Earnings Call Transcript - VRDN Q4 2021

Operator, Operator

Greetings, and welcome to the Viridian Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to John Jordan, Vice President of Investor Relations and Corporate Communications. Thank you. You may begin.

John Jordan, Vice President of Investor Relations and Corporate Communications

Thank you, everyone, and welcome to our fourth quarter and full year conference call. Today, after the market closed, we issued a press release providing our fourth quarter and full year financial results and business updates. A replay of today’s call will be available on the Investor Relations section of our website, one hour after completion. After our prepared remarks, we will open the call for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of today. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and our other periodic reports on Form 10-Q and 8-K filed with the SEC. I would now like to turn the call over to Jonathan Violin, President and CEO of Viridian.

Jonathan Violin, President and CEO

Thanks, John, and good afternoon, everyone. Thanks for joining us for our fourth quarter and year-end 2021 conference call. I’m also joined today by Kristian Humer, our Chief Financial Officer and Chief Business Officer. I’ll begin with a brief overview of the business, our recent milestones as well as a review of our pipeline, including progress we’ve made in advancing our lead candidates for thyroid eye disease. We founded Viridian to advance new biologic treatments for patients suffering from serious diseases who are underserved by today’s therapies. Our strategy is to employ a patient-centric model of innovation that leverages proven biology and validated technologies to reduce research and development risk. We target therapeutic indications in which we believe our efforts could address gaps related to access, delivery, quality of life, efficacy, safety or tolerability. We focus on product concepts that we can fulfill with our antibody discovery, engineering and development expertise, either in-licensing or creating de novo antibodies. We believe we can provide best-in-class solutions for patients who need more and better therapeutic options. 2021 was transformational for Viridian. In January, we were a newly public, preclinical startup. Today, we have over 50 full-time employees, two clinical stage programs, and a rapidly expanding discovery pipeline. We have just under $200 million in cash to fund our activities into 2024. It’s a testament to our team that we were able to rapidly complete IND-enabling activities for both VRDN-001 and VRDN-002 and initiate our first clinical trial in thyroid eye disease. Key additions to our team in 2021 included our Chief Medical Officer, Barrett Katz, a neuro-ophthalmologist with deep experience in both clinical trials and patient care, including thyroid eye disease patients; Deepa Rajagopalan, our Senior Vice President of New Product and Portfolio Development, who brings significant expertise in strategy and commercial launch planning; and Kristian Humer, our Chief Financial Officer and Chief Business Officer, who has over two decades of financing and M&A experience in biopharma banking. They have joined the existing leadership team, including our Chief Scientist and Co-Founder, Vahe Bedian, and we have quickly recruited highly experienced teams of individuals to support our mission of rapidly and efficiently advancing new monoclonal antibodies to fill gaps in the treatment paradigm for thyroid eye disease and other serious diseases. I’d like to spend a few minutes reviewing our pipeline, focusing on our lead programs. Thyroid eye disease is a new, large and rapidly growing market that aligns with our strategy. We see an opportunity to be the second entry in this market where we can advance patient care by providing differentiated product profiles that improve upon the currently approved treatment option. The only therapy approved by the FDA for thyroid eye disease is Tepezza, which is an intravenously administered monoclonal antibody that targets the IGF-1R. The Tepezza clinical trial data provides strong validation linking the targeting of IGF-1R to clinical benefit in thyroid eye disease. However, clinical trials for Tepezza reported to date employed a single-dosing regimen, providing little guidance as to the optimal dosing required for efficacy. We believe there are multiple opportunities to develop novel IGF-1R-targeted therapeutics that improve on Tepezza features, including dosing, schedule, route of administration, studies of care, and potentially safety and tolerability. Our strategy is to advance market segmentation, providing an improved IV option for patients where the control and oversight of an IV infusion is preferred, and a convenient, self-administered, low-volume subcutaneous injection for patients who could benefit from this route. We have two specific goals: first, to advance a higher affinity antibody with a less burdensome IV dosing paradigm, enabling a lower dose and/or fewer