Amylyx Pharmaceuticals Inc (AMLX) 2025 Q3 法說會逐字稿

Good morning. My name is Carly, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amylyx Pharmaceuticals third quarter earnings conference call.

(Operator Instructions)

I would now like to turn the call over to Lindsey Allen, Vice President, Investor Relations, and Communications. Please proceed.

Good morning and thank you all for joining us today to discuss our third quarter 2025 financial results and business updates. With me on the call today are Josh Cohen and Justin Klee, our Co-CEOs, Dr. Camille Bedrosian, our Chief Medical Officer, and James Frates, our Chief Financial 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 1,995.

These statements include but are not limited to our expectations with respect to a Avexitide, AMX 35 and 114, statements regarding other development candidates, statements regarding regulatory and clinical developments, the impact thereof, and the expected timing thereof, and statements regarding our cash runway.

Actual events and results could differ materially from those expressed or implied by any forward-looking statements. You were cautioned not to place any undue reliance on these forward-looking statements, and Amylyx 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.

Q3 was a quarter of progress as we continue to focus on our lead program of Avexitide in post bariatric hypoglycemia, or PBH. Avexitide is our investigational first in class inhibitor of GLP-1 receptor activity with FDA breakthrough therapy designation.

PBH is a condition characterized by recurrent hypoglycemic events, which can impose a significant and lasting burden on a person's quality of life. There is a robust body of data generated to date for Avexitide which includes 5 clinical trials demonstrating statistically significant and clinically meaningful reductions in hypoglycemic events.

Based on those results, we designed our pivotal phase 3 lucidity trial with the goal of replication. We remain focused on enrolling a similar patient population, collecting the data in a similar way, and executing Lucidity with high-quality. We continue to see high participant interest and broad engagement across clinical trial sites, which we believe supports the urgent need for an FDA approved treatment.

Our previous guidance for completion of recruitment was by the end of 2025 with top-line data in the first half of next year. Based on our most recent projections, we now expect to complete recruitment in Q1 2026 with top-line data expected in Q3 2026.

We anticipated more of a ramp in the enrollment rate at this stage, but we have seen more of a steady enrollment rate in the last few weeks. Timing for potential launch remains unchanged. With early NDA preparation efforts underway, we continue to expect to be in a position to launch Avexitide in 2027 pending FDA approval.

Having launched a commercial product in the past, we're focused on key areas required for a successful launch. We are already laying the groundwork to be ready in 2027 if approved. We've been taking the initial steps towards building the medical affairs and commercial organizations with targeted investments in market research, insights, disease education, market access strategy, and commercial infrastructure.

Our continued market research, claims analysis, and engagement in the field support our confidence in our estimate of 160,000 people with PVH in the US and bolsters our understanding of the unmet need.

Turning to our broader pipeline. In Wolfram syndrome, we are advancing the clinical development of AMX 0035, and pending alignment with FDA, we plan to initiate a focused pivotal phase 3 trial in the second half of 2026.

For AMX0114, our investigational antisense oligonucleotide targeting calpain-2 and ALS, we were pleased to share that in September we fully enrolled cohort 1 in the phase 1 Lumina trial. We anticipate early cohort data later this year and plan to share these safety data at the 36th International Symposium on ALS and MND, which is being held from December 5.

Based on biomarker collection and analysis timelines, we anticipate biomarker data will be available in the coming months and expect to present these at a medical meeting in the first half of 2026. We're excited by the potential of this novel mechanism and the fast-track designation from the FDA. Across all of our programs, our team is focused on execution as we head toward a pivotal year in 2026 with topline data from Lucidity anticipated next year.

Now I'll turn the call over to Camille.

Thank you, Justin. As a reminder, PBH is a serious, persistent, and life-altering condition with no FDA approved therapy. People living with PBH often experience frequent, unpredictable hypoglycemic events driven by an exaggerated GLP-1 response that can severely limit their independence and quality of life. Many people with PBH live with a constant anxiety around meals, social interactions, and basic daily activities.

Individuals with these experiences are not outliers. They reflect a broader underserved population that motivate our work. Avexitide is an inhibitor of GLP-1 receptor activity that reduces insulin secretion and stabilizes blood glucose levels.

