Amylyx Pharmaceuticals (NASDAQ:AMLX) Q1 2026 Earnings Call

0:00 Good morning. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals First Quarter twenty twenty six Earnings Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Lindsay Allen, Vice President, Investor Relations and Communications. Please proceed.

0:47 Good morning, and thank you all for joining us today to discuss our first quarter twenty twenty six financial results and business update. With me on the call today are Josh Cohen and Justin Klee, our co CEOs, doctor Camille Boudrejian, our chief medical officer, Jim Frates, our chief financial officer, and Dan Monaghan, our chief commercial officer. Before we begin, I would like to remind everyone that any statements we make or information presented on this call that are not historical facts are forward looking statements that are based on our current beliefs, plans and expectations and are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our expectations with respect to vexatide, AMX-thirty five, AMX-one hundred fourteen, and AMX-three eighteen statements regarding regulatory and clinical developments and the impacts thereof and the expected timing thereof and statements regarding our cash runway.

1:52 Actual events and results could differ materially from those expressed or implied by any forward looking statements. You are cautioned not to place any undue reliance on these forward looking statements, and AMLX disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin. Good morning, everyone, and thank you for joining us. The first quarter of twenty twenty six was marked by execution across our pipeline. Most notably, we continue to progress the pivotal Phase III lucidity trial of vevexetide, our investigational first in class GLP-one receptor antagonist with FDA Breakthrough Therapy designation in post bariatric hypoglycemia or PBH. We are executing on the three strategic imperatives for Avexatide that we outlined earlier this year.

2:44 First, we are advancing the pivotal Phase III lucidity trial toward top line data. Randomizing and dosing the last participant in late March was a significant milestone. We have a clear line of sight towards the completion of the sixteen week trial, and we remain on track for a top line readout next quarter. Second, we are advancing NDA readiness and regulatory preparations. We are already drafting NDA sections to support a potential submission. And third, we continue to strengthen our launch readiness. We are executing against a comprehensive commercial readiness roadmap to help ensure we are fully prepared for commercialization of vexatide if approved in 2027. In addition to Avexatide, we continue to make progress across our broader pipeline.

3:34 For AMX-three eighteen, our long acting GLP-one receptor antagonist, IND enabling studies are underway. We are targeting a 2027 IND filing. For AMX-thirty five in Wolfram syndrome, we anticipate presenting longer term week 96 data from the Phase II open label HELIOS clinical trial at an upcoming scientific meeting. And for AMX114 in ALS, we fully enrolled Cohort II of the Phase I LUMINA trial in March. At the NCALS Annual Meeting this June, we expect to present early biomarker data from Cohort one, the first and lowest of four doses being evaluated in the trial. We expect these data will provide initial information about the levels of the ALS biomarkers being assessed in the LUMINA trial from the first cohort.

4:25 As we continue to advance our pipeline, we are simultaneously preparing for the potential commercial launch of Avexatide. To discuss our launch readiness efforts, Dan Monahan, our Chief Commercial Officer, is with us on the call today. Dan joined Amylyx in January 2024, bringing more than two decades of experience. He was instrumental in the commercialization of Otseco's Rexulti, Novartis' Cosentyx and Sanofi's Lantus and Actinel, among others. With that, Dan, I'll turn the call over to you. Thank you, Justin, and good morning, everyone. I am pleased to be on the call today to discuss how we have been refining our launch strategies as we prepare for the potential commercialization of AveXatide next year. The more we engage with the PBH community, the more we understand the profound unmet need that exists.

5:16 We are operating with a deep sense of urgency. To date, our commercial efforts have been focused on gaining key insights into the PBH market. This includes gathering direct insights from people living with PBH and the healthcare professionals who are managing their condition. In addition, we are developing a deep understanding of the patient journey and continuing ongoing claims work to help us determine where patients are being treated. To enable our commercial preparations, we've made key hires across marketing, market access, and commercial operations. Ahead of the potential approval and commercial launch of Avexatide, our immediate focus is on disease state education. This includes raising stakeholder awareness of PBH with an emphasis on the pathophysiology, the importance of accurate and timely diagnosis, and the profound unmet need and burden of the condition.

