Shield Therapeutics (LSE:STX) — Interim results for the six months ended 30 June 2020

0:04 Good afternoon, ladies and gentlemen, and welcome to the SHIELD THERAPEUTICS Interim Results Investor Presentation. Throughout this presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time via the Q and A tab situated on the right hand corner of your screen. Simply type your question in the box below and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company will review all questions submitted today and publish responses where it is appropriate to do so. These will be

0:34 available on your Festimate company dashboard. I'd also like to remind you that this presentation is being recorded. Before we begin, we'd like to submit the following poll. I'd now like to hand over to Tim Watts, CEO of SHIELD THERAPEUTICS PLC. Good afternoon, Tim. Good afternoon, Mark, and thank you very much. And welcome, everybody. Good afternoon. For those who don't know me, I'm Tim Watts. I'm the CEO of SHIELD THERAPEUTICS, the role I've been in since April of this year. Prior to that, I was the CFO of SHIELD since August 2018. Okay. Let me get underway. First of all, the disclaimer. And moving on to the first slide, I'll cover the operational highlights that we mentioned in the RNS that went out this morning.

1:25 The first highlight of the year was that at the start of the year, we signed a license agreement for Ferrocrew, which is our lead product for the treatment of iron deficiency, with a company in China called ASK Farm, covers China, Hong Kong, Macau and Taiwan. Clearly, is the main territory there, and I'll come on to each of these in turn as go we through the presentation. So the second highlight, talking about the net sales of Ferrocrew in Europe. We have a commercialization partner, it's Norgene, who sell the product and we take royalties on those products. And their net sales in Europe, and that's primarily in The UK and Germany at the moment. Again, I'll explain a bit more later.

2:12 For the first six months of this current year, their net sales were 50% up over the second half of last year. The third highlight is that we have reanalyzed the data from the head to head study, that's h two h, which was a study that compared Ferrocru against the leading intravenous therapy. We had to announce in March of this year that there had been some issues with the data analysis of the first time we announced it a year earlier. So we've spent some time in the second quarter and early the third quarter reanalyzing that data. Again, I'll go through this a little bit more, but the headlines are that the reanalyzed data clearly demonstrates that Ferrocru is a credible oral alternative to the intravenous iron therapy and offers economic advantages.

3:07 And lastly, operational and the highlights is that we're making good continued progress to secure a commercialization partner to sell Ferrocrew or Aquifer as the brand name will be in The States in the in The United States. So those are the highlights. Let me now talk a bit more about each of those in in turn. So looking first of all at the China commercialization and and ASK farm. We announced in January of this year that we'd signed an exclusive license with ASK to develop and commercialize Ferrocrew in those territories. We received in January an $11,400,000 upfront. And under the terms of the agreement, when they secure approval for the product to be sold in China, we would do another $11,400,000.

4:01 Furthermore, when they sell, there are 40 up to $40,000,000 that we could receive in sales milestones when they hit sales thresholds. And there will be royalties payable to the to us depending on the level of sales ranging from 10% to 15%. Over the last eight months, ASK Farm have been working with the Chinese regulator known as CDE to define the development program that's required to get the product approved in the in in China. CDE have indicated, verbally at this stage that it may require only a phase three study in inflammatory bowel disease, and that they are unlikely to require a pharmacokinetic study nor they require a phase three study in chronic kidney disease.

4:48 And those studies might have been relevant because those are the studies that we would have conducted in Europe or at least to get the approvals in Europe and The US. But it looks like the authorities won't require all of those. And if that's confirmed, then it could lead to a submission for approval in the first half of twenty twenty two and potentially a launch in the second half of twenty twenty three. And as I said, the approval in 2023, if that's when it comes, would trigger that second $11,400,000 payment. I'm now going to move on to look at Europe and the commercialization there. So as I said a moment ago, the net sales of Ferrocrew by Norgene in Europe for the first six months of this year was 50% up over the second half of last year, and you can see there a chart of the packs sold.

