Dr Stephen Parker
Executive Chairman at SAREUM HOLDINGS PLC
Replay available
FY26 Results hosted by Sareum Holdings (LSE:SAR) on Investor Meet Company. Replay available.

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0:00 Good afternoon, and welcome to the SAREUM HOLDINGS PLC Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and could be submitted at any time just by using the Q and A tab situated on the right hand corner of your screen. Please just simply type in your questions and press send. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Doctor. Stephen Parker, Executive Chairman. Good afternoon, sir. Thank you very much. Good afternoon, ladies and gentlemen. Thank you for joining us on this IMC presentation. And also, thank you for the questions that
0:30 you've already sent in. This, of course, is primarily to cover the final results, which were published yesterday for the year ending June 30. But before we dive into those, and I'll just sort of go to the usual disclaimer, where, of course, we will be talking about forward looking events, which might not happen or might not happen in the way we're describing. Before we dive into the details, I would like to share a few thoughts on the recent fundraising that we've been through. Obviously, we are pleased that we have been supported to go forwards.
1:16 We would have liked it to have been in different circumstances and perhaps at a better premium than we achieved. But we are unfortunately living in a continually poor funding climate. Second half of sorry, the second quarter of twenty twenty six, there was 2.1 raised billion for UK Life Sciences, but there were no IPOs in the sector. And of that GBP 2,110,000,000, only GBP 58,000,000 were for public companies. So this sort of gives you a little bit of background. In addition to that, thirty years ago, there were about 50 UK funds prepared to invest in small caps. That's not specifically to the sector. That's overall small caps.
2:06 Now there are something like four or five. Out of all the companies that did raise funds in AIM this year, over 80% would have gone under without the fundraising. And your Board continues to believe in the attractiveness of the drug assets that we have, and so we were determined not to let us be one of that number. Delisting is an increasing phenomenon from AIM, and we've actually seen one example today. There's been more than one company in the sector which has gone that route. We don't believe that this is the route that we want to follow. It's not our intention at present to do that. And there has, of course, been high interest in Nasdaq. The grass is not always greener on the other side.
2:53 Having had over twenty five years of experience dealing with and in Nasdaq listed companies, I don't believe this is the right direction for for SAREUM in its present form. The costs are too high. We would have to recruit significantly to provide the support needed for such a listing. And, of course, that inevitably ramps up the burn rate in the support functions rather than where we want it to be in adding value through our development programs. So on that basis, overall, we're very pleased to have come to the attention of the two new institutional investors with the capacity to support the company as we come towards the completion of our role in the development of SDC eighteen oh one. We're delighted that several of our high net worth investors were also happy to continue to support our progress.
3:49 As you can imagine, in such a buyer's market, the terms have been harsh. We obviously recognize that. But the Board can assure you that we considered and declined other offers on worse terms than these. We are, therefore, ready to press ahead with the final stages of preparing 1801 for Phase two development, and we continue to believe that we can emerge as a best in class compound. We'll go into more details of this through John's slides in this presentation. So moving on, you obviously know I'm not going to give you background on the company you know it as well as as we do but we've obviously we have the four functions here or three three drug areas and then the finance question.
4:40 We, 1801, it was autoimmune disease. We are coming rapidly towards the end of the toxicology program. That will be completed, in terms of top line results in Q4 twenty twenty six and I am confident that we will have those data before the AGM in December. The full Phase one data set was published in in the British Journal of Clinical Pharmacology in June. And you will have noted, I'm sure, because I'm sure many of you will have looked at that that paper, that one of the issues that arose during the the study was the availability of drug being variable in different dose sizes.
5:30 We've been working, as we've reported to you, through the months recently to address that. And that is the the reason why having, we believe, done so, we need to have this PK study so that we can establish the the actual dose ready for phase two. Seven thirty seven, has moved on a little in that we have a new US patent granted, takes our protection out to March 2043, which is still a good long time to make it an attractive asset. The IND for the AML trial remains open, and there is certainly a lot an increasing amount of interest in that space, for companies to explore that.
6:27 Now neuroscience discovery program, we have emerged from the collaboration with Receptor AI, which I think was very effective. And out of the molecules that were predicted by Receptor AI, we found one molecule which seems to be effective in a mouse model of MS and was well tolerated after oral dosing. So obviously that potentially looks very interesting. And just to remind you, we do have 100% ownership of anything coming out of the neuroscience program. Cash, of course, is somewhat better after last week than it was at year end.
