Viridian Therapeutics, Inc. (NASDAQ:VRDN) Q1 2023 Outcomes Convention Name Could 9, 2023 4:30 PM ET
Firm Individuals
Louisa Stone – Supervisor, IR
Scott Myers – President and CEO
Kristian Humer – Chief Monetary and Enterprise Officer
Dr. Thomas Ciulla – Chief Improvement Officer
Todd James – SVP, Company Affairs and IR
Convention Name Individuals
Derek Archila – Wells Fargo
Gavin Clark-Gartner – Evercore ISI
Thomas Smith – SVB Securities
Laura Chico – Wedbush Securities
Kalpit Patel – B. Riley Securities
Jason Butler – JMP Securities
Rami Katkhuda – LifeSci
Operator
Welcome to the Viridian Therapeutics First Quarter 2023 Convention Name. [Operator Instructions] As a reminder, this convention is being recorded. I’d now like at hand the decision over to Ms. Louisa Stone, Supervisor of Investor Relations for Viridian. Please go forward.
Louisa Stone
Thanks, and welcome, everybody, to our first quarter 2023 earnings convention name. The press launch reporting our monetary outcomes and company updates is on the market on the Traders web page of our company web site at www.viridiantherapeutics.com.
Becoming a member of me on the decision this afternoon are Scott Myers, our President and Chief Government Officer; Kristian Humer, our Chief Monetary and Enterprise Officer; Dr. Deepa Rajagopalan, our Chief Product and Technique Officer; Dr. Thomas Ciulla, our Chief Improvement Officer; and Todd James, Senior Vice President, Company Affairs and Investor Relations.
Earlier than we start, I wish to remind everybody that this convention name and webcast will include forward-looking statements relating to our monetary outlook along with regulatory, product growth and commercialization plans and analysis actions. These statements are topic to dangers and uncertainties that might trigger precise outcomes to materially differ from these forecasted. An outline of those dangers will be present in our most up-to-date Kind 10-Q and 10-Okay on file with the SEC. I’d now like to show the decision over to Scott Myers, our President and CEO.
Scott Myers
Thanks, Louisa. Good afternoon, everybody. Thanks for becoming a member of us at the moment. We had a productive quarter, and I am excited to report on our progress at the moment after finishing my first 3 months as Viridian’s President and CEO. 2023 is a crucial yr for Viridian, a yr that features key milestones in all of our scientific applications. I’m happy with all of the progress our firm has made up to now and looking out ahead to persevering with our work to carry potential best-in-class therapies to sufferers with thyroid eye illness and extra illness areas sooner or later.
Our crew has grown quickly all through the primary quarter, and we made a number of key hires on our senior management crew, serving to to strategically place us for future success. Further particulars will be discovered within the press launch we issued earlier at the moment, however these hires embody Tony Casciano, Viridian’s first Chief Industrial Officer; Dr. Tom Ciulla, Chief Improvement Officer; Dr. Felix Geissler, Senior Vice President of Medical Affairs; and Dr. Erik Kupperman, Vice President, Program management. Every of those people have already made useful contributions to the group and will likely be integral leaders for our firm as we proceed to develop our groups, mature as a corporation and put together for future success.
I am going to now assessment the progress we made in our scientific applications through the first quarter, and Kristian Humer, our CFO, will focus on our monetary outcomes earlier than we take your questions. Let’s start with our TED applications, beginning with our lead asset, VRDN-001, a humanized monoclonal antibody administered intravenously as soon as each 3 weeks, which acts as a full antagonist of insulin-like progress issue I receptor, or IGF-1R.
Within the second half of 2022 and at first of this yr, we reported a collection of constructive topline scientific knowledge bulletins from 3 dose cohorts of the Section I/II scientific trial, evaluating the security and efficacy of VRDN-001 in sufferers with energetic TED. In December 2022, our crew initiated the worldwide Section III THRIVE trial, which is able to consider the efficacy and security of VRDN-001 in sufferers with energetic TED. Primarily based on our latest discussions with key stakeholders within the TED group, there’s specific enthusiasm for our shortened 5-dose 12-week remedy routine of VRDN-001 in contrast with the 8-dose 21-week routine of FDA accepted TEPEZZA.
