Futura Medical plc

Well, good morning, everybody, and welcome to the Futura webcast for our interim results for six months, ending 30 June 2022. I'm delighted to be joined by Angela Hildreth, our FD and CEO, and also by Ken James, our executive director and head of R&D. So without further ado, let's move on to slide four. A little bit about Future and the corporate overview. We describe ourselves as a virtual organisation. We have 13 staff with low overheads. We tend to subcontract a lot out, including our contract manufacturer, and we currently have around 30 consultants that we call on as and when we need them. Our key sort of expertise is applying skin science to deliver novel topical treatment treatments, and dermasis is kind of a our brand that embodies that. We've got an experienced team and we very much focus on developing clinically proven innovations, which we then look to license that to commercial partners. Our main product, Med3000, is a topical gel for rectal dysfunction, and it now has UK and EU approval to be available without a doctor's prescription. It is a highly differentiated treatment with a fast, onset of action and main claim that we can make in Europe is helps you get an erection within 10 minutes. The FDA dossier we expect to submit by the end of September and we are focusing on certainly over the next six months as we go into 2023, initial launches and further launches again in the back end or back half of 2023. Our other sort of key focus is very much looking to secure U.S. commercial partner to complement our existing distribution network. Med3000 on a commercial, our real aim is building a long-term, proper global distribution network, and I'll touch on that a little bit more in due course. We do have other products in our portfolio, the main one being CBD100, but Ken will talk a little bit about that a little later, but our main focus is very much on developing Med3000. So turning the page, Six months highlights, very much focusing on our strategic decision to maximize our R&D pipeline by de-risking the assets through getting approval. We've had a successful completion of F and 71 in August, but again, Ken will talk about that a little bit more in due course. And also our manufacturing now is really ready for initial launch supplies and beyond, and what we mean beyond, certainly for the next couple of years based on the forecast that we've got today. Med 3000, we've also, on a commercial perspective, We've signed a deal with Cooper Consumer Healthcare for distribution throughout basically all the EU and the UK and Switzerland. And we now have, again, I'm pleased to say, initial orders have already come in, are ready for the launch, which will be in the first half of 2023. Again, I think it's important to stress that a lot of this information will become commercially sensitive, and therefore, we won't necessarily be able to stay that much ahead of the launch, other than, as already said, we will be launching in a number of countries in the first of 2023, and then obviously further countries will be able to launch during the year. Again, on the clinical data, Ken will talk about the two studies that we've done in the last year, which is critical for the FDA submission to obtain marketing authorisation. And with that in mind, we have now appointed specialist corporate advisors, about the same company we've used previously, as we continue to build or hopefully complete our global distribution network, to very much focus on finding a commercial partner for the US. Angela.

Thanks, James. Not a lot to say, really, as financially everything is very much as we expect it to be. we had a net loss in the period of 2.5 million. This is an increase of around 1 million on the period last year, but also not surprising as FM71 began running in the second half of 2021 and continued to run through 2022 today. In terms of cash, we ended the period with 6.68 million in the bank. And then when added to the expected tax credit refund, we expect... to be received before year end, that provides the company with cash of just over seven and a half million. And we believe even without further milestone payments and other revenues generated from product sales of MED3000, this should be sufficient to take the company through to expected US regulatory approval and beyond under the current plans. Back to you.