7:14 Cash at the end of the period was GBP 1,200,000, with a loss after tax of GBP 3,300,000. We have, as you well know, raised overall about GBP 3,300,000 announced last week in the subscription of GBP $0.04 per share and the associated wrap that went after it. Our tax credits were received during the year. Obviously, they were down on the year before because the year before reflected the Phase one study, which was ongoing at that point. And we also raised GBP $05,000,000 from the warrant exercises in the period.
8:03 With that, I'd like to hand you over to John, who will take us through the overall pipeline and dive into the details. Yes. Thank you, Stephen. Good afternoon, everybody. John Reader, CSO. Showing a slide of our development pipeline. I'm sure you'll know all about these programs already, but just to reiterate, SDC eighteen o one, our lead asset, autoimmune disease therapeutic targeting, multiple... Well, with potential in multiple, autoimmune diseases such as psoriasis. The, has successfully completed a clinical phase one study in healthy volunteers. The cancer immunotherapy TYK2 JAK1 inhibitor SDC1802, which is targeted towards hematological cancers such as T ALL, B cell lymphoma.
9:01 And then the neuroscience project that Steven's just touched on. Again, multiple potential indications, multiple sclerosis, but also Parkinson's, Alzheimer's, serious unmet medical need, big patient populations. And then the check one program with our molecule SRA seven thirty seven has completed a couple of phase one b two a trials when it was in the hands of a former license holder. Good safety profile as a monotherapy, but no limited efficacy. But in combination with low dose gemcitabine, we saw some really meaningful efficacy, particularly in anogenital cancers. Again, it was had a good safety profile when combined with gemcitabine.
9:50 There have been multiple preclinical disclosures about the potential for Check-one inhibitors and or SRA737 in particular, in combination with a variety of multiple chemotherapeutics, targeted agents, other DDR inhibitors, immunotherapy, and low dose chemotherapeutics such as gemcitabine hydroxyurea, which has been demonstrated this year. So that tells you where we are with the programs. If I go into a little more detail on the TYK2 JAK1 inhibitors.
10:31 So the field has moved on this year in terms of validation and brepacitinib, which is Prevent's dual TYK2 JAK1 inhibitor. So has exactly the same mechanism of action as our SDC1801 molecule, has received FDA approval in summer to treat a disease called dermatomyositis in adults. It's the first FDA approved oral treatment for the condition and we believe demonstrates the potential utility of this dual TYK2 JAK1 inhibition profile. Amongst the selective TYK2 class then, the earliest exemplar is BMS' TYK2 inhibitor, so TYK2, which was approved without the black box warnings, boosts confidence in the TYK2 class.
11:22 And then, on the other side, JAK1 inhibitor, so AbbVie's selective JAK1 inhibitor, RINVOQ, which is increasingly showing to be well tolerated in long term safety studies post marketed analysis. So plenty of commercial potential in the field. Psoriasis alone affects more than one hundred and twenty five million people worldwide. There's an approximate market size of $29,000,000,000 in 2023. And you can see some of the peak sales forecasts, financials involved around this field. Tick to forecast peak sales of $3,000,000,000. KADA acquired the zasocitinib molecule from Nimbus for a $4,000,000,000 upfront when it was in phase two.
12:14 And Illumis have partnered their clinical stage TYK2 inhibitor in Japan for $140,000,000, so a lot of commercial potential. And then broad potential applicability in numerous diseases. So TYK2 is approved in psoriasis and psoriatic arthritis, RINVOQ in multiple diseases. We believe that TYK2 JAK inhibitors also have potential in multiple diseases and indeed have completed or are currently in clinical trials in psoriasis, psoriatic arthritis, rheumatoid arthritis, plus others that you can see there. So we think the approval of repacitinib really underlines the opportunity for a well tolerated TYK2JAK1 inhibitor.
13:08 Quick overview of the program. SDC eighteen oh one is being developed as a once daily oral treatment for autoimmune diseases. By blocking two pathways, TYK2 and JAK1, we believe SDC1801 has the potential for stronger disease control relative to a single pathway inhibitors. Published the full phase one dataset in the British Journal of Clinical Pharmacology during the year. The molecule was well tolerated at all doses tested. The half life supports once daily dosing. We had a very positive safety profile in that study. And most importantly, we think the positive phase one data really shows the potential for high level dosing that'll get us blood exposures comparable to brepacitinib at one hundred mg once daily, but without the side effects that brepacitinib demonstrated at that exposure level.