5:39 And we're pleased with that progress, bearing in mind that first half of this year has clearly been heavily influenced by the COVID pandemic. The fact that Nordgene have achieved a 50% growth, you know, we think is a good achievement. At the moment, as I said earlier, the product is primarily sold in The UK and Germany. There are one or two of the smaller markets in in Europe as well, but primarily UK and Germany. For the other major countries in Europe, such as France, Italy, and Spain, you have to submit applications for pricing and reimbursement and and and enter negotiations with the authorities in those countries. And what you need to underpin that those submissions to support your price application is health economic data. Now that health economics data was coming from the head to head data and the clinical study reports that we had initially provided.

6:39 When in March of this year, we realized that there was potential issue with head to head data, the processes of submitting applications in those countries were suspended because there was some doubt about the clinical study report. So we've now redone the analysis and the the updated clinical study report should be available in October 2020, and the pricing reimbursement submissions will will will start again. That unfortunately will delay the launches in those countries, and realistically we're expecting them now from late twenty twenty one onwards. So coming to the head to head study, which I've mentioned.

7:27 The slide essentially repeats what we said in August when we announced the results of the head to head study, the re analysis that we'd done. The study was to compare Ferrocru against the leading intravenous iron therapy, and it was intended primarily for health economics purposes for use in pricing and reimbursement and and so on. It was not a regulatory study. It does not affect the regulatory status of Aquifer or Ferrocrew. There was a key target that we set ourselves of achieving a non inferiority result, which is defined as our primary endpoint, that non inferiority endpoint was was defined as being a percentage of responders. Now responders were individual patients who responded to to treatment, and then we looked at the percentage of patients who were treated with Ferrocru and the percentage of patients who were treated with the intravenous therapy and compared those. So what was a responder? A responder was somebody whose response was, after being given treatment, did they get achieve a two grams per deciliter increase in hemoglobin, or was hemoglobin normalized?

8:46 And for women that's at the 12 grams per deciliter level, and men it's at the 13 grams per deciliter level. So over the first twelve weeks, did individual patients respond according to that definition? And then as I say, we we we measured we we aggregated the numbers and measured the responders. The primary endpoint under the study protocol required both the, there are two populations here. One is the, intention to treat, so that's essentially everybody who goes into the study, but the endpoint as defined in the protocol also required that the so called per protocol, that's the PP population also demonstrated non inferiority. Now per protocol is everybody who not only started the study, but went the whole way through the study in accordance with the design of the study.

9:35 Now unfortunately, the reanalysis of the data showed that we did not achieve the that that responder rate in either the ITT or the per protocol populations. But the secondary endpoints and the fact this was a fifty two week, we continue to study the patients over the fifty two weeks, the secondary endpoints and the health economics analysis, which is typically looked at over a fifty two week period, does remain very positive. And I'll try on the next few slides to explain why I'm saying that. So this first slide shows the hemoglobin concentration, and it's the average change in that concentration from the baseline when the patient started at the start of the study.

10:21 And it looks at the visits at week four, week 12, week 24, 36, and 52 when they they visit the physicians to be checked up. And this is on the intention to treat population. So this is everybody who went into the study, many of whom would not have completed it. So numbers over the over the course of the fifty two weeks fall away, but these are based on the on the averages. And what you see in week four and week twelve is that the blue lines, are the ferric maltol, which is ferrocrew, the average change from baseline is not quite as much in the ferrocrew arm as it is in the intravenous arm, the red the red intravenous arm. But nevertheless, even at week four, you can see there's a sort of one and a quarter grams per deciliter increase, and at week twelve, there's a 2.5 grams compared to a three grams, increase in the intravenous arm.

11:15 So although we weren't able to say that that was non inferior, it's nevertheless a a clinically relevant increase in in hemoglobin. And then if you look at this, the later weeks, 24, 36, and 52, you can see that the average change across the both arms is is comparable. If we look at the next slide, I'll just move it on. This shows the actual average of of hemoglobin concentration in each arm by visit. And here you can see the numbers are much closer at at four weeks and twelve weeks. Ferrocrew was slightly behind the intravenous, but after that, it's it's very comparable. So what you can see really from these this this chart and the previous chart is that, certainly, by the time you get after week twelve, the average change from baseline and the average concentration in the two arms is is very comparable.

