Good afternoon, ladies and gentlemen, and welcome to the Sareum Holdings plc EGM and half-year results investor presentation. Throughout this recorded meeting, investors will be, and attendees will be in listen-only mode. Questions are encouraged. They can be submitted at any time using the Q&A tab situated on the right-hand corner of your screen. Please just simply type in your questions and press send.
The company may not be in a position to answer every question received during the meeting itself. However, the company will review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll for those online. I'm sure the company will be most grateful for your participation. I'd now like to hand over to Dr. Stephen Parker, chairman of Sareum Holdings. Good afternoon, sir.
Good afternoon, ladies and gentlemen. I'm Stephen Parker, and I'm the Chairman of the company. It's now 2:30 P.M. At 2:31 P.M., I will start the meeting and welcome all of you. I'm informed that at least two members of the company are entitled to vote at the meeting or present in person or by proxy. The quorum is therefore present, and the meeting can proceed. The circular containing the notice convening this meeting was sent to the company shareholders on the fourth of February 2022. The notice sets out the resolutions proposed to be passed at this meeting. Does anyone object if I take the notice as read?
Thank you. In accordance with Article 56 of the company's Articles of Association, voting today will be done on a show of hands. I'm appointing the company's registrar, Link Asset Services, to act as scrutineers. I will now proceed to take the meeting through the resolutions proposed at this extraordinary general meeting.
Just so you understand the format, we will deal with the formal business first, and there have been a few questions received specifically regarding the, particularly the share consolidation, proposed share consolidation. I will deal with those before we go to the formal vote. Once the voting is completed, we'll go to the half-yearly review and deal with any other questions that arise after that's been completed. I should remind you that resolution one is a special resolution.
Resolution two is the ordinary resolution regarding the consolidation of shares. One of the questions that has been received is addressing the question that a higher relative price is more attractive to institutional investors. I have to say that in my 35+ years experience of dealing with city companies and investment funds, I have found this to be absolutely the case.
It may not be logical, but it is absolutely the case that penny stocks are strongly disliked by institutions in pretty much any country. Shares which are measured in multiples of pence or preferably pounds are much more easily tradable and favored by the institutions, which is the fundamental reason why we are seeking to make this change.
I would also point out that institutions may choose to come into any future fundraising, but of course, are free to trade on secondary markets. I'm hoping to see both of those events taking place as a result of the consolidation once it's happened. I think that's the main question that has been raised with this. Just throw it open to people in the room. Do you have any questions specifically on this, on the topics?
Not specifically on the consolidation, no.
Right.
I understand exactly.
Thank you. In which case I will proceed to the formal passing of the resolution. Resolution one is for the purpose of adopting new articles of association of the company. Such resolution, along with a summary of the proposed changes, is set out in full in the notice of the extraordinary general meeting. For this resolution to be passed, it requires votes in favor of no less than 75% of the votes cast.
Will all those in favor of the resolution please raise their hands. Thank you. Any against? Thank you. Accordingly, I declare resolution one duly passed as a special resolution. As mentioned earlier, I can now tell you the votes that have been received. The votes for 813,549,009.
The votes against, 129,225,243. Which represents a majority of 86.3% and therefore duly passed. Resolution 2. Resolution 2 is for the purpose of approving the share consolidation. Such resolution is set out in full in the notice of the extraordinary general meeting.
For this resolution to be passed, it requires votes in favor of more than 50% of votes cast. Will all those in favor of this resolution please raise their hands. Thank you. Those against? Thank you. Accordingly, I declare Resolution two duly passed as an ordinary resolution. The votes received from proxies were votes for, 809,024,537. Votes against, 135,837,347.
Representing a majority in favor of 85.6%, and therefore, is duly carried. Thank you for that. The final results of the voting, including the proxies, will be announced through the RNS and published on the website as soon as it is practical. If there's no other business, that concludes the business of this extraordinary general meeting. Thank you for attending the formal part. I declare the meeting closed. I'm very happy to pass over to Tim Mitchell, who will take us through the half-year results update.
