Theracryf (LSE:TCF) — Interim Results 2022-23

0:00 Good afternoon, and welcome to the Evgen Pharma PLC interim results investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time by the q and a tab situated in the right hand corner of your screen. Just simply type in your questions and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company will review your questions submitted today and publish responses where it's appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Hugh Jones, CEO. Good afternoon, sir.

0:32 Good afternoon. Hello, everybody, and thanks for attending our half year report to the end of September of twenty twenty two. It's been an interesting time. We've been in planning mode and moving to execution mode, particularly in the post period. As you know, Evgen Pharma PLC is a public company and the usual disclaimer applies And to remind you of who and what we are, we're developing a new class of pharmaceuticals based on some foraphane. We've got a lot of data in the public domain about the active moiety. Unfortunately, it can't be used in a druggable sense apart from in our technology. We've got a number of target diseases in cancer and inflammation that are of great interest to us and some recent business development activities.

1:22 The platform is covered by an extensive family of intellectual property. And we've been all of us in various other guises has been doing this for many decades, each as management and board. Over the last few years, we've done two collaborations, which are cash generative. The first one a couple of years ago was with Juvenescence, where we licensed the Sulfuridex technology for nutraceutical uses outside of the pharmaceutical world. And very recently, post this period actually, we did a major out licensing transaction with a Swiss company called Stellicke in neurodevelopmental disorders and schizophrenia. We'll cover in more detail our cash position as we go through this presentation.

2:09 The pipeline that you now see shows us in collaboration with the University of Manchester and the Christie Hospital in breast cancer, we're encouraged continually by that collaboration. A new, chevron on our pipeline chart is our Stellicular collaboration in neurodevelopmental diseases starting with autism spectrum disorder. Our internal program continues in glioblastoma, one of the more fatal of the brain cancers. Glioblastoma, late stage has a very low five year survival rate of about five percent. We're looking at a number of other cancers besides through academic collaborations, mainly, and we have rights to a bunch of analogues of sulforaphane, which may or may not be of use in individual diseases once we see some differentiation between them.

3:03 So what's what's new in the period? Well, we've substantially scaled up our manufacturing activity for our own clinical trials and are increasingly for use by Stellicla, our new collaborator. Not only have we made active ingredient in a new, more efficient way, but we've got a new tablet, which is enteric coated that is designed to pass the acid of the stomach and be released in the more appropriate area of the small bowel. We've extended our collaboration in breast cancer preclinically with the University of Manchester, and we've announced two new academic collaborations in the period, and that is with the Universidad Sapienza in Rome, which really looks at how SFXO one makes radiation more effective in combination, or even perhaps where radiation resistance has begun to develop, actually brings that back and makes radiation effective once more. That's the promise of that collaboration.

4:09 And a further collaboration in The US, this time with University of Michigan, in an area we haven't explored in that much detail for SFX01 and that's a bowel cancer or colorectal cancer. So a good deal of activity or planning or preparation in the period and a couple of more interesting academic collaborations commenced. In the post period, well, you know, we we did one of these webinars quite recently giving you a pretty high level of detail on the Stellickla transaction. It's a total number of milestones of a $160,500,000 with a double digit royalty in all scenarios. I'm pleased to say that collaboration has started in earnest. Our first milestone payment is in, and we've given guidance that we expect another $5,500,000 worth of milestone payments subject to our joint working together before the end of twenty twenty three.

5:04 And we've made some real steps forward with the regulatory authorities too, both in The UK with a very rapid approval of our healthy volunteer study, and indeed with The Netherlands authority, where we're going to start our brain cancer GBM study, where we've got a very positive scientific advice from them. And as we announced back in October, the way we're approaching glioblastoma now is via an investigator sponsored study with the Erasmus University in Rotterdam, and those activities have started in earnest too. To to the healthy volunteer study, we've, dosed our first group of volunteers. There are no showstoppers there at all. It's entirely predictable where we are. We've collected the samples and we're currently busy analyzing them. The second group of volunteers at the next dose up is due to be dosed imminently.

