, and then there's a further $2 billion available to Nimbus in sales milestones. Having introduced Sareum and the TYK2 space, I'll hand over to John Reader to walk us through why we think our TYK2/JAK1 combination has great potential in this area.
Thanks, Tim, and hi, everybody. So against the background that Tim set out, we think the combination of TYK2 and JAK1 has particular potential for a few reasons. We've known for a while of the potential of JAK signaling in autoimmune disease, but safety has been a concern. BMS's Sotyktu molecule, which is very selective for TYK2, was approved significantly without one of these so-called black box warnings, unlike some of the first generation JAK inhibitors, such as tofacitinib and baricitinib, which inhibit all of the JAKs to some extent. So we know that Sotyktu has a better safety profile. We believe SDC-1801, by combining TYK2 with JAK1 inhibition, has the potential to increase efficacy without compromising that safety.
Furthermore, TYK2 with JAK1 are, are good targets for several autoimmune diseases, which opens potential for us to explore other indications. Very high level, just walking through the science behind our proprietary pipeline. The JAK family is involved with maintaining balance in the immune system. TYK2 and JAK1 are involved in signaling pathways that are implicated in multiple autoimmune diseases, notably psoriasis, but also a host of other autoimmune diseases, such as inflammatory bowel disease, so that's Crohn's disease or ulcerative colitis, also lupus and, and several others. The inhibition of both TYK2 and JAK1 has the potential to yield superior efficacy compared with those agents that block just one of the two kinases.
TYK2 and JAK1, we believe, therefore, make optimal targets within the JAK family for autoimmune diseases, as targeting other members, such as JAK2 and JAK3 in particular, has led to unwanted side effects in some patients, leading to the black box warnings on the earlier first-generation JAK inhibitors. Moving on to the next slide. I mean, we've touched on this already, but to provide a bit more detail about where we currently are in the clinical development plan. We're in a phase I-A trial as a clinical unit in Australia. This is exploring the safety and tolerability, and the pharmacokinetics of an oral formulation of SDC-1801 in healthy subjects. We've progressed to what's called the multiple ascending dose, the MAD phase of the trial, and the single ascending dose phase is continuing through dose escalation.
The trial is blinded, and that means that neither we, the principal investigators, the medical monitors, and importantly, the participants, none of those people know which subjects receive SDC-1801 and which receive placebo. And, you know, obviously, we appreciate there's keen interest in the trial's progress, but given its blinded design, we will need to wait until the trial is completed before we can provide full details on the safety profile. That said, what we have shared already is that the initial safety indicates a favorable safety profile, and very importantly, the PK data supported once-daily oral dosing, which I think is very important for commercial purposes. Subject to continuing good safety data, and financing, regulatory, and recruitment considerations, our intention is to commence the phase I-B phase of the trial in psoriasis patients in 2024.
The synthesis of the drug substance for SDC-1801, and of the capsules for the clinical trial, have been successfully completed. The current plan is to recruit up to 120 subjects in total, and that's 96 for phase I-A, and 24 patients for phase I-B. The anticipated timelines of the trial are shown in the arrow below. So again, you know, subject to financing, regulatory approval, and recruitment going to plan, we'd anticipate a phase I-B readout before the end of 2024. Turning briefly to SDC-1802, our cancer immunotherapy program. This is an immunomodulating inhibitor of the TYK2/JAK1 family, which we believe has potential both in cancer and autoimmune disease. SDC-1802 has demonstrated good efficacy in preclinical cancer models.
We're working on translational studies, with the aim of defining the optimal cancer applications before moving into a phase I trial. We think that the experience of clinical development of SDC-1801 will support the development plan for SDC-1802, so the molecules are structurally quite related. During the period, we were pleased to have been granted a patent by the US Patents Office, covering the treatment of autoimmune diseases by SDC-1802, which further expands the protection of this compound beyond immuno-oncology. Moving on to SRA737, our CHEK1 inhibitor, and just to update you. I mean, I'm sure many of you are familiar with the history here.