6:10 We plan to launch this disease state education campaign this summer. Looking at the market opportunity, our independent claims analysis and ongoing field engagements continue to support our estimate of approximately one hundred and sixty thousand people living with PBH in The US who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux Y gastric bypass. Our estimates are firmly rooted in a growing body of prospective and retrospective published literature, including large long term cohort studies evaluating hypoglycemia in people who have undergone bariatric surgery. Importantly, our ongoing market research indicates that endocrinologists have a high intent to treat PBH if there were to be an approved medicine.

6:58 To reach appropriate patients, we have initiated our marketplace sizing efforts and continue to identify key centers and endocrinologists that manage this condition. Building up to the potential launch, we will refine these efforts as more insights are generated. Our commercial preparations are advancing in lockstep with our clinical progress, and we look forward to sharing additional details as we move closer to the commercialization of Avexatide, if approved. With that, I'll turn the call over to Camille to provide an update on our clinical and medical affairs progress this quarter. Thank you, Dan. To start, PVH is a chronic metabolic condition driven by an exaggerated GLP-one response, primarily after food intake, resulting in persistent, recurrent, and often debilitating hypoglycemia.

7:47 These events cause an inadequate supply of glucose to the brain known as neuroglycopenia with potential clinical consequences such as cognitive dysfunction, seizures, and loss of consciousness. For people living with TBH, this can create a life of perpetual vigilance where a meal with friends or a drive to work carries the risk of debilitating hypoglycemia and its ramifications. The SEER can disrupt independence and compromise safety, nutrition, and overall quality of life. Currently, there are no FDA approved therapies. Our pivotal Phase III lucidity trial is evaluating Avexatide ninety milligrams once daily in individuals with PBH following Roux en Y gastric bypass surgery using the FDA agreed upon primary outcome of reduction in the composite of level two and level three hypoglycemic events through week sixteen.

8:47 Lucidity was designed with the goal of replication. Five prior Avexatide trials in PBH, which demonstrated statistically significant results, including reductions in hypoglycemic events, directly informed the dose, the primary endpoint, inclusion criteria, and surgical subtype for lucidity. Echoing Justin's earlier remarks, our clinical team remains deeply focused on the execution of the lucidity trial. And we continue to work closely with our investigators as we approach our anticipated data readout next quarter. In parallel, with our clinical trial execution, we are actively ramping up our field medical affairs team to facilitate on the ground engagement with KOLs.

9:36 I also am pleased to share that we recently launched a US expanded access program to provide ofexitide for up to two fifty adults with PBH following rule on lie gastric bypass surgery. This program is a direct response to the urgent need we are hearing from individuals who are struggling with the devastating daily realities of PVH and the physicians who treat them. Initial eligible patients include individuals who have either completed lucidity or participated in previous clinical trials of Avexatide in PVH. As a reminder, Avexatide is an investigational drug and has not been approved by the FDA for any indication. Working directly with the PBH community and seeing the everyday impact of this devastating condition drives our continued commitment to our clinical and medical efforts.

10:32 And with that, I will now turn over the call to Jim to review our financials. Jim? Thanks, Camille. Our financial results for the first quarter were in line with our plans, and reflect our focus on the Phase III lucidity trial, and targeted investments in advancing our broader pipeline. We ended the fourth quarter with $279,800,000 in cash and marketable securities, compared to $317,000,000 at the end of the fourth quarter of last year. This capital funds our anticipated cash runway into 2028, including our key expected milestones, the lucidity top line readout expected in Q3 twenty twenty six, potential FDA approval, and potential commercial launch of vexatide in 2027. Turning now to our results for the quarter.

11:19 Total operating expenses for the quarter were $43,800,000 up 16% from the same period in 2025. Research and development expenses were $27,600,000 compared to twenty two point one million dollars in Q1 twenty twenty five. The increase was primarily due to an increase in spending related to the clinical development of evexatide and PVH. This quarter, we also recognized a milestone payment of $4,000,000 to GUPRA following the identification of AMX-three eighteen as a development candidate for PVH and other rare diseases. The increase was offset by decreased spending related to the clinical development of AMX thirty five for progressive supranuclear palsy. Selling, general and administrative expenses were $16,200,000 compared to $15,700,000 in Q1 twenty twenty five.