infusions to provide the efficacy of Tepezza in an improved product profile. Our second goal is to deliver a convenient, low-volume subcutaneous injection that enables treatment of thyroid eye disease patients in a broader setting of care, allowing simple dosing either self-administered at home or in the prescribing physician’s office. Our first goal in thyroid eye disease is addressed by our most advanced program, VRDN-001, a monoclonal antibody that blocks the IGF-1 receptor with sub-nanomolar potency, which we in-licensed from ImmunoGen. This antibody was previously developed as AVE-1642 and has been administered to over 100 oncology patients, providing a wealth of data that accelerated and de-risked our program. Data from preclinical studies and oncology trials suggest that VRDN-001 has the same mechanism of action as Tepezza and similar pharmacokinetics in humans. The key difference for VRDN-001 is its higher affinity. We built our own data and previously published data to show that VRDN-001 has sub-nanomolar affinity and potency against IGF-1R. This may help reduce the dose required to deliver efficacy in thyroid eye disease patients. We see an opportunity to develop VRDN-001 as a differentiated IV product addressing the need we've heard from thyroid eye disease stakeholders for a less burdensome dosing paradigm. In December, we announced dosing of the first subject in a Phase 1/2 proof-of-concept clinical trial for VRDN-001. This trial is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of VRDN-001. The trial includes both healthy volunteers and randomized placebo-controlled cohorts of thyroid eye disease patients and will assess multiple measures of the signs and symptoms of thyroid eye disease, including proptosis, the bulging of eyes characteristic of thyroid eye disease. The study is designed to achieve several aims. First, to test that VRDN-001 can deliver efficacy comparable to Tepezza at doses similar to Tepezza; to establish proof of concept that we have a highly active drug for treating thyroid eye disease; secondly, after we’ve shown efficacy comparable to Tepezza, the study can enroll further cohorts to explore differentiating dosing paradigms, including low doses that may enable the low-volume subcutaneous injection as an alternative to IV infusion. The study remains on track with our previous guidance, and we expect to deliver top-line proof-of-concept clinical data in the second quarter. To confirm that we can deliver efficacy comparable to Tepezza, we’re initially using doses of VRDN-001 similar to Tepezza and assessing potential efficacy in two cohorts of thyroid eye disease patients, each cohort will include eight patients, six receiving VRDN-001 and two receiving placebo. We want to see VRDN-001 deliver the same rapid improvement in thyroid eye disease symptoms as Tepezza, which we confirm that the preclinical and oncology data for VRDN-001 showing the same mechanism of action as Tepezza has translated to thyroid eye disease. And we know that we have a highly active drug we can advance quickly towards market. Our trial design includes two infusions on day 0 and day 21 and an efficacy assessment at week six or day 42. That is an interval that matches the Tepezza course of treatment. The first cohort will receive two infusions of 10 mg per kg of VRDN-001, and the second cohort will receive two infusions of 20 mg per kg. We’re bracketing the Tepezza dose, which is 10 mg per kg on the first infusion and 20 mg per kg thereafter. Given the sub-nanomolar affinity and potency of VRDN-001 and biomarker data for oncology trials, we believe that both doses should be well above what’s needed to saturate the receptor. We’re assessing multiple efficacy endpoints and expect to have at least three for top-line data: proptosis, diplopia, and clinical activity score. The primary efficacy measurement is proptosis at six weeks, which we’ll report as the same two analyses as Tepezza. Mean change from baseline, which will be our main focus, but also a responder analysis, defined as a 2-millimeter or greater reduction from baseline. Given the shared mechanism of action of VRDN-001 and Tepezza, we expect to see efficacy comparable to Tepezza. There are three Tepezza clinical data assets for us to consider: the Phase 2 trial, the randomized portion of the Phase 3 trial, and the open-label extension of the Phase 3 trial, in which placebo patients were crossed over to Tepezza. In those three data sets, the mean change from baseline in proptosis at week six ranged from approximately 1.7 millimeters to 1.9 millimeters with a 95% confidence interval of approximately 1.4 to 2.3. The data will also be complemented by diplopia assessments and clinical activity score which, like proptosis, reproducibly showed benefit at six weeks in the three Tepezza data sets. We’ll also have top-line safety and tolerability data and would anticipate sharing full data, including pharmacokinetics, pharmacodynamics, and further measures of efficacy at a future medical meeting. Demonstrating that we have