Fulcrum Therapeutics, Inc.

Good morning and welcome to Fulcrum's Seropetix Second Quarter 2024 Financial Results and Business Update Conference Call. Currently, all participants are on a listen-only mode. This call is being webcast live and can be accessed on the Investors section of Fulcrum's website at .fulcrumtx.com and is being recorded. Please be reminded the remarks during this call may contain forward-looking statements within the Meeting of the Private Securities Legislation Reform Act of 1995. It may include statements about the company's future expectations and plans, timing, timelines, and financial projections. While these forward-looking statements represent Fulcrum's views as of today, this should not be relied upon as representing the company's views in the future. Fulcrum may update these statements in the future, but it's not taking on an obligation to do so. Please refer to Fulcrum's most recent filings with the Securities and Exchange Commission for discussion of certain risks and uncertainties associated with the company's business. Leading up today will be Alex Sapir, CEO and President of Fulcrum. Joining Alex on the call are Alan Musso, Chief Financial Officer, Dr. Pat Horn, Chief Medical Officer, and Dr. Lene Fazer, Senior Vice President of Development. After providing updates on our key programs, there will be a brief Q&A in which Alex, Alan, and Pat will be available to answer your questions. With that, it's my pleasure to turn the call over to Alex.

That's great. Thank you, Lisa, and good morning, everyone, and thanks to all of you for joining us for our second quarter conference call. We've organized today's call to provide you with updates on recent progress and upcoming milestones for our two clinical stage assets, Los Mapamod and Posiradera. And after a brief introduction, we'll segue into our pipeline. I'll then ask Alan to review the financials, and finally, we'll end by taking your questions. I am happy to report that we are on track to report top-line data for the Phase 3 Reach Trial of Los Mapamod by the end of October, compared to our previous guidance of the fourth quarter. As we advance toward this important inflection point, we continue to build out the team and as we prepare for the potential NDA filing and the U.S. commercial launch of Los Mapamod. In parallel, we are working with Sanofi in preparation for regulatory filings and the launch of Los Mapamod outside of the United States. As a reminder, in May of this year, we announced our collaboration and license agreement with Sanofi for the development and commercialization of Los Mapamod for fasciose scapulomuscular dystrophy, or FSHD for short, for all territories outside of the U.S. We believe we selected the best possible partner for Los Mapamod as this collaboration combines fulcrum's expertise in FSHD with Sanofi's deep regulatory, development, and commercial capabilities in neuromuscular markets around the world. Together, we look forward to delivering on our shared commitment to address the high unmet need of patients in the FSHD community. Let me spend a bit more time on Los Mapamod, which as many of you know is an oral small molecule selective P38 alpha beta map kinase inhibitor that inhibits Dux 4 expression and many of its downstream transcripts and thus prevents muscle cell death in patients with FSHD. An estimated 30,000 patients in the U.S. have FSHD, which is characterized by a slow but relentless loss of muscle function year after year, resulting in significant impairment of upper extremity muscle function and mobility. And while there is a degree of heterogeneity in the onset and disease progression of FSHD, this relentless loss of muscle function means that approximately 20% of patients become wheelchair bound. I think it's important to remind everyone that there are currently no approved therapies for FSHD and no drugs used off label to help these patients. Now, let's turn our attention to our Phase III registrational trial called REACH, which I spoke about earlier. As a reminder, REACH is a 48-week Phase III trial intended to be registration enabling both here in the U.S. and in -U.S. geographies. In September of last year, we completed enrollment in REACH with a total of 260 patients. As presented at the 31st Annual FSHD Society International Research Congress in June of this year, baseline characteristics of the REACH study population are similar to those of our Phase II Redux IV study population. Building on the encouraging clinical benefit and favorable tolerability observed in our REACH Redux IV trial, the primary endpoint for the REACH study is the change from baseline in the relative surface area, or RSA, which is a quantitative assessment of reachable workspace and has been shown to correlate with disease severity and progression. RSA is a measure of upper extremity range of motion and muscle function that specifically evaluates shoulder and arm mobility using 3D motion sensor technology and is indicative of the ability to perform activities of daily living. Based on collaborative interactions with the Clinical Outcomes Assessment, or COA, group at FDA, we are further assessing the extent to which a specific change in the RSA score is meaningful to patients. I'm pleased to report that we are on track to complete the activities agreed upon with the FDA at the time of reporting the REACH top line data. Additional key secondary endpoints in REACH include muscle fat infiltration, or MFI, which is a marker of disease pathology measured by whole body MRI, shoulder dynamometry, and patient global impression of change, or PGIC for short. We believe that the implementation of self-reported quality of life measures and healthcare utilization questionnaires will help inform our payer strategy as we begin preparing for a commercial launch to deliver the first FSHD treatment for patients. We are now progressing toward the completion of the 48-week treatment phase of the trial for all enrolled patients. As of June 30, 2024, of the 234 out of the 260 who completed the 48-week treatment phase, 232 of those patients, or 98%, chose to enroll in Part B, the open label extension of the study in which all patients receive drugs. This very high percentage of patients opting to move into the open label phase is similar to what was observed in our phase two clinical trial, and we believe is indicative of the high unmet need for patients with FSHD. Again, we are on track to report top line data by the end of October, which will bring us one step closer to delivering the first ever FDA approved therapy for FSHD patients. Now let's talk a little bit about Posiridir, which is our oral HPF inducer for the potential treatment of patients with sickle cell disease. The elevation of HPF, or fetal hemoglobin, is a clinically validated therapeutic rationale for sickle cell disease, a lifelong inherited blood disorder that severely impairs quality of life for approximately 100,000 people in the U.S. and approximately 4.4 million people making sickle cell disease one of the most prevalent non-malignant hematologic diseases. Historically, the standard treatment for sickle cell disease has included blood transfusion, pain medication, and hydroxyurea that focus only on symptom relief. While exciting scientific progress has enabled the advancement, and more recently, the approval of gene editing therapeutic approaches, we believe there remains a high unmet need for an oral therapeutic option that is broadly protective of sickle cell disease symptomatology. As a first in class oral small molecule HPF inducer, we believe Posiridir has the potential to address this unmet need. Turning now to our phase 1b clinical trial, the Pioneer Trial, we continue to make progress. Given that many of the sites we are newly activating are academic sites here in the as well as outside the U.S., both of which have long site activation lead times, together with our narrower inclusion exclusion criteria, it is taking longer than initially expected. We expect to have study data to share with everyone in 2025. As a reminder, cohort three of the phase 1b trial will evaluate Posiridir at the 12 milligram once daily dose with a dosing duration of three months, followed by cohort four at the 20 milligram once daily dose also for three months. Both cohorts are expected to enroll approximately 10 patients each. We look forward to building on the encouraging clinical data obtained prior to the clinical hold, which demonstrated that Posiridir increased total fetal hemoglobin of a magnitude that could translate into a meaningful improvement in disease severity. These interim results of the phase 1b trial involving 16 patients were recently reported in June at the EHA conference in Madrid and were very well received by the medical community. We believe that Posiridir as an oral HPF inducer has the potential to provide a differentiated option for people living with sickle cell disease and addressing the significant unmet need in the sickle cell disease community remains a key priority for us. So with that update on the business, let me now turn it over to our chief financial officer, Alan Musso, to run through the financials. Alan, over to you.

