Our next company is LB Pharmaceuticals, traded on the NASDAQ under the ticker symbol LBRX. We cover LB with a buy rating and 12-month price target of $45 per share. It's my pleasure to welcome Heather Turner, Chief Executive Officer. Heather, it's a pleasure to have you with us today. It's a pleasure to be here. Thank you so much for having me. I don't want to steal too much of your thunder. I can obviously, as many in our audience know, talk incessantly about neuropsychiatry, generally speaking, and amisulpride in particular. Suffice it to say that LB is a rapidly advancing biopharmaceutical company focusing on the development of LB-102, a novel benzamide antipsychotic built upon the science of amisulpride. LB-102 is classified as an N-methylated analog of amisulpride, which has been used for decades in treatment of neuropsychiatric conditions, ex-U.S., but which was never approved in the United States. It is important for our audience to understand and remember that LB-102 is a chemically distinct compound with its own foundational composition of matter protection IP, among other patent claims. Maybe, Heather, you could talk a little bit about how the story of LB Pharmaceuticals came together, what the key unique attributes of LB-102 are relative to native amisulpride, and how LB is looking to optimize the value of this very intriguing compound, particularly in the context, of course, of its risk mitigated profile and well-established mechanism of action across, and I want to stress this, multiple neuropsychiatric conditions of significant commercial value. Sure. Happy to start with the beginning here. The company was founded in 2015 by three different founders, one of which was a pharmacist in the prison system and had familiarity with amisulpride. The group of them set out to see if there was an opportunity to bring it to the U.S. As you mentioned, it was never approved in the U.S., it was often lamented that it wasn't available. The founders looked at the various different IP landscape and the opportunities to really try to create a molecule that was a new chemical entity, issued composition of matter IP, really was an improvement and a novel advancement of amisulpride. They did this through methylating the molecule, that methylation allowed for more efficient transportation across the blood-brain barrier, which is really one of the biggest limitations of amisulpride. As a result of this methylation, LB-102 is a much more potent molecule. We were able to determine that about 50 mg of LB-102 is about the same as 400 mg of amisulpride, this is based on the dopamine receptor occupancy data that was generated. For amisulpride, it's dosed between 400 mg and 800 mg in schizophrenia. For LB-102, it's dosed between 50 mg and 100 mg. Importantly, the molecule is more potent, which allows for more penetration into the brain, which means you have less peripheral exposure. We think that this can lend to an improved tolerability profile. In addition, the molecule, LB-102, resides in the CNS longer, an improvement there results in LB-102 being able to be dosed once daily, whereas amisulpride has to be dosed twice daily. In these patient populations, it's very valuable to have once-daily dosing because of the challenges with adherence. We have this more potent molecule, once-daily dosing, we are able to keep the receptor binding profile. One of the attributes of amisulpride is that it has a very nice tolerability profile. It has one of the lowest all-cause discontinuation rates among the approved antipsychotics. We think this is because it has very few off-target effects. LB-102 is very similar in this way. It targets D2, D3, and 5-HT7, really nothing else. We have this opportunity to have what we believe to be a very nice balance of both efficacy and safety. The receptor targets are actually important to the foundational value proposition of LB-102. The target D2 is important for suppressing dopamine, which is really what you need to do in indications of psychosis or mania. The target of D3 and 5-HT7 is important because those are known to be procognitive and antidepressant. This is really what gives us an opportunity to move into development in the mood disorders, which really expands the TAM. Another important attribute of both LB-102 and amisulpride is the fact that it has a bimodal activity. What I mean by this is, at low doses, both LB-102 and amisulpride preferentially engage with the presynaptic autoreceptors that are implicated in mood, cognition, and anti-depression. What this means is that at high doses, it actually suppresses dopamine. At low doses, it actually triggers the release of dopamine. This is yet another reason to believe that we'll have a nice effect in the mood disorders. You see this in the way that amisulpride is used. At high doses, it's used in schizophrenia. At around 100 mg-300 mg, it's used in bipolar disorder, as well as negative symptoms. Then at very low doses, 50 mg, it's used in depression. You'll see with our clinical trials for LB-102, it's a very similar dosing scheme. Only all those levels are stepped down because of the improved brain bioavailability, right? That's right. In schizophrenia, the doses that we're using in our phase III trial, which is currently ongoing, is 50 and 100 milligrams. In the bipolar depression trial, which is also ongoing, it's 25 and 50. In the soon-to-be