Immupharma (LSE:IMM) — Annual General Meeting

0:02 Good morning, ladies and gentlemen, and welcome to the IMMUPHARMA PLC Annual General Meeting Proceedings. Throughout this presentation, attendees will be in listen only mode. Questions will be submitted at any time via the Q and A tab situated on the right hand corner of your screen. Simply click Q and A, type in your question and press send. The company may not be in a position to answer every question received during the meeting itself. Have the company review all questions submitted today and publish responses where appropriate to do so. And these will be available via your Investor Meet company dashboard and you'll be notified once these are ready for your review. I'd also like to remind

0:32 you that this presentation is being recorded. I'd now like to hand you over to Tim McCarthy, non executive chairman of IMMUPHARMA PLC. Good morning. Good morning. Thank you very much. Let me say a warm welcome to everybody who's on the webcast this morning. It's a pleasure to to address you all, albeit not in person. So let's start the formal business of the morning. So ladies and gentlemen, it is now 10:30AM, and I'd like to formally welcome you to the IMMUPHARMA AGM, which is being held via the Investor Me company platform. As just introduced, my name is Tim McCarthy, and I'm the chairman of the company. Before I carry on, let me just make apologies if if I'm constantly looking down. Maybe you'll see in the top of my head, which I'm sure you don't really need to see or want to see. But I have a script with the the numbers of the the voting, and, obviously, you don't wanna get that incorrect. So I will be looking down quite a lot to make sure that I get the right numbers. So please forgive me. So let's start.

1:42 There are two or more members present in person, so I declare that a quorum is present and called me open this afternoon during the meeting. As you're aware, due to the current issues surrounding COVID nineteen and the existing public health guidance in The UK, it has only been possible to admit the necessary quorum today on the grounds of safety. This will enable the AGM to take place safely. So under the company's Article Association, voting has taken place. And in the interest of shareholder democracy, this has been done by proxy votes. For every proxy vote or for every share that each shareholder holds, there is one vote. So because of the situation at this meeting, there shall be no requirement for any resolution to be proposed or seconded by any person.

2:32 So I'll address each resolution in turn. I'll read out the resolution and then give the votes. Overall, resolutions one to four are ordinary resolutions, which to be passed require a majority of 51% to vote in favor of each resolution. Resolution five is a special resolution which to be passed requires majority of 75% to vote in favor of that resolution. So turning to the resolution themselves. Resolution one is normally a resolution for the company to receive the accounts of the company for the year ending 12/31/2020 with a report that directs an audit to solve the company. I have received proxy votes in respect to 27,979,197 ordinary shares if favored resolution one and twenty thousand against the resolution. I have received no proxy votes where I have been given discretion to vote.

3:23 Therefore, resolution one has been passed as an ordinary resolution. Resolution two is an ordinary resolution to reappoint doctor Stefan Murray as the director of the company. I've received proxy votes in respect of 22,040,754 ordinary shares in favor of resolution two and 6,610,006 from 83 against the resolution. I have received no proxy votes where I've been given discretion to vote. Therefore, resolution two has been passed. Resolution three is normally a resolution to reappoint Nexia Smith and Williamson Audit Limited as the auditors of the company. I have received proxy votes in respect to 28,003,061 ordinary shares in favor of resolution three and twenty two thousand three hundred and forty eight against the resolution.

4:14 I received no proxy votes where I've been given discretion to vote. Resolution three, therefore, has been passed as an ordinary resolution. Resolution four is an ordinary resolution authorizing the directors to allot securities, to allot relevant securities up to an aggregate nominal amount of £10,008,852. I have received proxy votes in respect to 27,762,710 ordinary shares in favor of resolution four and forty eight thousand eight hundred and forty four against the resolution. I have received no proxy votes where I've been given discretion to vote. Resolution four has therefore been passed as an order resolution. Resolution five is a special resolution empowering the directors to allot equity securities assumed to the authority conferred on them by the previous resolution as if the pre ancient rights in section five six one of the Companies Act 2006 did not apply, provided that this power is limited to the allotment of equity securities set out in the notice.

