Q1 2022 Immunovant Inc Earnings Call
Okay.
Good morning, My name is Melissa and I will serve as your conference operator today.
At this time all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded and joining.
Joining me on the call today will be Dr. Piet Saltzman.
<unk> Executive officer of immune event and Dr. Frank Torty executive chairperson of immune event.
Before we begin I'd like to remind everyone that today's conference will include certain forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.
These forward looking statements include for example statements regarding the potential efficacy and safety of immune events per product candidate and immune events expectations regarding the timing design and results of clinical trials, including the timing of future data readouts and announcement of future indications.
These forward looking statements are not guarantees.
Future performance and are subject to various risks and uncertainties assumptions known or unknown, which could cause actual results to differ materially from those indicated or anticipated for more information and investors are encouraged to review them and events. Most recent quarterly report on form 10-Q filed with the SEC on August 9.2021.
Now I'd like to turn the call over to Dr. Pizza Hoffman and thank you Dr. Hoffman and you may begin.
Yeah.
Thank you Melissa.
I want to take this opportunity to thank everyone for joining the call today.
I realize that we do not always do quarterly earnings calls, but because we have been more limited and our ability to interact with the investment community over the last several months and typical we wanted to take the opportunity to have a call today to highlight the results for the quarter and engaged and the dialogue around our go forward strategy.
I will start the discussion today with a brief recap of our financial results and close with some comments on our progress.
With that I'd like to begin by briefly reviewing our financial highlights for fiscal first quarter ended June 30th 2021.
R&D expenses reached.
Search and development expenses were $18.7 million for the 3 months that ended June 30th 2021, compared with <unk> compared to $16.9 million for the 3 months that ended June 32020.
The year over year increase primarily reflected higher personnel related expenses and increases related to clinical activities for analyzing data and the program and why data revenue, partially offset by lower contract manufacturing costs.
N a.
General and administrative expenses were $11.2 million for the 3 months that ended June 30th 2021, compared to $9.7 million for the 3 months that ended June 32020.
The year over year increase was primarily due to higher personnel related expenses.
Net loss and net loss was $30.5 million or 31 cents per common share for the 3 months that I Didnt June 30th 2021, compared to $26.7 million for 38 cents per common share for the 3 months and ended June 32020.
Net loss for the 3 months that ended June 32021, and 2020 included 3.9 and 4.0 million respectively related to noncash stock based compensation expense.
In addition to the first quarter revenue results that I just briefly reviewed we announced last week, a $200 million direct investment by Roy man into immune event.
I'm joined today by Dr. Frank Torty, the executive Chairman of immuno Vantage was also a member of REIT and senior leadership team.
Frank I believe you are and a unique position to put this investment into perspective, which I'd like to ask you to do.
Thanks for you and it's a pleasure to join you today on the call and be able to express my excitement and support for the company and this investment not only as the executive chair and universe, but also with representatives from the worry about and management team.
As a member of <unk> and senior leadership team I know the rigor with which we're about the investments from SaaS and there's significant investment as further evidence of brake pads and continued confidence in and commitment to mirror that both now and importantly, and future funding.
Fundamentally we believe 14 and wanted to unique asset.
And our view of the mechanism and validated for successful phase II and III trials across numerous studies and sponsors and.
There was a proof of concept and multiple indications and we have the potential and 14 or wanted to deliver the most flexible and patient friendly dosing experience with the best form factor and the class.
And we've always found the class BMT FTR and market exceptionally attractive.
Due to a wide range of indications that the mechanism could potentially address and that's something that's been said before but if you look at the pace of new indication announcements from all the companies and the field.
And development intensity around the mechanism.
And there are now for example companies targeting approximately 15 more and more distinct indications with anti STR and therapies with at least 5 for those indications being disclosed only over the last several months.
And these indications are characterized by high unmet need.
With its feel outdated standard of care, often consisting of a broad spectrum suppressants and IPG and so the opportunity to take share and remake multiple existing markets as well as to create new ones is really remarkable.
