Lexicon Pharmaceuticals at Needham Conference: Strategic Shift in Focus

On Wednesday, 09 April 2025, Lexicon Pharmaceuticals (NASDAQ: LXRX) presented at the 24th Annual Needham Virtual Healthcare Conference. The company outlined a strategic pivot towards research and development, highlighting both recent successes and ongoing challenges. While partnerships and a robust pipeline are promising, the company also faces competitive pressures in certain markets.

Key Takeaways

• Lexicon is focusing on R&D with a leaner organizational structure to extend its cash runway into 2026.
• A significant partnership with Novo Nordisk for an obesity asset (LX9851) is expected to enhance clinical and commercial success.
• Pilobapentin shows promise as a potential first non-opioid treatment for diabetic peripheral neuropathic pain.
• Sotagliflozin is being developed for hypertrophic cardiomyopathy, with ongoing trials supported by Viatris.
• Lexicon ended 2024 with $238 million in cash, providing financial stability for future endeavors.

Financial Results

• Lexicon reported a cash position of $238 million at the end of 2024.
• The company anticipates a cash runway extending comfortably into 2026.
• This projection excludes potential revenue from ongoing partnership discussions.

Operational Updates

• Lexicon has restructured to focus on its R&D portfolio, emphasizing innovative pipeline development.
• A notable deal with Novo Nordisk for LX9851, a preclinical obesity asset, highlights partnership potential.
• Pilobapentin's Phase 2b study showed positive results, with Phase 3 trials planned for 2025.
• The SONARA trial for sotagliflozin in HCM is progressing, with Viatris aiding regulatory efforts outside the US and EU.
• Commercial operations for Mpefa in heart failure have been closed due to market competition, although the product remains available.

Future Outlook

• Full data from the pilobapentin study is expected soon, with an FDA meeting planned to discuss Phase 3 design.
• LX9851 will undergo IND enabling studies, allowing Novo Nordisk to proceed with clinical trials.
• The SONARA trial for sotagliflozin is actively enrolling, with all Phase 3 sites anticipated to be operational by Q3.

Q&A Highlights

• Key discussions with the FDA will focus on pilobapentin's 10mg dose efficacy and Phase 3 trial design.
• The Phase 3 trial for pilobapentin will include a two-arm design, aiming to reduce placebo response.
• Confidence in sotagliflozin's success in HCM is bolstered by SCORED data and mechanistic studies.

Readers interested in more detailed insights can refer to the full transcript below.

Full transcript - 24th Annual Needham Virtual Healthcare Conference:

Joey Stringer, Biotech Analyst, Needham and Company: Good morning, everyone. Thank you for joining the twenty fourth Annual Needham Healthcare Conference. My name is Joey Stringer, and I'm one of the biotech analysts at Needham and Company. It's my pleasure to introduce our next presenting company, Lexicon Pharmaceuticals. Joining us today from Lexicon is CEO, Mike Exton CFO, Scott Conti and CMO, Craig Granowitz.

For those of you joining on the webcast, if you would like to ask a question, please do so at any time. You can ask a question using the chat box at the bottom of your screen. With that, we'll get started. I'll turn it over to Mike for the presentation, and we'll follow-up with a bit of q and a.

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. Great. Thanks so much, Joey, and pleasure to be with all of you this morning. Really look forward to having a great discussion. So let me see if I can get this moving.

So, yeah, today, I'll likely give some forward looking statements and remind everyone to refer to our public filings if they want further information. And, at the end of last year, Lexicon went through a reorganization to really focus on our R and D portfolio, our innovative pipeline. And we're seeing great success for that already in quarter one. As a result of that, we've really come to a situation where as a company, we have a portfolio of diversified assets. We have, great candidates, lead candidates in the broad cardiometabolic space.

And each of those have significant partnership potential. And we've seen evidence of that already as, you've, probably seen recently. We signed a very significant deal for one of our preclinical assets in obesity with Novo Nordisk, which really gives it a great opportunity of clinical and commercial success. And each of these opportunities have, multiple indications, aligned with them. And we're able to take advantage of those assets because we have an incredibly strong development expertise led by Craig, and his team which designed very pragmatic, very effective trials that really get to strong evidence generation and allow us to provide our partners and clinical experts with the information that they need to take these medicines forward.

