Q2 2023 Ventyx Biosciences Inc Earnings Call
Yeah.
Good afternoon, ladies and gentlemen, and welcome Steven text Biosciences second quarter 2023 earnings Conference call.
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I'd now like to turn the call over to Dr. Marty Auster been Texas, Chief Financial Officer, Sir you may begin.
Thank you and good afternoon, everyone and welcome to vertex Biosciences conference call and webcast, where we will be discussing our second quarter 2023 financial results and providing a business update for you.
As a reminder, the company's most recent investor presentation can be found on our website at www Dot Bendix bio dot com in the investors using events section.
Before we begin today I'd like to remind everyone that this conference call and webcast will contain forward looking statements about the company, including without limitation statements about the anticipated timing of commencement enrollment and completion of clinical trials for our product candidates anticipated timing of release of clinical trial data the market opportunity for our product candidates and the expected timeframe for funding operation.
With our current cash cash equivalents in marketable securities.
Statements are subject to risks and uncertainties that could cause actual results to differ 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 periodic reports filed with the SEC, including our Form 10-Q for the quarter ended June 32023, which are filed.
Just a few minutes ago.
Please note that these forward looking statements reflect our opinions only as of the date of this call and we undertake no obligation to revise or publicly release the results of any revisions to these forward looking statements in light of new information or future events, except as required by law.
I'll hand, the call over now to Dr. Rajiv Mohan Fintech is founder and CEO would you. Please go ahead.
Thanks, Marty and good afternoon, everyone. Thank you for joining our second quarter 'twenty 'twenty financial results Conference call.
It's hard to believe that already in August and how the first half has flown by.
As you May have recalled from the R&D discussions in January and from our recent press releases, it's been a tremendously productive first half of the year for vertex and I am very proud of our team's execution across the entire pipeline.
So let me run through this afternoons agenda.
Begin by providing a high level business update and then I'll hand, the call over to Bill Sanborn, Our President and Chief Medical Officer, who will provide updates across our drug development programs and finally, Marta who will present, an overview of our second quarter of 2023 financial results before opening the call for Q&A.
So let me start by saying authentic.
I've always believed that novel oral therapies are poised to play a significant long term role in the treatment of numerous immune diseases indications that are currently dominated by injectable biologics, including indications such as psoriasis and primarily.
Inflammatory bowel disease, Psoriatic arthritis, lupus and others.
These large but under penetrated markets currently exceed over $50 billion in annual sales and we believe that as clinicians and patients are offered the choice of using a pill and oral drug instead of an injectable therapy.
The potential for a meaningful shift in market share as well as a general expansion of the treated populations in each of the diseases I referenced earlier.
We have seen an overall increase in excitement around the promise of oral therapies encompassing different targets and indications and we believe that our portfolio of internally discovered compounds positions us at the forefront of this revolution in all therapies.
Crowd.
Currently conducting five phase II trials across our wholly owned pipeline of novel small molecules.
Let me begin with the with what the compounds as you know are allosteric kick to any better E. T. X 95, eight is in phase two development for plaque psoriasis.
<unk> disease and Psoriatic arthritis.
Diseases, where it kicked to play a direct role in modulating IL 23 key cytokine implicated in the pathology of disease progression.
As previously discussed we are aiming to achieve trough coverage uptick two IC 90 at the highest phase two dose across all of the trials.
In June we announced that we completed patient enrollment in the phase II trial of <unk> 958 in moderate to severe plaque psoriasis.
This is an important milestone preventive and I'd like to thank our entire team for all their efforts with enrollment now complete we look for what they're reporting topline data from the face to face to save energy.
Trial in the fourth quarter of this year.
On the development of an extended release tablets E. Our cabinet for V. T X 95, eight we continue to make progress towards the target product profile and remain confident that we will have enough optimized once daily tablet, but advanced into phase III trials in 2024.
He discussed our development strategy incorporates an iterative process that allows us to sequentially evaluate multiple prototype formulations in humans, we look forward to providing a detailed update in the fourth quarter.
In June we announced that we completed enrollment in the ongoing phase II trial of E. T X 002 in patients with moderate to severely active ulcerative colitis I'd like to again congratulate the ventas team on this important milestone.
We look forward to reporting top line results from this trial early in the fourth quarter of this year. We believe we are the first company to demonstrate a greater magnitude of reduction in absolute lymphocyte counts or ALC relative to trust them out and it was not a lot and similar phase two trials with.
