Valirx (LSE:VAL) — Investor update presentation

0:04 Good afternoon, ladies and gentlemen, and welcome to the VALIRX Investor Presentation. 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's appropriate to do so. These will be available via your investment company dashboard and will notify you by email when they're ready for you to

0:35 review. I would like to remind you that this presentation is being recorded. Before we begin, I would like to submit the following poll. I would now like to hand over to Suzanne Dilley, CEO Mark Trahan, commercial director and doctor Kevin Cox, nonexecutive director. Good afternoon to you all. Good afternoon. Good afternoon. So thank you very much for the introduction, and thank you to everyone who's attending today. We've arranged this presentation so that we can provide information both to current shareholders and to new shareholders. So apologies if some of you have seen some of this before, but we promise there is some new information towards the back as we're hoping to introduce you to some of our new strategic thinking and how that's evolving as a result of the work that we've done over the past year.

1:30 So first of all, we have to remind you with this disclaimer that you should do your own research on the company and on all of our products before you consider investing in the company. Please don't take just this presentation as as your sole research. So, although, I appreciate that this disclaimer has far too many words on it for you to read and we'll go, we will make this presentation available on our website after today so you can look back at this at your leisure. So that actually applies to all of the information we're providing today because this presentation will be available. There are some slides that will click through quite quickly. And if you find you have questions on those when you look back at a later date, then feel free to email us on our shareholder communication system at questions at VALIRX. So I'd also like to apologize while we're doing this presentation that if we look like we're looking away from the camera, that is because we're we're looking at a laptop directly in front of us while we're doing the presentation.

2:22 So we will try and remember to look at the camera, but if at any point you you think we're not talking to you, please don't take that personally. So moving on and considering our our company strategy as it stands at the moment. This is the company strategy that we introduced last summer when myself and and Kevin moved on to the board at VALIRX. We refocused the direction of our research towards earlier, more preclinical stage programs. And in order to do that, we've been sending Mark, who's who's here today, to talk about exactly that, out to to universities, to charities, to other early stage biotech companies to look at the landscape of early innovative therapeutic programs which are available in the areas of women's health and oncology and looking specifically at preclinical stage programs that are either small molecules or synthetic peptide therapeutics that we might be able to bring in house into our programs in order to provide development of those through to the end of preclinical stage so that we can then find partners, whether that's external funders or industry partners, to fund the clinical trials in the future.

3:31 So just to be clear, we are focusing on on the preclinical development stage and and funding preclinical. And we believe if I move on to the next slide, I think I sort of draw this together. We believe that we are uniquely positioned to do this, to take programs from from universities or or early stage biotechs and bring together these three strands. So bringing together our science expertise, because we do have expertise in the company of running clinical trials in these areas, we can bring that clinical experience to bear earlier on in the development stage. In the preclinical stage, the work is carried out with a view to to the endpoint so we can run preclinical experiments that are ready for the programs to move into the clinic.

4:19 We believe we have the commercial experience. And, again, in particular with with Mark here, being able to draw together the the commercial and the finance experience to develop programs in a manner that's that's appropriate to industry, where Kevin steps in, and to to external investors. Right? So we believe that by drawing these three strands together, represented very broadly by the three of us sitting here, that that we offer a unique prospect so that when we go to universities and say, let us help you translate your programs from that early stage science to a a fully fledged clinic ready program that industry will recognize and want to partner, that we know we are the people who can achieve that. So moving on, where is the the pipeline that we have at the moment?

5:10 So this shows a mixture of mainly what we define as the legacy programs. So our two zero one, three zero one, and four zero one are the programs that have been in VALIRX for a number of years now. And in particular with two zero one and four zero one, they're programs that we are looking to actively license now because they have had clinical trials run on them, so they are just slightly later stage than the new programs that we're bringing in. So to briefly summarize these, so that if there are any new shareholders or potential shareholders in the audience, you can understand exactly where we're coming from. Barotero one is a short synthetic peptide that has been developed for the treatment of prostate cancer. So this completed a phase one two clinical trial last year, and those final results from that clinical trial fell out at the end of last year.

6:00 So our ambition at the moment for this program is to out license this, to to find a partner to to carry on the the clinical development, and to make sure that this program develops in a manner that's appropriate for patient use in the future. VALIRX four zero one similarly is is listed as a legacy asset that we are currently looking to outlicense. This completed a pilot phase two clinical trial in end stage lung cancer a couple of years ago, and we are also looking to outlicense that that program to a corporate partner in order that it can continue its clinical development and eventually reach market. Finally, for the the programs that have been in VALIRX PLOT for some time already, The program VALIRX PLAYER one labeled here is for the treatment of endometriosis.

6:48 It's the same active pharmaceutical ingredient as VALIRX PLAYER zero one, so the same synthetic dicopeptide. And this is using the same mechanism of action, but whereas in prostate cancer, it's inhibiting an activity caused by the androgen receptor. In endometriosis, exactly the same activity also prevents activity by the estrogen receptor. So So although endometriosis is a noncancerous condition, it's still characterized by cellular proliferation that is an overgrowth of cells in an area that you don't want them to be growing in. So this program is at preclinical stage. There are some further experiments to be run-in preclinical, and it's also subject to an evaluation agreement with the Japanese company at the moment.