12:14 From a health economic point of view though, one thing that you need to, take into account is if you are being treated intravenously, you need to go into a hospital or clinic to be treated. And so the top chart on this slide shows the number of patients who received infusions before their week twelve visit, and the second, the lower slide shows the number of patients receiving infusions following or at and after the week twelve visit. And so you can see here that clearly, if you're in the intravenous arm or if you're in if in out out in the real world, if you're a patient who's going to be treated, intravenously, you are likely to have a significant amount of, inconvenience and disruption by having to go into a hospital or clinic to receive your infusions.

13:02 Potentially, if you're a longer term patient, you're not going to just going to have the two or three infusions that you might see in the first twelve weeks, but you're going to have to go back for further infusions. So if I just go back to the previous slide, what that essentially means is that at the weeks '20 four, '30 six, and fifty two, the the sustaining of the levels of the red bars, the intravenous bars, is being achieved in part by the fact that patients are going back in for redosing, and therefore further cost, both of drug dosing of of the and of the administration costs in the clinic and the hospital, but also inconvenience to the patients and potentially lost wages. So from this data, you can start to build up your health economics argument as to why it's more cost effective potentially to treat patients with oral Ferrocrew rather than the intravenous therapy.

13:59 And what these charts don't capture is that for the intravenous patients, the reason they're going back for more infusions is because they're starting to, their iron is depleting again, they have an initial infusion, the iron levels increase, the hemoglobin levels increase, but then if they've got a chronic iron deficiency problem, over time the iron levels will deplete again, the hemoglobin will run down, they'll start to feel anemic, so they have to go back in for another dose to restore the iron again. So from a health point of view, patients on intravenous may well be feeling well for a while, then they deteriorate, they have their infusion, they start to feel better after a bit, and then and then they go through a cycle.

14:45 Whereas if you are on Ferrocru, you just take two capsules a day, morning and night, you can do that at home, and it just sustains your hemoglobin levels at the level that's optimal.

14:59 So now just to move to The US. Clearly, finding a an appropriate commercialization partner for Aquifer as as Ferrocru is known as in The US is a top priority for us in 2020. And what we're trying to achieve is a combination of optimal financial terms and a partner that can exploit Acrefa across the full range of therapy areas where iron deficiency is prevalent. So we're not just trying to seek the the company that might offer us the the biggest upfront payment or or potentially the highest royalties. We we also need to find a partner that that can actually deliver on that. There's there's no point in taking a big upfront if if the partner then underperforms on the sales line. So we so we've got to get both of these aspects right.

15:48 We've engaged with multiple companies. Many of those have signed confidentiality agreements, and a number of those have gone on to submit non binding offers. And we've obviously got into more detailed discussions with with a number of those as as well. So there's been plenty of activity and there continues to be plenty of activity. And we we continue to be confident that we will achieve a deal in 2020 and so much so that we've recently placed an order on our contract manufacturer for US launch stocks to be packed, and they should be available and released for for use by some by around the end of twenty twenty or or or early twenty twenty one.

16:36 One of the conditions of approval in both Europe and in The US is that we should, do a study in pediatrics. At the moment, Ferrocru and and Aquifer are approved for the treatment of iron deficiency in adults, whether or not they've got anemia. But at the moment it's not approved for children under the age of 19, so up to 18. So both the EMA and the FDA required us to do a pediatric study and in fact The US has asked us to do a study in infants as young as six months. So clearly a capsule formulation, which is the formulation for adults, A capsule formulation isn't going to work for small children.

17:22 So the first thing we've had to do is to develop a liquid formulation, which we have now succeeded in doing. It's been manufactured, released from our manufacturer, and it's been shipped to The USA. The first phase of the study, this pediatric study, is to confirm that the liquid formulation behaves in the same way as the existing capsules. And that's going to be done in an initial stage study, which will be using in The US 32 healthy adult volunteers. Recruitment is starting any day now. And we would expect to complete that study by around the end of twenty twenty, have results early twenty twenty and early in 2021. And assuming that the first phase is successful, then the main study, when we will recruit over 100 children and infants into the study, will start sometime in the first half of twenty twenty one.