We believe we are exploiting the full production potential of this mechanism by a greater direction of ALC, a validated biomarker and belief that this may translate into differentiated efficacy relative to other drugs developed for ulcerative colitis.
Our aspiration for this asset have always been very clear, which are to demonstrate efficacy and Margaret just see if you see patients that is differentiated from both across the market as opposed to Oh, sorry, newmont and its competitive with competitor with a superior to levels achieved by biologics.
Because he profile if achieved should position V T X.
<unk> as a potential for potential class, leading safe oral agent in UC.
And Bill will provide more color on this progress.
Bill will provide more color on progress of this trial.
Beyond these lead programs, we continue to advance our novel analog P. Three inhibitor portfolio, including our peripheral compound Beachy ex twenty-seventh 75, which is now in phase two trials in <unk> patients and our CNS Penetrant Enernoc Petri inhibitor V T X 32324, which we recently announced.
Initiation of dosing in phase one trial in healthy volunteers.
So in summary, I'm very proud of our team's execution during the first half with a year and we look forward to generating important phase II data for both V. T zero zero to N V. T X 958 in the fourth quarter, so with that I'll hand, the call over to Bill for a more detailed pipeline discussion bill.
Thank you Rajiv and good afternoon, everyone I'm excited to provide a brief pipeline update today and to highlight recent progress across our portfolio.
I'll begin with our allosteric TIK two inhibitor V. TX nine five days you will recall that we have three ongoing phase II trials for V. T X 958, the serenity trial in moderate to severe plaque psoriasis, the harmony trial and moderately to severely active crohns disease, and the tranquility trial and active psoriatic.
Writers as Rajeev mentioned, we announced in June that we completed patient enrollment in the <unk> trial in plaque psoriasis. The serenity trial includes the target enrollment of approximately 200 patients randomized to one of four P. T X 958 doses or to placebo and the <unk>.
Primary efficacy endpoint is the proportion of subjects achieving passey 75 at week 16 as previously disclosed we are exploring multiple dose cohorts in this phase two trial ranging from an anticipated minimally therapeutic dose at the low end to a high dose that is expected to achieve tick.
Two IC 90 coverage at trough as measured by IL 12 in 'twenty three.
Our team did.
Did an excellent job enrolling this trial in around six months with enrollment now complete and we are very excited to report topline data from the phase II Serenity trial during the fourth quarter.
In addition to the Serenity trial, we continue to make progress in rolling the harmony trial in Crohn's disease, and the tranquility trial in Psoriatic arthritis, and we expect to have more to say about our progress on these trials before the end of the year.
Now moving to V T X years here or two our potential best in class. That's one P. One receptor modulator.
In development for ulcerative colitis at the phase two stage recall that we have previously shared data from phase two open label extension demonstrating that our high dose of 60 milligrams is achieving steady state absolute lymphocyte count reductions and the approximately 70% or more range.
As compared to approximately 50% for a trap some odd in hosanna Mod and our thesis remains that this differentiated pharmacodynamic effect may translate into improved efficacy and ulcerative colitis based on our analysis of consistent observed efficacy driven dose responsive.
Across both ulcerative colitis, and multiple sclerosis trials evaluating S. One P. One receptor modulators.
As Rajiv mentioned and we announced in June that we completed enrollment in the ongoing phase two study of <unk> zero two and.
Patients with moderately to severely active ulcerative colitis. This trial in crude includes a target enrollment of approximately 180 patients randomized to one of B T X zero-zero, two doses or placebo for a 13.
We conduction treatment period, followed by a 39 week blinded long term extension period. The primary endpoint is the proportion of subjects achieving clinical remission is weak at week 13 as defined by the modified Mayo score I want to join Raj you and congratulating the team on this accomplishment.
It is no small feat to enroll a large phase two ulcerative colitis trial, and a challenging and dynamic environment and I'm grateful for the dedication and perseverance of our team. We are now looking forward to reporting topline data from this trial early in the fourth quarter, we expect to report phase II top line data for <unk>.
002, and ulcerative colitis ahead of the phase II top line data for <unk> 958 in psoriasis.
Finally, I'll touch briefly on our portfolio of novel and alert P. Three inhibitors, we announced in June that we had initiated dosing in a phase one trial of our CNS penetrant in all our <unk> three inhibitor V. T X 30 to 32.
In healthy volunteers. This is a two part single ascending and then multiple ascending dose trial designed to evaluate the safety Tolerability pharmacokinetics and pharmacodynamics of V. T X 30 to 32, including cereal cerebrospinal fluid sampling to assess CNS X.