Thanks, Alex. I'll now go over our results for the second quarter, ended June 30th, 2024. Let me start with our cash position. As of June 30th, 2024, cash, cash equivalents, and marketable securities were $273.8 million, as compared to $236.2 million as of December 31st, 2023. The increase in our cash position is due to the $80 million upfront payment received from in the second quarter of 2024, partially offset by cash used to fund our operating activities in the first half of the year. Collaboration revenue was $80 million for the second quarter of 2024, compared to $0.9 million for the second quarter of 2023. The increase of $79.1 million was primarily due to recognition of the $80 million upfront payment received from Sanofi during the second quarter of 2024. Our research and development expenses were $17.3 million for the second quarter of 2024, compared to $17.8 million for the second quarter of 2023. The decrease of $0.5 million was primarily due to the Lismappamod Global Development Cost-Sharing Reimbursement from Sanofi, partially offset by increased costs related to the advancement of the REACH Trial. The general administrative expenses were $10.2 million for the second quarter of 2024, compared to $10.3 million for the second quarter of 2023. The $0.1 million decrease was primarily due to lower employee compensation costs. For the second quarter of 2024, we had net income of $55.4 million, compared to a net loss of $23.8 million for the second quarter of 2023. For the foreseeable future, excluding the potential for future milestone payments under our Sanofi collaboration, we expect to be in a loss position, including for the year ended December 31, 2024. And finally, turning to our cash runway guidance, based on our current operating plans, we continue to expect that our existing cash, cash equivalents, and marketable securities will be sufficient to fund our operating requirements into 2027. And with that, let me turn the call back over to Alex.

