Thank you. Good morning, everyone, and thank you for joining us. Before we begin, I'd like to remind the audience that this conference call may contain forward-looking statements such as those related to the progress of our clinical trials, including trial commencement and anticipated data readouts, our future financial and operating results and investments, and our ability to commercialize our product candidates. These forward-looking statements involve risks and uncertainties that could cause our actual results and events to differ materially. We urge you to review the risk factors section of our Form 10-Q for the quarter ended September 30, 2023, and is also available on our website at acelyrin.com, along with today's press release and our slide presentation, which identifies certain factors that could cause our actual results, performance, and events to differ materially. Additionally, these statements are based on information available to us today, March 20, 2024, and we undertake no obligation to update them as circumstances may change. The presentation slides from today's call and a recording of the webcast will be archived on the events and presentation page of acelyrin.com for approximately 30 days. Joining us on today's call are Dr. Shao-Lee Lin, our founder and CEO; Gil Labrucherie, our Chief Financial Officer; and Dr. Shephard Mpofu, our Senior Vice President of Development. I will now turn the call over to Dr. Lin. Shao-Lee? Thank you, Agnes, and thank you, everyone, for joining us today. As we approach the one-year anniversary of our initial public offering last May, we've been working hard to ensure a strong start to 2024. Last week, we highlighted positive news for our lead program, izokibep, and a path forward. And today, we are delighted to share positive proof-of-concept results for lonigutamab, the first reported clinical responses with a subcutaneously delivered anti-IGF-1 receptor treatment in patients with thyroid eye disease, or TED. Today's results are meaningful for TED patients and the clinician community, and also for myself and many members of our Acelyrin team, having had the great privilege of leading the development and approval of the first available therapy for TED at a prior company. We are excited about achieving these proof-of-concept results as they represent the opportunity to continue to advance therapies with TED patients. Our goal is to address the unmet needs of depth and durability of response, safety liabilities, and convenience in a manner that we believe has the potential to be paradigm-shifting for these patients. lonigutamab is a clear example of our business model, where we seek to identify drug candidates we believe are diamonds in the rough, where based on molecule characteristics, our collective experience and expertise, and the evolving scientific and medical understanding, we can establish a development plan that tests our hypotheses around clinical differentiation and the potential benefits for patients. Combined with the izokibep news released last week in HS and PsA, today's announcement is another step forward in advancing our late-stage pipeline in immunology and inflammation. For izokibep, we've just shared the top-line results of phase II-B/III trial in PsA that we expect to be the first of two registrational trials. For HS and uveitis, we have phase III trials ongoing that we also believe will be the first of two registrational trials in those indications, and both of which we expect to read out top-line results within this year. And with these positive data for lonigutamab, we will be planning to initiate the first of two registrational trials for thyroid eye disease within the second half of this year. We believe both of these programs are on the forefront of development for the next generation of each mechanism with the potential to provide a clinically meaningful difference for patients. I want to thank all of our trial participants, clinical investigators, investors, and employees for continuing to stand with us in our mission to bring transformative medicines to patients. Now, let me start by taking a moment to talk about thyroid eye disease. Thyroid eye disease is a vision-threatening autoimmune disease in which there is both inflammation as well as expansion of the tissues behind the eye, resulting in eye bulging known as proptosis and the subsequent inability to close the eyelids. Double vision, or diplopia, can occur, as well as the potential for compression of the retinal nerve, which can lead to blindness. As such, TED is a progressive chronic inflammatory disease where longer-term treatment has the potential to improve depth and durability of response. I'm proud to say that the first approved therapy was a major step forward for managing this devastating disease, providing the potential to move patients from a surgical to a medical intervention as a fixed-dose course of IV administration of this anti-IGF-1 receptor treatment. As we continue to observe real-world evidence in TED, it's clear that there is a chronicity to the disease that can be treated longer term. There have been updates to the label in the past year that have included both effectiveness of this mechanism on treating more chronic disease, as well as an update on the potential for severe and even permanent hearing impairment associated with the current treatment paradigm. Although there have been explorations of other mechanisms for treatment of TED, existing data, including clinical response rates, has suggested this mechanism as likely most central