Closure.
We have a phase II proof of concept trial underway with V. T X 27, 35, our peripheral and our <unk> three inhibitor and familial cold auto inflammatory syndrome or F gas, which is the most common subpopulation of cryo fire and associated periodic syndromes or caps.
I'll reiterate that both with MLR Pete with both of our MLR P. Three inhibitors. Our goal is to establish a potential best in class profile in terms of safety pharmacokinetics and pharmacodynamics and to ensure that these compounds are phase II ready.
We believe that this approach will create strategic optionality and will unlock the value of these programs in a wide range of indications for future development with peripheral and all in all a repeat three inhibition. This includes large cardiovascular dermatologic and rheumatic disease indications and within all our P. <unk>.
<unk> inhibition in the CNS. This includes neurodegenerative diseases, such as Parkinson's disease, and Alzheimer's disease. Among others. In conclusion. This is a very exciting period for <unk> with important top.
Top line Phase II data for <unk>, 002, and V. T X 95, eight just around the corner in the fourth quarter of this year I'd like to thank our team again for their efforts during the quarter before moving on to question and answer I'll hand, the call back to Marty for a brief discussion of our financial results Marty.
Thanks, Bill I'm sure you'll find more detail on our financial results in the press release issued after the bell today as well as in our 10-Q, which filed are also after market close today.
I'll summarize the second quarter results briefly here that R&D expenses in the quarter were $48 6 million compared to $14 7 million in the second quarter of 2022, and this reflects the advancement of our pipeline into later stages of clinical testing, including the execution of the ongoing phase two trial of <unk> two in ulcerative colitis, and the broader phase II program for <unk>.
On page eight with phase two trial is being conducted in psoriasis crohn's disease in Psoriatic arthritis, G&A G&A expenses were $8 6 million for the second quarter 2023, compared to $5 7 million in the year ago period, reflecting the growth of the company.
Net loss of $53 3 million for the second quarter of 2023 compares to a net loss in the second quarter of 'twenty, two 'twenty 0.0 million cash cash equivalents in marketable securities were $332 3 million as of June 30 of 2023. This compares to $376 9 million in cash cash equivalent and marketable securities.
On March 31st 2023, we continue to believe our current cash equivalents in marketable securities are sufficient to support our planned operations into 2025.
This concludes our prepared remarks for the afternoons call and I'll now turn the call back over to the operator to begin the Q&A session and.
And I'll be joined by our CEO , Richie Mohan, President and CMO, Bill Sandborne, and our CPO, Chris Krueger operator.
Thank you Sir.
At this time the floor is now open for questions.
You have a question or comment please press star one on your telephone keypad.
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Thank you.
And our first question will come from Michael Yee with Jefferies.
Hey, guys. Thanks for the question and thanks for the updates today.
Maybe a two part question on the upcoming tick to results for you I know a lot of people kind of point to bristols data a b I D. Dosing you kind of get to 67, 5% plus 75, you look at some of the Nimbus data I guess they were in that range and then at 30 Threep kept pace 100.
How do you think about where you want it.
Relative to the profile of some of those.
Yeah, I guess higher the better of course, but what would you want to see there to say Hey look we're what better crosstalk person and then the second part of that is what does that lead you to believe for Crohn's, which would then follow that and maybe it's the PD marker about 30 inch maybe maybe you could walk through what you see in psoriasis.
And then how does the IL 13 data plays play into that to give you confidence on crops.
Yeah. Thanks, Mike So yeah, Bill why don't you walk you can take both of those.
Yes.
I think.
In terms of.
Where we would like.
Like to arrive really if we get into the zone that the nimbus dedicated product achieved especially where you see that.
Pass 100 up into the 30, so that's really getting up into.
Solid area of.
Efficacy for an oral agent and that's <unk>.
Generally the zone that we've seen recently with the protagonist Janssen.
World.
IL 23 antagonist as well so.
And then every but all of these are somewhat short of what you see with the monoclonal antibodies to IL 23, and so I think you know that.
The aspirational floor has been set with some of these other oral.
Sort of a second generation agents and you wanted to hit into that zone and above that would be further differentiating. So that's that's sort of how we see it and where we would hope to land is a low watermark.
And then how about for what the read through that is Crohn's and is it.
PD data that you see or maybe just clarify that that gives you the confidence.
Yeah I mean.
There were of course speculating on read through to chrome. So what we know is that.
