Hvivo (LSE:HVO) — Investor Presentation

0:01 Good afternoon, ladies and gentlemen, and welcome to the Open Orphan PLC Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Please, as usual, just type in your questions at any time and press send. The company, of course, given the significant attendance on today's call, will not be able to answer every question it receives, although the company review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll, and I'm sure the company will be most grateful for your participation as

0:32 usual. And I'd now like to hand over to Carthel Frill, Chairman of Open Wealth. Good afternoon. Mark, thank you very much, and thanks to all our investors who have, dialed in tonight to hear the joint presentation of myself and Moe. We beside each other, so we we split screens that make it less confusing. But yeah. So, look, I'm delighted to have Moe here on board. It's been a lot of activity, a lot of changes in the last two years, all for the positive. I think we're at a stage now where we're a really grown up company, and we, you know, really grown up and experienced CEO. And Moe and I have worked together closely since mid October. So we finally decided we could absolutely continue to build this company, and Moe is so happy to have him on board as a full time CEO. And that allows me to make up lost time on these spinouts, but let me come to that demand so I've got no excuses for not delivering spinouts after tonight. So let's take you briefly on the presentation to refresh people where we are and what's been happening.

1:37 First of all, and this is a a key part. I think some days I don't believe it. I can hardly believe it myself, but it's absolutely true. And Moe keeps reminding us that we bear in mind, we took two small CROs that kinda lost our way in, you say, the valley of darkness, and we pulled them together. And guess what? Look. It's the vision's a reality. We are the de facto world leader in the test of infectious and respiratory disease products using human challenge studies addressing this very large growing infectious disease market. And let me remind that sometimes, as important as better to be a lucky general run, a brave or a bright one. So that where we are, we put these companies together. This was not the most sexy place, the infectious disease market. Being honest, it was kinda graveyard shift market for thirty years as big pharma just didn't develop vaccines, didn't develop antivirals, didn't develop things for respiratory infections. They were all after cancer. They were all after orphan diseases.

2:36 Come the pandemic, suddenly, every pharma company in the world, every government, every biotech needs to have an infectious disease product. Basically, deal with the current pandemic, to deal with the current chest infections, and to deal with future pandemic. So it's a fantastic place to be. And the beauty with us, we get paid regardless. We get paid for testing these products. Whether it works, fails, or doesn't, we get paid in full. So it's a it's a nice place. We're almost, like, in a gold rush, and we're supplying the picks and shuffles. And that's the people we all know who made the most money in the Klondike gold rush with the picks and shuffle people. I'm gonna just take you through the first couple of slides and really hand over to Moe as his view on where we are and what we're doing. But, look, the big part is to recognize where we are now. This is subject to audit. We're a public company.

3:26 There's another month or so. These audits take time. But subject to audit, we last week, we already guided that we're on target to deliver full EBITDA profitability for last year. Really important, we expect to deliver the full 40,000,000 revenue for last year. That's pretty cool. We also confirmed with cash and cash equivalents on the balance sheet of 15,600,000. That's up about a million from June, and there was quite a lot of activity, expansion, new models. So it's very clear. We're we're we're growing the cash. And as we went into this year, that cash balance actually went up quite significantly in the early days of January as as money came in, but more of that unknown.

4:12 Really importantly, last year, on the present day, people say we announced a lot of studies that we confirmed in December with 95% odd of this year's targets already contracted. And people were saying, where the hell are gonna get all these extra beds? Well, guess what? We've increased our quarantine bed capacity by almost 50%. We now have 62 quarantine beds. That's pretty cool coming up 43, and that was done in a very, very low cost manner. A big part of that, we've moved out of the process, very expensive office we inherited from the previous management. It was our last gift we had to get rid of. And we're moving into a vastly lower cost office, vastly bigger one, and we're getting 12 beds in there as well as part of that move.

4:58 Moe's gonna take you through the very strong pipeline of Chinese studies. For the first time now, we've actually worked within the next year and they've gone into the following year. So that's now a grown up CRO. We've got a a back book. That's something we've never had before. I'll leave that to Moe. We're continuing to work towards monetization of noncore assets. Let me come to that in a minute because that's an area I have to deal with. And the past year, I've been so busy with a million other things, being CEO, executive chairman. Now Moe's on board. It's my job now to deliver on those noncore assets.

5:33 I really before I hand over to Moe, I think I'm very proud of what collectively the whole team in OpenOrth and HVIVO and VEN put together and have a look at the fast growing business and compare us. I know I come in for a lot of flack on the bulletin boards for overhype and everything else, but I think we did a pretty good job so far. A lot done. A lot more to do in the year ahead, I would say. But, look, we are a fast growing business. There's 46,600,000 starting. I say real money, not this euro stuff or dollars, but 46,600,000 of real money. That's disclosed contract wins in 2021. We did we announced seven challenge to the contract wins in 2021. Bear in mind under the previous management, HVIVO done an average of one to two studies.

6:18 The best year ever was a one off to the three studies. So we set them last year, and we see the target's about ten, twelve for this year. A current pipeline weighted Moltig into that BD probability awarded of 75,000,000. Nothing wrong with that. So I leave that to Moe. That's his expertise at the end. Expansion to facilitate the growing pipeline really of new service offering. That's really important. And most of the company, we're going to have a lot new areas such as doing actual phase two trials because we're always turning those down to vaccine trials, but I'll leave that to Moe to explain. QMB, we've added seven beds. By moving into our new admin building virtually around the corner, we freed up area for seven beds.

7:04 QMB's gone 24 to 31 beds. That's our main one. By Chapel 19, and this plumber's row, you'll see from Google Maps is literally a couple 100 meters from the main office and a vastly so the rent is one tenth per square foot of what we've been paying for the last three years in this office we inherited from the previous managing team. But we finally the minute we go to break class, we're right of there. And then separately, we've expanded the Manchester facility substantially on a low cost way for screening volunteers screening offer. So that's 45% increased bed facility. The old Manchester facility was 500 square feet. And, basically, we've increased that almost tenfold for the same for the same cost. Again, this is just being smart.