started adjunctive MDD trial, we're targeting doses of 15 mg and 25 mg. A very similar dosing scheme. I think, just to point out to our audience certain salient features of the target markets and historical context within neuropsychiatry that I think are important to delineate. As you mentioned, atypical antipsychotics have been mainstays of therapy, in particular schizophrenia, for a lengthy period of time. Many of these widely used, and I want to stress that, widely used, widely deployed drugs today bedevil the patients that they treat with a litany of off-target side effects. Extrapyramidal symptoms, akathisia, sedation, weight gain, metabolic syndrome, prolactinemia, et cetera. Many or most of these are simply not issues, historically has not been considered issues with amisulpride, and would not be considered problems with LB-102. From a safety standpoint, it has a very differentiated profile, a very different kind of pharmacological signature versus existing well-known atypical antipsychotics. In addition, I think it's important to note that when we think about the schizophrenia indication, I've looked at a lot of different atypicals over the years, the approval requirements are very clearly delineated. You need effectively two clinical studies. I think it's important here to delineate where LB is in the clinical development continuum for schizophrenia specifically, because you have already generated one potentially registrational clinical data set. This effectively strongly informs the clinical program that is currently the subject of focus, which is the registrational phase III trial, designated NOVA 2. Maybe you could talk through for us the NOVA 1 program and its scope, then compare and contrast that to what you're doing with NOVA 2, and maybe delineate for us some of the key salient aspects of the recent publication covering the NOVA 1 data set in JAMA Psychiatry. Yeah, happy to. Earlier in 2025, we announced the results of a phase II clinical trial for LB-102 in schizophrenia. This trial was designed to be registrational. What I mean by that is the N is large, we have very robust statistical analyses, we also have conservative imputation for missing data. These are all the things that you would need to do for a trial to be considered adequate and well-controlled. This trial had 359 patients in 25 sites in the U.S. It was a four-week inpatient study, as all the studies are in schizophrenia. We evaluated three doses, 50 mg, 75 mg, and 100 mg. The primary endpoint was the change in baseline at day 28. As I mentioned, this was a four-week study. At the conclusion of this trial, we had an end of phase II meeting with FDA. In that meeting, we asked whether FDA would consider this trial to be adequate and well-controlled, which was what you would need in order for it to be used for registrational purposes. FDA said that it had the characteristics of an adequate and well-controlled trial. It's for this reason that we believe that this trial could serve as one of two trials needed in order to seek approval. Coming out of this phase II trial, we decided to go with two doses into our phase III trial. We're taking 50 mg and 100 mg into our phase III trial. This trial is going to be a six-week inpatient trial, and it will be enrolling approximately 460 patients at 25 sites in the U.S. It will also include all of the various different secondary endpoints that we had in the phase II trial. There's actually quite a bit of commonality between these two trials. The scope and size of these trials are very similar, 25 sites in the U.S. We have the same vendors. We have quite a bit of overlap with many of the clinical sites. There's quite a bit of familiarity with LB-102 as well as the protocol. Of course, we learned from the phase II trial which doses to take into phase III. In addition to this phase III trial, we're also in parallel operating an open label safety trial. This is so we can accrue the safety exposure that we'll need to accrue in order to put ourselves in a position to seek approval with one successful phase III trial. The phase III schizophrenia trial is ongoing. We're currently on track to have top-line data in the second half of 2027. Yeah, we're really excited about the progress of our schizophrenia program. You had mentioned earlier, we've obviously talked through several key aspects of the safety profile and why the safety would be readily differentiable versus existing marketed atypical antipsychotic drugs. Maybe talk through some of the unaddressed or less addressed symptom areas in schizophrenia specifically, where 102 might be considered to have an effect. In particular, you talked about pro-cognitive aspects of this medication. Cognitive impairment associated with schizophrenia, or CIAS, is a well-documented sub-indication within schizophrenia that historically has been proven very difficult to address historically. Perhaps 102 would have the ability to differentiate there, and there are clearly key learnings from the NOVA-1 study that already point you in that direction. Maybe talk through some of those aspects for us, please. Yeah. Even with as many antipsychotics as there are out on the market, there continues to be significant unmet need in this space. As you rightly point out, there's tolerability. There continues to be challenges with tolerability, even with the second-generation