Theracryf (LSE:TCF) — Post AGM Presentation

0:01 Good afternoon, and welcome to the FGen Pharma PLC post AGM presentation. Throughout this recorded presentation, attendees are being in listen only mode. Questions are encouraged, can be submitted at any time via the q and a tab situated on the right hand corner of your screen. Simply click q and a, scroll to the bottom, type your question, and press send. Company may not be in a position to answer every question submitted today. However, all questions will be reviewed and responses published on the investment company platform where appropriate to do so. I'd now like to hand you over to Richard Moulson, CFO and doctor Hugh Jones, CEO. Good afternoon.

0:30 Good afternoon, Paul, and hello everybody from our head office here in Alderley Park in Cheshire. We're gonna bring you up to date on our mission to really harness the power of sulforaphane, a very biologically active agent. And And we'll start with the usual disclaimer. As everybody knows, we're a public company, so the normal rules apply. And to remind you what we are and what we do, we are a clinical stage drug development company. We focus on a number of cancers that you can see on screen, and three molecular targets of great interest to us are highly relevant in differing proportions to those cancers. So we're developing really a new class of pharmaceuticals based, as I said, on a massively biological agent which originated in nature, but now that we make fully synthetic as the only clinical grade drug of this sort in the world.

1:21 It's applicable in a number of therapeutic areas based on these three targets of interest. You can see there, staff three, n r f two, and ship two. Do ask us more about those should you wish to during this webinar. There's a lot of published data here both by ourselves and by third parties, preclinical and clinical data that helps us derisk what we do. And we've got four cut target diseases in cancer and inflammation, and I'll elaborate a bit about those shortly. The thing that's unique about s f x o one, our lead asset, is Sulfuridex. That's our unique platform technology that stabilizes something that's normally highly unstable and requires storage at minus 20 degrees c. Now with the Sulfuridex stabilization technology, we can store our tablets in the fridge.

2:08 Bit more about that later. We've got IP covering this this technology, and it's strong and much of it is granted covering the composition, the methods of manufacturing, and also some IP on other derivatives of sulforaphane where the chemical structure has been modified. We've got a very highly experienced board and management. Many of us have been in this industry for two to three decades each. And our business model harnessing all of this technology is to really get to proof of concept, whatever that means, partner. And because of that multiple partnering opportunities, we've got a lot of shots at goal in the shape of inflection points. The next point, well, we'll elaborate on this a bit later, but we've currently got £9,000,000 in cash as of the thirty first of of March this year, which is the close of our last peer reporting period.

3:00 So our strategy then, proof of concept and partner. So we're exploiting our leading and patented technology in the science around sulforaphane. Our lead molecule, different diseases, different inflammatory diseases, and indeed cancers, and we've got a funded plan to deliver phase two clinical proof of concept in one very serious cancer. And then we look to out license. We for non core indications, we'll think about early partnering where areas that are not completely aligned with our internal expertise. We've got a lot of academic partners and one or two commercial ones too. There's a compelling scientific rationale in a whole bunch of diseases, and we've got a number of leading academic institutions working with us. Do you have developing more data on a monthly basis? And, again, a bit more about that later.

3:49 We about the business model, though, will also include broadening the pipeline, if it's appropriate, through acquisition and licensing of self orophying analogs and indeed other molecules that might be complementary to what we're doing. There's the pipeline as it currently stands. And along the bottom there, you'll see a number of the academic institutions that we have been or are continuing to be actively involved with. We've got phase two a positive data in metastatic breast cancer. We have an active glioblastoma program for which you will see some more news this year. We've got data, very interesting data in various hematological malignancies, including a rare pediatric cancer called JMML or juvenile myelomonocytic leukemia.

4:35 And we have rights to a bunch of analogues from another academic institution that we're currently assessing. These, of course, are analogues of sulforaphane. So this one's a busy slide. It's busy because there's a lot been going on. So in in no particular chronological order, but last month, we announced a new collaboration with University of Michigan on bowel cancer. That's an area we haven't exploited very much to date, but the Michigan team are very keen on looking at s f x o one in a specific model or several models actually for bowel cancer. The month before, we announced a new academic collaboration with a university in Rome, La Sapienza. They're looking at potential administration of s f x o one and whether it radio sensitizes.

