Ventyx Biosciences Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 10, 2023

There are 9 speakers on the call.

Operator

Good afternoon, ladies and gentlemen, and welcome to the Vintech Biosciences Second Quarter 2023 Earnings Conference Call. At this time, all participants have been placed on a listen only mode and the floor will be open for your questions following the presentation. Sound quality. As a reminder, this conference call is being recorded. I would now like to turn the call over to Doctor.

Operator

Marty Oster, FinTech's Chief Financial Officer. Sir, you may begin.

Speaker 1

Thank you, and good afternoon, everyone. Welcome to Ventex Biosciences conference call and webcast, where we'll be atwww.ventixbio.com in the Investors, News and Events section. Before we begin today, I'd like to remind everyone that and the expected timeframe for funding operations with our current cash, cash equivalents and marketable securities. These 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 30, 2023, which filed just a few minutes ago.

Speaker 1

Please note that these forward looking statements reflect our opinions only as of the date of this We undertake no obligation to revise or publicly release the results of any revisions to these forward looking statements, and not of new information or future With that, I'll hand the call over now to Doctor. Raju Mohan, Fintech's Founder and CEO. Raju, please go ahead.

Speaker 2

Thanks, Marty, and good afternoon, everyone. Thank you for joining our Q2 2023 financial results conference call. It's hard to believe that we are already in August and how the first half has flown by. As you may have recall from the R and D discussions in January And from a recent press release, it's been a tremendously productive first half of the year for Aventics and I am very proud of our team's execution across the entire pipeline. So let me run through this afternoon's agenda.

Speaker 2

I will begin by providing a high level business update, And finally, Marty will present an overview of our Q2 2023 financial results before opening the call for Q and A. So, let me start by saying at Ventix, we've always believed that novel oral therapies are poised to play a significant long term role The treatment of numerous immune diseases indications that are currently dominated by injectable biologics, including indications such as psoriasis, inflammatory bowel disease, psoriatic arthritis, lupus and others. These large But underpenetrated markets currently exceed over $50,000,000,000 in annual sales. And we believe that as clinicians and patients are offered the choice Using a pill, an oral drug instead of an injectable therapy, there is the potential for a meaningful shift in market share as well as the 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 we believe that our portfolio of internally discovered compounds positions us at the forefront of this revolution in oral therapies.

Speaker 2

And I am proud We are currently conducting 5 Phase 2 trials across our wholly owned pipeline of novel small molecules. Let me begin with the compounds. As you know, our Allosteric TIG2 inhibitor, VTX-nine fifty eight, It's in Phase 2 development for plaque psoriasis, Crohn's disease and psoriatic arthritis. All diseases where TIK2 plays a Direct role in modulating IL-twenty three, a key cytokine implicated in

Speaker 3

the pathology of disease progression.

Speaker 2

As previously discussed, We are aiming to achieve trough coverage of TYK2IC90 at the highest Phase 2 dose across all the trials. In June, we announced that we completed patient enrollment in the Phase 2 Serenity trial of CTX-nine fifty eight And with moderate to severe plaque psoriasis. This is an important milestone for Ventix and I'd like to thank our entire team for all their efforts. With enrollment now We look forward to reporting top line data from the Phase II Serenity trial in the Q4 of this year. On the development of an extended release tablet ER tablet for VTX-nine fifty eight, we continue to make progress towards the target product profile and remain confident that we will have an optimized once daily tablet to advance into Phase III trials in 2024.

Speaker 2

As previously 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 Q4. In June, We announced that we completed enrollment in the ongoing Phase 2 trial of DTX-two in patients with moderate to severely active ulcerative colitis. And I'd like to again congratulate the Aventics team on this important milestone. We look forward to reporting top line results from this trial Early in Q4 of this year, we believe we are the 1st company to demonstrate a greater magnitude reduction in absolute lymphocyte counts or ALC relative to etrasimod and ozanimod in similar Phase II trials.