Thank you, Stephen. Good afternoon, everybody. Thank you for attending the meeting. Yes, myself and John will take you through a quick update that we published in our half-year results recently. I'll top and tail, and John will take us through the technical parts. I'll just move past the disclaimer. Just to remind everybody, we're working in two principal areas at Sareum.
Internally, we're looking at our TYK2/JAK1 inhibitors for autoimmune diseases, including the severe respiratory symptoms of COVID and other viral infections, and also in cancer. These programs are in preclinical, and the 1801 autoimmune COVID program is just completing its preclinical journey and will spend most of the technical time on that program.
We have the Checkpoint Kinase one program that's partnered with Sierra Oncology. Again, to remind you, it's completed two phase II trials. One is monotherapy, one in combination with low-dose gemcitabine. Recently, Sierra have noted that they are finalizing the designs on some further trials in combinations with other anti-cancer agents, and we'll give you a quick update of that, but that's based entirely on what Sierra have made public.
If I just run through some recent highlights then. For SDC-1801, the autoimmune and COVID program then, we're making good progress towards clinical development. We successfully completed the final toxicology studies to file the first exploratory clinical trials authorization. Those were completed at the end of last year.
That's the experimental stage. Preliminary results all look fine. We're expecting the final report in Q1. That's gonna be next month now. Our intention is still to file that CTA in mid-2022 and then start a phase Ia trial in healthy volunteers. This is to assess safety and dose levels in the second half of this calendar year. The production of the drug substance, that's the actual active ingredient and the drug product, and that's essentially the formulated product, is progressing to plan. Again, John will provide a few more details on that when we get into the details.
For 1802, the cancer program, we continue to design translational studies to work out the optimal cancer application before we complete the toxicology and manufacturing studies on this program. Just as a note, the IP property was further strengthened with another U.S. patent granted on that program. Highlights from the Checkpoint program, that's the SRA737 molecule. As I said earlier, Sierra's finalizing the design of several new clinical trials, which we hope will start in 2022. The first patient dosed in any of these trials will trigger a milestone payment to Sareum worth $550,000. We look forward to that.
Sierra have indicated that the potential types of trial that they could study SRA737 in is in combination with their newly in-licensed BET inhibitor. This is SRA515. It's a license from AstraZeneca that's in blood cancers. Another combination with SRA515, including standard of care in other solid tumors. I suppose a study that they have been planning for some time.
This is SRA737 plus low-dose gemcitabine plus immunotherapy. If you recall, some of the slides we've shown before when we've seen some very good results in small cell lung cancer, they'll be looking at this triple combination in solid tumors, or that's what they say they're finalizing designs of.
In terms of finances then, we raised a total of GBP 6.3 million in calendar year 2021, so that left us with cash in bank of GBP 5.6 million as at the end of December last year, comparing to GBP 1.3 million at the end of December 2020. That gives us sufficient funds to complete the phase 1a trial with SDC-1801 and also to accelerate the preclinical development of SDC-1802. Okay, with that introduction from me, if I hand over to John for a more deeper dive into the technical aspects.
Thank you, Tim. The JAK inhibitors are emerging targets of increasing industry interest. The JAK family of kinases are a key component in maintaining the balance and healthy immune system. The strong and emerging clinical validation of JAK inhibitors.
Particularly in the autoimmune disease area from BMS and Pfizer for their TYK2. In the case of BMS, TYK2 selective, and a dual TYK2/JAK1 inhibitor from Pfizer. They're publishing some nice data in psoriasis and psoriatic arthritis. There are a number of mid-stage clinical trials of TYK2 and dual TYK/JAK inhibitors ongoing for lupus, ulcerative colitis, Crohn's disease, and vitiligo, with some readouts that have come out recently and others into 2024.
There's good scientific evidence for a role of JAKs in modulating the severe inflammatory responses and for respiratory symptoms arising from coronavirus and other viral infections. Several JAK family inhibitors have been tested or are in the process of being tested against the severe respiratory symptoms of COVID infection.
