Immupharma (LSE:IMM) — Investor Presentation

0:01 Good afternoon, ladies and gentlemen, and welcome to the IMMUPHARMA PLC Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged. They can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Just please simply type in your questions at any time and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we would like to submit the following poll. And if you'll give that your kind attention, I'm sure be most appreciated by the company. And I'd

0:32 now like to hand over to chief operating officer Tim Franklin and chief executive officer Tim McCarthy. Good morning or good afternoon to you both. Good afternoon, Mark. Thank you very much for that introduction. Let me say good afternoon to all the listeners. Thank you very much for taking the time out to listen to the presentation today. As an introduction, I'm sure you're all aware that we put an r and s out yesterday concerning a fundraising which we're going through, and I'd I'd like to come back to that and maybe talk a little bit more about that at the end. But we thought we'd take the opportunity to make the presentation today, Tim and I, just to bring you up to speed with where we are with the company, what we see as a very exciting future going forward, and put the whole fundraising into context because we're clearly a period now, if you've read the RNS, where everyone has the opportunity to participate in the fundraising, which is something we we felt very strongly about giving people the opportunity to do. So having the background of doing the presentation today for anybody that may be thinking of making investment, we thought it was very important.

1:43 So we're gonna share the presentation between us. So I think I've got control of these slides somewhere. So let me disclaimer. This is the team. So I think depending how well you know the company, you'll be more or less familiar with us. So there's myself as chief executive officer. I also currently hold the role of chairman as well from before, if you're familiar. And that's just to put that in context for anybody who doesn't know the company that well, we we had a a change around of the board and the management team just about a year ago now. And I I was was non executive chairman at the time, and I took over as chief executive officer.

2:30 Tim was on the board, but he became chief operating officer at that time. So we're the two executive directors, and then we've got Sanjeev who joined the board last last year together with Lisa. Lisa, a lot of you know anyway because she's been with the company for a long time as head of investor relations. Sanjeev, who you probably wouldn't necessarily know, but he's a surgeon by background, worked in the NHS, but he's also had a a commercial career and has run a a as a CEO of an AIM company himself in in the sector. Eva who's our CFO, although she's not formally on the board.

3:11 So where are we in terms of right. So I'm just gonna adjust my screen so I can see. Hopefully, you can still see me, but so I can see the presentation. So an overview of of the company. We are listed on The UK market. We have been now for for over ten years. And our expertise is very much in developing peptide based drugs. And we have two areas that we concentrate on, and this is very much how Tim and I in the last year have focused the company company on two specific areas where we believe that we can be successful and where we can add real value. So we split those two areas into autoimmunity and inflammation and separately infection.

3:58 A lot of you will know the company through what we call the p one forty platform and specifically the drug we call Lupusor. And that is in a very exciting stage at the moment. We're just about to move into a phase three study, a second phase three study that drug later this year. And that's given us a lot of momentum going forward. And that drug is partnered with a company called ABION PHARMA for The US rights. I emphasize The US rights because we as a company still have all of the rights to exploit that drug in the rest of the world, which will be a source of more commercial deals as we go as we move forward. And then under under that that overall platform that we call p one forty, there are different indications which we are able to develop. And the one that we're focusing on at the moment is in CIDP.

4:53 And And that one, because of all the data which we've already collected through preclinical studies and clinical studies with the same product in lupus, we are able to put that indication straight into what we call an adaptive phase two a three study. So it's a very late stage study, and Tim will speak a little bit more about that indication and and the opportunity there as we we get get further into the presentation. But it's just a demonstration of how we have in the last twelve months refocused the portfolio, brought forward those opportunities which we believe can add value very quickly. Are other indication opportunities within the p one forty platform other than just lupus and CIDP.

5:43 And in the anti infective area, we have two products which we concentrate on, which, again, Tim will come back to later in the presentation.

5:53 So where we are at the moment and really the basis of of the fundraising which we've just launched, and and I what I'd like to sort of emphasize to everybody who might be thinking of investment is why do we believe as a management team is is a good opportunity at the moment. So I mentioned that we changed the the business around a year ago. We have done an awful lot of work in those twelve months in terms of streamlining the company, reorganizing the corporate structure, a massive reduction in the overhead cost that was there previously in the company,

6:28 and perhaps more importantly for adding value for shareholders become more commercially focused. So we will definitely, over the next period, be looking to do some more licensing deals, out licensing deals, one on Lupusor for lupus the rest of the world rights. The CIDP has already started garnering a lot of interest because it's a late stage product, and there's such a lot of data on it through what we've been doing with lupus. And even in the early stage programs, the anti infective programs, we've already got some outline interest from commercial partners. And this is something which, as a company, we have not done very much of in the past. Some of you know the history of the company will know that loop the Lupusor product was licensed out to Cephalon about ten years ago, and they were going to take that all the way through.

7:18 That didn't happen because they as a company got taken over, and we took the rights back, which in retrospect meant that we ended up with a product which is now in late stage, will add an awful lot of value going forward, and that's just the way it works sometimes. But the the Avion who we partnered LoopTool with a couple of years ago now are fully behind this. They are fully paying for the trial, which should be an international trial so we can use all the data from that phase three trial for other areas in the world as well, not just The US. And we've been working with them very closely over the last couple of years, we've built a very good relationship up with them. And as you may or may not be aware, but I'm sure you are if you're if you're following the company, we have an expected response from the FDA at the end of this month, which after that, both, I mean, ourselves, are looking forward to starting the the phase three trial.

8:19 The, the comparison, I think, which we would like you to look at is to look at our company with all of the portfolio we have and the late stage products and especially Luposol being in phase three and look at the the valuation we're currently at, which is less than £20,000,000. If you look at that on a comparative peer to peer basis, and when I say peer to peer, try and look at companies that are similar in shape, to IMMUPHARMA, with a late stage product, which they own themselves that, frankly, there aren't that many. I mean, if you look in The US, there's there's there's quite a few to compare, but certainly in The UK or even in Europe, there aren't many companies that have a similar profile, and all of those companies are valued at a much higher level than we are.