antipsychotics. Specifically with EPS or extrapyramidal symptoms, continues to be a challenge that often leads to discontinuation. In addition to that, there continues to be residual symptoms of cognitive impairment, as you mentioned, as well as symptoms of anhedonia or depressive-like symptoms. In the space of schizophrenia, this is called negative symptoms of schizophrenia. These are two areas where there continues to be really no alternative treatment available to these patients and can really impact the ability for these patients to function. What we observed in the phase II trial with respect to tolerability is a very nice tolerability profile, one that is arguably or has the potential to be better than that of even amisulpride. First, with respect to EPS, we saw a very low rate of EPS. We had a rate of just 1%- 5.6%. To put that in context, it's in the ballpark of the EPS rates for CAPLYTA and COBENFY, two therapeutics that really pride themselves on having very low rates of EPS. We also had very low and few adverse events associated with increases in prolactin. As you mentioned, D2 antagonists mechanistically increase prolactin. We saw a very low rate of adverse events that were a result of that increase, and all of them were mild to moderate, and none of them led to discontinuation. We also had an interesting time course on the increase in prolactin. The prolactin from our trial increased over 8 - 15 days, then it started to come back down. This is a shorter time course than that observed with other D2 antagonists, including amisulpride. We think this is because of the better potency with the molecule. In addition, we had only one case of sedation. We don't expect any sedation with the targeting of our drug, but we did see one case of sedation, which is quite favorable to other antipsychotics that are out there. With respect to the other two areas of unmet need, one being cognition. We evaluated cognition in our phase II trial utilizing Cogstate's battery of tests, in that, we saw a dose-dependent, robust effect on cognition. At the 100 mg dose, we had an effect of 0.66. Importantly, this was in a population that was not enriched for severe impairment at baseline. To see this kind of effect in a broader patient population, we think is quite interesting, we intend to explore and look at cognition in all of the other indications we're pursuing. Because cognition deficit, cognition impairment is a red thread that runs across all of these indications that we're pursuing and is an unmet need in all of these indications. The other area of unmet need is negative symptoms, which is predominantly characterized through anhedonia. Anhedonia is this inability to feel joy, and these patients really withdraw from society. At this point, there really isn't a treatment option. In our phase II trial, at our 50 mg dose, we saw a statistically significant benefit in the PANSS negative symptom subscale. It makes sense to see that at the 50 mg dose, because as you recall, at lower doses, we do see a greater antidepressant effect. We would expect to see this kind of effect at the lower dose. Amisulpride is one of the few antipsychotics that has shown in three randomized placebo-controlled trials to have a statistically significant benefit for patients with predominantly negative symptoms. This is in that very distinct patient population of predominantly negative symptoms. We think there's a really nice reason to believe that we'll have an effect on this patient population as well, we look forward to continue to investigate this in future clinical trials as well. Anhedonia, I'll just mention, is also a red thread of unmet need that runs across all of these indications. It continues to be a residual symptom in bipolar depression, it's also a residual symptom in major depressive disorder as well. This is an area where we could provide a differentiated effect across all of these indications. Maybe just delineate for our audience, you already mentioned what the key timeline is to release of top-line data from the NOVA-2 study, but maybe also give our audience a sense of within what timeframe one should expect top-line data from your clinical studies in bipolar depression as well as MDD. Yes. Where we sit today is we're very well positioned for very clinically meaningful value-creating milestones. I mentioned the phase III schizophrenia data is expected to come in the second half of 2027. The phase II bipolar depression data is expected to come in the first quarter of 2028, and the phase II adjunctive MDD data is expected to come in the first half of 2029. We have cash on the balance sheet that takes us into the second quarter of 2029. We're fully funded and very well positioned for these upcoming data readouts. I want to mention for our audience, simply because, again, I'm known for having talked about all of these things in various contexts, not specific to LB. Neuropsychiatry remains an area of high avidity, high interest from strategic pharmaceutical acquirers. We know the well-documented cases of Karuna Therapeutics, which developed COBENFY, which you mentioned earlier, which was acquired for over $14 billion by Bristol Myers Squibb in late 2023. Of course, the case of Cerevel Therapeutics, which was acquired by AbbVie for $8.7 billion. Most recently, of course, the case of Intra-Cellular Therapies, which developed CAPLYTA, or