Success within the 5-dose arm has the potential to supply welcome comfort to sufferers by shortening their remedy course and eliminating 3 journeys to an infusion middle. Enrollment is ongoing, and we proceed to anticipate reporting high line outcomes from THRIVE in the course of 2024. Shifting to power TED, we’re excited to announce that our proof-of-concept research evaluating VRDN-001 IV in sufferers with power TED is absolutely enrolled. As a reminder, the trial design in power TED is just like our proof-of-concept design that we utilized in energetic TED. Two infusions of VRDN-001, one at day 1 and the second at day 21 with analysis of security and scientific exercise at week 6.
There are 2 dose cohorts, 10 mg per kg and three mg per kg will goal enrollment of 8 sufferers in every cohort. Randomized 3:1 in favor of VRDN-001 versus placebo. Inclusion standards embody any scientific exercise rating at baseline. We count on to report outcomes from each dose cohorts of this proof-of-concept trial in both June or July.
Following the outcomes, we plan to start out our second international Section III trial, THRIVE-2, to guage the security and efficacy of VRDN-001 in sufferers with power TED. Topline outcomes from THRIVE-2 are anticipated by the tip of 2024. I would now like to maneuver to our subcutaneous applications, which embody VRDN-001, VRDN-002 and VRDN-003. All 3 candidates have the potential to be developed for supply with a patient-friendly self-administered pen system, which might considerably improve entry, scale back burden and develop remedy choices for sufferers residing with TED.
We plan to pick one in all these candidates as our lead subcutaneous program earlier than the tip of the yr. With our many learnings from VRDN-001 IV preclinical and scientific work, we consider that the differentiated mechanisms of motion with full antagonism of IGF-1R achieved by VRDN-001 and VRDN-003 make both of them the almost definitely to carry a best-in-class subcutaneous product to sufferers. Because of this, a trial evaluating VRDN-002 in sufferers with TED will solely proceed in 2024 if VRDN-002 is chosen because the lead subcutaneous program on the finish of the yr. This enables us to maintain VRDN-002 as a possible backup whereas steadfastly specializing in advancing our efforts with VRDN-003 and VRDN-001.
I’ll now spotlight the upcoming priorities to get the subcutaneous lead program choice by year-end. For VRDN-001, Section I leads to wholesome volunteers are anticipated within the fourth quarter of 2023. For VRDN-002, we proceed to generate knowledge from the continuing Section I wholesome volunteer trial. For VRDN-003, our plans stay on observe to file the investigational new drug utility with the FDA through the second quarter. We count on Section I leads to wholesome volunteers within the fourth quarter of 2023. After the lead subcutaneous candidates chosen, we count on to advance this system to a pivotal Section II/III trial, which is deliberate for the center of 2024.
Final month, our crew was thrilled to current a number of abstracts on the 2023 Affiliation of Analysis in Imaginative and prescient and Ophthalmology Annual Assembly. A platform presentation featured knowledge from our Section I/II trial of VRDN-001 in sufferers with energetic TED, whereas the poster shows featured new scientific and preclinical analysis on VRDN-002 and VRDN-003. This marked the corporate’s first presentation of VRDN-003 analysis at a medical congress, an thrilling milestone that applications growth. Our crew seems to be ahead to presenting at further medical congresses and additional partaking with TED affected person and doctor communities all through this yr.
Lastly, we proceed to advance our earlier-stage preclinical pipeline and can develop our illness focus past TED and into the uncommon and autoimmune house. Our preclinical applications embody VRDN-004, 005 and 006. Yesterday, we introduced a partnership with Allow Injections to make the most of their enFuse on-body drug supply system for one in all our preclinical applications. We plan to supply further info on a minimum of one of many applications later this yr. With that, I’ll flip the decision over to Kristian, who will present a monetary assessment for the primary quarter of 2023. Kristian?