6:01 And the other piece of news is the academic collaboration with La Sapiens Eye in Rome, I mentioned in the last slide. Well, that's showing early emerging data of a positive interaction as we've seen in some other cancers between radiation and SFX one. So this is a rare group of cancers called rhabdomyosarcoma. It's a connective tissue cancer mainly, quite rare. But the important message there is that we've got

6:31 the beginnings of an enhancement of the effect of radiation in the presence of SFXO one or even the return of radiation being effective in the presence of SFXO one. So we're excited by that collaboration and it's still ongoing. With regard to the financials, and we've got a question here as well, so we can deal with both of these in a single slide. I'll hand over to Richard to deal with our cash position. Somebody's asked us to comment a little bit further with regard to the cash runway to the end of twenty twenty four. So Richard, over to you. Okay. I just wonder, can we try and make this full because my hopeless website, my hopeless eyesight is Let's just do a bit of IT then.

7:18 That's a lot easier. A lot easier for me. Thank you. So I have a prescription minus 15. That's why I was struggling to see. Thank you. So the the post tax loss for the period was 2,100,000 against 1.5 in the equivalent period, and that's essentially higher because we've been doing more work in the clinic, and we've been scaling up our manufacturing production. The cash flow, the cash outflow was 1.9. Again, it's 1.5 before the last last equivalent period. And, again, that reflects the investment in, you know, clinical trials and manufacturing as well. So the cash and this is probably one of the of the biggest numbers that you'll be interested in. The cash was 7,200,000.

8:07 So in in other words, around 3,000,000 has been spent since the equipment time in September 21. And what that means is that we have a cash run bay runway, which will take us into the back end of q four twenty twenty four. Now there's a question which said, what what do I mean by cash runway? What that means is that will be sufficient funds to to enable us to execute all the programs we have going at the moment, which will be completed by the end of twenty twenty four and allows us to fund the ongoing costs of running a biotech business, which includes things like IP, listing costs, people, premises, all of those things. So it effectively means we're fully funded to do to continue our strategic objectives to the end of twenty twenty four, and we don't need any further funding to support those programs and and those those plans.

9:08 We did get our r and d tax credit in during September, so that's reflected in the cash balance. And that was the fastest HMRC that provided to her active for us, so that's that's encouraging. I think next slide then, please. So looking forward, we expect to get the results from the human volunteer study that was referred to by Hugh by the middle of next year, just before the middle of next year. And that will hopefully show not only that the drug is interacting with the body, but that it's hitting specific molecular targets that are important to both our cancer programs and the neurology program we have with Stellicla.

10:00 But we are we've already started work on preparing for the IND submission that Stellicla will will make during the course of next year. That's quite a major process because the FDA are are extremely have a much higher requirement for information than European regulators as a rule. But with the with the following wind, we should get that IND approved by the FDA before the end of next year, which is which well, firstly, generate it it it means that a $5,000,000 milestone is met, and that will be very that will help us with our cash position, obviously. But it's also recognized that your first IND is in the in the industry is recognized as a major step forward. It demonstrates competence in the way you've been developing drugs.

10:50 And if you pass the scrutiny of FDA, it's a big tick in the box and will be recognized as such by potential partners. We will continue to work on our glioblastoma study. There's preclinical work that will commence quite soon, and we're looking forward to preparing for the the clinical trial that is going to be managed by our investigators rather than us during the course of next year that will commence. And and that is that is based on feedback we got from, some key opinion leaders on a global basis who who advised us that we should do an additional bit of clinical work before we went into the programs that we'd planned in order to derisk it and provide confidence that the drug was going to get into the brain and again, interact with the molecules that we're interested in.

