Welcome to the Viridian Therapeutics conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this conference call is being recorded. I would now like to hand the conference call over to Miss Louisa Stone, Manager of Investor Relations at Viridian Therapeutics. Please go ahead. Thank you, and welcome everyone. Today, we are going to discuss Viridian's subcutaneous IGF-1R program selection. Joining me on the call this morning are Steve Mahoney, our President and Chief Executive Officer, Dr. Shan Liu, our Chief Business Officer, and Peter Harwin, a member of the Viridian Board of Directors. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements regarding our financial outlook, regulatory plans, product development and commercialization plans, and research activities. These statements are subject to risks and uncertainties that could cause actual results to materially differ from those forecasted. A description of these risks can be found in our most recent Form 10-Q on file with the SEC. I would now like to turn the call over to Steve Mahoney, our President and CEO. Thank you, Louisa. Good morning, everyone. Thank you for joining us today. We are very excited to share data from our half-life extended anti-IGF-1R subcutaneous monoclonal antibodies, and also to announce our plans to initiate pivotal subQ studies by mid-2024. We have selected VRDN-003 for pivotal development. 003's clinical data has exceeded our expectations and suggested it could constitute the best-in-class half-life extended IGF-1R therapy for patients with thyroid eye disease. This is because we anticipate it being a low volume, infrequent, and self-administered therapy that patients can use at home. 003 shows a confirmed half-life of 40-50 days, which is 4-5 times that of its parent antibody, VRDN-001. This is significantly longer than other first-generation IGF-1R inhibitors, including teprotumumab and lanadelumab. 003 is the same molecule as 001, except for a three amino acid change that enables half-life extension. The data shows that 003 reaches 001 exposures, which gives us confidence that we can potentially dose as infrequently as Q8 weekly and still achieve clinically efficacious exposures. We expect to take 003 directly into pivotal development by mid-2024, pending alignment with regulators. Our goal for this program is twofold. First, develop the best subQ IGF-1R for TED patients, and second, bring it to the market as fast as possible to meaningfully change the landscape for patients. For those who are new to the Viridian story, 003 is nearly identical to its parent antibody, 001. There are just three amino acid changes in the Fc region of the antibody with the sole purpose of extending half-life. The performance of the half-life extension mutations was remarkable, with a confirmed half-life of 40 days-50 days. As a reminder, TED or Thyroid Eye Disease, is a large market and is only currently served by one marketed IGF-1R IV therapy, so there is no self-administered option. The marketed therapy is only available in the U.S. currently, where it is annualizing close to $2 billion in sales. IGF-1R inhibition is the only clinically an commercially validated mechanism of action for Thyroid Eye Disease. That is an exciting proposition for our company as we have the potential to develop the best version of this highly effective class of medicines. We are excited about the potential to differentiate compared to Tepezza and other monoclonal antibodies. With 003, we hope to show the potential for a convenient, less frequent, low volume, self-administered auto-injector. We see significant potential within the current TED market and as well as the opportunity to expand it from there. Turning to Slide 6, we show two examples of diseases where a meaningful portion of the market converted from IV to a later entrant subQ. Keep in mind that these subQ examples have the same or worse dosing frequency than their IV counterparts. That will not be the case for 003. On the left is an example of converting IV to subQ with the same molecule, while on the right is the adoption of a new subQ entrant. In both examples, sales of the class grew after the launch of subQ. So subQ offerings can command substantial market share, even when launching several years after an incumbent IV, and can command that market share quickly. Further, subQ offerings can also grow the overall market size for their class. Importantly, none of these examples were in new start markets. TED is a new start market, which should be easier for us to break into. We think there is a significant opportunity for a long-acting, convenient, subQ anti-IGF-1R therapy. Moving to Slide seven. Here's a quick look at the study schematic for our healthy volunteer study to provide context for the data on the coming slides. We ran single-dose subQ and IV at low doses for 001 and 002, and then we most recently ran a single-dose subQ and IV at low and high doses for 003. Let's turn to the data that we've all been waiting for. Here is a PK and PD comparison across all three molecules, 001, 002, and 003. We have also included the published lanadelumab PK data on the slide for reference. As you can see, 003 has the best pharmacokinetics of any of the antibodies tested, with prolonged durability compared to its parent, 001. Although VRDN-001 subQ looks favorable compared to other first-generation