Kristian Humer
Thanks, Scott. Good afternoon, everybody. I would prefer to refer you to our press launch issued earlier at the moment for an in depth abstract of our monetary outcomes for the primary quarter 2023 and take this chance to assessment a couple of gadgets. We ended the primary quarter with roughly $373.9 million in money, money equivalents and short-term investments in contrast with $424.6 million as of December 31, 2022. We consider that our present money, money equivalents and short-term investments, excluding our $75 million credit score facility will likely be adequate to fund our operations into the second half of 2025.
Analysis and growth bills had been $50.7 million through the first quarter of 2023 in contrast with $17.7 million for a similar interval final yr. Analysis and growth bills for the primary quarter of 2023 embody a one-time $15 million upfront fee to Allow in consideration for the rights granted to Viridian to make the most of Allow Injections’ enFuse on-body drug supply system. Different drivers for the rise in analysis and growth bills embody greater CMC bills in preparation for the IND utility for VRDN-003 in addition to growth actions.
Larger personnel prices on account of a rise in headcount, greater preclinical prices on account of early-stage collaboration bills. As of Could 1, 2023, Viridian had roughly 58 million shares of frequent inventory excellent on an as-converted foundation. With that, I am going to ask the operator to open the decision for questions. Operator?
Query-and-Reply Session
Operator
[Operator Instructions] Your first query is from the road of Derek Archila with Wells Fargo.
Derek Archila
Congrats on the progress. Possibly simply two questions from us. Possibly simply first, are you able to simply discuss concerning the variables that might lead the power knowledge popping out in July versus within the second quarter? After which additionally, simply your considering on the TED market alternative given what we noticed from Horizon lately of their quarter outcomes. I imply do you assume something has modified available in the market? Or do you sort of chalk that as much as deal-related issues going — with the continuing Amgen deal?
Scott Myers
That is Scott. We’re anticipating an actual excessive likelihood that we will see scientific exercise in power TED as a result of it has been confirmed by the latest Horizon knowledge. They had been capable of submit a 62% and really significant response with a 2-millimeter discount in proptosis. Our trial is evaluating the exercise with solely 2 doses of VRDN-001 to determine the proof of idea and discount in proptosis of lower than 2 millimeters, excuse me, can be — nonetheless be very significant as a result of we nonetheless plan to guage the longer doses in THRIVE-2. We’re more than happy with what’s occurred in that trial. We have really overenrolled the three mg per kg cohort. So as soon as we get the method rolling the place we herald all the knowledge from the CRO, from the websites, the MRIs, we will want a while to essentially look via that and ensure it is proper. After which we’ll be able to announce both June or July.
After which with regard to your second query was about what we noticed within the Horizon knowledge. We thought it was really superb knowledge for sufferers affected by power TED, and there is nonetheless a really giant unmet want in that inhabitants as a result of surgical intervention is absolutely all they’ve left, except they use a systemic remedy. We sit up for seeing some extra of their info when they’re able to launch round affected person baseline traits, the efficacy finish factors and a few of the security as a result of this was the primary placebo-controlled knowledge on this power inhabitants. After which we sit up for reporting our knowledge in June or July of this yr.
And as a reminder, although, we had been — our research was arrange barely in a different way. It was for sufferers with proptosis of larger than or equal to three millimeters above regular values after which signs that had introduced themselves after 1 yr of research screening — excuse me, prior to review screening. And only a reminder, we didn’t have a money requirement whereas Horizon used a 0 or 1 for money. We’re enrolling 2 cohorts, as I discussed earlier than, with VRDN-001, there is a 10 mg per kg cohort and a 3 mg per kg cohort randomized at 3:1 versus placebo, and there was staggered enrollment, the ten mg per kg arm enrolled first with the three to comply with as I mentioned it was overenrolled.
So there’s solely 2 infusions in every of these at day 1 after which once more at day 21, which is q.3 weekly. After which the outcomes will likely be at day 42 and week 6. So excellent news from the Horizon knowledge. We predict that their outcome will play nicely within the market with that 2-millimeter discount and that may assist them hopefully get extra protection selections from insurance coverage firms and with their broader label that, that may create a very nice tailwind for the market.