Speaker 2

We believe we are exploiting the full The potential of this mechanism by a greater reduction of ALC validated biomarker and believe 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 in moderate to severe UC patients that is differentiated from both etrasimod and ZYPOSIA ozanimod and is competitive with or superior to levels achieved by Biologics. This efficacy profile, if achieved, should position BTX-two As a 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 NLRP-three inhibitor portfolio, including our peripheral compound, VTX-two thousand seven hundred and thirty five, which is now in Phase 2 trials in CASH patients and our CNS penetrant NLR P3 inhibitor, BTX3,232, for which we recently announced initiation of dosing in Phase 1 trial in healthy volunteers. So in summary, I'm very proud of our team's execution during the first half of the year and we look forward to generating Phase 2 data for both VTX-two and VTX-nine fifty eight in the Q4.

Speaker 2

So with that, I'll hand the call over to Bill for a more detailed pipeline discussion. Bill?

Speaker 3

Thank you, Raju, 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 TYK2 inhibitor, You will recall that we have 3 ongoing Phase II trials for VTX-nine fifty eight. The Serenity trial in moderate to severe Plaque psoriasis, the HARMONY trial in moderately to severely active Crohn's disease and the TRANQUILITY trial in active psoriatic arthritis. As Raju mentioned, we announced in June that we completed the patient enrollment in the Serenity trial in plaque psoriasis.

Speaker 3

The Serenity trial includes a target enrollment of approximately 200 patients randomized to 1 of 4 BTX-nine fifty eight doses OR2 placebo and the primary efficacy endpoint is the proportion of subjects achieving PASI 75 at week 16. As previously disclosed, we are exploring multiple dose cohorts in this Phase 2 trial ranging from an anticipated minimally dose at the low end to a high dose that is expected to achieve tick to IC90 coverage at trough as measured by IL-twelve and IL-twenty three. Our team did an excellent job enrolling this trial in around 6 months with enrollment now complete and we are very excited to report lot top line data from the Phase 2 Serenity trial during the Q4. In addition to the Serenity trial, we continue to make progress enrolling the HARMONY trial in Krems And we expect to have more to say about our progress on these trials before the end of the year. Now moving to BTX-two, our potential best in class S1P1 receptor modulator in development for ulcerative colitis at the Phase 2 stage.

Speaker 3

Recall that we have previously shared data from Phase 2 open label extension demonstrating that our high dose 60 milligrams is achieving steady state absolute lymphocyte count reductions in the approximately 70% or more range as compared to approximately 50% for etrasimod and ozanimod. And our thesis remains that this differentiated pharmacodynamic effect may translate into improved efficacy in ulcerative colitis based on our analysis of consistent Observed efficacy driven dose response have brought across both ulcerative colitis and multiple sclerosis trials evaluating S1P1 receptor modulators. As Raju mentioned, we announced in June that we completed enrollment in the ongoing Phase 2 study of BTX-two in patients with moderately to severely active ulcerative colitis. This trial includes a target enrollment of approximately 180 patients Randomized to 1 of BTX-two doses or placebo for 13 week induction treatment period, followed by a 39 week blinded long term extension period. The primary endpoint is the proportion of subjects achieving clinical remission At week 13, as defined by the modified Mayo Score, I want to join Raju in congratulating the team on this accomplishment.

Speaker 3

It is no small feat to enroll a large Phase 2 ulcerative colitis trial in a challenging and dynamic environment, I'm grateful for the dedication and perseverance of our team. We are now looking forward to reporting top line data from this trial Early in the Q4, we expect to report Phase 2 top line data for BTX-two and ulcerative colitis ahead of the Phase 2 top line data for BTX-nine fifty eight in psoriasis. Finally, I'll touch briefly on our portfolio of novel NLRP3 inhibitors. We announced in June that we had initiated dosing in a Phase 1 trial of our CNS penetrant NLRP3 inhibitor, BTX-three thousand two hundred and thirty two in healthy volunteers. This is a 2 part single ascending and then multiple ascending dose trial designed to evaluate the safety, tolerability, Pharmacokinetics and pharmacodynamics of VTX-three thousand two hundred and thirty two including serial cerebral spinal fluid sampling to assess CNS exposure.