In 2020, the JAK inhibitor market size was $18 billion and there's quite dramatic growth projected over the next few years, up to $320 billion by 2026. As an example of that, BMS are forecasting in excess of $4 billion sales for their TYK2 inhibitor, deucravacitinib, by 2029. The slide shows some of the key immunoregulatory cytokines that are affected by JAK signaling proteins and how JAK inhibition will interfere with these signaling pathways. You can see in the diagram a number of cytokines that are affected by TYK2 and JAK1. I think our areas of principal interest are the interferon alpha, IL-12 and IL-23.
They have roles in psoriasis, IBD, lupus, and potentially resistance to immuno-oncology therapies and the viral or bacterial pneumonia. Interestingly and importantly, JAK2 and JAK3 inhibition has been associated with the FDA black box warnings for serious infections, lymphoma, and thrombosis that Xeljanz, the JAK1/JAK3 inhibitor from Pfizer and Olumiant, the JAK1/JAK2 inhibitor from Eli Lilly, have been issued with.
We're focused on selective and potent inhibitors of TYK2/JAK1 inhibitors, so we want to avoid this inhibition of JAK2 and JAK3. I think there are significant clear opportunities available. There are no marketed products with selectivity for TYK2, which is important for differentiation, and there are no selective TYK2 inhibitors in clinical trials for cancer. We believe we have a first in class opportunity with SDC-1802.
SDC-1801 and SDC-1802 are potent and selective inhibitors of TYK2 and JAK1. They have a favorable selectivity profile versus JAK2 and JAK3, in contrast to tofacitinib and baricitinib. They are orally bioavailable. We use them twice daily when dosing to our preclinical disease species in mice, but we believe there's potential for once daily oral dosing in humans. There's also this potential to treat the cytokine storm, immune system overreaction that is frequently fatal in COVID-19 patients.
As Tim mentioned earlier, we have a strong intellectual property portfolio protecting these candidates in the key markets. Focusing on SDC-1801 then, which is our autoimmune disease candidate. This slide shows some timelines in our development strategy. Our internal focus is on progressing SDC-1801 into its first-in-human phase IA clinical trial.
We're working with a consultancy that has been appointed to assist in developing the clinical plan and selecting the initial indication for clinical studies beyond the phase IA. This will be in patients in an envisaged phase IB clinical trial. The strategy is to seek development partners for commercial licensing at the early to mid-clinical stage.
That strategy balances the costs versus the risk versus the potential returns of an early deal versus a later licensing opportunity, balancing that with the requirement for additional funding. In Q4 2021, we completed all of the laboratory work for the SDC-1801 toxicology studies. The reporting for this is in progress at the moment. We expect to have that complete by Q1 2022. We have seen all the data.
We know what it's gonna say, but there's an awful lot of GLP-type activities that need to go on before that report is finally signed off on. In Q1 2022, we are aiming to complete the synthesis of the SDC-1801 drug substance under GMP conditions and to finalize the clinical plan. In the next quarter, Q2 2022, we will complete the drug product development. This is the SDC-1801 in its capsule formulation, and we aim to file the CTA with the MHRA in the U.K. In H2 2022, we aim to initiate the phase I-A clinical trial to bring healthy volunteers with SDC-1801.
In the meantime, we're exploring the potential for further funding of SDC-1801 in severe COVID-19 from UK government, Therapeutics Taskforce or Agile Clinical Development Platform or one of the other equivalent programs. Moving on to SDC-1802. This is targeting multiple cancers. We've seen good efficacy in a number of immunotherapy disease models against multiple types of cancer.
The antitumor effects have been seen in models of kidney, colorectal, skin cancers, and B-cell lymphoma. There's evidence that SDC-1802 induces its anticancer activity through an immunotherapeutic mechanism. We've seen these positive results when dosed orally as a monotherapy and in combination with several chemotherapeutic agents. Recent patent grants have strengthened the IP portfolio in the major territories, which we've published on.