12:11 This increase was primarily due to an increase in consulting and professional services as we prepare for the potential commercial launch compensation expense for the quarter compared to $6,800,000 of non cash stock based compensation expense in Q1 twenty twenty five. Turning to our balance sheet. Our cash usage was slightly higher in Q1 compared to Q4 because of our GUPRA milestone payments and the payment of our annual corporate bonus during the quarter. We're in the midst of a pivotal year for AMLX, with the top line data readout for lucidity expected in Q3. The team will continue to focus on scaling our business with discipline, and we're actively laying the groundwork for a potential commercial launch.

12:58 This focus positions us well, particularly for our work with Avexatide. We continue to believe Avexatide has the potential to be a breakthrough treatment for PVH. With that, I'll turn the call over to Josh. Thanks, Jim. To close, we are focused on the execution of the LUCIDITY trial, as we track toward our anticipated top line readout next quarter. PBH is a chronic lifelong condition with symptoms that often emerge one to three years following bariatric surgery. Many people who receive bariatric surgery are in their 40s, suggesting that if they develop PBH, they may have decades of life impacted by this condition. The broader medical community continues to recognize this critical need in PBH.

13:46 In March, Doctor. Colleen Craig and her colleagues at Stanford published the first US prevalence model for PBH in surgery for obesity and related diseases. The official peer reviewed journal of the ASMBS. And in April, CMS published their annual list of ICD-ten codes to be potentially effective 10/01/2026, which includes an ICD-ten code specific to PBH. The planned adoption of an ICD-ten code shows the growing recognition of this condition by the medical community. We believe that vevexatide, if approved, could play a meaningful role in addressing this highly underserved patient population. In parallel with lucidity, we are actively preparing for a regulatory submission following top line results, while simultaneously scaling our commercial and medical teams to support a strong commercial launch of vexatide in 2027 if approved.

14:46 With that, I would like to now open the call up for questions. We will now begin the Q and A session. Session. Your first question comes from the line of CMS Hernandez with Guggenheim. Your line is open. Great. Thanks for the question. I hope you'll bear two for me quickly. The first question is really on the initiation of the EAP. Typically, we see companies sort of waiting for the completion of their Phase III and then the announcement of an EAP in the wake of a positive Phase III. Just wanted to get a better sense of, obviously, how you were able to execute this and get it approved.

15:49 And then also, how, you were really responding to the community, with the, implementation, and announcement of the EAP? And then just a quick follow-up question. Wanted to get a sense of just sort of that relative impact that working on the NDA now could actually have from a filing perspective. Typically, when we see biotech companies with positive Phase III data, it'll take as much as six to nine months to see that file. So just wanted to get a sense of how working on the NDA now might advance that ahead of those types of timelines. Thanks so much. Thank you very much, Seamus. This is Camille.

16:37 So for the EAP, indeed, we are responding to the community where there is currently no approved therapies for PBH. And we recognize and have received several requests and demands. Importantly, we're starting the EAP now because we want to be sure there's continuity of treatment for people in the lucidity study who are completing the OLEB portion of the lucidity trial. So that drives the timing for the EAP. Now with regard to your question about NDA preparation, yeah, we're sort of not typical for sure. And we are working, as noted, on NDA preparations.

17:22 And we do hope that that will allow us to be most efficient as we reach top line data next quarter. And because there is a great sense of urgency, there are no treatments for people with PBH. And if positive, we want to be sure that we're providing the opportunity for access as promptly as possible. Yeah. And I'd just maybe underscore from Camille as well. I think both of these activities both underscore too the unmet need in PBH. We know that patients urgently need a new therapy. And also our excitement about vexatide. We've had five prior trials of vexatide, all which showed very strong results. We have breakthrough therapy from FDA. So we want both to get patients access as quickly as possible, which of course is reflected with the EAP, but also pending positive results to be able to submit as soon as we possibly can, which is reflected by our ongoing work on the NDA.

18:21 And just one more thing to add. Thank you, Seamus, We also have a very experienced team here. Our team has experience with global regulatory approval, certainly a lot of experience with FDA as well. And so, that allows us to start working on the NDA documents now. Again, everything is driven by the urgent unmet need for people with TBH, but I think coupled with the strong experience we have here both for regulatory submissions and process as well as commercialization. Your next question comes from the line of Joseph Foam with TD Cowen. Your line is open. Hey, this is Jacob on for Joe. Thanks for taking our question.