SRA737 was developed by Sareum in collaboration with several Cancer Research UK-funded organizations, including the current co-development partnership that we have with the Cancer Research Technology Pioneer Fund, CPF. Under the terms of our co-development partnership, Sareum is entitled to 27.5% of any commercialization revenues associated with SRA737. SRA737 has completed two phase I/II clinical trials, which were funded by Sierra Oncology, and the asset demonstrated a good safety profile and promising clinical and preclinical efficacy, particularly in combination settings. Sierra Oncology was subsequently bought by GSK, driven by its interest in another of Sierra's assets. GSK decided to return SRA737, and all the clinical study reports and data and materials have now been received from Sierra. CPF is evaluating potential licensing opportunities.
We're very optimistic about the potential of this molecule, and we think there's scope for further development, but CPF is leading this process. I'll now hand back to Tim to cover any, the financials.
Thanks, John. So to briefly summarize the financial results that we published on Monday. Looking at the income statement then, so I've already mentioned higher R&D expenses that are associated with the setup and the start of the phase I trial, being responsible for the increased operating expenses. So the loss for the year was GBP 3.2 million this year, compared to GBP 2.2 million this year, but fully in line with market expectations, and as I say, reflecting these R&D costs. If you look on the tax line, there's plus GBP 833,000, so that represents the R&D tax credits.
As we noted in the results, RNS, we've already received the cash credit from the Australian government of around about GBP 400,000, and the rest we'll expect from the UK government. We normally get it around the end of the year, maybe early in the new year. Moving to the balance sheet then. So we had a cash position at the end of June of GBP 1 million. But of course, this doesn't include the finance facility from RiverFort, which I'll just touch on in a minute. But we've so far received GBP 2 million from that, and that was in August. So -- well, we are able to manage our cash resources very successfully. Just to recap on the RiverFort facility, as I say, this was agreed and set after the period end.
The facility is for GBP 5 million, and that will enable us to complete the phase I- A and B development of 1801 if it's fully drawn, plus also, when-- if we're in receipt of the expected tax credits. We've received GBP 2 million so far. There's a further two payments of GBP 300,000 each, one in November, one in February. They're committed, and then an additional GBP 1.4 million due in February. These are six-month anniversaries, hence the-- that's how the timings are working out. They're subject to standard trading conditions, and then beyond that, a further GBP 1 million is available by mutual agreement. That's essentially the bones of the agreement. Okay. That's the main parts of the presentation.
I'll finish by summarizing our progress before we hand over to the Q&A. We're very optimistic about the potential offered by TYK2/JAK1 kinase, as I hope we demonstrated in the presentation, because of the efficacy and safety benefits they can offer and the growing commercial excitement around them. So this is the basis of our conviction in our pipeline. Hopefully, we've shown you that SDC-1801 is a differentiated asset in this space, which we believe has the potential to yield superior efficacy while maintaining a good safety profile. We're funded to the next clinical inflection point, so that's the end of the phase I-B study. The RiverFort facility and the tax receipts will give us enough runway to complete this phase I-A/B clinical development. So with that, I will thank you for listening to the presentation. I hope it was useful, and we'll take some questions.
Perfect. Thank you very much for your presentation. Ladies and gentlemen, please do continue to submit your questions by using the Q&A tab, which is situated on the top right-hand corner of your screen. But just while the company take a few moments to review those questions that have been submitted today, I'd like to remind you that a recording of this presentation, along with a copy of the slides and the published Q&A, can be accessed via your investor dashboard. As you can see, we've received a number of questions, both pre-submitted and throughout today's live presentation. Lauren, at this point, if I may just hand over to you to chair the Q&A, I'll pick up from you at the end.
Great. Thank you, Alessandro, and good morning, everyone. Is the board able or willing to comment further on the progress of the 1801 trial? A question which is on all shareholders' lips. If not, then when do they anticipate they might be able to do so?