IGF-1R antibodies, VRDN-003 takes it a big step forward. We also wanted to see VRDN-003 at least match VRDN-002 on half-life, and we are very happy to see that it is superior to even VRDN-002's impressive performance. All three Viridian candidates showed excellent exposures with bioavailability consistent with approved subQ antibody therapies. We have previously shown that VRDN-001, a full antagonist of IGF-1R, produces best-in-class increases in IGF-1 levels, which is a key marker of target engagement. Consistent with the expectations set by VRDN-001, its parent molecule, VRDN-003, increased IGF-1 levels to a greater extent than other IGF-1R antibodies, including VRDN-002. We were hoping and expecting to see this sustained and potent pharmacodynamic effect with VRDN-003, and we see it very clearly here on the right. VRDN-003 was very well tolerated. There were no SAEs, and all treatment-related, treatment-emergent adverse events were grade one and mild. No ADAs were identified. VRDN-002 and VRDN-001 and VRDN-002 were also well tolerated in this study, with no SAEs and no adverse events of interest. Let's review the data for VRDN-001 as a frame of reference for why we are so excited about these VRDN-003 results we are reporting today. On the graph on the left, we show the VRDN-001 IV serum concentrations at the three different doses we evaluated in our phase I/II clinical trial. These were 20 mg/kg, 10 mg/kg, and three mg/kg. The three shaded boxes represent the exposure ranges that we saw from each of these doses, from Cmin at the bottom to Cavg at the top. Now, with that as a background, let's turn to the next slide, where we can look at the correlation of these exposures to clinical response. Here we again have the serum concentrations from the three doses we evaluated in our phase I/II clinical trial. On the right, we show the corresponding clinical responses in TED patients for three key endpoints: proptosis, CAS, and diplopia resolution. As you can see, all three doses showed highly effective clinical responses for VRDN-001 IV, including at the lowest dose of 3 mg per kg. In fact, looking closely at TED's primary endpoint of proptosis, VRDN-001 IV looks similar, if not favorable, to Tepezza, across all three doses. With this VRDN-001 IV data showing the connection between exposure levels of VRDN-001 IV and clinical responses, coupled with the fact that VRDN-003 and VRDN-001 are nearly identical antibodies, we can uniquely leverage the VRDN-001 data and rapidly advance VRDN-003 as a best-in-class, half-life extended, self-administered subQ program that we expect can meaningfully change the landscape for patients. Now that we've established VRDN-003's shared sequence in pharmacology with VRDN-001, confirmed its extended half-life, and confirmed its receptor engagement, what dosing regimens are available to us? Here, we've taken the pharmacokinetic data from VRDN-003 and modeled dosing intervals that have achieved or surpassed VRDN-001 exposure ranges. One exciting outcome from the surprise outperformance of VRDN-003 is that it unlocked an even more differentiated dosing regimen for patients. Dosing VRDN-003 as infrequently as Q8W is predicted to achieve and consistently surpass trough, or Cmin, levels of VRDN-001 IV dosed at 3 mg/kg. This enables an incredible combination of convenience and exposure that is still expected to be efficacious, and which could also positively impact the safety profile compared to the currently approved option. Dosing VRDN-003 at once monthly is predicted to achieve and consistently surpass trough levels of VRDN-001 IV dosed at 10 mg/kg. Achieving an exposure where we have seen clear clinical responses, and then being able to extend that to a once-a-month convenient dose, is a development that we are very excited about. Finally, we illustrate that our modeling suggests that dosing VRDN-003 at a Dupixent-like Q2W dose would be predicted to surpass trough levels of VRDN-001 dosed at even 20 mg/kg. So you see the properties of VRDN-003 give us a lot of headroom to work with here... and give, give us the potential to offer patients a best-in-class, low volume, self-administered subQ delivery option. This is a great result for patients. We expect to move quickly by moving directly into two pivotal registration-enabling studies with confidence, because our extensive experience with VRDN-001 effectively guides our dose selection efforts. We want to be sure that we are keeping the end game in mind by testing dosing regimens that we expect will provide a best-in-class product profile and maximize commercial impact, while also ensuring a successful outcome of these studies. Our VRDN-003 pivotal studies are expected to begin just as THRIVE and THRIVE-2 are completing enrollment, enabling us to leverage our clinical trial machinery and our extensive learnings, which we believe is a key advantage to Viridian. Our next step is to align with regulators on our pivotal design, and we will share more detail on our trial design and plans ahead of pivotal trial initiation. We are excited to rapidly advance a highly differentiated subQ VRDN-003 to patients. Just a quick look at our pipeline with the reminder that we are building what we believe is a world-class portfolio in thyroid eye disease, and based on today's announcement, we have the potential to bring a best-in-class IGF-1R therapy. We