lumateperone, by Johnson & Johnson for $14.6 billion. I think it would be helpful for our audience to understand When you look from a commercial standpoint at cases of drugs that have been successfully applied commercially across multiple large neuropsychiatric conditions, I'm talking specifically here about drugs like aripiprazole or ABILIFY, or more recently, CAPLYTA or lumateperone, which has been successfully advanced in schizophrenia and now also more recently now in patients with mixed symptoms of depression and schizophrenia. Perhaps most notably and most successfully to date, the case of VRAYLAR, or cariprazine, currently marketed by AbbVie, now running at close to an $8 billion a year annualized revenue run rate. When you think about those kinds of situations, how are you thinking about the way in which LB-102 could ultimately be commercially positioned, and what kind of commercial implications does this have for ultimately the long-term sales potential of the molecule? LB-102 is uniquely and very similarly situated to both CAPLYTA and VRAYLAR. Those drugs started in schizophrenia, then went into bipolar depression, and then went into adjunctive MDD. This was very deliberate. With schizophrenia being the highest dose, you can leverage the safety population from schizophrenia across these other indications because they are going with either the same or a lower dose. In addition, you get the antipsychotic pricing with schizophrenia that you can then pull through to these other indications. LB-102 is following that very well-trodden development path. LB-102 also has a mechanism that strongly supports moving into both the psychosis and the mood disorders, and as you rightly point out, this is not a mechanism that is shared with the muscarinics. They're really limited to just going into the psychosis type disorders. We have an opportunity to go into the mood disorders, which we're already planning to do. Beyond that, there are other psychosis indications, as well as other mood disorder indications that we have available to us. I think VRAYLAR has over 12 different approvals in various different indications, and I think that is something that could also be true for LB-102. In addition, LB-102 does have an opportunity to develop a long-acting injectable formulation. The success of the 50 milligram dose in our phase II trial really makes this opportunity feasible, and this would obviously be a global opportunity. amisulpride is not amenable to a long-acting injectable. The dose is just too high. We would have an opportunity to develop it globally as a long-acting injectable, and this is an opportunity that could be used not just in schizophrenia, but also in bipolar disorders as well. There's a lot of opportunity here to really expand the portfolio of LB-102. In terms of the strategy of the company, we're intent on developing a fully integrated neuroscience company where we are in a position to successfully launch into these approved indications, and we also would like to really build a portfolio of assets, and I think that those are all very doable for a biotech company, as demonstrated by Intra-Cellular before it was acquired. I want to touch on one aspect of what you just said, which is the long-acting injectable space, which is another area that we've been focusing on for a lengthy period of time. Why? For the edification of our audience, this is currently considered the most lucrative subsegment of the antipsychotic drug class domain. Why? Because long-acting injectables are considered the most desired among those high-volume prescribers of antipsychotic medications, specifically for schizophrenic patients, because schizophrenic patients are well documented to be very poorly compliant, very poorly adherent to once-daily orally bioavailable drugs. If you have a long-acting injectable as part of your long-term plan to optimize the value of LB-102, that is likely to be of significant importance, increasing importance in the coming years. I believe at this juncture, the long-acting injectable subsegment of the atypical antipsychotic drug class is running at around $5 billion a year and is probably going to double or triple within the course of the next five to six years. That is a very important aspect of the LB Pharmaceuticals story that I think you'd probably agree, hopefully our audience will agree, is completely underappreciated today and not reflected in the company's market cap. Yes. I also want to talk through two other aspects that I think our audience should be well-informed about. One is an element that you mentioned earlier about how differentiated LB-102's positioning is likely to be relative to the muscarinics. Okay? There's been a lot of focus brought to bear on muscarinics, starting with COBENFY, then to emraclidine. Whether you want to have M1, M4 dual receptor modulation and so on and so forth. As you said earlier, these things are going to have relatively narrow spectrum applicability. None of them can directly follow what LB is capable of pulling off with a drug like LB-102, which is much more in the vein of a cariprazine or a lumateperone. Also, I think it would be very helpful to understand how long your composition of matter patent protection lasts, what additional elements of intellectual property you are currently working on that you anticipate is going to provide LB-102, despite