5:18 I have received proxy votes in respect to 27,759,210 ordinary shares in favour of resolution five and fifty two thousand three hundred and forty four against the resolution. I've received no proxy votes where I've been given discretion to vote. Resolution five has therefore been passed as a special resolution. So ladies and gentlemen, that concludes the formal business of the AGM. And I'm gonna hand back to Paul just for a moment before we go to q and a. But perhaps I I should also take the time out to introduce two other people who are here with me on the call today. I think on camera you can probably see Doctor Tim Franklin who's our Chief Operating Officer and hopefully our Chief Executive Officer, Dmitry, will also be online.

6:07 I'm not sure if you can hear me, Dimitri, but I think we may only get his voice as opposed to a video due to connection issues. But the three of us will be looking at questions that have come in and answering accordingly. But before we do that, I'll hand back to Paul. Tim, thank you very much indeed for that presentation. And ladies and gentlemen, do please continue to submit your questions using the q and a tab situated on the top right hand corner of your screen. I would also like to remind you that your feedback is important to the company. And immediately after the presentation has ended, you'll be redirected for the opportunity to provide your feedback in order that the company can better understand your views and expectations.

6:46 Tim, attendees were given the opportunity to pre submit questions, which we've had, several come through. Perhaps if I could just hand back to you to through those pre submitted questions and any questions we have through the live event, if you could just perhaps click on that q and a tab and read out where appropriate to do so, that'd be fantastic. Thank you. Okay. Thank you. Yes. We have had a number of of pre submitted questions, which we're gonna answer between us all. The the first question was a general question about how does loop sort work, And it's obviously a a complicated scientific question. And what I'm gonna do, I'm gonna ask Dmitry if he can pick up the answer to this question. Thank you, Tim. And hello, everyone, from you too. So I will try to provide a kind of a summary, an explanation in a non very scientific way so that people can understand it.

7:47 I understand that not everybody is scientifically kind of aware or qualified. So to make it simply and to answer the question, we should consider the fact that Lupusre is being developed to treat diseases of the immune system. So they are called autoimmune diseases. They called it immune because the immune system attacks our own cells. The way in which it acts is connected to numerous autoimmune diseases. In the first instance, we have chosen to study Lipozol in the treatment of lupus, which I think many know that it's a very debilitating and often fatal disease. However, the hypothesis is that by demonstrating that lupus or successfully treats lupus, it should also treat all other or many other autoimmune diseases due to the way that it interacts with the body's immune system,

8:41 what is known, as its mechanism of action. So this has been supported by numerous animal model experiments in order to, in in in sorry. In in in other related autoimmune diseases. And the other thing to add is that the immune system is made up of many different types of cells throughout the body, and it is able to recognize foreign invaders and destroy them by producing antibodies, for example,

9:10 and also other chemical molecules. So sometimes, though, the immune system mistakenly recognizes some fragments from its own cells as foreign objects that create antibodies against itself. And that's why these antibodies are referred to as autoantibodies. Like you have an autoimmune disease, these are antibodies against itself, so the the autoantibodies. So these results in autoimmune diseases like lupus, which is not the only one, in the autoimmune space where you, effectively have the immune system attacking, one's, own body. To address this, lupus's mechanism of action is, as an immune modulating drug.

9:57 That's quite important as opposed to an immunosuppressive drug, which means less propensity for side effects,

10:05 caused by lower immune system, defense. So the mechanism of what is of of the next thing what the mechanism of act action for Lipozol is very elegant and does not block the immune system, which is important, as our immune system is needed to protect us from attack from various pathogens. So we are all constantly in contact with bacteria and viruses, but a healthy immune system can fight them before they can cause harm. So products that block the immune system will have side effects, for example, like increased infections. So the mechanism of action of Lipozone is quite unique. And as far as we know, no other drug for autoimmune diseases has the same mechanism, including those used, for lupus. They none of them work in the same way. And all the clinical trials of Lipozol up to date have demonstrated no side effect problems. So the drug is very safe.