look forward to sharing more on our unique FcRn portfolio in 2024. To close out, we are making excellent progress at Viridian on developing our pipeline, and we are executing across the board. We are enrolling our phase III trials, THRIVE and THRIVE-2, for active and chronic TED patients. We are on track to report THRIVE results in mid-2024 and THRIVE-2 results at the end of 2024. We also recently unveiled our FcRn inhibitor portfolio, where we are on track to file an IND for the VRDN-006 Fc fragment program for self-administered subQ delivery by the end of 2024, as well as advance our VRDN-008 program, which is our potentially first-in-class FcRn bispecific program, into non-human primates in 2024 as well. With that, I'll ask the operator to open the call for questions. At this time, I would like to remind everyone, in order to ask a question, press star, then the number one on your telephone keypad. Your first question comes from the line of Michael Yee from Jefferies. Your line is open. Hey, guys. Good morning. Congrats on the data. Appreciate that. We had quick questions for the team. One was trying about your view and perspective of the every four-week option and every eight-week option. And when you look at your PK for those, it looks like you could cover both bases. But I just wanted to understand your confidence around the efficacy, given the fact that comparing the coverage to 001, for example, I think which is on slide 22, and how you think about those two different ones. And then, related to that is by using PD data. So if you look at the PD data, I just wanted to understand your thoughts around that, because I think around after 40 days or so, I think the IGF-1R for one of the doses starts to fall off a little bit. So I just wanted to think about, again, comparing and contrasting your confidence on every four weeks and every eight weeks. Thank you. Thank you, Michael. Yeah. So first, just to anchor the discussion here, we can achieve or surpass exposures of the 10 mg/kg IV, which is the dose we are evaluating in our phase 3 THRIVE pivotal studies. A Q2W regimen is Dupixent-like, and it matches 10 mg/kg IV on the Cavg and is far above 10 mg/kg on the Cmin. Now, we would only need this level of exposure if the lower exposures didn't work, which would mean competitor molecules wouldn't work either. So we include that arm, or we're thinking about including an arm like that to ensure success, so although we highly doubt that those levels would be necessary for 003 when it's all said and done. Now, just to take the second part of the question, just to reinforce that we have a range of clinical activity that's helpful from our VRDN-001 IV studies, where we've showed clear activity at low exposures of the 3 mg/kg with similar activity at the 10 mg/kg levels. So we want VRDN-003 regimens across the exposure range of VRDN-001 IV, where, you know, quite frankly, maybe the most exciting regimens are those in the middle or near the bottom end of that range. You know, 3 mg/kg or somewhere in the middle, where we can we can might have the ability to improve safety with the same IGF-1R efficacy, while at the same time maximizing convenience. So just, just to reiterate the data that's in the slide, specific to your question. As I said, Q4 weekly, we achieve 10 MPK IV Cmin and C averages right between, right between 3 MPK and 10 MPK. So that's a good place to be. On the Q2 weekly, as I mentioned, above Cmin for 10 MPK and actually in line with, more than 20 MPK for Cmin, and then we match C avg for 10 MPK, so we're actually a little bit higher. So that just gives us a lot of confidence. Again, I mean, just to reinforce, it gives us a lot of confidence because we're in those exposure ranges, where in those exposure ranges correlated to clinical response with 001 and 003 and 001 are nearly identical in its antibodies. On the IGF-1 question, Michael, IGF-1 biomarker is a good biomarker. It tells us if VRDN-003 is acting the way it's supposed to be. You can see that VRDN-003, just like VRDN-001, raised IGF-1 levels to similar peak levels, times times baseline after a single dose. What we knew before today is that Tepezza and VRDN-002 had IGF-1 increases more in the 2- to 3-fold range. And quite frankly, we haven't seen Acelyrin's IGF-1 data, so we're not sure what their drug is capable of doing. We just haven't seen it. But IGF-1, a four fold increase with VRDN-001, combined with the clinical data for VRDN-001, that got everybody really excited about what we could do, and have a potential to differentiate on efficacy. So the... And then I would just point out the second characteristic about IGF-1 that is exciting for us is that it confirms the durability of target engagement. And you can see that 003 nicely sustains that elevation in line with its extended half-life, which again, is up to approximately 50 days. So- Yeah, and if I would- Michael, Michael Just had a follow-up comment. Michael, I'll just add a quick one there for you, just in case it's helpful. So, you know, every eight weeks since you were zoning in on that with your question, you know, it's clearly at or above the 3 mg per kg 001 IV exposures on Cmin and Cavg, which led to remarkable clinical benefits. So we're really confident about that. And then you asked about the IGF-1 levels. The IGF-1 levels, the magnitude increase, you know, clearly matches between 001 and 003, which just connects everything back beyond just the pharmacology to the efficacy data with 001. The IGF-1 data that you see in the slide, it is, of course, from single dose, right? There'll be a 600 mg loading dose in that regimen, followed by only 2 more doses. 