And we've now observed from the data and go to Matt described in June and and and other analyses that 14, and 1 is even more potent than we initially expected, which opens up a path for us to be uniquely flexible and our dosing and dose strategies.
The address the myriad of diseases that can be impacted by yes, you are right and.
And particularly the flexibility and dosing and not only enables and go to back to design programs to target the ideal level of Igt's depression, and a particular disease, but.
But we believe also will enable new bands and dosing regiments, where changes and albumin and that'll be all outside of normal limits will be mostly either modest or I'm sure for duration during the induction phase for example.
And in addition, when you think of a single like lipid elevation and our ability now to consider things like dose dose interval induction and maintenance and inclusion exclusion criteria baseline and lipid levels treatment with anti lipid therapy et cetera, and just generally bring a degree of thoughtfulness to the issue is of course much different now than it was 1 and this was the unexpected signal first with margin.
So I think you'll see design elements that take advantage of 14, and 1 flexible profile from our trials and in the future.
With that said this is a landscape that is moving fast with well capitalized competitors for certain indications aggressively.
And for example, the organic rates of about $1 billion and February 2.8 and the advancement of their drug and and now 6 different indications and they said they plan to have 15 by 2025 J&J is likewise moving aggressively post the acquisition of momentum and a field with that degree of the best and it taking a serial and stepwise approach and not the strategy, we're worried about and thought best position the company for long term.
Success, so and so our investments are really designed to allow the company to move forward and unencumbered way and and.
And let the team and really be aggressive with their clinical development approach.
And in particular, we fully appreciate the unique features of this anybody offers in terms of a very broad therapeutic window with its convenient and low volume subcutaneous injection form factor. So we think it made events for 10 and 1 can really make a big difference for many many patients but to realize that potential.
And we know of your advanced going to need to execute and ambitious clinical development plan and.
And some cases and meet them and is already ready to run and pivotal trial and include design elements that will differentiate fortino, 1 versus competing assets and the class.
Other cases and minimum that will be running first in class proof of concept studies and new indications.
And to be a leading anti SCR and which we definitely believe them yet and that can be in 14, and 1 can be will need to execute many of these trials in parallel and that.
That's where the incremental 200 million dollar investment really made a lot of sense to ensure we can drive from long term value creation.
Now when you step back drugs with validated mechanisms very large market opportunities and transformative potential markets. This big just don't come around very often.
And with approximately 575 million now and the balance sheet and is well equipped to focus on the execution of their trial as well as expanding into new indications.
And Arabian and incredibly excited about the prospects of working and are 1 and we're eager to support and you and event.
Through this investment and through broader engagement and I also look forward to personally and continuing to work closely with Pete and immune about team to help develop 14 and wanted to help maximize the benefits for patients and to drive future value for all of our shareholders and so.
Thanks for having me on the call today and with that I'll turn it back to Pete for some additional comments.
Yeah.
Thanks, Frank that's a great overview.
For I get to the 200 million dollar investment from right, Matt I'd like to discuss myasthenia gravis from both a strategic angle and in terms of execution.
Let's start with execution.
I believe we are on track to gain alignment on our pivotal Mg design with the FDA and Q4 of this calendar year.
In fact, we have communicated with FDA regarding a meeting early in Q4 to review modifications to our pivotal phase III study in Mg.
These modifications are based on the agency's advice and feedback changed during our previous and the phase 2 meeting and are also based on our recently communicated program wide review.
Contingent upon the Fda's feedback, we receive and Q4, we plan to initiate a study and the early part of 2020.2 and we're very excited about how this program is shaping up.
And any alignment with the FDA and getting back into the clinic will be and important catalysts for immuno and especially giving the remaining opportunity we see for patients and for 14 and won based on our understanding of patient needs and fortunate ones potential.
I also think the strategic opportunity for 14, and 1 is underappreciated by the market.
Not surprisingly and meet them and some market research highlights the enthusiasm that neurologists have for the anti F <unk> and class generally.
