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spk12: Welcome to the Viridian Therapeutics first quarter 2023 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 is being recorded. I would now like to hand the call over to Ms. Louisa Stone, Manager of Investor Relations for Viridian.
spk11: Please go ahead.
spk10: Thank you and welcome everyone to our first quarter 2023 earnings conference call. The press release reporting our financial results and corporate updates is available on the investor's page of our corporate website at www.viridiantherapeutics.com. Joining me on the call this afternoon are Scott Myers, our President and Chief Executive Officer, Christian Humer, our Chief Financial and Business Officer, Dr. Deepa Rajagopalan, our Chief Product and Strategy Officer, Dr. Tom Chula, our Chief Development Officer, and Todd James, Senior Vice President, Corporate Affairs and Investor Relations. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements regarding our financial outlook in addition to regulatory, 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 and 10-K on file with the SEC. I would now like to turn the call over to Scott Myers, our President and CEO.
spk02: Thank you, Louisa. Good afternoon, everyone. Thanks for joining us today. We had a productive quarter and I'm excited to report on our progress today after completing my first three months as Viridian's president and CEO. 2023 is an important year for Viridian, a year that includes key milestones in all of our clinical programs. I'm proud of all the progress our company has made thus far and looking forward to continuing our work to bring potential best-in-class therapies to patients with thyroid eye disease and additional diseases areas in the future. Our team has grown rapidly throughout the first quarter, and we made several key hires on our senior leadership team, helping to strategically position us for future success. Additional details can be found in the press release we issued earlier today, but these hires include Tony Cassiano, Viridian's first chief commercial officer, Dr. Tom Chula, chief development officer, Dr. Felix Geisler, senior vice president of medical affairs, and Dr. Eric Kupperman, vice president, program leadership. Each of these individuals have already made valuable contributions to the organization and will be integral leaders for our company as we continue to expand our teams, mature as an organization, and prepare for future success. I'll now review the progress we made in our clinical programs during the first quarter, then Christian Humer, our CFO, will discuss our financial results before we take your questions. Let's begin with our TED programs, starting with our lead asset, the RDN001. a humanized monoclonal antibody administered intravenously once every three weeks, which acts as a full antagonist of insulin-like growth factor 1 receptor, or IGF1R. In the second half of 2022, and at the beginning of this year, we reported a series of positive top-line clinical data announcements from three dose cohorts of the Phase 1-2 clinical trial, evaluating the safety and efficacy of BRDN001 in patients with active TED. In December 2022, our team initiated the Global Phase III THRIVE trial, which will evaluate the efficacy and safety of BRDN001 in patients with active TED. Based on our recent discussions with key stakeholders in the TED community, there is particular enthusiasm for our shortened five-dose, 12-week treatment regimen of BRDN001, compared with the eight-dose, 21-week regimen of FDA-approved Tepesic. Success in the five-dose arm has the potential to provide welcome convenience to patients by shortening their treatment course and eliminating three trips to an infusion center. Enrollment is ongoing, and we continue to anticipate reporting top-line results from Thrive in the middle of 2024. Moving to ChronicTED, we are excited to announce that our proof-of-concept study evaluating BRDN001IV in patients with ChronicTED is fully enrolled. As a reminder, the trial design in ChronicTED is similar to our proof-of-concept design that we used in ActiveTED. Two infusions of VRDN001, one at day one and the second at day 21, with evaluation of safety and clinical activity at week six. There are two dose cohorts, 10 mg per kg, and 3 mg per kg will target enrollment of eight patients in each cohort. Randomize three to one in favor of VRDN001 versus placebo. Inclusion criteria include any clinical activity score at baseline. We expect to report results from both dose cohorts of this proof of concept trial in either June or July. Following the results, we plan to start our second global phase three trial, Thrive 2, to evaluate the safety and efficacy of BRDN001 in patients with chronic TED. Top line results from Thrive 2 are expected by the end of 2024. I'd now like to move to our subcutaneous programs, which include BRDN001, BRDN002, and BRDN003. All three candidates have the potential to be developed for delivery with a patient-friendly, self-administered