transformative efficacy similar to Tepezza would significantly de-risk Viridian and put us in a position to be second to market. The next goal will be to rapidly evaluate lower doses and potentially different dosing intervals to understand how much we can differentiate VRDN-001 from Tepezza. As a reminder, this trial is designed to be flexible. The protocol allows for enrolling additional thyroid eye disease patient cohorts in which we can evaluate different doses, dose intervals, and the number of infusions. If we see positive results in the proof-of-concept cohorts, we will expose efficacy at the lower dose. This is an opportunity to differentiate VRDN-001 from Tepezza by dose and could also support our ability to achieve a low-volume subcutaneous injection. In parallel, we're already preparing VRDN-001 for pivotal trials, including manufacturing material with a commercial process. Pending positive proof-of-concept data, we anticipate advancing our program rapidly. We intend to sprint to market with a differentiated VRDN-001 product profile. We think lower doses, fewer infusions, and potentially different routes of administration will be welcome advancements in treating thyroid eye disease. Let’s now turn to VRDN-002, our next-generation IGF-1R-targeted program. VRDN-002 is a humanized monoclonal antibody that incorporates half-life extension technology and was designed by our scientists to support the administration of a convenient low-volume subcutaneous injection for the treatment of thyroid eye disease. This product presentation would maximize the settings of care, either at home, by patients via self-administration, or in the prescribing physician’s office. Data from preclinical and oncology studies showed us that across the IGF-1R class, while increasing target affinity may help lower dose, pharmacokinetics becomes limiting at low doses. The VRDN-002 half-life extension works as we expect; it should be very hard for any antibody lacking half-life extension to get to a more convenient subcutaneous product. At the end of January, we announced the FDA acceptance of our IND application for VRDN-002. We’re currently proceeding with our first-in-human Phase 1 clinical trial of VRDN-002, which is a single ascending dose study to explore safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenously administered VRDN-002 in healthy volunteers. We expect to announce data from this trial midyear. The key outcome from this trial is to demonstrate how well the half-life extension technology improves pharmacokinetics, and these data will inform the feasibility of a low-volume subcutaneous product. Should we see positive results? We expect to have everything we need, including our high-concentration subcutaneous formulation of 150 mg per mL, to rapidly advance to a subcutaneous proof-of-concept trial in thyroid eye disease patients. With our VRDN-001 and VRDN-002 programs, we believe Viridian has an extremely compelling test pipeline with two differentiated shots on goal, both with the ability to move quickly into registration-enabling studies. In addition to our efforts to create the best products in thyroid eye disease, we’re also expanding our pipeline by applying our strategy of discovering and developing more convenient, better-performing antibody products for indications in which proof of concept for a targeted mechanism of action already exists. VRDN-004 targets a proven mechanism of action in a rare disease where we see the opportunity to advance patient care and evolve the market with a new best-in-class entrant. Our antibody discovery and engineering team has generated and optimized promising lead antibodies, and we’re excited about this program. We’ll disclose the target and indication when the time is right from a competitive perspective. VRDN-005 is a new discovery stage program, again, targeting an opportunity we’ve identified to advance a new best-in-class therapeutic. As part of this effort, we’ve licensed antibody libraries from Xencor, which we believe provide a high-quality starting point for our program. Like VRDN-004, we’ll disclose the targets and indications for this program when we think the time is right along with our broader pipeline strategy. But for now, we’re committed and focused on the importance and sizable opportunity we have with our thyroid eye disease programs. Operationally, we’re very pleased with our progress over the last year. We’re executing on the strategy we laid out when we became a publicly traded company and are grateful to our excellent and growing team and also to our external partners, the contract research organizations, key opinion leaders, advisers, and of course, volunteers and patients in our clinical studies, all who help us advance our mission to provide new and better antibody therapeutics to patients who deserve new options. We look forward to another transformative year ahead for Viridian in 2022. I’ll now turn the call over to Kristian, who will discuss our financial results for the fourth quarter and full year ending 2021.