9:06 Now you might ask why. And since we took over last year, I I've I've been on various webcasts and and presentations and been quite honest about it. The company didn't deliver. It didn't deliver on a number of levels in terms of we we didn't get through the first phase three of Loopsource successfully, and there's there's reasons for that. And I'll let Tim explain when we we come come on on to that later in the presentation. But we didn't deliver on anything else. We haven't done any of the commercial deals. We haven't developed the portfolio in the way that it should have been developed, and we've been perfectly honest about that. We can't hide away from that fact. But we have we have spent an awful lot of time and effort in the last twelve months in turning that around, and we're just on the brink of something really special here with the company.

9:55 It's also worth mentioning mentioning the the partner that we have in The US. We did a fundraising in December, which Avion participated in. And I I I think I it's it's important for me to say at this point that Avion are not an investor. They are developer and a pharmaceutical company very much like we are, and that's why they're very interested in the in the drug because they're very excited about Luphor's potential in The US. When they invested in December, it was very much a conversation that I had with the CEO of Avion. And he he said to me, I didn't approach him, he said to me, Tim, would you accept an investment in your company? Because I want to I want to show support.

10:43 We're not an investment company, so don't think we're gonna continue to invest in in a similar way. But at this point that you've just taken over, I totally underwrite your new strategy. I totally underwrite the new team. We have confidence in you. And, you know, I'd like to be alongside you and support you and just put a little investment in and show our support. And and that actually meant a lot to us. And so Abion are equity investor in the company, but that's not their that's not their day job. Their day job is developing drugs, and that's what the most important. An exciting thing to me is that they're they're really they're really sort of jumping at the bit to get on with this phase three. So we're all in, in in the same mode. So an overview of the portfolio just before I hand over to Tim to go through some of the detail.

11:33 It's very much as I've I've just laid out. You have the two areas, the the autoimmunity, anti inflammatory, and the anti infective, loop sore drug which is based on the platform which we call p one forty. I mentioned lupus. I mentioned CIDP. There's another example there. We've got some really good preclinical data on asthma, for example. So this technology platform could be one that produces an awful lot of, of different opportunities, for drugs in the future. And, very much our r and d team based in Bordeaux are not only supporting the Lupusa program, but they're very integral, to the anti infective, portfolio which we're developing here. And although you see it on this screen as preclinical, I think Tim will explain that it's, it's it's not to be looked at really in terms of the opportunity in the development stage as a pure preclinical.

12:28 It's something which we can fast track through or or with a partner we can fast track through to add value very, very quickly. So on that note, I'm gonna hand over to Tim. So if you wouldn't mind picking up from here, Tim. Thanks, Tim. Yep. Sure. So clearly, the lead indication for us is is lupus, for Lupazil, p one forty as it's also known by. So what is lupus? It's at the moment, it's a chronic infection because all the therapies that are given don't stop the course of the disease, so they're on therapy, pretty much for the rest of their lives. It can be life threatening if there's certain organ involvement, for example, the kidneys.

13:14 And it's essentially a disease where you're attacking your own DNA. So the effect could be on any of the of the organs of the body. The the disease is pretty much out of control immune response, and it affects the the skin. There's a there's a very typical lupus presentation. It's more prominent in in women than men. And it can affect the joints, so it's very similar to rheumatoid arthritis in that way. It's very painful in the mornings, especially. It affect the kidneys, as I mentioned, blood cells, liver, heart, and lungs. It can even cause premature menopause, which is obviously a very significant issue for for for many younger women.

14:04 The the issue for lupus is that we in terms of therapeutics is we need something that's essentially a lot safer and more effective for patients. The current drugs which are approved specifically for lupus, Benlysta and Safnello, have, although very effective in certain segment of patients, have some very serious side effects which are illustrated on the prescribing information sheets for for health care providers.

14:35 So they they have very limited use at the moment and a very small number of patients. But nevertheless, combined, those two drugs are selling over a billion worldwide at the moment. The mainstay and the largest volume for therapy in this in this indication is steroids and antimalarials, which are not specifically approved for this disease, but are used off label in a lot of patients to try and manage the symptoms as best as best as possible. But we all understand the the issues and safety issues, especially with taking steroids and even anti malarials long term. The size of the market is around five million worldwide. And in The US, for example, it's still massively, massively underserved. There's probably around about, you know, a hundred thousand to 200,000 patients that we could potentially target with our drug alone, and that's not the whole market.

15:37 So why do we call p one forty Lipozor a paradigm shift in lupus therapy? Well, apart from the fact that it's a lot more patient friendly than taking therapy every day and trying to remember therapy every day or having to go in for a long infusion process at a hospital or or the specialist practice, it's a simple once a month injection under the skin. It's targeted. So so this comes back to why, you know, why why we're different and why the last clinical trial didn't deliver what we what we were hoping for. The the reason for that is that the last trial was designed in such a way that it didn't capture all those patients that will potentially react better to therapy.

16:27 And this is what we mean by a diagnostic biomarker. When we looked at the last trial, we could see that if that trial had been enriched and patient had been selected on the basis of a specific biological marker, they had more chance of responding more favorably to p one forty. We also know that p one forty is very safe. It's been looked in over 300 patients, exposed to the drug to date. And we know that it's not an immunosuppressant as are the current approved drugs. It doesn't suppress the immune system. It recalibrates the immune system due to its unique mechanism of action, which is distinct from from the other therapies. There are no interactions with vaccines, so that's you know, it's not affecting the immune system in such a way that you can't be vaccinated or it won't affect recent vaccinations to other drugs.

17:22 And it's a completely natural approach. The peptide, which is a very small sequence of amino acids, is naturally present in a protein that acts within this natural recalibrating mechanism, if you like, within the body. So the natural approach clearly is is more appealing, and that's probably why, you know, we've got very good safety data so far. However, which way you cut the cut the forecast, I mean, clearly, we can't define price just yet, but you could quite easily see a potential of 2,000,000,000 worldwide global sales. You know? But that's I mean, it it does get academic after a while trying to to look at those figures. But it's clearly a a large potential, commercial potential for us.

18:11 So behind that, and and that study, you know, we're looking to start that as soon as we we can once we've had the the FDA written response at the end of August. Behind that, we have CIDP. The mechanism by which p one forty works in lupus is also connected to another another a number of other disease states. CRDP being one of those. We are our inventor and and lead immunologist and and key collaborator, professor Muller, has also done a lot of work in animals to to show that it also works p one forty also works as CIDP. And the inflammatory effect of of of this disease causes loss of myelin around the nerves. So this is like the insulation around nerves, and when that starts to break down.