5:20 It's a really interesting property potentially. This study is it makes the effect of radiation more powerful. And as most people know, radiation is a factor of most cancers at some point during the duration of that cancer. On the manufacturing front, between the last couple of years, we've scaled up our active ingredient production to commercial scale with a new provider, and we've made a a number. It says a number there. We've made a huge number of process improvements. And that's led to us developing a brand new EC, enteric coated tablet. So we've got a new formulation made in a new manufacturing process, and this is as near commercial as we need to be at this point. So it's enteric coated. There's a special coat sprayed on the tablet to enable it to pass the acid of the stomach and release in the small intestine where most drugs get released and where the most efficient uptake of sulforaphane into the bloodstream happens.

6:15 So we've got this ready now to support our clinical trials and start later in the year. In metastatic breast cancer in March, we announced the expansion of an existing preclinical collaboration with with the University of Manchester and the Manchester Breast Biology Centre, very close to the folks up the road there and up the Christie. We're generating data to optimize the way SFXO one should be used in the next clinical trial in breast cancer treatment after we had positive phase two a open label clinical data couple of years ago. We've also been very busy with the regulatory authorities. So in January of this year, we received feedback from the FDA in The United States because we submitted for a pre meeting. That's really us discussing with the FDA what we require in order to conduct clinical trials in The United States. And that feedback was largely positive, and we're already working on how we can answer the additional questions the FDA have asked us. And in September of last year, through a previous interaction with the FDA, we achieved orphan drug status within The United States for malignant glioma. That confers a number of benefits. As many people know, often drug gives you a tax break on eventual sales. It gives you additional intellectual property protection on the asset in The United States and was our start of our serious interactions with The US regulator.

7:43 We've been busy with the UK MHRA as well, and we received formal scientific advice from them at the beginning of this year that's now being built in to our clinical program. In October, we published some of our key glioma data, in preclinical mouse glioma data from a academic collaborator we have in us in Italy, in in Italy. And that's available in the public domain, and there is a link on our website. Another collaboration with the Weatherall Institute in Oxford demonstrated, as I mentioned earlier, effectiveness in the test tube in a very rare and difficult to treat pediatric disease. That's JMML. Partnering continues with our partner, JuveLife, a division of juvenescence, and there's some reasonably chunky milestones due in that partnership as that agent approaches launch as a nutraceutical product.

8:38 So to the outlook then, we will start on schedule our phase one PKPD study. This is much more than a standard phase one volunteer study. We're combining, evaluating evaluating the the properties of our new enteric coated tablet in volunteers with what happens in the body once that sulforaphane gets released into the bloodstream. We will evaluate how we interact with our targets of interest. I mentioned at the beginning, that's SHIP two, NRF two and STAT three. We'll be measuring all of those things in the volunteers, and that is on schedule to start in the fourth quarter of this year. And we'll update the market, of course, with any results are relevant and complete that come out of that study. Also, in at the end of the year, we'll open our g o GBM, that's glioblastoma patient study to recruitment. We're doing the final preclinical work now, and we're doing the planning work required to produce a compelling study in this devastating brain cancer that's been quite prominent in the press lately. In fact, yesterday was the World Glioblastoma Day.

9:45 We We made a couple of tweets there. But more importantly, the late the mid stage phase one b two a trial that we are in deep planning and deep discussion with both regulators and with key opinion leaders will start right at the end of the year. It's a UK and Continental Europe study from a site point of view, multicenter, multicountry, and there's a thing called an adaptive design. That is we can adapt the design with the consent of the regulatory authorities and and the the investigators depending on what we find. So the news flow looking forward then to 2023 will re announce results of at least four of our preclinical collaborations, the two I mentioned earlier, plus a couple of others, including the Manchester Breast Centre. We'll be announcing results of our volunteer study, that big PKPD pharmacokinetic pharmacodynamic volunteer study, and a top line results will come from the first part of our adaptive glioblastoma study in patients. So a lot of clinical news in the outlook for the next twelve months. And we're looking also now to Juvenescence to launch towards the end of the year, and that will accompany a low seven figure milestone to us on the launch of that nutraceutical.

