Scholar Rock Holding Corporation Price & Performance (SRRK)

To 2025. For today's call, I'll start by providing a review of the Sapphire results, and our progress toward our regulatory milestones. Harry C. Saco, our Chief Commercial Officer will share the terrific progress we're making with our commercial preparation, and are planning for a 2025 launch. As we're working with a sense of urgency to serve those living with SMA globally starting with The U. S. And then I'll follow with a review of our innovative Myostatin platform and our ambition to transform the current GLP-one treatment paradigm weight management. Following our prepared remarks, Tracy and I will be joined by Ted Miles, Chief Operating Officer and Chief Financial Officer and Mo Kat Thunani, our Chief Scientific Officer, the Q and A portion of today's call. Moving to Slide four. With our success in 2024, the stage is set for what will be a transformative year for Scholar. And as I said, we are working with a sense of urgency to bring Epidigram after those living with and we continue to hit our milestones on time or ahead of schedule. Starting with the regulatory applications for ipitramab and SMA, we submitted the BLA in The U. S. In January and we remain on track to submit the MAA in The EU in March.

We look forward to sharing the Saphyr data the Muscular Dystrophy Association's Annual Meeting in Dallas on March 19, where the facility will feature as an oral presentation. We will also be sharing our work with the murine version of opitricimab in a nonclinical model of DMD setting the stage for us to expand the development of opitigramab into other neuromuscular indications. We also continue to make progress on our goal to expand treatment to even the youngest of those with SMAs we were on track to open the OPAL study for those under two years of age in the third quarter. For our Cardiometabolic program, we remain on track to share the top line data from Embrace in Q2 with the filing of the IND for 39, our highly selective anti ministatin designed for cardiometabolic indications in the third quarter. Turning to Slide five. Before I hand over to Tracy, I want to review the positive top line results for Safon. Our registration study with opitagramab the only muscle targeted therapy with clinical success in a pivotal study in SMA which has the potential to transform the standard of care. Opitigramab plus standard of care delivered gains of 1.8 points in improvement compared to placebo plus standard of care as measured by the gold standard SMA specific cameras meant functional motor scale at week 52.

Gains that were both clinically meaningful and statistically significant. Importantly, there was consistency across age groups two through 21, in a broad SMA population. In addition, thirty percent achieved an additional three point or greater improvement in their Hammersmith scores when compared to placebo plus an SMN therapy, we're only twelve point five percent achieved the same high bar. Further, as shown in the graph, displaying motor function over the fifty two week treatment period, those receiving opitagumab achieved a gain in function while those receiving an SMA therapy alone lost function. Over this fifty two week period, With respect to safety, the safety was consistent with the TOPAS data with over ninety five percent rolling over and remaining in the long term follow-up study. Adding to our experience in over two hundred patients. We remain the only muscle target therapy has over four years of clinical experience in SMA. Together, the data support an overall favorable benefit risk, with the potential to shift the treatment paradigm and usher in a new standard of care, to include a pitigramab a muscle targeted therapy with an SMN directed therapy as part of the treatment regimen, for SME. I will now turn the call over to Tracy, our Chief Commercial Officer to provide an update on our commercial preparations. [indiscernible] Thank you, Jay.

Moving to Slide seven, Despite successes in treating the motor neuron over the past eight years, progressive muscle weakness continues to be a critical unmet need in SMA and there's currently no approved muscle targeted therapy to treat this muscle neuromuscular disease. Patients and caregivers have described to us the debilitating impact of progressive muscle weakness and how it significantly detracts from their independence and their ability to perform basic daily activities. Like eating, dressing, getting in and out of bed or their car brushing teeth, climbing stairs and using the bathroom. This is why ninety seven percent of patients surveyed by CureSMA identified improving muscle strength as an important need that they want to see from a new SMA treatment. From our own market research, we know that more than eighty percent of treating neurologists agree that preserving muscle should start as early as possible in SMA. The SMA community is collectively calling for more to treat this relentless progression of muscle weakness and improved motor function SMA. Next slide.