19:08 So it's a neurological disorder. It causes pain and dysfunction in the nerves, and it causes a progressive weakness and impaired function in the limbs over time. It it is likened to MS in many ways, but the flaring and relapse rates are very predictable for CRDP, whereas they're more random for for multiple sclerosis. So it's a similar type of disease, similar debilitation. So it comes and it goes, but over time, it's still progressing if you like. The only therapy at the moment for this, which is widely used, is intravenous immunoglobulin. And this requires the patients to go to hospital visits every four to six weeks, and they have to sit there for for several hours to to have this intravenous injection intravenous infusion.

20:01 The prevalence is low, but the medical need is very high. So it's a typical orphan drug type indication. So a few patients got a very high price. So for example, the if you take the midpoint of point seven to ten point three cases per 100,000, there's probably around about twenty to thirty thousand in The US. But you can imagine, with the orphan drug type prices, this this clearly leads to a great opportunity commercially.

20:32 So we have the opportunity here because of the mechanism of action of p one forty to slow the progression of the the disease for the first time. There's a potential to do this, and this is what we're looking at in the design of the protocol. We're looking to reduce, the relapse and remission frequency. And, clearly, if we can do that, then there'll be less need for patients to come in in the future for intravenous regimens. It's more patient friendly. Again, it's gonna be very much the same as the lupus approach with once a month injections under the skin. We know it's safe at similar doses that have been used exposure levels, if you like, that have been used in lupus. And the phase two a three adaptive study allows, because of the size of the population of patients and the and the style and type of the design of the study, we it is possible to do this in one study, a study that we can we can submit to the regulators for approval after after just one study. And this is called a phase two a three adaptive pivotal trial.

21:39 And so the next stage, once we've approached the regulators regarding this design, is to seek IND approval and for orphan drug designation. And this will allow us to aim for that particular population. Again, with lupus, whichever way you put it, it's a big opportunity. But at the moment, we're looking at something that could potentially be 750,000,000 global sales potential. There are a number of companies, just coming back to the business development ideas, that are very interested in not only orphan drug indications, but neurological disorders and neuropathies as they're known. So we know there's a big appetite out there for therapies that can deal with this in a safe, simple, and effective way.

22:27 And

22:28 so on to anti infectives. Actually, before I say that, I I should also add that, you know, it doesn't stop at lupus and CIDP. There will be further indications that we're looking at based on the preclinical work that's that's been coming out of professor Muller's activities. So anti infectives is the other secondary key area. And, yes, when you look at the portfolio, the pipeline timelines, it is earlier on. But what we're trying to do here is take existing anti infectives, which are very, very effective, highly and some of the best, actually. So here, we've got amphotericin b modification called BioAmb, and the other one is BioSyn, a savancamycin

23:16 alteration. And what we're trying to do here is not make tiny adjustments, but to make drastic changes in the pharmacology, the way they work, which will provide better much better efficacies. It'll overcome some resistance issues that we're seeing out there. And so, for example, BIOM1 b, we want to reduce the toxicity associated with that. When a patient receives amphotericin b at the moment, they they go into very high fever.

23:47 There's very severe organ damage, kidney damage in in up to fifteen, twenty percent of patients with some of these formulations. So So there's a huge opportunity to work on that unmet need for for for patients receiving amphotericin b. And not only that, but amphotericin b is typically used in what they call chronic aspergillosis infections, and a very tiny fraction of that is currently being served

24:18 by existing amphotericin b because of the safety issues. So it's been reserved to third or fourth line. If one can improve on that and improve on the first line resistance in other with other therapies, then there's a great opportunity to not only hit the existing market, but to expand that as well. And at the moment, the the market sales for IMMUP are around about $600,000,000 worldwide, but we see there's a bigger opportunity there in the existing the existing market.

24:52 Biosyn, as I mentioned, this is so amphotericin b is antifungal, and Biosyn is an antibacterial. Vancomycin is very widely used at the moment. But there are, again, there are issues with this. It can only be used for certain bacteria types, positive and not negative. And so there are tox issues with that as well, absorption issues orally. So there's again, as I said before, there are there are gaps here for both of these where we can deliver, you know, some some real real improvements. And, you know, the WHO itself is very, very concerned about increased antibiotic, antifungal resistance. It's one of the biggest threats to global health.

25:38 Yes. Of course, you know, viruses like COVID are are are dangerous. But what we've also seen as a result of COVID infections, it's a secondary, infections and diseases which really, start to hit people. For example, I don't know if, any of you have looked at the black lung disease reports during COVID. This was due to aspergillosis, and amphotericin b was being used there. So, you know, one has to think of not just where we are today, but with the the concerns that, you know, any more viruses like this and and mutations around that could lead to the need for better antifungals and better anti antibiotics, antibacterials. And the reason why we're not including antivirals in in our our therapeutic approach is because that you know, there's many specialists doing antiviral research, and I think we'd be better placed to to offer something different in the market, which is what we're trying to do.

26:43 And I think it's back to you, Tim, if that's okay. Yeah. No. Thank you very much, Tim. So really good overview from Tim there of the portfolio. And I I say again, as I did earlier, that those of you who know the company, who've known the company for a while, hopefully, will see the difference that the portfolio offers now. And, of course, that speaks very well to this particular slide because we we are are determined to drive the value of this company up and give the return to shareholders, especially those shareholders that have been with us for year after year after year and are born with the ups and downs, and there's been quite a lot of downs recently rather than ups, and we all know the reasons why. And for business like ours, the only way that you can drive value is to get, one, the development programs moving forward, and then in turn convert that into some sort of commercial success, whether it be through licenses or or whatever way. And as I mentioned earlier, that's what's been sadly lacking in the past.

27:46 So the the key to that,

27:49 as far as the market is concerned, as far as the share price and getting the valuation up is is news flow. That's that's our currency, if you if you wanna put it in that way. And we have a very rich theme of news flow coming up the remainder of this year and into next year. So let's say the next eighteen months. And, obviously, what everybody's focused on is the start of, the phase three, the second phase three for for Lupusa and lupus.

