Q2 2023 Nektar Therapeutics Earnings Call
Good day and thank you for standing by welcome to the nectar Therapeutics second quarter 20, twenty-three financial results conference call.
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I would now like to hand, the conference over to your Speaker today Vivienne will please go ahead.
Thank you Chris all in good afternoon, everyone. Thank you for joining us today with us on the call or Howard Robin or President and CEO , Dr. Jonathan Lupski, our chief of research and development, Dr. Murray Tagliaferri, our Chief Medical Officer, Jennifer Roddick, our cheapest this officer, and Sandra Gardner or acting Chief Financial Officer.
On today's call, we expect to make forward looking statements regarding your business, including statements regarding the therapeutic potential of and future development plans for drug candidates in research programs.
The timing of the initiation of clinical studies and the availability of clinical data for a drug candidates the timing and plans for future clinical data presentations the formation future development plans or success of our collaboration agreements the expectations falling or corporate restructuring and reorganization plans financial guidance and certain other statements regarding this.
Feature of our business because forward looking statements relate to the future, they're subject uncertainties and risks are difficult to predict.
Many of which are outside of our control.
<unk> results may differ materially from these statements.
Important risks and uncertainties are set forth in her Form 10-Q that was filed on May 10th 2023, which is available at S. C C Dot Gov.
<unk> take no obligation to update any of these forward looking statements, whether as a result of new information future developments or otherwise.
[noise] webcast of this call will be available on the iron page of doctors website at <unk> Dot com.
Before turning over the call to Howard I would like to note that Jennifer will be moderating kunai session for our team. So we can avoid technical issues. During the session. We appreciate your patience with that said I would like to hand, the call over to our president and CEO How're Robyn Howard.
Oh, Thank you <unk> and thank you for joining us today.
First half of this year's been a pivotal time in April .
New strategic plan that focuses on our immunology programs and also extends are charged one word.
The middle of 2026.
Our most advanced programs Roseburg, which a large <unk> study is being initiated shortly for patients with a childhood dream hoteliers.
More about that than yesterday's announcement in a moment.
We're also continuing to advance are preclinical programs in an analogy a T N F. R. Two arguments and your body you have to see it.
First one program.
Our goal is to file an I M D for one of these programs in 2024.
Visually we're continuing the two phase two randomized clinical studies for an extra 255 and solid and liquid tumors.
With a new strategic plan.
We've we've created a company that is strongly positioned to get too important to value enhancing phase two catalysts in 2024 and 2025.
And these will come will before our cash one word gardens, which extends us into at least the middle of 26.
So first and foremost we're committed to advancing website.
Our first in class regulatory to sell program.
<unk> is now a wholly owned a set of letters and preparations are well under way to initiate a randomized phase two B's study forest Burg in patients with a topic during the charges and we expect to have initial data from this study in the first half of 2025.
Yesterday, we announced that clinical efficacy data previously generated by Eli Lilly for Rosemary <unk> incorrectly calculated for both the topic dermatitis and for psoriasis.
Discovery was made after all rights to Roseburg, where returned connector and the raw data files from the roadside clinical studies were transferred to nectar.
The internal statistical in clinical teams in charge of these two studies at Lily.
Aware that nectar discovered the data.
Lily confirm the errors in writing and written communications with nectar.
The new incorrect data from the topic dermatitis study demonstrates at 12 weeks of <unk> therapy at the highest dose resulted in a medium size for improvement of 83% and <unk> 75 response rate of 41% <unk>.
The correct data also show <unk> resulted in a very rapid and steep drop any size for us shortly after therapy start much sooner than existing biologic therapies approved today.
One of the most interesting attributes of <unk> is that when the 12 week induction treatment period was over and treatment stopped the.
The main drop any size four continues for patients were followed in this study.
The possibility that respected offer both a differentiated mechanism to the existing fields of Iowa, 13 therapies and are a bit of effect for patients is clearly a provocative one.
The biologic treatments landscape or a topic dermatitis is significantly growing the approvals of Dupixent and other IL 13 based biologics have driven this growth.
About 16 million people are living with a topic dermatitis in the U S alone with 75% of these affected by moderate to severe disease.
In 2021 biologic sales for atopic dermatitis, we're close to $5 billion in these sales continue to grow.
An agent like Red tag that eliminates the need for frequent dosing after induction treatment period would be highly disruptive to the multi billion dollar biologic treatments landscape for atopic dermatitis for the therapies available today and near approval.