10:58 So a lot of news to come, perhaps

11:00 even some more than this as well, and we will update the market as needed during the next twelve months or so. I wanted to give you a little bit more detail on these programs. And this whole slide deck will be available on our website shortly after this presentation. So we're doing on the blue dark blue slide on top there, some in vivo additional studies and models of glioblastoma. Down Down the left hand side, you'll see that we've, approaching the end of our enteric coated tablet CMC chemistry manufacturing controls program, refining our assays for assessing both sulforaphane and and its metabolites because sulforaphane is metabolites in the body, and there is quite a lot of information to say that those metabolites are also biologically active.

11:48 And then we have our assay program in late stage completion that is what does the drug do when it gets into the body in in model systems and indeed tissues taken from volunteers. So the red line shows the module one of our patient study. That's phase phase zero to phase one b. It's modular, so it will adapt and grow as we learn from the way the drug behaves in that disease. And that would be in recurrent glioma, starting with monotherapy, looking for tolerability, pharmacodynamic interaction targets, then adding in standard of care as necessary. And then healthy volunteers study, I think I've said more than enough about that. The deliverables are on the right hand side. I think that's the most important point within

12:34 quarter four twenty twenty twenty two right through to the end of twenty twenty three. Our patient study will deliver some tumor PK, some proof of mechanism, proof of principle. We'll certainly get a lot of information about how well tolerated SFXO one is and a bunch of other endpoints as well. Before that is delivered, we'll be also delivering these roughly in chronological order, the pharmacokinetic dynamic interaction of our drug in volunteers, how well tolerated it is as a new formulation. We're expecting better tolerability than previous formulations we've used, and it supports a lot of things, the oncology strategy and anything we do again in nonmalignant disease.

13:19 So I'll, take a quick voice break now, hand over to Richard to give you a little bit more detail about our financial position. Richard. Thank you. So good afternoon, everybody. P P and l terms, we the operating loss is 3,200,000, and the post tax loss is 2.7. Those are the same numbers when rounded to what we had in the pre previous year. And that's not me manipulating the figures. It it's it's more a reflection of of the level of activity in the last two years where we haven't been sponsoring our own trials. We have done different activities in the two years. In in the years '21, we were doing a lot of toxicology work and transferring the CMC program from The US to Sterling in The UK who we're using for scaling up.

14:13 In the current in the year just gone, we spent more time on preparing for the clinical trials and on actually manufacturing to scale and tableting the the compound that we're gonna use in the trials, s f x o one, as in a tablet form. The cash flow was very similar as you would expect with a similar operating loss, 2,600,000 versus 2.9 the prior year. But the difference is, frankly, just it's partly down to the difference in cost per the share base. You as you probably know, there's something called a share based payment cost that is a noncash item.

14:59 But in this case, the the 300,000 difference is mainly due to movements in working capital. So, you know, our debt and credit are slightly different at the end of each year, which caused a cash flow effect.

15:14 The cash at the end of last year, March 22, was 9,000,000. So overall, a reduction in 2,600,000 in cash, and we expect that to to last until until q four into q four twenty twenty three before allowing for any milestones that we might get from Juvenescence or elsewhere.

15:39 Now that's obviously a faster rate of burn than in the prior years, and that reflects the fact that we're ramping up our clinical programs or manufacturing a larger batch as a product to support those programs. So that is what you would expect. I think that's all I've got to say here on financials, so we can move on. Thanks, Richard. So a quick reminder of the experienced team. I'm not gonna dwell on this, but you can see these on our website. We've got a vastly experienced board and management team. We were all together at the AGM that occurred here in Alderly Park a little bit earlier on this afternoon, and we use some of the very best medical and scientific advisers in the world to to advise us on these programs.