18:15 Let's now look at the financial headlines for the first six months of the year. So thanks to the $11,400,000 upfront from ASK Farm in January, our revenues for the first half were $8,900,000.8700000 of that was the upfront and the rest was the royalty income that we get from Norgeen. Because of that revenue line, we saw a profit of CHF 3,100,000 in the first half of the year. The SG and A costs around CHF 4,800,000 do include some one off transaction costs associated with the China deal and also costs that we're incurring related to The US process that's ongoing.

19:04 And you that there's probably about GBP 1,000,000 of such one off type costs in that 4,800,000. The R and D cost of £700,000 is quite low and lower than I expected at the start of the year. And that's really because the pediatric study which we've just covered has started a little bit later than we envisaged. And a key reason for that is that, well, two reasons. One is that the development of the liquid formulation took a bit longer than we anticipated. But also due to the pandemic, the FDA were encouraging companies not to start clinical studies at the height of the pandemic.

19:49 But as I say, we're now comfortable to start that study and it's starting any day now. And so the r and d cost in the second half of the year is is going to be higher than the 700,000 you see for the first half. As a result of that profit, we made a net cash inflow of of 2,000,000. So we're cash positive. And that that means that the overall, the cash went up by well, in fact, slightly more than 2,000,000 because that's the cash from operations. We also had an exchange gain. So the cash went from £4,100,000 up to £6,500,000 at the end of June.

20:32 Looking at the outlook for the second half of the year, we expect the royalties from Norgene for Ferrocrew in The UK and Germany and as I said earlier, a few smaller markets to continue and continue to grow. But unfortunately, launches in France, Italy and Spain, again, I said earlier, are not expected for some time yet, so they're not going to impact on the second half of this year. The second half of SG and A cost base, once you've stripped out those one off costs I referred to a minute ago, we'll continue broadly at the levels we've seen through 2019 and the first half of twenty twenty. And also mentioned a moment ago, the r and d expenditure will accelerate in the second half of the year as the pediatric study gets underway. The cash runway that we have extends well into quarter one twenty twenty one, and that excludes any potential upfronts we might receive, not only that we might receive from a US out licensing deal, but also, and I we touched on this briefly in the r and s this morning.

21:36 We're continuing to have discussions with potential partners in other countries outside The US, outside the Europe and China. And we are hopeful that in the next few months, we may be able to strike one or two more deals with with with modest upfronts that would come in, which would extend the the cash runway somewhat. So just looking ahead to the news flow, and and these items are are going to be fairly obvious from what I've said said to date. So in the sometime later this year, we would expect to be able to announce a deal for Aquifer in The US.

22:15 The p t 20, which I haven't touched on, although it is referred to in the r and s, p t 20 is a product in development. It's a product for for the treatment. It's a it's a phosphate binder, so it mops up surplus phosphate in in the gut. We've got we think we have a very interesting product in p t 20, and the we've not spent any money on it in the last couple of years because we've we've been somewhat cash constrained. But we have got a plan to the first stage of of the next the next piece of work we need to do is a formulation study, formulation development, and we plan to start that as soon as, we have some finance that we that that will allow us to do that. By the end of twenty twenty, as I've said, we will conclude the first stage of the pediatric study, be in a position to confirm that we can go into the into the second and and main stage of that study, which will start in the second in the in the first half of of next year.

23:11 And then sometime early in 2021, we'll we'll be able to provide an update on European sales in the in the second half of this year. So those are are the likely key pieces of news that we we can expect. So just to summarize and conclude, so we've done a license agreement in China and that may only require now a Phase three study in inflammatory bowel disease to get approval. We've seen good sales growth in Germany and The UK, but the other markets aren't likely to come on stream until 2021 or late twenty twenty one. We've completed the re analysis of the head to head study and that confirms that Ferrocru is a credible oral alternative to IV therapy and that we get good health economic data from that.

