Q4 2021 Viridian Therapeutics Inc Earnings Call
Greetings and welcome to the Iridium 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. If anyone should require operator assistance. During the conference. Please press star zero on your touch.
My phone keypad.
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.
Thank you Daryl and good morning, 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 the 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 .
Our other periodic 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 Brittany.
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 Christian Huber, Our Chief Financial Officer, and Chief Business Officer.
Begin with a brief overview of the business, our recent milestones as well as an overview of our pipeline, including progress we've made in advancing our lead candidates for thyroid eye disease or Ted.
And then Christian will review, our fourth quarter and full year financial results. We'll then open the call for questions.
We found it already to advance new biologic treatments for patients suffering from serious diseases or underserved by today's therapies.
Our strategy is to employ a patient centric model of innovation that Leverages, driven biology invalidated 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.
And we focus on product concepts that we can fulfill with our antibody discovery engineering and development expertise either in licensing we're creating de Novo antibodies. We believe can provide best in class solutions for patients in need of more and better therapeutic options.
2021 transformation for Iridium in January we were newly public preclinical start up today, we have over 50, Ftes two clinical stage programs and advancing and expanding discovery pipeline and 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 CRD and below one <unk> and initiate our first clinical trial in test.
Key additions to our team in 2021 included our Chief Medical Officer, Eric Katz, and neuro ophthalmologists deep experience in both clinical trials and patient care, including <unk> patients.
Depot Roderick upon our SVP of new product and portfolio development, who brings significant expertise in strategy and the commercial launch planning and Chief Financial Officer, and Chief Business Officer, Christian <unk>, who has over two decades of financing and M&A experience in Biopharma banking.
Dave joined the existing leadership team, including our Chief scientist and co founder Bob.
And we quickly recruited a highly experienced teams and individuals to support our mission to rapidly and efficiently advancing new monoclonal antibodies to fill gaps in the treatment paradigm for Ted and other serious diseases.
I'd like to spend a few minutes reviewing our pipeline focusing on our lead programs.
Ted is a new large and rapidly growing market that aligns with our strategy.
We see an opportunity to be the second entrant in this market, where we can advance patient care by providing differentiated product profiles and improve upon currently approved treatment option.
The only therapy approved by the FDA for <unk>, which is an intravenously administered administered monoclonal antibody to target the IGF, one receptor or IGF one hour.
It depends of the clinical trial data provides strong validation linking of taking the targeting of IGF NR to clinical benefit and Chad. However.
However, clinical trials Bethesda, instead reported state employed a single dosing regimen, providing little guidance as to the optimal dosing required for efficacy.
I believe there are multiple opportunities to develop novel IGF, one targeted therapeutics that improve on tenant features including dosing schedule route of administration.
<unk> settings of care and potentially safety and Tolerability.
Our strategy is to advance market segmentation, providing an improved IV option for patients from the control and oversight of an IV infusion is preferred and a convenient self administered in low volume subcutaneous injection for patients who could benefit from this route of administration.
We have two specific goals first to adapt the higher 70 antibody a less burdensome IV dosing paradigm, enabling a lower dose and or fewer infusions to provide the efficacy.
And an improved product profile for.
Our second goal is to deliver a convenient low volume subcutaneous injection that enables treatment of tourette patients in broader settings of care, allowing simple dosing either self administered at home or in the prescribing physician's office.
Our first goal and that is addressed by our most advanced program <unk>, one a monoclonal antibody that blocks. The IGF one receptor with sub nanometer potency, which we in licensed from Immunogen.
This antibody was previously developed at <unk> 42, and has been administered to over 100 oncology patients, providing a wealth of data that accelerated and Derisked our program.
Data from our preclinical studies in oncology trials suggest that <unk> has the same mechanism of action a successor and similar PK in humans.
Key difference for <unk> is it a higher affinity build our own data and previously published data show that <unk> had sub affinity and potency against IGF one on.
This may help reduce the dose required to deliver efficacy in <unk> patients.
We see an opportunity to develop <unk> as a differentiated IV products addressing the need we've heard from Ted stakeholders for a less burdensome dosing paradigm.
In December we announced dosing of the first subject in a phase <unk> proof of concept clinical trial for <unk> one.