That with do crab citizen, Ed doses of six twice a day or 12 once a day have not been effective.
For ulcerative colitis, and Crohn's disease and of course, those total daily doses or regimens are both twice the six milligrams once a day dose that's approved for psoriasis with sort of.
Moderate efficacy.
The and then we know with.
Biologics with inhibition of either interleukin 12 twenty-three with Lora.
Or interleukin inhibition of interleukin 23 alone with sky risky or comply in Mira kitchen, Mab and others.
At the.
The doses that have been required to optimize efficacy in crohn's disease are higher than the doses that sort of plateaued efficacy.
For.
So it's reasonable to speculate that you would need that.
More intense target coverage for crohn's disease as well.
With blocking interleukin 23, and interleukin 12 with take two inhibition with of course need to generate primary data to show that in our trials are designed to do that so.
Well, we have four different active dosing groups in the psoriasis trial across a wide range of doses and exposures as I described a few minutes ago.
In Crohn's disease, we have just two active doses and there were the two highest active doses from the psoriasis trial. So we're emphasizing high exposure with the hypothesis that greater exposure will be required in crohn's disease, and we anticipate.
Being able to read that <unk> trial out next year.
Thank you.
Okay.
Thank you.
Our next question will come from Alex Thomson with Stifel.
Great. Thanks for taking my questions and congrats on the progress I guess two for me firstly on the QD formulation I Wonder if you could comment on what has been driving the delay here from the mid year update to Q4 and how much more buffer you have to get a QD formulation for phase III studies next year and then for the two phase III trials.
Quite as in psoriasis I Wonder if you could comment on whether discontinuation rates are tracking within your expectations. Thanks.
Yeah. So so you know all too.
The disclosure after after data are.
We're all used to complete the developed by the end of the year, Alex and leave ample buffer so you've got Apple a buffer.
To complete the prototype development, it's real the real actual <unk>.
A phase III acuity tablet happens after the data comes out from phase two to understand exactly where we line up with the doses and dose for phase III I've always felt that and there's plenty of buffer now.
As we outlined at the R&D day, you know what I mean to use the program to you guys that were had a strategy that sort of.
Iterative process, you build and test in humans.
Tablet a relationship between the E. R dose you're you have prototypes in the IR dose across multiple formulations that we're doing.
In human studies right just it's real.
Important for us to get it nailed.
Right a final formulation before you begin to make disclosures as we expect this formulation will be the drug that can be taken into phase III and that's the goal.
And so metrotech approval clinical trials, where it's all worked out so far.
First of all there's plenty of buffer you always plan to get this done by the end of the year in time with the the.
Phase II data coming out and then use that prototype to them actually get the actual tablet made manufactured regulatory stability ready for phase III start so it's.
There's no impact on phase III start.
So we were really confident in the process. We believe we made real progress towards achieving the target profile, but honestly, we recognize that our earlier timing of data release was probably a little over optimistic. So we're looking forward to sharing more details with you end up in Q4, but the key emphasis as theirs.
No.
Back to phase III, we've always built in the buffer and that includes manufacturing regulatory stability packaging and mailing. So just you know.
Stay tuned for an update.
Between now and and.
When we had the phase II data probably closer to more of the one of the phase two comes out.
And on the discontinuation rates.
Yes.
So I think.
We.
It wouldn't be appropriate to give granular.
Really clinical trial data, which is what the specific conversation about that would be what I would say is these are both.
Sort of shorter term or induction trials, if you will but the ulcerative colitis trial was 13 weeks in duration to the primary endpoint and the psoriasis trial was 16 weeks.
From a interpreted.
Interpreted ability standpoint, what is a typical.
Typical from a statistical standpoint is if you have patients that discontinued <unk> therapy prematurely and typically both ulcerative colitis trials in Crohns.
Psoriasis trials, we will have some of those the for the dichotomous outcome measures the patient's with missing data are treated as failures. So.
You actually don't lose any statistical power in the.
Analyses.
With any patients that do require discontinuation. So I think we're well set up in a very conventional fashion.
You know manage any patients that would discontinue but we.
Well.
Make any comments beyond that.
Great. Thank you.
Okay.
Thank you.
Our next question will come from Vikram <unk> with Morgan Stanley .
Hi, good afternoon, thanks for taking our questions.
From our side.
First I would just love to get your thoughts on.