3 administrations of VRDN-003 for that every 8-week regimen. We fully expect that to link back to that 3 mg per kg or better IV VRDN-001 efficacy. Thank you. Your next question comes from the line of Laura Chico from Wedbush Securities. Your line is open. Good morning. Thanks very much for taking the question. I guess I wanted to take a step back and maybe just clarify on the regulatory strategy. Does this remain filing for the VRDN-001 program first and then pursuing a follow-up sNDA or separate NDA for the subQ results? I guess I just wanted to clarify that. I didn't see that on the milestones. Then, Peter, I think you just mentioned there, you would be pursuing a loading dose. Does the 600 mg load, is that a single shot? And would that be regardless of whatever regimen you're advancing, whether it be Q8, Q4 weeks? Thank you. Okay. Well, I can take the first part of the question. Yes, the intention is to file VRDN-001 IV first. We, as we stated in the press release, the VRDN-001 subQ program has been deprioritized just in light of how great the VRDN-003 data is, and the speed in which we think we can bring VRDN-003 through pivotal studies. And that, but VRDN-003 is a new molecular entity and would require a separate BLA. And then, Peter, if you want to answer the question on loading dose. Yeah, yeah, just to add color to that, you know, and the 003 just is moving so fast, and it's so differentiated, Laura, that it ends up just making sense for the company to go all in on it, right? It's really that simple. And on the modeled exposures, yeah, it's using a typical loading dose regimen, actually in all three of the modeled regimens. And given we're at 150 mg at least per mL, a standard 2 mL injection would be two injections for the load, followed by a single injection thereafter. Thanks very much. You got it. Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open. Hey, guys. Good morning. Thanks for taking the questions, and congrats on the data. Just a quick one on the VRDN-003 safety. I was wondering if you could provide any additional color on the one case of liver enzyme increase and the injection site reaction there. And then just on the subQ formulation, if you could just remind us where you are with the subQ device. I know you just signed a deal for an auto-injector then back in October. Is that something you're looking to implement into the VRDN-003 pivotal studies next year? Is that part of a longer-term lifecycle management strategy? Thanks. Hi, thanks. Yeah, so we'll just talk about the safety on the 003. Just to set the stage, very well tolerated, no SAEs, all treatment-related treatment-emergent AEs were grade 1 and mild, no ADAs detected. On the hepatic data point there, that is a single data point. We haven't seen that in our 001 trial, so healthy volunteers, phase 1, 2, so that is not concerning to us. On the ISR, I think it was mild and it resolved. And what was the second question with respect to auto-injector? Yeah, I was just wondering if you could provide an update on where you are with the auto-injector, and if you intend to use that in the pivotal studies to start next year? Yeah, our goal is to launch with an auto-injector. We have been working on it for quite a while. It's all on track. There's, you know, your normal blocking and tackling you have to do when you develop an auto-injector. But it's on track, and we intend to have that available at launch, and so we'll introduce it into the pivotal studies as soon as practicable. Got it. That's helpful. Thanks for taking the questions, guys. Thanks. Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI. Your line is open. Hey, good morning. Congrats on the great data. So first, I know that you haven't aligned with regulators on the pivotal 003 trial design yet, but maybe you could just lay out the different scenarios or what your base case assumption is for the amount of dose-ranging work that may be required with that trial? Thanks, Gavin. We do not anticipate any need for dose ranging. I mean, the bottom line is, we know our doses. Given the similarities between zero zero three, the shared pharmacology with its parent, zero zero one, we have more information and have a higher comfort level with our data than you would probably otherwise have as a typical program. And just as a reminder, the exposures for subQ are already in the range that is being studied in with zero zero one in its pivotal studies. So again, you know, we know what our doses are, and we are confident that that's gonna move right into a pivotal study. Yeah, the only thing, you know, and we're giving some detail on sort of how we're thinking about it in the slides, and you heard in the prepared comments that we're probably gonna take more than one dose regimen forward. But we just wanna make sure that when we give the design to the investor community, that we say it once. So that's how we're thinking about it. Got it. And maybe just a quick housekeeping question, confirming that 003 doesn't fall under the Xencor partnership? Does not. Does not. Great. All right. Thanks so