Currently underway are various translational studies, designed to define the optimal cancer application. There'll be additional biomarker studies to really dig deep into the mechanism of action of the molecule, really with the objective of identifying a suitable patient population for a phase I clinical trial. We aim to complete this before we move on to the completing of the toxicology and the manufacturing studies.
I think the experience that we've had in the development of eighteen oh one will enable the development of eighteen oh two to be more rapid than it has been for eighteen oh one. For example, the significant overlap in the chemical synthesis of the two molecules. We'll be taking what we've learned with eighteen oh one forward into the synthesis of eighteen oh two.
Then moving on to SRA737, which is the inhibitor of CHK1 kinase, which we discovered in a collaboration with various Cancer Research UK organizations and is out-licensed to Sierra Oncology. We're showing here a slide from Sierra's corporate presentation from November of last year, I believe. Yeah, it's really just to reiterate what Tim said already. A number of clinical trials are in the planning process by Sierra.
Combinations with their BET inhibitor that they've been licensed recently from AstraZeneca and other combinations planned with the immuno-oncology agents and low-dose gemcitabine. There is a $550,000 milestone payment due to Sareum upon achievement of the next milestone event, which will be the first patient in the next clinical trial.
We remain eligible for up to $79.75 million in total milestone payments, plus royalties, a share of royalties. Obviously, we will aim to keep our shareholders updated as the program progresses. I'll hand back to Tim now to conclude the rest of the presentation.
Thank you, John. If we move to the results that we put out recently then, if you look at the income statement, just running down from the top, the operating expenses, so that includes generally admin expenses and R&D, are increased significantly over the corresponding period last time. This is because of the extra expenses in the preclinical studies we've been doing.
You can sort of see that reflected in the tax credit, which is significantly higher than the same period last year. Admin expenses have been pretty much the same. That extra spend is pretty much all in R&D, giving us a loss for the half year of GBP 850,000 after tax.
If we just have a quick look at the balance sheet. I suppose the highlight there is the GBP 5.6 million cash we've got, so that's significantly higher than previous periods. That's essentially building our war chest to run the phase I-A studies. Obviously, we're very pleased to have that and are very grateful to our recent high net worth subscribers over the last year. There's not really much more to say about the figures. Obviously, if there's anything particular you wanna ask a question about, if you post it in the Q&A, I'll be happy to answer it if I can.
I'll just move on to a quick look ahead at the coming year and things that we might be expecting to publish. It's really all about the transition of SDC-1801 into the clinic. We'd look to submit the exploratory CTA in the middle of the year, obviously subject to obtaining approvals and finalizing the drug substance and drug product. I suppose dependent on how quickly the MHRA can turn around our submission, we'd be looking to start the clinical trial in the second half of this year. We'll also finalize the initial indication for the phase Ib trial that John mentioned.
The intention would be to tack that on to the end of the phase Ia study. We'll also be looking to provide some further updates on the preclinical progress of SDC-1802. For SRA737, we're hoping this will all be about the new trials of SRA737 with the various agents we've already mentioned. Low-dose gemcitabine and immune checkpoint inhibitor and the SRA515 BET inhibitor combination. It's the initiation of the trials in those areas. Potentially three new trials. As we already mentioned, the first patient dosed in the first of these trials will trigger the milestone payment for us.
We're expecting to report a lot of important pre-clinical and clinical progress during 2022 for all three of the products, but I suppose primarily 1801 and 737, but also 1802. That concludes my part of the presentation. Mark, do you just wanna hand over?
That's very kind of you, Tim. Thank you so much for your update and presentation this afternoon. Ladies and gentlemen, please do continue to submit your questions using the Q&A tab situated on the right-hand corner of your screen. But just while the company take a few moments to review those questions submitted already, 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 Meet Company dashboard.