Commercial performance to date and how it's impacted if it has your view of the commercial opportunity for a therapy like 958 in psoriasis and then secondly, maybe a question for Marty can you just remind us what level of pipeline development is contemplated in your current cash guidance and runway and how far the runway gets you four the current set of lean programs.
Thanks.
Yeah.
So maybe Marty can take take both questions and start with the commercial so take to sort of thing and then they'll go back to the second one.
Well this is a virtue to get both of them. Thanks Vikram.
So in terms of the TIK two commercial performance I you know I think we're quite encouraged by the early days, particularly obviously, there's Bristol has been providing a.
Quarterly updates about the commercial performance in space, they're getting substantial significant market share relative to the other or approved oral therapy on the market in psoriasis, they're continuing to kind of see share coming from all different avenues, which is which is highly encouraging that includes sort of a treatment naive.
Systemic therapy patients and psoriasis are conversions from the other approved therapy oral therapeutic Tesla conversions from Ah patients currently taking biologics who are seeking to get off of injectables in over to oral <unk>.
We think long term about the market opportunity here. This is a $25 billion global class of Therapeutics, we think that oral agents overall are going to play a very significant and substantial meaningful portion of that market. Currently the oral a portion of that market is just about 10% or so we think that's going to grow meaningfully from here. We can take two is going to be a major player.
Clients, obviously with the with the introduction of Citic too and then obviously our own development and other tick two programs. We think look attractive that are coming are coming online in the next several years.
I think it all looks pretty favorable.
Shifting over to the cash guidance question Vikram.
So our cash guidance as a forecast to bring us into 2025.
And what that includes and is sort of phase III prep work and the ability for us to kind of be able to be on track for phase III launches in 2024 for both the <unk> program as well as for boutiques 958 in psoriasis.
It includes completion of the Gtx 958 phase two programs of <unk> in Crohn's disease, as well as in Psoriatic arthritis, both of which were expecting to report data in 2024.
It includes the completion of the phase one sad Mad that Bill described earlier for <unk> 32, 32 are CNS.
Directed and all of our <unk> three inhibitor as well as our phase II proof of mechanism trial in cancer patients with 27 35 does not you know obviously then get us through completion of those phase III trials for psoriasis or you see that then allows us to kind of being positioned to commence and allows us to complete all the other ongoing.
Clinical work that's happening now if we continue to kind of advance obviously that we'll have additional capital needs eventually.
Yeah.
Understood. Thank you.
Thank you.
Our next question will come from Yasmin Rahimi with Piper Sandler.
Yeah.
Hi, This is John speaking in for you guys or Haney paper. Thank you for taking my questions. My first question is as we will be eager to do our comparisons of serenity to other oral psoriasis agents, which Patty score in your view is the most reflective of drug activity and dose ranging.
What type of activities have been completed in regards to phase III V.
T X 958 <unk> to thank you so much.
Yeah.
Ill deal with the second question and I'll hop Bill addressed the first one.
So as we are.
Guided in the last earnings call.
We've initiated all necessary activities around a phase III prep for both programs. So this includes.
CMC work drug substance drug product.
Regulatory.
Preparation for end of phase two meetings all of the.
Clinical studies that are needed to support that Doug certain domain PK study. So all of that has been well.
Well plan and on track.
Again, you know we're planning for.
The data released in the fourth quarter, and then moving on seamlessly to phase III starts. So yes, all all all necessary activities there'll be no delay.
Due to anything that was not planned or executed both on the CMC side, they're excited to clinical side and all the other finding that goes close to these trials.
So bill once you address the first one first question.
Sure. So what what is the utility of the different passey outcome measures for phase II dose finding.
We have both phase two data fully published with so tick too and in abstract form with.
The Takeda Nimbus product, but we also have a phase two trial data with a number of the anti IL 23 antibody and what you see across both the TIK two inhibitors and the antibodies is that first of all we know that psoriasis, it's exquisitely sensitive to IL two.
Twenty-three inhibition.
So you see relatively high levels of respectively.
Irrespectively of passing 70, 590 and 100.
As you go up on dosing, but the I would say the most sensitive.
Outcome measure seems to be past E 75, and you will sometimes see sort of a blending of several dose groups across the range of three or four doses for past 675.
And then as you go up.
Heidi and especially pass 100 that seems to be more specific or differentiating so the absolute rates.
The rates of achieving a pass 100 in particular will be lower often half or less of what it is with.
Cassie 75 and that tends to separate.
Groups, better and that was seen.