Based on the data and consistency from our 5 previous trials in PBH, we designed the pivotal phase 3 lucidity trial to optimize the potential for success by being as consistent as possible with the previous phase 2 trials. Specifically, these studies directly informed the dose, endpoints, inclusion criteria, and surgical subtypes.

Lucidity is evaluating of Avexitide 90 mg once daily in individuals with PBH following Roux-en-Y gastric bypass surgery. The FDA agreed upon primary endpoint is reduction in the composite rate of Level 2 and Level 3 hypoglycemic events through week 16.

Based on prior phase 2 data, we believe the trial is well powered to detect clinically meaningful benefit. We continue to be encouraged by the execution of the trial that prioritizes scientific rigor and operational excellence. All clinical trial sites are now activated and screening participants.

There is high participant interest and engagement across our sites. In addition, investigators continue to report that participants are highly motivated to contribute to the study. Furthermore, participants have begun to move into the open label extension portion of the trial. As awareness of PBH continues to grow, we are seeing increased recognition of the burden and the urgent need for a treatment option.

We believe of Avexitide, which has been granted FDA breakthrough therapy designation, has the potential to be the first approved therapy for PBH and to meaningfully improve the lives of those affected.

With that, I'll turn over the call to Jim to review our financials.

Thanks, Camille. Our financial position is strong as we focus on careful execution of lucidity and preparing the company for a launch in 2027 should have Avexitide be approved by the FDA. We ended the third quarter with a strong cash position of $344 million compared to $181 million at the end of the second quarter.

This reflects the recent completion of our public offering in early September. This financing provided approximately $191 million in net proceeds and together with our existing cash positions us to support the potential launch of Avexitidein 2027 and provides us with an anticipated cash runway into 2028.

Turning now to our results for the quarter, total operating expenses for the quarter were $36 million down 53% from the same period in 2024. The decrease is primarily due to the one-time expenses related to the acquisition of a Avexitide that we incurred in the third quarter of last year.

Research and development expenses were $19.9 million compared to $21.2 million in Q3 2024. This decrease was primarily due to decreases in spending on AMX0035 for the treatment of PSP and ALS. The decrease was offset by increased spending related to the clinical development of the Avexitide in PBH.

Selling general and administrative expenses were $16.2 million compared to $17.8 million in Q3 2024. This case was primarily due to a decrease in consulting, professional services, and other expenses. We recognize $7.1 million of non-cash stock-based compensation expense for the quarter compared to $6.8 million of non-cash stock-based compensation expense in Q3 2024.

In summary, the more work we do, the more we learn about the patients and providers, the more we believe that there is a major unmet need for people living with PVH. The key for us operationally is to execute the lucidity study well and prepare for a positive outcome. We believe we have the scientific, operational, and financial resources we need to execute on our goals.

With that, I'll turn the call over to Josh.

Thanks, Jim. Our conviction in inhibiting the GLP-1 receptor as a therapeutic approach remains strong. While lucidity remains our primary focus, we also view it as a starting point, both for Avexitide and for advancing research into GLP-1 receptor antagonism more broadly. For instance, our research collaboration with GRA continues to show encouraging proof of concept data with new molecules demonstrating strong potency in vitro and in vivo, along with extended half-lives.

We are very pleased with how the partnership is progressing to develop a novel long-acting GLP-1 receptor antagonist. We expect to make a decision on a potential development candidate in the next few months, and pending a candidate nomination, we are preparing to initiate our ID enabling studies. Before we open the call up for Q&A, I would like to reflect on the urgent opportunity driving our work in post bariatric hypoglycemia.

PBH affects an estimated 8% of people in the US who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass. That translates to approximately 160,000 individuals living with PBH, many of whom experience frequent, unpredictable hypoglycemic events that disrupt daily life and limit independence.

Multiple lines of evidence support a belief in the significant unmet need in this market, including several robust published prospective and retrospective studies and our ongoing claims-based work. Most compelling is what we are hearing directly from the field, which has continued to corroborate the substantial burden in PBH.

We continue to be excited by the data generated to date in the 5 clinical trials of Avexitide and PBH. These findings, together with new analyses we shared last quarter at End 2025, reinforce the robust body of evidence and give us confidence as we advance lucidity towards top line results next year. We're committed to executing lucidity and preparing to be launch ready following FDA approval, and we look forward to keeping you updated.

