Q4 2022 Longboard Pharmaceuticals Inc Earnings Call
Speaker 1: dial star 11.
Speaker 2: Good day and thank you for standing by. Welcome to the Longboard Pharmaceuticals Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised.
Speaker 2: To withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. On that I'd like to hand the conference over to Chief Speaker today, Brandi Roberts, Chief Financial Officer. Please go ahead.
Speaker 3: Thank you and good afternoon everyone. Welcome to Longboard's conference call in Webcast where we will be discussing our 2022 financial results and providing a corporate review of the past year and an update on the year ahead. Before we begin today, I would like to remind everyone that this conference call in Webcast will contain forward-looking statements about the company.
Speaker 3: including without limitation, statements about the anticipated timing of commencement, enrollment, and completion of clinical trials for our product candidates. The anticipated timing of release of clinical trial data, the market opportunity for our product candidates, and the expected time frame for funding operations with current cash, cash equivalents, and short-term investments.
Speaker 3: These statements are subject to risks and uncertainties that could cause actual results to differ. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent reports filed with the SEC.
Speaker 3: Please note that these forward-looking statements reflect our opinions only as of the date of this call, and we undertake no obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. With that, I'll hand the call over to Kevin Lind, Longboard's President and CEO . Kevin?
Speaker 4: Thanks, Brandi. And thank you very much to everyone joining us today on our first earnings call.
Speaker 4: We wanted to provide an update since it's been just about 2 years since our IPO and just over 3 years since we started this endeavor.
Speaker 4: I'm extremely proud of what our team has accomplished during this time, and I'm incredibly excited about the opportunity ahead of us in 2023, as we expect top-line data readouts for both LP 352 and LP 659. On today's call, I will provide a high-level business update for our potentially best-in-class pipeline.
Speaker 4: Our Chief Medical Officer, Dr. Randall Kaye, will give key updates on LP 352, and then Brandy Roberts will provide an overview of our 2022 financial results before we open the line for Q&A.
Speaker 4: As many of you are aware, we spun out of arena pharmaceuticals and formed Longboard with the mission of advancing neurology assets with differentiated pharmacokinetics, pharmacodynamics, and targeted engagement.
Speaker 4: To do this, we've focused on building a world-class neuroscience team with the ability to strategically select the best indications, design the right clinical trials, and move the assets through clinical development in a differentiated way. Ultimately, our goal is for our compounds to deliver differentiated clinical outcomes.
Speaker 4: that meaningfully impact the lives of patients.
Speaker 4: What is so compelling to me today is that I'm seeing a lot of the same characteristics that we saw at Arena when I joined. And what drives our team is that our assets have the attributes of great medications that have successfully helped patients.
Speaker 4: First, each one utilizes a more precise approach targeting a well understood mechanism of action.
Speaker 4: Second, each one has been developed for our target patient population to remove receptor interactions that negatively impact patient safety or are not known to contribute toward efficacy.
Speaker 4: Third, each one is going after a potential billion plus opportunity with multiple relevant multi-billion dollar M&A analogs for similar mechanisms of action.
Speaker 5: importantly, each is going after a mechanism of action where the legacy arena
Speaker 5: So let's start with LP 352.
Speaker 5: LP 352 is an oral, highly selective, centrally acting 5HT2C super agonist.
Speaker 4: LP352 is the only 5HT2C receptor agonist being dose optimized for developmental and epileptic encephalopathies, or DEEs.
Speaker 5: Given its greater selectivity and specificity, we believe that LP 352 could be a treatment for individuals with DEEs who either, one, have not had access to newer therapies, or two, are still searching for a safer, more efficacious, easy-to-add-on treatment in the syndromes where current therapies are inadequate.
Speaker 5: We're advancing LP 352 in our ongoing Phase 1B 2A Pacific Study, which is a basket study accepting participants with a range of DEEs.
Speaker 5: And we expect to have top-line data from Pacific in the second half of this year.
Speaker 5: I'll now turn it over to Randall to go deeper into DEE's, the reason to believe for 352 and why we are so excited about the Pacific Study. Randall? Thanks, Kevin. Good afternoon, everyone. As Kevin mentioned, we have a really unique opportunity and responsibility to patients, given the value that we believe our highly selective molecules have.