Both with so tick too with the 12 milligram once a day dose in phase two and with the Nimbus Takeda product at the 30 milligram dose that each of the the highest doses and highest exposures had the greatest.
Achievement of passenger 100, so that's sort of how we how we see it.
Very helpful. Thank you so much.
Thank you.
Our next question will come from Garik <unk> with Wells Fargo.
Guys. Thanks for taking the questions and congrats on the progress here just two quick ones from US I guess first can you just remind us how we should be thinking about the geographical diversity from the phase II trial with <unk> in terms of like number of U S sites versus ex U S sites and then maybe I missed this in the prepared remarks, but I guess when are we.
To see the data for VTS 275, and how are you thinking about prioritizing either indications or potentially partnering that asset in the future. Thanks.
Bill why don't you take the.
Take both of them and then maybe I can add to that.
The future of 27 to 35 point you begin.
Yes.
So.
Four geographic diversity inflammatory valve disease trials, whether it's ulcerative colitis in the case of <unk> or two or Crohn's disease in the <unk>.
Case of VTS 95 eight.
You really require a lot of clinical trial sites.
As you get into phase two and you're requiring.
Anywhere from 132 patients target enrollment for Crohn's disease, or 180 patients our target enrollment for the for the now enrolled ulcerative colitis trial. So those end up being multiple countries in a worldwide development programs.
It's typical to have.
Greater enrollment in eastern Europe , but to have.
Enrollment in Western Europe , and North America as well we are in all of those jurisdictions in the ulcerative colitis trial, I think we will get into details about it.
Exactly the distribution of the trial sites, except to say, it's you know it's pretty conventional for a phase II trial, and I feel very comfortable with the geographic mix that we achieved and we'll report that when when we report the data in the fourth quarter.
And then for for VTS, 2700, 35, our peripheral and all our <unk> three inhibitor, we reported a year ago in June the phase, one sad and Mad data and then.
The we have an ongoing phase Iia trial in caps as I mentioned, we do have patients that are now enrolled in the trial and.
Remember this is an ultra rare disease, there's a couple of hundred patients in the U S. So.
Just if you had to patients that's 1% of the prevalent population. So this is not easy to recruit and the fact that we have patients enrolled.
We're pleased with.
You know get into the granular detail about where we are in that but I think we're we're pleased with the level of.
Screening and enrollment that's going on and I feel.
That will be able to.
<unk>.
Some data by law.
Late in the year with that program.
Good.
And then this is Roger so on an on.
Development strategy, but 27 35 as you know as we said.
R&D, Dan we've sort of continue to reiterate that we want to get both compounds phase II ready. So 27 75 is finished phase one we're in the middle of starting some chronic tox studies done with W. 232, again, we are finishing up phase one and expect to have that wrapped up early.
First half of next year.
There again, where we don't where CMC ready, we're planning on but Tox work so that both both coke.
<unk> phase II ready in the first or early first half of next year and and you know we'll have the data readout from the two phase two trials ongoing for 95 based on zeros. There were two and you know, we'll just look at the strategy across the portfolio as we pursue these two these two molecules, but no matter where we're there.
He's going trims, or whether we do it alone or whether we have a partner.
We are ready for the phase two starts and we.
We've got plenty of opportunities for both drugs. So the peripheral molecule as indications brought indications that bill outlined both in cardio cardio metabolic areas as well as some very specific derm indications.
And then for 30 to 32, there's a huge excitement in neuro degenerative diseases, including Parkinson's. So now our goal has been always been focus of the phase II trials.
Ready for phase III with the two compounds and get on.
The NLRB three portfolio phase two already.
Late this year or early first half and then you can sort of look at the entire portfolio and decide where do we take these 202 molecules.
Excellent. Thank you.
Thank you.
And once again, if you do have a question. Please press star one on your telephone keypad at this time.
And our next question will come from Chris <unk> with Goldman Sachs.
Yeah.
Thank you two questions if I may on the Psoriatic arthritis opportunity.
Kato Nimbus is expected to have to be data that reads out this year.
Can you share with us what your expectations are for this trial and any potential for a read through in terms of whats your ongoing psoriatic arthritis trial is.
And a question on Crohn's as far as enrollment in the phase two have you observed any changes in particular since Bristol compound failed. Its phase two study I did note that in Bill's prepared remarks about the S. One P. C study the words perseverance cause used thank you.
Yeah Bill go ahead.
Yeah I think.
The.
E <unk>.
Sorry, the totality of effect.
At the higher doses with the.
Memphis Takeda product in psoriasis as being you know a.