11:03 So as a as a kind of a slightly more scientific way of explaining it, Lipozol acts to calm any hyper reactive immune response, which is typical of autoimmune diseases. So Lipozol acts on a natural process, is called autophagy. And autophagy means the recycling of cell fragments because when cells die, they get recycled or the components. And, you know, to immunity, autophagy goes out of balance. So Lipozol effectively corrects this by soothing the hyperactive cells to a normal condition.

11:46 I think that's clear enough. No. No. It's very clear. Thank you very much. I'm sure that will help a great deal. The next question, I'm gonna ask Tim Franklin if he can respond to. And, again, several questions on this. To summarize the the question or questions, it's very much can we update everybody on the situation with lupus or? So having had the explanation for METRI on the the scientific rationale, it's now very much about the commercialization side of this and and late stage development. So I'm gonna ask, Tim if you can answer that for us. Thank you. Sure. Thanks. Thanks, Tim.

12:32 So as you all know, LupoZor is in the final stages of development clinical development. It's about to enter the second phase three clinical trial. Now the second enhanced trial has been conducted by our US government, Abion Pharmaceuticals. Last week, we put out an update to say that Abion are expecting a written response from the FDA around the end of July on the proposed design of the pharmacokinetic study, which the FDA requested as part of the phase three development. The phase three study is expected to commence later this year. It's also worth remembering the terms of the deal with Abion. We've licensed The US rights to Appian in return for them paying for this next phase three and securing milestone payments amounting to $75,000,000 and double digit percentage royalties on sales, which are tiered rising to 17%.

13:39 Avion is responsible for all the commercial activities for selling Lubazol in The US, and IMMUPHARMA will have no sales and marketing cost itself that it has to pay. All the rest of the world rights are retained by IMMUPHARMA to either sell alone in some countries or to do more corporate deals with other pharma companies in different regions. I think that's probably all we can say at the moment. Okay. Alright. Thank you very much, Tom. So we've we've had a number of questions coming also than whilst we've been here on the on the webcast about the pace of updates and the pace of other developments in the company other than lupus or and what I'd just like to say to that is that, you know, as we move forward in the next period, we do expect that we will be updating market on other product developments from the company.

14:37 And, hopefully, shareholders will see a regular news flow on all of that coming out as opposed to it being solely focused on Lupusor.

14:49 The the last set of questions which I'm going to address, and again, we've had a number of questions of a similar type that have come in pre the meeting. I'm going to term it board composition leadership of the company because as you'll all be aware, today marks the the retirement of the cofounder of IMMUPHARMA, doctor Rob Zimmer, and we wish him all the best for the future. But, clearly, it has raised some questions about the leadership of the scientific group and also, you know, what are we doing going forward post doctor Zimmer's retirement. So we're we're fully aware that we need to put some new leadership in place of of doctor Zimmerman from a scientific perspective.

15:39 We're also very aware that now Lupusre has moved into its late stage development and we're more focused now on this commercialization to with Avion and obviously the rest of the world that we need to bring on a number of the other product developments which we talked about in corporate updates over the last couple of years or so. And bearing all that in mind, we're looking at the leadership of, let's say, the scientific group. We're also looking at the skills and experience that we're gonna need across the company, including the board level in order to put that new strategy in place and and to bring on a number of new product developments other than just Lupusor. That's about all I can say, I think, at the moment, but I just wanted to send a message out to you all that it is something we're we're closely looking at, and we will be updating you all as soon as we've made the decisions.

16:36 And you've got a full update on all of that as soon as we can. Thank you. So I think I've answered all the questions that came before. I'm just gonna have a quick look, see if there's anything I've missed while I've been talking on the q and a. So if you give me a moment while I just run down the q and a. Okay. So there are there are couple of questions about lupus on the phase three and Avion. Let me just reiterate. And I think Tim also touched on this. We have a fantastic supportive partner with Avion. They're fully committed to bringing Lupusor to market in the in The US, and and we're equally committed to assisting them in any way that we need to and then expanding that reach out from The US. So there's absolutely no misunderstandings.