Today, roughly two thirds of the ten thousand people living with SMA in The U. S. And thirty five thousand individuals globally have already received an SMN targeted fair Yet we see from the data that Jay just presented that this these effective therapies, progressive muscle weakness still robs these individuals of their ability to function over time. This is why seventy four percent of neurologists recognize that in the future a combination of modalities to target the motor neuron and the muscle will be necessary to treat SMA. The future of SMA will be to directly treat both the muscle and the motor neurons to provide the best outcomes for patients. Opitigramab is the potential first approved muscle targeted therapy in SMA is leading the transformation of SMA care. Next slide. ScholarRock has been at the forefront of preparing the market for this potential new treatment paradigm in SMA. Last year, we introduced Life Takes Muscle, the first muscle focused SMA disease education campaign that amplifies what we've been hearing from patients and caregivers for years. About the devastating impacts of progressive muscle weakness. Lifetix Muscle has resonated with both the patient and HCP communities and led to continued strong engagement with Golarrock Scholar.

Additionally, our MSL team has also been meeting with the leading CureSMA centers and engaging with top treating neurologists and care teams to educate on our Phase three Saphyr top line data. And Scholar continues to partner and learn from our patient advocacy partners who have been so effective already in helping to bring new treatments to the SMA community. Next slide. We're doing all this with a team of experienced professionals with deep rare disease and launch experience. Including prior SMA launches, And we're continuing to be a magnet to attract top commercial talent as we build out our team. Next slide. 2025 is an important year for Scholar and we are positioned for a successful launch.

We'll continue to build on our stakeholder engagement and education and this quarter have initiated outreach to top U. S. Commercial and federal payers ahead of our potential Q4 launch.

We will also be scaling our customer facing team of roughly 50 sales, reimbursement and patient support personnel in late Q2 and early Q3 to be higher than onboarded ahead of our potential launch. And finally, Stellar Rock is building out our patient services offering and preparing to offer home infusion as an option at launch to provide excellent support and optionality to patients and treaters alike. We have been laying the groundwork for years and now we're putting the broader team and infrastructure in place for a successful U. S. Launch to meet a critical need in the fight to continue to improve the lives of those living with SMA. I'll now turn the call back to Jay. Well, thank you, Tracy.

Now turning to our Cardiometabolic programs, and moving to Slide 13. It's impressive to see the impact of the innovation from our end have transformed the management of weight loss. Obesity is a top global public health issue and the potential public health impact of these highly effective weight loss therapies have been incredible across a number of chronic conditions in With an estimated forty million projected to receive treatments to COP1 receptor agonists, the current market is anticipated to generate over $100,000,000,000 in sales. Moving to Slide 14. With the extraordinary amount of weight loss seen with the current GLP-one receptor therapies, there's also a substantial amount of lean muscle that is also lost. Ranging from 12% to 40%. With the widespread use of these therapies, there's an increased awareness of the associated weakness and reduced strength that accompanies this loss of lean muscle mass, and of the significant weight regain that occurs when stopping therapy with disproportionately more fat being regained than lean mass, leading to a worse body composition and leading to unhealthy weight gain. Beyond strength and mobility, muscle is the main metabolic organ and plays a significant role in energy metabolism, increasing vasometabolic rate, glucose uptake, and improving insulin sensitivity.

Given the critical role that muscle plays in overall health, we believe our highly selective approach to blocking Myostat when added to the GLP-one receptor agonists can enhance their profile by reducing the loss of lean muscle lens without introducing additional toxicity Lean's a healthy, sustainable weight management. Moving to Slide 15. To illustrate what can be expected from tirzepatide, this figure is from the [indiscernible] And illustrates the percent change in body weight over time. The area shaded in green represents the first twenty weeks of the study the time period corresponding to the efficacy assessment in EMBRACE our randomized Phase two proof of concept study with tirzepatide. As can be seen, even by week twenty four, there's an impressive amount of weight loss of 14% to 16% of body weight that continues to deepen over the course of seventy two weeks. Approximately 25% of this weight loss is lean mass, an area that we believe we can address through our highly selective approach to blocking MyoSpan the master regulator Scholar muscle. By preserving lean mass, and reducing the amount of lean muscle mass lost, that can lead to healthier and sustainable weight loss and potentially change the treatment paradigm for weight loss management.

Now moving to Slide 16. So what does preserving lean muscle mass mean with respect to clinical benefit? And what amount is needed to have a meaningful impact? Well, insights can be gained from a study of healthy young men who were confined to strict bed rest [indiscernible] and lost about a kilogram of lean mass as assessed by DEXIS gains. Remarkably, the loss of just one kilogram of lean mass resulted in significant decrease in leg strength exercise capacity and equally importantly in insulin sensitivity compared to baseline, Considering that adults 60 begin to lose 1% on lean mass per year, with a 10% to 15% decrease in strength per decade, the additive effect of loss of lean mass associated with GLV-one receptor therapy in this age group and other subsets can be profound. Now moving to Slide 17. With respect to Embrace, we had several key goals in mind when we designed Embrace, a randomized Phase two proof of concept study comparing tirzepatide plus opitigramab to tirzepatide plus placebo in obese or overweight adults. First, with respect to preserving lean muscle mass, we believe we can reduce the amount of loss as measured by DEXA scans at week twenty four with our highly selective approach blocking my stem.