to the disease and leads to the need to optimize benefit-risk for TED patients, which we believe the characteristics of lonigutamab enable us to do. Let's take a moment to talk about the characteristics of the molecule and how they suggested to us the hypothesis that it could lead to something clinically meaningfully different for patients. Lonigutamab is a humanized IgG1 monoclonal antibody targeting the IGF-1 receptor and is delivered subcutaneously. Relative to standard of care, lonigutamab binds to a distinct epitope, which results in internalization of the receptor within minutes. In a preclinical binding and functional laboratory assays, it's been shown to be 75-fold more potent. The characteristics of lonigutamab that enable subcutaneous delivery also enable the potential for longer-term dosing, which we believe can improve depth and durability of clinical response. Based on our preclinical and pharmacodynamic data from our completed single-ascending dose study with lonigutamab, we can optimize the therapeutic window utilizing the Sub-Q route of administration. The characteristics of lonigutamab also allow the potential to minimize exposures relative to IV therapy. IGF-1 is neuroprotective to cochlear cells of the inner ear and serves to repair damage that can occur over time. We hypothesize that high concentrations of anti-IGF-1R due to the maximal concentrations, or Cmax, from IV administration can penetrate the blood-labyrinth barrier and interfere with this normal function. Our current study cohorts are designed to provide data to allow us to choose a subcutaneous dose and frequency that optimizes the potential to improve depth and durability of response while minimizing safety risk. We are pleased that today's positive data demonstrates proof of concept for the first subcutaneous anti-IGF-1R product candidate in thyroid eye disease. Across two different cohorts, patients with active TED experienced rapid and meaningful proptosis and clinical activity score responses, as well as diplopia response. The placebo-adjusted responses observed in cohort 1 showed that by the first clinical assessment, which was within 3 weeks after the first dose of lonigutamab, patients achieved responses that were in line or better than what has been previously reported for IV therapies, representing the potential for an exciting paradigm shift for TED patients. While cohort 1 demonstrated proof of concept, we also are sharing the current cut of cohort 2, which is consistent with and supports the observations from cohort 1. Based on the strength of these data, we plan to initiate a phase II-B/III trial in the second half of this year, designed to be the first of 2 registrational studies. This is the design of the phase I-phase II trial evaluating subcutaneous lonigutamab in TED patients. It was designed to have a size and shape consistent with what others have shared as proof of concept for their candidate TED therapies. Cohort one was placebo-controlled with a randomization of 6 to 2. Patients received two doses of lonigutamab, one at baseline and one at three weeks. The demographics and baseline characteristics in cohort one were consistent with other TED studies and were otherwise unremarkable. At the first assessment, which was within three weeks of receiving the first dose of lonigutamab, 50% of patients achieved a proptosis response defined as a greater than or equal to 2 mm reduction in proptosis. This is actually the registrational endpoint for TED because it is approximately the amount of bone that an oculoplastic surgeon can scrape away from behind the eye before jeopardizing the brain in an attempt to reset the globe back into its orbit. We know from our studies that patients often have much more than 2 millimeters of proptosis, sometimes 10, 15, or even more than 20 millimeters. And this is why we think it's important for us to strive for longer-term dosing to have the potential to enable greater depth and durability of response. Remarkably, in this cohort, even with the last dose being administered at 3 weeks, responses seem to be holding out to 12 weeks. This suggests a durability effect that could factor into dosing decisions in the future. Clinical Activity Score, or CAS, is another important measure of disease activity for TED, where patients are scored based on pain, redness, and swelling around the eye. A greater than or equal to 2-point reduction in CAS is considered a clinically meaningful improvement for patients. As you can see from these data, there are rapid and deep responses, with 50% of patients receiving lonigutamab achieving a clinically meaningful reduction in CAS within 3 weeks and 100% within 6 weeks. As was observed with proptosis, these responses were again maintained through week 12. Ultimately, the goal for patients with chronic disease is resolution of all signs and symptoms to achieve a normal as normal a life as possible. It's core to our mission to strive for transformative benefits for patients. This is what we're trying to achieve by treating TED more like a chronic disease with longer-term dosing. In TED, CAS of 0 or 1 is a hurdle that approximates the sentiment. As you can see from the data, CAS 0 or 1 was achieved by 50% of patients by week 6. Based on all of these data, we believe that proof of concept has been demonstrated within this first cohort of treating TED patients subcutaneously with lonigutamab, with speed and magnitude of these responses at least comparable to the IV approaches. Now I'd like to turn it over to Shephard, who will walk through