Now, I would like to open the call up for questions.

(Operator Instructions)

Seamus Fernandez, Guggenheim.

Oh great. Thanks for the question and I appreciate all the updates. Why don't you just get a quick sense of the enrollment, update, with regard to a couple of things as we've been speaking with physicians, there were a couple of dynamics in play here. One was the very careful decisions on the part of the company to ensure that there is a broad enough participation, from a wide enough array of sites that it would take some time to basically start up those sites.

So just trying to get a better sense of the impact here. Is it site startup that has resulted in the, estimated modest delay of a quarter? Is it the, run-in period. That is potentially impacting the enrollment because again a 3 week with, the requirements for Level 3 events I could envision having an impact on enrollment just given the careful design there and then, another factor would be just ensuring that the patients that are enrolled are actually, fully dedicated and committed to, limiting any potential changes in diet over the 16 week period.

That could negatively impact the study. So, I just wanted to get a better sense of some of the operational dynamics that could be coming into play as it relates to the study. And then just a very quick, follow-up on the bra comments. The DC, development candidates selection to IND, can you just, give us a sense of the timeline, that might, come into play there. Thanks so much.

Great, yeah, thank you so much, Seamus. Great, questions and important points on the operations. Yeah, so I think first just to say at a, a high level, I think we're pleased with how the, study is being executed, how it's progressing, the first participants are going into the open label extension. And you know you raise really important points as well, which is our real focus is on quality, enrolling the right participants, ensuring the right data collection, especially in view of the 5 prior trials of Avexitide.

And PBH which demonstrated a very statistically significant and cleaning clinically meaningful reductions in hypoglycemic events. So, the update. Is on the timeline based on our most recent enrollment projections and estimates, and I would say that, certainly in every trial I've been a part of, as you have all of the sites up and running recruiting participants, you tend to see a ramp in the enrollment rate.

Now that could still happen, but so far, it's been a steady enrollment rate. And so that's why we're updating the projections to now estimated completion of recruitment in the first quarter. So, I hope that helps, but I really appreciate your points on the quality of the operations. That's definitely where our team is focused as well, and we're pleased with our team's focus.

And maybe just touching on your other questions too, included in that quality certainly is maintaining the dietary guidance. Throughout the whole trial, so just as a reminder, at every clinic visit, patients do receive, dietary guidance.

And, the goal of that is to keep everybody following closely with the recommended, PBH, diet, and we have heard that patients are, quite engaged, quite, excited to participate in the study and wanting to be, to follow the protocol as best as they possibly can you also asked about the drug candidate nomination from GR and the sense of the timeline. So, first I'll say we've been quite excited about the data from [GR].

We've seen really encouraging data both in vitro and in vivo, both on kind of efficacy outcomes as well as. Comes related to Half-Life and kind of the duration of the drug, we'll probably give more granularity and timeline as we, do nominate or as we get to the point of making the decision, to nominate a drug candidate, but certainly our goal will be to move as expeditiously as we as we possibly can.

Joe Thome, TD Cowen.

Hi there, good morning and thank you for taking my questions. Maybe the first one just on the phase 3 study, give you a general idea of how long patients have trialed dietary therapy and still are not able to respond to that before entering the study and maybe related to that, what's your kind of current screen failure rate, for patients maybe not meeting the necessary events in the observation period.

And then, follow if I can on the ALS program. Can you just clarify a little bit what you're going to present later this year? Will you have early biomarker data from that first cohort already in this presentation, or, are you going to present all the biomarker data next year when you have, a larger set?

Thank you.

Sure, so probably, within an ongoing trial we don't, necessarily kind of give interim data or interim updates, but what I can share is when you look at past studies with the Avexitide, it was often the case that people have had PBH, 6,7, 8 years, and the usual standard in PBH. Which is certainly the dietary therapy. So, most of these patients will, we do expect that most of the patients, if not all of the patients, will have been on dietary therapy, many years prior to entering, and we do require that the bariatric surgery was at least a year prior to entering the study. So everybody's had.

The bariatric surgery, well in their past as well, in terms of screen fail rates, similarly, we don't, kind of report interim data, as we're going through a study, but certainly our goal, as Justin suggested, is to enroll the right patients in the study and to, focus on quality throughout, getting patients, who have the appropriate level of severity.