I'll take this one. This is John. Yeah, well, we appreciate the keen interest in the progress of the 1801 trials, obviously. It's very difficult. Currently, the phase I-A trial is advancing as planned at the specialist clinical unit in Melbourne. As announced, we've transitioned from a single ascending dose phase to the multiple ascending dose phase, and that was following a review of the preliminary data from the initial three SAD cohorts. Comprehensive safety data from the phase I-A trial is anticipated during the first half of 2024. As I mentioned, the trial is blinded, so neither we nor the investigators or subjects are aware of which subjects are dosed with SDC-1801 or with placebo.
But again, as reported, the initial safety data and the PK data was looking good, indicates a favorable safety profile, supported once-daily oral dosing. And just to sort of put a bit of flesh on the bones, the way these studies progress, so a cohort is dosed, lots of sampling is done, lots of readings are taken, you know, physiological readings, et cetera. And then all of that data is presented to a safety review committee at the end of the cohort. That's all reviewed, and only when that is deemed successful, is the next cohort ready for dosing. So, the sort of cycle time's like that, and the three SAD cohorts were reviewed before moving on to a MAD. So, this is how it all works. We're committed to providing accurate and timely information, and as and when there are significant developments, shareholders will be promptly informed.
Thank you. Along similar lines, again, asking about the completion timing, but also, how long will it take for the analysis and for you to come to a decision based on the data obtained as to whether to proceed with the phase I- B?
Yeah. Yeah, so we're in the MAD phase. SAD phase is continuing. I think, yeah, we're very optimistic we'll have all of this phase I-A completed and data received and fully analyzed by the end of H1 2024, hopefully sooner. But some of this is out of our control, so you know, things like recruitment, capacity at the unit, for example. So, you know, we're just being slightly cautious about timelines here, but so far it's all gone to plan. It's all gone on schedule, so we're optimistic we'll have that all completed by the end of 2024. Sorry, by the end of H1 2024. The phase I-A, just as a reminder, comprises three parts.
We've got the single ascending dose, the multiple ascending dose, and there's also a food effect study, which we haven't really touched on today, but that's investigating how, you know, food affects the PK or the uptake of SDC-1801. Each part of the study consists of multiple cohorts or groups of subjects. As I've said, the data from them need to be reviewed by a safety review committee before we move on to the next phase. I think, you know, the start of the MAD phase demonstrated that the single ascending dose study has been going well. Safety profile's looking good, otherwise we would not have been allowed to begin the MAD phase. The exact timing of the subsequent phases depends on several factors, you know, recruitment, capacity in the clinical unit, et cetera.
Thank you. When do the board expect to receive the 1801 patents for the US, Europe, and other territories? And how important is it to have these outstanding patents granted before any future potential license deal?
Okay, I'll take this one as well. Unfortunately, it's not an exact science, so we can't give any prediction or forecast when the various patent offices will pick our case for examination. You know, really, we could hear something next week, or it might be another year or even longer. We just don't get any warning of when they're gonna pick up our particular docket and start to deal with it, which can be frustrating. But I think, you know, what's important is that the Chinese Patent Office has granted our 1801 case, and it's essentially the same application in the other territories. There are some very minor technical differences just to satisfy the different territories' requirements, but essentially, we're looking to protect the same molecules and with the same data.
So I think the fact that it was granted in China has given us a great deal of confidence that it will be approved in the other territories when they do come to examine it. And the other part of the question is how that might affect future license deals. You know, so it would be helpful if we had the granted patent, but it's not essential. And again, I think the fact that the patent was granted in China will give reassurance to anybody who's performing due diligence on our intellectual property, that the patent is very likely to be granted in the other territories as well. So I think really getting that first patent away was actually crucial in validating the approach.
Okay, still sticking with 1801. Can we have clarification on 1801's progress with regards to being developed to combat severe respiratory diseases?