our cohort 2 data. We're sharing data from the current cut of cohort 2, which is consistent with and supports the observations from cohort 1. Shephard? Thank you, Shao-Lee. Indeed, the results from cohort 1 are impressive and clearly demonstrated proof of concept for lonigutamab in thyroid eye disease with a Sub-Q treatment. I am super excited and thrilled to share further supporting evidence from cohort 2 that validates the proof of concept and helps us to further understand how we might optimize the benefit-risk of lonigutamab. Here, you see the demographics and baseline characteristics for cohort two, which were as expected and consistent with cohort one. In cohort two, we are looking at the next six patients assessed at six weeks, and the data are entirely consistent with cohort one in the first six treated patients. Depicted on this slide on the left, the line graph shows rapid improvement in proptosis response achieved by 67% of patients by week four, the first assessment point, which is maintained through week six. The middle bar chart shows clinically meaningful proptosis responses for both cohort one and two at the six-week time point. Finally, on the right side, you can observe reduction in clinical activity scores, with 83% of patients achieving a clinically meaningful reduction in clinical activity score by week six for cohort two. It's important to note that one of the most debilitating symptoms of thyroid eye disease is diplopia or double vision. Diplopia is measured by severity on a 4-point scale that ranges from constant to intermittent to diplopia only with far left to right gaze and to no diplopia. As you can imagine, a single-grade reduction on this scale would be important for patients and is what is called a diplopia response. In cohort one, 25% of patients with a variable diplopia at baseline achieved response, and this improved to 40% in cohort two. These diplopia responses are remarkable as they represent a level of response at six weeks in this difficult-to-treat manifestation that seems at least comparable to the 39% placebo-adjusted response observed at a later time point at 24 weeks in the teprotumumab registration program. So to summarize, across response measures and in both cohorts, lonigutamab demonstrated very early clinically meaningful and durable efficacy. Now, turning to safety, our experience to date demonstrates lonigutamab has been well tolerated with a favorable safety profile, which supports our ability to test our hypothesis for both the greater depth and durability of responses, as well as the potential to limit safety liability. In this trial, to note, nothing of concern was noted, with the majority of events being mild. There were no interruptions to study drug except optic neuropathy in the placebo patient. There were no events of hearing impairment or hypoglycemia reported, and we had no serious adverse events. Now I turn over back to Shao-Lee. Thank you, Shephard. In addition to establishing the clinical proof of concept with a favorable safety profile, observed exposures from cohorts 1 and 2 are represented on this slide. And of note, the Y-axis is a log scale. The most important takeaways are that the clinical responses achieved were at exposures below the Cmax for teprotumumab, which is an important consideration for testing our hypothesis of limiting safety liability seen with IV administration. We are extraordinarily pleased to have achieved the level of clinical responses seen in both cohorts. The 40 mg q3-week dose gives us confidence that we can achieve monthly q4-week dosing. And the durability of clinical responses out to 12 weeks further suggests the possibility of even less frequent dosing. Overall, the exposure-response relationship demonstrated provides the evidence needed to choose a dose to optimize efficacy while determining the potential to minimize safety risk. And so to wrap up on lonigutamab, we are pleased to be the first to present proof of concept for subcutaneous anti-IGF-1 receptor treatment in thyroid eye disease patients. We are excited with the strength of these results and look forward to initiating a phase II-B/III trial designed to be the first of two registrational trials in TED in the second half of 2024. In closing, I'd like to highlight that between the lonigutamab program and our lead program, izokibep, we have a robust late-stage pipeline covering a number of indications with a catalyst-rich year ahead of us. Similar to lonigutamab data shared today, we have the data shared last week from izokibep in HS and PsA that continue to suggest the potential for the unique characteristics of izokibep to differentiate in meaningful ways across indications. For PsA, we've seen response rates across disease manifestations, including high hurdles of response that appear to be at least as good as the best agents available today or in development without the safety liabilities and with the potential to further differentiate in resolution of enthesitis and with longer-term exposure. Similarly, for HS, the potential for differentiation has been demonstrated with earlier resolution of abscesses and nodules relative to what has been reported by other agents, as well as clinically meaningful improvements across disease manifestations. This is without evidence of increased risk of infection, especially fungal, or suicidal ideation and behavior in a patient population predisposed to infection and clinical depression. I'm pleased to update that we are seeing faster-than-expected enrollment in our ongoing phase III trial