And who hopefully we'll be able to complete the study also in terms of the 114 presentations in early December, that will focus on safety at this time we will have biomarker later we expect to report on that in the first half of the coming year at a medical conference. The biomarker, work just takes a little bit longer, hence that coming in the first half.

Great, thank you very much.

Geoff Meacham, Citi.

Hi guys, it's Ross on for Jeff. I guess, thanks for taking our question. We're curious about your sense of PBH. And kind of the addressable market and how is that continued to evolve.

Yeah, thank you, and I would say, as we've done more and more, commercial preparations, looking forward, I'd say it only increases in our confidence in both the unmet need in the market, so we've looked at multiple claims-based analysis now, as well as there's.

And independent work out of Stanford looking at the total population and our estimates continue to be that there are about 160,000 people today who have PBH and we expect more to come as well. Bariatric surgery rates continue to be quite significant. And with that we would expect the population to only continue to grow from already quite a substantial unmet need. The other thing that I think has really come out from being out in the field is the unmet need.

It's severe hypoglycemia as defined by Level 2, Level 3 events. These are frequent occurrences for people with PBH. To put it in context, severe hypoglycemia, according to the American Diabetes Association, a single event is a medical emergency, and these are people who are having frequent hypoglycemic events. So, it's highly debilitating.

And what we hear from clinics is that they're very worried for their patients because one, they really have very limited options to help them, and two, that these hypoglycemic events can occur often without warning and again so frequently. So, I think all of our research just continues to bolster our confidence in the unmet need and the opportunity here that we have with the Avexitide.

Thank you.

Corinne Jenkins, Goldman Sachs

Hi, this is Kevin on Corinne. Good morning. Just wanted to follow-up on the addressable market question, in terms of the, 160,000 PBH patients. As you do more work on that, what percentage of those patients do you think would be, uncontrolled on diet? And what percentage of those patients do you think would be eligible for your phase 3?

Thanks.

Yeah, good question. So maybe starting with, kind of uncontrolled on diet, so in coming up with the 160,000 estimate, which, as a reminder is based on published, prospective and retrospective data as well as, claims-based work and, direct work with physicians treating PBH.

We tried to eliminate up front those who were controlled on diet, so the 160,000 is intended to be those who are not controlled on diet and who are continuing to experience, unacceptable and clinically problematic, hypoglycemic events in terms of direct eligibility for the phase 3, that's not, an analysis we've done, directly through 160,000.

But again, we do view the 160,000 as people who are having, as Doctor Colleen Craig calls it from Stanford, a medically important PBH, which is significantly impacting their daily life and as Justin said, even a single significant hypoglycemic event is considered a medical emergency. So these are patients who, in fact are having frequent medical emergencies.

And just to give a picture of what we believe is going on from a pathophysiology perspective, the, we believe that PBH is caused by the body dramatically up regulating the production and secretion of GLP-1. So, people will have up to 10 times normal levels of GLP-1. And so, the reason that we think, we hear from both clinics and patients that kind of no matter what they do, they continue to have these drops in blood glucose is because of this GLP-1 effect.

So, if you think no matter what they do, their body is producing up to 10 times normal levels of GLP-1, their blood glucose is going to plummet. And that's also why we think a Avexitide has such potential, because really to get to the heart of PVH we believe that you need to blunt that GLP1 bolus, which is ultimately what's causing the hypoglycemia.

Thank you.

Marc Goodman, Leerink Partners.

Yeah, just to kind of come back to this delay in the timeline, can you help us understand like someone asked the question, but I wasn't sure if the answer was given about, I mean, we're talking about 75 patients in 20 sites, right? And this is 3 to 3 to 2 random, I mean what help us understand what's going on here like do we need to add more sites?

Do we have the right sites? Like what help us just understand what that issue is and then you talked about. These patients moving into the open label extension trial, talk about the side effects that you've seen. Is everything generally the same as what we've seen in the phase two studies? Anything unusual?

Thank you.

Sure, thanks, Mark. So first, I wouldn't, characterize this as an issue. I'd say that, as we continue to go along the study, we've updated our timeline, to expect a complete recruitment in the first quarter of next year and with data coming out in Q3 of next year. We have seen a lot of excitement across the trial.

