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 Miss Louisa Stone, Manager of Investor Relations for Viridian. Please go ahead.
Thank you. Welcome everyone to our first quarter 2023 earnings conference call. The press release reporting our financial results and corporate updates is available on the investors 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, Kristian Humer, our Chief Financial and Business Officer, Dr. Deepa Rajagopalan, our Chief Product and Strategy Officer, Dr. Thomas Ciulla, 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.
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 Chief Executive Officer. 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 Casciano, Viridian's first Chief Commercial Officer, Dr.
Thomas Ciulla, Chief Development Officer, Dr. Felix Geissler, Senior Vice President of Medical Affairs, and Dr. Erik 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 Kristian 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 VRDN-001, a humanized monoclonal antibody administered intravenously once every 3 weeks, which acts as a full antagonist of insulin-like growth factor 1 receptor, or IGF-1R.
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 3 dose cohorts of the phase 1/2 clinical trial evaluating the safety and efficacy of VRDN-001 in patients with active TED. In December 2022, our team initiated the global Phase 3 THRIVE trial, which will evaluate the efficacy and safety of VRDN-001 in patients with active TED. Based on our recent discussions with key stakeholders in the TED community, there is particular enthusiasm for our shortened 5-dose, 12-week treatment regimen of VRDN-001 compared with the 8-dose, 21-week regimen of FDA-approved TEPEZZA. Success in the 5-dose arm has the potential to provide welcome convenience to patients by shortening their treatment course and eliminating 3 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 chronic TED, we are excited to announce that our proof-of-concept study evaluating VRDN-001 IV in patients with chronic TED is fully enrolled. As a reminder, the trial design in chronic TED is similar to our proof-of-concept design that we used in active TED. 2 infusions of VRDN-001, 1 at day 1 and the second at day 21, with evaluation of safety and clinical activity at week 6. There are 2 dose cohorts, 10 mgs/kg and 3 mgs/kg will target enrollment of 8 patients in each cohort, randomized 3 to 1 in favor of VRDN-001 versus placebo. Inclusion criteria include any clinical activity score at baseline.
We expect to report results from both those cohorts of this proof-of-concept trial in either June or July. Following the results, we plan to start our second global phase 3 trial, THRIVE-2, to evaluate the safety and efficacy of VRDN-001 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 VRDN-001, VRDN-002, and VRDN-003. 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 VRDN-001 IV preclinical and clinical work, we believe that the differentiated mechanisms and actions with full antagonism of IGF-1R achieved by VRDN-001 and VRDN-003 make either of them the most likely to bring a best-in-class subcutaneous product to patients. As a result, a trial evaluating VRDN-002 in patients with TED will only proceed in 2024 if VRDN-002 is selected as the lead subcutaneous program at the end of the year. This allows us to keep VRDN-002 as a potential backup while steadfastly focusing and advancing our efforts with VRDN-003 and VRDN-001. I will now highlight the upcoming priorities to get the subcutaneous lead program selection by year-end.
For VRDN-001, phase 1 results in healthy volunteers are expected in the 4th quarter of 2023. For VRDN-002, we continue to generate data from the ongoing phase 1 healthy volunteer trial. For VRDN-003, our plans remain on track to file the investigational new drug application with the FDA during the 2nd quarter. We expect phase 1 results in healthy volunteers in the 4th quarter of 2023. After the lead subcutaneous candidate is selected, we expect to advance the program to a pivotal phase 2/3 trial, which is planned for the middle of 2024. Last month, our team was thrilled to present multiple abstracts at the 2023 Association for Research in Vision and Ophthalmology annual meeting.
A platform presentation featured data from our Phase 1/2 trial of VRDN-001 in patients with active TED, while the poster presentations featured new clinical and preclinical research on VRDN-002 and VRDN-003. This marked the company's first presentation of VRDN-003 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. We continue to advance our earlier-stage preclinical pipeline and will expand our disease focus beyond TED and into the rare and autoimmune space. Our preclinical programs include VRDN-004, 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 Kristian, who will provide a financial review for the first quarter of 2023. Kristian.