Continued in frequent dosing is required to maintain benefit.
And in many cases, when a therapies removed patient see their eczema atopic dermatitis return.
And we also know that at least 50% of patients and I owe 13 therapies sales to adequately respond to therapy.
So clearly respec holds great promise for treating patients with a topic term Titus.
And these corrected data.
Reinforce nichter strategic plan to invest in a robust phase two study for respect.
As we stated in our press release yesterday.
We plan on holding an investor meeting and key opinion leader meeting in the coming weeks.
To discuss these data insured the study designs for the fees to be trial for rest begging the topic dermatitis.
J Z will discuss more on the corrected respect data in a moment and also discuss are early stage immunology programs.
With respect to oncology asset an extra 255, we're continuing to evaluate potential strategic partnership options for the program at the same time as we are continuing to phase two clinical trials.
I've asked Mary to join us to share more about the ongoing clinical studies for <unk> 255, and with that I'll have to call over to J Z to discuss <unk> and our preclinical programs and immunology Josie.
Thank you Howard.
Starting off with our lead Immunology program <unk> is a unique molecule that aims to address the underlying too bad deficiencies and consequently over activity in the sector T cells and auto immune diseases.
Selectively activating an expanding T Rex.
<unk> provides a completely different mechanism of action compared to the other drugs that are currently approved or under development and the topic dermatitis space.
This program is uniquely positioned has the most advanced IL two based T. Reg mechanism in the clinic.
That's Peggy as potential then multiple auto immune diseases and while right now our focus is on a topic during the Titus there are plans to explore <unk> other auto immune indications in the future.
As Howard mentioned, we discovered the data previously reported for <unk> by Eli Lilly was miscalculated.
The primary errors were related to miscalculations for the easy score and the passing score is.
As well as the easy related and positive related clinical efficacy endpoints reported at DB in September of 2022, and the topic Durbin Titus and psoriasis posters that were presented.
This discovery was only made after all rights to rest pack were returned to nectar and the raw data files from the <unk> clinical studies were transferred to nectar.
A leading independent statistical firm was unemployed to analyze the raw data de novo.
The firm confirm that the original statistical analysis calculated by Lily were incorrect.
For a topic during the tightest easy as the validated and widely used standard measurement for a topic dermatitis studies.
That has been used by clinicians and reported in the literature for over 20 years.
The easy measures the severity of a topic term potatoes for patients and scoring ranges from zero no disease to 72 maximal disease.
The corrected and audited interim data analysis for the topic dermatitis study utilizes the validated 72 point easy scoring system and includes all the patient data that was available at the time of the E. A D V 2022 data.
The data demonstrate that 12 weeks of rest Peggy therapy at the highest dose resulted in a mean easy score improvement of 83 per cent with a P value of 0.002 as compared to placebo.
And an easy 75 response rate of 41%.
In addition to the strong efficacy we observed at 12 weeks of treatment with Raspberry, which is at least in line with or better than efficacy observed after 16 weeks of treatment with <unk>, which in phase two a in phase two these studies showed a 74% and 68% improvement respectively.
An important observation in the new incorrect data <unk> also provided a rapid and steep drop an easy scores immediately after initiation of therapy.
Specifically after only two doses of <unk>. The main drops was minus 71% for the highest dose the week for time point.
The corrected data also reinforces the remit of effect and durability of <unk> responses and atopic dermatitis patients is.
Howard stated the possibility that <unk> could provide for the first time the therapy that could be dose less frequently than anything patients have available now and.
And could provide real long-term durability.
With a differentiated T regulatory mechanism that we specifically designed.
The underlying scientific basis for why this is happening has been hypothesized for some time.
The concept is that stimulating the T regulatory cells could result in the re education of the immune system.
Treating the underlying pathology to not just the symptoms of the disease.
These clinical data provide for the first time, a novel clinical finding demonstrating at the tea rag mechanism can translate into effectively what looks like memory of the immune system, resulting both in long term durability and strong efficacy and a topic dermatitis.
This is the first clinical observation of a teabag stimulating therapy being efficacious and a topic dermatitis and has the key opinion leaders extremely enthusiastic.
The durability of response, we've observed has not seen with dupixent or the other agents in the aisle for an iOS 13 class or with Jack inhibitors.