Moving on to the next slide. Our core strategic objectives, which, as I said earlier, we're very much focusing on, I think we've done pretty well on, is gain U.S. marketing authorization for MED3000 over the next, or certainly within the next 12 months, complete our global distribution network, along with a robust supply chain to enable us to make MED into a long-term sustainable and profitable brand. Initial country launches of MED or Eroxon, which will be branded in certain markets next year, and to really validate consumer interest and repeat purchase potential, and to progress MED3000 commercial negotiations for the biggest market in the world, which is the US. Moving on. A little bit more now about eroxine itself. This will become the first topical gel to treat erectile dysfunction in adult men throughout Europe. It has already gained approval for there and also UK. Available without the need of a doctor's prescription. This is very critical as in most countries apart from I think the UK in Europe it still requires a doctor's prescription and obviously in the States which is by far the biggest market it is again all oral treatments, the PD-5, such as Viagra, which is known to most people, is a prescription-only product. Eroxon is a clinically proven gel to treat erectile dysfunction, and its key differentiating claim is it helps you get an erection within 10 minutes, so therefore removes the need to pre-plan when you're also normally taking oral treatment. It brings spontaneity back into the treatment of erectile dysfunction. Turning on to the next slide, There is a significant commercial potential against the backdrop of changing dynamics in the market. The global ED market has grown and continues to grow as volume rises, but it's also becoming more of a generic market. In other words, the main products of Viagra, now become what is known as generic. And therefore, as competitors can come in because their patent is now expired, it has had an impact on dropping price. Obviously, increased affordability drives up volumes, which is a good thing. Nevertheless, even with the reduction in price, there is definitely still a barrier for patients using the treatment, still because of costs, because they have to see a doctor and there are economic costs with And also, as inferred by that, because you have to see a doctor to get the treatment. Certainly, we're in the process of doing further market research at the moment. And one of the initial findings we've seen in this is that typically, US patients are paying between $600,000 and $3,500 per annum for their treatment for rectal dysfunction. Whilst the actual physical cost of the actual medication has dropped, they still have to pay, even taking into account what coverage they can claim back under insurance, the cost of the doctor's visits. And if you then kind of equate that into frequency of course, and again, research is showing that typically and men are having 70 intercourse attempts a year. This still means that typically a patient is paying between $10 and $50 each time they have an attempted intercourse. So to have a topical over-the-counter treatment, which is probably going to launch around the $5 mark, maybe a little bit more, there is still a huge opportunity there as the barriers of cost and the barriers of seeing a doctor do not exist. Turning the page to the next slide. Again, one of our core strategic objectives is to build a global network, and we're making very good progress on that. Over the last two years, we have signed five deals. The main exception is very much the U.S., and Having completed the recent study and the submission shortly, we do expect to focus very much on finding a commercial partner and have already instructed our core advisors to move ahead on that. All the deals to date very much focus on some key performance obligations. Obviously, where regulatory costs are required and submission timelines, we expect partners to adhere to those. And then there are certain performance obligations around launch timings. and advertising and promotional spend, which is going to be critical to really build the brand. As I've touched on earlier, our CMC or chemistry manufacturing controls is progressing well. We have an accredited supplier. We now have a 42-month shelf life product, which means that after manufacturer shipping, we would expect to see at least a three-year shelf life at the point of sale once it gets onto the shelves. Manufacturing is now sort of underway as we've already received the first orders and we have capacity based on the capex that we've made to supply us for certainly the first couple of years. And we are now really focusing on how we expand that as service build up and looking at alternative sites, just to again, increase the supply chain robustness. So moving on to the next slide, New research is underway, but I think the key components still remain. There are kind of traditional and perhaps newer segments that we see where Med3000, there's a big opportunity for. Yes, Viagra, Cialis are effective treatments, and for a lot of men, they're happy with this. Nevertheless, there are a number of men who either are contraindicated, in other words, they cannot use those medications. So at the moment, that is a completely untapped market. But a lot of men who drop out after using these products in the first year, and the reason cited behind that is the side effect profile and also the requirement to pre-plan before they take the treatment. There's no spontaneity, and therefore a treatment like MED, which has a rapid speed of onset within 10 minutes, can bring spontaneity back into treatment. Again, Viagra and Cialis are prescription-only products, other than in some markets, such as the UK, for Viagra only. There's an embarrassment of men going to see a doctor. There's the cost, as we've already touched on, and then the inconvenience associated with that. So there is huge interest, huge demand. The research historically has shown that typically this could account for two-thirds of men that suffer from erectile dysfunction. So huge appeal for a treatment that they were able to buy over the counter by just walking into the pharmacy or through the pharmacy's online website. There are also newer segments which are coming in. There's a growing amount of young men who, if you like, have grown up with widely available access to pornography, who have concerns around their performance at a treatment like MET3000. could help them with their concerns around this. And then finally, as an over-the-counter product, we've done market research, which has shown that a lot of women whose partners have a reptile dysfunction would be really interested in trying to help their partner overcome their issues. And now they would be able to buy treatment to help him in that regard. So we see this as a significant opportunity. Previous research has shown around about 660 women million as a global opportunity. We are doing some further research on that, which is halfway through, and we look forward to updating the market in due course. But we still see this as a big opportunity. And then I think finally from my side on this, intellectual property. If MED is as big an opportunity as we think it is, It's very important that we try and protect this asset as far as possible. And for us, the best way of doing that, having taken both corporate and strategic advice, is to have as many different layers of protection as we can do. Again, we're not going to tell everything, obviously, to the market for obvious reasons. But aside from the patent... which has been filed in a number of markets. And certainly initial EPO, European Patent Office examination, confirmed the novel and inventive nature of the patent application. And that is critical in the process of securing intellectual property or patent on the product is progressing well. Some other things that we've done, one of the excipients, one of the components in the It's under exclusivity to Futura. And even though it's used in other products, in the area of sexual health, it can only be supplied to us. And this company has two different factories. So again, from a robustness of supply, we feel comfortable around that. Also, we're looking for Med to launch under the Oroxon brand wherever possible. And again, you can build and establish global awareness and consumer trust behind that. On special controls, I kind of refer to Ken.