23:58 We continue to make good progress to secure a commercialization partner, and we've ordered the packs for delivery by the end of this year, which would allow us to launch in the first half of twenty twenty one. The cash extends into the first quarter of twenty twenty one, though, as I said, that excludes any upfronts that we might get from any licensed deals. And from a valuation perspective, I believe the significant upside potential, I believe the market is waiting for confirmation that we've got a route to commercialization in The US. So with that, I will conclude and open for questioning. Thank you very much indeed, Tim, for the presentation. 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. But just while Tim takes a few moments, I guess, to review investor questions submitted today, I'd like to remind you that recording of this presentation, along with a copy of the slides and the published Q and A, can be accessed via your Investor Meet company dashboard.

25:00 I'd 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 feedback in order that the company can better understand your views and expectations. Tim, obviously, you can see the Q and A tab, it is pretty full. But I guess before I ask you to perhaps draw your attention to that, could I possibly preaddress these presubmitted questions?

25:28 There's only four for investors on the call. The first question is, will Aquifer be on the shelves in The US for sand in 2020? The short answer is no. As I've just been explaining, we've got an order for material, for product, which should be released at the end of twenty twenty. It would be available for sale in 2021. Thank you very much. Are you satisfied on the progress of Norgene to expand sales of FerroQ throughout Europe as well as the current level of sales generated? I think they've done a good job in the first half of twenty twenty given the COVID situation. I think it's and this is as much, if you like, a hiatus caused by ourselves and the issue with the head to head study.

26:18 They have had their had their hands tied by the setback we had with the head to head data and the the doubt that cast on the clinical study report, which which was a key document to underpin their pricing reimbursement. So I think, as I say, the expansion of sales into other countries of of Europe has somewhat been knocked off course by that issue. Thank you very much. Can you outline the caliber of U. S. Partners that SHIELD is engaging in negotiations with? And and how they envision PHERAPEUTICUE and ACUEUR being rolled out? We've we've talked to a wide range of companies in The US ranging from quite big companies down to some some very small companies.

27:11 And so, you know, and and, you know, clearly that generally speaking, you would expect big companies to to to be very, very professional. But, actually, we found that that a lot of the small companies we we've talked to are also in incredibly professional. And very often, they are staffed by people who have got big company experience and are bringing bringing all the experience they've got and the professionalism which they developed in their in their big company experience into a small company environment. So, you know, generally speaking, we've been very encouraged by the the caliber of US partners that we've seen. How they envisage the product being rolled out does depend a bit from company to company and what is their area of specialization.

28:01 Iron deficiency crops up across a wide range of therapy areas. So, know, we've been talking to companies who specialize in in area one or to therapy area two. And and in naturally, if a company is specialized in one area, it's it's likely to launch the product there, and then it may broaden the product out over time into other therapy areas, or it may say, look, I'm going to go and look for partners in The US who could help me in these therapy areas that I'm not an expert in. And then it's that it's that diversity of of and and range of types of companies and so on, which is one reason why we haven't struck a deal perhaps quite as quickly as some some people might have expected. Thank you very much. And finally, the last question, it's a bit long, so bear with me. In retrospect, was it a mistake to aim for HB non inferiority to IV iron as the primary endpoint?

28:58 This seems to this seems like an extremely high bar to clear and muddied the, water a bit. FAIRACUE does an excellent job at ensuring satisfactory hemoglobin levels with better quality of life and safety than IV. This would seem to be more important from a clinical and patient welfare welfare perspective than simply comparing which product achieves the highest absolute HP levels. Yes. I understand the sort of the the the gist of the question. It's difficult for me to comment even with retrospect on, you know, precisely what the thinking was back in around 2015 when this study was originally designed. But I do think there's a case for saying that the primary endpoint of non inferiority at the twelve week point was not really the be all and end all of the study.

29:50 And and actually, it's not we found it isn't being treated as the be all and end all by by nor gene, and nor is it when we've we've obviously shared this data, with, those, potential US partners who signed confidentiality agreements. And by and large, they're not focused on that twelve week point either. So I think in the end, it it's created perhaps a slightly unfortunate headline for us in that we we've had to say it we didn't achieve the primary endpoint of non inferiority at twelve weeks. But when you actually look at the at the depth of the data, and I've tried to show, you know, just the the high level data in in the earlier slides, I think it it the study has demonstrated that Ferrocru restores hemoglobin, and it maintains hemoglobin on two capsules a day without having to go back into hospitals.