7:53 At Plumbers Lane, we've done 9,000 square foot, and that's it's green site, and we've done that for about a third of the cost of where we had the existing admin. So what we try and do, we treat the money on the balance sheet as our own money. A lot of public companies born through the cash and don't treat it as hard earned cash. It's hard earned cash. So that's how we treat that money. Finally, and it's a time up call. Where are you with the monetization of these noncore assets? Being honest with you, I think we did a pretty good job in Poolbag. And under the questionnaire, I want to talk you through about the dividend species. But at Poolbag, we handed 25,000,000 dividend species back June, and people don't realize the values that never will come to. That one is done.

8:39 And from the April 19, you're free to trade the shares. I would emphasize, don't rush trading your Build Back shares because, like everything, in the first six months after the IPO of open, share price is down 60%. And just bear in mind, with the eighteen months, we're up almost 10 x. So I almost tell people, just copy what we did in open orphan. If I've always said, if you get three, four, five extra money in pool bag, absolutely take profit off the table, but don't be selling with a down 30% at the moment because we have exciting plans afoot there. Prep pharma, we had a deal done. We own 62%. It was going in if you use we can't say the name of the company, but it had 80,000,000. It was being reversed in, had a market cap of 150,000,000,100% redemptions. That deal collapsed because the SPAC is now down 95%, no cash. We will get a new deal. But just to reassure people, that deal was done, and the plan had been on the January 10 to hand you all dividend species shares in a Nasdaq company. My model is we'd love just to hand everybody proper shares in a little listed company. That's what we had done with prep. Unfortunately, it did happen.

9:52 But we've done it once. Give us a little bit of time, and I'm sure we can get prep into another vehicle and hand the dividend species. The beauty about the pool bag, we now have that pathway. Once we get shares, we pass them straight through without paying any additional expense of lawyers, accountants, advice, because with the same structure, this dividend species business. Imutex, yes, very difficult 51% shareholders. I can't emphasize difficult. I now have time on my hands. I was doing three jobs last year. I've now got one job as executive chairman. I'm in the office of. And my job is to find buyers for these assets. So that's top of my list, and I will work very hard and get a resolution if it takes all that I'm trying to say. The 51% shareholder, you might have seen some of the presentations, doesn't seem that concerned about trying to monetize the asset.

10:45 It had probably two of the world's most exciting assets, a universal mosquito saliva vaccine and universal flu vaccine, and I haven't managed to cut a deal. But that's up to me now. I say I have no excuses doing two jobs. I've got one job to deliver a result in the Mutex. Finally, at z's in motion, that is now absolutely I've got to very much focus that that will happen in the months ahead. So what I'm trying to say, in summary, the benefits of spinouts, this cost synergies, pool bag share the office here, pool bag contribute to some of the staff costs. So the synergies, dividend will come back on all of these. The plan for each one of these is we've proved we could do it with pullback pharma. So each one of them will try and do it. And all that would emphasize, just think we've done with the core business.

11:35 The core business is in absolute fantastic shape. Growing, we'll continue. We've doubled the business in eighteen months, and Moe's firmly the belief that's a a good start. I'll knock out words in his mouth what he's gonna do, but he's not here to go steady at the basic. So I do apologize. People are disappointed in these monetization non core assets, but bear in mind, we've won done. The prep had been done, and just specs have gone away. But give us a bit more time. We'll deliver that plus a and z's in motion. Anyway, I think it's time now to look. Give me a summary. He's sitting here beside me. But Yaman Mohan, but to known to all of us as Mohan. He's formally appointed as CEO on the twenty fourth of February this year, a whole couple of weeks ago.

12:24 I will. I know some people are worried. Is Kyle gonna disappear off the sunset? Not really. Most of my network tied up in the company until I get that back. I'm going nowhere. So, no, look, I would get bored. I'm in the office in London three, four days every week. Moe will get on with a day job, and my job is get these spinouts done. He's extensive experience in the CRO. And all I would point out, the last two companies is what's got success. He sold for a very large return for investors, INOVIX acquired by Quintile and Farmaland acquired by PE. So no pressure, Moe. We want to a lot of our shareholders would like to see a a fantastic result here as well. So without further ado, I'll hand over to you, Moe. Thank you. So, yeah, thank you for those kind words, Kahal. It's a pleasure here to be sitting in front of you as CEO of OpenOffen. As Kahal mentioned, I took on the role formally on the February 24. I actually came to join OpenOpen as a nonexecutive director from October. I guess took three months to make up his mind up on what he wanted to do with me, and we finally agreed to come on you know, take on the role of the CEO.

13:36 Have extensive experience both on the sponsor, the biotech side, as well as the the CRO side. I spent some time at the Liposome company, which was a biotech based in West London, which was acquired by Elan Pharmaceuticals. But majority of my career has been in contract research organizations or CRO. I worked at a small UK based CRO called Innovex who were acquired by Quintiles or now IQVIA. I then spent majority of my career at a small niche Eastern European CRO called Farmolem. And after a nineteen year period, I co led their growth from a small people to country company to a a mid sized global CRO with presence in over 40 countries.

14:27 At the end of that, I co led the trade sale to private equity. And during my time at, I headed up both the product delivery operations on a global level and then also built and led the global business development team. So I have experienced both on commercial level as well as at a on operational level. And I'm now very pleased to be taking the helm at OpenOffone and hopefully growing this company as we move forward. So as this is my first time, talking to you guys, I thought it would be good to give you an overview of what OpenOffen is. And I truly believe OpenOffen is the world leader, especially when it comes to studies. I know this is a an often point you hear in service providers who say we are the world leader in x, y, or zed, but there's no doubt in my mind that OpenOpen is the global leader leader in challenge studies. And I don't think there's any any other commercial organization that can match the depth of experience, the scientific expertise, or all all the the breadth of the portfolio of challenges we offer. So we've been doing clinical trials for over thirty years and twenty years plus as in challenge agents.

15:50 We've conducted more than 60 challenge studies to date. That's more than any other commercial organization. We have, in fact, inoculated over 3,000 healthy subjects as well as some asthma patients. Again, this is world record beating numbers. We have the world's largest portfolio of challenge models. And as you can see on the on the right hand side there, the different models and the number of trials and patients we have inoculated. So some have been, you know, the old traditional ones, but we are always adding, and I'll come to that in a in a in a little while.

16:25 We also have a really good diverse client base, both big pharma. I think we work with five of the top 10 big pharma as well as the smaller mid sized biotech companies. And historically speaking, we do go back to the nineteen forties when the common cold unit first started conducting challenge studies in the in the common cold. And some of the founders of Retroscreen, which then became HVIVO, actually came from the common cold unit. So we have a long history and a strong depth of experience in in doing challenge studies. And I think one of the key things you have to remember that the the challenge studies are extremely safe. We are highly regulated. We have to get approval from the MHRA as well as the relevant ethics committee before we can start the trial.