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 equivalents and short-term investments, compared with $424.6 million as of December 31, 2022. We believe that our current 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' enFuse on-body drug delivery system. Other drivers for the increase in research and development expenses include higher CMC expenses in preparation for the IND application for VRDN-003, 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 first, 2023, Viridian had approximately 58 million shares of common stock outstanding on an as converted basis. With that, I'll ask the operator to open the call for questions. Operator?
Thank you. At this time, if you'd like to ask a question, please press star, then 1 on your telephone keypad. If you'd like to withdraw your question, press star 1 again. We'll pause for a moment to compile the Q&A roster. Your first question is from the line of Derek Archila with Wells Fargo.
Congrats on the progress. Maybe just two questions from us. Maybe just first, can you just talk about the variables that could lead the chronic data coming out in July versus in the second quarter? Just your thinking on the TED market opportunity, given what we saw from Horizon recently, in their quarter results. I mean, do you think anything has changed in the market, or do you kinda chalk that up to deal-related things going with the ongoing Amgen deal? Thanks.
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 'cause it's been confirmed by the recent Horizon data. They were able to post a 62% and very meaningful response with a 2-millimeter reduction in proptosis. you know, our trial is evaluating the activity with only 2 doses of VRDN-001 to establish the proof of concept, and reduction of proptosis of less than 2 millimeters, excuse me, would be, still be very meaningful because we still plan to evaluate the longer doses in THRIVE-2.
We're very pleased with what's happened in that trial. We've actually over-enrolled the 3 mg per kg cohort. 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 gonna need some time to really look through that and make sure it's right. We'll be ready to announce either June or July. 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, 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. You know, we look forward to reporting our data in June or July of this year. As a reminder though, our study was set up slightly differently. It was for patients with proptosis of greater than or equal to 3 millimeters above normal values, and then, symptoms that had presented themselves after 1 year of study screening, and, 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 VRDN-001. There's a 10 mg per kg cohort and a three mg per kg cohort randomized at 3 to 1 versus placebo. There was staggered enrollment. The 10 mg 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 1 and then again at day 21, which is Q3 weekly. Then the results will be at day 42 and week 6. You know, good news from the Horizon data.
We think that their results will play well in the marketplace, with that 2 millimeter reduction. 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.
Derek, this is Todd. As far as, you know, things that could be potentially impacting sales or, you know, 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 new market access and reimbursement for patients is, you know, absolutely great places to invest in. 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, you know, 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 educate and aware physicians and payers to hopefully drive additional sales in the chronic marketplace. I'd also, you know, just point out that, you know, integration isn't easy either. You know, people should probably expect some additional impact over the next couple quarters as Amgen's integrating the Horizon team. 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 Tepezza sales pick up again.
Got it. Thanks so much for the color and congrats on the progress.
Thanks, Derek.
Your next question is from a line of Alex Thompson with Stifel.
Hey, thanks for taking my question. I guess a couple for me. Maybe could you talk about, you know, whether the path forward with VRDN-001 sub Q to bridge PK if you have successful IV trials potentially on the markets faster? Then maybe as a follow-up to Derek Archila's question, you know, what are your current expectations around, you know, your label? Do you expect to get sort of the old TEPEZZA label, or do you expect there's a path forward for you to get the new label upon approval? If so, how that might impact, you know, the commercial opportunity? Thanks.
Hey, Alex. Yeah, so for the second one, both the THRIVE and the THRIVE-2 study are going to be supportive of the BLA. We would expect then that to translate into a broad TED label similar to what you're seeing today with the TEPEZZA label. Sorry, could you repeat your first question?
Yeah.
Oh, the 001 sub q.
Yeah.
Thanks. Yeah. The, the current way that we're thinking about it is really, you know, separate programs of IV versus sub q. We're, you know, moving ahead with THRIVE and THRIVE-2 to set up for approval with the IV. Then we're gonna select the lead candidate in sub q, which, based off of everything that we're seeing today, VRDN-003 looks like it would have the best profile from the binding affinity of VRDN-001 along with the half-life extension of VRDN-002. If there were a way for us to bridge from VRDN-001 sub q, from IV to sub q, that's certainly something we'll evaluate in the future. Currently no plans to update you on that right now.