pen device, which could significantly increase access, reduce burden, and expand treatment options for patients living with TED. We plan to select one of these candidates as our lead subcutaneous program before the end of the year. With our many learnings from BRDM001-IV preclinical and clinical work, we believe that the differentiated mechanisms and actions with full antagonism of IGF-1R achieved by BRDN001 and BRDN003 make either of them the most likely to bring a best-of-class subcutaneous product to patients. As a result, a trial evaluating BRDN002 in patients with TED will only proceed in 2024 if BRDN002 is selected as the lead subcutaneous program at the end of the year. This allows us to keep VRDN002 as a potential backup while steadfastly focusing and advancing our efforts with VRDN003 and VRDN001. I will now highlight the upcoming priorities to get the subcutaneous leave program selection by year end. For VRDN001, phase one results and healthy volunteers are expected in the fourth quarter of 2023. For VRDN002, we continue to generate data from the ongoing phase one healthy volunteer trial. For VRDN003, our plans remain on track to file the investigational new drug application with the FDA during the second quarter. We expect phase one results in healthy volunteers in the fourth quarter of 2023. After the lead subcutaneous candidate is selected, we expect to advance the program to a pivotal phase two slash three trial, which is planned for the middle of 2024. Last month, our team was thrilled to present multiple abstracts at the 2023 Association of Research in Vision and Ophthalmology annual meeting. A platform presentation featured data from our Phase 1-2 trial of BRDN001 in patients with active TED, while the poster presentations featured new clinical and preclinical research on BRDN002 and BRDN003. This marked the company's first presentation of BRDN003 research at a medical congress, an exciting milestone in the program's development. Our team looks forward to presenting at additional medical congresses and further engaging with TED patient and physician communities throughout this year. Finally, we continue to advance our earlier stage preclinical pipeline, and we'll expand our disease focus beyond TED and into the rare and autoimmune space. Our preclinical programs include BRDN004, 005, and 006. Yesterday, we announced a partnership with Enable Injections to utilize their Enfuse on-body drug delivery system for one of our preclinical programs. We plan to provide additional information on at least one of the programs later this year. With that, I will turn the call over to Christian, who will provide a financial review for the first quarter of 2023.
spk04: Christian? Thank you, Scott. Good afternoon, everyone. I'd like to refer you to our press release issued earlier today for a detailed summary of our financial results for the first quarter 2023 and take this opportunity to review a few items. We ended the first quarter with approximately $373.9 million in cash, cash equivalents and short-term investments, compared with $424.6 million as of December 31st, 2022. We believe that our current cash, cash equivalents and short-term investments, excluding our $75 million credit facility, will be sufficient to fund our operations into the second half of 2025. Research and development expenses were $50.7 million during the first quarter of 2023, compared with $17.7 million for the same period last year. Research and development expenses for the first quarter of 2023 include a one-time $15 million upfront payment to enable in consideration for the rights granted to Viridian to utilize, enable injections, and infuse on-body drug delivery system. Other drivers for the increase in research and development expenses include higher CMC expenses in preparation for the IMD application for BRDN003, as well as development activities, higher personnel costs due to an increase in headcount, higher preclinical costs due to early stage collaboration expenses. As of May 1st, 2020-23, Viridian had approximately 58 million shares of common stock outstanding on an ask-a-murder basis. With that, I'll ask the operator to open the call for questions. Operator?
spk12: Thank you. At this time, if you'd like to ask a question, please press star, then the number one on your telephone keypad. If you'd like to withdraw your question, press star, one again. We'll pause for a moment to compile the Q&A roster.
spk11: Your first question is from the line of Derek Archela with Wells Fargo.
spk06: Congrats on the progress. Maybe just two questions from us. Maybe just first, can you just talk about the variables that could lead the product data coming out in July versus in the second quarter? Then also, just your thinking on the TED market opportunity, given what we saw from Horizon recently and their quarter results. I mean, do you think anything has changed in the market, or do you kind of chalk that up to deal-related things with the ongoing Amgen deal? Thanks.