7:34 So this arrangement with the Japanese company has been ongoing for for just over a year now, and we send them some material just at the beginning of the pandemic, actually. So so we had to ensure there was sufficient material there for them to carry out all of the work that they wanted to do. But they've been carrying out further preclinical work to see whether or not it's appropriate for them to adopt into their pipeline in a very similar manner to how we do with our new programs. But alongside this, we've also been carrying out our own work on the peptide and better understanding the the biology and the the cellular interactions of the peptide because this impacts our understanding both for endometriosis, but also for prostate cancer. And this also leads to our final product that's above the line in this diagram here, and this is b c two zero one, which is our program for the treatment of COVID nineteen complications.

8:30 Now, again, one of the key components of this program is the VAL two zero one peptide, so the synthetic decapeptide. And this is in conjunction with with two other biotech companies, Oncolytica and Black Cat Bio. And the program is being run predominantly by Oncolytica. VALIRX is responsible for providing some small quantities of material. So our surplus clinical trial material of the the peptide is being supplied into this, but also our expertise and understanding of the peptide. So because we have clinical safety data from peptide from the prostate cancer trial, this has been able to translate directly across into the virus project to allow them to look at the activity in the reduction of the the hyperimmune response and in the the reduction of viral uptake into the cell by the peptide.

9:26 So that program is ongoing. There there are experiments going on to make sure that we understand the biology, looking at the three areas in which the peptide may impact the the virus, the viral replication within the cell, viral uptake into the cell, and the hyperimmune response caused by the rest of the body as a result of the the viral infection. Now finally, we have under the orange line here, and this is this is the news that we put out a week or so ago. We have a new program in under evaluations. This is very exciting for us as this is one of the the big areas that that we're developing under the new strategy. So it's good to be able to to have a program in again under evaluation. And this is a program that we brought in under an evaluation agreement from a top London university for the development of triple negative treatment of triple negative breast cancer. I'm going to have to practice saying that one if we get it through evaluation.

10:27 So I have a further slide to give greater detail of this. Now if you look at this presentation in greater detail when we make it available on our website, there are similar slides to this slide for our other programs, which would also be made available as an appendix to the presentation. But this this will be kept in the main presentation just to introduce you to the program because even established shareholders won't be familiar with this one yet. So there is not a huge amount of detail we can give on this just yet. The university in question is keen that that we keep these details so that you can't identify exactly what the program is because this evaluation is done on the basis of our opinions. It's our science and our commercial opinions and our fit for our pipeline.

11:12 So it may be that the science is absolutely perfect, and yet we still decide not to go ahead. So the university is is keen that we keep that anonymous for now. But we can tell you that the primary area of treatment will be triple negative breast cancer, but the mechanism of action is such that this might be useful for a number of other cancers as well. In particular, the difficult to treat cancers that don't have an obvious flag or an obvious target on the outside of the cell that marks them as as a cancer, we believe that the mechanism of action may indicate that this will be useful for a number of those hard to treat cancers. So we brought this in under an evaluation agreement, and what that the next about nine months looking at this program and funding some early stage preclinical work

12:05 from our own funds in order to look at whether or not this this is appropriate for us. This involves looking at cell line experiments. It involves looking at the immunogenicity of the the of the drug candidate, and it involves looking at synthetic routes and formulations in order to make sure it's a well rounded, good project for us to take forwards.

12:31 So we we will be able to update on that probably in in around nine months' time at the latest. We will be confirming whether or not that goes ahead. And as our standard structure, if that does go ahead, that will then be licensed into a special purpose vehicle, a subsidiary of VALIRX, which will enable that project to be developed through to clinic ready and partnership ready status. So just very briefly on the the background for why we believe VALIRX has a place in the market in this this area of taking programs from university. Now I know we've we've spoken about this a number of times before, so I'm I'm going to keep this fairly brief. But universities are absolutely the best place for early stage blue sky thinking, understanding biology, all the bells and whistles experiments that that really get to initiate projects, new ways of of targeting targeting cancers, new new targets, target validation, all of those things are are done absolutely brilliantly by academics.

13:39 However, when industry is is looking to to look for these these early stage programs and to look at which programs to bring forwards, quite often, it's difficult for them to recognize exactly where those opportunities are and how they're going to work. And one of the reasons for this is because the

13:58 the academic work is carried out in the academic labs, and it's not necessarily using standard protocols that are recognized by industry. So for us to to step in here as a bridge, people quite often refer to the valley of death for for drug projects that that go from from academia to industry and have to cross this valley in some way. And this is referred to in terms of the innovation development and in terms of funding. So for us to be able to provide this bridge, to be able to provide the funding to carry out those preclinical experiments to an industry standard, but we're working closely with the academics to make sure that research is translated effectively from a science perspective is is really what we're concentrating on. And that absolutely isn't going to change in our strategy going forwards.

14:47 So it is part of March job to to go out and forge those relationships with universities to make sure they understand what we're doing, why we're the best partner for this, as well as to make sure that we get to see the best programs. We've we've updated the numbers on on this for this presentation. In the last twelve months, we viewed a huge number of of projects. When when Mark first looks at these projects, he brings them to me to have a first look at the science. And then we look in greater detail with our scientific advisers

15:17 and put a a shorter list to the scientific advisory board. He then select the the best fume at each meeting for us to have more detailed conversations with. And as you'll appreciate from the fact that we launched this strategy a year ago, and we've we've had this is now our second project under evaluation that we've now brought in, that this is not a great process. The the process of evaluating is is one thing, but then the process of negotiating with the universities and the academics to make sure that the arrangement works for everyone is really what takes the time. So moving on. What we have discovered when we've been out talking to universities and to charities and and to biotechs is that there is a wealth of of opportunities out there. There's a wealth of projects there that are available to consider for partnering and to start negotiating with universities.