17:15 And all the trials we've conducted to date have been safe and have produced some excellent data. With addition of the VEN group to the open portfolio, it gives us the ability to be able be able to offer full service to our customers. That means that we can start from protocol design, write the full protocol. Can go and recruit all the subjects. We can treat all the subject, do all the clinical management. We inspect the data, conduct the data analysis, do all the biostatistics, and then write the final clinical study report as well as do all the lab work. It means that OpenOpen as a as an entity can conduct full service challenge studies. And this is something that most customers are asking for. So most customers want a one stop shop. They don't want to go to two or three or four vendors to be able to do their trial. So I think this is another a key advantage of having the HVIVO group and the VEN group under the open open umbrella.

18:19 Furthermore, we are an international company. We have a new facility in Manchester, so we are conducting our screening there. So remember, when it comes to doing challenge studies, you have to screen these patients prior to them coming into quarantine. So we want to expand our volunteer base. So we're able now to conduct the screening visits in Manchester or surrounding areas. And then when it comes to quarantine, the volunteers come to our London clinics. Once the quarantine visit finishes, they can go back to their local areas and do the follow-up visits locally to where they reside. And this is important for us to be able to expand our volunteer base. We also have a biobank facility. As you know, we've moved into Plumbers Row, East London as of Monday, as, Kahar mentioned.

19:09 This will mean that we have an increase in space. So we're able to screen more patients. We have more beds, and it will lead to releasing extra lab space in in our BMQ facility. On top of that, the two Ben facility, one in Breda in Netherlands, where we do preclinical. We also do, what's called, CMC as well as clinical consulting. And then finally, we have an office in Paris, again, under the Venn umbrella where we do biometrics. That basically means doing all the data management and the biostatistics for studies that we run. But, But, also, our Ven Paris group also actually markets itself as stand alone biometric studies locally to the the French market. Anybody who knows anything about clinical trials knows that the the major reason for delays in clinical trial delivery is patient or voluntary recruitment.

20:07 Sixty one percent of trials that are delayed are delayed due to poor or delayed patient recruitment. But here again, I think Open often has a a world leader with the brand Flukem. This brand has been utilized and nurtured over many, many years. We now advertise on social media, so you will see us on Instagram, Facebook, Google AdWords, but also in the in the traditional press and radio too. And we're using our Manchester hub to expand that Flukem brand. And with over thirty years of history, we currently have over quarter of a million unique subjects in our Flukem database. We we aim to screen around 160,000 volunteers through our Flutem database.

20:54 That's more than ever the highest in the history of OpenOpen. We now have the capacity to screen 1,000 subjects every week. And one of the key things we have to remember that when we do challenge studies, we have to ensure they're serosuitable. That means that these subjects cannot have antibodies against the the agent virus agent that we are currently work studying or working on. So we lose about eighty five percent of the volunteers from the challenge studies. And what we want to do is to market them elsewhere. So we're finding different ways. So for example, one, the opportunities that we are looking into and currently in discussion with third party phase one unit is to be able to market these ineligible subjects to the traditional first in human trials at other phase one units. We also want to be able to open them to our own services. So for example, we are looking to build on non first in human clinical trials in phase one, such as bridging trials or even PK trials and utilizing this eighty five percent who are ineligible for the challenge studies to go into the phase one. Similarly, we want them to be utilized in phase two environment, and that's something I'll talk about in the coming slides.

22:14 So one of the key questions really is why do people do challenge studies? Challenge studies are not your traditional phase one, phase two, phase three, but they give you some real insight to the mechanism of action and whether your drug is effective or not. So some of the reasons are listed here, but I and I'll pick up some key ones. So one of the reason, for example, is that the results of a challenge studies could give you fast track or breakthrough designation when it comes to regulatory approval. This could potentially decrease your regulatory pathway by two years, and that's a long time when it comes to clinical trial development. And we've seen some recent press releases from past sponsors who have been awarded breakthrough partly due to the data that has come out of challenge studies.

23:01 One of the key factor is that in the pharmaceutical development, there's a saying that if you got to fail, fail fast to reduce waste. And challenge studies are a great way of finding whether your drug is efficacious on a small scale. So without having to do a full blown field based phase two trial across 40 or 50 sites, we can actually do that at a single site, and that's important. Another key factor, especially with the biotechs we work with, challenge that it mean challenge that it is a way means in a way for our biotech companies to get into phase two very fast and very early. This could mean they get access to additional funding, increase their valuation, and potentially go to markets in such as as Nasdaq, for example.

23:49 They can also get a lot of savings by not going straight into a phase two or a phase three program and derisking that by being able to find a fix the at a challenge study, expedite your go, no go decision. I think that's key. We can also potentially reduce the number of patients you need in a phase three trial trial thereby reducing cost and time. And one of the key things about challenge studies is that it's able to answer the question about the mechanism of action that are impossible in field based trials. Remember, in challenge trials, you're able to study and get samples from patient just prior to inoculation and just post inoculation. And that is really good timing and good data insight for our potential sponsors.

24:39 Finally, in some cases, clients have been able to obtain approval from an emergency use authorization based purely on challenge studies. Now these are exceptions, but these have happened. But as we're moving forward, we we can see the interest in challenge that is is increasing. The The WHO has produced guidelines, and a lot of senior people in that we are working with are talking up to us more and more about challenge trials. So what is the potential market? So the first graph on the left shows that there is a a good steady increase in the number of phase one and phase two trials ongoing. Why is that important? Well, phase one is effectively our pipeline. So any phase one trials done in an ID or asthma COPD could potentially go into a challenge trial arena that we can conduct. On the right hand side, we saw we solely focus on some of the key ID and respiratory trial. Again, we're seeing a consistent increase in number of trials being conducted in phase one or phase one stroke, phase two. Again, this does mean that we have an increased pipeline, and that's one of the reasons why we are looking to expand the number of beds we have, expand in recruitment, investing in new technology, for example, in in in tracking our, new recruits using our Flukem brand.