Tim, I haven't given you a long while, but as you will know that you received a number of questions ahead of today's event. Of course, investors and attendees have had the ability to submit a number of questions throughout your presentation. Perhaps, if I may, if I could just hand back to you to read out any questions and give a response where it's appropriate to do so.
Yes. Thank you, Mark. Before we do that, perhaps, well, we do have shareholders in the room. I think it might be appropriate if there's the opportunity to ask questions from those shareholders first.
Yeah.
Can I make an observation? Also there's a question at the end of this. That in August 2019, it was stated that it was the company's intention to advance our first two Chk1 inhibitors through clinical trials in 2020. You also stated that the program continues to attract interest from international pharmaceutical companies.
In terms of where we are now, the share price is now half what it was 6 months ago. [Inaudiable] . As a shareholder, I'm concerned in terms of any potential slippage to these programs. Because clearly, as the news flow is slow, the share price slips. We've lost a lot of momentum. I was wondering if either you, Tim, or John, or Steve would like to comment in terms of how slippage can be prevented in the coming 12 months.
Okay. I'll take that if I can. We did have a delay, as you say, sort of 2019, 2020. We stumbled across a formulation issue which took us several months to finally crack. I think that's the reason for the slippage there. I'd like to. Well, I suppose the further down the track we go, the less problems there are to solve.
Yes.
I'm hoping that as we near the final hurdle, that there's very few problems left to solve. The chances of further slippage are lower. Obviously, you know, research is an uncertain business, and we can't make guarantees. Of course, we can never predict what problems or how long they are gonna take to solve. Any estimates we give are assuming a reasonable degree of success. Of course, if things go wrong, then generally timelines get longer than get shorter. I think it's fair to say we'd like to think we're on a fairly easy path now, to that finish line.
Yeah.
With all the usual health warnings.
I wouldn't say.
Yeah.
There are certainly fewer obstacles to overcome now because as, you know, as you progress, you're clearing more and more hurdles, and there are fewer hurdles ahead of you.
Right.
There are still hurdles. As Tim says, it's research. Things. Unexpected things can happen, and you have to work your way through them.
Okay. I mean, bearing in mind that back when I approached from the RNS, there was this interest from international pharmaceutical companies, and I understand from what you've just said, Tim, and John, that you know, there's consultancy helping with the design of the trials. Presumably that is being done in mind of who may be interested in either acquiring or licensing the molecules from us.
Yes. Yes, certainly. I mean, you know, part of the trial design is to create a package that will position the compound very favorably for licensing. Yes. I mean, there's. I suppose from our point of view, there's two results we'll get from the trial. One is to clear the path towards the next set of trials. And as you say, to also populate a data package with the information that a pharma partner would look for in a licensing deal.
Right. Okay.
We're taking a strategy of being therapeutic agnostic. We're developing a package whereby a larger company than us with the development experience can take the data that we're gonna generate and say, "Okay, yeah, it's safe." That's the most important one at this stage. "And there's evidence that it might work in this disease, that disease, the other disease."
That's really what we're trying to position. Now we are planning for a phase Ib subject to everything going well in a specific disease population. Not quite yet decided, but to be decided shortly. Which will provide, obviously, it will provide data in that specific disease, but it will also provide data that could be extended out to other diseases.
Right. That, that's being done with a view to improving shareholder value in what we've invested.
Absolutely. Yes.
Over the past 10 years. I think that's a very important point in a risk reduction and where we're going to in terms of potential value, whether it's licensing or whatever. Now I'm also assuming that the business model as published on Sareum website has not changed in that sense. That we're looking for that earlier rather than later.
Yes. I mean, I suppose not. I suppose the fact that we're funded through phase Ia now. It means that we can probably be a little bit more choosy with who we partner with.
Okay.
Yes. We can. We're not-
Tim, we have just lost connection with you sadly. If you could just please reconnect. It would appear that you've just lost internet connection. Ladies and gentlemen, please do bear with us, and we'll shortly recommence with the team at the general meeting. Please do bear with us. Thank you very much indeed. Ladies and gentlemen, I do apologize.