16:15 But we have found that the majority, and I'm going to say 95%, but perhaps Mark's actually going to round that up to a 100%. The majority of those are in oncology. We go out and we we introduce ourselves to to the universities, and we say that we're we're a company focusing on oncology and diseases associated with women's health. And by that, I we give the example of the endometriosis program, and they they they sometimes say, oh, yes. That that's that's an interesting one. I've heard of that. But there are a whole host of diseases associated with women's health that I don't seem to feature on the radars of of these lists of academic projects. And whether that's diseases associated with the menopause or premature menopause or hot flushes or even diseases that affect everyone but are predominantly women such as lupus, which is ninety percent women according to recent statistics.

17:14 It's really trying to trying to understand why that is the case. And we can find women's cancers. We can find programs for that. The triple negative breast cancer, again, it's not exclusively women, but it is predominantly women. And the the gynecological cancers, again, are a perfect example where where we can find projects in that overlap.

17:35 But really we really wanted to look at why academics appear to be not developing drugs for diseases associated with women's health. And when we looked at this with a little bit more of a critical mind, actually, may maybe the answer is more obvious than than we first thought. So as you can see from from the slide that we've presented here, the majority of early phase clinical trials recruit men.

18:01 Now that's if we just let that sink in for a moment, it's something that when we've been talking to people about this this strategy of of making sure we encompass women's health in in our pipeline, a lot of people don't seem to have appreciated why this is and why this causes a problem. So actually, why it causes a problem is probably the easiest one to answer. And quite simply, that the early stage clinical trials are those where a lot of things are learned about the drug, how the drug interacts with the body and how the body interacts with the drug, the dose levels that are required, the the immediate possible side effects, any interactions with with other drugs that that people might be taking. All of those are looked at, and big decisions made about how the drug development process is going to happen based on the earliest clinical trials.

18:51 And for a disease that affects both men and women, the majority of times,

18:57 those those first trials will be carried out in men. And the healthy volunteer trials as well, where you first get the idea of pharmacokinetic and drug dosing levels, those will be carried out in men.

19:11 Now you have to immediately ask the question of why. And one of the big reasons of why is because of the risk of of women, particularly of women of childbearing age, becoming unintentionally pregnant during that clinical trial. Now they said it seems like an absolutely obvious risk. Now if if the drug isn't fully tested yet, I mean, we're talking about early phase clinical trials. They would have been tested in preclinical. There will be a number of areas of testing to make sure we understand the biology before they go into the clinical trial. But, actually, why why would you take the risk of of testing a woman in the early trials?

19:49 And it's it's that question that appears to be most important. Why would you take that risk? So what we believe is is a major driver here is that when academics are first looking at the fact they have a potential drug candidate and how are they going to develop it, there there are very well established protocols for for testing potential cancer drugs in the clinic or in in the lab, sorry, and in the university labs. And that's that's a good route to go. There's there's an obvious market need. Everyone knows about about cancer. Everybody knows people who have died of cancer. And so everybody knows there is a commercial and a patient need for for new cancer drugs. But the areas of of diseases of women's health, it's it's just not quite the same.

20:35 The models to be used in the labs aren't as well established.

20:40 There's a that early stage risk of how you get it into to women at the early stages if you haven't had the ability to carry out all of the reproductive toxicology studies to start with. And are those reproductive toxicology studies enough? So even if you carry out the whole barrage of preclinical experiments, if that goes into the trial, are you still confident? And there there are changes happening in this at the moment. So the the regulatory situation is improving,

21:09 and we believe that the opportunity is now there to enable that to happen. So the the regulators are looking more flexibly at applications that involve bringing women in early. So if you can make a justification for why women should be in early trials because it is a disease of women's health, for example, there's no point putting putting an endometriosis drug into men to see whether or not it works.

21:37 But the fact that you even have to justify this and the fact that company knows that you have to justify this and you have to take steps is off putting from a commercial perspective. So we we want to change that. Oh, that's that's that's a very big ambition said said in two words. But this is where we want to start talking about an evolution of our strategic ambition. So we've always said that we're focused on developing treatments for oncology and women's health, and that hasn't changed at all. We might swap the words over and say women's health and oncology, and we're certainly looking very much in that overlap. But what we want to do is we want to build the capability into VALIRX to enable

22:20 our programs to be developed in a manner that allows women to be incorporated early on. So this can apply, of course, not just to diseases associated with women's health, but diseases across the board. So that if a condition is affecting men and women equally, that doesn't mean that the treatment will be equally effective in both men and women. Or even when you're looking at women, whether or not premenopausal and postmenopausal women will respond in the same way when the the hormonal environment in the body is so different.

22:52 So what we want to do is we want to build this in early into our drug development process. We want to make sure that the programs that we develop have that good understanding of biology that gives us confidence to take the programs into the clinic and into women at the earliest opportunity. Now we know that we have some expertise in this area, and we know that that we can access the expertise by using by using contract research organizations, by buying consultants time as we need it. But we're also looking at innovative technology platforms that can help us do that. So where we can use innovative technologies to to enhance our understanding and provide an enhanced translation of those programs that we're taking from universities, that's really what we want to do.