14:07 And I have a slide coming up which shows you where brepacitinib performed in a psoriasis study relative to other agents, at that one hundred mg dose. Since we completed the phase one, we've been working on phase two enabling activities. Dosing, as we reported, completed on the twentieth of July this year in the phase two enabling toxicology program. The top line results are expected in the near future. We've manufactured a GMP batch of SDC eighteen o one, so that's for powder, for molecule as a powder, ready to be used in any subsequent, clinical trial. And work is ongoing to finalize the capsule formulation aiming to improve drug release at higher doses and reduce the number of capsules required to get that high exposure.
15:01 The clinical plan then, funded by the post period subscription, is a short human PK study to determine how many daily capsules of a new formulation are needed to reach target blood exposures in any planned future phase two studies. And, obviously, we need to manufacture the capsules to do that to do that study. So this slide refers to why we believe SDC18A1 has this potential for best in class efficacy. We believe it can achieve superior efficacy to current oral, small molecule drugs, and the injectable biologic therapies.
15:49 What this diagram is showing is what's known as the PASI 90 score that, various agencies are approved or in development have achieved during clinical trials, in psoriasis patients. So PASI stands for psoriasis area and severity index. So how much of a body is affected by psoriasis and how severe are the symptoms. The 90 figure refers to a ninety percent improvement in those symptoms. So if I just draw your attention to SKYRIZI at week sixteen, what that box there is showing you, SKYRIZI is an IL 23 antibody, by the way, so a biological and injected therapy. But by week sixteen, after sixteen weeks of treatment, patients on SKYRIZI in this clinical trial, between seventy to eighty percent of them achieved a PASI 90 score.
16:44 You'll see icotide just below. Icotide is a new agent from J and J, which is a peptide therapeutic. By week sixteen, fifty percent of patients achieved a PASI 90 score. If you look at the top left, you'll see LISRAE or brepacitinib, to give it its generic name. So brepacitinib, in a short four week phase one b study, at a hundred mg dose gave a PASI 90 score of ninety percent. That's really very impressive. Outweighs any of the other agents here. And, unfortunately, for Prevantor and Lisrea, at that dose, there were poorly tolerated side effects, and this was principally effects on certain blood cell components. So reticulocytes, which are immature red blood cells, and then a component of white blood cells called neutrophils, part of the immune response.
17:50 But they were, quite markedly reduced by LISREA at one hundred mgs. And you can see the arrow pointing down to the LISREA box at thirty milligrams. So that is better tolerated. That is the dose that has been taken forward in subsequent clinical trials of brefacitinib or LISRAYA. Well tolerated, but you can see that the effects on the PASI 90 score are much more modest. So fifty percent of patients achieving that PASI 90 score after twelve weeks. Still impressive. Now why we're excited about SDC eighteen oh one is because we were able to dose SDC eighteen o one in the high dose cohort of our phase one study
18:36 to give blood exposures very similar to LISRAYA at one hundred milligrams. However, we did not see any of the side effects that LISREA demonstrates at at that high dose. So no effects on blood components. No effects on any other markers. So from a safety point of view, we believe we can be up there in that in that 90% PASI 90 box that Lisrear occupied. So if that was confirmed in further clinical studies, it would allow STC1801 to compete with the existing oral medicines, but also with the biological treatments that give the highest relief to psoriasis patients at the moment.
19:26 So there you see, we've put SDC1801 in that box. That's what we're hoping to occupy. Potentially, a Phase 1b clinical study could be conducted to test this hypothesis, but that's for something to come later.
19:46 Moving on to SDC1802 then, a cancer immunotherapy agent, again, a TYK2JAK1 inhibitor class. It's being developed for cancer and cancer immunotherapy applications. It's an immunomodulating molecule. It's demonstrated good efficacy in preclinical models of cancer. We've completed the translational work on this project and have a robust dataset in hand. The cancers which appear most susceptible are hematological disorders such as acute lymphoblastic leukemia, certain lymphomas, And we've demonstrated potential of eighteen o two both as a single agent and in combination with existing therapies. So we're looking to partner the program, primarily because of this hematological effect, And we believe that specialized knowledge of of that field will be an advantage in any ongoing clinical development of of SDC eighteen o two.
20:51 And then just touching briefly on the TYK2 neuroscience collaboration. We kicked this off in partnership with Receptor dot ai. The idea is to develop analogs of STC eighteen o one to use our existing compound collections and our existing expertise in the field to generate agents, which... For which we have good I... A good IP position, but agents that can cross into the brain to treat neuroinflammatory diseases. Receptor AI supported the work initially using computer aided design, models predictive of brain penetrance, and we oversaw the compound synthesis, the biological testing, the disease model work.