This trial is designed to evaluate the safety tolerability pharmacokinetics and efficacy of <unk>.
The trial includes both healthy volunteers and randomized placebo controlled cohorts of 10 patients and will assess multiple measures of the signs and symptoms of Ted including Proptosis or bulging, Nevada characteristic of 10.
The study is designed to achieve several aims first adjusted <unk> can deliver efficacy comparable to purser that Joseph similar to setup to.
Established proof of concepts that we have a highly active drug for treating tab cel.
Secondly, after we've shown efficacy comparable to Tulsa.
The study can enroll further cohorts to explore differentiated dosing paradigms, including low doses that may enable a 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.
Let's discuss our expectations for that data.
To confirm that we can deliver efficacy comparable to <unk>, where initially using doses one similar to 2000 and.
In assessing potential efficacy two cohorts of 10 patients. Each cohort will include eight patients six receiving over one and two receiving placebo.
We want to see one deliver the same rapid improvement in symptoms as deposit, which would confirm that the preclinical and oncology data for only one showing the same mechanism of action is to cover that translated to Ted and we'd note that we have a highly active drug we can adapt quickly towards market.
Our trial design includes two infusions on day Zero and day 21, and then efficacy assessment at week, six or <unk> 42.
That dosing interval matches, the precursor of course of treatment.
The first cohort will receive two infusions of <unk>, one and the second cohort will receive two infusions of 'twenty mix per kg. We're bracketing, the depositors, which is 10 mix for kicking the first infusion in 'twenty makes for kicked thereafter.
Given the sudden animal or affinity and potency of <unk> and biomarker data from oncology trials, we believe that both doses should be well above what's needed to SaaS right receptor.
We are assessing multiple efficacy endpoints and expect to have at least three for topline data proptosis diplopia and clinical activity score.
The primary efficacy measurement as Proptosis at six weeks, which we'll report at the same two analysis.
Mean change from baseline, which will be our main focus but also a responder analysis defined as a two millimeter or greater reduction from baseline.
Given the shared mechanism of action of <unk> and should.
We expect to see efficacy comparables.
There are three to further clinical datasets for us to consider the phase II trial. The randomized portion of the phase III trial and the open label extension of the Phase III trial in which placebo patients were crossover to further.
And those three datasets the mean change from baseline in Proptosis at week six range from approximately $1 seven millimeters to $1 nine millimeters with a 95% confidence interval for approximately one 4% to 3%.
The data will also be complemented, but sophie assessments of clinical activity score, which like Proptosis reproducible shut benefit at six weeks in the <unk> dependent datasets.
We will also have topline safety and Tolerability data and would anticipate sharing full data, including PK PD and further measures of efficacy at a future medical meeting.
Demonstrating that we have transformative efficacy similar to the Tesla would be significantly derisking Caribbean and put us in a position to be second to market.
The next goal will be to rapidly evaluate lower doses potentially different dosing intervals to understand how much we can differentiate one from stellar and so as a reminder, this trial is designed to be flexible. The protocol allows for enrolling additional 10 patient cohorts in which we can evaluate different doses dose intervals and number of infusions.
If we see positive results in the proof of concept cohorts will explore efficacy at a lower dose. This is an opportunity to differentiate one from the present by dose and also could support our ability to achieve a low volume subcutaneous injection.
In parallel we're already preparing a one for pivotal trials, including manufacturing material of commercial process.
Pending positive proof of concept data, we anticipate announcing a program rapidly and we intend to sprint to market with a differentiated product profile, we think lower fewer infusions and potentially different routes of administration would be welcome advancement in treating Ted.
Let's now turn to <unk>, our next generation IGF, one of our targeted program.
And with the humanized monoclonal antibody that incorporates half life extension technology and was designed by our scientists to support administration of the convenient low volume subcutaneous injection for the treatment of Ted.
This product presentation would maximize the settings of care either at home or patients via self administration or in the prescribing physician's office.
Data from preclinical oncology studies showed us that across the IGF monarch class, while increasing target affinity may help lower dose PK becomes limiting at low doses.
Oh, two athletic extension works as we expect this will be very hard for any antibody lacking tablets extension.
Get to a more convenient subcutaneous product.
At the end of January we announced the FDA acceptance of our IND application for <unk>.