Todd James
Derek, that is Todd. So far as issues that may very well be doubtlessly impacting gross sales or what was doubtlessly driving a discount from This fall to Q1, we predict so far as how Horizon was investing available in the market so far as increasing their gross sales drive the direct-to-consumer promoting in addition to the affected person and doctor help round attempting to expedite new market entry and reimbursement for sufferers is totally nice locations to spend money on. However I believe to your level, round potential distraction round an M&A course of as that was going down within the public headlines, actually not useful if you’re attempting to make in-flight operational adjustments to affect the gross sales trajectory of a drug.
The power knowledge that Scott simply described will definitely assist so far as with the ability to have educate and conscious physicians and payers to hopefully drive further gross sales within the power market. However I would additionally simply level out that integration is not straightforward both. And so individuals ought to in all probability count on some further affect over the following couple of quarters as Amgen is integrating the Horizon crew. After which with power, these adjustments that had been being made, I believe we should always have the ability to return to progress both later this yr or early subsequent yr and see the TEPEZZA gross sales choose up once more.
Operator
Your subsequent query is from the road of Alex Thomson with Stifel.
Unidentified Analyst
I suppose a pair for me. Possibly might you speak about whether or not the trail ahead with 001 subcu to bridge PK when you have profitable IV trials doubtlessly available in the market sooner? After which perhaps as a follow-up to Derek’s query, what are your present expectations round your label? Do you count on to get form of the previous TEPEZZA label? Or do you count on the trail ahead so that you can get the brand new label upon approval? And in that case, how which may affect the business alternative?
Scott Myers
So for the second, each the THRIVE and the THRIVE-2 research are going to be supportive of the BLA. And so then we’d count on then that to translate right into a broad TED label just like what you are seeing at the moment with the TEPEZZA label. And sorry, might you repeat your first query?
Unidentified Analyst
With the 001 subcu.
Scott Myers
So the present method that we’re interested by it’s actually separate applications of IV versus subcu. And so we’re shifting forward with THRIVE and THRIVE-2 to arrange for an approval with the IV, after which we will choose the lead candidate in subcu, which based mostly off of every part that we’re seeing at the moment, 003 seems to be like it will have one of the best profile from the binding affinity of 001 together with the half-life extension of 002. If there have been a method for us to bridge from 001 subcu — from IV to subcu, that is actually one thing we’ll consider sooner or later. However at the moment, no plans to replace you on that proper now.
Operator
Your subsequent query is from the road of Gavin Clark-Gartner.
Gavin Clark-Gartner
I had two. First, I simply wished to make it possible for should you do choose 003, there’s nothing else that might doubtlessly gradual you down, particularly questioning about any formulation manufacturing or preclinical toxicology work. And I am going to come again for my second query.
Scott Myers
Sure. No. All three applications are proper on observe, and we will proceed to guage them via the tip of the yr. And as of now, there is not any points with formulation or the preclinical work. The wholesome volunteer research will likely be underway and can full by the tip of the yr.
Todd James
After which we must be on observe, Gavin — that is Todd. We must be on observe to start out a Section II/III pivotal then for what different program is chosen because the lead in the course of subsequent yr.
Gavin Clark-Gartner
All proper. That is tremendous useful. After which individually, on the partnership for the on-body system that was introduced yesterday. I simply wished to make clear, was that for the following preclinical program that is going to be unveiled? Or is that for an earlier preclinical program that’s nonetheless to be mentioned?
Scott Myers
That is for 1 of the three applications we’re at the moment growing, and it’ll don’t have anything to do with TED in any way. So it is going to be for 1 of these 3.
Operator
Your subsequent query is from the road of Thomas Smith with SVB Securities.
Thomas Smith
A pair on our finish. I used to be questioning should you might present any further shade on how the THRIVE trial is enrolling at this level and the way that enrollment is monitoring relative to your preliminary modeling? After which secondly, I perceive the distinction between the inclusion standards between your research and the Horizon research, however I used to be simply questioning when you have any visibility into the baseline traits of the power character of an idea cohort and whether or not that is monitoring in direction of extra of a form of a low CAS inhabitants or sort of mid CAS affected person inhabitants?
Scott Myers
Sure. So with regard to the THRIVE research, we’re actually happy that we will announce the primary placement that was enrolled again in December. And we have now greater than 30 websites activated globally, however we’re not giving any interim updates on the enrollment. And the second query was round — that we do not — we have now not unblinded our baseline traits. I consider they’ve, however we have now not.