28:13 And our expectation, Avion's expectation, is we get that started, as as early as possible after we get the response from the FDA at the end of this month. So really, really exciting period we're coming into, and, we're all looking forward to it. Tim mentioned about the CIDP study. We've done a lot of work over the last twelve months in getting them in good shape with advisers and specialists in the area. We have a full protocol that we have developed with the with the help of our advisers. That's been backs and forwards, and we're that's in pretty good shape. We're not far off actually putting a submission in for IND to I think our first regulator will be the FDA. So, again, that's a big step forward because once we've done that and we've got approval to to start a study, not only does it allow us to move that development on, but that is the key point at which potential partners or licensees that we've spoken to already, you know, want to see. And that could very well, in its own way, lead to a commercial deal of some sort.

29:18 So then you you you go on to that's that's the second half of this year. The the first half of next year, we are very much looking to do some licensing on on the lupus and indication for lupus or for the rest of the world and also CIDP, which I've just mentioned. So the triggers there will very much be the start of the phase three for lupus and getting the IND and the orphan drug status for CIDP. And as you can imagine, that ticks a lot of boxes for potential commercial partners. And then we'll actually start the CIDP we're expecting in the first half of next year as well. And then in the second half of next year, we go back to the anti infective portfolio and the BioAMP especially between now and then, we will be running some studies ourselves just to confirm some of the the data we've already seen in that program.

30:13 And, again, that that is attracting an awful lot of attention already.

30:18 So our intention is to run one more study on that, confirm what we've already seen, but also just to add a little bit more data into that package, which makes it that much more attractive and valuable for when we go to out license that drug. So if you look over the next eighteen months, which is not that long a period, there's some pretty chunky bits of news there, all of which will drive the valuation in the right direction.

30:45 And to just try and illustrate in one way how we've seen in the past the share price of IMMUPHARMA react to development news and and progression. This is a a share price graph which some of you may be familiar with. You can see that for many years, the share price languished. And where you see that spike when it goes up to the $1.78, the progression of that share price was very much when we started the first phase three. And you if you if you've been a long standing observer of IMMUPHARMA, you will know that that our strategy during that was to keep the market informed on a regular basis in terms of patient recruitment, just confirming we we weren't getting any, side effect issues coming through as as we went through the recruitment and then obviously the

31:37 the operation of the study. And as we moved nearer nearer to the the, completion of that study and the and the deliverable of the results, you can see where that share price rose. And we expect that to happen again. The difference this time is we have learned an awful lot, as Tim mentioned in his presentation, about why that first phase three failed. We've had experts look at it. We've had Sylvianne, professor Muller look at it. We've looked at it. We pulled it apart and put it back together again. And the simple way of putting this is it was a failed trial, not a failed drug. The drug works. We could see the drug worked in the first phase three. We just weren't able to get the statistical that we we we wanted. However, if you split the the the the first phase three into two parts when when I say the two parts, it was one whole clinical study, but there was a US element to it and there was a European element to it.

32:44 And when you look at the European results on their own, we actually got statistical significance. So if we just run the study in Europe, we would have passed that phase three. However, in The US, it was the opposite side and we didn't get statistical significance. And the difference being that the the level of patients in the European cohort with this particular biomarker which we are now concentrating on with something like sixty six percent. So two thirds versus one third in the active group that had this biomarker. And because of that high level of patients with that biomarker they were able to react better to the drug and and then compared to the placebo comparator in that group, they showed statistical significance.

33:31 In The US, it was completely the opposite way around. It was one third of patients which had the biomarker, two thirds which didn't, and a stark comparison that we didn't meet the statistical endpoints in The US, and that was the reason. Now if you look at the phase three protocol that we've agreed with FDA, we agreed the phase three protocol with FDA last year. We we announced that. So that isn't in doubt. We have concentrated and the FDA agreed with us that we concentrate on recruiting patients in this next study only those patients that have the biomarkers. That is what we call a key part of the patient inclusion criteria. That is gonna make an enormous difference to the probability of success of this next phase three.

34:17 We've also made other little changes because you always learn something from clinical studies whether they're successful or not successful. So there are other subtle changes as well in the protocol going forward, And it's gonna be a bigger study in terms of more patients which makes the outcome more predictable. So we've got a high confidence level in going into this phase three later this year. And coming back to this particular slide, what we expect to see is that there'll be an anticipation as we move through that study as we saw last time and the share price should react. The additional thing we have this time around though and I go back to the portfolio and I always believe in the portfolio rather than a one drug company.

35:03 We have all the other drugs, the other indications in p one 40, the anti infectives that will also be going through their development phases to drive more interest, more value accretion points. And we have the whole commercial story, which we haven't had before. So you add all of that up and the the milestone slide, which I explained just previously, you look at the way the share price has reacted before and the value we created before, that is what we're anticipating will happen going forward. Now I think I've I've probably covered this in in my explanation of the the the phase three and and why we're very confident of the new phase three going forward.

35:52 And, yeah, just to to to finish that off, it's it's very important also and and and it's it's very supportive, the fact that FDA have looked through this with us. And, you know, they know development as as well as anybody, the FDA, because they they do it for a living clearly. And the fact that they have agreed with the protocol and the way that we've refocused the patient inclusion criteria, the way that we're running the study, you know, that gives us a lot of confidence, as I say, that it's it's not just our opinion. FDA recognize why we've we've made these changes. They recognize why the previous study failed. That's all really, really important going forward. So just to try and and wrap up and just to remind you, this is actually the the slide that we presented right on the the the the the beginning of this presentation.

36:48 I'm not gonna run through each bullet point because you you've heard it before, but, you know, I I just stand back and I say we've got a company here which is valued currently at less than £20,000,000. We have a phase three with a high probability of success about to start. We have a portfolio of other drugs which we can fast track through, a number of commercial deals coming up over the next period. All of this, I'm sure you will understand and recognize, will add tremendous value. And it's something different than what the company was doing even just before a year ago. So we we have to recognize that that the company is changing. We put our hands up previously. I'm doing it again today to say we didn't get it right previously, and we suffered because of that. The share price suffered.