Great. Thanks so much, Alan. So with that overview of the business and the financials, Lisa, let's go ahead and open it up for questions.

Thank you. At this time, if you would like to ask a question, please press star 1-1 on your telephone. You will then hear a message advised that your hand is raised. If you'd like to remove yourself from the queue, please press star 1-1 again. We also ask that you wait for your name and company to be announced before you proceed with your question. And our first question will come from Corinne Johnson of Goldman Sachs. Your line is open.

Maybe first, with respect to the work that you're doing to validate reachable workspace for the agency, has the agency specified specific metrics that are most important or the magnitude of change, like the change or the benefit they'd like to see, or are they just asking for general proof that reachable workspace is clinically beneficial? And then are there multiple analyses that they requested, and do they all sort of have to go in the same direction?

And then

my other question would just be, in terms of the cash-run like items you just provided into 27, what specific like clinical milestones and then commercial activities?

Thanks. Yeah, that's great. Thanks, Corinne, and thanks for the question. And if there are any more follow-up questions, maybe just speak up a little bit. You were a little bit difficult to hear. I think in terms of your questions around reachable workspace and some of the work we're doing to prove out the clinical meaningfulness of that work, I'll turn that one over to Ian and then I'll ask Alan to provide an update on your question around the financials. So, Ian?

Yeah, sure. Thanks, Corinne. So, since the reachable workspace has not previously been used for any approvals, there are no pre-established criteria. And so, there has not been a numerical criterion put forward by the agencies for this, and the work we are doing is in order to evaluate that across a range of different approaches leading towards an understanding of the meaningful score difference, which is the FDA term for a change within a given patient that is considered meaningful. So, as I say, there is no pre-specified numerical value for that, and the results coming out of the work that we are doing will inform that.

And then, Alan, maybe toward the second question that Corinne had. Yeah,

sure, Corinne. Good morning. Yeah, the cash runway guidance that we're giving, that does anticipate a whole sort of success scenario. So, it funds the sort of further development of filing and commercialization of Los Mathemaz. It also funds the completion of the ongoing posterior trial, as well as the follow-up trial that we anticipate, and funds pre-clinical work that we have ongoing, for which we expect that we'll have new products entering into the clinic from that work. So, it's sort of all in what we anticipate with the current portfolio of the continued advancement.

Thanks. Sorry for the audio quality.

No worries. Thanks, Corinne. Lisa, next question.

Thank you. Our next question will be coming from the line of Kristen Kruestock of Cancer Fitzgerald. Your line is open.

Hi. Good morning, everybody. Thanks for all the transparency and extra guidance today. So, on reasonable work space, we've been getting a lot of questions just because another company also had data on this. And to your point, given it really is a new endpoint and hasn't been previously used for approvals, wondering now that we have two data sets supporting the endpoint, if this helps, in your opinion, de-risk this endpoint for this disease?

Yeah, that's great. Hi, Kristen, and thanks for the question. And I think to answer that, I'll turn it over again to Ian.

Yeah, thanks, Kristen. I think it is encouraging for us to see that others are using this particular endpoint in FSHD. We certainly have hints from the agency that that's the case that they're hearing about this as we engage with them around our discussions around reachable work space. And I think it also reinforces the point that we've made previously that we haven't been suggested an alternative primary endpoint in FSHD. So I think we're overall encouraged by those reports that have been coming out.

Yeah, and the thing I would add, Kristen, this is Alex, and you had mentioned some other data that had recently been published or reported out. I assume you're referring to the Avidity data. I think what the Avidity data does is it certainly validates not only the Dux 4 pathway, but more specifically to your question, reachable work space. At the clinical endpoint, we believe that many of the registrational trials that will come after us will be required as part of their primary endpoint.

Okay, appreciate that. And then assuming that the trial is successful when you plan to meet with the FDA, can you just remind us first what the safety data set is, including from the previous company that had studies in other indications? And then second, how much open label extension data you're going to have from phase two at that point to add on to the pool of evidence. Thanks so much again.