We selected week twenty four as the time point to assess since this was the steepest portion of the weight loss curve with tirzepatide. Recognizing that we'll need to assess week 52 for SRK-four 39 program. As a proof of concept study, we're looking for trends in the magnitude of effect to help shape our thinking regarding clinical meaningful improvement. Extrapolating from the study in young men, assuming a loss of lean mass between five and four to five kilograms, by reducing the amount of lean mass loss by 20% to 40% we can preserve one to two kilograms of lean mass which we believe will translate into clinical meaningful benefit since every kilogram of lean muscle mass mass mass Second, based on our selective approach, one of our goals was to demonstrate that we can safely combine tirzepatide. And not introduce any additive toxicities that can be associated with blocking other TGF8 ligands [indiscernible] Third, with respect to weight loss at week 24, we are expecting to see comparable weight loss. At this time.

Fourth, based on our nonclinical data, we believe we can blunt the fat regain associated with stopping tirzepatide. And a built in an additional DEXA scan performed eight weeks after stopping treatment to assess this important question. We stated it will not be part of the top line results, that we look forward to sharing. Next quarter. Fifth, as a proof of concept study, where also included exploratory endpoints such as hemoglobin A1c, and functional measures but we did not power or enrich the study with subset of patients that show statistical significance for these exploratory And then finally, an important key goal for us to gain experience in the setting of obesity. We'll have the opportunity for detailed review of all the EMBRATE subject data to identify subgroups and to help inform the clinical development of SRK-four thirty nine a highly selective anti myastatin designed for cardiometabolic disorders We've already shown our ability to deliver and brace ahead of schedule, and this experience provides us with great momentum for SRK-four thirty nine Moving to Slide 18, And with respect to SRK-four thirty nine, we are very excited with the data that's been generated in our nonclinical program demonstrating we can preserve lean mass with further reduction in fat mass, We can improve the metabolic parameters such as blood glucose.

We've seen increase in lean mass gain and once the fat regain of fat mass after stopping the GLP-one receptor agonist therapy and we've demonstrated greater potency in a direct comparison with nanthectar plumantibol. Overall, the data suggest the best in class profile for SRK-four thirty nine which has been featured at key times of the conferences in 2024 and we look forward to bringing SRK-four thirty nine to clinic Moving to Slide 19, In summary, to address the important emerging problem of loss of lean mass associated weight loss therapies, we've taken a parallel path with our innovative industry leading portfolio of highly selective anti myastatin therapies by conducting a proof of study [indiscernible] and at the same time advancing SRK-four thousand three hundred and ninety two IND our highly selective novel anti myostatin designed specifically for cardiometabolic indications with the ambition to transform the current GLP-one receptor agonist treatment therapy. This strategy has resulted in two important milestones in 2025, and we look forward to the readout of the top line data from IMBRISE next quarter and the filing of the 39. Mid Q3. In closing, moving to Slide 21, 2025 will be a transformative year for Scholar.

We are off to a great start We've submitted the BLA for opitigramab in The U. S. In January We're on track to submit the MAA in The EU in March.

We were well on our way in our preparations to bring a pedigram muscle targeted therapy potential new treatment option for those living with SMA globally starting in The U. S. In Q4 with EU to follow in 2026, As we continue to work to expand our reach to the youngest of those with SMA, and two other rare neuromuscular disorder. We are on the threshold of establishing neuromuscular franchise starting with SMA, We look forward to reporting on our progress toward achieving our 2025 key mouse as we drive the commercialized and expand the development of Epidigraman, and advance our cardiometabolic programs. Overall, a very, very exciting year for Scholar. And operator, that closes the prepared remarks, we'll now open up the call for questions.

Our first question comes from Allison Bratzel with Piper Sandler. Your line is open.