26:08 I see I'm beginning to run run out of time, so I will go through this quite quickly because I've heard from that you guys are very interested in the q a q and a session. So but I do wanna talk about some of the ways we will grow OpenOffer. So there's three different buckets that I've put this into. So firstly, increasing capacity and offering. The new facilities in in in London and Manchester will increase the number of subjects we can screen per day per week. We can supplement recruitment for other CROs or sponsors who are slow or behind on the recruitment. We can conduct non first in human phase one trials. We talk about the the field based phase two trials and certain indication, for example, in asthma or, for example, in vaccine that we can conduct.

26:56 We can also act as a clinical site in multinational, multi site studies. So you you could could have a CRO or a sponsor conducting an international trial in asthma or vaccine, and we could

27:08 be part of that as a as a site contributing to their patients. Increased capacity in in the recruitment area means that we can enroll more patients. We're also looking at some cross selling opportunities between VEN and HVIVO. Challenge studies will remain our core business, and this is something we also will modernize and grow. So we have the STRIDE project going on internally, which is a survey used to identify new viruses and build new viral challenges. We've expanded into parasites via the malaria model, which is now live, and we are marketing this across the globe and have some key workshops next month. We're looking to make the most out of a COVID nineteen study that we have done in the past last year, and we're always looking at other opportunities that we can utilize in the challenge model.

28:02 On the laboratory side, with the new facilities in Plumbers Row, it means we have additional space for our labs to expand to. We will have increase in biomarker and molecular testing capabilities. We manufactured majority of the virus models that we we use, and this is something we will continue to do, and we're building a number of new models this year. And finally, we will be looking at cap and UCaaS accreditation for laboratory facilities so that we can sell them to third parties. The final slide, for me, in the main talk, really focusing some of the key numbers. I'm I'm I'm a metric different person. I'm a

28:40 scientist at heart, and I think these are some of the key numbers that I like to measure our performance and how well we're doing. So we are a rapidly growing company. We had projected revenue of £14,000,000 last year, and we still our guidance that we will definitely hit that. Of course, these are pre audit numbers. We are projected to hit 50,000,000 this year of non COVID revenue. We have a good amount of cash. We are in very good cash position as of end of last year. We are the leader in human challenge trials. I've talked about this, the number of trials we've done, the number of models we have, the amount of investment that has been put in place last in the last twenty years in building these models. And one of the key take home messages here is that not only do you need the facilities and the resources, but you need to invest a lot of money and effort into building the talent model.

29:33 So the hurdle to market entry is really quite high. On the operational excellence side, well, we we screened 84,000 new subjects last year. But the great thing about challenge studies is their value is around between 5 to £10,000,000, and the revenue generation period is under a year. A challenge study typically completes between eight to ten months. So you can recognize all the revenue on a challenge study under a ten month period, which is great news for us. And how are we positioned for future growth?

30:06 Well, we've hugely increased our bed capacity, which is a key component of driving revenue. We we we've done we completed 86,000 lab samples last year. We will be higher than that this year. And the weighted pipeline. So just to kind of explain that a little bit for those of you who are not aware of what what is weighted pipeline. So from a business development and sales activities, we have a pipeline of future work that's currently unsigned. Awarded. What we do is we assign a probability to each project. And then we basically multiply the total value of a project by the probability fact of how well we think we will do in in in getting that study on board. And that equals £75,000,000, and that is the highest it has been in the history of OPENO PLC.

30:54 That's my final slide.

30:56 Thank you. So now we will go through the q a q and a. So we've got a number of questions from from the audience. So I'll go through some of them myself and then hand some over to Gahal. The first question is, is the appointment of Yami Mokhan as CEO a good move? Is he awarded any free shares in open open? I think it's an excellent move. I hope Sahar agrees. And will I be awarded any free shares?

31:26 No. I will not be awarded any any free shares. And will the new CEO be buying any shares? Yes. As you guys know, I'm restricted to a certain time window. And when that window opens up, I do intend to buy shares in the company. I I truly believe I need to be part of the company and aligned with my shareholders. And that's that's important. Actually sorry, folks. Moe, I'm just jumping in. I think Mark or somebody there's only two mics. There's one here. Mark, maybe I checked. There's a live mic maybe at your end that a good bit of noise in the background there. I think people can hear it, so just in case. Okay. We've we're sharing our laptop, so we know we've only one live mic between us. Anyway, that perfect is gone again. The background noise is gone. Per or you again, Moe. Okay. The second bucket of questions is on facilities.

32:15 So this is a two part question. Are you able to recruit enough healthy people to meet all your current and potential facilities in London? The answer is yes. With the flu camp and the initiatives we have on the marketing and recruiting, we invest a lot of time and effort. We actually have got a a new software that we implemented last in January, in fact, which which basically means that now volunteers can make appointments from the for themselves, and we can track them through the the volunteer journey, which is important to us. So in fact, we we believe that we can recruit so many that we are now looking to market these volunteers to third parties such as phase one units. The second part of the question is, you have suggested the most efficient way to expand is in your existing facilities in Whitechapel.

33:03 Isn't this likely to cause problem with sufficient improvement? Well, not really because we are expanding to increase our screening facilities. London is a a large diverse city, so it has a a really good patient population pool that we need to tap in. We are nowhere near saturation. But in addition to that, we've also opened up our Manchester facility. So they get that gives us access to an additional patient or subject pool that we can utilize for future challenge studies too.

33:33 Are you expecting any work from the UK government 2022? I'm not expecting any direct work from the government, but I do expect for the COVID work to follow on. But that will come from commercial organization rather than nonprofit or any government organization. The next question is the the three part question. Is the company seeing any signs of new contracts or repeat contracts work for 2023? Yes. We are. In fact, we are already placing trials into our quarantine clinic for 2023. So we've had a a good amount of demand coming from our customers, and some of the studies that are currently ongoing will run from '22 into '23.

34:20 And other new studies will go into study into 2023 alone. How close the company hitting 100 contract target for 2022?

34:31 We are pretty close. We are very confident that that will happen. Are you expecting new contract wins anytime soon? Absolutely. We are expecting some new contracts soon. I asked for a little bit more patience and and watch this space. We we will be making some announcements in in the coming months. Okay. On on the second page, are there new challenge models being worked on and now in March 2022? Absolutely. We have to move with the time. We can't stand still. I said we are the world leader, but that doesn't mean we can rest on our laurels. We need to keep moving with the market, come up with new innovative models. We've just completed the malaria model. That's one of our first non viral models. But But even into q two, q three, we will be looking to build additional models in in different viral indications.