spk02: Yeah, thanks, Derek, for the question. This is Scott. You know, we're expecting a real high probability that we're going to see clinical activity in Chronic TED because it's been confirmed by the recent Horizon data. They were able to post a 62%. and very meaningful response with a two-millimeter reduction in proptosis. You know, our trial is evaluating the activity with only two doses of BRDN001 to establish the proof of concept, and reduction of proptosis of less than two millimeters would still be very meaningful because we still plan to evaluate the longer doses in Thrive2. We're very pleased with what's happened in that trial. We've actually over-enrolled the three MIG per KG cohort. So, you know, once we get the process rolling where we bring in all the information from the CRO, from the sites, the MRIs, you know, we're going to need some time to really look through that and make sure it's right. And then we'll be ready to announce either June or July. And then with regard, I think your second question was about what we saw in the Horizon data. We thought it was actually very good data for patients suffering from chronic TED, and there's still a very large unmet need in that population because surgical intervention is really all they have left unless they use a systemic treatment. We look forward to seeing some more of their information when they are able to release around patient baseline characteristics, the efficacy endpoints, and some of the safety, because this was the first placebo-controlled data in this chronic population. And then, you know, we look forward to reporting our data in June or July of this year. And as a reminder, though, our study was set up slightly differently. It was for patients with proptosis of greater than or equal to three millimeters above normal values, and then symptoms that had presented themselves after one year of study screening, excuse me, prior to study screening. And just a reminder, we did not have a CAS requirement, whereas Horizon used a 0 or 1 for CAS. We are enrolling two cohorts there, as I mentioned before, with BRDN001. There's a 10 MIG per KG cohort and a 3 MIG per KG cohort, randomized at 3 to 1 versus placebo. And there was staggered enrollment. The 10 MIG per KG arm enrolled first with the 3 to follow. As I said, it was over-enrolled. So there's only two infusions in each of those at day one, and then again at day 21, which is Q3 weekly. And then the results will be at day 42 and week six. So, well, you know, good news from the Horizon data. We think that their results will play well in the marketplace with that two millimeter reduction, and that will help them hopefully get more coverage decisions from insurance companies and with their broader label, that'll create a really nice tailwind for the market.
spk13: Derek, this is Todd. As far as things that could be potentially impacting sales or what was potentially driving a reduction from Q4 to Q1, we think as far as how Horizon was investing in the market as far as expanding their sales force, the direct-to-consumer advertising as well as the, you know, patient and physician support around, you know, trying to expedite, you know, market access and reimbursement for patients is, you know, absolutely great places to invest in. But I think to your point around potential distraction around an M&A process, you know, as that was taking place in the, you know, in public headlines, you know, certainly not helpful when you're trying to make in-flight operational changes to impact the sales trajectory of a drug. The chronic data that Scott just described will certainly help as far as being able to have educated and aware physicians and payers to hopefully drive additional sales. in the chronic marketplace, but I'd also, you know, just point out that, you know, integration isn't easy either. And so, you know, people should probably expect some additional impact over the next couple quarters as Amgen's integrating the Horizon team. And then with chronic, those changes that were being made, I think we should be able to return to growth either, you know, later this year or early next year and see the Tepeza sales pick up again.
spk06: Got it. Thanks so much for the color, and congrats on the progress. Thanks, Derek.
spk12: Your next question is from the lineup, Alex Thompson with Stiefel.
spk15: Hey, thanks for taking my question. I guess a couple for me. Maybe could you talk about, you know, whether there's a path forward with 001 sub-Q to bridge PK if you have successful IV trials, potentially on the markets faster? And then maybe as a follow-up to Derek's question, you know, what are your current expectations around, you know, your label? Do you expect to get sort of the old TPEZA label, or do you expect there's a path forward for you to get the new label upon approval, and if so, how that might impact, you know, the commercial opportunity? Thanks.
spk13: Hey, Alex. Yeah, so for the second one, both the Thrive and the Thrive 2 study are going to be supportive of the BLA, and so then we would expect then that to translate into a broad TEP label similar to what you're seeing today with the TBEZA label. And sorry, could you repeat your first question?
spk14: Yeah, I guess. Oh, yeah, the O01 sub-Q thing.
spk13: Yeah, so the current way that we're thinking about it is really, you know, separate programs of IV versus sub-Q. And so we're, you know, moving ahead with Thrive and Thrive 2 to set up for approval with the IV. And then we're going to select the lead candidate in sub-Q, which based off of everything that we're seeing today, 003 looks like it would have the best profile from the binding affinity of 001 along with the half-life extension of 002. If there were a way for us to bridge from 001 sub-Q from IV to sub-Q, that's certainly something we'll evaluate in the future, but currently no plans to update you on that right now. Great, thanks.
spk11: Your next question is from the line of Gavin Clark with Gartner.
spk15: Hey, thanks for taking the questions. I had two. I just wanted to make sure that if you do select 003, there's nothing else that could potentially slow you down, specifically wondering about any formulation, manufacturing, or preclinical toxicology work. And I'll come back for my second question.