Hi, good morning guys and thanks for taking the questions. Maybe one on SMA, just with Saphyr data being presented next month at MDA. Can you just discuss your sense of what additional data points are going to be most meaningful to patients and docs when you present that full data? Just maybe help frame that update for us? And then one on obesity, Just maybe help us understand what you need to see on the primary endpoint to be confident in taking four thirty nine forward. I think in the prepared remarks, you discussed 20% to 40% improvement in lean mass as being clinically meaningful. Just did I hear that right? And then then what are you hoping to see on additional endpoints like A1c and body composition? Just curious to get your thoughts there. Thank you. Yes. Good, Ali. Hey, good morning. So this is Jay. So first starting with Saphyr, We're really excited to have the opportunity for those data to be presented at a Congress and particularly the MDA conference where there's a lot of interest and a lot of investigators who have a chance to see the data beyond what we could share on the top line results.

And as we shared previously, I think what's really important is the overall and impact of the totality of the data. We've shared, we've got effect across age groups, and we're going to share additional endpoints and you'll see that again think there'll be interest in seeing the consistency and the impact we have across those additional endpoints. So I think that will be a really nice opportunity to really underscore that we really are on the threshold of bringing I think a really nice new effective therapy to change standard of care in SME. And then with respect to ABAZE and four thirty nine, I said we have a very unique opportunity. We've got a really I think, highly innovative platform of anti monosapam therapies. We took full advantage of idigramab being in clinic to study in BRAZE As we're looking, I try to put some context around what is clinically meaningful with lean mass loss because that's a question that comes to us constant. I do think there's insights gained from that study of young men who were confined to bed rest who lost a kilogram. Because that was a significant amount of strength lost even in a young healthy Right.

So as we think about going forward, that one kilogram, that translates to about a 20% effect. Can double that, that's two kilograms So I think we're in that range of signal seeking that will give us insight that will allow us to continue to really think deeply about how we develop four thirty nine. But I want to make a caveat. We're studying this at week 24 on the steepest [indiscernible] Of the curve of tirzepatide, And of course, we'll do a fifty two week study as we get into four thirty nine there's a potential for that effect on lean mass to deepen over time. So we're looking at a snapshot with 24 If we can show a nice effect, and in that range of 20% to 40%, what we can think we have meaningful incremental I think we have a really clear go signal to move forward four thirty nine. But we'll also be developing four thirty nine and we'll have to establish its own dose, etcetera. So lots to come with this total program. They're very excited to find for us.

One moment for our next question. Our next question comes from Michael Yeebuchies. Your line is open. Hey guys, thanks for the question. Good morning.

Just following up on thoughts around the obesity readout in the second quarter. Appreciate that the expectation is that you should preserve lean muscle I was just wondering about how you guys are thinking about the biology or the effects of what would happen on the weight loss there shouldn't be any material change, but I'm just wondering if there could actually be maybe more weight loss because of the metabolic effects of myostatin and building muscle or there could actually be headline a little bit less weight loss just because you're actually preserving the muscle So just thinking about the biology there certainly in the first twenty four weeks and how that put that in the context of preserving muscle.

Yes. Mike, thanks for the question. I try to frame that in a bit in the prepared remarks. So for week twenty four, given the magnitude of weight loss that's already occurring with tirzepatide, really don't expect that time point to see we think the way it's also be comparable recognizing that there's a potential with increasing muscle to potentially affect weight, but the magnitude of the weight loss which is separate is probably going to make that a wash. And so think it will be comparable to 24.

But then add to your point, now that's in week 24. If we look at effects over time and the potential effect on basal metabolic rate, and maintaining there absolutely is the potential to see some additional incremental weight loss over a period of time on treatment, But I want to set the expectations for week 24 we're expecting to be Got it. Thank you very much.

One moment for our next question. Our next question comes from Tess Romero with JPMorgan. Your line is open. [indiscernible] I look forward to seeing you guys at MDA. [indiscernible] what is the right way to think about the exploration of additional neuromuscular [indiscernible] where a pitigramab could have potential here. What framework can you give us with respect to those decisions? In other words, how you will best allocate capital, while also ensuring proper which you could or would start these clinical studies? Thanks so much.

Yes, Tess. Thank you for the question. Very important question. We're going through that work right now.

As I indicated, [indiscernible] And with the success of a Pedagram and SMA, mean, I almost feel obligated for us to take a look at the adjacent neuromuscular indications see if in fact we can have an opportunity to impact and improve lives for those that have other diseases like PMP FSHD, Beckers, and even ALS.