35:27 Now that Omicron is seen as less potent, will big pharma pull back on investing in infectious disease solutions? Well, I don't think they will. The current market states otherwise. We've seen a strong interest in COVID. Are currently four hundred ongoing phase one trials in COVID nineteen. So these are phase one very early trials. So it shows that the interest is still strong. And we expect the infectious disease market to grow into excess of $25,050,000,000,000 by 2025. Bucket next bucket is COVID. Where are you with COVID contracts? Well, we are currently negotiating with multiple cost customers on that. As you know, we completed the COVID dosing trial last year. That will be published in Nature Medicine this month, in fact, and and I expect us to see a lot more interest after that. But even already, have published some of the data already.

36:28 We've seen a lot more interest, and we expect to be doing more COVID work this year and next year. Next bucket talks about financial position. So what is the current cash position? If healthy, when can shareholders expect the dividend? As of end of last year, in the pre audit, we've see we've shown £15,600,000 in cash. So that's it's a great place to be, especially for an AIM company. I think we're one of the healthier companies on the market, and all options are currently on the table as to what we would do with this cash in the coming months. For year 2022, non COVID revenue target of 50,000,000. It was previously stated that the majority is already secured. Is this still the case?

37:18 Yes. It's still the case. Majority of the revenue is already secured, and we are continuing to build on that. And we we have, given guidance as last September and now that we will hit the 50,000,000 non COVID revenue for this year. The next one is a two part question. In recent presentation, you were you said there was a a 75,000,000 weighted pipeline of contracts. Can you clarify that? I hope my presentation clarified that. Are any of the 75,000,000 included in the 90 five percent twenty two secondure revenue? No. So the the difference between the 95% we mentioned earlier, that's signed work. The 75,000,000 of the weighted pipeline, that's unsigned work currently in the sales pipeline.

38:07 So those are two different categories. On communication, question have been raised via investor relations as directed on the open open website, not not not responded to. Why not? And this is one for you. Okay. Maybe it's time I give Moe a hand here. Not normally, this quiet. This is the new call. He's got a focus on the spin on it. It's why Moe Moe does the hard job of running the business. So communication. Yeah. The question is why Look. January is a company, I think, even tonight, we've got every pre submitted question, and then there's been another 40. I'm gonna have a crack and answer everything. Yeah. Sometimes when there's a steep fall rise or properly sharp rise, we get it down at sometimes fifty, sixty questions in over a twenty four hour period.

38:58 It does take a little while to answer them. So what we've done, we generally hand them to our IR company now because our nomads that we've grown is kinda keen that they're handled that way. And then and it comes in directly. So, look, I think they're being answered. Questions come in. Generally, no more problem. There had been brief periods that maybe when they weren't being answered three or four days. But, look, they're getting answered. I think there's another group of shares that maybe I'll try and do share price, share price performance. What has happened to the share price I'm thinking of selling? When do we go from here? And my answer here was simply my advice is that we've now built a fantastic business as a world leader, and we're one of the few companies on AIM that's subject to audit that's gonna do the 40,000,000 last year, and we're on target to do 50 plus plus plus this year.

39:46 We're absolutely profitable. People say, what's EBITDA profit? We are profitable. The cash pile is growing with huge expansion funds on all fronts. So I personally have a huge part of my network tied up in the company, and I remain exceptionally optimistic with the prospects, particularly now. There's two broad sets of shoulders here to build it going forward. We've done a lot on our own, myself and a couple of colleagues. So Moe was the expert in this field, I think we have a lot more to do. Thus, an answer to that question, I would say, show me any other company on AIM that has better credentials to invest your money. Yes. The share price is not what we wanted. I bought a lot of shares, £300,000 at 27 p last year. I'm not in the slightly worried because I know that's a very safe investment. So I think, yes, it's disappointing the shares are down. There's a lot of shares trading, but I'm absolutely convinced that people who sold out $30.35, 40 p can't believe their luck.

40:44 For every share that gets sold, there's a buyer. So that's where some of our buyers are coming from. Will the new CEO and chairman buy increase their shareholding at the current low price? So maybe I'll quote for myself first. First of all, to be clear, I've written checks all along every time we've ever raised money at full market price. I paid £300,000 starting at 26.5 p June last year. In January, the previous year, in January, we did a placing. I put in 300,000 at market price. And as part of the IPO and pre IPO, I put at 1,500,000. So I think there's very few AIM companies that the founders put so much money in at market price. I think in regards to Moe, I think he's made it very clear he's gonna invest.

41:30 He's not saying, oh, we've sat through one or two presentation recently where the the promoters duck and say, all you know is compliance. I can never run it. Look. There will be a window pretty soon where Moe is keen was keen to buy shares last couple of weeks. I think that probably brings us on to where is the contracts, the common waves. As soon as the there may be a wave coming through and soon as they're true, Moe will buy shares. So he's very keen to actual buy shares and real money. So I think answer that one. Question three that's coming in advance, and and we bundled some of these questions as similar questions that come in. Are Nasdaq listings for open orphan and pool bank now off the table following the collapse in many Nasdaq share prices. No. Nasdaq's got more interest than ever. For instance, pool bag, we've got Nasdaq biotechs that used to be worth 300,000,000.

42:18 No. They've got no cash. They're now worth $3.30. They've got really good products. They've got a listing, and they're offering to merge or for a pool bike to take them over. So, likewise, in the case of open orphan, absolutely. NASDAQ's great place for life science companies. All we see is that there's lots of possible options. We're not gonna charge it to any of the moment, but I wanna say don't rule out NASDAQ for either open orphan or pool bag. Another question, do you know who is selling the shares, and what are they in the low millions? Are the institutions left? I see on average, there's been 3,000,000 shares a day being sold for the last nine months. Well, my answer to that is, do we know? Most of we don't.

43:03 We have a number of institutions that are below the 3% disclosable stake. There's one institutions we can I'll go through. It's on the online quest that's sold off, but our other institutions are there. Myself, my own family investment, we're all sitting tight. But just I do bear in mind that everybody says there's 3,000,000 sellers shares sold every day. But bear in mind, for every seller, there's 3,000,000 shares being bought every day. So there's an equal and opposite bar for every person selling. And it's clear that we regularly have new investors coming back on our share register. And look. My feeling is there's a lot of people made some people made profit at thirty or forty p. I've always said, don't be afraid to take profit from when we were back down at five, six, seven p.