Speaker 3

We have a Phase 2 proof of concept trial underway with VTX-two thousand seven hundred and thirty five, Our peripheral NLRP-three inhibitor and familial cold auto inflammatory syndrome or FCAS, which is the most common subpopulation I'll reiterate that both with NLRP with both of our NLRP 3 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 2 ready. We believe that this approach will create strategic optionality and will unlock the value of these programs This includes large cardiovascular dermatologic and rheumatic disease indications. And with NLRP P3 inhibition in the CNS, this includes nerve degenerative diseases such as Parkinson's disease and Alzheimer's disease among others. In conclusion, this is a very exciting period for Ventex with important top line Phase 2 data for VTX-two And BTX-nine fifty eight is just around the corner in the Q4 of this year. I'd like to thank our team again for their efforts during the quarter.

Speaker 3

Before moving on to Question and answer, I'll hand the call back to Marty for a brief discussion of our financial results. Marty?

Speaker 1

Thanks, Bill. So you'll find more detail on our financial results I'll summarize the Q2 results briefly here though. R and D expenses in the quarter were $48,600,000 compared to $14,700,000 in the Q2 of 2022 And this reflects the advancement of our pipeline into later stages of clinical testing, including the execution of the ongoing Phase 2 trial of VTX002 in ulcerative colitis and the broader Phase 2 program for BTX-nine fifty eight with Phase 2 trials being conducted in psoriasis, Crohn's disease and psoriatic arthritis. G and A expenses were $8,600,000 for the Q2 of 2023 compared to $5,700,000 in the year ago period reflecting growth of the company and net loss of $53,200,000 for the Q2 of 2023 compares to a net loss in the Q2 of 20 20 2 of 20,000,000 Cash, cash equivalents and marketable securities were $332,300,000 as of June 30, 2023. This compares $376,900,000 in cash, cash equivalent and marketable securities on March 31, 2023.

Speaker 1

We continue to believe our current cash equivalents and marketable

Speaker 4

This concludes our prepared remarks for

Speaker 1

the afternoon's call. And I'll now turn the call back over to the operator to begin the Q and A session. And I'll be joined by our CEO, Luigi Mohan President and CMO, Bill Sanborn and our CTO, Chris Krueger. Operator?

Operator

Thank you, sir. At this time, the floor is now open for questions. Thank you. And our first question will come from Michael Yee with Jefferies.

Speaker 4

Hey, guys. Thanks for the question and thanks for the updates today. Maybe a 2 part question on the upcoming TYK2 results for you. I know a lot of people kind of point To Bristol's data, BID dosing, you kind of get to 67%, 69%, positive 75%. You relative to the profile of some of those, I guess, higher the better, of course.

Speaker 4

But what would you want to see there to Hey, look, we're better across all comparison. 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 of IL-thirteen. So maybe Bill could walk through what you see in psoriasis and then how does the IL-thirteen

Speaker 2

Yes. Thanks, Mike. So yes, Bill, why don't you what you can take both of those.

Speaker 3

Yes. So I think in terms of Where we would like to arrive, really if we get into the zone that the Nimbus Takeda product Achieved, especially where you see the PASI 100 up into the 30s, that's really getting up into a Solid area of efficacy for an oral agent and that's generally The zone that was seen recently with the protagonist Janssen oral IL-twenty three antagonist as well. So and then every but All of these are somewhat short of what you see with the monoclonal antibodies to IL-twenty 3. And so I think The aspirational floor has been set with some of these other oral sort of second generation agents And you want to hit into that zone and above that would be further differentiating. So That's sort of how we see it and where we would hope to land as a low watermark.

Speaker 4

And then how about what the read through that is to Crohn's? And is it the PD data that you see or maybe just clarify that, that gives you the confidence?

Speaker 3

Yes. I mean, we're, of course, speculating on read through to Crohn's. So what we know is That with ducravasitinib doses of 6 twice a day or 12 once a day Not been effective for ulcerative colitis and Crohn's disease and of course those total daily doses or Regimens are both twice the 6 milligrams once a day dose that's approved for psoriasis with sort of moderate efficacy. And then we know with biologics with inhibition of either interleukin-twelvetwenty three with STELARA or interleukin inhibition of interleukin 23 alone with SKYRIZI or Kymphia and mirikishumab and others that The doses that have been required to optimize efficacy in Crohn's disease are higher than the doses that Sort of plateaued efficacy for psoriasis. So it's reasonable These as well with blocking interleukin 23 and interleukin 12 with tick 2 inhibition.