23:43 And when the the opportunity is there, we would also like to be able to bring those opportunities in house so that if we have those technology platforms in house and we have those capabilities and that expertise in house, we will be able to use them to to enhance our drug development process in a really wholesale manner to make sure it's part of our culture to develop programs in this way. But we feel that this is also potentially of use to to other companies. We we're quite ambitious in that way. We don't just want to change what we're doing. We want to change what the industry is doing. So we want to make sure that if we put together technology platforms that enable our drugs to be developed better, we want to offer that opportunity to to other companies as well.

24:32 And by being able to offer this, being able to allow other companies to access our expertise and our capabilities, we think we can help affect a change in that culture in the industry.

24:44 But in addition, of course, it has the advantage that if we're offering this as a service, we've got the opportunity for early revenue to come to us as well. So we we have the the same strategy as previously that our in house program will be partnered through the the special purpose vehicle subsidiaries that we intend to set up, and income can flow back through through service revenues to those companies.

25:09 But we also believe we can do the same for the wider industry that by offering our services effectively operating as a CRO ourselves, a contract research organization, that we can bring service revenues back to VALIRX quicker while also affecting a much needed change in the industry. So I'm going to wrap up there. Hopefully, we've we've triggered lots of questions, and we we have a few questions sent in beforehand as well. So thank you to everyone who's done that. And the slide deck that will be available on our presentation on our website to show this presentation includes some extra slides as I detailed about the other programs, and we look forward to to hearing your questions. Thank you. See, that's great. And just maybe I mean, you've spoken now for about twenty minutes or so just to just to sort of make one point clear. As soon as you said, the presentation is going about something new, and that's that last slide I think we'd ask people to to look at and and and understand what we're going to be doing differently to what we've previously.

26:08 So we're still very keen to out license

26:10 the the legacy products. We still want to develop our pipeline, but it's this strategic ambition change, I think, that is we I think we've recognized over the last year in in dealing with universities and understanding where the market needs are. This is the bit that we think we can add something that's unique. And so we're going to be focusing very heavily on that over the next, six to twelve months. I think that's all I want to ask. Okay. Yeah. That's good. So I think So we're going back to, to the the Thank thank you very much indeed. Thank you. So, Susan, Mark, Kevin, thank you very much for your presentation. Ladies and gentlemen, please continue to submit your questions using the q and a tab situated on the top right hand corner of your screen. But just while the company takes a few moments to review the investor questions submitted already, I'd like to remind you that the recording of this presentation, along with a copy of the slides and

27:01 the published Q and A, can be accessed via your investor dashboard on the Investor Me company platform. I would also like to remind you that your feedback is important to the company. And immediately after today's presentation has ended, you 'll be redirected to for the opportunity to provide that feedback in order that the company can better understand your views and expectations.

27:20 So Susan, Mark, Kevin, we have received a number of pre submitted questions, as you had as you alluded earlier, from investors. And I wanted to start off Q and A session with these questions. The first one reads, obviously, it's key for shareholders that the company break the current never ending cycle of raise, spend, raise, spend, historically, continually eroded shareholding value. Would you be able to confirm that the company has a clear focus now on attempting to get at least one product line licensed before yet another capital raise? Yeah. I think I could probably answer that question. I think I could probably answer it in two parts. So first of all, I think since Susie and Kevin have come onto the board, I'd probably argue that the, that that that's that the cycle of raise spend raise spend at ever decreasing values has been, quite knocked on the head. I think if you look the last capital raise that that VALIRX actually undertook was, £1,350,000 at the end of July twenty twenty. We haven't got a capital raise since then in in in any way shape or form. The only money that has been coming into the business since then has has been the the exercise of warrants at 13 p associated with the placing in in early May of twenty twenty. So it's we've gone over a year without, without without doing a a capital raise, in in a in a in any sort of in any sort of form. So I think that that we we have kind of tried to change that culture and and try to become more sufficient. And I think if

28:51 you you you you you look at the the the interims that were published earlier this month, you can see that that the cash position of the business is still, is still very healthy. We're we're obviously all working harder at looking to to out license, at least one of the legacy assets. I think earlier this year, we we said that we'd like to be able to do that before before the end of the year. I think that we can safely say that we're we're we're still on track to to to to try and do that. So

29:18 I think that that kind of to to to sum it all up, I think that that that culture of of raised spend has has been has been finished. I think the cash position of the business is is strong, and and I think that that we we certainly plan to to out license, one one of the legacy assets, ahead of ahead of any any any further capital raise. As well. Yeah. I'm glad to do that. Yep. Good to know. Thank you very much. Regarding a license deal, what do you envisage this might look like? Are we talking a cash consideration upfront plus a percentage ongoing royalty? Shall I take that one? Yeah. Yeah. That's what I do. The licensing deal will be we imagine very similar to what you typically expect for a product of this type at this stage.

30:06 So it will comprise, an element of upfront. It will comprise, milestones associated with the development program, but also commercialization and ultimately royalties, subject to the drug actually going all the way through the market authorization and successful sales.

30:22 Given the nature of where we are with the development of two zero one, which is still really quite an early stage and not surprisingly, this to a degree, we're back end loaded. But all of those components, we hope, will be in the final agreement that we come to.