43:49 So I think there is people selling out. There's people buying in. We have a very liquid stock. Just think last Thursday or Friday with 5,000,000 shares traded at an average 15 p, and this is the issue in Pool Bank. We're trying to generate liquidity. Hopefully, that liquidity will come now when we free up the shares. But on the same day, whether it's 5,000,000 shares traded in Pool Bank, it over twice, almost twice more than twice the price of pool bag, pool bag would trade maybe 25,000. So, look, I liquidity is good. It allows people to trade in, trade out. Some investors, and it's very clear we can see, had bought up very big stakes in the last twelve, eighteen months using CFD and spread betting. And it's clear they're the ones that are dumping because we don't see the investor, but we can see the CFD provider regularly at times of the share. Other share of the market is down. So to answer your question, we don't know exactly who the sellers are, but it keeps saying for every seller, there's a bar.

44:46 A question is and this is actually probably an important one for every night as well. It'll take a few minutes. As regards the pool bag, and you all who were in the show register last day will hold. So the holdings in pool bag dividend species. Let me break down these quite question one. Can I hold my pool bag pharma dividend species share in the ISA account? Well, fortunately, we've had discussions just today with interactive investors and rest. So we've been in touch with interactive investors, and there was some confusion in recent weeks. Could you hold in your ISA account? This is now being clarified, and you can hold your pool bag share dividends. When you get it, I emphasize people have not got these dividend pieces until '19, so you can hold them. They are qualifying, and that's good news. That will be going up on our website tomorrow morning. There would be but the frequently asked question session on both open orphan and pool bag, but that's the clarity. So you can absolutely hold your pool bag dividend species in your ISA account and particularly your interactive investors, and that will be confirmed on our website tomorrow.

45:55 Another question, can I trade my dividend species shares in an online interactive app? Absolutely. First of all, you can't trade them at the moment because you don't have them, and nobody has the dividend species shares. When they're released, you can trade them anywhere you would like. They'll come through Crest. They'll come through whatever form. So they will no problem. If they're ISA, you can trade them your ISA account. So there's no issues. So that this will be clarified tomorrow. Question three, what tax will I pay on my pool bag dividend species shares? So if you hold them in an ISA, for instance, you hold open orphan shares in ISA, you will now have got income on your open orphan share that you held back in last May. The income happens to be a dividend. Instead of cash dividend, it's a share dividend. So your pool bag share will go in. Within your ISA, there's absolutely no tax you will pay. So no capital gains, no incomes if it's an ISA.

46:47 If you're a UK resident and you held your open orphan shares day one in your personal account or other vehicle, The good news, as we've always said, we had advanced clearing from the HMRC that you have no income tax, and the only tax you will pay is capital gains tax. You will only pay the capital gains tax if and when you sell your pool bag shares. And so you won't get them till after nineteenth. They will be distributed for the April 19 on, and then you're free to sell them. But my suggestion is you watch what happened open orphan. The first six, nine months, our share price went down by 60%. And the following eighteen months, they've been up five, six, seven, eight, nine, almost 10 x. So we would advocate our pool bag dividend species shareholders bear with us and see can we repeat history.

47:40 Next question. If my pool bag shares are in my own name, what is the base cost for the capital gains purpose? So no base cost, no relevance in ISO, so you won't have tax. But within your in your personal name, the base cost for your pool bag well, you didn't pay anything for them, so your base cost will be zero. So for capital gains tax purposes, your pool bag share, if you got them in your personal name through open often, you will unfortunately pay capital gains on the full consideration. I say these shares were rewarded virtually free and such the full capital gains. Please note, there'll be no capital gains or other tax due until the seller actually sells the shares. So while you sit on them, they're a tax free asset.

48:25 Another question, the market feels that open orphan dividend species shares are gonna create an overhang in the pullback share price. What are you doing to be able get that? Let's be honest. We're not hanging around. We're doing lots of things. We announced we're having an over the counter premium listing, the same listing that Vodafone, which are known as. That's underway. We're seeking permission at the general meeting. This was published on the April 4 that the company may be in a position to just pull back use some of its 21,000,000 to buy back some shares and or pay a dividend. The reason we're not doing that and again, that's like I almost see the question, well, why are not doing that in the open orphan? Well, the reason we're not doing that is an open orphan with vastly bigger daily trading and liquidity. So we're gonna the market to try and buy shares. We can throw an awful lot more to buy them back, whereas Pool Bank is tiny. We can deploy a small bit of cash to buy back shares in Pool Bank. Bear in mind, 25,000 shares traded a day at six seven p.

49:24 If we invest a couple 100,000, we could really drive the Pool Bank share price up very substantially, but we couldn't do that in Open Orphan. But we have guided in open often that we have very good plans and ideas for that cash. So all we can say is, for the moment, we would like to sit on the cash, and we want you to trust us with us. We're not burning through. It's not gonna go away, and we've got some particularly good idea of that cash. More to be said at another time. On the spinouts, I'm conscious of time as well, but a lot of questions have come in on the online. But let me go through the spinouts because I think that's one area that Moe has been annotated, and this is right. You take care of these. So first question, the spinners that come in in advance.

50:10 Any updates on future spinners and timing? What'd be perfect, as I said at the start, I've had a horrendously busy people. Bear with me. We were a tiny team the last two, three years, and it's only starting now. I will ensure we're off target and spinners, but the plan is let's get cracking, try and make them happen in the months ahead. So that's all I'm gonna say. I've got lots of time on my hands now. I'm a 100% focused on delivering the spinouts. Another question. Why is Seek Immunotec still not able to announce progress on the two key assets that OpenOrphan has a 49% stake? Well, I would love some of you ask that to the management team of the sick group because I'm struggling to answer the same question. And all that I can say, we find the sick group very difficult to engage with.

50:57 I can hear the lawsuit coming. And it's surprising and disappointing to us that they have not managed to commercialize these exciting assets. That's all I'd say. But guess what? I have a lot of free time on my hands, so I'll be trying to shift that Immutex asset very soon. Another question. If it's difficult to spin off disease in motion, why not put it into a subsidiary company? And I would answer, good point. Watch that space. These in motion could start moving sooner than expected. That's all I can say. What are the barriers for IMUTEX and prep bar prep bioparma spinouts? Market conditions being adverse to something else. We said prep was done. The Nasdaq's back collapsed on us, so we at least we still retain the assets. We will do it again. We won't go to SPAC. PACs are toxic at this stage. This so we'll put it into a normal there's over a 100 Nasdaq companies in life science trading below cash.