And we can do that now as a restructured lean organization where we've removed essentially most of the commercial organization promoting MPEFA, and I'll talk in a little while around how we're taking MPEFA forward. And that allows us to really focus our efforts, focus our efforts as a development company, continuing to provide value and evidence generation of our lead candidates, in a way that, has a great cash preservation now and really with significant cash runway into 2026. And so far this year, we've got a number of, strong catalysts and I'll talk to you about some of the performance that we've seen already both for pilobapentin, our asset for diabetic peripheral neuropathic pain, for sotagliflozin where we continue to enroll in our hypertrophic cardiomyopathy trial, SONARA, and for LX9851 as we continue to execute the IND enabling studies to enable Novo Nordisk to file the IND and move into the clinic. You know, Joey, what's important with our medicines in the portfolio is that they're all simple molecules. They're all small molecules.

They're all oral medicines dosed once daily. And aside from the dosing benefits that that gives you, it also allows these medicines to have the potential of each one being a pipeline in a pill. And we've already demonstrated that for sotagliflozin, where we have, we've got an approved label for heart failure in The U. S. And are now working with Viatris, our commercial partner ex U.

S. And ex Europe, to file in a number of countries this year. We continue to have studies underway that will generate more information supporting, further label expansion, for sotagliflozin. And, additionally, now, the pivotal phase three trial for, hypertrophic cardiomyopathy, with that medicine that's ongoing and we expect to conclude in the not too distant future. You know, following from sotagliflozin, importantly, we now have pilobapitan which read out the phase 2b study, just recently in the first quarter of this year.

And we're planning the phase three pivotal trials to initiate in 2025 in diabetic peripheral neuropathic pain, which is the lead and largest indication for pilobapentin. But there are many other indications, for this particular medicine as well. We've, got proof of concept data, phase two data in post hepatic neuralgia. And we have very compelling preclinical evidence in a range of spasticity indications including, MS and spinal cord injury. And then finally, LX9851 as you see at the bottom of the screen, which I mentioned, we've recently, executed a worldwide exclusive license to Novo Nordisk, for that asset.

We're, continuing the IND enabling studies and Novo will then take that forward not only in obesity, but there are a range of, other associated cardiometabolic, indications that are possible with this medicine. So you see a portfolio of medicines that, not only is diverse in the types of assets that we have, but within each particular medicine a range of indications that allow for this pipeline in a pill, approach with each of them. Now as I turn to the most recent advancement that we've got in our portfolio, and there's been a lot of, exciting stuff already in quarter one. Where in quarter one, we, completed the progress Phase 2b dose finding study. This study really set out, to achieve, a few things.

Firstly, to show that the loading dose that was included in the original phase two study was associated with the tolerability issues that we saw in that study. And, as we saw as progress read out, that indeed was the case because in the ten milligram arm, the tolerability was placebo like that was incredibly clean, which is important in this, disease state. But secondly, to find a single dose that we would take into, phase three studies, and we achieved that with the ten milligram arm. The ten milligram arm, separated significantly from placebo, whether it be the ten milligram straight in green or the, twenty milligram dosed for a week, followed by a ten milligram maintenance dose there in blue. This study did not hit its primary endpoint because it assumed as a part of the statistical analysis that all, doses would separate from placebo.

And that wasn't the case for the twenty milligram straight arm, which, we hypothesized and we're collecting the information, in the follow-up four week safety follow-up right now that this was, associated with a higher dropout rate from the twenty milligram arm and a greater level of dizziness. And those then, caused the lack of separation from placebo. But, you know, when we look at the time curves that we see with the ten milligram cooled arms here shown in blue from, from placebo, we see a significant separation very early in the treatment paradigm. At week two, the ten milligram arm already separates from placebo showing a reduced, pain response, reduced pain level, in those patients taking the medicine. And this continues to separate as we go through week eight.

That gives us a lot of confidence in taking the ten milligram arm, which now has been shown across multiple studies to separate significantly from placebo, and now has a very clean tolerability profile, which is very important in this disease state, to take that through into the phase, to the end of phase two meeting with the FDA. And we're looking forward to doing that later this year to presenting to them the data package and our thoughts for what the pivotal trial should be, which as we've said publicly a number of times now is going to be a very simple Phase III program. That's incredibly important in placebo controlled trials that we expect the phase three studies, to be a simple placebo versus ten milligram, design, which allows efficiency of getting the studies done, but importantly should also mitigate some of the placebo response that we see in multiple drug arm studies such as in progress. So why is all this important for us in neuropathic pain and DPNP in particular. Well, I mean, this is just a massive market, first of all.