A bit greater than what was seen with do crab sit in a particularly with where you end up at the final approved.
Dose and so given a really a meaningful signal with.
Both the.
Mm three milligram B I D as I recall.
12 milligram, six milligram, QD and 12 milligram QD doses.
In with too crowded Sydney I've been to my eye.
I thought there was a bit of a dose response, particularly as you got into the ACR of 15 74, the 12 milligram once a day.
Dose with Duke <unk> sit in them. So I anticipate that there would be a positive and meaningful effect.
Across ACR, 20% and 50 and 74.
The <unk>.
<unk> Takeda.
Drugs.
Don't know that we know exactly what doses they are.
Doing but it's reasonable to us.
Speculator anticipate that they would include some of the higher doses from the already completed psoriasis trials. So we do think that.
Concept of Tic, two inhibition being an effective therapy.
For Psoriatic arthritis is likely to be further confirmed with the nimbus vacated data and we wouldn't be surprised to see an effect that's at least as good and possibly a little better than what was seen with <unk>.
<unk> sit in them and we think that opens up.
The opportunity for other <unk>, two inhibitors with excellent target coverage like Gtx nine Friday.
And on the crumbs enrollment piece.
Yeah I mean.
We've.
Always resisted being too granular about that as we've gone along.
We have a lot of learnings about around then.
In my view.
Were quite successful in the ulcerative colitis program with.
Getting the right <unk> the right country mix, the right number of sites effectively interacting with the investigators and getting the trial enrolled in a timely basis and.
We've taken all of those learnings as a young company and applied to.
The Crohn's program there are many common sites between the ulcerative colitis, and the Crohn's program, which allowed us to leverage.
Contract negotiations we have relayed.
Our relationships with the sites with investigators study coordinators and all those things and so we have all those synergies going for us in the Crohn's trial and I'll, just say from my standpoint, the deed.
Site activation.
Rates that we had planned were on track the patient enrollment rates are on track and I feel confident that we can.
Deliver the results next year.
I'm going to.
Wait another quarter or two before we start to.
You know narrow the band around.
When exactly next year, but for our internal metrics, we're absolutely on track for where we intend to be right now and the trajectory is strong to stay on track so.
Great. Thank you.
Thank you.
Our next question will come from Lee <unk> with Wainwright.
Alright, Thanks for taking the question, maybe just to follow up on the previous question I'm, sorry, attic arthritis. If you can talk about how you think about the bar for you internally birth subtract your phase two data so far.
And then also Bristol talks about evaluating it takes to for other indications like SLE and alopecia or there's indications that you think might make sense for question inhibitor and are those ones that you maybe consider furby checkpoint target. Thank you.
No well until we have more data.
With that.
The Nimbus Takeda products, we have sort of another dataset.
With the <unk>.
Implied target coverage and things across a range of doses I think right now the more benchmark should probably really be what was seen with to craft a set of nib and maybe say that its that what we've seen with the 12 milligram dose as opposed to the six milligram dose.
If you do cross a mechanism of action comparisons those data with the 12 milligram dose actually look pretty favorable to other.
Agents and even the JAK inhibitors so.
Let let's see was we get some more data in that field, how high the floor can race, but that's probably how we would.
Think about it for other indications.
I'm not aware that there are any data yet for alopecia. It's interesting you know there is some.
Logic to it and.
We're of course thinking about different indications <unk> <unk> and <unk>.
<unk>.
Whether there are any and beyond psoriasis in dermatology.
Haven't pulled the trigger to go into that space, yet, but we're watching that with interest.
For lupus.
You'll recall that that really interleukin 12, 23 inhibition was to Laura was ultimately not effective.
And you.
The so I'm.
A little bit skeptical about.
Yeah.
Four.
IL 23.
Inhibition with that but of course, you have the interfere.
Interferon alpha side and that looks good so I think.
<unk> two inhibition, that's that's certainly an opportunity.
For us and one that is differentiated from the IL 12, 23, and IL 23 antibodies, where lupus cannot be a target.
These are large trials, the endpoints or are sort of a squishy if you'll remember.
The phase II study to craft a set of nib in lupus as I recall, it was 300 and <unk>.
60 patients.
Patients about 90 patients per arm for three doses plus placebo. It took about three and a half years to recruit that trial readout six month results. So it's really a long slog.
The effect sizes are often in the 10% to 15% range relative to placebo. So you need a lot of patients per group and we havent pulled the trigger on on that yet because we think it's a big undertaking but of course you know.