Operator
Your subsequent query is from the road of Laura Chico with Wedbush Securities.
Laura Chico
I simply have two. Simply sort of following up on the enFuse supply system, understanding that is for different applications exterior of TED, however simply sort of curious why the rationale for this system and executing on this proper now. Simply any benefits or standards you had been on the lookout for when it comes to choosing this specific associate? After which secondarily, on the money runway, simply any commentary or further shade there on levers to increase that. I believe R&D picked up just a little bit if I am studying issues accurately right here. I am simply attempting to grasp the expectations on the burn for the rest of the yr.
Scott Myers
Sure. So I am going to take the — that is Scott. I am going to take the primary query and Kristian will reply your second query. So the primary one actually goes across the hallmark and the philosophy of the corporate is that if we will enhance in a market that is been created round efficacy or doubtlessly security or mode of supply. These are the three standards that we handle close to and expensive and look exhausting to do this, and we consider this know-how will assist that compound that that is going to be put inside our preclinical pipeline. Kristian?
Kristian Humer
So look, we have got money just a little bit below $374 million. We proceed to information money runway into the second half of 2025, but it surely funds — on a program-by-program foundation, it funds mainly each THRIVE and THRIVE-2, all through knowledge on the finish of ’24 and just a little bit into ’25. Our subcu program is funded via to what we’re calling the date of determination level on the finish of this yr, the place we’ll choose this system to maneuver ahead into pivotal trials. Most significantly, pivotal trial prep is funded in order that we will transfer expeditiously on the finish of ’23 into pivotal trials.
Our non-TED pipeline is all funded both via to candidate choice or IND submitting, and you must count on us to unveil these applications one after the other, and we’ll let the market determine what they need to fund. We have now dedicated to unveiling a minimum of 1 of the three applications on our pipeline — one in all our non-TED applications on our pipeline chart over the course of the remainder of 2023. Type of — our money working bills in Q1 had been barely greater than they normally are largely on account of sort of the enabled fee of $15 million. You must count on barely elevated bills once more in Q2 as we provoke sort of THRIVE-2. And after that ought to normalize once more again to sort of a gradual state of someplace between $35 million and $45 million.
Operator
Your subsequent query is from the road of Kalpit Patel with B. Riley Securities.
Kalpit Patel
Possibly yet another available on the market alternative right here for thyroid eye illness. I suppose, based mostly in your conversations with KOLs within the house, is there a backlog of power TED sufferers which might be ready to be handled? And do you assume that it’s going to form of be a fast uptake on this setting like we noticed within the acute setting? Or would it not be a gradual construct given the decrease severity of the illness?
Scott Myers
That is Scott. I am going to take the primary half and perhaps Tom Ciulla will add just a little shade as a result of we have really been out within the area fairly a bit these days on the totally different conferences and visiting with our PIs and KOLs, and studying about that. I believe the assumption is that there was a low-hanging fruit state of affairs with the actives. However within the phrases of a few of the physicians I spoke with, there are strains of power sufferers. I believe the latest knowledge that is been put on the market bodes nicely with their broad label now and that they’ll take ahead, as I discussed earlier than, to get protection determination.
However I believe we see there’s actually important alternative on the market for market potential and to develop the market particularly once we take into consideration our 5-dose routine that is — as a part of our THRIVE research. The physicians are actually enthusiastic about that, even versus the 8-dose that is already obtainable. And I believe we actually have the chance to develop the market with our subcu providing. So we’ll have a really broad method to treating this ailments — illness, excuse me, with whether or not individuals need to use an IV or a subcu.
After which there’s additionally the way forward for loads of physicians are telling us round it is nonetheless 8 doses with TEPEZZA, form of an acute remedy for what seems now to be a power illness as a result of the TEPEZZA knowledge positively confirmed that these power sufferers do current themselves even after having the illness and their standards 2 to 10 years, and we have even heard longer than that, and they’re getting aid. However Tom, I do not know if you wish to add some shade?