in HS, and currently, we anticipate these top-line results in the second half of 2024. Based on our end-of-phase II interactions, we anticipate our ongoing phase III trial in HS and the recent phase II-B/III trial in PsA to be the first of two registrational trials for each of these indications. With all of this important work ahead of us, we are extremely fortunate to be in a strong financial position. We expect that our cash will enable us to fund the company's business over multiple years and through key data milestones for registrational studies for multiple indications and across programs, including the planned phase II-B/III for lonigutamab in TED. In closing, we've had a strong start to 2024. With lonigutamab, we have the opportunity to change the practice of medicine for TED patients and similarly with izokibep. That's the goal, the pursuit of helping patients achieve as normal a life as possible through resolution of their disease. Thank you for the opportunity to provide these exciting updates. Given the close proximity of this call to what would be our normal year-end earnings and business update, we will forego that earnings call and issue a press release and file our annual report on Form 10-K next week. I'm grateful for your belief in our vision of accelerating the development and commercialization of transformative medicines for patients. We look forward to speaking with you all again soon. Now we are ready to open up for questions. Operator? As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. Please limit yourself to one question and one follow-up. Please stand by while we compile the Q&A roster. One moment for our first question. And our first question will be coming from Yasmeen Rahimi of Piper Sandler. Your line is open. Good morning, team. Congrats on the data. Team, I think the first question is around it's exciting to see that there was no hypoglycemia or hearing inabilities or impairments reported. But questions that clients have for us is maybe six weeks too early to pick up any differences. Would love to get your thoughts on what type of analysis were conducted to really ensure that those two safety limitations are overcome with Loni. That's sort of question one. And then question two is, given cohort one and cohort data, could you provide some glimpse on how you're thinking about which doses you would be moving forward into a registrational study? And I'll jump back into the queue. Hi, Yas. Good morning. And thank you so much for those questions. They're both really, really important ones. I think absolutely. We shared the safety with regards to the first two cohorts reporting no hearing impairments and no hypoglycemia seen because those are obviously events of interest for the pathway. But you're exactly right. These sorts of safety events, especially hearing impairment, are really going to take longer-term treatment and larger numbers of patients to be able to have a good point estimate in terms of what's really happening with those. What we really want to communicate today, that's the most important, is that we have the opportunity to test that hypothesis, to do that experiment because of the data that we're seeing. And so really, the take-homes here are that number one, we are administering this potential therapy at this point as a subcutaneous administration in TED patients. We think that we're the first ones to be doing that. We are seeing response rates that are at least on par with where we would expect those therapies to be, but at exposures that are well below, at least a half log below the Cmaxes of what we saw with teprotumumab, which is what we're trying to avoid. And that was exactly the parameters that we were hoping to be able to achieve. With this dataset, we've achieved that in a way that I'm extraordinarily pleased about because, to be frank, I thought we would have to go to weekly dosing in order to narrow that therapeutic window enough to be far enough below the teprotumumab Cmaxes. And at this point, I think we've demonstrated that we can do that even with monthly dosing and perhaps beyond. And so your next question was about what do we expect in terms of dosing moving forward? I think we can safely say that we'll, at a minimum, include a monthly dosing cohort within the context of the 2B/3 trial that we've stated that will begin in the second half of this year. And the rest of the specific dose levels, etc., we will refine. But the purpose of that trial would be to enable us to look at the potential to improve not just convenience, but also the potential to improve efficacy as well as safety, efficacy with depth and durability of response, perhaps with longer-term dosing within the context of that study, and then safety by limiting our exposures relative to the maximum concentrations of teprotumumab, which we feel like we clearly can do. So we're excited because the overall data that we're seeing is completely consistent with what we had hoped we would see in terms of responses and from a pharmacodynamic perspective, allow us to proceed with actually better experiments than we would be able to do we thought we would be able to do before. Thank you so much, Shao-Lee. I'll jump back into the queue. Congrats again. And one moment for our next question. Our next question will be coming from Tyler Van Buren of TD Cowen. Your line is open. Hey, guys. Good morning. Congratulations on the initial MAD data for Loni here. So my primary question would be so obviously, the proptosis response rate of 50% at six weeks looks consistent with what