Yeah. So as hopefully, as you picked up from the presentation, our current focus and priority is on the development of SDC-1801 for autoimmune diseases, particularly psoriasis. And we believe that that current direction will best position the molecule to address significant unmet medical needs, within the autoimmune disease space, and that will deliver value to shareholders. But there is, broader potential for SDC-1801, both in autoimmune diseases, which we've mentioned, but also in other indications such as, severe respiratory diseases or the cytokine storm that was seen recently in the, in the COVID pandemic. We did some preclinical research in COVID. It, you know, certainly looked interesting. The results were positive, but I don't think we're envisaging undertaking any further preclinical studies.
So any next step for 1801 would be in patients with severe respiratory distress. And that would be possible if we've successfully completed the current phase I-A studies. So the data that we're generating at the moment could be applicable to severe respiratory diseases, if that's deemed a priority. But I think certainly for the moment, the priority is the autoimmune disease applications.
Okay, moving on. At the AGM, it was stated that you hope to get a signal of efficacy for 1801 from the phase I-B, and it may be enough to open up conversations. Does the board have a plan or options on the table for funding working capital beyond quarter four 2024, if a license deal isn't forthcoming at that point?
I'll take that then. Thanks Lauren , it's Tim. As we've seen, the current plan is to complete the phase I-B of 1801 by the end of 2024. I think we see that as a key inflection point where we'll have a good data package and one that we can compare to our competitors who have, who've run similar phase I-A/B trials. We will obviously have a big push on licensing the product at that point. If an attractive licensing deal isn't available, then we'll look at other financing options to advance our pipeline, and we can't... I suppose we can't really speculate on what those might be at this stage.
Okay, and then with cash burn being an ever more important factor for Sareum, what is the board's strategy to ensure we remain well-funded to complete our planned activities?
Mm-hmm. So, certainly in the medium term, the RiverFort facility, assuming it's fully drawn, plus our anticipated tax credits, allow us to complete the phase I-B, and that's really the... That's the priority for us, is to complete that phase I-B of SDC-1801.
Okay. Maybe sticking on this slide. Why did the company choose the funding arrangement with RiverFort, as opposed to securing investment from high net worth individuals or institutional investors? How do you justify that this is the best available option for the company at the current time?
Okay. The management team and the board, and along with our advisors, we assessed various funding options during the late summer, and carefully considered them all on their merits. Of those, we found this prepayment facility with RiverFort to be the best option available to us, to enable us to flexibly fund our further progress. To say yeah, the structure of the facility gives us potential to access capital in a nice, flexible and controlled manner. Obviously, we'll still continue to assess all opportunities that would serve the company's growth and development, should other funding opportunities arise.
Okay. Switching gears a little bit, we've had a number of questions relating to SRA737 . I'll read some of them out here. So first, last December, there was talk of conversations with numerous interested parties. What's the latest on this? Second, upon return of SRA737 , the board indicated that there was good interest in the compound. Can you please reiterate if there is still significant interest? And another one, things seem to have gone quiet. Has there been any progress?
Okay. So as John pointed out during the presentation, that this is being led by CPF. As you're aware, they're the major partner. We own 27.5% of the program, that they own the other 72.5%. So as a major partner, they're responsible for the ongoing commercialization of the program. We're not able to provide any updates about the status of any business discussions that might be going. I know-- I appreciate that might be frustrating to some people. But we can't say anything until, till we have something significant and concrete to say, but of course, we'll update the market as soon as there's anything significant to report.
Okay. Jumping to 1802, what timescale are we looking for, for 1802 to go into toxicology studies? And when do you expect 1802 to progress to the next stage of development?