30:38 Thank you very much indeed. The next one asks, your installed running cost is in the region of £800,000 a year. Do you see this remaining the same or significantly increasing should you secure a license deal? You can do that one. No. That's fine. That makes my turn. So I I think we we've been very open about our cash flow the last year. I'm not sure there are many AIM companies who have actually published their their bank account via RNS every quarter for most of the last year. So I'm not sure the 800,000 is is exactly correct, but it's it's not a bad ballpark. Now in terms of whether or not it's it's going to remain the same or significantly increase, I think that that's that's actually slightly independent of the licensing deal question because we are intending to enter a phase of high growth. We we intend, as you've just seen from our presentation, to be quite ambitious about what we can achieve on on the science side and the the development of of future programs.

31:38 So our our running cost, our standard cost for for working capital of of running those those initial programs, those evaluations, and then bringing in to run-in in the SPVs will increase as as more come in. We will probably have to look at increasing the core team that's that's working on those to make sure that that we have enough bandwidth to take programs on, evaluate them, as well as negotiate the the licensing of of the legacy programs. So I I think we are going to enter a period of growth. However, we have changed the culture of spending in the company. As as Mark's already said, this wasn't just a case of slashing a few costs here and there. We've changed the culture. The the culture of understanding exactly what we're spending on what and keeping a close eye on that and making sure every penny is accounted for will carry on. And although the cost is going to vary according to the programs and and the individual programs needs, We we believe that we can keep that under a tight rein and make sure it's appropriate to the development that's being carried out.

32:43 And then just to add to that, Susan, the board is an area of very intense focus for the board. We'll be keep obviously keep under control and ready to review where we are on the cash position. So it we will not we do not intend to suddenly sort of open the floodgates and and be be propagates. We'll be very efficient with the capital that comes in. Thank you very much. Are you predominantly focusing attention on the seeking projects in the easier and quicker to license fields, or do you have any plans to mix in some of the more challenging cancer fields? No. I think this this was a really interesting question. I'm not even going to give the others the opportunity to volunteer. This is a question I I came in and immediately flagged for for my attention because it speaks back to exactly those those issues that that I spoke about earlier.

33:30 That when we go to universities, we can only respond to what they have and and what they present to us. And we quite often find that academics have had opportunities to develop programs in those those big name areas, whether or not that's that's through charity funding or just just through through ground funding through the research councils, the money that they can get a hold of is is more often for the big name cancers. But that doesn't mean that those are the only cancers that get attention. And, obviously, there are specialist groups working on on rare diseases, and there are pros and cons of of both sides. And in fact, if you take a a disease, whether it's oncology or women's health, that has a a fairly limited number of sufferers, then you can apply for something called orphan status.

34:18 And this is a regulatory status that allows you to take a different regulatory pathway to starting those clinical trials in the first place, but also to eventual market authorization and use of patients at the end of those clinical trials. It allows more scope for extension of patents, so it it gives a better commercial landscape, and it gives better access to to those patients and being able to recruit those patients, not least because there are usually less researchers working in that area, so there's less competition for those patients. So it's very much there there are advantages to to the big name diseases, and certainly when it's at the academic stage, being able to get the money. But we will always be looking when we bring a program into evaluation and what other cancers it can be used for or even what other conditions it can be used for. We mustn't forget that our endometriosis program was launched from our prostate cancer program. So it's not necessarily even that the drug has sustained cancer just because that's what we brought it in for.

35:19 So I think I highlighted on our triple negative breast cancer evaluation program that we will be looking at other difficult to treat cancers, for use with with that particular drug candidate. And that's that's going to be very exciting for us looking to see whether or not there are other areas that the academic just haven't had the opportunity to look into. So so an answer to the the question in a one word way, no. We're we're certainly not going to limit it just to the big name answers. We we are looking across the board at at everything we possibly can to make sure, again, if we understand the science, we can understand what that science can be used for. I think that's that's a great answer, Susan. And, you know, ultimately, it's gonna be determined by, is there a real technical need? Is there a real commercial opportunity?

36:04 And do we believe in the science? I think those are the fundamental questions we'll be asking in in assessing all the progress we go to our pipeline. So it really you know, it's really the combination of factors that ultimately mean we'll select something to take forward. Thank you very much for that. This question was from a poster known as Stumble on the LSE board who asks, are quantities still being sent to Japan for testing by the unknown company? So thank thank you, Stubler. Stubler did actually send that to to me directly by email as well, so I'm I'm going to be very careful not not to use the real name. So I I think we've we've probably answered this in the main presentation as well anyway. But the the company that that is in Japan that's that's carrying out some of this preclinical testing on on VALIRX three zero one for use in endometriosis, they're carrying out an evaluation that's very similar to to the evaluations that we carry out on programs that that come into us.

37:02 We were aware when we sent the the first batch of of the peptide over to them that we were right at the beginning of the pandemic. The lockdowns were just starting to happen, so we made sure we we put a little bit extra in before we posted it. So so in terms of the the direct answer, we we sent one package. That that one package has has not yet expired, and we we made sure there would be plenty in there. We are carrying out work on program ourselves as well, and we are sharing the the data that we generate with them just to say they have shared data with us, and and we have provided feedback and and input on their protocols. So it's it's very much a two way street. We we keep open communication with them, But, actually, no. We we we haven't sent any further peptide out to them just yet.