21:36 We own all of the IP and all of the compounds, any matter arising from a collaboration.
21:44 So the results, the output from this will inform selection of a candidate or candidates for preclinical development. Current work is focused on the iterative design, the synthesis, and the testing of inhibitors with blood brain barrier penetration.
22:05 Moving on to SRA737, then our Check-one inhibitor. Again, a cancer therapeutic with potential broad applicability. The science is well validated, CHECK1 forms part of the DNA damage response pathway, a well validated pathway for cancer therapeutics. Seven thirty seven has demonstrated good tolerability in the clinical studies I mentioned previously. And, again, synergies between Check-one inhibitors, including seven thirty seven and many different types of, cancer agents, have been demonstrated in preclinical studies. Again, broad potential applicability. The clinical and preclinical studies support the use of a selective checkpoint inhibitor in different clinical settings and in different combinations.
22:59 And the commercial potential is large for a no currently approved Check-one inhibitors, so a first in class opportunity for SRA737. The earlier generation Check-one inhibitors suffered from a lack of selectivity and were unsuccessful in clinical trials, mainly due to dose limiting toxicity,
23:21 in large part due to off target effects. So that creates an opportunity for a selective and better tolerated Check-one inhibitor, such as SRA737. So as we reported previously, we now own 63.5% of the economics in this project, alongside Cancer Research UK, who own the remainder.
23:50 In March sorry, this year, we were able to achieve extended patent protection, for a crystal form of SRA seven thirty seven drug substance that extends the IP protection for the molecule out to March 2043. And we have an open IND with the US FDA for a phase one trial in AML and MDS, and sufficient capsule stock to conduct that trial. The positive phase one two data showed the good tolerability as monotherapy, the good safety profile and promising activity when combined with low dose gemcitabine, particularly in anogenital cancers where there's significant unmet medical need.
24:39 And this year, a group in Australia published in the British Journal of Cancer some really nice preclinical efficacy data combining SRO737 with low dose hydroxyurea in ovarian cancer models. They've also published in melanoma and non small cell lung cancer. So really nice body of work that they're building up, showing preclinical utility of of SRA seven thirty seven. So we continue to explore partnering opportunities. That could be relicensing, partnering, potentially internal development to maximize the value of SRA seven thirty seven. And we're working with a specialist US based business development consultancy to particularly pursue those opportunities in in The US.
25:34 Okay. I'm going to hand you over to Tim Mitchell now to talk you through the financial results for the year ended 06/30/2026. Thank you. Thank you, John, and good afternoon, everybody. Thank you for for me for joining us today. So you may have seen the results that were published earlier this week. I'll just take you through some of the highlights.
25:59 So looking at the income statement, we see administrative expenses. So so that includes r and d slightly up for this period, reflecting a slightly higher spend in r and d over the corresponding period last year. Just skipping down, you'll you'll see that there... There's a quite... Well, last year, there there was a fairly hefty charge read the warrants, which I suppose it it... I mean, it's... No cash was lost in this. It's just a paper thing on the income statement, but that's that's actually slightly reversed for this year. So so that that affects, I suppose, the headline figures of of the total loss for the year. So I think as Steve mentioned earlier, loss before tax for the year of 3,500,000.
26:50 Tax credits of... So that's a cash credit we get from from the government, slightly lower than before that that this this is the the credit that we actually receive, not not the one we put on our books, and it and it reflects a slightly lower spend in previous years. And and I suspect some of some of that spend last year was also done in Australia, which has a more generous tax rate raising than the than The UK where most of the previous years r and d came from.
27:25 Yes. So a a loss of of 3,200,000.
27:34 And then moving on to the balance sheet. Again, Steve's given a bit of an insight into this. So 1,200,000 of cash, a bit down from this time last year. It reflects the cash we we spent in the year. And, obviously, we've got another 3,200,000. There's a there's a few expenses to top that up with. So we're we're currently sitting on a on a healthy cash position. And then weighing on that, again, it's a paper charge, this warrant liability. As the warrants are as... Are exercised, then this this number will gradually reduce. So we we have a paper net assets of... In in a slight negative, but it... That's really very heavily influenced by this warrant liability, which which isn't a real charge at all. Okay.