Yeah, thanks, Kristen. Maybe I'll take the first question and I'll turn the second question over to Ian. Yeah, I think that is really one of the truly unique things about Los Mavimod. I don't know if this is unprecedented, but we will be filing our new drug application with a patient safety database that includes over 3,600 patients. So I think for a rare disease such as FSHD with a prevalence of 30,000 to have 3,600 patients in the patient safety database is quite remarkable. And I think one of the encouraging signs is the drug does have a fairly sort of unremarkable AE profile, and we've demonstrated that in our Redux 4 study and expect to replicate that in our REACH study. And then, Alan, sorry, Ian, maybe to Kristen's second question.

Yeah, so we'll have data from the Redux 4 phase two study. We remember that enrolled 80 patients and there's been a high rate of retention in the open label expansion of that study, now up to exceeding three years of exposure in some of those patients, the ones that were enrolled at the very earliest in that study. We have about 11 patients in a separate open label study in Europe that also has a prolonged duration of treatment. And then in the REACH study itself, there are 260 patients, and as Alex mentioned in the original remarks, a very high proportion of those are electing to roll over into the open label extension. And so they will continue to experience exposure to LASMAPAMAD as we move towards filing. So there is not only a large safety database from other indications that preceded the work that we had done, but also a large and growing safety database for this relatively rare disease.

Thank you.

That's great. Thanks, Kristen. Lisa, next question.

Thank you. And our next question will be coming from the line of Joseph Schwartz of Leverett Partners.

Hi, thanks for the update. Sorry. So I was wondering a couple things on Pociradir first and then LASMAPAMAD. Can you talk a little bit more about why it's taking longer to proceed with the cohort three group of patients for Pociradir? Is this at the IRB level? Is it enrollment? Can you give us any clearer progress update and maybe talk about what initiatives you have to accelerate things? And then I have a question on LASMAPAMAD.

Sure. That's great, Joe. Thanks for the question. This is Alex. I'll take the first one and then depending on what the second question is, we'll figure out who we can triage that one to. Yeah. So as I mentioned, and maybe I'll give a little bit more color, the seven or eight sites that were involved in the Pioneer trial prior to the initiation of the clinical hold, which I think in February of 2023, most of those sites tended to treat younger patients that didn't have the disease severity that was matching our new inclusion exclusion criteria that we reached agreement on with the agency in order to get off clinical hold. So many of those existing sites would have been terrific to reactivate. It would have taken several months to get the new protocol through the IRB. All the contracting had been done. But because what we were hearing from those PIs is that they did not have those patients, essentially, we had to activate all new sites, both in the U.S. as well as in countries outside of the U.S., specifically in Africa. Our goal is still to activate about 15, call it 17, 18 sites in the U.S. and a handful of sites outside of the U.S. So we should have 20 sites, which should be more than adequate to enroll these 20 patients in these next two cohorts. So I think it's really just this long lead time of activating these sites, many of which are academic sites. And as many of you know, it can take up to nine months from contracting to IRB approval, all of the back and forth of the sites to get these sites activated again at these major academic institutions. In terms of what we're doing to try to speed that up, I think we're trying to do, I think we're doing a couple of things. Number one, when a contract provision comes in, we're typically returning that around in about 24 to 48 hours. So the people in our legal group knows that Pioneer is the top priority and anything that comes in from Pioneer gets put to the top of the pile. Unfortunately, we're sort of at the whim of the large institutional bureaucracy and unfortunately, things just take time. But I will say that of the sites that we have activated, and we have activated a number of sites, they continue to be very encouraged of the transformational potential that posterior deer could bring to their patient population. There is a relatively small number of patients, somewhere between .5% to 10% of that 100,000 that I mentioned that do meet our inclusion exclusion criteria, so call it about 10,000 patients. But we believe that's more than an adequate number to be able to recruit these 20 patients. And as I mentioned, we will expect to have data that we can share with everybody sometime in 2025. And maybe turning to your Los Mapamod question.

Yeah, thanks. That was helpful color on posterior deer. So as far as Los Mapamod goes, I was wondering if you could talk about the output that will emerge from the work to define the minimally clinically relevant difference on the RWS. Is this just one single number? Is it a range which might provide more context? And how do you feel about the ability of Los Mapamod to provide a benefit which exceeds whatever you define as the MCD?

Sure. Thanks, Joe. I think to answer that, let me turn that one over to Ian as well.