There are currently nine million people in The US alone with a diagnosis of DPNP. You know, this is a market that is incredibly unsatisfied, incredibly dissatisfied. More than half of the patients have tried multiple treatments. In fact, they don't stay on current treatments for very long. They cycle through, the gabapentinoids, duloxetine, and in many cases opioids because they just don't either get the, pain relief that they're looking for, or they suffer from side effects, dizziness, nausea, and other tolerability issues that really make it untenable for a long term treatment paradigm.

So it's a completely dissatisfied market that has seen no innovation for two decades. It's a patient population that's crying out for new options. And this combined with the fact that, as I mentioned, there's a pretty significant opioid use in this population, about 20% of all scripts written for DPNP are an oral opioid. And we've got a situation now where there's political tailwinds such as the Alternatives to Pain Act or the No Pain Act, which will facilitate the pathway of new medicines, new non opioid medicines in neuropathic pain through the managed care process and into the market. And really getting as we have here with pilovapentin, the potential to have the very first non opioid oral medicine in neuropathic pain, offers a significant commercial opportunity where there are likely very few, if not zero competitors in this marketplace.

So having a new option, being the first one and potentially only medicine in this space, offers Lexicon an immense opportunity, not only commercially, but also to bring significant relief to patients. Let me just pivot to talk about what we're doing with sotagliflozin now. As I mentioned, towards the end of last year, we closed down essentially our commercial operations for Mpefa in heart failure due to the current competitive dynamics. But we still have Mpefa on the market. We've got the tools in place to support the ongoing use and commercial availability of Inpefra in the market, albeit with a skeleton staff, so to speak.

But importantly, our efforts with SOTA continue because we believe that when we see the results from Sonata, our phase three trial in hypertrophic cardiomyopathy, we have an incredible opportunity to take advantage of this medicine. In the meantime, as I mentioned, we continued the Sonata trial. We continue to support our partner ex US and ex EU, Viatris, to do the regulatory filings that they need to do to launch this medicine in their countries. And we expect a number of those filings to take place this year. But, importantly, the evidence generation for SOTA and building the differentiation for the time that we launch in hypertrophic cardiomyopathy is ongoing.

And all of these trials which are not actually funded by Lexicon, they're all funded by third party partners, are really differentiating Lexicon not only in the spaces that they operate, but, also from the other SGLT inhibitors. And perhaps the best example of that is the recent publication in The Lancet, where it was demonstrated for the first time that sotagliflozin and only sotagliflozin, reduced, MACE, MI, and stroke, significantly reduced MACE, MI, and stroke. And this is an effect that is not seen with other SGLT two inhibitors. And this differentiation will be incredibly important, not only for, soda in HCM, but also in in heart failure as we march toward towards a potential launch in, hypertrophic cardiomyopathy. And let me just speak about HCM a little bit here, Joey, because, you know, there's a lot of interest in HCM at the moment, and rightfully so.

Like in neuropathic pain, it's an area where there are very few treatment options at the moment. You know, as you see in in the gray there, patients, these are the approved, agents at the moment. Currently, people start out on a beta blocker or a calcium channel blocker, and oftentimes, the the effectiveness of those medicines is is not particularly great. And there are currently, or there is currently one cardiomycin inhibitor mavacamten or Camzius on the market. And there promises to be more as some companies bring other CMIs to the market.

And that's attracted a lot of attention and rightfully so because it's giving a new option in what is a large market. This is a market with over a million patients currently, about seventy percent of those have obstructive HCM, for which the, CMI seem to be very effective. It's unclear yet or unknown whether they'll be effective in non obstructive HCM. And the cardiomyocin inhibitors are being used. Now, they are being used, but there's a number of limitations that come alongside the use of a CMI.

As you know, they have a pretty significant Kamsios and we'll see, what happens with africanctin. They have pretty significant REMS attached to them that involve significant logistics for any treating site. And rightfully so because, the CMIs do, have pretty significant drug drug interactions that need to be, accommodated. And as you can imagine, these patients do take a number of concomitant medications. And in fact, that, also about a fifth of these patients, actually turn into systolic heart failure with, EF drops, below fifty five percent.

So that results in a number of tests, a lot of echos that need to take place, and all of these, elements together, with the pricing approach that these medicines have taken means that it's a very specialized utilization. And in fact, BMS, reported in the end of, 2024 that they had ten thousand patients on Kamsios currently. I mean, that's less than one percent of the total population. So the utilization of CMIs, in my opinion, will continue to be pretty restricted, to academic centers who have the staff, who have the capability, and frankly, the patients to go through all of the, the testing and and monitoring requirements that's involved in the CMI. And that really leaves the blue opportunity for other medicines.