We are just waiting reconnection from the venue. Hopefully, that won't be too much longer. Please do bear with us, and I will give you updates in a moment's time. I do apologize, ladies and gentlemen. We are just waiting reconnection. I will update you shortly. We have made contact, ladies and gentlemen, with the venue. They have had a small issue with the connection. That should be back on very, very shortly.
I do apologize once again, and then we can pick up with the Q&A where Tim and the team left off. Thank you very much indeed again. We are, as I say, just waiting for reconnection. We do have they are aware of the disconnection locally, and we will hopefully have them reconnected shortly. Please do bear with us. James M, thank you for your message.
We are here, and obviously, as soon as we have contact, we will reconnect you. Thank you once again. Please don't feel that I'm telling you the same thing, but we are just waiting for the team to connect back online. Obviously, I'm mindful that there is silence, and that's probably not good for you if you're just waiting there seeing nothing change.
If I do come on and tell you the same thing 100 times, I do apologize, but just so you know that we are still trying to reconnect you. Thank you. Hi. Ladies and gentlemen, I do believe that we do have connection. If you just bear with me one second, we should have you connected back in two seconds time, and then we can carry on. Bear with me just one second, please. Thank you. If you just acknowledge the control and I'll be able to turn on your microphone. That's it. Perfect. Thank you very much indeed.
Can you hear me, Mark?
Hi, Tim. Can you hear us okay?
Yes. Apologies for that. We've had a slight technical issue here with the
Don't worry. I thought power might have gone or something.
Yes.
Yeah. I thought it may have done. Well, look, you've reconnected now. I have held everybody on. We still have nearly 200 people still on the call. Thank you once again to everybody for being so patient during that outage. If I may, Tim, if I could just hand back to you to carry on. Obviously, I think we got the last question that was submitted from the room, and obviously, you know you've got the online questions there as well. Thank you. I'll hand back to you now. Thank you.
Okay. I'll be brief. Very good news to see we're making some progress with SRA737 at last. The one thing I'm slightly surprised about is I do recall conversations in the past about the combination with PARP inhibitor. I don't know whether that is not on the agenda or.
We haven't seen that on Sierra's plans. Yeah. Yeah, there's preclinical data that looks very encouraging, but we haven't seen that yet. Sierra hasn't. You know, and we only know what Sierra tell us. We haven't seen any more information on that.
It may be there, but we just don't know it.
Yeah.
Okay. Fine. All right. I think I'll probably take up enough time for the next set of people.
Thank you.
Thank you.
Yeah. Stephen, have you got some more of those? They also handed to John for some.
I think most of these ones now are technical.
Okay. John, do you want to? There are some pre-posted technical questions.
Okay.
Uh.
Yeah. Okay. Let me take this one. From Sareum's statement on toxicology assessment has successfully determined the organs which are affected by SDC-1801. Are these in line with other TYK2 compounds which have recently been shelved? Or do these initial results provide current side effects as being projected to be less severe than competitors?
Well, the first thing I'll say it's impossible to compare with competitors' molecules, of course, because nobody really publishes their toxicology results, so we're not able to compare directly our data with what our competitors' compounds are showing in the clinic.
What I will say is just, well, a reminder that the purpose of toxicology studies is to look at higher concentrations of your molecule than you would expect to use in the clinic, and with the objective of finding some toxicity and identifying what organs that toxicity affects. Our toxicology studies have been successful, and I would just say, really, we're only seeing JAK inhibitor, typical JAK inhibitor effects.
But as I say, it's impossible to compare them with competitor compounds. We're very confident that we have a suitable therapeutic window so that the concentrations we're looking at, where we saw those effects, is much greater than we would expect to achieve in the clinic. There are a few TYK2 failures noted recently.
Can you explain what Sareum's key differentiator is, which gives some indication that Sareum's TYK2 would not immediately fall into the same failure bucket? I'm assuming this refers to the BMS allosteric inhibitor BMS-986165, which did not achieve its primary endpoint in a clinical trial against inflammatory bowel disease.