Speaker 3

We, of course, need to generate primary data to show that and our trials are designed to do that. So while we have 4 different active dosing groups psoriasis trial across the wide range of doses and exposures as I described a few minutes ago. In Crohn's disease, we have just 2 active doses and they're the 2 highest active doses from the psoriasis trial. So we're emphasizing exposure with the hypothesis that greater exposure will be required in Crohn's disease and we anticipate Being able to read that Crunch trial out next year.

Speaker 4

Thank you.

Operator

Thank you. Our next question will come from Alex Thompson with Stifel.

Speaker 5

Great. Thanks for taking my questions and congrats on the progress. I guess 2 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 3 studies next year. And then for the 2 Phase 2s for ulcerative

Speaker 2

Outside the disclosure of the data, our goal will always complete develop by the end of the year, Alex, can leave ample buffer. So you got ample buffer to complete the prototype development. The real actual Selection of Phase 3 QD tablet happens after the data comes out from Phase 2 to understand exactly where we line up with the doses and the Those were Phase 3, right. So always note that in, there's plenty of buffer. Now, as we outlined in the R and D Day, when we introduced the program You guys, we're had a strategy that sort of sort of process you build and test in humans, establish a relationship between the ER dose, ER prototype in the IR dose across multiple formulations that we're doing and testing them in human studies, right?

Speaker 2

So it's really important for us to get it nailed To have the right final formulation before we begin to make disclosures as we expect this formulation will be the drug that we take into Phase 3 and that's the goal And submit for REG approval, clinical trial awards all worked out. So first of all, there's plenty of buffer. We always plan to get this done by the end of the year in The Phase 2 data coming out and then use that prototype to then actually get the actual tablet Made manufactured regulatory stability ready for Phase 3 start. So there's no impact on Phase 3 start. And so we're really confident in the process.

Speaker 2

We believe we've made real progress towards achieving the target profile. But honestly, we recognize that our earlier timing of data release was probably a little overoptimistic. So looking forward to sharing more details with you in Q4. But the key emphasis is there's no Impact to Phase 3, we've always built in the buffer and that includes manufacturing, regulatory stability, packaging and mailing. So just Stay tuned for an update somewhere between now and when we have the Phase 2 data, probably closer to more of the when the Phase 2 comes out.

Speaker 5

And on the distribution rate?

Speaker 3

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. The ulcerative colitis Trial was 13 weeks in duration to the primary endpoint and the psoriasis trial was 16 weeks. From a Interpretability standpoint, what is typical from a statistical standpoint is if you have patients that Discontinue therapy prematurely and typically both ulcerative colitis trials and Crohn's Psoriasis trials will have some of those for the dichotomous outcome measures, the patients with missing data are treated as failures.

Speaker 3

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 to manage Any patients that would discontinue, but we won't make any comments beyond that.

Speaker 2

Great. Thank you.

Operator

Thank you. Our next question will come from Vikram Drora with Morgan Stanley.

Speaker 4

Hi, good afternoon. Thanks for taking our questions. So 2 from our side. First, would just love to get your thoughts on The TEG2's commercial performance to date and how it's impacted, if it has your view of the commercial opportunity for a therapy like non titrated psoriasis? And then secondly, maybe a question for Marty.

Speaker 4

Could you just remind us what level of pipeline development is contemplated into your current cash guidance and runway? And how far the runway gets you for the current set of new programs? Thanks.

Speaker 2

So maybe Marty can take both questions and start with the commercial sort of thing and then go back to the second one.

Speaker 1

Yes, this is it's a very good to get both of them. Thanks Vikram. So in terms of TICC-two commercial performance, I think we're quite encouraged by the Dave, this is Sitikki. Obviously, there is Bristol has been providing quarterly updates about their commercial performance in the space. They're getting substantial significant market share relative to the other approved oral therapy on the market in psoriasis.

Speaker 1

They are continuing to kind of see share coming from all different avenues, which is highly encouraging. That includes sort of treatment naive to systemic therapy patients in psoriasis, conversions from the other approved therapy, oral therapy at Tesla, conversions from patients currently taking biologic who are seeking to get off of injectables and over to oral, we think long term about the market opportunity here. This is a $25,000,000,000 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 Portion of that market is just about 10% or so.