So what we're showing at MDA is a bit of the work and thinking behind our approach to this. I'm very keen on translational models to the extent that they can give us insight. And I feel very fortunate with Mo and his team to be able to do these models so we're going to start showcasing how we're beginning to think about, for example, VMD a little bit of that nonclinical We're actively engaging experts across these indications to really begin to think about how we can take a look at both not only the opportunity in terms of the unmet need, but the probability of technical success and can we understand and enrich a patient subset of patients that we can really show meaningful benefit? We're doing all of that work. And as we put all that together, that'll set the framework as we think about further investment in those indications. Which as you can imagine is going to be function of technical success, unmet need, potential opportunity, etcetera. So we're doing all that work now over the course of frankly, we started that work even last year. So that work continues. And as we get closer to that, we'll certainly share how we think.

With respect to our ability to to do this in addition to doing our launch, We have a clinical team that really has demonstrated their ability to execute clinical trials. SenaFire is finished. We have the ongoing study in the long term follow-up but we're positioned to be able to take on an additional clinical study, if not two, but certainly one, as we think about going forward, And again, what I tried to share at JPMorgan was if you think about what we're trying to build here, the value we're trying to create at Scholar Rock, It starts with SNA. And as we said, we think that there's a potential $2,000,000,000 plus opportunity for us in SMA alone. Considering what we believe will be a paradigm shift in treatments And then if you start to build around these additional neuromuscular indications, we're on the threshold assuming execution and success to build a multibillion dollar neuromuscular franchise. And I think at the end of the day, if we do that properly, we'll definitely increase shareholder value but importantly extend our reach to those in the Thank you.

Our next question comes from Mark Tharme with TD Hey, Hi, this is Alex on for Mark. Thanks so much for taking my question. So the FDA recently issued a draft guidance on obesity clinical trials, which appear to reinforce the agency's focus on BMI and overall weight loss rather than shifting the focus to body composition changes and preservation of lean muscle mass. What do you view as the potential implications here for your cardiometabolic program program, namely four thirty nine? Yes, it's a good question. We're obviously following this with great intent and seeing and looking carefully at FDA's updated guidance, From my perspective, kind of watching FDA over the years, they tend to move slowly. They tend not to go as fast as the field is trying to get them to go in terms of endpoint. So we were not surprised that they retained The things that we took of interest though from that guidance which I think further reinforces why I think we're actually on the right track here, Is it now very clearly in that guidance, they're asking all sponsors to include within their clinical development very least a subset of their patients to understand the amount of lead mass loss So it's recognizing that the loss of lean mass has the potential to not be a good thing.

So let's assess that at baseline and understand that across programs. So I think that further reinforces the question around lean mass. They clearly indicated in that guidance of if there's an interest in body composition, come talk to us.

So that to me is a bit foreshadowing where they may be tilting, but clearly that's not within the guidance now. The body composition matters and the field is declaring that as a really important event. Or endpoint. So I think that's something that will continue to follow with great attention. But also which I believe we will affect positively if in fact we preserve lean mass. So we'll have a nice impact on that. But then they also said what is very clear is that if you're doing a combination program, then you need to demonstrate some additional benefit from our drug, for example, SRK-four thirty nine, And what I was trying to showcase in today's discussion to bring further clarity to that, but what I said pretty consistently across our entry into this Is it those endpoints that could be regulatory approval endpoints are metabolic such as further reduction in hemoglobin A1c, Clearly, there's a potential for that given the role of muscle. And there's clearly an opportunity to find a way to demonstrate that losing this amount of lean mass really results in functional loss that's significant and we have the potential within a subgroup of patients to show those functional measures and improvement, which ultimately I think will be sustainable And then there's other ways that we can look at how we can manage through mitigating weight regain, maintenance approach, etcetera.

We have a lot of ideas that's how to move this forward when we get into clinic. But I think the guidance to come back to it are consistent, but I think also we're pointing the way And I feel very good about fact that we're in this space. Great. Thank you. One moment for our next question. Our next question comes from Gary Nachman with Raymond James. Your line is open.

Thanks and good morning. So back on Embraer's if you hit the one to two kilograms of lean mass preservation with opitigramabulin, How would you expect four thirty nine to perform based on that? So how much better could it potentially be than a pentagramam based on the preclinical data that you've seen since the space is getting a lot more competitive, trying to think from a commercial marketing perspective as well, And then just with SMA, maybe just a bit more on how the initial payer discussions are going? And any update on how you're thinking about pricing as a combination drug? How that's going to be received in the market? Thanks.