37:38 We didn't deliver on what we should have delivered. That's why the share price is where it is. I get it. You know, all the board gets it. We're not trying to hide away from it. What we're trying to do is fix it, and I think we've come a long way in the last twelve months. So coming back to the the the fundraising, we decided to go for funding at this point because we wanted to put that cash into the other programs and keep them moving because that is the only way you can add value. And that's that is putting money into the programs and developing through getting those commercial deals going. The way we have structured the the the deal this time, the fundraising, is different to what the company has ever done previously.

38:24 And there's a certain acknowledgment a a a big acknowledgment, I should say, not a certain acknowledgment, that one of the criticisms that the company has had, and actually a lot of small companies get this criticism when they do fundraisings, is they they there's never an opportunity for the non institutional, either shareholders or or institutional investors that come to company new, that there's there's no opportunity for the the non institutional shareholders or non institutional investors to be able to participate in a fundraising like that we're just doing now. So you will you will notice if you've read the r and s we went out yesterday that we have a cornerstone investment from loop from who are our largest investor, and I'll come back to to that structure in a moment. And then we put it out to what's called a broker option, which is open now for a week.

39:21 And during that period, anybody can apply to our broker, Stanford Capital, through their own broker because we we we can't take sort of nonqualifying investors or what's what's deemed as retail investors directly. They have to come through a regulated body such as another broker. But But it's open to everybody to apply through their broker, whether they be an existing shareholder, whether non existing shareholder. And they have the everyone has the opportunity to invest alongside the existing shareholders. And also, I should should say, alongside the team as well. So you may or may not notice, but as a as a board, we have committed a £100,000 into this fundraising, and I think that's important for everyone to understand.

40:09 We think it's a great opportunity, investment opportunity, but we also wanted to send, you know, the message out that we're fully behind this. We're we're very confident of of the the period coming up. And so it would look a bit odd, frankly, if we hadn't invested, but notwithstanding that, you know, we all think it's a great opportunity. So everybody on this call, everybody out there that looks at this opportunity can apply through their broker, And and I think that's that's right. We've had a lot of shareholders, non institutional shareholders for many, many years that supported this company. And it's only right that all of those people should have the opportunity to invest alongside the board, alongside Landstead, alongside anybody else that that comes in.

40:54 Let me just come back to Landstead. I know that there are criticisms, there are observations, there are comments about the structure of the Landstead funding. We have entered into deals with Lancet now for a number of years. In fact, this will be our our fifth deal with Lancet. And we have seen the good and the bad outcomes, if I can put it that way, of those type of deals. When we did the first deal, and interestingly, that was when I first joined the company as chairman and we we we went out to raise money to run the first phase three study. Lou Landsted were a key investor in that funding.

41:40 And because of the way the structure of the Landsted deal works, because it's it's very much dependent on the share price, the company gained over £600,000 in addition to what Lamstead had originally committed at that time, and I emphasize without any further dilution. So whenever we do a deal with Lamstead, the shares that we issue are fixed on day one. They don't they don't go up or down. What goes up or down is how much money the company earns out of that depending on the performance of the share price. So the very first deal we did with them, we actually gained. The next few deals, we didn't. And that goes right back to what, you know, I've said many times and I've said again today that the company didn't perform. It didn't deliver.

42:26 It didn't perform. Share price, you know, stayed on the floor after the the failure of the first phase three, and there was no opportunity to for the company and in turn the shareholders to gain the benefit of of a deal. We are now at the point when we're entering to a very exciting period of news flow and value accretion. Doing a Landstead deal at this point, we're we're we've got a commitment from Landstead for a million pounds at at the, what's called the benchmark price, which is 6.7p. If we achieve everything which we are confident we are going to achieve over the next twenty four months, which is the period of the deal, we will get a multiple of the initial commitment of £1,000,000 into the company for no further dilution whatsoever.

43:16 So to give you an example, if the share price went to $13.14 pence, we're effectively doubling where we are with the benchmark. We will get £2,000,000 out of this deal, not not 1,000,000. I am looking for that share price to go above 14p to 20p to 25 to 30p. That every time that share price rises by 6 or 7p, we get another million pound. So So when people ask me to justify why we're going into another Landstedt deal, that's why. This is the right time for us to and our shareholders to get the benefit of this type of deal. It it it went against us in the last two or three years, and and that's obvious, and it's obvious why. But now is the time to do this deal.

44:01 And and a lot of people are saying, why are you doing the fundraising now? Why don't you wait until the autumn and the share price has gone up and you've got the response from FDA? Well, the opportunity is now, for example, to take the best value out of a landscape type deal. It's also a great opportunity for all of our shareholders that have been with us for many years and have have gone through the ups and downs and felt the pain for all of you to be able to invest alongside Lamstead, alongside the board at this price, and get the benefit of that going forward. So I hope that I'm I'm gonna go to the q and a in a sec and see if there are any questions to to answer. But I wanted to make that point because I understand why people are asking why we've done the fundraising now, why we've done a deal now.

44:55 That is the reason why. That is the basic reason why. That's great. Tim, let me just jump in there just to give you guys a a small break before looking at the q and a. But, ladies and gentlemen, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your screen. Just please simply type in your question and press send. But just while the company review the 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 and A, can be accessed from your Investor Meet company dashboard after today's event. To both of you, Tims, as you can see that you received a number of questions from investors throughout today's presentations. And thank you, firstly, to all of you for your engagement this afternoon. And maybe if I may, Tim, back to you. And if I could ask you to read out the questions where it's, of course, appropriate to do so and give a response, that would be great, and I'll pick up from you at the end. Okay.

45:42 No no worries. So we we haven't had a chance to see these questions, obviously, because they've come in during the presentation. So Tim and I are just reviewing them now. So we'll we'll try we'll share them between us, and we'll try and answer as many as we can. But I think as Mark said right up front, if there are any that, regulatory perspective or or whatever, that we can't answer, please forgive us. We're not trying to dodge questions, but we also wanna stay the right side of the law. So the very first question, that I see here, which was put on just after we started, is from from Andrew. Why did the FDA ask for a PK study when the drug had already been through a phase three study? Were they concerned about the half life and or the distribution?