Dr. Thomas Ciulla
Certain. That is Tom Ciulla. So we — as Scott talked about, we have been via quite a lot of congresses lately. We had been on the Affiliation for Analysis in Imaginative and prescient and Ophthalmology, the North America Neuro-Ophthalmology Society and the North American Society of Tutorial Orbital Surgeons, the place we had a number of shows at every of those congresses. Scott really has attended and has met with a number of of the investigators and KOLs. And uniformly, they’re very captivated with our a number of ascending dose proof-of-concept research in acute TED.
I believe we have gotten loads of constructive suggestions about that knowledge. We have additionally gotten loads of constructive suggestions about Horizon’s latest knowledge in power TED, and we see this as a win for sufferers affected by power TED. What the KOLs and investigators have informed us is that they do certainly have a backlog of sufferers they usually — lots of them have requested to participate in our scientific trial as investigators. So we predict there’s a groundswell of optimism, not just for energetic TED, however for power TED, the place there is a backlog, simply as you requested about.
Kalpit Patel
Okay. Received it. And may you give us just a little extra — perhaps extra shade between the choice of the suitable subcu candidate and the timing of the beginning of that pivotal trial in mid-2024. What steps are remaining to start out that trial?
Scott Myers
Sure. So there are — a few the 002 wholesome volunteer research is ongoing proper now, and we have even reported a few of that info out at one of many more moderen conferences. After which the 003 and 001 wholesome volunteer research, which will likely be taking a look at bioavailability and security. These will likely be accomplished early sufficient to have by the tip of the yr, after which we’ll wind up all that info, make the choice about which one of many candidates we’d transfer ahead with. After which based mostly on that info, we’d then search enter from the stakeholders and plan to start out the trial midyear.
Operator
Your subsequent query is from the road of Jason Butler with JMP Securities.
Jason Butler
Scott, you pointed to earlier than the significance of the shortened remedy period within the THRIVE research for the IV. Are you able to simply speak about how that considering rolls over to your planning for the subcu pivotal program and I suppose, additionally the power TED program?
Scott Myers
Sure. So we’re studying quite a bit about what is going on on within the market. And I’d say the market has modified fairly dramatically over the launch of TEPEZZA and the way physicians are literally utilizing these medication, as I discussed earlier than, the best way that it is sort of an acute remedy paradigm at the moment the place you give 8 doses after which a minimum of that is how the label learn and also you see the way it goes. However what you notice is that if the thyroid is just not being managed nicely and the pathway is uncovered and never blocked by utilizing a TEPEZZA-like compound, the signs of TED return.
And so one of many issues — and one of many causes we have now the 5-dose routine in there’s, one, it is faster to enroll within the sufferers once they — in the event that they see a outcome or not, they’re going to have the ability to roll over after their doses on to an energetic as we have seen earlier than. However the physicians simply actually like the concept that you perhaps capable of deal with and induce a response with TED at a decrease variety of doses, and we additionally level to a few of the unwanted side effects that present up on TEPEZZA in these greater dose numbers and the flattening of the curve.
So we really consider we’ll begin to see a few individuals would name it a deal with and retreat or it may very well be an induction in upkeep method and the place we predict we’re very nicely positioned, each with our infused product line that may — as soon as it is accepted, clearly, however the entire subcu, so then you definitely put the remedy within the fingers of the affected person, clearly, after being identified and also you simply have much more flexibility and quite a bit higher expertise for the sufferers who do not need to go to infusion facilities to be handled.
So we really see a fairly important paradigm shift that you would have form of an induction section the place you get the acute indicators and signs below management, and then you definitely go to an actual upkeep paradigm the place there are doubtlessly with our know-how, you would get to a q.4 weekly or as soon as a month dosing within the fingers of the affected person and never seeing the caregiver, which we predict is differentiated from a minimum of the best way we perceive TEPEZZA goes.
Jason Butler
Received it. And I suppose only a follow-up to that then. Are you listening to from physicians but that there they’re using that deal with and retreat with TEPEZZA. So sufferers are getting remedy within the acute section after which both retreated in a power section? Or is it simply too early to say that?