37:48 It's also probably worth recognizing that endometriosis is a difficult disease. There are very there are very limited models, good models that can be used to help to understand the disease. I think this is in part why we've begun to recognize and to wake up to the fact that there are opportunities here for companies that begin to address these issues, whether these models are preclinical or in human systems or whatever. And so I think that's it's been really helpful actually having this dialogue and over this this last year to understand how we can, I guess, add more capability to continue to enhance the development of of of treatment for diseases like this or treatment for diseases of diseases like this? So so it's it's that's really sort of in a part of what's led to our evolution strategy towards, I guess, increasing internal capability much more so. It's also probably worth mentioning that just because we're we we've got this evaluation agreement with with this one Japanese farmer, it doesn't actually preclude us from negotiating and speaking to other farmers as well. We have had numerous other calls from from inbound interested parties asking about the program and and and wanting to be kept in touch. So Yes. From both Japan and Europe, in fact.

38:54 Definitely. So so yeah. So so so it's although although, we we do have this evaluation agreement with with this this one Japanese, company that it it doesn't preclude us from from speaking and working with others. Thank you very much. The next question reads, can you update us, please, regarding which project is likely to license first? Yeah. So I think, this this is part of a a longer question. I'm I'm going to spoil spoil the surprise then because I know this this question was shared more broadly anyway talking about the specifically about the outlicensing of of legacy programs. Now we're we're being entirely upfront about this. In any process of outlicensing, it's it's a negotiation. The timing isn't entirely under our control.

39:43 But the VALIRX PLC program finished its clinical trial last year, and we were very keen to make sure that that potential partners had those results as they were hot off the press. And, really, our focus has been predominantly on introducing the the VALIRX PLC one program, the the new results to as many people as possible this year in order to make sure that that we could select the the right team, the the right partners in order to take this program forwards to find somebody who truly understands the science and understands exactly what needs to be done to this program to develop it. Now that's that's not to say that we've neglected the others. We we always have a have an eye on the entire VALIR pipeline.

40:30 And we've we have more recently turned our focus again towards VALIRX PORTER one. We feel VALIRX PERE one is in in a position now where where we are comfortable with the with the stage of negotiation, and we've been able to divert more of our focus onto VALIRX PLC. So that's not to say that we necessarily believe in any particular order because it is out of our control. However, we have focused the majority of our early attention this year onto the outlicensing of VALIRX PLC. Is that a fair fair summary? Yes. I'm sorry. Think that answered the question. It was a very long question. But it was a very long answer as well. So apologies if that came across a bit political, but it's it's out of our control that we we have been focusing primarily on two zero one first this year.

41:20 Thank you very much. The next question reads, the extension to the collaboration agreement with Physiomics in February 2021 included the offer to Physiomics of a seat on the VALIRX scientific advisory board. Was this offer accepted? And if so, how many SAB meetings has the Physiomics representative attended to date? Yeah. So so I'll I'll I'll cover that one. We're very, very fortunate that the the offer of the seat on the the VALIRX SAB board, was accepted, by representative of Physiomics. These meetings are held quarterly, and are kind of where the kind of the great scientific minds of VALIRX get together and and evaluate the the the projects that that that that we've come across in in the previous kind of three months. And and I can confirm that alongside the other academics and and and industry professionals that the the, the physiomics representative has has been a been a, both of the the SAP meetings and and played a very active role in in helping us to to evaluate new projects coming in.

42:21 I should add to that. I mean, whilst we talk about the SAP, we should acknowledge the fact that we've got some really very experienced people sitting on the SAP who have made it in in a really important contribution to our assessment of the technologies and selection of ones we take forward. And I think interestingly, they've also quite often been able to feedback to the universities about how they can improve their own internal activities to have a greater success in taking a drug through to the the next stage. So we're very lucky in having some some some excellent representatives on that. So something we've been. And I I would just expand on that that still further and say that it's not just the the quarterly meetings where they interact either. All of the members and the the physiomics representative included in this take an active communication role in the projects directly with the universities and and with us feeding back information when when we see new data from from the universities and and share that. They they will help with the interpretation as well as volunteering what what they can do in the future to to look at it. We even have SAP meet members visiting universities when they're when they're on holiday, which we've which we've had in the last couple of weeks for a program that that we were interested in. Yes.

43:33 Yes. It's it's it's it's been a really positive experience actually having been able to get this this group together in order to look at the science. Okay. Great. Thank you. The next question, AstraZeneca confirmed success in their phase three trials and data released from the clinical trial for its Lynparza tablet showed a statistically significant and clinically meaningful improvement in the survival of men suffering from prostate cancer. As a result, has this now rendered VAL two zero one as unlikely to secure a license deal, and have we missed the boat? So, Kevin, are you back in for that or for me? No. No. I'll back you up. Kevin, no. That's that's fine. I mean, we we saw this this news from AstraZeneca last week, and it it's absolutely fantastic. It's fantastic news for the patients.

44:19 It's fantastic news for the industry because it shows how drugs are coming through, how drugs are being developed, and making a meaningful impact on patients' lives. Does it mean we've missed the boat? Not in the slightest. I'm I'm if anything, when when these items of news come out about big companies hitting the big name cancers, we we celebrate it completely because it shows us which companies are interested in which cancers. It shows that the companies are still interested in those cancers. And the amount of times people say, oh, no. That cancer, that's solved. And you just want to turn around to those patients and ask whether or not they would like to hear that they had that cancer because it's solved, it's not a problem anymore. As long as people are still dying of these cancers, there is still room for improvement in the treatments. There is still room for for more treatments.

