Futura Medical plc (FUM) Earnings Call Transcript & Summary

Well, good morning, everybody. My name is James Barder. I'm the CEO of Futura Medical, and I wanted to welcome you to our webcast today, where Ken James, Executive Director and Head of R&D, will go through the excellent results that we have recently achieved on FM71. So without stealing anymore thunder from Ken, let me pass you across to him to go through the results. Ken?

Thanks, James. And yes, I'm very pleased and actually very excited to be able to present these clinical results to you because they're excellent. So the headline is that we met all the primary and secondary objectives. So both co-primary endpoints agreed with the FDA were met, and we agreed the secondary objective, agreed with FDA to support our key differentiated claim, which is first signs of an erection within 10 minutes. And beyond that, we also were able to gather some efficacy, onset of action and safety data in comparison with a leading prescription product, and we believe that data is very, very supportive in paving the way for OTC or nonprescription approval in the United States, which just happens to be the biggest market for ED products. Go on to the next slide. So I'm going to walk you through the clinical design and then the details of the results on what we call FM71. This is the pivotal study that was agreed with FDA, the confirmatory study that we needed to conduct to help us get approval. It's designed as a Phase III multicenter comparative randomized open-label study in a home-use environment. It's a parallel group study of MED3000 and tadalafil 5-milligram in 100 patients over 24 weeks. We actually use 96 patients, but that's closing up to the 100. The study was designed to have a 4-week run-in period, where the subjects were asked to have a minimum of 4 intercourse attempts, and this helps us establish a baseline reading, pretreatment reading. And then go into 1 of the 2 treatment groups, so MED3000 or tadalafil, and that was run for 24 weeks. So time points where we did a detailed analysis, so 4, 8, 12, 16, 20 weeks, leading up to the 24-week final time point. And then there's a 1-week follow-up period, where the patients are finally interviewed by the investigators. So if we go on to the next study. I'm going to be referring here to the key measure, which was used, which is given the terminology, IIEF-EF. That's the International Index for Erectile Functionality, the erectile function domain to its full title. But it is, importantly, a gold standard measure of how erectile dysfunction products are considered. And our 2 co-primary end points required us to show a statistically significant improvement over the baseline at 24 weeks using this measure and importantly, achieve a 4-point improvement in the score over baseline at 24 weeks. And that is judged as being a clinically important difference. So clinically significant, if you will, or a difference that the patients really noticed in the study. Now just to amplify how IIEF-EF is measured. There are 6 questions that are asked. I'm not going to run through all of them. But number one, for example, is how often were you able to get an erection during sexual activity? Number 6, how do you rate your confidence that you could get and keep an erection? So they are all relevant questions to -- relating to the functionality of the person's erection. Each question has a 5-point scale with a maximum score of 30. The minimum score is 1 for each question. So the minimum score overall would be 6, but you can go between 6 and 30. So in the pretreatment level, anyone who scores less than 10 is classified as having severe ED. Moderate EDs scored 11 to 16; and mild ED, 7 to 25. No ED is classified as 26 to 30. So we wouldn't include any subjects who came into that final category there. And we measured the change from baseline, as I've mentioned previously at these specific time points up to and including 24 weeks. And FDA required the primary endpoint to be determined at 24 weeks with the other time points to show consistency over time. So if you go on to the next slide, there are also some other things I want to point out in relation to the study. The inclusion of tadalafil was not related to the primary or secondary endpoints, but really for exploratory purposes only to enable us to frame the benefit to risk ratio in terms of relative safety, speed and efficacy. The label claim, which we hope FDA will approve, which will be -- helps you get an erection within 10 minutes, the statistical design for that is embodied within the secondary endpoint, and that was pre-agreed with FDA as well. We included a mix of mild, moderate and severe ED sufferers. Again, FDA asked us to do this. We're very happy to do it. And the study was run in 4 countries. In the U.S., we included, again, with agreement with FDA, a number of African-Americans in that, but also Poland, Georgia and Bulgaria. So it's a multi-country study. We move on to the next slide. And these are the primary endpoint data that we have here. On the left, we've got a tabulation. On the right, we can see the results mapped out graphically. You can see that we got a score of greater than 4 units in IIEF at all the time points