And again this has us in kols very enthusiastic about the potential for long lasting responses and infrequent maintenance dosing with rest peg into setting of atopic dermatitis.
There were no underlying swarm your leg or mathematical miscalculations of the other efficacy and points presented at a D V last year.
However, I'll point out there with all the patient data included in the new incorrect data.
Was also some improvement in the V. I G. A responder and N. R. S. Itch responder endpoints from what was previously reported at a T V.
For the highest dose of Ratbag V. Iga increase from 24% reported it E. A D V up to 29%.
And for the N R. S. H measurement the improvement was from 35 per cent reported E D D up to 41%.
First psoriasis and points related to the <unk> <unk> were similarly, miscalculated for the validated 72 point <unk> scoring system.
<unk> is also the validated and widely used standard for over 20 years, which is used by clinicians and reported in the literature to measure the severity of psoriasis plaques in patients.
The scoring also ranges from zero with no disease to 72 for maximal disease.
The corrected and audited final data analysis for the psoriasis study utilizes the validated 72 point pozzy scoring system.
The correct data showed a 44% change from baseline Patsy.
And has a 50 and Patsy 75 response rates of 32 per cent and 21% respectively.
The statistical and clinical teams in charge of the two studies at Lily were made aware that an extra discovered the data errors.
The Lily team confirm the errors and written communications with nectar.
We plan to hold an investor meeting with key opinion leaders in the coming weeks to present additional new data from the topic dermatitis study for the 12th we conduction.
And for the 36 week follow up period for rest pack.
Which strengthens the concept of <unk>, providing a remit of effect.
We will also share more details about the new study design for the phase two be study and biologic naive patients with moderate to severe atopic dermatitis will have progressed on topical corticosteroids.
We expect to initiate the trial in October of this year.
And we expect data in the first half of 2025.
While our near term focus for Rez Peg is on a topic dermatitis. We continue to believe that rest peg has broad potential and multiple indications.
As development of this program progresses, we will continue to evaluate further opportunities and indications for <unk>.
Now turning to our immunology preclinical research programs.
We are advancing our research pipeline for two auto immune disease programs.
The first program. We are working on is R. T N F receptor to a T N F. R. Two agonist antibody.
Being developed in collaboration with biologic design.
T enough or too is highly expressed on teabags neuronal cells and endothelial cells and cannot far too agonism has been shown to potentiate, the suppressive effect and overall functional properties of T. Rex.
It's absent.
This is associated with auto immunity and other genetic conditions resembling Fox P. Three loss of function.
In contrast, its presence has been associated with immuno regulatory function and protective effects for multiple cell populations and tissues in the body.
Working with our collaborator we have identified two lead antibodies that had been validated for selective TNF are too binding cell types specificity and TNF are two agonism primary human so based athletes.
The lead down the bodies are currently undergoing manufacturing cell line development.
We along with the immunology community are very excited about the T. N F. R. Two target.
And our lead TNF or two I can to Santa Buddies show, a desirable biochemical and cellular profile.
We are aggressively progressing this program Tobar Dion D, enabling study and believe that a selective T. N F. R. Two agonist holds great promise for the treatment of multiple auto immune disease.
Our second preclinical program is a conjugate version of the C. S. S. One protein.
This molecule was engineered to optimize the receptor ligand interactions and the exposure to selectively modulate the resolution processes of inflammation.
So traditionally C. S. F. One is a myeloid targeting cytokine that's involved in monocyte development and monocyte mobilization.
And the right side of the Continental U C. S. F. One creates the kind of resolution macrophages that are ideal whenever you need to turn off and inflammatory response.
The C. S. F. One we have tuned the ligand receptor binding property to generate a novel signal through the C. S. F. One receptor.
We are characterizing this biology in multiple biologic context, including acute and chronic inflammation as well as fibrosis.
We are very excited about these programs and plan to file an int for at least one of the programs in 2024 and look forward to keeping you updated on our progress as these program is mature.
And now I'd like to turn the call over to marry to provide an update on our oncology program, an extra 255 alright.
Thank you J D. We have two different development pathways connected 2551 in solid tumors and a second in liquid tumors. The cell therapy. So let's talk about our bladder, Kansas, 31st and our partners program with Mark K T. A marquez conducting a randomized clinical trial comparing avelumab versus.