And at the moment, sotagliflozin is the only other medicine being investigated in hypertrophic cardiomyopathy. And really, we see sotagliflozin as living alongside the CMIs and the beta blocker and CCBs, Not necessarily as a competitor, but, really occupying a very different space. It's a class that is very well known. It has limited side effects. We expect Sonata to read out positively, so it'll have great impact on the quality of life and symptomology of these patients.

And importantly, we believe as Sonata is set up, looking across both non obstructive and obstructive HCM that this potentially could be the first medicine with an indication for non obstructive hypertrophic cardiomyopathy. Now from a pricing perspective, it's important to note this will be a very different situation to what we experienced in heart failure. Whenever you become a first in indication medicine, unlike in heart failure where you have a number of SGLT inhibitors approved, for that particular indication, the discussions with PBMs and other payers are very, very different. And so we expect that when and if Sonata ends up positive, we have an opportunity to launch this medicine. This has the potential to be a very, very significant medicine in Lexicon's portfolio.

And finally, let me just touch on LX nine thousand eight hundred fifty one, which I mentioned, is again an oral small molecule dosed once daily for obesity and related indications. Novo Nordisk was, incredibly impressed by this asset as they themselves see the future of, weight management moving into oral therapy as well as, non incretin therapies or combination therapies with GLP-1s and other incretins. And so we're really happy to do this deal with them. We think we have the perfect partner to take this medicine forward into the clinic, and realize the potential of the asset. And just to show you what they saw, this is just one piece of data of the importance of this medicine.

As you see, semaglutide shown there in the blue and green bars significantly reduced, weight in high fat diet, mice. But when you remove semaglutide in the blue bars shown there circled in red treatment withdrawal, of course, you get a rebound back baseline levels of weight. But if you replace semaglutide with LX9851, you get a maintenance of the weight reduction, which was one of the elements alongside the synergistic weight loss that you see between semaglutide and LX9851. So they're very compelling preclinical evidence that excited Novo to do this deal. And really, I I think that deal just just recently announced shows our willingness and ability to make the most value of our medicines, for patients, for other pharmaceutical, strategic companies, and frankly for all shareholders.

Because initially when we did the Viatris deal at the end of last year, that was a significant opportunity for us to capitalize in geographies that we don't operate. And now, having a worldwide exclusive license with Novo enabling us to take forward medicine that, really, they have the absolute world expertise to continue to develop and commercialize, provides us with a great financial position and a great pathway, over the next decade to continue to maximize the opportunity in our portfolio. But nonetheless, we've got a lot of great things coming up this year, Joey, for pilavapitan. We're going to have the full progress data in the not too distant future. As I mentioned, we've got our end of phase two meeting coming up soon.

We're going to present that all at an upcoming medical meeting. For 09/1951, we're going to complete the IND enabling studies this year and, enable Novo to complete the IND submission. For sotagliflozin, Sonata is enrolling at full speed. We've got sites now in The EU and LATAM. We expect that all the phase three sites will be up and running by q three, so Sonata will be firing on all cylinders.

And for heart failure in, in SOTA, we continue to support Viatris and we have a potential type c meeting to look at that MACE data and see if that's something that can be incorporated into the label. And finally, for sotagliflozin, for Zynquista, we will, have our end of review meeting in the not too distant future with the the agency as well. So really a lot going on for us, Joey. Look forward to having a further discussion with you with with Craig and Scott here as well.

Joey Stringer, Biotech Analyst, Needham and Company: Great. Thank you so much, Mike, for the presentation. To members of the audience, once again, if you'd like to ask a question, you can do so anonymously using the chat box at the bottom of your screen. Get started with a a couple for me, Mike, and others. Heading into the LX 9211 end of phase two meeting with FDA, what are some of the key, questions or aspects of the phase two pain data that you'd like to discuss with, FDA?

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. I think the the the first piece is, obviously confirming our confidence in the ten milligram dose, that we see that that is a dose that is, both from an efficacy and tolerability, perspective, worth taking forward, as well as how we see the Phase three design. I think what we feel very confident with now is that we've really refined the design in such a way that allows us to be confident that we can continue to design trials that will separate from placebo. So really, it's just confirming, a continuation of the trial design that we will continue to, incorporate patients that have, background standard of care as a part of the trial design. We think that's really important, because it's pragmatic, it's how patients are treated in the real world.

And we are believers in enabling patients to continue on their single background pain med, so that you don't wash them out and get this artificially high baseline pain score. So that will be the the key elements that we're going to take forward.