17:34 We're committed. They're committed. Our target is to get the phase three started before the end of this year. We we actually see no reasons why it shouldn't. We don't see any hurdles. We're actually going through a process with FDA at IMMUPHARMA, which is a process. We have to go through it. It's regulatory, but it shouldn't send any any negative signals to anybody at all, quite the opposite. We're getting really, really good feedback from FDA and very, very supportive meetings that that we're having. So I I hope if if anything I can alleviate people's concerns on that. We're very excited about it, Hoops, all going forward. But as I just said, we're equally excited to have some of other product developments which are coming through as well, which, again, I will just reiterate the real up to date update market as soon as we can on that.

18:22 So give me a look at the q and a again. Somebody's asking about cash burn rate. We're we're very well funded, and let's not forget that I'll be on a painful phase three cost. And if you look at some of the financial results for the last two or three years, clearly, reflect the fact that we were directly paying for the first phase three. So we don't have any of those costs going forward. We did a fundraising last year, as I'm sure most of you would be aware. So we're we're in pretty good shape, actually. So no worries on cash burn. Can I see anything else? Somebody's asking, if phase three starts this year, when is it likely to complete?

19:08 That's always a difficult one to pin down dates. But just to remind you, the phase three program for Lupusor is a twelve month dosing period of patients. So one has to account for the recruitment period, obviously, how quickly the recruitment occurs. And then in terms of so the the start date is when the first patient is recruited. Oh, sorry. We've got pre I wouldn't say the start date, but we obviously prepare and point sites and all of all of that before the first patient is is dosed. But in terms of when the likely finish could be, you have to take the last patient recruited in that recruitment process and then count twelve months from there because all patients have twelve month exposure to the drug.

19:56 So in overall terms, that's likely to be around a two year time frame from the time you start recruitment to to when the last patient comes out. And I say that, you know, not please don't pin me down on those those timings because that's just an approximation. A lot of it does depend on the recruitment rate. So that will give you an idea. It's not gonna be six months, and it will be five years. It could be somewhere at the middle. But I think you can probably take some guidance from the the the first phase three. We're not expecting it to be much different in terms of of length of time than than that one. Think I've covered everything that's on q and a. I'm just working through it now.

20:43 Forgive me if I haven't answered any, but I think I have. But if there's any that we see later on that we feel we have answered, Or if there's any more questions coming afterwards, then clearly, we'll we'll put some we'll post some some answers on on the website. Tim, Dimitri, Doctor. Frankie, thank you very much. I think you have addressed those questions you can. And and as you said, Tim, you will have the opportunity to review all questions submitted there and we will publish responses where it's appropriate to do so. Tim, perhaps I could just hand back to you just to wrap up before we redirect the attendees to give you some feedback if possible. Yes, of course. Thank you. Firstly, let me thank you all for attending the AGM today. It's it's unfortunate that we have to do it via this this medium, but it's the same for all companies at the moment, unfortunately.

21:35 And let's just wish and hope that the situation in The UK continues to improve in terms of COVID. And this time next year, we're all able to meet in person, and we would absolutely be delighted to welcome you to a to a venue where we can see you face to face and and and talk to you and and answer your questions on the day as well. But thank you for all your questions. I hope we've addressed them sufficiently. And as I say, if there's any more, we will respond via the website. But let me emphasize that we are always here. I think most of you have got our contact details in in including Lisa, how the communications who I know a lot of you speak to on a regular basis. But please keep in contact with us. We wanna make this an interactive company with yourselves as our shareholders. And we're always open to your questions, your queries, or your suggestions or or anything else.

22:34 So once again, thank you very much for your time this morning, and look forward to seeing you all next year in person, hopefully. Okay. Thank you. Tim, Dimitri, Doctor. Franking, thank you very much for updating attendees today. Could I please ask attendees not to close the session as you'll be automatically redirected for the opportunity to provide your feedback in order the management team can better understand your views and expectations. It will only take a few moments and will be greatly valued by the company. On behalf of the management team of IMMUPHARMA PLC, we'd like to thank you for attending today's proceedings. That concludes today's session. Thank you, and good morning.