Speaker 1

We think that's going to grow meaningfully from here. We think TYK2 is going to be a major player within that class, obviously, with the Introduction us to TIC II and then obviously our own development and other TIC II programs we think look attractive that are coming online in the next several years. So I think that all looks pretty favorable. Shifting over to the cash guidance question, Vikram. So our cash guidance is Forecast to bring us into 2025.

Speaker 1

And what that includes then is sort of Phase 3 prep work and the ability for us to kind of be able to be on track for Phase 3 launches in 2024 for both the VTX-two ulcerative colitis program as well as for VTX-nine fifty eight in psoriasis. It includes completion of the VTX-nine fifty eight Phase 2 programs of Crohn's disease as well as psoriatic arthritis, both of which we're expecting to report data in 2024. It includes completion of the Phase 1 SAVNAV that Bill described earlier for BTX-three thousand two hundred and thirty two, our CNS Directed an LRP3 inhibitor as well as our Phase 2 proof of mechanism trial in CAHPS patients with 2,735. It does not obviously then get us through completion of those Phase 3 trials for psoriasis or UC, but 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, we'll have additional capital needs eventually.

Speaker 4

Understood. Thank you.

Operator

Thank you. Our next question will come from Yasmeen Rahimi with Piper Sandler.

Speaker 6

Hi. This is Jung Gu speaking in for Yasar Heaney at Piper. Thank you for taking our questions. Our first question is, as we will be eager to do our comparisons of serenity To other oral psoriasis agents, which PADI score in your view is the most reflective of drug activity in dose ranging? 2nd, What type of activities have been completed in regards to Phase 3 prep across BTX-nine fifty eight and BTX-two?

Speaker 6

Thank you so much.

Speaker 2

Yes. I'll deal with the second question and I'll have Bill address the first one. So as we guided in the last Earnings call, we've initiated all necessary activities around Phase 3 PrEP for both programs. This includes CMC work, drug substance, drug product, regulatory preparation for end of Phase 2 meetings, all of the clinical studies that are needed to support that certain domain PK study. So all that has been Well planned and it's been on track.

Speaker 2

Again, we're planning for data release in the 4th quarter And then moving on seamlessly to Phase 3 starts. So yes, all necessary activities, there will be no delay due to anything that was not planned or executed both on the CMC So Bill, why don't you address the 1, first question.

Speaker 3

Sure. So what is the utility The different PASI outcome measures for Phase 2 dose finding. We have both Phase 2 data Fully published with Sotek II and in abstract form with the Takeda nimbus product. But we also have Phase 2 trial data with a number of the anti IL-twenty three antibodies. And what you see across both the TYK2 inhibitors And the antibodies is that, first of all, we know that psoriasis is exclusively sensitive to IL-twenty So you see relatively high levels of respectively of PASI 7,590 and 100 A measure seems to be PASI-seventy five.

Speaker 3

And you will sometimes see sort of a blending of Several dose groups across the range of 3 or 4 doses for PASI 75. And then as you go up PASI 90 and especially PASI 100 that seems to be more specific or differentiating. So the absolute Rates of achieving PASI 100 in particular will be lower often half or less of what it is with PASI 75 and that tends to separate groups better and that was seen Both with so TYK2 with the 12 milligram once a day dose in Phase 2 and with the nimvesticated The 30 milligram dose that each of the highest doses and highest exposures had the greatest Achievement of Pasi 100. So that's sort of how we see it.

Speaker 6

Very helpful. Thank you so much.

Operator

Thank you. Our next question will come from Derek Archila with Wells Fargo.

Speaker 4

Guys, thanks for taking the questions and congrats on the progress here. Just two quick ones from us. Guess first, can you just remind us how we should be thinking about the geographical diversity from the Phase 2 trial with BTX002 in terms of like number of U. S. Sites Ex U.

Speaker 4

S. Sites. And then maybe I missed this in the prepared remarks, but I guess when are we going to see the data for BTX-two thousand seven hundred and thirty How are you thinking about prioritizing either indications or potentially partnering that asset in the future? Thanks.