11:52 So the news flow really stems from the points that I've just made. We look to get data from all of our preclinical collaborations during the course of the year. We very much hope that we will get data that is positive from our human volunteer study. That'll be middle of the year. We'll be progressing the glioblastoma study in that, and we will report on that over the course of the year, preclinical data that comes out of that. And if we get the IND submission agreed by the FDA and the Hb study comes out as we hope, then that's another $5,500,000 that we will receive from our partner.

12:38 So that that in essence is is what we'll be working on during the course of next year. And I think that is Yeah. A quick cast of characters here, which you've seen many times. The team is stable and very productive. It's a small team, but we're all working very hard. There are a couple of other key people in the office, not reflected on this slide, that are working very hard both on our internal programs and indeed our external collaborations. So that concludes the formal part of the presentation. Thank you, Richard. If I may just come in and say thank you very much for that. Ladies and gentlemen, please do continue to submit your questions just by using the q and a tab, which is situated on the top right hand corner of your screen. But just while the company take a few minutes to review the questions submitted today, I'd like to remind you that a recording of this presentation along with a copy of the slides and the published q and a can be accessed via your investor dashboard.

13:36 As you can see, we've received a few questions throughout today's presentation. And if I could just ask you to read those and provide responses where it's appropriate to do so, I'll pick up from you both at the end. Okay. So first question then is, really about how much comfort we have on the out licensing deal or deals actually. In fairness, there are two. And the milestones delivering on time and what time frame we're working to. So there's two parts to that question. When you do a contract like this that's legally binding, you make sure that, you know, at least from sitting where you are today, you can readily deliver the milestones that are contractually determined. And we're confident of that actually. We work very hard with our new partner in defining a plan that is achievable in essence. So achievable for us, achievable for them, and therefore with that achievability comes the payments that are contractually governed. So a pretty high level of comfort today, and the two next big steps were covered in the presentation, and to remind you, are delivering our healthy volunteer data both to our internal programs and to our new collaborators, Stellickler, and we've said guidance in this presentation is first half of next year.

14:50 We're on track. We've dosed the first group of volunteers on schedule. Samples are where they need to be being analyzed. The next group of volunteers are also on schedule to be dosed before Christmas. So we are entirely on track for delivering the next piece of data, and the activity after that during 2023 in parallel largely is preparing our bit of the IND investigational new drug application for the US FDA with our new partner preparing their bits and bringing those things together. We're working closely with them in order to submit for the IND and without too much luck required, to be honest with you, get the IND by the end of next year and the 5,000,000 that accompanies it. So that pretty good pretty good level of confidence there in the plan that drives to the milestones.

15:40 We're also working very closely with Juvenescence with the nutraceutical rights, and we speak to them pretty frequently to making sure that they're on track with their very different nutraceutical naturally derived product.

15:57 So what there's a question here about what do we need to accelerate our growth? Is it capital, people or partners? I think right now we are more than adequately staffed, so people we've got enough. Remember, we're a virtual company, so we've got a very core team of six. We're in a hub and spoke model where we then did, you know, work with a large group of consultants, collaborators, contract manufacturers, contract research people to deliver the data that we need. It's a good model, it's flexible. So we are flexible, we're agile, and this is a very capital efficient model as well. We don't have enormous labs or factories to have to fund overhead on. We only buy the service when we need it. So capital, well, with regard to capital, Richard's made it clear we've got more than adequate capital to deliver that this plan through to 2024.

16:53 And that's actually, I should remind you, is before the 5,000,000 milestone from our new partner. We're not reliant on that. The capital base today is enough to take us beyond, you know, 2023 into the end of twenty twenty four. So I think it it's worth saying in terms of acceleration growth, would we need to raise money to do that, providing we get the the milestones that we've discussed from Solitla and there's potentially another $1,500,000 from our partner, Juvenescence, which we might see in 2024, then we have a good amount of capital, which isn't allocated, that would enable us to take products into later stage clinical trials than we're currently planning or other areas where we think there's strategic benefit in using that funding.