30:42 And and and so I think the time has come when raking over now what happened in the past probably doesn't get us any further. We now need to make the most of the very positive data that we have got out of That's very, very kind of you. Thank you, Tim. Well, that concludes the pre submitted questions, which I guess leaves us now to deal with the questions that have come in during the live event. So if I could just draw your attention to the Q and A tab. I guess if you start at the top, and there's a scroll bar on the right hand side. Obviously, no investor has been able to see another investor's question. So it would be particularly useful and grateful if you wouldn't mind reading out the question, even who it's from, and then perhaps, where appropriate, to give your response.

31:30 Okay. The first question is about is is what measurable steps are we taking to conserve and maximize cash and avoid raising capital by a discounted share issue, which would dilute existing shareholders. At the moment, because we are confident about securing a deal and also that we have other smaller when I say securing a US deal, should say, and because we have other smaller potential deals in the pipeline, I am not expecting and not we're not even thinking about raising capital by raising equity discounted or otherwise. And, you know, I I don't believe that that's that's a likely outcome. So if I move to the next question, the Vitra pharmaceutical payment and asset purchase agreement was a surprise. Why?

32:25 Well, the asset purchase agreement, you know, we I've certainly it's been talked about before. It's I think we've referenced it in our annual reports. It's it it was in the IPO admission document, so it shouldn't be a surprise. What perhaps is a surprise is that under the terms of the asset purchase agreement, Vitra was the original owner of the intellectual property that underpinned the development of Ferrocrew, and the the company back in 2010 struck a deal with VITRA to acquire the intellectual property. Under the terms of that deal, if SHIELD sells Ferrocrew itself, then VITRA is entitled to a 5% royalty on all on all sales.

33:19 If sorry. In all sales, whilst their patents, whilst their patents are in existence and and and are still valid. If, SHIELD licenses the ferrocrew to a third party as it has done for Norgene and as it has done to ASK farm in China, then Feature has a choice. It can either take the 5% of net sales as a royalty, whilst the patents are in place, or it can elect to have 10% of any upfront and 10% of any, future sales milestones. Not but but if it takes that choice, it doesn't get a 5% royalty. So, obviously, our strategy commercialization strategy is to license out license the product.

34:08 When we signed the Norgene agreement, we showed it or we we we we showed the pieces of it that we're allowed to show to to Vitra. And they said, okay. On that deal, we will take the 5% royalty. So on the Norgene

34:24 deal or on European sales, Vitra received from us a 5% royalty, which we put through the cost of cost of goods line. When we came to the China deal earlier this year, Vitra said, actually, on this occasion, we would like to take the 10% of the upfront payment, which is what they've done and what we've paid them. And as a consequence, they will not receive a 5% royalty on sales that are made in China. So that's that's what that's about. It's they've made a a different choice for China as they they did for for the Nordgene agreements, and and and that's fine. And at and at this stage, we we don't well, they are obviously not inside. Once we've done a US deal, we'll explain it to them, and they will have the opportunity to make their choice again for that for that deal.

35:21 There's a question here. It's it's again perhaps about the cash flow. What makes what makes us sorry. In the going concern section of the of the results, you said that we we should be able to raise money if required by debt or royalty finance. What makes you certain that this is achievable? I guess I'm not completely certain, and so there is always a a bit of doubt, But, I am approached on a very regular and quite frequent basis by, specialist, finance houses, who, would off would offer debt, or or royalty. And I've I've I've got experience of raising debt in the past, and I absolutely believe that that would be possible if if we if we had to. But it's not it's not something we're planning on doing. As I say, we are planning to finance the company

36:09 through through licensing upfront. There's a question here. SHIELD repaid some of an upfront payment to Norgeen. Given the latest demonstration data of Ferrocrew, there any likelihood of recovering some of the repayment from Norgeen? Unfortunately, answer to that is no. The criteria in the agreement we have with Norgeene is very clear that the payment that we originally received from them in 2019 was only due if the primary endpoint of the head to head study was met. The primary endpoint, as we ultimately discovered, was not met. We had to achieve non inferiority in both the intention to treat arm and the per protocol arm, and we didn't do. So, even though the data is good and even though Norgene are using the data, unfortunately, under the terms of the agreement, there is no prospect of of get clawing any of that money back from Norgene.