19:09 We were wondering how the baseline for the enrolled Phase III population would compare to the patients in the Phase II studies. And then what the expected placebo response in Phase III might be versus what we know about the patients in Phase II and the differences in the run-in periods? Thanks. Sure. So the study is ongoing and blinded. And so we will not really comment on the details of this ongoing study. Having said that, we are very much looking forward to top line data next quarter, where we'll share the top line data with you. And hope you're sharing our excitement as well for this possibility. With regard to the placebo, remind as well, we've had five prior highly successful trials.

20:03 The phase two trials showed statistical significance and clinically meaningful reductions in the composite as we presented at ENDO. In the PREVENT study, fifty five percent reduction with a highly statistically significant value. And in the phase 2B with a ninety milligram dose, the dose in lucidity, 64% reduction with a p value of 0.0031. Those p values do take into account all aspects of the trial, including the possibility of any placebo effect. We designed lucidity with the goal of replicating these prior successful trials. And we powered we're highly powered, ninety percent, to detect a clinically meaningful reduction in events, even under the most conservative circumstances.

21:01 Great. So, yeah, you're welcome. Your next question comes from the line of Corinne Johnson with Goldman Sachs. Your line is open. Good morning. This is Kevin on for Corinne. Could you just talk about the steps that you've taken beyond the event rate quota to ensure patient quality in the study for lucidity and then also to ensure sort of as much as possible adherence to study protocols for the full sixteen week treatment period? Thanks. Sure. So we again, we're replicating as much as possible the way lucidity is being conducted, mirroring what was done in the successful phase II and phase IIb studies.

21:48 We have extensive training of the clinical sites at the onset of the clinical trial. That training is reinforced throughout the conduct. And we also have materials for the participants to guide them on the study procedures throughout the study as well. And we also do have quality checks on the data overall to be sure that things are moving along well. Yeah, and I just add too, we have a very experienced team at Amylyx and quality starts from selecting great sites, having strong oversight. And I think throughout the whole course of the study, I've been quite proud of the team's efforts, just kind of continually keeping close and making sure that quality is kind of built in from the start and continues through the whole study.

22:43 Your next question comes from the line of Michael Lefior with Evercore ISI. Your line is open. Hi, guys. Thanks so much for taking my questions and congrats on all the continued progress. First one for me is now that lucidity is fully enrolled, can you help us think through what the top line disclosure will actually look like? What it will contain beyond whether the primary endpoint is met? What do you think will be the most important aspect of the data for people to understand, again, beyond the primary endpoint in that initial release? And secondly, since you're already preparing for NDA, since the last update, can you share more light on what work remains to be done between top line and potential submission, maybe in terms of QC, any additional studies, etcetera? Thank you.

23:39 Yeah. Thank you, Mike. So, I think first in terms of top line disclosure, you know us well, we're a transparent company. So, our goal is always to present things as they are. I think what's important in this study is probably two things to remind. The first is that the primary outcome, which is level two, level three hypoglycemic events, not only is it the primary outcome, it's in FDA guidance, but it's also very well known by endocrinologists and it's inherently clinically meaningful. Level two events being less than 54 milligrams per deciliter blood glucose, which is the blood value at which neuroglycopenia occurs. Level three, of course, means that the clinical manifestations of hypoglycemia have already occurred.

24:31 So, those are inherently clinically meaningful. And then I think a second important point is that there are currently no treatments for PVH. And so, what we have heard consistently, not just from people with PVH, but from physicians as well, is that any reduction in hypoglycemic events is meaningful. Each one of these events is a medical emergency. And so, what we hear from physicians often is that they are worried for their patients and they have really very few tools to help prevent these medical emergencies. So, reduction in these hypoglycemic events is meaningful. In terms of the NDA, we're working hard on everything we can now. I think the goal would be that the last really substantial piece of work would be everything associated with the Phase III trial.

25:24 So, we're trying to write everything in advance that we can. As I said, we have a very experienced team who's been through many regulatory submissions before. So, they're hard at work as we speak. Your next question comes from the line of Mark Goodman with Leerink Partners. Your line is open. Yes, good morning. This process of adjudicating the claims data, can you give us an example or two of just some of these efforts and just so we understand what you have done so far and how confident you are that you're finding these patients in the places that you think they are based on the claims data? Thank you. And are you only counting the moderate to severe ones? You're not counting the benign ones. Right?