Scott Myers
So I believe you just about hit it proper on the pinnacle, really. So what we begin to hear anecdotally after which a number of instances from physicians who had been treating through the pandemic, they could not get their full 8 doses as a result of TEPEZZA had been sidelined for the COVID vaccines. So that they got restricted variety of doses, and what they might do is give a couple of doses after which watch and see the outcome and have the affected person return after which they nonetheless had a couple of extra doses to offer them or generally we have heard of they’re going to give individuals as much as 5, mainly ship them residence and say, keep in contact.
And should you begin to hear these — excuse me, really feel these outcomes, you’ll be able to come again and we will infuse you once more. So no, it’s nearly turning into — I heard from one doctor. It is like give a couple of doses after which flip it right into a PRN because the affected person wants it. So we’re selecting up that intel, and we do benefit from foresight versus hindsight and so we will use this Intel to regulate how we go to market.
Operator
[Operator Instructions] Your subsequent query is from the road of Rami Katkhuda with LifeSci.
Rami Katkhuda
Two fast ones for me. I suppose, first, is there something particular that you are looking out for within the confirmed idea power TED research that may affect the THRIVE-2 protocol? After which secondly, in your conversations with physicians and payers, have market entry or reimbursement concerns modified with TEPEZZA after the power knowledge?
Todd James
Sure. So particular to the power knowledge and the way that might affect the THRIVE-2 Section III design. So we have now, after all, some preliminary considering of what that Section III design might seem like previous to the info. We lately received some very high-level topline outcomes from Horizon. That was sort of useful for us to consider how we will take into consideration scientific exercise. We’ll then additionally be told by the exercise that we see in our trial after which not one particular factor that I’d sort of name out at the moment, however we’ll be absolutely knowledgeable by that knowledge and sort of relative to that preliminary considering make any obligatory concerns and impacts to the trial design, if it’s a necessity to hunt both KOL and/or well being authority suggestions earlier than we kick off the trial. In fact, we’ll try this as nicely.
So far as market entry selections following that power knowledge from Horizon simply — now 4 weeks in the past, I believe it is actually too early for us to be getting intelligence round that. And in order that’s one thing we’ll positively be listening to so far as for intelligence that we’re getting from {the marketplace} and the survey work that we do. And naturally, if we begin to handle issues, then it will be extra applicable to offer you that intel as we’re listening to in actual time.
Operator
Your subsequent query is from the road of Gavin Clarke-Gartner.
Gavin Clark-Gartner
I simply wished to circle again on the prolonged period or retreatment dynamic that you just simply talked about. As a result of at the moment, loads of the payer insurance policies explicitly do not enable for greater than 8 TEPEZZA doses. I am questioning the way you method pricing and likewise what scientific knowledge you must present to permit for this dynamic sooner or later?
Scott Myers
Sure. So this may be clearly post-approval method we’d take. However if you’re going — when you would shift out of — from a deal with to retreat to induction and the upkeep, the pricing may very well be very totally different as a result of you have got — you could be utilizing the subcu the entire time that method. So at the moment, they’re at 8. However with their broader label now and a retreatment, they might get — they’ll resubmit for reimbursement on the following bid. And as an alternative of going 8 and eight is what I have been referring to and have heard from loads of the physicians is it is a power illness, and the label is mainly now at any time you have got TED, you will be handled with the drug.
So it is — I believe persons are battling utilizing 8 after which 8 and eight after which additionally with that very excessive dose, you would perhaps — should you use smaller doses like with our full antagonism, we’re about 1/3 on the 5-dose cohort and never fairly about half of the place they’re going to be with their 150 mg per kg. So with the ability to dose with totally different dose regimens, whether or not it is subcu or deal with or retreat with a decrease variety of infusion doses appears to be a most well-liked method.
Operator
Presently, we have now reached the conclusion of the question-and-answer session. I’d now like to show the decision again over to Viridian’s President and CEO, Scott Myers, for closing remarks.
Scott Myers
Thanks, operator, and thanks, everybody, in your time this afternoon. Please be happy to achieve out to Todd or Louisa when you have any follow-up questions, and we’re comfortable to the touch base with you. Thanks once more, and have an awesome night.
Operator
This concludes the convention name at the moment. You might now disconnect your strains. Thanks for taking part.
