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spk08: for listening today and thank you for your continued support of Lexicon. And I will welcome any questions you may have at this time.
spk09: Please open the line for questions.
spk06: Ladies and gentlemen, at this time, if you would like to ask a question, please press star, then the number one on your telephone keypad. Again, that's star one. To withdraw your question, press the pound key. We will pause for just a moment to compile the Q&A roster. Your first question is from the line of Igel Notamobitz with Citigroup.
spk03: Hi, Ronel and team. Thank you for taking the question. Ronel, I'm curious, what do you make of the fact that ESC included soda-biflozin in the heart failure guidelines in type 2 diabetes, even though soda is the only one that has yet to be approved in this setting?
spk08: Igel, great question. We were very pleased to have that happen. I think what they look at is the preponderance of evidence, of clinical evidence that has been published, and they make their decisions based on that overall evidence. And so we were very pleased that they accepted our evidence as it was in the absence of actually having it approved at this point. So it was a very significant win for us, and we certainly look forward to leveraging that win going forward as we seek regulatory approval.
spk03: And one for Jeff on the neuropathic pain programs. Jeff, could you just talk a little bit about what you need to see on the efficacy side in the two phase twos that you believe would be the kind of profile that you would need to advance 9-2-1-1 into pivotal trials in both diabetic peripheral neuropathic pain and post-therapeutic neuralgia?
spk01: Sure. So the first thing I would say, these are proof of concept studies. So these are the first studies that we've done in patients. So what we're really looking for is a signal in neuropathic pain in these studies. And then we'll be making decisions about next steps in development post that time period. So that's mostly what we're looking at is to prove the concept of AAK1 inhibition and neuropathic pain. And following that, we'll decide whether we can go or we need to do more dose ranging, whether we can go into, you know, some other phase two, three setting or the like. But that'll basically depend on the outcome of these studies.
spk03: And could you advance both, both into phase three, both indications, that is?
spk01: Diabetic peripheral neuropathic pain is obviously a much larger market opportunity than post-traumatic neuralgia. Obviously, we're going to look at the data from both of these studies. And I would just say that, you know, preclinically, we have evidence of an effect in multiple different areas, multiple different models of neuropathic pain. Our goal with this overall or what we would envision is that there is an opportunity across multiple types of neuropathic pain and would ultimately want to be developing it broadly across different types of neuropathic pain. So as we think about how to develop this further, we're going to be looking at that and looking at these first two proof of concept studies as launching point off for different elements of neuropathic pain. Great. Got it. Thank you.
spk06: Your next question is from the line of Yasmeen Rahimi with Piper Sandler.
spk00: Hi, everyone. It's Adeb on the line for Yaz. Thanks for taking my questions. I have a couple of questions here, so I'll just start out with the first one. So based on the efficacy data generated today from all the SGLT inhibitors and the recently updated EC guidelines, I was just wondering if you could just, you know, opine on how you think soda glyphosate could be positioned, if approved, And what would be the critical point of care for this drug? And I had an additional question after that.
spk08: Well, I think it's a great question, so I'm going to have Craig, you know, restate some of the things I think he carried forward in the presentation. Craig, your thoughts?
spk05: Yeah, thank you, Lynell, and thank you for the question. You know, we believe that the data set, as we went through in the data, particularly in the recent worsening heart failure, is differentiating at this point. and we'll really be the only one with that data, and assuming we achieve the outcome with the FDA regarding patient indication, that we will be indicated for that use. I think the data is compelling. We hope all of it that was presented today provides that background. But I think in summary, it is really the breadth of the data, the speed of the onset, and the magnitude of the benefit particularly across the patients with the range of ejection fraction and with the additional MACE benefit, particularly the stroke signal, and particularly with specific outcomes data in recent and worsening heart failure are three key milestones that others that have studied other agents in the SGLT class do not have.
spk00: Great. Thanks for that. And then my second question here. Do you think the initiation of sotagliflozin treatment in the hospital setting could resonate well with patients and could lead to better adherence compared to patients in the outpatient setting with less severe heart failure on SGLU2 inhibitors? And I just wanted to see if you've had any feedback from cardiologists who treat hospitalized HF patients.