<unk> plus <unk> 255 at maintenance therapy for Unresectable, our minutes static bladder cancer. After completion of first line platinum days chemotherapy.
Alright joint scientific hypothesis is that neck, 255 will synergize with avelumab by generating new cytotoxic and memory T cells as well as N K cells to enhance the unique adc's the effect of the value of that.
With the ability to capitalize on this tool mechanism of action in the chaplain bladder medley steady we are excited about the combination of Avelumab inaccurate 255.
Enrollment in the murky Ta studies on track and the first <unk> data analysis for progression free survival is scheduled for the second half of 2024.
Our second development pathways in liquid tumors.
Enhancing depot teeth.
T cell function or fitness <unk> has been a key focus to improve the efficacy of cellular therapy.
Studies have nausea that higher endogenous I owe 15 concentrations post lymphodepletion are associated with greater car T cell expansion and improve persistence as well as clinical responses.
Because of this foundational data we are evaluating <unk> 255, and one nectar sponsored study and two investigators sponsored trials to enhance the cellular P. K a car T cell therapy to improve response rate and clinical outcome.
We believe there is a potential fraud application for an extra 255 to enhance the efficacy of cellular therapies, including a <unk> an allergy NASCAR T cells and other cell therapy products from pills to TCR based therapies.
And with that I'll turn the call over to Sandra for a review if our financial guidance Sandra.
Thank you Mary and good afternoon, everyone.
We ended the second quarter with $409.4 million in cash and investments with no debt on our balance sheet and we still expect and 20 twenty-three with at least 315 million in cash and investments.
Rapidly executed or restructuring and strategic plan in April and because of this our financial position remains strong with a cash runway that extends at least through the metal at 2026.
Will take us through several key value generating milestones for our pipeline.
As discussed in May we reduced our San Francisco based workforce by approximately 60% and this personnel reduction represents approximately $30 million a year in operating expense reductions.
It costs related to the restructuring or substantially paid in the second quarter and we have begun to realize the cost savings in this third quarter and will fully realize the annual savings in 2024.
And you too we recorded a 13.3 million dollar non-cash impairment charge for least assets.
For the full year 2023, we now expect to recognize restructuring impairment and cost of terminated programs of approximately $40 million to $45 million, which includes 27 million at non-cash impairment charges recognized in the first half of 2023.
I will now review the remainder of our 20th 23 financial guidance, which remains unchanged.
Gaffer Avenue for the full year 2023 is expected to be between $80 million and $90 million. This revenue includes $65 million to $70 million in non-cash royalties and 15 to 20 million and product sales.
We anticipate full year 2000, twenty-three gap R&D operating expenses will range between 105 million and 115 million, which includes approximately 15 to 20 million non-cash depreciation and stock compensation expense.
We expect TNA operating expense for full year 2023 to be between 75 million and 80 million, which includes approximately 50 815 million to 20 million of non-cash depreciation in stock compensation expense.
Full year 2023 non-cash interest expense is expected to be between 20 and $25 million.
As I mentioned earlier, we expect to end 2023 with at least 315 million in cash and investments.
We will now open the call for questions operator.
Thank you.
As a reminder to ask a question. Please crestar one wanting your telephone and wait for your name to be announced to withdraw. Your question. Please press star one one again.
In the interest of time, we do ask that you. Please limit yourself to one question at this time.
<unk> well, we compile the Q&A roster.
And our first question will come from J Olson from Oppenheimer. Your line is open.
Oh, Hey, this is <unk>. Thanks for taking my question.
Can I have a couple of questions. That's package, we may and yeah. Congrats on the correct. The data on the state's won't be a trial.
I guess, one thing that caught our attention M. J V you a little bit to his beds.
<unk> data now seemed to have even stronger alright separation vaccaro upset would come out to see like over 70%.
The improvement that week four weeks six so I'm just curious if you think this is like something.
Potentially differentiating from others and how important is the already some some improvement cellular market research and okay, all feedback and to have a follow up.
Yeah sure.
Yeah, certainly yeah. So thank you for the the question. So <unk> you know.
<unk> noted and then you saw in the materials there'll be released with the press release yesterday that there is a very rapid and steep drop and that week for time point is is very interesting because it's basically after patients have taken to dose administration, Sir <unk> first week zero. The next week too and you see a pretty strong.
Flexion point and actually a change in the slope in the curve and you reach a minus 70 per cent reduction in easy score.