46:28 And then he's followed straight up with another follow on question. Where is the site of action of the drug? So, Tim, do you wanna pick that one up? Sure. Thank thank thanks, Andrew, for the questions. So why did the FDA ask for PK study? Well, it it was a little surprising in one sense because previously, they let the the FDA had been okay to allow the study to the previous study to proceed. However, that was quite unusual because normally, a PK study is required for any drug for a clinical program. The PK study essentially shows you how the drug's absorbed or where it's distributed, how it's metabolized and excreted. And it's a it's a a common study to do. So this is a diff very different FDA panel from several years several years ago, and they often ask different questions.

47:29 And sometimes the FDA can be a little bit inconsistent like this. So it was quite a a reasonable request. They essentially wanted to know if the if the drug was there in the blood. They could see the effects that it was having, but it's just a a requirement. I don't think there was any concern about the half life or or they just wanted to know that it was there, so they needed to be able to detect it. And then years ago, also, the detection sensitivities were not as good as they are today. So, you know, that that PK study that we did was, you know, highly successful. We got what we wanted out of that, and and we answered we answered the question for for the for the FDA.

48:19 I don't know if you want to add anything else to that, Tim, before I go on to the site of action. Yeah. Actually, because I'm just scrolling through the the questions here, Andrew has has had has got a further follow on, which I think is probably if I answer that, and then you can go on to the action. So so Andrew is also asking, what is the plan for lupus or lupus if the FDA decide not to give the go ahead for the phase three study? I think as we said during the presentation, they have already given the go ahead for the phase three study. They've approved the protocol a year ago. But at the same time, they asked us to run a PK study, which Tim has just explained. So just to to clear up any misunderstandings there are, we could have we and Avion could have started that phase three last year.

49:09 It's that that's the that's the simple point. But, you know, when you get the FDA, the regulator who's in charge is is the gatekeeper here asking you to do a PK study, You you don't don't ignore that. And, you know, they're asking for all the reasons that Tim has just explained, and it's pretty clear that they they they would prefer they wanted to see the results of that PK study before we entered a, you know, a very big and long three study in lupus patients. Now we could have carried on, but, you know, do you do you upset the main regulator and the person who's got the gateway to the marketplace by ignoring their their request to run a PK study and and just just crack on without doing that study or or saying we'll do it in two or three years' time.

49:59 We'd have to have done it anyway before they'd give approval. So the decision that AbbVie and ourselves took was the best way would be to get the PK study done. You are working with the FDA then, and you then stand, you know, a very good chance of getting the the drug through to market as quickly as possible because getting a drug to market is not just about running the study. It's about talking to the regulator, in this case, the FDA, you know, that that it's negotiation at the end of the day. And like any negotiation, you have to you have to do the right thing. So to answer your point, Andrew, we have already got the approval for the protocol and phase three study from the FDA. And that's the position, you know, that we're trying to communicate here that we obviously, we're an under obligation to report the PK study results to to FDA, and that's the process that we're currently going through at the moment. They're they're looking at those, and they're gonna give their formal written response at the end of the month.

51:03 So I I wanna just follow through that because it sort of followed on from what you were saying, Tim. But if you wanna sort of flip back to Andrew's supplementary question, which is essentially what is the mechanism of action or or what where is the drug working? Yeah. I mean, thanks thanks again for that question because it's it it also helps us to put put into perspective the difference of therapies. So, you know, Safnello and Ben Lister are acting right at the end of a cascade of events which starts up here and and end ends down here. There's lots of activities in between. And they're acting on and they're acting on something called B cells. And this immunosuppresses the the immune system completely. P one forty is binding to a protein on the surface antigen presenting cells called HSP eight, and this is expressed very highly during autoimmune disease Mhmm. During a a relapse.

52:04 And p one forty binds to this and is internalized into these cells and helps to normalize this overactivity, if you like, it's then sent down the cascade. So it's acting right at the beginning in a very different way that other other therapies are working at the moment. And this is why, you know, we believe that it will have what we can we've we can obviously see in the subset of of data if we know that patients definitely have a lupus flare and they're presenting this protein on the on the surface of cells and p one four is gonna bind to it, it's got much better chance of actually working in those patients. And so I hope that it helps to explain the the mechanism.

52:50 Thanks, Tim. Okay. Next question is from Simon. Assuming FDA approval for phase three, is it likely the trial will complete by end of May two twenty four when doctor Zimmer's locking over shares comes to an end? So just to put that in context for anybody that doesn't know, doctor Zimmer was one of the cofounders of the company and the chief scientific officer. And when he left last year, he he he's got a big shareholding in the company. And when he left last year, he he agreed. He he wanted to send a positive message out to the marketplace that he was although he was leaving and retiring, he was still fully confident of the company and wanted to support it. And we and he wanted to send the message to the company that there wasn't this big overhang of shares.

53:38 And the the only way you can really do that convincingly is for that shareholder to enter into a lock in agreement, which she has done for three years. So the question from Simon is is is is saying, you know, what's gonna happen with doctor Zimmer's shares. So nobody can predict exactly what the period of a a study will be. If doctor Zimmer's when doctor Zimmer's shares come up for lock in, I know that he will be very responsible. He's not about to dump his shares on the market. We We speak to to Robert, you know, on a on a regular basis on this. And and we if at some point he wishes to to to to sell some of his shares, then we will work with him to to make sure that's an orderly sort of process.

54:28 So if, Simon, your question was about that in terms of the orderly market of of of a major shareholder shares, Believe me, we we've had many discussions with Robert about this, and it it won't be an issue in terms of whether his lock in comes off or or not. And then we have a couple of questions from Oscar. I'm just gonna so we're being completely transparent here. I'm gonna read them out as as Oscar has has has written it. So why why did not participate in this placing if they are so confident about? We ended up getting pennies from sharp lenders. You are promising repeated occasions that you will deliver value for shareholders.

55:16 Happened with those promises? We have been losing value month after month. And he's followed up to say, how much money is the company spending each month? Taking into account the recent placing, how long can the company keep running without the need for further funding? And then he's followed on again. Why you still haven't made a substantial investment in IMMUPHARMA if you believe so much in its promising future? So let me let me start to address those, Oscar. I think we have actually because clearly you were writing this as we were doing the presentation. So I think we probably have addressed a number of these points in the presentation already. In terms of, think I explained that their investment in December was very much a one off. I'm not saying they they they wouldn't potentially invest in the future again, but the value we're gonna get from Avion is when they launch that drug and we start to get the milestones and the royalties, you know, under the agreement we have with them, that they are very confident. We are very confident about Lupusor.