Tepezza showed at the same time point. But can you say anything about the depth of response or change from baseline in proptosis? The follow-up to that would be also with Tepezza, there are meaningful improvements in responses on the various endpoints from week 6 to week 24. So would you expect a similar dynamic with Loni with continued dosing in terms of improvement on these various endpoints, or how might this dynamic differ with subcutaneous dosing versus IV? Yeah. Thanks so much, Tyler, for that. Really all terribly important questions and very central to what we, frankly, hope to be able to offer patients. So remember, the top of the heap in terms of what we're trying to improve for patients is, number 1, efficacy, then number 2, safety, and then number 3, convenience because that's the typical order of importance as we're developing, frankly, any drug. And exactly to your point, what we've been able to provide to you so far as top-line data is our proptosis response rates. Remember, that's the registrational endpoint. Therefore, what we felt was both important as well as enabling us an opportunity to sort of compare apples to apples across as best we can in early days in small datasets. We feel very good about what we saw. One of the very most important things is that moving from an IV administration to sub-Q, the ability to see that as rapidly as we have that is at least consistent with the IV therapies is part of what's been so remarkable here. One could imagine that if you delivered something sub-Q, it might take longer to get up to the IV levels of response. So we're not seeing that happen. And then there's no reason then once you get up to an applicationist or therapeutic level that if you're able to maintain that and we think we can maintain that actually with a more optimal therapeutic window or therapeutic level, if you will, by delivering it sub-Q, then there's no reason to believe that you wouldn't continue to maintain that efficacy like others have with the same mechanism of action or at the same target, at least, not exactly the same molecule. So exactly to your point, we do expect to see that continued benefit over time. We are looking for that in our longer-term next trial to determine whether or not we can get that efficacy benefit, not just the 2 millimeters of response, but really when we talked about patients having 10, 15, even 20 millimeters of proptosis, really striving towards resolution of proptosis for patients. That's going to have to be tailored on a patient-by-patient level. Giving physicians and patients the flexibility to be able to dose for longer term we think is going to be important. We think that that's actually already been demonstrated and updated in the Tepezza label within the context of last calendar year in terms of treating more chronic patients who have had the disease for multiple years and showing the efficacy of this pathway or this mechanism for those patients. And so really a fundamental tenet of what we're trying to achieve, longer-term dosing for these patients, skirting some of the safety liability as well as providing the convenience of sub-Q. And one moment for our next question. Our next question will be coming from Akash Tewari of Jefferies. Akash, your line is open. Hey, this is Amy on for Akash. Thanks so much for taking our questions. Just a quick one. In terms of the doses that you tested, I think in some of your earlier MAD studies, you were looking at higher doses. In your clinical trials, you had a monthly dose option. Just wanted to see if you had any of those data on file and how that looked in terms of safety and efficacy. Thanks so much. Yeah. No, thanks for that, Amy. Yeah. So in addition to cohort 1 and cohort 2, we do have a cohort 3 that's ongoing, and that is a monthly dose. And we don't have those data for you. In fact, for cohort 2, we provided you the sort of current cut of that dataset. And those 6 patients do 6 weeks is what we have available at this time of cut-off. Got it. Thank you so much. And one moment for our next question. And our next question will be coming from Emily Bodnar of H.C. Wainwright. Your line is open, Emily. Hi. Good morning. Thanks for taking the questions. I kind of wanted to follow up on one of the previous questions about longer-term treatment. Since the Tepezza's used for only six months, are you planning to evaluate any endpoints looking at time periods further than six months to kind of see if there might be additional efficacy beyond that time period? If so, what time periods might you look at? And given the Tepezza phase III study wasn't that large, I believe it was like 80 patients, is there potential to use the first phase II-B/III study as just the registrational study and then the second one for confirmatory purposes? Thanks. Yeah. Both absolutely fabulous questions, Emily, and thanks for those. So I'll start with the second one first because it's easier. The bottom line is yes. We're intending to design the study that will start in the second half of this year as a 2B3 with the potential to utilize it as part of the registrational package, definitely. In terms of the longer-term dosing, absolutely. That's the point of what we're trying to achieve. Because of the 6-month fixed regimen and IV administration of Tepezza, there were a couple of things that we were hoping to address or a couple of things that we understand from that patient population. Number one is that, again, terribly proud because it's made a tremendous difference for patients, and we feel that that's been an