Pending a successful in.
Robust data in and some of our other ongoing phase II trials that that could be revisited at any time.
Well thank you.
Okay.
Thank you.
Our next question will come from Sam Slutsky with lifestyle capital.
Hey, good afternoon, everyone and thanks for the questions.
Quick question for Bill just on the S. One P class you know obviously as opposed to guesthouse and you see I think has so far underwhelmed versus earlier expectations that Chad Pfizer. Obviously, when you started trust me that's going to be a blockbuster in IBD and then obviously paying for an amount of money to get the drug.
Asthma IBD position it would be good to get your view on what factors could have contributed to the slow long term proposed yeah.
And what potential profile for Nexgen excellent P. One could lead to better uptake, where it does oh 20, resorting blockbuster potential like expected premium class.
Go ahead bill.
I'll opine, a little bit and then maybe Marty given all of this life experience could talk a little bit about the launch as well for suppose here, but.
I think.
Whenever there's a new.
Mechanism of action.
Robust.
<unk> and provider engagement and education.
Is required.
No therapeutic therapies, usually don't sell themselves.
Require an educational and ultimately marketing campaign and I think the sense from that I get from all of my.
Colleagues in the field is that you know that just hasn't happened in any.
Robust way with suppose here, so I think that plays a lot.
Into it that the drug has also been priced for the multiple sclerosis market. So.
And the.
$890100 range $100000 range.
So as a starting price for an IBD drug that's that's kind of high end and that really.
Then sets barriers to access side I think it's heavily those things I do have the sense that there is a rising experience with using the drug and.
<unk> be interesting to see where <unk>.
Pfizer sets their pricing I would anticipate that they're going to put a lot more marketing and education muscle behind it and that that the launch of <unk> will really start to grow the class water.
Physicians and ultimately patients.
Looking for I think it's really heavily about efficacy and most of our legacy drugs were about 10% better than placebo, so 10% placebo adjusted remission rates for induction.
Some of the newer entrants Renvoi oak is 20.
25% placebo adjusted Delta some of the phase two data with Tijuana antibodies.
Prometheus and revamping the Pfizer molecules had 25 and 20% respectively.
Remission deltas.
<unk>, depending and you look at it phase two was 25% phase III was 20% in one trial and about 10% and the other trial blended average is probably high teens pushing 20%. So I think the next generation drugs that would be really differentiated and exciting you'd probably want to see it.
At least the 15.
Ideally, 20% or more placebo.
Placebo adjusted for emission rate and.
If that's what we're aspiring to and if we land in that zone on not only the primary endpoint, but with consistency in.
The secondary endpoints and some of the differentiating things like getting <unk>.
Complete into Scopic remission and stuff like that.
You know that that's going to be very interesting to people. Our drug is not aimed at multiple sclerosis. So it could be appropriately priced for and ulcerative colitis market. We think all of that will be a real opportunity. Martin did you want to add anything about the sort of what the trajectory of supposedly as you see it.
Yeah, Bill I think you hit on a lot of the things that we see and we talked about internally, what we hear from from Kols and engagement from the field I think its a combination of the factors you cited along with also as you as you sort of talked around the efficacy there.
Salmon supposedly was in sort of very low double digits. So it wasn't particularly sort of it wasn't groundbreaking are exciting efficacy, it's perceived as a slower onset of action drug as well, which is better to have a fast onset of action of course with the active metabolite that the drug works through so I think we've got some some benefits with <unk>.
So to that I think are hopefully more attractive attributes for the market and obviously, we'll be watching closely as you and our investors.
Our sponsors.
Regulatory outcome and commercial launch.
It goes to the trials later this year.
No problem. Thanks.
Yeah.
Thank you.
At this time there are no further questions in the queue.
Like to turn the floor back over to Dr. Mohan for additional or closing remarks.
Okay, Great and then thank you all again, all you analysts all the investors for your <unk>.
Interesting benthic.
Hopefully, we'll connect with you with many of you at one of the upcoming conferences.
We plan to attend in the third quarter.
And we're really excited.
For the fourth quarter approaches.
Looking forward to sharing our phase two top line results with you for both starting with over two and you see and then followed by Vicki X 95, eight in psoriasis. So thanks. Thank you all once again.
Okay.
Thank you.
Concludes today's <unk> Biosciences second quarter 2023 earnings conference call.
Please disconnect. Your line at this time and have a wonderful day.
Hmm.
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Hum.
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