The rapid onset of symptom control and the percentage of deep responders have been impressive, especially given that studies reported to date have involved short term dosing.
Recently, our marketing and medical teams dug deeper with patients and with physicians, who treat large populations of patients with myasthenia gravis.
This research highlights something very important specifically the patients strongly desire to avoid relapse.
When patients with myasthenia gravis relapse weakness and symptoms can occasionally get much worse very quickly.
Relapse can be a crisis.
And so patients 1 study control.
At the same time physicians and patients do desire to minimize immuno suppression and the long run.
I think that is why and induction and maintenance approach resonates with clinicians.
Fortunate ones broad therapeutic window is very well suited here our higher dose has achieved the rapid and deep agg reduction needed to maximize the initial clinical response.
And then a broad therapeutic window and convenient subcutaneous dosage form enable us to design, a study that steps down and ITG suppression to match patient's needs without the PK PD extreme so cyclic therapy.
On June 1st we disclose data regarding fortunate ones broad therapeutic window and the insights gained from the comprehensive program review.
I want to emphasize that these insights inform our enthusiasm for the potential of 14 and 1 broadly not just in Mg.
Patient needs differ by indication by severity and by stage of disease and we believe this variability is best addressed with a therapeutic option that offers a range of treat to target IGD suppression levels.
The flexibility and dosing not only enables us to design programs with the ideal level of IGD suppression.
But as Frank said, we believe this will also enable us to design dosage regimens, where changes and albumin and L. D. L outside of normal limits will mostly be a short term duration during induction.
What we've seen to date is that dose dependent changes in LDL are predictable and reversible.
We've also seen that the PK PD curves for agg differ from the PK P. J curves for albumin and therefore LDL.
And our models predict that as we go from high doses during the induction phase to more modest dose during the maintenance phase and the albumin and LDL will generally will generally returned to values within normal limits, while IGT and will remain suppressed at levels that are likely to maintain a clinical response for most patients.
I expect our Mg protocol, and frankly, our protocols and many other conditions to be unique and differentiated in this regard.
Moving onto another condition and I'd also like to review our approach to thyroid eye disease as.
As we previously disclosed we had to prematurely terminate our phase <unk> study for 14 and 1 in moderate to severe Ted due to our unanticipated program wide lifting from you.
Prematurely just continuing our study is always difficult, especially for patients and investigators and in this case more so it was only 41 of the projected 77 subjects to be randomized completed the primary efficacy evaluation at week 13, a bit over 50 per cent.
Consequently, the question that this study was designed to answer that is whether a 12 week course of 14, and 1 improves proptosis could not be answered with any certainty what.
What we did observe is that 14, and 1 and a dose dependent manner decreases total agg and thyroid stimulating stimulating immunoglobulins and.
Previously disclosed and review of the data from the early study visits when approximately 85 per cent and be enrolled patients were assessed for Proptosis response at each visit.
That's a 680 milligram dose and possibly the 340 milligram dose, but achieved a meaningful separation from placebo.
We believe that the 14th and want induced declines and total agg and thyroid stimulating immunoglobulins, coupled with the efficacy trends observed at the early visits when most of the enrolled subjects were evaluated for these efficacy parameters are promising.
We've also been following the evolution of the market carefully over the last couple of quarters.
Right and it was a very early believer and the potential of thyroid eye disease, that's an indication having design studies as early as 2019.
The initial enthusiasm was driven by and understanding of the unmet need is very high and that the addressable population was solidly in the range of other rare diseases.
It might surprise people to recall the temperature and the mass phase II data was originally published and the New England Journal of Medicine and 2017.
Nevertheless by 2019, Juan Ramon was designing the 14 and 1 trials I don't think the opportunity was fully appreciated.
Today that is certainly no longer the case as temperature momentum launches clearly validating the market opportunity.
Physicians and patients are enthusiastic about medical therapy for thyroid eye disease with decreased ocular symptoms and reduced need for surgery.