We're currently proceeding with a first in human phase one clinical trial of <unk>.
What's the single ascending dose study to explore safety Tolerability pharmacokinetics and pharmacodynamics of intravenously administered <unk> in healthy volunteers.
We expect to announce data from this trial mid year.
The key outcome from this trial is to demonstrate how well the half life extension technology improves PK and these data will inform the feasibility of low volume subcutaneous <unk>.
Should we see positive results, we expect to have everything we need including our high concentration subcutaneous formulation of 150 <unk> per mil to rapidly adapt to subcutaneous proof of concept trial test patients.
With our over one and no two programs. We believe brilliant is an extremely compelling test pipeline with two differentiated shots on goal both with the ability to move quickly to registration enabling studies.
In addition to our efforts to create best in Ted product and Ted 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 the targeted mechanism of action already exists.
Dr. Janet before targets, a proven mechanism of action in a rare disease, where we see opportunity to advance patient care and evolve the market with a new best in class entrants.
Antibody discovery and engineering team has generated optimize promising media and bodies and we're excited about this program.
We will disclose the target indication when the time is right from a competitive perspective.
<unk> five is a new discovery stage program again targeting opportunity we've identified to advance a new best in class therapeutic.
As part of this effort, we've licensed antibody libraries from Suncor, which we believe provide a high quality starting point for our program.
<unk> four 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 are committed and focused on the importance and sizable opportunity we have with our test programs.
Operationally, we're very pleased that our progress over the last year, we are 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 also helped us with that.
Our mission to provide new and better antibody therapeutics to patients who deserve new options.
We look forward to another transformative year ahead for iridium in 2022.
I'll now turn the call over to Christian who will discuss our financial results for the fourth quarter and full year ended 2021 Christian.
Jonathan Good afternoon, everyone. We entered 2022 and a strong financial position. This year, we look to advance multiple programs in Ted while expanding our discovery pipeline, we closed out 2021 with approximately $197 million in cash cash equivalents and short term investor.
As of December 31st 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 our press release issued after 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 31st 2021, compared with $15 3 million and.
And $28 3 million for the comparable 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 31st 2021, compared with $5 5 million.
And $13 3 million for the comparable periods 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 31st 2021, compared to $97 million and $110 7 million for the comparable period last year.
As of December 31, 2021, Meridian 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 <unk>.
Volume of shares.
<unk> date and series B preferred stock with that I'll ask the operator to open the call for questions.
Thank you we will now be conducting a question and answer session.
I'd like to ask a question. Please press star one on your telephone keypad.
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Please while we poll for your questions.
Our first question is come from the line of Chris Howerton with Jefferies. Please proceed with your questions.
Great. Thank you so much for taking the questions and I 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 differentiation that you think could be made in that setting for oh, one relative to <unk> and for example, with less frequent IV infusions be important in that type of setting.
Second question I would have would be.
Is the O two data from the mid year going to be gating in any way to opening up.
New cohorts for the phase two study with <unk> one.
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 O two versus no longer trying to evaluate O. One thank you.
Thanks, Chris Thanks.
So with respect to the.
I'd.
Product and how that fits against.
<unk> product.
We actually see having done a lot of market research and commercial forecasting.
Our revenue can be maximized by having both IV and subcutaneous is a big market. We believe it's going to the segment.
There are patients and prescribers are going to prefer IV, although in the long run do you think that level of volume sub Q would be the biggest category in the market and so we see a lot of value and with both of these programs forward.
With respect to the IV product.
There are a number of ways that this could be interesting and you keep in mind that the great majority of the market right now is acute patients treated by the IV route right. So.
This is a proven market now.
We think we're going to grow as we segment it by bringing in different products forward. So with respect to IV. It seems like a lower dose fewer infusions.
Can really reduce but we think of as the overall burden of care on patients at 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 the high dose.
It is adding a lot of.
A lot of truck burden right and so.
If we can get to lower doses there is always the upside.
That maybe we will start to see better Tolerability, we don't know, but something that we're interested in and we'll collect data as we go.
But less drug is always better and so if we can do that we can have fewer infusions, we think theres room for a compelling IV entrants.
With respect to your question is is <unk> data.
Gating for what we're going to do with over one.