Yeah, thanks, Joe. And just to clarify, I think that the number that in the FDA terminology is the meaningful score difference. And I think the important thing to emphasize about that is that that's not a mean score for the overall population that needs to be exceeded, but that's the score for within patient change. So that's understanding what a change in the reachable workspace score is for an individual patient. And so what that's most likely to be reflected in looking at the clinical trial data is proportions of patients, individual patients, that exceed that meaningful score difference. So I think that's just conceptually a way of thinking about it. That's an important piece of it. And that's really the focus of this. There might well be a range of these depending on the outputs of that work. And we'll report that at the time of the top line data. Very helpful. Thank you.

Thanks, Joe. Leek, next question.

And our next question will be coming from the line of Daegon Ha of Stiefel. Your line is open.

Hey, great. Good morning. Thanks for taking our questions. I'll stick my two questions with the Los Mapamod side of things, specifically on powering. So maybe a question for Ian. So the first question is, you previously talked about powering for reach as having benefited from the over-enrollment. I think it was 96% to show 10% placebo-adjusted RSA. Just to clarify, was this just for the FSHD type 1 or inclusive of type 2? And now that you do have the type 2 baseline characteristics disclosed, what would that powering be, if any, different from the original one? And then second question on powering as well. Just curious, have you guys done additional sensitivity analysis around sort of the evolving resolve natural history data? And what might that mean for the powering of reach? Thanks so much.

That's great. Thanks, Daegon, and thanks for the question. Yeah, Ian, you want to take that one?

Yeah, hi, Daegon. As I think we've articulated before, the powering for reach was based on specifically the FSHD-1 patient population. And that's because the data that we used for the powering was from redox 4, and that study enrolled only FSHD type 1s. And so that was the approach that was taken, even though the primary endpoint for the reach trial will include not only the type 1s, but also the type 2s. And so initially, the powering was based on 210 FSHD type 1 patients, and that was the powering at 93%. And the expectation was that we would, in addition, have 20 FSHD type 2 patients, so push the total up to 230. The over-enrollment pushed the total enrollment from 230 to 260, and the type 1s went from 210 to 242. So that's really the comparison for the powering was the 210 to 242 type 1s, moving it from 93 to 96%. As you indicated, we have the baseline characteristics. We know there are 18 FSHD type 2 patients, and we also know that the randomization is stratified for that. So the expectation is that there'll be nine and nine in each of the groups placebo-enacted. Great.

Thanks again for the question, Dagon. Lisa?

Thank you. And our next question will be coming from the line of Gregory Redlin.

Yes. Hey. Hey. Good morning, Alex and team. Congrats on the progress. We're looking forward to the data in October. Alex, just on Lismappamod, as you touched a bit upon pair engagement, maybe just give us a glimpse of what that engagement will and has been looking like. What do you see as the potential tailwinds from the potential data package and Lismappamod's profile? And maybe what do you foresee as some of the greatest challenges when it comes to establishing the value proposition, assuming that the data cards flipped, as you foresee?

Yeah. Great question. And thanks for that. Yeah. I think so. We've done some pair research following the results of the Redux for study results. And what we heard from the payer community, and again, we probably went out and talked at the time to about 15 or so payers. The majority of those were US-based payers. And I think what we heard across the board is it'll be difficult to restrict access to this drug when approved for patients, given the fact that there are clearly nothing available and nothing used off label to help these patients with FSHD. I think the other thing that we heard from that payer research when probing a bit on what they expected the pricing to look like for the drug, and we have not given any specific guidance around pricing. But what we clearly heard back from the payers is they would expect this to look very similar to other rare disease drugs that have been priced in the, call it hundreds of thousands of dollars every year per patient. I think it's also important to remind people that patients that will start on this drug, we assume will more than likely stay on this drug for very, very long periods of time. We've been seeing that now. Greater than 85% of patients in the Redox IV study are still on drug after a three-year period of time. So once we get the REACH trial results, Greg, we'll go ahead and do more significant payer research. But to your question around the tailwind, and we spent a lot of time thinking about this, I think that one of the biggest tailwinds we'll have with payers is the requirement for a confirmed genetic test at the time or prior to the approval of the drug. And what we know right now from the work that we've done is only about 20% to 30% of patients are actually receiving a confirmed genetic test. So if every payer, we're operating under the assumption that payers will require that confirmed genetic test before approving the drug. So we're doing a lot of work now. There's a lot of examples out there of other rare diseases in which payers have required genetic tests. So this is not a new concept. We're essentially sort of replicating the playbook of many other rare disease products that have come before us. But we will make sure at the time of launch that a lack of a...or we will make sure that genetic testing does not become an impediment to access. And whether that's through a partnership that we do with the FSHD Society or whether we do it directly and provide genetic testing free of charge to patients, we're working through that right now to make sure that at the time of launch that that does not become the tailwind that you mentioned.