These benefits are great for many patients.
However, insulin growth factor also appears to be a pretty foundational pathway across many organ systems.
Walking this pathway may have consequences beyond the extra ocular tissue that is the target and thyroid eye disease.
I'm aware of a recent study presented at Endo 2021 Virtual conference that reported 65 per cent of patients receiving tempur Timna Mab and a small case series experienced autological symptoms.
Hearing impairment, including deafness is also reported and the FDA label, that's having a greater incidence on tap for 2 of them Atlas compared to placebo.
It's early days, so we'll have to see how this all plays out in terms of clinical experience and product lately, but I do think it highlights and opportunity for our product with a different mechanism of action and a potentially different benefit risk ratio.
Another important point regarding thyroid eye disease relates to the market potential that ROI and that recognized a couple of years back based on really understanding patient needs and.
And my experience across a wide range of autoimmune conditions with high unmet need physicians and patients not only appreciate but also really need medications with different mechanisms of action.
Given the diversity of individual patients, it's almost inevitable that some patients will respond better to 1 mechanism and others will respond better to a different mechanism of action.
And that patients who are severely or even moderately impacted often require sequential therapy with different mechanisms of action to get close to being fully well.
Bottom line and I'm really excited about the opportunity for patients and for 14 and wanted to Ted.
We've also been working on getting the warm autoimmune hemolytic anemia program and he started.
We found the data are generated prior to the clinical caused to be compelling, albeit on a small dataset of only 3 patients who completed 11 for 12 weeks of therapy.
Extra experts, who reviewed our data with us shared with us that spontaneous improvement is uncommon and these patients after failing multiple rounds of steroids and immunosuppressants.
In particular I find our observation that 1 of the 3 patients experienced a very strong response and maintain this response throughout the treatment period to be very encouraging.
This large improvement and hemoglobin can be achieved with very high dose steroids, but very high dose steroids, just arent a long term solution.
And so pain patients and up tapering down relapsing or partially relapsing and then many of them are still getting intimate and blood transfusions and <unk>.
Certainly not an ideal standard of care.
I said earlier that I wanted to get back to talking about the importance of right around $200 million direct investment and this is probably a good point to do that.
As Frank mentioned earlier, there are 15 indications being actively studied across the MTF sooner and class.
And that's remarkable.
People are very excited about this class and I agree with Frank that the REIT strategy is for ambitious parallel development.
We're now well positioned to pursue this strategy.
With regard to the timeline for providing additional updates updates I'll just reiterate that we expect to provide a meaningful update on our MG program by the end of the year, specifically that we've achieved alignment with the FDA.
We expect to do the same thing for our Tad and weihai programs and early 2022.
Behind that will be announcements of our new indications later in 2022. Once these are ready to go with regulatory alignment.
We also plan to hold and R&D day, and the first quarter of 2020.2.
And I'm sure that will be very interesting.
In summary, we expect a steady stream of strategic and execution updates that we believe will be very exciting for investors followed later by data across a wide range of indications.
This strength of updates and even more so the stream of progress and immune events development program and it gets very enthusiastic about our prospects.
With that I'll ask the operator to open the line for questions.
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Our first question comes from the line of Robert and Carnival with true Securities. Please proceed with your question.
Hey, guys. Good morning. Thanks. Thank you so much for taking my call. This is Chris on for Robyn and so the peer mentioned comp to initiate clinical trials and at least 2 indications. Maybe you can talk you talked about all the 15 indications that etsy I ended up being investigated in cash.
You talk a little bit of other rationale behind and selection of these indications and.
And just a little confused you said that at least 1 of these trials will be a pivotal trial is that beyond M G pad and way huh.
And then maybe it's a little too early to talk about it but at 14 O..1 plays out the way you expected to income how do you see the market evolve and Ted Thank.
Thank you.
Thanks for you on a great set of questions. There. So first your first question related to our selection criteria and and <unk>.