Which is quite fast now this is a really important element because remember in this disease patients are used to being treated with topical corticosteroids.
Basically those patients expect pretty fast relief by applying a cream now in our patient population patients have progressed their diseases no longer under control by topical corticosteroids and they're moving onto his stomach biologic therapy as they are.
Our in our study so again, having a really rapid response is very good it's very good for the patient and it's very good for the expectations. We do think this is a sign of differentiation for <unk> and it goes quite well with the depth of the response so be reported a week 12 and of course, the additional very highly.
Differentiated element of that prolonged disease control that we observed for 36 weeks. After we stop dosing all all three of those elements really go together and we think that's one of the elements that comes from this novel mechanism.
So then I thought you had a second question.
Yeah. Thanks, I'm, just like with a more robust data now just curious how you are.
Thinking about the timing and also interest level and exploring additional.
<unk> <unk> <unk> <unk> <unk>.
Ordering some potential.
Opportunity and even like newer inflammatory diseases. Thank you.
Yeah, I can I can answer that look it's a very good question I think at this point.
Given our capital position or a strong financial position.
I would like to focus our company on a topic dermatologist right now I think Chris Peg.
If it proves successful in the proper term Titus, which I think at this point it will based on that this very robust data as you said I think there's opportunities and other on my auto immune diseases I I still while while lupus is much smaller market of course and a carpet during the times I think I think it worked fairly well of mucus in your data corrections there that also.
So we're analyzing.
And I do think there's other indications type one diabetes.
Food allergy, there's a number of places where one could develop roseburg. If we believe we have a drug that proliferates.
Regulatory 2000, the proper fashion, but <unk> for <unk> for now for nectar. Our focus is on getting excellent results in phase. Two these study randomized phase to be studying the carpet during the Titus.
And then from that point on.
That successful we can we can go from there.
Thank you.
And our next question will come from <unk> from Goldman Sachs per line is open.
Hi, everyone. Thank you for taking your questions. This is Charlie on for Chris and also Alex and my Congrats on the correct, let's pick data. So just two quick ones from US first just wondering if.
Lily provide any basis for the exclusion of the three atopic dermatitis patience just wondering if there was a specific reason behind that explosion. There that they may have provided and then also with the corrected red picked at just wondering if there was any impact on the safety and Tolerability results that were presented last year. Thank you.
Thanks, Charlie I'm Gonna ask J Z to comment on.
Both of those questions.
J D.
Yeah. Thank you. Thanks for the question. So so really the in terms of the data that was excluded so that was really a judgement that really made and it was a judgment on using criteria around topical medications.
Medications that were permitted by the protocol.
And so in reality. This is something that you know all the patient data should have been included from from the very beginning is all of that patient data and the use of all of those components are specified in the protocol.
Now. The next question you asked for it was about safety and Tolerability and said those results are are the same as they were in the a T V presentation. So in terms of what we did it at Metro as we reviewed everything we calculated recalculated all of the components and for the safety.
Probation that was presented <unk> <unk> from last year that is the same.
Great. That's very helpful. Thank you so much.
Thank you.
Our next question will come from <unk> from Missoula Ho Your line is open.
Great. Thanks, so much I apologize I signed in late so if if this is repetitive. Please excuse me, but two questions for you and what is given the re analysis of data and clinical or do you have to approach.
F D. A with this I mean, obviously you're planning on launching a trial, but uhm is this something that they need to be a price. That's number one and then the second question is on the loss of an understanding that you can't comment on cause you're inactive litigation. Maybe you can just tell us procedurally what are the next steps here since you have filed that suit.
Yeah Uhm. Thanks, My Mary could you take the first part about F. D. A and then I'll ask Howard to comment on the second.
Sure regarding the reporting of data to the F. B I agree with you that in a clinical study report at this time, we have not finalized clinical study report and we will be providing all of the updated and corrected data into the clinical study report, which will be submitted to the F. D. A.
And then turn it over to Howard for the next question. The next part of the question.
Sure we broke regard to the lawsuit obviously as you as you correctly stated.
We're not going to comment on an active litigation so.
Prices to fix it to say that.
We will move forward on this and we take a look we take this list is very seriously it's.
<unk> it's substantial.
If you look at if you look at the the.
The development of <unk> <unk> could have likely been in a phase two studying topic dermatitis, a year ago, a year and a half ago. So we take this lawsuit very seriously we went out to a very very well known and well respected outside statistical firm to have them recalculate Everything's dinovo basically gave them.