Kristian Humer, CFO and Chief Business Officer

Thank you, Jonathan. Good afternoon, everyone. We entered 2022 in a strong financial position. This year, we look to advance multiple programs in thyroid eye disease while expanding our discovery pipeline. We closed out 2021 with approximately $197 million in cash, cash equivalents and short-term investments as of December 31, 2021. Our current cash, cash equivalents, and short-term investments will be sufficient to fund operations into 2024. Turning to expenses, which we also summarized in the press release issued after the market today. We reported research and development expenses of $22.4 million for the quarter ended December 31, 2021, and $56.9 million for the year ended December 31, 2021, compared with $15.3 million and $28.3 million for the comparable periods in 2020. The increase in research and development expenses was primarily driven by the advancement of our lead programs, including expenses related to manufacturing and IND-enabling studies. General and administrative expenses were $6.9 million for the quarter ended December 31, 2021, and $25.8 million for the year ended December 31, 2021, compared with $5.5 million and $13.3 million for the comparable period in 2020. The increase in G&A expenses last year was primarily due to increases in personnel-related costs, including severance, share-based compensation charges, and consulting expenses. Net loss was $28.9 million for the fourth quarter of 2021 and $79.4 million for the year ended December 31, 2021, compared to $90.7 million and $110.7 million for the comparable period last year. As of December 31, 2021, Viridian had approximately 42.8 million shares of common stock outstanding on an as-converted basis, which included 23.9 million shares of common stock outstanding and approximately 18.9 million shares of common stock issuable upon the conversion of shares of Series A and Series B preferred stock. With that, I’ll ask the operator to open the call for questions.

Operator, Operator

Thank you. Our first questions come from the line of Chris Howerton with Jefferies. Please proceed with your questions.

Chris Howerton, Analyst

Great. Thank you so much for taking the questions and appreciate all the progress. So I guess maybe for me, a few questions. One would be in the context of IV formulations what would be some of the differentiations that you think could be made in that setting for VRDN-001 relative to Tepezza? And for example, would less frequent IV infusions be important in that type of setting? Second question I would have would be, is the VRDN-002 data from the midyear going to be gating in any way to opening up new cohorts for the Phase 2 study with VRDN-001? And then the final question, if I may, was just if maybe without asking specifics, if there would be anything that would happen from competition, let’s say, from Horizon that would accelerate your strategy to go towards VRDN-002 versus no longer trying to evaluate VRDN-001?

Jonathan Violin, President and CEO

Thanks, Chris. With respect to the IV product now that fits against a subcutaneous product, we actually see – having done a lot of market research and commercial forecasting, our revenue has been maximized by having both the IV and subcutaneous. This is a big market. We believe it’s going to segment. There are patients and prescribers who are going to prefer IV. We do think that low volume subcutaneous will be the biggest category in the market in the long run. So we see a lot of value when we build through these programs forward. So with respect to the IV product, there are a number of ways that this could be interesting. The great majority of the market right now is acute patients treated by the IV route. This is a proven market now with room to grow as we segment it by bringing different products forward. So with respect to IV, things like a lower dose, fewer infusions can really reduce what we think of as the overall burden of care on patients. Each trip to an infusion center adds to the total cost of care. It's a hassle for patients. And we also know that every infusion, particularly at a high dose, adds a lot of drug burden. If we can get to lower doses, there’s always the upside that maybe we’ll start to see better safety and tolerability. We don’t know. It’s something that we’re interested in, and we’ll collect data as we go. But this drug is always better. If we can do that, we can have fewer infusions. We think there’s room for a compelling IV entrant. With respect to your question of is VRDN-002 data gating for what we’re going to do with VRDN-001. No, we’re going to move VRDN-001 forward as quickly as we can. And we don’t need to see the VRDN-002 data to make decisions about VRDN-001. The 002 program should be able to move forward quite quickly. Once we have this first-in-human data, understanding how well the half-life extension technology improves the pharmacokinetics, once we have that half-life, we’ll be able to construct the dosing paradigm that we want to test in a subcutaneous trial in thyroid eye disease patients. So we’re really excited about both of these programs.