the fact that it is, in a sense, a fast follower, despite the fact that it is built on well-documented science, a native drug that has been around for decades. It can still be protected from a commercial perspective against generic erosion for a very long time. That is correct. This is a new chemical entity that has composition of matter intellectual property that has been issued globally. The expiration date of this patent is 2037. If you include a patent term extension, you end up in the 2040s, depending on where that ultimately lands. We're also pursuing the secondary patent portfolio that comes along, which is all of the methods of use patents and all of the patents associated with your expected label, as well as any sort of patents that might relate to safety and/or efficacy as the data starts to emerge from our phase III trial. Those are all the Orange Book patents that we'll be readily pursuing to ensure that we've got a robust situation at the time that we submit for the NDA. There are also other patents that may not be considered Orange Book patents, but could be very valuable relating to formulation and manufacturing. We have a very experienced team within our company that are really building out a robust IP portfolio that will put us in a very strong position at the time that we submit the NDA. In the few minutes that we have left, you had touched upon this before. I think everyone's familiar with the commercial trajectory of VRAYLAR. It did not become an $8 billion or so drug overnight, as you pointed out earlier. AbbVie pursued indefatigably and relentlessly label expansion into indication after indication. In the case of CAPLYTA, this is an example that I think is particularly noteworthy given the current positioning of LB Pharmaceuticals because Intra-Cellular Therapies developed this drug, got it approved, and then launched it independently. Given these two poles of the spectrum, what implications does this have for how you are thinking as the Chief Executive Officer of LB Pharmaceuticals about the best way strategically to optimize the intrinsic value of LB-102 for investors? I think in particular, it would be important to touch upon the following four points. Firstly, when you think about the optimal rollout of LB-102 in the U.S., what kind of commercial infrastructure, what kind of capital demands might that have? Secondly, when you think about market access, formulary positioning, reimbursement, bulk contracting, and so on and so forth, what unique attributes of LB-102 would potentially make that process less fraught, more easy to accomplish than, for example, what might happen with a typical second-generation atypical antipsychotic? Thirdly, how are you thinking about ex-U.S. markets, especially in the context of things like MFN? Lastly, with respect to potential exit strategy and so on and so forth, what do you think is likely to be the most value-added approach? Is it something bifurcated, something nuanced, something opportunistic, all of the above when it comes to determining whether the best approach for LB is forward integrating, as you said earlier, specifically in the U.S., forward integrating in multiple regions, or potentially looking to do what companies like Karuna and Cerevel did? I think the most important thing we could do today, given that we're in the midst of our phase III trial, is to do all that we can to plan ahead. We have hired a Chief Commercial Officer who's very experienced in this space. She's launched a number of CNS assets. Her name is Kaya Pai Panandiker, and she's been with us now since the end of last year. Now that we have this opportunity to really start to build and think through the planning, so that we're in a position to appropriately and competitively respond on the payer side of things, as well as on the brand and positioning side of things, in addition to contracting. All of those activities are now being planned, and we're thinking through the evidence generation that we need in order to be competitive in those discussions, as well as just thinking through the labeled claims that we'd like to have and how we might go about pursuing those. All of this, I think, comes under the rubric of having an opportunity and the time to really carefully plan. We do intend to commercially launch these assets. I think the best thing that we can do for both employees, patients, and stockholders is to put ourselves in the strongest position that we possibly can with respect to our capital, our assets, as well as the team and infrastructure that we have built, so that we have ourselves, and we've provided ourselves with a lot of opportunity and flexibility to pursue very strategic and what I hope to believe, successful engagements. I think the best thing we can do is just to continue to build the strongest company that we can, and then we'll see how that plays out. That's, I think, the most important thing that we can do right now. Thank you so much. I think we're going to have to leave it there, but hopefully our audience will have come to understand intimately that LB-102 is a very intriguing neuropsychiatric-focused asset in one of the hottest areas within biopharmaceuticals today. Heather, thank you so much for walking us through. Yeah. salient features of the LB Pharmaceuticals story, and thank you to our audience for their attention. Thank you so much. Bye-bye.