Speaker 5: over existing medications in the space. Let's begin with healthy 352. Just as a reminder, DEs refer to a group of severe heterogeneous epilepsies that are characterized by significant developmental delay, treatment refractory seizures.
Speaker 5: and abnormalities in brain wave function, as an example, on EETs.
Speaker 5: While there have been significant advances in the treatment of DEs over the past decade, the unmet medical need of these patients and their families is striking. Most of you are familiar with a few of the DEs, syndromes like Dravet and Lennox-Castou.
Speaker 5: But beyond these two, there are over 20 other DE syndromes that are described. And in total, only four of these DEs actually have specifically approved therapies.
Speaker 5: These patients still have a significant unmet medical need and multiple seizures that interfere with their development. Physicians and caregivers are looking for a safe, efficacious, and easy to add on therapy. And we know that safety is incredibly important to this community.
Speaker 5: So why do we believe that LP 352 is a potential best in class 5-HT2C super agonist for the treatment of DEs?
Speaker 5: Let's start with selectivity and precision. 352 is the only 5HT agonist that has no detected activity and receptors that are associated with significant adverse side effects in the case of 5HT2B, with valve-earth heart disease, and pulmonary arterial hypertension.
Speaker 5: and in the case of 5-HT2A with psychiatric AEs such as insomnia, hallucinations, and euphoria. Second, preclinical validation. We have reported multiple preclinical models that demonstrate significant reduction in seizure activity and epileptiform events where we expected to.
Speaker 5: and this is similar to other compounds that are in the class. Third, clinical validation. In our phase one SAD-MAD studies, 352 was demonstrated to have favorable safety and tolerability and with adverse events that are generally consistent with the expected effects of serotonergic medications. And fourth,
Speaker 5: clinical CSF EEG data, we designed an interesting CNS phase 1 study to see if we could further characterize 352 in plasma and CSF as well as get a read on EEG or brain wave function.
Speaker 5: The results confirm that plasma and CSF-PK concentrations increased in a dose-dependent and consistent manner and that LP352 demonstrated effects on QEEV activity within the first two doses with a sustained dose-dependent effect on this activity.
Speaker 5: after continuous dosing. This is really important because this indicates that LP 352 is getting into the brain as evidenced by receptor engagement.
Speaker 5: Well, let's turn to the Pacific Study.
Speaker 5: I'd like to start by thanking the epilepsy community as we are extremely motivated internally by the engagement that we have had with parents, caregivers, physicians, our trial sites, as well as advocacy groups. In my 30 years involved in drug development, I have never seen a more engaged community.
Speaker 5: As a dedicated company, we take an extremely hands-on approach to the conduct of our clinical trial. We personally conduct in-person visits at every one of our participating sites. We feel this is incredibly valuable in order to ensure the speed of enrollment, as well as the consistency across the seizure analysis.
Speaker 5: We also work very closely with the epilepsy study consortium to help review every trial participant and train sites and caregivers on how to categorize and count every seizure for even greater consistency.
Speaker 5: In the Pacific study, we plan to enroll 50 participants, 40 on medication, 10 on placebo, across 30 sites in the U.S. and Australia. And our goal is to have a mixture of patients across multiple DEs with approximately 10 patients with Dravet.
Speaker 5: 10 patients with lemic gasto and then a combination of 30 patients diagnosed with other dies.
Speaker 5: Well, as we're out there and we're interacting with our sites, what do we hear from our study sites? Excitement, commitment, passion, and we're excited to be part of this journey. And we continue to hear that there's tremendous remaining unmet medical need across both the D's with approved recent medications and the D's without any recent approvals.
Speaker 5: We are looking forward to the completion of the enrollment of the Pacific Study in the first half of this year and presenting top-line data in the second half of this year. I'd like to now pass it back over to Kevin.
Speaker 4: Thanks, Randall, as you can tell, we're very enthusiastic about 352, but this is also an important year for LP 659. A significant reason why we started Longboard, because we saw the striking results generated by a TrasMod and realized that there remained a tremendous opportunity for more selective next generation S1P receptor modulators with optimized pharmacology.