Operator, Operator

Thank you. Our next questions come from the line of Thomas Smith with SVB Leerink. Please proceed with your questions.

Thomas Smith, Analyst

Good afternoon. Thanks for taking the questions and congrats on all the progress. Just on the upcoming VRDN-001 proof-of-concept data. Can you just remind us regionally where you’re enrolling the study? And then can you provide any additional color on where you are in terms of enrolling the first two cohorts?

Jonathan Violin, President and CEO

Yes. So as you heard, we reiterated our guidance for data in the second quarter. The study is enrolling in North America, in the U.S. and Canada where we’re looking at a large number of sites, many of whom have experience in this space that have enrolled in thyroid eye disease, some of the top sites, including key opinion leaders and investigators who know how to run these studies well and recruit patients. We’ve been very pleased, particularly as Barrett, our Chief Medical Officer, has been sharing our vision for both VRDN-001 and VRDN-002. We’ve seen a lot of enthusiasm for what we’re trying to do here. So we’ve been very pleased about how all that’s going.

Thomas Smith, Analyst

Okay. And maybe just a follow-up. On the competitive front, it sounds like Horizon is evaluating both Halozyme and non-Halozyme subcutaneous formulations for Tepezza. How are you thinking about competitive timelines and competitive profiles? And what are your current expectations in terms of when you think you’ll get your subcutaneous to market versus Horizon?

Jonathan Violin, President and CEO

Right. So we’ve heard that Tepezza is now being formulated in high concentration. But let’s think about what that might mean. Horizon’s published data suggests that concentrations necessitate a 20 mg per kg dose, which in the average-sized patient is 1.5 grams for each dose. So a good high concentration formulation would be useful, but we’ve been able to develop a 150 mg per mL formulation. So we’ll see what they’re planning. We’ve heard some comments from them about having a BLA for a Halozyme-enabled subcutaneous formulation by the middle of this decade, which again would be a large volume. We have not given guidance yet for late-stage development. But as you’ve heard, we’re designing both the VRDN-001 and VRDN-002 programs to move very quickly and efficiently towards registration. Given the opportunity we think we have with these molecules with higher affinity and hopefully better pharmacokinetics, we think we can get to a low volume, and that is something pretty special on a compelling timeline.

Thomas Smith, Analyst

Okay. That makes sense. All right guys, thanks for taking the questions. Appreciate it.

Operator, Operator

Thank you. Our next questions come from the line of Maneka Mirchandaney with Evercore ISI. Please proceed with your questions.

JP Solomon, Analyst

This is JP Solomon on for Maneka. Just on VRDN-001, what would be a win for you in terms of the proptosis response at 12 weeks since you’re not dosing all the way until then?

Jonathan Violin, President and CEO

The question on a 12-week follow-up. As we described, we’re mimicking the timing of Tepezza dosing through two doses, one on day zero and another on day 21, and then measure efficacy at week six or day 42. We do have a six week follow-up point at week 12 without continuing the dosing. The question on what happens between week six and week 12 is interesting and informative. This will help inform our capacity that our drugs have to support a lower dose or reduce infusion interval. Does efficacy rebound, does it plateau? Or does it continue to improve? That will be very informative for us.

JP Solomon, Analyst

Got it. Thank you so much.

Operator, Operator

Thank you. Our next questions come from the line of Rami Katkhuda with LifeSci Capital. Please proceed with your questions.

Rami Katkhuda, Analyst

Hey, guys. Thanks for taking my questions. Two quick ones for me. First, is there any additional guidance that you can provide as to when in Q2 we can expect the data from the proof-of-concept study with VRDN-001?