We're going to move up going forward as quickly as we can.
And don't need the CTO to data to.
To make our own decisions.
And.
The third question, then would be accelerating the <unk>.
The <unk> two program should be able to move forward quite quickly once we have this first in human data.
Understanding how.
How well the half life extension technology has improved the PK. Once we have that have like we will be able to rock.
The dosing paradigm that we want to test in a substitute rile and temptation. So <unk> can move forward quite quickly on its own. So we're really excited about both of these programs.
Yeah, maybe I set up a false choice there to some degree yes, okay.
Okay, that's very clear I appreciate it Jonathan and thanks for taking my questions.
Thank you. Our next question is coming from the line of Thomas Smith with <unk> Leerink. Please proceed with your questions.
Yeah.
Hey, guys. Good afternoon, thanks for taking the questions and congrats on all the progress just on.
On the upcoming Euro there one proof of concept data can you just remind us regionally where youre enrolling the study and then.
Can you provide any additional color on where you are in terms of enrolling the first two cohorts.
Yes, so as you heard we reiterated our guidance for data in the second quarter. The study is enrolling in North America to the U S and Canada.
Where we're looking at.
A large number of sites many many of whom have experienced in this space that have enrolled in our <unk> some of the top sites.
As of studies.
And including obviously, Kols and investigators who know how to run these studies as well.
So we've been very pleased particularly as Barry our Chief Medical Officer has done.
Sharing our vision for <unk>, we've seen a lot of enthusiasm for what we're trying to do here. So.
We're pleased with how all that's going.
Okay.
And.
Maybe just a follow up on the.
On the competitive front it sounds like horizon evaluating both <unk> and non <unk> sub Q formulation sports.
Yeah.
How are you thinking about competitive timelines I guess competitive profiles and what are your current expectations in terms of when you think youll get your.
Q to market versus horizon.
Yes.
Right so with Insureds.
Thats dependent now has been formulated in high concentration.
Let's think about what that might mean right. So.
Horizons.
Published data, suggesting that needs.
Plasma concentrations that necessitate <unk> dose and the average size of patient, that's a gram and a half for each dose.
So.
Good high concentration formulation will be but what we have been able to Q.
150 mixed nuts, that's 10 minutes right.
So we'll see what what they are what they are planning.
We've heard some comments from them about kind of middle of this decade.
BLA for <unk> enabled sub Q, which again would be a large volume.
We've not given guidance yet for late stage development, but as you've heard we're designing.
102 programs to move very quickly and efficiently towards registration and given the opportunity. We think we have with these molecules and higher affinity with hopefully better PK.
We think we can get to a low volume and thats, something pretty special and a compelling timeline.
Right, Okay that makes sense alright, guys. Thanks for taking the questions I appreciate it.
Thanks, Tom.
Thank you. Our next question is coming from the line of Monika Mirchandani with Evercore ISI. Please proceed with your questions.
Hey, this is J P on for Monika.
Oh, one what would be a win for you in terms of the PARP doses response at 12 weeks, just it's about dosing all the way until that.
So the question is on the 12 week follow up front. So as we described where we're mimicking the timing to desert dosing through weeks. Thanks, Franz you dose on day zero dose on day 21, and the measure of efficacy and we expect to $2 42, we do have a six week follow up point at week 12.
Without continuing to dose it seems just given those first two infusions so.
To do cross trial comparisons, we can really look at week six.
The follow up through week 12 is an interesting question.
We will start to inform the capacity.
Our drug SaaS at lower dose reduce infusion interval so.
Whats going to happen between $6 12 as ethics. It quickly rebound does it flatten or does it continue to improve.
So that's going to be really informative for us.
But it's really the week six data that will through the cross trial comparison, hopefully tell us yet we've got a highly active drug.
Hence the de risking the company should put us in a really good place to move forward quickly.
Got it thank you so much.
Thank you. Our next question is coming from the line of Rami cap Cana with lifestyle capital. Please proceed with your questions.
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 <unk>.
Sure well so as you heard we did reiterate second quarter as we've been saying for a while now but look it's not going to be early in the second quarter. We just started the study in December so everything is on track and we would expect.
More like in the second half of the second quarter.
So that's.