much. Thank you. Your next question comes from the line of Gregory Renza from RBC Capital Markets. Your line is open. Hey, good morning, guys. Congrats on, on the data this morning, and thanks for taking my question. Maybe Steve, certainly commenting on the commercial opportunity up at the top, top of the call, and as you mentioned, the, the global opportunity, obviously the, the convenience, as, as, as well as several other, other, other factors. I'm just curious if you could just, maybe put into context the hierarchy of where you see that, that reach extending, and, and would this necessitate the need of, of maybe a, a, a partner sooner than later when you think about commercialization? And then my second question, just related to the intellectual property. As it comes to VRDN-003 and VRDN-001, just remind us of the intellectual property portfolio, how the overlap and the contrasting of both assets. Thanks so much. Okay. Yeah. So, look, I think what we see as, the commercial opportunity, I think, you've got Tepezza at 20 mg/kg, in the market. There, it's already annualizing close to $2 billion. We think, our IV, our VRDN-001 IV, has a very solid place in that market, and we look forward to, we look forward to the THRIVE results and possible differentiation there, which would be great. And IV will have a place in the market. But the introduction of a subQ like VRDN-003, we would expect to have assist with penetrating the active population further, gaining more access or more penetration in the chronic population as well. But also, we would expect it to grow the market, and we have some examples in the slides that show that the introduction of a subQ can grow the market. Now, on top-- that's just the U.S. market. We are also looking at other market opportunities outside the U.S., and we have more work to do there and see what those opportunities present. But we think, we're set up very nicely with 001 IV, followed by a 003 subQ, in terms of both penetrating the existing market and also being able to grow. Got it. And just on the intellectual property portfolio? Yeah, I can take that. This is Sean. We have coverage IP-wise across all of our molecules into 2040. Your next question comes from the line of Alex Thompson from Stifel. Your line is open. Hey, great. Thanks for taking my questions. I guess, first one on 003. I guess, is your current expectation that you would run the active and chronic pivotals in parallel, or do you expect to stagger them in a similar way as you did with 001? And then maybe for 001, maybe you could set the stage for expectations around the mid-2024 data for THRIVE, I guess, in terms of efficacy and then also safety in terms of some AEs like hearing loss, et cetera. Thanks. Well, on the first question, I think we haven't locked down the studies yet, but we would expect that they'd probably be staggered. We'll start the first one as soon as we can. But we'll get more details on that. The second question was what, Alex? I guess, could you just set the expectations for, you know, THRIVE data in mid-2024? Like, what should we expect? What do you think the bar is for, you know, efficacy and safety at the top line? I can chime in there. I mean, I think we'll set that up, you know, more fully. We might do some sort of a capital markets day ahead of that event to set that up, possibly with KOLs, as you've seen some other companies do. You know, just as a refresh, overall efficacy across all endpoints, and we put the data back in the deck today. It's also in the appendix. On CAS, proptosis, diplopia, it looks as good or better than Tepezza at that week 6 endpoint comparing across studies. You'll also recall that if you look at the Tepezza studies, whether it's active or chronic, the efficacy gets maxed out right around that five dose time point. That's why we're super excited about our five-dose schedule for VRDN-001. Also, that gives us the potential for differentiation on safety, which was the other point of our regimen, and we're really excited about that readout. We don't want to set any expectations that that will be superior, but it is very exciting that all of the efficacy endpoints were as good or better and sometimes clearly better than Tepezza when you compare it across studies. Great. Thanks. Your next question comes from the line of Jason Butler from JMP Securities. Your line is open. Hi. Thanks for taking the question, and congrats on the results. Just a quick one on understanding you still have to align with regulators on the Phase III design. Should we still think about 15 weeks as the timing for the primary endpoint? Or, given the different dosing duration options you have, could the primary endpoint timing be different? Thanks. Yeah, great. Thanks. So yeah, we expect to run... Just, just to set it up, we expect to run two pivotal studies, one in active, one in chronic. We expect to bring forward at least one active arm, and we're looking at a 24-week endpoint. Again, we haven't locked everything down, and we'll update on specific details once we get confirmed alignment with regulators. But that's our current thinking. As Peter said, we want to say this once and say it right, and not have to go back and change things. So we're essentially following what we did for THRIVE, and just across the board, we're just gonna move as quickly and as aggressively as we can. Great. Thanks