Great. Thanks.
Your next question is from the line of Gavin Clark with Gartner.
Hey, thanks for taking the questions. Had two. First, 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. I'll come back for my second question.
Yeah, no. All three programs are right on track, and we're gonna continue to evaluate them through the end of the year. As of now, there's no issues with formulation, or the preclinical work that the healthy volunteer studies will be underway and will complete by the end of the year.
We should be on track, Gavin. This is Todd. We should be on track to start a phase 2/3 pivotal then for what other program is selected as the lead in the middle of next year.
All right. That's super helpful. Then, separately, on the partnership for the on-body 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?
That's for one of the three programs we're currently developing, and it will have nothing to do with TED whatsoever. It'll be for one of those new three.
Got it. Thanks.
You're welcome.
Your next question is from the line of Thomas Smith with SVB Securities.
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. Secondly, I understand the difference between the inclusion criteria between your study and the Horizon study, was just wondering if you have any visibility into the baseline characteristics of the chronic proof-of-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.
With regard to the THRIVE study, we're really pleased that we can announce the first patient that was enrolled back in December. We have more than 30 sites activated globally, but we're not giving any interim updates on the enrollment. The second question was around. We have not unblinded our baseline characteristics. I believe they have, but we have not.
Okay. Understood. Appreciate it. Thanks, guys.
Your next question is from the line of Laura Chico with Wedbush Securities.
Hey, good afternoon, guys. Thanks very much for taking the questions. I just have two. Just kinda following up on the enFuse delivery system, understanding this is for other programs outside of TED, but just kinda 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? Secondarily, on the cash runway, just any commentary or additional color there on levers to extend that. I think R&D ticked up a little bit, if I'm reading things correctly here. I'm just trying to understand the expectations on the burn for the remainder of the year. Thank you.
Yeah. I'll take the... This is Scott. I'll take the first question, and Kristian will answer your second question. 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. We believe this technology will help the compound that this is gonna be put with in our preclinical pipeline. Kristian.
Thank you, Laura. 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 2024 and a little bit into 2025. Our SoftQ program is funded 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 2023 into pivotal trials. Our non-TED pipeline is all funded either through to candidate selection or IND filing.
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 payment of $15 million. You should expect slightly elevated expenses again in Q2 as we initiate, kind of THRIVE-2. After that should normalize it again back to kind of a steady state of somewhere between $35 million-$45 million.
Thanks very much.
Of course.
Your next question is from the line of Kalpit Patel with B. Riley Securities.
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? 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?
Hi, this is Scott. I'll take the first part, and maybe Tom Ciulla 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. In the words of some of the physicians I spoke with, there are lines of chronic patients. I think, you know, the recent data that's been put out there, you know, bodes well with their broad label now and that they can take forward, as I mentioned before, to get coverage decision.
I think we see there's really significant opportunity out there for market potential and to grow the market, especially when we think about, you know, our 5-dose regimen that's as part of our THRIVE study that the physicians are really excited about that, even versus the 8-dose that's already available. I think we really have the opportunity to grow the market with our subQ offerings, so we'll have a very broad approach to treating this diseases. Disease, excuse me, with whether people wanna use an IV or a subQ.
Then there's also the future of, you know, a lot of physicians are telling us around, you know, it's still 8 doses with TEPEZZA, sort of an acute treatment for what appears now to be a chronic disease because the TEPEZZA data definitely showed that these chronic patients do present themselves even after having the disease from. In their criteria, it was 2-10 years, and we've even heard longer than that, and they are getting relief. Tom, I don't know if you want to add some color.
Sure. Yeah, this is Tom Ciulla. As Scott mentioned, we've been to a variety of congresses recently. We were 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. 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.
Okay. got it. Can you give us a little more maybe more color between the selection of the right subQ candidate and the timing of the start of that pivotal trial in mid-2024? What steps are remaining to start that trial?