That's helpful. Maybe related, and as Alan has provided some detail on your runway, how are you coordinating the urgency, but the planning for building a commercial organization when it comes to the leadership in such a capability and slotting that with respect to the data coming?

Yeah, great question, Greg. And thanks for asking it. Yeah, so we have begun building out our commercial organization. I would expect that sometime in the third quarter of this year, we will announce the appointment of our chief commercial officer. And one of the things that I said to this individual while I was interviewing with them is we will make sure that we properly resource this launch. We will make sure that if it's a question of do we fund it or do we not fund it, we will always err on we should fund it instead of not funding it, because we have to make sure that this is properly resourced. And as Alan mentioned in one of the earlier questions, the runway guidance that we have provided assumes a launch that we have very properly resourced beginning in 2026. Is that fair, Alan?

Okay. Got it. Thanks as always for the call. Yeah, thanks so much, Greg.

Thank you. One moment for the next question. And our next question will be coming from Matthew Begler of OPCO. Your line is open.

Hey, guys. Good morning. We were curious if in your discussions with the FDA, they'd ever asked for more data around Lismapp-LeMod's mechanism of action. You know, as you mentioned, Avidity had some biomarker data on ducts for reduction clinically. I know preclinically you showed that, but you hadn't been able to clinically. So I'm just kind of curious if, you know, you'd be open to rerunning archived biopsies from redux using maybe a more sensitive assay if the FDA wanted you to, or if not, if you think, you know, really at this point the FDA is only concerned with, you know, validating the RWS tool. Thanks.

Yeah, thanks, Matt. Great question. And let me turn that over to Ian as well.

Hey, Matt. Thanks. The issue of going back to biomarkers has not been something that's come up in any of the discussions with the agency. The focus, I think, has very much been on the endpoints, given that it's a functional endpoint and the secondary endpoint similarly are functional or related to muscle health. So we haven't up to this point received any specific requests around that. So we don't have any specific plans to do so. The evidence that we have both in the original discovery of Les Mappemott as well as in the characterization of it was done in muscle cells derived from patients with FSHD. And you can perform the characterizations of the effects on Dux4 and all the downstream transcripts pretty convincingly in that in vitro system where you don't have competition from other cell types and issues related to the biopsy and so on. And I think those data are very robust and show the mechanism of action of Les Mappemott on the reductions of Dux4 and the downstream transcripts.

OK, that makes sense. Thanks for that, Ian. Maybe just squeeze one on the REACH III guidance. Is this a revision or just more fine tuning from the prior guidance, which was year end? And if it's a revision, what are some of the factors driving that faster cadence going from year end to now end of October? Thanks again. Yeah, Matt,

this is Alex. Yeah, no, it's nothing more than simply fine tuning. As we're getting closer and we're seeing the last handful of patients having their last visit, we feel very confident in terms of our ability to report out the top line results by the end of October.

Appreciate it. Looking forward to it.

Great. Thanks so much, Matt.

Thank you. At this time, if you would like to ask a question, please press star 1-1 on your telephone. There are no more questions in the queue. I would like to turn the call back to Alex for closing remarks. Please go ahead.

That's great. Thanks so much, Lisa. And again, thanks to everybody for joining. Thanks to everyone for your interest in all the great things we're doing here at Fulcrum. And I guess before we conclude, I want to remind everyone that we continue to make progress with our Phase 1 Pioneer Trial of Posiradier and our on track to report top line data for the Phase 3 Reach Trial by the end of October of this year. In parallel, we continue to prepare for the potential NDA filing and commercial launch of Los Mapamont in the U.S. With our cash runway into 2027, we believe we are well positioned to execute on our corporate objectives and look forward to building on this momentum in the months and years ahead. And as I always like to do before we jump off the call, I would be remiss if I did not extend my sincere appreciation and gratitude to my fellow Fulcrum teammates, to the physicians we work with to advance our clinical studies, to our partners at the FSHD Society, and finally and most importantly to the patients and their families around the world. Without you and your commitment to become involved in clinical trials, none of what we do would be possible. Thanks again to everyone who joined the call this morning. Please stay safe and healthy. Thanks so much. Thank you for today's conference call. You all may disconnect.