important, obviously, a tremendously important advancement for patients. We also know that after six months of therapy, not everyone is all better, certainly not to full resolution of their disease. And a significant percentage of patients lose response over time or need additional rounds of therapy. There have been publications specifically about this. And we know from, again, the studies and label updates within the context of the last year in more chronic patients, patients that have had disease for years, we know from biopsy samples that they have continued receptor expression, that they have continued cytokines within the context of those tissues. And the studies have shown that treatment can actually improve them in a way that resulted in label updates to ensure that that was also described. And so we think that the potential to provide patients with longer-term treatment is terribly important, that only enabling a fixed-dose regimen in months will have the kinds of limitations that we've seen. And so we would expect that within the context of our 2B3, that although the primary endpoint may be will be earlier, the study as a whole will be run out to a year of treatment for patients. That's the paradigm that we've used within the context of other autoimmune and chronic inflammatory diseases to enable us the potential for longer-term chronic dosing for patients. Exactly how long that is, I think, is something we're going to need to determine for these patients and this population over time. But certainly, it's unlikely to be months. It's more likely to be a year or more. Great. Thank you so much. And one moment for our next question. And our next question will be coming from Vikram Purohit of Morgan Stanley. Your line is open. Hi. Good morning. Thanks for taking our question. We had one as a follow-up to the last question. But on a broader commercial note on TED and your view on lonigutamab's prospects given the data you have in hand today, I know there are some open questions you'll be looking to understand through later-stage studies for lonigutamab. But just based on the KOL feedback you received from the space and any market research you may have done recently, how compelling do you think a sub-Q option would be versus an IV option for TED prescribers and patients? Again, keeping in mind the data profile you have in hand today, we'd be curious to hear any thoughts you might have at this point on what portion of patients on IV you think would represent a share shift to sub-Q and how you think lonigutamab may end up settling versus other agents in the space, both IV and sub-Q, that could be available by the time lonigutamab is in the market? Yeah. Thank you so much for that, Vikram. I think in a word, we're ecstatic. We're ecstatic with the level of results that we've seen across the manifestations of disease. We're ecstatic at how quickly that's happening. We've tried to compare apples to apples for you within the context of our slide presentation to give you a flavor of why we use the word ecstatic. And we've shared with you since before these data, ultimately, that we were after not a me too and not a piece of the bigger pie, but really to try to make something that we thought would advance the therapeutic options for these patients, really to bring something clinically meaningfully different for them. Everything we understand from the disease states, from the patient advocates, from the opinion leaders and experts out there is that longer-term treatment is necessary and important to bridge the gap in terms of what we're seeing from a fixed-dose regimen perspective. Certainly, people are after the convenience of sub-Q, and that's going to be necessary or will help tremendously with regards to the potential to provide longer-term treatment. And then for this particular molecule and its unique characteristics, we think we have the ability to test this hypothesis around hearing impairment or the most significant safety liability within the context of this mechanism that could limit it moving forward. And it is a hypothesis, but the ability to test that and actually test that in a convenient way, which is still monthly instead of weekly, again, back to the word ecstatic about all of this. So I think fundamentally, as I said earlier, we think that this has the potential to really change the practice of medicine for these patients. And fundamentally, that's what we're after. Understood. And if I could ask a follow-up and apologies if you mentioned this and we missed it, but at what time point would you expect to see hearing impairment show up in your trial results? At what time point, rather, would you if you didn't see hearing impairment, would you have confidence that it's not a signal that you're seeing associated with this molecule? Yeah. That's a fabulous question, Vikram. So we saw within the context of the Tepezza registrational program, the hearing impairment typically came up around the third or fourth dose. So for that program as every 3-week dosing after the third or fourth month, which is sort of consistent with the hypothesis for what we think might be happening, which is these IV exposures with the big sawtooth pattern, if you will, for what those exposures look like and at some point having an exposure high enough to penetrate the blood-labyrinth barrier. We give medicines IV in oncology all the time specifically to push them across the blood-brain barrier to enable us to penetrate and treat in the brain. About 0.1% of your biologic therapy gets across. So there's a