Speaker 4: PK, and target engagement. In this case, LP 659 was designed to be a centrally acting S1P receptor modulator focused on the modulation of the S1P1 and P5 receptors that are known to contribute toward efficacy, while having no observable impact on the S1P2 and P3 receptors.
Speaker 4: conditions, and we look forward to initiating our Phase 1 shortly.
Speaker 4: So why do we think 2023 will be an important year for LP 659? Typically phase 1 data are not particularly telling but in this phase 1 we think we will see some really interesting potential data Which could highlight certain differentiating characteristics of 659 First we obviously will be looking at safety and tolerability
Speaker 4: Secondly, we expect to see rapid reduction in lymphocytes, as well as...
Speaker 4: rapid recovery of lymphocytes, which we have seen in preclinical models. Of note, this was a significant advantage that Atrazmod has seen over some of the other S1P receptor modulators. We look forward to sharing that SAD data later this year and framing the opportunity and thoughts on initial indications as we get closer to advancing the compound beyond healthy...
Speaker 3: expenses were $34.6 million for 2022 compared to $19.8 million in 2021. Our 2022 R&D expenses increased over 2021 levels as we progressed both of our programs and added headcount to our team.
Speaker 3: GNA expenses were $10.2 million for 2022 compared to $8.1 million in 2021. Our 2022 GNA expenses increased over 2021 levels as we continue to build out support functions as appropriate for a public company of our size.
Speaker 3: Net loss was $43.9 million or $2.56 per share for the full year 2022, compared to $27.8 million or $1.93 per share for the full year 2021. We expect that our expenses will trend upward during 2023 as we continue the development of LP 352 and advance LP 659 into the clinic.
Speaker 3: We are providing expected guidance for 2023 operating expenses to be in the range of $57 to $63 million, excluding stock-based compensation.
Speaker 3: We are focused on spending responsibly as we progress our programs. We have built a very solid team with a lot of expertise and they are able to do a tremendous amount of work. As we prepare for a Phase 3 program with LP 352 and down the road, a Phase 2 for LP 659, we are planning for the resources we will need both internally and externally.
Speaker 3: and will bring them on board at the appropriate time. We want to be able to move our programs through clinical development as quickly and efficiently as possible. I also wanted to take this opportunity to provide a little bit more color on our recent financing. In February , we completed a $23 million follow-on public offering of our common stock.
Speaker 3: This financing was a result of receiving several reverse inquiries from strong institutional funds that indicated interest in building a position in our stock.
Speaker 3: We are happy that we were able to bring some new funds into the Longboard family, as well as increase investments from some of our existing holders who have strongly supported us through our Series A financing in October of 2020, our IPO in 2021, and now our follow-on offering.
Speaker 3: We are focused on creating long-term value for those who believe in our technology and are supporting us through our journey.
Speaker 3: We believe that the proceeds from this financing, along with our cash, cash equivalents and short-term investments as of year end 2022, will be sufficient to fund our current planned operations into mid-2024 and importantly through our Pacific data later this year. I'll now turn the call back to the operator to open the line for Q&A. Operator?
Speaker 2: Thank you. As a reminder to ask a question, please press star 101 on your telephone and wait for your name to be announced. To withdraw your question, please press star 101 again. Please stand by and we'll compile the Q&A roster.
Speaker 2: One moment for our first question.
Speaker 2: Our first question comes from Nina from Citi.
Speaker 6: Thanks for taking my question. I was just wondering if you could remind us of a few things on the Pacific study design. So first, appreciate you giving updates on the number of patients with survey and LGS that you expect to have in the study, but can you remind us if you will have both active and placebo patients in each of those subgroups.
Speaker 5: Thanks. Thanks, Nina. Yeah, happy to take those questions. Randall, do you want to take both of them in terms of study design, active and placebo? Sure. So we put, as we noted, 10 patients with Dravet, approximately 10 with Lenox-Casto and a mixture of the other.