56:17 The the reason why and I think I I explained this earlier on. The reason they haven't invested is because that's not their business. Their business is developing drugs and launching drugs and selling drugs working with companies like ourselves. So I don't think anybody should take any negativity out of the fact that they they haven't invested, you know, in this particular round. Not at all. They are committing an awful lot of money to to getting Lupusre to the market. So we shouldn't we shouldn't forget that. Your your reference to SharpLenders, I I can only interpret that in terms of some of the funding options that we've done in the past, and I've mentioned Landstead. I've mentioned the the reasoning that we've gone into another Landstead deal this time. You know, I I hope that's, you know, sufficient explanation for that one, Oscar.

57:13 And then you've asked about the runway. Well, I I all I can say is what we put in the r and s because I I can't give anybody any more details than that. And I'm reading from the r and s now, so if you'll forgive me just reading it out. But there is a section in there that that says the directors are confident that the fundraising together with existing funding and funding arrangements will provide the company with sufficient working capital for at least the next twelve months. If I can try and put a bit of color on that, you know, we are always very conservative when we we do our projections in terms of making that sort of statement as one has to be. And, for example, you know, we have taken the most conservative view in terms of what we funding we will receive under the deal. So as I've explained, as that share price moves upwards, then we will we will get a lot more cash out of that deal, which will extend that cash runway even further.

58:10 But I I I do put it in context that if one was to look at the the reporting accounts for the company for previous years, you might think, wow, that's there's a big spend there. We have addressed that. Firstly, a lot of the spend that you see in the reporting accounts in previous years was very much geared to the fact that we were running phase three under our own steam. So, you know, that's our own expenditure. So there's a lot of of cash went there. We have taken a pretty severe approach to the level of overheads in the company that was was present previously. And so when I look at going forward and I look at cash projections, we have a much, much lower level of overhead spend expenditure.

59:02 That includes the cost of the board. And And I I know know that's been a criticism in the past about the total cost of the board. You know, when you see future reports coming out, you will see the cost of that board as as the cost of it has come down significantly. So, again, we've taken that, heart in terms of of of what people have have questioned before. Forgive me. I'm I'm actually reading this as I go, so I need to read the question before I can give an answer. Right. So Mona has asked, given the market conditions and retail investors notoriously not holding stock for more than a few percent profit, would a lock in period for twenty four months be more suitable for broker option share to allow allow an an increase in the share value without any blockage?

59:50 And also, how can you ensure Lancet won't sell aggressively into any rise again causing share price decrease share value appreciation as you've seen in the last six months. In terms of the lock in, I don't think it's appropriate to ask people in this sort of situation to enter into lock in. It's not as if we're a new company come to the market on an IPO when you would expect certainly existing shareholders to maybe enter into lock in agreement. There was a specific reason I've just explained why we asked doctor Zimmer to enter into a lock in agreement. In fact, why he wanted to enter into a lock in agreement to show that that confidence. I I don't think it's appropriate to ask people to enter into lock in agreement at this point. And I may be in interpreting your question incorrectly, but you mentioned just for the broker option.

1:00:40 But But then then that would be differentiating between investors that come in or have already committed in the subscription and the and the placing, which is Landstead and and and those institutions in the placing who would not be asking for a twenty four twenty four month lock in versus those people coming to broker option. So I think there's a there's a conflict there and and one which I I don't really think is appropriate. Yeah. I personally think that that people, institutions, individuals, investing in companies, whether it be ours or others, should be free to buy and sell their shares as as they wish. And it's up to us as a company to deliver value going forward and and hopefully make sure that, you know, the share price continues on an upward track. It's never it's never one way.

1:01:29 But over a period of time that we add that value to to the share price to appreciate. And then it should be up to every single investor, whether they be a large investor like Landstead, whether it be a small investor who's maybe only got a few shares and everybody in between to, you know, to make their own decision on whether they buy or sell shares. And and as I say, I I I include Landstead in that because, you know, I know there's there's there's been some observations that, you know, they buy and sell shares, and and that that may be affecting the the the the momentum of the share price. The bottom line here, and I keep coming back to it, but it's important that if we have the momentum in the share price, if we have positive news flow coming out, you if know, that if if people are reacting and recognizing the value we are adding, then the share price will look after itself.

1:02:30 You know, it's always an equation between buyers and sellers. And if we've got positive news flow and we're adding value and everyone is is appreciating that, it will be a fact that there will be more buyers than sellers. And when you've got more buyers than sellers, the share price goes up. It's as simple as that. And, you know, I don't believe in restricting people as as there've been a suggestion with with lock ins. You know, I think that distorts the market, and it distorts what we're trying to do, and that is is add value with 100% of our shareholders, albeit in this case with with Robert Zimmer being a special case, should be should be free to buy and sell the shares as they wish. Let me see if I can say just any of the relevant questions.

1:03:26 Andrew, Tim, maybe you can pick this one up. Can you you set out towards the patent expiry dates for v 140? Sure. In a nutshell, it's you can look at the sort of mid twenty thirty period as being the the the patent expiry period. So we'd expect to have at least perhaps another ten years market once once it's launched. But, of course, one needs to remember that that we are also looking at a second generation p one forty. So we're looking at the product life cycle management there and trying to develop that for, you know, other indications as well.

1:04:16 Okay. There's a question here from David, which I'll read out, but I think, David, I probably need to to to clarify a few things to answer your question. So assuming phase three starts October 22 and you are fully recruited, how long before readout? Last time, this was a fifty week fifty two week trial. How long is it expected this time? I note h one two thousand twenty three in the slides. Is that for finalization and readout? So a lot of questions there, and and and we need to clarify this. Absolutely. So assuming we start this phase three later this year, the first part of that is the recruitment. Recruitment doesn't happen all in one go. You know, we are recruiting. We haven't put all the the the details of the phase the new phase three out.