28:27 So with that, I will hand you back to Steve to to wrap up. Thank you, Tim. Thank you, John. So looking forward now with at the priorities that we have in front of us, just to remind you, the top line TOX results we're expecting in this quarter.
28:50 And as I say, confident that we will have some prior to the AGM. The Phase II regulatory package has required the additional step of the PK study that we explained before arising from the reformulation to make sure that we're getting a proper dose exposure. And we're not having to provide so many capsules to a patient that they simply wouldn't be in compliance.
29:24 At the present, we are still looking at psoriasis. It is the planned initial indication. And as John was explaining, our confidence in that arises from the potential to to be best in class and to to outperform on the the PASI 90 score as as on the charts. Eighteen oh two, seven thirty seven, both of them in the business development rather than clinical development box. We continue to work actively in those fields and are very sort of happy that we are getting some levels of interest in there. It's worth reminding you, of course, that seven thirty seven has only been fully in our control for a matter of months once we agreed new terms with the cancer research people.
30:22 So both we and in conjunction with our U. S. Biz dev consultancy colleagues are working hard to see if we can get a resolution to seven thirty seven in short order. And then lastly, on the neuroscience side,
30:43 moving well towards a development candidate and very much hope that we will have something we can report before too long. It's worth saying, of course, that with all this, 1801 has been very much front and center and our top priority. So in financially constrained times, we've focused on eighteen oh one rather than the other assets. So with that, we'll draw it to an end. Thank you all very much for listening. And I will hand you back to Tim to be the emcee for the Q and A session.
31:24 Thank you, Steven. And, yes, thank thank you everyone for the questions you submitted either in advance of the meeting, or I see a nice list of questions to come through during the meeting. So I'll I'll... I don't think we're gonna have time. I I see half an hour left to answer everything. We'll get through as many as you can, and I'll I'll do a mix of preselected and and ones submitted during the day. And anything else will... Any questions that we don't get down to answering, we will put up a written response to in the coming weeks. So if I start off with a slightly curious question there. Have you misled us through 2026, Steven? I'm I'm hoping the answer is gonna be no.
32:17 I'll just toss a coin. Obviously, the answer is no. Throughout the year, we've reported a steady progress through the RNS announcements, results statements and indeed the new Chairman's Corner letters, which I hope you've found helpful. The main commitments we made earlier in the year have been delivered with dosing and the tox program completed in July 26 on the timetable we expected, and we continue to expect top line results reports in this quarter.
32:47 In partnering discussions during the year, it became apparent that prospective partners saw the lack of validation of the new formulation in human PK studies as a risk. We therefore decided to conduct human PK study in order to validate the new formulation and to allow us or prospective partners to determine the capsule requirements at any future patient trial. It's probably worth noting that we did we have had offers for assets during the year,
33:17 But because it's been too easy to point to the risk rather than reward, those we did not, as a Board, consider those offers were in any way acceptable to bring forward. So
33:34 that's where we currently stand. Current longer time line for 1801 relates to the addition of the short human PK study and the manufacture of capsules and stability work required before we can conduct such a study. The steps depend one on one another and on the supply of materials and indeed availability of manufacturing slots, much of which is outside of our control. When you engage third parties for this sort of work, basically, there's a queue and you get allocated a slot, which if you're not ready, you simply lose and you go back in the queue to be allocating another one. So we've opted to give our shareholders a realistic timetable, and we're now targeting completion in mid-twenty twenty seven.
34:23 So, and it is important, of course, to note that we are continuing partnering discussions whilst this work is going on.
34:33 Thank you, Steven. Maybe actually another one for you here. So 2026 has been described as year of stakeholder value. Do we still believe this and why? If not, when you see this value being delivered? Well, we believe that 2026 has been an important year for the programs, and we don't want... But we don't want to overstate what that means to shareholders today. We believe that shareholder value will be delivered by reaching the milestones ahead of us. During the year, we completed dosing in the toxicology studies for 1801, published the full Phase I data set in a peer reviewed journal and strengthened the SAREUM HOLDINGS with a new U. S. Patent and independent peer reviewed data. We have also secured the funding needed to take eighteen oh one to a Phase two ready position, Although through a fundraiser, that was through a fundraiser, that was obviously dilutive, and and we're we're not sort of we're not shying away from that.
35:31 The issue of stakeholder value is is really a question, I I believe, of risk management.
35:39 Once we can once the balance tips away from risk and towards reward, then I think we will see and enjoy a significant jump in stakeholder value from partners looking at the assets.