threshold by which this will cross the blood labyrinth barrier, which is just like the blood-brain barrier, and have the potential to be toxic, if you will, or to interfere with the normal function of IGF-1 in the hair cells of your inner ear. Our hypothesis is that that's what happens. It's It's happening over time. It takes some time for that to develop because you have insults all the time to your inner ear, your hair cells. You need that pathway to regenerate, and you're not able to do that because we're blocking it. So we're hoping and no one will know for sure. So this is a hypothesis that we're testing at this time that if we can get as far away from the Cmax as possible and still have efficacy and still have convenience, that hopefully we can improve that safety, maybe not make it go away completely, but at least improve that benefit-risk ratio in a way that's meaningful for patients. Understood. Thank you very much. One moment for our next question. Our next question will be coming from Derek Archila of Wells Fargo. Your line is open, Derek. Hey. Good Good morning. Congrats on the data. Thanks for taking the question. Just first, I just wanted to confirm the safety data is through 12 weeks. So that's question number one. And then second question, I guess, can you just remind us if the trial excluded patients with hearing impairment? I guess to the three tinnitus AEs seen in the trial, I guess, can you just talk about the magnitude and when they appeared and when they resolved? Thanks. Yeah. Thanks so much, Derek. Let me try to break that down. In terms of the safety overall, the cohort one has been followed through 12 weeks and cohort two through six weeks. In terms of the hearing impairment, this study included patients that could have some degree of hearing impairment at baseline, but no audiology changes at baseline. In terms of the tinnitus cases, there were three cases of individuals who had reported mild tinnitus. Ultimately, they resolved without intervention, and there were no audiology changes in any of those subjects. You can imagine the difficulty within the context of any studies, frankly, where we are obviously informing patients appropriately of the potential risk given the mechanism of hearing impairment and therefore sort of a bit hypervigilant about hearing impairment. Really, that highlights the importance of audiometry at baseline as well as moving forward for these studies, which we have implemented and will continue to implement moving forward. Understood. Then maybe just one follow-up. Just in terms of the introduction of a sub-Q into the TED marketplace, I guess, how much do you think that do you think that's more of an expansion through longer duration of therapy as you talked about more chronic dosing, or is it more deeper penetration into the market just because it's maybe easier to treat patients? They're more apt to do a sub-Q. How do you think about that once these are introduced into the market? Thanks. Yeah. A little bit early days for some of the details of that. Obviously, we need to fully understand the benefit-risk here. And obviously, the full understanding of the benefit-risk is really going to drive ultimately what that market share looks like. So I think more to come there as we get into longer-term studies. Great. Appreciate it. Thank you. And one moment for our next question. And our next question will come from Samantha Semenkow of Citi. Your line is open. Hi. Good morning. Thanks very much for taking the questions. Two for me. So Shao-Lee, you mentioned this a few times in your prepared remarks and also in the Q&A. It seems that you're seeing meaningfully quicker responses in proptosis, at least compared to the Tepezza dataset. I'm curious your thoughts on what's driving this. Is this purely a difference in the formulation or some other differentiating aspect of lonigutamab? And then secondly, can you just remind us of the type of administration here? Was it a prefilled syringe or some other form of subcutaneous administration? Thanks very much. Yeah. Thanks so much, Samantha, for those questions. So with regards to speed of response, I would say the important takeaway is that we're seeing responses within our first measurement, both in cohort one and cohort two. So it's happening rapidly, and then the levels of responses that we're seeing are at least consistent with what we've seen for this mechanism. If not numerically better, again, small sample size in the early days for sure, but all within the ballpark of where we would like to be and therefore are excited and across all of the important measures, proptosis, clinical activity score, as well as diplopia. So super excited about all of that, including the speed aspect. The speed aspect is where we would have thought we might have taken the biggest hit moving from IV to sub-Q, and that's not what we're seeing. That's an important part of the takeaway there. In terms of the mode of delivery, ultimately, we expect this to be available at launch in an autoinjector, kind of a single injection, super easy standard autoinjector without a prolonged period of time for administration, etc. At the moment, this is proof of concept in a phase I/II trial, and we are in drug and vial in syringes. And so it's not a prefilled syringe as yet. We anticipate being able to introduce those as single injections moving forward in our later-stage studies. Okay. And this concludes today's conference call. Thank you for participating. You may now disconnect.
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