Okay. Yeah, I'll take this. It's John again. So, as mentioned, we're still working on the translational studies for SDC-1802, so trying to determine the optimal cancer application for the molecule. And once we finalize those, we can then move forward into the toxicology studies and the other preclinical development, issues. So the synthesis of a molecule on scale, formulation and synthesis of the, formulated product. We should be quite quick once we get going on that, because we do have a lot of compound in hand already, so we can move to the toxicology studies quite rapidly, but I can't really give a, a definite timeline on that at the moment. But, yeah, just to say, we'll keep, our shareholders updated as we reach milestones in the, in the development process.
Okay. Thanks, John. Another question here. So with Sareum in phase I now, has there been an increase in the level of conversations on deals with possible partners? i.e., is Sareum getting noticed?
We're certainly being noticed. Yeah. So it's Tim again. So yeah, we're seen as a clinical player in this space, and I think, yeah, that's an important step, in that, the program is significantly de-risked now that we have got approval to go into the clinic. So independent assessors have looked at the data and says, "Yes, that's suitable for clinical development." And obviously, moving onto the MAD phase, again, real humans, volunteers have taken, well, in this case, single doses of 1801, and the Safety Review Committee has considered that it's all fine for the trials to progress into the multiple ascending dose stage. So there's, excuse me.
There's some good validation coming in, and obviously, potential pharmaceutical partners like to see all that. So we can't comment in detail about the status of any discussions again, they're obviously commercially confidential, but we continue to engage with potential partners as part of our ongoing business development activities.
Okay.
Yeah, thanks.
Okay. What key milestones are you hoping to hit before the end of 2023?
Shall I pick that one up? So in terms of the 1801 trial, the single ascending dose stage should finish by the end of the year. So we will have an understanding of the maximum single dose that our volunteers can take. And then also the food effect study, which John mentioned, that is expected to start before the end of the year, as an example of some trial milestones that will continue. And then... Yeah, for the other programs, we can't really speculate on what and when milestones will be hit.
Okay. Thank you. You've guided that cash is sufficient to Q4 2024, and that we can expect safety data in the second half of 2024 for the phase I-A/B. Thinking about the Nimbus Takeda deal for a phase II asset for $4 billion, can you give us a rough guide as to what range of costs you think about internally for a phase II for 1801?
Okay, so I mean, the current priority is to look for a license partner at the end of phase I- B. If we really thought that the balance of the risk reward, financing, and everything else balance of going to phase II, we could consider it. We haven't really investigated the costs because I suppose it's, it can be disease area dependent. If we-- And I'm talking highly speculatively here, but if we were to look at a phase II, you know, would it be psoriasis? Would it be something else? I don't know. I mean, these are sort of things that are in the back of our minds, but we haven't got a costed plan for phase II, because so the priority is to look for a license partner at the end of the phase I- B.
Yeah. So, yeah, just to add to that, a typical phase II-A in, let's say, psoriasis, you'd be looking at something like 200 patients, two, you know, 22 0 patients, multiple sites, as many as 30 different clinical trial sites to recruit those patients. So it's a significant endeavor to move to phase II-A. Hence, our priority being to complete the phase I-B and look to license.
Okay. What do you consider the most important step in validating 1801 with regard to licensing? When do you expect to hit that point? Is it the first half of 2024 or more likely 2025?
Do you want to take it?
I think there, there's two aspects in the current trial. There's the safety data from the, the phase I-A . This will be the end of the multiple ascending dose in healthy volunteers. I think there's two key aspects, we'll be looking for there. I suppose, particularly if we want to compare, 1801 to our competitors. One will be the, the PK, that's pharmacokinetics. That's really how long the, the drug stays in the body once it's, once it's been administered. We'll be looking for, a nice, smooth, long duration of action, from that. Then there's also the, the side effects, side of it. What, if any, side effects are seen and at what doses?
And then there'll be the phase I- B study. As John's noted, it's quite a small study, so 24 patients, but we will see some data there. And again, we'd look to see for improvements in clinical signs, so for people's psoriasis to get better. Excuse me. And then also, we'll be running some biomarker studies, so we'll be running blood tests to see how the body biochemistry responds to the treatment. And again, our competitors have published similar data, and we'll look for comparisons to those. And we should have that data by the end of 2024.