26:15 Thanks, Mark. Appreciate the question. Just to talk a little bit about the claims analysis. So within the claims databases, we start with identifying patients that have a presence of bariatric surgery. And then we look at patients who also have documented hypoglycemia, so non diabetic hypoglycemia. And then after that, we'll then apply, and we have applied additional signs and symptoms associated with PBH, such as fatigue, dizziness, seizures, even blood glucose tests, or even ER visits. And then to add to that, we can look at it from how many of those type of events they've also had within the claims databases. So that's really how we've continued to look at the databases. I'll say we've done it several times, and each time we do it, we are confident in the 160,000 patient population that we've mentioned a few times.

27:03 Yeah, and I might just add to some added work that the team's done too, is both speaking to many of the sites and doing kind of market research with many of the sites to validate what we're finding in claims. For example, if the claims are saying, a site has 50 patients, actually checking with the site and seeing if they do have 50 patients. And so far, have been quite confirmatory as well. And I'll also just add from the call today, we also received notification kind of through the CMS manual list that there's likely to be an ICD-ten code for PBH going live in October, which will provide an additional tool kind of to track the claims data as well. And to directly your point too on excluding benign, you know, based the coding both on hypoglycemia as well as the signs and symptoms, these are people who have severe hypoglycemia.

28:01 Thank you. Your next question comes from the line of Geoff Meacham with Citibank. Your line is open. Great. Morning, guys. Thanks for the question. I have two quick ones. So ahead Lucidity top line, I know the primary outcome measure is level two or three events as a composite. But is there a thought of looking at, you know, each one of those separately, in particular level three, just to have a cleaner, you know, look at the profile from maybe a more commercial context? And then the second question, as you guys begin to focus on commercial and further evaluate the PDH prescriber base, how's your thinking evolved in terms of size and scope of Salesforce and MSL teams? Thank you. Hi, Jeff. I'll take your first question and then pass to Dan for your second.

28:52 So as you say, our primary endpoint, which is FDA agreed upon, We were looking at the reduction in the composite of level two and level three events. And that is well established in the ADA Diabetes Association literature and community as well. We do intend, as well as our secondary endpoints, are looking separately at level two, which is by finger stick a blood glucose level of less than 54 grams per deciliter, and separately level three, which is independent of glucose level of signs and symptoms that require individuals to have another individual help, or signs and symptoms that would have required someone else to help them if no one else is around.

29:52 And that is adjudicated by an independent group of experienced endocrinologists who are blinded to the data as well. And they do that adjudication on an ongoing basis. And I'll just add too from the sort of commercial point of view. So, you're right. Absolutely, level three means the person has had the manifestation of hypoglycemia. And so, course that's important. But level two being less than 54 is very well established too. So, think endocrinologists will be interested in both. And if you think about the outcome, it's really a nice mix. You have a blood value which indicates severe hypoglycemia, so you kind of know what's happening in the body. And then you have a clinical outcome in level three where you know the person has had the impact of severe hypoglycemia?

30:46 And then, for your question on prescriber base, I'll pass Sure. It Jeff, thanks for the commercial question. So, on the sales force sizing, we are initiating the go to market efforts at this moment. I would say, this is a rare endocrine launch. So, from an expectation, you can expect that sales force would reflect this particular size of a sales force. I'd also add that on Camille's team and the medical affairs function, we have initiated hiring our regional scientific director team, also known as an MSL team, but those hires are in place. Your next question comes from the line of Rami Kakuta with LifeSci Capital. Your line is open. Hi, James. Thanks for taking my questions as well. I guess can you touch on the degree of natural variability there is in level two and level three hypoglycemic events for PBH patients? Do you expect a massive difference from one week to another?

31:39 And then secondly, from a commercial perspective, are these PBH patients generally managed at centers of excellence? Or would you need to target endocrinologists more broadly? Sure. Maybe starting with the variability. So all of that's taken into account in our powering analysis. And I think we were quite conservative in our powering both on the effect size and on the placebo effect, whereas we saw a fifty and sixty four percent effect size at the sixty and ninety mg doses, we powered to a 35% effect. And then of course, retaining power up to a 50% placebo effect, even though I don't think we expect that in this condition. You can certainly look at the variability kind of from previous studies. But again, that's all kind of accounted for in our powering analysis. And generally, it's a chronic condition. Generally, people are not able to prevent these events from occurring.