35:58 Thank you. Thank you. I've got a question about the raise here. Mhmm. So so it it talks about the dilution for retail investors. It's it's asking if institutional investors have been given preferential rates. And, again, it's it's it's the year of stakeholder value. Yeah. Can we form how how how the raise represents that?
36:25 Well, I think putting it bluntly, if you remember in my preamble, I referred to the fact that 80 to 90% of of AIM companies that undertook fundraisings would not be here today had they not done so, and we are within that number. So so the the the bottom line is we we live we live to tell another to fight another day and to continue to seek to achieve the shareholder value that we do believe that the portfolio contains. All investors paid the same price of 14p per share, and there were no preferential rates. What there was was a
37:14 the wrap we were advised and and indeed required to keep the wrap to a a a low number so that... Which was why the numbers ended up as they were. I would just observe the people who applied for the wrap, the the retail the retail investors were the only people to get anything.
37:42 Others are retail brokers that operating separately and outside of our shareholder lists, weren't... Did not receive anything at all. So whilst I'm sorry that, there was a scaling back, at the same time, as I say, others received nothing. Thank you. On a slightly diff... Topic then, Steve, Can the board inform us if if the company intends to recommend bonus payments this year? And if so, based on what? That that is entirely a matter for the remuneration committee, which is, comprised of our two nonexec directors.
38:28 I no longer sit on that as an... As exec chair, and so I'm afraid you're asking the wrong people. We're as curious to know as you.
38:39 Thanks. And and I suppose I'll add to that that the the bonus payments and, in fact, all remuneration is disclosed in the annual report. That that will get published in due course. Yep. So, actually, it's another one going back to the raise again. Was any market sensitive information shared with investors prior to the recent raise? Yes. It was. The fact the fact that we were intending to raise funds, and that was it. So I know that the... I I know that within the the announcement last week, there was a reference to insiders being cleansed, but the the the inside information was the fact that there was a fundraise being proposed. Yeah. So so so to be clear, no inside technical information was disclosed Yeah. In Okay.
39:31 Thank you, Steven. John, one for you. Has the SDCA 18 o one toxicology study confirmed our belief that we have the potential to be a class leading compound, and will you publish any of the studies data?
39:47 It's... But it's too early to draw any conclusion from the tox studies at the moment. So dosing is complete, as we said. The data is being analyzed. We're expecting the top line reports in q four so shortly. We won't be publishing study data. I mean, that's not... You know, industry practice is is not to publish study data even once a drug is approved. These tox reports are are heavily redacted. So, no, we won't publish the data. I mean, we will certainly indicate to our shareholders,
40:24 you know, have they succeeded in their objective, which is to be suitable for submission to a regulatory authority. So to get a bit technical, have we been able to demonstrate a a no observed adverse effect level, which is really what, you know, the outcome we're we're looking for from these studies? And and we will be able to give that indication. But I I mean, in terms of best in class, just again, go back to that data from a phase one trial that that showed good safety at high blood exposures of eight... Eighteen o one in the same range as brepacitinib at a hundred meg, but without the side effects that brepacitinib showed.
41:10 So, certainly, from from human studies, we still believe it has the potential. From the tox studies yet that can inform on that. Great. Thank you. Back to you, Steven. Will the company be looking to appoint a CEO in the near future? Yeah. Yeah. At the present, our focus is on delivering the milestones ahead of us, and we believe that we do have the right structure in place to execute on on those priorities. But, of course, the board does keep the structure of the company under review, and will consider any future appointments when the time is right where they can add value. And indeed, should the need for succession planning arise as an urgent matter as opposed to a standard everyday topic.
42:00 Thank you. Actually, I'll pick this one up. Do you believe the US business development team are adding tangible value, and has their work led to serious talk to potential partners? Yes. So we engaged the consultancy nearly a year ago now to broaden to broaden the range of potential partners we speak to. There's an awful lot of US companies out there which are a little bit under the radar for us over this side of The Atlantic. They've been very successful in that. But the business development discussions we have just have to be confidential, and so we can't characterize where along that business development path or or name anybody we're speaking to, I'm afraid. Okay. Moving on then. So another one to John.
42:51 You you mentioned the the the high... Hydroxyurea combination study earlier. So so have we approached approached research team with with a view to any in human studies?
43:07 Well, I'd say, I mean, yeah, we're certainly aware of a paper in British Journal of Cancer and the other papers that the same group published. They're very interesting, showed compelling efficacy for around seven thirty seven combination of low dose hydroxyurea in a variety of cellular and mouse models in high grade serous ovarian cancer, melanoma, non small cell lung cancer.