Joey Stringer, Biotech Analyst, Needham and Company: Got it. And and I guess, could the phase two b trial potentially serve as maybe one of the pivotal trials? What are your thoughts on that?

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. That that's not our base case, Joey. We we think that we will need to run, two phase three trials, two confirmatory trials. If one of those comes out that it could require some supporting evidence from the phase 2b, it could potentially be supporting evidence, but we don't expect that the PROGRESS trial will form one of the pivotals.

Joey Stringer, Biotech Analyst, Needham and Company: Got it. And Mike, you touched on it earlier in terms of what you're thinking about a potential Phase III design. Anything else you can provide on, design here in similarity to the phase two b? Thoughts on powering and effect size, types of patients enrolled, inclusion, exclusion criteria, background and things like that.

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. No. No. Great question. We look.

We think that, as we've said publicly before, that, this is likely to be a two arm design, around 300 patients per arm, 300, three 50 patients per arm, which is interesting because it's not too dissimilar, in fact, in size, to the PROGRESS study, albeit with just two arms. So significantly powered to see separation from placebo. We will likely power it for a separation as we've done in the previous phase two studies. But really a lot of the other conditions should remain pretty consistent. Having said that, the execution of the trial, I think we will really dig into the data in some granularity, to see, are there any other potential ways that we can continue to reduce that placebo response?

So it it it's it's it's an important, but, somewhat overlooked aspect of of pain trials that the more active arms you have in the trial, Joey, and this is published, in a lot of literature, the higher the likely placebo response. And it makes sense, right? If you're a patient and you come into a trial and three of the four arms are active, and you know that, of course, because you signed the informed consent, then you're already thinking there's a high likelihood I'm going to be put on an active treatment. And we did this very deliberately so that in the phase three pivotal trials, we end up with only two arms. And that in itself has the effect of reducing the expectation, which as we know is a significant part of the placebo response in the Phase two trial.

So that really is going to be a very important aspect for us. But we'll less so in the design, but in the execution. As you know, there were 18 new sites that we bought on for the PROGRESS trial that, we'll take a look at and, ensure that they were really, executing the trial to our expectations. But you know, overall, I think the design will be very similar to what we've seen, in the previous phase two studies.

Craig Granowitz, CMO, Lexicon Pharmaceuticals: Mike, can I add a couple comments as well? Yeah. Yeah. I think, Joey, one of the things that we really wanna make sure that we reinforce, and this is something we've heard very strongly from the patient groups and the medical community, is patients and their providers assess the reduction in pain of patient to baseline. So, you know, what Mike was really focusing on appropriately is our discussions with the regulatory authorities, which is gonna be the placebo adjusted reduction in score.

And there, as Mike mentioned, we're powering the study similarly to what we've already done and achieved twice, is really that, reduction in pain score, which is similar to what pregabalin has experienced historically against placebo. But when you look at the progress study, the patient to baseline was 1.75 points in reduction in pain score. Importantly, and some of the other elements that we're gonna reinforce in the phase three in our discussions with FDA, is the tolerability is that the completion rate of patients was identical to placebo. So eighty eight percent of patients on the ten milligram dose arm completed treatment, which was identical to one tenth of one percent of what was achieved with placebo. So we have a really well tolerated drug with few to no drug drug interactions in a group of patients that have significant drug drug interactions.

We also believe that we're gonna have significant, ability to enroll even a broader group of patients based on some of the additional supportive work that we're bringing to bear. We also think some of the secondary endpoints such as, burning pain, which we've showed briefly, sleep interference are gonna be very important supportive points that could be very important in promotion. So I think these are the kinds of things, particularly in light of a breakthrough designation that we have with the FDA, that allows us to have quite a bit of dialogue with the agency that we hope that we can bring to bear as a very important novel option for patients with neuropathic pain.

Joey Stringer, Biotech Analyst, Needham and Company: Got it. Thanks, Greg. Excuse me. That's very helpful. In terms of the asset itself, nine two one one, what are you thinking in terms of potential partners?

Obviously, you'll wanna have your end of phase two meeting, get the phase three trial program hammered out here. But do you plan to take it forward yourselves into phase three, or are you in active discussions with partners around the program?

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. We're we're in active discussion with, quite a lot of companies at the moment to really take them through, data beyond what we've, shared top line, to help them understand the context, the commercial opportunity. I think, as I mentioned in the presentation, this is an area where, as Craig was saying, you know, we've got sort of two objectives. One from a regulatory objective, what do you need to demonstrate to regulators? But then what do patients in the market need, particularly in this area where you're a potential first to market in an area that hasn't had any innovation for two decades and has this, real, if you like, political tailwind against oral opioids, you know, helping, partners understand that from a commercial opportunity.