Speaker 2

Bill, why don't you Take both of them and then maybe I can add to the future of 2,735 once you begin.

Speaker 3

Yes.

Speaker 4

So for

Speaker 3

geographic diversity, inflammatory bowel disease trials, Whether it's ulcerative colitis in the case of VTX-two or Crohn's disease in the case of VTX-nine fifty eight, You really require a lot of clinical trial sites As you get into Phase 2 and you're requiring anywhere from 132 patients target enrollment For Crohn's disease or 180 patients target enrollment for the now enrolled ulcerative colitis trial. So those end up being multiple countries and 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 won't get into details about Exactly the distribution of the trial sites except to say it's pretty conventional for a Phase 2 trial and I feel very comfortable with the geographic mix that we achieved and we'll report that when we report the data in the Q4.

Speaker 3

And then for VTX-two thousand seven hundred and thirty five, our peripheral NLRP3 inhibitor, we reported a year ago in June The Phase 1 SAD and MAD data. And then the we have an ongoing sort Phase 2a 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 100 patients in the U. S.

Speaker 3

So just if you had 2 patients, that's 1% of Population, so this is not easy to recruit and the fact that we have patients enrolled, we're pleased with. I won't Get into the granular detail about where we are in that, but I think we're pleased with the level of Screening and enrollment that's going on and I feel confident that we'll be able to have some data by Late in the year with that program.

Speaker 2

Good. And then and this is Raju. So on Development strategy for 2,735, as we said on R and D Day and we've sort of continued to reiterate that, We want to get both compounds Phase 2 ready. So 2,735 has finished Phase 1. We're in the middle of some starting some chronic tox studies and with 3,232, Again, we are finishing up Phase 1, expect to have that wrapped up early first half of next year.

Speaker 2

And again, there again, we We're CMC ready. We're planning on the cost work. So we'll have both compounds Phase 2 ready in the first Early first half of next year and we'll have the data readouts on the 2 Phase 2 trials ongoing for 958 and 2. And We'll just look at the strategy across the portfolio as where we pursue these 2 molecules. But no matter Where these go in terms of whether we do it alone or whether we have a partner, we are ready for the Phase 2 start.

Speaker 2

And we've outlined the opportunities for both drugs. So the peripheral molecule as indications, broad indications that Bill outlined, both in cardiocardiometabolic areas as Some very specific derm indications and then for 3,232 there's a huge excitement in neuro Degenerative diseases including Parkinson's. So our goal has always been focus on the Phase 2 trials, get ready for Phase 3 with the 2 compounds And get the NLRP3 portfolio Phase 2 ready late this year or early first half and then we can sort of look at the entire portfolio and decide Where we take these 2 molecules.

Speaker 4

Excellent. Thank you. Thank

Operator

And our next question will come from Chris Shibutani with Goldman Sachs.

Speaker 7

Thank you. Two questions, if I may. On the Psoriatic arthritis opportunity, the Takeda nimbus is expected to have Phase 2b 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 what's your ongoing psoriatic arthritis trial is? And a question on Crohn's as far as enrollment in the Phase 2.

Speaker 7

Have you observed any changes in particular since Bristol's I did note that in Bill's prepared remarks about the S1P UC study, the word Perseverance was used. Thank you.

Speaker 2

Yes. Bill, go ahead.

Speaker 3

Yes. I think The you saw the Tocalli of effect at the higher doses With the nymphasticated product in psoriasis as being A bit greater than what was seen with ducravasitinib, particularly with where you end up in the final approved And so given really a meaningful signal with Both the 3 milligram BID as I recall and 12 milligram or 6 milligram QD and 12 milligram QD doses in with bucravasitinib. And to my eye, I thought there was a bit of dose response, particularly as you got into the ACR-fifty and 70 for the 12 milligram once a day Dose with ducravasitinib. So I anticipate that there would be a positive and meaningful effect Across ACR-two thousand and fifty and seventy for the nimbus takeda Drugs, I don't know that we know exactly what doses they are doing, but It's reasonable to speculate or anticipate that they would include some of the higher doses from the already completed psoriasis trial. So we do think that the concept of TIK2 inhibition being an effective therapy for psoriatic arthritis is likely to be further confirmed with the nimbiscated 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 Dupravacitinib, we think that opens up the opportunity for other TYK2 inhibitors with Excellent target coverage like BTX-nine fifty eight.