1:05:04 But rest assured, there are a lot more patients in this than one than were in the first phase three, which means that recruitment will take a certain amount of time. And, yes, it is a fifty two week trial. But in terms of how long that trial goes on for, you've got to look at the period it takes from day one to recruiting the total number of patients in the study because the last patient that's recruited has to go fifty two weeks from there. So it it isn't doesn't all just happen recruitment is on day one, bang, and then fifty two weeks, and then a bit after that, you get your results. As we saw last time, as we see in any any clinical study, there is a period of time for recruitment, and then there is the fifty two weeks from last patient recruited.

1:05:50 And then there is a period of time to to pull all the data together, and then we record. So it it is very difficult to put an accurate timetable on that. But I think there may have been a bit confusion in your question. You say, I know h 01/2023 in the slide. So I'm just looking again at the slide. What we're talking about in h one twenty three is not the development, not the clinical study. We're talking about looking to conclude more outlicensed deals on Lupusor in lupus for the rest of the world because the license that Avion have is just for The US. So I hope that clears up any confusion. Steve has followed on with a a similar sort of point. How long would it get take to get to the endpoint from from phase three p one forty trial?

1:06:39 So, hopefully, Steve, you'll take the answer that I've that I've just given to to the previous question. Right. Robin, for phase three, is there any fast track or special to reduce the time frame? I think you're you're you're talking about fast track status or special status. The the the the trial will take whatever time it takes as I've just been explaining. Now we can't alter that. But going back to the the amount of time it takes to deliver results and get a data package together for FDA, this goes back to my earlier point that the more you work with FDA, you know, the the better that that process takes, frankly.

1:07:28 And, you know, we and Avion are gonna be, be, you you know, know, on it, and we're gonna continue to build our relationship with FDA. And so whilst we can't ask for any favors as such in terms of of getting the product to market any quicker, you know, I think there is a recognition that in in this this area, there needs to be drugs like like lupus or for lupus. And we've got a lot of support with it from FDA on that general concept. So I think there will be, you know, a lot of a lot of momentum behind getting this drug to market, you know, as as quickly as possible. Right. Mohit, I have invested over a 100,000 thinking that it will sort my pension and now down by 90 k. When you talk about potential sales, is it per year or for the foreseeable future, and what percentage will the company actually see?

1:08:25 I can't comment on your investment, Mohit, and and and so I won't. In terms of the the sales potentials we've put out there, that's based on a view of the size of the market, the the sort of proportion of that market we we could realistically hope to achieve. And our revenues are gonna come from our partners. So Avion are the partners that we sign up. And as they sell the drug through, the deals that that we have will involve royalties. So we've we've gone public with the deal with Avion, for example, to say that we will get double digit royalties up to a maximum of 17%, which is a very, very good deal. And so, you know, if this is selling, you know, say, selling a a billion dollars a year in The US, which is which is a credible target to look at, you know, we're gonna get $150,000,000 a year in royalties straight to our top line with no cost associated with it. So that just one illustration of which one market, one drug in The US.

1:09:26 I think this is as good an illustration as I can give you. But clearly, with a portfolio of drugs, you know, we're hoping that'd be replicated across different territories in the world and across different drugs, you know, that we are that we are developing. Andrew, one one for you, Tim. Thanks. What is the half life of Lupusre? Okay. So remember, this is an injection under the skin. So it's not a tablet which is absorbed, and and then you measure it's the the measure its half life. That way, it's it's it's injected directly into the skin. It's fair to say that the the way this works is there's a delay. So we need to bear this in mind first.

1:10:12 It's injected. It disappears. And then a week later, the immune system is is is doing its the immune response is doing its thing. So in actual fact, you you don't you don't see any p one forty in the blood after after about an hour. So you see it come up very quickly. You detect it, and then it then it dies off. But a week later, the the T cell responses are all doing their thing. So I hope that helps to explain the question and put it in context. I'm I'm just clicking through the questions. I think we've covered them all. There are some repeat questions, so there's no point sort of going to those particularly.

1:11:00 And yeah. I I think we we can do it all. So Yeah. Hand back to you if you don't mind. That's great, Tim. Thank you very much. And thank you for your generosity. We've gone nearly fifteen minutes through the hour. So thank you for addressing all those questions that you can from investors. Thank you to everyone for submitting their questions online. As Tim said, all these questions could be reviewed post today's meeting, and any further responses will be published as it will be appropriate to do so. Tim, I wondered if I may, I know investor feedback is important to you and to the management team. I'll And shortly redirect investors on the call to provide you with their thoughts and expectations. But I wanted to before doing so, if I may, just ask you for a few closing comments to wrap up with, and then I'll send investors to give you their feedback. Yeah. Thank you, Mark. Firstly, let me just say thank you to all of you who've in today.

1:11:48 You know, it's been an hour and a quarter. It's a it's a long time to to to listen to anybody talk, frankly. But the the the purpose of the day was to to to for everyone to have the opportunity to have a good catch up on the company. What we've been doing over the last year, a lot of which has been, you know, under the radar screen, it's not subject to RNSs or public notices, but it's important you understand that we take this seriously. We have spent an awful lot of time and effort over the last twelve months. Tim and I, the executive directors and the nonexecutive directors supporting supporting us and and the rest of the team, including, you know, the guys in in Bordeaux. And we're all we're all geared up. We're all fired up. We're very excited about the future.

1:12:35 You know, we've explained in the in the presentation what we believe is is is is the value proposition here. We explained why we've done the fundraising the way that we have. So, you know, I hope this hour and a bit has been useful for everybody. It's addressed a lot of questions, addressed some criticisms, which we've received, which which I understand. And and, yeah, more than happy to to follow-up at a later stage. Maybe we'll do another one of these presentations, Mark, maybe in the autumn, you know, once we're we're progressing through again to update everybody. But I actually I found I find the q and a extremely useful because, you know, we're we're we're able to address those questions straight away. And it gives it gives us a lot of feedback as well about how people are thinking and and and that sort of concerns they have.

1:13:30 So, yes, thank you once again to everyone. Mark, thank you for you for setting this up and introducing us. And let's see where we go from here. Great. Tim, Tim, thank you once again for updating investors this afternoon. Can I please ask investors not to close this session as we'll now automatically redirect investors in order that you can provide your feedback directly to the company? This will only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of IMMUPHARMA PLC, we'd like to thank you for attending this afternoon's presentation. That now concludes today's session, and may I wish you all a very pleasant afternoon. Thank you.