I'd remind that timeline would still be recruiting, phase 3 study in under a year, and, phase 3 studies entail, not just finding the patients but also all the work that goes into activating sites, everything else, so we actually do see that as a very good timeline, for a phase 3 as well. We probably won't report, at this point on, side effects or otherwise we don't report, interim data from a trial.

But I think as we mentioned, we are excited to see, quite a lot of participant engagement and patients moving into the OLE as well, so, excited overall about the execution of the study and our team's great efforts, in the space.

Rami Katkhuda, LifeSci Capital.

Hey guys, thanks for taking my questions as well. I guess in lucidity, are you measuring diet adherence via the blinded CGM and can you intervene based on blood glucose levels if the patient is kind of liberalizing their diet as they start to feel better?

Yeah, hi, Romi. Great question. So, I would say that our team as well as the monitors are looking at all of the, available blinded data, including CGM as you mentioned, which we get in virtually real time, and the goal there is really to make sure that, one, yes, people are adhering to diet, and That people are collecting events as we would expect in the study, so yes, our teams are continuing to do that and if we see, significant, deviations that we think need addressing, then our team will indeed reach out to the site and retrain as necessary.

Got it. Makes sense. And then, I know I'm jumping the gun a little, but a number of KOLs are excited to use a Avexitide for hypoglycemia associated with other GI surgeries as well. I guess, have you talked to the FDA on the regulatory path forward there? Would you have to run a study in each population, or is there a potential for kind of a basket study across a number of these surgery types?

Sure, so, the phase 3 study is in people, with Roux-en-Y gastric bypass, it, it's early to, label discussions happen later in the process, so it's early to say, what an FDA label would or wouldn't be, but, given that the study is in ruin Y, that is a potential risk, that we, that, element finds its way into a label or otherwise. That being said, we do believe, both physiologically, based on the biology of these different surgeries that the pathophysiology is similar or the same, for why people are getting PBH across them.

And in addition, our phase 2B study included people with multiple surgical types and the effects look similar, across the surgical types as well. So, it's certainly something that. That we want to pursue, we do exactly as you suggested, get a lot of interest, from academics and otherwise with surgeries, beyond Roy, including, people who have had a gastrectomy for gastric cancer, Nissen fundoplication for gastro gastroesophageal reflux disorder, and otherwise, so it's definitely an area where we're quite excited to pursue, and yeah, I'd say stay tuned in that regard.

Sounds great. Thank you.

Graig Suvannavejh, Mizuho Securities.

Hi there, this is SAM with On for Graig. Thanks for taking our question. Can you just remind us of the manufacturing and CMC processes for Avexitidein terms of the commercial doses, and the process there, and if you anticipate any snags, moving forward.

Thank you.

Yeah, hi, SAM. Yeah, and, important question. So, I would say, we're doing, all of the expected work as we move toward commercialization, hopefully with commercialization, on the CMC side. So, I'd probably touched on a number of points. So, first, as you may expect, we have manufactured our registration batches, and they're up on stability.

I'd say second, the suppliers that we're working with both on the drug substance being the peptide and the drug products being, the final finished product are manufacturers that have multiple commercial products and have very good inspection.

As well, and I would say then on the internal side, we're focused on all of the quality parameters, inspection readiness activities as you might expect with the anticipated approval in 2027. So, I'd say, our team is laser focused on all of the things that would be required for both NDA submission and then eventual approval.

That's very helpful. Thanks for the color.

Christopher Chen, RW Baird.

Morning team. Thanks for taking my questions. Just going back to the lucidity and the clinical sites, have you, noticed any differences in the ramp, between sites, and are you kind of maybe learning from those sites that maybe are enrolling faster, to kind of, overall just make the ramp, increase across those sites?

Yeah, thanks Chris, and I would say, in a clinical trial, of course, you always have differences across sites and you know that's why we have 21 sites. All sites are activated, and I would say again in my experience as you have all of the sites activated and you go into the latter part of the study.

That's when you tend to see an increase in the enrollment rate so that that could still come, but so far in the in the last few weeks we've seen more of a steady enrollment rate again our goal is to conclude enrollment as expeditiously as possible but of course making sure that we're enrolling the right participants.

we have the right clinical oversight as well I'd say on a sort of site engagement level, the main message I would say is that the unmet need here is very real. I think we have high engagement from the sites. They're very eager to have potential treatment options for their patients. So, that's really come through in all of our engagements.