Yes, Gary, thanks for the question. I'll start with the four thirty nine question and then then I'll turn to Tracy to to address the question on our interactions so far with payers. It's interesting. It's like Having two children and you're going to say which one is better, right? I mean, I think what I would say to you, Gary, on April, I really like the profile that we're developing. I really do. I think the work that Moe and his team are showing is this is performing beautifully. It has greater affinity for the target and that could potentially help us certainly at least with a very much with the dosing such that we can then go in with this low dose subcu formulation. So that is a clear, clear advantage and we're looking forward to that. Now with respect to how much different and how much better that's a really interesting question, Gary, because what I was trying to say is that PDGM-one is like signal seeking. Yes, we can show this. Four thirty nine is the program and we will need to further explore four thirty nine how we optimize the dose of four and how we begin to get some better insight into how its impact across these functional measures.

So that's part of our thinking on the IND opening studies. So it's more to come with four thirty nine at the very least It's going to have similar effect I do think though it's designed to be low subcu presentation which in this highly competitive space, I think is something that we need to do. And so more to come, but we're really moving rapidly on that toward IND. And then, Tracy, you want to make a comment on the payer interactions today?

Yes, sure. Payers have been very receptive to hearing from us even as a new company and are very interested in learning more about our innovation as the first muscle targeted therapy in SMAs.

They are familiar with SMA and recognize that their still a continued need to treat this relentless disease And we know today that there are already a third of lives covered of U. S. Commercial payers already have policies covering what I would call combination treatment an SMN targeted therapy post gene therapy. So that's a reflection of the openness to address this recognition of unmet need. Ultimately, we expect U. S. And European payers alike to enable access reflective of the value of PDGMAD brings in SMA our data and overall profile are really strong. We have a clear added benefit across all cohorts and high highly favorable safety profile it sets us up for really strong discussions.

Okay. And just pricing, any way to start there? Just typical like in line with the other SMN treatments?

Yes. I mean at this point, we're not in a position to share pricing, but ultimately we expect that access to be covered reflective of the value we bring. And we do have a sense of what the pricing is in the SMA market today.

One moment for our next question. Our next question comes from Kripa De Viroccondo with Truist Securities. Your line is open.

Hi, this is Alex on for Kripa. Thanks for taking our question.

So talk about the future development path for the muscle preservation drug. To be a little specific, we know that that overall, we definitely see the benefit of more muscle in better. But when it comes to the regulatory review, and the specifics on the endpoint, you mentioned a couple of different avenues that that you could explore with the HbA1c and the Medicaid weight regain But when it comes to the strength endpoints, We've seen grip or stair climb. Are these endpoints that are On the discussion table or are there other strength related functional outcomes that come to mind? As potential options going forward for the program.

Thanks.

Really good question. As you can imagine, we've given this a lot of thought as we think about how to then really meaningfully move four thirty nine four beyond just identifying the right dose. And what I just kind of add color to your point, so I think about once we establish the dose, can envision that we would then have subgroups of patients in our proof of concept efforts to demonstrate the impact we could have on, for example, hemoglobin A1c. And in that context, we would definitely enrich for a subset of patients where we think we can meaningfully show that they're [indiscernible] that's a very clear regulatory path forward. That's the metabolic value, the additional benefit of preserving that lean muscle. So that's one example. And the other example that you touched on, which comes immediately to mind, we've demonstrated functional improvement in SMA. So clearly functional measures and functional improvement are interesting. We're not wed to ripstern. And stairpline. We're giving a lot of thought around this I think there's a lot of insight that we're gaining from our work and our review and the And we'll have a really good opportunity when we open up the IND with four thirty nine and begin to meaningfully engage FDA in our thinking around the development program, thinking around meaningful functional measures and endpoints, and at the same time [indiscernible] sense of how we impact those functional measures as we build the program from SAB, MAD into those early POCs, so that we'll be in a really strong position to know exactly how to run-in a registration program.

So that's our thinking, right? I feel really good about it. It's like stair stepping, right? I love the fact that we've got Embrace coming in the INDs going into 04/29. I mean, we've really taken advantage of our platform. As we're both coming that this momentum at 04:39 and now we're already beginning to see what the next couple steps are. So I tell you, I can't wait to share all that with you. One step at a time though, we're driving to get the IND open. We're doing all this nice work. More to come, but I feel really good. We've got great momentum running into this IND. Yes, that's great. Thank you for the color.

And I'm not showing any further questions at this time. I'd like to turn the call back over to Jay any further remarks.

All right. But just to close, so thank you for your interest. I mean, it really is an exciting time. I try to put energy into my voice when I do this prepared remarks. I feel like I have more energy when we get into the Q and A period. But honestly, with this team is hustling Thank you for your interest and we look forward to sharing the updates and progress over the course of the year. And then we'll close the call.

Thank you. Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.