But as we've said to these partners, you know, we think that we have developed a really strong development expertise in this area. Running trials in neuropathic pain, is complex, for the reasons of placebo control, of, there's a number of factors that you need to be very, careful with. And we think that, you know, having a partner that can maximize the commercial opportunity of this particular medicine because it's a multibillion dollar opportunity. It's a multibillion dollar market currently and it's fully genericized. A partner that can take advantage of that, but at the same time that we can work with to continue to develop the breadth of indications makes sense.

But we certainly intend on having a significant piece of this asset moving forward as well.

Joey Stringer, Biotech Analyst, Needham and Company: Got it. Well, I wanna ask a couple of questions on HCM. First one is on sotagliflozin. You haven't specifically evaluated the drug in just HCM patients prior to the phase three trial, you know, in your traditional phase two, phase two b sense, of the word. So I guess, what gives you confidence that the, in the phase three trial success?

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. Great. Great.

Craig Granowitz, CMO, Lexicon Pharmaceuticals: Great question, Joey. You know, we we've done a lot of analysis of the SCORED data set, which is, you recall is about 11,500 patients. We look specifically as a starting point at the group of patients with, left ventricular hypertrophy and normal blood pressure. That group probably contains quite a significant percentage of patients with non obstructive HCM. And in that regard, we showed a fifty percent reduction in both heart failure events and a fifty percent reduction in stroke in MI events.

Those numbers are even more impressive than the overall sport population, overall that included, you know, all all of the eleven thousand five hundred patients. It was not a small sample. It was over five hundred total patients. We've also looked mechanistically, and some of this data was presented by, doctor Charlene Day at There are two major fundamental issues that seem to be at play in HCM hearts. The first is that there is an overdynamic, use of energy, in those hearts.

The second is that there is diastolic dysfunction. And we've demonstrated with soda an impact on both of those. And in fact, some of the data that Charlene's team, doctor Day's team presented at and was is gonna continue to present throughout the year, is that if you take explants of human heart tissue from surgical excision of obstructive HCM patients and you put it in their model system, you show a reduction in overall cardiac work. And we also know from a lot of other studies that use of sotagliflozin is associated with a improvement in diastolic dysfunction. So we already know his his overall, the drug works to reduce heart failure events, reduce MACE events, has no impact on A fib.

We've now demonstrated in HCM hearts a reduction in work. We know that the drug is associated with improvement in diastolic function. So we we are continuing to run additional mechanistic studies, but we have a very high degree of confidence that the drug is gonna work in this subset of Hefkef. And, you know, as as we've shared with you, Joey, and your listeners on a number of occasions, we believe that the direct effects of SGLT one inhibition on the heart and on the platelet and endothelium are associated with a continuous improvement of soda to reduce heart failure events across the entire range of ejection fraction, which is not something that you see with SGLT two inhibitors where you seem to have a a reduction in benefit as ejection fraction approaches near normal ejection fraction. So, again, all of these are indications as well as the fact that the primary endpoint that we've negotiated with FDA, which is an improvement in KCCQ, is something that we feel quite confident that we can achieve in the trial and similar to the range on a placebo adjusted basis that the CMIs are are, achieving in, obstructive HCM.

Sorry for such a long answer.

Joey Stringer, Biotech Analyst, Needham and Company: No. Very insightful, and, thank you for for the color. Very helpful. One last quick one. We're running up on time, but the thoughts on cash position and cash runway and what readouts does this get you through?

Scott Conti, CFO, Lexicon Pharmaceuticals: Yeah. Thanks, Joey. We ended 2024 with $238,000,000 in cash. And as Mike alluded to on the one slide, we're fully funded to achieve all those milestones and catalysts outlined on the one slide that he went through. And we are, you know, have cash runway comfortably into 2026.

And, again, that excludes any, potential results from partnering discussions that that we've, indicated are ongoing at this time.

Joey Stringer, Biotech Analyst, Needham and Company: Great. Well, Mike, Craig, and Scott, thank you so much for the presentation and the excellent discussion.

Mike Exton, CEO, Lexicon Pharmaceuticals: Yeah. Thanks for having us, Joey.

Craig Granowitz, CMO, Lexicon Pharmaceuticals: Pleasure. Thank you, Joey.

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