16:26 So that more or less concludes our formal presentation as a result of our AGM, and we'll hand over now to questions. We've got some presubmitted ones, and I can see a few coming in from the webinar platform. So we'll try and do as many of those as we possibly can. Fantastic. Thank you very much indeed to you, Richard, for for that update. Ladies and gentlemen, as you said, please do continue to submit your questions using the q and a tab situated on the right hand corner of the screen. But just while the team take a few moments to review those questions submitted today, I'd like to remind you the recording of the presentation along with a copy of the slides and the published q and a can be accessed via your investor dashboard. As you rightly said to you, we did receive several pre submitted questions and perhaps we can start the q and a session these. The first one reads as follows. Evgen has invested much management time to establish 15 academic collaborations. Can you expand on these?

17:18 Yeah. I mean, some of those are still ongoing, a majority, in fact. And some of them are already completed and the data already published. For example, we've published, as I mentioned in October last year, a collaboration in models of glioblastoma that led us very strongly to that very difficult to treat and rapidly fatal cancer. That was published in a prestigious peer reviewed journal towards the end of last year in quarter four, in fact. Before that, another academic collaboration we had with University of Auckland generated some

17:50 in vitro, that's in test tube data, in relatively fresh tissue from brain tumors, from glioblastoma tumors, and it also showed compelling efficacy in the test tube of SFX one. The Manchester Breast Center collaboration we've got has continued for some years. We've, in fact, expanded it and invested more in it in this year, we're very close to that. And the goal there is to really look in the post CDK four six, post palbociclib

18:20 setting in ladies who develop metastatic breast cancer and where palbociclib shows resistance developing where s f x o one is best used. So that's a little bit about our academic collaborations. The radiosensitization one I mentioned and the bowel cancer one I mentioned, those are our predominantly live collaborations now, and they will feature in our news flow in the next year or so. Fantastic. Thank you very much indeed. The next question we've got here is, Richard's, doctor Jones, understanding the need to comply with obligations of confidentiality, please describe the effort being made in business development. Yeah. Well, our entire business model is predicated, of course, on business development because we're not the sort of company that will take some innovation, develop it all the way through to the market, and then launch it with the Salesforce. That's not our business model. Our business model is to take it to a certain point where larger organizations then want to take it on and take it all the way through large scale phase three trials, the registration process,

19:17 and on to marketing. So business development is critical to what we do. We've had for over twelve months a new chief business officer, and we've been very busy in the formal partnering meetings both in Europe. They were mainly virtual in 2021 and indeed at the beginning of this year where the JPMorgan and biotech showcase partnering events in San Francisco were held entirely virtual. We had 29 meetings at that partnering conference really discussing our technology and indeed if there's any complementary technology we could bring into the company. And more recently, some of you may have seen on another platform, we were at San Diego in the first face to face partnering conference post COVID, and we held over 32 meetings in that partnering conference. It's a very productive one, the bio San Diego or East Coast sometimes alternating years.

20:06 And we're following up on all those conversations now. I think a bit of patience is powerful, though, because pharmaceutical partnering takes quite a bit of time. There's a bit of introduction. There's getting to learn about the asset on a nonconfidential basis. If there's interest and appetite

20:21 to do more, and we are signing CDAs currently, then we'll sign confidentiality agreements, and then the con the conversation continues about what each party are interested in. BD is absolutely key to everything we do other than research and development. An absolutely key platform. You can understand that I can't tell you more about discussions that may or may not be happening with whatever size company we're dealing with, but I can reassure the entire audience that there's a lot of activity on this front. It occupies a large chunk of of the management's time. Fantastic. Thank you indeed. The ultimate pre question we have here is could you expand on director and or share staff staff share purchases? Apologies. Yeah. I'll I'll take this one.

21:09 Yeah. We as you might imagine, we we're frequently asked this question by investors that we meet here. And just by way of background, in the last couple of years, two directors bought shares in the last the last funding round, which is over two years ago in twenty twenty twenty twenty one, year and a half, actually. Sorry. And a senior member of staff has bought shares in the market in the last six to nine months. I can't remember exactly when they were bought. So there has been buying of shares by management and directors. Right now, we we're not in a position to buy shares under stock exchange rules, but we do take the point that that other people mentioned to us that the share price looks very attractive at the moment.