Yeah. there are a couple of the... The zero zero two healthy volunteer studies is ongoing right now, and we've even reported some of that information out at one of the more recent conferences. The zero zero three and zero zero one 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. We'll line up all that information and make the decision about which one of the candidates we would move forward with. Based on that information, we would then seek input from the stakeholders and plan to start the trial midyear.
Okay. Thank you.
Your next question is from the line of Jason Butler with JMP Securities.
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 subQ pivotal program and I guess also the chronic TED program? Thanks.
We are learning a lot about what's going on in the marketplace. I would say the market has changed pretty dramatically over the, you know, the launch of TEPEZZA and how physicians are actually using these drugs. As I mentioned before, the way that it's kind of an acute treatment paradigm today where you give 8 doses and then at least that's how the label read, and you see how it goes. What you realize is if the thyroid is not being controlled well and the pathway is uncovered and not blocked by using a TEPEZZA-like compound, the symptoms of TED re-return. One of the things and one of the reasons we have the five-dose regimen in there is one, it's quicker to enroll.
The patients, you know, if they see a result or not, they'll be able to roll over after their doses onto an active as we've seen before. 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. We also point to some of the side effects that show up on Tepezza in those higher dose numbers and the flattening of the curve. 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.
Where we think we're very well positioned both with our infused product line that will, once it's approved, obviously, but all of those subQ's, 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.
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 Tepezza's going.
Got it. I guess just to follow up that then, are you hearing from physicians yet that they're employing that treat and retreat with Tepezza? 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 that's happening yet?
No, that... No, I think you pretty much hit it right on the head, actually. What we started to hear anecdotally and then multiple times from physicians who were treating during the pandemic, they couldn't get their full 8 doses because TEPEZZA had been, you know, sidelined for the COVID vaccines. 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.
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, we'll, you can come back and we can infuse you again." No, it is, you know, almost turning into... I heard from one physician, it's like a, give a few doses and then turn it into a PRN as the patient needs it. 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. Great. Thanks for taking the questions.
Sure. Thank you.
As a reminder, to ask a question, press star one on your telephone keypad. If you would like to ask a question, press star one. Your next question is from the line of Rami Katkhuda with LifeSci Capital.
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 TED study that can influence the THRIVE-2 protocol? Secondly, in your conversations with physicians and payers, have market access or reimbursement considerations changed with TEPEZZA after the chronic data came?
Yeah. Specific to the chronic data and how that could impact the THRIVE-2 phase 3 design. We have, of course, some preliminary thinking of what that phase 3 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, will then also be informed by the activity that we see in our trial. 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.
If it's necessary to seek either KOL 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. 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. Of course, if we start to hear things, then it would be, you know, more appropriate to give you that intel as we're hearing it real-time.
Got it. Thank you very much.
Your next question is from the line of Gavin Clark with Gartner.
Hey, thanks for taking the follow-up here. Yeah, I just wanted to circle back on the, you know, extended duration or retreatment dynamic that you just mentioned, because today a lot of the payer policies explicitly don't allow for more than 8 times TEPEZZA 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.
Yeah. This would be obviously post-approval, post-approval approach we would take. When you could shift out of a from a treat and retreat to induction and a maintenance, the pricing could be very different because you might be using the subQ the whole time that way. Today they are at 8, but with their broader label now and a retreatment, they can resubmit for a reimbursement on the next bid. Instead of going 8 and 8, 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.
It's, I think people are struggling with using 8 and then 8 and 8. Also with 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 mgs per kg. Being able to dose with different dose regimens, whether it's subQ or treat and retreat with a lower number of infusion doses, seems to be a preferred approach.
I got it. Thanks so much.
At this time, we have reached the conclusion of the question and answer session. I will now let hand the call back over to Viridian's President and CEO, Scott Myers, for closing remarks.
Thank you, operator, and thanks everyone for your time this afternoon. Please feel free to reach out to Todd or Lisa if you have any follow-up questions, and we are happy to touch base with you. Thanks again, and have a great evening.
This concludes the conference call today. You may now disconnect your lines. Thank you for participating.