45:08 And the fact that big name companies are carrying out their drug programs on that shows that there there is scope for partnership with those companies and that there is still a commercial need under market. Kevin, you want I think that absolutely right. I mean, this this drug is a combination drug anyway. Still still haven't fully read out the the the data, but it looks very promising indeed, and that's correct for patients. But I I think we all know that not all patients respond to all drugs, and so there's an absolute need to have more than one treatment for any particular disease. And so it's it simply demonstrates there's an opportunity an opportunity to continue to improve treatment for this this horrible condition. So we're we're we're very encouraged and very enthused about the whole thing, and absolutely no way impacts what we can do with with our particular product. Okay. That's then that one. Thank you. Thank you, indeed.

45:58 This one is the last of the presubmitted questions. What are your future plans for PR? We need to see a further step improvement in communications in order to attract new shareholder interest and support existing shareholders. Yeah. So that's that's that's what I'm going to volunteer to take it again before, yes, you have the opportunity to step in. I so there's a there's a number of answers to these questions. So first of all, everyone have seen the news recently that that we've appointed SENCOs as a broker, and they they will be helping with our communication strategy, and they will certainly be helping to introduce us to new investors and new types of investor. So we're we're very excited by that. But, actually, looking at the suggestion of a step improvement in in communications, that is something that that we're very keen to do. And everyone knows that that we enjoy shareholder communications, that we actively encourage shareholders to to communicate with us so that we know whether or not our messaging is working, whether or not it's getting to the people who matter, and whether or not people understand what we're saying and understand the the purpose behind the company. So all of that is absolutely invaluable.

47:04 But I'd like to make one one further comment on this. So I I noted earlier that our new evaluation agreement for the triple negative breast cancer drug candidate was a good example of how our strategy is now being implemented. Now we believe that the next stage in our strategy being implemented will be the outlicensing of the legacy programs. And when we achieve that, we will be able to shout it from the rooftops that we have announced our strategy and we have implemented our strategy and that we are performing. At that stage, the PR will will be ramped up, hopefully, to the the expectations and the approval of of all shareholders. Because until that point, what we're saying is is great on paper. The new strategy is great on paper. The the strategic ambition is great on paper, but we need to deliver on it. And until we can deliver on it, anything out that we give is is a, beautiful strategy on paper in a business term, and we need to deliver, and then we need to shout about it.

48:07 I can't really add very much to that, Sue. The other other than to say this, and I think our objective over the last year or so has been to really just talk about the things that are meaningful to the company and demonstrate a real move and transition towards the implementation strategy. So rather than just comment comment safe, we'd like to say things which are are meaningful and, and impactful. And we hope that over this next period, there will be a number of things which we can, communicate as effectively as possible. It's fair to say there's always room for improvements, and people got ideas of how we can continue to improve what we do. Very much want to hear them. We also need to recognize, I think, that there are different types of people who want to hear our messaging. And so we have to open up all those channels to all the investors and indeed stakeholders to be as effective as possible. So we we hope to continue to improve and maintain the progress made that we've achieved so far.

49:00 I think that's that's a very good point, actually, Kevin, that I think every everybody when they're considering what they're reading instinctively considers it from their own perspective. So you you guys who I hope are there in the audience today because we can't see you, are are most likely private investors or or retail investors. But this this video will be available to to anyone who wants to see it. So that could be potential industry partners. That could be academics at universities who have spoken to taking a look at whether or not we're we're respectable people to do science with, and we have to consider all of the people who could be watching. So it's it's actually a really careful balance to to get that right between making sure that everybody hears what they want to hear, but the best way of doing that is to be as transparent as possible and make sure you see exactly what we're doing in the most truthful way possible so that people see see reality.

49:55 The academic we're we're not just giving a polished production for we're going to spend all this money on the science so that they they they feel encouraged while also saying to to individual investors, don't worry. We're looking after the pennies because it's the the two have to marry together. So so we we have to take that center of line if we we're doing proportionate spending to make sure the science is achieved. And it's it's that that balance that I think is is really important and the awareness from from the audience that that there are other areas of the audience. Yep. I think I'm okay. Yep. I think we're with that one. Suzanne, Mark, Kevin, thank you very much for those. However, investors have submitted a number questions during the presentation today, and I wanted to hand back to you to respond to those where it is appropriate for you to do so. Could I ask that you please read out the question and say who is it from?

50:48 Sure. So so I'll do the reading out. I know Kevin put his glasses on. I'm reading. See what I'm reading. So first, we have a question for I'm not sure this is coming exactly the right order. I think I'm gonna go this order anyway. So we have a a question from Chris R. The question is, how are you dealing with the challenges faced by academics during the commercialization process? And so so I think the the phrase commercialization process could mean a couple of things. It can mean the translation of academic research into the industry settings. That's that's exactly what what we're trying to help them with. The commercialization can also mean right at the end of the development process where they the drug actually moves from clinical testing onto the market. Now that second one, I'm not gonna say doesn't concern us. Perhaps that's the wrong phrase. But it's it's an area that we're focused on because that's beyond our stage of of when we're going to work on the drug. We'll have handed that over to commercialization partner at that stage.

51:50 But that that process of taking the the drug candidate from the academics lab into the industrial lab, that's that stage of commercialization. We are keen to work with the academics as much as possible in order to ensure that's that history of the science, that science knowledge that's built up around the drug candidate is transferred to the the SPV, the the special purpose subsidiary that we set up in order have that that drug candidate. So we we interact with them as much as possible. We explain to them exactly what we're doing, why we're doing it. We try to involve them in as many of the the meetings, whether that's with patent agents or with with contract research organizations who are going to be carrying out work and just make sure they understand what's going on and that they're comfortable with the process.