22:00 I wish we could. I really do. So, yeah, there we go. Fantastic. Thank you, Rich. So the final question we've got here is why has James Kite been such a keen buyer over the last twelve months? Do you know his motive? Well, we obviously have a good dialogue with James since you started buying shares. His precise motives, his precise reasons, these are obviously confidential between him and us that it it would not be ethical to to to for us to put words in his mouth and tell other investors what he's doing about. That is confidential. What we can say is that he's extremely infused by the technology we have and the opportunities we have. And he has said to us, he has a very high regard for the management team and thinks it's a quality management team. So I I say that to try and answer a question more more than anything else.

22:54 But he is definitely committed, and he's enthusiastic about the company. That's fantastic. That concludes the presubmitted questions. If I may, as you can see, we've received a number of questions throughout today's presentation. If I could just ask you just to click on that q and a tab, perhaps start at the top of the list. And where appropriate to do so, if you could just read out the question and give your response, please. Sure. There's there's two linked questions about the potential for the business and time scales and what does success look like. And they're very good questions. Thank you for those. So the potential of the business is measured in generating good clinical data from this point on. We've got an extremely talented team of of consultants and staff preparing for those clinical trials I described earlier. Success looks like generating good PKPD data in volunteers showing that the drug gets in, gets in reliably, interacts with targets of interest. We're very confident that those all are gonna happen. So success and we should get reward because biotech companies generally get rewarded for good quality clinical data.

23:55 So success in the short term looks like a good PKPD study in volunteers followed by some good readouts of positive trends in seriously ill glioblastoma patients in 2023. Biotech scales are measured along relatively long periods, as you know. So a 2023 win for us would be positive data in glioblastoma having already understood exactly how our new tablet behaves in volunteers, and then we can transition to giving it to seriously ill people. Timescales, I'm afraid I can't comment on. We know what our plans are clinically. We expect to open our volunteer study in quarter four and our GBM study at the end of the year and then generate data throughout 2023.

24:43 So watch this space for the next year, year and a half is probably the summary of that one. We've got another one, which which is linked perhaps in about and thanks again. Catalysts and milestones, you can expect to highlight the progress. I'll do the first part of that question first and maybe deal with the second one second because it's a two part question. I think we've explained pretty clearly. We we don't publish exact clinical milestones. There are lots of moving parts that are currently going on. That is making and packaging tablets to pharmaceutical standard. It's happening right now. It is interacting with the regulatory authorities on the exact design of these studies, getting ethical committee approvals for these studies. It's all in hand and all going to plan, and then opening the study for recruitment once all those approvals are in hand. And said we that happens for a volunteer study beginning of quarter four and in our patient study in brain cancer at the end of quarter four.

25:45 So the catalysts for us are really those opening of the studies in not many months' time now, actually. There's an awful lot of running around this office happening, getting all that ready. The other one is what, if anything, can can speed up development. I can honestly say we're going as fast as it is possible to do so in biotechnology at this moment. The planning phase is coming to an end. In parallel to the planning phase, we've been making drug to the the full pharmaceutical standard, getting buy in for the regulatory authorities plans, and then executing those plans in making drugs, designing studies, getting the key opinion leaders in the world, backing for those studies, finding centers in The UK and Europe who prepare to conduct our patient study. All of that is well in hand and then hitting the market, the study market that is, with those drugs when the requisite approvals have been achieved.

26:41 So, again, watch the space for 2023 when this data is rich and well prepared, data plan starts delivering real volunteer and patient data. Do you wanna take that one? Yeah. Yeah. There's question here why it took us six weeks to update shareholders on the results of the that we announced in June. I think very simply, we we felt it was more more helpful, more appropriate to do it on the day of the AGM. We had our AGM earlier this afternoon. Generally, there is a presentation given at an AGM. Usually, this is done to the audience at the AGM, which today was pretty low.