Speaker 5: Other, other, we have not stratified in this in this design because of the size of the, because of the size of the study statistically, we'd expect to see equal numbers of placebo and drug in each of the groups. But. You know, that's the, that would be the, that would be the general hope.
Speaker 5: In terms of efficacy expectations, remember primarily this is a safety and tolerability study as the most important of the endpoints. We are looking in the primary end point position at reductions in seizure frequency.
Speaker 5: relative to baseline. We haven't put out a number of what the expectations are. What we're looking to see is our hypothesis is that the reduction in seizure frequency is similar qualitatively across the DE spectrum. And I think that's something that we would be looking more closely at.
Speaker 4: Has been in a fairly acceptable band in the kind of 7 to 20% range along the way. And so we didn't feel that it was necessary to stratify.
Speaker 6: Got it. Okay, that's super helpful. And then can you just remind us as well of what we should expect and what you're kind of looking for on the AE side? I know you're not doing any cardiovascular monitoring in the study, but, you know, anything in particular that we should be looking out for there.
Speaker 5: Hey, it's Randall again. You know, the AE profile that we've seen so far has been relatively, relatively benign. The most common adverse event has been headache, to some degree, some mild GI symptomatology.
Speaker 5: we'd expect to continue to see that to some degree. You know, again, we're focusing more on tolerability. Can we get patients, you know, on an initial starting dose and maintain them during the overall maintenance period? And thanks for bringing up the...
Speaker 5: the point about other adverse events. Since our compound 352 does not interact with the 5-HT2V receptor, we do not anticipate the typical cardiovascular risks that are associated with other medications out there like...
Speaker 5: such as centepa. In fact, in our study protocol, FDA did not require us to do echocardiogram. So we're just doing routine monitoring. So remember, from a long-term perspective, we fundamentally believe safe and easy to add on to current standard of care.
Speaker 4: is going to be incredibly important. At the same time, we're balancing out that this is the only 5-HT2C that's being dose optimized for these patients. And so what we're trying to do is really, in this study, figure out where do we want to push, how do we want to push, how do we want to get patients to that optimal dose where we're balancing both that safety profile that we hope to have as well as that efficacy.
Speaker 2: Your line is open.
Speaker 2: Thanks for taking the questions. First, on 3.5.2, would you consider a SWITCH study from patients on Fintepla, and if so, any thoughts on what that might look like? And then for 6.5.9, as you're considering potential indications, there are a number of indications that S1P modulators.
Speaker 4: Already addressed such as MS and ulcerative colitis, would you be inclined to pursue those or find new territories? And what might your thinking be to identify the best applications of this mechanism? Thanks. Sure, thanks, Josh 659. we think that there are there's tremendous unmet need beyond and mass and ulcerative colitis again, the unique characteristics.
Speaker 4: need in these orphan neurological conditions where lymph site reduction, T cell trafficking, all these things that we've seen with these S1Ps over the last, you know,
Speaker 4: 10 to 15 years could be incredibly valuable to patients who have tremendous unmet need. So that's more we're thinking about for 6'5'9. Randall, do you want to take a first cut at the Switch Study?
Speaker 5: Sure. So a switch study from Contepla over to LP352. So I'm going to answer this as a clinician. I'm not sure you need to do that. You have a medication that has one of the most restrictive rams that are out there in the marketplace. In a patient population that is fragile and challenging.
Speaker 5: LP 352 would be safer and would be a right thing to switch without the study. But it's a provoking question. I'll think about it a little bit more.
Speaker 4: Yeah, it's something we've been thinking a lot and it kind of gets down to, you know, how do we want to handle Drovey? Given Fenn Floramy's usage there, but, you know, as of right now, we're not seeing a tremendous uptake with Fenn Floramy and in even Drovey alone, let alone in Lennox, Gastot, such that we think it's necessary, but it's something we...
Speaker 2: They have to choose which to prioritize.
Speaker 4: Look, we think we are going to be able to have the resources. As Brandy mentioned, this last financing was not about funding the phase 3s for LP 352 and the phase 2 for LP 659. This was really a bunch of folks who could not find volume in our stock wanting to get into the market.