Mentioned that there are 15 different indications now posted to Clint trials don't cover across the entire anti F. Sierra and class, how we select which indications we're going to pursue next.
I think that's a you know a pretty classic type of analysis that we're doing with the probably the 2 most important elements being the probability of technical success. How good of a fit is the anti F zero and Max mechanism for the.
Particular disease and question as 1 element and then secondly, the degree of unmet need how much op.
<unk> is there to benefit patients and addition of course, we'll consider the unique features of fortune and 1 that I had discussed including the broad therapeutic window and they're really simple subcutaneous form factor.
And and then some other logistical factors like the clarity of regulatory endpoints. So all that goes into.
Our decision, making ultimately we want to have a set of indications some of which we have an opportunity to be best in class, where there's already been clinical validation and perhaps buy another asset and then some indications where we can be first in class.
And I think that's for your.
For your first question with regard to the statement around <unk>.
And 1 of our indications beyond M G being pivotal.
That could apply to weigh how Ted or 1 of the new indication. So we're thinking about those for indications as a group and we believe that 1 of them.
I'll begin with a pivotal trial in 2020.2 and then we'll also have the previously announced pivotal trial and M. G. So that's 2 pivotal programs in 2022.
Finally, with regard to thyroid eye disease, I think it's just a really really interesting market you know, it's a like many of the auto antibody conditions for a long time, there wasn't a good therapy and there were some therapies for sure and there was good surgical therapy for patients who had extreme.
Impact of thyroid eye disease, but there just wasn't a good medical therapy.
So with the advent of new innovation and.
With the launch of temperature and my math I think what physicians are experiencing is that there is a lot of unmet need and this marketplace and a lot of opportunity for patients to benefit.
Separate from that it was of course indicated for relatively short term therapy, having been studied for 6 months and that achieves the high degree of initial Proptosis response, which is great.
And thyroid eye disease is not.
And as chronic or the condition is something like myasthenia gravis, but some patients are still impacted after their 6 month course of therapy and other patients relapse. After the therapy has stopped so all of that makes me think that over time. This market will evolve to a situation where patients many patients will be true.
And sequentially with more than 1 mechanism of action to get them as close to normal as close to fully well as they can be and to maintain that response as long as possible.
Great. Thank you so much.
Yeah.
Thank you. Our next question comes from the line of Thomas Smith with SBB Leerink. Please proceed with your question.
Yeah.
Hey, guys. Good morning, Thanks for taking the questions and thanks for the update.
And I guess first in terms of 14 and 1 dosing are there any additional analyses that are being conducted on the previously collected data and if so when can we expect to see these analyses communicated.
Yeah. Thanks, Tom for that question. So we are taking the totality of.
Data that we have from all the patients who were dosed with 14 and 1 prior to the.
Pause and dosing and.
And continuously refining our models to give us and understanding of how dosage regimens that we havent yet studied might perform that's obviously as you know the the the rationale for our PK PD modeling. So yeah. We're looking at a lot of different potential dosage regimens and we expect.
Those to inform our protocols going forward and I would expect that.
Detailed information regarding the output of our models and the design of our protocols, including any new dosage regimens would be part of our R&D day, and the first quarter of 2022.
Okay that makes sense, that's true and then.
It sounds like you're relatively close to.
And then a pretty good idea of the trial design for the pivotal MG study I guess, what else would you be able to share with us.
In terms of details around that study and then I guess you know what the.
What you feel are the major outstanding perhaps gating factors to starting that study and gaining alignment with the agency.
Right right. So in terms of the the protocol itself I mean, I think you know as I've indicated I see a lot of opportunity for and induction and maintenance type of approach. So I think the protocol that we.
We ultimately achieve alignment with the FDA on which of course is.
Dependent on any final feedback they have will we'll have a we'll have that flavor.
In terms of gating factors, it's really just the logistics of.
And the back and forth and gaining alignment with the F D. A.
That we have 2.
<unk> worked through at this point.