I mean, just to say our molecule does have a different mechanism of action. It is not an allosteric inhibitor. It's a direct inhibitor of the catalytic site of TYK2, and it also has a JAK1 activity. So, you know, that's not to say that we will definitely take it into an IBD trial or that if someone licenses the compound, they will take it into an IBD trial.
I don't think that single failure really reads through to our molecule. I know there were also a couple of disappointing results from the Theravance clinical trials. They're really looking at pan-JAK inhibitors where they are tissue-specific. So, for example, they had a compound that only stays in the lung. It does not get systemic exposure.
And I think it's fair to say it's been disappointing in an asthma trial. I believe they had an IBD trial which was also disappointing. Again, that molecule, pan-JAK, was restricted to the gastrointestinal tract. Again, our molecule is quite different. We are aiming for systemic delivery. So, you know, the molecule is in the bloodstream. And we have the TYK2/JAK1 selectivity profile.
There's another question about a recent Type 1 diabetes study of TYK2 allosteric BMS molecule showed a negative correlation between TYK2 and K-RAS. Does our TYK2 have similar results preclinical, and what does this mean for safety of the molecule? Secondly, have Sareum initiated any preclinical models of SDC-1801 against Type 1 diabetes?
And do you see this as a potential target in the future? If I can take the second part first. We haven't done any preclinical models of SDC-1801 against Type 1 diabetes. I don't know if we were still connected when I was addressing the gentleman who's in the room here with us was asking a question about therapeutic areas. We've tried to take a very agnostic view with therapeutic areas.
We're looking for sort of, you know, biomarker-driven effects, which should give some indication of the therapeutic areas to focus on. It may be that Type 1 diabetes is one of those. You know, there's certainly an interferon alpha effect in T1D, and our molecule inhibits interferon pathway signaling. There's potential there, but we have not looked at it.
I think the question about the negative correlation between TYK2 and K-RAS giving a safety concern. I mean, we haven't seen it, but we haven't looked for it. What I will say is the BMS molecule has been used for multiple years now in the clinic. They are not seeing any increase in cancer, which I imagine is what the question is concerned about this K-RAS increase.
I think the other thing, just to quickly say without getting too technical. K-RAS driven cancers are driven by mutations in K-RAS generally, which switches on K-RAS permanently, so it's constantly signaling. I don't think that an increase in expression of K-RAS would have the same effect.
I'm not brushing that, you know, under the carpet as a concern, but I think there's a lot of safety data being generated both by BMS, other JAK inhibitors, Pfizer molecule and, but there's no reports of increased cancer, at least driven by a K-RAS pathway. I hope that addresses those concerns. There was another question. What is the delay with the toxicology results? I'm not sure there is a delay. As I mentioned earlier-
Tim, I think you've lost connection one more time. Just bear with us one second while we try to reconnect you. Thank you. Do bear with us, ladies and gentlemen. Thank you very much. I do apologize for the inconvenience. This is being localized at the venue, so do bear with us.
Ladies and gentlemen, we have just spoken to the venue. They are attempting now to dial in, I hope so. It shouldn't be too much longer, and then we can carry on with the Q&A. Thank you very much indeed. Yes, James, the sound has gone. We are waiting for the venue. This is localized to the venue, so we do apologize, but bear with us. We should be with them. They've just clicked back in now, so.
Do apologize.
Hi, Tim. Just to say you're back in the room. I have supplied the venue with a dial-in number, so in the event that happens, they'll make that available to you, sir. You're back in there.
Yes. Can you hear me, Mark?
I can hear you, sir, yes. Yeah, that's gone. You had the other microphone. You're good to go, sir.
Great. Thank you. John, are you getting an echo there?
I am. Let me just remove the other link from the room, and then you'll just have that one link.
Hang on.
Your screen's gone in the room. That's fine. If you could just carry on with this link.
Do you want me to use this one?
Yeah, yeah.