that we looked at. We started off at 4.59. That increased interestingly throughout the rest of the time points, which is something that we found in the previous clinical study that we had as well, that it takes a little bit of a while for the full effect to build up. But it was clinically significant at 4 weeks. But you can see that at 24 weeks, this is what the FDA asked us to look at. At 24 weeks, we've got a score of 5.73, which was very highly significant. So we achieved both of the primary objectives. We've got a mean IIEF change from baseline at 24 weeks that are statistically significant. And we achieved a minimal clinically important difference, we call that an MCID, of at least 4 units. And on the right-hand side, you can see the results presented here graphically. The gray area is the baseline or pretreatment result. And then we've superimposed on that, the yellow bars there, which is the improvement that you get at the various time points, and the green line running through it all is the MCID. So in essence, we have to show that we are exceeding the MCID, particularly at the 24-week time point, which is the primary endpoint. Importantly, one of the issues that FDA raised with us in the discussion in relation to the previous clinical study that we had, FM57, was that we only studied it up to 12 weeks. And they said in their experience, medical devices can drop off their performance between 12 and 24 weeks. But you can see quite clearly from the data that we have between 12 and 24 weeks in the graph, and actually the tabulation as well, that there's no drop off there at all. In fact, you could argue, there's been a slight increase. But at the very least, there is no drop-off in performance between 12 and 24, which is really good news for us and puts us in a good place with the FDA. So if we go on to the next slide. This actually compares the results of our FM71 clinical with the previous clinical study that was conducted, which was used to achieve approval in Europe, we call this FM57. So the left-hand chart is exactly the same as the one I showed in the previous slide. The right-hand chart plots out the equivalent data at 4, 6 and 12 weeks for FM57. We didn't go beyond that, of course, because it was only a 12-week study. You'll see the gray bars are a little bit higher on the right-hand side because the baseline scores sort of a little bit higher for IIEF, and that was because we included a higher proportion of mild and moderate sufferers. So push the baseline up. In fact, we chose to put more severe sufferers as a real acid test of the efficacy of the product into FM71. So the gray bar is a little bit lower. But the important thing here between the 2 graphs is that the yellow bars are pretty consistent between the 2 studies and exceed the MCID, which is the 4-unit change. So very, very good consistency between the 2 studies. We can also look at the number of patients achieving this MCID, minimal important difference. And you can see overall between the 2 studies. At 12 weeks, we've got over 60% -- 63% in both cases between the 2 studies. Mild 55, 61; moderate 57, 59. And actually, the severe cohort that we put into FM71 did quite well. We got 85% achieved in the MCID, which is a very good score. So very good consistency between the 2 studies. If you go into the next slide. We did a breakout of efficacy in mild, moderate and severe for FM71. And here, the MCID, the minimal clinically important difference, there is depending on the severity of the condition. So what's been established by Rosen and his coworkers is that a change of IIEF of 2 units for mild is clinically significant and 5 units for moderate and 7 units for severe. And those are the green bars that you see, mild, moderate and severe. And you can see that in all instances, across the -- when we average all the data for FM71, that we were clinically significant and met them and exceeded the minimal clinically important difference, and therefore, patients really noticed the difference for mild, moderate and severe ED. And you can see the overall result on the right-hand side there, which is what I presented in earlier slides. So a very good result. And I think that will be reassuring to FDA that we seem to be effective in all subgroups. I think that's quite important to establish that. When we compare as one of our exploratory endpoints with tadalafil, which is the next slide, you can see plotted on the right-hand side, the results that were achieved with tadalafil. They were a little bit higher than we got for MED, a little bit more efficacious. We got a number of people overall, who at 24 weeks, got clinical significance of 61% for MED and 87% for tadalafil, not really surprising because tadalafil is a prescription product at the high end of the efficacy scale. But we did get some important differences in favor of MED in the next 2 slides. So if we move on to this one here. The secondary endpoint, you remember was measuring the speed of action and looking at significance at 10 minutes. So MED3000 achieved onset of action endpoint predetermined with FDA and how that should be measured. And it was highly statistically significant at 10 minutes. So we got first signs of an erection