43:36 It's it's it's independent peer reviewed academic work. So, you know, very, very useful. It's early translational studies, but it provides valuable third party evidence in cancers with significant unmet need, and there was a a novel and interesting mechanism of action. I mean, the research itself was conducted under the terms of an agreement between an earlier license holder for SARE seven three seven. And so we've inherited that agreement as part of that, you know, as we now hold the license for SARE737. So, yes, we we we are very much aware of the research going on at the at the METR Institute. Yes. Thank you.
44:23 Moving on, actually, another one for you, John, then. So we understand the money is raised. I assume that that that refers to the previous... Or or the recent fundraise to get us ready for phase two. What do you think will be the biggest cost for this?
44:41 Well, the main outstanding item that we've discussed today is this short short human PK study in healthy volunteers. So so this will be a... What's called a crossover study where the same volunteers receive the old formulation, the the original clinical formulation used in the phase one. Then there'll be a washout period, so to clear any of the drug from the... From a system. Then they'll take the new formulation, and then we compare the formulations behaved. So you're looking at the same the same volunteers with the two different formulations to see how how they behaved. And and that's the biggest component of the
45:28 the new plan for getting us to the phase two ready position. So prior to that, though, we obviously need to manufacture capsules. They'll need to be under GMP as they're going into humans. We need to start to generate stability data so we can get a shelf life for the for the capsules to satisfy the regulators. And so so the plan is to conduct that... All of that work alongside the continued work on the on the neuroscience program. Great. Thank you, John. I'm just gonna switch over to some questions submitted during the course today. I I I see time's marching on a bit. I'll I'll I'll go back to the presubmitted ones if if there's there's time afterwards. But I've just I've just picked out three or four here that I think are worth answering in person.
46:18 They're on the priority list, John and Steve, if you want to Mhmm. Preview. So, actually, I'll pick this one up up first. So a question that says, your stated strategy is to complete early development and then outlicense. Would the board consider a partnering discussion on s p c 18 o one once the tox data is in, or is the plan on... To to hold on until the phase two ready is complete? And and the answer is, yeah. Yeah. All of the above. We we continue
46:48 to to update potential partners with our progress, And and I think we'd be ready to do a deal as soon as we thought we we could we we could be offered one that that that delivered the value that that we think there is in SDC 18 l one. So, yeah, I mean, if if we if we get a good enough offer in the meantime, we'll take it. If not, we'll continue till that phase two ready package is complete. One one for you, Steven. Yes. Can you... Well, envisioning scenarios in which we take the company private. I I think it's... Yes. We've sort of clarified that there really are no plans to take the company private. Well, there are certain... There there there are certainly not. And and and if the... Actually, I'm going to read out the full question, which is can you envisage any scenarios in which you take the company private, leaving existing shareholders with nothing?
47:41 And I think it needs to be very clear that even if, which we do not intend to do, the company were to be taken private, the shares do not disappear. You would not have nothing. What you would have, what you would lose would be the ability to trade those shares. But in any case, the company couldn't be taken private without a shareholder vote.
48:05 You'll note that companies that have been taken private in recent times have had dominating shareholder blocks, which would vote the thing through. So we are not in that happy or otherwise position. We have a broad spread of shareholders, and we're looking to look after and reward, we hope, every one of them, including, of course, the shareholders who are sitting on this side of the board table. So no, there is no I cannot envisage any scenario. Thank you. Thank you for that clarification. I think I will pick this one up. Yes.
48:50 Does the current funding cover the complete mid mid twenty seven readiness program and a meaningful period afterwards for licensing negotiation?
49:01 And and I think that's the main crux of the of the question. As in have... Does does the fundraising give us plenty of room after we've we've completed the the phase two readiness to to to to complete a a licensing discussion? And and the answer is yes. We we have got money that that that will take us at least to the end of twenty twenty seven. There's some specific questions about net fundraising proceeds, cash position, assumptions about tax credit receipts. I think we'll cover those, if you don't mind, when we release our half yearly figures in... It's generally February or March next year.