32:37 So often if people are having events that will be a continuous thing. They don't kind of come in fits and starts, so to speak, all that often. In terms of the question of how we'll target centers of excellence versus the broader endo community, I'll pass over to Dan. Sure. Thanks, Josh. I appreciate the question on potential launch of Rami. On where the patients are potentially treated. So we have initiated that work, we are aware. And Josh mentioned this earlier. But there are centers of excellence. There are also key opinion leaders. And that's likely where we'll start from a launch perspective. We know that there's potentially 50 to 60 patients at certain centers, and some centers have even mentioned even more. But we'll start there. We know there's a concentration, and then as our disease state education efforts take a foothold, we'll expand into the broader endocrinology community.

33:28 Your next question comes from the line of James Candolis with Stifel. Your line is open. Hey, this is Mark on for James. Thanks for taking our question. One for me on Recordati. I believe we should be getting some data this quarter. And just curious your thoughts here as it relates to potential placebo effect and, you know, what the implications are for INFINITY, and whether really this is something that can actually be sort of read through onto your trial? Thanks. Yeah, thank you, Mark. So, I would say no, I wouldn't think there should be any read through. They're very different studies. And of course, we're conducting our study and Recordati is conducting their study. As I understand it, I think their study is at Phase II looking at mixed meal tolerance tests.

34:19 And ours is based on the prior Phase IIs, which is a much more real world type approach looking at level II, level III hypoglycemic events, which of course is within FDA guidance to support a potential registration. So, no, I don't think there should be any read through between the studies. Plus the mechanism of the drugs are very different as well. Your next question comes from the line of Gregg Zvanovitch with Mizuho. Your line is open. Hi, this is Emma on for Gregg. Thanks for taking questions. Maybe switching over to 114 with the ALS data coming up shortly.

35:04 Can you just remind us of the specific biomarkers to potentially look out for? Know there was some prior analysis done by you guys highlighting certain biomarkers, but maybe just a reminder, and then also some of the expectations that you guys have, or we should be thinking about going ahead into the data. Thank you. Sure. Thanks very much. So just to remind, our ALS study with AMX114, which is an ASO against CALPAIN II, is ongoing. We announced that we completed enrollment of cohort one in March, and that we are recruiting cohort two at the moment. And earlier this year, we reported on the safety data for cohort one.

35:51 And we do anticipate, as you point out, reporting on the biomarker data. Actually, it will be this June at NCALS in Madrid, Spain. So the biomarkers that we're studying are related to the mechanism of the CALPain-two ASO blocking this protease, as well as biomarkers that are related also to the ALS disease process. And we look forward very much to sharing those data with you. And just to add as well, as Camille said, study is proceeding incredibly well. So I think as Camille was mentioning, we've completed enrollment in cohort two. And we're now recruiting for cohort three as well.

36:40 Your next question comes from the line of Jason Gerberry with Bank of America. Your line is open. Hi, good morning. This is Dina Ramadin on for Jason. Thank you for taking our question. Maybe just a couple of commercial questions on vexatide. I think you've mentioned before that the ICD-ten code was not necessary for successful commercialization, but just curious how ultimately having an ICD-ten coach kind of alters your confidence in identifying and capturing patients at scale. You know, I know you've outlined the centers you're targeting and what your commercial strategy is, but just curious if it impacts how you're approaching your commercial plan.

37:26 And then just a second quick follow-up. I believe you plan to position of exercise as a chronic therapy. I'm just curious what assumptions you're making around expectations for persistence and adherence in the real world. Thank you. Great. Thanks, Dina. So on the ICD-ten question. So in April, CMS, they published a list of ICD-ten codes to be effective October 1. These codes demonstrate a recognition of PBH in the broader medical community. The ICD-ten code, yes, it is helpful for diagnosis and tracking of patients. However, it's not it's not a necessity. ICD pen codes are often used for epidemiology.

38:12 So an implementation of the code, this will enable patients to be tracked across the various electronic medical record systems. It's also important to note that patients today, they still can be identified via the claims analysis. And that's how we validated the 160,000 patient population. And then to your other question too about kind of chronic therapy and persistence, it's probably early to comment there. We're quite excited about Avexotat. And PVH is a chronic condition where the means do not go away over time. So certainly, we do think that patients will have an ongoing need for therapy. Your next question comes from the line of Chris Chen with Baird. Your line is open. Good morning. Thanks for taking my question and congrats on the progress. Just a quick one on the OLE.