52:40 Because I although we we can do it without them, I'd rather not do it without them. I'm not going to go as if I were to say we can't do it without them. But it's it's not far off that. You you need that history. You need that understanding. You need to know where drugs come from in order to develop it effectively. Things often commented that The UK is not to be good at translating innovation out of universities and and into a commercial environment. What we found and and actually throughout my career, I found actually quite often the academic is the one who's absolutely very keen to get it out there and get some impact from it to actually get it commercialized. And and and when we found that all the way through the last through the last twelve months, the academics themselves really wanna work closely with us. What we find is the most challenging bit is the system in which we operate, And and that that's the bit which can can actually create delays and and sort of Stability to progress. Yeah. It's a bottleneck. That's right. The academics themselves are really keen to make to take it forward.

53:38 I think that that we think that's very encouraging. And so wherever as soon as says, we want to embrace the academic and bring them into whatever system we set up to be able to develop their their baby, their technology. Okay. You want me ask about your watch? So, hopefully, that has answered the question. We have another question from from David T. I brought into VALIRX consequent to the promising prostate count trial results, but that was some time ago. What's happened since I u y no positive uptake or move forward on that? David's given his full name, which I'll I'll hold back. I guess we'd like to think, David, we've we've tried to address your question already in in what we said so far. Hopefully, we've made it clear. If there's anything that is unclear, you can let us know afterwards. But I think I think we, you know, we we we have continued to focus very heavily on on the out licensing process.

54:34 And I I think just to highlight that it is only a year ago, less than a year ago, that the full trial results were available. There was a lot of speculation earlier than that about what the trial results were going to be. So possibly people felt that they knew the results before they came out. But, actually, until the trial was closed formally closed and made the results formally analyzed and entered into the database, that that process couldn't begin if the post trial activities. Yeah. Okay. Hopefully, you covered that one. I have another question here from Spars C. Can you explain to us SENCOS' involvement? So, Mark Yeah. So, I mean, I think that's that's probably one for me. So we've we've obviously recently appointed SENCOSS as our broker. What we want to do as VALIRX as a company is is is we as as Susie spoke about earlier is that is that we are planning on becoming a growth company in in, in a very interesting area of women's health.

55:32 And we felt that SENCOSP were the best partners to help us grow, in in in that area that that that we feel that they have probably the the best, access to it and and, relationships with institutional investors, which which is ultimately, the the the the the type of new investor that we are looking to target and and become attractive too. So, certainly, they're they're gonna help us with with kind of marketing to the stock market, which which would would obviously hopefully benefit shareholders, like yourself who obviously own shares, but but but also help us with with the the the branding and the and and the the marketing of the story itself. So so they are going to be playing a very active part in in the in the growth of the business over the next few years. I I think I would actually add that they've been really useful to date. I I think I think we've had several really valuable conversations with them because they are they they understand business. They understand science. They understand the market.

56:36 And it's it's the the combination of of skills that they can offer just provides us with another group of people who we can go to external to the company who can provide us with with strategic advice, who we can bounce ideas off, and we can really rationalize things through it. And in exactly the same way as a scientific advisory board helps us to look through the science and make sure we're not missing anything or or seeing anything incorrectly, SendCross are providing that. But from that perspective, that that they can see the the company from an external viewpoint and really help us to develop into that high grade company that we're aiming for. They also really, really bought into to us refocusing into into women's health. I think they say that that is a massive gap in in the in the listed market space, that there isn't really a way of of playing a a women's health company, on AIM, and and they think that it it is an area that is crying out or that that the investors are crying out for for for a way of of of accessing that.

57:36 I think that's, that's great answers. I think that pretty much answers the question. I'm certainly keeping us on our toes anyway. So I'm gonna wrap up here, actually. I think we've sort of spoken along. We have one final question from Porky. I think Porky can be well known to many. And I think probably we have addressed this or hopefully we have. The question is, are there any license offers that you are looking likely to go with? And I I think you've probably given enough points through the presentation of where we stand on that. So rather than answering specifically, I think if if you if you reflect on what we said through the whole presentation, hopefully, you'll have a much better idea of where we stand in in a number of areas at this point in time. So from our perspective now, I think we we think we're gonna stop here. If there are any other questions coming through as as said by the, part of the the investor meat company, we'll address them afterwards.

58:29 But I'll I'll hand back to to them or hand over to Susie to sort of wrap this up. Watch Yeah. Thank you. Then. No. That's that's fine. All I would like to say is that as a wrap up, is really to thank everyone for for attending today. We are entering a period where we hope that the the cultural changes we've made in the company are going to bear fruit. We are developing our our new strategic ambitions to to fit into that women's health arena and to fit into the high growth companies arena. And so we will be holding meetings, which allow shareholders to communicate with us on a regular basis, hopefully. We we would like your your feedback as well on what what works, what you'd like to see more of, and whether or not we've we've managed to talk to you in in a way that helps you to understand the company because we can only get better from from receiving.

59:22 And it's that communication that I think is is very important. So thank you all very much, and we hope to talk to you again soon. Susan, Mark, Kevin, thank you very much indeed for updating investors today. Could I please ask investors not to close this session as you will now be automatically redirected for the opportunity to provide your feedback in order that management can better understand your views and expectation. This will only take a few moments to complete, and it's greatly valued by the company. On behalf of the management of VALIRX PLC, we would like to thank you for attending today's presentation. This now concludes today's session. Thank you. Thank you.