Jonathan Violin, President and CEO

Sure. We reiterated second quarter guidance. However, it’s not going to be early in the second quarter. We just started the study in December. Everything is on track, but we would expect data more like in the second half of the second quarter. So we’re quite pleased with our progress.

Rami Katkhuda, Analyst

Got you. And then can you remind us if VRDN-001 and VRDN-002 kind of bind the same epitope of IGF-1R and if there’s any potential learnings from this proof of concept to 002 development?

Jonathan Violin, President and CEO

Yes. When we look at VRDN-001 and VRDN-002, the molecular pharmacology and the mechanism of action are highly conserved. They all share an epitope. They all cause similar amounts of receptor internalization. They block receptor autophosphorylation. The mechanism of action suggests that VRDN-001 should deliver efficacy like Tepezza, but we need to prove that. That’s why we’re running the proof-of-concept cohorts for VRDN-001 the way we are. If that data proves positive, that would suggest that the benefits of Tepezza are generalizable, which should lend confidence to VRDN-002’s development.

Rami Katkhuda, Analyst

Makes a lot of sense. Thanks, guys.

Operator, Operator

Thank you. Our next questions come from the line of Laura Chico with Wedbush. Please proceed with your questions.

Laura Chico, Analyst

Hey, good afternoon, guys. Thanks for making the time. I’ve got three for you. First, Jon, you mentioned the differentiation on the affinity between Tepezza and VRDN-001. I’m wondering, could you clarify how you think about the differences in half-life between VRDN-001 and Tepezza?

Jonathan Violin, President and CEO

If we look at non-human primates and oncology studies, the pharmacokinetics are very similar for VRDN-001 and Tepezza. And that makes sense as they're both unmodified IgG-1s. Our expectation is that in thyroid eye disease patients, likewise, they should also have similar pharmacokinetics, while the key differentiator for VRDN-001 is the higher affinity.

Laura Chico, Analyst

Okay, great. One follow-up then, I guess I wanted to ask on the potential to demonstrate any separation from Tepezza on the adverse event profile in this first proof-of-concept study. I guess, what duration of treatment would you need to see potentially to tease out differences on adverse effects and what areas would seem the most logical to see differentiation on? I guess there was a recent publication that detailed hearing dysfunction among Tepezza patients. This was still demonstrating about 10% continuing to have hearing loss at long-term follow-up.

Jonathan Violin, President and CEO

We’re starting with small cohorts at Tepezza-like doses. Our baseline expectation would be similar levels to what they need. In fact, as we mentioned, we’re bracketing the Tepezza dose. The ultimate goal of the program is to get to lower doses. If we see similar frequency of adverse events from Tepezza at 10 mg per kg and a slightly higher rate at 20 mg per kg, that’s fine. The goal of these proof-of-concept cohorts is to demonstrate a highly active drug quickly. We will be able to look at different doses and regimens to achieve lower burden treatment paradigms. We expect that differences in adverse event profiles will emerge over the long run.

Laura Chico, Analyst

Okay. That’s very helpful. And maybe last question for Kristian. How reflective of the forward spend or fourth-quarter levels? I guess should we presume these are reasonable run rates to build off of in 2022 in terms of R&D and SG&A spend? Or were there any one-time costs in the fourth-quarter numbers that we should consider as we’re modeling forward estimates? Thanks.

Kristian Humer, CFO and Chief Business Officer

No, these are reasonable rates to assume going forward. The spend would get us into 2024.

Operator, Operator

Thank you. Our next questions come from the line of Jason Butler with JMP Securities. Please proceed with your questions.

Jason Butler, Analyst

Hi, thanks for taking the question. Congrats on the progress. Just one on potential path to market for a subcutaneous formulation of VRDN-001, is there a potential for a parallel path here and both in IV and subcutaneous being included in the first BLA, or is it more likely that if you advance to subcutaneous VRDN-001, it would be a subsequent filing?