The raw data gave them to clinical plan said, what did you come up with and they came up with the same corrected numbers. We did so we take it seriously I can't comment on how it proceeds but it's it's it's important to us obviously.
Thank you.
And our next question comes from Roger song from Jeffries. Your line is open.
19. This is comedies on for Roger Uhm, why have you decided to move into phase two b and specifically bio naive patients any preclinical and that kind of action glided reasons respect to work better in those patients.
Things can be Tuesday, I'll ask you to address that.
Sure things can be so one of the things that we wanted to do importantly is to build upon the data from the phase one study that we've just been speaking about today and for which we released corrected data yesterday. So that study was run and biologic naive patients. So we wanted to continue the development and the same.
<unk> patient population and the strength of the data that we discussed today as well as all of the elements of differentiation that <unk> provides in this patient population. We wanted to just really continue to build on and the very next focused clinical development step for <unk>.
Now in terms of maybe your broader question, which is what is the applicability of this this mechanism and specifically in atopic dermatitis. One of the things that we think is is quite compelling about the <unk> component of the mechanism is that it really should have the ability to work in multiple lines. So while we're starting our focus.
And the biologic now your patient population, there's a very good scientific rationale to also expect there will be efficacy and patients that are post biologics. So for example patients that have stopped to respond or never responded to an aisle 13th therapy like dupixent or abri.
And even other mechanisms that are in development you you should be able to provide a teabag component in that post population as well and so in our future development plans will be looking as well into the biologic experienced population.
Thank you.
Our next question will come from Greg Harrison from Bank of America. Your line is open.
Hi. This is Mary can also great. Thanks for taking my question and going through all the program I guess.
Looking at the potential you're with fries.
Definitely <unk>.
Any president to the situation and if so what was your password here.
Well, let me let me let me let me try this password again.
Yeah I'm not when you say are there any precedents for this I'm I'm I'm I don't know of any President's for you know companies, making this kind of a calculation error. So I can't I can't comment on that the path forward as you know as we are we are now that we have what I think is very impressive phase one b data in a randomized trial.
So I believe that we're we're certainly very enthusiastic about moving forward interface to where it where I think we can demonstrate that respect becomes a novel and <unk> novel therapeutic mechanism for treating.
To order, a new disease patients that topic to repititis in this case.
The lawsuit the lawsuit that we filed against slowly will will will be working on that and as I said, it's very very important to us, but I don't know with many precedence for this it's a it's it's in my mind is an egregious error.
Thank you.
And our next question will come from Boris Speaker from T. D. Cowan Your line is open.
Thank you for taking my question visit the Jose Perez.
So for for the.
<unk> <unk> are you still exploring psoriasis as you are next indication where are you explain that indication.
And I have a <unk>.
<unk> and you have a follow up is spelled J V. I'll ask you to take the first part of your question.
Sure Yeah. Thank you. So so so one of the things. We we discussed today right was about the passing score calculation and sort of the the under reporting of the data for me a D V, which we're very pleased to have been able to correct yesterday and in terms of those a longterm focus of <unk> development.
<unk> from our dermatology standpoint, we're clearly focused on a topic dermatitis, where we see a very very profound activity for <unk> been discussing on this call.
And psoriasis there are other mechanisms of action that are quite well and transfer such as the Isle 17 inhibitors.
And so we might consider psoriasis as a potential development in the future or maybe even in the lifecycle management setting for right now near term, we're really focusing on a topic dermatitis for our development and determine tolerance space.
Oh. Thank you for the next question is regarding your developing preclinical assets targeting T. N F. R. Two M. C. S. F. One can you just tell the generally regarding that competitive landscape over those two targets and you're all potential market opportunities Sam. Thank you.
Sure that's.
Okay. Yeah. Thank you for that question. So so their their early assets, obviously in the research setting, but I can give you some some flavor around the targets and the opportunities. So with 10 F. R. Too that is certainly a very kind of hot target and there are.
Just a couple of companies sort of that are coming up that are studying that target and trying to create agonistic drugs.
Some of the companies are focusing on applications for oncology and others are focusing on applications for auto immune disease.
We're interested in the auto immune disease applications for the T. N F R. Two target and our agonistic antibodies now.