spk08: Wow, that's a really, really good question. I'm going to turn it back over to Craig.
spk05: Yeah, we agree. You know, I've worked in the industry a long time. I've worked across products that were indicated shortly after discharge from the hospital and the patient goes back to the community cardiologist. I think what you have to remember in the group of patients with recent worsening heart failure is they're really teetering on a knife's edge. And they are really playing this very delicate dance between their kidney and their heart regarding the amount of fluid that is not too little that they go into heart failure because they don't have enough volume or too much and they go into heart failure because they've got too much volume. And so generally the hospitalization is to get the treatment right. As you can see, there's lots of drugs these patients are on, and this is just for their heart failure. They're on many other medications as well. So we believe that when the patient, to use the terminology in the hospital, gets tuned up, in the hospital, they don't want to change that regimen. Nobody wants to change that regimen when the patient shortly leaves the hospital, the patient, the provider, the payer. If the patient is stable when they leave the hospital and they spent a couple days getting to that point, everybody's incentivized to really give this new regimen a good try, a good trial. So we believe that's the ideal time because if you're trying to get the patient shortly after the discharge, who's going to stop and change the patient's care? It's a very timely and challenging clinical scenario. Get it right when they're in a hospital. Discharge them when they're in good shape, and hopefully they'll stay out of the hospital at least for 30 days, and hopefully much longer.
spk00: Great. I appreciate the additional color.
spk06: Your next question is from the line- Is there a third question?
spk00: I'm sorry. No, that was it. Thank you. Thank you.
spk06: Your next question is from the line of Jessica Fye with the JPMorgan.
spk07: Hey, guys. Thanks for taking my question. With this data for sotogliflozin, what's your latest thinking on a ex-US partner to help you maximize the potential of the product?
spk08: You know, Jessica, great question. Subsequent to the ESC guidelines, I would say that those interests have grown.
spk09: And so our confidence is growing that we most likely will get a partner outside the United States.
spk07: Got it. And have you tried to pursue breakthrough designation at all for SOTA? I think I saw that EMPA got it for HEPPF, so wondering if that's something you've got.
spk08: Yeah, we were very curious about it because generally breakthrough designation is assigned to phase two products where you have more engagement with the FDA around the program going into phase three. So we're a little bit surprised about that outcome. The other thing is that once you seek breakthrough designation, it sometimes can slow you down in terms of what you want to accomplish. So for us, you know, we've made the decision to just push ahead. and go as fast as we can to get the NDA submitted. They were in a unique position because the product was already in market. They only really had to do one additional study for SNDA, where we have two very significant studies. And so it takes a little bit more work for us to get that done. But I'm very pleased to see they got a breakthrough designation. It just, to the point we've made earlier, it just puts more emphasis on SGLT class being an incredibly important class for heart failure. And from our perspective, they can lay the groundwork and lay the path, and we'll be happy to get on that path and run with them because we believe the market is absolutely going to grow astronomically.
spk07: Okay, got it. Maybe shifting gears, is it possible to refine at all your expectations for timing for the pain data?
spk08: No, I think we're going to stick with first half of next year. You know, I have not been silent about we've had some challenges around recruiting as we started this study in the middle of the COVID challenges and trying to get patients out of the house and into these studies. So we expanded the timeline to give ourselves a little bit more time to get it right. The second thing that was important was to make sure we work with our CRO who also may have had some challenges along the way that we needed to iron out. And I think at this point in time, we just have to take the time and effort to make sure we enroll the right patient, because as you know, CNS studies tend to have a very high failure rate, and a lot of that is because patient selection. We don't want to put ourselves in that category. Our best effort here, as Jeff has said, is we're looking to get a signal, and the best way to do that is to have very tight inclusionary and exclusionary criteria so we can get that signal and better understand how best we go from there.
spk06: Got it. Thank you.
spk09: You bet.
spk06: Again, to ask a question, please press star 1 on your telephone keypad. Again, that's star 1. Your final question is from the line of Joseph Stringer with Needham and Company.
spk02: Hi, this is Ben Ricard, speaking for Joey. Can you just, I think you already pretty much reviewed this, but if you could just kind of talk, what would the potential psilocybin label in heart failure look like? In other words, how would you see that really positioning the drug?