Quite pleased with our progress is gone.
Gotcha, and then can you remind us of your zero, one and here's your two kind of bind the same epitope of IGF. One are in there is any potential learnings from this proof of concept to <unk> development.
Yeah.
So when we look at chaparral, so want to know too.
The molecular pharmacology the mechanism of action is highly conserved so obviously the same target they all share an episode.
All cause for example, similar amounts of receptor internalization.
Miller Lite block receptor Autophosphorylation, when we say similar mechanism of action. That's that's the preclinical data that will be referred to.
So that gives us high confidence in <unk> that it should deliver efficacy like tecumseh, but.
We need to prove that right. That's why we're running proof of concept cohort for <unk>. One the way we are so very quickly answer the question can we see.
Strong robust efficacy in the ballpark.
Yes that was positive I would argue that we've we've proven that the benefits of tests are generalizable.
And I think that should read through to some extent or to <unk>.
That's a different molecule. So we're not going to argue anything for <unk>.
Regulatory perspective, but it would certainly increase our confidence.
It makes a lot of sense. Thanks, guys.
Thank you. Our next question is coming from the line of Laura Chico with Wedbush. Please proceed with your questions.
Hey, good afternoon, guys. Thank you for making the time I've got three for you first.
John You mentioned the differentiation on the affinity between tip has oh, one I'm wondering could you clarify how you think about the differences and half life between one one and to peso.
Sure well, if we look at non human primates in oncology studies. The Teekay is very similar for <unk>, one and 2000.
And that makes sense, they're both unmodified IGT ones.
And so our expectation would be that in 10 patients. Likewise that has similar PK and so the difference for <unk> is both the higher Syn <unk>, how we're going to study it.
Okay.
Okay great.
One follow up then.
I guess I wanted to ask on the potential to demonstrate any separation from <unk> on the adverse event profile in the first proof of concept study I guess, what duration of treatment, Virginia to see potentially could tease out differences on aes and what areas would seem the most logical to see differentiation on I guess there was a recent public.
Patients that detailed hearing dysfunction among separate patient case studies report this was still demonstrating about 10% continuing to have hearing loss had a longer term follow up.
Right. So keep in mind that we're starting with small cohorts to pencil in doses and so are our baseline expectation would be similar levels of aes.
In fact, as we said, we're sort of bracketing the positives right.
Nicole the programs to get to lower doses. So if we see.
The similar frequency the easiest of Plaza attendees for good reason that they will go hire the 20th for Kingdom, that's fine right.
Goal is not to be commercialized at those doses. The goal of these proof of concepts cohorts is to as quickly as we can prove to be up a highly active drug stream.
From there then extension cohorts will be able to look at different doses different dosing regimens.
To see if there is an opportunity to have a we're describing it as a less burdensome treatment paradigm with lower dose lower numbers fusions.
But the kind of differences in adverse event profiles that we're interested in that we're actually quite excited about theyre only going to emerge over the long run. So the baseline we should expect a similar rate of aes with an upside that overtime as we collect data.
Maybe we'll be able to see a lower rate and lower severity of disease.
Okay. That's very helpful and maybe last question for Christian.
Reflective of the forward spend our corky levels I guess should we presume. These are reasonable run rates to build off of in 'twenty. Two in terms of R&D and SG&A spend or were there any kind of onetime costs in the <unk> numbers that we should consider as we're modeling forward that's not thanks.
No these are reasonable rates to assume going forward.
So as.
As I mentioned.
The spend.
Get us into 2024.
Thanks, guys.
Thank you our next questions come from the line of Jason Butler with JMP Securities. Please proceed with your questions.
Hi, Thanks for taking the question then.
That's on the progress just want on a potential path to market for a sub Q formulation of O. One.
Is there a potential for a parallel path here and both an IV and a sub Q being included in our first BLA or is it more likely that that is.
If you would advance the sub Q1 it would be subsequent subsequent filing.
Yeah.
Yeah. Thanks, Jason So we've not we've not given any guidance sort of later stage development honestly, we don't want to tip, our hand, too soon but between the high affinity, but one as we've said we see a lot of value in it.
As an upside opportunity, possibly for sub Q, but then with the <unk> with half life extension that we think should really differentiate.
Monarch is performance from everything else in between class right now.