51:56 So we will do our best, but prep in, get Nasdaq shares, and pass them to your shareholders via dividends PC, and you can decide what to do with those shares then. Can you not use some of your cash pile to buy out the difficult 51% shareholder group in Immutex? Because open often certainly seems to be able to move faster and commercialize things much faster than the management team in Immutex. Yeah. That's a good point. So I don't think we're gonna spend our cash that way. But let's say I've got time and effort and interest now to sort the mutex situation. So so bear with us now. That's the advanced questions. I'm just trying to look how many more. We've got a lot of online ones. Let me probably actually do these here easier. We can read them here. So how about when we just take them with we'll alter them over and back. Some of these there's a lot of repeats. So yeah. That one. First, I'll just take them to the top, actually. They're coming in at we'll do them reverse. So this one just came in there now. 634 from.

52:59 I guess one for you, Mo. Is that Yeah. Is your weighted current pipeline annualized? If not, or what period is this pipeline expected to deliver? So it's not annualized. It's it's based on our total pipeline in the sales pipeline, and that will depend on when the the each each study will close when the clients are expecting to start in kicking off the clinical trial. Do you open often have any Russian, Ukrainian clients that we won't be expecting more revenue from in the future? But it is very unfortunate and horrific what's happening in in that region. But for OpenOpen, we have no customers or clients or employees from that region, so it won't impact us directly. Have you thought about buying challenge models of universities or research association, small fee, and expand the portfolio greatly?

53:52 But we have a very strong scientific expertise. We are very careful and strict about the purity and the infectivity of the challenge models we manufacture, so we keep that in house. In addition, not all universities produce their models according to good manufacturing practice, GMP. So we we we need to be careful, and we we have the expertise and the know how to do this internally. And in fact, a lot of the cases, it's sponsored by our clients too, so it's not something we would be looking to outsource. Why does it take nearly six months to announce the audit final results as many companies are able to complete theirs in three to four months? Hopefully, we can beat the six months or watch this space, something we we we look it's a challenge. We we look to beat that.

54:42 It has been noted that a North Pawnbridge Investment Management sold down their remaining holdings start of March. Yeah. While not a cornerstone investor for. What is the feedback from your remaining institutional investors, especially give giving the share price performance in the last fifty two weeks? What is the interest like from other institutional players not currently holding? I'd probably answer that. So maybe on the I think the question is six months. Sorry. I was looking a lot. Yeah. Look. We will get it out. We have a Dutch company, a French company, an Irish company, an English company. It does take three or four months of those audits. And our Irish and our UK audits, we get them in two, three months, but we we can't publish till we get our French. So that can take three or four. So we will have audited the cons. But bear in mind, we have guided the market. We're more or hitting the numbers as guided, so I think people should be panicking about the out of the accounts. We're not gonna say we're on target, and then the audit says something different. The audit is a formality.

55:39 Yeah. Thornbridge Investment Manager, we've seen that. That's the only institution we can see in the last six months that's sold on. Yeah. Naturally, people have the their own reasons for selling down. We have a bunch of other institutions who haven't moved. And, actually, the really interesting part with Moe on board, it's not to be derogative myself, but institutions probably like people like Moe rather than maybe people like me. So yeah. So Moe certainly has an institutional following, and we're now he's doing a series of institutional meetings. I tried. I brought institutions in at the places that did well in the state with us, but I think this is the ideal time for a mono to outreach, and I think I would be surprised if you don't see you've seen it in a number of other aimless companies.

56:26 A new CEO comes in. The founder's around, brings it so far, and then you have actually substantial buying So I think most get a great reception for institutions to say, oh, wow. We looked at that company at twenty five and thirty and thirty five. It's really interesting at fifteen, sixteen, seventeen, twenty. So I think, yeah, I think you will see real institutions come in because, look, is a lifetime in clinical trials. I'm not. So I think institutions are great comfort. But both of us being around, I must say, I'm going absolutely nowhere. So that one might be viewed. Thomas b at So is 35,000,000 pipeline include the anticipated full year 2022 50,000,000? No. 50,000,000 is projected revenue. 75,000,000 is the sales pipeline. It's two different numbers.

57:12 Seventh challenge study contracts wins last year. When are we expecting to see one sign in 2022? There. Folks, I'm probably jumping in there. What I would say, again, the common waves takes two, three, four months. We had a large wave of them run up to Christmas people, and then we yeah. We've had very few. But let's say the wave might be very far away. That's all I can see. And when you see one, there's always more. So that's just the nature of business. They come. They're always five, six, seven, eight, nine, ten million. So all they say, what why is this space? And, yes, it's been disappointing. There's no one in January, February, But let's say, I think, hopefully, the next wave of contracts, since it's not one or two, should be kicking off. And as soon as that wave comes, you'll be you'll see them as soon as we do. I think there's quite a few here. I don't think we'll have time, but this one's quite important thing for you. Oh, yes. Alan a at 06:19.

58:09 Carl, you only committed this day until 2022. Will you commit beyond this? Folks, Bad news for you. If you're stuck with me, going nowhere around here. So, yeah, it was hard going on me. I want Moe here. It's actually great fun because I can get my head off for air and do stuff. So I I'm gonna be here for a lot longer than 2022. What else have we Michael W. Maybe that's for you, Mo. It's probably mRNA drugs. Yeah. That wasn't there. With mRNA drugs being granted instantaneous regulatory approval with no liabilities, why would Big Pharma choose to submit their new product for HCS? I don't think that's gonna be in the long term. We're getting different companies doing, kind of, mRNA studies. So remember, challenge study gives you a fixed data in a very short time frame.

59:01 And and that's the key reason why this company will do challenge studies. We're currently actually in in contact and in negotiating with a number of companies using mRNA technologies for challenge studies. So this is something that we will see more of going forward. Mark, is that I think he says, when do you where do you see the offshore market cap into look. I've guided it very wrong loads of times. I'm not gonna answer other than I've never been more excited. The shares are very cheap currently. The business has never been better shaped, loads of revenue stream. So there'd be something very wrong if our share price wasn't much higher in twelve months' time. I can't become a share adviser and tell you to do this or do that where they're gonna go all of that twelve months' time. Absolutely. We have we will certainly they have to be lot higher.