within 10 minutes. And we hope, subject to FDA approval, that we will get the claim, which has already been approved for Europe, helps you get an erection within 10 minutes as depicted on the packet. We hope to get that approved. Oral tadalafil did not meet that FDA criteria. And that's not really surprising. Because the prescription oral medications take a little while work. I mean typically, they take 30 to 60 minutes before they start working and therefore, preplanning before sex is required. Interestingly, aside here from another study that we've conducted with consumers is that 25% of people who take PDE5 inhibitors never actually get to have intercourse because I guess something changed between when they thought they were going to have intercourse and the 30 -- 60 minutes later, where they were not able to have intercourse. So we don't suffer that problem because our product does allow spontaneity in use. It's applied at the point you're actually having intercourse. So that's a key differentiation between ourselves and the competitive products. If we move on to the next slide. The other important difference between ourselves and tadalafil is that because oral tadalafil is a systemic product, you would expect systemic adverse events to occur, and this is what we found. So there's a little bit of background here with headache occurs in MED, a couple of subjects got headache through the 24 weeks of the study. That's not surprising, really. Because if you ask anyone, if I'd like to have a headache within a 6-month period, I mean, I think that's general, the level of incidences that you would get. But importantly, for tadalafil, 19.1% of the subjects experienced headache. We also got 2 instances of backache occurring with tadalafil. That is a known adverse event as well as headache. And we got 2 subjects and 4 instances overall of what was classified as noncardiac chest pains occurring with tadalafil. And neither got back pain nor any chest pains occurring MED, which is kind of what you'd expect, really. We had a couple of people who experienced a little bit of nausea. I don't think that was treatment-related. And then in the female population, again, the background noise on headache there, we got 3 subjects who've got a mild headache. Interestingly, it's not actually depicted on this slide here. But we did only get 1 instance across all the intercourse attempts in males of mild penile burning, just 1 instance. And in the females, we've got no local side effects that were incurring, 0. So very, very clean safety profile. And as to be expected with the oral systemic medicine tadalafil, you're getting some systemic side effects coming through. And also, I think it's worth pointing out that aside from the side effects that you get with the PDE5 inhibitors, there are also a number of adverse drug interactions that potentially could occur. So for example, PDE5 inhibitors are contraindicated in nitrate users. Nitrate is very commonly used to treat cardiovascular conditions. So that opens up the opportunity for people who are not currently able to use the PDE5 inhibitors, who would be able to use an effective treatment option, which is MED3000. So if I can summarize on the next slide, M3000 has been shown to be a clinically effective treatment for ED. In contrast to the PDE5 inhibitors, MED3000 has a fast onset of action, no significant side effects and no potentially serious drug interactions. Already approved throughout the EU and the U.K. as an OTC treatment. And in our belief, it's ideally suited to become the first major OTC clinically proven treatment for ED in the U.S.A. because all the oral medications are currently prescription. We move on to the next slide, which explains where we are on the journey from a regulatory perspective in the U.S. We've had a number of pre-submission meetings with FDA, 5 in actual fact. We've narrowed a lot of issues that were a source of debate between us and FDA and got agreement on them. We've got agreement to the clinical study, the protocol and the endpoints. So all that's behind us now. We've now completed the FM71 clinical, and we're on track for submission by the end of September. And because we had so many constructive pre-submission meetings with FDA, we're hopeful that we will get a very rapid review process, and we will get approval end of Q1 next year, 2023. So in conclusion, next slide. FM71, we're very, very happy about this. Very successful study, meeting all the primary secondary end points. Comparison with a leading prescription product demonstrates a favorable risk versus benefit profile. And successful completion of the study enables us to proceed with filing with FDA CDRH by the end of September 2022 as a de novo medical device with OTC classification, marketing authorization anticipated Q1 2023. So on that note, I'll hand you back to James and we'll draw things to a close.

Ken, thank you for that. And I know you and your team have got a huge effort in getting this study done, not only on time, but actually on budget, actually slightly under budget, which always keeps Angela happy. So I now on behalf of shareholders and the Board, would really just say thank you for doing a spectacular job.

Thank you, James.