Okay, and then maybe 1 last question Pete in terms of.
I guess your your overall engagement with the agency across 3 different divisions. If you can maybe speak to.
I guess any other gating factors that you feel like are outstanding in terms of being able to restart the Whitehall and thyroid eye disease programs.
Right right.
It's really the same element is what I just mentioned for myasthenia gravis, obviously, we have the most.
Data and myasthenia gravis and so that is.
And that's a good place to start having completed and under phase 2 meeting with the division previously and so.
So that that interaction will be will be the first 1 and then the interactions with the other divisions will follow and there's obviously a whole host of background information that.
Is the same for any interaction and a lot of that will be reviewed first with the agency via the interactions with the neuro Division.
Okay, great. Thanks, Pete and I appreciate you guys for taking the questions.
Yeah no problem.
Thank you. Our next question comes from the line of Douglas Tsao with H C. Wainwright. Please proceed with your question.
Okay.
Hi, good morning, Thanks for taking the questions.
Yeah, Pete as you think through indications and prioritization is there and any change for thinking I'm, just given sort of some of the flexibility in terms of dosing and managing the albumin levels and LDL levels that will be needed. Thank you.
Yeah, I think the big insight came.
Just as we were doing our final preparation for the June 1st.
Call and finalizing our 10-K and that was really rooted honestly and.
Optimizing efficacy within immunology conditions and what we.
Came to realize dog is that.
Across a wide variety of immunology indications.
Hugh you want to optimize efficacy by treating hard upfront with induction and then minimize the patient's long term immuno suppression by tapering down a little bit maintenance phase. So this induction and maintenance phase is really.
Used across a wide variety of mechanisms and indications to optimize the efficacy. So I think efficacy is always 1 of the most important things for any new asset.
We then realized that this approach was also attractive from an albumin and they'll be all standpoint, primarily because as I mentioned earlier today and previously the PK PD models are different for.
Agg and for albumin and so you get a.
Much steeper.
All off of the albumin impact as you stepped down the dose as compared to the reduction and the agg. So that allows for a sort of a sweet spot to be achieved for chronic dosing with a with a more mid range.
It was put in and see that still have really good hi, Judy reduction remember, we reported a 62% median reduction and hygiene for the 255 dose while having a much more modest impact on albumin, and therefore, LDL where that dose at a <unk>.
16%.
The decrease and albumin and <unk> 15 per cent increase and LDL speaking about the <unk> 5 dose. So that's really that's really fundamentally what I think is going to provide us a great path forward and a lot of indications.
Okay, and so just to clarify so you don't really see this being sort of a limiter in terms of what indications you may or may not pursue at this point.
I don't because again and the and the short term when you are and that induction phase.
The goal of the of the finished up with other physician and the goal of the patient is really to get the symptoms under control is really around efficacy there will certainly be some small percentage of patients who for whom.
Medication that changes albumin or LDL, even for a short term may not be appropriate, but that's going to be true of any asset there'll be a small percentage of patients that aren't our and ideally suited and then there'll be a large majority of patients who for whom this can be a really nice really nice option.
Maybe I'll ask Frank to make a point as well and this because I know he's thought a lot about this topic.
And we're not here and it yet.
He might be on mute, thanks, Pete and I think the and other people are aware of obviously as others and the field or thinking about some other issues right and if you. If you see how this manifest for example, and the need for calendar <unk> phase III design that and that has just been released by J&J and they did they didnt change much from the protocol. They wanted to go forward with.
Other than adding net.
Exclusion criteria for.
Patients, who had myocardial infarction and unstable angina heart disease or stroke within within 12 weeks.
And of screening so clearly other companies are grappling.
And the field kind of similar kind of issues with the FDA and thinking about how they go forward and we'll take the lessons obviously from those.
And those points.
Okay.
Great. Thank you so much.
Thanks, Doug.
Thank you. Our next question comes from the line of Sam Slutsky with lifestyle camping and I'm. Please proceed with your question.