Thank you.

Tim Anderson, Bank of America.

Hi, good morning. This is Susan on for Tim. I have a couple of questions. First question, given that you now have a timeline estimate for the pivotal Wolfram syndrome trial, what can you tell us about the potential trial parameters and just, how have your discussions with the FDA gone? And I'll follow-up with my second question.

Okay, thanks very much. This is Camille. As, we have indicated based actually on the HELIOS data and AMX0035 for Wolfram syndrome and the very encouraging results out to 48 weeks, we are advancing the clinical development of 35 for Wolfram and plan to initiate our focused pivotal trial second half of 2026.

We are, pending, of course, FDA alignment and we're, actively, seeking that alignment. Now, not only with the FDA but also we are engaging a number of additional stakeholders, clinicians who treat people with Wolfram syndrome, researchers who study the disease as well as the Wolfram Community itself, and we're seeking alignment across all those stakeholders.

Thank you. And, sorry to keep coming back to this, but you've mentioned a couple of times already that you typically see a rampant enrollment, when all trial sites are activated, but rates have been steady. Why do you think this is? Would you characterize this more as a system-wide issue or specific to the lucidity trial?

Yeah, I don't think I would characterize this as, a system-wide issue or an issue really. I think just as we're updating our projections we're trying to be as accurate as we possibly can and given the current rate we expect Q1 of the coming year, I remind that's still enrolling a phase 3 trial in less than a year, which, I think is a good timeline for phase 3 overall.

Ananda Ghosh, H.C. Wainwright.

Hi guys, thanks for taking my question. I have 21 for Lucidity and the other, and the other from the LS program. So maybe the first question, how is the level 2 or 3 weighed in for the composite scale, and is there a way to kind of, like the nocturnal and the diurnal rates differ, or how is that kind of taken care of? And the other question you might have, discussed about discussed beforehand, but just to reiterate, how are prior therapies handled like GLP-1 agonist?

Yeah, thank you, Ananda. So, two important questions. So, first, coming off of 5 prior trials of the Avexitide in people with PBH that showed statistically significant and clinically meaningful reductions in hypoglycemic events, the goal really here is replication. So to TRY to enroll a similar patient population, collect the events in the same way, etc.

So. For the primary outcome, level 2 events are done by finger stick blood glucose, and level 3 is an e-diary that's adjudicated by an expert committee. So that's, so that's how the data are collected. People can collect those during the day or during the night.

Now people also have CGMs on which have continuous monitoring. And so, obviously we will be looking at both, in the phase 2B trial where they use the 90 mg dose that we're using in the phase 3, there were significant reductions, both as measured by the finger stick as well as by the CGM day and night. But, again, our goal really here is with replication, so we're trying to keep things as consistent as possible.

In terms of use of GLP-1 receptor agonists or really any therapeutic that could alter blood glucose, we have a washout period before people can be randomized into the study so that we don't have things that could that could affect people's blood glucose levels, given that, of course that is a key part of this study.

Great, thanks. Maybe just one question on this is that how are those level 2 or 3 weighed in the composite scale? Like how are they weighted? They are they weighted like equally?

Yes, they're weighted equally.

Got it, the next question on the ALS program, if you can take, like, how are you measuring the calpain and NFL levels in terms of, and also given the short trial length, what magnitude of NFL change might be practically feasible.

Yeah, so the calpain, I'd say we're measuring kind of different points in the pathway, so we're certainly, working to measure mRNA, in the CSF, we are also looking at measures of calpain activity including things like a spectrum breakdown product 145 or SBDP 145, which is a specific protein cleavage fragment, that calpain makes and is, an element of, calpain activity.

And then as you mentioned downstream looking at markers of axonal degeneration like neurofilament, to kind of see that downstream effect of potential calpain inhibition. I'd say, an initial study, we don't quite know yet what the kinetics of changes in those markers, might be, in our pre-clinical work, we've seen, changes on multiple of those markers, which certainly makes us encouraged, but we'll have to see clinically, how that bears out.

Great, thank you guys.

There are no further questions at this time. If you have any follow-up questions, please reach out to the company. This concludes today's conference call.

Thank you for joining. Have a great rest of your day.