Please. If you could, that'd be great. The link in the room, Tim, has gone. Right, the screen one has gone, so you should be just using the one in front of you now.
Yes. Yeah. Have you got the battery on that one?
Yes, it's fully charged.
Okay, great. Hi, Mark.
Yeah, please go ahead, Tim. We can hear you. If you'd carry on with the Q&A. I have turned off the other link that was causing you the echo.
Yeah.
If you could just use this one in the meantime, that'd be great.
Yeah.
You have 170 people on the call currently.
Yeah.
Thank you.
Apologies again, everybody. We have a new laptop here and with a full charge, so hopefully will see us through. I think you'd finished up, had you, John, with the pre-posted questions?
I think so, yeah. Hopefully everyone got to the end of my answer. Obviously, you know, we'll address these online anyway, so answers will be posted on our website to all of the questions we've received.
Okay, I'll just pick through. We've got about five or 10 minutes left now. I'll just pick through some of the questions that have been posted live. Thank you again for posting those. Question from Glenn G. "Are there any plans to dual list on NASDAQ?" The answer is no. We don't have any plans to dual list on NASDAQ. I did see some questions on. Sorry, bear with me. There's some questions on the timing of the toxicology report. I think we have covered this in the presentation, though. As John said, the experimental stage of the toxicology studies were completed, the back end of last year.
The report is quite a complex document that has to be produced to good laboratory practice. But we said that we're expecting it by Q3, by the end of March. We're still on track for that Q1. Sorry, Q1. Sorry, yes. Sorry. Month three, yes. Paul B has asked a question about, "Can you give details on how the capsule is progressing and what the current date for completion is expected to be?" That is progressing to schedule, and we are expecting to have the capsules this summer. I think is probably yeah is the current expected date.
We don't actually have to receive the capsules before we file the CTA. They just have to be fully in progress. We can file for the Clinical Trial Authorisation before we've actually received in our hands capsules for the study. Question from Phil M. "Please can you clarify what patents have been granted and what patents are awaiting decision?"
If you look on our website on the patents at publication stage, that lists all the patents that have been granted or that have been published and are awaiting final grant. There are a lot of them. I can't really go through them all now, but the website contains all that information for you. Question from Paul B.
So what will you be able to share in terms of details of the tox results?" I think looking through the questions there's a number of questions related to this. As John mentioned, it's not usual practice or no other companies publish this level of detail of the toxicology results, and we have no intention of doing that either.
There's a question about the consolidation. Consolidation price if we close the business today, I think that's my understanding that as markets open tomorrow, then that's when the new share price will appear. Okay. That concludes all the questions that we can give an immediate verbal answer to. We will, as John says, we'll publish answers to the questions online in due course. This concludes our session now. Mark, shall I hand back to you? Sorry.
Yeah.
To Stephen for a final
Yeah, that's great. Just as I say, to remind investors that Tim, as soon as you and the team have had a chance to review these questions, we'll notify everybody on the call that they're ready for their review. Absolutely, thank you for that, Tim. As you've quite rightly said, Tim, I'll shortly redirect investors and attendees to give you their thoughts and expectations and feedback. Apologies for the disconnection issues that they've experienced today. Perhaps before I finish up, if I could hand back to Dr. Stephen Parker, just for a few closing comments before redirecting investors.
Principally, to thank you all for both attending this EGM and briefing and your forbearance with the technical issues that we came across. We would expect to obviously produce news as it arises, but the next brief following our year-end results, which is of course June, and that will be some time in the autumn round about October, November time. Thank you for bearing with us. Thank you for your support for the company, and we look forward to producing more news and more data as time moves on. Thank you.
That's great. Thank you very much indeed, Dr. Stephen Parker. Later on, please can I ask you not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete, but I'm sure will be greatly valued by the company.
Once again, our apologies for the localized issues that the company experienced this afternoon. On behalf of the management team of Sareum Holdings plc, we'd like to thank you very much for your time today. That concludes today's session and good afternoon to you all.