17:46 But certainly, we do have a cash reserve, if you like, to enhance our growth. Great. So we've got a couple of questions on the brain cancer or GBM trial. Really around, is it possible to get a partner now before we produce any clinical data or partner later? And I think the general rule in our industry is there's an inflection point around clinical data and we'd rather, because it's worth more to us, wait until our investigator sponsored study is generating data before concluding a partnership. Now that said, the business of doing deals, as we saw with our new partners, the business of doing deals between biotech and biotech or between biotech and pharma is a pretty long courtship, to be honest with you. And that courtship is ongoing. We are reaching out in partnering conferences. We we did a little recording from the BIO convention in San Diego in the summer. We are going to the JPMorgan Healthcare Conference in California early in January.

18:51 This this partnering activity isn't a do you want to buy it okay then. It's actually do you know us? Do you trust us? Do you understand what our plan is? Do you like our plan? And when our plan delivers, that's the time to conclude a transaction. And that's exactly the process that we're going through. So yes, partnership is possible. It's less likely before clinical data than after clinical data, but we're talking all the time to a large number of interested companies and we're still looking for new potential partners, through our business development outreach. So that hopefully covers the two. And the other one is our directors still unable to buy shares. Yeah. I'll say what I said before and I'll say it again. We are still unable to buy shares. Our advice is that we can't, we'd like to again, but our advice remains that we're still unable to buy shares because of other things that may well be material in the business.

19:51 So I think I think that covers brain cancer, we've covered share purchasing, but do still give us the questions. And our academic collaborations, thank you. So new academic collaborations. So the Italian collaboration that's just started to give data out, and that's with professor Marampon in the University La Sapienza in Rome. We've had pretty frequent updates with them. What that emerging data is telling us is that our hypothesis is looking more and more strong, and that is the presence of SFXO one when you put radiation into a cell makes that radiation either more powerful, and we don't know what that means in the clinic, it could mean you could get away with a lower dose of radiation, which makes patients pretty sick, or get more out of the same dose of radiation in the presence of SFXO1.

20:49 There's a third hypothesis, as yet unproven, that we're testing, and that is can you reverse this development of resistance? Every cancer develops resistance. They're very agile things, our tumours, in getting around whatever treatment, be it chemical or radiological, that you give them. And can we then restore the sensitivity of cancers to radiation where that's started to be lost. That's a really interesting piece of work that we're doing with Glass Sapienza in continuing that collaboration. And it it might worth saying to you that the implications of this work of it that if if the hypothesis stacks up, then potentially SFXO1 is relevant in any cancer where radiation is a significant part of the treatment pathway.

21:40 It it wouldn't be limited to cancers where we are ourselves looking at or even which our other researchers are looking at. So it could have potentially broad application. It's very early, but it's quite exciting in that way. And it makes us ask new questions, both of the preclinical effort and indeed of clinical effort. To remind you, when you're first diagnosed with a stage four glioma or glioblastoma, the first two steps are surgery pretty quickly once symptoms have been identified and the brain scan has been done and the neuro oncologist has found a tumor, first thing to do is to cut it out if it's accessible. And very soon after that, to expose that tumor site to a beam of radiation to stop it coming back or at least to slow it from coming back.

22:31 So our interest there is what does SFXO one do in that context? You know, do we give people a longer period of progression free survival after the radiation? We don't know yet and that's the question we're asking and starting to ask with our investigator sponsored study. Can we show evidence of the drug getting into the tumor? Can we show evidence of the drug interacting with molecular targets in the tumor that are relevant? We've got a lot of test tube work which says when the drug is there, it makes radiation more powerful. We're excited about that question. The other academic collaboration, just for completeness on this question, is with the University of Michigan. The the models that you build for bowel cancer take a lot longer than popping some cells from a rare cancer into a test tube and shining a beam beam of radiation at them. So these are much longer term experiments.