27:32 And we felt that it made sense to combine comment on the the year that's just gone with the AGM that we've just held. There's there's a question here about our pharmaceutical partner that my friend can't really give you any detail on. I mean, you're about whether they were intending to go public and had said so. And and the honest answer is we can't comment because that's the business of an entire separate company with an entirely separate management and board. All I can tell you is that our relations are very good and very strong, and we're working together on the sulfonylidex based product that they've licensed from us. Yep. Should we do I think we can do this one. Yeah. Yeah. There's another subsidiary question about what good looks like. Good looks like good clinical data from now on.

28:26 And And we are on track. If I answer that question here, I've gotta give you exactly the same answer. Actually, good looks like a well thought out plan. This is not easy medicine to develop in, but a well thought out plan maximizes the chance of success. I'd have given you the same answer. Good quality clinical data in a well thought out clinical experiment, which is what we've been working on the entirety of the year. Should I talk to the share price? I mean, mean, there was a question about why the share price has gone down by 60%. Why do we think that is? There are a couple of reasons here. I I think the first is since we did the raise, the trial in COVID reported, and as you'll be aware, sadly, it didn't didn't get the positive data we wanted in common with about ninety five percent of trials in in COVID.

29:17 And that given that that that was an opportunistic trial in the first place, we didn't have to pay for it. We didn't have to run it. It was a purely upside trial. It was disappointing that when it when it came out that it hadn't worked, the share price dropped by a significant probably about about half, actually. So a big chunk of the share price reduction is due to a trial that was only ever opportunistic and potentially we did our bit in COVID. We felt we should. We had a molecule that looked like it might work. In reality, the patients that came into the trial were too ill to respond to our sort of to the sort of drug we have. It it was always going to be a really difficult trial to to succeed. And so whilst it was disappointing, it hasn't affected anything, our our core programs and and what our focus, but sadly, it did hit the share price.

30:16 I think the other element following the decline from that is is anyone who's looked at AIM in particular or biotech stocks worldwide and certainly in on Nasdaq, the market sentiment towards biotech has gone from a high in 2020 to a low at the moment, and share prices across the board in our sector have declined very substantially because it's always a bit of a cyclical share prices for biotech companies are always a bit cyclical. And at the moment, we're at a real low, and that's that's a market reaction, we believe, rather than anything that we have or haven't done since the fundraise.

31:03 We've got a question here, and I think this is probably the last question we've got time for, about, you know, our our interactions with investors. And the answer to this is really simple. We absolutely adhere to the rules of the stock market in all our investor communications. Everybody gets the same information. Nobody gets any preferential information. That's the law. That's the rules of the market, we absolutely stick to that. So nobody gets anything special here. Everybody gets the same information set. And this this is available publicly to you now this afternoon, and nobody else gets anything more. We are scrupulous about this. Neither of us wants to end up in jail, frankly. So with that, sort of slightly somber point, you know, that we are absolutely rigorous and have been in both both our thirty year careers in the public and private markets about information. I hope you've enjoyed the information we've presented to you today. We're excited about the progress in the clinic that we're gonna push towards towards the end of the year. We're excited about our business development activities.

32:09 More on that when we can conclude transactions around our asset, and and we're excited in general about the plan and the financial support we've received from our shareholders. That's fantastic. You, Richard. Thank you indeed for addressing those questions from investors. Of course, any further questions that do come through, you will have the ability to review those. And we publish responses where appropriate to do so on the Investor Meet company platform. Hugh Hugh, was gonna ask you for a few closing comments, but I think we've just had those. So thank you indeed for updating us. What we'll do now is just redirect investors to give you some feedback if that's okay. Again, thank you very much indeed for updating attendees today. Can I please ask attendees not to close this session? It should be automatically redirected to provide your feedback in order the team can better understand your views and expectations.

32:54 This will only take a few moments to complete It's greatly appreciated by the company. On behalf of Evgen Pharma PLC, we'd like to thank you for attending today's presentation. That concludes today's session. Thank you, and good afternoon to you all. Thank