37:14 There's a question about again, another question about Norgeen that the progress is slow for growing sales. Are there any guaranteed minimum payments to be received? The answer to that is no. How confident is the board in repelling the Teva IP appeal? And are there any costs associated with well, there are there are costs that are that they're not they're not they're not too excessive. I'd I'd say at the moment, we are reasonably confident, but we obviously, we again, we can't we can't guarantee that that we will win. But we we we think we've got good arguments to defend our our our patents against the Teva challenges.

38:11 Is the pediatric study going to cause any more delays? No. I don't think so. As I say, I think the the the FDA wasn't keen on companies starting clinical studies during the the first half of the year because of COVID, and we also had to develop the formulation as I described earlier on. That's that's now done, and it's it's underway. Overall, if I take the entire cost of the pediatric study, which could which includes not just the first p stage that we're going through this year, but but the, the main study, which will then go on for probably through 2021, 2022, it's probably going to cost us in the region of 5 to £6,000,000, over that, two and a half, three year time period. Question here. What is the strategy for ensuring the widest possible access to Ferrocru for patients who need it?

39:10 Is are SHIELD considering a middle income and developing nation strategy with region appropriate pricing? What we're doing is looking for licensed partners in in all parts of the world. We are a small company. We can't do too many at once. So but but we do have expressions of interest from Latin America, from Sub Saharan Africa, from India, from parts of the Far East and The Middle East. So clearly, there's many range of of countries and and nations there. And the pricing strategy would be decided by the licensed partners that we choose in those in those countries. Do the nonbinding offers from The US exceed the value of the China deal?

40:03 I'm I'm obviously not gonna give much detail on that, but bear in mind that the China deal was for a product which was not approved and requires ASK farm to do further development work. So inevitably, the $11,400,000 upfront was probably lower than you would expect to get for a product that is ready to launch. And therefore, I think you can deduce from that that we would expect to get a higher upfront from in The US where the product is ready to launch. Question. Since you're looking for one company to cover all the different indications, is the partner likely to be a large pharma?

40:55 I think what we're doing is looking for one company who can effectively, who may be able to cover all the indications, but more likely is a is a company that can take the lead in making sure there is a consistent brand and consistent pricing, but who may in turn seek to either find partners, themselves in The US who could co promote or potentially sublicense the product too. So we're not necessarily looking for a large, company which covers all the all the indications. It's quite quite possible to select a smaller company who covers maybe one, two, three indications who could then partner, in in in The US themselves? Sorry, I'm just reading down.

41:49 Take your time, Tim. Obviously, there's number of questions that come in and, of course, you've got to read it. So I guess I just will remind investors that, obviously, with a number of questions that have been pre set. So there's one here, if we were on the other side negotiating with SHIELD, the fact that SHIELD's cash runway only lasts until quarter one must mean they think they've got a good chance of getting a deal and I guess putting pressure on us. But we haven't seen any of that. Absolutely not seen any of that. And as I say, we are fairly confident that we could get debt on board if we needed to, and and therefore push back on any participant who was trying to to gain it that way. The other thing, of course, is by having more than one partner in play, they can't assume that if if they play games that that any of their competitors to license the product would do the same thing. They might lose out that way.

42:55 This question here, has SHIELD considered the Indian market as that could be a huge one after China? Yes, we have had some approaches from India. I'm not going to then predict when we might be able to strike a deal there. Is Ferrocrew available off the shelf, or is it prescription only? It's it's a prescription it's a prescription only, product. Question and I guess this is asking the question from the perspective of of a of a physician. Why not consider intravenous for rapid impact within four weeks followed by ferrocrew from week four to fifty two?