Speaker 4: along the way knowing that there has been this movement towards the haves versus the have nots, but we don't think we need to raise massive amounts of capital to really be still considered a have.
Speaker 3: Brandi, do you want anything to add? No, I just want to say that I think we've really done a great job at building a lot of talent in the organization as well. We've grown from just three employees back in 2022 to 33 at the end of 2022, and have brought in a lot of people with great epilepsy and neurology experience, and I think we plan to capitalize on that and continue to move these programs forward ourselves.
Speaker 4: Yes, good afternoon, Kevin and team. Thanks for the good cadence on the update and taking our question. I had a couple of questions on 352. I'm just wondering if you could provide us a little bit more color on the types of patients you have for us.
Speaker 2: that are really joining into this study. Can you tell us whether or not they skewed to the younger ages? And I note that exclusion criterion includes use of femflormine. Is that ever forever in a drabate patient, completely naive, or could some of those people have been exposed to femflormine in the past?
Speaker 5: Randall, do you want to take that? Yeah, hey, Charles and Randall. Thanks for those questions. We opened up the study originally starting as an adult population 18 and above.
Speaker 5: And then drop the population as additional confirmatory preclinical safety data emerged. So we felt comfortable moving into the adolescent population down to 12. We are seeing patients coming into the study and the...
Speaker 5: within the adolescent population. We haven't put specific numbers out, so it'd be hard to answer your question about skewing towards, but we're satisfied that we're getting a nice balance of patients. Your second question, let me clarify. We exclude patients who have failed...
Speaker 5: confloremean. Failure would mean they had no discernible treatment response to confloremean or they had an adverse event profile or side effect profile that would preclude that would preclude its use.
Speaker 5: if a patient, let's say, had been on finfluramine but insurance wasn't covering it, or the parents didn't like the inconvenience of regular echos, then that would be a subject that would potentially be included.
Speaker 2: Okay, that's helpful. In terms of the actual conduct of the study, are you allowing down-hydration during the maintenance phase or is that just not necessary? Are you not seeing any of that over the course of the study so far?
Speaker 5: Yes, it's an interesting question. So the way the protocol is written, we use the up-tritration portion to get them on a dose that they're tolerating. So start at 6, go up to 9, go up to 12. But we're going up by tolerability. We're not forcing and pushing everyone up to 12. So the expectation is when they get into the maintenance period,
Speaker 5: They're tolerating 352 well. Our expectation is that they will stay on that dose for that time period. You know, would we theoretically allow some flexibility? I guess we could potentially, but generally, the approach is that we'll have them on the right dose so they can tolerate and stay on that.
Speaker 5: during the maintenance period.
Speaker 2: Okay, gotcha. Last question quickly is if you considered success, I think the first analyst asked a question about seizure reduction frequency. Anything beyond just simple seizure reduction that you would be looking at from an efficacy standpoint?
Speaker 5: I think it's important to frame this as a safety and tolerability study and also proof of concept that you can treat a heterogeneous group of patients across the spectrum. So success would be safe, well tolerated, and some comparable seizure reduction.
Speaker 5: I'd love to start to talk about some of the other potential areas that you can start to look at in large, well, in large, larger studies, such as quality of life, clinical global improvement, and so forth. But that's just going to have to wait until we move into pivotal studies next year.
Speaker 2: Okay, good deal. Thanks for taking the questions. One moment for our next question.
Speaker 7: Our next question comes from Laura Chico from Wedbush. Your line is open.
Speaker 6: Good afternoon, thanks for taking the question. I've got two more strategic questions for you, I guess. The first one, assuming success with Pacific, I'm wondering how we should be thinking about the potential or the feasibility of using a basket registrational study, kind of expanding on the Pacific design, if you would.
Speaker 6: And then secondarily Kevin maybe from a strategic perspective wondering if you could take a step back for us and comment on what gives you confidence in the market opportunity within the D space specifically. Thanks very much.
Speaker 4: Yeah, thanks Laura. Great question. Look, I think from a company perspective, from a philosophy, a philosophical perspective.