Speaker 7

And on the Crohn's enrollment PACE?

Speaker 3

Yes. I mean, we've always resisted being too granular About that as we've gone along, we had a lot of learnings around And in my view, we were quite successful in the ulcerative colitis program with Getting the right CRO, the right country mix, the right number of sites effectively interacting with the Investigators and getting the trial enrolled on a timely basis and we've Taken all 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 programs, which allowed us to leverage contract negotiations. We had relationships with the sites, with the investigators, with 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 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.

Speaker 3

I'm going to wait another quarter or 2 before we start To narrow the band around when exactly next year, but for our internal metrics, we're absolutely on track

Operator

Thank you. Our next question will come from Emily Bozner with Wainwright.

Speaker 8

Hi. Thanks for taking the questions. Maybe just to follow-up on the previous question on psoriatic arthritis, if you can kind of talk about how you think about The bar for you internally versus SUTIQUE Phase 2 data so far. And then also Bristol has talked about evaluating SUTIQUE 2 for other indications like SLE and alopecia. Are those indications that you think might make sense for type 2 inhibitor and are those ones Maybe consider for VTX-nine fifty eight?

Speaker 8

Thank you.

Speaker 3

No? Well, until we have More data with the Nimbus Takeda products, have sort of another data set with the implied target coverage and things across the range of doses. I think right now, the Our benchmark should probably really be what was seen with ducapacitinib and maybe say that it's the what was seen with the 12 milligram dose as opposed to the 6 If you do cross mechanism of action comparisons, those data with the 12 milligram dose actually look Pretty favorable to other agents and even JAK inhibitors. So let's See, as we get some more data in that field, how high the floor can raise, 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.

Speaker 3

It's Interesting. There is some logic to it and

Speaker 1

we're of course

Speaker 3

We haven't pulled the trigger to go into that space yet, but we're watching that with interest. For lupus, You'll recall that really interleukin-twelvetwenty three inhibition with Stelara It was ultimately not effective. And the so I'm A little bit skeptical about

Speaker 1

for

Speaker 3

IL-twenty three inhibition with that, but of course you have the interferon alpha And that looks good. So I think for TYK2 inhibition, that's certainly an opportunity For us and one that is differentiated from the IL-twelvetwenty three and IL-twenty three antibodies where Lupus cannot be a target. These are large trials. The endpoints are sort of squishy. If you'll remember, The Phase 2 study ducarvosidenib in lupus, as I recall, it was 3 60 patients, about 90 patients per arm for 3 doses plus placebo.

Speaker 3

It took about three and a Fears to recruit that trial and read out 6 month results. So it's really a long slog. The effect sizes are Then the 10% to 15% range relative to placebo. So you need a lot of patients per group and we haven't pulled the trigger On that yet because we think it's a big undertaking, but of course pending successful and robust data And some of our other ongoing Phase II trials that could be revisited at any time.

Speaker 8

Very helpful. Thank you.

Operator

Thank you. Our next question will come from Sam Zlisky with LifeSci Capital.

Speaker 5

Hey, good afternoon, everyone. Thanks for the questions. Quick question for Bill. Just on the S1P class, obviously, symposia sales and UC, I think, have so far underwhelmed versus That said, Pfizer obviously believes that etrasimod is going to be a blockbuster in IBD and they obviously paid a good amount of money to get the drug. I guess as an IBD position, it would be good to get your view on what factors could have contributed to the slow launch of Ciposia And then what potential profile for next gen S1P1 could lead to better uptake or does ultimately result in blockbuster potential like expected for the class?

Speaker 2

Go ahead, Doug.

Speaker 3

I'll opine a little bit and then maybe Marty, given all of his Life experience could talk a little bit about the launch as well for symposia. But I think whenever there's a new Mechanism of action, robust physician and provider engagement and education Is required. Therapies usually don't sell themselves. They 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 that just hasn't happened in any robust way with So I think that plays a lot into it.