That's sort of the long term win for sub Q, but exactly how we build out our portfolio.
We're excited about what we're working on it.
<unk>.
Great and then.
How predictive worthy.
The preclinical PK data for it to pass earn for all one and I guess, just how does that speak to your confidence in the ultimate PK profile, you'll see for O. Two based on the preclinical data you've already generated.
Yes so.
Both temporary and over one and really all of the first generation <unk> antibodies.
Very chip that will have lives that were in IGT, one antibody nothing stood out about them.
So.
We don't expect any strange funded with <unk> with half life extension.
There've been a number of examples now of these FC modifications that increase antibody recycling, so theyre jumps back into the bloodstream rather than destroyed.
Very reproducible nonhuman primate PK is translated to.
Better PK in humans in fact, many many.
The precedent clinical programs should a bigger increase in humans then.
<unk>.
Non human primates.
So it's a highly validated technology, we've seen about a two fold improvement in halfway through two in non human primates compared to over one from chaparral.
And we'd be looking to see that or better.
As a differentiated profile in our first in human study.
Great. Thanks, Thanks for taking the questions.
Thank you. Our next question is coming from the line of Michael Higgins with Ladenburg Thalmann. Please proceed with your questions.
Thanks, guys for taking the questions just a follow up on your comments I think in your prepared remarks, Jonathan about the market research on the IV and so Q, it's intriguing that youre finding value because the idea if you could expand on that a bit is that related to reimbursement as it related to the setting of the patients curious thanks.
Yeah. Thanks, Thanks, Michael Hi.
Look I think this market is bigger than people realize a few years ago.
Certainly other markets quite.
Quite different in their own way, but thats.
Durably supports different routes of administration and think about the multiple sclerosis market right.
It's just not the case that.
Markets turned over fully from one.
Dosing route to another so Ivy obviously is growing quickly it is going to be established treatment paradigm and well, we do think that a lower volume of Q.
And it's going to be easier.
Represent for patients the IV market is never going to go away and it's big enough.
Do you think Thats, an interesting things to do there as well as bringing affordable sub Q.
Okay.
Interesting and then.
The question on <unk>.
And the data we're looking for 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 our second cohort. Thanks.
Yes, I don't know that depends on timing and of course, what we what we want to hold back for a medical meeting.
So I just don't know yet obviously, we're focused on the six week endpoint.
10 point, that's where I think everyone will do cross trial comparisons to ask is just delivering depends on like efficacy, where and again, we will have the proptosis measurement, but combining that with the clinical activity score with.
Opiate double vision, we should have a very rich sense of how the drug is performing so that six week endpoint for US is really the key and then as we talked about a few minutes ago. The 12 week follow up I think is really interesting in terms of informing us what might be possible as we go into the team.
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 that's come through and coming through just curious how at this stage here in March how much value you put on the additional cohorts from go below two.
Since it's kind of a.
Our sequential or at least a delayed start from Buffalo on of course.
If you continue to wait or are you just simply.
Pursue advancing go below one.
So I had a quick question is would we wait for two data.
Advancing older ones that your question.
Yes, basically just wondering how far deep in the double low twos cohorts do you go before deciding what to do a couple of months.
Yes, so so.
As we talked about earlier, we think <unk> is a lot of value.
And a second entrant, we think we can do with the performance.
It's really cool.
So we'll be moving forward, assuming we have positive data as quickly as we can and situations.
That's not really dependent.
Two.
The healthy volunteer data.
Sue.
Really it's going to help define how.
How we developed though too right. Once we have left we understand how well the half life technologies. Working then we can construct sub Q dosing paradigms that makes sense.
And patients based on the data already PK models, they're going to continue to evolve as we have clinical data.
<unk>.
Well have everything else we need.
From a non clinical and CMC perspective to move into sub Q proof of concept ROE too. So we really see or want to know to moving forward in parallel.
That's great Super helpful. Thanks, Sean.
Thanks, Mike.
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.
Yes.
Thank you and thanks, everyone for joining us today.
Hope you heard we are very excited about the <unk>.
And the progress, we're making across the pipeline and our upcoming milestones. This year. So we will look forward to updating you as our programs events and with that we'll close the call.
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.
Yes.