Speaker 4: We would like to get to a broad DE approval because we think it's the right thing for patients in the community and the caregivers. We think that it's tremendously unfair. Rare disease day was earlier this week. We think it's tremendously unfair that some of these DEs and these families and these patients with DEs don't have access to some of these newer medications.
Speaker 4: and Lennox-Gastaut well beyond what has been seen with Epidiolex or phenfluoramine or some of these other synobamate that are more niche. And so we would like to get there. From a practical perspective...
Speaker 4: We want to make sure we do the right thing for this molecule. And we want to do the right thing for our shareholders because the last thing we want to do is create a development path forward that doesn't work with regulators. That doesn't help anyone. And so we are going to continue to work on.
Speaker 4: This messaging and this strategy over time, and I think the most important thing we're going to see that will impact whether we go down the individual indication route versus the broader basket route is the data from Pacific. And so that's why we're so excited about that this year, because right now we can have great conversations with. Carl.
Speaker 4: KLLs and patient advocacy groups didn't walk through why we think this will be so transformative. But until we see that data set, we can't make that call and frankly, it's all theoretical. So. What gives me confidence today is we haven't seen these molecules work in 1 indication and fail in another. Remember, Lennox gas though is is really a catch all basket.
Speaker 4: If these molecules were just working in SCN1A patients, then that's a very, very different thing. We already are starting to see that with some of the molecules in TSC that are more focused on the tumor side versus the epilepsy side. So-
Speaker 4: For us, we think this molecule has this tremendous opportunity, but what we have to do is make sure it gets to patients. And whether we can get it to the broadest group of patients is our hope and our dream, but we need to see this specific data. Does that answer your question?
Speaker 4: think this molecule has this tremendous opportunity, but what we have to do is make sure it gets to patients. And whether we can get it to the broadest group of patients is our hope and our dream, but we need to see this specific data. Does that answer your question? Yes, it does. Thanks, Kevin.
Speaker 7: Thank you. One moment for our next question. Our next question comes from Yatin Tsuneja from Guggenheim Partners. Your line is open.
Speaker 8: Yeah, so Kevin, could you expand a little bit more on the doors optimization point that you make? I think it is our understanding that Fintap levels never doors optimized. So I'm just curious to understand from you what you are seeing on a PKP deep perspective in terms of CNF exposure.
Speaker 8: that gives you confidence that the molecule is better optimized than let's say FinTEPLa. So that's first question.
Speaker 8: The second one is what work you might be doing on the formulation to bring it, you know, current rates, TIDs, so maybe do a QD or a BID.
Speaker 4: if you can comment on these two questions. Thanks. Sure. So, look, remember, cenfluramine was the weight loss dose arbitrarily cut by some folks in Belgium. Great outcome for the molecule, but we really don't know what's the optimal safety.
Speaker 4: to efficacy balance with that molecule along the way. We saw some dose responses between the low dose and the high dose in a number of their studies, but we didn't ever really see where the top is. Loracicacin, whether that drug ever makes it to market or not, we don't know. But again, that's the weight loss dose just carried over.
Speaker 4: And so for 352, what we're excited about is the opportunity to really figure out how much receptor engagement we really want to have. And it's why we got so excited about the 102 data. So Randall, do you want to walk through the 102 data for a second? Sure. So in our 102 data, we learned that
Speaker 5: concentrations that we observed relative to the KI, or the dissociation constant. And what we found is that we were getting at, or in most cases well above the KI, at our top dose at 12 milligrams, TID.
Speaker 5: And we also found that even at 6 milligrams, which is the start of the titration, we're getting great receptor engagement, somewhere around 70% or so of the KI. So what that tells us is that means you can dose optimize, you can modify, you can adjust as we as we go into further clinical studies next year, that we can go up and down based on the data that we're seeing.
Speaker 5: And that is the opposite of what you can do with centepilah, currently. At a point in time, as these patients go from young children to adolescents and older, as they gain weight, you will cap out, so you cannot continue to increase the level of floor mean.
Speaker 5: in order to match the increasing weight, you just can't dose optimize the drug that has a restrictive rinse.
Speaker 4: And then on the second question, the BID formulation. Again, we are focused on making sure we have that BID for the Phase III. There's some intellectual property involved in that that we're not ready to disclose at this point and work through, but we remain on track for BID for the Phase III.