spk09: Great question. I'll turn that one over to Craig.
spk04: Thank you for the question.
spk05: It really is very much similar to the two populations that were in the New England Journal of Medicine papers and we described today, is that we are seeking two different populations, both of which with the similar endpoints of heart failure defined by cardiovascular death, hospitalization for heart failure, and urgent unscheduled visit. in both a high-risk group of patients with diabetes and other risk factors for major cardiovascular events and heart failure, and for patients with recent and worsening heart failure for heart failure-related events. And that is really the path that we are taking with the agency, and we believe we've got the data as we walk through with you the two clinical studies that would support those two distinct populations as we tried to show in the stylized graphic, both of which have the heart failure endpoints as their primary endpoint.
spk04: Great, thanks.
spk02: And just another question, if you could just talk about what it would take to commercialize Cetagliposin for heart failure on your own and what would be the next steps in terms of building out commercial infrastructure?
spk08: Yeah, great question. I'll start and I'll turn it over to Jeff. We've already started. I think we have to move a lot faster than we have moved historically. Based on our engagement, as I've said in the last call, based on our engagement with the FDA, based on what I think Jessica questioned around breakthrough designation that one of the others have received, we fully expect that we're going to be on a pathway where this drug will be in market much sooner than later going into next year. So for us, we have to start that build out much sooner than later. So this year, we've already started. And so from there, we'll be uniquely positioned once the product is submitted and once we certainly get the designation that we're looking for after we've submitted the NDA, I think you'll see us move even faster. We're laying the groundwork now that allows us to have those trigger points where we can pull the team on pretty fast. I'll stop there, and Jeff, I'll let you add anything you want to add from there.
spk01: Sure. I mean, we're building out our leadership team right now. We expect to have some people in. We already have some people in. We're expecting some others in before the end of the year, and we're engaged in a number of activities with external collaborators and partners to be well prepared for launch. A lot of what we do will be tied into, you know, to the NDA submission acceptance, which will be happening over the course of the end of this year, beginning of next year for the acceptance. But we are already doing a lot of the work to get ready. We were a relatively short time period off from launch, so those preparations need to be underway, and they are.
spk02: Awesome. Thanks. I just have one last quick one. Do you think there's any additional gating factors for the NDA submission? No.
spk09: Get it submitted. Thanks for the question. Turn it back over to Opera if there's other questions.
spk06: There are no further questions. Are there any closing remarks?
spk08: Yeah, let me take a moment just, you know, thank everybody for joining us. It really is an exciting time here at Lexicon. We're managing multiple priorities, and we're very fortunate as a fairly small company with multiple priorities. So we're very, very, very pleased about that. I think that the ESC guidelines have played out the way we had hoped, and I believe the American Heart Association may follow suit in the future. It really is laying the – is laying down the future for what the SGLT class can do. We believe very strongly we have found a very unique position for soda-giflozin that we can carve out at the point in which there is a great need for change. And I think we've tried to describe that today, where that is. And when we look at that very clearly and concisely, we know that we can hire a fairly very well-talented and ready group of folks that can get into that space and make a big difference. We certainly will punch above our weight grade. I feel very confident about that. The first big decision we made, I think, to move into this space, you heard today, that was Dr. Granowitz, who we brought on in August, and we haven't slowed down since then and will continue to bring in the talent that's necessary for Lexicon to make a big difference as we go forward. We're keeping a very close eye on 9-2-1-1. I think this could be something remarkably special, and we'll have to make sure that we stay very diligent about how we manage the clinical program and not try to rush it and make sure we get the signal that we're looking for. So stay tuned. We have much more to say. And last but not least, we have been engaged with the FDA around T1D type 1 for Sotagiflozin. We will characterize those conversations as we have, you know, future closure on some of those conversations that I think will be coming forward in the near future and make sure that we call that back out. So a lot of good things happening at the company. We're going to have to manage it all the way through, but we're very confident that we'll go into 2022 well positioned to take advantage of those opportunities.
spk09: Thanks again for listening and we look forward to the next call.
spk06: This concludes Lexicon Pharmaceuticals third quarter financial results conference call. Thank you for participating. You may now disconnect.
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