for taking the question. Your next question comes from the line of Rami Katkhuda from Life Sci Capital. Your line is open. Hey, guys. Congrats on the update, and thanks for taking my questions as well. I guess a couple quick ones. First, will you wait for the THRIVE results before initiating a pivotal study with 003, or is it just whatever comes quick, more quickly? And then, in the future, do you imagine assessing retreatment with either 001 or 003 in patients who don't kind of achieve full efficacy, based on the clinical trials? Thanks. Yeah. So the answer to the first question is we do not intend to wait. We're gonna move quickly. Again, you know, we have extreme confidence in VRDN-003 based on what we've seen and based on its similarities to VRDN-001. So there's no reason to wait on that. With respect to retreatment, we haven't really kind of dove into that yet in terms of our disclosing our plans for that. It's certainly an option. There's certainly things that are out there that we wanna consider, and probably the opportunities available to do that, but we just need more time to kind of sort through that. But we'll definitely update the market on that at another time. Awesome. Thank you. Your next question comes from a line of Derek Archila from Wells Fargo. Your line is open. Hey, good morning, and, congrats on the update here. I just one from us, I guess, is there any consideration for maybe looking at, you know, the every 8-week dosing as potential, like a maintenance, you know, post-monthly dosing, you know, kind of looking more at an induction period? Would that be a consideration in the Phase III? Thanks. Yeah, I think you got to give us a little bit more time to kind of lock down exactly what we're going to do. I can tell you that we have a lot of faith in that Q8 weekly dose. I mean, matching 3 mg/kg in that lower end of the activity range, where we saw—it's at the lower end of the range, but we saw quite a bit of clinical activity at 3 mg/kg. So that's a pretty exciting place to be. So give us a little bit of time, and we'll come back on that one. Yeah, I would assume that, you know, a standard way of treating the patients that you've... You know, we've all become used to, and Steve just mentioned that we're probably going to run a 24-week period. I mean, every 8-week, you know, you've got the potential for this IGF-1R efficacy, that's just dramatic, that we've all come to know. You've maximized differentiation. It's three- I mean, one of the coolest things about that one, it's 3 administrations, and you're done. And there's also the potential to uniquely test whether we can improve upon safety as well. So it's a really exciting regimen. Then I just want to just one for clarification, just on the loading dose. Is it just a single loading dose or are there multiple? I just wanted to be clear on that. Single. It's a standard load. There's nothing unique about it. Dupixent, Lebrikizumab, you know, there's Stelara and Skyrizi have different ways to load. This is a standard load. Perfect. Thanks. Congrats again. Your final question comes from the line of Kalpit Patel from B. Riley Securities. Your line is open. Yeah. Hey, good morning. Thanks for taking the questions. Maybe one follow-up on the liver enzyme elevation in that one patient. Can you characterize how soon after this AE occurred and how quickly it resolved? And was it in the 600 mg dose or the 300 mg subq dose, the liver enzyme elevation? Kalpit, this... So I don't think we've looked at it that closely. This was a spurious finding. I mean, the safety was outstanding across the board. And if you look at... You got to recall as well, 003 is an almost identical antibody to 001. So we have 001 data in TED patients and healthy volunteer patients, in IV and subQ and across 003 and 001. The safety looks outstanding, so I wouldn't overthink this one. Okay. Okay, and you sort of touched on this earlier, but how confident are you that no additional data will be required for 003, since this is a, you know, new molecule, new entity, you can go straight into the pivotal development without any data in patients? Yeah. I mean, look, we're really confident in that. I mean, just the, again, they're nearly identical antibodies. The only difference is the half-life extension, same binding domain, CDRs. So and as I said, we're already testing those exposures at in the pivotal studies, so that's already been through regulators. So we feel really confident that that's. And we know what our doses are, so we feel really confident that we'll be able to move into a pivotal. Yeah, just to put an exclamation point on that, you know, confident enough to talk about it as an accelerated program going into pivotal today. We just want to make sure that when we put out the precise design, that you guys see it once, and that it doesn't change. At this time, we have reached the conclusion of the question and answer session. I would now like to turn the call back to Viridian's President and CEO, Steve Mahoney, for some closing remarks. Thank you, operator, and thanks to everyone for your time this morning. We are thrilled to be ending the year on a high note, and we are preparing for an exciting 2024 for Viridian. We wish everybody a happy holidays, and thank you again. This concludes today's conference call. You may disconnect your lines. Thank you for participating.