59:56 What Steven or what can shareholders look forward to in q two and q two and q three? I would say wait for the next wave. It's a wave of contract signings. And then, Moe, maybe rolling out some of the new product here. Is that the right Absolutely. Yeah. I mean, we see an increase in revenue. The quarantine will be full, and we will be looking to market our phase one, phase two site capabilities across the board. So and with the addition of Manchester screens and coming on, we we expect to see more volunteers coming through the gates too. Kent, Harald, do you have a target number of beds you're aiming for? Any ambition for geographic expand? Look. The beauty about we had, we started off two years ago with 24 beds without spending very much money, like, less than maybe a minute, a minute and a half.

1:00:42 We've got it up to sixty one? Sixty two. 62 beds today. The our model is we can add beds in a low cost manner. And, yeah, international expansion that has to always be cars. But, hey. Look. East London rents are cheap. It's a huge catchment area, great amount of volunteers. We're not rushing anywhere beyond that for the moment. I think sometimes you you charge overseas, do the expansion, and it costs more money. So the at the moment, we've got an awful lot to do for where are. Just to add also, the the regulatory environment in The UK is the best in the world. We can get approval and challenges much faster than anywhere else. We can build challenge models much easier in in The UK than anywhere else. So we do have a huge advantage over the rest of Europe as well as The US when it comes to starting and building challenge studies.

1:01:34 And then Barry c, has OpenOrphan received regulatory approval for COVID studies yet? If not, when will you get approval? How many companies present interest in doing it? The big issue there is look. Being honest with you, is that I would have been holding back. We didn't wanna go charging out signing contracts could deliver. The study has now been published, peer reviewed. I think it's in Nature magazine next week, and that reassures our customer this is a safe study. The government pumped prime but got it going. So, yeah, a key key part of our delivery this year will be doing COVID challenge studies. We're guiding it. That will be on top of what we're guiding the 50 odd million for this year. So I will be the probably the most disappointed person we don't sign them, and I think we're working hard on signing challenges as we believe. There should be COVID challenge studies, a number of them every year from this year forward, and we don't need the government anymore to pay for them. I think the government's a wonderful partner, but I think now we can move much faster and swifter as treating the COVID studies as we do with flu, RSV, malaria, and everything else.

1:02:37 What has happened to the 40,000,000 government? Are you still received believe it or not, the government spent quite a bit of that in some of the partners. We got a certain slice of it. So think where we are, we prefer now to go and sign up a lot of studies with third party companies. We've always guided the market. The COVID challenge studies will be eight to ten million. And the funny part is our flu and RSV studies are almost getting up there as minute as well. So yeah. So there will be we we're not chasing government contracts. I think we're chasing COVID for commercial purposes. Yeah. This is an interesting one from ML. There's a lot of good work done under the banner of HVIVO is lost on potential investors as HVIVO isn't a tradable company in the market. OpenOp is always referred to publication.

1:03:26 It's a tricky one. We acquired HVIVO. It was unknown. We've kinda made it known that. That's something we'll deal with. Do we run, I think, changing the company name look. Our customers around the world knows HVIVO. You are retail shareholders know OpenOp. So, look, sorting them out, work in progress. Kieran, you still locked into OpenOp for some years to come? Are you looking to sell OpenOp? Absolutely not. The problem of being a director, if you know what'll happen, they declare it, and the share price will certainly collapse. So now the only time I'm doing is potentially buying shares. I'm not really and and absolutely no plans in selling open, orphan shares. So I'm gonna reassure that there's no need to lock me in. But while you're a director, if a director sells, I think that's a a sign for every ticket out. So I think the only thing Moe will be buying shares, and I think if you see me selling shares, I would in open offer, if I sell shares, I think the company have so absolutely no intention of selling any shares in open orphan.

1:04:29 Next one, Greg w, given the human challenge, what is your institutional investors? Yeah. Again, I think, look, institutional investors, I think we're getting there. That's Moe's job. Look. I was probably feeling myself trying to bring in and say, well, Kyle, when have you run a clinical trial company before? What's your experience? So now the institutions are are much more comfortable. We've now got a really professional management team. Maybe leave the last one, maybe this one. Yeah. Once you have really weighted percentage for the $105,000,000 project, it seems the the weighted probability is showing a lot of interest. So, yeah, they they do they do go from maybe 20% to 75, 80%. So there's a whole rainbow of of probabilities there. That's I think folks I mean, I think that's we got through all the pre submitted question and all the questions online. So, Mark, really appreciate that. So I think we're in good shape. Thank you.

1:05:24 Car Car Hill, Moe, thank you very much, and thank you for being so generous with your time. Look. I know investor feedback is particularly important to you both, and I'll shortly redirect investors to provide you with their thoughts and expectations. But before doing so, perhaps if I could just ask you for a few closing comments. Well, maybe. So, I mean, look, I'm new to OpenOpen, and this is my first time to speak so many people in a in a meeting. I'm very excited, very honored to be here. From the outside, when I when I first talked to Kahal, I was wondering whether it's actually ethical to do these challenge studies by inoculating, you know, healthy volunteers with the with the the viral challenge model. But now having read up and and looked at the the benefits of of these trials, I'm kind of amazed why why not all of these ID companies that are doing research in in in in antivirals and vaccine? Why aren't they all doing it?

1:06:15 So that's one of the my key goals is try to educate smaller biotechs and other big pharma to make them understand the benefits and and the speed with which you can get really useful results. And I think on the back of that, I I expect us to grow across the board, across all the businesses, and then also build the new service lines. We talked about the phase one and the phase two and and the site abilities. And then together with the the then life sciences and HVIVO, I think, build a a a world leading full service CRO as as as an enterprise, which I think will be hugely benefit to all of us. And, yeah, I'm I'm very optimistic for the future. That's great. I hope no. Thank you very much indeed for your time, and thank you once again to all the investors for their participation, the the questions that they submitted.

1:07:06 Could I please ask investors not to close this session as we'll now automatically redirect you for the opportunity to to provide your feedback in order that the company can better understand your views and expectations. This will only take a few moments to complete, but I'm sure it'll be greatly appreciated by the company. On behalf of the management team of Open Orphan PLC, we'd like to thank you for attending today's presentation. That now concludes today's session, and good evening to you all.