Hey, good morning, everyone. Thanks for.
Yeah. The presentation. Just 1 question for me in terms of resuming development and way Hot and Ted are you able to discuss what the general design and size of the next studies might look like.
And then for Ted can we expect to see data from the phase III study prior to next steps.
Yeah, Great question, Sam So the 200 million dollar investment from ROI events, obviously allows us a lot of flexibility in our thinking for where we're thinking about the best way to approach both of those conditions and terms of next steps.
And the context of what we've learned so far and and the context of what we ultimately want to achieve which is a differentiated approval and those indications. So I am not yet able to to get more specific.
Beyond that in terms of the the releasing the thyroid eye disease data and greater granularity.
Prior to gaining alignment with the FDA on our next trial I don't think we'll do that I think right now we have a lot of information that we're pouring over.
Confidentially with some advisors and design and using that to design our next.
Our next trial and thyroid eye disease, and then probably at the time that we announced that.
That design for that next trial it would be a good time to share more detail on what we've observed.
Okay got it thanks.
Thank you. Our next question comes from the line of your attention Egypt with Guggenheim. Please proceed with your question.
Hi, This is evan on for yacht and thank you for taking our questions.
And what specific steps would you take to mitigate the LDL issue.
And the Ted trial that Youre, starting up again is there anything that you're doing beyond potential adjustments and the dosing regimen and.
And then I have a quick follow up.
Yeah, Thanks for that and so Howard I diseases is a little bit unique and that it's.
Likely a shorter duration of therapy.
So this is a condition that.
May just have induction and then.
And the maintenance phase could be off medication and that's essentially the temperature and the mab design, which makes sense and it and a condition that is somewhat self limited and thyroid eye disease resolves over a period of years versus many many for versus the other conditions, which don't resolve spontaneously. So I think given that the dosing.
And thyroid eye disease is likely to be of a shorter term duration.
And then it may be that there's nothing particular that needs to be done for lipid management, given that shorter terms of scary excursions and LDL.
For the vast majority of patients, particularly with some modest inclusion and exclusion criteria changes.
It won't really be an issue that said we are considering you know the kinds of things that you would imagine and and Frank highlighted briefly in his prepared remarks wishes dosage modification or anti lipid therapy that could that could that could play a role and thyroid eye disease programs as well. So all of that stuff is are things, we're looking at and we will get finalized over the next.
6 months here.
Got it and then just 1 quick follow up are there indications.
Vacations or subsets of patients within a particular indication across the 15 indications that you mentioned that are currently being investigated in the CRM space you know where these lipid issues are not that big of a deal.
Yeah, Theres, a theres a wide variety of comorbidities.
For most of the auto antibody conditions. The comorbidities are not actually that significant and that may be because for many of the auto antibody conditions theres not as a there is not as significant of a sort of total body inflammatory state is there are and some other more general autoimmune.
And conditions, but but certainly if you look across all 15, you'll find you'll find some variability I think you know maybe the most important point, though just to kind of keep hammering at home is that short term changes and now be L are not a concern for the vast majority of patients. So when there is a short term change associated with induction.
And I think that's not going to be such an important consideration, particularly if that short term excursions associated with higher efficacy because of the deep production and <unk> that can be achieved with induction with 14 and 1.
Got it thank you.
No problem.
Thank you ladies and gentlemen, this concludes our question and answer session and I'll turn the floor back to Dr. Hoffman for any final comments.
Thanks Melissa.
Well I appreciate everyone joining today's call and I'm sure you can really hear our enthusiasm based on.
Remarkable market opportunity and 15 announced indications across the classes. It's is really really unique I think.
Our enthusiasm is also based on 14 and one's differentiated profile with a broad therapeutic window and a simple subcutaneous injection and form factor and.
And based now on a strong balance sheet, enabling us to pursue and ambitious parallel development program.
Thanks, everyone.
Good day.
Thank you. This concludes today's conference you may disconnect. Your lines at this time. Thank you for your participation.