Speaker 9: Thank you.
Speaker 7: Thank you. Thank you. One moment for our next question.
Speaker 7: And our last question, a couple line of Patrick Kuchio from H.C. Wayne Wright, your line is open.
Speaker 5: Thanks. Good afternoon. I'm wondering first if you can tell us if there's any evidence that the 5-8-2 mechanism could be complementary or synergistic without a cannabidiol. And would you expect a portion of patients enrolled in Pacific to be on cannabidiol background treatment, and if so, what portion of those patients? Hey, Patrick, it's Randall. Great question. Thanks for those. I probably should have discussed them earlier.
Speaker 5: differently. When you think about these complicated patients with these developmental and epileptic encephalopathies, multiple modality treatment with the right medication is going to make sense. So I can see a time, you know, I'll kind of refer to this as precision and...
Speaker 5: and targeted treatment of patients where the clinician is going to the shelf and saying, I want to have the best safest efficacious cannabidiol and I think they're all going to be reaching up to that shelf in the DE space.
Speaker 5: for the most efficacious and safest 5-HT2C. So I can't say whether they'd be synergistic, but they certainly one would expect them to be complementary. Yep, that's helpful. And then, how big of a concern is the Intefla black box and adoption among clinicians and patients?
Speaker 5: the 5-HT2B receptor. So up priori, there's no expectations to do the kind of work that was required with centipola. So we asked the FDA specifically about conducting echocardiograms. They're not required by this program, and we wouldn't anticipate that that would be part of it.
Speaker 5: To answer your question more clinically, what I'm hearing from other clinicians,
Speaker 5: To answer your question more clinically, what I'm hearing from other clinicians, it's
Speaker 5: These are really complicated patients and they're very, very fragile. Adding on the compoiment of an echocardiogram, getting it scheduled, it's not like it's right down the hall in these clinics. It could be in another building. These are not the most mobile of patients. So it's very, very inconvenient.
Speaker 5: and they have to continue getting echocardiograms for the duration of their therapy, and then one more if they do choose to discontinue it. We've heard numerous instances across the country where echocardiograms are available, but they're not readily available. There'll be a waiting list in order to obtain one.
Speaker 5: I think it's a significant challenge for patients. And we feel really confident in the approach of interaction with 5-HT2C, but you've got to do it in a way where it's going to be safe and convenient for patients. We think that's what LP 352 has the promise of.
Speaker 4: Yeah, and again, you know, congrats to everyone involved in the send-flour-mean approval and launch. I don't want to speak negatively about them, but UCB just mentioned that they expect peak sales of that model to be about 800 million euros. And if you kind of back into what that translates to from a patient perspective.
Speaker 4: And so we're not hearing a lot of feedback from the community. I don't have any patience for you because all of my patients are on femtleramine. We're not hearing a lot of feedback that, oh my gosh, I don't know how you're going to beat femtleramine in the marketplace. That gives us great tremendous and tremendous.
Speaker 4: You know, hope for our molecule and hope for these patients to make their, these parents, these caregivers lives easier. And we think it's safe for molecule does that. And, you know, it's back to that conversation that we are having based on Josh's question, which is, you know, do even need a switch study.
Speaker 4: And I think that's going to be an interesting 1 along the way. And the good news is we can see this specific data. And see the, the continued launch trajectory of and then make that decision down the road. But. You know, now been on the market for 2 and a half years and the sales are what they are. And so I think we're.
Speaker 4: not overly concerned about our ability to differentiate ourselves and hopefully have a preferred molecule on the market down the road.
Speaker 4: not overly concerned about our ability to differentiate ourselves and hopefully have a preferred molecule on the market down the road. That's great. Thank you very much.
Thank you. This concludes our Q&A session. I would like to turn the conference back to Kevin for closing remarks. Thanks, operator. And I want to thank everyone for joining the call today and for sharing in our enthusiasm in the longboard story as we approach data readouts across our pipeline in the second half of this year. Have a great day.
To raise and lower your hand during Q&A, you can dial star 1-1.
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