43:45 I mean, I'm not I'm not a doctor, but you know, I guess that is a strategy that some doctors could could could follow. That said, and although we've not been able to establish non inferiority, you know, we think the data that we've seen, not just from the head to head study, but it's absolutely consistent with the data that we saw in our own IBD, inflammatory bowel disease, and chronic kidney disease studies. The the the increase in hemoglobin at four weeks, at eight weeks, at twelve weeks is is pretty good even with Ferrocru, even if it's not necessarily quite as fast as as intravenous. And, course, with Ferrocru, you haven't got the inconvenience of of having to go and and go to a clinic or a hospital to be to be in to receive the infusion.

44:40 Can you please give some indication of the size of the market for the product? I'll assume that that's a question about The US market. What what we know is that the The US market is for iron deficiency products at the moment, oral and intravenous, is something in the region of a couple of billion dollars. Probably about half of that is intravenous or and and and the rest in in a whole range of of oral products. Sorry. There are a lot of questions here. If there are any placings required, please can you consider existing retail investors?

45:31 Well, as as I said, I'm not at the moment. I don't believe that we're we're gonna be considering we've we've got no no thoughts at the moment of doing a placing. That's brilliant, Tim. I think I think Yeah. There are there's a lot here, and I'm afraid I haven't been able to get to everything. No problem at all. We'll we'll we'll make all of these available, and I guess we can put up responses where it's appropriate to do so. We'll And publish that back to investors unless there's any other that you feel that stand out. No. I'm just trying to scroll up and down. What there's a question here. What is causing the delay in signing The US deal? There's nothing there's nothing there's no one re if we we are obviously trying to get get to the right deal.

46:26 I mean, one of the things that we found is that companies' engagement, if you like, can come and go somewhat. You know, they they every company obviously, and SHIELD is no exception, has its own all sorts of things going on in the business and and, you know, then some sometimes you can find that there are distractions, which mean companies go quiet for a while. And and and also one of the things we have been trying to do is to make sure we've got as many companies in play as possible. And, you know, when you've got companies who all have their own internal dynamics and and issues going on and maybe somebody's doing an acquisition or that somebody's got a clinical study about to report or whatever, Everybody's moving at different paces and and, you know, one of the things we've been trying to do, bring as many along together. And it's a bit like been a bit like herding herding cats. So it's, you know, it's it's it's a shame we've not yet been able to do it, but, you know, we we've still got we've we've we're still in in good shape, I think.

47:45 Does it increase the likelihood of a takeover of SHIELD by having the fact we haven't done a deal? I don't see why that a takeover is more or less likely now than than than it was a year ago. So and, obviously, if we'd been approached, then, you know, and if we'd been approached with a with a credible offer, it's something we would be required to, announce and and, deal with publicly. I think that probably covers it. Thank you very much, Tim. Thank you. And as I mentioned, obviously, we can review anything else that you feel appropriate post this meeting.

48:32 Perhaps, Tim, I could just ask you to wrap up, then I know feedback is important, and then I will redivide back to investors to provide feedback. Okay. So now I would just conclude by saying, you know, we remain very confident about commercializing the product in The US. I remain confident that over time, Europe will become a big market. China, I think, is extremely exciting. So there are some really big opportunities here. We have a patent going out to 2035. So we've got the company has many, many years to drive value from from ferrocrew and aquifer. And I don't think I think at the moment, the markets and I and I'm not surprised, and I don't blame the market, but I think the moment that the market is waiting for effectively the confirmation of a US deal. And I'm I'm sure that although the potential is there and people understand the potential, it will be the confirmation that there is a path to commercialization in The US, which I think will will trigger a fairly significant rerating.

49:43 So I think from an investment thesis, I think that's what I would major on. Tim, thank you very, very much indeed. And thank you for updating investors today as part of your investor roadshow. Could I please ask investors not to close the session as you'll now be automatically redirected for the opportunity to provide your feedback? If you access this meeting from our website, the feedback page will appear. If you access this via the link sent you by email, you'll be asked to log in to submit your feedback, and we very much encourage you to do that where it is possible. So on behalf of Tim Watts, CEO of SHIELD THERAPEUTICS and Investor Meat Company, we'd like to thank you for attending today's presentation. That concludes the session.