spk02: Yeah, no. All three programs are right on track and we're going to continue to evaluate them through the end of the year. And as of now, there's no issues with formulation. or the preclinical work, the healthy volunteer studies will be underway and will complete by the end of the year.
spk13: And then we should be on track, Gavin. This is Todd. We should be on track to start a phase two, three pivotal then for what other program is selected as the lead in the middle of next year.
spk15: All right, that's super helpful. And then separately, on the partnership for the OnBody system that was announced yesterday, I just wanted to clarify, was that for the next preclinical program that's going to be unveiled, or is that for an earlier preclinical program that is still to be discussed?
spk02: That's for one of the three programs we're currently developing, and it will have nothing to do with TED whatsoever. So it will be for one of those new three.
spk16: Got it. Thanks. Welcome.
spk12: Your next question is from the line of Thomas Smith with SVB Securities.
spk14: Hey, guys. Good afternoon. Thanks for taking our questions. A couple on our end. I was wondering if you could provide any additional color on how the Thrive trial is enrolling at this point and how that enrollment is tracking relative to your initial modeling and then Secondly, I understand the difference between the inclusion criteria between your study and the Horizon study, but was just wondering if you have any visibility into the baseline characteristics of the chronic characteristic concept cohorts and whether this is tracking towards more of a sort of a low-CAS population or kind of mid-CAS patient population? Thanks.
spk02: Yeah, so with regard to the THRIVE study, we're really pleased that we could announce the first patient that was enrolled back in December. and we have more than 30 sites activated globally, but we're not giving any interim updates on the enrollment. And the second question was around, oh, that we have not unblinded our baseline characteristics. I believe they have, but we have not.
spk16: Okay. Understood. Appreciate it. Thanks, guys.
spk12: Your next question is from the line of Laura Chico with Webless Securities.
spk01: Hey, good afternoon, guys. Thanks very much for taking the questions. I just have to, and just kind of following up on the infused delivery system, understanding this is for other programs outside of TED, but just kind of curious why the rationale for the program and executing on this right now, just any advantages or criteria you were looking for in terms of selecting this particular partner? And then secondarily, on the cash runway, just any commentary or additional color there on levers to extend that? I think R&D picked up a little bit, if I'm reading things correctly here, and just trying to understand the expectations on the burn for the remainder of the year. Thank you.
spk02: Yeah, so I'll take the – this is Scott. I'll take the first question, and Christian, I'll answer your second question. So the first one really goes around the hallmark and the philosophy of the company is if we can improve in a market that's been created around efficacy or potentially safety or mode of delivery. Those are three criteria that we take very near and dear and look hard to do that, and we believe this technology will help the compound that this is going to be put within our preclinical pipeline. Christian?
spk03: Thank you. Laura? So, look, we've got cash a little bit under $374 million. We continue to guide cash runway into the second half of 2025. What it funds on a program-by-program basis, it funds basically both Thrive and Thrive 2 all the way through data at the end of 24 and a little bit into 25. Our SoftQ program is funded through to... through to what we're calling the bake-off decision point at the end of this year, where we will select the program to move forward into pivotal trials. Most importantly, pivotal trial prep is funded so that we can move expeditiously at the end of 23 into pivotal trials. Our non-TED pipeline is all funded either through to candidate selection or IND filings. And you should expect us to unveil these programs one by one, and we'll let the market decide what they want to fund. We have committed to unveiling at least one of the three programs on our pipeline, one of our non-TED programs on our pipeline chart over the course of the rest of 2023. Kind of our cash operating expenses in Q1 were slightly higher. than they usually are, mostly due to kind of the enable payments of $15 million. You should expect slightly elevated expenses again in Q2 as we initiate kind of Thrive 2. And after that should normalize again back to kind of a steady state of somewhere between $35 and $45 million.
spk01: Thanks very much. Of course.
spk12: Your next question is from a line of called Patel, would be Raleigh Securities.
spk05: Yeah. Hey, good afternoon. Thanks for taking the questions. Maybe one more on the market opportunity here for thyroid eye disease. I guess based on your conversations with KOLs in this space, is there a backlog of chronic TED patients that are waiting to be treated? And do you think that it'll sort of be a rapid uptake in this setting like we saw in the acute setting, or would it be a slow build given the lower severity of the disease?