23:26 So we'd expect a later readout of data there from Michigan than we're beginning to see from La Sapienza in Rome. So watch this space for that one. We're confident. There's an interesting hypothesis being explored there too in gut cancers, particularly colorectal. But that's going to take a bit longer because the experiments, quite frankly, just take longer to do. It's worth saying, this is a a very distinguished group in Michigan who who approached us because they wanted to see how sulforaphane might act in specific models. And and we we are basically a go to a go to company to get clinical grade sulforaphane to enable them to conduct experiments in a controlled way. So that's that's encouraging to us, we'll we'll see what comes out.

24:16 Yeah. We're the only people, in fact, you can you can get clinical grade material from that is stable and approved by regulatory authorities, particularly in Europe, for use in patients. So, you know, that's that's our USP essentially. If you want the activity that sulforaphane offers, you have to come to us. And we get a lot of incoming requests on that that subject. And some of them may not be appropriate for us to supply drug. Some of them, as as in the two we've announced in this period, is, you know, a good idea for us to supply drug, and we're doing that and working closely with those academics, just exploring those hypotheses. We've got a question on bad cholesterol. Yes. The sulforaphane has, as you say, sir, been shown to lower LDL cholesterol in in the lab and in in animals.

25:08 So we've taken a look at this market and concluded it's probably not something we could attack as a small biotech company. That's the honest answer. The starting mark, I've worked in the cardiovascular field, that the starting market is vast and largely generic. Is so there are two access problems there. Access problem number one is it's dominated by very large companies with very deep pockets. And the studies you have to show with cholesterol lowering in order to get an approval, involve mortality endpoints. So you're talking a minimum of 5,000 patients, usually up to 15 or 20,000 patients on drug versus standard of care, which might be a statin on one of the other three or four other treatments available to lower cholesterol.

25:55 So they're enormous multi $100,000,000 studies. That was part one. Part two is, the statin market is now generic, and that means pricing is very low, so much harder to get a collaboration going in a market that's generic. It's unfortunate in our industry that it works that way, but where there's less money in the market per pill, then there's less interest in the market for collaborating. That's just a truth of, you know, the pattern driven world that we live in. So, yes, we we know of the data, thanks for bringing it again to our attention. We've concluded for largely commercial reasons and reasons of scale, that it's not something we can hit.

26:41 And because of the genericization of that market, then even atorvastatin, the largest statin ever, one of the largest ever drugs by sales in the world when it was on brand, is not generic and is worth a fraction of a tenth of what it was at peak sales. And that makes it a disincentive for people to collaborate. Even if, you know, sulforaphane may well have a a novel effect there, the market is crowded and genericized, unfortunately. You Richard, thank you very much for that. I think you've actually addressed those questions you can from investors. And, of course, the company will review all the questions submitted today, and we'll publish those responses on the investor meet company platform. But just before redirecting investors to provide you with their feedback, which one is particularly important to you both, Hugh, could I just ask you for a few closing comments?

27:31 Sure. So, a very interesting, period for us, and an even more interesting post period ironically. So a lot of planning and execution going in in the period and some of the fruits of those labors coming good in the post period. We feel we're in a good place with Evgen currently. We've got great collaborators in preclinical and academic circles and great partners that will generate non dilutive funds into the company to continue executing on the power of sulforaphane. We've got a cash runway that we extended during the period from end twenty three to end twenty twenty four before any payments on the non dilutive deals we've got. So overall, I commend, you know, this report to you as a positive period for Evgen and with much more interesting and exciting things to come.

28:23 Thanks very much. Thank you. Thank Richard. Thanks once again for updating investors today. Could I please ask investors not to close the session as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few minutes to complete, but I'm sure we'll be greatly valued by the company. On behalf of the management team of Edge FGEM Pharma PLC, we'd like to thank you for attending today's presentation, and good afternoon to you all.