Thank you, James. So special controls are controls which are applied to de novo medical devices, which ensure the safety and effectiveness of the device, and they're enshrined in the marketing authorization which is granted by FDA. And what they do is create a very high bar of clinical and non-clinical data, which generic products have to replicate if they attempt to use our product as a predicate for a 510K approval.

Okay, thank you, Ken. So moving on, in fact, I'm going to switch it back to Ken again.

The key event for R&D over the last few months has been the completion of a study that was requested by FDA for us to carry out as part of the approval process. We had some very productive pre-submission meetings with FDA leading up to the conduct of FM71. And in essence, they agreed the protocol, they agreed the endpoints in advance. So on that basis, the study was reported out just over a week ago and very good news. We met all the primary and secondary endpoints specifically on the secondary endpoint that related to the differentiated claim that we have, which is the first signs of an erection within 10 minutes, which we hope will be translated into more consumer-friendly language of helps you get an erection within 10 minutes, which is the same claim that we're using in the EU. Overall, the clinical study, in our opinion, presents a very favourable benefit to risk profile versus the leading prescription product paving the way for OTC marketing authorization in the USA. The next slide gives a little bit of color around the primary endpoints. And the measure that was used for both primary endpoints is called the IIEFDF domain, which is the internationally accepted gold standard measure for all erectile dysfunction products in clinical studies. And there were two elements of this which comprised the co-priority endpoints. The first one was that at 24 weeks, we had to get a statistically different improvement in erectile functionality over the baseline or pre-treatment result. And that was achieved. We were highly significantly better than the baseline result. And the second element of this was that the magnitude of that difference had to be so large that we exceeded the minimal clinically important difference, which is a value of four units bigger than the baseline. And you can see the tabulation on the left-hand side that through the entire study, week 4, 8, 12, 16, 20, 24, we exceeded four units, the critical one in respect of the co-primary endpoints, in excess, obviously, of four. And as I've mentioned, we got highly statistically significant difference over baseline at that. So both the co-primary endpoints were achieved. The graph on the right is merely a graphical representation of the tabulation on the left-hand side. So we're very, very pleasing on that. Both MED and Tadalico were clinically effective at all time points, although Tadalico showed a slightly greater improvement than MED. But there are some advantages that MED achieved over Tadalka, which I'll now come on to talk about. The secondary endpoint focused on achieving a speed of action claim. And the criteria for proving this claim was agreed ahead of time with FTA. And I'm pleased to report that MED achieved that onset of action endpoint at 10 minutes. And that difference was highly statistically significant again. Oral Tadalafil, when you apply the same criteria, did not meet the FDA criteria, which is not surprising because the oral medications typically take 30 to 60 minutes before they start working. So 10 minutes was probably never going to be achieved with Tadalafil. But it's good to have that data supporting the product, which is a key differentiating claim for our product. Helps you get an erection within 10 minutes. The other advantages that we achieved with med over tetanus pill, again, perhaps not unexpectedly, are the adverse event profile. It's a well-known phenomenon that the PD-5 inhibitors have side effects of headache, backache, and stomach upsets occasionally. And the differences that we've got here are, were certainly the instance of headaches where 19.1% of Tadalafil subjects had headaches, only 4.3 on med. Back pain was a significant issue with Tadalafil and also non-cardiac chest pains of two subjects, just happened to be the US subjects who achieved that particular side effect. On med, we got two instances of nausea and three instances of female headache. Given the product only works topically, we think that that's purely idiosyncratic. We got virtually no local side effects on med. We got a mild burning sensation