I'll just add again, we are looking at certain biomarkers within the healthy subjects as well, so during the MAD phase. In particular, a lot of biomarkers are examined. I mean, the thing is, there's no, you know, generally no background inflammation in those subjects, so it's sometimes you don't get a very clear picture, but there are certain markers that we're expecting to show a response to our compound, and that will really give us a hint of the potential for future efficacy in the phase I-B study.
Okay, thank you. Do you have any expectations as to what, if anything, the Autumn Statement might bring for life science companies such as Sareum, where tax R&D tax payments are so important?
Yeah. So I think the-- I know in the last Autumn Statement, R&D tax credits for small companies were essentially stripped away to a pretty large extent, they have come back. So yes, the tax credits are almost what they were. I'm not expecting anything new on that front. I mean, you know, we have no particular insight on what the government are actually doing, but of course, we're members of the BioIndustry Association, so that's essentially the industry lobbying body. So if there's things that we think could be done better by the government, we can lobby via the BIA, on that. But I think the changes to tax credits following the last Autumn Statement have yet to be tried out. I think, yeah, I'm not sure that there's a big call for change until we've seen how the current system actually operates.
Okay, thank you. What is the strategy after phase I-B for SDC-1801?
Yeah. So it's
Cover.
Yeah, I suppose for the-
Yeah.
Number one is to look for a license partner, unless there's very compelling evidence to either continue into a phase II or a I-B in another disease area. Say, the current focus is looking for a license partner.
Okay. Have Sareum and/or CPF been able to go through all the clinical data that's been returned by Sierra? How useful is this data in supplementing what you already knew about SRA737?
I'll take this one. Obviously, I can't speak for CPS, with respect to what we— So I've had a good trawl through it. I can't say that I've looked at all of it, because I don't know. It— there's literally thousands and thousands of pages of documents in these trial master files and the clinical study reports. So what I've done is read the summaries, gone through any particular data where I was aware of any questions or, you know, areas of concern that we had from the preclinical studies and from the, I suppose from the headline clinical reports. And just reassured myself that everything was, you know, as we understood it to be, which it was, I'm happy to say.
So I think, yeah, to summarize SRA737, I would say it's, it's got a good safety profile, and that means it's ideally suited for combining with other molecules. And it's really, you know, I think the development path will be to identify the optimal partner to combine SRA737 with. You know, the optimal partner drug to combine SRA737 with. And there was nothing that I saw in the data that would prevent that strategy from going ahead.
Okay, thanks. There's a couple more on 1802, which I'll, I'll ask here. So how much longer will translational studies take with SDC-1802? And can you elaborate how 1802 will progress quicker, as it is a different molecule and would still need to go through the same trials, which would take the same time?
Yeah. So with respect to the sort of, you know, the preclinical translational studies, there's always more that can be done, right, in an experiment. You can always do more, but I think, you know, there is gonna come a point where we have to say, "Oh, okay, we've done enough now. This is our, this is gonna be our patient population in any future phase I trial." All I can say really is we're not there yet. We have not decided. And it could be that the, you know, the data guides us towards what's called an all-comers trial. So we don't identify any particular patient population, but we just go for, let's say, all solid tumor patients, or all blood cancer patients or something of that.
What we're hoping to do is narrow it down to a more specific subset of patients who we identify as having the best chance of responding to 1802. With respect to the timelines, yeah, it's really the preclinical development timelines, which have potential to be shortened by its similarity to 1801. For example, the structure, the chemistry is quite similar, and at least the first three steps in the synthesis, we've done already for 1801. While that might not sound like a lot, it actually shaves off quite a lot of development time in terms of the chemistry. With respect to toxicology and any phase I trial, yeah, the timelines will not be affected by our experience with SDC-1801. It's really in the chemistry sphere where we'd expect to make some time savings.