39:05 Can you just remind us what the setup is specifically for that? And are you able to kind of share high level how enrollment in that is going? Sure. So are you seeing the OLE or the EAP? Just so that I'm clear, please. The OLE for Lucidity, the Yep. Open label Yep. Yes. So while I will not comment on details of our ongoing blinded trial, I am pleased to share that lucidity is proceeding well, including participants transitioning from the double blind period to the OLE portion of the study. We're confident that we're running the right study, And we're very pleased on how the team has been executing on the trial. We have such an experienced team. And they're overseeing the trial with great focus and care.

40:01 Yeah. And you asked the OLE set up. So just to add there as well. So we expect the randomized double blind study is the study that we expect to use in NDA to support potential commercialization. The OLE itself, though, also has a Part A and a Part B. During the Part A, we keep the study very similar to how it's conducted during the double blind. That allows to look at kind of data in a similar way to we look at as the double blind. And then later they enroll in the OLEB after eight weeks in the OLE, at which point it's a little more there's less burden, some kind of trial participation at that point. But overall, to kind of reiterate what Camille said as well. We're very pleased with the contact of the study.

40:54 There's a lot of excitement from sites and otherwise as well. And we'll look forward to reporting our data in Q3. And I think it's obvious, but just to say also for the open label extension, I think very important when you work in rare debilitating conditions like post bariatric hypoglycemia that you always try to think about the people we're trying to help. And so, for an open label extension, if you're on treatment and you believe that you're benefiting, an open label extension allows you to continue. And if you're randomized to placebo, then allows you to take active medication. So, that's it's something that we always really try to think about in our programs. Your next question comes from the line of Ananda Grouch with H. C. Wainwright. Your line is open.

41:47 Hey, hi. Good morning, guys. Thanks for the question. Maybe one question, you know, people have been focusing on U. S. Opportunities. So one question would be, have you done work with respect to vexatide on ex U. S. Opportunities? You know, what are you hearing from the KOLs, the stakeholders? And then I have one follow-up question on LUMINA. Absolutely. Thank you, Ananda. So, there's a tremendous unmet need globally for post bariatric hypoglycemia. Now, our focus is very much on The U. S. Right now. With one hundred and sixty thousand people in The U. S. With PVH today, that's a substantial unmet need and people to help and address. But our first of all, bariatric surgeries occur globally.

42:37 And also, as we mentioned before, virtually any gastric surgery has the potential to cause the same debilitating hypoglycemia. So, for example, in major Asian countries, gastric cancer rates, esophageal cancer rates are very high, and so gastrectomy or esophagectomy is often indicated. And so, for people with those surgeries, they also have the potential of developing the same debilitating hypoglycemia. And we have data from the Phase IIb study of vexatide that vexatide may be beneficial for people who had those surgeries leading to this debilitating hypoglycemia as well with pathophysiology is the same regardless of the surgical intervention.

43:24 So, our focus is really on The U. S, really on The U. S. Population of post bariatric hypoglycemia, but absolutely there's a huge unmet need internationally. We get compassionate use requests from people around the world constantly. Got it. Great. Thanks. One question on LUMINA. I know there was a question on biomarkers. So, given that it's the lowest dose, you know, do we are we can we expect, you know, the preliminary NfL data or target engagement data with respect to levels or, you know, other downstream markers like SPD 145 in the data readout or that is for later? Yeah. I mean, it's hard to sorry to interrupt.

44:10 It's hard to know until we have the data. I'd say, we do pre clinically believe we have a potent ASO. As you look at past ASOs that have been in clinic, usually they've been studied between the range of generally about ten mgs to one hundred mgs for CSF injection. And we're at the very low end of that range. So we may see signals, but it also may require us to go to a higher dose before we start significantly moving the biomarkers. But I'll add to Ananda to your point, we really are our goal is to have a picture of first, are we replicating the biology that we saw in the pre clinic to the clinic? Are we seeing the implications of CALPIN-two knockdown? And then are we seeing effects on biomarkers that we believe to be prognostic for ALS as well? So, that is indeed the goal of the biomarkers in all of these cohorts is to try to get a picture of are we seeing the impacts of CALPIN-two and are we seeing potential impacts on ALS as well.

45:12 Thank you. There are no further questions at this time. I'll turn the call back to Mr. Klee. Thank you, operator, and thank you all for your time. If you have any follow-up questions, please reach out to Lindsey, and we hope you have a great rest of your day.