49:50 And then once... One last one from the one submitted during the presentation. When will the board be purchasing shares as indicated on the RNS? Steve, is that best for you to pick up? Yep. I'm happy to to say that. One of the the answer is that it's it's a process that is currently underway. So there will be an RNS once those purchases have been completed, hopefully,
50:21 tomorrow or the day after. Thank you. Okay. A few more minutes left. Let's... We carry on with presubmitted ones. So so that I think many of the ones submitted during the presentation, I think, have already been answered. Obviously, yeah, we'll we'll we'll answer every question with a written answer in due course. But let's go back to to what we've got. So quite a lengthy question here. I'm I'm... I'll read it out verbatim, and it's it's one for Steven. So whilst understanding the usual lengthy time scales in drug development, in in the meantime, there is limited communication appraising the many investors who have faced the company's which begs the question, is SAREUM running a generous director's remuneration facility and science project by the stock market, or is there a genuine belief in progress towards becoming a viable company?
51:25 You guys want take that A long a long a long question, but a short answer. We have an absolute belief that we have some extraordinarily attractive assets, which I would say, the size of this company and the resources available to this company, we and John in particular has done an extraordinary job in developing to this stage. Mean it is the you know just sort of stop and think about it for a moment. We are talking about having the potential of a best in class compound compared against a drug that Pfizer developed or discovered, currently developed by ROYVANT. That is an extraordinary thing for a company like SAREUM to have.
52:13 And the... And and I am absolutely determined that the the the critical thing is that we develop the the data and the story to the point where people see the opportunity rather than the risk. So, it take... Yes, it does take time. Yes, trials take time. Yes, when you're involving third party contractors in order to do those trials for you, that takes time. But I have no doubt whatsoever that this... It's... The the the reward that is potentially there will be well worth waiting for. Thank you. Yeah. And, actually, if I may, I'm actually gonna address that. There's a comment about limited communication appraising the investors.
53:03 But I think, you know, compared to many companies and and and particularly our peer companies, actually, we put out a huge amount of detailed information. So we've given out, for for instance, more or less step by step progress with the toxicology studies. So at start, the we had some some problems which we had to address and then and then restart, and then we've we've said we've finished in life phases. No other company gives out information to that detail. So I I think I've refute the the the limited communication part of that question. Yep. Let me move on for a bit. Actually, John, yes. Moving bit further down the list, it's about the tox study.
53:52 And I think it's it's it's a useful time to clarify exactly what goes on in a tox study. So this is why did the sixteen week tox study take twenty weeks to complete, and why after fifteen weeks is there no results? Is the extended study deaths?
54:07 No. It isn't. During this study, which would extend the analysis work. Yeah. I mean, that's the one thing we can update on the on the tox study. So there were no deaths in either of the sixteen week tox studies that were due to SDC eighteen o one. So that's a absolutely positive bit of data. I mean, I think, you know, after after you've completed dosing, there's a recovery period, which is designed to see if for... If any toxicological effects are are permanent or if they're reversible once dosing stopped. And that's followed by a significant period of analysis, interpretation of results. The the CRO of the, you know, the guys who do the study, they have to complete the pathology, histopathology, analyze all of the data, interpret any findings.
55:01 That all then goes to an external peer review. And then that's all brought back in house prior to preparation of quality assured GLP report. So just the amount of work involved in ensuring the validity of these reports is enormous. And, you know, unfortunately, the process takes several months. Our our timelines for reporting are are normal. They are the industry standard timelines. And I just say again, we're... We we should have the top line results in the near future. Thank you. Thank you, John. Okay. I think with that, I... I'll hand back to IMC and Stephen to conclude the meeting.
55:47 Perfect. Thank you for updating investors today. Before we ask investors to share their feedback, which you know is particularly important to the company, Stephen, can I please just ask you for some closing comments? Yes, indeed. Well, once again, thank you all for being on the call and for listening to the presentation and indeed for asking the challenging questions, which I hope have been answered satisfactorily. I do want to thank not only you for being here today, but the shareholders who have stood by the company in the recent fundraise,
56:23 both in terms of the new institutions, but also the high net worth investors who have seen fit to stand by us and to support the company as we go forward. We will look forward to seeing many of you, I hope, at the AGM in December. And so until then, once again, thank you very much. Thank you for supporting the company, and we will talk to you soon. Thank you. Absolutely. Thank you to the team once again for the presentation this afternoon. Could I please ask investors not to close this session? It shall now be automatically redirected to provide your feedback. On behalf of the management team of SAREUM HOLDINGS PLC, we'd like to thank you for attending today's presentation, and good
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Executive Chairman at SAREUM HOLDINGS PLC
COO at SAREUM HOLDINGS PLC
CSO at SAREUM HOLDINGS PLC