Okay. Can you confirm that the RiverFort funding will take 1801 to phase I-B completion? What is the plan after that for financing?
So I think we've touched on this already. So yes, the RiverFort GBP 5 million facility, if we fully draw it, along with the anticipated tax credits, is expected us to take SDC-1801 to the end of phase I-B studies. Beyond that, I think we'll. Let's say, we've got options, well, to look for a licensing partner and think that's our priority. And obviously, that will generate income. So if there really is compelling reasons to continue development, we could say, which we're not particularly considering at the moment, but I guess we never say never, then we'd look for financing to cover those. But I think to reiterate and stress that plan A and probably plan B as well, you know, the real focus is on completing that phase I-B study and then looking for a license partner.
Okay, thanks. So I've maybe got a couple more questions here, and I think we might have addressed one of them already. One's more a point of clarification, actually. So if the trial is blinded, who actually knows who had 1801 and who had the placebo? I think it's just clarifying clinical trial design.
Yeah. No, yeah, it's an important question. Yeah, somebody has to know. So there are a few unblinded members of the study team. So, for example, in the pharmacy, there are unblinded people who prepare the, you know, so it's literally a little tray of capsules that is taken out to the subjects. It's sort of, it's pushed through a hatch, and the nurse picks it up and takes it to the subjects. So they're unblinded. They're preparing the capsules and the placebo capsules, which look identical, and pushing them through. And obviously they're keeping the records of which subject receives placebo and which subject receives active SDC-1801 capsules. And then at the other end of the process, there are a bioanalytical team.
So they are looking at. They're analyzing blood to look at the levels of SDC-1801 in the blood at various time points after they've swallowed the capsule. And so there are certain people within that group who are unblinded. For example, we're not analyzing the blood of the placebo recipients. So of necessity, the bioanalytical guys have to be unblinded. But then, once they've generated their results, that data is reblinded, sent over to our experts in pharmacokinetic analysis, and they compile a report for us based on the reblinded data. So we get a report of the average concentrations of SDC-1801 in the blood of the recipients. And then all of the safety data that we receive is blinded as well.
So, you know, we're looking at safety data, the laboratory chemistry of the subjects in the trial, you know, trying to see if there are any areas of concern, but of course, not knowing if those people have received placebo or SDC-1801. So I hope, yeah, I hope that answers the question.
Thanks very much. I think we'll just take this one last question, which I think we've addressed previously, but just to confirm, maybe, Tim, is there a phase I-C, or does the potential interest usually occur after the phase I-B results? I think this is talking about interest in a potential deal.
Yeah. So there's not really such thing as a phase I-C. From phase I-B, the next step would be a phase II-A. But yeah, I think we're expecting to generate sufficient data at the I-B stage to enables us to get the licensing deal that we've been looking for.
Thank you.
Perfect, and thank you very much for that. I think you've addressed all those questions you can from investors, and of course, the company will review all the questions submitted today, and we'll publish those responses on the Investor Meet Company platform. But just before redirecting investors to provide you with their feedback, which is particularly important to the company, Stephen, can I just ask you for a few closing comments?
Yes, of course. Well, thank you very much, everybody, for joining us today and for your continued support for Sareum. We do hope that we've demonstrated a continuing progress in advancing 1801 through the clinic. And I think it's very important to add, and just to emphasize what's already been said, that every progress step that we have is something which has been approved by the independent safety board looking at this study. So it's not just a question of us pushing as quickly as we can through the stages. This is, you know, the box is ticked every time that we do. So we very much look forward to the next opportunity of sharing that progress with you. So with that, have a good day and many thanks. Bye.
Perfect. Thank you once again for updating investors today. Can I please ask investors not to close this session, as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will then take a few moments to complete, but I'm sure be greatly valued by the company. On behalf of the management team of Sareum Holdings PLC, we'd like to thank you for attending today's presentation, and good morning to you all.