spk02: Yeah, hi, this is Scott. I'll take the first part, and maybe Tom Shula will add a little color because we've actually been out in the field quite a bit lately at the different conferences and visiting with our PIs and KOLs and learning about that. I think the belief is that there was a low-hanging fruit situation with the actives, but in the words of some of the physicians I spoke with, there are lines of chronic patients. I think the recent data that's been put out there bodes well with their broad label now and that they can take forward, as I mentioned before, to get coverage decision. But I think we see there's really significant opportunity out there for market potential and to grow the market. especially when we think about our five-dose regimen that's as part of our Thrive study. The physicians are really excited about that, even versus the eight-dose that's already available. And I think we really have the opportunity to grow the market with our sub-Q offering, so we'll have a very broad approach to treating this disease with whether people want to use an IV or a sub-Q. And then there's also the future of a lot of physicians are telling us around You know, it's still eight doses with Tepeza, sort of an acute treatment for what appears now to be a chronic disease because the Tepeza data definitely showed that these chronic patients do present themselves even after having the disease. And their criteria was two to ten years, and we've even heard longer than that. And they are getting relief. But Tom, I don't know if you want to add some color.
spk09: Sure. Yeah, this is Tom Chula. So we, as Scott mentioned, we've been to a variety of Congresses recently. We're at the Association for Research in Vision and Ophthalmology. the North American Neuro-Ophthalmology Society, and the North American Society of Academic Orbital Surgeons, where we had multiple presentations at each of these congresses. Scott actually has attended and has met with several of the investigators and KOLs. And uniformly, they're very enthusiastic about our multiple ascending dose proof of concept study in acute TED. I think we've gotten lots of positive feedback about that data. We've also gotten a lot of positive feedback about Horizon's recent data in chronic TED, and we see this as a win for patients suffering from chronic TED. What the KOLs and investigators have told us is that they do indeed have a backlog of patients, and many of them have asked to take part in our clinical trial as investigators. We think there's a groundswell of optimism, not only for active TED, but for chronic TED, where there's a backlog, just as you asked about.
spk05: Okay. Got it. And can you give us a little more, maybe more color between the selection of the right sub-Q candidate and the timing of the start of that pivotal trial in mid-2024? what steps are remaining to start that trial?
spk02: Yeah, so there are a couple of the 002 healthy volunteer studies is ongoing right now, and we've even reported some of that information out at one of the more recent conferences. And then the 003 and 001 healthy volunteer studies, which will be looking at bioavailability and safety, those will be completed early enough to have by the end of the year, and then we'll line up all that information, make the decision about which one of the candidates we would move forward with. And then based on that information, we would then seek input from the stakeholders and plan to start the trial mid-year.
spk05: Okay. Thank you.
spk12: Your next question is from the line of Jason Butler with JMP Securities.
spk08: Hi. Thanks for taking the questions. Scott, you pointed to before the importance of the shortened treatment duration in the THRIVE study for the IV. Can you just talk about how that thinking rolls over to your planning for the sub-Q pivotal program and I guess also the chronic TED program? Thanks.
spk02: Yeah, so we are learning a lot about what's going on in the marketplace, and I would say the market has changed pretty dramatically over the launch of Tepeza and how physicians are actually using these drugs. As I mentioned before, it's kind of an acute treatment paradigm today where you give eight doses, and then at least that's how the label read, and you see how it goes. But what you realize is if the thyroid is not being controlled well and the pathway is uncovered and not blocked by using a tepezolite compound, the symptoms of TED return. And so one of the things and one of the reasons we have the five-dose regimen in there is, one, it's quicker to enroll in the patients. You know, if they see a result or not, they'll be able to roll over after their dose is on to an active, as we've seen before. But the physicians just really like the idea that you may be able to treat and induce a response with TED at a lower number of doses. And we also point to some of the side effects that show up on tepezorin, those higher dose numbers and the flattening of the curve. So we actually believe we would start to see a couple of people would call it a treat and retreat, or it could be an induction and maintenance play, and where we think we're very well positioned both with our infused product line that will, once it's approved, obviously, but all those sub-Qs, so then you put the treatment in the hands of the patient, obviously, after being diagnosed, and you just have a lot more flexibility and a lot better experience for the patients who don't have to go to infusion centers to be treated. So we actually see a pretty significant paradigm shift that you could have sort of an induction phase where you get the acute signs and symptoms under control, and then you go to a real maintenance paradigm where there are potentially with our technology, you could get to a Q4 weekly or once a month dosing in the hands of the patient and not seeing the caregiver, which we think is differentiated from at least the way we understand TPEZA is going.