Speaker 3

The drug has also been priced for The multiple sclerosis market, so it's in the $80,000,000 $90,000 $100,000 range. So as a starting price for an IBD drug, that's kind of high and that really then sets barriers to access. But I think it's heavily those things. I do have the sense that there is a rising experience with using the drug and So behind it and that the launch of etrasimod will really start to grow the class. What are physicians and ultimately patients looking for?

Speaker 3

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, Renvoke is 20% to 25% placebo adjusted Delta, some of the Phase 2 data with KL1a antibodies, both Prometheus and Roy Van Pfizer molecules had 20 5% 20%, respectively, remission deltas. Etrasimod, depending on you look at it, Phase 2 was 25%, Phase 3 was 20% in one trial and about 10% in the other trial. Blended average is probably high teens pushing 20%.

Speaker 3

So I think The next generation drugs that would be really differentiated and exciting, you probably want to see at least the 15 And ideally 20% or more placebo adjusted remission rate. And if That's what we're aspiring to. And if we land in that zone, not only the primary endpoint, but with consistency in The secondary endpoints and some of the differentiating things like getting complete endoscopic remission and stuff like That's going to be very interesting to people. Our drug is not aimed at multiple sclerosis, so It could be appropriately priced for an ulcerative colitis market. We think all of that will be a real opportunity.

Speaker 3

Marty, did you want to add anything about the sort of launch trajectory of Zposia as you see it?

Speaker 1

Yes. Bill, I think you hit on a lot of the things that We see and we talk about internally when we hear from KOLs and folks we engage with in the field. I think it's a combination of the factors you Dave, along with also as you sort of talked around the efficacy there, Sam, on supposing it was in the sort of very low double digits. So Wasn't particularly sort of it wasn't groundbreaking or exciting efficacy. It's perceived as a slower onset of action drug as well, which Now it's better to have a fast onset of action, of course, with the active metabolite that the drug works through.

Speaker 1

So I think we've got Some benefits in the VTX-two that I think are hopefully more attractive attributes for the market and obviously we'll be watching closely as you and Investors will on how Pfizer's regulatory outcome and commercial launch goes with etrasimod over this year.

Speaker 5

You're welcome. Thanks.

Operator

Thank you. And at this time, there are no further questions in the queue. So I'd like to turn the Back over to Doctor. Mohan for additional or closing remarks.

Speaker 2

Yes, great. And then thank you all again, all your analysts, all the investors for your Continued interest in Ventex. Hopefully, we'll connect with you with many of you at one of the upcoming conferences we plan to attend in the Q3. And we're really excited for the 4th quarter approaches. Looking forward to sharing our Phase 2 top line results with you For both, starting with 2 in UC and then followed by VTX-nine fifty eight in Surae.

Speaker 2

So thanks. Thank you all once again.

Operator

Thank you. This concludes today's FinTechs Biosciences Q2 2023 earnings conference call. Please disconnect your line at this time and have a wonderful day.

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Key Takeaways

  • Ventex has completed enrollment in the Phase 2 Serenity trial of VTX-958 for moderate-to-severe plaque psoriasis and in the Phase 2 DTX-2 study in ulcerative colitis, with topline data from both trials expected in Q4 2023.
  • The company is advancing an optimized once-daily extended-release tablet for VTX-958 toward Phase 3 initiation in 2024, with a detailed formulation update slated for Q4 2023.
  • Earlier studies show VTX-2 achieves ~70% reductions in absolute lymphocyte count versus ~50% for etrasimod and ozanimod, suggesting potential for differentiated efficacy; Phase 2 topline data are due early in Q4 2023.
  • Ventex’s NLRP3 inhibitor portfolio is progressing with VTX-2735 in Phase 2 trials for CAPS and VTX-3232 in Phase 1 healthy volunteer studies assessing CNS exposure, positioning both compounds for broader inflammatory and neurodegenerative indications.
  • In Q2 2023, R&D expenses rose to $48.6 million (vs. $14.7 million a year ago) and net loss was $53.2 million, while cash, cash equivalents and marketable securities of $332.3 million provide a runway into 2025 for ongoing clinical programs.
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Earnings Conference Call
Ventyx Biosciences Q2 2023
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