in one subject. very clean from a local or topical side effect profile. And, of course, because med is a medical device that contains no drug, there's no potential for med to have adverse drug interactions, which is a problem with the PD-5 inhibitors, the oral medications, where they're currently precluded from using a number of prescription medicines, such as nitrates, whilst they're on the erectile dysfunction medication. So we have a very favorable side effect profile compared to the PD-5 inhibitors. So turn to the next slide. So in summary then on FM71, we've shown that MED3000 is a clinically effective treatment for erectile dysfunction. And in contrast to the PDE5 inhibitors, the oral medications, MED has a fast onset of action with a 10-minute onset claim. no significant side effects, no potentially serious drug interactions, and therefore, in our opinion, has an ideal benefit-to-risk profile for OTC classification. And indeed, in the EU and the UK, it already has OTC status. If we move finally on to the regulatory status, we've gone through a number of pre-submission meetings with FDA participants, which are designed at FDA's behest really to help companies get an understanding of what FDA's requirements are and to discuss areas of potential differences of opinion and agree the programme going forward. So we've had a number of productive meetings with FDA already. They identified two key areas that they wanted us to develop. adequacy of the OTC label leaflet. That was successfully completed at the end of December. We got excellent results in that study. And then, of course, the additional clinical study FM71, which is now complete, and that protocol for that and the endpoints were We're fully agreed with FDA prior to the conduct of that study, and we've met the requirements there, we feel. We're now on a very fast track, actually, to wrap all that information up into a submission, which is going into FDA at the end of this month, the end of September. And if FDA keeps their timeline for approval and there are no major issues with that submission, which we don't think there will be, We are optimistic that we will get approval at the end of Q1 next year. Thank you. Now, moving on beyond the first product of the pipeline, which is MED3000, we do intend to follow on MED with a number of pipeline initiatives. So we've got the lead product here, the A1, which is coming in a unit dose tube. We think there is scope to potentially improve the packaging and even reduce the cost of goods even further by using some more elegant sachet or snap pack packaging. That's already in the development pipe. Beyond that, we think that there is scope to improve the sexual experience with new delivery devices, such as a mousse or a spray. And then longer term, potentially going into new indications, such as premature ejaculation or female sexual disorder. And we're already doing some exploratory work with our key opinion leaders on that. So we don't just see this as a one-trick pony. We see this as a succession of products coming off the pipeline over the next few years. So that concludes the discussion on MED. I just wanted to mention very, very briefly another development that we have in our pipeline, and that's topical cannabidiol. Now, the focus very much of the whole organization has been on MED and the Roxxon and conducting the clinical study and applying the filing in the U.S. So this work is really only at an exploratory stage, but we do have an excellent prototype which has been developed of cannabidiol using the Dermasys technology and it's able, as you can see here, to deliver cannabidiol into the skin and through the skin very, very effectively. And we're seeking potential licensing partners on that as part of the exploratory work that we're doing.

So, looking out to next year and beyond with positive FM 71 results in hand. Our first priority is for us to submit the dossier for MED3000 to the FDA. And this is scheduled for the end of this month. We're also looking forward to initial EU launches of MED3000 under the Aroxon brand with other regional launches throughout next year. We also expect the FDA to grant marketing authorization in Q1 2023, enabling MED3000 to be available as a clinically proven treatment 3D, which is available without a doctor's prescription. And finally, and very importantly, we look to progress curing commercial agreements for MED3000 in the US, which will allow us to deliver long-term sustainable value.

Thank you, Angela. And that concludes the webcast for today. Thank you for listening.