spk08: And I guess just to follow up on that then, are you hearing from physicians yet that they're employing that treat and retreat with TPEZA? So, you know, patients are getting treatment in the acute phase and then either, you know, retreated in a chronic phase, or is it just too early to say that? I think you pretty much hit it right on the head, actually.
spk02: So what we started to hear anecdotally, and then multiple times from physicians who were treating during the pandemic, they couldn't get their full eight doses because Tepeza had been you know, sidelined for the COVID vaccines. So they were given limited number of doses. And what they would do is give a few doses and then watch and see the result and have the patient return. And then they still had a few more doses to give them. Or sometimes we've heard of they'll give people up to five, basically send them home and say, you know, stay in touch. And if you start to hear these, excuse me, to feel these results, well, you can come back and we can infuse you again. So no, it is You know, almost turning into, I heard from one physician, it's like give a few doses and then turn it into a PRN as the patient needs it. So we're picking up that intel, and, you know, we do have the benefit of foresight versus hindsight, and so we can use this intel to, you know, adjust how we go to market. Got it. Thanks for taking the question.
spk16: Sure. Thank you.
spk12: As a reminder, to ask a question, press star 1 on your telephone keypad. Again, if you would like to ask a question, press star 1. Your next question is from the line of Rami Kakouda with Life Science.
spk07: Hey, guys. Thank you for taking my questions as well. Two quick ones for me. I guess first, is there anything specific that you're looking out for in the proof of concept chronic test study that can influence the Thrive2 protocol? And then secondly, in your conversations with physicians and payers, have market access or reimbursement considerations changed with TPEZA after the chronic data came out?
spk13: Yeah, so specific to the chronic data and how that could impact the Thrive program, to phase three design. So we have, of course, some preliminary thinking of what that phase three design could look like prior to the data. You know, we recently got some very high level top line results from Horizon that was kind of helpful for us to think about how we can think about clinical activity. We'll then also be informed by the activity that we see in our trial. And then, you know, not one specific thing that I would kind of call out today, But, you know, we'll be fully informed by that data and kind of relative to that preliminary thinking, make any, you know, necessary, you know, considerations and impacts to the trial design. It's necessary to seek either KLL and or health authority feedback before we kick off the trial. Of course, we'll do that as well. As far as market access decisions following that chronic data from Horizon just Now, four weeks ago, I think it's really too early for us to be getting intelligence around that. And so that's something we'll definitely be listening to as far as for intelligence that we're getting from the marketplace and the survey work that we do. And, of course, if we start to hear things, then it would be more appropriate to give you that intel as we're hearing it real time.
spk07: Got it. Thank you very much.
spk12: Your next question is from the line of Gavin Clark with Gartner.
spk15: Hey, thanks for taking the follow-up here. Yeah, I just wanted to circle back on the, you know, extended duration or re-treatment dynamic that you just mentioned. Because today, a lot of the payer policies explicitly don't allow for more than eight time TPEZA doses. I'm wondering how you approach pricing and also what clinical data you need to show to allow for this dynamic in the future?
spk02: Yeah, so this would be obviously a post-approval approach we would take, but when you could shift from a treat and retreat to induction and a maintenance, the pricing could be very different because you have... you might be using the sub-Q the whole time that way. So today they are at eight, but with their broader label now and a retreatment, they could get, they can resubmit for a reimbursement on the next bit. And instead of going eight and eight is what I've been referring to and have heard from a lot of the physicians is, you know, this is a chronic disease. And the label is basically now at any time you have TED, you can be treated with the drug. So I think people are struggling with using 8 and then 8 and 8, and then also at that very high dose, you could maybe, if you use smaller doses, like with our full antagonism, we are about a third at the 5-dose cohort and not quite, about half of where they'll be with their 150 mg per kg. So, being able to dose with different dose regimens, whether it's sub-Q or treat and retreat with a lower number of infusion doses, seems to be a preferred approach.
spk15: I got it. Thanks so much.
spk12: At this time, we have reached the conclusion of the question and answer session. I would now like to turn the call back over to Viridian's President and CEO, Scott Myers, for closing remarks.
spk02: Thank you, Operator, and thanks, everyone, for your time this afternoon. Please feel free to reach out to Todd or Elise if you have any follow-up questions, and we are happy to touch base with you. Thanks again, and have a great evening.
spk12: This concludes the conference call today. You may now disconnect your lines. Thank you for participating.
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