It's a very unique target because it really controls a lot of tissue protective and tissue regenerative pathways and it can particularly well act on regulatory T cells once they move into individual compartments in the body and they undergo different kinds of sinus pressure and basically <unk>.
Capital B signaling through the Tnf's superfamily become much more critical for driving their biological importance. So we can see a lot of application for a T. N F. R. Two agonist antibody and certain kinds of Oregon and you know.
Sort of pathology type of inflammatory conditions, so the G I and a family of Gi diseases as one.
<unk> and your own inflammatory diseases or another for example M S and so there's really a range of opportunities for a T. N F. R. Two agonist in.
In the case of R. C. S. F. One program you know that targets of my Lloyd component of the immune system and it targets it with the goal of creating an immuno regulatory effect. So this is not targeting lymphocytes not targeting T cells like the other molecules in our pipeline, but targeting a whole different set of immuno <unk>.
<unk>, an immuno suppressing cell populations and we think that could happen again also very broad application because of my leg compartment participates in a large number of diseases from the common like rheumatic diseases to even some more more rare ones as well.
Thanks for the questions.
Thank you.
And as a reminder to ask a question. Please press star one one.
And our next question will come from Dana <unk> from Leering partners. Your line is open.
Hi, Thank you I have two questions I wonder for the E. C score recalculation, if you could help us by separating out the impact of the two changes Lilly mathematical error and then the inclusion of the additional patient how much of the additional total benefit and the speed of benefit.
Came from those two changes and then I'll have a follow up after that.
Thanks, Dana I appreciate it yeah.
Yep.
Sorry, sorry, Jennifer.
Yeah, Hi, Dana Yeah. Thanks for the question. So so basically the the majority if not the totality of the difference in the data that we presented on Monday really comes from the mathematical calculations of.
Of the easy score.
So for example, if you correctly calculate the easy score and you include all the patient data the week 12 L. S. Mean result, so we presented yesterday 83 per cent reduction.
If you're correct the easy score, but not correct. The data that was excluded and the L. S being results of week 12 or 82%.
Alright. So the two numbers are are virtually the same really the the majority.
Of the effect and the the the change right in the correct. The data that we reported came from the mathematical calculation of the easy score.
That is very helpful. Thank you my second one is it seems like they made a mistake and correct me if I'm wrong in setting up their staff. So what was the mistake consistent for all patients, meaning a certain column or certain multiplier was consistently locked out and does that actually tell us.
Anything about the biology of Red Tag that we got such a big benefit from that consistently being left out.
Is there anything you want them.
That is well yeah sure yeah.
Yeah. Thank you yeah. So so basically when you when you calculate the 72 point easy or passing score.
There are multiple components that make up that does the mathematics to get you to the 72 number. So so the first set are typically what are kind of known as the severity scores.
They score components of eczema or components of psoriasis, depending on if the easier <unk> is used and they score those categorically and four sections of the body.
And then the next components of the score really assess the area.
So they assess how much skin and each region.
Is affected by disease and then they also take into account if you're scoring the head that's less <unk> on your body, then if you're scoring lower extremities, which is much more <unk>.
So sort of consistently uhm the same.
Error was made across both the easy in the <unk>.
That didn't capture all of those saverio severity and area components.
And so consistently score was arrived at there was less than the 72 point score and that same mathematical calculation was done for every person and every time point.
No. It was basically like an error kind of like in the code.
Was used if you could do the.
Calculation.
So a couple of important points to it says add to that you know to sort of.
Complete the thought of your question is that.
Really for over 20 years, there's been only one <unk>.
Measure used for either a topic Durham or psoriasis studies.
Not only is it validated but these are the key and points that have been seen in study. After study after study as well as just didn't use in dermatology clinics and the only score is 72 point score anything other than that is not even an apple to apple kind of a comparison.
So I hope that that answers your question and give us some more color around us.
Thank you.
I am showing no further questions from our phone lines and I'd like to turn the conference back over to Howard Robin for any closing remarks.
Well. Thank you everyone for joining us today, and we remain focused on executing on the development of <unk>.
And our immunology focused research programs and I'd like to think of course, all of our employees for their efforts and their extraordinarily hard work and I want to thank our shareholders for their continued support. So we look forward to providing you with updates on our progress and stay too. Thanks again for joining us today.
This concludes today's conference call. Thank you for your participation you may now disconnect everyone have a wonderful day.
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