Jonathan Violin, President and CEO

We’ve not given any guidance at a late-stage development. Honestly, we don’t want to tip our hand too soon. But between the high affinity of VRDN-001 and as we’ve said, we see a lot of value in IV. There’s an upside opportunity for subcutaneous. But then with VRDN-002, with a half-life extension that we think should really differentiate the molecule’s performance from everything else in the class right now. That’s sort of the long-term win for subcutaneous but exactly how we build out our portfolio will depend on further developments.

Jason Butler, Analyst

Great. And then how predictive were the preclinical pharmacokinetics data for Tepezza and VRDN-001? And I guess, just how does that speak to your confidence in the ultimate pharmacokinetic profile you’ll see for VRDN-002 based on the preclinical data you’ve already generated?

Jonathan Violin, President and CEO

Both VRDN-001 and Tepezza had very typical half-lives for an IgG-1 antibody, nothing stood out about them. So we don’t expect any unusual findings. With VRDN-002 and the half-life extension, we have seen a number of examples of Fc modifications that increase antibody recycling, allowing them to stay in the bloodstream longer. This has been highly reproducible, showing better pharmacokinetics in humans than in non-human primates. We’ve seen about a twofold improvement in half-life for VRDN-002 in non-human primates compared to VRDN-001 or Tepezza and we’re looking to see that or better as a differentiated profile in our first-in-human study.

Jason Butler, Analyst

Great, thanks. Thanks for taking the questions.

Operator, Operator

Thank you. Our next questions come from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your questions.

Michael Higgins, Analyst

Thanks guys for taking the questions. Just a follow-up on your comments about market research on the IV and subcutaneous. It’s intriguing that you’re finding value for the IV, if you could expand on that a bit. Is that related to reimbursement? Is that related to the setting of the patients?

Jonathan Violin, President and CEO

This market is bigger than people realized a few years ago. There are certainly other markets quite different in their own way, but markets don’t entirely turn over from one dosing route to another. IV is growing quickly and will establish a treatment paradigm. While we do think low volume subcutaneous will be better, the IV market will not go away. It is large enough to support both routes of administration, and we believe there are interesting opportunities with the IV product as we bring forward VRDN-001.

Michael Higgins, Analyst

Interesting. And then another question on the data we’re looking forward to here in the back half of Q2. It sounds like we’re getting six and 12-week data from the first cohort. Just curious if you think we can get that 12-week data from the second quarter.

Jonathan Violin, President and CEO

That depends on timing and of course, what we want to hold back for a medical meeting. So we just don’t know yet. Obviously, we’re focused on the six-week endpoint. That’s where we think everyone will do cross-trial comparisons to see if we’re delivering Tepezza-like efficacy. We should have a very rich understanding of how the drug is performing through the six-week endpoint. The 12-week follow-up will be interesting in terms of what we might see in terms of ongoing efficacy.

Michael Higgins, Analyst

That’s helpful. And then just one last one, if I could here. It looks like the back half of the year, you’ve got a lot of data coming through. Just curious how you value additional cohorts from VRDN-002 since it seems to be a sequential or at least a delayed start from VRDN-001. If you continue to wait, or you just simply pursue advancing VRDN-001?

Jonathan Violin, President and CEO

We think VRDN-001 has a lot of value and will quickly be the second market entrant. We will move VRDN-001 forward as quickly as we can, pending positive data. Thus, its advancement is not contingent on the progress of VRDN-002. The healthy volunteer data for VRDN-002 will help define its development going forward. Once we have that data, we can construct subcutaneous dosing paradigms based on existing PK models. We see both programs moving forward in parallel. Thanks, Mike.

Operator, Operator

Thank you. There are no further questions at this time. I would now like to turn the call back over to Jonathan Violin for any closing comments.

Jonathan Violin, President and CEO

Thank you, and thanks, everyone, for joining us today. As I hope you’ve heard, we are very excited about the ongoing progress we’re making across the pipeline and our upcoming milestones this year. We will look forward to updating you as the programs advance. With that, we’ll close the call.

Operator, Operator

Thank you. This does conclude today’s teleconference. We appreciate your participation. You may disconnect your lines at this time. Enjoy the rest of your day.